Paper No. UNITED STATES PATENT AND TRADEMARK OFFICE...

ME1 19120309v.1

Paper No._______

UNITED STATES PATENT AND TRADEMARK OFFICE _______________

BEFORE THE PATENT TRIAL AND APPEAL BOARD

_______________

BIODELIVERY SCIENCES INTERNATIONAL, INC. Petitioner

v.

MONOSOL RX, LLC Patent Owner

US Patent No. 8,765,167

Inter Partes Review No. _____________

_______________

PETITION FOR INTER PARTES REVIEW OF US PATENT NO. 8,765,167

UNDER 35 USC §§ 311-319 AND CFR § 42.100, et. seq.

Patent No. 8,765,167 Attorney Docket No. 117744-00054

Table of Contents Page

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TABLE OF CONTENTS

I. INTRODUCTION ........................................................................................... 1

II. MANDATORY NOTICES AND CERTIFICATIONS .................................. 1

III. SUMMARY OF THE CHALLENGED CLAIMS ......................................... 5

IV. SUMMARY OF THE PROSECUTION HISTORY ....................................... 6

V. THE UNDISCLOSED REEXAMINATIONS AND BOARD

DECISION ....................................................................................................... 8

VI. CLAIM CONSTRUCTION .......................................................................... 10

1. “controlled drying process” ...................................................... 10

2. “substantially uniform distribution” / “substantially

uniformly distributed” ............................................................... 14

i. The Board’s previous finding that “substantially

uniform” is indefinite ...................................................... 15

ii. MonoSol’s attempt to rescue “substantially

uniform” from indefiniteness.......................................... 16

VII. CHALLENGED CLAIMS AND STATUTORY GROUNDS ..................... 18

VIII. THE CHALLENGED CLAIMS ARE UNPATENTABLE .......................... 18

Ground 1: Tapolsky Anticipates Claims 17, 18, 30, 31, 37, 49, 56,

70, 77, 80, 87, 93, 110, 112, 114-116, and 124 ........................ 18

1. “self-supporting” ....................................................................... 28

2. “controlled drying process …viscoelastic matrix … lock-

in ...” .......................................................................................... 28

3. “substantially uniform distribution” ......................................... 30

4. “anti-tacking agent” .................................................................. 31



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Ground 2: Claims 17, 18, 30, 31, 37, 49, 56, 63, 70, 77, 80, 81, 87,

93, 110-116 and 124 are Obvious over Tapolsky in view

of Chen ...................................................................................... 31

1. “self-supporting” ....................................................................... 32

2. “controlled drying process” ...................................................... 33


4. The Board has already made findings relating to Chen ............ 37

5. Dependent Claims ..................................................................... 39

Ground 3: Claims 17, 18, 30, 31, 37, 49, 56, 63, 70, 77, 80, 81, 87,

93, 110-116, and 124 are Obvious over Tapolsky in view

of Chen in further view of Modern Coating ............................. 42

Ground 4: Claims 17, 18, 30, 31, 37, 49, 56, 63, 70, 77, 80, 81, 87,

93, 110-116 and 124 are Obvious over Chen in view of

Tapolsky .................................................................................... 43

1. “controlled drying process …viscoelastic matrix … lock-

in ...” .......................................................................................... 54


3. “anti-tacking agent” .................................................................. 57

4. “a second film layer comprising … an ingestible, water-

soluble […] polymer matrix” .................................................... 57

5. Dependent claim 18 .................................................................. 59

Ground 5: Claims 17, 18, 30, 31, 37, 49, 56, 63, 70, 77, 80, 81, 87,

93, 110-116, and 124 are Obvious over Chen in view of

Tapolsky in further view of Modern Coating ........................... 60



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IX. THE REFERENCES ARE NOT CUMULATIVE ....................................... 60

X. CONCLUSION .............................................................................................. 60


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LIST OF EXHIBITS

Exhibit Description

Ex. 1001 US Patent No. 8,765,167 (the ‘167 patent) Ex. 1002 WO 00/42992 to Chen et al. (Chen)

Ex. 1003 WO 99/55312 to Tapolsky et al. (Tapolsky) Ex. 1004 US Patent No. 5,393,528 (Staab) Ex. 1005 WO 00/18365 to Leung et al. (Leung)

Ex. 1006 Complaint, BioDelivery Sciences International, Inc. v. Reckitt

Benckiser Pharmaceuticals, Inc., et al., 5:14-cv-00529 (EDNC) Ex. 1007 Declaration of Edward Cohen, Ph.D. (Cohen Decl.)

Ex. 1008 US Patent No. 370,110, entitled “Process of Coating Photographic Paper” and assigned to Eastman Dry Plate & Film Co. on Sept. 20, 1887 (the 1887 patent)

Ex. 1009 Excerpts from MODERN COATING AND DRYING TECHNOLOGY, Cohen, E. and Gutoff, E., eds., John Wiley & Sons, Inc. (1992) (MODERN

COATING)

Ex. 1010 Cohen, E. & Gutoff, E., “Coating Processes, Survey,” ENCYCLOPEDIA OF CHEMICAL TECHNOLOGY, Vol. 6, Wiley (1993)

Ex. 1011 Gelderblom, H., et al., “Cremophor EL: the drawbacks and advantages of vehicle selection for drug formulation,” EUROPEAN J. OF CANCER, Vol. 37, 1590-98 (2001)

Ex. 1012 Excerpts from HANDBOOK OF PHARMACEUTICAL EXCIPIENTS, Pharmaceutical Press (3rd ed. 2000) (HANDBOOK)

Ex. 1013 Excerpts from Ansel, H., PHARMACEUTICAL DOSAGE FORMS AND

DRUG DELIVERY SYSTEMS (7th ed. 1999) (PHARMACEUTICAL DOSAGE

FORMS) Ex. 1014 Excerpts from MERRIAM-WEBSTER’S COLLEGIATE DICTIONARY, (10th

ed. 2000) Ex. 1015 Excerpt from PHYSICIANS’ DESK REFERENCE (56th ed. 2002)

Ex. 1016 Excerpt from Ferry, J. D., VISCOELASTIC PROPERTIES OF POLYMERS, John Wiley & Sons, Inc. (3rd ed. 1980)

Ex. 1017 December 31, 2013 Amendment and Response, Excerpt from File History of ‘167 patent (‘167 History, Amendment and Response

12/31/13) Ex. 1018 November 19, 2013 Interview Summary, Excerpt from File History

of ‘167 patent (‘167 History, Interview Summary 11/19/13) Ex. 1019 July 31, 2013 Office Action, Excerpt from File History of ‘167

patent (‘167 History, Office Action 7/31/13)


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Exhibit Description

Ex. 1020 July 8, 2013 Reply to Office Action, Excerpt from File History ‘167 patent (‘167 History, Reply 7/8/13)

Ex. 1021 April 8, 2013 Office Action, Excerpt from File History of ‘167 patent (’167 History, Office Action 4/8/13)

Ex. 1022 May 2, 2012 Amendment and Response, Excerpt from File History ‘167 patent (‘167 History, Amendment and Response 5/2/12)

Ex. 1023 November 2, 2011 Office Action, Excerpt from File History of ‘167 patent (‘167 History, Office Action 11/2/11)

Ex. 1024 February 19, 2010 Amendment and Response, Excerpt from File History of ‘167 patent (‘167 History, Amendment and Response

2/19/10) Ex. 1025 Partial Patent Family Tree Ex. 1026 US Patent No. 7,824,588 (the ‘588 patent)

Ex. 1027 Apr. 17, 2014 Decision on Appeal of ‘588 patent reexamination, Control No. 95/001,753, Appeal 2014-000547 (‘588 History, Board

Decision) Ex. 1028 Excerpt from June 24, 2013 Patent Owner Appeal Brief, ‘588 patent

reexamination, Control No. 95/001,753

Ex. 1029 Jan. 23, 2013 Right of Appeal Notice, ‘588 patent reexamination, Control No. 95/001,753 (‘588 History, RAN)

Ex. 1030 US Patent No. 7,897,080 (the ‘080 patent)

Ex. 1031 July 31, 2013 Action Closing Prosecution, ‘080 patent reexamination, Control No. 95/002,170 (‘080 History, ACP)

Ex. 1032 December 6, 2013, Right of Appeal Notice, ‘080 patent reexamination, Control No. 95/002,170 (‘080 History, RAN)

Ex. 1033 US Patent No. 7,666,337 (the ‘337 patent) Ex. 1034 December 17, 2013 Right of Appeal Notice, ‘337 patent

reexamination, Control No. 95/002,171 (‘337 History, RAN) Ex. 1035 US Patent No. 7,425,292 (the ‘292 patent)

Ex. 1036 Ex Parte Reexamination Certificate for US Patent No. 7,425,292 Ex. 1037 US Patent No. 7,357,891 (the ‘891 patent) Ex. 1038 Ex Parte Reexamination Certificate for US Patent No. 7,357,891

Ex. 1039 US Patent No. 8,652,378 (the ‘378 patent) Ex. 1040 Transcript of Mar. 26, 2014 Oral Hearing on Appeal of ‘588 patent

reexamination, Control No. 95/001,753, Appeal 2014-000547 (‘588

History, Hearing Transcript)

Ex. 1041 Electronic Comparison of Specifications of the ‘167 Patent and the ‘588 Patent


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Exhibit Description

Ex. 1042 Trademark Registration No. 1,107,737 for VICODIN

Ex. 1043 Status of Trademark Registration No. 1,107,737 for VICODIN (2008)

Ex. 1044 Package Insert for VICODIN (2014)

Ex. 1045 Coating Technology Handbook, D. Satas (ed.), Marcel Dekker, Inc. (1991) (“Coating Technology”)

Ex. 1046 U.S. Patent No. 2,681,294 issued June 15, 1954 (the “1954 Kodak patent”)


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I. INTRODUCTION

To obtain allowance of US Patent No. 8,765,167 (the ‘167 patent, Ex. 1001),

patent assignee (MonoSol) relied on a product-by-process recitation for

patentability of product claims. MonoSol argued that conventional methods do not

achieve the claimed “substantially uniform distribution” of the active in its claimed

film because the recited “controlled drying process” is needed to achieve that

uniformity. But there was nothing new about a controlled drying process. Indeed,

the ‘167 patent admits that examples of “controlled drying processes” include the

use of apparatus disclosed in a prior art patent to Magoon. See Ex. 1001, at 6:22-

27. Petitioner (BDSI) presents multiple references that, alone or in combination,

explicitly disclose or render obvious each and every claim element, including

“controlled drying process” and “substantially uniform distribution.” Thus, neither

the product-by-process recitation nor its claimed result is novel.

II. MANDATORY NOTICES AND CERTIFICATIONS

Notice of Real Party-in-Interest

The real party in interest for this petition for inter partes review is

BioDelivery Sciences International, Inc. (BDSI); 801 Corporate Center Drive,

Suite 210; Raleigh, North Carolina 27606 USA.

Notice of Related Matters

The ‘167 patent issued on July 1, 2014. The ‘167 patent is part of a large


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family of patents claiming substantially similar subject matter. See Ex. 1025,

Partial Patent Family Tree. In inter partes reexaminations of three of these

patents, MonoSol relied on claim terms and arguments that were the same or very

similar to those it relied upon when prosecuting the ‘167 patent. Unlike the

Examiner in the ‘167 patent, after considering those terms and arguments, this

Board affirmed the rejection of all claims of US Patent No. 7,824,588 (the ‘588

patent, Ex. 1026) (see Ex. 1027, Control No. 95/001,753, Appeal 2014-00547,

Board Decision), a decision that MonoSol could have appealed to the Federal

Circuit, but did not. Similarly, the CRU finally rejected all reexamination claims

of US Patent Nos. 7,897,080 (the ‘080 patent, Ex. 1030) and 7,666,337 (the ‘337

patent, Ex. 1033). See Ex. 1032, Control No. 90/002,170, RAN; Ex. 1034, Control

No. 90/002,171, RAN. Appeals are currently pending with oral hearings scheduled

for November 5, 2014. A petition for inter partes review (IPR2014-00794) has

been filed challenging claims in US Patent No. 8,652,378 (Ex. 1039), deemed

patentably indistinct from the finally rejected claims of the ‘080 patent.

Currently, BDSI is aware of at least seventeen additional pending patent

applications in this patent family that claim or may claim priority to the ‘167

patent. See US App. Nos. 11/092,217; 11/674,223; 13/052,655; 13/096,996;

13/342,614; 13/853,223; 13/853,253; 13/853,276; 13/853,290; 13/890,542;


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13/974,376; 13/974,389; 13/974,401; 13/974,413; 14/032,588; 14/195,362; and

14/284,019.

The genesis of the above challenges is MonoSol’s assertion of the ‘588

patent, US Patent No. 7,425,292 (the ‘292 patent, Ex. 1035), and US Patent No.

7,357,891 (the ‘891 patent, Ex. 1037) against BDSI in MonoSol RX, LLC v.

BioDelivery Sciences International, Inc., et al., D. N.J. Civil Action No. 10-cv-

5695. The litigation is stayed; a status conference is scheduled for November 24,

2014. The ‘292 and ‘891 patents were subject to ex parte reexamination, and all

original claims were either cancelled or substantially amended. See Ex. 1036; Ex.

1038.

After public announcement that Reckitt Benckiser Pharmaceuticals, Inc.

(“RBP”) would assert more MonoSol patents against BDSI, BDSI filed an action

seeking declaratory judgment that US Patent No. 8,475,832,1 the ‘080 patent, and

the ‘378 patent are invalid and not infringed. See Ex. 1006, Complaint,

BioDelivery Sciences International, Inc. v. Reckitt Benckiser Pharmaceuticals,

1 RB and MonoSol asserted this patent against BDSI in a case filed last fall,

captioned Reckitt Benckiser Pharma., Inc., et al. v. BioDelivery Sciences Int’l.,

Inc., 5:13-cv-760 (E.D.N.C.). The case was dismissed without prejudice on May

21, 2014 as untimely. An inter partes review of US 8,475,832 has been instituted

(IPR2014-00325) and a second petition is pending (IPR2014-00998).


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Inc., et al., 5:14-cv-00529 (EDNC). RBP and MonoSol subsequently filed another

complaint asserting the instant ‘167 patent, captioned Reckitt Benckiser

Pharmaceuticals Inc., et al. v. BioDelivery Sciences International, Inc., et al.,

3:14-cv-5892 (D. N.J.).

Notice of Lead and Back-Up Counsel and Service Information

Lead Counsel Back-Up Counsel

Danielle L. Herritt , Reg. No. 43,670

[email protected]

617-449-6513

Kia Freeman, Reg. No. 47,577

[email protected]

617-449-6549

Both partners at McCarter & English, LLP, 265 Franklin Street, Boston, MA

02110. BDSI consents to service by email at both [email protected] and

[email protected].

Standing

Pursuant to 37 CFR § 42.104(a), Petitioner certifies that the ‘167 patent is

available for inter partes review and that Petitioner is not estopped or barred from

requesting inter partes review of the ‘167 patent on the grounds identified in the

present petition.

Fees

The undersigned authorizes the Office to charge a payment of $26,200 (the

$9,000 request fee for the first 20 claims; the $200 request fee for each of the 2

claims in excess of 20; the $14,000 post-institution fee for the first 15 claims; and


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the $400 post-institution fee for each of the 7 claims in excess of 15) for the fees

set forth in 37 CFR § 42.15(a) due for this Petition; and payment for any additional

fees that might be due for this Petition, to Deposit Account 50-4876, under Order

No. 117744-00054.

III. SUMMARY OF THE CHALLENGED CLAIMS

The independent claims challenged in this petition are product claims

directed to multi-layer films for delivery of a desired amount of an active

component. See preamble of claims 17 and 110. These product claims have three

types of limitations:

(i) product limitations, e.g., requiring a polymer matrix, an active

component, etc.;

(ii) a product-by-process recitation, i.e., the “controlled drying process”

(“said film being formed by a controlled drying process which rapidly forms a

viscoelastic matrix to lock-in said active [component] in place [within said matrix]

and maintain said substantially uniform distribution”); and

(iii) an alleged result of the product-by-process recitation, i.e.,

“substantially uniformly distributed” active (“wherein … the active component is

substantially uniformly distributed, whereby said substantially uniform distribution

is measured by substantially equal sized individual unit doses which do not vary by

more than 10% of said desired amount of said active component”) (claim 17), (“a


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substantially uniformly distributed active component, … whereby said

substantially uniform distribution of said active component is measured by

substantially equal sized individual unit doses which do not vary by more than

10% of said desired amount of said active component”) (claim 110).

The dependent claims recite well-known water-soluble polymers, additives,

and actives (claims 37, 49, 56, 63, 70, 77, 80, 81, 87, 93,111-116), properties of the

film (claims 30, 31, 124), and a process by which the two film layers are combined

(claim 18).

IV. SUMMARY OF THE PROSECUTION HISTORY

In the underlying examination, the Office rejected the recited product as

obvious, and properly afforded the product-by-process recitations no patentable

weight. See, e.g., Ex. 1021, ‘167 History, Office Action 4/8/13, at 3.

In response, MonoSol argued that because the prior art did not use

“controlled drying,” it lacked the “substantially uniformly distributed” active:

Because [US Patent No. 5,393,528 to Staab] does not use a controlled

drying process which rapidly forms a visco-elastic matrix to lock-in

the active, Staab’s resulting film will not have a substantially uniform

distribution of an active component, whereby the substantially

uniform distribution is measured by substantially equal sized

individual unit doses which do not vary by more than 10% of the

active component.

Ex. 1020, ‘167 History, Reply 7/8/13, at 6.


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However, in the contemporaneous reexamination of two related patents, the

CRU found that Staab (Ex. 1004) discloses the use of a controlled drying process

and film with substantially uniform active distribution. See Ex. 1032, ‘080

History, RAN, at 57-59; see also id. at 114-116; Ex. 1034, ‘337 History, RAN at

46-48; see also id. at 99-102. MonoSol did not disclose those findings to the

Examiner during the prosecution of the ‘167 patent.

In addition, MonoSol perpetuated, rather than corrected, the Examiner’s

mistaken belief that Staab does not disclose the “anti-tacking agents” recited in the

‘167 patent claims. See Ex. 1024, ‘167 History, Amendment and Response

2/19/10 at 10-11 (“Although, Staab mentions film as a possible form of its

dissolvable device, nowhere in Staab is it disclosed, taught or suggested to utilize

an edible film for delivery of an active comprising an anti tacking agent selected

from the group consisting of … sodium oleate; sodium lauryl sulfate….”); see also

Ex. 1022, ‘167 History, Amendment and Response 5/2/12, at 11 (2nd paragraph)).

In fact, Staab explicitly discloses at least four recited anti-tacking agents: (i)

polyethylene glycol; (ii) a surfactant; (iii) sodium oleate; and (iv) sodium lauryl

sulfate. See Ex. 1004 at 6:11-26.

Unaware of the relevant disclosure in Staab and the CRU decision, the

Examiner allowed the claims, relying on a “controlled drying process” and a result,

“substantially uniform distribution.” See Ex. 1019, ‘167 History, Office Action


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7/31/2013, at 2 (“While various components appear to have been known for use in

forming matrices … none appear to teach adjusting the drying process to lock in

the active in a uniform distribution.”). However, as the ‘167 patent specification

admits, both “controlled drying processes” and dosage forms that do “not vary by

more than 10% in the amount of active present” were known. See Ex. 1001 at

6:22-28 (“Examples of controlled drying processes include, but are not limited to,

the use of the apparatus disclosed in U.S. Pat. No. 4,631,837 to Magoon … herein

incorporated by reference, as well as hot air impingement across the bottom

substrate and bottom heating plates.”); 2:16-18 (“Currently, as required by various

world regulatory authorities, dosage forms may not vary by more than 10% in the

amount of active present.”). This is exactly the type of patent the AIA was meant

to address.

V. THE UNDISCLOSED REEXAMINATIONS AND BOARD DECISION

In prosecution of the ‘167 patent, MonoSol argued that the recitations of

“controlled drying process,” “substantially uniformly distributed,” and “do not

vary by more than 10%” render the claims patentable. See, e.g., Ex. 1020, ‘167

History, Reply 7/8/13, at 4-8; Ex. 1017, ‘167 History, Amendment and Response

12/31/13, at 24. However, when MonoSol previously argued that the same (or

strikingly similar) recitations rendered claims patentable in three co-pending inter

partes reexaminations, these arguments were rejected. See, e.g., Ex. 1031, ‘080


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History, 7/31/2013 ACP, at 36-38 (Chen) and 56 (Staab) (CRU finding that the

cited prior art discloses film in which “active varies by no more than 10%,”); Ex.

1032, ‘080 History, 12/6/2013 RAN, at 34-37, 87 (Chen) and 54-55, 95 (Staab)

(CRU affirming the finding in the ACP that the cited prior art discloses film in

which “active varies by no more than 10%”); Ex. 1034, ‘337 History, 12/17/13

RAN, at 26-40, 90-92 (Chen), 42-53, 99-102 (Staab).

Similarly, in the related ‘588 patent reexamination proceeding, this Board

specifically affirmed, in a final, unappealed decision, that Chen (Ex. 1002) teaches

(i) “controlled drying”; (ii) “substantially uniform” content of active per unit of

film; and (iii) less than 10% variation of active content per film unit:

i. “[W]e find that Chen teaches controlled drying….” Ex. 1027, ‘588

History, Board Decision, at 17. “[W]e find that Chen describes a

substantially identical process to that described in the ‘588 patent.”

Id. at 15-16 (affirming Ex. 1029, RAN 1/23/2013, at 70 and 75).

ii. “We agree with the Examiner that there is sufficient evidence to

find that Chen inherently discloses a film with a substantially

uniform content of therapeutic active composition per unit of

film.” Id. at 15 (affirming Ex. 1029, RAN, at 21, 69-73, and 75).

iii. “[W]e find that a weight deviation of ± 0.001 satisfies the

limitation of ‘substantially uniform’ active content. This amount is

well within the less than 10% variation of active content per film

unit requirement of claim 3.” Id. at 19.


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MonoSol did not inform the Examiner of this Board’s decision, even though the

‘167 patent did not issue until several months later. See Ex. 1001.

VI. CLAIM CONSTRUCTION

In an inter partes review, the Board interprets claims of an unexpired patent

using the broadest reasonable construction in light of the specification of the

patent. See 37 CFR § 42.100(b). Under the broadest reasonable construction

standard, the claim wording is read in light of the specification, as it would be

interpreted by the person of ordinary skill in the art (POSITA). See In re Am.

Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004).

1. “controlled drying process”

The term “controlled drying process” is recited in claims 17 and 110. These

claims do not recite any process steps or conditions of the “controlled drying

process,” nor do the claims elucidate how the “controlled drying process” is

different from drying processes known in the art prior to October 12, 2001. See

Ex. 1007, Cohen Decl. at ¶¶28, 34. Indeed, the ‘167 patent admits that its

“controlled drying process” encompasses several prior art processes. See Ex. 1001

at 6:22-25 (“Examples of controlled drying processes include, but are not limited

to, the use of the apparatus disclosed in U.S. Pat. No. 4,631,837 to Magoon ….”).

The ‘167 patent further admits that its claimed “process is not limited to any

particular apparatus for the above-described desirable drying ....” Ex. 1007, Cohen


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Decl., at ¶36 (quoting Ex. 1001 at 11:36-37). The ‘167 patent discloses many

controlled drying embodiments, including but not limited to controlling any one or

more of the following parameters: controlled microwaves (Ex. 1001 at 6:42-47,

10:27-30), infrared radiation (id. at 6:27-30, 25:24-33), controlled air currents (id.

at 6:47-55), which can include controlled top side and/or bottom side air currents

(id. at 10:43-48, 24:51-61), controlled drying times (id. at 24:51-59), controlled

temperatures (id. at 25:4-6), and controlled humidity (id. at 25:7-12). See also id.

at 24:30-25:45 (section entitled “Drying the Film”). As Dr. Cohen explains, while

a “controlled drying process” thus refers to drying with at least one drying

parameter controlled, it is not clear what is excluded by this term. See Ex. 1007 at

¶¶34-37.

In the ‘588 patent reexamination appeal, the Board agreed. Ex. 1027 at 16-

17. In its decision on that appeal, the Board discussed “controlled drying” at

length. See Ex. 1027, ‘588 History, Board Decision, at 15-18. The Board found

that “Claim 1 [of the ‘588 patent] does not recite any particular film drying steps.”

Id. at 16. Here, challenged independent claims 1 and 109 also do not recite any

particular film drying steps. See Ex. 1001 at 40:62-41:22, 47:37-64; see also Ex.

1007, Cohen Decl., at ¶34. As Dr. Cohen explains, the phrase recited in the

challenged independent claims (“which rapidly forms a viscoelastic matrix to lock-

in said active in place within said matrix [and] maintain [said] substantially


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uniform distribution”) provides no meaningful process conditions or requirements:

First, the terms “rapidly” and “maintain” in the context of these claims

would have no meaning to the person of ordinary skill in the art (i.e.,

“Rapidly” relative to what? “Maintained” beginning at what point?).

Second, essentially any film made from drying a viscoelastic coating

solution will form a “viscoelastic matrix” with the solid components

“lock[ed] in...place within said matrix.”

Ex. 1007, Cohen Decl., at ¶35.

The term “rapidly” is a term of degree. “Such terms require a standard for

measuring the degree; otherwise the scope of what is claimed cannot be

determined.” Sony Corporation v. Network-1 Security Solutions, Inc., IPR2013-

00092, Paper No. 21, at 8 (PTAB May 24, 2013) citing Playtex Prods., Inc. v.

Procter & Gamble, Co., 400 F.3d 901, 908 (Fed. Cir. 2010). The ‘167 patent

specification does not provide a standard.

The recitation to “maintain” a substantially uniform distribution in an

undefined precursor to the recited film raises similar issues. “Substantial”

uniformity is indefinite without a reference standard. See, e.g., Ex. 1027 at 9-11.

Even if it were clear what was being maintained and when such maintaining were

to begin, claims 17 and 110 still provide no discernible process steps or conditions

for accomplishing this goal. See Ex. 1007, Cohen Decl., at ¶¶34-37. This analysis

is consistent with the Board’s decision in the related ‘588 patent reexamination.


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Relying on several passages identical to passages in the ‘167 patent, the Board

found that the ‘588 patent “describes its drying process generally and does not

clearly identify how a drying step can vary from a conventional drying process….”

Ex. 1027, ‘588 History, Board Decision, at 16-17; compare Ex. 1026, ‘588 patent,

at 6:31-34, 14:13-14, 7:6-25, 25:15-16, 6:50-61, 10:67-11:4, 25:2-8, 11:6-23,

25:22-23 with Ex. 1001, ‘167 patent, at 5:66-6:2, 11:36-37, 6:42-60, 24:44-45,

6:19-30, 10:30-34, 24:31-37; 10:36-58, 24:51-52.

Moreover, the ‘167 patent discloses that the liquid phase in the film

manufacturing process should be viscoelastic. See Ex. 1001 at 8:1-3 (“The

viscosity of the liquid phase is critical and is desirably modified by customizing the

liquid composition to a viscoelastic non-Newtonian fluid….”) (emphasis added).

“The rheology requirements for the inventive compositions and film are quite

severe … due to the need to produce a stable suspension of particles … in a

viscoelastic fluid matrix.” Id. at 8:45-49 (emphasis added). Accordingly, it is not

even clear that the formation of a viscoelastic matrix is something that is

necessarily generally associated with drying. See, e.g., Ex. 1007, Cohen Decl., at

¶58 (“Removing a portion of the solvent from a coating solution containing

viscoelastic polymers under normal drying conditions will not produce or eliminate

this viscoelastic property.”).

For the foregoing reasons, BDSI proposes, and Dr. Cohen agrees, that the


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broadest reasonable interpretation of the term “controlled drying process” in light

of the ‘167 specification is “drying with at least one controlled drying parameter

such as air current temperature, air current velocity, air current humidity, drying

time, type of radiation, or intensity of radiation.” See Ex. 1007 at ¶¶34-38.

2. “substantially uniform distribution” / “substantially uniformly distributed”

This term appears several times in challenged independent claims 17 and

110. While the term “substantially uniform distribution” (and its variant

“substantially uniformly distributed”) is not defined in the ‘167 patent, “uniform

distribution” is discussed in the specification—without the “substantially”

qualifier. The ‘167 patent identifies a “uniform distribution” of components in

film as having little or no aggregation or conglomeration of components:

Further, there is a need for methods of preparing such films, which

maintain the uniform distribution of components therein, thereby

preventing undesired aggregations and promoting uniformity in the

final film product.

Ex. 1001 at 4:32-36.

For the purposes of the present invention the term non-self-

aggregating uniform heterogeneity refers to the ability of the films of

the present invention, which are formed from one or more

components in addition to a polar solvent, to provide a substantially

reduced occurrence of, i.e. little or no, aggregation or conglomeration

of components within the film as is normally experienced when films


15 ME1 19120309v.1

are formed by conventional drying methods such as a high-

temperature air-bath using a drying oven, drying tunnel, vacuum drier,

or other such drying equipment. …. Uniform heterogeneity includes

the substantial absence of aggregates or conglomerates as is common

in conventional mixing and heat drying methods used to form films.

Id. at 5:60-6:8; see also, e.g., id. at 7:4-10.

i. The Board’s previous finding that “substantially uniform” is

indefinite

In the appeal of the reexamination of the related ‘588 patent, MonoSol

proposed constructions of “substantially uniform” based on an FDA requirement,

which is referenced in the background of both the ‘588 and ‘167 patents. See Ex.

1040, ‘588 History, Hearing Transcript, at 18:18-19:7. Nonetheless, MonoSol

acknowledged the existence of a reasonable disagreement about the proper scope

of “substantially” uniform content. See id. at 13:11-14:10, 20:16-23.

In that appeal, Board made findings with respect to the construction of

“substantially uniform.” See Ex. 1027 at 5-19. Relying on passages of the ‘588

patent, several of which are identical to passages in the ‘167 patent, the Board

found that uniformity is characterized “with respect to the lack of agglomeration of

active material in any part of the film.” Id. at 7; compare Ex. 1026, ‘588 patent, at

6:25-32, 7:26-29 with Ex. 1001, ‘167 patent, at 5:60-6:8, 6:61-7:3. The Board also

found that the term “uniform” is directed to “non-agglomerated and evenly

dispersed active content for any area of a given film.” Id. at 9. The Board further


16 ME1 19120309v.1

found that “the qualifier ‘substantially’ expand[ed] the scope to encompass some

undefined agglomeration or some undefined degree of unevenly dispersed active

material….” Id. at 14. Ultimately, the Board found that “while the term ‘uniform’

appears definite … we are not instructed as to the scope to which a film may be

‘substantially uniform.’” Id. at 9.

ii. MonoSol’s attempt to rescue “substantially uniform” from

indefiniteness

In the examination of the ‘167 patent, although not made aware of the

Board’s findings in the ‘588 decision, the Examiner also found the term

“substantially” uniform to be indefinite. See Ex. 1021, ‘167 History, Office Action

4/8/13, at 2. To overcome the indefiniteness rejection, MonoSol argued that the

“substantially uniform” recitation was necessarily limited by the 10% variation

recitation. See Ex. 1020, ‘167 History, Response 7/08/13, at 3 (“[T]he

substantially uniform distribution is measured by substantially equally sized

individual doses which do not vary by more than 10% of the active

component….”). The Examiner accepted MonoSol’s argument, noting that “the

term ‘substantially uniform’ for the distribution of the active also has to meet the

less than 10% variance in the matrix limitation, and therefore is not indefinite.”

Ex. 1019, ‘167 History, Office Action 7/31/13, at 2. Thereafter, MonoSol made all

of the independent claims recite a whereby clause requiring “said substantially

uniform distribution [of said active component] is measured by substantially


17 ME1 19120309v.1

equal[ly] sized individual unit doses which do not vary by more than 10% of said

desired amount of said active component.” See Ex. 1017, ‘167 History, Office

Action 12/31/13, generally.

BDSI agrees with the Board that the term “substantially uniform” is

indefinite. While BDSI does not agree that the construction suggested in the ‘167

claims is supported by the specification, under the broadest reasonable

interpretation standard, and in the context of the ‘167 patent prosecution, the term

“substantially uniform distribution” at least encompasses “substantially uniform

distribution as measured by substantially equally sized individual unit doses which

do not vary by more than 10% of said desired amount of said active component.”

See also, Ex. 1007, Cohen Decl., at ¶¶39-43.

Summary

claim term proposed construction

“controlled drying process” drying with at least one controlled drying

parameter such as air current temperature, air

current velocity, air current humidity, drying

time, type of radiation, or intensity of radiation

“substantially uniform

distribution” / “substantially

uniformly distributed”

substantially uniform distribution as measured by

substantially equally sized individual unit doses

which do not vary by more than 10% of said

desired amount of said active component


18 ME1 19120309v.1

VII. CHALLENGED CLAIMS AND STATUTORY GROUNDS

In this petition, BDSI challenges claims 17, 18, 30, 31, 37, 49, 56, 63, 70,

77, 80, 81, 87, 93, 110-116, and 124.

Grounds Claims

1: Anticipation by Tapolsky under

§102(b)

17, 18, 30, 31, 37, 49, 56, 70, 77, 80, 87,

93, 110, 112, 114-116, 124

2: Obvious over Tapolsky in view of

Chen under §103(a)

17, 18, 30, 31, 37, 49, 56, 63, 70, 77, 80,

81, 87, 93, 110-116, 124

3: Obvious over Tapolsky in view of

Chen and MODERN COATING

17, 18, 30, 31, 37, 49, 56, 63, 70, 77, 80,

81, 87, 93, 110-116, 124

4: Obvious over Chen in view of

Tapolsky

17, 18, 30, 31, 37, 49, 56, 63, 70, 77, 80,

81, 87, 93, 110-116, 124

5: Obvious over Chen in view of

Tapolsky and MODERN COATING

17, 18, 30, 31, 37, 49, 56, 63, 70, 77, 80,

81, 87, 93, 110-116, 124

VIII. THE CHALLENGED CLAIMS ARE UNPATENTABLE

Ground 1: Tapolsky Anticipates Claims 17, 18, 30, 31, 37, 49, 56, 70,

77, 80, 87, 93, 110, 112, 114-116, and 124

Claims 17, 18, 30, 31, 37, 49, 56, 70, 77, 80, 87, 93, 110, 112, 114-116, and

124 are anticipated by International Patent Publication WO 1999/055312 to

Tapolsky et al. (Tapolsky, Ex. 1003). Tapolsky published in November 1999,

more than a year before the earliest priority date recited in the ‘167 patent.


19 ME1 19120309v.1

Tapolsky is directed to a multi-layer pharmaceutical carrier device (e.g., layered

film disk) suitable for delivery of pharmaceutical components to mucosal surfaces.

See Ex. 1003, at Title and 7:14-27. Tapolsky provides numerous examples of

delivery devices, each comprising multiple layers, including an ingestible water-

soluble polymer matrix, an active, and the other recited additives. See id. at 25:17-

41:6. In Example 37, Tapolsky exemplifies a multi-layer film containing a water-

soluble matrix formed of polymers, a pharmaceutical agent (i.e., albuterol sulfate),

and a recited anti-tacking agent (e.g., sodium benzoate). Id. at 37:4-22. Tapolsky

further discloses using a controlled drying process (i.e., controlled drying

temperature and time) and reports uniform distribution of active (i.e., 1.46 mg/cm2)

in the film. Id. at 37:7-24.

Ground 1: Anticipation by Tapolsky

Claim Tapolsky (Ex. 1003)

17. A multi-layer film for delivery of a desired amount of an active component comprising:

Tapolsky discloses that an embodiment of the device is a film disk. 7:24-27.

Tapolsky discloses and exemplifies multi-layer film. See, e.g., 37:4-25 (describing Example 37 as a multi-layer film containing “backing layers” and “bioadhesive layers”).

“The present invention relates to a pharmaceutical delivery device for application of a pharmaceutical to mucosal surfaces. The device comprises an adhesive layer and a nonadhesive backing layer, and the pharmaceutical may be provided in either or both layers. Upon application, the device adheres to the mucosal surface, providing localized drug delivery and protection to the treatment site.” Abstract.


20 ME1 19120309v.1



(a) at least one first film layer comprising:

Tapolsky’s Example 37 comprises at least one first film layer, e.g., a “backing layer.” See, e.g., 37:4-25.

(i) an ingestible, water-soluble polymer matrix; and

Each “backing layer” and each “adhesive layer” of the film of Example 37 comprises a water-soluble polymer matrix. 37:4-6 (“A gel for the backing layers was prepared which contained 79.74% water, … 13.5% hydroxyethyl cellulose, and 4.5% hydroxypropyl cellulose by weight.”); 37:15-19 (“A gel for the bioadhesive layers was prepared which contained 45.2% water, … 1.6% hydroxyethyl cellulose, 0.6% hydroxypropyl cellulose, … by weight.”); see also 5:20-27, 10:14-11:1. The ‘167 patent classifies these as water soluble polymers. Ex. 1001 at 12:35-54.

Tapolsky teaches that its water-soluble polymer matrix is ingestible. Ex. 1003 at 7:2-5 (“[T]he term ‘water-erodable’ means that the component, device, layer, etc. erodes in water-based media such as saliva, over time. Such erosion in water may be due to factors such as dissolution, dispersion, friction, gravity, etc.”); see also 9:7-11 (“[T]he user of the present invention does not have to remove the device following treatment. … [U]pon application, water absorption softens the device, and over time, the device slowly dissolves.”). Tapolsky discloses application of its film to a mucosal surface, such as the mouth. 7:14-18. “Typically, such treatment sites include the oral…mucosal tissue….” 21:13-14.

Further, in Example 40, Tapolsky describes applying the film to the mouth of a dog for a systemic availability study of actives (i.e., albuterol sulfate, testosterone). See 39:14-28.

(ii) at least one anti-tacking agent selected from the

Tapolsky discloses that each backing layer in the film of Example 37 comprises sodium benzoate.


21 ME1 19120309v.1



group consisting of …sodium benzoate… and combinations thereof; and

37:4-5.

(b) a second film layer comprising:

Tapolsky’s Example 37 comprises at least one second film layer, e.g., a “first bioadhesive layer.” 37:19-24.


Each bioadhesive layer of Example 37 comprises a water soluble polymer matrix. 37:15-19 (“A gel for the bioadhesive layers was prepared which contained 45.2% water USP, … 1.6% hydroxyethyl cellulose, 0.6% hydroxypropyl cellulose, … by weight.”). The ‘167 patent teaches that these polymers are water soluble. Ex. 1001 at 12:35-54.

See also disclosure cited for element (a)(i) of this claim regarding “ingestible … matrix.”

(ii) a substantially uniform distribution of said desired amount of said active component within said polymer matrix, wherein said active component is selected from the group consisting of cosmetic agents, pharmaceutical agents, vitamins, bioactive agents and combinations thereof,

Tapolsky discloses a second film layer with a pharmaceutical agent substantially uniformly distributed within the polymer matrix. See, e.g., 37:15-19 (disclosing Example 37’s bioadhesive layers each comprise the active component, i.e., albuterol sulfate); 37:22-24 (confirming the film of Example 37 contained a uniform distribution of active, specifically, 1.46 mg/cm2 albuterol sulfate).

The ‘167 patent acknowledges that albuterol sulfate is a pharmaceutical active. See Ex. 1001 at 16:34-45.

See also disclosure cited for last element of claim 17 and discussion in subsection entitled “substantially uniform distribution” below chart.

wherein said first film layer is substantially in contact with said second film layer;

“Using the gel, a first bioadhesive layer of 0.5 mm was coated directly on top of the two layer flexible backing film and dried at 60oC for 8 minutes.” Ex. 1003 at 37:19-21.


22 ME1 19120309v.1



said film being formed by a controlled drying process which rapidly forms a viscoelastic matrix to lock-in said active in place within said matrix and maintain said substantially uniform distribution; and

In Example 37, Tapolsky discloses that each of the backing layers and each of the bioadhesive layers is formed by a controlled drying process. 37:6-10 (“The gel was then made into a two layer flexible backing film ... by first coating a 0.8 mm thick layer of the formulation on a substrate and then drying it at 80°C for 8 minutes. A second 0.8 mm thick layer was then coated directly on top of the first layer and dried at 80°C for 8 minutes.”); 37:19-22 (“Using the gel, a first bioadhesive layer of 0.5 mm was coated directly on top of the two layer flexible backing film and dried at 60 oC for 8 minutes. A second bioadhesive layer of 0.7 mm was then coated directly on top of the first bioadhesive layer and dried at 60 oC for 20 minutes.”).

Tapolsky reports that the active in the film of Example 37 was locked in such that uniformity in the active distribution was maintained. 37:22-24 (confirming that the dried film contained 1.46 mg/cm2 albuterol sulfate).

See also disclosure cited for last element of claim 17 and discussion in subsections entitled “controlled drying process…viscoelastic matrix…lock-in…” and “substantially uniform distribution” below chart.

wherein said film is self-supporting and the active component is substantially uniformly distributed, whereby said substantially uniform distribution is measured by substantially equal sized individual unit doses which do not vary by more than 10% of said

The ‘167 patent states that films that are “self-supporting” are “in other words able to maintain their integrity and structure in the absence of a separate support.” Ex. 1001 at 23:37-39.

Tapolsky describes its film as being used without a separate support: Tapolsky discloses that its film “may be easily peeled off the substrate after drying….” 22:27-29. Tapolsky discloses that its “film may also be readily removed by peeling without significant damage to tissue.” 21:23-24.


23 ME1 19120309v.1



desired amount of said active component.

“Unlike bandages and other non-water-erodable film systems, the user of the present invention does not have to remove the device following treatment.” 9:6-8. Tapolsky reports the film “exhibited excellent tensile strength.” 37:24-25.

Tapolsky discloses that its film is cut into substantially equally sized individual unit doses. For example, film of Examples 38 and 39 is die-cut in 1/2 inch diameter discs. 39:14-16.

In Example 37, Tapolsky reports the amount of active out to the second decimal point (i.e., 1.46 mg/cm2). 37:22-24.

See also discussion in subsections entitled “self-supporting” and “substantially uniform distribution” below.

18. The multi-layer film of claim 17, wherein said first film layer is laminated to said second film layer.

“The film layers may be filmed independently and then laminated together … The film obtained after the two layers have been laminated together...may be cut, if desired, into any shape which is suitable for application to the mucosal tissue.” 20:19-23; see also Examples 18 and 29 (exemplifying film containing multiple layers laminated together).

30. The film of claim 17, wherein the anti-tacking agent is present in an amount sufficient to yield a film with a coefficient of friction which reduces adhesion of the film to adjacent surfaces during processing.

“Using this procedure, the film may be easily peeled off the substrate after drying, or may be left on the substrate and rolled, to be laminated later, or for use as a substrate for the adhesive layer.” 22:27-29 (Example 1). See also 28:20-22 (Example 18) (“The backing film was peeled off of its substrate ….”).

31. The film of claim 17, said film having a coefficient of friction which

“In one embodiment, the present invention comprises a film disc having an adhesive layer and non-adhesive backing layer which can be


24 ME1 19120309v.1



is low enough to reduce adhesion of said film to the roof of a mouth of a user of said film upon placement into the user's mouth.

comprised of components having a similar or different hydrophilicity.” 10:7-9.

In Example 37, Tapolsky exemplifies film containing a non-adhesive backing layer containing sodium benzoate. 37:4-5. Sodium benzoate is classified as an anti-tacking agent in claim 17.

37. The process of claim 18, wherein said water-soluble polymer comprises hydroxyethyl cellulose.

In Example 37, Tapolsky exemplifies a film including a bioadhesive layer and a backing layer, both of which include hydroxyethyl cellulose. 37:4-6, 37:15-19; see also 5:20-21 (“The adhesive layer(s) comprise(s) a film-forming polymer such as hydroxyethyl cellulose ....”); 5:29-30 (“The non-adhesive backing layer(s) comprise(s) hydroxyethyl cellulose….”).

49. The film of claim 17, said at least one first film layer or said second film layer further comprising a buffer.

Tapolsky discloses that its film may contain “the sodium and potassium salts of ... citrate [and] ... phosphate, ....” 13:28-30.

Sodium citrate, sodium phosphate, potassium citrate, and potassium phosphate are “buffering agents.” See, e.g., Ex. 1013, PHARMACEUTICAL

DOSAGE FORMS, at 88; Ex. 1012, HANDBOOK OF

PHARMACEUTICAL EXCIPIENTS, at 429, 482, 493, 496.

56. The film of claim 17, said at least one first film layer or said second film layer further comprising a sweetener.

In Examples 7 and 39, Tapolsky exemplifies film that includes a sweetener (i.e., sweet peppermint). Ex. 1003 at 24:26-29, 38:22-24.

70. The film of claim 17, said at least one first film layer or said second film layer further comprising a flavoring agent.

In Example 37, Tapolsky exemplifies film that includes a flavoring agent. 37:4-6 (“A gel for the backing layers was prepared which contained … 2.5% peppermint flavor … by weight.”).

77. The film of claim 17, In Example 37, Tapolsky exemplifies film that


25 ME1 19120309v.1



said at least one first film layer or said second film layer further comprising a coloring agent.

includes a coloring agent. 37:4-6 (“A gel for the backing layers was prepared which contained … 0.01% FD&C red dye 40 … by weight.”).

80. The film of claim 17, wherein said water-soluble polymer matrix in said first film layer and/or in said second film layer comprises hydroxyethyl cellulose.

See disclosure cited for claim 37.

87. The film of claim 17, wherein the anti-tacking agent comprises sodium benzoate.

See disclosure regarding sodium benzoate cited for element (a)(ii) of claim 17 above.

93. The film of claim 17, wherein the active component comprises an active selected from the group consisting of an opiate, opiate derivative, analgesic and combinations thereof.

Tapolsky teaches that its film may comprise “[p]harmaceuticals … either alone or in combination, [such as] anti-inflammatory analgesic agents ….” 15:20-22; see also 15:28-16:2. The ‘167 patent states “[a]nalgesics include opiates and opiate derivatives ….” Ex. 1001 at 16:19.


See disclosure cited for preamble of claim 17.

(a) a first film layer comprising:

See disclosure cited for element (a) of claim 17.

(i) an ingestible, water-soluble or water-swellable polymer matrix; and

See disclosure cited for element (a)(i) of claim 17.

(b) at least a second film layer comprising:

See disclosure cited for element (b) of claim 17.

(i) an ingestible, water- See disclosure cited for element (b)(i) of claim


26 ME1 19120309v.1



soluble or water-swellable polymer matrix comprising a water-soluble or swellable polymer;

17.

wherein the first and/or second layers further comprise:

a desired amount of a substantially uniformly distributed active component, said active component being selected from the group consisting of cosmetic agents, pharmaceutical agents, vitamins, bioactive agents and combinations thereof;

a component selected from the group consisting of an anti-tacking agent, a sweetener, a flavor, an acidulent, an oxide filler, propylene glycol, vitamin E acetate, polyacrylic acid, a preservative, a buffer, a coloring agent and combinations thereof; and

See disclosure cited for element (b)(ii) of claim 17 (addressing the “active component” Markush group recited in this claim).

See disclosure cited for claims 56 and 70 (addressing the sweetener and flavoring agent recited in the second Markush group recited in this claim).

In Example 37, Tapolsky exemplifies “[a] gel for the bioadhesive layers … which contained … 0.1% titanium dioxide, and 1.9% albuterol sulfate by weight.” 37:15-19. The ‘167 patent identifies albuterol sulfate as an active (Ex. 1001 at 16:34-44) and titanium oxide as a “filler” (id. at 22:13-14).

See also discussion regarding “substantially uniform distribution” below chart.


See disclosure cited for identical recitation in claim 17.

said film being formed by a controlled drying process which rapidly forms a viscoelastic matrix to lock-in said active component in place and maintain said

See disclosure cited for second to last element in claim 17.


27 ME1 19120309v.1



substantially uniform distribution; and

wherein said film is self-supporting, whereby said substantially uniform distribution of said active component is measured by substantially equal sized individual unit doses which do not vary by more than 10% of said desired amount of said active component.

See disclosure cited for last element in claim 17.

112. The multi-layer film of claim 110, wherein the flavor comprises peppermint oil.

“A gel for the backing layers was prepared which contained … 2.5% peppermint flavor … by weight.” 37:4-6 (Example 37).

114. The multi-layer film of claim 110, wherein the active is selected from the group consisting of opiates, opiate derivatives, analgesics and combinations thereof.

See disclosure cited for claim 93 above.

115. The multi-layer film of claim 110, further comprising sodium benzoate.


116. The multi-layer film of claim 110, wherein the water-soluble or water-swellable polymer matrix comprises a polymer selected from the group consisting of hydroxyethylcellulose, hydroxypropylcellulose,

In Example 37, Tapolsky discloses that “[a] gel for the backing layers was prepared which contained … 13.5% hydroxyethyl cellulose, and 4.5% hydroxypropyl cellulose by weight….” (37:4-6) and “[a] gel for the bioadhesive layers was prepared which contained … 1.6% hydroxyethyl cellulose, 0.6% hydroxypropyl cellulose… by weight.” 37: 15-19.


28 ME1 19120309v.1



carboxymethyl cellulose and combinations thereof.

124. The film of claim 17, wherein the anti-tacking agent is present in an amount sufficient to impart reduced film-to-film coefficient of friction.

See also disclosure cited for claims 30 and 31 above.

1. “self-supporting”

As Dr. Cohen explains, based on the disclosure cited with respect to the last

element claim 17 above, Tapolsky discloses self-supporting film. See Ex. 1007 at

page 25.

2. “controlled drying process …viscoelastic matrix … lock-in ...”

Claims 17 and 110 recite the product-by-process step of “said film being

formed by a controlled drying process which rapidly forms a viscoelastic matrix to

lock-in said active in place within said matrix and maintain said substantially

uniform distribution.”

As a matter of law, this process limitation merits no weight in the

patentability analysis. “In determining validity of a product-by-process claim, the

focus is on the product and not on the process of making it.... As a result, a

product-by-process claim can be anticipated by a prior art product that does not

adhere to the claim’s process limitation.” Amgen Inc. v. F. Hoffman-La Roche


29 ME1 19120309v.1

Ltd., 580 F.3d 1340, 1369-70 (Fed. Cir. 2009). The USPTO has adopted this rule,

explaining that “[i]f the product in the product-by-process claim is the same as or

obvious from a product of the prior art, the claim is unpatentable even though the

prior product was made by a different process.” MPEP § 2113 (citing In re

Thorpe, 777 F.2d 695, 698 (Fed. Cir. 1985)). Following the MPEP and Federal

Circuit precedent, the Board has affirmed rejection of claims as anticipated or

obvious in view of a product not made by the recited process. See, e.g., Ex parte

Levy, Appeal 2012-002883, 2014 WL 2466993, at *3 (PTAB, May 29, 2014)

(“The patentability of a product does not depend on its method of production”).

The process in a product-by-process claim merits weight in the prior art

comparison only if it imparts some unique and novel property or structure in the

resulting product. Such is not the case here. Specifically, MonoSol argued during

prosecution that “controlled drying” imparted the novel property of “substantially

uniform distribution” of active. Ex. 1020, ‘167 History, Reply 7/8/13, at 6.

However, the ‘167 patent admits that the desired uniformity of the active may

result from other prior art manufacturing processes that are not excluded by the

claims. See Ex. 1001, at 24:37-40 (“An alternative method of forming a film with

an accurate dosage, that would not necessitate the controlled drying process, would

be to cast the films on a predetermined well.”). Moreover, even if it were entitled

to weight, the ‘167 patent further admits that “controlled drying processes” were


30 ME1 19120309v.1

known in the art prior to the first claimed priority date citing, for example, the

process of Magoon. Id. at 6:22-27.

Finally, Tapolsky discloses “controlled drying processes” in that it discloses

controlling both drying temperature and drying time. See disclosure cited in chart

above; see also Ex. 1007, Cohen Decl., at ¶¶48-49. As Dr. Cohen explains, under

the broadest reasonable interpretation of the term “controlled drying process” in

light of the ‘167 specification, Tapolsky discloses drying film using a “controlled

drying process.” Id. Further, as Dr. Cohen explains, the solid components in the

polymer matrix of Tapolsky necessarily become “locked in” or immobilized during

the drying process (id. at ¶55-56), and Tapolsky’s film will necessarily be

viscoelastic (id. at ¶57-59). See also id. at ¶¶18-21, 32. If MonoSol invented a

novel “controlled drying process,” it has not claimed it.

3. “substantially uniform distribution”

In Example 37 of Tapolsky, the amount of active, albuterol sulfate, in the

dried product is reported to be 1.46 mg/cm2. See Ex. 1003 at 37:22-24. Given the

reported degree of certainty (i.e., out to the second decimal place), the greatest

difference in the amount of active per centimeter squared would be, at most, 0.009

mg (i.e., the difference between 1.464 mg/cm2 and 1.455 mg/cm2). Thus, the

greatest variation in active between equally sized individual unit doses of

Tapolsky’s film that could exist given the reported value is 0.61% (0.009 mg/cm2


31 ME1 19120309v.1

divided by 1.46 mg/cm2), a value well within the recited “does not vary by more

than 10% of said desired amount of said active component.” This percentage does

not change with unit size. Accordingly, Tapolsky discloses film having a

“substantially uniform distribution” of an active component “whereby said

substantially uniform distribution is measured by substantially equally sized

individual unit doses which do not vary by more than 10% of said desired amount

of said active component.” See Ex. 1007, Cohen Decl., at ¶¶50-54.

4. “anti-tacking agent”

Claims 17 and 87 identify various materials as “anti-tacking agent[s].” But

ascribing a property to a material already disclosed in the prior art, e.g., the sodium

benzoate of Tapolsky, does not make it new. See, e.g., MPEP 2112 (“Thus the

claiming of a new use, new function or unknown property which is inherently

present in the prior art does not necessarily make the claim patentable.”) (citing In

re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977)).

For at least the foregoing reasons, the claims challenged in Ground 1 are

anticipated by Tapolsky. See also Ex. 1007 at ¶¶44-60.

Ground 2: Claims 17, 18, 30, 31, 37, 49, 56, 63, 70, 77, 80, 81, 87, 93,

110-116 and 124 are Obvious over Tapolsky in view of Chen

For the reasons set forth in Ground 1, Tapolsky anticipates claims 17, 18, 30,

31, 37, 49, 56, 70, 77, 80, 87, 93, 110, 112, 114-116, and 124. BDSI incorporates


32 ME1 19120309v.1

by reference the discussion in Ground 1. To the extent the Board nonetheless

believes that any element of any challenged claim is not expressly or inherently

disclosed in Tapolsky, the claims challenged in Ground 1 and claims 63, 111, and

113 are obvious over Tapolsky in view of International Patent Publication WO

2000/042992 to Chen et al. (“Chen,” Ex. 1002).

Chen published in July 2000, more than a year before the earliest priority

date recited in the ‘167 patent. Both Tapolsky and Chen disclose film for delivery

of a desired amount of an active component to mucosal surfaces. Compare Ex.

1003 at Title & 7:15-27 with Ex. 1002 at 6:19-26 & Abstract. Both Tapolsky and

Chen disclose film comprising ingestible, water-soluble polymers, including

hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose,

and polyethylene oxide. Compare Ex. 1003 at 5:20-25 with Ex. 1002 at 14:22-

15:3. Like Tapolsky, Chen discloses the use of a controlled drying process to

produce film featuring a uniform distribution of active. See subsections below.

Like Tapolsky, Chen discloses multi-layer film. See, e.g., Ex. 1002 at 4:31-32.

Thus, as Dr. Cohen explains, the POSITA would naturally have considered

Tapolsky and Chen together when making water-soluble polymer-based film for

delivery of a desired amount of active. See Ex. 1007 at ¶¶63-65.

1. “self-supporting”

As Dr. Cohen explains, even if Tapolsky did not disclose self-supporting


33 ME1 19120309v.1

film, which it does, it would have been obvious to the POSITA to ensure that the

film was self-supporting. See Ex. 1007 at ¶72. Chen expressly discloses that its

film is “self-supporting.” Ex. 1002 at 15:30-31. As Dr. Cohen explains, the

POSITA would have been motivated to combine Chen’s teaching of “self-

supporting” film with the multi-layer film of Tapolsky in order to ensure that the

film could be removed from the production equipment, packaging, and/or other

film without tearing or otherwise disturbing the integrity of the film, and to

dissolve during use, thus allowing it to be used for its intended purpose. See Ex.

1007 at ¶72.

2. “controlled drying process”

As explained in subsection 2 of Ground 1 above, and as a matter of law, the

process limitation—“said film being formed by a controlled drying process which

rapidly forms a viscoelastic matrix to lock-in said active in place within said matrix

and maintain said substantially uniform distribution,” recited in claims 17 and

110—merits no weight in the patentability analysis.

But to the extent that it is believed that Tapolsky does not disclose a

“controlled drying process,” it would have been obvious. Indeed, the ‘167 patent

admits that both controlled drying processes and the motivation for using such

processes were known in the art prior to the first claimed priority date. See Ex.

1001 at 6:22-27, 2:16-19.


34 ME1 19120309v.1

Indeed, as evidenced by a patent issued in 1887, the use of controlled drying

to set a coating and maintain its uniformity, has been known for at least a century.

See Ex. 1008, the 1887 patent, generally. The 1887 patent describes forming a

coating solution by mixing a polymer, water, and an active (i.e., silver salts). See

id. at 1:48-53. The 1887 patent describes applying and drying the coating solution.

See id. at 2:72-83, 3:10-24. The 1887 patent discloses a controlled drying process

that locks-in the distribution of active. Id. at 3:1-24; see also Ex. 1007 at ¶20.

As evidenced by a reference book published in 1992, achieving uniformity

and maintaining it by controlling the drying process was known long before the

priority date of the ‘167 patent. See, e.g., Ex. 1009, MODERN COATING AND

DRYING TECHNOLOGY (Cohen, E. et al. eds. 1992) (“MODERN COATING”), at 25,

268 (“The purpose of the drying process is to produce a uniform dry coating from

the applied wet coating…the dryer must immobilize it and maintain its uniformity

throughout the drying process.”); see also Ex. 1007 at ¶¶22-24, 66-69.

Further, as Dr. Cohen explains, numerous variables of the drying process

were known as of October 2001, as were numerous drying processes, each of

which involves controlling variables of the drying process. Id. at ¶¶25-28, 70-71.

As Dr. Cohen further explains, the POSITA “would have been able to optimize

drying variables in ... known drying processes in order to avoid film defects and

produce film with a high degree of uniformity.” Id. at ¶28. “Producing uniform


35 ME1 19120309v.1

and defect-free film was then—and is today—critical to producing usable film.”

Id.

While claims 17 and 110 recite that the process “rapidly forms a viscoelastic

matrix to lock-in said active in place within said matrix and maintain said

substantially uniform distribution,” this language does not exclude any particular

process for drying a polymer-based film. As Dr. Cohen explains:

First, the terms “rapidly” and “maintain” in the context of this claim

would have no meaning to the person of ordinary skill in the art (i.e.,

“Rapidly” relative to what? “Maintained” beginning at what point?).

Second essentially any film made from drying a viscoelastic coating

solution will form a “viscoelastic matrix” with the solid components

“lock[ed] in...place within said matrix.”

Ex. 1007 at ¶35; see also id. at ¶¶34-37. The concept of “locking in” has been

understood and documented for over a century. Id. at ¶20. As Dr. Cohen explains,

“[d]uring drying, all film becomes more viscous such that the components are

eventually ‘locked in’.” Id. at ¶19.

Finally, the Board’s finding—that “Chen teaches controlled drying” (Ex.

1027, ‘588 History, Board Decision, at 15-17)—should be applied here. See

Section V and subsection 4 below. The Board also found that “Chen describes a

substantially identical process to that described in the ‘588 patent.” Ex. 1027 at

15-16. Importantly, other than typographical errors, the sections of the ‘167 patent


36 ME1 19120309v.1

and ‘588 patent entitled “Drying the Film” are identical. Compare Ex. 1026, ‘588

patent, at 25:1-26:18 with Ex. 1001 at 24:30-25:45; see also Ex. 1041, Comparison

of ‘588 and ‘167 specifications, at 30-32. If necessary to produce a film featuring

acceptable uniformity, the POSITA would have been motivated to use a

“controlled drying process,” such as those known in the art and disclosed in Chen,

to produce such film. See Ex. 1007, at ¶¶69-71.


To the extent that it is believed that the film of Tapolsky with an exemplified

and reported uniform distribution of active out to second decimal point is somehow

not a “substantially uniform distribution” of active, it would have been obvious to

create film with such a distribution of active. The POSITA would have been

motivated to adjust the film manufacturing process to produce film featuring a

distribution of active that does not vary by more than 10% of the desired amount.

As admitted in the ‘167 patent, the recited uniformity was a known regulatory

requirement. See, e.g., Ex. 1001 at 2:16-19 (“Currently, as required by various

world regulatory authorities, dosage forms may not vary more than 10% in the

amount of active present.”). As Dr. Cohen explains, the person of ordinary skill in

the art of making film would have been able to produce films with the claimed

levels of uniformity without undue experimentation. See Ex. 1007 at ¶¶67-71.

Finally, the Board’s findings—that (i) “Chen inherently discloses a film with


37 ME1 19120309v.1

a substantially uniform content of therapeutic active composition per unit of film”;

and (ii) Chen’s “weight deviation of ± 0.001 satisfies the limitation of

‘substantially uniform’ active content[, and] is well within the less than 10%

variation of active content per film unit requirement…” (Ex. 1027, ‘588 History,

Board Decision, at 15, 19)—should be applied here. See subsection below.

4. The Board has already made findings relating to Chen

The Board has already found that Chen discloses films (i) having

“substantially uniform” active content; (ii) formed by “controlled drying”; and (iii)

having “a weight deviation of ±0.001 [which] is well within the less than 10%

variation of active content per film unit …”. See Section V and Ex. 1027, ‘588

Board Decision, at 17-19.

Collateral estoppel precludes examiner-shopping and reargument of issues

fully heard and finally decided in a prior Patent Office inter partes proceeding.

The Board has applied collateral estoppel to bar re-argument in subsequent Office

proceedings of issues finally decided in inter partes Patent Office proceedings or

district court cases when “(1) the issue is identical to one decided in the first

action; (2) the issue was actually litigated in the first action; (3) resolution of the

issue was essential to the final judgment in the first action; and (4) [the party] had a

full and fair opportunity to litigate the issue in the first action.” Ex Parte Shaw,

Appeal 1997-3258, 2004 WL 5580635, at *13 (BPAI May 21, 2004) (applying


38 ME1 19120309v.1

collateral estoppel to bar applicant from rearguing enablement issue decided in

prior interference, citing In re Freeman, 30 F.3d 1459, 1465 (Fed. Cir. 1994)); see

also, e.g., Ex parte Northpoint Tech., Ltd, Appeal 2014-001668, 2014 WL 986346

(PTAB Mar. 13, 2014); Ex parte Bonadio, Appeal 2010-011789, 2013 WL

1279861 (PTAB Mar. 22, 2013). In Shaw, the Board noted that the Supreme Court

itself has held that principles of res judicata and collateral estoppel can be based

on the final decisions of administrative agencies. See Shaw, 2004 WL 5580635 at

*14 (citing Astoria Fed. Sav. and Loan Ass’n v. Solimino, 501 U.S. 104, 107

(1991) and United States v. Utah Constr. & Mining Co., 384 U.S. 394, 421

(1966)).

Here, the four requirements for collateral estoppel are met: (1) the issue is

identical to the one presented here, i.e., whether Chen discloses the three

limitations; (2) MonoSol actually litigated the issue before an examination panel

and before the Board resulting in final Decision on Appeal; (3) resolution of the

issue was essential to the Board’s decision in the ‘588 patent reexamination, i.e.,

patentability depended on whether Chen disclosed these three limitations; and (4)

MonoSol fully participated in the inter partes reexamination and the appeal to this

Board. MonoSol could have petitioned for a rehearing and/or appealed that

decision to the Federal Circuit but chose not to do so. Thus, the Board’s decision

is final and should apply here to estop MonoSol from contesting the Board’s


39 ME1 19120309v.1

findings as to Chen.

5. Dependent Claims

Dependent Claims 30, 31, and 124. Neither the claims nor the ‘167 patent

provides any guidance or limits as to what satisfies “reduces adhesion of the film

to adjacent surfaces during processing,” “reduce adhesion of said film to the roof

of a mouth of a user,” or “reduced film-to-film coefficient of friction”—or even the

benchmark to which “reduce” is referring. See Ex. 1007 at ¶73. Thus, there is no

basis to argue any criticality with respect to amount or extent of reduction. In any

event, determining how much anti-tacking agent must be included to achieve a

coefficient of friction/adhesion that is reduced by any amount with respect to any

benchmark requires only routine experimentation.

For example, Chen teaches adjusting levels of “wet tack” and “dry tack” in

film for delivery of a desired amount of an active component. Ex. 1002 at 12:13-

19 (describing “dry tack” and “wet tack” as quantitative values for tackiness,

disclosing measuring “tack” properties, and providing ranges of tack values).

Chen teaches that its film when dried is “self supporting, non-tacky, and flexible”

and is packaged into “multiple unit dispensers (Figure 3).” Id. at 15:30-16:8. As

Dr. Cohen explains, the POSITA would have been motivated to combine the

teachings in Chen of adjusting the tackiness of film with the multi-layer film of

Tapolsky to create film with the desired level of adhesion and the desired


40 ME1 19120309v.1

coefficient of friction so that the film could be processed and used for its intended

purpose. See Ex. 1007 at ¶¶73-78. As Dr. Cohen further explains, the POSITA

would have been able to combine the knowledge of optimizing the amounts of

components in film to achieve the desired level of adhesion, using only routine

experimentation, so that the film could be processed and used for its intended

purpose. See id.

Dependent claim 81. Example 37 of Tapolsky discloses film including a

bioadhesive layer that contains sodium carboxymethyl cellulose. See Ex. 1003 at

37:15-21. Sodium carboxymethyl cellulose is the sodium salt of carboxymethyl

cellulose. See Ex. 1012, HANDBOOK, at 87. As Dr. Cohen explains, using

carboxymethyl cellulose in place of sodium carboxymethyl cellulose would have

been a simple substitution of known elements with predictable results, i.e., a

polymer-based film. See Ex. 1007 at ¶83.

Further, Chen expressly discloses film comprising carboxymethyl cellulose.

See Ex. 1002 at 14:24-27. As Dr. Cohen explains, substituting the carboxymethyl

cellulose of Chen for the sodium carboxymethyl cellulose of Tapolsky would have

been a simple substitution of known elements with predictable results, i.e., a film

made according to Tapolsky containing carboxymethyl cellulose. See Ex. 1007 at

¶84.

Dependent claims 63 and 111. Acesulfame-K and sodium saccharin were


41 ME1 19120309v.1

both known to be sweeteners and were used to sweeten the taste of products well

before the priority date of the ‘167 patent. See, e.g., Ex. 1012, HANDBOOK, at 3

(Acesulfame-K) and at 457 (sodium saccharin).

Examples 7 and 39 of Tapolsky exemplify films that include a sweetener

(i.e., sweet peppermint). See Ex. 1003 at 24:26-29, 38:22-24. Chen discloses film

containing a number of sweeteners, including Acesulfame-K and sodium

saccharin. See Ex. 1002 at 10:7-14. Using one known sweetener (Acesulfame-K

or sodium saccharin), in place of another known sweetener (sweet peppermint),

would have been a simple substitution of known elements with a predictable result,

i.e., film made according to Tapolsky with a sweetened taste. See Ex. 1007 at

¶¶79-82. As the saying goes, a spoonful of sugar helps the medicine go down: it

would have been obvious to add a sweetener to the film of Tapolsky’s Example 37

to make the film more palatable. See id.

Dependent claim 113. Citric acid was known and used in pharmaceutical

products well prior to October 2001 for several purposes, including as an

“acidifying agent” and “buffering agent.” Ex. 1012, HANDBOOK, at 140. Chen

exemplifies film containing “citric acid.” Ex. 1002 at 21:12 (Table 5, Examples 5-

8). As explained by Dr. Cohen, it would have been obvious to the POSITA to

combine the teachings in Chen of film containing citric acid with the multi-layer

film of Tapolsky, for any known uses of citric acid, including as an acidulent. Ex.


42 ME1 19120309v.1

1007 at ¶¶85-86.


obvious over Tapolsky in view of Chen. See also id. at ¶¶61-87.

Ground 3: Claims 17, 18, 30, 31, 37, 49, 56, 63, 70, 77, 80, 81, 87, 93,

110-116, and 124 are Obvious over Tapolsky in view of

Chen in further view of MODERN COATING

MODERN COATING (Ex. 1009) was published in 1992, more than a year

before the earliest priority date recited in the ‘167 patent. MODERN COATING

discloses in great detail how to control a drying process to produce a uniform film.

See Ex. 1009 at 267-295. As MODERN COATING discloses, “[t]he purpose of the

drying process is to produce a uniform dry coating.” Ex. 1009 at 268. MODERN

COATING sets forth the principal drying variables, techniques, and apparatus known

in the art before October 2001. MODERN COATING identifies the key variables in

the drying process, including “dry bulb temperatures, the solvent content of the air,

… the air velocities …”, “film temperature,” and “line speed.” Id. at 286-287.

MODERN COATING also describes known drying apparatus, including air

convention dryers (278), spiral dryers (279-280), single-side impingement dryers

(280-283), and two-sided floater dryers (283-284), as well as drying using infrared

or radiant heat (285-286). And MODERN COATING describes how to avoid defects

that may result from drying a film. See id. at 287-295.

BDSI incorporates by reference the discussion in Grounds 1 and 2. To the


43 ME1 19120309v.1

extent the Board finds that Tapolsky and Chen somehow fail to disclose a

“controlled drying process” under the broadest reasonable interpretation of that

term, BDSI submits it would have been obvious to the POSITA to use any one of

the “controlled drying processes” disclosed in MODERN COATING to produce

uniform film. See Ex. 1007 at ¶92.

Ground 4: Claims 17, 18, 30, 31, 37, 49, 56, 63, 70, 77, 80, 81, 87, 93,

110-116 and 124 are Obvious over Chen in view of Tapolsky

Claims 17, 30, 31, 37, 49, 56, 63, 69, 70, 77, 80, 81, 87, 93, 110-116, and

124 are also obvious over Chen in view of Tapolsky. The discussion in Grounds 1

and 2 is incorporated by reference.

Chen discloses a film manufacturing process that begins by combining a

hydrocolloid, a solvent, an active agent, and at least one reagent into a substantially

homogenous coatable mixture. See Ex. 1002 at 4:24-29. As exemplary

hydrocolloids, Chen discloses ingestible, water-soluble polymers that are recited in

challenged dependent claims. See id. at 14:22-15:3. Chen discloses exemplary

reagents that are recited in the “anti-tacking agent” Markush groups recited in

challenged independent claims. See disclosure cited for element (ii) of claim 17 in

chart below. Chen also discloses exemplary reagents that are recited in challenged

dependent claims and exemplary active agents that are recited in challenged

independent and dependent claims. See, e.g., Ex. 1002 at 10:7-11:31.


44 ME1 19120309v.1

Chen discloses forming a film from the coatable mixture and coating the

mixture onto a backing film. See id. at 4:24-32. This would produce a multi-layer

film. As discussed in subsections 2 and 4 of Ground 2, Chen discloses the use of a

controlled drying process. However, Chen’s disclosure of the application of a

controlled drying process to a multi-layer film is limited.

Tapolsky discloses film intended for the same purpose and containing many

of the same polymers, actives, and excipients as Chen. For reasons explained in

Ground 2, and as confirmed by Dr. Cohen, the POSITA would naturally have

considered Chen and Tapolsky together when making water-soluble polymer-

based film for delivery of a desired amount of active. See Ex. 1007 at ¶¶94-99.

As Dr. Cohen explains, multi-layer film was known—and successfully

made—prior to the earliest priority date identified in the 167 patent. See id. at

¶¶29-31, 100-101. The POSITA would have been motivated to combine existing

knowledge of polymer-based, multi-layer film, such as disclosed in Tapolsky, with

Chen’s teaching of polymer-based film to create multi-layer, polymer-based film

for oral delivery of a desired amount of active. See id. at ¶¶100-101.

Ground 4: Obviousness over Chen and Tapolsky

Claim Chen (Ex. 1002)


Chen discloses film. Abstract. Chen discloses that its film may be a multi-layer film. 4:31-32 (“The method may further include the step of coating the mixture onto a backing film.”).

Chen discloses “Compositions and Methods for


45 ME1 19120309v.1



Mucosal Delivery” (Title), and specifically films including “an effective dose of active agent” (Abstract). See also 3:30-32.

(a) at least one first film layer comprising:

See disclosure cited immediately above.


Chen discloses films with a water-soluble polymer matrix, i.e., films made from coating solutions comprising water-soluble hydrocolloid polymers. 14:22-15:3. See also Ex. 1001 at 12:34-53.

Chen discloses that its films are ingestible. “The dosage unit may be prepared for use by selecting a film that is capable of delivering an effective dose and administering the film to the patient by placing it on a mucosal surface such as the oral mucosa (Figure 1) where it dissolves in the body fluid for example, saliva (0.5-10 minutes) and is swallowed in liquid form.” Ex. 1002 at 16:22-25.

(ii) at least one anti-tacking agent selected from the group consisting of… vegetable oil;…sodium benzoate; … polyethylene glycol; … amorphous silicon dioxide;… Vitamin E, ... and combinations thereof; and

Chen discloses that its film-forming mixtures can include “at least one reagent selected from the group consisting of an emulsifier, a plasticizer, a taste modifier, a water soluble inert filler, a coloring agent, a preservative, a permeation enhancer, a stabilizer and a buffering agent”—components in this group are also recited in the “anti-tacking agent” Markush group of this claim. For example, Chen exemplifies vegetable oil as an emulsifying agent (10:15-19), polyethylene glycol as a plasticizer (10:20-21), silicon dioxide as a coloring agent (11:20-22), Vitamin E as a stabilizer (11:23-27), sodium benzoate as a preservative (11:28-31); see also 14:24-31 (identifying silicon dioxide and polyethylene glycol as exemplary hydrocolloids).

Further, Chen discloses that “[t]he dry film formed by this process is a … non-tacky … film.” 15:30-31.

(b) a second film layer Chen discloses multi-layer film. 4:31-32 (“The


46 ME1 19120309v.1



comprising: method may further include the step of coating the mixture onto a backing film.”).



(ii) a substantially uniform distribution of said desired amount of said active component within said polymer matrix, wherein said active component is selected from the group consisting of cosmetic agents, pharmaceutical agents, vitamins, bioactive agents and combinations thereof,

“Active agents…include therapeutic agents, nutritional supplements and hygiene aids.” 10:22-23. Chen identifies pharmaceutical agents, such as, analgesics, anti-Alzheimer’s disease medication, anti-depressants, muscle relaxants, and cough/cold remedies as therapeutic agents. 10:23-11:12.

See disclosure cited for last element of claim 17 below and discussion in subsection entitled “substantially uniform distribution” below.


Chen teaches that “[t]he method may further include the step of coating the mixture onto a backing film.” 4:31-32.

said film being formed by a controlled drying process which rapidly forms a viscoelastic matrix to lock-in said active in place within said matrix and maintain said substantially uniform distribution; and

“This homogeneous mixture (coating solution) …was…coated on … a polyester film (10) at 5-50 mil wet film thickness (9), more preferably 5-20 mil wet film thickness and dried under aeration at a temperature between 40-100 °C so as to avoid destabilizing the agents contained within the formulation (11). The manufacturing process for forming the dosage unit is illustrated in Figure 2.” 15:24-30; see also FIG 2.

Chen discloses Examples 1-8 in which the homogenous mixtures were “dried in a hot air circulating oven at 50 °C for 9 minutes.” 17:14-15. The water content (ranging from 65-85%) of the homogenous mixtures used to prepare the films of


47 ME1 19120309v.1



Examples 1-8 was reduced (to about 1.5-8.5%). Tables 1, 2, 5, and 6.

See also disclosure cited for last element of claim 17 and discussion in subsections entitled “controlled drying process…viscoelastic matrix…lock-in” and “substantially uniform distribution” below chart.

wherein said film is self-supporting and the active component is substantially uniformly distributed, whereby said substantially uniform distribution is measured by substantially equal sized individual unit doses which do not vary by more than 10% of said desired amount of said active component.

Chen discloses that “[t]he dry film formed by this process is a … stand alone, self supporting … film.” 15:30-31; see also 17:15-16 (“A glossy, substantially transparent, stand alone, self-supporting, non-tacky and flexible film was obtained after drying.”).

“In an embodiment of the invention, the solvent casting method includes a natural or synthetic hydrocolloid that is completely dissolved or dispersed in water or in a water alcoholic solution under mixing to form a homogenous formulation. In addition to the active agent and the hydrocolloid, any of the ingredients listed above may be added and dispersed or dissolved uniformly in the hydrocolloid solution.” 15:19-24 (emphasis added).

Chen’s Examples 1-8 demonstrate films that are substantially uniform. Uniform distribution is demonstrated in two ways: (1) visual inspection and (2) consistent dosage weight. See 17:15-16 (“A glossy, substantially transparent, stand alone, self-supporting, non-tacky and flexible film was obtained after drying.”); and 20 (Table 4) (reporting dosage weight of Example 1 film product as 0.028 ± 0.001 g/dosage form).

See also discussion in subsection entitled “substantially uniform distribution” below.

18. The multi-layer film of claim 17, wherein said first film layer is laminated to

See discussion below chart regarding claim 18.


48 ME1 19120309v.1



said second film layer.

30. The film of claim 17, wherein the anti-tacking agent is present in an amount sufficient to yield a film with a coefficient of friction which reduces adhesion of the film to adjacent surfaces during processing.

The ‘167 patent explains: “Anti-taking [sic] agents also may impart reduced film-to-film coefficient of friction, thereby reducing the problem of film dosage units, i.e., strips, adhering to one another. …The incorporation of anti-tacking agents may permit the individual strips to slide smoothly against one another as each unit is removed from the packaging.” Ex. 1001 at 19:11-17.

Chen discloses that its dry films are self-supporting, non-tacky and flexible such that they can be “packaged into a single pouch package, multi-unit blister card or multiple unit dispenser (Figure 3).” Ex. 1002 at 15:30-16:8. This is exemplified in Chen where the films of Examples 1-8 are described as non-tacky. 17:15-16.

And in Examples 4-8, for example, Chen exemplifies films where the relative amount of the anti-tacking agent is increased and both the wet and dry tack values decrease. Tables 5 and 6 (compare Examples 7 and 8 where the ratio of the anti-tacking agent (the surfactant Cremophor EL40 (see Ex. 1011)) relative to the other ingredients is higher in Example 8 because the relative amount of active is reduced—and the wet tack and dry tack values are reduced).

Chen describes “dry tack” and “wet tack” (quantitative values for tack), how to measure these properties, and describes embodiments as having tack values across a broad range of tack. 12:13-19; see also 29:9-13 (claims 2 and 3).

31. The film of claim 17, said film having a coefficient of friction which is low enough to reduce adhesion of said

See detailed disclosure directly above for claim 30.

Chen describes “wet tack” as “simulat[ing] the adhesion of film upon the contact with a moist mucosal surface.” 12:15-17.


49 ME1 19120309v.1



film to the roof of a mouth of a user of said film upon placement into the user’s mouth.

37. The process of claim 18, wherein said water-soluble polymer comprises hydroxyethyl cellulose.

“In embodiments of the invention, the hydrocolloid may...further be selected from a group of synthetic hydrocolloids exemplified by any of the following:...hydroxyethyl cellulose ....” 14:22-26.

49. The film of claim 17, said at least one first film layer or said second film layer further comprising a buffer.

Chen teaches the use of a buffer in a coating solution. “In addition to hydrocolloids and the active agents, the films may contain any or all of the following ingredients: … buffering agents …” 15:4-7; see also 11:17-19, 9:19-21. Examples 5-8 include citric acid. 21:12 (Table 5). Citric acid is a “buffering agent.” Ex. 1012, HANDBOOK, at 140.

56. The film of claim 17, said at least one first film layer or said second film layer further comprising a sweetener.

Chen discloses that its films may contain sweetening agents—such as sugar, sucrose, malitol, acesulfame potassium, sucralose, aspartame, saccharin, and honey—and exemplifies films with sweetening agents. 10:7-14, 15:4-7, Tables 1, 5, and 7, 21:11.

63. The film of claim 56, wherein said sweetener is Acesulfame-K.

Chen discloses that its films may include sweeteners such as acesulfame potassium (also known as Acesulfame-K). 10:7-13.

70. The film of claim 17, said at least one first film layer or said second film layer further comprising a flavoring agent.

Chen discloses that its films may contain flavoring agents—such as peppermint, clove, lemon, and spice—and exemplifies films with flavoring agents. 10:7-14, 15:4-7, Tables 1, 5, and 7, 21:11.

77. The film of claim 17, said at least one first film layer or said

Chen discloses that its films may contain coloring agents—such as FD&C colors—and exemplifies films with coloring agents. 11:20-22, 15:4-7, Tables


50 ME1 19120309v.1



second film layer further comprising a coloring agent.

1 and 5, 21:15-16.

80. The film of claim 17, wherein said water-soluble polymer matrix in said first film layer and/or in said second film layer comprises hydroxyethyl cellulose.


81. The film of claim 17, wherein said water-soluble polymer matrix in said first film layer and/or in said second film layer comprises carboxymethyl cellulose.

“In embodiments of the invention, the hydrocolloid may . . . further be selected from a group of synthetic hydrocolloids exemplified by any of the following: . . . carboxymethyl cellulose . . . .” 14:22-26.

87. The film of claim 17, wherein the anti-tacking agent comprises sodium benzoate.

Chen discloses that its film may contain sodium benzoate. 11:29. Claim 17 recites sodium benzoate in its “anti-tacking agent” Markush group.

93. The film of claim 17, wherein the active component comprises an active selected from the group consisting of an opiate, opiate derivative, analgesic and combinations thereof.

Chen discloses films with analgesics as an active agent. 10:22-24.

Chen further discloses that its films can include the active component hydromorphone. 4:6-9. Chen’s Example 6 is a film that includes hydromorphone as its active component. 21:3-17; Table 5.

Hydromorphone is a derivative of morphine. See, e.g., Ex. 1015, PHYSICIAN’S DESK REFERENCE, at 1994.

110. A multi-layer film for delivery of a desired amount of an active

See disclosure cited for preamble of claim 17.


51 ME1 19120309v.1



component comprising:

(a) a first film layer comprising:

See disclosure cited for element (a) of claim 17.

(i) an ingestible, water-soluble or water-swellable polymer matrix; and


(b) at least a second film layer comprising:

See disclosure cited for element (b) of claim 17.

(i) an ingestible, water-soluble or water-swellable polymer matrix comprising a water-soluble or swellable polymer;

See disclosure cited for element (b)(i) of claim 17.

wherein the first and/or second layers further comprise:

a desired amount of a substantially uniformly distributed active component, said active component being selected from the group consisting of cosmetic agents, pharmaceutical agents, vitamins, bioactive agents and combinations thereof;

a component selected from the group consisting of an anti-tacking agent, a sweetener, a flavor, an acidulent, an oxide

Chen discloses film containing multiple layers. 4:31-32 (“The method may further include the step of coating the mixture onto a backing film.”).

“In an embodiment of the invention, the solvent casting method includes a natural or synthetic hydrocolloid that is completely dissolved or dispersed in water or in a water alcoholic solution under mixing to form a homogenous formulation. In addition to the active agent and the hydrocolloid, any of the ingredients listed above may be added and dispersed or dissolved uniformly in the hydrocolloid solution.” 15:19-24. See also disclosure cited for last element of claim 17.

“Active agents…include therapeutic agents, nutritional supplements and hygiene aids.” 10:22-23. Chen identifies pharmaceutical agents, such as, analgesics, anti-Alzheimer’s disease medication, anti-depressants, muscle relaxants, and cough/cold remedies as therapeutic agents. 10:23-11:12.


52 ME1 19120309v.1



filler, propylene glycol, vitamin E acetate, polyacrylic acid, a preservative, a buffer, a coloring agent and combinations thereof; and

Chen discloses that its film may include one or more of an emulsifier, a plasticizer, a taste modifying agent, a preservative, a coloring agent, and a stabilizer. 15:4-7. See also disclosure cited for claims 70, 77, and 112. Chen also discloses that its film may contain polyacrylic acids. 14:24-28.


See disclosure cited for identical recitation in claim 17.

said film being formed by a controlled drying process which rapidly forms a viscoelastic matrix to lock-in said active component in place and maintain said substantially uniform distribution; and

See disclosure cited for second to last element of claim 17.

wherein said film is self-supporting, whereby said substantially uniform distribution of said active component is measured by substantially equal sized individual unit doses which do not vary by more than 10% of said desired amount of said active component.

See disclosure cited for last element of claim 17.

111. The multi-layer film of claim 110, wherein the sweetener

Chen discloses that its films may contain taste modifying or sweetening agents—such as sodium saccharin. 10:7-14, 15:4-7.


53 ME1 19120309v.1



comprises sodium saccharin.

112. The multi-layer film of claim 110, wherein the flavor comprises peppermint oil.

Chen provides various taste modifying agents on page 10, including different flavoring agents including, for example, essential oils or water soluble extracts of peppermint. Ex. 1002 at 10:7-14. Table 5 of Chen exemplifies films in Examples 5-8 that include peppermint. 21:8.

113. The multi-layer film of claim 110, wherein the acidulent comprises citric acid.

Chen teaches that its film may include a buffering agent or stabilizer in the form of citric acid. 11:17-18, 11:23-26. Chen also exemplifies films including citric acid. 21:12 (Examples 4-8 in Table 5).

114. The multi-layer film of claim 110, wherein the active is selected from the group consisting of opiates, opiate derivatives, analgesics and combinations thereof.


115. The multi-layer film of claim 110, further comprising sodium benzoate.


116. The multi-layer film of claim 110, wherein the water-soluble or water-swellable polymer matrix comprises a polymer selected from the group consisting of hydroxyethylcellulose, hydroxypropylcellulose, carboxymethyl cellulose and

Chen discloses that its film may include the polymers hydroxyethyl cellulose, hydroxypropyl cellulose, or carboxymethyl cellulose. 14:24-27.


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combinations thereof.

124. The film of claim 17, wherein the anti-tacking agent is present in an amount sufficient to impart reduced film-to-film coefficient of friction.

The ‘167 patent explains: “Anti-taking [sic] agents also may impart reduced film-to-film coefficient of friction, thereby reducing the problem of film dosage units, i.e., strips, adhering to one another. …The incorporation of anti-tacking agents may permit the individual strips to slide smoothly against one another as each unit is removed from the packaging.” Ex. 1001, at 19:11-17.

Chen discloses that its dry films are self-supporting, non-tacky and flexible such that they can be “packaged into a single pouch package, multi-unit blister card or multiple unit dispenser (Figure 3).” Chen at 15:30-16:8. This is exemplified in Chen where the films of Examples 1-8 are described as non-tacky. 17:15-16.

And in Examples 4-8, e.g., Chen exemplifies films where the relative amount of the anti-tacking agent is increased and both the wet and dry tack values decrease. See, id. at Table 5 and 6 (compare Examples 7 and 8 where the difference is that the ratio of the anti-tacking agent (the surfactant Cremophor EL40) relative to the other ingredients is higher in Example 8 because the amount of active reduced by 50%—and the wet tack and dry tack values are reduced by 50%).

Chen describes “dry tack” and “wet tack” (quantitative values for tack), how to measure these properties, and describes embodiments as having tack values across a broad range of tack. 12:13-19. See also 29:9-13 (claims 2-5).

1. “controlled drying process …viscoelastic matrix … lock-in ...”

As explained in subsection 2 of Ground 1 above, and as matter of law, the


55 ME1 19120309v.1

process limitation—“said film being formed by a controlled drying process which

rapidly forms a viscoelastic matrix to lock-in said active in place within said matrix

and maintain said substantially uniform distribution”—merits no weight in the

patentability analysis.

As explained in subsection 2 of Ground 2 above, both controlled drying

processes and the motivation for using such processes were known in the art prior

to the first claimed priority date.

Further, Chen discloses controlled drying. As Dr. Cohen explains, in Figure

2, Chen illustrates “controlling top air flow through the use of an aeration

controller 11, which controls the top air flow and avoids direct top air flow when

drying begins, followed by an increasingly direct air flow as drying proceeds.” Ex.

1007 at ¶46. Chen also discloses that its “homogenous mixture (coating solution)

… was … coated on … a polyester film … and dried under aeration at temperature

between 40-100 °C so as to avoid destabilizing the agents contained within the

formulation.” Ex. 1002 at 15:24-30. As Dr. Cohen explains, drying a viscoelastic

coating solution under normal drying conditions will form a “viscoelastic matrix”

with the solid components “lock[ed] in” within the matrix. Ex. 1007 at ¶35.

As explained in subsection 2 of Ground 1 above, Tapolsky discloses a

“controlled drying process” that forms a “viscoelastic matrix” and lock[s]-in” the

active. And as explained in subsection 4 of Ground 2 above, if necessary, the


56 ME1 19120309v.1

Board’s finding—that “Chen teaches controlled drying” (Ex. 1027, ‘588 History,

Board Decision, at 15-17)—should be applied here.


Subsection 3 of Ground 2 and subsection 3 of Ground 1 are incorporated by

reference. Further, Chen confirms uniform distribution of active in two ways: (1)

consistent dosage weight and (2) visual inspection. First, Chen reports the dosage

weight of the film of Example 1 as 0.028 ± 0.001 g/dosage film. Id. at 20:3 (Table

4). Second, Chen reports uniformity of its film by visual inspection: “[a] glossy,

substantially transparent, stand alone, self-supporting, non-tacky and flexible film

was obtained after drying.” Ex. 1002 at 17:15-16 (Examples 1-8). The ‘292

patent—which is incorporated by reference into the ‘167 patent (Ex. 1001 at 1:8-

14)—teaches that both visual inspection and consistent dosage weight are

acceptable means for determining uniformity. See, e.g., Ex. 1035, ‘292 patent,

20:53-61 (“The individual dosages were consistently 0.04 gm, which shows that

the distribution of the components within the film were consistent and uniform.”),

19:56-63 (“The uniform distribution of the components within the film was

apparent by examination by either the naked eye or under slight magnification.”).

See Ex. 1007 at ¶¶110-113.

Additionally, Chen’s process begins by forming a homogenous mixture. See

Ex. 1002 at 15:19-25, 17:6-12; see also Ex. 1007 at ¶¶108-109. Maintaining


57 ME1 19120309v.1

uniformity in the intermediate steps and in the final product would have been

obvious. See id. at ¶¶108-109, 114-117. Indeed, as Dr. Cohen stated, “[w]hen

working with a homogenous or completely dissolved coating solution, like the one

described in Chen, it would be difficult for a person of ordinary skill in the art not

to obtain a film that has uniform content of active.” Id. at ¶109.

3. “anti-tacking agent”

Claims 17 and 87 identify various materials as “anti-tacking agent[s].” But

ascribing a property to a material already disclosed in the prior art, e.g., the sodium

benzoate of Tapolsky, does not make it new. See subsection 4 of Ground 1.

4. “a second film layer comprising … an ingestible, water-soluble […] polymer matrix”

Chen discloses forming a film from a homogenous mixture of ingredients.

See Ex. 1002 at 4:24-31. Chen then discloses coating the homogenous mixture of

ingredients on a backing film. See id. at 4:31-32. Chen thereby discloses a two-

layer film and suggests that both layers can be made of the same homogenous

mixture of ingredients.

The homogenous mixture is a combination of a hydrocolloid, a solvent, an

active agent, and at least one reagent. See id. at 4:24-29. As exemplary

hydrocolloids, Chen discloses ingestible, water-soluble polymers. See id. at 14:22-

5:3 and disclosure cited in chart for Ground 4. Chen discloses exemplary active

agents that are recited in claim 17. See id. at 10:22-23 and disclosure cited in chart


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in Ground 4. Chen discloses exemplary reagents that are recited in the “anti-

tacking agent” Markush groups . See disclosure cited in chart in Ground 4.

For reasons explained in Ground 2, and as confirmed by Dr. Cohen, the

POSITA would naturally have considered Chen and Tapolsky together when

making water-soluble polymer-based film for delivery of a desired amount of

active. See Ex. 1007 at ¶¶63-65, 94-99. To the extent the Board considers Chen’s

disclosure of the content of the first film layer recited in claims 17 and 110 (i.e.,

Chen’s “backing film”) somehow lacking, the POSITA would naturally consider

Tapolsky’s disclosure as it pertains to a backing film. See Ex. 1007 at ¶¶100-101.

As explained in Ground 1, Tapolsky discloses a multi-layer film. See Ex.

1003 at 5:9-13. With respect to Example 37, Tapolsky discloses a film comprising

four layers. See id. at 37:4-25. Two layers of the Example 37 film form a backing

film that contains sodium benzoate, which is recited in the “anti-tacking agent”

Markush group of claim 17. See id. at 37:4-9. As Dr. Cohen explains, the

POSITA would have been motivated to combine the second film layer of Chen

with the backing film of Tapolsky’s Example 37, for example, to adjust or reduce

adhesion on one surface of Chen’s oral film. See Ex. 1007 at ¶¶100-101, 121-122.

As Dr. Cohen explains, the POSITA would have been able to successfully make

that combination without undue experimentation. See id.


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5. Dependent claim 18

Dependent claim 18, which depends on claim 17, recites “wherein said first

film layer is laminated to said second film layer.” As explained in subsection 2 of

Ground 1, this recited process merits no weight in the patentability analysis.

Nonetheless, Tapolsky discloses film in which the layers are laminated

together. See Ex. 1003 at 20:19-23 (“The film layers may be filmed independently

and then laminated together or may be filmed one on top of the other. The film

obtained after the two layers have been laminated together ... may be cut, if

desired, into any shape which is suitable for application to the mucosal tissue.”);

see also Examples 18 and 29 (exemplifying film containing multiple layers

laminated together). As explained in Ground 2 and confirmed by Dr. Cohen, the

POSITA would naturally have considered Chen and Tapolsky together when

making water-soluble polymer-based film for delivery of a desired amount of

active, including Tapolsky’s teaching of forming a multi-layer film by laminating

layers together. Ex. 1007 at ¶¶63-65, 94-99, 120-122. The POSITA would have

been able to laminate layers of Chen’s film together without undue

experimentation. See Ex. 1007 at ¶¶120-122.


obvious over Chen in view of Tapolsky. See also id. at ¶¶94-123.


60 ME1 19120309v.1

Ground 5: Claims 17, 18, 30, 31, 37, 49, 56, 63, 70, 77, 80, 81, 87, 93,

110-116, and 124 are Obvious over Chen in view of

Tapolsky in further view of MODERN COATING

BDSI incorporates by reference the discussion in Ground 3. See also Ex.

1007 at ¶¶124-128.

IX. THE REFERENCES ARE NOT CUMULATIVE

Tapolsky, Chen, and MODERN COATING are not cumulative with respect to

each other. The Board already expressly considered Chen in an appeal of the

reexamination of a related patent and issued a final decision including relevant

findings about Chen. See Ground 2. Tapolsky exemplifies a multi-layer film

having uniform active expressed out to the hundredths of g/cm2 of active. See

Ground 1. MODERN COATING discloses in detail several control drying processes

that may be used to produce uniform film. See Ground 3.

X. CONCLUSION

For the foregoing reasons, institution of inter partes review of the

challenged claims is respectfully requested.

Respectfully submitted,

Dated: October 28, 2014 By: /Danielle L. Herritt/

Danielle L. Herritt (Reg. No. 43,670) Kia Freeman (Reg. No. 47,577)


61 ME1 19120309v.1

CERTIFICATE OF SERVICE

The undersigned hereby certifies that a copy of the foregoing petition for

inter partes review (including Exhibits 1001-1046) was served on October 28,

2014 by transmitting a copy via EXPRESS MAIL to the patent owner at the

correspondence address of record for the subject patent:

Daniel A. Scola

HOFFMANN & BARON, LLP

6900 JERICHO TURNPIKE

SYOSSET, NY 11791,

By: /Danielle L. Herritt/ Danielle L. Herritt

Registration No. 43,670 Attorney for Petitioner

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