Filed on behalf of: Fisher & Paykel Healthcare …...Fisher & Paykel Healthcare Petition – IPR of...

Filed: October 12, 2016 Filed on behalf of:

Fisher & Paykel Healthcare Limited By: Brenton R. Babcock

Benjamin J. Everton KNOBBE, MARTENS, OLSON & BEAR, LLP 2040 Main Street, 14th Floor Irvine, CA 92614 Tel.: (949) 760-0404 Fax: (949) 760-9502 Email: [email protected]

UNITED STATES PATENT AND TRADEMARK OFFICE __________________________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD

__________________________________

FISHER & PAYKEL HEALTHCARE LIMITED, Petitioner

v.

RESMED LIMITED, Patent Owner

Case No. IPR2017-00062 U.S. Patent No. 9,119,931

PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 9,119,931

TABLE OF CONTENTS Page No.

i

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

II. THIS PETITION IS NOT REDUNDANT UNDER 35 U.S.C. § 325(D) .............................................................................................................. 5

III. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(A)(1) ........................ 7

A. Real Party-In-Interest (37 C.F.R. § 42.8(b)(1)) .................................... 7

B. Related Matters Under 37 C.F.R. § 42.8(b)(2) ..................................... 7

C. Lead and Back-up Counsel Under 37 C.F.R. § 42.8(b)(3) ................... 8

D. Service Information Under 37 C.F.R. § 42.8(b)(4) ............................... 9

IV. REQUIREMENTS FOR REVIEW UNDER 37 C.F.R. § 42.104 .................. 9

A. Grounds for Standing (37 C.F.R. § 42.104(a)) ..................................... 9

B. Statement of Relief Requested Under 37 C.F.R. §§ 42.104(b)(1)–(2) ............................................................................... 9

1. Prior Art ...................................................................................... 9

a. WO 2007/041751 (“D’Souza”) (Ex. 1102) .................... 10

b. Ultra Mirage Full Face Mask Brochure (“Ultra Mirage”) (Ex. 1103 at 6–7) ............................................. 11

c. U.S. Publication No. 2007/0044804 (“Matula-II”) (Ex. 1105) ................................................................ 12

d. FlexiFit Series, HC 431 Full Face Mask, Instructions for Use (“FlexiFit”) (Ex. 1106 at 9–10) ............................................................................... 12

e. U.S. 6,412,488 (“Barnett”) (Ex. 1107) ........................... 14

f. U.S. Publication No. 2004/0226566 (“Gunaratnam-II”) (Ex. 1110) ........................................ 14

TABLE OF CONTENTS (continued)

Page No.

ii

g. U.S. 6,851,425 (“Jaffre”) (Ex. 1112) .............................. 14

2. Grounds ..................................................................................... 15

C. Claim Construction (37 C.F.R. § 42.104(b)(3)) .................................. 16

V. THE ’931 PATENT ....................................................................................... 16

A. Example Embodiments ....................................................................... 16

B. Summary of the Prosecution History of the ’931 Patent .................... 19

VI. LEVEL OF ORDINARY SKILL IN THE ART ........................................... 20

VII. THE CHALLENGED CLAIMS OF THE ’931 PATENT ARE UNPATENTABLE ........................................................................................ 21

A. Legal Standard for Obviousness ......................................................... 21

B. Ground #1: Claims 57, 58, 61, 65, 68, 69, 71, 77–79 would have been obvious over D’Souza in view of Ultra Mirage, Barnett, and Matula-II ........................................................... 22

1. Overview of D’Souza (Ex. 1102) ............................................. 22

2. Overview of Ultra Mirage (Ex. 1103) ...................................... 23

3. Overview of Barnett (Ex. 1107)................................................ 24

4. Overview of Matula-II (Ex. 1105) ............................................ 25

5. Potential Differences from the Prior Art ................................... 26

a. “a pair of upper headgear connectors” ........................... 28

b. “elbow” ........................................................................... 30

c. “removably snap-fit” ...................................................... 32

d. “protruding vent” ............................................................ 34


Page No.

iii

e. “one or more folds” ........................................................ 35

f. “plurality of snap fingers” .............................................. 38

g. “each of the shroud module and the frame comprise polycarbonate” ................................................ 40

6. Reasons to Combine ................................................................. 40

C. Ground #2: Claim 60 would have been obvious over D’Souza in view of Ultra Mirage, Barnett, Matula-II, and FlexiFit ................................................................................................ 43

1. Overview of FlexiFit (Ex. 1106) ............................................... 43


a. “each upper headgear connector includes a slot” ................................................................................. 45


D. Ground #3: Claims 62–64 would have been obvious over D’Souza in view of Ultra Mirage, Barnett, Matula-II, FlexiFit, and Gunaratnam-II ................................................................ 47

1. Overview of Gunaratnam-II (Ex. 1110) ................................... 47


a. “headgear” ...................................................................... 48

b. “upper straps provide padding” ...................................... 50

c. “rear straps and the top straps form a closed loop”................................................................................ 52



Page No.

iv

E. Ground #4: Claims 43, 48–50, and 70 would have been obvious over D’Souza in view of Ultra Mirage, FlexiFit, Barnett, Jaffre, and Matula-II .............................................................. 54

1. Overview of Jaffre (Ex. 1112) .................................................. 54

2. Potential Differences from Prior Art ........................................ 55

a. “the elbow including a swivel” ....................................... 56

b. “anti-asphyxia valve” ..................................................... 57


F. Ground #5: Claims 46, 51, and 53–56 would have been obvious over D’Souza in view of Ultra Mirage, FlexiFit, Barnett, Jaffre, Matula-II, and Gunaratnam-II .................................... 58

1. Potential Differences from the Prior Art and Reasons to Combine .................................................................................... 58

VIII. CLAIM CHART ............................................................................................ 59

IX. SECONDARY CONSIDERATIONS ........................................................... 95

TABLE OF AUTHORITIES Page No(s).

v

ABS Global Inc. v. XY, LLC, IPR2014-01161, Paper No. 9 (PTAB January 13, 2015) .................................... 7

In re Cuozzo Speed Techs., LLC, 793 F.3d 1268 (Fed. Cir. 2015), aff’d, 136 S. Ct. 2131 (2016) .......................... 16

EMC Corp. v. Personalweb Techs., LLC, IPR2013-00084, Paper No. 64 (PTAB May 15, 2014) ................................ 12, 13

Graham v. John Deere Co., 383 U.S. 1 (1966) ....................................................... 21

KSR Int’l v. Teleflex Inc., 550 U.S. 398 (2007) ....................................................................21, 40, 43, 54, 59

Leapfrog Enters. Inc. v. Fisher-Price, Inc., 485 F.3d 1157 (Fed. Cir. 2007) .......................................................................... 95

Newell Cos., Inc. v. Kenney Mfg. Co., 864 F.2d 757 (Fed. Cir. 1988) ............................................................................ 95

Sony Corp. v. Raytheon Co., IPR2016-00209, Paper No. 12 (PTAB March 19, 2016) .................................... 6

Wyers v. Master Lock Co., 616 F.3d 1231 (Fed. Cir. 2010) .......................................................................... 95

OTHER AUTHORITIES

35 U.S.C. § 102 .................................................................................................passim

35 U.S.C. § 103 ............................................................................................ 15, 16, 21

35 U.S.C. §§ 311–319 ................................................................................................ 1

35 U.S.C. § 325 .......................................................................................................... 5

37 C.F.R. § 42.8 ................................................................................................. 7, 8, 9

37 C.F.R. § 42.100 ............................................................................................... 1, 16

37 C.F.R. § 42.104 ............................................................................................... 9, 16

Fisher & Paykel Healthcare Petition – IPR of U.S. Pat. 9,119,931

Exhibit List, Page 1

EXHIBIT LIST

Exhibit No. Description

1101 U.S. Patent No. 9,119,931

1102 PCT Publication No. WO 2007/041751 (D’Souza)

1103 Affidavit of Christopher Butler, Ultra Mirage Brochure (Ultra Mirage), dated September 6, 2016

1104 U.S. Patent No. 7,827,990 (Melidis)

1105 U.S. Publication No. 2007/0044804 (Matula-II)

1106 Affidavit of Christopher Butler, FlexiFit Instructions (FlexiFit), dated September 6, 2016

1107 U.S. Patent No. 6,412,488 (Barnett)

1108 U.S. Patent No. 6,631,718 (Lovell)

1109 PCT Publication No. WO 2007/045008 (Worboys)

1110 U.S. Publication No. 2004/0226566 (Gunaratnam-II)

1111 U.S. Publication No. 2004/0182398 (Sprinkle)

1112 U.S. Patent No. 6,851,425 (Jaffre)

1113 Declaration of Jason Eaton, P.E.

1114 Excerpts from the File History of U.S. Patent No. 9,119,931

1115 Malloy, Robert A., Plastic Part Design for Injection Molding: An Introduction, pp. 336–345 (Hanser Gardner Publications, Inc. 1994) (Malloy)

1116 Declaration of Fiona Cresswell, dated September 21, 2016


Exhibit List, Page 2

Exhibit No. Description

1117 Complaint of ResMed Ltd, ResMed Inc., and ResMed Corp. Under Section 337 of the Tariff Act of 1930, as amended, Investigation No. 337-TA-1022

1118 Answer of ResMed Corp. to Complaint for Patent Infringement and Counterclaims, Fisher &Paykel Healthcare Ltd. v. ResMed Corp., Case No. 3:16-cv-02068-DMS-WVG (S.D. Cal.)

1119 U.S. Provisional Application No. 61/064,406



1122 PCT Publication No. WO 2007/147088 (Matula-I)

1123 U.S. Patent No. 6,796,308 (Gunaratnam-I)

1124 PCT Publication No. WO 2005/123166 (Frater)


1

Pursuant to 35 U.S.C. §§ 311–319 and 37 C.F.R. § 42.100 et seq., Petitioner

Fisher & Paykel Healthcare Limited (“Petitioner” or “Fisher & Paykel”) requests

inter partes review of Claims 43, 46, 48–51, 53–58, 60–65, 68–71, and 77–79

(“Challenged Claims”) of U.S. 9,119,931 (“’931 Patent”) (Ex. 1101), which is

purportedly owned by ResMed Limited (“Patent Owner” or “ResMed”).

I. INTRODUCTION

Continuous positive airway pressure (CPAP) is a treatment that delivers

pressurized gas to a patient to keep the airways open and can be used to treat

obstructive sleep apnea. The ’931 Patent relates to CPAP mask systems used for

treatment of sleep-disordered breathing. The disclosed mask systems include a

seal that contacts the face of the patient and a frame that supports the seal.

Headgear holds the frame and seal in place on the patient.


2

The ’931 Patent discloses a CPAP mask system that allegedly enhances the

efficacy of therapy and patient compliance with therapy. Ex. 1101 at col. 1:39–41.

However, the Challenged Claims merely recite long lists of mask features that

were well-known prior to the ’931 Patent, and their combination in the claims

provided no unexpected results or benefits. As shown in the annotated figures on

the next page, many of the claimed features were described in ResMed’s own prior

art publication WO 2007/041751 (D’Souza). Ex. 1102.


3

’931 Patent

Prior Art D’Souza (rotated and reversed)

Elbow

Shroud

Vent

Cushion

Frame

Shroud Cushion

Frame

Lower headgear connectors

Lower headgear connectors

Elbow hole

Elbow hole

Vent Receiving Hole

Receiving Hole

Opening

Opening

“an annular elbow connection seal 448 adapted to engage an inlet conduit, e.g., elbow.”

448


4

D’Souza may not disclose a vent on the portion of the frame that protrudes

through the receiving hole on the shroud. However, it was well-known and

common in the CPAP prior art to place a vent on the frame at that precise nasal

bridge location. See § VII(B)(5)(d), infra; Ex. 1013 ¶¶ 73–74, 90–91. For

example, as shown in the figure below, Ultra Mirage teaches an air vent positioned

in the nasal bridge region. Ex. 1103 at 6.


5

Moreover, any additional differences (e.g., headgear straps providing

padding, headgear buckles, Velcro® on headgear) between the Challenged Claims

and the teachings of D’Souza were similarly well-known and disclosed in prior art

CPAP masks (e.g., FlexiFit, Matula-II, Barnett, and Jaffre), including ResMed’s

own prior art publications (e.g., Ultra Mirage and Gunaratnam-II). See §§ VII(B)–

(F), infra; Ex. 1013 ¶¶ 43–127. As explained below, the Challenged Claims’

lengthy recital of these well-known CPAP features resulted in nothing new or

unexpected. It would have been obvious for a skilled artisan at the time of the

invention to combine these known features with the mask assembly of D’Souza to

arrive at the mask assemblies of the Challenged Claims. Since the Challenged

Claims include lists of simple and well-known mechanical features, a skilled

artisan would have had a reasonable expectation of success in combining the

features of D’Souza with features in other prior art CPAP masks.

II. THIS PETITION IS NOT REDUNDANT UNDER 35 U.S.C. § 325(D)

This petition is not redundant under 35 U.S.C. § 325(d) with Petitioner’s

three other co-pending IPR petitions challenging the ’931 Patent. However, these

petitions include different grounds challenging different claims and involving

different prior art references.

For example, as explained in detail herein, the present petition requests

review of Claims 43, 46, 48–51, 53–58, 60–65, 68–71, and 77–79 using D’Souza


6

in view of other patent and non-patent prior art. Petitioner has concurrently filed a

second IPR petition requesting inter partes review of Claims 1, 4–8, 10–22, 25, 26,

28–37, and 40–42 using the same prior art. Although these two petitions rely on

the same prior art, these petitions are not redundant because there is no overlap in

the claims being challenged.

ResMed may argue that D’Souza is prior art under 35 U.S.C. §§ 102(a) and

102(e) for at least some of the Challenged Claims in both petitions based on

D’Souza, and may try to swear behind D’Souza and argue that D’Souza is not prior

art. Petitioner has concurrently filed a third IPR petition requesting inter partes

review of Claims 33–37, 40–43, 48–50, 57, 58, 60–64, 68–71, 77–79 using U.S.

6,412,488 (Barnett) in view of other patent prior art. Because Barnett issued more

than one year before the earliest filing date of the ’931 Patent, it is prior art under

35 U.S.C. § 102(b). Since D’Souza may be prior art under 35 U.S.C. §§ 102(a)

and 102(e) for at least some of the Challenged Claims and may be subject to

swearing behind, Petitioner respectfully requests that the Board institute both

D’Souza IPR proceedings and the Barnett IPR proceeding. See Sony Corp. v.

Raytheon Co., IPR2016-00209, Paper No. 12 (Decision on Institution of Inter

Partes Review) at 8–9 (PTAB March 19, 2016).

Additionally, both IPR petitions relying on D’Souza are being used in

combination with non-patent prior art publications that ResMed may try to argue


7

were not prior art to the ’931 Patent. Petitioner has concurrently filed a fourth IPR

petition requesting inter partes review of Claims 1, 4–8, 10–22, 25, 26, 28–32, 46,

51, 53–56 and 65 using WO 2007/147088 (Matula-I) in view of other patent prior

art. Because the petitions based on D’Souza rely on at least some non-patent prior

art and the petitions based on Barnett and Matula-I rely entirely on prior art patent

publications, Petitioner respectfully requests that the Board institute all four IPR

proceedings. See ABS Global Inc. v. XY, LLC, IPR2014-01161, Paper No. 9

(Decision on Institution of Inter Partes Review) at 19 (PTAB January 13, 2015).

III. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(A)(1)

A. Real Party-In-Interest (37 C.F.R. § 42.8(b)(1))

Fisher & Paykel Healthcare Limited is the real party-in-interest. Fisher &

Paykel Healthcare Limited is publicly traded on the NZSX and ASX stock

exchanges under the symbol FPH. Petitioner Fisher & Paykel provides patients

with a broad range of innovative products and systems for use in the treatment of

obstructive sleep apnea (OSA) and sells its products in over 120 countries.

B. Related Matters Under 37 C.F.R. § 42.8(b)(2)

ResMed and Fisher & Paykel are currently involved in proceedings with the

United States International Trade Commission in which ResMed has asserted that

certain Fisher & Paykel products infringe one or more claims of the ’931 Patent

(Investigation No. 337-TA-1022). Ex. 1117.


8

ResMed and Fisher & Paykel are currently involved in pending litigation in

the Southern District of California involving the ’931 Patent. See Fisher & Paykel

Healthcare Ltd. v. ResMed Corp., Case No. 3:16-cv-02068-DMS-WVG (S.D.

Cal.). ResMed asserted a claim for infringement of the ’931 Patent in its

counterclaims on September 7, 2016. Ex. 1118. The ’931 Patent, which was filed

after Fisher & Paykel launched its accused Simplus™ and Eson™ masks, does not

claim any inventive concept. Instead, the ’931 Patent claims laundry lists of well-

known mask features in an attempt to cover Fisher & Paykel’s products.

Fisher & Paykel has concurrently filed three other petitions for inter partes

review of the ’931 Patent that would affect, or be affected by, a decision in this

proceeding.

C. Lead and Back-up Counsel Under 37 C.F.R. § 42.8(b)(3)

Fisher & Paykel provides the following designation of counsel, all of whom

are included in Customer No. 20,995 identified in Fisher & Paykel’s Power of

Attorney.

Lead Counsel Back-up Counsel Brenton R. Babcock (Reg. No. 39,592) [email protected] Postal and Hand-Delivery Address: Knobbe, Martens, Olson & Bear, LLP 2040 Main St., 14th Floor Irvine, CA 92614 Telephone: (949) 760-0404 Facsimile: (949) 760-9502

Benjamin J. Everton (Reg. No. 60,659)[email protected] Postal and Hand-Delivery Address: Knobbe, Martens, Olson & Bear, LLP 2040 Main St., 14th Floor Irvine, CA 92614 Telephone: (949) 760-0404 Facsimile: (949) 760-9502


9

D. Service Information Under 37 C.F.R. § 42.8(b)(4)

Service information for lead and back-up counsel is provided in the

designation of lead and back-up counsel above. Petitioner also consents to service

by email at the following email address: [email protected].

IV. REQUIREMENTS FOR REVIEW UNDER 37 C.F.R. § 42.104

A. Grounds for Standing (37 C.F.R. § 42.104(a))

Petitioner hereby certifies that the ’931 Patent is available for inter partes

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

review challenging the claims on the grounds identified in this petition.

B. Statement of Relief Requested Under 37 C.F.R. §§ 42.104(b)(1)–(2)

1. Prior Art

Petitioner respectfully requests inter partes review of the Challenged Claims

of the ’931 Patent, filed July 31, 2014, which is a continuation of U.S. Application

No. 13/964,280, filed August 12, 2013, which is a continuation of U.S. Application

No. 13/745,077, filed January 18, 2013 (U.S. 8,528,561), which is a continuation

of U.S. Application No. 12/736,024 (U.S. 8,550,084), filed as PCT Application

No. PCT/AU2009/000241 on February 27, 2009, which claims priority benefit of

U.S. Provisional Application Nos. 61/064,406, 61/071,893, and 61/136,617

(collectively the “Provisional Applications”), filed March 4, 2008, May 23, 2008,


10

and September 19, 2008, respectively. Ex. 1101 at 1–2. The earliest possible

priority date of the ’931 Patent is March 4, 2008.

The Challenged Claims of the ’931 Patent would have been obvious in view

of the following prior art references:

a. WO 2007/041751 (“D’Souza”) (Ex. 1102)

D’Souza was filed on January 12, 2006 and published in English on April

19, 2007. Ex. 1102 at 1.

The earliest-filed provisional application from which the ’931 Patent claims

priority benefit, U.S. Provisional Application No. 61/064,406 (Ex. 1119), disclosed

a vent on the elbow or the silicone seal, but did not disclose a vent on the frame.

Ex. 1119 ¶¶ 66–69; Ex. 1113 ¶ 31. Thus, the earliest possible priority date for at

least Claims 43 and 48–50 of the ’931 Patent is the filing date of second-filed

provisional application, U.S. Provisional Application No. 61/071,893 (Ex. 1120),

filed on May 23, 2008.

A protruding vent arrangement is not shown or described in any of the

Provisional Applications. Ex. 1119; Ex. 1120; Ex. 1121; Ex. 1113 ¶ 31. Thus, the

earliest possible priority date for at least Claims 46, 51, 53–56, and 65 of the ’931

Patent is the filing date of the parent application of the ’931 Patent, U.S.

Application No. 12/736,024 (now U.S. 8,550,084), filed as PCT Application No.

PCT/AU2009/000241 on February 27, 2009.


11

Additionally, at least the first and second provisional applications did not

disclose the shroud module including a retaining portion positioned rearwardly of

the front opening. Ex. 1119; Ex. 1120; Ex. 1113 ¶ 31. Thus, the earliest possible

priority date for at least Claims 57, 58, 60–65, 68–71, and 77–79 is the filing date

of the third provisional application, U.S. Provisional Application No. 61/136,617,

on September 19, 2008.

Because D’Souza published more than one year before September 19, 2008,

D’Souza is prior art under 35 U.S.C. § 102(b) for the Challenged Claims.1

b. Ultra Mirage Full Face Mask Brochure (“Ultra Mirage”)

(Ex. 1103 at 6–7)

Ultra Mirage was publicly available on ResMed’s website at least by

September 1, 2006 and various pages bear the copyright dates of 2004 and 2005.

Ex. 1103 at 7; Ex. 1113 ¶ 50. The Internet Archive Wayback Machine shows that

the public had access to a ResMed webpage containing links to Ultra Mirage by at

least September 1, 2006. Ex. 1103 at 8. The authenticity of Ultra Mirage is

established by the accompanying affidavit of Christopher Butler, attaching Ultra

Mirage and testifying as to how the Wayback Machine works and its reliability.

1 Reference to 35 U.S.C. §§ 102 and 103 throughout this Petition are to the pre-

AIA versions of these statutes, which are applicable to the ’931 Patent.


12

Ex. 1103 at 1–2; see also EMC Corp. v. Personalweb Techs., LLC, IPR2013-

00084, Paper No. 64 at 45 (PTAB May 15, 2014).

The prior art status of Ultra Mirage is further supported by the declaration of

Jason Eaton, P.E. (Ex. 1113), explaining that a person of skill in the art would have

kept informed about CPAP products on the market and would have visited the

websites of well-known companies providing CPAP products, such as ResMed.

Ex. 1113 ¶¶ 48–50.

Because Ultra Mirage was available to the public more than one year before

the earliest possible priority date of the ’931 Patent, Ultra Mirage is prior art under

35 U.S.C. § 102(b).

c. U.S. Publication No. 2007/0044804 (“Matula-II”) (Ex. 1105)

Matula-II published on March 1, 2007. Ex. 1105 at 1. Because Matula-II

published more than one year before the earliest possible priority date of the ’931

Patent, it is prior art under 35 U.S.C. § 102(b).

d. FlexiFit Series, HC 431 Full Face Mask, Instructions for

Use (“FlexiFit”) (Ex. 1106 at 9–10)

FlexiFit was publicly available by at least October 16, 2006. Ex. 1113 ¶ 51;

Ex. 1106 at 5, 8, 11. The authenticity of FlexiFit is established by the

accompanying affidavit of Christopher Butler, attaching FlexiFit and testifying as

to how the Wayback Machine works and its reliability. Ex. 1106 at 1–2; see EMC


13

Corp., Paper No. 64 at 45. The Wayback Machine shows that the public had

access to a Fisher & Paykel webpage containing links to FlexiFit by at least

October 16, 2006. Ex. 1106 at 5, 8, 11.

The authenticity and public availability of FlexiFit is further supported by

Fiona Cresswell, testifying to personal knowledge that the documents are authentic

and were available. Ex. 1116 at 1–4; see EMC Corp., Paper No. 64 at 45. Ms.

Cresswell, a Fisher & Paykel employee, confirmed that: (1) Fisher & Paykel made

.PDF files of the most recent marketing materials and instructions for use (“IFUs”)

for its products available for public download by visitors to the website through

hyperlinks on the product webpages; (2) she has personally directed customers,

potential customers, business partners, alliances, and others to Fisher & Paykel’s

website when they asked for additional information; and (3) she has personal

knowledge of and recognizes FlexiFit and confirms that the document control

number and revision letter published thereon indicate that these IFUs were

uploaded to the webpage before October 2006 and were the current revision as of

April 6, 2005. Ex. 1116 at 1–4.

The prior art status of FlexiFit is further supported by the declaration of

Jason Eaton, P.E. (Ex. 1113), explaining that a person of skill in the art would have

kept informed about CPAP products on the market and would have visited the


14

websites of well-known companies providing CPAP products, such as Fisher &

Paykel. Ex. 1113 ¶¶ 48–50.

Because FlexiFit was available to the public more than one year before the

earliest possible priority date of the ’931 Patent, FlexiFit is prior art under

35 U.S.C. § 102(b).

e. U.S. 6,412,488 (“Barnett”) (Ex. 1107)

Barnett issued on July 2, 2002. Ex. 1107 at 1. Because Barnett issued more

than one year before the earliest possible priority date of the ’931 Patent, it is prior

art under 35 U.S.C. § 102(b).

f. U.S. Publication No. 2004/0226566 (“Gunaratnam-II”) (Ex.

1110)

Gunaratnam-II published on November 18, 2004. Ex. 1110 at 1. Because

Gunaratnam-II published more than one year before the earliest possible priority

date of the ’931 Patent, it is prior art under 35 U.S.C. § 102(b).

g. U.S. 6,851,425 (“Jaffre”) (Ex. 1112)

Jaffre issued on February 8, 2005. Ex. 1112 at 1. Because Jaffre issued as a

patent more than one year before the earliest possible priority date of the ’931

Patent, it is prior art under 35 U.S.C. § 102(b).


15

2. Grounds

Fisher & Paykel requests inter partes review of Claims 43, 46, 48–51, 53–

58, 60–65, 68–71, and 77–79 of the ’931 Patent. Because ResMed claimed a

laundry list of many well-known features in its many lengthy patent claims, this

petition necessarily includes several different prior art references that disclose

those various common features. The grounds below are not overlapping in that

each challenged claim of the ‘931 patent is subject to only one ground of

unpatentability.

Ground #1. Claims 57, 58, 61, 65, 68, 69, 71, and 77–79 would have been

obvious over D’Souza in view of Ultra Mirage, Barnett, and Matula-II under

35 U.S.C. § 103.

Ground #2. Claim 60 would have been obvious over D’Souza in view of

Ultra Mirage, Barnett, Matula-II, and FlexiFit under 35 U.S.C. § 103.

Ground #3. Claims 62–64 would have been obvious over D’Souza in view

of Ultra Mirage, Barnett, Matula-II, FlexiFit, and Gunaratnam-II under

35 U.S.C. § 103.

Ground #4. Claims 43, 48–50, and 70 would have been obvious over

D’Souza in view of Ultra Mirage, FlexiFit, Barnett, Jaffre, and Matula-II under

35 U.S.C. § 103.


16

Ground #5. Claims 46, 51, and 53–56 would have been obvious over

D’Souza in view of Ultra Mirage, FlexiFit, Barnett, Jaffre, Matula-II, and

Gunaratnam-II under 35 U.S.C. § 103.

C. Claim Construction (37 C.F.R. § 42.104(b)(3))

The claims of the ’931 Patent should be accorded their “broadest reasonable

construction” in light of the specification of the ’931 Patent.2

37 C.F.R. § 42.100(b); In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1278–79

(Fed. Cir. 2015), aff’d, 136 S. Ct. 2131 (2016). All terms have their ordinary and

customary meaning in light of the specification, as commonly understood by those

of ordinary skill in the art at the time of the invention. In re Translogic Tech., 504

F.3d 1249, 1257 (Fed. Cir. 2007).

V. THE ’931 PATENT

A. Example Embodiments

The ’931 Patent discloses a CPAP mask system 1010 having a frame 1040

that supports a cushion 1060 and attaches to the shroud 1020, as illustrated in Fig.

3 on the next page. Ex. 1101 at col. 6:51–54; Figs. 1–5. The frame 1040 defines a

breathing chamber and includes an opening 1046 that communicates with the 2 Petitioner’s position regarding the scope of the claims should not be taken as an

assertion regarding the appropriate claim scope in other adjudicative forums where

a different standard of claim construction and/or claim interpretation may apply.


17

elbow 1070. Id. at col. 6:60–65. The frame 1040 includes a vent arrangement

1076 for gas washout. Id. at 65-66. The shroud 1020 is structured to removably

attach to headgear and includes a vent receiving hole 1021 to accommodate the

vent arrangement 1076 that protrudes from the frame 1040. Id. at col. 7:9–23. The

bottom of the shroud 1020 includes an elbow hole 1032 to allow access for the

elbow 1070 to the frame 1040. Id. at col. 7:23–25.

Upper headgear connectors 1024 extend from each side of the top portion of

the shroud and lower headgear connectors 1025 extend from each side of the lower


18

portion. Id. at col. 7:28–30. Each lower headgear connector 1025 includes a clip

receptacle 1031 at the free end of the arm that interlocks with a headgear clip on a

headgear strap. Id. at col. 8:29–32.

As shown in Fig. 9 above, the headgear 1090 includes a pair of upper and

lower straps 1092, 1094. The upper and lower straps 1092, 1094 can be removably

attached to the upper and lower headgear connectors 1024, 1025. Id. at col. 10:41–

45. The free end of each strap can include a Velcro® tab that allows adjustment of

the length of the straps. Id. at col. 10:45–49. Upper straps 1092 split into top

straps 1096 that pass over the top of the patient’s head and can be connected by a

buckle (not shown). Id. at col. 10:52–59.


19

As shown in Figs. 11 and 14 above, the shroud can be connected to the

frame by a lower retaining mechanism at the opening of the shroud 1132. Id. at

col. 18:48–53. The opening 1132 of the shroud 1120 includes snap fingers 1145(1)

that resiliently deflect and engage the collar 1149 to removably retain the shroud

1120 to the frame 1140. Id. at col. 18:62–67.

B. Summary of the Prosecution History of the ’931 Patent

The ’931 Patent was originally filed as U.S. Application No. 14/447,673 on

July 31, 2014.

On December 8, 2014, the Examiner issued a rejection of all pending claims

based on U.S. Publication No. 2006/0272646 (“Ho”) in view of other prior art

references. Ex. 1114 at 244–255. The Examiner also rejected all of the pending

claims on the ground of nonstatutory double patenting. Id. at 252–254. None of


20

those pending claims are being challenged in this petition, but in response, the

Applicant added Claim 22–33 (of which Claim 30 corresponds to issued Claim

43). Id. at 320–324.

On February 3, 2015, the Examiner issued a final rejection of almost all of

the pending claims based on U.S. Publication No. 2006/0042629 (“Geist”) in view

of other prior art references. Id. at 343–361. The Examiner also indicated that

Claims 29 and 33 would be allowable if rewritten in independent form. Id. at 359.

With respect to Claim 30 (now Claim 43), applicant argued against the

combination of cited references. Id. at 449–450. Applicant also added Claims 34–

83, which recite different permutations of the previously pending claims. Id. at

436–446. The Examiner issued a notice of allowability on July 15, 2015. Id. at

465–472.

VI. LEVEL OF ORDINARY SKILL IN THE ART

A person having ordinary skill in the field at the time of the purported

invention of the ’931 Patent would have at least a bachelor’s degree in mechanical

engineering, biomedical engineering or other similar type of engineering degree

combined with at least two years of experience in the field of masks, respiratory

therapy, patient interfaces or relevant product design experience. Ex. 1113 ¶ 27.


21

VII. THE CHALLENGED CLAIMS OF THE ’931 PATENT ARE

UNPATENTABLE

This Petition explains, in detail, why the Challenged Claims of the ’931

Patent are unpatentable. The Petition is supported by the declaration of Jason

Eaton, P.E. Ex. 1113. Mr. Eaton is a Principal Mechanical Engineer at MSA

Safety. As explained in his declaration, Mr. Eaton has extensive academic and

industry experience in CPAP mask systems and design. Id. ¶¶ 3–8. His

declaration explains the basis for his conclusions that the Challenged Claims would

have been obvious. Id. ¶¶ 38–128.

A. Legal Standard for Obviousness

A claim is obvious “if the differences between the subject matter sought to

be patented and the prior art are such that the subject matter as a whole would have

been obvious at the time the invention was made to a person having ordinary skill

in the art to which said subject matter pertains.” 35 U.S.C. § 103. The

obviousness analysis includes an assessment of the Graham factors: (1) the scope

and content of the prior art; (2) any differences between the claims and the prior

art; (3) the level of ordinary skill in the art; and (4) any objective indicia of

nonobviousness. KSR Int’l v. Teleflex Inc., 550 U.S. 398, 406 (2007) (citing

Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966)).


22

B. Ground #1: Claims 57, 58, 61, 65, 68, 69, 71, 77–79 would have been obvious over D’Souza in view of Ultra Mirage, Barnett, and Matula-II

1. Overview of D’Souza (Ex. 1102)

D’Souza was submitted during the prosecution of the ’931 Patent, but was

not cited by the Examiner. Ex. 1101 at 9.

D’Souza discloses mask assemblies for the treatment of sleep disordered

breathing. Ex. 1102 ¶ 2. As shown in Figs. 6–7 (below), D’Souza discloses a

mask assembly 410 having a skeleton frame 412 that is removably interlocked with

a cushion/frame sub-assembly 430. Id. ¶¶ 96–100.


23

The skeleton frame 412 includes an upper support member 444 adapted to

support a forehead support (not shown), lower headgear clip receptacles 446

adapted to engage headgear clips (not shown), and an annular elbow connection

seal 448 adapted to engage an elbow (not shown). Id. ¶ 100. The cushion/frame

sub-assembly 430 includes a polycarbonate frame 414 interlocked with a liquid

silicone rubber cushion 416. Id. ¶¶ 97– 98.

2. Overview of Ultra Mirage (Ex. 1103)

Ultra Mirage was not submitted or cited during the prosecution of the ’931

Patent. Ex. 1101 at 1-12.


24

Ultra Mirage is a brochure for a full face commercial ResMed CPAP mask.

Ex. 1103 at 6. As shown above, Ultra Mirage discloses top and bottom removable

headgear clips to facilitate removal of the mask without resetting the headgear. Id.

Ultra Mirage further discloses an air vent to provide CO2 washout. Id. The mask

assembly receives a 360° rotating elbow with a quick release swivel to facilitate

easy disconnection from tubing. Id. The elbow includes a safety valve to provide

breathable fresh air when the flow generator does not provide flow. Id.

3. Overview of Barnett (Ex. 1107)

Barnett was submitted during the prosecution of the ’931 Patent, but was not

cited by the Examiner. Ex. 1101 at 5.


25

As shown above in Fig. 6, Barnett discloses a nasal mask assembly 30

includes a seal member 32 that contacts the patient’s face and a collar 34 that is

fixed and not movable relative to the seal member 32. Ex. 1107 at col. 3:48–52. A

conduit coupling member or elbow 36 is rotatably mounted to the collar 34 and

freely rotates 360° about a central axis of collar 34. Id. at col. 3:52–56.

4. Overview of Matula-II (Ex. 1105)

Matula-II was submitted during the prosecution of the ’931 Patent, but was

not cited by the Examiner. Ex. 1101 at 7.

Matula-II discloses a CPAP interface including a faceplate 36 mechanically

coupled to a seal member 38. Ex. 1105 ¶¶ 52–53. As shown in Fig. 4 of Matula-II


26

(above), coupling member 46 includes a pair of prongs 48 that define a channel 50

to receive the wall of the faceplate 36 and the end of the seal member 38. Id. ¶ 53.

Additionally, Matula-II discloses the seal member 38 having at least one

fold 106 provided at an upper portion of the seal member “so that the seal member

has the desired degree of flexibility.” Id. ¶ 66.

5. Potential Differences from the Prior Art

As detailed in the claim chart below, D’Souza discloses nearly all of the

limitations of Claims 57, 58, 61, 65, 71, 77–79. Any differences between the

Challenged Claims and the teachings of D’Souza were minor, well-known, and

disclosed in other prior art CPAP masks. 1113 ¶ 59.

With respect to Claim 57, D’Souza teaches a mask system for treating a

patient with sleep disordered breathing with a supply of air at positive pressure, the

system comprising: headgear including headgear straps (Ex. 1102 ¶ 3); and a

shroud module (skeleton frame 412) having a pair of lower headgear connectors

adapted to removably attach to the respective headgear straps of the headgear

(headgear clip receptacles 446). Id. ¶ 100. The shroud module has a front opening

(front opening of annular elbow connection seal 448). Id. ¶ 101. D’Souza further

teaches a cushion module (cushion/frame sub-assembly 430) comprising a frame

defining a breathing chamber (frame 414). Id. ¶¶ 97–98. The frame has a frame

opening leading to the breathing chamber (opening 418 of the frame 414). Id.


27

¶ 98. The cushion module further includes a cushion to form a seal with the

patient’s face (cushion 416). Id. ¶¶ 81 & 97. The cushion comprises a first,

relatively soft, elastomeric material and the frame comprises a second material that

is more rigid than the cushion (cushion 416 is constructed of liquid silicone rubber

and frame 414 is constructed from polycarbonate). Id. ¶¶ 97–98. The front

opening of the shroud module and the frame opening of the frame are aligned

along a common longitudinal axis (annular elbow connection seal 448 and opening

418 are aligned along a common longitudinal axis), and the shroud module and the

cushion module are structured and arranged to be removably snap-fit attached to

one another by moving the shroud module and the cushion module towards one

another along the longitudinal axis (annular elbow connection seal 448 and

opening 418 are arranged to be removably snap-fit by moving the skeleton frame

412 and the cushion/frame sub-assembly 430 along the longitudinal axis). Id.

¶ 101. The shroud module includes a retaining portion (annular elbow connection

seal 448) positioned rearwardly of the front opening, towards the frame, and

structured to snap fit with the cushion module. Id.


28

Many of the features of these claims are identified in the annotated versions

of Figs. 6–7 of D’Souza provided below. 1113 ¶ 61.

a. “a pair of upper headgear connectors”

Claim 57 recites “a shroud module having a pair of upper headgear

connectors and a pair of lower headgear connectors adapted to removably attach to

the respective headgear straps of the headgear.” As shown in Fig. 7 of D’Souza

(below), the shroud module 412 includes an upper support member 444 adapted to

Shroud module Lower headgear connectors First opening

Second opening to receive elbow

Silicone cushion

Polycarbonate frame

Cushion module

Annular retaining portion


29

support a forehead support (not shown) and lower headgear clip receptacles 446

adapted to engage headgear clips (not shown). Ex. 1102 ¶ 100.

D’Souza does not expressly disclose upper headgear connectors, but Ultra

Mirage teaches a shroud having a forehead support with upper and lower headgear

connectors, as shown on the next page. Ex. 1103 at 6. As explained in the

Reasons to Combine below, a skilled artisan at the time of the invention would

have been motivated to provide upper headgear connectors as taught by Ultra

Mirage to the forehead support of D’Souza. Ex. 1113 ¶ 63; see § VII(B)(6), infra.


30

Additionally, to the extent the removability of the headgear in D’Souza is

unclear, Ultra Mirage discloses this feature as shown above. Ex. 1103 at 6. Ultra

Mirage discloses, “Quick release headgear clips: top and bottom allows mask to be

removed without resetting the headgear and provides convenience and safety.” Id.

b. “elbow”

Claim 57 includes “a rotatable elbow directly attached to the shroud.” Claim

61 depends from Claim 57 and further includes, “the elbow is adapted to be

connected to an air delivery tube that delivers breathable gas to the patient.”

D’Souza discloses mask assemblies for use with a flow generator and

adapted to engage an elbow, but does not expressly disclose a rotatable elbow


31

directly attached to the shroud or the elbow being connected to an air delivery tube.

Ex. 1102 ¶¶ 3 & 100. However, as taught by Ultra Mirage and shown below, it

was well-known at the time of the invention to include a 360° rotating elbow on a

CPAP mask to provide control over a tubing system. Ex. 1103 at 6; Ex. 1113 ¶ 66.

Additionally, as shown in Figs. 1A–1B (below), Barnett discloses an elbow

36 that is mounted to the shroud 34 and freely rotates over a range of 360° in

direction A. Ex. 1107 at col. 3:52–57. As explained in the Reasons to Combine

below, a person of skill in the art at the time of the invention would have been


32

motivated to attach the elbow directly to the shroud as taught by Barnett while

allowing 360° rotation of the elbow module. Ex. 1113 ¶ 67; see § VII(B)(6), infra.

c. “removably snap-fit”

Claim 57 includes “the shroud module and the cushion module are

structured and arranged to be removably snap-fit attached to one another by

moving the shroud module and the cushion module towards one another along the

longitudinal axis,” and “the shroud module includes a retaining portion positioned

rearwardly of the front opening, towards the frame, and structured to snap fit with

the cushion module.”

D’Souza expressly discloses that the shroud and frame are adapted to

removably interlock, and a person of skill would understand that this assembly

comprises a removable snap-fit with elastic deformation and a release into the


33

interlocked position. Ex. 1102 ¶¶ 96 & 100; Ex. 1113 ¶¶ 69–70. As shown in Fig.

8 of D’Souza (below), the collar 440 passes through the retaining portion 448 and

removably interlocks with the retaining portion 448 in a snap-fit manner. Ex. 1113

¶ 70.

To the extent D’Souza provides insufficient teachings for a snap-fit, such

removable snap-fit arrangements were common and well-known in CPAP masks.

Ex. 1113 ¶¶ 69–72. For example, Matula-II teaches a plurality of snap fingers 48

that facilitate elastic deformation to mechanically and removably couple the seal

member 38 to the faceplate 36. Ex. 1105 ¶ 53. Based on the teachings of Matula-

II, a skilled artisan would have been motivated to incorporate such snap fingers

into the removable interlocking arrangement of D’Souza. Ex. 1113 ¶¶ 71–72; see

§ VII(B)(6), infra.


34

d. “protruding vent”

Claim 65 depends from Claim 57 and further includes “the frame includes a

protruding vent arrangement having a plurality of gas washout holes, wherein the

shroud module includes an upper opening to accommodate said protruding vent

arrangement.” As shown in Figs. 7–8 of D’Souza (below), when the mask

assembly 410 is assembled, the top portion 431 (nasal bridge region) of the frame

414 protrudes through the opening (between the elongated frame members 450) in

the shroud 412. Ex. 1102 ¶ 101.

D’Souza does not expressly disclose a vent on the protrusion. However,

vents positioned in the region of the D’Souza protrusion (nasal bridge region) were

common in prior art CPAP masks. Ex. 1113 ¶ 74. For example, as shown below,

Ultra Mirage teaches an air vent positioned in the nasal bridge region of the mask


35

assembly to provide CO2 washout and minimize noise output. Ex. 1103 at 6. As

explained in the Reasons to Combine, a skilled artisan at the time of the invention

would have been motivated to provide the vent of Ultra Mirage in the same nasal

bridge region of D’Souza, and thus on the protruding portion of D’Souza. Ex.

1113 ¶¶ 74, 90; see § VII(B)(6), infra.

e. “one or more folds”

Claim 68 depends from Claim 57 and further includes “a nasal bridge

portion of the cushion includes one or more folds to provide in use a higher level

of adaptability or flexibility to the nasal bridge region of the cushion module


36

relative to another region of the cushion module.” D’Souza does not expressly

disclose a fold, but as shown below, Matula-II discloses a fold 106 in the nasal

bridge portion of the cushion 38 to provide “the desired degree of flexibility.” Ex.

1105 ¶ 66.

Claim 68 also includes “each of said one or more folds comprises adjacent

first side walls interconnected by a second side wall.” The ’931 Patent shows each

fold having adjacent first side walls 52(1) interconnected by a second side wall

52(2), as illustrated on the next page in the annotated Fig. 32-3. Ex. 1101 at col.

14:40–42.


37

As shown in Fig. 4 below, Matula-II teaches a similar fold 106 having first

side walls interconnected by a second side wall. Ex. 1113 ¶ 77.

First side walls

Second side wall

Second side wall

First side wall First side wall


38

f. “plurality of snap fingers”

Claim 69 depends from Claim 57 and further includes “the retaining portion

of the shroud includes a plurality of snap fingers structured to engage the collar

with a snap-fit.”

As shown in Fig. 7 of D’Souza (below), the frame 414 has a collar 440

surrounding the opening 418. Ex. 1102 ¶ 98. The shroud 412 includes a retaining

portion 448 structured to engage and interlock with the collar 440. Id. ¶ 101.

As explained above, because the assembly of the interlocking portions of the

D’Souza shroud and frame requires elastic deformation of one or both components

for the larger diameter collar 440 to pass through the smaller diameter retaining

portion 448, the resulting interlocking is a snap-fit. Ex. 1102 ¶¶ 98 & 100; Ex.

1113 ¶ 81. As shown in Fig. 8 of D’Souza (above), the collar 440 snaps into


39

interlocked position on the front edge of the retaining portion 448. Ex. 1113 ¶ 81.

D’Souza does not expressly disclose a plurality of snap fingers, but such snap

fingers were common in prior art CPAP masks. Id. ¶ 82. For example, as shown

in Fig. 4 and the partial view of Fig. 5 (below), Matula-II discloses a “pair of

prongs 48” structured to mechanically couple the seal member 38 to the faceplate

36. Ex. 1105 ¶ 53. Because the faceplate 36 of Matula-II is semi-rigid, the snap-

fingers 48 deflect radially inward and elastically recover to mechanically couple

the seal member 38 to the faceplate 36 with a snap-fit. Id. ¶ 51; Ex. 1113 ¶ 82.

FIG. 4 FIG. 5 (PARTIAL)


40

g. “each of the shroud module and the frame comprise

polycarbonate”

Claim 71 depends from Claim 57 and further includes “each of the shroud

module and the frame comprise polycarbonate and the cushion comprises

silicone.” D’Souza discloses a cushion 416 constructed of liquid silicone rubber

and a frame 414 constructed of polycarbonate. Ex. 1102 ¶¶ 97–98. D’Souza

further discloses the shroud being formed of plastic, but does not expressly

disclose that the plastic is polycarbonate. Id. ¶ 100. However, it was common at

the time of the invention to construct CPAP components, including the shroud,

from polycarbonate. Ex. 1113 ¶ 84.

6. Reasons to Combine

Based on the teachings of the prior art, a person of skill in the art at the time

of the invention would have been motivated to provide each of the features

discussed above. See supra § VII(B)(5); see also KSR, 550 U.S. at 419. Such

modifications would have been mere combinations of familiar elements according

to known methods that do no more than yield predictable results. KSR, 550 U.S. at

416. Because D’Souza, Ultra Mirage, Barnett, and Matula-II all teach CPAP

masks for the treatment of sleep disordered breathing, the features taught in Ultra

Mirage, Barnett, and Matula-II would have been readily compatible with and easily


41

incorporated into the mask of D’Souza with a reasonable expectation of success.

Ex. 1113 ¶ 85.

A person of skill in the art at the time of the invention would have been

motivated to provide removable headgear straps to the mask assembly of D’Souza

to enable quick and easy mask fitting and removal (e.g., for cleaning or

replacement). Ex. 1103 at 6; Ex. 1113 ¶ 86. Additionally, a skilled artisan would

have known to add upper headgear connectors as taught by Ultra Mirage to the

forehead support of D’Souza to secure the upper portion of the mask and to

stabilize the mask assembly. Ex. 1113 ¶ 86.

As explained above with respect to Ultra Mirage, it was well-known at the

time of the invention to provide an elbow that is rotatable over a 360° range to

provide control over the tubing. Ex. 1103 at 6; Ex. 1113 ¶¶ 87–88. The rotatable

elbow would allow the wearer to position the tubing to provide the most

convenient, comfortable, and low force mask connection. Ex. 1113 ¶ 87.

Additionally, a skilled artisan would have been motivated to directly attach

the elbow to the shroud as taught in Barnett to make it easier to detach the elbow

without affecting the engagement of the mask components. Id. ¶ 89. Attaching the

elbow directly to the shroud instead of the frame would have also provided more

design flexibility. Id. A skilled artisan would have understood that it would be


42

easier to attach the elbow to a shroud than a component of the breathing chamber

because the breathing chamber requires an air tight seal. Id.

A skilled artisan would have also known to modify D’Souza to include a

vent as taught by Ultra Mirage for CO2 washout. Ex. 1103 at 6; Ex. 1113 ¶¶ 90–

91. A skilled artisan would have recognized the benefits in positioning the vent on

the protruding portion of the frame to minimize noise output. Ex. 1103 at 6; Ex.

1113 ¶ 90. Additionally, a person of skill would have been motivated to place the

vent in the nasal bridge region to minimize dead space and because air from the

inlet would flow by the patient’s nose and exit the vent to flush exhaled air

effectively and minimize re-breathing of exhaled air. Ex. 1113 ¶ 90.

Additionally, a skilled artisan would have known to incorporate the folds

taught by Matula-II with the D’Souza cushion to provide a higher degree of

flexibility in the delicate nose bridge region compared to other regions. Ex. 1105

¶ 66; Ex. 1113 ¶ 92.

To the extent D’Souza provides insufficient teachings for a removable snap-

fit between the shroud and the cushion module, a person of skill in the art at the

time of the invention would have been motivated to modify the retaining portion of

D’Souza to include the plurality of snap fingers to make it easier to join the shroud

to the cushion module. Ex. 1113 ¶¶ 93–94. Based on the teachings of Matula-II, a

skilled artisan would have understood that it would be advantageous to provide a


43

plurality of snap-fit fingers on the retaining portion of D’Souza to facilitate

repeated insertion of the collar 440 through the rigid retaining portion 448 without

destroying the parts. Id. Although the Matula-II snap fingers are on the elbow,

incorporating such snap fingers in the retaining portion of D’Souza would have

involved a simple substitution of one known feature for another to obtain

predictable results and achieve the same purpose of providing a removable

mechanical interlock between the shroud and the cushion module. See KSR, 550

U.S. at 416; Ex. 1102 ¶ 96.

Further, it was well-known at the time of the invention to construct CPAP

mask components, including the shroud, from polycarbonate to provide good

mechanical properties of strength, rigidity, and toughness to support the headgear.

Ex. 1113 ¶ 95. Polycarbonate CPAP components can also be cleaned, disinfected,

and/or sterilized by most commonly used methods. Id.

C. Ground #2: Claim 60 would have been obvious over D’Souza in view of Ultra Mirage, Barnett, Matula-II, and FlexiFit

1. Overview of FlexiFit (Ex. 1106)

FlexiFit was not submitted during the prosecution of the ’931 Patent. Ex.

1101 at 1–12.

As shown below, FlexiFit shows headgear (K) removably coupleable to

mask base (A). Ex. 1106 at 10 (“FITTING YOUR MASK”). The headgear (K)

has upper horizontal straps and lower horizontal straps. Id. The upper horizontal


44

straps split to form a pair of top crown straps and rear straps that form a closed

loop. Id. The headgear straps have Velcro® tabs. Id. at 10 (“ASSEMBLING

YOUR MASK”).

Lower Horizontal

Straps

Upper Horizontal

Straps

Top Crown Straps Closed Loop


45

As shown in Figs. 3–5 of FlexiFit (below), the upper horizontal straps attach

to corresponding slots in the mask base (A). Id. at 10 (“ASSEMBLING YOUR

MASK”). The lower headgear straps are secured to headgear clips (H), which

attach to GliderTM strap (E). The upper and lower horizontal straps and top crown

straps can be re-adjusted to prevent leaks between the mask and the user. Id. at 10

(“FITTING YOUR MASK”).


a. “each upper headgear connector includes a slot”

Claim 60 depends from Claim 57 and further includes “each upper headgear

connector includes a slot adapted to receive a respective headgear strap in use,”

and “each lower headgear connector is adapted to be removably interlocked with a

headgear clip associated with a respective headgear strap.” As explained above,

the combination of D’Souza and Ultra Mirage teaches a mask assembly with upper

headgear connectors. See supra § VII(B)(5)(a). D’Souza does not expressly


46

disclose upper headgear connector slots, and Ultra Mirage shows the slots on

headgear clips. However, as shown on the previous page in Fig. 3, FlexiFit

discloses attaching top horizontal straps to corresponding slots in the Mask Base.

Ex. 1106 at 10 (“ASSEMBLING YOUR MASK”); Ex. 1113 ¶ 97.

D’Souza discloses lower headgear connectors adapted to engage clips, but to

the extent D’Souza provides insufficient teachings for the removability of the clips,

Ultra Mirage and FlexiFit both disclose removable lower headgear clips. Ex. 1102

¶ 100; Ex. 1103 at 6; Ex. 1106 at 10 (“FITTING YOUR MASK”).



motivated to combine the features of D’Souza, Ultra Mirage, Barnett, Matula-II,

and FlexiFit to arrive at the claimed mask systems of Claim 60 for at least the

reasons provided above. Ex. 1113 ¶ 100; see supra §§ VII(B)(6).

Additionally, a person of skill in the art would have been motivated to

provide the combination of upper headgear connectors having slots and lower

headgear connectors adapted to engage headgear clips as taught by FlexiFit. Ex.

1106 at 10; Ex. 1113 ¶ 101. When headgear is pulled over a user’s head, the lower

headgear straps undergo tension, making it difficult to properly position or remove

the lower headgear straps. Ex. 1113 ¶ 101. At the time of the invention, a skilled

artisan would have been motivated to provide lower headgear clips with removable


47

clips as taught by FlexiFit, so that the user would not have to force the lower

headgear straps over his/her head. Id. Since upper headgear straps do not undergo

as much tension as the lower headgear straps when positioning the mask assembly,

a skilled artisan would have known that a simpler design option would have been

to provide upper headgear connectors with slots as taught by FlexiFit and that such

an alternative arrangement would simplify manufacturing and reduce parts. Id.

Because D’Souza, Ultra Mirage, Barnett, Matula-II, and FlexiFit all teach

similar CPAP masks for the treatment of sleep disordered breathing, the features

taught in Ultra Mirage, Barnett, Matula-II, and FlexiFit would have been readily

compatible with and easily incorporated into the mask of D’Souza with a

reasonable expectation of success. Ex. 1113 ¶ 100.

D. Ground #3: Claims 62–64 would have been obvious over D’Souza in view of Ultra Mirage, Barnett, Matula-II, FlexiFit, and Gunaratnam-II

1. Overview of Gunaratnam-II (Ex. 1110)

The Examiner cited Gunaratnam-II during prosecution, but for a different

feature and as a secondary reference. Ex. 1101 at 6; Ex. 1114 at 358–359.


48

Gunaratnam-II discloses nasal assemblies having headgear. Ex. 1110 at

Abstract. As shown in Fig. 135 (above), Gunaratnam-II discloses headgear having

a pair of top straps and rear straps. Id. at Fig. 135. The top straps are removably

and adjustably coupled with a buckle. Id. ¶ 316.


a. “headgear”

As detailed in the Claim Chart below, Claim 62 depends from Claim 57 and

recites various headgear features.

As explained above, the combination of D’Souza and Ultra Mirage teaches

headgear connectors adapted to removably attach to respective headgear straps and

upper and lower headgear connectors. See supra § VII(B)(5)(a). D’Souza and

Ultra Mirage do not expressly disclose the specific headgear configuration recited


49

in Claim 62, but as shown in the annotated figure below, FlexiFit teaches headgear

(K) having the above-mentioned features. Ex. 1106 at 10 (“FITTING YOUR

MASK” & “ASSEMBLING YOUR MASK”).

FlexiFit discloses adjustable upper and lower headgear straps, top crown

straps configured to pass over the top of the patient’s head, and rear straps adapted

to pass behind the patient’s head. Id. at 10 (“ASSEMBLING YOUR MASK”). As

shown in the figure below, the upper straps split to form the pair of top crown

straps and the pair of rear straps. Id.

Additionally, FlexiFit discloses Velcro® tabs on the straps. Id. at 10

(“FITTING YOUR MASK”). To the extent there is insufficient teaching that the

Velcro® tabs are positioned at the free ends of the straps, such positioning would

Top Crown Straps

Rear Straps

Lower Straps

Upper Straps


50

have been obvious to a person of skill in the art and typical for headgear straps in

prior art. Ex. 1113 ¶ 106.

Gunaratnam-II also discloses a pair of top straps removably and adjustably

threaded through a buckle, as shown in Fig. 135 (below). Ex. 1110 ¶ 316 & Fig.

135; Ex. 1113 ¶ 107. Gunaratnam-II discloses that each top strap is wrapped

around a respective cross-bar associated with the buckle. Ex. 1110 ¶ 316.

b. “upper straps provide padding”

Claim 63 includes “the upper straps provide padding to the respective

headgear connectors of the shroud module on the patient’s face in use.”


51

As shown in Figs. 2 and 3 (below), FlexiFit teaches flexible headgear straps.

Ex. 1106 at 10.

Additionally, as shown below, FlexiFit shows that a portion of each upper

strap of headgear (K) is sufficiently flexible to extend across the patient-facing side

of the upper headgear connector of the mask frame (A) and loop through the upper

headgear connector, and around to the outside-facing side of the mask frame (A).

Id. A person of skill in the art would have recognized that the flexible headgear

strap between the upper headgear connector and the user’s face provides padding.

Ex. 1113 ¶ 110.


52

c. “rear straps and the top straps form a closed loop”

Claim 64 includes “the rear straps and the top straps form a closed loop to

encircle a rear portion of the patient’s head when in use.” As shown below,

FlexiFit teaches the rear straps and the top straps forming a closed loop. Ex. 1106

at 10; Ex. 1113 ¶ 111.



motivated to combine the features of D’Souza, Ultra Mirage, Barnett, Matula-II,

FlexiFit, and Gunaratnam-II to arrive at the claimed mask systems of Claims 62–

Closed Loop

Top Crown Straps

Rear Straps


53

64 for at least the reasons provided above. Ex. 1113 ¶ 112; see supra §§ VII(B)(6),

VII(C)(3).

Further, D’Souza and Ultra Mirage disclose CPAP mask assemblies adapted

to engage headgear, and FlexiFit and Gunaratnam-II disclose headgear. Ex. 1113

¶¶ 113–114. As explained above, FlexiFit teaches each of the headgear features

recited in Claims 60–64. As shown in the annotated drawings below, the mask

assembly of D’Souza as modified by Ultra Mirage teaches a mask assembly with

upper and lower connectors that would be compatible with the upper and lower

straps of the FlexiFit headgear. Id. ¶ 113.

FlexiFit (partial) D’Souza (rotated) Ultra Mirage

A person of skill in the art would have recognized the benefits of using the

FlexiFit headgear in connection with upper headgear connectors. Doing so would


54

provide padding between the upper headgear connectors and the user’s face to

provide comfort, without increasing the number of components. Id. ¶¶ 110, 114.

Further, a skilled artisan at the time of the invention would have been motivated to

provide a headgear configuration with a rear loop, as taught by FlexiFit, to stabilize

the upper and lower straps, while minimizing the total amount of material required

for the headgear. Id. ¶ 114. A skilled artisan would have also known to join the

top crown straps of the FlexiFit headgear using a buckle as taught by Gunaratnam-

II to allow for adjustment and to maintain the straps in a desired position. Ex.

1110 ¶ 316; Ex. 1113 ¶ 115.

These modifications would have been a mere combination of familiar

elements according to known methods that does no more than yield predictable

results. KSR, 550 U.S. at 416.

E. Ground #4: Claims 43, 48–50, and 70 would have been obvious over D’Souza in view of Ultra Mirage, FlexiFit, Barnett, Jaffre, and Matula-II

1. Overview of Jaffre (Ex. 1112)

Jaffre was submitted during the prosecution of the ’931 Patent, but was not

cited by the Examiner. Ex. 1101 at 5.


55

Jaffree discloses CPAP devices having an exhaust port assembly. Ex. 1112

at col. 1 at 13–33. As shown in Figs. 8–9 (above), the exhaust port assembly 62

includes an auxiliary opening 88 with a valve member 68. Id. at col. 10:11–14.

When the pressure system is functioning properly, a cantilevered member 90 of the

valve member 68 flexes to block the opening 88 (see Fig. 8). Id. at col. 10:14–17.

If the pressure of the gas in the interior 92 is not greater than ambient atmosphere,

cantilever member 90 returns to its normal position and unblocks auxiliary opening

88 so that the patient has access to ambient atmosphere (see Fig. 9). Id. at col.

10:23–28.

2. Potential Differences from Prior Art

As detailed in the Claim Chart below, D’Souza discloses nearly all of the

limitations of Claims 43, 48–50, and 70. Any differences were well-known at the

time of the invention and taught by other prior art CPAP masks. Ex. 1113 ¶ 117.

For example, as discussed above with respect to Claims 57, 60–62, and 65, the


56

combination of D’Souza, Ultra Mirage, FlexiFit, Barnett, and Matula-II teaches

most of the features of Claims 43, 48–50, and 70. See supra §§ VII(B)–VII(D).

a. “the elbow including a swivel”

Claim 43 further includes “the elbow including a swivel adapted to connect

to an air delivery tube.” D’Souza discloses an elbow adapted to engage the mask,

but does not expressly disclose the elbow including a swivel. Ex. 1102 ¶ 100.

However, as shown below, Ultra Mirage does.

Ultra Mirage specifically discloses a 360° rotating elbow having a “[q]uick

release swivel [that] allows easy disconnection from tubing.” Ex. 1103 at 6.


57

b. “anti-asphyxia valve”

Claim 43 includes “the elbow including an anti-asphyxia valve (AAV) and a

port that is selectively closed by a flap portion of the AAV.” Claim 70 depends

from Claim 57 and further incudes “the elbow includes an anti-asphyxia valve and

wherein the anti-asphyxia valve includes a flap portion adapted to selectively close

a port provided in the elbow.”

D’Souza discloses a mask assembly adapted to engage an elbow and Ultra

Mirage discloses a safety valve in the elbow, but Ultra Mirage does not expressly

disclose that the valve includes a flap portion. Ex. 1102 ¶ 100; Ex. 1103 at 6.

However, such valve assemblies in CPAP elbows were well-known prior to the

’931 Patent. Ex. 1113 ¶ 121. As shown in Figs. 8–9 of Jaffre (below), the valve

has a flap portion 68 that selectively closes port 88. Ex. 1112 at col. 10:14–28.


58



motivated to combine the features of D’Souza, Ultra Mirage, FlexiFit, Barnett,

Jaffre, and Matula-II to arrive at the claimed mask features of 43, 48–50, and 70

for at least the reasons provided above. Ex. 1113 ¶ 122; see supra §§ VII(B)(6),

VII(C)(3), VII(D)(3).

Based on the teachings of Ultra Mirage, a person of skill in the art would

have been further motivated to provide an elbow with a swivel to facilitate easy

adjustment and disconnection from tubing. Ex. 1103 at 6; Ex. 1113 ¶ 123.

Additionally, a person of skill in the art would have been motivated to

provide the anti-asphyxia valve of Jaffre to the D’Souza elbow to allow patients to

breathe fresh air when the flow generator does not provide flow. Ex. 1103 at 6;

Ex. 1109 ¶ 106; Ex. 1113 ¶ 124. A skilled artisan would understand that an anti-

asphyxia valve using a flap is advantageous because the flap easily moves by

airflow and pressure. Ex. 1113 ¶ 125.

F. Ground #5: Claims 46, 51, and 53–56 would have been obvious over D’Souza in view of Ultra Mirage, FlexiFit, Barnett, Jaffre, Matula-II, and Gunaratnam-II

1. Potential Differences from the Prior Art and Reasons to Combine

As detailed in the Claim Chart below, D’Souza discloses nearly all of the

limitations of Claims 46, 51, and 53–56. Any differences were well-known at the

time of the invention and taught by other prior art CPAP masks. Ex. 1113 ¶ 126.


59

For example, as discussed above with respect to Claims 43, 62, 63, 65, and 69, the

combination of Ultra Mirage, FlexiFit, Barnett, Jaffre, Matula-II, and Gunaratnam-

II teach the potentially different features. See supra §§ VII(B)–VII(E). A person

of skill in the art at the time of the invention would have been motivated to

combine the features of D’Souza, Ultra Mirage, FlexiFit, Barnett, Jaffre, Matula-II,

and Gunaratnam-II to arrive at the claimed mask features of Claims 46, 51, and

53–56 for at least the reasons provided above. Id. ¶ 127; see supra §§ VII(B)(6),

VII(C)(3), VII(D)(3); VII(E)(3). Additionally, combining these features would

have been a mere combination of familiar elements according to known methods

that does no more than yield predictable results. KSR, 550 U.S. at 416.

VIII. CLAIM CHART

’931 Patent Prior Art 43. A mask system for delivery of a supply of air at positive pressure to a patient's airway, the mask system comprising:

D’Souza: “[M]ask assembl[ies] for use with blowers and flow generators in the treatment of sleep disordered breathing (SDB) . . . . [P]atient interface is held in a sealing position by headgear so as to enable a supply of air at positive pressure to be delivered to the patient's airways.” Ex. 1102 ¶ 3.

[A] a cushion module comprising a frame defining a

breathing chamber configured to receive the positive pressure air, and

a cushion to form a seal with the patient's face in a nasal bridge

D’Souza: “[F]rame 414 and a cushion 416 are . . . interlocked to provide a cushion/frame sub-assembly 430. . . . [C]ushion 416 is constructed of liquid silicone rubber (LSR).” Ex. 1102 ¶ 97. “[F]rame 414 includes an upper wall that provides an opening 418 for communicating with an inlet conduit. . . . A side wall 420 extends from the upper wall . . . . [F]rame 414 is constructed of polycarbonate.” Id. ¶ 98.


60

region, a cheek region and a lower lip/chin region of the patient's face,

wherein the cushion is constructed of a first, relatively soft, elastomeric material and the frame is constructed of a second material that is more rigid than the cushion,

“[C]ushion provides a seal around the patient's nose and mouth to enable the delivery of breathable gas to the patient's nose and mouth.” Id. ¶ 81.

[B] the frame including a washout vent,

Ultra Mirage: “Air vent provides excellent CO2 washout and minimal noise output.” Ex. 1103 at 6.

[C] the frame including an opening;

D’Souza: “[A]nnular elbow connection seal 448 interlocks with the annular wall 440.” Ex. 1102 ¶ 101.

[D] headgear to maintain the mask

D’Souza: “[P]atient interface is held in a sealing position by headgear.” Ex. 1102 ¶ 3.


61

system in a desired position on the patient's face, the headgear comprising a pair of upper headgear straps each configured to extend above a respective one of the patient's ears in use and a pair of lower headgear straps each configured to extend below a respective one of the patient's ears in use,

“[S]keleton frame 412 includes an upper support member 444 adapted to support a forehead support, lower headgear clip receptacles 446 adapted to be engaged with clips provided to straps of a headgear assembly (not shown).” Id. ¶ 100. Ultra Mirage: “Quick release headgear clips: top and bottom allows mask to be removed without resetting the headgear and provides convenience and safety.” Ex. 1103 at 6.

FlexiFit: “Gently adjust the Top Horizontal straps then the Lower Horizontal straps.” Ex. 1106 at 10 (“FITTING YOUR MASK”). “[A]ttach the four straps in to the corresponding slots in the Mask Base and the GliderTM strap (E).” Id. at 10 (“ASSEMBLING YOUR MASK”).


62

[E] wherein a free end of each of the upper headgear straps and the lower headgear straps includes a hook tab structured to engage a remainder of the respective upper headgear strap and respective lower

FlexiFit: “Gently adjust the Top Horizontal straps then the Lower Horizontal straps . . . . If leaks occur . . . tighten the top horizontal straps. . . . If leaks occur . . . tighten the lower horizontal straps.” Ex. 1106 at 10 (“FITTING YOUR MASK”). “[A]ttach the four straps in to the corresponding slots in the Mask Base and the GliderTM strap (E). This can be done without undoing the Velcro® Tabs by sliding the Headgear into the slots.” Id. at 10 (“ASSEMBLING


63

headgear strap to secure the upper and lower straps in place in a length adjustable manner,

YOUR MASK”).

[F] wherein the headgear includes a pair of top straps and a pair of rear straps, each said top strap being configured to extend from generally above a respective ear of the patient such that the top straps cross over the top of the patient's head in use, the rear straps being adapted to pass behind the patient's head in use, and

FlexiFit: “Gently adjust . . . Top Crown straps.” Ex. 1106 at 10 (“FITTING YOUR MASK”).

[G] wherein the rear straps and the top straps together at least partly form a closed loop to encircle a rear portion of the patient's head when

FlexiFit: Ex. 1106 at 10.


64

in use;

[H] a shroud module including headgear connectors adapted to removably attach to the headgear,

D’Souza: “[S]keleton frame 412 includes . . . lower headgear clip receptacles 446 adapted to be engaged with clips provided to straps of the headgear assembly (not shown).” Ex. 1102 ¶ 100.

Ultra Mirage: “Quick release headgear clips: top and bottom allows mask to be removed without resetting the headgear and provides convenience and safety.” Ex. 1103 at 6.


65

[I] wherein the headgear connectors include two upper connectors associated with the upper headgear straps,

D’Souza: “[S]keleton frame 412 includes an upper support member 444 adapted to support a forehead support, lower headgear clip receptacles 446.” Ex. 1102 ¶ 100.



66

[J] the shroud module having an opening of circular shape, and two lower connectors associated with the lower headgear straps,

D’Souza: “[S]keleton frame 412 includes an upper support member 444 adapted to support a forehead support, lower headgear clip receptacles 446 . . . .” Ex. 1102 ¶ 100. “[A]nnular elbow connection seal 448 interlocks with the annular wall 440 of the cushion/frame sub-assembly 430. Id. ¶ 101, Fig. 7.



67

[K] each said upper headgear connector including a slot or receiving hole adapted to receive one of the upper headgear straps,




68

FlexiFit: “[A]ttach the four straps in to the corresponding slots in the Mask Base.” Ex. 1106 at 10 (“ASSEMBLING THE MASK”).

[L] wherein the shroud module and the frame of the cushion module are configured to be removably snap-fit

D’Souza: “[S]keleton frame 412 that is adapted to removably interlock with a cushion/frame sub-assembly 430.” Ex. 1102 ¶ 96. “[A]nnular elbow connection seal 448 interlocks with the annular wall 440 . . . upper support member 444 interlocks with a top portion 431 . .


69

attached to one another in a non-rotatable manner by pushing the shroud module towards the frame along a longitudinal axis of both the opening of the frame and the opening of the shroud;

. and the elongated frame members 450 interlock with respective protrusions 442.” Id. ¶ 101.

Matula-II: “Coupling member 46 includes a pair of prongs 48 that define a channel 50 to receive the wall of the faceplate and the end of seal member 38.” Ex. 1105 ¶ 53.

[M] and an elbow rotatably attached to and carried by the shroud module or the frame of the cushion module, the

D’Souza: “[S]keleton frame 412 includes . . . an annular elbow connection seal 448 adapted to engage an inlet conduit, e.g., elbow.” Ex. 1102 ¶ 100. Ultra Mirage: “360° rotating elbow provides control


70

elbow being configured to deliver the positive pressure air to the breathing chamber,

over tubing system.” Ex. 1103 at 6.

Barnett: “[C]onduit coupling member 36 is preferably rotateably mounted on a second side of collar 34 . . . so that conduit coupling member 36 freely rotates over a range of 360°.” Ex. 1107 at col. 3:52–57; see also id. at col. 8:66—col. 9:43. “Conduit coupling portion 88 attaches conduit coupling member 36 to a patient circuit 92, . . . which carries a flow of breathing gas generated by a flow generating device 94 . . . to nose receiving cavity 42.” Ex. 1107 at col. 8:49–54.


71

[N] the elbow including a swivel adapted to connect to an air delivery tube,

Ultra Mirage: “360° rotating elbow provides control over tubing system.” Ex. 1103 at 6. “Quick release swivel allows easy disconnection from tubing.” Id.

[O] the elbow including Ultra Mirage: “Safety valve allows patient to breathe


72

an anti-asphyxia valve (AAV) and a port that is selectively closed by a flap portion of the AAV.

fresh air when flow generator does not provide flow.” Ex. 1103 at 6. Jaffre: “During normal use, where the pressure support system is functioning properly, a cantilever member 90 of valve member 68 flexes, as shown to FIG. 8, to block auxiliary opening 88. . . . If, however, the pressure of the gas in interior 92 is not greater than ambient atmosphere, cantilever member 90 returns to its normal, undeflected position shown in FIG. 9 and unblocks auxiliary opening 88 so that the patient has access to the ambient atmosphere as indicated by arrow H.” Ex. 1112 at col. 10:14–28.

46. The mask system of claim 43, wherein: [A] the elbow is rotatably attached the shroud module,

See supra Claim 43[M].

[B] the upper headgear straps provide padding to the respective headgear connectors of the shroud on the



73

patient's face in use,

[C] the frame includes a protruding vent arrangement having a plurality of holes, wherein the shroud module includes a first opening to accommodate said protruding vent arrangement,

D’Souza: “[S]keleton frame 412 is engaged with the cushion/frame sub-assembly 430 such that . . . upper support member 444 interlocks with a top portion 431 . . . and the elongated frame members 450 interlock with respective protrusions 442.” Ex. 1102 ¶ 101.

Ultra Mirage: “Air vent provides excellent CO2 washout and minimal noise output.” Ex. 1103 at 6.


74

[D] further wherein the shroud module includes a second opening to accommodate the elbow,


[E] the frame includes an opening and the frame further includes a collar surrounding said opening, and wherein the shroud module includes a retaining portion with one or more rearward extending snap fingers structured to engage the collar with a snap-fit, and

D’Souza: “[A]nnular wall 440 surrounds the opening 418 [of the frame 414].” Ex. 1102 ¶ 98. “[A]nnular elbow connection seal 448 interlocks with the annular wall 440.” Id. ¶ 101.


75


[F] the top straps are connected together with a buckle allowing independent adjustment of each of the top straps.

FlexiFit: “Gently adjust the . . . Top Crown straps.” Ex. 1106 at 10 (“FITTING YOUR MASK”).


76

Gunaratnam-II: “[H]eadgear buckle 570 includes a first locking portion 571 and a second locking portion 572. The first locking portion 571 is adapted to be removably and adjustably coupled with one of the upper straps 598 . . . and the second locking portion 572 is adapted to be removably and adjustably coupled with the other of the upper straps 598 . . . . Each of the upper straps 598 may be wrapped around the cross-bar of the associated locking portion 571, 572.” Ex. 1110 ¶ 316, Fig. 135.

48. The mask system of D’Souza: “[F]rame 414 is constructed of


77

claim 43, wherein the frame is semi-rigid or rigid.

polycarbonate.” Ex. 1102 ¶ 98.

49. The mask system of claim 48, wherein the frame is rigid.

D’Souza: “[F]rame 414 is constructed of polycarbonate.” Ex. 1102 ¶ 98.

50. A system for treating a patient with sleep disordered breathing, comprising: the mask system of

claim 43; and a flow generator to

generate a supply of air at positive pressure to be delivered to the mask system, wherein

the air delivery tube is configured to deliver the supply of air from the flow generator to the mask system.

See supra Claim 43. D’Souza: “[M]ask assembl[ies] for use with blowers and flow generators in the treatment of sleep disordered breathing (SDB) . . . . [P]atient interface is held in a sealing position by headgear so as to enable a supply of air at positive pressure to be delivered to the patient's airways.” Ex. 1102 ¶ 3. “[C]ushion provides a seal . . . to enable the delivery of breathable gas to the patient's nose and mouth.” Id. ¶ 81. Ultra Mirage: “360° rotating elbow provides control over tubing system.” Ex. 1103 at 6. “Quick release swivel allows easy disconnection from tubing.” Id.

51. A mask system for See supra Claim 43, preamble.


78

delivery of a supply of air at positive pressure to a patient's airway, the mask system comprising: a cushion module comprising a frame defining a

breathing chamber configured to receive the positive pressure air, and

a cushion to form a seal with the patient's face in a nasal bridge region, a cheek region and a lower lip/chin region of the patient's face,

wherein the cushion is constructed of a first, relatively soft, elastomeric material and the frame is constructed of a second material that is more rigid than the cushion,

See supra Claim 43[A].

the frame including a washout vent;

See supra Claim 43[B].

headgear to maintain the mask system in a desired position on the patient's face, the headgear comprising a pair of upper headgear straps each configured to extend above a respective one of the patient's ears in use and

See supra Claim 43[D].


79

a pair of lower headgear straps each configured to extend below a respective one of the patient's ears in use, wherein a free end of each of the upper headgear straps and the lower headgear straps includes a hook tab structured to engage a remainder of the respective upper headgear strap and respective lower headgear strap to secure the upper and lower straps in place in a length adjustable manner,

See supra Claim 43[E].

wherein the headgear includes a pair of top straps and a pair of rear straps, each said top strap being configured to extend from generally above a respective ear of the patient such that the top straps cross over the top of the patient's head in use, the rear straps being adapted to pass behind the patient's head in use, and

See supra Claim 43[F].

wherein the rear straps and the top straps together at least partly form a closed loop to encircle a rear portion of the patient's head when

See supra Claim 43[G].


80

in use; a shroud module including headgear connectors adapted to removably attach to the headgear,

See supra Claim 43[H].

wherein the headgear connectors include two upper connectors associated with the upper headgear straps and two lower connectors associated with the lower headgear straps,

See supra Claim 43[I] & 43[J].

each said upper headgear connector including a slot or receiving hole adapted to receive one of the upper headgear straps,

See supra Claim 43[K].

wherein the shroud module and the frame of the cushion module are configured to be removably snap-fit attached to one another in a non-rotatable manner;

See supra Claim 43[L].

and an elbow rotatably attached to and carried by the shroud module or the frame of the cushion module, the elbow being configured to deliver the positive pressure air to the breathing chamber,


the elbow including a swivel adapted to connect to an air

See supra Claim 43[N].


81

delivery tube, the elbow including an anti-asphyxia valve (AAV) and a port that is selectively closed by a flap portion of the AAV;

See supra Claim 43[O].

the elbow is rotatably attached the shroud module,

the upper headgear straps provide padding to the respective headgear connectors of the shroud on the patient's face in use,

the frame includes a protruding vent arrangement having a plurality of holes, wherein the shroud module includes a first opening to accommodate said protruding vent arrangement,

further wherein the shroud module includes a second opening to accommodate the elbow,

the frame includes a frame opening and the frame further includes a collar surrounding said frame opening, and wherein the shroud module includes a retaining

See supra Claim 46.


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portion with one or more rearward extending snap fingers structured to engage the collar with a snap-fit, and

the top straps are connected together with a buckle allowing independent adjustment of each of the top straps.

53. The mask system of claim 51, wherein the second shroud opening and the frame opening are aligned along a common longitudinal axis, and wherein the shroud and the frame are removably snap-fit attached to one another by moving the shroud and the frame towards one another along the longitudinal axis.


54. The mask system of claim 51, wherein the frame is semi-rigid or rigid.

See supra Claim 48.


See supra Claim 49.


claim 51; and a flow generator to

See supra Claims 50 & 51.


83

generate a supply of air at positive pressure to be delivered to the mask system, wherein

the air delivery tube is configured to deliver the supply of air from the flow generator to the mask system.

57. A mask system for treating a patient with sleep disordered breathing with a supply of air at positive pressure, comprising:

See supra Claim 50.

headgear including headgear straps;

D’Souza: “[P]atient interface is held in a sealing position by headgear.” Ex. 1102 ¶ 3. “[S]keleton frame 412 includes an upper support member 444 adapted to support a forehead support, lower headgear clip receptacles 446 adapted to be engaged with clips provided to straps of a headgear assembly (not shown).” Ex. Id. ¶ 100.

a shroud module having a pair of upper headgear connectors and a pair of lower headgear connectors adapted to removably attach to the respective headgear straps of the headgear,

See supra Claim 43[I] & 43[J]. Ultra Mirage: “Quick release headgear clips: top and bottom allows mask to be removed without resetting the headgear and provides convenience and safety.” Ex. 1103 at 6.


84

the shroud module having a front opening;

See supra Claim 43[J].

a rotatable elbow directly attached to the shroud; and


a cushion module, the cushion module comprising a frame defining a

breathing chamber, the frame having a frame opening leading to the breathing chamber; and

a cushion to form a seal with the patient's face,

wherein the cushion comprises a first, relatively soft, elastomeric material and the frame comprises a second material that is more

See supra Claim 43[A]. D’Souza: “[F]rame 414 includes an upper wall that provides an opening 418 for communicating with an inlet conduit. . . . A side wall 420 extends from the upper wall.” Ex. 1102 ¶ 98.


85

rigid than the cushion; wherein: the front opening of the shroud module and the frame opening of the frame are aligned along a common longitudinal axis, and wherein the shroud module and the cushion module are structured and arranged to be removably snap-fit attached to one another by moving the shroud module and the cushion module towards one another along the longitudinal axis,


and the shroud module includes a retaining portion positioned rearwardly of the front opening, towards the frame, and structured to snap fit with the cushion module.

D’Souza: “[S]keleton frame 412 that is adapted to removably interlock with a cushion/frame sub-assembly 430.” Ex. 1102 ¶ 96. “[A]nnular elbow connection seal 448 interlocks with the annular wall 440 of the cushion/frame sub-assembly 430. Id. ¶ 101, Fig. 7.


86


58. The mask system of claim 57, wherein the shroud module and the cushion module are structured and arranged to be detached from one another by moving the shroud module and the cushion module away from one another along the longitudinal axis.

D’Souza: “[S]keleton frame 412 that is adapted to removably interlock with a cushion/frame sub-assembly 430.” Ex. 1102 ¶ 96.

60. The mask system of claim 57, wherein each

See supra Claim 43[K].


87

upper headgear connector includes a slot adapted to receive a respective headgear strap in use; and wherein each lower headgear connector is adapted to be removably interlocked with a headgear clip associated with a respective headgear strap.




88

61. The mask system of claim 57, wherein the elbow is adapted to be connected to an air delivery tube that delivers breathable gas to the patient.

See supra Claim 43[N] & 50.

62. The mask system of claim 57, wherein: the headgear includes upper straps and lower straps,

See supra Claim 43[D].

a free end of each of the upper straps and the lower straps includes a hook tab structured to engage a remainder of the respective upper strap and respective lower strap to secure the upper and lower straps in place in a length adjustable manner,

See supra Claim 43[E].

the upper straps split to FlexiFit: “Gently adjust . . . Top Crown straps.” Ex.


89

form a pair of top straps and a pair of rear straps,

1106 at 10 (“FITTING YOUR MASK”).

the top straps being connected together by a buckle and configured to pass over the top of the patient's head in use, the rear straps being adapted to pass behind the patient's head in use, and

See supra Claims 43[F] & 46[E].

a free end of each of the top straps has a hook tab threaded through the buckle to engage a remainder of the respective top strap to secure the top straps in place relative to the buckle in a length adjustable manner.

FlexiFit: “Gently adjust the . . . Top Crown straps.” Ex. 1106 at 10 (“FITTING YOUR MASK”). “[A]ttach the four straps in to the corresponding slots in the Mask Base and the GliderTM strap (E). This can be done without undoing the Velcro® Tabs by sliding the Headgear into the slots.” Id. at 10 (“ASSEMBLING YOUR MASK”).


90

Gunaratnam-II: “[H]eadgear buckle 570 includes a first locking portion 571 and a second locking portion 572. The first locking portion 571 is adapted to be removably and adjustably coupled with one of the upper straps 598 . . . and the second locking portion 572 is adapted to be removably and adjustably coupled with the other of the upper straps 598 . . . . Each of the upper straps 598 may be wrapped around the cross-bar of the associated locking portion 571, 572.” Ex. 1110 ¶ 316 & Fig. 135.


91

63. The mask system of claim 62, wherein the upper straps provide padding to the respective headgear connectors of the shroud module on the patient's face in use.

See supra Claim 46[B].

64. The mask system of claim 62, wherein the rear straps and the top straps form a closed loop to encircle a rear portion of the patient's head when in use.


65. The mask system of claim 57, wherein the frame includes a protruding vent arrangement having a plurality of gas washout holes, wherein the shroud module includes an upper opening to accommodate said protruding vent arrangement.

See supra Claim 46[C].

68. The mask system of claim 57, wherein a

Matula-II: “[S]eal member 38 includes at least one pleat 106 (which can also be referred to as a fold or


92

nasal bridge portion of the cushion includes one or more folds to provide in use a higher level of adaptability or flexibility to the nasal bridge region of the cushion module relative to another region of the cushion module; and further wherein each of said one or more folds comprises adjacent first side walls interconnected by a second side wall.

gusset) provided at a portion of the seal member so that the seal member has the desired degree of flexibility. In this case, pleats 106 are provided at and upper portion of the seal member so that this portion of the seal member can expand and contract with adjustment of the adjustment mechanism.” Ex. 1105 ¶ 66.

“Pleats 106 are oriented such that the pleat protrudes into chamber 44 with a channel 108 defined on the exterior surface of the seal member.” Id.

69. The mask system of claim 57, wherein the frame includes a collar surrounding said frame opening, and wherein the retaining portion of the shroud includes a plurality of snap fingers structured to engage the collar with a snap-fit.

D’Souza: “[A]nnular wall 440 surrounds the opening 418 [of the frame 414].” Ex. 1102 ¶ 98. “[A]nnular elbow connection seal 448 interlocks with the annular wall 440.” Id. ¶ 100.


93


70. The mask system of claim 57, wherein the elbow includes an anti-asphyxia valve and wherein the anti-

See supra Claim 43[O].


94

asphyxia valve includes a flap portion adapted to selectively close a port provided in the elbow. 71. The mask system of claim 57, wherein each of the shroud module and the frame comprises polycarbonate and the cushion comprises silicone.

D’Souza: “[C]ushion 416 is constructed of liquid silicone rubber (LSR).” Ex. 1102 ¶ 97. “[T]he frame 414 is constructed of polycarbonate.” Id. ¶ 98. “[T]he skeleton frame 412 is formed of plastic.” Id. ¶ 101.

77. The mask system of claim 57, wherein the frame is semi-rigid or rigid.

See supra Claim 48.


See supra Claim 49.


claim 57; a flow generator to

generate a supply of air at positive pressure to be delivered to the mask system; and

an air delivery tube configured to deliver the supply of air from the flow generator to the mask system.

See supra Claims 50 & 57.


95

IX. SECONDARY CONSIDERATIONS

Secondary considerations should be taken into account, but they do not

control the obviousness conclusion. Newell Cos., Inc. v. Kenney Mfg. Co., 864

F.2d 757, 768 (Fed. Cir. 1988). And where a strong prima facie obviousness

showing exists, as here, the Federal Circuit has repeatedly held that even relevant

secondary considerations supported by substantial evidence may not dislodge the

primary conclusion of obviousness. See, e.g., Leapfrog Enters. Inc. v. Fisher-

Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007). For example, evidence of

commercial sales generally would not be sufficient to overcome the strong prima

facie showing of obviousness. Further, there would be no nexus between the

commercial sales and the claims of the ’931 Patent. See, e.g., Wyers v. Master

Lock Co., 616 F.3d 1231, 1246 (Fed. Cir. 2010).

Petitioner is not aware of any secondary considerations that would be

relevant to the obviousness inquiries presented here. Further, Petitioner does not

believe that any potential secondary considerations could outweigh the strong

prima facie case of obviousness. In the event that the Patent Owner puts forth any

allegations regarding secondary considerations of non-obviousness, Petitioner will

address those allegations in due course.


96

Respectfully submitted,

KNOBBE, MARTENS, OLSON & BEAR, LLP Dated: October 12, 2016 By: /Brenton R. Babcock/

Brenton R. Babcock (Reg. No. 39,592) Benjamin J. Everton (Reg. No. 60,659) Customer No. 20,995

Attorneys for Petitioner Fisher & Paykel Healthcare Limited

(949) 760-0404


97

CERTIFICATE OF TYPE-VOLUME LIMITATIONS

UNDER 37 C.F.R. § 42.24

Pursuant to 37 C.F.R. § 42.24(d), Counsel for Petitioner Fisher & Paykel

Healthcare Limited hereby certifies that this document complies with the type-

volume limitation of 37 C.F.R. § 42.24(a)(1)(i). According to Microsoft Office

Word 2010’s word count, this document contains approximately 13,582 words,

including any statement of material facts to be admitted or denied in support, and

excluding the table of contents, table of authorities, mandatory notices under

§ 42.8, exhibit list, certificate of service or word count, or appendix of exhibits or

claim listing.

Respectfully submitted,

KNOBBE, MARTENS, OLSON & BEAR, LLP Dated: October 12, 2016 By: /Brenton R. Babcock/

Brenton R. Babcock (Reg. No. 39,592) Benjamin J. Everton (Reg. No. 60,659) Customer No. 20,995

Attorneys for Petitioner Fisher & Paykel Healthcare Limited

(949) 760-0404


98

CERTIFICATE OF SERVICE

I hereby certify that true and correct copies of the foregoing PETITION

FOR INTER PARTES REVIEW OF U.S. PATENT 9,119,931 and Fisher &

Paykel Healthcare Exhibits 1101-1124 are being served on October 12, 2016, via

FedEx Priority Overnight service on counsel of record for U.S. Patent 9,119,931

patent owner RESMED LIMITED at the address below:

Correspondence Address of Record for U.S. Patent 9,119,931 at the U.S.

Patent and Trademark Office:

Nixon & Vanderhye, PC 901 North Glebe Road, 11th Floor

Arlington, VA 22203

Dated: October 12, 2016 By: /Brenton R. Babcock/

Brenton R. Babcock Registration No. 39,592 Attorney for Petitioner Fisher & Paykel Healthcare Limited

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