Filed: October 12, 2016 Filed on behalf of: Fisher...

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. IPR2017-00061 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 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. 1002) .................... 10

b. Ultra Mirage Full Face Mask Brochure (“Ultra Mirage”) (Ex. 1003 at 6–7) ................................ 11

c. U.S. Publication No. 2007/0044804 (“Matula-II”) (Ex. 1005) ................................................. 12

d. FlexiFit Series, HC 431 Full Face Mask, Instructions for Use (“FlexiFit”) (Ex. 1006 at 9–10) ............................................................................... 12

e. U.S. 6,412,488 (“Barnett”) (Ex. 1007) ........................... 14

f. U.S. 6,631,718 (“Lovell”) (Ex. 1008) ............................ 14

TABLE OF CONTENTS (continued)

Page No.

ii

g. U.S. Publication No. 2004/0226566 (“Gunaratnam-II”) (Ex. 1010) ........................................ 14

h. U.S. 6,851,425 (“Jaffre”) (Ex. 1012) .............................. 14

2. Grounds ..................................................................................... 14

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

V. THE ’931 PATENT ....................................................................................... 17

A. Example Embodiments ....................................................................... 17

B. Summary of the Prosecution History of the ’931 Patent .................... 20

VI. LEVEL OF ORDINARY SKILL IN THE ART ........................................... 21

VII. THE CHALLENGED CLAIMS OF THE ’931 PATENT ARE UNPATENTABLE ........................................................................................ 22

A. Legal Standard for Obviousness ......................................................... 22

B. Ground 1: Claims 1, 6, 10, 11, 18, 31, and 32 would have been obvious over D’Souza in view of Ultra Mirage ......................... 23

1. Overview of D’Souza (Ex. 1002) ............................................. 23

2. Overview of Ultra Mirage (Ex. 1003) ...................................... 24

3. Potential Differences from Prior Art ........................................ 25

a. “headgear connectors adapted to removably attach to respective headgear straps” .............................. 27

b. “protruding vent arrangement” ....................................... 28

c. “upper and lower headgear connectors” ......................... 30

d. “air delivery tube”........................................................... 31


Page No.

iii

e. “the shroud module and the frame comprise polycarbonate” ................................................................ 32

4. Reasons to Combine ................................................................. 33

C. Ground #2: Claims 4, 5, 26, 33, 37, and 40–42 would have been obvious over D’Souza in view of Ultra Mirage and Matula-II ....................................................................................... 34

1. Overview of Matula-II (Ex. 1005) ............................................ 34


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

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

c. “removably snap-fit” ...................................................... 40


D. Ground #3: Claims 7 and 8 would have been obvious over D’Souza in view of Ultra Mirage and FlexiFit ........................... 43

1. Overview of FlexiFit (Ex. 1006) ............................................... 43


a. “each upper headgear connector includes a slot” ................................................................................. 44

b. “each lower headgear connector is adapted to be removably interlocked with a headgear clip” ................................................................................. 45



Page No.

iv

E. Ground # 4: Claims 12, 14, 16, and 17 of the ’931 Patent would have been obvious over D’Souza in view of Ultra Mirage and Barnett .............................................................................. 46

1. Overview of Barnett (Ex. 1007)................................................ 46


a. “elbow module” .............................................................. 47

b. “at least first and second cushion modules” ................... 49

c. “a small cushion module, a medium cushion module and a large cushion module” ............................. 49

3. Reasons to Combine D’Souza, Ultra Mirage, and Barnett ....... 50

F. Ground #5: Claim 13 would have been obvious over D’Souza in view of Ultra Mirage and Lovell...................................... 51

1. Overview of Lovell (Ex. 1008) ................................................. 51


a. “elbow module comprises polycarbonate” ..................... 52


G. Ground #6: Claim 15 would have been obvious over D’Souza in view of Ultra Mirage and Jaffre ....................................... 52

1. Overview of Jaffre (Ex. 1012) .................................................. 52


a. “anti-asphyxia valve” ..................................................... 53



Page No.

v

H. Ground #7: Claims 19–21 and 25 would have been obvious over D’Souza in view of Ultra Mirage, FlexiFit, and Gunaratnam-II .............................................................................. 55

1. Overview of Gunaratnam-II (Ex. 1010) ................................... 55


a. “headgear” ...................................................................... 56

b. “upper straps provide padding” ...................................... 58

c. “the rear straps and the top straps form a closed loop” .................................................................... 58


I. Ground #8: Claim 22 would have been obvious over D’Souza in view of Ultra Mirage, FlexiFit, Gunaratnam-II, and Matula-II .................................................................................. 61

1. Potential Differences from the Prior Art and Reasons to Combine ................................................................................ 61

J. Ground #9: Claims 28–30 would have been obvious over D’Souza in view of Ultra Mirage, Matula-II, FlexiFit, and Barnett .......................................................................................... 62


K. Ground #10: Claim 34 and 36 would have been obvious over D’Souza in view of Ultra Mirage, Matula-II, and Barnett ................................................................................................. 62



Page No.

vi

L. Ground #11: Claim 35 would have been obvious over D’Souza in view of Ultra Mirage, Matula-II, and FlexiFit ................. 63

1. Potential Differences from the Prior Art and Reasons to Combine .................................................................................... 63

VIII. CLAIM CHART ............................................................................................ 65

IX. SECONDARY CONSIDERATIONS ........................................................... 90

TABLE OF AUTHORITIES

Page No(s).

vii

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) ................................ 11, 12

Graham v. John Deere Co., 383 U.S. 1 (1966) ................................................................................................ 22

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

Leapfrog Enters. Inc. v. Fisher-Price, Inc., 485 F.3d 1157 (Fed. Cir. 2007) .......................................................................... 91

Newell Cos., Inc. v. Kenney Mfg. Co., 864 F.2d 757 (Fed. Cir. 1988) ............................................................................ 90

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

In re Translogic Tech., 504 F.3d 1249 (Fed. Cir. 2007) .......................................................................... 16

Wyers v. Master Lock Co., 616 F.3d 1231 (Fed. Cir. 2010) .......................................................................... 91

OTHER AUTHORITIES

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

35 U.S.C. § 103 ............................................................................................ 15, 16, 22

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

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

TABLE OF AUTHORITIES (continued)

Page No(s).

viii

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

1001 U.S. Patent No. 9,119,931

1002 PCT Publication No. WO 2007/041751 (D’Souza)

1003 Affidavit of Christopher Butler, Ultra Mirage Brochure (Ultra Mirage), dated September 6, 2016

1004 U.S. Patent No. 7,827,990 (Melidis)

1005 U.S. Publication No. 2007/0044804 (Matula-II)

1006 Affidavit of Christopher Butler, FlexiFit Instructions (FlexiFit), dated September 6, 2016

1007 U.S. Patent No. 6,412,488 (Barnett)

1008 U.S. Patent No. 6,631,718 (Lovell)

1009 PCT Publication No. WO 2007/045008 (Worboys)

1010 U.S. Publication No. 2004/0226566 (Gunaratnam-II)

1011 U.S. Publication No. 2004/0182398 (Sprinkle)

1012 U.S. Patent No. 6,851,425 (Jaffre)

1013 Declaration of Jason Eaton, P.E.

1014 Excerpts from the File History of U.S. Patent No. 9,119,931

1015 Malloy, Robert A., Plastic Part Design for Injection Molding: An Introduction, pp. 336–345 (Hanser Gardner Publications, Inc. 1994) (Malloy)

1016 Declaration of Fiona Cresswell, dated September 21, 2016


Exhibit List, Page 2

Exhibit No. Description

1017 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

1018 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.)

1019 U.S. Provisional Application No. 61/064,406



1022 PCT Publication No. WO 2007/147088 (Matula-I)

1023 U.S. Patent No. 6,796,308 (Gunaratnam-I)

1024 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 1, 4–8, 10–22, 25, 26, 28–37, and 40–42

(“Challenged Claims”) of U.S. 9,119,931 (“’931 Patent”) (Ex. 1001), 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 patient’s face and a frame that supports the seal. Headgear

holds the frame and seal in place on the patient.


2

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

efficacy of therapy and patient compliance with therapy. Ex. 1001 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 combinations 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. 1002.


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)(3)(b), infra; Ex. 1013 ¶¶ 72–73. For example, as

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

bridge region. Ex. 1003 at 6.

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

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


5

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

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

ResMed’s own prior art literature (e.g., Ultra Mirage and Gunaratnam-II). See

§§ VII(B)–(L), infra; Ex. 1013 ¶¶ 49–140. 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 ’931 Patent

claims a list 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.

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

review of Claims 1, 4–8, 10–22, 25, 26, 28–37, and 40–42 using D’Souza in view

of other prior art. Petitioner has concurrently filed a second IPR petition

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


6

77–79 using the same prior art. Although these two petitions rely on the same

prior art, these petitions are not redundant because there are no overlapping claims.

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 and argue that D’Souza is not prior art for

those claims. 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

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


7

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. 1017.

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.


8

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

counterclaims on September 7, 2016. Ex. 1018. 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 additional 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 address: [email protected].

IV. REQUIREMENTS 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,

and September 19, 2008, respectively. Ex. 1001 at 1–2. The earliest possible


10

priority date of the ’931 Patent is March 4, 2008, but this date does not apply to the

Challenged Claims, as explained below.

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. 1002)

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

19, 2007. Ex. 1002 at 1.

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

priority benefit, U.S. Provisional Application No. 61/064,406 (Ex. 1019), disclosed

a vent on the elbow or the seal, but did not disclose a vent on the frame. Ex. 1019

¶¶ 66–69; Ex. 1013 ¶ 31. Indeed, a protruding vent arrangement is not shown or

described in any of the Provisional Applications. Ex. 1019; Ex. 1020; Ex. 1021;

Ex. 1013 ¶ 31. Thus, the earliest possible priority date for at least Claims 1, 4–8,

10–22, 25, 26, and 28–32 of the ’931 Patent is the filing date of the parent

application of the ’931 Patent, U.S. 8,550,084, filed as PCT Application No.

PCT/AU2009/000241 on February 27, 2009.

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

disclose the shroud module including a retaining portion extending rearwardly

from the front opening. Ex. 1019; Ex. 1020; Ex. 1013 ¶ 31. Thus, the earliest

possible priority date for at least Claims 33–37 and 40–42 is the filing date of the


11

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. 1003 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. 1003 at 7; Ex. 1013 ¶ 56. 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. 1003 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.

Ex. 1003 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. 1013), explaining that a person of skill in the art would have

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

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

Ex. 1013 ¶ 55.

Because Ultra Mirage was available to the public 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).

c. U.S. Publication No. 2007/0044804 (“Matula-II”) (Ex. 1005)

Matula-II published on March 1, 2007. Ex. 1005 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. 1006 at 9–10)

FlexiFit was publicly available by at least October 16, 2006. Ex. 1013 ¶ 57;

Ex. 1006 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. 1006 at 1–2; see EMC

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. 1006 at 5, 8, 11.

The authenticity and public availability of FlexiFit is further supported by

the declaration of Fiona Cresswell, testifying to personal knowledge that the


13

documents are authentic and were available. Ex. 1016 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. 1016 at 1–4.

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

Jason Eaton, P.E. (Ex. 1013), 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 Fisher &

Paykel. Ex. 1013 ¶ 55.

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).


14

e. U.S. 6,412,488 (“Barnett”) (Ex. 1007)

Barnett issued on July 2, 2002. Ex. 1007 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. 6,631,718 (“Lovell”) (Ex. 1008)

Lovell issued on October 14, 2003. Ex. 1008 at 1. Because Lovell 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).

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

1010)

Gunaratnam-II published on November 18, 2004. Ex. 1010 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).

h. U.S. 6,851,425 (“Jaffre”) (Ex. 1012)

Jaffre issued on February 8, 2005. Ex. 1012 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).

2. Grounds

Fisher & Paykel requests inter partes review of Claims 1, 4–8, 10–22, 25,

26, 28–37, and 40–42 of the ’931 Patent. Because ResMed claimed a laundry list


15

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 1, 6, 10, 11, 18, 31, and 32 would have been obvious

over D’Souza in view of Ultra Mirage under 35 U.S.C. § 103.

Ground #2. Claims 4, 5, 26, 33, 37, and 40–42 would have been obvious

over D’Souza in view of Ultra Mirage and Matula-II under 35 U.S.C. § 103.

Ground #3. Claims 7 and 8 would have been obvious over D’Souza in

view of Ultra Mirage and FlexiFit under 35 U.S.C. § 103.

Ground #4. Claims 12, 14, 16, and 17 would have been obvious over

D’Souza in view of Ultra Mirage and Barnett under 35 U.S.C. § 103.

Ground #5. Claim 13 would have been obvious over D’Souza in view of

Ultra Mirage and Lovell under 35 U.S.C. § 103.


Ultra Mirage and Jaffre under 35 U.S.C. § 103.

Ground #7. Claims 19–21 and 25 would have been obvious over D’Souza

in view of Ultra Mirage, FlexiFit, and Gunaratnam-II under 35 U.S.C. § 103.


16


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

Ground #9. Claims 28–30 would have been obvious over D’Souza in view

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

Ground #10. Claims 34 and 36 would have been obvious over D’Souza in

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


Ultra Mirage, Matula-II, and FlexiFit 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).

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

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. 1001 at col. 6:51–54, Figs. 1–5. The frame 1040 defines a

breathing chamber and includes an opening 1046 that communicates with the

elbow 1070. Id. at col. 6:60–66. The frame 1040 includes a vent arrangement

1076 for gas washout. Id. The shroud 1020 is structured to removably attach to

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

vent arrangement 1076. Id. at col. 7:9–23.


18

Upper and lower headgear connectors 1024, 1025 extend from each side of

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

clip receptacle 1031 that interlocks with a headgear clip on a headgear strap. Id. at

col. 8:29–32.


19

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 strap length. Id. at col. 10:45–49. Upper straps 1092 split into top straps 1096

that pass over the patient’s head. Id. at col. 10:52–59.


20

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

frame by a 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. Ex.

1014 at 244–255. The Examiner also rejected all of the pending claims on the

ground of nonstatutory double patenting. Id. at 252–254. In response, applicant


21

amended Claim 1 to include the “non-rotatably coupleable” limitation. Id. at 318.

In an interview on December 16, 2014, the Examiner indicated that the proposed

amendment was sufficient to overcome Ho. Id. at 303.

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

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

other prior art. Id. at 343–361. The Examiner also indicated that Claims 29 and 33

would be allowable if rewritten in independent form. Id. at 359. In response,

applicant amended Claim 1 to include “a protruding vent arrangement having a

plurality of holes.” Id. at 429. Applicant also added Claims 34–83, which recite

different permutations of the previously pending claims. Id. at 436-444. In an

interview on July 1, 2015, the Examiner indicated that applicant’s amendments

were sufficient to overcome the rejections. Id. at 464. 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. 1013 ¶ 27.


22

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. 1013. 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. ¶¶ 38–141.

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)).


23

B. Ground 1: Claims 1, 6, 10, 11, 18, 31, and 32 would have been obvious

over D’Souza in view of Ultra Mirage

1. Overview of D’Souza (Ex. 1002)

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

not cited by the Examiner. Ex. 1001 at 9.

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

breathing. Ex. 1002 ¶ 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.


24

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. Polycarbonate frame

414 interlocks with a silicone rubber cushion 416. Id. ¶¶ 97–98.

2. Overview of Ultra Mirage (Ex. 1003)

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

Patent. Ex. 1001 at 1–12.


25

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

Ex. 1003 at 6. As shown on the previous page, Ultra Mirage discloses top and

bottom removable headgear clips. 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 fresh air when the flow generator does not

provide flow. Id.

3. Potential Differences from Prior Art

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

limitations of Claims 1, 6, 10, 11, 18, 31, and 32.

With respect to Claim 1, D’Souza teaches a mask system, comprising: (i) a

shroud module (skeleton frame 412); wherein the shroud module includes

headgear connectors adapted to removably attach to respective headgear straps of

headgear (headgear clip receptacles 446); and (ii) a cushion module (cushion/frame

sub-assembly 430). Ex. 1002 ¶¶ 96–97 & 100. The cushion module comprises a

rigid or semi-rigid frame defining a breathing chamber (frame 414); 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 (cushion 416). Id. ¶¶ 81 & 97–98. 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 (cushion 416


26

is constructed of liquid silicone rubber and frame 414 is constructed from

polycarbonate). Id. ¶¶ 97–98. The shroud module and the cushion module are

configured to be removably and non-rotatably coupleable to one another. Id.

¶ 101. The shroud module includes a first opening to accommodate a protruding

portion (opening defined by elongated frame members 450). Id. The shroud

module includes a second opening positioned to align with a frame opening of the

frame leading to the breathing chamber (annular elbow connection seal 448). Id.

Many of the features of Claims 1, 6, 10, 11, 18, 31, and 32 are identified in

the annotated figures of D’Souza provided on the next page. Ex. 1013 ¶ 61. As

discussed below, any differences were well-known at the time of the invention and

taught by Ultra Mirage. Id. ¶¶ 62–69.


27

a. “headgear connectors adapted to removably attach to

respective headgear straps”

Claim 1 includes “headgear connectors adapted to removably attach to

respective headgear straps of headgear.”

D’Souza discloses lower headgear clip receptacles 446 adapted to engage

clips provided to headgear straps. Ex. 1002 ¶ 100. To the extent D’Souza

provides insufficient teachings for the removability of the headgear straps, Ultra

Shroud module Lower headgear connectors First opening

Second opening to receive elbow

Silicone cushion

Polycarbonate frame

Cushion module

Annular retaining portion


28

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

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

1003 at 6.

b. “protruding vent arrangement”

Claim 1 includes “a protruding vent arrangement having a plurality of holes,

wherein the shroud module includes a first 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. 1002 ¶ 101.


29

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. 1013 ¶¶ 64, 72–73.

For example, as shown above, Ultra Mirage teaches an air vent positioned in

the nasal bridge region to provide CO2 washout and minimize noise output. Ex.

1003 at 6. As explained in the Reasons to Combine below, a skilled artisan 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. 1013

¶¶ 64, 72–73; see § VII(B)(4), infra.


30

c. “upper and lower headgear connectors”

Claim 6 depends from Claim 1 and includes “upper and lower headgear

connectors on each side of the shroud module.” As shown in Fig. 8 of D’Souza

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

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

adapted to engage headgear clips (not shown). Ex. 1002 ¶ 100.

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

Mirage teaches a shroud having a forehead support with headgear connectors, as

shown on the next page. Ex. 1003 at 6. As explained in the Reasons to Combine

below, a skilled artisan would have been motivated to provide upper headgear

connectors as taught by Ultra Mirage to the forehead support of D’Souza. Ex.

1013 ¶¶ 65–66; see § VII(B)(4), infra.


31

d. “air delivery tube”

Claim 11 depends from Claim 1 and includes “an elbow module adapted to

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

Claim 32 depends from Claim 1 and includes “an air delivery tube configured to

deliver the supply of air from the flow generator to the mask system.”

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

adapted to engage an elbow. Ex. 1002 ¶¶ 3 & 100. To the extent D’Souza

provides insufficient teachings for the air delivery tube, as taught by Ultra Mirage

and shown on the next page, it was well-known at the time of the invention to use

tubing to connect an elbow to a flow generator. Ex. 1003 at 6; Ex. 1013 ¶ 68.


32

e. “the shroud module and the frame comprise

polycarbonate”

Claim 18 depends from Claim 1 and includes “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. 1002 ¶ 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. 1013

¶ 69.


33

4. 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)(3); 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. See KSR, 550

U.S. at 416. Because D’Souza and Ultra Mirage both teach CPAP masks for the

treatment of sleep-disordered breathing, the features taught in Ultra Mirage would

have been readily compatible with and easily incorporated into the mask of

D’Souza with a reasonable expectation of success. Ex. 1013 ¶ 70.

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). Id. ¶ 71; Ex. 1003 at 6. 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 assembly and to

stabilize the mask assembly. Ex. 1013 ¶ 71.

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

vent for CO2 washout. Ex. 1003 at 6; Ex. 1013 ¶ 72. A skilled artisan would have

recognized the benefits in positioning the vent on the protruding portion of the


34

frame to minimize noise output. Ex. 1003 at 6; Ex. 1013 ¶ 72. Additionally, it was

well-known 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. 1013

¶ 72.

Additionally, a skilled artisan would have known to use tubing to connect

mask assemblies to flow generators, as taught by Ultra Mirage. Ex. 1013 ¶ 74.

The mask assembly of D’Souza is readily compatible with commercially available

and standardized tubing commonly used to deliver breathable air to mask

assemblies. Id.

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

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

rigidity, and toughness to support the headgear. Id. ¶ 75. Polycarbonate CPAP

components can also be cleaned, disinfected, and/or sterilized by commonly used

methods. Id.

C. Ground #2: Claims 4, 5, 26, 33, 37, and 40–42 would have been obvious over D’Souza in view of Ultra Mirage and Matula-II

1. Overview of Matula-II (Ex. 1005)

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

not cited by the Examiner. Ex. 1001 at 7.


35

Matula-II discloses a CPAP mask including a faceplate 36 coupled to a seal

member 38. Ex. 1005 ¶¶ 52–53. As shown in Fig. 4 of Matula-II (below),

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.


a. “one or more folds”

Claim 4 depends from Claim 1 and includes “a nasal bridge portion of the

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


36

or flexibility to the nasal bridge region of the cushion module relative to another

region of the cushion module.” Independent Claim 33 recites the same limitation.

D’Souza does not expressly disclose a fold, but such folds were well-known

in the prior art. Ex. 1013 ¶¶ 82–83. For example, as shown below, Matula-II

teaches folds 106 in the nasal bridge portion of the cushion 38 to provide “the

desired degree of flexibility.” Ex. 1005 ¶ 66.


37

Claim 4 also includes “each of said one or more folds comprises adjacent

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

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

wall 52(2), as shown below in the annotated Fig. 32-3. Ex. 1001 at col. 14:40–42.

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

side walls interconnected by a second side wall. Ex. 1013 ¶ 82.

First side walls

Second side wall

First side wall

First side wall Second side wall


38

b. “plurality of snap fingers”

Claim 5 depends from Claim 1 and includes “a retaining portion with 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. 1002 ¶ 98.

The shroud 412 includes a retaining portion 448 structured to engage the

collar 440. Id. ¶ 101. The shroud and frame are constructed from plastic and their

assembly would require elastic deformation of the collar 440 or the retaining

portion 448 for the larger diameter collar 440 to pass through the retaining portion

448. Thus, the retaining portion 448 engages the collar 440 with a snap-fit. Id.

¶¶ 98, 100; Ex. 1013 ¶¶ 85–86. As shown in Fig. 8 of D’Souza (above), the collar

440 snaps over the front/top edge of the retaining portion 448. Ex. 1013 ¶ 86.


39

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

fingers were common in prior art CPAP masks. Id. ¶¶ 87–88. 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. 1005 ¶ 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. 1013

¶ 87.

FIG. 4 FIG. 5 (PARTIAL)


40

c. “removably snap-fit”

Claim 26 depends from Claim 1 and includes “a snap-fit arrangement to

removably snap-fit attach the shroud module and the cushion module to one

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

along the longitudinal axis.” Independent Claim 33 recites, “a retaining portion

extending rearwardly from the front opening, towards the frame, and structured to

snap-fit with the cushion module.” Claim 37 depends from Claim 33 and includes

“the shroud module and the cushion module are removably snap-fit attached to one

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

along the longitudinal axis.”

D’Souza teaches a shroud module having an annular opening 448 with a

retaining portion extending rearwardly from the opening 448. Ex. 1002 ¶ 101.


41

The shroud module can be removably interlocked with the cushion module.

Id. ¶ 96. As explained above, assembly of the D’Souza arrangement requires

elastic deformation between the retaining portion and frame collar, resulting in a

snap-fit interlock between the shroud module and cushion module. Id. ¶¶ 98, 100;

Ex. 1013 ¶ 90. Such engagement is formed by moving the shroud module and the

cushion module towards one another along the longitudinal axis. Ex. 1013 ¶ 90.

However, to the extent D’Souza provides insufficient teachings for a removable

snap-fit, Matula-II teaches a plurality of snap fingers 48 that elastically deform to

mechanically and removably couple the seal member 38 to the faceplate 36, as

explained above. Ex. 1005 ¶ 53; see supra § VII(C)(2)(b). 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. 1013 ¶ 91;

see § VII(C)(3), infra.



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

arrive at the claimed mask system features of Claims 4, 5, 26, 33, 37, and 40–42

for at least the reasons provided above. Ex. 1013 ¶ 92; see supra § VII(B)(4).

Additionally, based on the teachings of Matula-II, a skilled artisan would

have known to incorporate the folds taught by Matula-II with the D’Souza cushion


42

to provide a higher degree of flexibility in the delicate nose bridge region

compared to other regions. Ex. 1005 ¶ 66; Ex. 1013 ¶ 93.

A skilled artisan would have also been motivated to modify the rearward

extending retaining portion of D’Souza to include the plurality of rearward

extending snap fingers, as taught by Matula-II, to facilitate formation of the

removable snap-fit of D’Souza. Ex. 1013 ¶¶ 94–95. Although the Matula-II snap

fingers are on the elbow, incorporating such snap fingers into 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. 1002 ¶ 96.

Besides being a matter of design preference, such a modification would

facilitate deformation of the engagement parts and make it easier to join the shroud

to the cushion module. Ex. 1013 ¶¶ 94–95. Based on the teachings of Matula-II, a

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

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

insertion of the rigid collar 440 through the rigid retaining portion 448 and to allow

for repeated interlocking without destroying the parts. Id.


43

D. Ground #3: Claims 7 and 8 would have been obvious over D’Souza in view of Ultra Mirage and FlexiFit

1. Overview of FlexiFit (Ex. 1006)

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

1001 at 1–12.

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

mask base (A). Ex. 1006 at 10 (“FITTING YOUR MASK”). The headgear (K)

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

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


44

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

to corresponding slots in the mask base (A). Id. The upper and lower horizontal

straps and top crown straps can be re-adjusted to prevent leaks. Id. at 10

(“FITTING YOUR MASK”).


a. “each upper headgear connector includes a slot”

Claim 7 depends from Claim 6 and includes “each upper headgear connector

includes a slot adapted to receive a respective headgear strap in use.” D’Souza

does not expressly disclose upper headgear connector slots and Ultra Mirage shows

the slots on headgear clips, but as shown in Fig. 3 (above), FlexiFit discloses

attaching upper horizontal straps to corresponding slots in the mask base. Ex. 1006

at 10 (“ASSEMBLING YOUR MASK”); Ex. 1013 ¶ 98.


45

b. “each lower headgear connector is adapted to be

removably interlocked with a headgear clip”

Claim 8 depends from Claim 7 and includes “each lower headgear connector

is adapted to be removably interlocked with a headgear clip associated with a

respective headgear strap.” 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. 1002 ¶ 100; Ex. 1003 at 6; Ex. 1006 at 10 (“FITTING YOUR

MASK”).



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

at the claimed mask system features of Claims 7 and 8 for at least the reasons

provided above. Ex. 1013 ¶ 100; see supra § VII(B)(4).

Additionally, a skilled artisan would have provided the headgear connector

configuration as taught by FlexiFit to make headgear positioning easier. Ex. 1013

¶¶ 100–101. When headgear is pulled over a user’s head, lower headgear straps

undergo tension, making it difficult to position the lower headgear straps. Id. A

skilled artisan would have been motivated to provide removable lower headgear

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


46

headgear straps over his/her head. Id. Since upper headgear straps undergo less

tension than lower headgear straps when positioning the headgear, 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.

E. Ground # 4: Claims 12, 14, 16, and 17 of the ’931 Patent would have been obvious over D’Souza in view of Ultra Mirage and Barnett

1. Overview of Barnett (Ex. 1007)

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

cited by the Examiner. Ex. 1001 at 5.

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

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


47

that is fixed and not movable relative to the seal member 32. Ex. 1007 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.

Additionally, as shown below, Barnett discloses seal members 32, 32’ that

differ in the “contour of the first end portion, size, and shape” to accommodate

different patient populations (e.g., adults and children). Id. at col. 6:1–4, 5:52–67.

The different seal member include a neck portion 46 of the same size and

configuration “so that seal members 32 and 32′ can be used in conjunction with a

commonly sized collar 34 and conduit coupling member 36.” Id. at col. 6:9–13.


a. “elbow module”

Claim 12 depends from Claim 11 and includes “elbow module is provided to

the shroud module.” Claim 14 depends from Claim 11 and includes “elbow


48

module and the shroud module are directly connected with a mechanical interlock

while allowing 360 degree rotation of the elbow module.”

D’Souza discloses an elbow adapted to engage the mask assembly (Ex. 1002

¶ 100) and Ultra Mirage discloses that the elbow rotates 360° (Ex. 1003 at 6), but

D’Souza and Ultra Mirage do not expressly disclose an elbow that directly

connects to the shroud module. However, as shown in Figs. 1A–1B (below),

Barnett discloses an elbow 36 that is mounted to the shroud 34 and freely rotates

360° in direction A. Ex. 1007 at col. 3:52–57.

As discussed in the Reasons to Combine, a person of skill would have been

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

allowing 360° rotation of the elbow. Ex. 1013 ¶ 106; see § VII(E)(3), infra.


49

b. “at least first and second cushion modules”

Claim 16 depends from Claim 1 and includes “the cushion module includes

at least first and second cushion modules adapted to be provided to the shroud

module, said at least first and second cushion modules being different from one

another in at least one aspect.” D’Souza does not expressly disclose this feature,

but as described above, Barnett discloses different sized cushion modules 32, 32' to

accommodate different patient populations. Ex. 1007 at col. 6:1–4, 5:52–67. The

cushion modules 32, 32' attach to the same shroud 34 and elbow 36. Id. at

col. 6:1–14.

c. “a small cushion module, a medium cushion module and a

large cushion module”

Claim 17 depends from Claim 1 and includes, “a small cushion module, a

medium cushion module and a large cushion module, wherein each of said small

cushion module, said medium cushion module and said large cushion module is

removably coupleable to the same shroud module.” As explained above with

respect to Claim 16, Barnett discloses different sized cushion modules 32, 32'

configured for use with a common shroud 34 and elbow 36. Ex. 1007 at col. 6:1–

14. Barnett discloses larger cushion modules for larger adult patients and smaller

cushion modules for small adults and children. Id. at col. 6:1–14, 5:52–67.


50

Moreover, Ultra Mirage specifically discloses product sizes for small, medium, and

large masks. Ex. 1003 at 7.



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

at the claimed mask system features of Claims 12, 14, 16, and 17 for at least the

reasons provided above. Ex. 1013 ¶ 109; see supra § VII(B)(4).

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 mask components. Ex. 1013 ¶ 110. A skilled

artisan would have also understood that attaching the elbow to the shroud would

provide more design flexibility than attaching the elbow to a component of the

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

Based on the teachings of Ultra Mirage, a skilled artisan would have also

been motivated to make the elbow rotatable over a 360° range to provide control

over the tubing. Ex. 1003 at 6; Ex. 1013 ¶ 111. The rotatable elbow would allow

the wearer to position the tubing to provide a convenient, comfortable, and low

force mask connection. Ex. 1013 ¶ 111.

Additionally, a skilled artisan would have been motivated to provide

different-sized, interchangeable cushions (e.g., small, medium, and large) for


51

different-sized patient populations. Ex. 1007 at 6:1–14; Ex. 1013 ¶ 112. A skilled

artisan would have recognized that providing different sized and interchangeable

cushion modules to fit a common shroud would reduce the number of components

required (as compared to distinct shroud sizes to match distinct cushion module

sizes). Ex. 1013 ¶ 112.

F. Ground #5: Claim 13 would have been obvious over D’Souza in view of Ultra Mirage and Lovell

1. Overview of Lovell (Ex. 1008)

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

specifically cited by the Examiner. Ex. 1001 at 5.

Lovell discloses CPAP mask assemblies having a shroud and cushion

module that also include a polycarbonate conduit elbow 10. Ex. 1008 at col. 1:5–

8, 5:29–33.


52


a. “elbow module comprises polycarbonate”

Claim 13 depends from Claim 11 and includes “the elbow module comprises

polycarbonate.” D’Souza and Ultra Mirage both disclose an elbow, but do not

expressly disclose a polycarbonate elbow. However, Lovell specifically discloses

a polycarbonate elbow. Id. at col. 1:5–8, 5:33–35.


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

the features of D’Souza, Ultra Mirage, and Lovell to arrive at the claimed mask

system features of Claim 13 for at least the reasons provided above. Ex. 1013

¶ 115; see supra § VII(B)(4).

Additionally, it was well-known to use polycarbonate elbows as taught by

Lovell because polycarbonate provides strength, rigidity, and toughness, and

polycarbonate can be cleaned, disinfected, and/or sterilized by commonly used

methods. Ex. 1013 ¶ 115.

G. Ground #6: Claim 15 would have been obvious over D’Souza in view of Ultra Mirage and Jaffre

1. Overview of Jaffre (Ex. 1012)

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

cited by the Examiner. Ex. 1001 at 5.


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Jaffree discloses CPAP devices having an exhaust port assembly. Ex. 1012

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

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

pressure system is functioning properly, 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 falls below ambient, valve member 68 returns to its normal position and

unblocks opening 88 so that the patient has access to ambient atmosphere (see Fig.

9). Id. at col. 10:23–28.


a. “anti-asphyxia valve”

Claim 15 depends from Claim 11 and includes “the elbow module includes

an anti-asphyxia valve and wherein the anti-asphyxia valve includes a flap portion


54

adapted to selectively close a port provided in the elbow module.” 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. 1002 ¶ 100; Ex. 1003 at 6. However, such valve

assemblies in CPAP elbows were well-known prior to the ’931 Patent. Ex. 1013

¶ 117. As shown in Figs. 8–9 of Jaffre (above), the valve has a flap portion 68 that

selectively closes port 88. Ex. 1012 at col. 10:14–28.


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

the features of D’Souza, Ultra Mirage, and Jaffre to arrive at the claimed mask

system features of Claim 15 for at least the reasons provided above. Ex. 1013 ¶

118; see supra § VII(B)(4).

Further, a skilled artisan would have been motivated to provide the anti-

asphyxia valve of Jaffre to the D’Souza elbow to provide breathable air to the user

when the flow generator does not provide flow. Ex. 1003 at 6; Ex. 1009 ¶ 106; Ex.

1013 ¶ 118. A skilled artisan would have understood that an anti-asphyxia valve

using a flap is advantageous because the flap easily moves by airflow and pressure.

Ex. 1013 ¶¶ 118–119.


55

H. Ground #7: Claims 19–21 and 25 would have been obvious over D’Souza in view of Ultra Mirage, FlexiFit, and Gunaratnam-II

1. Overview of Gunaratnam-II (Ex. 1010)

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

feature and as a secondary reference. Ex. 1001 at 6; Ex. 1014 at 358–359.

Gunaratnam-II discloses nasal assemblies having headgear. Ex. 1010 at

Abstract. As shown in Fig. 135 (above), Gunaratnam-II teaches 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.


56


a. “headgear”

As detailed in the Claim Chart below, Claim 19 depends from Claim 1 and

further recites various headgear features.

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

upper and lower headgear connectors adapted to removably attach to respective

headgear straps (see supra §§ VII(B)(3)(a) & VII(B)(3)(c)). D’Souza and Ultra

Mirage do not expressly disclose the specific headgear configuration recited in

Claim 19, but as shown in the annotated figure below, FlexiFit teaches headgear

(K) having the claimed features. Ex. 1006 at 10 (“FITTING YOUR MASK” &

“ASSEMBLING YOUR MASK”).

Top Crown Straps

Rear Straps

Lower Straps

Upper Straps


57

FlexiFit teaches adjustable upper and lower headgear straps, adjustable 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 above, the upper straps split to form the pair of top crown

straps connected by a buckle and the pair of rear straps. Id.; Ex. 1013 ¶ 123.

Additionally, FlexiFit discloses Velcro® tabs on the straps. Id. To the extent

there is insufficient teaching that the Velcro® tabs are positioned at the free ends of

the straps, such positioning would have been obvious to a person of skill and

typical for headgear straps in the prior art. Ex. 1013 ¶ 124.

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

threaded through a buckle, as shown in Fig. 135 (below). Ex. 1010 ¶ 316 & Fig.

135; Ex. 1013 ¶ 125. Gunaratnam-II discloses that each top strap is wrapped

around a respective cross-bar associated with the buckle. Ex. 1010 ¶ 316.


58

b. “upper straps provide padding”

Claim 20 depends from Claim 19 and includes “the upper straps provide

padding to the respective headgear connectors of the shroud module on the

patient’s face in use.” As shown in Figs. 2–3 (below), FlexiFit teaches flexible

headgear straps. Ex. 1006 at 10.

FlexiFit also shows that a portion of each upper strap of headgear is

sufficiently flexible to extend across the patient-facing side of the mask frame and

loop through its respective upper headgear connector and around to the outside-

facing side of the mask frame. A person of skill would have recognized that the

flexible headgear strap between the upper headgear connector and the user’s face

provides padding. Ex. 1006 at 10; Ex. 1013 ¶¶ 126–128.

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

Claim 21 depends from Claim 19 and includes “the rear straps and the top

straps form a closed loop to encircle a rear portion of the patient’s head when in


59

use.” As shown below, FlexiFit teaches the rear straps and the top straps forming a

closed loop. Ex. 1006 at 10; Ex. 1013 ¶ 129.



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

Gunaratnam-II to arrive at the claimed mask system features of Claims 19–21 and

25 for at least the reasons provided above. Ex. 1013 ¶ 130; see supra §§ VII(B)(4),

VII(D)(3).

Closed Loop

Top Crown Straps

Rear Straps


60

Additionally, a skilled artisan would have provided the headgear features of

FlexiFit and Gunaratnam-II to the D’Souza mask assembly. Ex. 1013 ¶¶ 130–131.

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. ¶ 130.

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

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

provide comfort, without increasing the number of components. Id. ¶¶ 128, 131.

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


61

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. ¶ 131.

A skilled artisan would have also known to join the top crown straps of the

FlexiFit headgear using a buckle to allow for adjustment and to maintain the straps

in a desired position. Ex. 1010 ¶ 316; Ex. 1013 ¶ 132.

I. Ground #8: Claim 22 would have been obvious over D’Souza in view of Ultra Mirage, FlexiFit, Gunaratnam-II, and Matula-II

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

As detailed in the Claim Chart below, Claim 22 depends from Claim 1 and

includes features taught by D’Souza. Claim 22 further includes the removably

snap-fit feature recited in Claim 26. To the extent D’Souza provides insufficient

teachings for this feature, as described above, Matula-II specifically teaches this

feature. Ex. 1013 ¶ 133; see supra § VII(C)(2)(c). 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, Gunaratnam-II, and Matula-II to arrive at the

mask system features of Claim 22 for at least the reasons provided above. Ex.

1013 ¶ 134; see supra §§ VII(B)(4), VII(C)(3), VII(D)(3), VII(H)(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. See KSR, 550 U.S. at 416.


62

J. Ground #9: Claims 28–30 would have been obvious over D’Souza in view of Ultra Mirage, Matula-II, FlexiFit, and Barnett


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

limitations of Claims 28–30. Any differences were well-known at the time of the

invention and taught by other CPAP prior art. Ex. 1013 ¶ 135. For example, as

discussed above with respect to Claims 5–8, 11, and 14, the combination of

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

features recited in Claims 28–30. See supra §§ VII(B)(3)(d)–(e), VII(C)(2)(b),

VII(D)(2), VII(E)(2)(a). 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,

Matula-II, FlexiFit, and Barnett to arrive at the claimed mask system features of

Claims 28–30 for at least the reasons provided above. Ex. 1013 ¶ 136; see supra

§§ VII(B)(4), VII(C)(3), VII(D)(3), VII(E)(3), VII(H)(3). Moreover, combining

these features would have been a mere combination of familiar elements according

to known methods that does no more than yield predictable results. See KSR, 550

U.S. at 416.

K. Ground #10: Claim 34 and 36 would have been obvious over D’Souza in view of Ultra Mirage, Matula-II, and Barnett


Claims 34 and 36 depend from Claim 33. As discussed above with respect

to Claim 14, to the extent D’Souza provides insufficient teachings for these


63

features, Ultra Mirage and Barnett specifically teach the features of Claims 34 and

36. Ex. 1013 ¶ 137; see supra §§ VII(E)(2)(a). 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, Matula-II, and Barnett to arrive at the claimed mask

features of Claims 34 and 36 for at least the reasons provided above. Ex. 1013

¶ 138; see supra §§ VII(B)(4), VII(C)(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. See KSR, 550

U.S. at 416.

L. Ground #11: Claim 35 would have been obvious over D’Souza in view of Ultra Mirage, Matula-II, and FlexiFit


Claim 35 depends from Claim 33. As discussed above with respect to

Claims 6–8, to the extent D’Souza provides insufficient teachings for these

features, Ultra Mirage, and FlexiFit specifically teach the features of Claim 35.

Ex. 1013 ¶ 139; see supra §§ VII(B)(3)(c) & VII(D)(2). 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, Matula-II, and FlexiFit to arrive at the claimed mask

features of Claim 35 for at least the reasons provided above. Ex. 1013 ¶ 140; see

supra §§ VII(B)(4), VII(C)(3), VII(D)(3). Additionally, combining these features

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


64

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

416.


65

VIII. CLAIM CHART

’931 Patent Prior Art 1. A mask system, comprising:

D’Souza: “[M]ask assembly 410 including a cushion to frame assembly mechanism.” Ex. 1002 ¶ 96.

(i) a shroud module; wherein the shroud module includes headgear connectors adapted to removably attach to respective headgear straps of headgear; and

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. 1002 ¶ 100.

Ultra Mirage: “Quick release headgear clips: top and bottom allows mask to be removed without resetting the


66

headgear and provides convenience and safety.” Ex. 1003 at 6.

(ii) a cushion module, comprising: a rigid or semi-rigid

frame defining a breathing chamber; 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,

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. 1002 ¶ 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. “[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.

[A] wherein the shroud module and the cushion module are configured to be removably and non-rotatably coupleable to one another; and

D’Souza: “[S]keleton frame 412 that is adapted to removably interlock with a cushion/frame sub-assembly 430.” Ex. 1002 ¶ 96. “[A]nnular elbow connection seal 448 interlocks with the annular wall 440 . . . upper support member 444 interlocks with a top portion 431 . . . and the elongated frame members 450 interlock with respective protrusions 442.” Id. ¶ 101.


67

[B] wherein 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, and

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. 1002 ¶ 101.

Ultra Mirage: “Air vent provides excellent CO2 washout and minimal noise output.” Ex. 1003 at 6.


68

[C] further wherein the shroud module includes a second opening positioned to align with a frame opening of the frame leading to the breathing chamber.

D’Souza: “[A]nnular elbow connection seal 448 interlocks with the annular wall 440.” Ex. 1002 ¶ 101.

4. The mask system of claim 1, wherein a nasal bridge portion of the

Matula-II: “[S]eal member 38 includes at least one pleat 106 (which can also be referred to as a fold or gusset) provided at a portion of the seal member so that


69

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.

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. 1005 ¶ 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.

5. The mask system of claim 1, wherein the frame includes a collar surrounding said frame opening,

D’Souza: “[A]nnular wall 440 surrounds the opening 418 [of the frame 414].” Ex. 1002 ¶ 98.


70

and wherein the shroud includes a retaining portion with a plurality snap fingers structured to engage the collar with a snap-fit.

D’Souza: “[A]nnular elbow connection seal 448 interlocks with the annular wall 440.” Ex. 1002 ¶ 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. 1005 ¶ 53.

6. The mask system of claim 1, wherein the shroud module includes

D’Souza: “[S]keleton frame 412 includes an upper support member 444 adapted to support a forehead support, lower headgear clip receptacles 446.” Ex. 1002


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upper and lower headgear connectors on each side of the shroud module.

¶ 100.

Ultra Mirage: “Quick release headgear clips: top and bottom.” Ex. 1003 at 6.

7. The mask system of claim 6, wherein each upper headgear connector includes a slot adapted to receive a respective headgear

See supra Claim 6. FlexiFit: “[A]ttach the four straps in to the corresponding slots in the Mask Base.” Ex. 1006 at 10 (“ASSEMBLING THE MASK”).


72

strap in use.

8. The mask system of claim 7, wherein each lower headgear connector is adapted to be removably interlocked with a headgear clip associated with a respective headgear strap.

D’Souza: “[L]ower headgear clip receptacles 446 adapted to be engaged with clips provided to straps of a headgear assembly (not shown).” Ex. 1002 ¶ 100.

Ultra Mirage: “Quick release headgear clips: top and bottom.” Ex. 1003 at 6.

10. The mask system of claim 1, wherein the

D’Souza: “[A]nnular elbow connection seal 448 interlocks with the annular wall 440 of the


73

shroud module includes an annular or part annular cushion retaining portion structured to retain the cushion module.

cushion/frame sub-assembly 430.” Ex. 1002 ¶ 101, Fig. 7.

11. The mask system of claim 1, further comprising an elbow module adapted to be connected to an air delivery tube that delivers breathable gas to the patient.

D’Souza: “[S]keleton frame 412 includes . . . an annular elbow connection seal 448 adapted to engage an inlet conduit, e.g., elbow.” Ex. 1002 ¶ 100. Ultra Mirage: “360° rotating elbow provides control over tubing system.” Ex. 1003 at 6. “Quick release swivel allows easy disconnection from tubing.” Id.


74

12. The mask system of claim 11, wherein the elbow module is provided to the shroud module.

D’Souza: “[S]keleton frame 412 includes . . . an annular elbow connection seal 448 adapted to engage an inlet conduit, e.g., elbow.” Ex. 1002 ¶ 100. “[S]keleton frame 412 . . . provides attachment points for . . . an inlet conduit.” Id. ¶ 101. Barnett: “[C]onduit coupling member 36 is preferably rotateably mounted on a second side of collar 34.” Ex. 1007 at col. 3:52–57; see also id. at col. 8:66—col. 9:43.

13. The mask system of Lovell: “[C]onduit elbow 10 also can be manufactured


75

claim 11, wherein the elbow module comprises polycarbonate.

from . . . a polycarbonate material.” Ex. 1008 at col. 5:33–35.

14. The mask system of claim 11, wherein the elbow module and the shroud module are directly connected with a mechanical interlock while allowing 360 degree rotation of the elbow module.

See supra Claim 12. Ultra Mirage: “360° rotating elbow provides control over tubing system.” Ex. 1003 at 6. Barnett: “[C]onduit coupling member 36 freely rotates over a range of 360°.” Ex. 1007 at col. 3:52–57, 8:66—col. 9:43.

15. The mask system of claim 11, wherein the elbow module 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 module.

Ultra Mirage: “Safety valve allows patient to breathe fresh air when flow generator does not provide flow.” Ex. 1003 at 6. Jaffre: “[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. 1012 at col. 10:14–28.


76

16. The mask system of claim 1, wherein the cushion module includes at least first and second cushion modules adapted to be provided to the shroud module, said at least first and second cushion modules being different from one another in at least one aspect.

Barnett: The seal members 32, 32’ differ in the “contour of the first end portion, size, and shape.” Ex. 1007 at col. 6:1–4. The seal member 32 is configured for a relatively large population of adult patients and the seal member 32’ is configured for small adults and children, and seal members 32 and 32′ can be used in conjunction with a commonly sized collar 34.” Id. at col. 5:52–67, 6:1–13.

17. The mask system of claim 1 comprising a small cushion module, a medium cushion module

See supra Claims 1[A] & 16. Ultra Mirage: Brochure provides product codes for small, medium, and large sizes. Ex. 1003 at 7, 9.


77

and a large cushion module, wherein each of said small cushion module, said medium cushion module and said large cushion module is removably coupleable to the same shroud module. 18. The mask system of claim 1, wherein the shroud module and the frame comprise polycarbonate and the cushion comprises silicone.

D’Souza: “[C]ushion 416 is constructed of liquid silicone rubber (LSR).” Ex. 1002 ¶ 97. “[T]he frame 414 is constructed of polycarbonate.” Id. ¶ 98. “[T]he skeleton frame 412 is formed of plastic.” Id. ¶ 100.

19. The mask system of claim 1, wherein: [A] the headgear includes a pair of upper straps and pair of lower straps, with the upper straps being removably attached to respective ones of the headgear connectors and the lower straps being connected to respective ones of the headgear connectors,

D’Souza: “[P]atient interface is held in a sealing position by headgear.” Ex. 1002 ¶ 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).” 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. 1003 at 6. FlexiFit: “2) Unclip the Headgear (K) from the GliderTM strap (E) . . . . 4) Re-attach the Headgear Clip (H) to the GliderTM Strap. 5) Gently adjust the Top Horizontal straps then the Lower Horizontal straps.” Ex. 1006 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”).


78

[B] 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,

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. 1006 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”).

[C] the upper straps split FlexiFit: “Gently adjust . . . Top Crown straps.” Ex.


79

to form a pair of top straps and a pair of rear straps,

1006 at 10 (“FITTING YOUR MASK”).

[D] the top straps being connected together by a buckle and configured to pass over the top of the patient's head in use,

FlexiFit: Ex. 1006 at 10.

Gunaratnam-II: “[U]pper straps 598 are coupled to one another by a headgear buckle 570.” Ex. 1010 ¶ 316 & Fig. 135.


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[E] the rear straps being adapted to pass behind the patient's head in use,


[F] and 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

FlexiFit: “Gently adjust the . . . Top Crown straps.” Ex. 1006 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”).


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adjustable manner.

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. 1010 ¶ 316 & Fig. 135.


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20. The mask system of claim 19, wherein the upper straps provide padding to the respective headgear connectors of the shroud module on the patient's face in use.


21. The mask system of claim 19, 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.



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22. The mask system of claim 19, [A] wherein the frame includes a frame opening leading to the breathing chamber, and

See supra Claim 1[C].

[B] 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 removably snap-fit attached to one another by moving the shroud module and the cushion module towards 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. 1002 ¶ 96. “[A]nnular elbow connection seal 448 interlocks with the annular wall 440.” 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. 1005 ¶ 53.


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25. The mask system of claim 19, wherein the frame is rigid.

D’Souza: “[F]rame 414 is constructed of polycarbonate.” Ex. 1002 ¶ 98.

26. The mask system of claim 1, wherein the second opening of the shroud module and the frame opening of the frame are aligned along a common longitudinal axis, and wherein the mask system further comprises a snap-fit arrangement to removably snap-fit attach the shroud module and the cushion module to one another by moving the shroud module and the cushion module towards one another along the longitudinal axis.

See supra Claim 22[B].

28. The mask system of claim 1, wherein: the

See supra Claim 5.


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frame includes a collar surrounding said frame opening, and wherein the shroud includes a retaining portion with at least one snap finger structured to engage the collar with a snap-fit,

the shroud module includes upper and lower headgear connectors on each side of the shroud module,

See supra Claim 6.

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

See supra Claim 7.

each lower headgear connector is adapted to be removably interlocked with a headgear clip associated with a respective headgear strap,

See supra Claim 8.

the mask assembly further comprises an elbow module adapted to be connected to an air delivery tube that delivers breathable gas to the patient, and

See supra Claim 11.

the elbow module is rotatably attached to the shroud module while allowing 360 degree rotation of the elbow module.

See supra Claim 14.

29. The mask system of claim 28, wherein each

See supra Claim 18.


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of the shroud module and the frame comprises polycarbonate, and the cushion comprises silicone. 30. The mask system of claim 28, wherein the frame is rigid.

See supra Claim 25.


See supra Claim 25.

32. A system for treating a patient with sleep disordered breathing, comprising: the mask system of

claim 1; a flow generator to

generate a supply of air at positive pressure to be delivered to the mask system; and

See supra Claim 1. 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. 1002 ¶ 3.

an air delivery tube configured to deliver the supply of air from the flow generator to the mask system.

See supra Claim 11.

33. A mask system, comprising:

See supra Claim 1, preamble

(i) a shroud module; wherein the shroud module includes headgear connectors adapted to removably attach to respective headgear straps of headgear; and

See supra Claim 1(i).

(ii) a cushion module, See supra Claim 1(ii).


87

comprising: a frame defining a

breathing chamber; and

a cushion to form a seal with the patient's face in at least a nasal bridge region and a cheek 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, and

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 relative to another region of the cushion module;

See supra Claim 4.

wherein the shroud module and the cushion module are configured to be removably coupleable to one another, and

See supra Claim 1[A].

wherein the shroud module includes a front opening of substantively circular shape and a retaining portion

D’Souza: “[A]nnular elbow connection seal 448 interlocks with the annular wall 440 of the cushion/frame sub-assembly 430.” Ex. 1002 ¶ 101; Fig. 7.


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extending rearwardly from the front opening, towards the frame, and structured to snap-fit with the cushion module.

See supra Claim 22[B].

34. The mask system of claim 33, further comprising an elbow module directly mechanically interlocked with the shroud module while allowing 360 degree rotation of the elbow module.

See supra Claim 14.

35. The mask system of claim 33, wherein the shroud module includes upper and lower headgear connectors on each side of the shroud module;

See supra Claim 6.

wherein each upper headgear connector includes a slot adapted to receive a respective headgear strap in use;

See supra Claim 7.


89

and wherein each lower headgear connector is adapted to be removably interlocked with a headgear clip associated with a respective headgear strap.

See supra Claim 8.

36. The mask system of claim 33, further comprising an elbow module adapted to be connected to an air delivery tube that delivers breathable gas to the patient,

See supra Claim 11.

wherein the shroud module is structured to directly retain and carry the elbow module.

See supra Claim 14.

37. The mask system of claim 33, wherein the frame includes a frame opening leading to the breathing chamber, and 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 removably snap-fit attached to one another by moving the shroud module and the cushion module towards one another along the longitudinal axis.

See supra Claim 22.


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40. The mask system of claim 33, wherein the frame is semi-rigid or rigid.

See supra Claim 1(ii).


See supra Claim 25.

42. A system for treating a patient with sleep disordered breathing, comprising: the mask system of

claim 33; 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 32 & 33.

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


91

commercial sales as a secondary consideration of non-obviousness 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.

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


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 13,602 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


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 1001-1024 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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