filed: october 11, 2016 filed on behalf of: fisher & paykel ......malloy, robert a., plastic...

Filed: October 11, 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. IPR2017-00057 U.S. Patent No. 8,960,196

PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,960,196

TABLE OF CONTENTS

Page No.

i

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

II. THIS PETITION IS NOT REDUNDANT UNDER 35 U.S.C. § 325(D) .......................................................................................... 6

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

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

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

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

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

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

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

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

1. Identification of Claims and Prior Art ........................................ 9

2. Grounds ..................................................................................... 11

C. Claim Construction (37 C.F.R. § 42.104(b)(3)) .................................. 11

V. THE ’196 PATENT ....................................................................................... 11

A. Example Embodiments ....................................................................... 11

B. Summary of the Prosecution History of the ’196 Patent .................... 14

VI. LEVEL OF ORDINARY SKILL IN THE ART ........................................... 14

VII. THE CHALLENGED CLAIMS OF THE ’196 PATENT ARE UNPATENTABLE ........................................................................................ 15

A. Legal Standard for Obviousness ......................................................... 15

TABLE OF CONTENTS (continued)

Page No.

ii

B. Ground #1: Claims 23–78, 80–82, and 84–86 of the ’196 Patent would have been obvious over Gunaratnam in view of Lovell ..................................................................................... 16

1. Overview of Gunaratnam (Ex. 1002) ....................................... 16

2. Overview of Lovell (Ex. 1003) ................................................. 18

3. Potential Differences Between the Prior Art and Claims 23–40 and Reasons to Combine ................................... 20

a. “a rigid mask frame having a bore and an interfacing structure associated with the bore” .............. 22

b. “the mask frame and the sealing cushion together forming a breathing cavity” .............................. 25

c. “fixed forehead support” ................................................ 27

d. “at least a portion of said headgear connector is shaped to conform to a portion of said mask frame” ............................................................................. 29

e. “an elbow assembly” ...................................................... 31

f. “the bore is located on a front face of the mask frame” ............................................................................. 32

g. “the sealing cushion and the mask frame are permanently attached” .................................................... 33


a. “said bore and said opening being concentrically disposed about a common axis” ............. 35


TABLE OF CONTENTS (continued)

Page No.

iii

a. “a rigid mask frame having a bore and a cylindrical projection extending around the bore . . . the attachment structure removably attached to the cylindrical projection of the rigid mask frame with a snap-fit” ................................... 38

b. “the attachment structure and the cylindrical projection are engaged with the snap-fit when the attachment structure and the cylindrical projection are engaged in a nested arrangement” ................................................................... 40

6. Potential Differences Between the Prior Art and Claims 73–78, 80–82, and 84–86 and Reasons to Combine ................................................................................ 41

a. “a headgear connector including a plurality of tabs structured to removably attach the headgear connector to the rigid mask frame with a snap-fit” ............................................................... 41

C. Ground #2: Claims 79 and 83 of the ’196 Patent would have been obvious over Gunaratnam in view of Lovell and Geist .............................................................................................. 43

1. Overview of Geist (Ex. 1004) ................................................... 43

2. Potential Differences Between the Prior Art and Claims 79 and 83 of the ’196 Patent and Reasons to Combine ................................................................................ 44

VIII. CLAIM CHARTS .......................................................................................... 48

IX. SECONDARY CONSIDERATIONS, EVEN IF CONSIDERED, FAIL TO OVERCOME THE PRIMA FACIE EVIDENCE OF OBVIOUSNESS ............................................................................................ 92

TABLE OF AUTHORITIES Page No(s).

iv

In re Cuozzo Speed Techs., LLC, 793 F.3d 1268 (Fed. Cir. 2015), aff’d, 136 S. Ct. 2131 (2016) .......................... 11

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) .......................................................................... 92

Newell Cos., Inc. v. Kenney Mfg. Co., 864 F.2d 757 (Fed. Cir. 1988) ............................................................................ 92

Ricoh Corp., Xerox Corp., and Lexmark Intl. v. MPHJ Tech. LLC, IPR2014-00539, Paper 7 (PTAB August 25, 2014) ............................................ 7

Thorley Indus. LLC v. Kolcraft Enterprises, Inc., IPR2016-00352, Paper 14 (PTAB June 23, 2016) .............................................. 7

In re Translogic Tech., 504 F.3d 1249 (Fed. Cir. 2007) ......................................................................... 11

Wyers v. Master Lock Co., 616 F.3d 1231 (Fed. Cir. 2010) .......................................................................... 92

OTHER AUTHORITIES

35 U.S.C. §102 ................................................................................................... 10, 14

35 U.S.C. § 103 .................................................................................................passim

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

35 U.S.C. § 325 .......................................................................................................... 6

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

37 C.F.R. § 42.100 ............................................................................................... 1, 11

37 C.F.R. § 42.104 ............................................................................................... 9, 11

Fisher & Paykel Healthcare Petition – IPR of U.S. Pat. 8,960,196

Exhibit List, Page 1

EXHIBIT LIST

Exhibit No. Description

1001 U.S. Patent No. 8,960,196

1002 U.S. Patent No. 6,796,308 (Gunaratnam)

1003 U.S. Patent No. 6,631,718 (Lovell)

1004 U.S. Patent No. 7,353,827 (Geist)

1005 Declaration of Jason Eaton

1006 Excerpts from the File History of U.S. Patent No. 8,960,196

1007 Malloy, Robert A., Plastic Part Design for Injection Molding: An Introduction, pp. 336–345 (Hanser Gardner Publications, Inc. 1994) (Malloy)

1008 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

1009 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.)

1010 U.S. Patent No. 6,412,488 (Barnett)

1011 U.S. Patent No. 5,662,101 (Ogden)


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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 23–86 (“Challenged Claims”) of U.S. 8,960,196

(“’196 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 breathing airways open, and can be used to

treat obstructive sleep apnea. The ’196 Patent relates to CPAP mask systems used

for treatment of sleep-disordered breathing. CPAP mask systems usually include a

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

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


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Many mask assemblies prior to the ’196 Patent had a frame that supported

the seal and attached to the headgear, including U.S. 6,796,308 to Gunaratnam:

As shown above, these prior art mask assemblies included headgear connectors

and connection points on the frame.

The ’196 Patent claims to have invented a mask system that can be used

with a variety of different types of headgear and frames that attach to the headgear.

The ’196 Patent discloses a common frame that supports the cushion seal and

various headgear connector frames adapted to attach to the common frame. Ex.

1001 at col. 1:51–58. The headgear connector frame connects to the headgear and

supports the common frame and seal on the patient’s face. Thus, instead of using a

single frame, the mask assemblies of the Challenged Claims include two frames.

In particular, the ’196 Patent discloses (1) a mask frame 220 (first frame) attached


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to the seal and (2) a headgear connector 250(1) (second frame) that attaches to the

headgear, as shown in Fig. 2A:

As explained in detail below, this two-frame arrangement and the various

components included in the Challenged Claims were well-known prior to the

earliest priority date of the ’196 Patent, and their combination in the claims

provided no unexpected results or benefits. See Section VII(B)(3), infra. Indeed,

the relevant embodiments disclosed in the ’196 Patent are nearly identical to

embodiments from ResMed’s own prior art patents.


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For example, Gunaratnam discloses a frame 160, shown in Fig. 5c, that is

nearly identical to the mask frame 220 and headgear connector 250(1) shown in

Fig. 2B of the ’196 Patent, as illustrated below:

Challenged ’196 Patent (Ex. 1001) Prior Art Gunaratnam (Ex. 1002)

Ex. 1001 at col. 6:63—7:2.

The only difference between the prior art frame of Gunaratnam and the

frame of the ’196 Patent is that the unitary frame of Gunaratnam has been divided

into two parts in the ’196 patent. But this difference was well-known in the prior

art.


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For example, Lovell discloses a CPAP mask assembly having a two-piece

frame. In particular, Lovell discloses (1) a shell 204 (first frame) attached to a seal

and (2) a headgear connector 212 (second frame) that supports the first frame and

is attached to the headgear, as shown in Fig. 10A below:

A skilled artisan at the time of the claimed invention would have been

motivated to slightly modify the masks of Gunaratnam in view of Lovell to arrive

at the mask assemblies of the Challenged Claims. See Sections VII(B)(3)–(6),

infra; Ex. 1005 ¶¶ 80–88. Any other differences between the Challenged Claims

and Gunaratnam were also minor, well-known, and disclosed in prior art CPAP

masks (e.g., Geist). See Sections VII(C)(2), infra; Ex. 1005 ¶¶ 93–94. Because the

claimed features are simple mechanical features commonly used in CPAP masks, a


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

the features of Gunaratnam with Lovell and Geist.

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

other co-pending IPR petition challenging the ’196 Patent’s claims based on a

different ground involving different prior art references.

As explained in detail herein, Gunaratnam is a prior art ResMed patent that

discloses mask systems that are nearly identical to the mask systems of the ’196

Patent and a person of skill would have been motivated to modify the Gunaratnam

masks to include the two-frame arrangement explained above, as taught by Lovell.

The other petition requests inter partes review of the Challenged Claims in

view of Ogden (U.S. 5,662,101), Lovell, Gunaratnam, and Geist (U.S. 7,353,827).

The obviousness analysis presented in that IPR is considerably different from the

obviousness analysis presented herein because there Ogden is used as the primary

reference. As explained in that petition, Ogden expressly discloses a mask system

having the two-frame feature of the ’196 Patent, but may not teach other features

of the claimed mask system. However, a person of skill would have been

motivated to modify Ogden to include those mask features, as taught by the other

prior art references.


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Because these two petitions present different primary references that

disclose different features of the Challenged Claims, Petitioner respectfully

requests that the Board institute both IPR proceedings. See Thorley Indus. LLC v.

Kolcraft Enterprises, Inc., IPR2016-00352, Paper 14 (Decision on Institution of

Inter Partes Review) at 20–21 (PTAB June 23, 2016); see also Ricoh Corp., Xerox

Corp., and Lexmark Intl. v. MPHJ Tech. LLC, IPR2014-00539, Paper 7 (Decision

on Institution of Inter Partes Review) at 17 (PTAB August 25, 2014).

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 ’196 Patent

(Investigation No. 337-TA-1022). Ex. 1008.


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

the Southern District of California involving the ’196 Patent. See Fisher & Paykel

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

Cal.). ResMed asserted a claim for infringement of the ’196 Patent in its

counterclaims on September 7, 2016. Ex. 1009. The ’196 patent, which issued

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

claim any inventive concept. Instead, it claims laundry lists of well-known mask

features in an attempt to cover Fisher & Paykel’s products. While the ’196 Patent

was filed on May 29, 2013, the Challenged Claims were not introduced until

September 30, 2014, after the launch of Fisher & Paykel’s Simplus™ and Eson™

masks.

Fisher & Paykel has concurrently filed a second petition for inter partes

review of Claims 23–86 of the ’196 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.


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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 FOR REVIEW UNDER 37 C.F.R. § 42.104

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

Petitioner hereby certifies that the ’196 Patent is available for inter partes

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

review.

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

1. Identification of Claims and Prior Art

Petitioner respectfully requests inter partes review of Claims 23–86 of the

’196 Patent, filed May 29, 2013, which is a continuation of U.S. Application No.

12/010,680 (now U.S. 8,517,023), filed January 29, 2008, which claims priority

benefit of U.S. Provisional Application No. 60/898,108, filed January 30, 2007.

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


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Ex. 1001 at 1. The earliest possible priority date of the ’196 Patent is January 30,

2007.

The Challenged Claims of the ’196 Patent would have been obvious in view

of the following prior art references:

U.S. 6,796,308 (“Gunaratnam”) (Ex. 1002), which issued on September 28,

2004. Ex. 1002 at 1. Because Gunaratnam issued more than one year before

the earliest possible priority date of the ’196 Patent, it is prior art under 35

U.S.C. § 102(b).1

U.S. 6,631,718 (“Lovell”) (Ex. 1003), which issued on October 14, 2003.

Ex. 1003 at 1. Because Lovell issued more than one year before the earliest

possible priority date of the ’196 Patent, it is prior art under 35 U.S.C. §

102(b).

U.S. 7,353,827 (“Geist”) (Ex. 1004). Geist was filed on September 1, 2004

and issued on April 8, 2008. Ex. 1004 at 1. Because Geist is an issued

patent that was filed by another before the earliest possible priority date of

the ’196 Patent, it is prior art under at least 35 U.S.C. § 102(e).

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 ’196 Patent.


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2. Grounds

Ground #1. Claims 23–78, 80–82, and 84–86 of the ’196 Patent would

have been obvious over Gunaratnam in view of Lovell under 35 U.S.C. § 103.

Ground #2. Claims 79 and 83 of the ’196 Patent would have been obvious

over Gunaratnam in view of Lovell and Geist under 35 U.S.C. § 103.

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

The claims of the ’196 Patent should be accorded their “broadest reasonable

construction” in light of the specification of the ’196 Patent.2 37 C.F.R.

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

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

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

skill in the art at the time of the invention. In re Translogic Tech., 504 F.3d 1249,

1257 (Fed. Cir. 2007).

V. THE ’196 PATENT

A. Example Embodiments

The ’196 Patent discloses a mask system including “a common frame

provided without built-in or integral headgear attachment points and at least first

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.


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and second headgear connectors adapted to be provided to the frame.” Ex. 1001 at

Abstract.

3

The ’196 Patent describes various headgear connectors that can attach to and

support a common mask frame. Id. at col. 6:10–20, Figs. 2A–5B. Figure 2B of the

’196 Patent (above right) illustrates a mask system that includes a headgear

connector 250(1) attached to a frame 220 and a forehead support 272 adjustably

mounted to the headgear connector 250(1). Id. at col. 7:3–12. The headgear

connector 250(1) includes an opening adapted to engage the interfacing structure

3 Drawings of mask components circumscribed by dashed blue line, adapted from

commercial ResMed product literature, used for illustration purposes. The mask

frame 220 and headgear connector 250(1) are from the ’196 Patent.


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of the frame 220 with a snap-fit or other suitable attachment mechanism. Id. at col.

6:32–38. Headgear connector 250(1) and forehead support 272 receive “headgear

including a pair of lower side straps attached to respective clips 276 and a pair of

upper side straps attached to respective openings 273 on the forehead support 272.”

Id. at col. 7:12–16.

Fig. 1B of the ’196 Patent (below) illustrates a different mask system with a

full-face interface. Id. at col. 3:26–29. The mask system 10 includes a frame 20, a

cushion 30 provided to the frame, an elbow assembly 40, a headgear connector

50(2), and headgear 60(2). Id. at col. 3:29–38. Fig. 1D-1 (below) illustrates an

embodiment of the headgear connector 150(1) that is a cushion clip adapted to

retain the cushion 30 to the frame. Id. at col. 4:65–67. “The headgear connector

150(1) includes a plurality of tabs 144 structured to attach to the frame 20 with a

snap-fit.” Id. at col. 5:1–2.


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B. Summary of the Prosecution History of the ’196 Patent

The ’196 Patent was originally filed as U.S. Application No. 13/904,748

(“’748 Application”) on May 29, 2013 and the non-challenged claims were

allowed after a single Office Action dated July 1, 2014. The only rejection in the

Office Action was a nonstatutory double patenting rejection over Claims 45–66 of

U.S. 8,517,023, which is the parent of the ’196 Patent. Ex. 1006 at 3–4. ResMed

overcame this rejection by filing a terminal disclaimer on September 29, 2014 and

also added new claims. Id. at 6–7. The ’748 Application was allowed on October

10, 2014 without any substantive rejections under 35 U.S.C. § 102 or § 103. See

id. at 21. After allowance, ResMed submitted a Request for Continued

Examination on November 25, 2014, adding Claims 42–87 (Claims 41–86 of the

issued ’196 Patent). Id. at 22–39. Another Notice of Allowance was issued on

December 22, 2014 without any substantive rejections under 35 U.S.C. § 102 or

§ 103. See id. at 44.

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 ’196 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. 1005 ¶ 27.


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VII. THE CHALLENGED CLAIMS OF THE ’196 PATENT ARE

UNPATENTABLE

This Petition explains, in detail, why the Challenged Claims of the ’196

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

Eaton, P.E. Ex. 1005. Mr. Eaton is a Principal Mechanical Engineer at MSA

Safety, a leading manufacturer of safety products. He 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. ¶¶ 32–95.

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).


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B. Ground #1: Claims 23–78, 80–82, and 84–86 of the ’196 Patent would

have been obvious over Gunaratnam in view of Lovell

1. Overview of Gunaratnam (Ex. 1002)

Gunaratnam was submitted during the prosecution of the ’196 Patent, but

was not cited by the Examiner. Ex. 1001 at 5.

Gunaratnam generally relates to nasal and full-face masks for delivering

breathable gases to a patient to treat sleep disordered breathing. Ex. 1002 at col.

1:21–25. Figs. 5a, 5c, 6a, and 7a of Gunaratnam illustrate various components of a

mask system:

Figs. 5a and 5c illustrate a T-shaped headgear connector. Id. at col. 4:46–48.

The headgear connector 160/162 has headgear strap connection points 630 and a

forehead support 162. Id. at col. 4:32–33. The strap connection points 630 can

connect to the headgear via clip connectors 200. Id. at col. 4:34. The frame 160


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can be made of rigid polycarbonate and includes a gas inlet aperture for connection

to a gas delivery conduit. Id. at col. 4:22–26.

Fig. 6a illustrates a cushion 180 that is formed of soft material such as

silicone, and projects rearwardly of the mask frame 160 to space the rigid frame

away from the patient's face. Id. at 5:22–24.

Fig. 7a illustrates a clip 800 constructed from polycarbonate and having a

complementary shape with the cushion and frame to hold the cushion in secure

engagement with the frame. Id. at 5:31–47. The clip 800 includes securing tabs

820 that form resilient detents to be retained in recesses 660 (viz., 660a, 660b, and

660c (not shown)) on the frame. Id. at 5:34–38. To disengage, the detents may be

forced outwardly to release the securing tabs 820 from the recesses 660. Id. at

5:38–42.


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Gunaratnam provides an example of headgear from ResMed’s Mirage®

Mask. See id. at Fig. 1 (below). The headgear 140 includes a pair of upper side

straps 145, a pair of lower side straps 145, and a rear portion near the occiput (back

part of the head) of the patient. Id. at col. 1:40–45.

Although the Gunaratnam embodiment illustrated in Figs. 5a, 5c, 6a, and 7a

is a nasal mask, the engagement features of the mask frame 160, cushion 180, and

clip 800 are similarly applicable to a full-face mask. Id. at col. 6:30–34.

2. Overview of Lovell (Ex. 1003)

Lovell was submitted during the prosecution of the ’196 Patent, but was not

cited by the Examiner. Ex. 1001 at 5.

Lovell generally relates to CPAP masks. Ex. 1003 at col. 1:5–8. The Lovell

masks include a “seal [] disposed along a perimeter of the shell so as to form a

chamber within the shell when the mask is donned by a user.” Id. at Abstract, col.


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2:56–58. The seal and the shell can be permanently attached by bonding. Id. at

col. 4:34–36.

As shown in Figs. 10A–10B of Lovell (above), the mask 201 has a retainer

212 that is contoured to match the surface of the shell 204 and is coupled to an

inlet 208 on the front face of the shell 204. Id. at col. 9:43–46. The inlet 208 is

adapted to connect with a conduit elbow via a connector. Id. at col. 5:20–22, 9:34–

36, 9:57–59. The shell 204 has depressed annular regions 280 (extending between

tabs 211, 211′) on the inlet 208 that mate with the tabs (extending between slots

213, 215) formed in the headgear connector 212. Id. at col. 9:57–66.


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3. Potential Differences Between the Prior Art and Claims 23–40

and Reasons to Combine

As detailed in the claim charts below, Gunaratnam expressly discloses

nearly all of the limitations of independent Claim 23 and its dependents (Claims

24–40).

For example, with respect to independent Claim 23, Gunaratnam teaches

masks for delivering breathable gas to a patient at positive pressure to treat sleep

disordered breathing, the mask comprising: a rigid mask frame (clip 800) having

an interfacing structure (securing tabs 820), said mask frame having no built-in or

integral headgear attachment points (clip 800); a sealing cushion provided to the

mask frame and adapted to form a seal with the patient's face (cushion 180), the

mask frame and the sealing cushion together forming a breathing cavity (clip 800

and cushion 180); and a headgear connector (frame 160) adapted to engage the

interfacing structure with a snap-fit (frame 160 has recesses 660a and 660b to

retain the securing tabs 820 of the clip 800), said headgear connector including a

pair of lower headgear clip anchors (strap connection points 630) adapted to be

engaged with respective ones of a pair of lower headgear clips to attach a pair of

lower side straps (connectors 200), said headgear connector including a fixed

forehead support (forehead support 162), said fixed forehead support including a

pair of openings adapted to attach to respective ones of a pair of upper side straps

(forehead support 162 includes two openings separated by bridge portion 164).


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Ex. 1002 col. 1:21––39, 3:30–32, 4:32–34, 4:46–48, 5:14–24, 5:29–47, Figs. 5a–

7e. Many of these claimed features are identified in the annotated versions of

Gunaratnam Figs. 5c, 6a, and 7a provided below.

Any differences between the claims and Gunaratnam were minor and well-

known at the time of the invention and taught by Lovell. Ex. 1005 ¶¶ 42–56. As

discussed below, modifying Gunaratnam to include these minor features would

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

does no more than yield predictable results, a simple substitution of one known

element for another to obtain predictable, a choice from a finite number of

identified, predictable solutions, and/or was taught or suggested by the prior art.

See KSR, 550 U.S. at 416–20. Because Gunaratnam and Lovell both teach

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

Sealing Cushion

Mask Frame Interfacing

Structure

Headgear Connector

Forehead Support

Openings

Clip Anchors Clip

Clip


-22-

the features taught in Lovell would have been readily compatible with and easily

incorporated into the mask of Gunaratnam with a reasonable expectation of

success. Ex. 1005 ¶ 80.

a. “a rigid mask frame having a bore and an interfacing

structure associated with the bore”

Claim 23 includes “a rigid mask frame having a bore and an interfacing

structure associated with the bore.”

As shown in Figs. 5c and 7a (below), Gunaratnam teaches a rigid frame 160

with an inlet bore, and a rigid clip 800 that attaches to the frame 160 via interfacing

structure (three security tabs 820) along the perimeter of the clip 800. Ex. 1002 at

col. 4:22–24, 5:33–38.

To the extent Gunaratnam provides insufficient teachings for this feature,

two-frame mask assemblies in which the inner mask frame and the outer headgear


-23-

connector attach at the bore were disclosed in the prior art before the earliest

priority date of the ’196 Patent. Ex. 1005 ¶ 45. For example, Lovell discloses a

frame 204 that has an annular bore 208 on a front face, as shown in Figs. 10A–10B

(below). Ex. 1003 at col. 9:44–46. The bore 208 is associated with an interfacing

structure (annular depressed region 280 between two tabs 211 and 211') that mates

with the headgear connector 212, resulting in a snap-fit. Id. at col. 9:46–64; Ex.

1005 ¶ 45.

If the mask assembly of Gunaratnam were modified in view of the frame

204 of Lovell, the result would be the frame 220 of the ’196 Patent, as

demonstrated in the figures on the next page. Ex. 1005 ¶ 45.

Depressed Regions Tabs


-24-

Figs. 5c and 7a of Gunaratnam

Fig. 10a of Lovell

Fig. 2a ’196 Patent


-25-

A person of skill in the art would have been motivated to modify the frame

(clip 800) of Gunaratnam to include an interfacing structure associated with an

annular bore, as taught by Lovell, to simplify manufacturing and control

manufacturing tolerances. Id. ¶ 84. Modifying the mask of Gunaratnam to include

the frame features of Lovell would have been a combination of familiar elements

according to known methods that does no more than yield predictable results. See

KSR, 550 U.S. at 416.

b. “the mask frame and the sealing cushion together forming a

breathing cavity”

Claim 23 includes “the mask frame and the sealing cushion together forming

a breathing cavity.”4 To the extent this limitation is somehow interpreted as

requiring the frame and the cushion to alone form the entire breathing cavity, such

breathing cavities were well-known prior to the ’196 Patent. Ex. 1005 ¶ 47.

4 Under a broadest reasonable interpretation of this claim, in this limitation, the

empty volume within the cushion 180 and frame 800 assembly of Gunaratnam

forms a breathing cavity. Ex. 1005 ¶ 46.


-26-

For example, Lovell discloses a “seal is disposed along a perimeter of the

shell so as to form a chamber within the shell when the mask is donned by a user.”

Ex. 1003 at Abstract, col. 2:56–58.

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

motivated to modify the frame of Gunaratnam in view of Lovell so that the cushion

and the frame of the modified mask form the entirety of the breathing cavity and

the headgear connector would not be exposed to the patient’s exhalation. Ex. 1005

¶ 82. A skilled artisan would have been motivated to make these modifications so

that the breathing cavity (cushion and frame) could be removed and cleaned (or

replaced) without disconnecting the headgear straps from the headgear connector.

Id. ¶¶ 81–82; Ex. 1004 at col. 2:6–16, 6:63—7:18. Because the headgear

connector in the modified mask is not exposed to the patient’s breath or the

supplied gas, the headgear connector does not necessarily need to be cleaned or

replaced. Ex. 1005 ¶¶ 81–82.


-27-

c. “fixed forehead support”

Claim 23 includes “a fixed forehead support.” Gunaratnam discloses an

adjustable forehead support 162 connected to the frame 160 and the forehead

support 162 can have multiple discrete positions relative to the frame 160. Ex.

1002 at col. 4:46–48. The forehead support 162 is fixed relative to the headgear

connector at any of its discrete positions. Ex. 1005 ¶ 48.

To the extent the term “fixed forehead support” is construed narrowly to

mean that the forehead support has a single fixed position relative to the headgear

connector, such forehead supports were also well-known prior to the ’196 Patent.

Id. ¶ 49.

For example, as shown in Figs. 1 and 2a (below) and described in the

background section of Gunaratnam, masks were known to include fixed forehead

Forehead Support


-28-

supports. Ex. 1002 at col. 1:29–35. Also, Fig. 16a of Gunaratnam (below)

illustrates a mask assembly with a fixed forehead support.

Modifying the forehead support of Gunaratnam to be fixed in a single

position would involve substitution of one known feature for another to obtain


-29-

predictable results. See KSR, 550 U.S. at 416. A person of skill in the art would

have recognized that simplifying the forehead support to be fixed in a single

position would make the forehead support simpler to use, provide a unitary

structure that is easier to manufacture, provide a greater field of view around the

forehead support, and provide a more aesthetic streamlined interface. Ex. 1005 ¶

85.

d. “at least a portion of said headgear connector is shaped to

conform to a portion of said mask frame”

Claims 26 and 37 include “at least a portion of said headgear connector is

shaped to conform to a portion of said mask frame.” The clip 800 of Gunaratnam

has a complementary shape to the headgear connector 160, such that the tabs 820

are retained in the recesses 660a, 660b, and 660c (not shown). Ex. 1002 at col.

5:30–47, Figs. 5c and 7a. Thus, Gunaratnam discloses this feature. Ex. 1005 ¶ 50.


-30-


Lovell clearly discloses it. Id. ¶ 51. If the frame 800 of Gunaratnam was modified

as described above in Section VII(B)(3)(a) to include features of the frame 204 in

Fig. 10A of Lovell (below) (e.g., an annular bore 208), an inner surface of the

headgear connector would be shaped to conform to an outer surface of the frame.

As illustrated in Fig. 10A below, Lovell specifically discloses that the retainer 212

“is contoured such that it approximately matches the external curvature of the

contoured shell 204.” Ex. 1003 at col. 9:44–46.

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

motivated to provide a headgear connector that conforms to a portion of the frame,

as taught by Lovell, to provide stability and support to the frame and maintain the

headgear connector structure closer to the frame so that it lessens any obstruction

of the wearer’s field of vision. Ex. 1005 ¶ 83. Such a modification would have


-31-

been a combination of familiar elements according to known methods that does no

more than yield predictable results. See KSR, 550 U.S. at 416.

e. “an elbow assembly”

Dependent Claims 27 and 37 include “an elbow assembly.” Gunaratnam

discloses that the headgear connector 160 incorporates a gas inlet aperture for

connection to a gas delivery conduit of a patient gas delivery system, but

Gunaratnam may not explicitly disclose that the gas delivery conduit is an elbow

assembly. Ex. 1002 at col. 4:22–26. However, such elbow assemblies were

common in prior art CPAP masks. For example, as shown in Fig. 10A of Lovell

(below), a conduit elbow is adapted to connect to the inlet 208 to permit gas from a

breathable gas source to flow into the mask. Ex. 1003 at col 7:29–32, 9:34–36.

It was well-known at the time of the invention to connect an elbow assembly

to mask assemblies to allow the air delivery tube to be routed in different

directions based on patient position and preference, while minimizing loads

Elbow Assembly


-32-

applied to the mask assembly from the air delivery tube. Ex. 1005 ¶ 86.

Combining the mask of Gunaratnam with the elbow assembly of Lovell would

merely be a combination of familiar elements according to known methods that

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

f. “the bore is located on a front face of the mask frame”

Dependent Claim 30 includes “the bore is located on a front face of the mask

frame.” The frame 160 of Gunaratnam includes an inlet opening on its front face

and the clip 800 also includes an opening. Ex. 1005 ¶ 53. Thus, Gunaratnam

generally discloses an opening or bore located on the front face of the frame. Id.


Lovell clearly discloses it. Id. ¶ 54. If, as described above in Section VII(B)(3)(a),

the frame 800 of Gunaratnam were modified to include an annular bore as shown

in the frame 204 in Fig. 10A of Lovell (below), the bore would be located on a

front face of the frame. Id.

Bore


-33-

A person of skill would have been motivated to provide an annular bore on a

front face of the frame, as taught by Lovell, to provide a connection for an elbow.

Ex. 1005 ¶ 84; Ex. 1003 at col. 7:28–31.

g. “the sealing cushion and the mask frame are permanently

attached”

Dependent Claims 33 and 37 include “the sealing cushion and the mask

frame are permanently attached.” Gunaratnam teaches that it was well-known to

permanently attach the cushion and the frame together using glue. Ex. 1005 ¶ 55.

However, to the extent Gunaratnam provides insufficient teachings for this feature,

Lovell discloses “a seal 2 affixed to a shell 4, for example by bonding.” Id. ¶ 56.

Ex. 1003 at col. 4:34–36; see also id. at col. 2:62–64, 4:14–16.

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

the invention would have been motivated to modify Gunaratnam to permanently

attach the cushion to the frame in order to prevent leakage at the interface between


-34-

the cushion and the frame. Ex. 1005 ¶ 87; Ex. 1003 at col. 4:55–58; see also KSR,

550 U.S. at 419.



As detailed in the claim charts below, Gunaratnam discloses nearly all of the

limitations of Claim 41 and its dependents (Claims 42–56). Any differences

between the claims and Gunaratnam were minor and well-known at the time of the

invention and are taught by Lovell. Ex. 1005 ¶¶ 57–61.

Gunaratnam teaches nearly all of the features of Claim 41, including “a one-

piece rigid mask frame having a bore and an interfacing structure at least partly

surrounding the bore,” “a breathing cavity defined by the rigid mask frame and the

soft sealing cushion,” and “a fixed forehead support.” Id. ¶ 59. Gunaratnam also

teaches “at least a portion of said headgear connector is shaped to conform to a

portion of said rigid mask frame,” as recited by Claim 44, and “the bore is located

on a front face of the rigid mask frame,” as recited by Claim 46. Id. However, to

the extent Gunaratnam somehow provides insufficient teachings for these features,

Lovell teaches these limitations as described above with respect to Claims 23, 26,

30, and 37 (see Sections VII(B)(3)(a)–(d) and (f)).

Further, Gunaratnam may not expressly disclose “an elbow assembly,” as

recited by Claim 41, or “the soft sealing cushion and the rigid mask frame are


-35-

permanently attached,” as recited by Claim 53. However, as described above in

Sections VII(B)(3)(e) and (g), Lovell teaches these limitations.

Additional features beyond those discussed above are described below.

a. “said bore and said opening being concentrically disposed

about a common axis”

Claim 41 includes “said bore and said opening being concentrically disposed

about a common axis.” Under a reasonable interpretation of this limitation,

Gunaratnam teaches that the opening in the clip 800 and the opening in the

headgear connector (frame 160) are concentrically disposed about a common axis

when they are assembled, as shown below in Figs. 5c and 7a. Ex. 1005 ¶ 60.

However, to the extent the term “concentrically disposed” is interpreted to

require an annular bore and an annular opening being concentrically disposed

about a common axis, Lovell discloses such a configuration. Id. ¶ 61. As shown

in Fig. 10A of Lovell (below), the inlet 208 of the frame 204 and the opening in the


-36-

headgear connector 212 are concentrically disposed about a common axis, when

assembled. Ex. 1003 at col. 9:57–64.

As discussed above in Sections VII(B)(3)(a) and (f), a person of skill in the

art would have been motivated to modify the frame of Gunaratnam to include an

annular bore on a front face of the frame to simplify manufacturing, control

manufacturing tolerances, and provide a connection for the elbow. When the

annular bore mates with the opening in the headgear connector, the frame bore and

the headgear connector opening are concentrically disposed about a common axis.

Ex. 1005 ¶ 84.




limitations of Claim 57 and its dependent claims. Any differences were minor and


-37-

well-known at the time of the invention and are taught by Lovell. Ex. 1005 ¶¶ 62–

69.

Gunaratnam teaches nearly all of the limitations of Claim 57, including “a

rigid mask frame having a bore,” “said soft sealing cushion and said rigid mask

frame defining a breathing cavity from which the breathable gas is accessible by

the patient in use,” and “said opening and said bore are concentrically disposed

about a common axis.” Id. ¶¶ 63–64. Gunaratnam also teaches “an inner surface

of said headgear connector is shaped to conform to an outer surface of said rigid

mask frame,” as recited by Claim 60, and “the bore is located on a main body of

the rigid mask frame,” as recited by Claim 62. Id. ¶ 64. However, to the extent

Gunaratnam provides insufficient teachings for these features, Lovell teaches these

limitations as described above with respect to Claims 23, 26, 30, 37, and 41 (see

Sections VII(B)(3)(a)–(b), (d) and (f) and VII(B)(4)(a)).

Further, Gunaratnam may not expressly disclose “an elbow,” as recited by

Claim 57, or “the soft sealing cushion and the rigid mask frame are permanently

attached,” as recited by Claim 65. However, as described above in Sections

VII(B)(3)(e) and (g), these limitations are taught by Lovell.



-38-

a. “a rigid mask frame having a bore and a cylindrical

projection extending around the bore . . . the attachment

structure removably attached to the cylindrical projection

of the rigid mask frame with a snap-fit”

Gunaratnam does not expressly disclose a rigid mask frame having a bore

and a cylindrical projection around the bore, as required by Claim 57, but Lovell

discloses this limitation. Ex. 1005 ¶¶ 66–68. As shown in Figs. 10A–10B of

Lovell (below), the frame 204 has a cylindrical inlet 208. Ex. 1003 at col. 9:57–

59. The cylindrical inlet 208 has depressed annular regions 280 that mate with the

tabs extending between slots 213, 215 on an opening of the headgear connector

212, resulting in a snap fit. Id. at col. 9:57–66; Ex. 1005 ¶¶ 66–68.

Projection

Attachment Structure


-39-

The ’196 Patent discloses that a snap-fit occurs when the frame 20 receives a

plurality of tabs 144 on the headgear connector 150(1), as shown below in Figs. 1C

and 1D-1. Ex. 1001 at col. 5:1–2.

Lovell discloses a similar snap-fit connection in which two tabs (extending

between slots 213, 215) formed in the headgear connector 212 engage the

cylindrical inlet 208 with an interference fit and then are received into the two slots

(depressed annular regions 280) on the inlet 208. Ex. 1003 at col. 9:59–64, Figs.

10A–10B; Ex. 1005 ¶¶ 66–68.

A person of skill would have been motivated to modify the frame of

Gunaratnam to include a cylindrical projection on a front face of the frame, as

taught by Lovell, to simplify manufacturing and control manufacturing tolerances.

Ex. 1005 ¶ 84.


-40-

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

a snap-fit connection like the one taught by Lovell to ensure that the frame and

headgear connector are fully and correctly attached when the tabs snap into the

recesses. Id. Such a snap-fit arrangement provides consistent fit and function,

regardless of surface condition or contaminants. Id. A skilled artisan would have

recognized snap-fits are configured to permit repeated assembly/disassembly

without destroying parts. Id.

These modifications would have been a combination of familiar elements

according to known methods that does no more than yield predictable results. See

KSR, 550 U.S. at 416.

b. “the attachment structure and the cylindrical projection are

engaged with the snap-fit when the attachment structure

and the cylindrical projection are engaged in a nested

arrangement”

Dependent Claim 69 includes “the attachment structure and the cylindrical

projection are engaged with the snap-fit when the attachment structure and the

cylindrical projection are engaged in a nested arrangement.” If, as described above

in Section VII(B)(5)(a), the frame of Gunaratnam were modified to include a

cylindrical projection as taught by Lovell, the frame 204 and the headgear

connector 212 would be coupled in a nested arrangement with a snap-fit. Ex. 1005

¶ 69.


-41-

6. Potential Differences Between the Prior Art and Claims 73–78,

80–82, and 84–86 and Reasons to Combine


limitations of independent Claim 73 and its dependent claims. Any differences

were minor and well-known at the time of the invention and are disclosed by

Lovell. Ex. 1005 ¶¶ 70–79.

Gunaratnam teaches nearly all of the features of Claim 73, including “a rigid

mask frame having a bore,” and “the rigid mask frame and the soft sealing cushion

together forming a breathing cavity to receive the breathable gas.” However, to the

extent Gunaratnam provides insufficient disclosure of these features, Lovell

teaches these limitations as described above with respect to Claim 23 (see Sections

VII(B)(3)(a)–(b)).


a. “a headgear connector including a plurality of tabs

structured to removably attach the headgear connector to

the rigid mask frame with a snap-fit”

Claim 73 includes “a headgear connector including a plurality of tabs

structured to removably attach the headgear connector to the rigid mask frame with

a snap-fit.”


-42-

As shown in Figs. 5c and 7a of Gunaratnam (below), the headgear connector

(frame 160) includes recesses 660a, 660b, and 660c (not shown) to retain the tabs

820 of the frame (clip 800) in a snap-fit arrangement. Ex. 1005 ¶ 73.

A skilled artisan would have understood that the location of the securement

structures could be switched so that the tabs 820 were on the headgear connector

160 and the recesses 660a, 660b, and 660c were on the frame 800. Id. ¶¶ 74–79.

Such a modification would involve substitution of one known feature for another

to obtain predictable results. See KSR, 550 U.S. at 416.

Indeed, Lovell teaches this placement of the tabs and recesses. Ex. 1005 ¶

74. As shown in Fig. 10A on the next page, Lovell teaches that the tabs (edges of

aperture between slots 213, 215) are on the headgear connector (retainer 212) and

they snap into recesses (depressed annular regions 280) on the frame 204. Id.; Ex.

1003 at col. 9:59–64.


-43-

C. Ground #2: Claims 79 and 83 of the ’196 Patent would have been obvious over Gunaratnam in view of Lovell and Geist

1. Overview of Geist (Ex. 1004)

Geist (U.S. 7,353,827) was submitted during the prosecution of the ’196

Patent, but was not cited by the Examiner. Ex. 1001 at 6.

depressed regions

tabs


-44-

Geist relates to a nasal CPAP mask for supplying pressurized breathing gas

for treatment of obstructive sleep apnea.” Ex. 1004 at col. 1:9–14. Geist discloses

a mask assembly with a mask shell 12 supported by a headgear connector 20. Fig.

10 of Geist (below) is a bottom perspective view of a mask shell 12 with vent holes

60 on the bottom of the shell. Id. at col. 3:4–6, 5:11–14.

2. Potential Differences Between the Prior Art and Claims 79 and 83

of the ’196 Patent and Reasons to Combine

Claims 79 and 83 include “wherein the rigid mask frame further comprises a

vent assembly for gas washout.”

As shown in Fig. 15 of Gunaratnam (below), Gunaratnam discloses an air

vent assembly 940. Ex. 1002 at col. 6:25–30. If, as discussed above, Gunaratnam

were modified to include the features of the Lovell frame (see Section


-45-

VII(B)(3)(a)), the vent of Gunaratnam would be positioned on the frame to vent air

from the breathing cavity. Ex. 1005 ¶¶ 91–92.

To the extent the combination of Gunaratnam and Lovell provide

insufficient teachings for this feature, positioning the vent on the mask frame

would have been a matter of simply choosing between a few identified, predictable

solutions that were well known prior to the earliest filing date of the ’196 Patent.

Id. ¶¶ 92–94.


-46-

For example, as shown in Figs. 2B and 10 (below), Geist taught that the vent

holes 60 could be positioned on the mask shell 12. Ex. 1004 at col. 5:11–14.

As explained above, a person skilled in the art at the time of the invention

would have been motivated to modify the frame 800 of Gunaratnam to include

features of the frame 204 of Lovell. See supra Sections VII(B)(3)–(6). A skilled

artisan would have understood that positioning the vent in Gunaratnam on the

mask frame was a matter of design choice among a finite number of known

locations. Ex. 1005 ¶ 94; see also KSR, 550 U.S. at 420. Additionally, a skilled

artisan would have known that it would be advantageous to position the vent on a

portion of the mask frame so that the vent is in fluid communication with the

breathing chamber and closer to the patient. Ex. 1005 ¶ 94. This would reduce

“dead space,” which is the volume in which expired air is trapped between the

user’s nose and an upstream vent. Id.


-47-

Because Gunaratnam, Lovell, and Geist teach structurally similar CPAP

masks for treating obstructive sleep apnea, the features of the Geist masks would

have been readily compatible with the masks of Gunaratnam and Lovell with a

reasonable expectation of success. Id. ¶ 93.


-48-

VIII. CLAIM CHARTS

’196 Patent Prior Art 23. A mask for delivering breathable gas to a patient at positive pressure to treat sleep disordered breathing, the mask comprising:

Gunaratnam: “The invention relates to a method and apparatus for connecting a nasal or full-face mask cushion to a mask frame, where the mask is suitable for the delivery of breathable gases to a patient for the treatment of sleep disordered breathing (SDB).” Ex. 1002 at col. 1:21–25.

a rigid mask frame having a bore and an interfacing structure associated with the bore, said mask frame having no built-in or integral headgear attachment points;

Gunaratnam: “The clip is conducted from polycarbonate or similar material. . . . The rear of the clip has an inwards flange (840) which engages behind the shoulder (720) of the cushion so as to hold the cushion securely in position on the frame when the tabs (820) are engaged on the rim (600) of the frame.” Ex. 1002 at col. 5:29–47, Figs. 7a–7e.

Lovell: “The retainer 212 is disposed about the inlet 208 to facilitate retention of the mask 201 on a user. . . . Also, a depressed annular region 280 on the inlet 208 mates with the edges of an aperture passing through the retainer 212.” Ex. 1003 at col. 9:43–59.


-49-

a sealing cushion provided to the mask frame and adapted to form a seal with the patient's face, the mask frame and the sealing cushion together forming a breathing cavity; and

Gunaratnam: “The mask may comprise a rigid shell (160), termed a frame, and a soft portion (180), termed a cushion.” Ex. 1002 at col. 1:33–39. “The cushion is formed of soft material such as silicone, and projects rearwardly of the mask frame so as to space the rigid frame away from the patient's face.” Id. at col. 5:14–24.

Lovell: “The seal is disposed along a perimeter of the shell so as to form a chamber within the shell when the mask is donned by a user.” Ex. 1003 at Abstract, col. 2:56–58. “[T]he nasal mask should be comfortable to wear and conform well to the nasal area, thereby defining a substantially sealed chamber.” Id. at col. 1:30–34; see also id. at col. 2:52–58.


-50-

a headgear connector adapted to engage the interfacing structure with a snap-fit, said headgear connector including a pair of lower headgear clip anchors adapted to be engaged with respective ones of a pair of lower headgear clips to attach a pair of lower side straps,

Gunaratnam: “On the front surface of the frame, are strap connection points (630) for connection of the mask to patient headgear. Connectors (200) are shown in FIGS. 5c-5f.” Ex. 1002 at col. 4:32–34, Figs. 5a–5f.

“[T]he clip (800) includes three securing tabs (820) such that inwards projections on the detents are formed as resilient detents which extend past the outer edge of flange (640) to be retained in recesses (660) on the front of the flange (640). . . . The rear of the clip has an inwards flange (840) which engages behind the shoulder (720) of the cushion so as to hold the cushion securely in position on the frame when the tabs (820) are engaged on the rim (600) of the frame.” Id. at col. 5:34–47.


-51-

Lovell: “The retainer aperture and the inlet 208 are generally sized in an interference fit so that the retainer 212 is properly retained by the cooperation of the tabs 211, 211′, the slots 213, 215, and the depressed annular region 280 when fully seated against the shell 204.” Ex. 1003 at col. 9:59–64.

said headgear connector including a fixed forehead support, said fixed forehead support including a pair of openings adapted to attach to

Gunaratnam: “As compared to FIGS. 5a-5b, FIGS. 5c-5f also show an adjustable forehead support (162) connected to the frame (160).” Ex. 1002 at col. 4:46–48.


-52-

respective ones of a pair of upper side straps.

“Nasal and full-face masks systems suitable for the delivery of air or other breathable gases to patients for the treatment of sleep disordered breathing may include a mask (100), a forehead support (120) and headgear (140), as depicted in FIG. 1.” Id. at col. 1:29–35.

24. The mask Gunaratnam: “The invention relates to a method and


-53-

according to claim 23, wherein the mask frame and the sealing cushion comprise a full-face mask.

apparatus for connecting a nasal or full-face mask cushion to a mask frame, where the mask is suitable for the delivery of breathable gases to a patient.” Ex. 1002 at col. 1:21–25.

25. The mask according to claim 24, wherein the sealing cushion is secured to the mask frame.

Gunaratnam: “The rear of the clip has an inwards flange (840) which engages behind the shoulder (720) of the cushion so as to hold the cushion securely in position on the frame when the tabs (820) are engaged on the rim (600) of the frame.” Ex. 1002 at col. 5:30–47, Figs. 6a–7e.

Lovell: “Referring to FIGS. 1 and 2, one embodiment of a nasal mask 1 according to the invention includes a seal 2 affixed to a shell 4, for example by bonding.” Ex. 1003 at col. 4:34–36; see also id. col. 2:62–64, 4:14–16, Fig. 2a.

26. The mask according to claim 25, wherein at least a portion of said headgear connector is shaped to conform to a portion of said mask frame.

Gunaratnam: “The clip is formed as a collar of a complementary shape to the rims of the mask cushion (700) and frame (600) and fits over them.” Ex. 1002 at col. 5:30–33. Lovell: “The retainer 212 is contoured such that it approximately matches the external curvature of the contoured shell 204.” Ex. 1003 at col. 9:44–46.


-54-

27. The mask according to claim 23, further comprising an elbow assembly, said elbow assembly being adapted to be connected to an air delivery tube to deliver the breathable gas to the breathing cavity.

Gunaratnam: “The frame (160) . . . incorporates a gas inlet aperture (610) for connection to a gas delivery conduit (not shown) of a patient gas delivery system.” Ex. 1002 at col. 4:22–26. Lovell: “[T]he conduit elbow 10, connected to the inlet 8, allows for gas from a breathable gas source to flow through the conduit elbow 10, past the apertures 17, and into the cavity 80 formed by the nasal mask 1.” Ex. 1003 at col. 7:28–32; see also id. at col. 5:9–35.

28. The mask according to claim 23, wherein the headgear connector is removably attachable to the mask frame.

Gunaratnam: “[T]he clip (800) includes three securing tabs (820) such that inwards projections on the detents are formed as resilient detents which extend past the outer edge of flange (640) to be retained in recesses (660) on the front of the flange (640). To disengage, for example for cleaning of the mask assembly or replacement of the cushion, the detents may be forced outwardly against their natural resilience to release from the recesses (660) and ride over the outer edge of flange (640).” Ex. 1002 at col. 5:34–43.


-55-


29. The mask according to claim 28, wherein when said mask frame and said headgear connector are attached, the mask frame and the

Gunaratnam: “The clip is formed as a collar of a complementary shape to the rims of the mask cushion (700) and frame (600) and fits over them. . . . The rear of the clip has an inwards flange (840) which engages behind the shoulder (720) of the cushion so as to hold the cushion securely in position on the frame.” Ex. 1002 at col. 5:30–47. Lovell: “The retainer aperture and the inlet 208 are generally


-56-

headgear connector are not movable relative to one another.

sized in an interference fit so that the retainer 212 is properly retained by the cooperation of the tabs 211, 211′, the slots 213, 215, and the depressed annular region 280 when fully seated against the shell 204.” Ex. 1003 at col. 9:59–64.

30. The mask according to claim 23, wherein the bore is located on a front face of the mask frame.

Gunaratnam: “The clip is formed as a collar of a complementary shape to the rims of the mask cushion (700) and frame (600) and fits over them.” Ex. 1002 at col. 5:29–33.

Lovell: “The retainer 212 is disposed about the inlet 208 to facilitate retention of the mask 201 on a user.” Ex. 1003 at col. 9:43–44.


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31. The mask according to claim 23, comprising a vent assembly for gas washout.

Gunaratnam: “The frame (160) is adapted to cover both the mouth and nose region of the patient's face, and includes . . . an aperture (930) for receiving an air vent (940) (FIG. 15) and ports (950).” Ex. 1002 at col. 6:25–30.

Lovell: “These apertures 17 vent the pressurized chamber 80 in order to allow the release of gases exhaled by the user.” Ex. 1003 at col. 5:36–40.

32. The mask according to claim 23, wherein the fixed forehead support is T-shaped.



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33. The mask according to claim 23, wherein the sealing cushion and the mask frame are permanently attached.

Gunaratnam: “In one form of known mask, the cushion and frame are glued together, as shown in FIG. 2a to 2c . . . There is a corresponding rim portion (220) on the cushion (180) which fits inside the rim (200) on the frame. The two rims (200, 220) are glued together.” Ex. 1002 at col. 1:49–55.

Lovell: “Referring to FIGS. 1 and 2, one embodiment of a nasal mask 1 according to the invention includes a seal 2 affixed to a shell 4, for example by bonding.” Ex. 1003 at col. 4:34–36; see also id. col. 2:62–64, 4:14–16, Fig. 2a.


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34. The mask according to claim 23, wherein said headgear connector is constructed of a similar material as the mask frame.

Gunaratnam: “The frame (160) is constructed as a substantially rigid shell of polycarbonate or similar transparent plastics material.” Ex. 1002 at col. 4:22–26. “The clip is conducted from polycarbonate or similar material.” Id. at col. 5:33–34.

35. The mask according to claim 23, wherein said headgear connector and said mask frame are constructed of a substantially rigid, non-malleable plastic material.

Gunaratnam: “The frame (160) is constructed as a substantially rigid shell of polycarbonate or similar transparent plastics material.” Ex. 1002 at col. 4:22–26. “The clip is conducted from polycarbonate or similar material.” Id. at col. 5:33–34.

36. The mask according to claim 35, wherein said headgear connector and said mask frame are constructed of polycarbonate.

Gunaratnam: “The frame (160) is constructed as a substantially rigid shell of polycarbonate . . . .” Ex. 1002 at col. 4:22–26. “The clip is conducted from polycarbonate or similar material.” Id. at col. 5:33–34.

37. The mask according to claim 23, further comprising: an elbow assembly, said elbow assembly being adapted to be connected to an air delivery tube to deliver the breathable gas to the breathing cavity; and

See supra Claim 27.

a vent assembly for See supra Claim 31.


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gas washout, wherein the mask frame and the sealing cushion comprise a full-face mask,

See supra Claim 24.

wherein at least a portion of said headgear connector is shaped to conform to a portion of said mask frame,

See supra Claim 26.

wherein the headgear connector is removably attachable to the mask frame,

See supra Claim 28.

wherein when said mask frame and said headgear connector are attached, the mask frame and the headgear connector are not movable relative to one another,

See supra Claim 29.

wherein the sealing cushion and the mask frame are permanently attached, and

See supra Claim 33.

wherein said headgear connector and said mask frame are constructed of a substantially rigid, non-malleable

See supra Claim 35.


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plastic material. 38. A mask system for delivering breathable gas to a patient at positive pressure to treat sleep disordered breathing, the mask system comprising:

Gunaratnam: “The invention relates to a method and apparatus for connecting a nasal or full-face mask cushion to a mask frame, where the mask is suitable for the delivery of breathable gases to a patient for the treatment of sleep disordered breathing (SDB).” Ex. 1002 at col. 1:21–25.

a headgear including the pair of upper side straps, the pair of lower side straps, and a rear portion;


“In the case of the Mirage® Mask (ResMed Limited), shown in FIG. 1, the headgear (140) is constructed from fabric and includes a rear portion which engages the region near the occiput of the patient, and four straps (145) which are secured to a forehead support (2 straps) and nasal mask frame (2 straps).” Id. at col. 1:40–45.


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and the mask according to claim 23,

See supra Claim 23.

wherein the pair of lower headgear clips are adapted to receive respective ones of the pair of lower side straps.


39. The mask system according to claim 38, wherein the pair of upper side straps are arranged to extend above the patient's ears and the pair of lower



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side straps are arranged to extend below the patient's ears.

“[I]n FIG. 1, the headgear (140) is constructed from fabric and includes a rear portion which engages the region near the occiput of the patient, and four straps (145) which are secured to a forehead support (2 straps) and nasal mask frame (2 straps).” Id. at col. 1:40–45.

40. The mask system according to claim 39, wherein the rear portion of the headgear is adapted to cup the occiput of the patient's

Gunaratnam: “[I]n FIG. 1, the headgear (140) is constructed from fabric and includes a rear portion which engages the region near the occiput of the patient, and four straps (145) which are secured to a forehead support (2 straps) and nasal mask frame (2 straps).” Ex. 1002 at col. 1:40–45.


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head.

41. A mask for delivering breathable gas to a patient at positive pressure to treat sleep disordered breathing, the mask comprising:

See supra Claim 23, preamble.

a one-piece rigid mask frame having a bore and an interfacing structure at least partly surrounding the bore, the rigid mask frame having no built-in or integral headgear attachment points;

Gunaratnam: “A clip (800) according to an embodiment of the invention, suitable for a nasal mask, is shown in FIG. 7a to 7e. . . . The clip is conducted from polycarbonate or similar material. . . . The rear of the clip has an inwards flange (840) which engages behind the shoulder (720) of the cushion so as to hold the cushion securely in position on the frame when the tabs (820) are engaged on the rim (600) of the frame.” Ex. 1002 at col. 5:29–47, Figs. 7a–7e.


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Lovell: “The retainer 212 is disposed about the inlet 208 to facilitate retention of the mask 201 on a user. . . . Also, a depressed annular region 280 on the inlet 208 mates with the edges of an aperture passing through the retainer 212.” Ex. 1003 at col. 9:43–59.

a soft sealing cushion provided to the rigid mask frame and adapted to form a seal with the patient's face;

See supra Claim 23, a sealing cushion provided to the mask frame and adapted to form a seal with the patient's face. Gunaratnam: “The cushion is formed of soft material such as silicone . . . .” Ex. 1002 at col. 5:22–24.

an elbow assembly, said elbow assembly being adapted to be

See supra Claim 23, the mask frame and the sealing cushion together forming a breathing cavity. See supra Claim 27.


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connected to an air delivery tube to deliver the breathable gas to a breathing cavity defined by the rigid mask frame and the soft sealing cushion; and a headgear connector having an opening and an attachment structure associated with the opening, the attachment structure being adapted to engage the interfacing structure of the rigid mask frame to removably connect the headgear connector to the rigid mask frame, said bore and said opening being concentrically disposed about a common axis,


“[T]he clip (800) includes three securing tabs (820) such that inwards projections on the detents are formed as resilient detents which extend past the outer edge of flange (640) to be retained in recesses (660) on the front of the flange (640). To disengage, for example for cleaning of the mask assembly or replacement of the cushion, the detents may be forced outwardly against their natural resilience to release from the recesses (660) and ride over the outer edge of flange (640). . . . The rear of the clip has an inwards flange (840) which engages behind the shoulder (720) of the cushion so as to hold the cushion securely in position on the frame when the tabs (820) are engaged on the rim (600) of the frame.” Id. at col. 5:34–47.


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See supra Claim 28.

wherein the headgear connector and the rigid mask frame are detachably connected together by translating the

Gunaratnam: “[T]he clip (800) includes three securing tabs (820) such that inwards projections on the detents are formed as resilient detents which extend past the outer edge of flange (640) to be retained in recesses (660) on the front of the flange (640). To disengage, for example for cleaning of the mask assembly or replacement of the cushion, the detents may be forced outwardly against their natural resilience to


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rigid mask frame and the headgear connector towards one another along the common axis until a snap-fit connection is established between the attachment structure of the headgear connector and the interfacing structure of the rigid mask frame, and

release from the recesses (660) and ride over the outer edge of flange (640). . . . The rear of the clip has an inwards flange (840) which engages behind the shoulder (720) of the cushion so as to hold the cushion securely in position on the frame when the tabs (820) are engaged on the rim (600) of the frame.” Ex. 1002 at col. 5:34–47.


See supra Claim 28.

wherein said See supra Claim 23, said headgear connector including a


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headgear connector includes a fixed forehead support.

fixed forehead support.

42. The mask according to claim 41, wherein the rigid mask frame and the soft sealing cushion comprise a full-face mask.

See supra Claim 24.

43. The mask according to claim 41, wherein the soft sealing cushion is secured to the rigid mask frame.

See supra Claim 25.

44. The mask according to claim 41, wherein at least a portion of said headgear connector is shaped to conform to a portion of said rigid mask frame.

See supra Claim 26.

45. The mask according to claim 41, wherein when said rigid mask frame and said headgear connector are attached, the rigid mask frame and the headgear connector are not movable relative to one another.

See supra Claim 29.

46. The mask according to claim

See supra Claim 30.


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41, wherein the bore is located on a front face of the rigid mask frame. 47. The mask according to claim 41, comprising a vent assembly for gas washout.

See supra Claim 31.

48. The mask according to claim 41, wherein the fixed forehead support is T-shaped.

See supra Claim 32.

49. The mask according to claim 41, wherein the soft sealing cushion and the rigid mask frame are permanently attached.

See supra Claim 33.

50. The mask according to claim 41, wherein said headgear connector is constructed of a similar material as the rigid mask frame.

See supra Claim 34.

51. The mask according to claim 41, wherein said headgear connector and said rigid mask frame are constructed of a substantially rigid, non-malleable

See supra Claim 35.


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plastic material. 52. The mask according to claim 51, wherein said headgear connector and said rigid mask frame are constructed of polycarbonate.

See supra Claim 36.

53. The mask according to claim 41, further comprising a vent assembly for gas washout,

See supra Claim 31.

wherein the rigid mask frame and the soft sealing cushion comprise a full-face mask,

See supra Claim 24.

wherein at least a portion of said headgear connector is shaped to conform to a portion of said rigid mask frame,

See supra Claim 26.

wherein when said rigid mask frame and said headgear connector are attached, the rigid mask frame and the headgear connector are not movable relative to one another,

See supra Claim 29.

wherein the soft sealing cushion and the rigid mask

See supra Claim 33.


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frame are permanently attached, and wherein said headgear connector and said rigid mask frame are constructed of a substantially rigid, non-malleable plastic material.

See supra Claim 35.

54. A mask system for delivering breathable gas to a patient at positive pressure to treat sleep disordered breathing, the mask system comprising:


a headgear including a pair of upper side straps, a pair of lower side straps, and a rear portion;

See supra Claim 38, a headgear including the pair of upper side straps, the pair of lower side straps, and a rear portion.

a pair of lower headgear clip anchors formed on said headgear connector and adapted to be engaged with respective ones of a pair of lower headgear clips to attach the pair of lower side straps, the pair of lower headgear clips being adapted to

See supra Claim 23, said headgear connector including a pair of lower headgear clip anchors adapted to be engaged with respective ones of a pair of lower headgear clips to attach a pair of lower side straps. See also supra Claim 38, wherein the pair of lower headgear clips are adapted to receive respective ones of the pair of lower side straps.


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receive respective ones of the pair of lower side straps; a pair of openings formed on said forehead support adapted to attach to respective ones of the pair of upper side straps; and

See supra Claim 23, said fixed forehead support including a pair of openings adapted to attach to respective ones of a pair of upper side straps.

the mask according to claim 41.

See supra Claim 41.

55. The mask system according to claim 54, wherein the pair of upper side straps are arranged to extend above the patient's ears and the pair of lower side straps are arranged to extend below the patient's ears.

See supra Claim 39.

56. The mask system according to claim 55, wherein the rear portion of the headgear is adapted to cup the occiput of the patient's head.

See supra Claim 40.

57. A mask system for delivering breathable gas to a patient at positive pressure to treat sleep disordered



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breathing, the mask system comprising: a rigid mask frame having a bore and a cylindrical projection extending around the bore, the rigid mask frame having no built-in or integral headgear attachment points;

Gunaratnam: “A clip (800) according to an embodiment of the invention, suitable for a nasal mask, is shown in FIG. 7a to 7 e. . . . The clip is conducted from polycarbonate or similar material. . . . The rear of the clip has an inwards flange (840) which engages behind the shoulder (720) of the cushion so as to hold the cushion securely in position on the frame when the tabs (820) are engaged on the rim (600) of the frame.” Ex. 1002 at col. 5:29–47, Figs. 7a–7e.

Lovell: “The retainer 212 is disposed about the inlet 208 to facilitate retention of the mask 201 on a user. . . . . Also, a depressed annular region 280 on the inlet 208 mates with the edges of an aperture passing through the retainer 212.” Ex. 1003 at col. 9:43–59.


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a soft sealing cushion provided to the rigid mask frame and adapted to form a seal with the patient's face, said soft sealing cushion and said rigid mask frame defining a breathing cavity from which the breathable gas is accessible by the patient in use;

See supra Claim 23, a sealing cushion provided to the mask frame and adapted to form a seal with the patient's face, the mask frame and the sealing cushion together forming a breathing cavity. Gunaratnam: “The invention relates to a method and apparatus for connecting a nasal or full-face mask cushion to a mask frame, where the mask is suitable for the delivery of breathable gases to a patient for the treatment of sleep disordered breathing (SDB).” Ex. 1002 at col. 1:21–25.

an elbow having a first end adapted to be connected to an air delivery tube and a second end in communication with the bore to deliver the breathable gas from the air delivery tube to the breathing cavity;

Gunaratnam: “The frame (160) is constructed as a substantially rigid shell of polycarbonate or similar transparent plastics material, and incorporates a gas inlet aperture (610) for connection to a gas delivery conduit (not shown) of a patient gas delivery system.” Ex. 1002 at col. 4:22–26. Lovell: “Still referring to FIG. 3, the conduit elbow 10, connected to the inlet 8, allows for gas from a breathable gas source to flow through the conduit elbow 10, past the apertures 17, and into the cavity 80 formed by the nasal mask 1.” Ex. 1003 at col. 7:28–32; see also id. at col. 5:9–35.


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headgear including a pair of upper side straps, a pair of lower side straps, and a rear portion from which the upper side straps and the lower side straps extend; and

See supra Claim 38, a headgear including the pair of upper side straps, the pair of lower side straps, and a rear portion. Gunaratnam: “The headgear (140) is constructed from fabric and includes a rear portion which engages the region near the occiput of the patient, and four straps (145) which are secured to a forehead support (2 straps) and nasal mask frame (2 straps).” Ex. 1002 at col. 1:40–45.


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a headgear connector having an opening with an attachment structure associated with the opening,

See supra Claim 41, a headgear connector having an opening and an attachment structure associated with the opening.

the attachment structure removably attached to the cylindrical projection of the rigid mask frame with a snap-fit such that when said cylindrical projection and said attachment structure are attached, the rigid mask frame and the headgear connector are not movable relative to one another, wherein said opening and said bore are concentrically disposed about a common axis,

Lovell: “The retainer 212 is disposed about the inlet 208 to facilitate retention of the mask 201 on a user. . . . Also, a depressed annular region 280 on the inlet 208 mates with the edges of an aperture passing through the retainer 212. The retainer aperture and the inlet 208 are generally sized in an interference fit so that the retainer 212 is properly retained by the cooperation of the tabs 211, 211′, the slots 213, 215, and the depressed annular region 280 when fully seated against the shell 204.” Ex. 1003 at col. 9:43–64.

wherein said headgear connector includes a pair of lower headgear clip anchors adapted to secure respective ones of the lower side straps, and

See supra Claim 23, said headgear connector including a pair of lower headgear clip anchors adapted to be engaged with respective ones of a pair of lower headgear clips to attach a pair of lower side straps.

wherein said headgear connector

See supra Claim 23, said headgear connector including a fixed forehead support, said fixed forehead support including


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includes a forehead support including a pair of openings adapted to attach to respective ones of the pair of upper side straps.

a pair of openings adapted to attach to respective ones of a pair of upper side straps.

58. The mask system according to claim 57, wherein the rigid mask frame and the soft sealing cushion comprise a full-face mask.

See supra Claim 24.

59. The mask system according to claim 57, wherein the soft sealing cushion is secured to the rigid mask frame.

See supra Claim 25.

60. The mask system according to claim 57, wherein an inner surface of said headgear connector is shaped to conform to an outer surface of said rigid mask frame.

Lovell: “The retainer 212 is contoured such that it approximately matches the external curvature of the contoured shell 204.” Ex. 1003 at col. 9:44–46.

61. The mask Gunaratnam: “The adjustable forehead support (162)


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system according to claim 57, wherein the forehead support is adapted to contact the patient’s forehead in use.

includes a bridge portion (164) adapted to locate at least one and preferably two spaced apart pads (not shown) adapted to contact the forehead of the patient.” Ex. 1002 at col. 4:49–52, Figs. 5c–5f.

62. The mask system according to claim 57, wherein the bore is located on a main body of the rigid mask frame.

Gunaratnam: “A clip (800) according to an embodiment of the invention, suitable for a nasal mask, is shown in FIG. 7a to 7e. The clip is formed as a collar of a complementary shape to the rims of the mask cushion (700) and frame (600) and fits over them.” Ex. 1002 at col. 5:29–33, Figs. 7a–7e.

Lovell: “The retainer 212 is disposed about the inlet 208 to facilitate retention of the mask 201 on a user.” Ex. 1003 at col. 9:43–44.


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63. The mask system according to claim 57, comprising a vent assembly for gas washout.

See supra Claim 31.

64. The mask system according to claim 57, wherein the forehead support is T-shaped.

See supra Claim 32.

65. The mask system according to claim 57, wherein the soft sealing cushion and the rigid mask frame are permanently attached.

See supra Claim 33.

66. The mask system according to claim 57, wherein said headgear connector is constructed of a

See supra Claim 34.


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similar material as the rigid frame. 67. The mask system according to claim 57, wherein said headgear connector and said mask frame are constructed of a substantially rigid, non-malleable plastic material.

See supra Claim 35.

68. The mask system according to claim 67, wherein said headgear connector and said rigid mask frame are constructed of polycarbonate.

See supra Claim 36.

69. The mask system according to claim 57, wherein the attachment structure and the cylindrical projection are engaged with the snap-fit when the attachment structure and the cylindrical projection are engaged in a nested arrangement.

Lovell: “Also, a depressed annular region 280 on the inlet 208 mates with the edges of an aperture passing through the retainer 212. The retainer aperture and the inlet 208 are generally sized in an interference fit so that the retainer 212 is properly retained by the cooperation of the tabs 211, 211′, the slots 213, 215, and the depressed annular region 280 when fully seated against the shell 204.” Ex. 1003 at col. 9:57–64.


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70. The mask system according to claim 57, further comprising a vent assembly for gas washout,

See supra Claim 31.


See supra Claim 24.

wherein an inner surface of said headgear connector is shaped to conform to an outer surface of said mask frame,

See supra Claim 60.

wherein the forehead support is adapted to contact the patient’s forehead in use,

See supra Claim 61.

wherein the soft sealing cushion and the rigid mask frame are

See supra Claim 33.


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permanently attached, and wherein said headgear connector and said rigid mask frame are constructed of a substantially rigid, non-malleable plastic material.

See supra Claim 35.


See supra Claim 39.


See supra Claim 40.

73. A mask for delivering breathable gas to a patient at positive pressure to treat sleep disordered breathing, the mask comprising:



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a rigid mask frame having a bore and no built-in or integral headgear attachment points;

See supra Claim 23, a rigid mask frame having a bore and an interfacing structure associated with the bore, said mask frame having no built-in or integral headgear attachment points.

a soft sealing cushion attached to the rigid mask frame and adapted to form a seal with the patient's face, the rigid mask frame and the soft sealing cushion together forming a breathing cavity to receive the breathable gas; and

See supra Claim 57, a soft sealing cushion provided to the rigid mask frame and adapted to form a seal with the patient's face, said soft sealing cushion and said rigid mask frame defining a breathing cavity from which the breathable gas is accessible by the patient in use.

a headgear connector including a plurality of tabs structured to removably attach the headgear connector to the rigid mask frame with a snap-fit,

Gunaratnam: “In the illustrated embodiment the clip (800) includes three securing tabs (820) such that inwards projections on the detents are formed as resilient detents which extend past the outer edge of flange (640) to be retained in recesses (660) on the front of the flange (640).” Ex. 1002 at col. 5:34–38. Lovell: “The retainer aperture and the inlet 208 are generally sized in an interference fit so that the retainer 212 is properly retained by the cooperation of the tabs 211, 211′, the slots 213, 215, and the depressed annular region 280 when fully seated against the shell 204.” Ex. 1003 at col. 9:59–64.


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a pair of crossbars to removably attach a pair of lower side straps, and


“The mask frame and forehead supports include loops through which straps can pass.” Id. at col. 1:46–48.


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Lovell: “These connection points 14, 14′, 16, 16′ form slots which allow for connection of the retainer 12 with straps of a headgear apparatus, as shown in FIG. 3.” Ex. 1003 at col. 4:10–13.


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an extension having a plurality of openings to removably attach a pair of upper side straps.


74. The mask according to claim 73, wherein the rigid mask frame and the soft sealing cushion comprise a full-face mask.

See supra Claim 24.

75. The mask See supra Claim 25.


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according to claim 74, wherein the soft sealing cushion is secured to the mask frame. 76. The mask according to claim 73, further comprising an elbow adapted to be connected to an air delivery tube to deliver the breathable gas to the breathing cavity.

See supra Claim 27.

77. The mask according to claim 73, wherein when said rigid mask frame and said headgear connector are attached, the rigid mask frame and the headgear connector are not movable relative to one another.

See supra Claim 29.

78. The mask according to claim 73, wherein the bore is located on a front face of the rigid mask frame.

See supra Claim 30.

79. The mask according to claim 73, wherein the rigid mask frame further comprises a vent assembly for

Gunaratnam: “The frame (160) is adapted to cover both the mouth and nose region of the patient's face, and includes . . . an aperture (930) for receiving an air vent (940) (FIG. 15) and ports (950).” Ex. 1002 at col. 6:25–30, Fig. 15. Geist: “FIG. 10 is a perspective view taken generally from


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gas washout. the bottom of the mask shell of the present invention and illustrating the vent holes of the present invention.” Ex. 1004 at col. 3:4–6. “The vent holes are exit vent holes and are for venting the exhaled breath of a wearer of the mask 10.” Id. at col. 5:11–14.

80. The mask according to claim 73, wherein said headgear connector is constructed of a similar material as the rigid mask frame.

See supra Claim 34.

81. The mask according to claim 73, wherein said headgear connector and said rigid mask frame are constructed of a substantially rigid, non-malleable plastic material.

See supra Claim 35.

82. The mask according to claim 81, wherein said headgear connector and said rigid mask frame are

See supra Claim 36.


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constructed of polycarbonate. 83. The mask according to claim 73, further comprising: an elbow adapted to be connected to an air delivery tube to deliver the breathable gas to the breathing cavity,

See supra Claim 27.

wherein the rigid mask frame further comprises a vent assembly for gas washout,

See supra Claim 79.


See supra Claim 24.

wherein when said rigid mask frame and said headgear connector are attached, the rigid mask frame and the headgear connector are not movable relative to one another, and

See supra Claim 29.

wherein said headgear connector and said rigid mask frame are constructed of a substantially rigid, non-malleable

See supra Claim 35.


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plastic material. 84. A mask system for delivering breathable gas to a patient at positive pressure to treat sleep disordered breathing, the mask system comprising:


a headgear including the pair of upper side straps, the pair of lower side straps, and a rear portion; and

See supra Claim 38, a headgear including the pair of upper side straps, the pair of lower side straps, and a rear portion.

a mask according to claim 73.

See supra Claim 73.


See supra Claim 39.


See supra Claim 40.


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IX. SECONDARY CONSIDERATIONS, EVEN IF CONSIDERED, FAIL

TO OVERCOME THE PRIMA FACIE EVIDENCE OF OBVIOUSNESS

To overcome the strong showing of obviousness set forth above, the Patent

Owner may attempt to present alleged secondary considerations of non-

obviousness. However, secondary considerations do not support a finding of non-

obviousness here. Although secondary considerations should be taken into

account, they do not control the obviousness conclusion. Newell Cos., Inc. v.

Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988). And where a strong prima

facie obviousness showing exists, as here, the Federal Circuit has repeatedly held

that even relevant secondary considerations supported by substantial evidence may

not dislodge the primary conclusion of obviousness. See, e.g., Leapfrog Enters.

Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007). For example,

evidence of commercial sales generally would not be sufficient to overcome the

strong prima facie showing of obviousness. Further, there would be no nexus

between the commercial sales and the claims of the ’196 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


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allegations regarding secondary considerations of non-obviousness, Petitioner will

address those allegations in due course.

Respectfully submitted,

KNOBBE, MARTENS, OLSON & BEAR, LLP Dated: October 11, 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 13,960 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 11, 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 8,960,196 and Fisher &

Paykel Healthcare Exhibits 1001-1011 are being served on October 11, 2016, via

FedEx Priority Overnight service on counsel of record for U.S. Patent 8,960,196

patent owner RESMED LIMITED at the address below:

Correspondence Address of Record for U.S. Patent 8,960,196 at the U.S.

Patent and Trademark Office:

Nixon & Vanderhye, PC 901 North Glebe Road, 11th Floor

Arlington, VA 22203

Dated: October 11, 2016 By: /Brenton R. Babcock/

Brenton R. Babcock Registration No. 39,592 Attorney for Petitioner Fisher & Paykel Healthcare Limited

24372277

filed: october 11, 2016 filed on behalf of: fisher & paykel ......malloy, robert a., plastic...

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