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: BoxFPH529-4@knobbe.com Filed: October 12, 2016 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. IPR2017-00065 U.S. Patent No. 9,119,931 PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 9,119,931
TABLE OF CONTENTS Page No. I. INTRODUCTION... 1 II. THIS PETITION IS NOT REDUNDANT UNDER 35 U.S.C. 325(D)... 5 III. MANDATORY NOTICES UNDER 37 C.F.R. 42.8(A)(1)... 6 A. Real Party-In-Interest (37 C.F.R. 42.8(b)(1))... 6 B. Related Matters Under 37 C.F.R. 42.8(b)(2)... 6 C. Lead and Back-up Counsel Under 37 C.F.R. 42.8(b)(3)... 7 D. Service Information Under 37 C.F.R. 42.8(b)(4)... 7 IV. REQUIREMENTS FOR REVIEW UNDER 37 C.F.R. 42.104... 8 A. Grounds for Standing (37 C.F.R. 42.104(a))... 8 B. Statement of Relief Requested Under 37 C.F.R. 42.104(b)(1) (2)... 8 1. Prior Art... 8 a. WO 2007/147088 ( Matula-I ) (Ex. 1302)... 9 b. U.S. 6,796,308 ( Gunaratnam-I ) (Ex. 1303)... 9 c. U.S. Publication No. 2004/0226566 ( Gunaratnam-II ) (Ex. 1304)... 10 d. WO 2007/045008 ( Worboys ) (Ex. 1306)... 10 e. U.S. 6,412,488 ( Barnett ) (Ex. 1309)... 10 f. U.S. 5,662,101 ( Ogden ) (Ex. 1310)... 10 g. U.S. 6,631,718 ( Lovell ) (Ex. 1311)... 11 h. U.S. Publication No. 2007/0044804 ( Matula- II ) (Ex. 1319)... 11 i
TABLE OF CONTENTS (continued) Page No. 2. Grounds... 11 C. Claim Construction (37 C.F.R. 42.104(b)(3))... 12 V. THE 931 PATENT... 13 A. Example Embodiments... 13 B. Summary of the Prosecution History of the 931 Patent... 16 VI. LEVEL OF ORDINARY SKILL IN THE ART... 16 VII. THE CHALLENGED CLAIMS OF THE 931 PATENT ARE UNPATENTABLE... 17 A. Legal Standard... 17 B. Ground 1: Claims 1, 6 8, 11, 12, 26, and 31 32 would have been obvious over Matula-I in view of Ogden and Gunaratnam-I... 18 1. Overview of Matula-I (Ex. 1302)... 18 2. Overview of Ogden (Ex. 1310)... 19 3. Overview of Gunaratnam-I (Ex. 1303)... 21 4. Potential Differences from Prior Art... 22 a. headgear connectors adapted to removably attach to respective headgear straps... 23 b. rigid or semi-rigid frame defining a breathing chamber... 24 c. the cushion is constructed of a first, relatively soft, elastomeric material and the frame is constructed of a second material that is more rigid than the cushion... 26 ii
TABLE OF CONTENTS (continued) Page No. d. protruding vent arrangement... 27 e. upper and lower headgear connectors... 28 f. headgear clip... 30 g. removably and non-rotatably coupleable and snap-fit... 31 5. Reasons to Combine... 32 C. Ground 2: Claims 4, 5, 10, and 65 of the 931 Patent would have been obvious over Matula-I in view of Ogden, Gunaratnam-I, and Matula-II... 34 1. Overview of Matula-II (Ex. 1319)... 34 2. Potential Differences from Prior Art... 35 a. one or more folds... 35 b. collar... 38 c. snap fingers... 39 d. retaining portion... 40 3. Reasons to Combine... 44 D. Ground 3: Claims 13, 14 and 18 would have been obvious over Matula-I in view of Ogden, Gunaratnam-I, and Lovell... 45 1. Overview of Lovell (Ex. 1311)... 45 2. Potential Differences from Prior Art... 46 a. elbow module comprises polycarbonate... 46 iii
TABLE OF CONTENTS (continued) Page No. b. elbow module and shroud module are directly connected with a mechanical interlock while allowing 360 degree rotation of the elbow module... 46 c. the shroud module and the frame comprise polycarbonate... 47 3. Reasons to Combine... 47 E. Ground 4: Claims 28 30 would have been obvious over Matula-I in view of Ogden, Gunaratnam-I, Matula-II, and Lovell... 48 1. Potential Differences from Prior Art and Reasons to Combine... 48 F. Ground 5: Claim 15 would have been obvious over Matula-I in view of Ogden, Gunaratnam-I, and Worboys... 49 1. Overview of Worboys (Ex. 1306)... 49 2. Potential Differences from Prior Art... 51 a. anti-asphyxia valve... 51 3. Reasons to Combine... 51 G. Ground 6: Claims 16 and 17 would have been obvious over Matula-I in view of Ogden, Gunaratnam-I, and Barnett... 52 1. Overview of Barnett (Ex. 1309)... 52 2. Potential Differences from Prior Art... 53 a. at least first and second cushion modules... 53 b. a small cushion module, a medium cushion module and a large cushion module... 54 iv
TABLE OF CONTENTS (continued) Page No. 3. Reasons to Combine... 54 H. Ground 7: Claims 19 22 and 25 of the 931 Patent would have been obvious over Matula-I in view of Ogden, Gunaratnam-I, and Gunaratnam-II... 56 1. Overview of Gunaratnam-II (Ex. 1304)... 56 2. Potential Differences from Prior Art... 57 a. a pair of upper straps and pair of lower straps... 57 b. hook tab... 58 c. top straps... 59 d. rear straps... 60 e. upper straps provide padding... 60 3. Reasons to Combine... 62 I. Ground 8: Claims 46, 51, and 53 56 would have been obvious over Matula-I in view of Ogden, Gunaratnam-I, Matula-II, Gunaratnam-II, and Worboys... 63 1. Potential Differences from Prior Art... 63 a. swivel... 63 2. Reasons to Combine... 64 VIII. CLAIM CHARTS... 65 IX. SECONDARY CONSIDERATIONS...124 v
TABLE OF AUTHORITIES Page No(s). ABS Global Inc. v. XY, LLC, IPR2014-01161, Paper No. 9 (PTAB January 13, 2015)... 6 In re Cuozzo Speed Techs., LLC, 793 F.3d 1268 (Fed. Cir. 2015), aff d, 136 S. Ct. 2131 (2016)... 13 KSR Int l v. Teleflex Inc., 550 U.S. 398 (2007)...17, 33, 44, 49, 64 Leapfrog Enters. Inc. v. Fisher-Price, Inc., 485 F.3d 1157 (Fed. Cir. 2007)... 124 Newell Cos., Inc. v. Kenney Mfg. Co., 864 F.2d 757 (Fed. Cir. 1988)... 124 In re Translogic Tech., 504 F.3d 1249 (Fed. Cir. 2007)... 13 Wyers v. Master Lock Co., 616 F.3d 1231 (Fed. Cir. 2010)... 124 OTHER AUTHORITIES 37 C.F.R. 42.8... 6, 7, 8 37 C.F.R. 42.100... 1, 13 37 C.F.R. 42.104... 8, 13 35 U.S.C. 102... 9, 10, 11 35 U.S.C. 103... 12, 17 35 U.S.C. 311 319... 1 35 U.S.C. 325... 5 vi
EXHIBIT LIST Exhibit No. Description 1301 U.S. Patent No. 9,119,931 1302 PCT Publication No. WO 2007/147088 (Matula-I) 1303 U.S. Patent No. 6,796,308 (Gunaratnam-I) 1304 U.S. Patent Publication No. 2004/0226566 (Gunaratnam-II) 1305 U.S. Patent Publication No. 2004/0067333 (Amarasinghe) 1306 PCT Publication No. WO 2007/045008 (Worboys) 1307 U.S. Patent No. 7,827,990 (Melidis) 1308 U.S. Patent Publication No. 2004/0182398 (Sprinkle) 1309 U.S. Patent No. 6,412,488 (Barnett) 1310 U.S. Patent No. 5,662,101 (Ogden) 1311 U.S. Patent No. 6,631,718 (Lovell) 1312 Declaration of Jason Eaton, P.E. 1313 Excerpts from the File History of U.S. Patent No. 9,119,931 1314 1315 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 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.) 1316 U.S. Provisional Application No. 61/064,406 Exhibit List, Page 1
Exhibit No. Description 1317 U.S. Provisional Application No. 61/071,893 1318 U.S. Provisional Application No. 61/136,617 1319 U.S. Publication No. 2007/0044804 (Matula-II) 1320 1321 Affidavit of Christopher Butler, Ultra Mirage Brochure (Ultra Mirage), dated September 6, 2016 Affidavit of Christopher Butler, FlexiFit Instructions (FlexiFit), dated September 6, 2016 1322 U.S. Patent No. 6,851,425 (Jaffre) 1323 Malloy, Robert A., Plastic Part Design for Injection Molding: An Introduction, pp. 336 345 (Hanser Gardner Publications, Inc. 1994) (Malloy) 1324 PCT Publication No. WO 2005/123166 (Frater) Exhibit List, Page 2
Pursuant to 35 U.S.C. 311 319 and 37 C.F.R. 42.100 et seq., Petitioner Fisher & Paykel Healthcare Limited ( Petitioner or Fisher & Paykel ) requests inter partes review of Claims 1, 4 8, 10 22, 25, 26, 28 32, 46, 51, 53 56, and 65 ( Challenged Claims ) of U.S. 9,119,931 ( 931 Patent ) (Ex. 1301), which is purportedly owned by ResMed Limited ( Patent Owner or ResMed ). I. INTRODUCTION Continuous positive airway pressure (CPAP) is a treatment that delivers pressurized gas to a patient to keep the patient s airways open and can be used to treat obstructive sleep apnea. The 931 Patent relates to CPAP mask systems that include a frame supporting a seal and headgear that holds the frame and seal in place on the patient. 1
The 931 Patent discloses mask systems that allegedly enhance efficacy and improve patient compliance. Ex. 1301 at col. 1:39 41. However, the Challenged Claims merely recite long lists of mask features that were well-known prior to the 931 Patent, and their combinations in the claims provided no unexpected results or benefits. As shown in the annotated figures on the next page, nearly all of the claimed features were described in prior art publication WO 2007/147088 (Matula). Ex. 1302. 2
931 Patent Cushion Vent Receiving Hole Vent Shroud Elbow Elbow hole Opening Frame Matula-I Lower Headgear Connectors Cushion Receiving Hole Shroud Elbow Hole Elbow Frame Opening Headgear Connectors 3
Matula-I does not show a vent on the portion of the frame that protrudes through the receiving hole on the shroud as required by the Challenged Claims. However, it was well-known to place a vent on the frame at that precise nasal bridge location. See VII(B)(4)(d), infra; Ex. 1312 63 67. For example, as shown below, Gunaratnam-I teaches an air vent positioned in the nasal bridge region. Ex. 1303 at col. 6:25 29. As explained below, any additional differences (e.g., headgear straps providing padding, headgear buckles, Velcro on headgear) between the Challenged Claims and the teachings of Matula-I were well-known and disclosed in other prior art CPAP masks, including ResMed s own prior art literature (e.g., Worboys, and Gunaratnam-I and II). See VII(B) (I), infra; Ex. 1312 46 166. A skilled artisan at the time of the invention would have been motivated to 4
combine these known features with the mask assembly of Matula-I to arrive at the mask assemblies of the Challenged Claims. Since the Challenged Claims include simple and well-known mechanical features, a skilled artisan would have had a reasonable expectation of success in combining the features of Matula-I with features in other prior art CPAP masks. II. THIS PETITION IS NOT REDUNDANT UNDER 35 U.S.C. 325(D) This petition is not redundant under with Petitioner s other co-pending IPR petitions challenging the 931 Patent. These petitions include different grounds challenging different claims. For example, the present petition requests review of Claims 1, 4 8, 10 22, 25, 26, 28 32, 46, 51, 53 56, and 65 using Matula-I in view of other patent prior art. Petitioner has concurrently filed a second IPR petition requesting inter partes review of Claims 33 37, 40 43, 48 50, 57, 58, 60 64, 68 71, 77 79 using U.S. 6,412,488 (Barnett) in view of other patent prior art. These petitions are not redundant because there are no overlapping claims. Petitioner has also concurrently filed a third IPR petition requesting inter partes review of Claims 1, 4 8, 10 22, 25, 26, 28 37, and 40 42 and a fourth IPR petition requesting inter partes review of Claims 43, 46, 48 51, 53 58, 60 65, 68 71, and 77 79 both based on WO 2007/041751 (D Souza) in view of other patent and non-patent prior art. Because the petitions based on D Souza rely on a 5
different primary reference and at least some non-patent prior art and this petition relies entirely on patent prior art, Petitioner respectfully requests that the Board institute all four IPR proceedings. See ABS Global Inc. v. XY, LLC, IPR2014-01161, Paper No. 9 (Decision on Institution) at *19 (PTAB January 13, 2015). III. MANDATORY NOTICES UNDER 37 C.F.R. 42.8(A)(1) A. Real Party-In-Interest (37 C.F.R. 42.8(b)(1)) Fisher & Paykel Healthcare Limited is the real party-in-interest. Fisher & Paykel Healthcare Limited is publicly traded on the NZSX and ASX stock exchanges under the symbol FPH. Petitioner Fisher & Paykel provides patients with a broad range of innovative products and systems for use in the treatment of obstructive sleep apnea (OSA) and sells its products in over 120 countries. B. Related Matters Under 37 C.F.R. 42.8(b)(2) ResMed and Fisher & Paykel are currently involved in proceedings with the United States International Trade Commission in which ResMed has asserted that certain Fisher & Paykel products infringe one or more claims of the 931 Patent (Investigation No. 337-TA-1022). Ex. 1314. ResMed and Fisher & Paykel are currently involved in pending litigation in the Southern District of California involving the 931 Patent. See Fisher & Paykel Healthcare Ltd. v. ResMed Corp., Case No. 3:16-cv-02068-DMS-WVG (S.D. Cal.). ResMed asserted a claim for infringement of the 931 Patent in its 6
counterclaims on September 7, 2016. Ex. 1315. The 931 Patent, which was filed after Fisher & Paykel launched its accused Simplus and Eson masks, does not claim any inventive concept. Instead, the 931 Patent claims laundry lists of wellknown mask features in an attempt to cover Fisher & Paykel s products. Fisher & Paykel has concurrently filed three other petitions for inter partes review of the 931 Patent that would affect, or be affected by, a decision in this proceeding. C. Lead and Back-up Counsel Under 37 C.F.R. 42.8(b)(3) Fisher & Paykel provides the following designation of counsel, all of whom are included in Customer No. 20,995 identified in Fisher & Paykel s Power of Attorney. Lead Counsel Brenton R. Babcock (Reg. No. 39,592) 2brb@knobbe.com 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 Back-up Counsel Benjamin J. Everton (Reg. No. 60,659) 2bje@knobbe.com 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 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: BoxFPH529-4@knobbe.com. 7
IV. REQUIREMENTS FOR REVIEW UNDER 37 C.F.R. 42.104 A. Grounds for Standing (37 C.F.R. 42.104(a)) Petitioner hereby certifies that the 931 Patent is available for inter partes review and that Petitioner is not barred or estopped from requesting inter partes review regarding the Challenged Claims on the grounds identified in this petition. B. Statement of Relief Requested Under 37 C.F.R. 42.104(b)(1) (2) 1. Prior Art Petitioner respectfully requests institution of an inter partes review of the Challenged Claims of the 931 Patent, filed July 31, 2014, which is a continuation of U.S. Application No. 13/964,280, filed August 12, 2013, which is a continuation of U.S. Application No. 13/745,077, filed January 18, 2013, which is a continuation of U.S. Application No. 12/736,024, filed as PCT Application No. PCT/AU2009/000241 on February 27, 2009, which claims priority benefit of U.S. Provisional Application Nos. 61/064,406, 61/071,893 and 61/136,617 (collectively the Provisional Applications ), filed March 4, 2008, May 23, 2008 and September 19, 2008, respectively. Ex. 1301 at 1 2. The earliest possible priority date of the 931 Patent is March 4, 2008. The Challenged Claims of the 931 Patent are obvious in view of the following prior art: 8
a. WO 2007/147088 ( Matula-I ) (Ex. 1302) Matula-I was filed on June 14, 2007 and published in English on December 21, 2007. Ex. 1302 at 1. The earliest-filed provisional application from which the 931 Patent claims priority benefit did not disclose a vent on the frame. Ex. 1316 66 69; Ex. 1312 31. Indeed, a protruding vent arrangement is not shown or described in any of the Provisional Applications. Ex. 1316; Ex. 1317; Ex. 1318; Ex. 1312 31. Thus, the earliest possible priority date for the Challenged Claims is the filing date of the parent application, U.S. Application No. 12/736,024, on February 27, 2009. Because Matula-I published more than one year before February 27, 2009, Matula-I is prior art under 35 U.S.C. 102(b) for the Challenged Claims. 1 b. U.S. 6,796,308 ( Gunaratnam-I ) (Ex. 1303) Gunaratnam-I issued on September 28, 2004. Ex. 1303 at 1. Because Gunaratnam-I issued more than one year before the earliest priority date of the Challenged Claims, it is prior art under 35 U.S.C. 102(b). 1 Reference to 35 U.S.C. 102 and 103 throughout this Petition are to the pre- AIA versions, which are applicable to the 931 Patent. 9
c. U.S. Publication No. 2004/0226566 ( Gunaratnam-II ) (Ex. 1304) Gunaratnam-II published on November 18, 2004. Ex. 1304 at 1. Because Gunaratnam published more than one year before the earliest priority date of the Challenged Claims, it is prior art under 35 U.S.C. 102(b). d. WO 2007/045008 ( Worboys ) (Ex. 1306) Worboys was filed on January 12, 2006 and published on April 26, 2007. Ex. 1306 at 1. Because Worboys published more than one year before the earliest priority date of the Challenged Claims, it is prior art under 35 U.S.C. 102(b). e. U.S. 6,412,488 ( Barnett ) (Ex. 1309) Barnett issued on July 2, 2002. Ex. 1309 at 1. Because Barnett issued more than one year before the earliest priority date of the Challenged Claims, it is prior art under 35 U.S.C. 102(b). f. U.S. 5,662,101 ( Ogden ) (Ex. 1310) Ogden issued on September 2, 1997. Ex. 1310 at 1. Because Ogden issued more than one year before the earliest priority date of the Challenged Claims, it is prior art under 35 U.S.C. 102(b). 10
g. U.S. 6,631,718 ( Lovell ) (Ex. 1311) Lovell issued on October 14, 2003. Ex. 1311 at 1. Because Lovell issued more than one year before the earliest priority date of the Challenged Claims, it is prior art under 35 U.S.C. 102(b). h. U.S. Publication No. 2007/0044804 ( Matula-II ) (Ex. 1319) Matula-II published on March 1, 2007. Ex. 1319 at 1. Because Matula-II published more than one year before the earliest priority date of the Challenged Claims, it is prior art under 35 U.S.C. 102(b). 2. Grounds Petitioner requests inter partes review of the Challenged Claims. Because ResMed claimed a laundry list of many well-known features in its many lengthy patent claims, this petition necessarily includes several different prior art references that disclose those various common features. The grounds below are not overlapping in that each challenged claim is subject to only one ground of unpatentability. Ground 1. Claims 1, 6 8, 11, 12, 26, and 31 32 would have been obvious over Matula-I in view of Ogden and Gunaratnam-I under 35 U.S.C. 103. Ground 2. Claims 4, 5, 10, and 65 would have been obvious over Matula-I in view of Ogden, Gunaratnam-I, and Matula-II under 35 U.S.C. 103. 11
Ground 3. Claims 13, 14, and 18 would have been obvious over Matula-I in view of Ogden, Gunaratnam-I, and Lovell under 35 U.S.C. 103. Ground 4. Claims 28 30 would have been obvious over Matula-I in view of Ogden, Gunaratnam-I, Matula-II, and Lovell under 35 U.S.C. 103. Ground 5. Claim 15 would have been obvious over Matula-I in view of Ogden, Gunaratnam-I, and Worboys under 35 U.S.C. 103. Ground 6. Claims 16 and 17 would have been obvious over Matula-I in view of Ogden, Gunaratnam-I, and Barnett under 35 U.S.C. 103. Ground 7. Claims 19 22 and 25 would have been obvious over Matula-I in view of Ogden, Gunaratnam-I, and Gunaratnam-II under 35 U.S.C. 103. Ground 8. Claims 46, 51, and 53 56 would have been obvious over Matula-I in view of Ogden, Gunaratnam-I, Matula-II, Gunaratnam-II, and Worboys under 35 U.S.C. 103. C. Claim Construction (37 C.F.R. 42.104(b)(3)) The Challenged Claims should be accorded their broadest reasonable construction in light of the specification of the 931 Patent. 2 37 C.F.R. 42.100(b); In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1278 79 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 may apply. 12
(Fed. Cir. 2015), aff d, Cuozzo Speed Techs. v. Lee, 136 S. Ct. 2131 (2016). All terms have their ordinary and customary meaning in light of the specification, as commonly understood by those of ordinary skill in the art at the time of the invention. In re Translogic Tech., 504 F.3d 1249, 1257 (Fed. Cir. 2007). V. THE 931 PATENT A. Example Embodiments The 931 Patent discloses a CPAP mask system 1010 having a frame 1040 that supports a cushion 1060 and attaches to a shroud 1020, as illustrated in Figure 3 below. Ex. 1301 at col. 6:51 54; Figs. 1 5. The shroud 1020 includes a vent receiving hole 1021 to accommodate a vent arrangement 1076 that protrudes from the frame 1040. Id. at col. 7:9 23. The bottom of the shroud 1020 includes an elbow hole 1032. Id. at col. 7:23 25. 13
Upper and lower headgear connectors 1024, 1025 extend from each side of the shroud. Id. at col. 7:28 30. Each lower headgear connector 1025 includes a clip receptacle 1031. Id. at col. 8:29 32. 14
As shown in Figure 9 below, headgear 1090 includes upper and lower straps 1092, 1094 that can be removably attached to headgear connectors 1024, 1025. Id. at col. 10:41 45. The free end of each strap includes a Velcro tab that allows adjustment of the strap length. Id. at col. 10:45 49. As shown in Figures 11 and 14 below, the frame is connected to the shroud 1132 by snap fingers 1145(1) that engage the collar 1149. Id. at col. 18:48 67. 15
B. Summary of the Prosecution History of the 931 Patent The 931 Patent was originally filed as U.S. Application No. 14/447,673 on July 31, 2014. On December 8, 2014, the Examiner rejected all pending claims based on U.S. Publication No. 2006/0272646 ( Ho ) in view of other prior art. Ex. 1313 at 247. The Examiner also rejected all of the pending claims for nonstatutory double patenting. Id. at 252. In response, applicant amended Claim 1 to include the nonrotatably coupleable limitation. On February 3, 2015, the Examiner rejected almost all the pending claims based on U.S. Publication No. 2006/0042629 ( Geist ) in view of other prior art. Id. at 345. The Examiner also indicated that Claims 29 and 33 would be allowable if rewritten in independent form. Id. at 359. In response, applicant amended Claim 1 to include, inter alia, a protruding vent arrangement. Id. at 429. Applicant also added new Claims 34 83. Id. at 436 446. The Examiner issued a notice of allowability on July 15, 2015. Id. at 493. VI. LEVEL OF ORDINARY SKILL IN THE ART A person having ordinary skill in the field at the time of the purported invention of the 931 Patent would have at least a bachelor s degree in mechanical engineering, biomedical engineering or other similar type of engineering degree 16
combined with at least two years of experience in the field of masks, respiratory therapy, patient interfaces or relevant product design experience. Ex. 1312 27. VII. THE CHALLENGED CLAIMS OF THE 931 PATENT ARE UNPATENTABLE This Petition explains, in detail, why the Challenged Claims are unpatentable. The Petition is supported by the declaration of Jason Eaton, P.E. Ex. 1312. Mr. Eaton is a Principal Mechanical Engineer at MSA Safety. As explained in his declaration, Mr. Eaton has extensive academic and industry experience in CPAP mask systems and design. Id. 3 8. His declaration explains the basis for his conclusions that the Challenged Claims would have been obvious. Id. 38 167. A. Legal Standard 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). 17
B. Ground 1: Claims 1, 6 8, 11, 12, 26, and 31 32 would have been obvious over Matula-I in view of Ogden and Gunaratnam-I 1. Overview of Matula-I (Ex. 1302) Matula-I was submitted during the prosecution of the 931 Patent, but was not cited by the Examiner. Ex. 1301 at 9. Matula-I discloses a CPAP mask assembly 1230 including a body portion 1240 and a patient interface 1260. Ex. 1302 101. The body portion 1240 includes an opening 1250, and the patient interface portion 1260 includes a protrusion 1262 sized and configured to fit snugly into opening 1250. Id. 104. The body portion 1240 also includes a circuit coupling portion 1246 that is rotatably and releasably attached to an elbow providing a flow of gas. Id. 105. 18
2. Overview of Ogden (Ex. 1310) Ogden was cited during the prosecution of the 931 Patent as a secondary reference. Ex. 1301 at 4. Ogden discloses a respiratory nasal mask, but the disclosure is equally applicable to full-face masks. Ex. 1310 at col. 1:6 10, 2:44 50. As shown in Figure 1 below, a rigid shell 3 supports a soft seal 5 and encloses the patient s nose. Id. at col. 2:50 57. A rigid plate 9 is mounted to the rigid shell 3 at three locations A, B, C by detents 39, 41 and 43 being received in channels 45, 47, and 49. Id. at col. 3:26 29. At least one of the detents snaps into the channel to secure the rigid plate 9 on the shell 3. Id. at col. 5:15 18. 19
The rigid plate 9 attaches to headgear 11 that includes two lower side straps 13R and 13L, upper side straps 15R and 15L, and a top strap 17. Id. at col. 2:57 3:22. 20
3. Overview of Gunaratnam-I (Ex. 1303) Gunaratnam-I was submitted during the prosecution of the 931 Patent, but was not cited by the Examiner. Ex. 1301 at 5. Gunaratnam-I discloses masks that deliver breathable gas to treat sleep disordered breathing. Ex. 1303 at col. 1:21 25. Figures 5a and 5c (above) illustrate a headgear connector 160/162 with strap connection points 630 that connect to the headgear via clip connectors 200. Id. at col. 4:32 34. 21
As shown below in Figure 15, Gunaratnam-I also discloses a full-face mask system that includes a mask frame 160, cushion 180, and clip 800. Id. at col. 6:3 7. The mask frame 160 includes an aperature 930 for reciving an air vent 940. Id. at col. 6:25 29. 4. Potential Differences from Prior Art As detailed in the claim charts below, Matula-I discloses nearly all of the limitations of Claims 1, 6-8, 11, 12, 26, and 31 32. Many of these claimed features are identified in the annotated version of Figure 49 of Matula-I provided below. Ex. 1312 53 54. Any differences were 22
minor and well-known at the time of the invention and taught by Ogden and Gunaratnam-I. Id. 52 84. Headgear Connectors Shroud Cushion Module Cushion Receiving Hole Elbow Hole Elbow Frame Opening a. headgear connectors adapted to removably attach to respective headgear straps Claim 1 includes headgear connectors adapted to removably attach to respective headgear straps. Matula-I discloses headgear attachment elements 1248 that receive headgear straps, but does not expressly disclose removable headgear straps. Ex. 1302 103. However, Ogden discloses removable headgear straps attached to the rigid plate 9 23
by hook and loop materials (Velcro ) on the strap themselves. Ex. 1310 at col. 2:62 3:17; 1312 56. b. rigid or semi-rigid frame defining a breathing chamber Claim 1 recites a rigid or semi-rigid frame defining a breathing chamber. Claim 31 depends from Claim 1 and recites the frame is rigid. 24
As shown below, Matula-I discloses a cushion module that covers both the user s nasal passages and mouth. Ex. 1302 101. Cushion module The cushion module of Matula-I includes a frame that defines a breathing chamber, but does not expressly disclose a rigid frame. However, rigid frames that support a cushion were common in prior art CPAP masks. Ex. 1312 59 60. 25
For example, as shown below, Ogden discloses, a rigid, cup-shaped shell 3 made of hard plastic. Id.; Ex. 1310 at col: 2:50 54. c. the cushion is constructed of a first, relatively soft, elastomeric material and the frame is constructed of a second material that is more rigid than the cushion As noted above, Matula-I does not expressly disclose the materials recited in Claim 1. However, a soft, elastomeric cushion and a more rigid frame were common in prior art CPAP masks. Ex. 1312 61 62. For example, Ogden discloses, a rigid, cup-shaped shell 3 made of hard plastic and a soft pliable seal 5 of elastomer, urethane foam, or rubber. Id. 62; Ex. 1310 at col. 2:50 57. 26
d. protruding vent arrangement Claim 1 recites a protruding vent arrangement having a plurality of holes. As shown in Figures 48 49 of Matula-I (below), the cushion frame 1260 includes a protrusion 1262 (highlighted in red) that protrudes through the opening 1250 of the body portion 1240. See Ex. 1302 104. Matula-I also discloses that an exhaust vent assembly can be provided on the cushion frame 1260. Id. To the extent Matula-I provides insufficient teaching for a vent on the protruding portion, Gunaratnam-I discloses an air vent (940) in the nasal bridge region, as shown in Figure 15 below. Ex. 1303 at col. 6:25 29. As explained in the Reasons to Combine below, a skilled artisan at the time of the invention would have been motivated to provide the vent of Gunaratnam-I in the 27
same nasal bridge region of Matula-I, and thus on the protruding portion of Matula-I. Ex. 1312 65; see VII(B)(5), infra. e. upper and lower headgear connectors Claim 6 depends from Claim 1 and recites, the shroud module includes upper and lower headgear connectors. 28
Matula-I discloses headgear attachment elements 1245, 1248 on the shroud 1240 that receive headgear straps (not shown), as shown in Figure 49 below. Ex. 1302 102 103. Thus, Matula-I shows upper and lower headgear connectors. Ex. 1312 69. 29
In a similar embodiment (Figure 50 below), Matula-I discloses a body portion 1340 that includes a pair of attachment elements 1348 (upper and lower headgear connectors) for attaching headgear straps. Ex. 1312 70; Ex. 1302 108. f. headgear clip Claim 8 depends from Claim 7 and recites each lower headgear connector is adapted to be removably interlocked with a headgear clip associated with a respective headgear strap. Matula-I discloses snaps, hooks, loops, clamps, or other connectors for attaching headgear straps to the shroud. Ex. 1302 51. To the extent this is insufficient, Gunaratnam-I discloses headgear connectors 630 that removably interlock with clips 200, as shown below. Ex. 1303 at col. 4:31 33; 1312 73. 30
g. removably and non-rotatably coupleable and snap-fit Claim 1 includes the shroud module and the cushion module are configured to be removably and non-rotatably coupleable. Claim 26 depends from Claim 1 and includes a snap-fit arrangement to removably snap-fit attach the shroud module and the cushion module to one another by moving the shroud module and the cushion module towards one another along the longitudinal axis. Matula-I discloses a shroud module and a cushion module being nonrotatably coupleable. Ex. 1302 104. Matula-I does not expressly disclose that the coupling is removable or is a snap-fit, but such removable snap-fit connections were well-known in prior art CPAP masks. Ex. 1312 75 77. For example, Ogden discloses that the rigid shroud 9 is mounted to rigid shell 3 by interlocking 31
detents 39, 41, 43 into channels 45, 47, 49, as shown in Figure 2 below. Ex. 1310 at col. 4:20 23. The detent 43 and the channel 49 are dimensioned to snap together to hold or maintain the rigid plate 9 on the rigid shell 3. Id. at col. 5:14 18. The removable snap-fit interlock results from moving the shroud module and the cushion module towards one another along a longitudinal axis. Ex. 1312 75. 5. Reasons to Combine A person of skill in the art at the time of the invention would have been motivated to provide each of the features discussed above. See supra VII(B)(4). Such modifications would have been mere combinations of familiar elements according to known methods that do no more than yield predictable results. See 32
KSR, 550 U.S. at 416. Because Matula-I, Ogden, and Gunaratnam-I all teach CPAP masks for the treatment of sleep disordered breathing, the features taught in Ogden and Gunaratnam-I would have been readily compatible with and easily incorporated into the mask of Matula-I with a reasonable expectation of success. Ex. 1312 79. A person of skill in the art would have been motivated to provide removable headgear straps (e.g., using headgear clips) to the mask assembly of Matula-I to enable quick and easy mask fitting and removal (e.g., for cleaning or replacement). Id. 80. Further, it was well-known at the time of the invention to use a rigid plastic frame and a relatively soft elastomeric cushion. Id. 81 82. One of skill in the art would have known to include a rigid structure to support a soft cushion comfortably against a patient s face and to ensure a seal around the patient s nose and mouth. Id. 82. A person of skill in the art also would have been motivated to modify Matula-I to include a vent for CO 2 washout. Id. 83. A skilled artisan would have recognized the benefits in positioning the vent on the protruding portion of the frame to minimize noise output. Id. Additionally, it was well-known to place the vent in the nasal bridge region to minimize dead space and because air from the 33
inlet would flow by the patient s nose and exit the vent to flush exhaled air effectively and minimize re-breathing of exhaled air. Id. Additionally, a person of skill in the art would have known to include upper and lower headgear connectors on the CPAP mask of Matula-I to provide the user freedom and flexibility in selecting the pa[i]r of attachment structures for attaching the headgear to the mask that is best suited for example the most comfortable, stable, and/or minimizes unintentional leakages, for that user. Ex. 1302 108; Ex. 1312 80. A person of skill in the art would have also known to include removable snap-fit features on the shroud module and the cushion module. Ex. 1312 84. It was well-known to provide a snap-fit connection to ensure that the collar and cushion member are fully attached and correctly aligned. Id.; Ex. 1310 at col. 5:14 19. Further, a person of skill would have been motivated to provide a removable snap-fit connection so that the cushion module could be replaced or removed for cleaning. Ex. 1312 84. C. Ground 2: Claims 4, 5, 10, and 65 of the 931 Patent would have been obvious over Matula-I in view of Ogden, Gunaratnam-I, and Matula-II 1. Overview of Matula-II (Ex. 1319) Matula-II was submitted during the prosecution of the 931 Patent, but was not cited by the Examiner. Ex. 1301 at 7. 34
Matula-II discloses a CPAP mask assembly including a faceplate 36 mechanically coupled to a seal member 38. Ex. 1319 52 53. The seal member 38 has folds 106 provided at an upper portion of the seal member so that the seal member has the desired degree of flexibility. Id. 66. 2. Potential Differences from Prior Art a. one or more folds Claim 4 depends from Claim 1 and includes a nasal bridge portion of the cushion includes one or more folds to provide in use a higher level of adaptability or flexibility to the nasal bridge region of the cushion module relative to another region of the cushion module. 35
Matula-I does not expressly disclose folds, but as shown below, Matula-II discloses folds 106 in the nasal bridge portion of the cushion 38 to provide the desired degree of flexibility. Ex. 1319 66. Claim 4 also includes each of said one or more folds comprises adjacent first side walls interconnected by a second side wall. The 931 Patent discloses each fold having adjacent first side walls 52(1) interconnected by a second side wall 52(2), as shown below in the annotated Figure 32-3. Ex. 1301 at col. 14:40 42. 36
First side walls Second side wall As shown in Figure 4 below, Matula-II teaches similar folds 106 having first side walls interconnected by a second side wall. Ex. 1312 90. First side wall Second side wall First side wall 37
b. collar Claim 5 depends from Claim 1 and includes a collar surrounding said frame opening. Matula-I discloses an outward facing collar (circuit coupling portion 1246) on the body portion 1240 that aligns with an opening 1264 on the cushion module 1260, but does not expressly disclose placement of the collar around the frame opening. Ex. 1302 105. 38
However, as shown in Figures 4 and 5 below, Matula-II discloses a cushion module frame having a collar 52 surrounding the frame opening. Ex. 1319 53; Ex. 1312 93. FIG. 4 FIG. 5 (PARTIAL) c. snap fingers Claim 5 depends from Claim 1 and includes the shroud includes a retaining portion with a plurality snap fingers structured to engage the collar with a snapfit. Matula-I does not expressly disclose a plurality of snap fingers, but such snap-fit connections were well-known in prior art CPAP masks. Ex. 1312 96. As explained above, Ogden discloses that the rigid shroud 9 is mounted to rigid shell 3 by interlocking detents 39, 41, 43 (snap fingers) into channels 45, 47, 49, as 39
shown in the partial views of Figures 2, 7, and 8 of Ogden below. Ex. 1310 at col. 4:20 23. The detent or snap finger 43 and the channel 49 are dimensioned to snap together to hold or maintain the rigid plate 9 on the rigid shell 3. Id. at col. 5:14 18. d. retaining portion Claim 10 depends from Claim 1 and includes the shroud module includes an annular or part annular cushion retaining portion structured to retain the cushion module. Claim 65 depends from Claim 57 which includes a retaining portion 40
positioned rearwardly of the opening, towards the frame, and structured to snap fit with the cushion module. Matula-I discloses, in a related embodiment, that the shroud can include a circuit coupling portion 1346 providing an annular mounting surface to retain the opening 1364 of the cushion module. Ex. 1302 110. Also, these claimed features were common in the prior art. Ex. 1312 98. For example, Matula-II discloses a shroud 36 with an annular, rearward extending retaining portion and a cushion module 38 with a collar 52. Id.; Ex. 1319 53. As shown below in Figure 4, Matula-II also discloses a pair of prongs 48 that extend rearwardly from the shroud 36 and are structured to mechanically couple the collar 52 to the shroud 36. Ex. 1319 53. Because the shroud 36 of Matula-II is substantially rigid, the snap-fingers 48 deflect radially inward and elastically recover to mechanically couple the cushion module 38 to the shroud 36 with a snap-fit. Id. 51; Ex. 1312 98. 41
Figure 5 (partial) Retaining Portion Figure 4 (annotated) Collar Snap Fingers 42
Although the snap fingers of Matula-II are on coupling member 46, a skilled artisan would have known to incorporate such snap fingers directly on the rearward extending retaining portion. Ex. 1312 99. For example, the snap fingers 39, 41, 43 of Ogden are on the rigid shroud 9 and snap into channels 45, 47, 49 on the frame, as shown in in the partial views of Figures 2, 7, and 8 of Ogden below. Ex. 1310 at col. 5:14 18, 4:20 23. 43
3. Reasons to Combine A person of skill in the art at the time of the invention would have been motivated to combine the features of Matula-I, Ogden, Gunaratnam-I, and Matula- II to arrive at the claimed mask system of Claims 4, 5, 10, and 65 for at least the reasons provided above. Ex. 1312 103; see supra VII(B)(5). A person of skill in the art would have known to include the fold(s) taught by Matula-II in the Matula-I cushion to provide a higher degree of flexibility in the delicate nose bridge region compared to other regions. Ex. 1319 66; Ex. 1312 105. Although the collar 1246 of Matula-I is located on the shroud 1240, a skilled artisan would have known to place the collar on the cushion frame, as taught by Matula-II, so that the collar on the cushion module would be engaged by a retaining portion on the shroud. Ex. 1312 107. Such a rearrangement would have involved a simple substitution of one known feature for another to obtain predictable results and achieve the same purpose of mechanically interlocking the shroud and the cushion module. See KSR, 550 U.S. at 416. Further, it was well-known to provide a snap-fit connection between the shroud module and the cushion module (e.g., using snap fingers) to ensure that the collar and cushion member are fully attached and correctly aligned. Ex. 1312 108; Ex. 1310 at col. 5:14 19. A skilled artisan would have appreciated that 44
snap fingers would facilitate deformation of the engagement parts and make it easier to join the shroud to the cushion module. Ex. 1312 108. Based on the teachings of Matula-II, a skilled artisan would have understood that it would be advantageous to provide a plurality of snap-fit fingers on the shroud module of Matula-II to facilitate a snap-fit engagement with the cushion module. Id. D. Ground 3: Claims 13, 14 and 18 would have been obvious over Matula-I in view of Ogden, Gunaratnam-I, and Lovell 1. Overview of Lovell (Ex. 1311) Lovell was submitted during the prosecution of the 931 Patent, but was not cited by the Examiner. Ex. 1301 at 5. Lovell discloses CPAP mask assemblies that include a nasal mask 201 having a retainer 212 and a shell 204. Ex. 1311 at col. 1:5 8, 9:43 64. The retainer 212 is disposed about the inlet 208 of the shell 204 to facilitate retention of the mask 201 on the user. Id. at col. 9:43 44. 45
2. Potential Differences from Prior Art a. elbow module comprises polycarbonate Claim 13 depends from Claim 11 and recites, the elbow module comprises polycarbonate. Matula-I discloses an elbow, but does not expressly disclose a polycarbonate elbow. However, Lovell specifically discloses a polycarbonate elbow and it was common to use polycarbonate for different parts of mask assemblies. See Ex. 1311 at col. 1:5 8, 5:33 35; Ex. 1312 114. b. elbow module and shroud module are directly connected with a mechanical interlock while allowing 360 degree rotation of the elbow module Dependent Claims 14 depends from Claim 11 and includes the elbow module and shroud module are directly connected with a mechanical interlock while allowing 360 degree rotation of the elbow module. Matula-I discloses an 46
elbow that is directly and rotatably connected to the shroud, but does not expressly disclose that the elbow can rotate 360. However, as taught by Lovell, it was wellknown at the time of the invention to provide an elbow that rotates 360. See Ex. 1311 at col. 5:16 26; Ex. 1312 115 116. c. the shroud module and the frame comprise polycarbonate Claim 18 depends from Claim 1 and includes the shroud module and the frame comprise polycarbonate. Matula-I does not expressly disclose that the shroud module and frame comprise polycarbonate. However, it was well-known at the time of the invention to construct CPAP components, including the shroud from polycarbonate. Ex. 1312 117. For example, Lovell discloses that the shroud 212 can be constructed from a polycarbonate material. Ex. 1311 at col. 6:13 14. Similarly, Gunaratnam-I discloses that the frame may be constructed from a material such as polycarbonate, and clip is conducted [sic] from polycarbonate. Ex. 1303 at col. 1:34 39, 5:33 34. 3. Reasons to Combine A person of skill in the art at the time of the invention would have been motivated to combine the features of Matula-I, Ogden, Gunaratnam-I, and Lovell 47
to arrive at the claimed mask systems of Claims 13, 14, and 18 for at least the reasons provided above. Ex. 1312 118; see supra VII(B)(5). A skilled artisan would have been motivated to make the elbow rotatable over a 360 range as taught by Lovell to allow the wearer to position the tubing to provide the most convenient, comfortable, and low force mask connection. Ex. 1311 at col 5:16 26; Ex. 1312 119. Further, it was well-known at the time of the invention to construct CPAP mask components, including the shroud, frame, and elbow from polycarbonate to provide strength, rigidity, and toughness to support the headgear. Ex. 1312 120 121. Additionally, polycarbonate CPAP components can be cleaned, disinfected, and/or sterilized by most commonly used methods. Id. E. Ground 4: Claims 28 30 would have been obvious over Matula-I in view of Ogden, Gunaratnam-I, Matula-II, and Lovell 1. Potential Differences from Prior Art and Reasons to Combine Claim 28 depends from Claim 1 and Claims 29 30 depend from Claim 28. As detailed in the Claim Chart below, Matula-I discloses nearly all of the limitations of Claims 28 30. Any differences were well-known at the time of the invention and taught by other CPAP prior art. Ex. 1312 122. For example, as discussed above, the combination of Matula-I, Ogden, Gunaratnam-I, Matula-II, and Lovell teaches each of the features recited in Claims 48
28 30. See supra VII(B)(4)(e) (f), VII(C)(2)(b) (d), and VII(D)(2)(b) (c). A person of skill in the art at the time of the invention would have been motivated to combine the features of Matula-I, Ogden, Gunaratnam-I, Matula-II, and Lovell to arrive at the claimed mask system features of Claims 28 30 for at least the reasons provided above. Ex. 1312 122; see supra VII(B)(5), VII(C)(3), and VII(D)(3). Moreover, combining these features would have been a mere combination of familiar elements according to known methods that does no more than yield predictable results. KSR, 550 U.S. at 416. F. Ground 5: Claim 15 would have been obvious over Matula-I in view of Ogden, Gunaratnam-I, and Worboys 1. Overview of Worboys (Ex. 1306) Worboys is a ResMed application and was not submitted or cited by the Examiner during the prosecution of the 931 Patent. See Ex. 1301 at 1 9. Worboys discloses respiratory mask elbow assembly 5 connected to an air delivery tube with a swivel joint. Ex. 1306 104 105. 49
As shown in Figure 1 (above), Worboys discloses a respiratory mask elbow 10 having an anti-asphyxia valve (AAV) assembly 15. Id. 106. As shown in Figure 2 of Worboys (below), AAV assembly 15 includes a flap portion 45 that selectively closes port 40. Id. 50
2. Potential Differences from Prior Art a. anti-asphyxia valve Claim 15 depends from Claim 11 and includes the elbow module includes an anti-asphyxia valve and wherein the anti-asphyxia valve includes a flap portion adapted to selectively close a port provided in the elbow module. Matula-I discloses an elbow, but does not expressly disclose that the elbow includes an antiasphyxia valve including a flap portion. Ex. 1312 at 124. However, such valve assemblies in CPAP elbows were well-known prior to the 931 Patent. Id. As shown in Figures 1 2 (above), Worboys discloses an AAV assembly 15 located in the elbow 10 and includes a flap portion 45 that selectively closes port 40. Ex. 1306 106. 3. Reasons to Combine A person of skill in the art at the time of the invention would have been motivated to combine the features of Matula-I, Ogden, Gunaratnam-I, and Worboys to arrive at the claimed mask system of Claim 15 for at least the reasons provided above. Ex. 1312 126; see supra VII(B)(5). A skilled artisan would have known to provide the anti-asphyxia valve of Worboys to the Matula-I elbow to provide breathable fresh air when the flow generator does not provide flow. Ex. 1306 4; Ex. 1312 126. A skilled artisan would have understood that an anti-asphyxia valve using a flap is advantageous because the flap easily moves by airflow and pressure. See Ex. 1312 127. 51
G. Ground 6: Claims 16 and 17 would have been obvious over Matula-I in view of Ogden, Gunaratnam-I, and Barnett 1. Overview of Barnett (Ex. 1309) Barnett was submitted during the prosecution of the 931 Patent, but was not specifically cited by the Examiner. Ex. 1301 at 5. Barnett discloses nasal CPAP mask assemblies having a seal member 32 that contacts the patient s face and a collar 34 that is fixed and not movable relative to the seal member 32. Ex. 1309 at col. 3:48 52. 52
Additionally, Barnett discloses multiple seal members 32, 32 that differ in the contour of the first end portion, size, and shape to accommodate different patient populations. Id. at col. 6:1 4, 5:52 67. The different seal members 32, 32 can be used in conjunction with a commonly sized collar 34 and conduit coupling member 36. Id. at col. 6:9 13. 2. Potential Differences from Prior Art a. at least first and second cushion modules Claim 16 depends from Claim 1 and includes the cushion module includes at least first and second cushion modules adapted to be provided to the shroud module, said at least first and second cushion modules being different from one another in at least one aspect. Matula-I does not expressly disclose this feature, but as described above, Barnett discloses different sized cushion modules 32, 32' to accommodate different patient populations. Ex. 1309 at col. 6:1 4, 5:52 67; Ex. 53
1312 130. The cushions 32, 32' are configured for use with the same shroud 34 and elbow 36. Ex. 1309 at col. 6:1 14. b. a small cushion module, a medium cushion module and a large cushion module Claim 17 depends from Claim 1 and includes a small cushion module, a medium cushion module and a large cushion module, wherein each of said small cushion module, said medium cushion module and said large cushion module is removably coupleable to the same shroud module. As explained above, Barnett discloses different sized cushion modules 32, 32' configured for use with a common shroud 34 and elbow 36. Ex. 1309 at col. 6:1 14. Barnett discloses larger cushion modules for larger adult patients and smaller cushion modules for small adults and children. Id. at col. 6:1 14, 5:52 67. A person of skill in the art would have known to provide various different sized cushion modules, including small, medium, and large. Ex. 1312 132. 3. Reasons to Combine A person of skill in the art at the time of the invention would have been motivated to combine the features of Matula-I, Ogden, Gunaratnam-I, and Barnett to arrive at the claimed mask systems of Claims 16 and 17 for at least the reasons provided above. Ex. 1312 133; see supra VII(B)(5). 54
A person of skill in the art would have been motivated to provide differentsized, interchangeable cushions (e.g., small, medium, and large) for different-sized patient populations. Ex. 1309 at 6:1 14; Ex. 1312 134 136. A skilled artisan would have recognized that providing different sized and interchangeable cushion modules to fit a common shroud module would reduce the number of components required (as compared to distinct shroud sizes to match distinct cushion module sizes). Ex. 1312 135 136. 55
H. Ground 7: Claims 19 22 and 25 of the 931 Patent would have been obvious over Matula-I in view of Ogden, Gunaratnam-I, and Gunaratnam-II 1. Overview of Gunaratnam-II (Ex. 1304) Gunaratnam-II is a ResMed publication that was cited by the Examiner during prosecution, but for a different feature. Ex. 1301 at 6. Top Straps Buckle Rear Straps Gunaratnam-II discloses a nasal assembly having a headgear assembly. Ex. 1304 at Abstract. As shown in Figure 38 (above), straps 392 split to form upper strap 398 and rear strap 399. Id. 263. Also, as shown in Figure 135 (above), Gunaratnam-II discloses side straps splitting into pairs of top and rear straps. Id. at Figure 135. The top straps are removably and adjustably coupled with a buckle. Id. 316. 56
2. Potential Differences from Prior Art As detailed in the Claim Chart below, Claim 19 depends from Claim 1 and recites various headgear features. Matula-I does not expressly disclose all of the headgear features recited in Claim 19 21, but Ogden and Gunaratnam-II specifically describe these features as outlined below. Claim 22 further includes the removably snap-fit feature recited in Claim 26, and Claim 25 includes the rigid frame feature recited in Claim 31. To the extent Matula-I provides insufficient teachings for these features, as described above, Ogden specifically teaches these features. See supra VII(B)(4)(b) (c), VII(B)(4)(g). a. a pair of upper straps and pair of lower straps Claim 19 includes the headgear includes a pair of upper straps and pair of lower straps. While Matula-I generally discloses the use of upper and lower headgear straps (Ex. 1302 4, 108), to the extent these limitations are not explicitly disclosed in Matula-I, they are disclosed in Ogden. Ex. 1312 141. 57
For example, Ogden discloses attaching the upper and lower headgear straps 13R, 13L, 15R, 15L to their respective headgear connectors 27, 29, 31. Ex. 1310 at col. 3:10 22. b. hook tab Claim 19 includes a free end of each of the upper straps and the lower straps includes a hook tab. Matula-I does not expressly disclose the use of a hook tab or Velcro on the free end of the headgear straps, but Velcro on headgear straps was common in prior art CPAP masks to allow for strap adjustment. Ex. 1312 145. For example, Ogden discloses that each of the straps 13R, 13L, 15R, 15L can be looped through its respective headgear connector 27, 29, 31 and fastened back on itself by hook 58
and loop material. Ex. 1310 at col. 3:13 17. To the extent there is insufficient teaching that the hook tabs are positioned at the free ends of the straps, such positioning would have been obvious to a person of skill and typical for headgear straps in the prior art. Ex. 1312 147. c. top straps Claim 19 includes the upper straps split to form a pair of top straps and a pair of rear straps and the top straps being connected together by a buckle and configured to pass over the top of the patient s head in use. Matula-I does not expressly disclose headgear having the upper straps split to form two pairs of straps, but they were known in the prior art. Ex. 1312 148. Top Straps Buckle Rear Straps For example, as shown above, Gunaratnam II specifically shows headgear straps splitting to form a pair of top and rear straps. Ex. 1304 at Fig. 135. 59
Regarding the buckle, Gunaratnam II also discloses a pair of top straps removably and adjustably threaded through a buckle, as shown above. Id. 316. d. rear straps Claim 19 includes rear straps being adapted to pass behind the patient s head in use. Claim 21 depends from Claim 19 and includes the rear straps and the top straps form a closed loop to encircle a rear portion of the patient's head when in use. Matula-I does not expressly disclose these features, but as shown below, Gunaratnam-II shows the rear straps and the top straps forming a closed loop. Ex. 1304 263; Ex. 1312 151. Closed Loop e. upper straps provide padding Claim 20 depends from Claim 19 and recites that the the upper straps provide padding to the respective headgear connectors of the shroud module on the patient s face during use. Matula-I does not expressly disclose that the headgear 60
straps provide padding, but the use of padded straps was common in prior art CPAP masks. Ex. 1312 154. For example, Ogden discloses that the headgear straps are preferably made of flexible material and may have some slight elasticity to them to comfortably fit about the patient s head. Ex. 1310 at col. 3:22 24. Additionally, as shown below, each upper headgear strap 15R, 15L is looped around its respective headgear connector 27, such that a portion of each strap is on a patient-facing side of its respective headgear connector. Id. at col. 2:62 col. 3:24. Thus, the upper headgear straps 15R, 15L provide padding between the headgear connectors and the patient s face. Ex. 1312 155. 61