IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`In re Patent of: McAuley, et al.
`U.S. Patent No.: 8,479,741 Attorney Docket No.: 36784-0043IP1
`Issue Date:
` July 9, 2013
`Appl. Serial No.: 12/353,640
`Filing Date:
` January 14, 2009
`Title:
`BREATHING ASSISTANCE APPARATUS
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`PETITION FOR INTER PARTES REVIEW
`OF UNITED STATES PATENT NO. 8,479,741
`PURSUANT TO 35 U.S.C. §§ 311–19, 37 C.F.R. § 42
`
`
`
`
`
`
`
`
`In re Patent of: McAuley, et al.
`U.S. Patent No.: 8,479,741 Attorney Docket No.: 36784-0043IP1
`Issue Date:
` July 9, 2013
`Appl. Serial No.: 12/353,640
`Filing Date:
` January 14, 2009
`Title:
`BREATHING ASSISTANCE APPARATUS
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`PETITION FOR INTER PARTES REVIEW
`OF UNITED STATES PATENT NO. 8,479,741
`PURSUANT TO 35 U.S.C. §§ 311–19, 37 C.F.R. § 42
`
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`
`
`
`
`V.
`
`Page
`INTRODUCTION ........................................................................................... 1
`I.
`II. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8 ................................... 1
`Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1) ............................ 1
`
`Related Matters Under 37 C.F.R. § 42.8(b)(2) ..................................... 1
`Lead And Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3) ................. 2
`Service Information ............................................................................... 3
`
`PAYMENT OF FEES – 37 C.F.R. § 42.103 ................................................... 3
`III.
`IV. REQUIREMENTS FOR IPR UNDER 37 C.F.R. § 42.104 ............................ 3
` Grounds for Standing Under 37 C.F.R. § 42.104(a) ............................. 3
`Challenge Under 37 C.F.R. § 42.104(b) and Relief Requested ............ 3
`
`BACKGROUND: ’741 PATENT AND PROSECUTION HISTORY ......... 4
`Primary features of the patient interface in the ’741 patent .................. 5
`
`The ’741 Patent’s Prosecution History ................................................. 7
`Person of Ordinary Skill in the Art ..................................................... 10
`
`VI. CLAIM CONSTRUCTION UNDER 37 C.F.R. § 42.104(B)(3) .................. 10
`The phrase “the mask base comprising a housing that defines a
`
`through passage” (claim 1) .................................................................. 11
`VII. THE CHALLENGED CLAIMS ARE UNPATENTABLE AS OBVIOUS. 13
` Ground 1 – Claims 1, 21-24, 27-31, and 33-34 Are Unpatentable Over
`Gunaratnam in view of Ging ............................................................... 16
`Ground 2 – Claim 25 is Unpatentable Over Gunaratnam in View of
`Ging and Kopala .................................................................................. 51
`VIII. CONCLUSION .............................................................................................. 53
`
`
`
`
`
`
`
`
`
`
`i
`
`
`
`EXHIBIT LIST
`
`
`
`EX. #
`RMD1001
`
`Exhibit Description
`U.S. Patent No. 8,443,807 to McAuley et al. (“the ’807 patent”)
`
`RMD1002
`
`U.S. Patent No. 8,479,741 to McAuley et al. (“the ’741 patent”)
`
`RMD1003
`
`[RESERVED]
`
`RMD1004
`
`RMD1005
`
`U.S. Patent Application Publication No. 2004/0226566 to
`Gunaratnam et al. (“Gunaratnam”)
`
`U.S. Patent Application Publication No. 2003/0196658 to Ging et al.
`(“Ging”)
`
`RMD1006
`
`[RESERVED]
`
`RMD1007
`
` U.S. Patent No. 6,691,707 to Gunaratnam et al. (“the ’707 patent” or
`“Gunaratnam II”)
`
`RMD1008
`
`Declaration of Dr. John Izuchukwu, Ph.D., P.E. (“Izuchukwu Decl.”)
`
`RMD1009
`
`File History of U.S. Patent No. 8,443,807 to McAuley et al.
`
`RMD1010
`
`File History of U.S. Patent No. 8,479,741 to McAuley et al.
`
`RMD1011
`
`[RESERVED]
`
`RMD1012
`
`U.S. Patent No. 7,219,669 to Lovell et al. (“Lovell”)
`
`RMD1013
`
`RMD1014
`
`The American Heritage Dictionary of the English Language, Fourth
`Edition (2006) (selected portions)
`
`Merriam-Webster’s Collegiate Dictionary, Eleventh Edition (2004)
`(selected portions)
`
`RMD1015
`
`U.S. Patent No. 4,944,310 to Sullivan (“Sullivan”)
`
`RMD1016
`
`U.S. Patent 4,676,241 to Webb
`
`RMD1017
`
`[RESERVED]
`
`RMD1018
`
`PCT Publication No. WO 2004/022147 to Drew
`
`
`
`ii
`
`
`
`EXHIBIT LIST
`
`
`
`RMD1019
`
`U.S. Patent No. 4,782,832 to Trimble et al. (“Trimble” or “’832
`Patent”)
`
`RMD1020
`
`U.S. Patent No. 6,431,172 to Bordewick
`
`RMD1021
`
`U.S. Patent 6,192,886 to Rudolph
`
`RMD1022
`
`U.S. Patent 6,581,594 to Drew
`
`RMD1023
`
`PCT Publication No. WO 2008/007985 to McAuley
`
`RMD1024
`
`ResMed “Mirage Vista™ Nasal Mask: Components Card”
`publication, ©2005 ResMed Ltd.
`
`RMD1025
`
`U.S. Patent 4,919,128 to Kopala
`
`RMD1026
`
`[RESERVED]
`
`RMD1027
`
`[RESERVED]
`
`RMD1028
`
`PCT Publication No. WO2004/073778 to Gunaratnam et al.
`
`RMD1029
`
`PCT Publication No. WO2004/041341 to Amarasinghe
`(“Amarasinghe”)
`
`RMD1030
`
`U.S. Patent No. 6,907,882 to Ging et al.
`
`RMD1031
`
`[RESERVED]
`
`RMD1032
`
`RMD1033
`
`ACP Composites Core Materials & Foam Webpage, available at
`https://www.acpsales.com/Core-Materials-and-Foam.html (October
`5, 2015)
`
`Fibre Glast Developments Corp. Guidelines for Sandwich Core
`Materials, available at
`http://www.fibreglast.com/product/guidelines-for-sandwich-core-
`materials/Learning_Center, (October 5, 2015)
`
`RMD1034
`
`PCT Pub. WO 2005/079726 to McAuley et al. (“McAuley”)
`
`
`
`iii
`
`
`
`EXHIBIT LIST
`
`
`
`RMD1035
`
`RMD1036
`
`ResMed “Mirage Swift™ Nasal Pillows System from ResMed”
`publication, ©2004 ResMed Ltd.
`
`ResMed “Mirage Swift™ Nasal Pillows System: User’s Guide”
`publication, ©2004 ResMed Ltd.
`
`RMD1037
`
`U.S. Patent No. 7,178,528 (“Lau”)
`
`WeddingBands.com – Men’s Wedding Ring Shopping Page
`(Retrieved October 16, 2015 from
`http://www.weddingbands.com/ProductPop_wedding_bands_metal/4
`8214W.html)
`
`HomeDepot.com – Ring Nut Sales Page (Retrieved October 16, 2015
`from http://www.homedepot.com/p/Everbilt-1-2-in-Galvanized-Hex-
`Nut-804076/204647893)
`
`ResMed Origins Brochure (Retrieved April 17, 2016 from
`http://www.resmed.com/us/dam/documents/articles/resmed-
`origins.pdf)
`
`Statutory Declaration made by Alistair Edwin McAuley, Apr. 9,
`2015, in the matter of an Opposition by Fisher & Paykel Healthcare
`Limited of Australian patent application 2009221630 in the name of
`ResMed Limited
`
`Patent Owner’s Complaint for Fisher & Paykel Healthcare Ltd. v.
`ResMed Corp., Case No. 3:16-cv-02068-GPC-WVG (S.D. Cal.)
`
`Patent Owner’s Complaint for Fisher & Paykel Healthcare Ltd. v.
`ResMed Corp., Case No. 2:16-cv-06099-R-AJW (C.D. Cal.)
`
`Patent Owner’s Notice of Voluntary Dismissal Without Prejudice for
`Fisher & Paykel Healthcare Ltd. v. ResMed Corp., Case No. 2:16-
`cv-06099-R-AJW (C.D. Cal.)
`
`Petitioners’ Complaint for ResMed Inc., et al. v. Fisher & Paykel
`Healthcare Corp. Ltd., et al., Case No. 3:16-cv-02072-JAH-MDD
`(S.D. Cal.)
`
`iv
`
`RMD1038
`
`RMD1039
`
`RMD1040
`
`RMD1041
`
`RMD1042
`
`RMD1043
`
`RMD1044
`
`RMD1045
`
`
`
`
`
`EXHIBIT LIST
`
`
`
`RMD1046
`
`Petitioners’ Notice of Voluntary Dismissal Without Prejudice for
`ResMed Inc., et al. v. Fisher & Paykel Healthcare Corp. Ltd., et al.,
`Case No. 3:16-cv-02072-JAH-MDD (S.D. Cal.)
`
`
`
`v
`
`
`
`
`
`I.
`
`INTRODUCTION
`
`ResMed Inc., ResMed Corp, and ResMed Limited (collectively “ResMed”
`
`or “Petitioners”) petition for inter partes review (“IPR”) under 35 U.S.C. §§ 311-
`
`19 and 37 C.F.R. § 42 of claims 1, 21-25, 27-31, and 33-34 of U.S. Patent No.
`
`8,479,741, assigned to Fisher & Paykel Healthcare Limited (“F&P”).
`
`II. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8
`
` Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1)
`
`ResMed Limited, ResMed Inc. and ResMed Corp are the Real Parties-in-
`
`Interest.
`
` Related Matters Under 37 C.F.R. § 42.8(b)(2)
`
`ResMed Corp is currently a defendant in a pending litigation in the Southern
`
`District of California involving the ’741 patent. See Fisher & Paykel Healthcare
`
`Ltd. v. ResMed Corp., Case No. 3:16-cv-02068-GPC-WVG (S.D. Cal.). Patent
`
`Owner filed the complaint in this case on August 16, 2016, and alleges that
`
`ResMed infringes the ’741 patent. RMD1042.
`
`On August 15, 2016, Patent Owner both filed and dismissed (without
`
`prejudice) a complaint in the Central District of California also alleging that
`
`ResMed infringes the ’741 patent. RMD1043; RMD1044.
`
`Petitioners have also filed and dismissed (without prejudice) a complaint
`
`related to the ’741 patent. On August 16, 2016, Petitioners filed a complaint in the
`
`
`
`1
`
`
`
`
`
`Southern District of California alleging infringement of several patents held by
`
`Petitioners, and seeking declaratory judgment on non-infringement and invalidity
`
`of the ’741 patent. RMD1045. Petitioners voluntarily dismissed this complaint
`
`without prejudice on August 18, 2016. RMD1046.
`
`Petitioners’ withdrawn action for declaratory judgment regarding the
`
`invalidity of the ’741 patent has no effect under 35 U.S.C. § 315(a) because it was
`
`voluntarily dismissed without prejudice. See Macuato U.S.A. v. BOS GmbH &
`
`KG, IPR2012-00004, Paper No. 18 at pp. 15-16 (PTAB Jan. 24, 2013); see also
`
`Oracle Corp., et al. v. Click-to-Call Techs. LP, IPR2013-00312, Paper No. 52 at
`
`pp. 12-13 (PTAB Oct. 28, 2014). Additionally, Patent Owner’s pending suit
`
`against Petitioners regarding the ’741 patent has no effect under 35 U.S.C. §
`
`315(b) since it was filed less than a year ago.
`
`Petitioners are also seeking IPR of claims 2-4, 6-10, 12-17, 19-20, and 35 of
`
`the ‘741 patent in a separate petition, in addition to petitions challenging the ’807
`
`patent. The ’741 patent issued from a continuation application to the ’807 patent.
`
` Lead And Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3)
`
`Petitioners provide the following designation of counsel.
`
`
`
`2
`
`
`
`
`
`LEAD COUNSEL
`Stephen R. Schaefer, Reg. No. 37,927
`3200 RBC Plaza, 60 South Sixth Street
`Minneapolis, MN 55402
`Tel: 612-337-2508 / Fax 612-288-9696
`schaefer@fr.com
`
`
`BACK-UP COUNSEL
`Michael J. Kane, Reg. No. 39,722
`3200 RBC Plaza, 60 South Sixth Street
`Minneapolis, MN 55402
`Tel: 612-337-2502 / Fax: 612-337-9696
`kane@fr.com
`
`Service Information
`
`
`Petitioners consent to electronic service by email at IPR36784-
`
`0043IP1@fr.com and PTABInbound@fr.com (cc’ing schaefer@fr.com and
`
`kane@fr.com).
`
`III. PAYMENT OF FEES – 37 C.F.R. § 42.103
`
`Petitioners authorize charging Deposit Account 06-1050 for the petition fee
`
`specified in 37 C.F.R. § 42.15(a) and for any other required fees.
`
`IV. REQUIREMENTS FOR IPR UNDER 37 C.F.R. § 42.104
`
` Grounds for Standing Under 37 C.F.R. § 42.104(a)
`
`Petitioners certify that the ’741 patent is available for IPR and that
`
`Petitioners are not barred or estopped from requesting IPR.
`
` Challenge Under 37 C.F.R. § 42.104(b) and Relief Requested
`
`Petitioners request IPR of claims 1, 21-25, 27-31, and 33-34 on the grounds
`
`listed in the table below. These references and other evidence cited in this Petition
`
`including testimony of expert Dr. John Izuchukwu, Ph.D. (RMD1008) demonstrate
`
`invalidity of the claims.
`
`
`
`3
`
`
`
`
`
`Basis for Rejection
`§ 103 – Gunaratnam, Ging
`
`Claims
`Ground
`Ground 1 1, 21-24, 27-
`31, and 33-34
`Ground 2 25
`§ 103 – Gunaratnam, Ging, Kopala
`Gunaratnam (RMD1004) published in November 2004, and is therefore
`
`
`
`prior art to the ’741 patent under at least pre-AIA 35 U.S.C. § 102(b).
`
`
`
`Ging (RMD1005) published in October 2003, and is therefore prior art under
`
`at least pre-AIA 35 U.S.C. § 102(b).
`
`
`
`Kopala (RMD1025) issued in April 1990, and is therefore prior art under at
`
`least pre-AIA 35 U.S.C. § 102(b).
`
`V. BACKGROUND: ’741 PATENT AND PROSECUTION HISTORY
`The ’741 patent relates to continuous positive airway pressure (“CPAP”)
`
`treatment for obstructive sleep apnea (“OSA”). See, e.g., RMD1002 at 1:29-60.
`
`Specifically, the ’741 patent relates to CPAP “patient interfaces,” including
`
`headgear that holds a CPAP mask against the patient’s face. See id. at 1:61-2:37,
`
`2:62-3:33.
`
`As background, CPAP therapy delivers pressurized air to a patient’s airway
`
`to help keep the patient’s airway open. RMD1008 at ¶ 22. The idea of using
`
`CPAP therapy to treat OSA was invented nearly thirty-five years ago in June 1980
`
`by Dr. Colin Sullivan, whose early inventions formed the basis of Petitioner’s
`
`business. RMD1008 at ¶ 22; RMD1040. As was well-known, a CPAP system has
`
`
`
`4
`
`
`
`
`
`three main parts: a mask that delivers pressurized air to the mouth and/or nose; a
`
`tube that connects the mask to a motor; and a motor that blows air into the tube.
`
`See, e.g., RMD1015 at 2:9-54; RMD1005 at ¶¶ 3-5. Different styles of masks are
`
`used in CPAP therapy, such as full face masks that cover the mouth and nose, nasal
`
`masks to cover the nose but not the mouth, and “nasal pillows” masks with two
`
`nozzles that extend into the patient’s nares (nostrils). See generally RMD1005 at ¶
`
`5.
`
`The ’741 patent generally describes that patient discomfort is a disadvantage
`
`of prior art masks; however it is unclear what, if any, feature(s) in the ’741 patent
`
`were new and overcame discomfort. See generally RMD1002 at 1:56-2:40, 2:58-
`
`61. Though it is unclear, the inventors seemed to believe that headgear with a
`
`“continuous and substantially elongate member” addressed discomfort. See
`
`RMD1002 at Abstract. That feature, however, is not present in the ‘741 patent
`
`claims.
`
`Primary features of the patient interface in the ’741 patent
`
`
`The ’741 patent describes a headgear design for several known CPAP mask
`
`types. For example, the headgear design can be used for nasal pillow masks that
`
`leave the mouth uncovered (Figures 2-8 and 20-22) or cover the mouth (Figures 9-
`
`10); mouth-only masks (Figures 11-14); “full face” masks that cover the mouth
`
`and nose (Figure 15); and integral mouth and nasal pillows masks (Figures 16-17).
`
`
`
`5
`
`
`
`In all of the embodiments, the common headgear is shown in Figures 2 and 3.
`
`
`
`
`
`The headgear assembly 21 includes a continuous and substantially curved elongate
`
`member 34 that extends below a user’s nose, and also two headgear side straps 37,
`
`38 that attach to the ends, or arms 41, of the curved elongate member 34. See
`
`RMD1002 at Abstract, 6:61-65, 7:8-11. The side straps 37, 38 connect to two
`
`other straps – a top strap 35 and a back strap 36. RMD1002 at Fig. 3, 7:1-4. The
`
`’741 patent’s background discussion of prior art, however, acknowledges that
`
`headgear with side arms and side straps was known. Indeed, the references cited in
`
`the background are even Petitioner’s own references. See RMD1002 at 2:49-58
`
`(citing RMD1028, RMD1029, and RMD1030).
`
`
`
`The mask – which in Figure 3 includes a mask body 23 with two nasal
`
`pillows and a mask base 22 – is supported by the curved elongate member’s central
`
`
`
`6
`
`
`
`
`
`section 42 where the base 22 of the mask slides into and attaches to the central
`
`section 42. RMD1002 at 7:50-59. Although the ’741 patent describes several
`
`different mask types, independent claim 1 is limited to one type of mask – a nasal
`
`pillows mask that leaves the mouth uncovered. RMD1002 at 11:32-33, 12:5. Such
`
`nasal pillows masks, however, date back to the 1980s, having been introduced not
`
`long after Dr. Sullivan invented the use of CPAP for OSA. See, e.g., RMD1019 at
`
`Figs. 1, 2, and 9; see also generally RMD1020, RMD1012.
`
`
`
`The ’741 Patent’s Prosecution History
`
`
`The application that matured into the ‘741 patent was filed in January 2009
`
`with claims only nine lines long. RMD1010 at 94. That application was a
`
`continuation from a patent application that eventually matured into the ’807 patent
`
`(RMD1001), the prosecution history of which is shown in Exhibit 1009
`
`(RMD1009). Almost three years after the ’741 patent application was filed,
`
`Applicant cancelled the original claim set in a November 2011 preliminary
`
`amendment and filed a new claim set with claims that were twenty-five lines long.
`
`The new set of claims included two independent claims (claims 30 and 31).
`
`The office presented a single office action in July 2012 that rejected independent
`
`claims 30 and 31 with a double patenting rejection over the’807 patent application.
`
`There were no other rejections for independent claim 30. Id. The office action
`
`rejected independent claim 31 over Lovell (US 7,210,481) in view of Gunaratnam
`
`
`
`7
`
`
`
`
`
`(US 2004/0226566). RMD1010 at 466-471. The Examiner argued that it would
`
`have been obvious to modify Lovell’s nasal mask to have a pair of molded side
`
`arms, as disclosed by Gunaratnam. RMD1010 at 468-69.
`
`In a December 2012 response, Applicant made no substantive amendments
`
`to independent claim 30 (issued claim 1), and amended claim 31 (issued claim 2)
`
`to add the following three features:
`
` “a plane substantially bisecting the ring, each of the two nasal
`pillows positioned on opposite sides of the plan”
`
`
`
` “wherein the molded side arms overlap the side straps and the side
`straps are made from a soft foam material, and wherein the side straps
`overlap the molded side arms on a portion of the molded side arms
`that is spaced from the ring, the side straps extending away from the
`ring along the molded side arms”
`
`
`
` “wherein the ring is configured to connect to only two molded side
`arms and wherein each of the two molded side arms is configured to
`connect with a single side strap”
`
`RMD1010 at 494-95. Applicant’s response, however, only addressed the last
`
`limitation (the ring limitation), and argued that Lovell discloses a mask that is
`
`connected to four side straps (rather than “only two” as required by the claim
`
`amendment). RMD1010 at 499-500. Applicant asserted – without any evidence –
`
`
`
`8
`
`
`
`
`
`that removing two of Lovell’s straps would prevent the mask from being securely
`
`positioned, and would require substantial reconstruction and redesign. RMD1010
`
`at 499-500. Applicant did not address the Examiner’s contention that it would
`
`have been obvious to modify Lovell to include Gunaratnam’s molded side arms.
`
`Following Applicant’s amendments, the Examiner issued a March 2013
`
`Notice of Allowance. RMD1010 at 508. The Examiner stated that the claims were
`
`allowable because “none of the prior art . . . teach a patient interface including the
`
`feature of a first and second side arms that are three dimensionally molded and
`
`having a varying cross-sectional thickness that overlap with a first and second side
`
`strap of headgear, as claimed.” RMD1010 at 514.
`
`
`
`Applicant filed a June 2013 statement that took issue with the reasons for
`
`allowance arguing generally that a combination of features in the claims were not
`
`in the prior art, perhaps because Applicant may have been aware that three
`
`dimensionally molded side arms with varying cross-sectional thickness that
`
`overlap side straps of a headgear were well known. RMD1010 at 523-24. As will
`
`be explained further below, Applicant’s concerns in its June 2013 statement were
`
`well-founded. Side arms that are three dimensionally molded, with varying cross-
`
`sectional thickness and that overlap with headgear straps were well-established in
`
`the prior art before the purported inventions of the ’741 patent. In fact, every claim
`
`limitation in the ’741 patent is present in Gunaratnam and Ging, and it would have
`
`
`
`9
`
`
`
`
`
`been a trivial exercise to combine the teachings of these references to arrive at the
`
`’741 patent claims.
`
`Person of Ordinary Skill in the Art
`
`
`In view of the subject matter of the ’741 patent, a person of ordinary skill in
`
`the art as of any of the claimed priority dates (as early as July 2006) would have
`
`had a bachelor’s degree in mechanical engineering, biomedical engineering, or a
`
`related discipline, and at least five years of relevant product design experience in
`
`the field of medical devices or respiratory therapy, or an equivalent advanced
`
`education. See RMD1008 at ¶ 17. This level of knowledge and skill is applied
`
`throughout the Petition.
`
`VI. CLAIM CONSTRUCTION UNDER 37 C.F.R. § 42.104(B)(3)
`
`For inter partes review, a claim in an unexpired patent is given its broadest
`
`reasonable construction in light of the specification in which it appears. 37 C.F.R.
`
`§ 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142-46 (2016).
`
`Claim terms are given their ordinary and customary meaning, as would be
`
`understood by one of ordinary skill in the art in the context of the entire disclosure.
`
`In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). The
`
`constructions offered below are intended to aid this proceeding, and do not waive
`
`any arguments concerning indefiniteness or claim breadth in proceedings applying
`
`different construction standards.
`
`
`
`10
`
`
`
`
`
` The phrase “the mask base comprising a housing that defines a
`through passage” (claim 1)
`
`Independent claim 1 of the ’741 patent recites a “mask base comprising a
`
`housing that defines a through passage.” This phrase should be construed to refer
`
`to a portion of the mask base that defines an opening or space through which
`
`something (e.g., pressurized gas or a swivel elbow) can pass. The claims
`
`themselves and the plain meaning of the term support this construction.
`
`The claims refer to the “through passage” in three instances. As noted
`
`above, claim 1 requires that the “mask base compris[e] a housing that defines a
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`through passage.” Claim 1 further recites that “a proximal portion of the through
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`passage [is] surrounded by a recess,” where “the recess of the mask base receiv[es]
`
`[a] generally tubular portion of [a] mask body that defines [a] mask body inlet
`
`opening.” Dependent claim 21 then adds that the patient interface of claim 1 may
`
`further comprise “an elbow releasably and rotatably engaged with the through
`
`passage of the mask base.” In short, the “through passage” is surrounded by a
`
`recess (claim 1) and is in some cases engaged by an elbow (claim 21).
`
`
`
`11
`
`
`
`
`
`There is no mention of the terms “housing” or “through passage” in the
`
`specification. Applicant instead appears to have used these terms to refer to
`
`structures of the mask base 22, depicted in Figures 4 and 5, for example. As can
`
`be seen from Figure 5 below, the mask base 22 includes a circular inner passage
`
`that the Applicant presumably believed to be a “through passage” as claimed. The
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`through passage is defined
`
`by walls and other
`
`structures of the mask base
`
`22 that are presumably the
`
`claimed “housing.” There
`
`is also a channel 45
`
`surrounding the through passage, which is presumably intended as the “recess” of
`
`claim 1. See RMD1002, ’741 Patent, 6:22-41, Figs. 4-5.
`
`A standard dictionary definition of “passage” also supports Petitioner’s
`
`construction. For example, Webster’s defines “passage” as a “road, path, channel,
`
`or course by which something passes.” RMD1014 at 4. It follows that the ’741
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`patent’s through passage provides a path for pressurized air to flow from the elbow
`
`on one side of the base 22 to the mask body 23 on the other side. See, e.g.,
`
`RMD1002 at Fig. 10. Nothing in the file history requires a narrower construction.
`
`
`
`12
`
`
`
`
`
`VII. THE CHALLENGED CLAIMS ARE UNPATENTABLE AS
`OBVIOUS.
`
`All of the claims are obvious over Gunaratnam in view of Ging, except for
`
`claim 25, which requires a third reference to describe an “offset” construction for
`
`nasal pillows.
`
`As previously described, the ’741 patent relates to masks and headgear that
`
`supply air to a patient’s airways at an air pressure that is higher than the ambient
`
`air pressure in order to keep the airways open, for example, as part of continuous
`
`positive airway pressure (CPAP) therapy to treat obstructive sleep apnea. The
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`claims are directed to a flexible mask body with nasal pillows that go in a patient’s
`
`nostrils, a rigid mask base to which the flexible mask body connects and which
`
`supplies the pressurized air to the flexible mask body, and headgear that retains the
`
`mask base (and thus the flexible mask body) positioned against a user’s nose.
`
`
`
`13
`
`
`
`
`
`
`
`This type of design is nothing new, and it is surely rendered obvious by the
`
`Gunaratnam reference in view of the Ging reference. Figure 135 of the
`
`Gunaratnam reference (assigned to ResMed Limited) shows an almost identical
`
`patient interface assembly. All that differs is that the design of Figure 135 has a
`
`flexible mask body that fits around the user’s nose rather than the claimed design
`
`in which each nostril has a separate pillow cushion, but several other figures in
`
`Gunaratnam show mask bodies with pillow cushions, and Gunaratnam explains
`
`that the different styles of mask bodies are interchangeable.
`
`
`
`Although Figure 135 of Gunaratnam generally discloses the claimed
`
`features, Gunaratnam is silent regarding some aspects of the Figure 135
`
`embodiment, such as whether the flexible mask body mates with the mask base by
`
`resting in a channel that surrounds the opening through which air is introduced into
`
`the mask body. Gunaratnam, however, explicitly states that the Figure 135
`
`embodiment is like ResMed’s VISTA mask, and that mask is described in further
`
`detail by Ging (indeed, both Gunaratnam and Ging are assigned to ResMed
`
`Limited, and Gunaratnam incorporates by reference the provisional applications
`
`that form the basis of Ging). Ging discloses an almost identical mask base and
`
`describes how the mask body mates with a channel in the mask base, where that
`
`channel surrounds the opening through which air is introduced to the mask base.
`
`
`
`14
`
`
`
`
`
`This Petition explains why and how a skilled artisan would have modified
`
`Gunaratnam’s Figure 135 to include a nasal cushion mask body, and would have
`
`understood that structure to contain (or would have modified the structure to
`
`contain) a channel to accept the mask body. All in all, this Petition explains how
`
`the references disclose all features of the IPR claims, thus raising a reasonable
`
`likelihood of prevailing. Indeed, because the ’741 patent “‘simply arranges old
`
`elements with each performing the same function it had been known to perform’
`
`and yields no more than one would expect from such an arrangement, the
`
`combination is obvious.” KSR Int’l v. Teleflex Inc., 550 U.S. 398, 417 (2007)
`
`(citing Sakraida v. Ag Pro Inc., 425 U.S. 273 (1976)).
`
`
`
`15
`
`
`
`
`
` Ground 1 – Claims 1, 21-24, 27-31, and 33-34 Are Unpatentable
`Over Gunaratnam in view of Ging
`Claim 1: “A patient interface.” Gunaratnam discloses various designs for
`
`CPAP system “patient interfaces” (the portion of the CPAP system that interfaces
`
`with the patient), which all include mask assemblies and associated headgear
`
`assemblies applicable to nasal pillows type mask assemblies. See RMD1004,
`
`throughout.
`
`One patient interface design
`
`being relied upon is the patient
`
`interface design shown in Figure
`
`135 (showing a mask assembly
`
`with pressurized air provided to
`
`the mask assembly through a
`
`swivel elbow at the front of the
`
`mask assembly, a cushion that surrounds a user’s nose, and a headgear assembly
`
`having two side straps that connect to the sides of the mask assembly, a top strap,
`
`and a back strap).
`
`Additional patient interface design features being relied upon are shown in
`
`other figures. For example, Gunaratnam’s Figures 1-8, show that the interface
`
`design can include, instead of a cushion that surrounds a user’s nose, a nozzle
`
`
`
`16
`
`
`
`
`
`assembly 18 with nozzles 50 that go in a
`
`user’s nostrils. RMD1004 at ¶ 185.
`
`Specifically, nozzle assembly 18 includes “a
`
`base portion 48 and a pair of nozzles 50
`
`attached thereto,” as depicted in Figure 5.
`
`RMD1004 at ¶ 185 and Fig. 5.
`
`Gunaratnam further shows that a nasal
`
`pillows assembly, like that shown in Figures
`
`1-8, was used in a mask that had the air
`
`supplied through an elbow at the front of the mask, with side straps, a top strap,
`
`and a back strap (like the Figure 135
`
`embodiment) as illustrated by
`
`Gunaratnam’s Figure 107 (see RMD1004
`
`at ¶¶ 148 & 360) and Figures 107G-H (see
`
`RMD1004 at ¶¶ 157 & 369-370).
`
`
`
`17
`
`
`
`
`
`
`
`
`
`Ging is a reference whose three provisional applications are incorporated by
`
`reference in their entirety into Gunaratam (see Gunaratnam at ¶ 341) and that is
`
`commonly assigned to ResMed Limited. The Ging reference also relates to CPAP
`
`patient interface designs. See RMD1005 at ¶ 2; see also RMD1004 at ¶ 2. Ging
`
`discloses various designs for CPAP system patient interfaces, which all include
`
`mask assemblies and associated headgear assemblies. See RMD1005 throughout,
`
`including for example Figures 1 and 3 (shown below).
`
`
`
`18
`
`
`
`
`
`
`
`As will be discussed more below, Ging also discloses the details of an example
`
`swivel elbow design, how that swivel elbow is connected to the front of a mask
`
`assembly, and how the cushion mates with the mask assembly. These details and
`
`disclosures are inherent in the design of the Gunaratnam’s Figure 135 patient
`
`interface, or at least are obvious implementation details of the Figure 135 patient
`
`interface.
`
`
`
`19
`
`
`
`
`
`
`
`Limitation 1.2: “a mask body comprising a substantially flexible plastics
`
`material.” Gunaratnam’s Figure 135 embodiment has a flexible around-the-nose
`
`mask body. Further, and as described above, Gunaratnam describes various nasal
`
`pillows patient interface designs throughout the lengthy patent specification (for
`
`example, Figures 1, 5-8, 24-27, and 41-44), which include a mask body that
`
`comprises a substantially flexible plastics material. Although this claim limitation
`
`does not require that the mask body have nasal pillow cushions, other limitations
`
`require such features, and thus the description from here forward will refer to such
`
`a nasal pillow cushion mask body (and the reasons to include such a mask body in
`
`the Figure 135 embodiment).
`
`
`
`20
`
`
`
`
`
`As described throughout
`
`this document, a skilled artisan
`
`would have seen a reason to
`
`substitute the around-the-nose
`
`cushion that is shown in Figure
`
`135 with the nasal pillows cushion that is shown in Figures 1-8 and elsewhere,
`
`which include a mask body represented by flexible nozzle assembly 18.
`
`RMD1008 at ¶¶ 58-69 (discussing limitations 1.2 and 1.3). Indeed, long before the
`
`’741 patent, nasal pillows masks were well-known alternatives to full nasal masks.
`
`See, e.g., RMD1012; RMD1019;
`
`RMD1020; RMD1008 at ¶ 73. Doing so
`
`would have been nothing more than
`
`applying known teachings in a known way
`
`to achieve a predictable result. See id.; see
`
`also KSR Int'l Co. v. Teleflex Inc, 550 U.S.
`
`398, 416 (2007). Applying a known nasal
`
`pillows mask body to Gunaratnam’s
`
`Figure 135 patient interface yields a
`
`configuration shown to the side herein.
`
`
`
`21
`
`
`
`
`
`The obviousness of applying a known nasal pillows mask to Gunaratnam’s
`
`Figure 135 patient interface is supported by at least two reasons. First,
`
`Gunaratnam suggests it. In particular, Gunaratnam teaches the interchangeability
`
`of a nasal pillows type mask (shown for example in Figures 1-8, 107, and 107G-H
`
`of Gunaratnam) for the around-the-nose nasal mask assembly that is shown in
`
`Figure 135. Indeed, Gunaratnam expressly states that “the nozzle assembly and/or
`
`its associated cushion could be replaced with a nasal mask and/or nasal cushion.”
`
`RMD1004 at ¶ 403 (emphasis added). One of skill in the art would have
`
`understood that the statement in paragraph 403 of Gunaratnam explicitly suggests
`
`that the patient interface design shown in Figure 135 could alternatively employ
`
`(or be designed to employ) a nasal pillows type mask described previously in
`
`Gunaratnam (for example, in Figures 1-8 and 107G-H) instead of the nasal mask as
`
`shown in Figure 135. See also Izuchukwu Decl., RMD1008 at ¶¶ 63-69.
`
`Second, the interchangeability of a nasal pillows mask assembly for the
`
`nasal mask assembly as shown in Figure 135 is further illustrated by the fact that
`
`both the Figure 107G-H mask assembly design and the Figure 135 mask assembly
`
`design utilize an elbow connected at the front of the mask assembly, and that the
`
`Figure 107G-H mask assembly uses a nasal pillows mask assembly. See
`
`RMD1008 at ¶¶ 68-69; see also RMD1004 at Figure 108; RMD1035 at page 4;
`
`
`
`22
`
`
`
`RMD1036 at page 1 (nasal pillows masks with headgear similar to Gunaratnam
`
`Figure 135).
`
`
`
`
`
`Substantially flexible plastics material. With further reference to at least
`
`Figures 1 and 5, Gunaratnam states that “the nozzle assembly 18 includes a base
`
`portion 48 and a pair of nozzles 50 attached thereto.” RMD1004 at ¶ 185. The
`
`nozzle assembly 18 is described as comprising a substantially flexible plastics
`
`material. For example, Gunaratnam discusses that “the base portion 48 is
`
`structured such that it can expand and contract to alter a distance between the
`
`frame 16 and the pair of nozzles 50” and that “the central wall 54 [of nozzle
`
`assembly 18] is preferably made of a res
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