Filed: January 9, 2017
`
`
`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. IPR2017-00634
`U.S. Patent No. 8,944,061
`
`__________________________________
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. 8,944,061
`
`
`
`
`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: BoxFPH538-2@knobbe.com
`
`
`
`
`
`
`
`
`
`
`
`
`
`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. IPR2017-00634
`U.S. Patent No. 8,944,061
`
`__________________________________
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. 8,944,061
`
`
`
`
`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: BoxFPH538-2@knobbe.com
`
`
`
`
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`
`Page No.
`
`INTRODUCTION ........................................................................................... 1
`
`THIS PETITION IS NOT REDUNDANT UNDER
`35 U.S.C. § 325(D) .......................................................................................... 5
`
`I.
`
`II.
`
`III. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(a)(1) ......................... 7
`
`A.
`
`B.
`
`C.
`
`D.
`
`Real Party-in-Interest (37 C.F.R. § 42.8(b)(1)) ..................................... 7
`
`Related Matters Under 37 C.F.R. § 42.8(b)(2) ..................................... 7
`
`Lead and Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3) .................. 8
`
`Service Information Under 37 C.F.R. § 42.8(b)(4) ............................... 8
`
`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.
`
`Claims and Statutory Grounds (37 C.F.R. § 42.104(b)(1)
`& (b)(2)) ................................................................................................ 9
`
`1.
`
`2.
`
`Prior Art ...................................................................................... 9
`
`Ground ...................................................................................... 10
`
`C.
`
`Claim Construction ............................................................................. 11
`
`1.
`
`2.
`
`“annular connection adapted to engage an elbow”
`and “inlet elbow engages the second frame” ............................ 12
`
`“annular opening and the elbow are sealingly
`connected” ................................................................................. 14
`
`V.
`
`THE ’061 PATENT ....................................................................................... 16
`
`A.
`
`B.
`
`Example Embodiments ....................................................................... 16
`
`Summary of the Prosecution History of the ’061 Patent .................... 20
`
`-i-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`VI. LEVEL OF ORDINARY SKILL IN THE ART ........................................... 21
`
`VII. THE CHALLENGED CLAIMS OF THE ’061 PATENT ARE
`UNPATENTABLE ........................................................................................ 21
`
`A.
`
`B.
`
`Legal Standard for Obviousness ......................................................... 21
`
`Claims 17, 18, 20–23, 26–30, 32, 33, 35–38, 41–46, 48–
`50, and 81–91 Would Have Been Obvious Over Lovell in
`View of Gunaratnam and Gelinas ....................................................... 22
`
`1.
`
`2.
`
`3.
`
`4.
`
`Overview of Lovell (Ex. 1102) ................................................. 22
`
`Overview of Gunaratnam (Ex. 1103) ....................................... 25
`
`Overview of Gelinas (Ex. 1104) ............................................... 27
`
`Potential Differences and Reasons to Combine the
`Prior Art .................................................................................... 28
`
`a.
`
`b.
`
`c.
`
`d.
`
`e.
`
`f.
`
`g.
`
`h.
`
`seal around a patient’s nose and mouth .......................... 31
`
`cushion material more flexible than frame
`material ........................................................................... 34
`
`“forehead support” .......................................................... 35
`
`“clip attachments” ........................................................... 37
`
`“annular connection adapted to engage an
`elbow” or “elbow engages the second
`frame” ............................................................................. 40
`
`separate opening ............................................................. 44
`
`“first frame and the cushion are integrally
`molded” ........................................................................... 48
`
`“connecting members” or “frame members” ................. 50
`
`-ii-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`“opening is substantially triangular” .............................. 54
`
`“annular opening and the elbow are
`sealingly connected” ....................................................... 55
`
`i.
`
`j.
`
`k.
`
`“snap fit” ......................................................................... 59
`
`VIII. CLAIM CHARTS .......................................................................................... 62
`
`IX. SECONDARY CONSIDERATIONS, EVEN IF
`CONSIDERED, FAIL TO OVERCOME THE PRIMA FACIE
`EVIDENCE OF OBVIOUSNESS ................................................................ 97
`
`
`
`-iii-
`
`
`
`TABLE OF AUTHORITIES
`
`
`ABS Global Inc. v. XY, LLC,
`IPR2014-01161, Paper No. 9 ................................................................................ 7
`
`Page No(s).
`
`
`In re Bigio,
`381 F.3d 1320 (Fed. Cir. 2004) .......................................................................... 30
`
`In re Cuozzo Speed Techs., LLC,
`793 F.3d 1268 (Fed. Cir. 2015), aff’d, 136 S. Ct. 2131 (2016) .......................... 11
`
`Graham v. John Deere Co.,
`383 U.S. 1 (1966) ................................................................................................ 22
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .....................................................................................passim
`
`Leapfrog Enters., Inc. v. Fisher-Price, Inc.,
`485 F.3d 1157 (Fed. Cir. 2007) .......................................................................... 97
`
`Newell Cos. v. Kenney Mfg. Co.,
`864 F.2d 757 (Fed. Cir. 1988) ............................................................................ 97
`
`Wyers v. Master Lock Co.,
`616 F.3d 1231 (Fed. Cir. 2010) .......................................................................... 97
`
`OTHER AUTHORITIES
`
`35 U.S.C. § 102 ........................................................................................................ 10
`
`35 U.S.C. § 103 .................................................................................................. 10, 22
`
`35 U.S.C. §§ 311–319 ................................................................................................ 1
`
`35 U.S.C. § 325 .......................................................................................................... 5
`
`37 C.F.R. § 42.8 ..................................................................................................... 7, 8
`
`37 C.F.R. § 42.100 ............................................................................................... 1, 11
`
`37 C.F.R. § 42.104 ..................................................................................................... 9
`
`-iv-
`
`
`
`Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.
`IPR Petition - U.S. Patent No. 8,944,061
`EXHIBIT LIST
`
`Exhibit No.
`
`Description
`
`1101
`
`1102
`
`1103
`
`1104
`
`1105
`
`1106
`
`1107
`
`1108
`
`1109
`
`1110
`
`1111
`
`1112
`
`1113
`
`1114
`
`1115
`
`U.S. Patent No. 8,944,061
`
`U.S. Patent No. 6,631,718 (“Lovell”)
`
`U.S. Patent No. 6,796,308 (“Gunaratnam”)
`
`U.S. Publication No. 2003/0029454 (“Gelinas”)
`
`Declaration of Jason Eaton, P.E.
`
`Curriculum Vitae of Jason Eaton, P.E.
`
`Excerpts of the File History of U.S. Patent No. 8,944,061
`
`PCT Publication No. WO 2004/041342 (Berthon-Jones)
`
`U.S. Patent No. 5,662,101 (“Ogden”)
`
`Malloy, Robert A., Plastic Part Design for Injection Molding: An
`Introduction, pp. 336-345 (Hanser Gardner Publications, Inc.
`1994) (“Malloy”)
`
`U.S. Patent No. 6,412,488 (“Barnett”)
`
`U.S. Publication No. 2004/0118406 (“Lithgow”)
`
`U.S. Publication No. 2002/0020416 (“Namey”)
`
`U.S. Publication No. 2005/0155604 (“Ging”)
`
`Complaint for Patent Infringement, ResMed Inc. v. Fisher &
`Paykel Healthcare Corp. Ltd., et al., Case No. 3:16-cv-02072-
`JAH-MDD (S.D. Cal.)
`
`Exhibit List, Page 1
`
`
`
`Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.
`IPR Petition - U.S. Patent No. 8,944,061
`Exhibit No.
`
`Description
`
`1116
`
`Answer of ResMed Corp. to Complaint for Patent Infringement
`and Counterclaims, Fisher &Paykel Healthcare Ltd. v. ResMed
`Corp., Case No. 3:16-cv-02068-GPC-WVG (S.D. Cal.)
`
`Exhibit List, Page 2
`
`
`
`Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.
`IPR Petition - U.S. Patent No. 8,944,061
`
`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 17, 18, 20–23, 26–30, 32, 33, 35–38, 41–46, 48–50,
`
`and 81–91 (“Challenged Claims”) of U.S. Patent No. 8,944,061 (“the ’061 Patent”)
`
`(Ex. 1101), which is purportedly owned by ResMed Limited (“Patent Owner” or
`
`“ResMed”).
`
`I. INTRODUCTION
`
`For decades, face masks have been used to facilitate breathing by delivering
`
`gas to the wearer or protecting the wearer from inhaling harmful particles or gases.
`
`Such face masks can be used to deliver pressurized gas to keep patient airways
`
`open and treat sleeping disorders, such as sleep apnea, in a medical treatment
`
`called continuous positive airway pressure (“CPAP”). CPAP masks cover the
`
`patient’s nose and/or mouth, and are usually supported on the patient’s head by
`
`headgear.
`
`
`
`-1-
`
`
`
`Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.
`IPR Petition - U.S. Patent No. 8,944,061
`
`The Challenged Claims of the ’061 Patent include a CPAP mask having a
`
`first frame 414 associated with a cushion 416, and a second frame 412 that attaches
`
`to the first frame 414 and headgear, among other features. The second frame 412
`
`includes a first, annular opening 448 adapted to engage an elbow (not shown), and
`
`a second opening (unlabeled) between the first annular opening 448 and an upper
`
`Second Frame
`
`support member 444.
`
`Upper Support
`Member
`
`Second
`Opening
`
`First Frame
`
`Annular
`Opening
`
`Cushion
`
`
`
`However, as shown on the next page, many of the claimed features were
`
`well-known and included in the prior art (e.g., Lovell) before the earliest priority
`
`date of the ’061 Patent. Ex. 1105 ¶ 56.
`
`-2-
`
`
`
`Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.
`IPR Petition - U.S. Patent No. 8,944,061
`
`’061 PATENT (ROTATED)
`
`Cushion
`
`First Frame
`
`Upper Support
`Member
`
`Second
`Opening
`
`Annular
`Opening
`
`PRIOR ART LOVELL
`
`
`Second Frame
`
`Cushion
`
`First Frame
`
`Upper Support
`Member
`
`Annular
`Opening
`
`Second Frame
`
`
`
`-3-
`
`
`
`Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.
`IPR Petition - U.S. Patent No. 8,944,061
`
`Lovell discloses a second frame with open spaces that allow access to the
`
`first frame, but it does not disclose a second opening positioned between the
`
`annular opening and the upper support member. However, such arrangements
`
`were well-known and taught in the prior art. See infra § VII(B)(4)(f); Ex. 1105
`
`¶¶ 92–98. For example, Gelinas discloses a two-frame arrangement in which the
`
`second frame includes a first, annular opening and a second opening between the
`
`first opening and an upper support member, as shown below in Figure 7. See
`
`Ex. 1104 ¶¶ 26, 32.
`
`PRIOR ART GELINAS
`
`Upper Support
`Member
`
`Second
`Opening
`
`Annular
`Opening
`
`
`
`Second Frame
`
`
`
`-4-
`
`
`
`Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.
`IPR Petition - U.S. Patent No. 8,944,061
`
`As explained in more detail below, a person of skill in the art would have
`
`been motivated to modify the second frame of Lovell to include a second opening,
`
`as taught by Gelinas. Ex. 1105 ¶¶ 92–98; see infra §§ VII(B)(4)(f), (4)(h), (4)(i).
`
`Any additional differences between the Challenged Claims and Lovell were
`
`minor, well-known features, and their combination in the claims provided no
`
`unexpected results or benefits. See infra §§ VII(B)(4)(a)–(k); Ex. 1105 ¶¶ 41–127.
`
`The Challenged Claims consist of long lists of simple and well-known mechanical
`
`mask features, and a person of skill in the art would have had a reasonable
`
`expectation of success in combining the features of Lovell with those of the other
`
`prior art respiratory masks to arrive at the claimed assemblies.
`
`II. THIS PETITION IS NOT REDUNDANT UNDER 35 U.S.C. § 325(d)
`
`This petition is not redundant with Petitioner’s other co-pending IPR
`
`petitions challenging the ’061 Patent. These petitions include different grounds
`
`challenging different claims and involving different prior art.
`
`For example, the present petition requests review of Claims 17, 18, 20–23,
`
`26–30, 32, 33, 35–38, 41–46, 48–50, and 81–91 over Lovell in view of other patent
`
`prior art. Petitioner has concurrently filed a second IPR petition challenging
`
`Claims 51–80 in view of the same prior art. Although these two petitions rely on
`
`the same prior art, these petitions are not redundant because there are no
`
`overlapping claims.
`
`-5-
`
`
`
`Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.
`IPR Petition - U.S. Patent No. 8,944,061
`
`Petitioner has concurrently filed a third IPR petition challenging Claims 17,
`
`18, 20–23, 26–30, 32, 33, 35–38, 41–46, and 48–91 of the ’061 Patent in view of
`
`different prior art, specifically WO 2004/041342 (Berthon-Jones). As mentioned
`
`above, the claims of the ’061 Patent include numerous extensive lists of well-
`
`known features. Lovell and Berthon-Jones disclose different subsets of these
`
`common features. For example, Lovell discloses a second frame with an annular
`
`opening that interlocks with the first frame at the inlet opening of the first frame.
`
`Berthon-Jones discloses a full-face mask assembly and a second frame with an
`
`opening at least partially defined by two elongate frame members. Although
`
`Lovell and Berthon-Jones both describe CPAP masks, they have different
`
`structural designs that result in different obviousness analyses.
`
`In addition, the prior art combinations of the first two petitions are different
`
`from the combinations of the third petition, as are the reasons why a person of skill
`
`would combine those references. Accordingly, while Petitioner’s obviousness
`
`analysis in these petitions is compelling, those analyses differ in the references, the
`
`nature of the combinations, and the reasons for the combinations. Likewise,
`
`ResMed’s defense of its patent will likely focus on different structural features,
`
`which Petitioner cannot fully anticipate.
`
`Also, the present Petition and the second petition rely on prior art reference
`
`U.S. Publication No. 2003/0029454 (Gelinas) which relates to a respirator
`
`-6-
`
`
`
`Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.
`IPR Petition - U.S. Patent No. 8,944,061
`
`breathing mask and not specifically to a CPAP mask. ResMed may argue that
`
`Gelinas is not analogous art and therefore cannot be considered as part of the
`
`obviousness analyses. Although such an argument is without merit, as discussed
`
`below, the third petition does not rely on Gelinas and provides alternative
`
`obviousness grounds in the event the Board determines that Gelinas is somehow
`
`not analogous art. Thus, the petitions rely on different prior art references for one
`
`of the main features of the Challenged Claims and provide alternative grounds
`
`subject to different arguments by ResMed. See ABS Global Inc. v. XY, LLC,
`
`IPR2014-01161, Paper No. 9 (Decision on Institution of Inter Partes Review) at 19
`
`(PTAB January 13, 2015).
`
`III. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(a)(1)
`
`A. Real Party-in-Interest (37 C.F.R. § 42.8(b)(1))
`
`Fisher & Paykel Healthcare Limited is the real party-in-interest. 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)
`
`On August 16, 2016, ResMed filed a complaint in the Southern District of
`
`California alleging infringement of the ’061 Patent. Ex. 1115. ResMed voluntarily
`
`dismissed this complaint on August 18, 2016.
`
`-7-
`
`
`
`Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.
`IPR Petition - U.S. Patent No. 8,944,061
`
`ResMed and Fisher & Paykel are currently involved in pending litigation in
`
`the Southern District of California involving the ’061 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 ’061 Patent in its
`
`counterclaims on September 7, 2016. Ex. 1116.
`
`Fisher & Paykel has concurrently filed two other petitions for inter partes
`
`review of the ’061 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)
`
`Petitioner 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 Street, 14th Floor
`Irvine, CA 92614
`Telephone: (949) 760-0404
`Facsimile: (949) 760-9502
`
`D.
`
`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 Street, 14th Floor
`Irvine, CA 92614
`Telephone: (949) 760-0404
`Facsimile: (949) 760-9502
`
`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
`
`-8-
`
`
`
`Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.
`IPR Petition - U.S. Patent No. 8,944,061
`
`by email at the following email address: BoxFPH538-2@knobbe.com.
`
`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 ’061 Patent is available for inter partes
`
`review and that Petitioner is not barred or estopped from requesting inter partes
`
`review challenging the patent claims on the grounds identified herein.
`
`B. Claims and Statutory Grounds (37 C.F.R. § 42.104(b)(1) & (b)(2))
`
`1.
`
`Prior Art
`
`Petitioner respectfully requests inter partes review of the Challenged Claims
`
`(Claims 17, 18, 20–23, 26–30, 32, 33, 35–38, 41–46, 48–50, and 81–91) of the
`
`’061 Patent, filed on March 15, 2013, which is a continuation of U.S. Application
`
`No. 11/989,137, filed as PCT Application No. PCT/AU2006/000035 on January
`
`12, 2006, which claims priority to Provisional Application Nos. 60/726,265 and
`
`60/734,746 filed on October 14, 2005 and November 9, 2005, respectively.
`
`Ex. 1101 at 1. The earliest possible priority date of the ’061 Patent is October 14,
`
`2005.
`
`The Challenged Claims would have been obvious in view of the following
`
`-9-
`
`prior art references:
`
`
`
`
`
`Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.
`IPR Petition - U.S. Patent No. 8,944,061
`
` U.S. Patent No. 6,631,718 to Lovell (“Lovell”) (Ex. 1102) issued on October
`
`14, 2003. Ex. 1102 at 1. Because Lovell issued more than one year before
`
`the earliest possible priority date of the ’061 Patent, it is prior art under
`
`35 U.S.C. § 102(b).1
`
` U.S. Patent No. 6,796,308 to Gunaratnam et al. (“Gunaratnam”) (Ex. 1103)
`
`issued on September 28, 2004. Ex. 1103 at 1. Because Gunaratnam issued
`
`more than one year before the earliest possible priority date of the ’061
`
`Patent, it is prior art under 35 U.S.C. § 102(b).
`
` U.S. Publication No. 2003/0029454 to Gelinas et al. (“Gelinas”) (Ex. 1104)
`
`published on February 13, 2003. Ex. 1104 at 1. Because Gelinas published
`
`more than one year before the earliest filing date of the ’061 Patent, it is
`
`prior art under 35 U.S.C. § 102(b).
`
`2. Ground
`
`The Challenged Claims (Claims 17, 18, 20–23, 26–30, 32, 33, 35–38, 41–
`
`46, 48–50, and 81–91) would have obvious over Lovell in view of Gunaratnam and
`
`Gelinas under 35 U.S.C. § 103.
`
`
`
` 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 ’061 Patent.
`
`-10-
`
`
`
`Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.
`IPR Petition - U.S. Patent No. 8,944,061
`C. Claim Construction
`
`Solely for the purpose of this review, Petitioner construes the Challenged
`
`Claims of the ’061 Patent such that the claims are given their broadest reasonable
`
`interpretation in light of the specification of the ’061 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). In that light, Petitioner provides the
`
`following analyses for the construction of two limitations of the Challenged
`
`Claims, which is consistent with the plain and ordinary meaning of the claim terms
`
`in light of the ’061 Patent’s specification.
`
`
`
` 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.
`
`-11-
`
`
`
`Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.
`IPR Petition - U.S. Patent No. 8,944,061
`1.
`
`“annular connection adapted to engage an elbow” and “inlet
`
`elbow engages the second frame”
`
`Independent Claim 17 includes a second frame comprising an “annular
`
`connection adapted to engage an elbow of an inlet conduit.” Dependent Claims 50
`
`and 91 include the inlet elbow or elbow “engages the second frame.”
`
`The term “engage” in these phrases should be construed in a way that would
`
`not require direct contact or coupling between the second frame and the elbow.
`
`Ex. 1105 ¶¶ 32–36, 81–85. In the context of the relevant embodiments shown in
`
`Figures 3, 4, and 6–8, the ’061 Patent uses the term “engage” to describe
`
`arrangements in which the annular connection on the second frame would not
`
`directly contact the elbow. Id. ¶¶ 32–36, 83–85.
`
`With respect to Figures 3–4, the ’061 Patent describes the second frame 212
`
`as including “an annular elbow connection seal 248 adapted to engage an inlet
`
`conduit, e.g., elbow.” Ex. 1101 at col. 7:11–17. The specification describes the
`
`second embodiment shown in Figures 6–8 in the same way. Id. at col. 8:27–34.
`
`Yet, as shown below, the figures for these embodiments show that, when
`
`assembled, the annular connection 248/448 of the second frame 212/412
`
`(unshaded) is partially covered by the annular wall 240/440 of the first frame
`
`214/414 (shaded in blue), such that the annular wall 240/440 is positioned between
`
`the annular connection 248/448 and any elbow that would be coupled thereto.
`
`-12-
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`Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.
`IPR Petition - U.S. Patent No. 8,944,061
`
`Ex. 1105 ¶¶ 33–35, 83–85.
`
`
`
`Annular Wall of
`First Frame
`
`[4]*
`
`Annular
`Connection of
`Second Frame
`
`
`
`
`
`
`*Apparently mislabeled as “218”
`
`
`Although the ’061 Patent does not show an elbow in any of its figures, a
`
`person of skill in the art would have understood that such an elbow would contact
`
`the annular wall 240/440 of the first frame 214/414 and not the annular connection
`
`248/448 of the second frame 212/412. Id. ¶¶ 35–36, 83–85.
`
`The ’061 Patent provides no teachings of how the annular connection
`
`248/448 of the second frame 212/412 could directly contact or couple with the
`
`elbow when the mask is assembled. Id. ¶ 35. Nor does it describe any second
`
`frame with an annular connection that directly contacts the elbow. Id.. Thus,
`
`when the specification uses the term “engage,” in this context, it does not require
`-13-
`
`
`
`Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.
`IPR Petition - U.S. Patent No. 8,944,061
`
`that the second frame and the elbow directly contact one another. Id. ¶¶ 35–36.
`
`Based on the claim language and the teachings of the specification, a proper
`
`construction of the term “engage,” in the context of Claims 17, 50, and 91, would
`
`include arrangements that support in an operable position relative to, either directly
`
`or in cooperation with other components. Id. ¶¶ 32–36.
`
`2.
`
`“annular opening and the elbow are sealingly connected”
`
`Dependent Claims 46 and 48 recite “the annular opening and the elbow are
`
`sealingly connected.” The term “sealingly connected” with respect to these claims
`
`should not be construed to require direct coupling or sealing between the elbow
`
`and the annular opening of the second frame. Ex. 1105 ¶¶ 37–39.
`
`As described above with respect to the term “engage,” the relevant
`
`embodiments of the ’061 Patent show an annular opening 248/448 on the second
`
`frame 212/412 that would not directly contact or seal with the elbow. See supra
`
`§ IV(C)(1). Although the specification describes that the second frame 212/412
`
`includes an annular opening 248/448 adapted to engage an elbow (Ex. 1101 at cols.
`
`7:11–17, 8:27–34), the specification also teaches that the annular opening 248/448
`
`of the second frame 212/412 interlocks with the annular wall 240/440 of the first
`
`frame 214/414. Id. at col. 7:23–25, 8:38–46. As shown in the corresponding
`
`figures below, the annular wall 240/440 on the first frame 214/414 (shaded in blue)
`
`extends through the annular opening 248/448 of the second frame 212/412
`
`-14-
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`Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.
`IPR Petition - U.S. Patent No. 8,944,061
`
`(unshaded), and thus would be positioned between the annular opening 248/448
`
`and any elbow that would be coupled thereto. Ex. 1105 ¶¶ 37–39.
`Annular Wall of
`First Frame
`
`
`
`[4]*
`
`Annular
`Connection of
`Second Frame
`
`
`*Apparently mislabeled as “218”
`Based on the figures and description, a person of skill would have
`
`
`
`
`
`understood that an elbow would contact and form a seal with the annular
`
`wall 240/440 of the first frame 214/414 when the mask is assembled, not with the
`
`second frame 212/412. Id. ¶¶ 37–39. Although element 248/448 is described as an
`
`“annular elbow connection seal,” the figures show there would be no direct
`
`connecting or sealing between the annular opening 248/448 of the second frame
`
`212/412 and the elbow. Id. Thus, a person of skill in the art would have
`
`understood that the term “sealingly connected,” in this context, does not require
`
`that the elbow directly connect or seal with the annular opening 248/448 of the
`-15-
`
`
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`Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.
`IPR Petition - U.S. Patent No. 8,944,061
`
`second frame 212/412. Id.
`
`Based on the claim language and description in the specification, a proper
`
`construction of “sealingly connected,” in the context of Claims 46 and 48, would
`
`include arrangements that are directly or indirectly coupled to allow a seal between
`
`the interior of the elbow and the breathing chamber. Id.
`
`V. THE ’061 PATENT
`
`A. Example Embodiments
`
`The ’061 Patent discloses CPAP full-face mask assemblies for treating sleep
`
`disordered breathing. Ex. 1101 at Abstract.
`
`The Challenged Claims of the ’061 Patent are relevant to only two of the
`
`disclosed mask embodiments. Ex. 1105 ¶ 28. In particular, the Challenged Claims
`
`are directed to the mask embodiments that include a first frame and cushion
`
`constrained by a second frame (or skeleton frame), where the second frame
`
`receives the straps of a headgear assembly. Ex. 1101 at 2:34–42. The purpose of
`
`the second frame is to “maintain the cushion to the frame.” Id.
`
`-16-
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`
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`Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.
`IPR Petition - U.S. Patent No. 8,944,061
`
`In the first relevant embodiment, the ’061 Patent discloses a mask assembly
`
`210 with a cushion/frame sub-assembly 230 that engages a second frame 212 (or
`
`skeleton frame), as shown in Figure 3 below. Id. at col. 6:56–58.
`Elongate Frame
`Members
`
`Upper Support
`Member
`
`Clip
`Receptacles
`
`Annular
`Connection
`
`Opening
`
`
`
`Second Frame
`
`Cushion/Frame
`Sub-assembly
`
`The cushion/frame sub-assembly 230 has an opening 218 for communicating
`
`with an elbow (not shown), and an annular wall 240 surrounding the opening 218.
`
`Id. at col. 6:53–68. The second frame 212 includes an annular elbow connection
`
`248 adapted to engage the elbow. Id. at col. 7:11–16. The second frame 212 also
`
`includes lower headgear clip receptacles 246 and an upper support member 244
`
`that supports a forehead support (not shown). Id. The upper support member 244
`
`and clip receptacles 246 are interconnected by elongate frame members 250. Id. at
`
`-17-
`
`
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`Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.
`IPR Petition - U.S. Patent No. 8,944,061
`
`col. 7:16–18.
`
`As shown in Figure 4 below, when the mask is assembled, the second frame
`
`212 (shaded in red) interlocks or frictionally engages the cushion/frame assembly
`
`230. Id. at col. 7:24–27.
`
`
`
`-18-
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`
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`Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.
`IPR Petition - U.S. Patent No. 8,944,061
`
`The second embodiment, shown in Figures 6–8, is very similar to the first
`
`embodiment, except that the first frame 414 and the cushion 416 are separately
`
`formed and then interlocked to provide a cushion/frame sub-assembly 430. Id. at
`
`col. 8:1–3; Ex. 1105 ¶¶ 28–30. As shown in Figure 6 below, the second frame 412
`
`engages the cushion/frame sub-assembly 430 in the same way as the first
`
`embodiment. Ex. 1101 at col. 8:38–48.
`
`Second Frame
`
`First Frame
`
`Cushion
`
`
`
`-19-
`
`
`
`Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.
`IPR Petition - U.S. Patent No. 8,944,061
`B.
`
`Summary of the Prosecution History of the ’061 Patent
`
`The ’061 Patent issued from U.S. Patent Application No. 13/834,189, filed
`
`on March 15, 2013. Ex. 1101 at 1.
`
`On February 26, 2014, the Examiner rejected all of the pending claims based
`
`on ResMed’s own U.S. Publication No. 2002/0108613, which later issued as the
`
`Gunaratnam patent (Ex. 1103). Ex. 1107 at 219–226. In the Office Action, the
`
`Examiner pointed out that Gunaratnam “discloses a full-face mask assembly
`
`comprising a frame 800, a cushion 180 provided to the frame, the cushion adapted
`
`to seal around the patient’s nose and mouth, and a skeleton frame 160 to maintain
`
`the cushion to the frame, the skeleton frame including lower headgear clip
`
`receptacles 920 adapted to be engaged with clips provided on the straps of a
`
`headgear assembly, and an annular elbow connection seal 910 adapted to engage
`
`an inlet conduit (fig. 8; page 3, paragraph 0050).” Id. at 222.
`
`In response to the Examiner’s rejections, the Applicant canceled all of the
`
`pending claims and added 31 entirely new claims. Id. at 280–289. The Examiner
`
`issued a Notice of Allowance on September 9, 2014, allowing all but one of the
`
`pending claims. Id. at 297–301. On October 16, 2014, the Applicant filed an
`
`amendment with a request for continued examination. Id. at 373–393. In this
`
`amendment, the Applicant amended two of the pending claims “to correct
`
`typographical errors” and added new Claims 71–130. Id. at 373–392. On
`
`-20-
`
`
`
`Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.
`IPR Petition - U.S. Patent No. 8,944,061
`
`December 12, 2014, the Examiner issued another Notice of Allowance, allowing
`
`all of the pending claims. Id. at 399–403.
`
`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 ’061 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. 1105 ¶¶ 24–
`
`26.
`
`VII. THE CHALLENGED CLAIMS OF THE ’061 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. 1105.
`
`Mr. Eaton is Principal Mechanical Engineer at MSA Safety and has extensive
`
`industry experience in CPAP mask systems and design.
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