IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`In re Patent of: McAuley, et al.
`U.S. Patent No.: 8,443,807 Attorney Docket No.: 36784-0042IP1
`Issue Date:
` May 21, 2013
`Appl. Serial No.: 12/307,993
`Filing Date:
` June 17, 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. 8,443,807
`PURSUANT TO 35 U.S.C. §§ 311–19, 37 C.F.R. § 42
`
`
`
`
`
`
`
`

`
`TABLE OF CONTENTS
`
`
`
` 
`
` 
`
` 
`
` 
`
`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 
` 
`THE ’807 PATENT AND ITS PROSECUTION ........................................... 4 
`A. 
`The ’807 patent’s disclosure ................................................................. 4 
`B. 
`The ’807 patent’s prosecution history. .................................................. 5 
`Person of ordinary skill in the art. ......................................................... 7 
` 
`VI.  CLAIM CONSTRUCTION UNDER 37 C.F.R. § 42.104(B)(3) .................... 7 
`The claimed “ring” (claim 1). ............................................................... 7 
` 
`The phrase “a plane substantially bisecting the ring, each of the two
`nasal pillows positioned on opposite sides of the plane” (claim 1). ... 11 
`The phrases “wherein the two side straps are configured to connect
`and disconnect with the mask assembly” and “wherein the mask
`assembly is configured to connect to only the two side straps” (claim
`1). ......................................................................................................... 12 
`VII.  THE CHALLENGED CLAIMS ARE UNPATENTABLE AS OBVIOUS . 14 
`  Ground 1: Claims 1-7, 17-19, 24, and 25 are unpatentable as obvious
`over Gunaratnam in view of Ging. ..................................................... 14 
`Obviousness of substituting a nasal pillows mask body as
` 
`disclosed elsewhere in Gunaratnam for the full nasal mask
`body in Gunaratnam’s Figure 135 patient interface ................. 15 
`Gunaratnam’s Figure 135 patient interface and further detail
`regarding that patient interface disclosed in Ging teach the
`i
`
`V. 
`
` 
`
`
`
`

`
`
`
` 
`
` 
`
`claimed “ring” and ring “socket,” and an elbow “fiting into” the
`ring and socket, as claimed. ...................................................... 18 
`Correspondence between the ‘807 patent claims and the
`teachings of Gunaratnam and Ging. ......................................... 21 
`Ground 2: Claims 1-7, 17-19, 24, and 25 are unpatentable as obvious
`over Gunaratnam in view of Ging and McAuley. ............................... 40 
`Ground 3: Claims 1-7, 17-19, 24, and 25 are unpatentable as obvious
`over Lovell in view of Gunaratnam. ................................................... 44 
`The combined teachings of Lovell and Gunaratnam. ............... 44 
` 
`Correspondence between the ‘807 patent claims and the
`teachings of Lovell and Gunaratnam. ....................................... 46 
`VIII.  GROUNDS 1, 2, AND 3 ARE NOT REDUNDANT ................................... 65 
`IX.  CONCLUSION .............................................................................................. 66 
`
` 
`
` 
`
`
`
`ii
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`

`
`EXHIBIT LIST
`Exhibit Description
`EX. #
`RMD1001 U.S. Patent No. 8,443,807 to McAuley et al. (“the ’807 patent”)
`
`
`
`RMD1002
`
`[RESERVED]
`
`RMD1003
`
`[RESERVED]
`
`RMD1004 U.S. Patent Application Publication No. 2004/0226566 to
`Gunaratnam et al. (“Gunaratnam”)
`
`RMD1005 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
`
`[RESERVED]
`
`RMD1011
`
`[RESERVED]
`
`RMD1012 U.S. Patent No. 7,219,669 to Lovell et al. (“Lovell”)
`
`RMD1013
`
`[RESERVED]
`
`RMD1014 Merriam-Webster’s Collegiate Dictionary, Eleventh Edition
`(2004) (selected portions)
`
`RMD1015
`
`[RESERVED]
`
`RMD1016 U.S. Patent No. 4,676,241 to Webb et al. (“Webb”)
`
`RMD1017
`
`[RESERVED]
`
`RMD1018
`
`PCT Publication No. WO 2004/022147 to Drew (“Drew”)
`
`
`
`iii
`
`

`
`
`
`RMD1019 U.S. Patent 4,782,832 to Trimble et al. (“Trimble” or “’832
`Patent”)
`
`RMD1020 U.S. Patent 6,431,172 to Bordewick (“Bordewick”)
`
`RMD1021 U.S. Patent 6,192,886 to Rudolph (“Rudolph”)
`
`RMD1022 U.S. Patent 6,581,594 to Drew et al. (“Drew”)
`
`RMD1023
`
`[RESERVED]
`
`RMD1024
`
`ResMed “Mirage Vista™ Nasal Mask: Components Card”
`publication, ©2005 ResMed Ltd.
`
`RMD1025
`
`[RESERVED]
`
`RMD1026
`
`[RESERVED]
`
`RMD1027
`
`[RESERVED]
`
`RMD1028
`
`[RESERVED]
`
`RMD1029
`
`[RESERVED]
`
`RMD1030
`
`[RESERVED]
`
`RMD1031
`
`[RESERVED]
`
`RMD1032
`
`[RESERVED]
`
`RMD1033
`
`[RESERVED]
`
`RMD1034
`
`RMD1035
`
`RMD1036
`
`PCT Publication No. WO 2005/079726 to McAuley et al.
`(“McAuley”)
`
`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”)
`
`
`
`iv
`
`

`
`RMD1038
`
`WeddingBands.com – Men’s Wedding Ring Shopping Page
`(Retrieved October 16, 2015 from
`http://www.weddingbands.com/ProductPop_wedding_bands_m
`etal/48214W.html)
`
`
`
`RMD1039
`
`RMD1040
`
`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
`RMD1042 U.S. Patent No. 6,119,694 to Correa et al. (“Correa”)
`Patent Owner’s Complaint for Fisher & Paykel Healthcare Ltd.
`RMD1043
`v. ResMed Corp., Case No. 3:16-cv-02068-GPC-WVG (S.D.
`Cal.)
`
`RMD1041
`
`RMD1044
`
`RMD1045
`
`RMD1046
`
`RMD1047
`
`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.)
`
`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 Limited, ResMed Inc., and ResMed Corp (collectively “ResMed”
`
`or “Petitioners”) petition for inter partes review (“IPR”) of claims 1-7, 17-19, 24,
`
`and 25 of U.S. Patent No. 8,443,807, 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 ’807 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 ’807 patent. RMD1043.
`
`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 ’807 patent. RMD1044; RMD1045.
`
`Petitioners have also filed and dismissed (without prejudice) a complaint
`
`related to the ’807 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 ’807 patent. RMD1046. Petitioners voluntarily dismissed this complaint
`
`without prejudice on August 18, 2016. RMD1047.
`
`Petitioners’ withdrawn action for declaratory judgment regarding the
`
`invalidity of the ’807 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 ’807 patent has no effect under 35 U.S.C. §
`
`315(b) since it was filed less than a year ago.
`
`By separate petition, Petitioner seeks IPR of claims 8, 20, 21, 26, and 27 of
`
`the ’807 patent, and also separately petitions for IPR of the ’741 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)
`
`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: 612-288-9696
`kane@fr.com
`
`
`
`2
`
`

`
`
`
`
`
`Service Information
`
`Petitioners consent to electronic service by email at IPR36784-
`
`0042IP1@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 the ’807 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 1-7, 17-19, 24, and 25 of the ’807 patent,
`
`and a finding of unpatentability as follows:
`
`Ground
`1
`
`2
`
`3
`
`References
`Claims 1-7, 17-19, 24, and 25 are obvious under 35 U.S.C. § 103 over
`Gunaratnam (RMD1004) in view of Ging (RMD1005)
`Claims 1-7, 17-19, 24, and 25 are obvious under 35 U.S.C. § 103 over
`Gunaratnam in view of Ging and McAuley (RMD1034)
`Claims 1-7, 17-19, 24, and 25 are obvious under 35 U.S.C. § 103 over
`Lovell (RMD1012) in view of Gunaratnam
`
`All of these references are prior art printed publications under pre-AIA 35 U.S.C. §
`
`102(b), even assuming the ’807 claims are entitled to the earliest claimed priority,
`
`
`
`3
`
`

`
`
`
`July 14, 2006. Specifically with respect to McAuley, its publication was Sep. 1,
`
`2005, which is more than one year before the filing in the United States (i.e., the
`
`PCT filing designating the United States made on July 13, 2007), therefore making
`
`McAuley prior art under pre-AIA 35 U.S.C. § 102(b). The unpatentability of the
`
`claims is supported by the references and other evidence referenced in this Petition,
`
`including testimony of expert Dr. John Izuchukwu, Ph.D., P.E. (RMD1008).
`
`V. THE ’807 PATENT AND ITS PROSECUTION
`A. The ’807 patent’s disclosure
`The ’807 patent relates to a particular patient interface design for systems
`
`that supply pressurized air to a person’s airway, used for example by people
`
`suffering from sleep apnea. See, e.g., RMD1001, col. 1:10-13, 1:24-55, 1:56-2:32,
`
`2:58-3:30; see also RMD1008, ¶¶ 24-29; RMD1040 (discussing history of field);
`
`RMD1008, ¶¶ 24-27. Figures 2 and 3 illustrate the claimed subject matter:
`
`
`
`4
`
`
`
`

`
`
`
`RMD1001, FIGS. 2, 3. The patient interface shown here includes a “mask
`
`assembly” defined in the claims to include: (a) a nasal pillows type mask 2
`
`including (i) a mask body 23 with nasal pillows 24, 25, and (ii) a mask base or
`
`“ring” 22; and (b) a swivel elbow connector 30 that connects at the front center of
`
`mask 2. See id. at col. 5:25-47, 6:38-45, 8:38-52. Headgear assembly 21 secures
`
`the mask assembly on the face of the user. See id. at col. 6:57-7:3; see also
`
`RMD1008, ¶¶ 28-29.
`
`The ‘807 specification features the headgear having “a continuous and
`
`substantially curved elongate member [34] extending in use below a user’s nose.”
`
`See, e.g., RMD1001, Abstract, FIGS. 2-3, col. 2:62-65, 3:11-17, 6:57-61, 7:4-8:6;
`
`but see RMD1042 (disclosing such an elongate member). But before prosecution
`
`on the merits, limitations directed to that feature were dropped. See RMD1009, pp.
`
`3-8, 515-519. The claims as issued are simply an obvious collection of patient
`
`interface features.
`
`B.
`The ’807 patent’s prosecution history.
`During prosecution after a rejection based on Lovell (RMD1012) – at issue
`
`in Ground 3 – applicants amended independent application claim 38 [issued claim
`
`1], and argued two distinctions. See RMD1009, pp. 587, 614, 620-21, 629-33;
`
`RMD1012, FIGS. 1B, 2B, 5; RMD1008, ¶¶ 30-39.
`
`First, as claimed the rotatable elbow fits into the claimed ring, as opposed to
`
`
`
`5
`
`

`
`
`
`fitting over the ring in Lovell (i.e., elbow 14 fits over swivel connector 12,
`
`identified by the examiner as a ring). See RMD1009, pp. 614, 620-621. But
`
`before the ‘807 patent, that difference would have been considered an obvious
`
`design choice, and in fact it was well known at the time that elbow connectors fit
`
`into masks. See RMD1008, ¶¶ 33-35. And regardless, Lovell discloses alternative
`
`structure (namely, lower mask shell 8), that meets all limitations of the claimed
`
`ring, and an elbow “fits into” the mask shell 8. See supra Section VII.C.
`
`Second, as claimed the mask assembly connects to the headgear assembly
`
`only by two side straps, in contrast to four side straps in Lovell. See RMD1009, p.
`
`614, 620-622; see also RMD1012, FIG. 5, col. 6:18-48. But the headgear
`
`assembly as claimed was already known, and indeed already known in connection
`
`with nasal pillows masks. See ResMed’s 2004 prior art Swift™ nasal pillows
`
`patient interface (RMD1035, RMD1036); ResMed’s 2004 Gunaratnam patent
`
`filing (RMD1004, see especially FIGS. 107G-H, see also, e.g., FIGS. 18, 37-39,
`
`52-56, 59-60, 76A-D, 84, 107, 107-1 to 107-2, 107D-E, 107I, 108). Thus, the
`
`second distinction over Lovell cannot support patentability. See RMD1008, ¶¶ 37-
`
`38.
`
`Despite the flawed arguments, the examiner allowed the claims, giving no
`
`reasons for allowance. See RMD1009, pp. 629-33.
`
`
`
`6
`
`

`
`
`
`
`
`Person of ordinary skill in the art.
`
`In view of the subject matter of the ’807 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, ¶ 21. 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.
`
`
`
`The claimed “ring” (claim 1).
`
`The claimed “ring” is a structure with a generally circular inner passage to
`
`
`
`7
`
`

`
`
`
`enable the claimed rotatable engagement with an elbow that fits into the ring, and
`
`does not require a particular outside shape for the ring. See generally RMD1008,
`
`¶¶ 40-41.
`
`The term “ring” does not have a special meaning in the applicable field of
`
`the ’807 patent, and is not defined in the ’807 specification. See RMD1008, ¶ 41.
`
`The context in claim 1 for the claimed “ring” is that it is engaged with a “mask
`
`body” (e.g., body 23), and an elbow (e.g., “connector” 30) is “rotatably engaged
`
`with,” and “fits into,” the ring. See RMD1001, col. 11:35, 39-42, 5:31-33. As
`
`such, the structure in the ’807 specification corresponding to the “ring” is “mask
`
`base” 22; indeed, mask base 22 is said to be “a ring or sleeve type attachment.”
`
`Id., col. 6:20 (emphasis added); see also 6:46-48 and 8:38-40 (focusing on curved
`
`inner surface of the mask base 22 for forming a socket in which the connector end
`
`46 of elbow 30 swivels). The ring-shaped mask base 22 is shown in FIGS. 3-5
`
`copied below:
`
`
`
`8
`
`

`
`
`
`Connector end
`(flange) 46
`
`Mask base 22
`
`Circular inner
`passage
`
`
`
`RMD1001, FIGS. 3, 4, 5. Note that connector end 46 of elbow connector 30 has
`
`an annular flange that is also ring shaped, but that flange of end 46 does not
`
`correspond to the claimed “ring” because it is not described as being “rotatably
`
`engaged with” an elbow, as required by claim 1. Because claim 1 recites the elbow
`
`fitting into, and rotatably engaging, the ring, the context of claim 1 supports the
`
`ring having a generally circular inner passage.
`
`Regarding the outer surface of the claimed “ring,” however, nothing within
`
`the plain language of the term “ring” or from the intrinsic record requires that the
`
`outer surface of the ring be of a particular shape. In the ‘807 specification, an
`
`outer surface of the ring (mask base 22) complements a central section 42 of a
`
`separate curved elongate member 34, see, e.g., id., FIG. 3, col. 7:46-55, but in the
`
`claims of the ‘807 patent that elongate member 34 component or any other
`
`
`
`9
`
`

`
`
`
`component that interacts with the outer surface of the claimed ring is unclaimed.
`
`In addition, in an alternative embodiment shown in Figures 20-22, an alternative
`
`design for a mask base 301 is shown that is integrally formed with two curved
`
`members 302 extending to the side of mask base 301 and attaching to respective
`
`headgear straps. See id., FIGS. 20-22 and col. 7:62-8:6. Indeed, the outside shape
`
`of the ‘807 patent’s mask base or ring 22 is not circular. See, e.g., RMD1001 at
`
`Figs. 3-5. This is important because the “ring” feature is not recited in the original
`
`patent claims, and was only introduced by the preliminary amendment and thus
`
`draws its support from the original disclosure. More specifically, the rings in
`
`Figures 3-5 include projections on their top and lower portions (the lower portion
`
`projection best seen in Figure 3). RMD1001 at Figs. 3-5.
`
`Also, dictionary definitions for “ring” do not impose a limitation on the
`
`shape of the outside surface of a “ring.” See, e.g., RMD1014, p. 1074 (“an
`
`encircling arrangement”). Indeed, many structures are considered “rings” yet do
`
`not have a circular outside shape. For example, a “ring” for one’s finger may have
`
`an outer periphery that is square or rectangular, or that includes a setting with
`
`prongs and a stone. See RMD1038 (showing a non-circular finger ring, copied
`
`below at left). Also, a “nut ring” is hexagonal. See RMD1008, ¶ 41; RMD1039
`
`(showing a galvanized nut ring, copied below at right):
`
`
`
`10
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`

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`
`
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`
`
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`
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`RMD1038
`
`
`
`
`
`
`
`
`
`
`
`RMD1039
`
`
`
`In addition, the first named inventor McAuley of the ‘807 patent has referred to a
`
`triangle structure in a different mask (specifically, the ResMed Mirage Quattro full
`
`face mask) as a “triangular shaped ring.” See RMD1041, ¶ 12.4. As such, a
`
`construction that the periphery of the claimed ring need not be generally circular is
`
`well supported. See also RMD1008, ¶ 41.
`
`
`
`The phrase “a plane substantially bisecting the ring, each of the
`two nasal pillows positioned on opposite sides of the plane” (claim
`1).
`
`This phrase requires that the “ring” (and elbow rotatably engaged therewith)
`
`be located generally at the mask’s front center. See RMD1008, ¶ 42. Referring to
`
`Figure 3 of the ‘807 patent, if a vertical plane were defined to bisect an opening in
`
`the ring 22 (as shown below), that plane would extend between the two nasal
`
`pillows 24, 25, leaving one pillow on each side of the plane, as shown below:
`
`
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`11
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`
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`RMD1001, FIG. 3. This differs from some prior art configurations in which an
`
`elbow fits into a ring located at the side of the mask. See, e.g., RMD1004, FIGS.
`
`108-114 (depicting a nasal pillows-type mask having a swivel elbow that connects
`
`to a side of the mask assembly).
`
` The phrases “wherein the two side straps are configured to
`connect and disconnect with the mask assembly” and “wherein the
`mask assembly is configured to connect to only the two side
`straps” (claim 1).
`
`These clauses require that the two side straps of the headgear assembly be
`
`capable of connecting and disconnecting with the mask assembly, whether that
`
`connection be direct or via an intermediate structure, and require that only the side
`
`straps and no other strap of the headgear assembly be connectable to the mask
`
`assembly. See RMD1008, ¶ 43.
`
`The first part of the construction not requiring a direct connection is
`
`supported by the ’807 specification, which discloses only indirect connections
`
`between straps and mask assemblies. In Figures 2-3 for example, side straps 38
`12
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`

`
`
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`connect to a rigid side arm 41 (part of member 34), which in turn connects to the
`
`mask assembly 2. See RMD1001, col. 6:57-61, 7:4-55. Other embodiments in
`
`Figures 8-16 are similar. And in Figures 20-23, side straps 308 (or straps 411, 415
`
`in FIG. 23) similarly connect to a curved elongate member 302 (405 in FIG. 23)
`
`and not to the mask assembly directly. Further, dependent claim 6 adds that
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`“molded side arms extend away from the ring to connect with the side strap,” (see,
`
`e.g., side arms 41 in Figure 3), and thus requires an indirect connection between
`
`the mask assembly and the side straps, the premise of that being claim 1
`
`necessarily covers an indirect connection.1
`
`The second part of the construction requiring that only the two side straps
`
`and no other strap of the headgear assembly be connectable to the mask assembly
`
`is supported by the prosecution history as discussed above in Section V.B, in
`
`which the “four strap” connection to the mask assembly of Lovell was
`
`
`1 If the molded side arms 41 of the ‘807 patent are considered to be part of the
`
`claimed “mask assembly,” then it may be argued that the ‘807 specification does
`
`disclose a direct connection, but in that case similar side arm structures in the prior
`
`art would be part of the claimed “mask assembly” and there would be a direct
`
`connection in the prior art also. See Discussion under Ground 1, limitation 1.15;
`
`Ground 3, limitations 1.11-1.17.
`
`
`
`13
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`
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`distinguished. See RMD1012, FIG. 5; RMD1009, pp. 585-90, 613-23; RMD1008,
`
`¶¶ 36-38.
`
`VII. THE CHALLENGED CLAIMS ARE UNPATENTABLE AS
`OBVIOUS
`
` Ground 1: Claims 1-7, 17-19, 24, and 25 are unpatentable as
`obvious over Gunaratnam in view of Ging.
`Gunaratnam discloses numerous patient interface designs. The design
`
`shown in Figure 135 and described in Gunaratnam (¶ 403) serves as the starting
`
`point for the Ground 1 obviousness
`
`analysis. The Figure 135 patient interface
`
`includes a nasal mask assembly and an
`
`elbow rotatably connected at the front
`
`center of the mask, and includes a
`
`headgear assembly where only two side
`
`straps are connectable to the mask assembly. See RMD1008, ¶¶ 44-48, 62-63.
`
`The Figure 135 interface includes all limitations of claim 1, except the nasal mask
`
`being a nasal pillows mask, and detail of the claimed “ring” and the elbow fitting
`
`into the ring. Those features are taught elsewhere in Gunaratnam and in Ging, and
`
`it would have been obvious to have applied those teachings to Gunaratnam’s
`
`Figure 135 patient interface, as discussed below. See generally RMD1008, ¶¶ 44-
`
`54, 61-119, 168-174, 176-179.
`
`
`
`14
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`
`
`
` Obviousness of substituting a nasal pillows mask body as
`disclosed elsewhere in Gunaratnam for the full nasal mask
`body in Gunaratnam’s Figure 135 patient interface
`Claim 1, limitation 1.3 (see claim charts, Section V.A.3 below) recites the
`
`mask body having “two nasal pillows.” Gunaratnam’s Figure 135 patient interface
`
`includes a full nasal mask covering the nose entirely, not nasal pillows. Long
`
`before the ’807 patent though, nasal pillows masks were well-known alternatives
`
`to full nasal masks. See, e.g., RMD1019; RMD1020; RMD1012; RMD1004, ¶¶ 4-
`
`9; see also RMD1008, ¶¶ 66-73. Gunaratnam also discloses patient interfaces
`
`using nasal pillows masks in Figures 1-133, and that is its primary focus. See
`
`RMD1004, FIGS. 1-133, ¶ 403, including FIGS. 1, 5-6, ¶¶ 185-93 (details of an
`
`example nasal pillows mask, which includes a frame and a “nozzle assembly” or
`
`mask body with two “nozzles” or pillows); see also RMD1035 and RMD1036
`
`(ResMed’s prior art “Mirage Swift™” Nasal Pillows patient interface from 2004);
`
`RMD1008, ¶¶ 66-73.
`
`It would have been obvious before the ‘807 patent to have substituted, into
`
`the Gunaratnam Figure 135 patient interface, a nasal pillows mask body in place
`
`of the full nasal mask body, in view of the knowledge in the field at the time about
`
`nasal pillows masks including the teachings in Gunaratnam. See RMD1008, ¶¶
`
`71-73. 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.
`
`
`
`15
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`

`
`
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`Teleflex Inc, 550 U.S. 398, 416 (2007). Moreover, Gunaratnam teaches that the
`
`claimed headgear is adaptable to be used with either a full nasal mask (FIG. 135)
`
`or a nasal pillows mask (FIGS. 107G-H, 108).
`
`Applying a known nasal pillows mask body to Gunaratnam’s Figure 135
`
`patient interface yields a configuration shown below:
`
`
`
`RMD1004, FIG. 135. The obviousness of applying a known nasal pillows mask
`
`body to Gunaratnam’s Figure 135 patient interface is well supported. Indeed,
`
`Gunaratnam suggests it, in describing Figure 135, stating “the nozzle assembly
`
`and/or its associated cushion [i.e., the nasal pillows masks shown in Figures 1-133]
`
`could be replaced with a nasal mask and/or nasal cushion [i.e., the full nasal mask
`
`
`
`16
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`

`
`
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`of Figure 135].” Gunaratnam, ¶ 403; see also RMD1008, ¶ 73. One of skill in the
`
`art would have understood the converse is also true, namely, the full nasal mask of
`
`Figure 135 could be replaced with a nasal pillows mask. See RMD1008, ¶ 73.
`
`Moreover, Gunaratnam specifically teaches a nasal pillows mask specifically in
`
`combination with the elbow being connected at the front center of the mask as
`
`claimed, and with the same four-strap headgear as claimed. See RMD1004, FIGS.
`
`107G-H, copied and annotated below:
`
`
`
`RMD1004, FIGS. 107G, 107H. The similarity of these aspects of the patient
`
`interface to the Figure 135 patient interface suggests the interchangeability of a full
`
`nasal mask and a nasal pillows mask in Gunaratnam Figure 135. See RMD1008, ¶
`
`73; see also RMD1004, FIG. 108; RMD1035, p. 4 and RMD1036, p. 1 (nasal
`
`pillows masks with headgear similar to Gunaratnam Figure 135).
`
`
`
`17
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`

`
`
`
` Gunaratnam’s Figure 135 patient interface and further detail
`regarding that patient interface disclosed in Ging teach the
`claimed “ring” and ring “socket,” and an elbow “fiting into”
`the ring and socket, as claimed.
`Limitations 1.5, 1.7, and 1.8 (see claim charts, Section VII.A.3 below)
`
`require (1) a “ring” engaged with the mask body, and (2) a rotatable elbow that fits
`
`into a socket formed by the ring. Section VI.A provides a construction for “ring” –
`
`“a structure with a generally circular inner passage to enable the claimed rotatable
`
`engagement with an elbow that fits into the ring, and does not require a particular
`
`outside shape for the ring.” Section V.B details the prosecution history relating to
`
`the “fits into” limitation.
`
`Gunaratnam’s Figure 135 discloses the claimed ring by virtue of its mask
`
`frame. The “mask frame” meets the claimed ring, in that it engages with a mask
`
`“cushion” serving as the
`
`claimed mask body, and
`
`has an opening in the
`
`front center of the mask
`
`frame into which a
`
`rotatable elbow fits and
`
`through which air flows.
`
`See RMD1004, FIG. 135; see generally RMD1008, ¶¶ 77-85, 89. The same nasal
`
`mask structure shown in Gunaratnam Figure 135, including the nasal mask frame,
`18
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`

`
`
`
`is shown in more detail in another ResMed patent filing, Ging, for example Figure
`
`6b of Ging shown above at right, with the mask frame referenced as 20. Compare
`
`RMD1004, FIG. 135, ¶ 403 with RMD1005, FIGS. 1, 2-6B, ¶¶ 108-116; see also
`
`RMD1005, FIGS. 5, 5c, 6b, 24, 27-29, ¶¶ 114-115, 195-223 (describing mask
`
`frame 20 engaged with mask cushion 40).
`
`The applicability of Ging’s details for a nasal mask frame and swivel elbow
`
`to Gunaratnam’s Figure 135 is clear. Gunaratnam specifically refers to ResMed’s
`
`Vista Mask (RMD1024), and it is the Vista mask that is disclosed in Ging (indeed,
`
`Gunaratnam incorporates by reference the provisional applications that form the
`
`basis of Ging). See RMD1004, ¶ 341, 403; see also RMD1008, ¶¶ 47-48, 51, 61-
`
`63. The similarity of the designs in these three documents is illustrated below:
`
`
`
`RMD1004
`
`
`
`
`
` RMD1024
`
`
`
` RMD1005
`
`Note the identical design of the forwardly protruding flange on the mask frame,
`
`and the design detail of the swivel elbow (160 in Ging) including textured
`
`
`
`
`
`19
`
`

`
`
`
`protrusions 185 on the side and groove 167. Note also that the swivel elbow 160
`
`design shown in Ging’s Figure 16b is said to be an alternative for the swivel elbow
`
`shown in Ging’s FIG. 6b, and thus would be used with same mask 20 shown in
`
`Ging’s FIG. 6b. See RMD1005, ¶¶ 151-162.
`
`The Gunaratnam/Ging mask frame 20 meets the claimed “ring,” despite not
`
`having a circular periphery, given the proper interpretation of “ring” discussed in
`
`Section VI.A. See also RMD1008, ¶¶ 77-85. Indeed, in the context of the ‘807
`
`claims, the shape of the mask ring’s periphery has no criticality because the
`
`disclosed structure on the outside of that ring (the curved elongate member 34,
`
`FIG. 3) is unclaimed, as described above in Section V.A. See RMD1008, ¶ 41;
`
`KSR, 550 U.S. at 416. But even if “ring” were read narrowly to require that the
`
`ring have a more circular perimeter, that shape would nevertheless have been an
`
`obvious, as will be discussed in Ground 2. See RMD1008, ¶¶ 85, 181-185.
`
`Regarding the elbow fitting into a socket formed by the ring (mask frame) as
`
`claimed, it was well known at the time for elbows to fit into an aperture in a mask
`
`frame, and indeed Ging expressly shows a swivel elbow’s end portion 169 that is
`
`“fit into” a mask frame aperture 24:
`
`
`
`20
`
`

`
`
`
`
`
`RMD1005, FIG. 5c (above left, showing mask frame aperture 24), FIG. 19c-1
`
`(above right, showing elbow fit into mask frame); see also RMD1005, FIGS. 1-6b,
`
`19a-1 – 19c-2, ¶ 161; RMD1004, FIGS. 110-111 (swivel elbow fits into mask
`
`frame, albeit at the side of the mask frame); RMD102