Paper 9
`Entered: March 6, 2017
`
`Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`RESMED LIMITED, RESMED INC., AND RESMED CORP,
`Petitioner,
`v.
`FISHER & PAYKEL HEALTHCARE LIMITED,
`Patent Owner.
`_______________
`
`Case IPR2016-01726
`Patent 8,443,807 B2
`_______________
`
`
`
`Before RICHARD E. RICE, BARRY L. GROSSMAN, and
`JAMES J. MAYBERRY, Administrative Patent Judges.
`
`RICE, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`

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`IPR2016-01726
`Patent 8,443,807 B2
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`I. INTRODUCTION
`A. Background
`ResMed Limited, ResMed Inc., and ResMed Corp (collectively,
`“Petitioner”) filed a Petition (Paper 4, “Pet.”) requesting an inter partes
`review of claims 1–7, 17–19, 24, and 25 of U.S. Patent No. 8,443,807 B2
`(Ex. 1001, “the ’807 Patent”). Petitioner supported the Petition with a
`declaration from John Izuchukwu, Ph.D., P.E. (Ex. 1008). Fisher & Paykel
`Healthcare Limited (“Patent Owner”) filed a Preliminary Response (Paper 8,
`“Prelim. Resp.”).
`Under 35 U.S.C. § 314, an inter partes review may not be instituted
`“unless . . . there is a reasonable likelihood that the petitioner would prevail
`with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C.
`§ 314(a). Upon considering the Petition and the Preliminary Response, we
`determine that Petitioner has not shown a reasonable likelihood that it would
`prevail with respect to at least one of the challenged claims. Accordingly,
`we do not institute an inter partes review.
`
`B. Related Proceedings
`The parties identify a related federal district court case involving the
`’807 Patent: Fisher & Paykel Healthcare Ltd. v. ResMed Corp., Case No.
`3:16-cv-02068-GPC-WVG (S.D. Cal.). Pet. 1; Paper 6, 1–2.
`Petitioner has filed a second petition for inter partes review of the
`’807 Patent (see IPR2016-01734), as well as two petitions for inter partes
`review of U.S. Patent No. 8,479,471 B2, which is related to the ’807 Patent
`(see IPR2016-01714, IPR2016-01718).
`The parties inform us that Petitioner filed and then voluntarily
`dismissed, without prejudice, a declaratory judgment action challenging the
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`validity of the ’807 Patent (ResMed Inc. v. Fisher & Paykel Healthcare
`Corporation Limited, Case No. 3:16-cv-02072-JAH-MDD (S.D. Cal.).
`Pet. 1–2; Prelim. Resp. 9–10.
`
`C. Statutory Bar Under 35 U.S.C. § 315(a)(1)
`Patent Owner argues that the Petition is barred under 35 U.S.C.
`§ 315(a)(1) because Petitioner filed a declaratory judgment action for
`invalidity of the ’807 Patent on August 16, 2016, and before filing the
`instant Petition. Prelim. Resp. 9–16. That action, however, was voluntarily
`dismissed without prejudice on August 18, 2016, well before the instant
`Petition was filed. Pet. 2. As such, Patent Owner’s argument fails because
`prior Board decisions have consistently interpreted 35 U.S.C. § 315(a)(1) as
`not barring inter partes review if the previously filed civil action was
`dismissed without prejudice, which is the case here. See, e.g., Microsoft
`Corp. v. Parallel Networks Licensing, LLC, Case IPR2015-00486, slip op. at
`6–7 (PTAB Jul. 15, 2015) (Paper 10); Oracle Corp. v. Click-to-Call Techs.
`LP, Case IPR2013-00312, slip op. at 12–13 (PTAB Oct. 28, 2014)
`(Paper 52).
`Patent Owner now challenges the Board’s consistent interpretation of
`35 U.S.C. § 315(a)(1). But Patent’s Owner’s arguments are in direct
`contrast to a decision in the related district court action, which relied upon
`the Board’s consistent interpretation of 35 U.S.C. § 315(a)(1) in deciding
`whether to impose a stay pending our resolution of this proceeding.
`Ex. 3001. There, Patent Owner argued the statutory bar as a reason the court
`should not impose a stay. Id. at 3. The district court, noting that Petitioner’s
`declaratory judgment action was voluntarily dismissed “without prejudice”
`prior to the instant Petition being filed, held that “the effect of a voluntary
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`dismissal w/out prejudice is to render the prior action a nullity” such that it
`is “treated as if it was not ‘filed’ at all” and thus “cannot give rise to a
`statutory bar under 35 U.S.C. § 315(a)(1).” Id. at 4. In doing so, the district
`court relied upon, and expressly adopted, the reasoning of prior Board
`decisions that came to a similar conclusion.1 Id. Moreover, the district court
`noted that “at least eight Circuits had likewise determined that a dismissal
`without prejudice makes the situation as if the action had never been filed.”2
`Id.
`
`We see no reason to deviate from our prior decisions interpreting
`35 U.S.C. § 315(a)(1) or the district court’s concurring analysis of this issue,
`and Patent Owner’s arguments to the contrary do not persuade us
`otherwise. As such, we hold that the Petition is not barred by 35 U.S.C.
`§ 315(a)(1).
`
`D. The ’807 Patent
`The ’807 Patent, titled “Breathing Assistance Apparatus,” issued on
`May 21, 2013, and claims priority from applications filed in New Zealand
`on July 14 and November 6, 2006. Ex. 1001, 1. The ’807 Patent relates to a
`
`
`1 The district court may have recognized that “an agency’s interpretation of
`the statute under which it operates is entitled to some
`deference.” Southeastern Community College v. Davis, 442 U.S. 397, 411
`(1979).
`2 See, e.g., Holloway v. U.S., 60 Fed. Cl. 254, 261 (2004), aff’d 143 F. App’x
`313 (Fed. Cir. 2005) (treating civil action dismissed without prejudice “as if
`it never existed.”); Bonneville Assoc., Ltd. P’ship v. Barram, 165 F.3d 1360,
`1364 (Fed. Cir. 1999) (“The rule in the federal courts is that ‘[t]he effect of a
`voluntary dismissal without prejudice pursuant to Rule 41(a) is to render the
`proceedings a nullity and leave the parties as if the action had never been
`brought.’”) (citations and some internal quotations omitted).
`
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`nasal interface for the supply of positive pressure respiratory gases to a
`person suffering from obstructive sleep apnea. See, e.g., Pet. 4 (citing Ex.
`1001, 1:10–13, 1:24–2:32, 2:58–3:30; Ex. 1008 ¶¶ 24–29; Ex. 1040).
`Figures 2 and 3 of the ’807 Patent as annotated by Petitioner are
`reproduced below.
`
`
`Id. at 4. The annotated figures above depict a patient interface embodiment
`including nasal mask 2, mask body 23 with nasal pillows 24, 25, mask base
`22, swivel elbow connector 30, contoured side arms 41, 54, headgear
`assembly 21, and side straps 37, 38. See id. at 5 (citing Ex. 1001, 5:25–47,
`6:38–45, 6:57–7:3, 8:38–52; Ex. 1008 ¶¶ 28–29). “The nasal pillows 24, 25
`are preferably frustoconical in shape and in use rest against a patient’s
`nares,3 to substantially seal the patient’s nares.” Ex. 1001, 5:29–31. As
`described in the Specification, “mask base 22 is a ring or sleeve type
`attachment.” Id. at 6:19–20. The side straps extend underneath the side
`arms, to which they are glued or otherwise attached as shown in Figure 2,
`
`
`3 “Nares” as used in the Specification is interchangeable with “nostrils.” See
`Ex. 1001, 2:4–10, 5:29–31, 6:9–12.
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`but in an alternative embodiment, the distal ends of the side straps are
`connected to the side arms, for example, by hook and loop material. Id. at
`7:4–16, 38–45.
`Of the challenged claims, claim 1 is the only independent claim, and
`claims 2–7, 17–19, 24, and 25 depend, directly or indirectly, from claim 1.
`Claim 1 is reproduced below:
`1. A patient interface comprising:
`a mask assembly having:
`a mask body including two nasal pillows
`extending from
`it, which
`in use rest
`in a
`substantially sealed manner against the nares of a
`user, the mask body sized and shaped to leave the
`mouth of the user uncovered by the mask body
`when in use;
`a ring engaged with the mask body;
`a plane substantially bisecting the ring, each
`of the two nasal pillows positioned on opposite
`sides of the plane;
`an elbow rotatably engaged with the ring, the
`ring forming a socket into which a portion of the
`elbow fits to facilitate the rotatable engagement
`between the elbow and the ring, the elbow
`comprising a plurality of vent holes; and
`a tube or conduit extending from the elbow;
`
`and
`
`a headgear assembly having:
`two side straps that pass down the cheeks of
`the user to secure the mask body to a face of the
`user;
`
`a top strap including a buckle configured to
`facilitate length adjustment of the top strap; and
`a back strap adjustably connected to at least
`one of the top strap and the two side straps;
`wherein the two side straps are configured to
`connect and disconnect with the mask assembly
`while the elbow remains rotatably engaged with the
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`
`ring and the ring remains engaged with the mask
`body wherein the mask assembly is configured to
`connect to only the two side straps; and
`wherein the top strap connects only with one
`or more of the side straps and the back strap.
`Id. at 11:28–59.
`
`E. Prosecution History
`During prosecution, the Examiner rejected application claims 45, 47,
`51, 52, 54 and 55 under 35 U.S.C. §103 as unpatentable over U.S. Patent
`No. 7,219,669 B1 (Ex. 1012, “Lovell”) and Figure 135 of U.S. Patent
`Publication No. 2004/0226566 A1 (Ex. 1004, “Gunaratnam”). Ex. 1009,
`588–89. To overcome that rejection, Applicants amended the independent
`claims, including application claim 38 (patent claim 1), to recite that the
`mask assembly is configured to connect to only two side straps, and argued
`that removing two of the four side straps from Lovell’s mask would change
`the principle of operation of Lovell’s four point restraining system for
`securely positioning the mask against the nares of a user. Id. at 614–22.
`The Examiner then allowed the claims. Id. at 633.
`
`F. The Asserted Grounds
`Petitioner challenges claims 1–7, 17–19, 24, and 25 on the following
`grounds (Pet. 3):
`
` Reference(s)
`
`Gunaratnam and Ging4
`
` Basis
`§ 103(a)
`
`Claims Challenged
`
`1–7, 17–19, 24, and 25
`
`
`4 U.S. Patent Publication No. 2003/0196658 A1, pub. Oct. 23, 2003
`(Ex. 1005, “Ging”).
`
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`
` Reference(s)
`Gunaratnam, Ging, and
`McAuley5
`Lovell and Gunaratnam
`
`
` Basis
`
`§ 103(a)
`
`§ 103(a)
`
`Claims Challenged
`
`1–7, 17–19, 24, and 25
`
`1–7, 17–19, 24, and 25
`
`II. ANALYSIS
`A. Level of Skill in the Art
`Petitioner asserts that a person of ordinary skill in the art (“POSITA”)
`“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.” Pet. 7 (citing Ex. 1008 ¶ 21).
`As Patent Owner does not dispute Petitioner’s definition at this stage of the
`proceeding (Prelim. Resp. 32), we adopt it for the purposes of our Decision.
`
`B. Claim Construction
`In an inter partes review, the Board gives claim terms in an unexpired
`patent their broadest reasonable interpretation in light of the specification of
`the patent in which they appear. 37 C.F.R. § 42.100(b); see Cuozzo Speed
`Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016). Under that standard, a
`claim term generally is given its ordinary and customary meaning, as would
`be understood by one of ordinary skill in the art in the context of the entire
`disclosure. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`2007). While our claim interpretation cannot be divorced from the
`specification and the record evidence, see Microsoft Corp. v. Proxyconn,
`
`
`5 International Publication No. WO 2005/079726 A1, pub. Sept. 1, 2005
`(Ex. 1034, “McAuley”).
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`Inc., 789 F.3d 1292, 1298 (Fed. Cir. 2015) (quoting In re NTP, Inc., 654
`F.3d 1279, 1288 (Fed. Cir. 2011)), we must be careful not to import
`limitations from the specification that are not part of the claim language.
`See SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir.
`2004). Any special definition for a claim term must be set forth in the
`specification with reasonable clarity, deliberateness, and precision. See In re
`Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`
`1. “ring”
`Claim 1 recites “a ring engaged with the mask body” (emphasis
`added). Petitioner contends that the term “ring” requires “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.” Pet. 7–8; Ex. 1008 ¶¶ 40–41. Petitioner argues that
`“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.”
`Pet. 9.
`Patent Owner disagrees with Petitioner’s construction, and argues that
`“the term ring should be given its ordinary meaning, namely ‘a generally
`circular band of material.’” Prelim. Resp. 33. Patent Owner asserts that its
`proposed construction is consistent with the description in the Specification
`of mask base 22 as “a ring or sleeve like type attachment” (id. at 33–34
`(citing Ex. 1001, 6:23, Figs. 4, 5)), and supported by standard dictionary
`definitions (id. at 34–35 (citing Ex. 1014, 5; Ex. 2001, 3; Ex. 2003, 3)).
`Patent Owner further argues that Petitioner’s construction is overly broad
`because it encompasses “[v]irtually any structure, regardless of its shape,
`that includes ‘a generally circular inner passage.’” Id. at 35.
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`
`We agree with, and adopt, Patent Owner’s arguments. For the
`purposes of this Decision, we determine that the broadest reasonable
`interpretation consistent with the Specification of the term “ring” is a
`generally circular band of material.
`
`2. Other Claim Terms
`We determine that no other explicit claim interpretation is required for
`the purposes of this Decision. See Vivid Techs., Inc. v. Am. Sci. & Eng’g,
`Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).
`
`C. Asserted Obviousness
`A claim is unpatentable for obviousness under 35 U.S.C. § 103(a) if
`the differences between the subject matter sought to be patented and the
`prior art are such that the subject matter as a whole would have been obvious
`at the time the invention was made to a person having ordinary skill in the
`art to which the subject matter pertains. See KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398, 406 (2007). In analyzing the obviousness of a combination of
`prior art elements, it can be important to identify a reason that would have
`prompted one of skill in the art to combine the elements in the way the
`claimed invention does. Id. The question of obviousness is resolved on the
`basis of underlying factual determinations, including: (1) the scope and
`content of the prior art; (2) any differences between the claimed subject
`matter and the prior art; (3) the level of skill in the art; and (4) objective
`evidence of nonobviousness, i.e., secondary considerations, if in evidence.
`See Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`
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`
`1. Asserted Obviousness over
`Gunaratnam and Ging
`
`a. Overview of Gunaratnam
`Figure 135 of Gunaratnam is reproduced below.
`
`
`Ex. 1004, Fig. 135. Figure 135 of Gunaratnam depicts a mask having an
`elbow “provided to the front of the mask frame, like [ResMed’s] VISTA
`mask.” Id. ¶ 403. Petitioner asserts that “it is the Vista mask [specifically
`referenced in Gunaratnam] that is disclosed in Ging.” Pet. 19 (citing
`Ex. 1004 ¶¶ 341, 403; Ex. 1008 ¶¶ 47–48, 51, 61–63).
`Petitioner acknowledges that Gunaratnam’s Figure 135 discloses “a
`full mask covering the nose entirely, not nasal pillows,” but asserts that
`Gunaratnam also discloses patient interfaces that use nasal pillows masks.
`Id. at 15 (citing Ex. 1004, Figs. 1–133; Ex. 1035; Ex. 1036; Ex. 1008 ¶¶ 66–
`73). Petitioner provides annotated versions of the nasal pillows masks
`depicted in Gunaratnam’s Figures 107G and 107H, which are reproduced
`below.
`
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`Id. at 17 (citing Ex. 1004, Figs. 107G, 107H). According to Petitioner,
`annotated Figures 107G and 107H illustrate “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.” Id.
`Petitioner provides an annotated figure, reproduced below, to illustrate
`the asserted configuration achieved by “[a]applying a known nasal pillows
`mask body to Gunaratnam’s Figure 135 patient interface”:
`
`
`
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`Id. at 16 (citing Ex. 1004, Fig. 135). Petitioner asserts that the similarly
`configured Gunaratnam embodiments “suggest[] the interchangeability of a
`full nasal mask and a nasal pillows mask in Gunaratnam Figure 135.” Id.
`at 17 (citing Ex. 1008 ¶ 73; Ex. 1004, Fig. 108; Ex. 1035, 4; Ex. 1036, 1).
`
`b. Overview of Ging
`Petitioner asserts that “[t]he same nasal mask structure shown in
`Gunaratnam Figure 135, including the nasal mask frame, is shown in more
`detail in another ResMed patent filing, Ging, for example Figure 6b of Ging
`. . . , with the mask frame referenced as 20.” Id. at 18–19. Figure 6b of
`Ging is reproduced below.
`
`
`Ex. 1005, Fig. 6b. Figure 6b shows mask frame 20, elbow assembly 60 (not
`identified in the figure), and C-clip 23, which is used to attach elbow
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`assembly 60 to mask frame 20. Id. ¶ 113.
`
`c. Analysis
`
`(i) “a ring engaged with the mask body”
`Petitioner argues that the mask frame in Gunaratnam’s Figure 135,
`which Petitioner asserts is identical to mask frame 20 in Ging’s Figure 6b,
`corresponds to the “ring” in claim 1. Pet. 18. Petitioner provides an
`annotated figure, reproduced below, identifying the mask frame in the
`asserted Gunaratnam/Ging combination:
`
`
`Id. Petitioner argues that “[t]he Gunaratnam/Ging mask frame 20 meets the
`claimed ‘ring,’ despite not having a circular periphery.” Id. at 20 (citing
`Ex. 1008 ¶¶ 77–85). This argument is based on Petitioner’s proposed
`construction of “ring,” which we have rejected. See supra Section II.B.1.
`Patent Owner argues that the mask frame in Gunaratnam and Ging is
`not a generally circular band of material and thus is not a “ring” under a
`proper claim construction. Prelim. Resp. 44–45. We agree with, and adopt,
`Patent Owner’s argument. As Patent Owner argues, the mask frame in the
`Gunaratnam/Ging combination is “oblong” or “horseshoe-shaped”—i.e., it
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`“includes upper and lower peripheral edges that form two surfaces that are
`generally parallel with each other across the length of the frame”—and thus
`is not a generally circular band of material as required under our claim
`interpretation of “ring.” See id.; supra Section II.B.1.
`
`(ii) “wherein the two side straps are configured
`to connect and disconnect with the mask assembly”
`Petitioner argues that the side straps in Gunaratnam’s Figure 135 are
`“configured to connect and disconnect with the mask assembly” as claim 1
`requires “because the elbow is connected at the front center of the mask
`assembly, and the two side straps independently connect and disconnect at
`the sides.” Pet. 28 (citing Ex. 1008 ¶¶ 96–99). In support of Petitioner’s
`argument, Dr. Izuchukwu testifies that a skilled person would have
`understood that the side straps in Figure 135 could be connected to and
`disconnected from the mask assembly:
`[A] person of ordinary skill in the art would have understood that
`the straps located on either side of the mask frame depicted in the
`patient interface in Figure 135 of Gunaratnam could be
`connected to and disconnected from the mask assembly
`(indirectly, via the yokes (side arms)) while the swivel elbow
`remains rotatably engaged with the ring and the ring remains
`engaged with the mask body. The details of how the side arms
`could be connected and disconnected from the frame are shown
`and described with respect to Figs. 108–114 in Gunaratnam, for
`example. Of course, Figure 135 is different from Figs. 108–114
`in that the elbow is located in front of the frame, rather than
`inserted from the side, but the manner in which the yokes connect
`to the frame would be substantially the same.
`Ex. 1008 ¶ 97.
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`
`Petitioner provides an annotated version of Figure 135, reproduced
`below, purporting to show side arms configured to connect and disconnect
`with the mask assembly:
`
`
`Pet. 28. The figure above includes an annotation that states “[s]ide arm
`configured to connect and disconnect with the mask assembly.” Id.
`Petitioner explains that “[t]he side straps in Figure 135 do not connect
`directly to the mask assembly, but the claims do not require a direct
`connection.” Id.
`Patent Owner disputes Petitioner’s argument that the side arms (side
`yokes) of Figure 135 are removable from the frame. Prelim. Resp. 58–59.
`Patent Owner asserts that instead, as shown in Figure 135, “the side yokes
`are formed as a single piece with the frame.” Id. at 58. Patent Owner also
`disputes Petitioner’s assertion that the side arms in Figure 135 attach to the
`frame in a manner similar to the side arms in Figures 108–113. Id. at 59.
`Patent Owner asserts that Figures 108–113 disclose a nozzle assembly
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`affixed to a “tubular shaped frame,” but the nozzle assembly in Figure 135
`does not have a tubular shaped frame. Id. Patent Owner further argues that
`Petitioner “provide[s] no explanation why it would have been obvious to
`further alter Petitioners’ already modified Figure 135 to add a removable
`connection for the yokes.” Id.
`We are not persuaded by Petitioner’s argument that the two side straps
`in Figure 135 independently connect and disconnect at the sides. See
`Pet. 28. Nor are we persuaded by Dr. Izuchukwu’s testimony that a skilled
`person would have understood that the side straps in Figure 135 could be
`disconnected indirectly from the mask assembly via the side arms or yokes.
`See Ex. 1008 ¶ 97.
`Petitioner’s assertion “that the two side straps in Figure 135
`independently connect and disconnect at the sides” is unsupported by any
`evidence in the record. As depicted in Figure 135, the side straps are
`attached to the inside of the side arms or yokes. Nothing in Figure 135 or
`elsewhere in Gunaratnam or in Ging teaches or suggests that the side straps
`can be disconnected from the side arms or yokes.
`Further, we agree with Patent Owner that nothing in Gunaratnam,
`including Figures 108–113, teaches or suggests that the side arms or yokes
`in the Figure 135 embodiment can be disconnected from the mask assembly.
`See Prelim. Resp. 58–59. Rather, as Patent Owner argues, the side arms or
`yokes in Figure 135 are formed as a single piece with the frame. Id. at 58.
`Thus, we are not persuaded that the side straps in Figure 135 could be
`connected to and disconnected from the mask assembly via the side arms or
`yokes.
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`
`Finally, Petitioner and Dr. Izuchukwu have not explained why a
`skilled person would have modified the side arms or yokes in Figure 135
`such that they “connect and disconnect with the mask assembly.” See In re
`Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[T]here must be some
`articulated reasoning with some rational underpinning to support the legal
`conclusion of obviousness.”). Dr. Izuchukwu’s testimony that the side arms
`“could be connected to and disconnected from the mask assembly
`(indirectly, via the yokes (side arms))” is insufficient to show that a person
`of ordinary skill would have been motivated to do so. See Ex. 1008 ¶ 97
`(emphasis added); see also InTouch Techs., Inc. v. VGO Comms., Inc., 751
`F.3d 1327, 1352 (Fed. Cir. 2014) (determining that an expert witness had
`“succumbed to hindsight bias in her obviousness analysis” in testimony that
`“primarily consisted of conclusory references to her belief that one of
`ordinary skill in the art could combine [the] references, not that [the person
`skilled in the art] would have been motivated to do so.”).
`Moreover, Dr. Izuchukwu’s further testimony that Figures 108–114
`provide the details of how the side arms in Figure 135 could be configured
`to connect and disconnect from the frame is conclusory and unpersuasive.
`See Ex. 1008 ¶ 97. In particular, Dr. Izuchukwu fails to reconcile the
`differences between the embodiments depicted in the figures. As shown in
`Figure 108, one end of cushion assembly 604 is provided with plug 622 and
`the other end is provided with swivel elbow 612. Ex. 1004 ¶ 377, Fig. 108.
`Figure 109 shows that yokes 608 include yoke rings 610. Id. ¶ 379. As
`depicted in Figure 109, yoke rings 610 connect yokes 608 to the tubular
`shaped ends of cushion assembly 604. In the Figure 135 embodiment,
`however, the side arms are formed as a single piece with the mask frame, the
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`elbow connects in front of the mask frame, and the mask frame lacks a
`tubular shape that would accommodate attachment of the side arms in the
`manner depicted in Figures 108–114. See Prelim. Resp. 59. Accordingly,
`we are not persuaded that the yoke connections depicted in Figures 108–114
`teach or suggest a manner of connecting and disconnecting the side arms in
`Figure 135.
`Petitioner also argues that it would “have been an obvious
`modification for the Gunaratnam Figure 135 headgear assembly to have the
`side straps connect directly to the mask assembly, rather than connecting via
`yokes as in Figure 135.” Pet. 29 (citing Ex. 1008 ¶ 98). To support its
`argument, Petitioner cites the testimony of Dr. Izuchukwu. Id. In the
`opinion of Dr. Izuchukwu, “it would have been predictable, and indeed
`obvious to apply the strap connect[-]and[-]disconnect feature from
`Figures 107G–H6 of Gunaratnam into the Figure 135 embodiment (as
`modified by Ging).” Ex. 1008 ¶ 98. Dr. Izuchukwu asserts that the goal of
`more readily and easily connecting and disconnecting the mask assembly
`from the headgear assembly would have motivated the modification:
`One of ordinary skill would have been motivated to apply the
`teachings from Figures 107G–H to allow patients to more readily
`connect and disconnect the mask assembly from the headgear
`assembly, thereby minimizing the effort required for a patient to
`don and remove the mask and headgear assemblies in use.
`
`Id.
`
`Dr. Izuchukwu’s testimony is conclusory, and does not explain
`sufficiently why or how a person of ordinary skill in the art would have
`chosen to incorporate the side strap connect-and-disconnect feature from
`
`
`6 Figures 107G and 107H are reproduced above.
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`Figures 107G–H of Gunaratnam into the Figure 135 embodiment. As
`discussed above, the side straps in the Figure 135 embodiment are attached
`to the inside of the side arms or yokes, which each are formed as a single
`piece with the frame. Dr. Izuchukwu does not explain how the attachment
`of the side straps to the side arms or yokes in the Figure 135 embodiment
`would need to be changed in order to incorporate the side strap connect-and-
`disconnect feature from Figures 107G–H. In particular, Dr. Izuchukwu does
`not explain whether the side straps would need to be detached from the
`inside of the side arms or yokes and, if so, how the functionality of the side
`arms or yokes would be affected. Moreover, Dr. Izuchukwu fails to disclose
`any underlying facts or data on which he bases his opinion that the side strap
`connect-and-disconnect feature of Figures 107G-H would have allowed
`patients to connect and disconnect, more readily and easily, the mask
`assembly from the headgear assembly in the Figure 135 embodiment.
`Accordingly, we give little weight to Dr. Izuchukwu’s testimony. See
`37 C.F.R. §42.65(a).
`For these reasons, we are unpersuaded that a person of ordinary skill
`in the art would have incorporated the side strap connect-and-disconnect
`feature of Figures 107G–H into the Figure 135 embodiment.
`
`(iii) Summary
`For the reasons discussed above, we determine that Petitioner has not
`established a reasonable likelihood of prevailing on its challenge to
`independent claim 1 as obvious over Gunaratnam and Ging. As Petitioner’s
`arguments and evidence with respect to dependent claims 2–7, 17–19, 24,
`and 25 do not remedy the deficiencies with respect to independent claim 1,
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`we also determine that Petitioner has not established a reasonable likelihood
`of prevailing on its challenges to those dependent claims.
`
`2. Asserted Obviousness over
`Gunaratnam, Ging, and McAuley
`Petitioner contends that McAuley remedies any failure of the
`Gunaratnam/Ging combination to teach or suggest a “ring.” See Pet. 43.
`Petitioner provides an annotated version of McAuley’s Figure 9, reproduced
`below, depicting McAuley’s “nasal cannula”:
`
`
`Id. at 41. As shown in annotated Figure 9 above, McAuley’s cannula
`includes body part 62, which Petitioner asserts is a “ring” as recited in
`claim 1. Id. at 42. The nasal cannula also includes “a flexible prong part 61
`(i.e., a nasal pillows mask body) . . . and a ball jointed connector 63 (swivel
`elbow).” Id. at 41–42 (citing Ex. 1034, 6:11–7:26). Petitioner explains that
`McAuley’s “body part 62 has a generally-circular exterior and serves as a
`frame or base to which the swivel elbow 63 and the nasal pillows mask
`body 61 connect.” Id. at 42 (citing Ex. 1034, 7:5–10).
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`Petitioner argues that one of skill in the art would have been
`motivated to use McAuley’s teachings to modify the Gunaratnam/Ging
`patient interface [i.e., to make the exterior of the frame generally circular],
`because, according to Petitioner, “doing so would reduce the weight of the
`mask on the patient’s face, make the frame more compact (and therefore less
`obstructive to the patient’s view), and reduce material costs in
`manufacturing the frame.” Id. at 42–43 (citing Ex. 1008 ¶¶ 181–185).
`Petitioner relies on Dr. Izuchukwu’s testimony to support its rationale for the
`combination:
`With McAuley’s teachings in mind, I believe that persons
`of ordinary skill in the art would have seen reason to have
`modified the combination of Gunaratnam and Ging (i.e., the
`Figure 135 embodiment from Gunaratnum modified to include
`nasal pillows and additional detail of certain features shown by
`Ging) to make the exterior of Gunaratnam’s frame generally
`circular. I believe this, because skilled artisans would have
`understood that the circular configuration would have been
`smaller and therefore would have reduced the weight of the
`mask, which would have increased patient comfort when
`wearing the mask. Another reason that skilled artisans would
`have seen a reason to have designed the Gunaratnam frame to be
`circular was that the circular frame would have been more
`compact and therefore users would have had a view that was less
`obstructed by the patient interface. And even further, a
`modification to make Gunaratnam’s frame circular would have
`required less material and therefore would have reduced the
`material costs in manufacturing. In a patient interface that has
`been modified to have a generally circular frame, I believe that
`Gunaratnam’s headgear straps could connect to structures that
`project from the sides of the generally-circular frame, like
`McAuley’s extension members 72 and 73, or could connect
`directly to attachment points on the surface of the rounded frame,
`without extensions 72 and 73. In some instances, connecting the
`headgear straps to extension members 72 or 73 would serve to
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`provide additional stability of the mask assembly on the patient’s
`face due to the connection points being further outward from the
`center of the patient’s