Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper 12
`Entered: March 10, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`RESMEDLIMITED, RESMED INC., AND RESMED CORP,
`Petitioner,
`Vv.
`
`FISHER & PAYKEL HEALTHCARE LIMITED,
`Patent Owner.
`
`Case IPR2016-01714
`Patent 8,479,741 B2
`
`Before RICHARD E. RICE, BARRY L. GROSSMAN,and
`JAMES J. MAYBERRY,Administrative Patent Judges.
`
`GROSSMAN,Administrative Patent Judge.
`
`DECISION
`Denying Institution ofInter Partes Review
`37 CER. § 42.108
`
`

`

`IPR2016-01714
`Patent 8,479,741 B2
`
`I.
`
`INTRODUCTION
`
`A. Background
`
`ResMed Limited, ResMedInc., and ResMed Corp (collectively,
`
`Petitioner’) filed a Petition (Paper4, “Pet.”) requesting an inter partes
`
`review of claims 1, 21—25, 27-31, 33, and 34 of U.S. Patent No.
`
`8,479,741 B2 (Ex. 1001, “the ’741 patent’). Petitioner supported the
`
`Petition with a 142 page declaration from John Izuchukwu,Ph.D., PE.
`
`(Ex. 1008). Fisher & Paykel Healthcare Limited (“Patent Owner’’)filed a
`
`Preliminary Response (Paper8, “Prelim. Resp.”).
`
`Under35 U.S.C. § 314, an inter partes review maynot beinstituted
`
`“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). The Board acts on behalf of the Director. 37 C.F.R. § 42.4(a).
`
`Uponconsidering the Petition and the Preliminary Response, we determine
`
`that Petitioner has not shown a reasonablelikelihood 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
`
`Theparties identify a related federal district court case involving the
`
`°741 Patent: Fisher & Paykel Healthcare Ltd. v. ResMed Corp., Case No.
`
`3:16-cv-02068-GPC-WVG(S.D. Cal.). Pet. 1; Paper 8, 1—2.
`
`Theparties also inform usthat Petitioner filed and then voluntarily
`
`dismissed, without prejudice, a declaratory judgmentaction challenging the
`
`validity of the °741 Patent (ResMed Inc. v. Fisher & Paykel Healthcare
`
`Corporation Limited, Case No. 3:16-cv-02072-JAH-MDD(S.D. Cal.).
`
`

`

`IPR2016-01714
`Patent 8,479,741 B2
`
`Pet. 1-2; Paper 8, 1; see Ex. 1046 (Petitioner’s Notice of Voluntary
`
`Dismissal Without Prejudice).
`
`There are several pending inter partes reviews betweenthe parties
`
`related to the ’741 patent. Petitioner is seeking inter partes review of claims
`
`2-4, 6-10, 12-17, 19-20, and 35 of the ’741 patent in a separate petition
`
`(IPR2016-01718). The ’741 patent is a continuation of the application that
`
`matured into Patent No. 8,443,807 (‘the ’807 patent’). Petitioner alsois
`
`seeking inter partes review ofthe claimsin the ’807 patent (IPR2016-01726;
`
`01734).
`
`Petitioner also seeks inter partes review of several patents related to
`
`the general subject matter of the ’741 patent, including IPR2016-01716;
`
`01717; 01719; 01723; 01724; 01725; 01727; 01729; 01730; 01731; and
`
`01735.
`
`C. Statutory Bar Under 35 U.S.C. § 315(a)(1)
`
`Patent Ownerarguesthat the Petition is barred under 35 U.S.C.
`
`§ 315(a)(1) because Petitionerfiled a declaratory judgmentaction for
`
`invalidity of the ’741 patent on August 16, 2016, and beforefiling the instant
`
`Petition. Prelim. Resp. 8-16. That action, however, was voluntarily
`
`dismissed without prejudice on August 18, 2016, well before the instant
`
`Petition wasfiled. Pet. 1—2 (citing Ex. 1046). As such, Patent Owner’s
`
`argumentfails 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
`
`

`

`IPR2016-01714
`Patent 8,479,741 B2
`
`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
`
`whetherto imposea stay pending ourresolution of this proceeding.
`
`Ex. 3001. There, Patent Owner argued the statutory bar as a reason the court
`
`should not impose a stay. Jd. at 3. Noting that Petitioner’s declaratory
`
`judgmentaction was voluntarily dismissed “without prejudice”prior to the
`
`instant Petition being filed, the district court held that “the effect of a
`
`voluntary 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 “cannotgiverise
`
`to a statutory bar under 35 U.S.C. § 315(a)(1).” Jd. at 4. In doing so, the
`
`district court relied upon, and expressly adopted, the reasoning ofprior
`
`Board decisions that came to a similar conclusion.! Jd. Moreover, the
`
`district court in the related action noted that “at least eight Circuits had
`likewise determined that a dismissal without prejudice makesthe situation as
`
`if the action as had neverbeenfiled.” Jd.
`
`' The district court may have recognized that “an agency’s interpretation of
`the statute under whichit 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 “asif
`it never existed.”); Bonneville Assoc., Ltd. P’ship v. Barram, 165 F.3d 1360,
`1364 (Fed. Cir. 1999) (“The rule in the federal courtsis that ‘[t]he effect of a
`
`

`

`IPR2016-01714
`Patent 8,479,741 B2
`
`Wesee noreason 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. Prior Consideration ofArguments under §$ 325(d)
`
`Under35 U.S.C. § 325(d), the Board, acting on behalf of the Director,
`
`may take into account whether, and reject a petition because, the same or
`substantially the sameprior art or arguments previously were presented to
`the Office. Patent Ownerargues that the Board should exercise its discretion
`
`under § 325(d) and denyinstitution of a trial because Gunaratnam was
`
`expressly considered by the PTO during prosecution of the ’741 patent.
`
`Prelim. Resp. 30. We recognize that Gunaratnam was considered and
`
`applied by the Examiner during the PTO proceedings leading to issuance of
`
`-
`
`the ’741 patent. The specific combination of references asserted in the
`
`Petition, the evidence provided by the Declaration testimony of Dr.
`
`Izuchukwu,andthe specific factual issues raised by the Petition and newly
`
`cited references, however, were not previously considered. Accordingly, we
`
`do not reject or deny the Petition under § 325(d),
`
`I. The '741 Patent
`
`In an effort to treat obstructive sleep apnea, a technique known as
`
`Continuous Positive Airway Pressure (CPAP) was devised to supply
`
`voluntary dismissal without prejudice pursuant to Rule 41(a) is to render the
`proceedingsa nullity and leave the parties as if the action had never been
`brought.””) (citations and someinternal quotations omitted).
`
`

`

`IPR2016-01714
`Patent 8,479,741 B2
`
`pressurizedair to a patient, usually through a nasal mask. Ex. 1002, 1:39—
`
`43. The pressurized air supplied to the patient “acts as a pneumatic splint”
`
`(id. at 1:48) and thusassists the muscles to keep the patient’s airway open
`
`(id. at 1:43-45). The ’741 patent discloses that prior art devices provide the
`pressurized air to “a nose, full face, nose and mouth,or oral mask”thatis
`
`sealingly engaged to a patient’s face by a harness or other headgear.
`
`Td. at 1:50-54.
`
`The ’741 patent relates to a headgear and respiratory maskthat
`
`provides a nasalinterface for the supply of air from a CPAP machine. Jd. at
`116-18,
`
`Figures 2 and 3 of the ’741 patent, as annotated by Petitioner (Pet. 6),
`
`are reproduced below.
`
`Side
`
`strap 37
`
`
`
`
`Mask body 23, having
`
`nasal pillows 24,25
`
`at
`
`
`™\ sia
`
`
`Ns arm 41
`
`
`\
`J
`Central
`Py \ am
`Curved and
`
`
`»
`section 42 o/ x
`Elongate Member 34
`a
`Le
`FIGURE 3
`
`FIGURE 2
`
`*
`
`Figures 2 and 3 of the ’741 patent as annotated by Petitioner.
`Figure 2 is a perspective view of a nasal mask and headgear.
`Figure 3 is an exploded view of the nasal mask and headgear of Figure2.
`
`

`

`IPR2016-01714
`Patent 8,479,741 B2
`
`The annotated figures above depict a patient interface embodiment
`
`including mask 2 and headgear 21. Mask 2 includes mask base 22 (see Fig.
`
`5 below) and mask body 23 (see Fig. 7 below).
`
` 28
`
`FIGURE 5|
`Maskbase 22
`
`FIGURE 7
`Mask body 23
`
`As shownin Figure 7, mask body 23 includesnasal pillows 24, 25.
`
`Ex. 1001, 5:28-36. Nasal pillows 24, 25 are frustoconical in shape and in
`use rest against a patient’s nares,’ to substantially seal the patient’s nares.
`
`Ex. 1001, 5:32-34; Figs. 6, 7. As shownin Figure 5, mask base 22 is a ring
`
`or sleeve type attachment. Jd. at 6:22—23. One end of swivel elbow
`
`connector 30 is connected to one side of mask base 22 (id. at 6:42—46), and
`
`mask body 23 is connected to the other side of mask base 22 (id. at 5:34—
`
`36). The other end of connector 30 is attached to tube 31, which connects to
`
`a source of pressurized air. Jd. at 6:47—-50; see Figs. 1 and 2. In use, air
`
`flows through tube 31, connector 30, mask base 22 and mask body 23, and
`
`exits from nasal pillows 24, 25 through outlets 26, 27 into the patient’s
`
`nostrils.
`
`3 Nares also are referred to as nostrils. See Ex. 1002, 6:12-13 (“This allows
`easier insertion ofthe pillow 24 into a user’s nostrils... .”).
`
`

`

`IPR2016-01714
`Patent 8,479,741 B2
`
`Mask 2 andits related components, as described above,are held in
`
`place on the patient by headgear 21. As shown in Figures 2 and 3, headgear
`
`21 includes headgearstraps 35, 36, 37, 38 and substantially curved,rigid,
`
`elongate member34. Jd. at 6:61-65. Elongate member 34 of headgear 21
`
`includes central section 42 and contoured side arms 41, 54. Jd. at 7:8-10.
`
`Preferably the side arms of curved member34 are integrally molded with
`
`central section 42. [d. at 21-22; see also 7:53—54 (“The central section 42is
`
`a half circle that is integrally moulded with the side arms 41, 54.”).
`
`Alternatively, left and right side arms 41, 54 may be “attached,”
`
`respectively, to each side of base 22. Id. at 8:29-30.
`
`A substantial length of each of side arms 41 and 54 overlaps andis
`
`attached to respective side straps 37, 38. Side straps 37, 38 are made from a
`
`soft foam type material to make the headgear more comfortable, whereas
`
`curved member 34 and side arms 41, 54 are made from a morerigid material
`
`to provide stability to headgear 21 and nasal mask 2. See generally
`
`id. at 7:8-18.
`
`When everything is assembled, elongate member 34 supports mask
`
`base 22 and mask body 23 suchthat pillows 24, 25 are positioned properly
`
`against the patient’s nares.
`
`Ofthe challenged claimsin this Petition, claim 1 is the only
`
`independent claim andis reproduced below:
`
`1. A patient interface comprising:
`a mask body comprising a substantially flexible plastics
`material, the mask body comprising a first nasal pillow and a
`second nasal pillow, the first nasal pillow and the second nasal
`pillow being angled toward one another, the first nasal pillow
`comprising a first generally conical portion anda first generally
`cylindrical portion, the second nasal pillow comprising a second
`
`

`

`IPR2016-01714
`Patent 8,479,741 B2
`
`generally conical portion and a second generally cylindrical
`portion, the first nasal pillow comprising a first outlet opening
`and the second nasal pillow comprising a second outlet opening;
`the mask body also comprising a mask bodyinlet opening,
`the mask body inlet opening being spaced apart form the first
`outlet opening and the secondoutlet opening, the mask bodyinlet
`opening defined within a generally tubular portion of the mask
`body;
`
`a mask base comprising a plastics material that is less
`flexible than the substantially flexible plastics material of the
`mask body, the mask base comprising a housing that defines a
`through passage, a proximalportion of the through passage being
`surrounded bya recess, the recess of the mask base receiving the
`generally tubular portion of the mask bodythat defines the mask
`body inlet opening;
`a first side arm removably connected to the mask base and
`a second side arm removably connected to the mask base, the
`first side arm being three dimensionally molded and having a
`varying cross-sectional thickness and the second side arm being
`three dimensionally molded and having a varying cross-sectional
`thickness; and
`headgear comprising a first side strap and a second side
`strap, the first side strap and the second side strap comprising a
`composite foam material, the first side arm overlapping with and
`secured to the first side strap, the second side arm overlapping
`with and secured to the second side strap, the first side strap
`extending only partially along the first side arm, the second side
`strap extending only partially along the second side arm.
`
`F. Prosecution History
`
`During prosecution, the Examiner rejected independent application
`
`claim 31, which becamepatent claim 2, under 35 U.S.C. §103 as
`
`unpatentable over U.S. Patent No. 7,210,481 (Ex. 2006, “Lovell’”) and U.S.
`
`Patent Publication No. 2004/0226566 A1 (Ex. 1004, “Gunaratnam”’).
`
`Ex. 1010, 466-471. We note that independent patent claim 2 is not involved
`
`in this proceeding. It is, however, involved in the related proceeding,
`
`

`

`IPR2016-01714
`Patent 8,479,741 B2
`
`IPR2016-01718. Concerning Gunaratnam, the Examinerstated that
`Gunaratnam “discloses another nasal mask that incorporates a pair of arms
`in numerous embodiments (see elements 608 and the unnumbered armsin
`
`Figure 135) so as to enhancethe fit between the mask and face of a user by
`
`adding rigidity between the straps and mask.” Jd. at 468. Independent
`
`application claim 30, which becamepatent claim 1, was rejected only on the
`
`non-statutory ground of obviousness-type double patenting based on
`
`pending claimsin its parent application, which matured into the 807 patent.
`
`Id. at 470.
`
`Following a substantive amendmentto application claim 31 (patent
`
`claim 2) (id. at 493-501), the application was allowed by the Examiner
`
`(id. at 513-515). The Examiner’s reason for allowance was:
`
`noneofthe priorart of record including the device defined by the
`patented claims of Application 12/307,993 [now the parent ’807
`patent], alone or
`in combination,
`teach a patient
`interface
`including the feature of a [sic] first and second side armsthat are
`three dimensionally molded and having a varying cross-sectional
`thickness that overlap with a first and second side strap of
`headgear, as claimed.
`
`Ex. 1010, 514.
`
`G. The Asserted Grounds
`
`Petitioner challenges claims 1, 21-25, 27-31, 33, and 34 on the
`
`following grounds (Pet. 3-4):
`
`
`Reference(s)|Basis|Claims Challenged
`
`
`
`4U.S. Patent Publication No. 2003/0196658 Al (Ex. 1005, “Ging”).
`
`10
`
`

`

`IPR2016-01714
`Patent 8,479,741 B2
`
`Reference(s)|Basis|Claims Challenged
`Gunaratnam, Ging, and
`103(a
`
`
`
`Il. ANALYSIS
`
`A. Level ofSkill in the Art
`
`Petitioner asserts that a person of ordinary skill in the art “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
`
`experiencein the field of medical devices or respiratory therapy, or an
`
`equivalent advanced education.” Pet. 10 (citing Ex. 1008 4 17). Patent
`
`Ownerdoes notproposea level of skill. We adopt Petitioner’s proposed
`
`level of skill 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 reasonableinterpretation 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 oneof 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).
`
`Petitioner proposes a specific construction for the phrase “the mask
`
`base comprising a housing that defines a through passage,” whichis in
`
`independent claim 1. Patent Owner does not propose any specific
`
`construction of the claim terms.
`
`> U.S. Patent No. 4,919,128 (Ex. 1025, “Kopala”).
`
`11
`
`

`

`IPR2016-01714
`Patent 8,479,741 B2
`
`Wedeterminethat a specific construction of the challenged claimsis
`
`unnecessary for purposesof this Decision.
`
`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 madeto a person having ordinaryskill in the
`
`art to which the subject matter pertains. See KSR Int’l Co. v. Teleflex Inc.,
`
`550 U.S. 398, 406 (2007). The question of obviousnessis 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 priorart; (3) the level of skill in the art; and (4) objective
`
`evidence of nonobviousness,i.e., secondary considerations. See Graham vy.
`
`John Deere Co., 383 U.S. 1, 17-18 (1966).
`
`1. Asserted Obviousness over
`Gunaratnam and Ging
`
`Gunaratnam is a published patent application relating to a nasal
`
`assembly patient interface for a mask usedin treating sleep apnea. Ex. 1004,
`
`{ 2. It is a comprehensive disclosure, including 109 pages of drawings, with
`
`135 drawing figures, and 404 paragraphsof explanatory text.
`
`12
`
`

`

`IPR2016-01714
`Patent 8,479,741 B2
`
`Figure 135 of Gunaratnam,as annotatedby Petitioner (Pet. 16), is —
`
`reproduced below.
`
`Back strap
`
`Side straps
`
`
`
`Headgear assembly
`
`
`
`FIG.13S
`
`Mask assembly
`
`Figure 135 of Gunaratnam depicts a headgear and respiratory mask
`
`that provides a nasalinterface for the supply of air from a CPAP machine.
`
`Id. § 403.
`
`Gingalso is a published patent application that relates to a headgear
`
`and respiratory mask that provides a nasal interface for the supply ofair
`
`from a CPAP machine. Petitioner provides the following annotated figures
`
`from Ging.
`
` FIG. 1076
`
`13
`
`

`

`IPR2016-01714
`Patent 8,479,741 B2
`
`Pet. 18.
`
`Throughout the 53 page Petition, Petitioner provides a detailed clause-
`
`by-clause analysis of each limitation in the challenged claims along with an
`
`analysis of why it would have been obviousto a person ofordinary skill to
`
`_ glean selected features from the disclosures in Gunaratnam and Ging and
`combinethem. Throughoutits analysis, Petitioner relies on the Declaration
`testimony of Dr. John Izuchukwu. Dr. Izuchukwu earned a Ph.D. in
`
`Industrial and Mechanical Engineering and an MBA degree. Ex. 1008 § 2.
`
`Hehas extensive experience in the developmentof various medical
`
`technologies, including CPAP machines,ventilators for respiratory support,
`
`and sleep masks. /d. at [] 3-4.
`
`a. Side Arms Removably Connected To the Mask Base
`
`Patent Ownerasserts, among otherissues, that Gunaratnam and Ging
`
`do not teach or make obvious“a first side arm removably connected to the
`
`maskbase and a second side arm removably connected to the mask base”as
`
`required by claim 1. Prelim. Resp. 44. We agree andfind this issue
`
`dispositive.
`
`Asdiscussed above, and as shownin the annotated Figures 2 and 3
`
`reproduced above, elongate member 34 of headgear 21 includes central
`
`section 42 and contoured side arms 41, 54. Ex. 1002, 7:8-10. In a preferred
`
`embodiment, the side arms of curved member34 are integrally molded with
`
`central section 42. Id. at 7:21-22; see also id. at 7:53—-54 (“The central
`
`section 42 is a half circle that is integrally moulded with the side arms41,
`
`54.”). Elongate member34 is not part of mask base 22; it is part of headgear
`
`21. Thus,in this preferred embodiment, the side arms are connected
`
`indirectly to mask base 22. The ’741 patent also discloses an alternate
`
`14
`
`

`

`IPR2016-01714
`Patent 8,479,741 B2
`
`embodiment wherein left and right side arms 41, 54 may be “attached,”
`
`respectively, to each side of base 22. Id. at 8:29-30.
`
`Petitioner asserts that ““Gunaratnam’s Figure 135 embodiment
`
`includes side arms described as yoke members(e.g., yokes 608 illustrated in
`
`Figures 109 through 135) that are removably connected to the base (‘frame’)
`
`to which the cushion attaches.” Pet. 33. Figure 135 from Gunaratnam,as
`
`annotated by Petitioner, is reproduced below. Yoke / Side arm
`
`FIG.155
`
`Figure 135 from Gunaratnam,as annotated by Petitioner,
`showing a mask and headgear assembly, with a yoke/side arm
`
`Gunaratnam discloses that the headgear assembly in Figure 135 shows
`a frame that includes an elbow connector on the front of the mask frame and
`
`opposile aperturesor first connector portions on the sides, each of whichis
`provided with seal ring 500. Seal ring 500 includes a separateor integral
`plug to close unuscd apertures or connectorportions of the frame, for
`
`

`

`IPR2016-01714
`Patent 8,479,741 B2
`
`example, when the elbow connectoris positioned on the front of the mask
`
`frame as shownin Figure 135. Ex. 1004
`
`403.
`
`According to Petitioner, the removable nature of the side arms in
`
`Gunaratnam’s Figure 135 is described in connection with Gunaratnam’s
`
`“Seventh Illustrated Embodiment.” Pet. 33 (citing Ex. 1004 7 375). The
`
`seventh embodimentis illustrated in Figures 108-113, and describedin the
`
`associated text. Ex. 1004 J] 376-381. Petitioner asserts this embodiment
`
`discloses that frame 616 is sealed with a plug 622. Pet. 34 (citing Ex. 1004,
`
`Figs. 108, 110, J] 376-381). Petitioner states that “[y]oke structures 608
`
`may be removed from the frame byfirst removing either the plug 622 or the
`
`swivel elbow 612 (depending on which side the yoke 608 is being removed
`
`from), then removing seal ring 614 to access yoke ring 610, which secures
`
`the yoke to the frame.” Jd. Petitioner concludes that because the swivel
`
`elbow in Figure 135 is on the front of the frame, the seal rings can be
`
`removed and the yokes disconnected from the mask while the elbow remains
`
`engaged with the frame, and while the frame remains engaged with the mask
`
`body (e.g., with nozzle assembly 18). Jd. (citing Ex. 1008 { 77).
`
`Dr. [zuchukwutestifies that in his opiniona skilled artisan “would
`
`have understood that the yokes in Figure 135 were similarly removably
`
`attachable, or at least that the Figure 135 embodiment could have been
`
`designed as shown with respect to Figure 108-113.” Ex. 1008 4 77
`
`(emphasis added). The reason “why”a skilled artisan would makethis
`
`modification, according to Dr. Izuchukwy,is “so that a user could replace or
`
`clean a portion of the patient interface.” Jd. Dr. IZuchukwu doesnot
`
`provide any persuasive facts or analysis as to why a patient interface cannot
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`IPR2016-01714
`Patent 8,479,741 B2
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`be removed for cleaning without also removing the side arms of the
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`headgear, or how removingthe side armsfacilitates cleaning.
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`Patent Ownertakes a different view of the evidence on which
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`Petitioner relies. According to Patent Owner, “Gunaratnam doesnot
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`describe that the yokes of Figure 135 are removable from the frame.”
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`Prelim. Resp. 44. It is Patent Owner’s position that Gunaratnam’s Figure
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`135 showsthat the side yokes are formedas a single piece with the frame.
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`Id.
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`We agree with Patent Owner’s analysis. Petitioner bears the burden
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`of establishing a reasonable likelihood of unpatentability of one or more
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`claims. 37 C.F.R. § 42.108(c). Here, the evidence on which Petitionerrelies
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`does not meet this burden.
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`The evidence on which Petitioner relies allows a connector andair
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`delivery tube to be repositioned into different openings, with the unused
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`openings sealed (plugged). Petitioner has not directed us to persuasive
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`evidencethat the seal rings and associated plugs can be removed and the
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`yokes disconnected ftom the mask while the elbow remains engaged with the
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`frame, and while the frame remains engaged with the mask body (e.g., with
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`nozzle assembly 18), as argued (Pet. 34). Rather, as Patent Ownerargues,
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`the side arms or yokes in Figure 135 are formed as a single piece with the
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`frame. Prelim. Resp. 44.
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`Norare we persuaded by Dr. Izuchukwu’s testimonythat a skilled
`person would have understood that the yoke in Figure 135 of Gunaratnam
`could have been designed as shown with respect to Figure 108-113. See
`
`Ex. 1008 § 77. This testimonyis insufficient to show that a person of
`
`ordinary skill would have been motivated to do so. See also InTouchTechs.,
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`Inc. v. VGO Comms., Inc., 751 F.3d 1327, 1352 (Fed. Cir. 2014)
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`(determining that an expert witness had “succumbedto hindsightbias in her
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`obviousnessanalysis” in testimonythat “primarily consisted of conclusory
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`referencesto her belief that one of ordinary skill in the art could combine
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`[the] references, not that [the person skilled in the art] would have been
`
`motivated to do so.”).
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`Moreover, Dr. Izuchukwu’s testimonythat Figures 108—113 provide
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`the details of how the side arms or yoke in Figure 135 could be configured to
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`connect and disconnect from the frame is conclusory and unpersuasive. See
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`Ex. 1008 § 77. In particular, Dr. Izuchukwu fails to reconcile the differences
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`between the embodiments depicted in the figures. As shownin Figure 108,
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`one end of cushion assembly 604 is provided with plug 622 and the other
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`end is provided with swivel elbow 612. Ex. 1004 7377, Fig. 108. Figure
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`109 showsthat yokes 608 include yoke rings 610. Id. § 379. As depicted in
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`Figure 109, yoke rings 610 connect yokes 608 to the tubular shaped ends of
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`cushion assembly 604. In the Figure 135 embodiment, however, the side
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`armsare furmed as a single piece with the mask frame, the elbow connects
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`in front of the mask frame, and the mask framelacks a tubular shapethat
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`would accommodate attachmentof the side arms in the manner depicted in
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`Figures 108-113. See Prelim. Resp. 44-45.
`Figure 111 of Gunaratnam, reproduced below,is includedin the
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`seventh embodiment (Figures 108-113) in Gunaratnam, on which Petitioner
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`(Pet. 33-34) and Dr. Izuchukwu (Ex. 1008 77)rely.
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`
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`FIG. 111 is an exploded perspective view
`showingthe interface between the seal ring and elbow swivel
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`As shownin Figure 111, the seal ring is removed, allowing the elbow
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`swivel to be repositioned while yoke 608 remains connected to nasal cushion
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`assembly 604. Petitioner has not directed us to persuasive evidencethat,
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`based on the disclosure of Gunaratnam’s seventh embodiment, it would have
`
`becn obvious to make the side arms or yoke in Gunaratnam’s Figure 135
`removably connected to the maskbase, as recited in claim 1.
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`Based on the evidence and arguments presented, we are not persuaded
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`that the yoke connections depicted in Figures 108-113 teach or suggest a
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`mannerof connecting and disconnecting the side arms in Figure 135.
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`Accordingly, it is not reasonably likely, based on the record before us,that
`Petitioner will prevail in its assertion that independent claim 1, and claims
`21-24, 27— 31, 33, and 34, which depend from claim 1, are unpatentable
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`over Gunaratnam and Ging.
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`In general, taken out of a specific context, making an element
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`“removably connected”to another element may seem like a simple, common
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`sense modification that would have been obviousto a person of ordinary
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`skill and creativity. We do not abandon our commonsense in considering
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`obviousness of claimed inventions. KSR Int’l v. Teleflex Inc., 550 U.S. 398,
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`421 (2007) (“Rigid preventative rules that deny factfinders recourse to
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`commonsense, however, are neither necessary underourcase law nor
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`consistent with it.””). Our decision is based on the evidence and arguments
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`before us. The evidence on whichPetitioner relies does not disclose or
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`suggest the “removably connected”side armsas recited in the challenged
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`claims. In the highly developedfield of patient interfaces and nasal masks
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`for the supply ofair to a patient, small differences may produce a
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`nonobvious advance. See Outside the Box Innovations, LLC v. Travel
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`Caddy, Inc., 695 F.3d 1285, 1298 (Fed. Cir. 2012). See also Unigene Labs.,
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`Inc. v. Apotex, Inc., 655 F.3d 1352, 1360-61 (Fed.Cir.201 1) (providing that
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`the inquiry under § 103 is not whether the claimed inventionis “sufficiently
`
`simple to appear obviousto judgesafter the discovery is finally made”).
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`“The emphasis on nonobviousnessis one of inquiry, not quality” of the
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`advance. Graham v. John Deere Co., 383 U.S. 1, 17 (1966). While “the
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`commonsenseofthose skilled in the art demonstrates why some
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`combinations would have been obvious where others would not,” (Leapfrog
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`Enters., Inc. v. Fisher—Price, Inc., 485 F.3d 1157, 1161 (Fed.Cir.2007)), the
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`determination is made not after observing what the inventor actually did, but
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`in light of the state ofthe art before the invention was made. Outside the
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`Box Innovations, 695 F.3d at 1298.
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`2. Asserted Obviousness over Gunaratnam, Ging, and Kopala
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`Petitioner asserts claim 25, dependent from claim 1, would have been
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`obvious based on Gunaratnam, Ging and Kopala. Pet. 51-53. Kopalais
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`cited for the asserted disclosure of a nasal pillow patient interface with an
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`inner profile offset inwardly relative to its outer profile. Jd. at 51. Kopalais
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`not cited for, and does not cure, the deficiencies discussed above in the
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`Gunaratnam reference concerning side arms removably connected to the
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`mask base. Accordingly, it is not reasonably likely, based on the record
`
`before us, that Petitioner will prevail with respect to claim 25
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`I. CONCLUSION
`
`For the reasonsgive, Petitioner has not shown a reasonable likelihood
`
`that it would prevail in establishing unpatentability of at least one of claims
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`1, 21-25, 27-31, 33, and 34 of the ’741 patent.
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`IV. ORDER
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`In consideration of the foregoing,it is hereby:
`
`ORDEREDthat Petitioner’s Petition for an inter partes review of
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`claims 1, 21-25, 27-31, 33, and 34 of U.S. Patent No. 8,479,741 B2 is
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`denied.
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`PETITIONER:
`
`Michael Hawkins
`hawkins@fr.com
`Michael Kane
`kane@fr.com
`Stephen Schaefer
`schaefer@fr.com
`Christopher Hoff
`hoff@fr.com
`Andrew Dommer
`dommer@fr.com
`
`PATENT OWNER:
`
`Brenton Babcock
`2brb@knobble.com
`Joseph Jennings
`2jfj@knobble.com
`
`22
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