Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper 12
`Entered: March 13, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`RESMEDLIMITED, RESMED INC., AND RESMED CORP,
`Petitioner,
`V.
`FISHER & PAYKEL HEALTHCARE LIMITED,
`Patent Owner.
`
`Case IPR2016-01718
`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 CFR. § 42.108
`
`
`Tel: 571-272-7822
`
`Paper 12
`Entered: March 13, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`RESMEDLIMITED, RESMED INC., AND RESMED CORP,
`Petitioner,
`V.
`FISHER & PAYKEL HEALTHCARE LIMITED,
`Patent Owner.
`
`Case IPR2016-01718
`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 CFR. § 42.108
`
`
`
`IPR2016-01718
`Patent 8,479,741 B2
`
`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 2-4, 6-10, 12-17, 19, 20, and 35 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., P.E.
`
`(Ex. 1008). Fisher & Paykel Healthcare Limited (“Patent Owner”) filed a
`
`Preliminary Response (Paper 10, “Prelim. Resp.”).
`
`Under 35 U.S.C. § 314, an inter partes review may not beinstituted
`
`“unless . .. there is a reasonable likelihood that the petitioner would prevail
`
`with respect to at least 1 of the claims challengedin the petition.” 35 U.S.C.
`§ 314(a). The Board acts on behalf of the Director. 37 C.F.R. § 42.4(a).
`Upon considering the Petition and the Preliminary Response, we determine
`that Petitioner has not showna 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 7, 1-2.
`Theparties also inform usthat Petitioner filed and then voluntarily
`dismissed, without prejudice, a declaratory judgmentaction challenging the
`validity of the °741 Patent (ResMedInc. v. Fisher & Paykel Healthcare
`Corporation Limited, Case No. 3:16-cv-02072-JAH-MDD(S.D.Cal.).
`
`
`
`IPR2016-01718
`Patent 8,479,741 B2
`
`Pet. 1-2; Paper 7, 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
`
`1, 21-25, 27-31, 33, and 34 of the ’741 patent in a separate petition
`
`(IPR2016-01714). The ’741 patent is a continuation of the application that
`
`matured into Patent No. 8,443,807 (‘the °807 patent’’). Petitioner also is
`
`seeking inter partes review ofthe claims in 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 before filing the
`
`instant Petition. Prelim. Resp. 10-17. That action, however, was voluntarily
`
`dismissed without prejudice on August 18, 2016, well before the instant
`
`Petition was filed. Pet. 1—2 (citing Ex. 1046). 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, whichis 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
`
`
`
`IPR2016-01718
`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). Prelim. Resp. 10-17. But Patent’s Owner’s
`
`argumentsarein 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 ourresolution of
`this proceeding. Ex. 3001. There, Patent Ownerarguedthe statutory baras
`a reason the court should not imposea stay.
`/d. at 3. Noting that
`
`Petitioner’s declaratory judgment action was voluntarily dismissed “without
`prejudice”prior to the instant Petition beingfiled, the district court held that
`“the effect of a voluntary dismissal w/out prejudice is to renderthe prior
`
`action a nullity” suchthat 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).” Jd. at 4. In
`doing so, the district court relied upon, and expressly adopted, the reasoning
`of prior Board decisions that cameto a similar conclusion.'
`/d. 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 never had been filed.” Id.
`
`| 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 “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
`
`
`
`IPR2016-01718
`Patent 8,479,741 B2
`
`Wesee no reasonto 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, wehold that the Petition is not barred by 35 U.S.C.
`
`§ 315(a)(1).
`
`D. Prior Consideration ofArguments under § 325(d)
`
`Under 35 U.S.C. § 325(d), the Board, acting on behalf of the Director,
`
`maytake into account whether, andreject a petition because, the same or
`
`substantially the sameprior art or arguments previously were presented to
`
`the Office. Patent Owner argues 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. 38-39. We recognize that Gunaratnam wasconsidered 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).
`
`E. The ’741 Patent
`
`In aneffort to treat obstructive sleep apnea, a technique knownas
`
`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 some internal quotations omitted).
`
`
`
`IPR2016-01718
`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 thus assists the muscles to keep the patient’s airway open
`(id. at 1:43-45). The ’741 patent disclosesthat prior art devices provide the
`pressurized air to “a nose, full face, nose and mouth,or oral mask”that is
`
`sealingly engaged to a patient’s face by a harness or other headgear.
`
`Id. at 1:50—54.
`
`The ’741 patent relates to a headgear and respiratory mask that
`
`providesa nasalinterface for the supply of air from a CPAP machine. Id.at
`
`1:16-18.
`
`Figures 2 and 3 of the ’741 patent, as annotated by Petitioner (Pet. 6),
`
`are reproducedbelow.
`
`Side
`strap 37
`
`“
`
`
`
`Mask body 23, having
`nasal pillows 24,25
`
`
`
`Side
`
`arm 54
`
`
`
`Curved and
`Central
`
`section 42
`Elongate Member 34
`
`FIGURE2
`FIGURE3
`
`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 headgearofFigure 2.
`
`
`
`IPR2016-01718
`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 includes nasal 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 shown in Figure 5, mask base 22is 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 connectsto
`a source of pressurized air. Id. 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... .”).
`
`
`
`IPR2016-01718
`Patent 8,479,741 B2
`
`Mask2 andits related components, as described above,are held in
`
`place onthe patient by headgear 21. As shownin 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. Jd. at 21-22; see also 7:53—54 (“The central section 42 is
`
`a half circle that is integrally moulded with the side arms 41, 54.”).
`A substantial length of each of side arms 41 and 54 overlapsandis
`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 member34 and side arms 41, 54 are made from a morerigid material
`
`to providestability to headgear 21 and nasal mask 2. See generally
`
`id. at 7:8-18.
`Wheneverythingis assembled, elongate member34 supports mask
`base 22 and mask body 23 suchthatpillows 24, 25 are positioned properly
`against the patient’s nares. In an alternative form, the mask base and the
`curved elongate memberareintegrally formed, such as by moldingor the
`
`like. Id. at 8:3-6.
`
`Ofthe challenged claims in this Petition, claim 2 is the only
`
`independent claim and is reproduced below:
`
`2. A patient interface comprising:
`a mask body comprising a molded elastomeric material,
`the mask body comprising two extending nasal pillowsandalip,
`the nasalpillows, in use, resting in a substantially sealed manner
`against corresponding nares of a user;
`a ring engaged withthe lip of the mask body;
`
`
`
`IPR2016-01718
`Patent 8,479,741 B2
`
`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 elbow
`comprising a wall, a vent being formedin the wallof the elbow,
`the vent comprising a plurality of holes;
`a tube or conduit extending from the elbow; and
`a headgear comprising side straps that pass down the
`cheeks ofthe user, a top strap connectedto the side straps, a back
`strap extending from at least one of the side straps and the top
`strap,
`the headgear
`further comprising molded side arms
`extending away from the ring to connect with the side straps,
`wherein the molded side arms overlap the side straps andthe side
`straps are made from a soft foam material, and whereinthe side
`straps overlap the molded side arms on a portion of the molded
`side arms that is spaced from thering, the side straps extending
`away from the ring along the molded side arms;
`the elbow being capable of swiveling in the ring such that
`the tubing can beattached to the top strap or can fall freely;
`in use, gases flow from the tube or conduit, through the
`elbow, throughthe ring, through the mask body and through the
`pillows;
`wherein the ring is configured to connect to only two
`molded side arms and wherein each of the two moldedside arms
`is configured to connect with a single sidestrap.
`
`F. Prosecution History
`During prosecution, the Examinerrejected independentapplication
`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 Al (Ex. 1004, “Gunaratnam”’).
`Ex. 1010, 466-471. 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 andface ofa user by
`
`
`
`IPR2016-01718
`Patent 8,479,741 B2
`
`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 maturedinto 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:
`
`noneoftheprior art 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 2-4, 6-10, 12-17, 19, 20, and 35 under
`
`35 U.S.C.§ 103(a)* on the following grounds (Pet. 3-4):
`
`4 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125
`Stat. 284, 296-07 (2011), took effect on September 16, 2012. Because the
`application for the patent at issue in this proceeding hasan effective filing
`date before that date, we refer to the pre-AIA versionsofthe statute.
`
`10
`
`
`
`IPR2016-01718
`Patent 8,479,741 B2
`
`Claims Challenged
`
`
`
`
`
`Reference(s)
`2-4, 6-9, 12-17, 19, 20,
`Gunaratnam and Ging?
`
`
`and 35
` Gunaratnam, Ging, and
`Kopala®
`
`
`
`Gunaratnam, Ging,
`McAuley’
`Gunaratnam, Ging,
`McAuley, Kopala
`
`—©o
`
`
`
`2-4, 6-9, 12-17, 19, 20,
`and 35
`1
`
`
`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 arelated 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. 10-11 (citing Ex. 1008 417). Patent
`Ownerdoes not propose a 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 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). Underthat standard, a
`claim term generally is given its ordinary and customary meaning, as would
`
`5 U.S. Patent Publication No. 2003/0196658 Al (Ex. 1005, “Ging”’).
`6 U.S. Patent No. 4,919,128 (Ex. 1025, “Kopala”.
`TPCT Pub. WO 2005/079726 (Ex. 1034, McAuley).
`
`1]
`
`
`
`IPR2016-01718
`Patent 8,479,741 B2
`
`be understood by one of ordinary skill in the art in the context ofthe entire
`
`disclosure. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`
`2007).
`
`Petitioner proposes a specific construction for the term “ring”
`
`(Pet. 11) and the phrase “a plane substantially bisecting the ring, each ofthe
`
`two nasal pillows positioned on opposite sides of the plane” (id. at 15),
`
`which are recited in independentclaim 2.
`
`Patent Owner doesnot propose any specific construction, but disputes
`
`Petitioner’s proposed construction of “ring.” Prelim. Resp. 31-36.
`
`Weconsider the construction of the term “ring” below.
`
`I. “ring”
`
`Claim 2 recites “a ring engaged with the lip of the mask body”
`(emphasis added). Petitioner asserts “[t]he claimed “ring” is a structure with
`
`a generally circular inner passage to enable the claimedrotatable
`engagementwith an elbowthat fits into the ring, and does not require a
`
`particular outside shapefor the ring.” Pet. 11.
`Accordingto Petitioner, the structure in the ’741 Specification
`correspondingto the “ring”is “mask base” 22. Id. at 12. As discussed
`above, the Specification discloses that mask base 22 is “a ring or sleeve type
`
`attachment.” Ex. 1002, 6:22—23 (referring to Figs. 4 and 5).
`
`Petitionerstates that the term “ring” does not have a special meaning
`
`in the applicablefield of the ’741 patent, and is not defined in the *741
`Specification. Pet. 11-12 (citing Ex. 1008, 27-28). Petitioner argues that
`“nothing within the plain language of the term ‘ring’ or from theintrinsic
`record requires that the outer surface of the ring be of a particular shape.”
`
`Td. at 13.
`
`
`
`IPR2016-01718
`Patent 8,479,741 B2
`
`Dr. Izuchukwutestifies that a person of ordinary skill would have
`
`understood that the term “ring” “does not require a particular outside shape.”
`
`Ex. 1008 927. Dr. Izuchukwualsotestifies that “although the term ‘ring’
`implies a structure having a circular inner passage,there is no requirement
`that its outer geometry also be circular.” Jd. at { 28.
`
`Patent Ownerdisagrees with Petitioner’s construction, and arguesthat
`
`“the term ring should be given its ordinary meaning, namely ‘a generally
`
`circular band of material.’” Prelim. Resp. 31. Patent Ownerassertsthatits
`
`proposed construction is consistent with the description in the Specification
`of mask base 22 as “a ring or sleeve like type attachment.” Jd. at 31-32
`
`(citing Ex. 1001, 6:22—23). Patent Owneralso asserts that its proposed
`construction is supported by standard dictionary definitions. Id. at 32-33
`
`(citing Ex. 2001, 3; Ex. 2003, 3). Patent Ownerfurther arguesthat
`
`Petitioner’s construction is overly broad because it encompasses“[v]irtually
`
`any structure, regardlessof its shape, that includes ‘a generally circular inner
`
`passage.’” Jd. at 33.
`Weagree with, and adopt, Patent Owner’s proposed claim
`construction. It is more consistent with the “ring” structure claimed,
`disclosed in the Specification, and supported by the dictionary definitions of
`record. We are awarethat the Specification also discloses that mask base 22
`
`|
`
`may include additional structures, such as a channel 45 on oneside of base
`22 to receive lip 28 on mask body 23, and a semi-tubular projection 29 on
`
`the other side of base 22 to receive a ball joint connector end to
`
`accommodate connector 30. Ex. 1002, 6:27—30; 42-46. Various other
`
`structures also are disclosed for allowing mask body 23 and connector 30 to
`
`connect to base 22. Jd. at 6:30-42. Neither channel 45, semi-tubular
`
`13
`
`
`
`IPR2016-01718
`Patent 8,479,741 B2
`
`projection 29, nor the other disclosed structures are recited in claim 2 as part
`
`of the “ring.” The structure recited in claim 2 is simply a ring.
`
`For the purposesof this Decision, we determinethat the broadest
`
`reasonable interpretation consistent with the Specification of the term “ring”
`
`is a generally circular band of material.
`
`2. Other Claim Terms
`
`Wedeterminethat 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 madeto 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). The question of obviousness is resolved on the
`
`basis of underlying factual determinations, including: (1) the scope and
`
`contentof the priorart; (2) any differences between the claimed subject
`matter andthepriorart; (3) the level of skill in the art; and (4) objective
`evidence of nonobviousness, i.e., secondary considerations. See Graham v.
`
`John Deere Co., 383 U.S. 1, 17-18 (1966).
`
`1. Asserted Obviousness over Gunaratnam and Ging
`Claims 2-4, 6-9, 12-17, 19, 20, and 35
`Gunaratnamis a published patent application relating to a nasal
`
`assembly patient interface for a mask usedin treating sleep apnea. Ex. 1004,
`{ 2. It is a comprehensivedisclosure, including 109 pages of drawings, with
`
`14
`
`
`
`IPR2016-01718
`Patent 8,479,741 B2
`
`135 drawing figures, and 404 paragraphs of explanatory text. Figure 135 of
`
`Gunaratnam is reproduced below.
`
`FIG.ISS
`
`Figure 135 of Gunaratnam depicts a headgear and respiratory mask
`that provides a nasal interface for the supply of air from a CPAP machine.
`
`Id. § 403.
`Gingalso is a published patent application that relates to a headgear
`and respiratory maskthat provides a nasalinterface for the supply ofair
`from a CPAP machine. Figure 6b from Ging is reproduced below.
`
`15
`
`
`
`IPR2016-01718
`Patent 8,479,741 B2
`
`
`
`enAo
`
`65
`
`FIG. 6b
`
`Figure 6b from Ging is an exploded view
`of an elbow assembly, mask frame, cushion, and air delivery tube
`
`Ging discloses nasal mask assembly 10, having frame 20, cushion 40,
`and elbow assembly 60 (see Figure 1). A headgear assembly (see Figure 1)
`
`can be attached to frame 20. C-clip 23 is used to attach elbow 60 to mask
`
`frame 20.
`
`Throughoutthe 55 page Petition, Petitioner provides a detailed clause-
`by-clause analysis of eachlimitation in the challenged claims along with an
`analysis of why, in Petitioner’s view, it would have been obviousto a person
`of ordinary skill to glean selected features from the disclosures in the cited
`references and combine them. Throughout its analysis, Petitionerrelies on
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`the Declaration testimony of Dr. John Izuchukwu. Dr. Izuchukwuearned a
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`Ph.D. in Industrial and Mechanical Engineering and an MBAdegree.
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`Ex. 1008 § 2. He has extensive experience in the developmentof various
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`16
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`IPR2016-01718
`Patent 8,479,741 B2
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`medical technologies, including CPAP machines, ventilators for respiratory
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`support, and sleep masks. Jd. at J] 3-4.
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`a. A Ring Engaged With the Lip Ofthe Mask Body
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`Claim 2 recites ‘“‘a ring engaged with the lip of the mask body.”
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`Patent Ownerasserts, among otherissues, that this asserted ground of
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`unpatentability “fails because neither Gunaratnam nor Ging disclose or make
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`obvious the claimed ‘ring.’” Prelim. Resp. 42. We agree andfindthis issue
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`dispositive.
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`Petitioner asserts that “Gunaratnam’s Figure 135 design includes ‘a
`
`ring engaged with the mask body’ inherently, or at a minimum obviously in
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`view of Ging, which showsa similar or identical mask bodyto that in Figure
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`135 of Gunaratnam in greater detail.” Pet. 28. According to Petitioner,
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`Ging discloses a “ring” in the form of mask frame 20, in that mask frame 20
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`is a structure that includes a circular inner passage that is configured to
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`receive an elbow. /d. (citing Ex. 1005, Fig. 6b). Additionally, Petitioner
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`asserts Ging discloses that the central portion of mask frame 20 is engaged
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`with mask cushion 40. Jd. Petitioner concludes that mask cushion 40 “‘is
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`engaged with a mask bodyas claimed. Jd. (citing Ex. 1005).
`
`Regarding the requirementin claim 2 that the “ring”is “engaged with
`the lip of the mask body,”Petitioner asserts this feature is disclosed by
`Gunaratnam aloneor in combination with Ging. Jd. at 29 (citing Pet. 24-27
`
`for the discussion ofthe lip structure in Gunaratnam and Ging).
`
`Petitioner’s argumentis based on Petitioner’s proposed construction
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`of “ring,” which we haverejected in our claim construction discussion
`
`above. As wehave determined for purposesofthis decision, the broadest
`
`reasonable interpretation consistent with the Specification of the term “ring”
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`Patent 8,479,741 B2
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`is a generally circular band of material. The claimedring is not any
`
`structure that includes a circular inner passage.
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`Patent Ownerarguesthat the mask frames in Gunaratnam and Ging
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`are not a generally circular band of material and thusare not a “ring.”
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`Prelim. Resp. 42-45. We agree with, and adopt, Patent Owner’s argument.
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`As Patent Ownerargues, the mask frame in the Gunaratnam/Ging
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`combinationis “oblong” or “horseshoe-shaped”—.e., it “includes upper and
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`lower peripheral edges that form twosurfaces that are generally parallel with
`
`each other across the length of the frame”—andthusis not a generally
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`circular band of material as required underourclaim interpretation of “ring.”
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`Id.
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`Petitioner bears the burden of establishing a reasonable likelihood of
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`unpatentability of one or more claims. 37 C.F.R. § 42.108(c). Here, the
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`evidence on which Petitioner relies does not meet this burden.
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`“Ring” is an ordinary, simple English word, the meaning of which is
`
`clear and unquestionable. It means exactly what it says. See ChefAm., Inc.
`
`v. Lamb-Weston, Inc., 358 F.3d 1371, 1373 (Fed. Cir. 2004). The claim
`
`construction inquiry begins and endsinall cases with the actual words of the
`claim. Renishaw PLC v. Marposs Societa'per Azioni, 158 F.3d 1243, 1248
`
`(Fed. Cir. 1998)(citations omitted). The intrinsic evidence, and, in some
`cases, the extrinsic evidence, can shed light on the meaning of the terms
`
`recited in a claim, either by confirming the ordinary meaning of the claim
`
`/d. (citations
`termsor by providing special meaning for claim terms.
`omitted). As Petitioner acknowledges, the term “ring” “does not have a
`special meaningin the applicable field of the ’741 patent, and is not defined
`in the °741 Specification. Pet. 11. The resulting claim interpretation must,
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`Patent 8,479,741 B2
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`in the end, accord with the words chosen bythe patentee to stake out the
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`boundary of the claimed property. Renishaw, 158 F.3d at 1248. Ultimately,
`
`the interpretation to be given a term can be determined and confirmed only
`
`with a full understanding of whatthe inventors actually invented and
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`intended to envelop with the claim.
`
`/d. at 1250. The construction that stays
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`true to the claim language and most naturally aligns with the patent’s
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`description of the invention will be, in the end, the correct construction. Id.
`Claim 2 simply recites a ring. Dependent claim 3 adds the limitation
`
`that the ring comprises a channel for receiving the lip of the mask body.
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`Dependentclaim 35 recites that the ring is configured to releasably connect
`
`to the two molded side arms. These additional limitations indicate that the
`
`structure recited in claim 2, a ring, is just that, a generally circular band of
`
`material. The structures relied on by Petitioner from Gunaratnam and Ging
`
`admittedly have a generally circular inner passage. That alone, however,
`
`does not establish that these structures are a generally circular band of
`
`material.
`
`Neither curved, rectangular frame 20 of Ging nor the horseshoe-
`
`shaped frame in Gunaratnam is a generally circular band of material.
`
`Moreover, Petitioner’s proposed ground of unpatentability under § 103 is
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`based on a combination of Gunaratnam and Ging. Pet. 4, 20. Petitioner
`
`asserts that the “ring” elementis “disclosed by Gunaratnam alone,or in
`
`combination with Ging.” Pet. 29. We determined that neither Gunaratnam
`nor Ging disclose a ring. In asserting the combination of Gunaratnam and
`Ging, however, Petitioner offers no rationale in the Petition in its Ground 1
`analysis as to why a personof ordinary skill would modify Gunaratnam’s
`frame with the frame in Ging. In determining whether there would have
`
`19
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`IPR2016-01718
`Patent 8,479,741 B2
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`been a motivation to combinepriorart references to arrive at the claimed
`
`invention,it is insufficient to simply conclude the combination would have
`
`been obvious without identifying any reason why a personofskill in the art
`
`would have made the combination. Metalcraft ofMayville, Inc. v. The Toro
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`Co., No. 2016-2433, 2017 WL 631749, at *4 (Fed. Cir. Feb. 16, 2017).
`
`“(W]e cannotallow hindsight bias to be the thread that stitches together
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`prior art patches into something that is the claimed invention.” Jd. at *5
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`In general, taken out of a specific context, modifying the shape or
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`structure of an elementto be a “ring” may seem like a simple, common
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`sense modification that would have been obviousto a person of ordinary
`
`skill and creativity. We do not abandon our commonsensein 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
`
`commonsense, however, are neither necessary under our case law nor
`
`consistent with it.”). Our decision is based on the evidence and arguments
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`before us. See Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1362 (Fed. Cir.
`
`. cannot be used as a wholesale
`.
`2016) (“[R]eferences to ‘commonsense’ .
`substitute for reasoned analysis and evidentiary support... .”). The
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`evidence on which Petitioner relies does not disclose or suggest the “ring”
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`recited in the challenged claims. In the highly developedfield of patient
`
`interfaces and nasal masksfor the supply of air to a patient, small
`
`differences may produce a nonobvious advance. See Outside the Box
`Innovations, LLC v. Travel Caddy, Inc., 695 F.3d 1285, 1298 (Fed.Cir.
`2012). See also Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352, 1360-61
`(Fed.Cir.2011) (providing that the inquiry under § 103 is not whetherthe
`claimed inventionis “sufficiently simple to appear obvious to judges after
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`20
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`IPR2016-01718
`Patent 8,479,741 B2
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`the discovery is finally made”). “The emphasis on nonobviousnessis one of
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`inquiry, not quality” of the advance. Graham v. John Deere Co., 383 U.S.1,
`17 (1966). While “the commonsenseofthose skilled in the art
`
`demonstrates why some combinations would have been obvious where
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`others would not,” (Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F.3d
`1157, 1161 (Fed.Cir.2007)), the determination is madenotafter observing
`
`what the inventor actually did, but in light of the state of the art before the
`
`invention was made. Outside the Box Innovations, 695 F.3d at 1298.
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`For the reasons discussed above, we determine that Petitioner has not
`
`established a reasonable likelihood of prevailing on its challenge to
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`independentclaim 2 as obvious over Gunaratnam and Ging. Petitioner’s
`arguments and evidence with respect to dependentclaims 3, 4, 6-9, 12-17,
`19, 20, and 35 do not remedy the deficiencies with respect to independent
`
`claim 2. Accordingly, we also determinethat Petitioner has not established
`a reasonable likelihood of prevailing on its challenges to those dependent
`
`claims.
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`2. Asserted Obviousness over Gunaratnam, Ging, and Kopala
`
`Petitioner asserts claim 10, dependent from claim 2, would have been
`
`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
`innerprofile offset inwardly relative to its outer profile. Jd. at 49. Kopala is
`not cited for, and does not cure, the deficiencies discussed abovein the
`Gunaratnam and Ging references concerning the ring. Accordingly,it is not
`reasonablylikely, based on the record before us, that Petitioner will prevail
`
`with respect to claim 10.
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`21
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`IPR2016-01718
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`3. Asserted Obviousness over Gunaratnam, Ging, and McAuley
`Claims 2-4, 6-9, 12-17, 19, 20, and 35
`
`Petitioner asserts that if the Board construes the claimed “ring” more
`
`narrowly than proposedby Petitioner “to require a generally circular outer
`periphery (which it should not),” McAuley teaches such a ring. Pet. 51. We
`emphasize that we have not construed the term ring to require a generally
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`circular outer periphery. We have construed the term ring to mean a
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`generally circular band of material.
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`Petitioner contends that McAuley
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