Trials@uspto.gov
`571-272-7822
`
`
`Paper No. 43
`
`Entered: January 23, 2019
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`FISHER & PAYKEL HEALTHCARE LIMITED,
`Petitioner,
`
`v.
`
`RESMED LIMITED,
`Patent Owner.
`____________
`
`Case
`IPR2017-00632
` Patent 8,944,061 B2
`____________
`
`
`Before BARRY L. GROSSMAN, BEVERLY M. BUNTING, and
`JAMES J. MAYBERRY, Administrative Patent Judges.
`
`BUNTING, Administrative Patent Judge.
`
`
`
`
`
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`
`
`571-272-7822
`
`
`Paper No. 43
`
`Entered: January 23, 2019
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`FISHER & PAYKEL HEALTHCARE LIMITED,
`Petitioner,
`
`v.
`
`RESMED LIMITED,
`Patent Owner.
`____________
`
`Case
`IPR2017-00632
` Patent 8,944,061 B2
`____________
`
`
`Before BARRY L. GROSSMAN, BEVERLY M. BUNTING, and
`JAMES J. MAYBERRY, Administrative Patent Judges.
`
`BUNTING, Administrative Patent Judge.
`
`
`
`
`
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`
`
`
`IPR2017-00632
`Patent 8,944,061 B2
`
`I. INTRODUCTION
`Fisher & Paykel Healthcare Limited (“Petitioner”) filed a Petition
`(Paper 1, “Pet.”) requesting an inter partes review of claims 17, 18, 20–23,
`26–30, 32, 33, 35–38, 41–46, and 48–91 (“the challenged claims”) of U.S.
`Patent No. 8,944,061 B2 (Ex. 1001, “the ’061 patent”). ResMed Ltd.
`(“Patent Owner”) filed a preliminary response to the Petition. Paper 7
`(“Prelim. Resp.”). On July 25, 2017, we entered a Decision on Institution
`(Paper 8, “Decision” or “Dec.”), determining that Petitioner had presented
`sufficient arguments and evidence demonstrating a reasonable likelihood
`that it would prevail in showing claims 17, 18, 20, 21, 23, 28–30, 32, 33, 35,
`36, 38, 43–46, 81, 84, 85, 87, and 88 of the ’061 patent would be
`unpatentable, but not claims 22, 26, 27, 37, 41, 42, 48–80, 82, 83, 86, 89–91.
`Petitioner timely filed a Request for Rehearing (Paper 10), which we denied
`(Paper 26).
`Subsequent to institution, Patent Owner filed a Patent Owner
`Response (Paper 14, “PO Resp.”), and Petitioner filed a Reply (Paper 16,
`“Reply”).1 Pursuant to the U.S. Supreme Court’s decision on April 24,
`2018, in SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348 (2018), we modified our
`Decision on Institution on May 3, 2018, to include the challenge to claims
`22, 26, 27, 37, 41, 42, 48–80, 82, 83, 86, and 89–91.2 Paper 29 (modifying
`the Decision on Institution to include all claims and all grounds presented in
`the Petition). Based on the parties’ requests for additional briefing to
`
`
`1 Patent Owner filed a Motion for Observations (Paper 34), and Petitioner
`filed a Response (Paper 38).
`2 In our Decision Denying Petitioner’s Request for Hearing, we recognized
`that the Decision on Institution erroneously listed claim 91 as an instituted
`claim. (Paper 26).
`
`
`
`2
`
`
`
`IPR2017-00632
`Patent 8,944,061 B2
`address the newly-added challenges, we determined that good cause existed
`to permit additional briefing addressing the newly added challenges. Paper
`31. Patent Owner submitted a Supplemental Response (Paper 32, “Supp.
`Resp.”) and Petitioner filed a Supplemental Reply (Paper 33, “Supp.
`Reply”). Oral argument was held on July 11, 2018, and a transcript has been
`entered into the record. 3 Paper 42 (“Tr.”). Although the one-year period
`normally available to issue a Final Written Decision was to expire on July
`25, 2018, the Chief Judge determined that good cause existed to extend this
`deadline by up to six months. Papers 40–41.
`This Final Written Decision is entered pursuant to 35 U.S.C. § 318(a).
`For the reasons that follow, we conclude that Petitioner has demonstrated, by
`a preponderance of the evidence, that certain of the challenged claims
`identified in the Order, i.e., Section V., are unpatentable.
`
`II. BACKGROUND
`A. Real Party in Interest
`Petitioner identifies Fisher & Paykel Healthcare Limited as the real
`party in interest. Pet. 11.
`
`B. Related Matters
`The parties indicate that the ʼ061 patent has been asserted in: Fisher &
`Paykel Healthcare Ltd. v. ResMed Corp., No. 3:16-cv-02068-DMS-WVG
`(S.D. Cal.). Pet. 11; Paper 4, 2. Petitioner concurrently filed two other
`petitions challenging the ’061 patent, IPR2017-00634 and IPR2017-00635,
`both of which were denied. Pet. 11; Paper 4, 2.
`
`
`3 Oral argument was rescheduled at the request of the parties to provide time
`for additional briefing directed to the newly instituted claims. Paper 28.
`
`
`
`3
`
`
`
`IPR2017-00632
`Patent 8,944,061 B2
`
`C. The ʼ061 Patent (Ex. 1001)
`The ’061 patent, titled “Cushion to Frame Assembly Mechanism,”
`issued on February 3, 2015, and claims priority from an application filed on
`January 12, 2006, and two provisional applications filed on October 14 and
`November 9, 2005, respectively. Ex. 1001, (45), (54), (60), (63). The ’061
`patent relates to a patient interface for use in treatment of sleep disordered
`breathing, such as obstructive sleep apnea, and, in particular, to an apparatus
`for securing a face-contacting portion of a patient interface, such as a
`cushion, to a frame or shell of the patient interface. Id. at 1:17–23.
`The patient interface includes mask assembly 210, as illustrated in
`Figure 3, and is reproduced below. Ex. 1001, 6:53–58.
`
`
`
`4
`
`
`
`IPR2017-00632
`Patent 8,944,061 B2
`
`
`Figure 3 is an exploded view of the mask assembly.
`Mask assembly 210 includes skeleton frame 212, which is adapted to
`interlock removably with cushion/frame sub-assembly 230. Id. at 6:56–58.
`Cushion/frame sub-assembly 230 incorporates an integrally molded one-
`piece frame and cushion. Id. at 6:59–60. Cushion/frame sub-assembly 230
`includes upper wall 220, having opening 218 surrounded by annular wall
`240, for communicating with an inlet conduit. Id. at 6:64–67. Skeleton
`frame 212 further includes upper support member 244, adapted to support a
`forehead support, lower headgear clip receptacles 246 that engage a
`
`
`
`5
`
`
`
`IPR2017-00632
`Patent 8,944,061 B2
`headgear assembly, and annular connection seal 238 adapted to engage an
`inlet conduit. Id. at 7:11–17.
`Figure 4, reproduced below, illustrates engagement of skeleton frame
`212 with cushion/frame sub-assembly 230. Ex. 1001, 7:22–23.
`
`
`Figure 4 is a perspective view of the assembled mask assembly.
`Skeleton frame 212 engages with cushion/frame sub-assembly 230 by
`interlocking annular elbow connection seal 248 with annular wall 240,
`interlocking or frictionally engaging upper support member 244 with top
`portion 231 of cushion/frame sub-assembly 230, and interlocking elongated
`frame members 250 with corresponding protrusions on cushion/frame sub-
`assembly 230. Ex. 1001, 7:22–30.
`
`D. Challenged Claims
`Of the challenged claims, claims 17, 32, 51, 58, 65, 74, and 81 are
`independent. Ex. 1001, 20:58–28:34. Each of the independent claims
`
`
`
`6
`
`
`
`IPR2017-00632
`Patent 8,944,061 B2
`recites, inter alia, a “first frame” or “frame,” a cushion, and a “second
`frame” or “skeleton frame.” Claims 51, 65, and 81 are illustrative of the
`claimed subject matter, and are reproduced below:
`51. A mask assembly for treatment of sleep disorder breathing
`by delivering a flow of pressurized gas to a patient, the mask
`assembly comprising:
`a first frame with a first opening adapted to fluidly
`communicate an interior of the first frame with an inlet
`conduit, the first frame being made of a first material;
`a cushion with a side wall and a face contacting portion
`extending from the side wall, wherein the cushion is over-
`molded to the first frame to form a cushion/frame sub-
`assembly and the cushion is adapted to form a seal around
`a patient’s nose and mouth, the cushion being made of a
`second material that is less rigid than the first material; and
`a second frame adapted to removably interlock with the
`cushion/frame sub-assembly, the second frame including
`an upper member configured to provide forehead support;
`lower portion with a second opening aligned with the first
`opening so that the inlet conduit fluidly communicates
`with a breathing chamber formed by the cushion and
`the first frame, and with headgear attachment structures
`on opposed lateral sides of the second opening, the
`headgear attachment structures being adapted to
`engage with headgear attachments;
`two elongate frame members that interconnect the upper
`member and lower portion; and
`an open space bounded at least in part by the two elongate
`frame members and the lower portion;
`wherein the first frame protrudes at least partially through the
`open space.
`Id. at 24:1–31.
`65. A mask assembly for treatment of sleep disorder breathing
`by delivering a flow of pressurized gas to a patient, the mask
`assembly comprising:
`a cushion adapted to form a seal by abutting a patient’s face
`around the patient’s nose and mouth, the cushion
`
`
`
`7
`
`
`
`IPR2017-00632
`Patent 8,944,061 B2
`comprising a face contacting portion with a sealing portion
`that contacts the patient’s face around the patient’s nose
`and mouth and comprising a first material;
`a frame integrally molded to the cushion, the frame
`comprising an annular wall surrounding an opening that is
`adapted to allow fluid communication of the pressurized
`gas to an interior of the frame and a second wall
`surrounding the annular wall and connected to the cushion
`and comprising a second material that is more rigid than
`the first material;
`an inlet conduit in fluid communication with the frame to
`communicate the pressurized gas to the interior of the
`frame; and
`a skeleton frame adapted to be removably engageable with
`the frame, the skeleton frame comprising an upper support
`member adapted to receive a forehead contacting portion,
`a lower frame member comprising attachment locations
`adapted to engage with clips for straps, two frame
`members interconnecting the upper support member and
`the lower frame member and forming an open space
`between the two frame members and the lower frame
`member, wherein
`the skeleton frame and the frame are adapted to be releasably
`engageable to one another at the opening, and
`the frame is at least partially accessible through the open
`space.
`Id. at 25:37–67.
`81. A mask assembly for treatment of sleep disorder breathing
`by delivering a flow of pressurized gas to a patient, the mask
`assembly comprising:
`a first frame made of first material;
`a cushion connected to the first frame, the cushion being
`adapted to form a seal around the patient’s nose and mouth
`and being made from a second material that is more
`flexible than the first material, the first frame and the
`cushion together forming a breathing chamber; and
`a second frame adapted to constrain the first frame, the second
`frame comprising an upper member, a lower member with
`an annular opening adapted to allow an inlet conduit to
`
`
`
`8
`
`
`
`IPR2017-00632
`Patent 8,944,061 B2
`provide pressurized gas to the patient, and a separate
`opening located between the annular opening and the
`upper member, the separate opening providing access to
`the first frame when the mask assembly is fully assembled,
`wherein the first frame and the second frame snap-fit together.
`Id. at 27:13–31.
`
`E. Grounds of Unpatentability
`Petitioner challenges claims 17, 18, 20–23, 26–30, 32, 33, 35–38, 41–
`46, and 48–91 of the ’061 patent on the following grounds (Pet. 15):
`
` References
`Berthon-Jones4 and
`Barnett5
`Berthon-Jones, Barnett,
`and Lithgow6
`Berthon-Jones, Barnett,
`Lithgow, and Burns7
`
` Basis
`§ 103(a)
`
`§ 103(a)
`
`§ 103(a)
`
`Claims Challenged
`81–91
`17, 18, 20–23, 26–30, 32,
`33, 35–38, 41–46, 48–50,
`and 58–73
`51–57 and 74–80
`
`
`
`In support of its arguments, Petitioner relies on the declaration of
`Jason Eaton, P.E. (Ex. 1006) and Patent Owner relies on the declaration of
`Mr. Alexander Virr (Ex. 2003). The parties rely on other exhibits as
`discussed below.
`
`III. ANALYSIS
`A. Legal Principles
`1. Burden of Proving Unpatentability
`In an inter partes review, the petitioner bears the burden of proving
`unpatentability of the challenged claims, and the burden of persuasion never
`
`
`4 WO 2004/041342 A1, pub. May 21, 2004 (Ex. 1002, “Berthon-Jones”).
`5 US 6,412,488 B1, iss. July 2, 2002 (Ex. 1003, “Barnett”).
`6 US 2004/0118406 A1, pub. June 24, 2004 (Ex. 1004, “Lithgow”).
`7 US 5,062,421, iss. Nov. 5, 1991 (Ex. 1005, “Burns”).
`
`
`
`9
`
`
`
`IPR2017-00632
`Patent 8,944,061 B2
`shifts to the patent owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail in this proceeding,
`Petitioner must support its challenges by a preponderance of the evidence.
`35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). Accordingly, all of our findings
`and conclusions are based on a preponderance of the evidence.
`
`2. Obviousness
`A claim is unpatentable under § 103(a) if the differences between the
`claimed subject matter 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 said subject matter pertains.
`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 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) where in evidence, so-called secondary considerations.
`Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). The U.S. Court of
`Appeals for the Federal Circuit has made clear that a petitioner in an inter
`partes review proceeding cannot “satisfy its burden of proving obviousness”
`by “employ[ing] mere conclusory statements” and “must instead articulate
`specific reasoning, based on evidence of record” to support an obviousness
`determination. In re Magnum Oil Tools Int’l, 829 F.3d 1364, 1380–81 (Fed.
`Cir. 2016).
`We analyze the following grounds of unpatentability in accordance
`with the above-stated principles. Because Patent Owner does not provide
`evidence regarding secondary considerations, our determination is based on
`the first three factors. See PO Resp.; Pet. 106; see also ZUP, LLC v. Nash
`Mfg., Inc., 896 F.3d 1365, 1373 (Fed. Cir. 2018) (“While [the] burden of
`
`
`
`10
`
`
`
`IPR2017-00632
`Patent 8,944,061 B2
`persuasion remains with the challenger, a patentee bears the burden of
`production with respect to evidence of secondary considerations of
`nonobviousness.”).
`
`B. Level of Skill in the Art
`In determining the level of ordinary skill in the art, various factors
`may be considered, including the “type of problems encountered in the art;
`prior art solutions to those problems; rapidity with which innovations are
`made; sophistication of the technology; and educational level of active
`workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995)
`(citation omitted). In that regard, Petitioner asserts that a person having
`ordinary skill in the art (“POSITA”) “would have at least a bachelor’s
`degree in mechanical engineering, biomedical engineering or other similar
`type of engineering degree combined with at least two years of experience in
`the field of masks, respiratory therapy, patient interfaces or relevant product
`design experience.” Pet. 21 (citing Ex. 1006 ¶ 26). Patent Owner does not
`expressly state its position on the level of ordinary skill in the art in its
`Patent Owner Response. See generally PO Resp. Mr. Virr, Patent Owner’s
`expert, generally accepts Petitioner’s framework. See e.g., Ex. 2003 ¶ 25
`(“My analysis is thus based on the perspective of a POSITA having this
`level of knowledge and skill.”).
`Thus, based on the entire record, we accept Petitioner’s formulation,
`finding that the POSITA “would have at least a bachelor’s degree in
`mechanical engineering, biomedical engineering or other similar type of
`engineering degree combined with at least two years of experience in the
`field of masks, respiratory therapy, patient interfaces or relevant product
`design experience.” Ex. 1006 ¶ 26.
`
`
`
`11
`
`
`
`IPR2017-00632
`Patent 8,944,061 B2
`
`C. Claim Construction
` The Board interprets claims of an unexpired patent using the broadest
`reasonable construction in light of the specification of the patent in which
`they appear. 8 37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131, 2144–46 (2016). Under the broadest reasonable
`interpretation standard, and absent any special definitions, claims terms are
`given their ordinary and customary meaning, as would be understood by one
`of ordinary skill in the art in the context of the entire disclosure. In re
`Translogic Tech. Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special
`definitions for claim terms or phrases must be set forth with reasonable
`clarity, deliberateness, and precision. In re Paulsen, 30 F.3d 1475, 1480
`(Fed. Cir. 1994). In the absence of such a definition, limitations are not to
`be read from the specification into the claims. See In re Van Geuns,
`988 F.2d 1181, 1184 (Fed. Cir. 1993).
`Petitioner does not propose a specific construction for any claim term
`in its Petition, applying the “broadest reasonable interpretation in light of the
`specification of the ’061 patent.” Pet. 16. Patent Owner agrees. PO Resp.
`17–18. In our Decision on Institution, we determined that no express
`construction of any claim term was necessary. Dec. 9–10 (citing Vivid
`Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).
`Now, having considered the entire record, we conclude that our
`determination regarding the obviousness of the challenged claims does not
`turn on the interpretation of any of the claim terms, and that no express
`
`
`8 The USPTO revised its rules to harmonize the Board’s claim construction
`standard with that used in federal district court. 83 Fed. Reg. 51,340 (Nov.
`13, 2018). This rule change applies to petitions filed after November 13,
`2018, however, and does not apply to this proceeding. Id.
`
`
`
`12
`
`
`
`IPR2017-00632
`Patent 8,944,061 B2
`construction of any claim term is necessary for purposes of this Final
`Written Decision.
`
`D. Obviousness Based on Berthon-Jones and Barnett
`Petitioner challenges the patentability of claims 81–91 of the ’061
`patent under 35 U.S.C. § 103 as obvious based on Berthon-Jones and
`Barnett. In support thereof, Petitioner identifies the disclosures in the cited
`references alleged to describe the subject matter in the challenged claims, as
`well as a reason why a POSITA would have modified Berthon-Jones based
`on the teachings of Barnett. Id. at 23–56. Petitioner supports its arguments
`and evidence with the testimony of its declarant, Mr. Eaton. Ex. 1006.
`Patent Owner disputes that Berthon-Jones teaches certain limitations
`in claims 81–91, and further argues that the proposed combination of
`Berthon-Jones and Barnett is unavailing for the reasons discussed infra. PO
`Resp. 18–49. Patent Owner supports its arguments and evidence with the
`testimony of its declarant, Mr. Virr. Ex. 2003.
`For the reasons that follow, we conclude that Petitioner has
`established by a preponderance of the evidence that claims 81, 84, 85, 87,
`and 88 are unpatentable, but not claims 82, 83, 86, and 89–91. We begin our
`analysis with a brief summary of the cited references and then address the
`parties’ contentions in turn.
`1. Berthon-Jones (Ex. 1002)
`Berthon-Jones is a PCT publication titled “Mask and Components
`Therof” having an international publication date of May 21, 2004. Ex. 1002
`(43), (54). Berthon-Jones relates to a “comfortable low-leak mask assembly
`for use with Non-Invasive Positive Pressure Ventilation (NIPPV).” Id.
`¶ (57). Figure 51 of Berthon-Jones, reproduced below, is representative.
`
`
`
`13
`
`
`
`IPR2017-00632
`Patent 8,944,061 B2
`
`
`Figure 51 is an exploded perspective view of mask assembly 510.
`Mask assembly 510 includes semi-rigid chassis 512 that connects to
`headgear, and cushion/secondary frame 514 adapted to form a seal with the
`user’s face. Id. ¶ 177. Cushion/secondary frame 514 includes fixedly
`connected cushion portion 516 and secondary frame portion 518. Id. ¶ 179.
`“[S]econdary frame portion 518 maybe be made of a flexible or semi-
`flexible material, e.g., polypropylene.” Id. ¶ 180. Cushion portion 516 is “a
`generally soft and conforming structure.” Id. ¶ 181. Cushion/secondary
`frame 514 includes connecting members 524, which interface with receiving
`holes 526 in chassis 512 to provide a snap-fit connection between
`cushion/secondary frame 514 and chassis 512. Id. ¶ 182.
`Mask chassis 512 includes central aperture 536 adapted to receive
`raised, central portion 518 of cushion/secondary frame 514, to provide a
`conduit for gas delivery through central aperture 536. Id. ¶ 184. Adjustment
`wheel retaining portions 542 are positioned adjacent each side of central
`aperture 536, and correspond to projections 528 on cushion/secondary frame
`
`
`
`14
`
`
`
`IPR2017-00632
`Patent 8,944,061 B2
`514. Id. The user turns adjustment wheels 530 to modify the sealing force
`and/or fit between the user and cushion portion 516. Id. ¶ 186.
`2. Barnett (Ex. 1003)
`Barnett is a U.S. Patent titled “Low-Contact Nasal Mask and System
`Using Same” having an issue date of July 2, 2002. Ex. 1003, (54), (45).
`Barnett is directed to a low contact nasal mask having “a one-piece, light
`weight seal member defining a nose receiving cavity, a collar coupled to the
`seal member, and a conduit coupling member, and to a system for supplying
`a flow of gas to a patient that incorporates such a low contact nasal mask.”
`Ex. 1003, 1:9–13. As shown in Figure 1a, reproduced below, nasal mask
`assembly 30 includes collar 34 and conduit coupling member 36. Id. at
`3:48–50.
`
`
`Figure 1a is a sectional side view of the nasal mask assembly.
`Conduit coupling member 36 is rotatably mounted to collar 34 “so that
`conduit coupling member 36 freely rotates over a range of 360° about a
`center axis of collar 34.” Id. at 3:53–56.
`3. Discussion
`a. Petitioner’s Challenge to Claim 81
`i. Undisputed Limitations of Claim 81
`
`
`
`15
`
`
`
`IPR2017-00632
`Patent 8,944,061 B2
`Claim 81 is independent. Petitioner relies on the disclosure in
`Berthon-Jones for most of the limitations of claim 81, and Barnett for the
`rest. Pet. 27–46. Petitioner annotated Figure 51 of Berthon-Jones,
`reproduced below, to illustrate the purported correspondence between
`Berthon-Jones and claim 81. Id. at 28.
`
`
`Figure 51 of Berthon-Jones shows an exploded view of mask
`assembly 510, as annotated by Petitioner.
`For example, the preamble of claim 81 is directed to “[a] mask
`assembly for treatment of sleep disorder breathing by delivering a flow of
`pressurized gas to a patient” (Ex. 1001, 27:13–14), and Petitioner contends
`that Berthon-Jones’ mask assembly 510 likewise delivers pressurized gas to
`a patient to treat sleep disordered breathing (Pet. 30). Claim 81 also requires
`“a first frame made of a first material.” Ex. 1001, 27:16. Petitioner
`contends that this limitation is satisfied by the teaching in Berthon-Jones that
`first frame 518 “may be made of a flexible or semi-flexible material, e.g.,
`polypropylene.” Pet. 31 (citing Ex. 1002 ¶ 180).
`
`
`
`16
`
`
`
`IPR2017-00632
`Patent 8,944,061 B2
`Claim 81 also requires “a cushion connected to the first frame, the
`cushion being adapted to form a seal around a patient’s nose and mouth and
`being made from a second material that is more flexible than the first
`material, the first frame and the cushion together forming a breathing
`chamber.” Ex. 1001, 27:17–21. Petitioner contends that this claim element
`is satisfied by the disclosure in Berthon-Jones of cushion 516, which is made
`of a soft material that is more flexible that the semi-soft material of first
`frame 518, and that when connected, cushion 516 and first frame 518 form a
`breathing chamber. Pet. 32–33 (citing Ex. 1002 ¶ 179–181; Ex. 1006 ¶¶ 55–
`57).
`
`Claim 81 additionally recites that “the first frame and second frame
`snap-fit together.” Ex. 1001, 27:31–32. Petitioner asserts that the disclosure
`in Berthon-Jones regarding the snap-fit engagement of connecting members
`524 on the secondary frame portion into corresponding receiving holes 526
`in the mask chassis satisfies this claim limitation. Pet. 46 (citing Ex. 1002
`¶ 182).
`Patent Owner does not dispute Petitioner’s contentions with regards to
`these undisputed claim limitations of claim 81. See PO Resp.9 Now, in
`view of the entire record, we adopt as our own Petitioner’s analysis of the
`
`
`9 The scheduling order in this proceeding reminded Patent Owner that
`“any arguments for patentability not raised in the [Patent Owner
`Response] will be deemed waived.” Paper 9, 3; see also In re
`Nuvasive, Inc., 842 F.3d 1376, 1380–81 (Fed. Cir. 2016) (holding that a
`patentee waived an argument by presenting it only in the preliminary
`proceeding and not during the trial, despite the Board cautioning the
`patentee that arguments not briefed in the response would be deemed
`waived).
`
`
`
`17
`
`
`
`IPR2017-00632
`Patent 8,944,061 B2
`undisputed claim limitations as recited in independent claim 81, and find
`that Berthon-Jones teaches these limitations.
`ii. Annular Opening Limitation
`We turn next to the disputed limitations of claim 81. Claims 81 also
`recites a second frame that constrains the first frame, and includes “an upper
`member, [and] a lower member with an annular opening adapted to allow an
`inlet conduit to provide pressurized gas to the patient.” Ex. 1001, 27:22–25.
`Petitioner contends that Berthon-Jones teaches second frame 512 as having
`upper member 540 and opening 536 that receives and constrains the raised
`portion of first frame 518. Pet. 34 (citing Ex. 1002 ¶¶ 177, 183–184).
`Petitioner explains that opening 536 in the lower portion of second frame
`512 provides an inlet conduit to provide pressurized gas to the patient, but
`recognizes that Berthon-Jones does not expressly disclose that opening 536
`is annular. Id. at 35 (citing Ex. 1002 ¶ 184; Ex. 1006 ¶¶ 59–70). Relying on
`the testimony of Mr. Eaton, Petitioner contends that “configuring the second
`frame 512 to directly support the inlet conduit (elbow) at an annular opening
`that allows pressurized gas to pass from the elbow to the patient was well-
`known and common in the prior art.” Id. (citing Ex. 1006 ¶¶ 59–70).
`Petitioner relies on Barnett’s teaching regarding “second frame 34 that
`directly attaches to and supports the inlet conduit 36 at an annular opening
`76,” to illustrate that it was known to utilize a frame having an annular
`opening to receive an inlet conduit. Id. at 36 (citing Ex. 1003, 3:52–57,
`8:66–9:43). Petitioner also contends that it was known to provide an annular
`opening in the second frame for directly attaching the inlet conduit with the
`second frame, as also taught by Barnett. Id. at 39 (citing Ex. 1006 ¶ 67; Ex.
`1003, 3:52–57, Pet. § I). Petitioner annotated Figure 1A of Barnett,
`
`
`
`18
`
`
`
`IPR2017-00632
`Patent 8,944,061 B2
`reproduced below, to illustrate the alleged correspondence between Barnett
`and claim 81. Id. at 36.
`
`
`
`Figure 1A of Barnett illustrating a side view of
`the mask assembly, as annotated by Petitioner.
`Petitioner argues that a POSITA “would have viewed these two types
`of frame-elbow arrangements as two design choices for establishing a seal
`between an interior of an elbow and a breathing chamber.” Pet. 41 (citing
`Ex. 1006 ¶¶ 61–70). According to Petitioner, “[a] person of skill in the art
`would have selected the Barnett configuration as one of a finite number of
`predictable solutions for providing a connection between the interior of the
`elbow and the breathing chamber.” Id. (citing KSR, 550, U.S. at 421).
`Petitioner contends that the advantages of the proposed Berthon-Jones and
`Barnett arrangement would have motivated a POSITA to modify Berthon-
`Jones in view of Barnett. Id. Namely, because
`Berthon-Jones and Lovell10 utilize a direct connection between
`the elbow and the cushion sub-assembly, which requires only a
`
`10 US 6,631,718 B1, issued Oct. 14, 2003 (Ex. 1012, “Lovell”).
`
`
`
`19
`
`
`
`IPR2017-00632
`Patent 8,944,061 B2
`single seal, and Barnett and Gunaratnam11 teach separate sealed
`connections between: 1) the second frame and the inlet conduit,
`and 2) the second frame and the cushion-frame sub-assembly.
`[Ex. 1006] ¶¶ 66–68. Although Barnett and Gunaratnam require
`two separate seals, directly attaching the inlet conduit to the
`second frame would make it easier for a patient to detach the
`cushion-frame sub-assembly from the second frame without
`affecting the engagement of the inlet conduit with the second
`frame. Id. ¶¶ 62, 69.
`Id. Petitioner maintains that the proposed modification would enable
`the user to remove the cushion-frame sub-assembly without having to
`disconnect the elbow from the second frame, “making reassembly
`easier for the user.” Id. at 42 (citing Ex. 1006 ¶¶ 62, 69).
`Patent Owner does not dispute Petitioner’s assertion that Barnett
`teaches a second frame that attaches and supports an inlet conduit at an
`annular opening. Instead, Patent Owner advances arguments and evidence
`challenging the reasons offered by Petitioner to combine Berthon-Jones and
`Barnett. For example, Patent Owner argues that Petitioner improperly used
`hindsight in proposing that a POSITA would have modified Berthon-Jones’
`mask to use Barnett’s collar connection. PO Resp. 18–46. We address
`Patent Owner’s arguments regarding the proposed modification of Berthon-
`Jones using the teachings of Barnett below.
`a) Whether Petitioner’s Proposed Modification Is Based On
`Hindsight
`Patent Owner argues that Petitioner’s proposed modification to
`Berthon-Jones, including “(1) modif[ing] Berthon-Jones’s mask chassis to
`incorporate Barnett’s collar structure, (2) further modif[ing] the proposed
`mask chassis/collar structure to include an annular opening that directly
`
`
`11 US 6,796,308 B2, issued Sept. 28, 2004 (Ex. 1014, “Gunaratnam”).
`
`
`
`20
`
`
`
`IPR2017-00632
`Patent 8,944,061 B2
`engages with Barnett’s elbow inlet conduit, and (3) includ[ing] a sealed
`connection between the mask chassis/collar structure and Berthon-Jones’s
`cushion/frame sub-assembly,” is based on hindsight. PO Resp. 19. Key to
`Patent Owner’s argument is its contention that a POSITA “would have
`understood that Petitioner’s proposed modifications to the ‘Tenth
`Embodiment’ of Berthon-Jones would directly conflict with several critical
`structures that allow Berthon-Jones’s mask assembly to provide Berthon-
`Jones’s stated purpose for a low-leak mask with enhanced/tailored sealing
`and fit at selected locations on the patient’s face.” Id. at 20–21 (citing Ex.
`1002 ¶¶ 11, 182, 185–186; Ex. 2003 ¶¶ 44–49).
`We recognize the impropriety of basing a conclusion of obviousness
`upon facts gleaned only through hindsight. Nonetheless,
`[a]ny judgment on obviousness is in a sense necessarily a
`reconstruction based upon hindsight reasoning, but so long as it
`takes into account only knowledge which was within the level of
`ordinary skill at the time the claimed invention was made and
`does not include knowledge gleaned only from applicant’s
`disclosure, such a reconstruction is proper.
`In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971); see also KSR, 550
`U.S. at 421 (“A factfinder should be aware, of course, of the distortion
`caused by hindsight bias and must be cautious of arguments reliant upon ex
`post reasoning.”). For the reasons discussed below, we do not find that
`Petitioner’s proposed modification to Berthon-Jones using Barnett is based
`impermissibly on hindsight.
`Whether Petitioner’s Proposed Modification Deviates from the
`Intended Purpose and Principle of Operation of Berthon-Jones
`Patent Owner first argues that the proposed modification, i.e.,
`incorporating Barnett’s rigid collar in Berthon-Jones’s mask chassis, is
`unavailing because operation of Berthon-Jones’s adjustment wheels would
`
`
`
`21
`
`
`
`IPR2017-00632
`Patent 8,944,061 B2
`compromise the air-tight seal between the mask and the user, thus rendering
`the resulting mask inoperable for its intended purpose. Id. at 22–29.
`Referring to the specific embodiment in Berthon-Jones that Petitioner relies
`on as “the Tenth Embodiment,” Patent Owner argues that the intended
`purpose of this embodiment “is to provide adjustment wheels that cause its
`cushion/secondary frame to move or deform relative to its mask chassis so
`as to provide small adjus
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
