Filed: April 10, 2019
`
`Filed on behalf of:
`Fisher & Paykel Healthcare Limited
`By: Douglas G. Muehlhauser
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`Jon W. Gurka
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`KNOBBE, MARTENS, OLSON & BEAR, LLP
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`2040 Main Street, 14th Floor
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`Irvine, CA 92614
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`Tel.: (949) 760-0404
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`Fax: (949) 760-9502
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`Email: BoxFPH892-4@knobbe.com
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
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`RESMED LIMITED, RESMED INC., and
`RESMED CORP.,
`Petitioners
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`v.
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`FISHER & PAYKEL HEALTHCARE LIMITED,
`Patent Owner
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`Case No. IPR2019-00178
`U.S. Patent No. 9,974,914
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`PATENT OWNER FISHER & PAYKEL HEALTHCARE LTD.’S
`PRELIMINARY RESPONSE
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`
`
`Filed on behalf of:
`Fisher & Paykel Healthcare Limited
`By: Douglas G. Muehlhauser
`
`Jon W. Gurka
`
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`
`2040 Main Street, 14th Floor
`
`Irvine, CA 92614
`
`Tel.: (949) 760-0404
`
`Fax: (949) 760-9502
`
`Email: BoxFPH892-4@knobbe.com
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`RESMED LIMITED, RESMED INC., and
`RESMED CORP.,
`Petitioners
`
`v.
`
`FISHER & PAYKEL HEALTHCARE LIMITED,
`Patent Owner
`
`
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`Case No. IPR2019-00178
`U.S. Patent No. 9,974,914
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`PATENT OWNER FISHER & PAYKEL HEALTHCARE LTD.’S
`PRELIMINARY RESPONSE
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`TABLE OF CONTENTS
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`Page No.
`
`I.
`II.
`
`INTRODUCTION ........................................................................................... 1
`BACKGROUND ............................................................................................. 2
`A. Overview Of The ’914 Patent ............................................................... 2
`The ’914 Patent Specification ..................................................... 2
`1.
`2.
`The Claims .................................................................................. 3
`Overview Of Petitioner’s References .................................................... 4
`1.
`Sleeper ......................................................................................... 4
`2. Wood ........................................................................................... 8
`Claim Construction ............................................................................. 10
`C.
`Level Of Skill In The Art .................................................................... 12
`D.
`Petitioner’s Asserted Grounds ............................................................. 12
`E.
`Relationship To IPR 2019-00177 ........................................................ 13
`F.
`III. ARGUMENT ................................................................................................. 13
`A.
`Legal Standard ..................................................................................... 13
`1.
`Threshold For Institution .......................................................... 13
`2.
`Obviousness Combinations ....................................................... 14
`The Petition Fails To Demonstrate That All Limitations
`In Claim 9 Are Found In The References, And The Board
`Should Deny The Petition ................................................................... 16
`1.
`Petitioner Fails To Show Nasal Prongs Adjacent A
`Curved User-Side Portion ......................................................... 16
`
`B.
`
`B.
`
`i
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`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
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`C.
`
`2.
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`2.
`
`Petitioner Fails To Show A Nasal Cannula Or
`Conduit Configured To Supply Humidified Gases .................. 21
`The Petition’s Reliance On Combined References Fails .................... 22
`1.
`Sleeper Fails To Disclose First Sides Of The Two
`Prongs Disposed Further Apart Than The Second
`Sides Of The Two Prongs ......................................................... 23
`Petitioner’s Motivation To Combine Is
`Unsupported By The Record .................................................... 24
`a.
`Reason 1 (improved patient comfort) is
`untethered to Wood’s oval-shaped nasal
`apertures .......................................................................... 25
`Reason 2 (better seal) is untethered to
`Wood’s oval-shaped apertures and disclosed
`in Sleeper ........................................................................ 27
`Reason 3 (known technique to a known
`apparatus) is unsupported by the evidence ..................... 28
`i.
`Sleeper and Wood provide distinct
`and dissimilar mask designs ................................. 29
`Petitioner’s combination would
`remove a key feature from Sleeper for
`a redundant function ............................................. 31
`IV. CONCLUSION .............................................................................................. 33
`
`
`
`b.
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`c.
`
`ii.
`
`ii
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`TABLE OF AUTHORITIES
`
`Page No(s).
`
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) .......................................................................... 24
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,
`688 F.3d 1342 (Fed. Cir. 2012) .......................................................................... 14
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ................................................................................ 14, 15, 16
`MBC Medical Co. et al. v. ResMed Ltd.,
`IPR 2014-01363, Paper 7 at 7 (P.T.A.B. Jan. 21, 2015) .................................... 21
`MBC Medical Co. et al. v. ResMed Ltd.,
`IPR 2014-01363, 2016 WL 287090 (P.T.A.B. Jan. 20, 2016) ........................... 21
`Microsoft Corp. v. Proxyconn, Inc.,
`789 F.3d 1292 (Fed. Cir. 2015) .......................................................................... 10
`In re Nuvasive, Inc.,
`842 F.3d 1376 (Fed. Cir. 2016) .......................................................................... 15
`In re Ratti,
`270 F.2d 810 (C.C.P.A. 1959) ................................................................ 16, 31, 32
`ResMed Ltd. v. Fisher & Paykel Healthcare Ltd.,
`IPR2019-00172, Paper 11 (P.T.A.B. April 4, 2019) ............................................ 1
`South-Tek Sys., LLC v. Engineered Corrosion Sols., LLC,
`No. 2017-2297, 2018 WL 4520013 (Fed. Cir. Sept. 20, 2018) .............. 28, 31, 32
`OTHER AUTHORITIES
`35 U.S.C. § 314 ........................................................................................................ 14
`37 C.F.R. § 42.108 ................................................................................................... 14
`M.P.E.P. § 2143.01 .................................................................................................. 15
`
`iii
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`
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`ResMed v. Fisher & Paykel
`IPR2019-00178
`
`EXHIBIT LIST
`
`
`Description
`Declaration of Patrick W. Truitt, Jr.
`Curriculum Vitae of Patrick W. Truitt Jr.
`The New Oxford American Dictionary
`The American Heritage Dictionary
`
`Exhibit No.
`FPH2001
`FPH2002
`FPH2003
`FPH2004
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`
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`
`
`iv
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`
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`ResMed v. Fisher & Paykel
`IPR2019-00178
`
`I. INTRODUCTION
`Petitioners ResMed Limited, ResMed Inc., and ResMed Corp. (together,
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`“Petitioner”) present two grounds challenging claims 9 and 11-21 of U.S. Patent No.
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`9,974,914 (the ’914 patent). Independent claim 9 requires a prong part with a
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`“curved user-side portion” and “two prongs having a first side adjacent the user-side
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`portion.”1
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`Petitioner fails to provide any explanation as to how the references disclose
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`this adjacency requirement of all the challenged claims. For claim 9, Petitioner relies
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`on Sleeper. For some limitations, Petitioner proposes modifications to Sleeper based
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`on Wood. However, neither Sleeper nor Wood (nor any of Petitioner’s other
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`references) disclose nasal prongs adjacent a curved user-side portion on the prong
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`part. Petitioner’s failure to demonstrate how the references disclose this critical
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`limitation is fatal to every challenged claim. Likewise, both references teach against
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`the use of humidified gases, another limitation common to all claims. Therefore,
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`Petitioner cannot establish a reasonable likelihood of prevailing on any claim. The
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`Board should deny institution.
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`
`1
`In IPR2019-00172 and IPR2019-00173, which both relate to the ’914
`patent, the Board requested that each party file a brief on “the parties’ positions
`regarding the claim phrases ‘curving inwardly toward an interior of the prong part
`body’ and ‘curving inward toward an interior of the body part.’” See ResMed Ltd.
`v. Fisher & Paykel Healthcare Ltd., IPR2019-00172, IPR2019-00172, Paper 11 at
`4-5 (P.T.A.B. April 4, 2019).
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`1
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`ResMed v. Fisher & Paykel
`IPR2019-00178
`
`II. BACKGROUND
`A. Overview Of The ’914 Patent
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`1.
`The ’914 Patent Specification
`The ’914 patent describes several embodiments of a nasal cannula that allows
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`delivery of humidified gases and creates positive airway pressure in a user’s airway.
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`For example, as shown below, figure 11 of the ’914 patent illustrates particular
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`components of the nasal cannula, including a prong part, a body part and a ball-
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`jointed connector.
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`
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`In some embodiments, the outside surface of the prong part includes a curved
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`segment or curved user-side portion that curves inwardly toward an interior of the
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`prong part. This curved user-side portion is illustrated in figure 12 of the ’914 patent,
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`shown below (rotated 90 degrees from original) with the curved user-side portion
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`highlighted in yellow adjacent to the nasal prongs (64 and 65):
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`2
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`ResMed v. Fisher & Paykel
`IPR2019-00178
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`Fig. 12
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`Also visible in figure 12 above is an aspect of an embodiment of the ’914
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`patent whereby the prongs are angled towards each other such that the user side of
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`the prongs is spaced farther apart than the opposite side of the prongs (reflected in
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`the angle α above).
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`2.
`The Claims
`The ’914 patent has 28 claims, but only claims 9 and 11-21 are challenged in
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`the Petition. The Petition challenges one independent claim: claim 9. For ease of
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`reference, the relevant portions of claim 9 are reproduced below:2
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`Claim 9 relevant limitations:
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`. . .
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`9.1
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`a prong part comprising: a prong part body having a first end
`with two openings, a second end with a single opening, and an
`
`
`2
`The Petition applies a limitation-numbering scheme to the limitations
`of claim 9. While the limitation numbers are not part of these claims, Patent Owner
`includes them and uses them herein for ease of reference. Also, to be clear, Patent
`Owner does not suggest these claims are representative or that the patentability of
`the other claims would fall with either of these claims.
`
`3
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`ResMed v. Fisher & Paykel
`IPR2019-00178
`outer surface extending between the two openings of the first end
`and the single opening of the second end and having at least a
`curved user-side portion facing toward a user's face in use, the
`user-side portion curving inwardly toward an interior of the
`prong part body; and,
`
`9.3
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`each of the two prongs having a first side adjacent the user-side
`portion and a second side opposite the first side, the first sides of
`the two prongs being disposed further apart than the second sides
`of the two prongs. . .
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`Petitioner has failed to show that the relevant limitations of claim 9 above are
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`disclosed in the references. Since all other challenged claims depend from this
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`claim, Patent Owner focuses its response on the deficiencies common to this
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`independent claim and, therefore, fatal to all other claims in this petition.
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`B. Overview Of Petitioner’s References
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`1.
`Sleeper
`U.S. Pat Pub. No. US 2005/0028822
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`to Sleeper discloses several
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`embodiments of a nasal ventilation interface. For example, figures 6 and 7 show a
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`particular embodiment of Sleeper.
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`4
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`ResMed v. Fisher & Paykel
`IPR2019-00178
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`Petitioner identified the following curved segments in this embodiment of Sleeper
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`reproduced below.
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`5
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`ResMed v. Fisher & Paykel
`IPR2019-00178
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`
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`Pet. at 26. This embodiment includes a top housing portion 510 with “barrel-shaped
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`nasal prongs 540,” which are designed to compress “in a radial direction such that a
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`substantially uniform pressure is applied across its outer surface against an inner
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`surface of a respective naris.” RMD1014 ¶ [0046]. The top housing portion 510
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`also contains a “bellows structure 530,” that acts “in a manner similar to a
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`compression spring to apply a gentle upward pressure to a bottom surface of the
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`nose.” Id.
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`Noticeably, Petitioner fails to identify any curved segment or curved user-side
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`portion on the ridge (highlighted in yellow below) between the nasal prongs (540)
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`and the curved segments identified by Petitioner.
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`6
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`ResMed v. Fisher & Paykel
`IPR2019-00178
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`
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`RMD1014 at figure 6.
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`The specification further describes the relationship of the nasal prongs and
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`this highlighted ridge. The nasal prongs extend “from a top surface 550 of the top
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`housing portion 510,” and the ridge is a part of the “bellows structure 530” that is
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`used as a “compression spring to apply a gentle upward pressure to the bottom
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`surface of the nose.” RMD1014 ¶ [0046]. Both the bellows and nasal prongs are
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`included in the “top housing portion 510.” Id. Given this disclosure, Sleeper fails
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`to disclose nasal prongs that are adjacent a curved user-side portion on the prong
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`part that curves inwardly toward an interior of the prong part.
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`7
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`ResMed v. Fisher & Paykel
`IPR2019-00178
`2. Wood
`U.S. Pat. No. 6,478,026 to Wood discloses the nasal ventilation interface
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`with a “hollow body 32” depicted in figures 1 and 3 below.
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`
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`
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`RMD1012 at figure 1 and 3. Notably, there are no segments or portions on the user-
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`side portion curving inwardly into the hollow body.
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`8
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`ResMed v. Fisher & Paykel
`IPR2019-00178
`Wood also discloses oval-shaped nasal apertures 36, shown, for example, in
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`figures 3 and 4, and two nasal insert tubes 44, shown, for example, in figures 5 and
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`6.
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`
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`Id. at figures 4, 5, and 6. Each nasal insert tube 44 includes an annular sleeve 46.
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`Wood discloses that the annular sleeves 46 “preferably have a generally oval shape
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`for conforming to the shape of the patient’s nostrils to form the seal as described.
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`As shown, Wood does not disclose any nasal prongs adjacent a curved segment or
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`curved user-side portion that curves inwardly toward an interior of a prong part.
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`9
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`ResMed v. Fisher & Paykel
`IPR2019-00178
`C. Claim Construction
`
`Because the Petition was filed prior to November 13, 2018, the Board applies
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`the broadest reasonable interpretation standard for any claim construction. In
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`considering what construction is broadest while remaining reasonable, the Board
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`reads the claims in light of the specification, prosecution history, and record
`
`evidence. Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292, 1298 (Fed. Cir. 2015).
`
`Ultimately, the Board’s construction must be consistent with the one that those
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`skilled in the art would reach. Id. A construction that is unreasonably broad and
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`that does not reasonably reflect the patent’s plain language and disclosure “will not
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`pass muster.” Id.
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`For purposes of this Preliminary Response, Patent Owner does not dispute
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`Petitioner’s contention that the claims terms of the ’914 patent should be given their
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`plain meaning under the BRI standard. Pet. at 17-18. However, Patent Owner
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`proposes that the Board construe the term “adjacent” as it appears in claims 1 and 9
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`to mean “next to or adjoining.”
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`Patent Owner’s construction is supported by the intrinsic record and conveys
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`the plain and ordinary meaning of the term. “Adjacent” appears IN claims 1 and 9
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`to indicate the relative position of the first side of the two prongs to the curved
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`segment or the user-side portion. In each instance, “adjacent” is used consistent with
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`the construction “next to or adjoining.” Likewise, a POSITA reviewing the claims
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`10
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`ResMed v. Fisher & Paykel
`IPR2019-00178
`and specification would understand that the term “adjacent” means “next to or
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`adjoining.” FPH2001 ¶ 28. For example, figure 12 shows a curved segment or
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`curved user-side portion (highlighted in yellow) next to or adjoining the nasal prongs
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`(64 and 65):
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`
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`Fig. 12
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`RMD1001 at figure 12 (annotated). Accordingly, the intrinsic record supports
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`Patent Owner’s construction.
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`Common dictionary definitions further support Patent Owner’s construction
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`of “adjacent.” For example, The New Oxford American Dictionary defines adjacent
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`as “next to or adjoining something else.” FPH 2003. Likewise, The American
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`Heritage Dictionary defines “adjacent” as: “1) [c]lose to; lying near; 2) [n]ext to;
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`adjoining.” FPH2004. Thus, Patent Owner’s construction of “adjacent” is
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`consistent with its common meaning. Under such a construction, two structures
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`(e.g., nasal prongs and a curved segment) are not adjacent if they are separated by a
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`third, intervening structure (e.g., a ridge).
`
`11
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`ResMed v. Fisher & Paykel
`IPR2019-00178
`Patent Owner reserves the right to take differing claim construction positions
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`in other forums or in other situations where claim construction standards may be
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`different.
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`D. Level Of Skill In The Art
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`For purposes of this Preliminary Response, Patent Owner does not dispute
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`Petitioner’s stated level of ordinary skill in the art in 2004. Pet. at 18.
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`E.
`
`Petitioner’s Asserted Grounds
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`Petitioner presents three grounds for inter partes review based on the
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`following four references:
`
`Exhibit No. Reference
`RMD1009 Declaration of Anthony Michael
`Ging
`RMD1011 U.S. Pat. Pub. 2004/0226566
`RMD1012 U.S. Pat. No. 6,478,026
`RMD1014 U.S. Pat. Pub. 2005/0028822
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`Shorthand Name
`
`Ging Declaration
`
`Gunaratnam
`Wood
`Sleeper
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`
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`12
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`ResMed v. Fisher & Paykel
`IPR2019-00178
`Petitioner contends claims 9 and 11-21 are obvious based on the following
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`two grounds:
`
`Ground References
`
`1
`
`2
`
`Sleeper in view of Wood
`Sleeper in view of Wood and
`Gunaratnam
`
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`F. Relationship To IPR 2019-00177
`
`Basis
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`§ 103
`
`§ 103
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`Claims
`Challenged
`9
`
`11-21
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`Both the present Petition and the co-pending IPR2019-00177 Petition
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`challenge claim 9 of the ’914 patent based on Sleeper in view of Wood. In IPR2019-
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`00177, Petitioner also relies on the Sleeper, Wood, and Gunaratnam references to
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`challenge the claims depending from claim 1. The POPRs submitted in each Petition
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`are roughly the same because they focus on Petitioner’s failure to provide evidence
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`showing the critical limitations in claim 9 as being disclosed in the references.
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`A. Legal Standard
`
`III. ARGUMENT
`
`1.
`Threshold For Institution
`The statutory threshold that must be met to institute an IPR reads as follows:
`
`(a) Threshold – The Director may not authorize and inter partes review to
`be instituted unless the Director determines that the information presented
`in the petition . . . shows that there is a reasonable likelihood that the
`petitioner would prevail with respect to at least 1 of the claims challenged
`in the petition.
`
`13
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`
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`ResMed v. Fisher & Paykel
`IPR2019-00178
`35 U.S.C. § 314(a) (emphasis added); accord 37 C.F.R. § 42.108(c). As explained
`
`below, Petitioner has failed to provide any evidence that the references disclose nasal
`
`prongs adjacent a curved user-side portion of the body part. The failure to disclose
`
`this critical element alone shows that Petitioner has not shown a reasonable
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`likelihood of success with respect to any challenged claim of the ’914 patent.
`
`2. Obviousness Combinations
`All grounds of the Petition rely on obviousness. To prevail on obviousness,
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`
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`it is not enough to simply show that a combination of references discloses the claim
`
`limitations; in addition, a reason to modify and combine the references must be
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`provided. See, e.g., KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418-19 (2007)
`
`(“[R]ejections on obviousness grounds cannot be sustained by merely conclusory
`
`statements; instead there must be some articulated reasoning with some rational
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`underpinning to support the legal conclusion of obviousness. . . . [I]t can be
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`important to identify a reason that would have prompted a person of ordinary skill
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`in the relevant field to combine the elements in the way the claimed new invention
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`does.” (internal quotation marks and citations omitted). Even if prior art references
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`disclose all claim limitations when combined, there must be evidence to explain why
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`a POSITA would have combined the references to arrive at the claimed invention.
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`Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1366-67 (Fed. Cir.
`
`14
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`ResMed v. Fisher & Paykel
`IPR2019-00178
`2012) (citing Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374 (Fed. Cir.
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`2008)).
`
`
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`Moreover, Petitioners cannot rely on conclusory attorney argument and expert
`
`testimony to establish a reason to combine the prior art. E.g., In re Nuvasive, Inc.,
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`842 F.3d 1376, 1382 (Fed. Cir. 2016) (vacating Board’s finding of a motivation to
`
`combine prior art references that “relied on only one conclusory statement by
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`[Petitioner]’s expert” and “conclusory statements” by petitioner’s attorneys). In the
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`obviousness analysis, one must “determine whether there was an apparent reason to
`
`combine the known elements in the fashion claimed by the patent at issue.” KSR,
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`550 U.S. at 418.
`
`
`
`Several principles also signal when a motivation to make a proposed
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`combination is lacking. See, e.g., M.P.E.P. § 2143.01. For example, “[i]f [the]
`
`proposed modification would render the prior art invention being modified
`
`unsatisfactory for its intended purpose, then there is no suggestion or motivation to
`
`make the proposed modification.” Id. (citing In re Gordon, 733 F.2d 900, 902 (Fed.
`
`Cir. 1984) (explaining that if a reference’s device “were turned upside down, it
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`would be rendered inoperable for its intended purpose”)). Likewise “[i]f the
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`proposed modification or combination of the prior art would change the principle
`
`operation of the prior art invention being modified, then the teachings of the
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`references are not sufficient to render the claims prima facie obvious.” M.P.E.P.
`
`15
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`
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`ResMed v. Fisher & Paykel
`IPR2019-00178
`§ 2143.01 (citing In re Ratti, 270 F.2d 810, 813 (C.C.P.A. 1959)). Moreover, “when
`
`the prior art teaches away from combining certain known elements, discovery of a
`
`successful means of combining them is more likely to be nonobvious.” KSR, 550
`
`U.S. at 416 (citing U.S. v. Adams, 383 U.S. 39, 51-52 (1966)).
`
`B.
`
`The Petition Fails To Demonstrate That All Limitations In Claim 9 Are
`Found In The References, And The Board Should Deny The Petition
`Petitioner relies on Sleeper as the primary reference to challenge claim 9. But
`
`Sleeper fails to disclose several critical limitations, such as the adjacency of nasal
`
`prongs and curved segment/curved user-side portion, of these independent claims.
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`Wood also fails to disclose the adjacency of nasal prongs and curved segment/curved
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`user-side portion.
`
`1.
`
`Petitioner Fails To Show Nasal Prongs Adjacent A Curved User-
`Side Portion
`Limitation 9.3 requires “each of the two prongs having a first side adjacent
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`the user-side portion” with the user side portion “curving inwardly toward an interior
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`of the prong part body.” Pet. at 31-36.
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`Petitioner’s entire analysis of this adjacency requirement is a single sentence
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`that merely concludes without support that the resulting nasal prongs of Sleeper
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`modified in light of Wood “would be positioned such that the first sides of the prongs
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`(which are disposed further apart) were positioned adjacent to the user-facing curved
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`segment of Sleeper’s nasal cannula . . . .” Pet. at 36. The petition provides no
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`16
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`ResMed v. Fisher & Paykel
`IPR2019-00178
`evidence of nasal prongs adjacent a curved “user-side portion,” nor does Petitioner
`
`provide any figures showing any adjacency. RMD1001 at claim 9.
`
`Instead, Petitioner focuses its discussion on modifying Sleeper in view of
`
`Wood such that the first sides of the two prongs would be further apart than the
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`second sides of the two prongs. But neither Sleeper nor Wood show nasal prongs
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`adjacent the required curved user-side portion.
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`For example, Petitioner identified the following curved segments in figure 6
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`of Sleeper reproduced below.
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`17
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`ResMed v. Fisher & Paykel
`IPR2019-00178
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`Pet. at 26.
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`Noticeably, Petitioner fails to identify any curved segment or curved user-side
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`portion on the ridge (highlighted in yellow below) between the nasal prongs (540)
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`and the curved segments identified by Petitioner.
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`RMD1014 at figure 6.
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`18
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`ResMed v. Fisher & Paykel
`IPR2019-00178
`The specification further describes the relationship of the nasal prongs and
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`this highlighted ridge. The nasal prongs extend “from a top surface 550 of the top
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`housing portion 510,” and the ridge is a part of the “bellows structure 530” that is
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`used as a “compression spring to apply a gentle upward pressure to the bottom
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`surface of the nose.” RMD1014 ¶ [0046]. Both the bellows and nasal prongs are
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`included in the “top housing portion 510.” Id. Given this disclosure, a POSITA
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`would understand that the nasal prongs are not adjacent to any of the alleged curved
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`segments identified by Petitioner. FPH2001 ¶ 46.
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`Likewise, Wood fails to disclose nasal prongs adjacent the required curved
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`segment or curved user-side portion. While Wood has a generally curved interface,
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`it lacks claim 1’s required curved segment in a first portion of an outer surface facing
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`toward a user’s face in use, and likewise lacks claim 9’s required curved user-side
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`portion facing toward a user’s face in use. These deficiencies are illustrated in
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`figures 1 and 3 below.
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`19
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`ResMed v. Fisher & Paykel
`IPR2019-00178
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`RMD1012 at figures 1, 3. Thus, because Wood fails to disclose the required curved
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`user-side portion, Wood cannot and does not disclose nasal prongs adjacent the
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`curved segment or curved user-side portion. Petitioner’s failure to provide any
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`evidence satisfying this adjacency requirement is fatal to its entire petition.
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`20
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`ResMed v. Fisher & Paykel
`IPR2019-00178
`2.
`Petitioner Fails To Show A Nasal Cannula Or Conduit
`Configured To Supply Humidified Gases
`The preamble to claim 9 recites “[a] nasal cannula configured to deliver
`
`humidified gases to a user, the nasal cannula comprising.” Petitioner argues that this
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`requirement is not a limitation through a citation to MBC Medical Co. et al. v.
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`ResMed Ltd., IPR 2014-01363, Paper 7 at 7 (P.T.A.B. Jan. 21, 2015).3 Nevertheless,
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`the body of claim 9 requires the second end of the prong part body be “configured
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`to receive the humidified gases.” RMD1001 at claim 9. Petitioner does not contest
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`that this is a requirement for all claims in the Petition. Pet. at 22-24, 37-39.
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`To meet these limitations, Petitioner points to a single passage in Sleeper that
`
`states:
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`It is normally unnecessary to humidify or add moisture to the air supplied
`by the ventilation device in using the nasal interface of the present
`invention, as the nasal interface is designed to avoid stripping moisture
`from the nares. Thus, moisture does not have to be added to relieve patient
`discomfort from drying or burning sensations in the nasal airways.
`RMD1014 ¶ [0036] (emphasis added).
`
`Petitioner states that “a POSITA would have recognized from Sleeper’s
`
`teaching that the nasal cannula 500 was configured to deliver humidified gases to a
`
`
`3
`The Board actually held that the term “humidifier” used in the preamble
`was “not accorded patentable weight beyond requiring that the prior-art structure be
`capable of claimed use.” MBC Medical Co. et al. v. ResMed Ltd., IPR 2014-01363,
`2016 WL 287090, at *4 (P.T.A.B. Jan. 20, 2016) (emphasis added). Thus, the Board
`still required a showing that the structure was capable of the claimed use.
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`21
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`ResMed v. Fisher & Paykel
`IPR2019-00178
`user.” Pet. at 24. Likewise, Petitioner’s declarant states that “a POSITA would have
`
`recognized from this disclosure that Sleeper’s statement that using humidified air
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`was ‘normally unnecessary’ (RMD1014, [0036]) discloses the fact that delivery of
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`humidified air was necessary in some circumstances.” RMD1009 ¶ 203.
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`Petitioner’s statement and expert declaration are wholly contradicted by the patent
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`specification and should be given no weight. The passage explicitly states that
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`“moisture does not have to be added” and “[i]t is normally unnecessary to humidify
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`or add moisture to the air supplied by the ventilation device in using the nasal
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`interface of the present invention.” RMD1014 ¶ [0036].
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`Recognizing that it has failed to show that Sleeper discloses a nasal cannula
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`configured to deliver humidified gases, Petitioner states that “[t]his recognized
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`capability is corroborated by Wood, which confirms the traditional practice in which
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`‘[t]he gas is often room air or oxygen-enriched air, but can be a mixture of other
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`gases.’” Pet. at 23-24. However, nothing that Petitioner cites discloses a nasal
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`cannula configured to deliver humidified gases to a user as Petitioner argues.
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`Petitioner’s failure to provide any evidentiary support is fatal to its entire petition.
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`C. The Petition’s Reliance On Combined References Fails
`Petitioner’s obviousness theories based on a combination of references also
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`fail. As explained in detail below, the petition fails to establish disclosure of
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`22
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`ResMed v. Fisher & Paykel
`IPR2019-00178
`limitation 9.3, and fails to provide a motivation or suggestion to combine in the
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`references themselves.
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`1.
`
`Sleeper Fails To Disclose First Sides Of The Two Prongs Disposed
`Further Apart Than The Second Sides Of The Two Prongs
`Claims 9 requires “first sides of the two prongs being disposed further apart
`
`than the second sides of the two prongs.” Sleeper fails to disclose this requirement.
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`Sleeper describes the nasal prongs 540 as “barrel-shaped.” See RMD1014 ¶ [0046].
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`Nevertheless, Petitioner notes that Sleeper “also expressly contemplates other
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`versions in which the nasal prongs can ‘assume any suitable shape’ when inflated
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`under the positive pressure during use.” See Pet. at 31 (citing RMD1014 ¶ [0053]).
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`The cited disclosure relates to nasal prongs 1310 of the separate embodiment of
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`figures 14 and 15. Sleeper also mentions that nasal prongs 2030 of the embodiment
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`of figures 20 and 21 can be “of any suitable shape.” See RMD1014 ¶ [0061]. But
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`Sleeper does not mention that the embodiment of figures 6-8 can be of any suitable
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`shape, nor does Sleeper’s disclosure of “any suitable shape” say anything about the
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`positioning of the nasal prongs relative to each other. In fact, the barrel shape of
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`figures 6-8 is expressly disclosed as “compressed in a radial direction such that a
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`substantially uniform pressure is applied across its outer surface against an inner
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`surface of a respective naris, thus forming a substantially airtight seal between the
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`prong 540 and the naris over a large surface area.” RMD1014 ¶ [0046]. Only a
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`possible addition of “two or more rings formed on the nasal prongs” is contemplated
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`23
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`ResMed v. Fisher & Paykel
`IPR2019-00178
`as a variation of the prongs in this embodiment. A POSITA would not understand
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`the prongs in figures 6-8 to include “any suitable shape” as stated by Petitioner.
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`FPH2001 ¶ 78. Recognizing the deficiencies of Sleeper’s disclosure, Petitioner
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`argues that Wood discloses nasal prongs satisfying this limitation and seeks to meet
`
`this limitation with that combination.
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`2.
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`Petitioner’s Motivation To Combine Is Unsupported By The
`Record
`To establish a prima facie case of obviousness, Petitioner has the “burden to
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`demonstrate both that a skilled artisan would have been motivated to combine the
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`teachings of the prior art references to achieve the claimed invention, and that the
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`skilled artisan would have had a reasonable expectation of success in doing so.”
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`Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367-68 (Fed.
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`Cir. 2016). The legal requirement of a reasonable expectation of success is a
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`separate requirement from a motivation or reason to combine. Id. at 1367. Petitioner
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`fails to establish its prima facie case of obviousness.
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`The Petition asserts that it would have been obvious to modify the nasal
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`prongs of Sleeper “based on Wood’s suggestion to use oval-shaped nasal
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`prongs/apertures that are arranged in an angular orientation further apart at the first
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`sides than the second sides.” Pet. at 33-34. As explained below, Petitioner entirely
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`glosses over the significant differences between Sleeper and Wood.
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`24
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`ResMed v. Fisher & Paykel
`IPR2019-00178
`Petitioner asserts three reasons why a POSITA would have modified the nasal
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`prongs of Sleeper to use oval-shaped nasal prongs/apertures:
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`1.
`
`It
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