throbber
Filed: April 24, 2019
`
`
`By:
`
`Filed on behalf of:
`Fisher & Paykel Healthcare Limited
`Jon W. Gurka
`Douglas G. Muehlhauser
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
`Tel:
`(949) 760-0404
`Fax: (949) 760-9502
`E-mail: BoxFPH892-5@knobbe.com
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`RESMED PTY LTD., RESMED INC., AND RESMED CORP.,
`Petitioners,
`
`v.
`
`FISHER & PAYKEL HEALTHCARE LIMITED,
`Patent Owner.
`__________________________________
`
`Case No. IPR2019-00179
`Patent No. 9,333,315
`__________________________________
`
`PATENT OWNER FISHER & PAYKEL HEALTHCARE LIMITED’S
`PRELIMINARY RESPONSE
`
`
`
`
`

`

`TABLE OF CONTENTS
`
`Page No.
`
`I.
`
`INTRODUCTION ........................................................................................... 1 
`
`II. BACKGROUND ............................................................................................. 2 
`
`A.  Overview Of The ’315 Patent ............................................................... 2 
`
`1. 
`
`2. 
`
`The ’315 Patent Embodiments .................................................... 2 
`
`The Independent Claims ............................................................. 6 
`
`B. 
`
`C. 
`
`D. 
`
`Claim Construction ............................................................................... 8 
`
`Level Of Skill In The Art ...................................................................... 9 
`
`Petitioner’s Asserted Grounds ............................................................... 9 
`
`III. ARGUMENT ................................................................................................. 10 
`
`A. 
`
`Legal Standard ..................................................................................... 10 
`
`B.  Grounds 1 And 2 Fail Because Gunaratnam Alone Does Not
`Disclose The Claimed Headgear Extension Limitations .................... 12 
`
`1. 
`
`The First And Second Gunaratnam Embodiments Do
`Not Disclose The Claimed Headgear Extension
`Limitations ................................................................................ 13 
`
`a. 
`
`b. 
`
`Gunaratnam’s crossbar headgear connections
`do not disclose the claimed headgear extension
`limitations ....................................................................... 15 
`
`Gunaratnam’s “second connector portions” are
`not connected “on a distal side of the prong
`part” or “spaced from a user in use” ............................... 17 
`
`-i-
`
`

`

`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`c. 
`
`Petitioner’s reliance on the “second connector
`portion” is inconsistent with Petitioner’s
`argument on limitations 6.2 and 17.2 ............................. 20 
`
`2. 
`
`The Third Gunaratnam Embodiment Does Not
`Disclose The Headgear Extension Limitations ......................... 21 
`
`C.  Grounds 3-6 Fail Because Thomlinson In View Of
`Gunaratnam Does Not Disclose The Claimed Headgear
`Extension Limitations ......................................................................... 24 
`
`1. 
`
`2. 
`
`3. 
`
`Petitioner Presents No Evidence Why A POSITA
`Would Apply Gunaratnam’s Rotation Yokes To
`Thomlinson ............................................................................... 25 
`
`Petitioner’s Hypothetical Combination Is Based On
`Hindsight ................................................................................... 28 
`
`Petitioner Has Not Shown That Any Benefits
`Disclosed In Gunaratnam Would Motivate A POSITA
`To Derive Petitioner’s Hindsight Combination Device............ 31 
`
`IV. CONCLUSION .............................................................................................. 35 
`
`
`
`
`
`-ii-
`
`

`

`TABLE OF AUTHORITIES
`
`Page No(s).
`
`Becton, Dickinson and Co. v. Tyco Healthcare Grp.,
`616 F.3d 1249 (Fed. Cir. 2010) .................................................................... 20, 21
`
`Gaus v. Conair Corp.,
`363 F.3d 1284 (Fed. Cir. 2004) .......................................................................... 21
`
`Innogenetics, N.V. v. Abbott Labs.,
`512 F.3d 1363 (Fed. Cir. 2008) .......................................................................... 11
`
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,
`688 F.3d 1342 (Fed. Cir. 2012) .......................................................................... 11
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ...................................................................................... 11, 12
`
`Microsoft Corp. v. Proxyconn, Inc.,
`789 F.3d 1292 (Fed. Cir. 2015) ............................................................................ 9
`
`In re Nuvasive, Inc.,
`842 F.3d 1376 (Fed. Cir. 2016) .................................................................... 11, 12
`
`In re Warsaw Orthopedic, Inc.,
`832 F.3d 1327 (Fed. Cir. 2016) .......................................................................... 23
`
`OTHER AUTHORITIES
`
`35 U.S.C. § 103 ........................................................................................................ 10
`
`35 U.S.C. § 314 ........................................................................................................ 11
`
`37 C.F.R. § 42.108 ................................................................................................... 11
`
`M.P.E.P. § 2143.01 .................................................................................................. 12
`
`
`
`-iii-
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`
`EXHIBIT LIST
`
`Exhibit No.
`FPH2001
`FPH2002
`
`Description
`Declaration of Patrick W. Truitt, Jr.
`Curriculum Vitae of Patrick W. Truitt, Jr.
`
`
`
`Exhibit List, Page 1
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`
`I. INTRODUCTION
`
`Patent Owner Fisher & Paykel Healthcare Limited is a world leader and
`
`innovator in respiratory therapy devices for critical care and home care use. U.S.
`
`Patent No. 9,333,315 (the “’315 patent”) at issue in this IPR claims an innovative
`
`respiratory mask that may be used with Continuous Positive Airway Pressure
`
`(CPAP) machines to treat sleep apnea.
`
`Petitioners ResMed Pty Ltd., ResMed Inc. and ResMed Corp. (together,
`
`“Petitioner”) seek inter partes review of claims 1-19 of the ’315 patent. The Petition
`
`presents six grounds challenging the validity of claims 1-19 of the ’315 patent. The
`
`’315 patent contains three independent claims, claims 1, 6 and 17. Each independent
`
`claim shares a limitation requiring that the distal ends of each headgear extension
`
`connect to the rigid mask body “on a distal side of the prong part at a location spaced
`
`from a user in use” (the “headgear extension limitations”). Petitioner argues that the
`
`Gunaratnam reference alone, or in combination with the Thomlinson reference,
`
`renders obvious this “headgear extension” limitation in each independent claim.
`
`However, a person of ordinary skill in the art (“POSITA”) would not find that
`
`Gunaratnam discloses the headgear extension limitations. Petitioner has not
`
`provided evidence that the specific structures in two Gunaratnam embodiments that
`
`attach the headgear disclose the headgear extension limitations. Moreover, the
`
`headgear structures disclosed in a third Gunaratnam embodiment attach to the mask
`
`-1-
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`frame on lateral and proximal sides of the prong part, not on a distal side as required
`
`by every claim in the ’315 patent. Additionally, the headgear structures connect
`
`close to, and not spaced away from, a user in use as required by every claim in the
`
`’315 patent. Thus, Petitioner’s arguments based on Gunaratnam alone fail.
`
`Thomlinson does not cure Gunaratnam’s fatal deficiencies. Petitioner’s
`
`hypothetical mask assembly combination of Thomlinson and Gunaratnam is an
`
`inoperable hodgepodge of components strung together by resort to hindsight reliance
`
`on the ’315 patent. Furthermore, in view of the disparate structures and teachings in
`
`Thomlinson and Gunaratnam, a POSITA would not be motivated to construct
`
`Petitioner’s hindsight-driven combination.
`
`Petitioner’s failure to show that the claimed headgear extension limitations
`
`would have been obvious is fatal to the entire petition, as all claims in the ’315 patent
`
`require those limitations. Because Petitioner cannot establish that Gunaratnam
`
`alone, or in combination with Thomlinson, renders obvious the headgear extension
`
`limitations, the entire Petition must be denied.
`
`II. BACKGROUND
`A. Overview Of The ’315 Patent
`1.
`
`The ’315 Patent Embodiments
`
`The ’315 patent describes several embodiments of a mask assembly for
`
`delivering positive airway pressure to a user. For example, as shown below, Figure
`
`-2-
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`11 of the ’315 patent illustrates particular components of the mask assembly,
`
`including a prong part (61), a rigid mask body (70), and first and second headgear
`
`extensions (72, 73).
`
`
`An exploded view of Figure 9, as seen in annotated Figure 11 below, shows
`
`that the headgear extensions (72, 73) connect to the rigid mask body (70) on a distal
`
`side of the prong part (61).
`
`-3-
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`
`
`As can be seen in the Figure 11 embodiment above, relative to the prong part,
`
`the headgear extensions connect to the rigid mask body on a distal side of the prong
`
`part. Moreover, because the prongs are fitted to a user’s nares when in use
`
`(RMD1003 (’315 patent) at 6:52-54), the connection of the headgear extensions to
`
`the rigid mask body are also spaced from a user in use. The spatial relationship of
`
`the headgear extensions relative to the prong part is also seen in the side-view
`
`perspective of Figure 10 below (with annotations).
`
`-4-
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`
`
`The exploded view of Figure 10, as shown below in Figure 13, again shows
`
`the headgear extension connected to the rigid mask body, on the distal side of the
`
`prong part and spaced from a user in use.
`
`
`
`-5-
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`
`2.
`
`The Independent Claims
`
`Petitioner challenges all 19 claims of the ’315 patent. Only claims 1, 6 and
`
`17 are independent. Claim 17, the shortest of the independent claims, is reproduced
`
`below, with emphasis on the headgear extension limitations that are the focus of this
`
`Preliminary Response (17.4, 17.6):1
`
`Claim 17
`
`17.P A mask assembly for delivering positive airway pressure to a
`user, the mask comprising:
`17.1 a rigid mask body;
`17.2 an inspiratory conduit connected to the rigid mask body;
`17.3 a prong part comprising a hollow body and first and second nasal
`prongs extending from the hollow body, the hollow body
`removably connected to the mask body;
`17.4 a first headgear extension having a distal end connected to the
`rigid mask body on a distal side of the prong part at a location
`spaced from a user in use, and a proximal end disposed
`proximally toward a user in use,
`
`1 The Petition applies a limitation-numbering scheme to the limitations of the
`
`’315 patent claims. While the limitation numbers are not part of the claims, Patent
`
`Owner includes them and uses them herein for ease of reference. Also, to be clear,
`
`Patent Owner does not suggest that independent claims 1, 6 and 17 are representative
`
`or that the patentability of the other claims would fall with the independent claims.
`
`-6-
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`
`17.5
`
`the first headgear extension extending from the rigid mask body,
`at least along a first lateral direction extending laterally away
`from the rigid mask body and beyond an outer periphery of the
`prong part and along a second direction extending more
`proximally toward the user than the first direction in use; and
`17.6 a second headgear extension having a distal end connected to the
`rigid mask body on the distal side of the prong part at a location
`spaced from a user in use, and a proximal end disposed
`proximally toward a user in use,
`the second headgear extension extending from the rigid mask
`body at least along a third lateral direction extending laterally
`away from the rigid mask body and beyond the outer periphery
`of the prong part and along a fourth direction more proximally
`toward the user than the third direction in use.
`
`17.7
`
`The above emphasized headgear extension limitations identify at least three
`
`requirements: that the headgear extensions (1) connect to the rigid mask body, (2) on
`
`a distal side of the prong part, (3) spaced from a user in use. A separate requirement
`
`follows each headgear extension limitation, namely, that the headgear extensions
`
`have a proximal end disposed proximally toward a user in use. The headgear
`
`extension limitations have counterparts in independent claims 1 and 6. The relevant
`
`limitations of those claims are reproduced below, with claim 6 appearing first
`
`because of the similarity of its relevant claim language to that in claim 17.
`
`-7-
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`
`Claim 6
`
`6.6
`
`6.4
`
`a first headgear extension having a distal end connected to the
`rigid mask body on a distal side of the prong part at a location
`spaced from a user in use, and a proximal end disposed
`proximally toward a user in use,
`a second headgear extension having a distal end connected to the
`rigid mask body on the distal side of the prong part at a location
`spaced from a user in use, and a proximal end disposed
`proximally toward a user in use,
`Claim 1
`
`1.5
`
`1.7
`
`the first headgear extension having a distal end connected to the
`left peripheral side of the rigid mask body on a distal side of the
`prong part at a location spaced from a user in use, and a
`proximal end disposed proximally toward a left side of a user’s
`face in use,
`the second headgear extension having a distal end connected to
`the right peripheral side of the rigid mask body on the distal
`side of the prong part at a location spaced from a user in use,
`and a proximal end disposed proximally toward a right side of a
`user’s face in use,
`
`B. Claim Construction
`
`Because the Petition was filed prior to November 13, 2018, the Board applies
`
`the broadest reasonable interpretation (“BRI”) standard for any claim construction.
`
`In considering what construction is broadest while remaining reasonable, the Board
`
`-8-
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`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
`
`skilled in the art would reach. Id. A construction that is unreasonably broad and
`
`that does not reasonably reflect the patent’s plain language and disclosure “will not
`
`pass muster.” Id.
`
`For purposes of this Preliminary Response, Patent Owner does not dispute
`
`Petitioner’s contention that the claims terms of the ’315 patent should be given their
`
`plain meaning under the BRI standard. Pet. at 6-7. Patent Owner reserves the right
`
`to take differing claim construction positions in other forums or in other situations
`
`where claim construction standards may be different. Patent Owner notes that
`
`Petitioner’s comments about the claim term “tube” (Pet. at 7) do not bear on this
`
`Preliminary Response, as all claims containing the term “tube” also contain the
`
`headgear extension limitations that Petitioner’s references do not teach.
`
`C. Level Of Skill In The Art
`
`For purposes of this Preliminary Response, Patent Owner does not dispute
`
`Petitioner’s stated level of ordinary skill in the art in 2004. Pet. at 7-8.
`
`D.
`
`Petitioner’s Asserted Grounds
`
`Petitioner presents six grounds for inter partes review based on the following
`
`three references:
`
`-9-
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`
`Record Citation
`
`RMD1009
`
`RMD1010
`RMD1011
`
`Shorthand Name
`
`Reference
`Declaration of Anthony
`Michael Ging
`U.S. Pat. Pub. 2005/0011524 Thomlinson
`U.S. Pat. Pub. 2004/0226566 Gunaratnam
`
`Ging Declaration
`
`
`
`
`
`Petitioner contends claims 1-19 are obvious based on these six grounds:
`
`Ground
`
`References
`
`1
`2
`
`3
`
`4
`
`5
`
`6
`
`Gunaratnam
`Gunaratnam in view of Ho
`Thomlinson in view of
`Gunaratnam
`Thomlinson in view of
`Gunaratnam and Madaus
`Thomlinson in view of
`Gunaratnam, Madaus and Ho
`Thomlinson in view of
`Gunaratnam and Ho
`
`Basis
`
`§ 103
`§ 103
`
`Claims
`Challenged
`1, 4-14, 16-19
`2, 15
`
`§ 103
`
`6-7, 9-14, 16-18
`
`§ 103
`
`1, 3-5, 8, 19
`
`§ 103
`
`§ 103
`
`2
`
`15
`
`III. ARGUMENT
`
`A. Legal Standard
`
`Petitioner must meet the following statutory threshold:
`
`(a) Threshold – The Director may not authorize and inter partes review
`to be instituted unless the Director determines that the information
`
`-10-
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`
`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.
`
`35 U.S.C. § 314(a) (emphasis added); accord 37 C.F.R. § 42.108(c).
`
`All grounds of the Petition rely on obviousness. For any IPR ground to prevail
`
`based on obviousness, 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 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 underpinning to support the legal conclusion of
`
`obviousness. . . . [I]t can be important to identify a reason that would have prompted
`
`a person of ordinary skill in the relevant field to combine the elements in the way
`
`the claimed new invention does.”) (internal quotation marks and citations omitted).
`
`Even if prior art references disclose all claim limitations when combined, there must
`
`be evidence to explain why a POSITA would have combined the references to arrive
`
`at the claimed invention. Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d
`
`1342, 1366-67 (Fed. Cir. 2012) (citing Innogenetics, N.V. v. Abbott Labs., 512 F.3d
`
`1363, 1374 (Fed. Cir. 2008).
`
`-11-
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`
`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.,
`
`842 F.3d 1376, 1382-84 (Fed. Cir. 2016) (vacating Board’s finding of a motivation
`
`to combine prior art references that “relied on only one conclusory statement by
`
`[Petitioner]’s expert” and “conclusory statements” by Petitioner’s attorneys). In the
`
`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,
`
`550 U.S. at 418.
`
`Several principles also signal when a motivation to make a proposed
`
`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. Likewise “[i]f the 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 references are not sufficient to
`
`render the claims prima facie obvious.” Id.
`
`B. Grounds 1 And 2 Fail Because Gunaratnam Alone Does Not Disclose
`The Claimed Headgear Extension Limitations
`
`For Grounds 1 and 2, Petitioner argues that the headgear extension limitations
`
`in independent claims 1, 6 and 17 are obvious in view of Gunaratnam alone. Pet. at
`
`-12-
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`12-15, 17, 34-35.2 Petitioner argues that three separate embodiments in Gunaratnam
`
`disclose the headgear extension limitations. Pet. at 12-13, 17. As examples of these
`
`embodiments, Petitioner identifies Figures 1-8 (“first embodiment”), Figures 25-31
`
`(“second embodiment”), and Figures 60-61 and 108-113 (“third embodiment,”
`
`which Petitioner notes is referred to in Gunaratnam as the “seventh embodiment”).
`
`Pet. at 8-9. Patent Owner notes that these embodiments appear to be discussed in
`
`Gunaratnam at least in paragraphs [0176]-[0234], [0235]-[0251] and [0375]-[0395],
`
`respectively. None of these embodiments discloses the claimed headgear extension
`
`limitations.
`
`1.
`
`The First And Second Gunaratnam Embodiments Do Not
`Disclose The Claimed Headgear Extension Limitations
`
`Petitioner identifies Gunaratnam components 26 and 226 in the First and
`
`Second Gunaratnam embodiments, respectively, as satisfying the headgear
`
`extension limitations for each of independent claims 1, 6 and 17 in Grounds 1 and
`
`
`
`
`2 See Pet. at 3 (Ground 1 challenging claims 1, 4-14, 16-19; Ground 2
`
`challenging claims 2 and 15, which depend from claims 1 and 6, respectively).
`
`-13-
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`2. Pet. at 12-14, 17, 34-35.3 Components 26/226 are described in the specification
`
`as “second connector portions,” and comprise hollow conduits that deliver gas to the
`
`frame and nozzle assembly. See, e.g., RMD1011 at [0199], [0242]. These are shown
`
`in Gunaratnam Figures 9-10 and 32-33 below.
`
`First Embodiment
`
`
`
`
`3 Petitioner’s analysis on these first and second embodiments appears only at
`
`Pet. at 12-14, where Petitioner addresses limitations 6.4 and 17.4. Petitioner relies
`
`on that analysis for its showing on the remaining limitations having the headgear
`
`extension limitations (i.e., Limitations 6.6, 17.6, 1.5 and 1.7). Pet. at 17, 34-35.
`
`-14-
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`
`Second Embodiment
`
`
`a. Gunaratnam’s crossbar headgear connections do not
`disclose the claimed headgear extension limitations
`
`
`
`Gunaratnam discloses two functions for the second connector portions
`
`26/226: (1) to connect the frame to the headgear assembly, and (2) to connect the
`
`gas inlet conduits to the frame/nasal assembly. See, e.g., RMD1011 at [0177],
`
`[0236]. As seen above in Figures 9-10 and 32-33, the structures on the second
`
`connector portions 26/226 that actually connect to a headgear assembly are crossbars
`
`70 and 270, respectively. See also RMD1010 at [0197], [0241]; FPH2001 (Truitt
`
`Decl.) ¶ 39. Crossbars 70/270 are structured to connect to headgear assembly
`
`20/220, which is shown for headgear assembly 20 in Figure 18 below.
`
`-15-
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`
`
`
`Thus, crossbars 70/270 represent the potential “headgear extension” counterparts
`
`disclosed in Gunaratnam, not the entire structure of the second connector portions
`
`26/226. FPH2001 ¶¶ 39-41.
`
`Petitioner ignores the crossbars 70/270 in its discussion of the headgear
`
`extension limitations. Pet. 12-14. Thus, Petitioner has not shown that the orientation
`
`of the crossbars 70/270 relative to the rigid mask body, prong part and user satisfy
`
`the headgear extension limitations of the ’315 patent. Id.; FPH2001 ¶ 42. For
`
`example, as shown above, the crossbars 70/270 are attached to the second connector
`
`portions 26/226, not the frame 16/216, and thus do not even disclose headgear
`
`-16-
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`extensions that are “connected to the rigid mask body.” Pet. at 12.4 Petitioner’s
`
`failure to demonstrate how crossbars 70/270 disclose the claimed headgear extension
`
`limitations is fatal to Grounds 1 and 2.
`
`b. Gunaratnam’s “second connector portions” are not
`connected “on a distal side of the prong part” or “spaced
`from a user in use”
`
`Ignoring the actual headgear-attachment structure disclosed in Gunaratnam,
`
`Petitioner instead relies on the entire structure of the second connector portions
`
`26/226. However, that structure does not disclose the claimed headgear extension
`
`limitations as Petitioner argues. The second connector portions 26/226 attach to the
`
`frame (16/216, respectively) using large, circular connection structures. FPH2001
`
`¶ 45. As Figures 1 and 25 show below, these connections are made on the side of
`
`the frame, relative to what Petitioner admits is the “lateral” side of the nasal
`
`assembly. Pet. at 13-14; FPH2001 ¶ 44.
`
`
`4 Gunaratnam’s headgear-connecting crossbars 70/270 also do not disclose
`
`independent claim limitations 1.6, 1.7, 6.5, 6.7, 17.5 and 17.7. FPH2001 ¶ 43.
`
`-17-
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`
`
`
`
`
`Thus, the second connector portions 26/226 do not connect to the frame “on the
`
`distal side of the prong part” as required by the claimed headgear extension
`
`limitations. FPH2001 ¶ 44.
`
`-18-
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`
`Petitioner attempts to sidestep this problem by simply declaring that the
`
`connection to the frame on a lateral side is also somehow a connection on the “distal”
`
`side of the nasal assembly. Pet. at 13-14. However, Petitioner provides no support
`
`for this characterization. On the contrary, Gunaratnam’s figures show the second
`
`connector portions 26/226 employ a large, circular connection structure that attaches
`
`to a corresponding circular structure (24/224) on the side of frame 16/216.
`
`Gunaratnam specifically requires this type of large, circular connection structure to
`
`allow the frame (and thus the nasal assembly) to rotate/adjust relative to the second
`
`connector portions 26/226 to facilitate positioning of the nasal assembly in a
`
`customized position. RMD1011 at [0179], [0240]; FPH2001 ¶ 45.
`
`As Figures 1 and 25 above show, the large, circular structure of the second
`
`connector portions 26/226 are positioned next to the user’s face in use and thus
`
`connect to the frame not only on the lateral side of the nozzle assembly, but on the
`
`proximal side as well. FPH2001 ¶ 46. As the specification states: “The front and
`
`rear portions 60, 62 are angled with respect to one another such that the second
`
`connector portions 26 follow the contour of the patient’s face in use, as shown in
`
`FIG. 1.” RMD1011 at [0194] (emphasis added). Thus, Gunaratnam’s figures and
`
`specification show that the “first/front side 60,” Pet. at 13, runs along the contour of
`
`the user’s face in use based on a connection to the frame that is neither on a distal
`
`side of the prong part, nor at a location spaced from a user in use as required by
`
`-19-
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`independent claims 1, 6 and 17. FPH2001 ¶ 46. Petitioner’s unsupported,
`
`conclusory assertions to the contrary are insufficient to meet its showing on this
`
`Petition. Pet. at 13-14.
`
`c.
`
`Petitioner’s reliance on the “second connector portion” is
`inconsistent with Petitioner’s argument on limitations 6.2
`and 17.2
`
`Petitioner’s attempt to rely on the second connector portions 26 as the
`
`headgear extension, rather than the crossbars 70 that actually connect to the
`
`headgear, also is inconsistent with Petitioner’s arguments on limitations 6.2 and
`
`17.2. FPH2001 ¶¶ 47-49. Those limitations require that the claimed “inspiratory
`
`conduit connect[] to the rigid mask body.” Pet. at 10. When arguing that inspiratory
`
`conduit limitations 6.2 and 17.2 are satisfied, Petitioner relies on the specific
`
`structure of the second connector portion 26 dedicated to supplying air (i.e., conduit
`
`72). Id.
`
`In contrast, as discussed above, when relying on the second connector portion
`
`26 for the headgear extension limitations, Petitioner does not rely on the specific
`
`structure (crossbar 70) dedicated to connecting the headgear. Pet. at 12-13. Instead,
`
`Petitioner relies on the entire second connector portion 26, including the structure
`
`dedicated to supplying air (conduit 72), as it did for the inspiratory conduit
`
`limitations 6.2 and 17.2. Id. In addition to being inconsistent, Petitioner’s reliance
`
`on the same overall structure to satisfy two separate limitations is improper. See
`
`-20-
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`Becton, Dickinson and Co. v. Tyco Healthcare Grp., 616 F.3d 1249, 1254-55 (Fed.
`
`Cir. 2010) (“Where a claim lists elements separately, ‘the clear implication of the
`
`claim language’ is that those elements are ‘distinct component[s]’ of the patented
`
`invention.”) (citing Gaus v. Conair Corp., 363 F.3d 1284, 1288 (Fed.Cir.2004).
`
`In sum, Petitioner has failed to show that the first and second embodiments in
`
`Gunaratnam disclose the claimed headgear extension limitations.
`
`2.
`
`The Third Gunaratnam Embodiment Does Not Disclose The
`Headgear Extension Limitations
`
`Petitioner identifies yoke 608 in Figures 108-110, which Petitioner describes
`
`as the “third embodiment” in Gunaratnam, as disclosing the claimed headgear
`
`extension limitations in each of independent claims 1, 6 and 17 in Grounds 1 and 2.
`
`Pet. at 14-15, 17, 34-35.5 However, this third embodiment also fails to disclose the
`
`claimed headgear extension limitations for many of the same reasons above. As
`
`Petitioner admits, the yokes attach via ring 610. Pet. at 14; RMD1011 at [0379].
`
`This can be seen in Figures 109 and 110 below.
`
`
`5 Petitioner’s analysis of this third embodiment appears only at Pet. at 14-15,
`
`where Petitioner addresses limitations 6.4 and 17.4. Petitioner again relies on that
`
`analysis for its showing on the remaining limitations (i.e., limitations 6.6, 17.6, 1.5
`
`and 1.7). Pet. at 17, 34-35.
`
`-21-
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`
`This circular ring structure allows the cushion assembly to be “adjustably rotated
`
`with respect to the headgear, to a position which best fits the patient.” RMD1011 at
`
`
`
`-22-
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`[0379]; FPH2001 ¶ 52. As can be seen from the figures above, this ring structure
`
`connects to the frame circumferentially, attaching on lateral and proximal sides of
`
`the nasal interface assembly. Id. Thus, this ring structure does not disclose the
`
`headgear extensions connecting “on a distal side of the prong part” as required by
`
`the claims.
`
`Moreover, as the figures above also show, the attachment location of the yokes
`
`to the frame are not “spaced from a user in use” as required by the claimed headgear
`
`extension limitations. Id. ¶ 53. Rather, the figures above show that the yokes attach
`
`at points directly abutting the user’s face. Id. Petitioner offers no evidence to
`
`support that Gunaratnam’s yokes attach at a location “spaced from a user in use.”
`
`Instead, Petitioner baldly declares that “[t]he connection location is also spaced from
`
`the user during use.” Pet. at 14. Petitioner’s expert offers the same conclusory
`
`statement with no support. RMD1009 ¶ 51 (at page 42). Such a conclusory
`
`statement is insufficient to satisfy Petitioner’s burden of establishing the “spaced
`
`from user in use” requirement, especially in view of Gunaratnam Figures 109 and
`
`110 that show otherwise. See, e.g., In re Warsaw Orthopedic, Inc., 832 F.3d 1327,
`
`1335 (Fed. Cir. 2016) (conclusory assertion that prior art reference “appears to”
`
`satisfy a “positioned over” limitation insufficient to establish obviousness).
`
`
`
`-23-
`
`

`

`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`
`For at least the reasons discussed above, Petitioner has failed to provide
`
`evidence that either of the first, second or third embodiments in Gunaratnam disclose
`
`the headgear extension limitations of independent claims 1, 6 and 17, which is fatal
`
`to the enti

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