throbber
Filed: December 22, 2016
`
`
`
`
`Filed on behalf of
`
`Patent Owner Fisher & Paykel Healthcare Limited
`By: Brenton R. Babcock
`
`Joseph F. Jennings
`
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
`Telephone: 949-760-0404
`Facsimile: 949-760-9502
`Email: BoxFPH771-2@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.
`__________________________________
`
`Case No. IPR2016-01734
`U.S. Patent No. 8,443,807
`__________________________________
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`
`
`

`
`TABLE OF CONTENTS
`
`Page No.
`
`I.
`
`II.
`
`INTRODUCTION AND SUMMARY OF ARGUMENT .............................. 1 
`
`THE STATUTE BARS INSTITUTION OF AN INTER PARTES
`REVIEW .......................................................................................................... 8 
`
`A. 
`
`B. 
`
`C. 
`
`Petitioners’ Contrary Construction of Section 315 Is
`Meritless ................................................................................................ 9 
`
`Petitioners’ Cited Authorities Are Contrary to Two Lines of
`Supreme Court Precedents .................................................................. 10 
`
`Petitioners’ Cited Authorities Are Also Contrary to the
`Rules Enabling Act .............................................................................. 13 
`
`III. BACKGROUND ........................................................................................... 16 
`
`A.  Overview of the ’807 Patent ................................................................ 16 
`
`B. 
`
`Overview of the Alleged Prior Art ...................................................... 19 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`U.S. Patent Pub. No. 2004/0226566 (“Gunaratnam”) .............. 19 
`
`U.S. Patent Pub. No. 2003/0196658 (“Ging”) .......................... 23 
`
`PCT Pub. No. 2005/079726 (“McAuley”)................................ 25 
`
`U.S. Patent No. 7,219,669 (“Lovell”) ....................................... 26 
`
`C. 
`
`Overview of the Prosecution History of the ’807 Patent .................... 28 
`
`IV. CLAIM CONSTRUCTION .......................................................................... 32 
`
`A. 
`
`B. 
`
`C. 
`
`Legal Standard ..................................................................................... 32 
`
`Identification of a Person of Ordinary Skill In the Art ....................... 32 
`
`Construction of “Ring-Like Connector” ............................................. 33 
`
`- i -
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`

`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`V. ARGUMENT ................................................................................................. 39 
`
`A. 
`
`B. 
`
`C. 
`
`D. 
`
`Legal Standard ..................................................................................... 39 
`
`Institution Should Be Denied Because Both Gunaratnam
`and Lovell were Expressly Considered by the PTO During
`Prosecution of the ’807 Patent ............................................................ 41 
`
`The Claim Charts in the Declaration of Petitioners’
`Declarant, Dr. Izuchukwu, Should Be Given Little or No
`Weight ................................................................................................. 43 
`
`Petitioners Have Not Established a Reasonable Likelihood
`of Prevailing on Ground 1 (Alleged Obviousness of Claims
`8, 20, 21, 26, and 27 over Gunaratnam and Ging) .............................. 44 
`
`1. 
`
`2. 
`
`Gunaratnam and Ging Do Not Teach or Make
`Obvious “a ring-like connector” as Required by
`Claim 8 ...................................................................................... 45 
`
`Petitioners Have Not Shown that it Would Have
`Been Obvious to Modify the Nasal Cushion Mask Of
`Figure 135 To Include a Nasal Pillow Assembly ..................... 48 
`
`a. 
`
`b. 
`
`Gunaratnam Does Not Teach or Suggest that
`Nasal Cushions May Be Replaced with Nasal
`Pillows ............................................................................ 48 
`
`Figures 107G-H of Gunaratnam Do Not Teach
`or Make Obvious the Interchangeability of
`Nasal Pillows and Nasal Cushions ................................. 49 
`
`- ii -
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`

`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`i. 
`
`ii. 
`
`The Mask Design Shown in Figure 135
`Is Fundamentally Different from and
`Incompatible with the Other
`Embodiments of Gunaratnam Relied
`Upon by Petitioners .............................................. 49 
`
`Petitioners Have Not Shown that Nasal
`Pillows Could Be Incorporated into
`Gunaratnam Figure 135 with a
`Reasonable Expectation of Success ..................... 52 
`
`iii.  Gunaratnam Teaches Against
`Petitioners’ Proposed Modification ...................... 56 
`
`iv. 
`
`Petitioners’ Reliance on Ging Shows It
`Would Not Have Been Obvious to
`Incorporate Nasal Pillows into
`Gunaratnam Figure 135 ........................................ 58 
`
`c. 
`
`The Other Reasons Identified By Dr.
`Izuchukwu Do Not Provide a Reason to
`Replace the Nasal Cushion of Gunaratnam
`Figure 135 with Nasal Pillows........................................ 58 
`
`3. 
`
`Gunaratnam and Ging Do Not Teach or Make
`Obvious “wherein the first side strap and the second
`side strap are configured to connect and disconnect
`with the mask assembly” as Required by Claim 8 ................... 59 
`
`E. 
`
`Petitioners Have Not Established a Reasonable Likelihood
`of Prevailing on Ground 2 (Alleged Obviousness of Claims
`8, 20, 21, 26, and 27 over Gunaratnam, Ging, and
`McAuley) ............................................................................................. 61 
`
`1. 
`
`Ground 2 Should Not Be Instituted for at Least the
`Reasons Provided for Ground 1 ................................................ 61 
`
`- iii -
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`

`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`2. 
`
`It Would Not Have Been Obvious to Further Modify
`Gunaratnam Figure 135 to Include a “ring-like
`connector” as Required by Claim 8 .......................................... 62 
`
`F. 
`
`Petitioners Have Not Established a Reasonable Likelihood
`of Prevailing on Ground 3 (Alleged Obviousness of Claims
`8, 20, 21, 26, and 27 over Lovell and Gunaratnam) ........................... 69 
`
`1. 
`
`2. 
`
`3. 
`
`Petitioners’ Proposed Replacement of the “Four
`Point Restraining System” of Lovell with the
`Headgear of Figure 135 of Gunaratnam Would
`Change the Basic Principle of the Restraining System
`and Would Not Have Been Obvious ......................................... 70 
`
`The Reasons Identified by Petitioners for Replacing
`the Four Point Restraining System of Lovell with the
`Headgear Designs of Gunaratnam Are Conclusory
`and Insufficient ......................................................................... 72 
`
`Petitioners’ Proposed Combination of the Mask
`Assembly of Lovell with the Nasal Pillows From Yet
`Another Embodiment of Gunaratnam Would Not
`Have Been Obvious .................................................................. 76 
`
`VI. CONCLUSION .............................................................................................. 78 
`
`
`
`- iv -
`
`

`
`TABLE OF AUTHORITIES
`
`Page No(s.)
`
`Bonneville Assocs. v. Barram,
`165 F.3d 1360 (Fed. Cir. 1999) .................................................................... 12, 13
`
`Brennan v. Silvergate District Lodge No. 50,
`503 F.2d 800 (9th Cir. 1974) .............................................................................. 15
`
`Carcieri v. Salazar,
`555 U.S. 379 (2009) .................................................................................... 8, 9, 11
`
`Digital-Vending Servs. Int’l, LLC v. Univ. of Phoenix, Inc.,
`672 F.3d 1270 (Fed. Cir. 2012) .......................................................................... 38
`
`Funai Elec. Co., Ltd. v. Gold Charm Ltd.,
`No. IPR2015-01491, Paper No. 15 (P.T.A.B. Dec. 28, 2015) ........................... 42
`
`In re Gordon,
`733 F.2d 900 (Fed. Cir. 1984) ............................................................................ 41
`
`InfoBionic, Inc. v. Braemer Mfg., LLC,
`IPR2015-01704, Paper No. 11 (P.T.A.B. Feb. 16, 2016) ................................... 43
`
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) .......................................................................... 52
`
`John Hancock Life Ins. Co. v. J.P. Morgan Chase & Co.,
`938 F. Supp. 2d 440 (S.D.N.Y. 2013) ................................................................ 15
`
`Kinetic Techs., Inc. v. Skyworks Solutions, Inc.,
`IPR2014-00529, Paper No. 8 (P.T.A.B. Sept. 23, 2014) .................................... 43
`
`K Mart Corp. v. Cartier, Inc.,
`486 U.S. 281 (1988) .............................................................................................. 8
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .......................................................................... 40, 41, 58, 74
`
`- v -
`
`

`
`TABLE OF AUTHORITIES
`(cont’d)
`
`Page No(s).
`
`Macuato U.S.A. v. BOS GmbH & KG,
`IPR2012-00004, Paper No. 18 (P.T.A.B. Jan. 24, 2013) ................. 10. 11, 13, 14
`
`Merck & Co. v. Teva Pharms. USA, Inc.,
`395 F.3d 1364 (Fed. Cir. 2005) .......................................................................... 38
`
`Microsoft Corp. v. Proxyconn, Inc.,
`789 F.3d 1292 (Fed. Cir. 2015) .......................................................................... 32
`
`In re Morris,
`127 F.3d 1048 (Fed. Cir. 1997) .......................................................................... 32
`
`In re: Nuvasive, Inc.,
`No. 2015-1670, 2016 WL 7118526 (Fed. Cir. Dec. 7, 2016) .....................passim
`
`Oracle Corp. v. Click-to-Call Techs. LP,
`IPR2013-00312, Paper No. 52 (P.T.A.B. Oct. 28, 2014) ................. 10, 11, 13, 14
`
`In re Ratti,
`270 F.2d 810 (CCPA 1959) .................................................................... 31, 41, 71
`
`Semtek Int’l, Inc. v. Lockheed Martin Corp.,
`531 U.S. 497 (2001) .....................................................................................passim
`
`Sullivan v. Stroop,
`496 U.S. 478 (1990) .................................................................................... 8, 9, 11
`
`Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc.,
`200 F.3d 795 (Fed. Cir. 1999) ............................................................................ 33
`
`OTHER AUTHORITIES
`
`28 U.S.C. § 2072 ................................................................................................ 14, 15
`
`35 U.S.C. § 102 .................................................................................................. 29, 31
`
`35 U.S.C. § 103 ............................................................................................ 28, 29, 31
`
`- vi -
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`

`
`TABLE OF AUTHORITIES
`(cont’d)
`
`Page No(s).
`
`35 U.S.C. § 314 ........................................................................................................ 39
`
`35 U.S.C. § 315 .................................................................................................passim
`
`35 U.S.C. § 325 .................................................................................................... 2, 41
`
`37 C.F.R. § 42.100 ................................................................................................... 32
`
`37 C.F.R. § 42.108(c) ............................................................................................... 39
`
`M.P.E.P. § 2143.01 ...................................................................................... 31, 40, 71
`
`Federal Rules of Civil Procedure Rule Rule 23 ....................................................... 15
`
`Federal Rules of Civil Procedure Rule Rule 24 ....................................................... 15
`
`Federal Rules of Civil Procedure Rule Rule 41 .............................................. passim
`
`Rules Enabling Act ...................................................................................... 13, 14, 15
`
`
`
`- vii -
`
`

`
`IPR2016-01734
`ResMed v. Fisher & Paykel
`
`
`
`Exhibit No.
`
`TABLE OF EXHIBITS
`
`Description
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`The Oxford American College Dictionary (2002) (definition of
`“ring”)
`U.S. Patent No. 4,782,832 to Trimble et. al.
`
`Webster’s New World College Dictionary (5th ed. 2014)
`(definition of “ring”)
`FPH Opus 360 Brochure
`
`U.S. Patent No. 6,907,882 to Ging et. al.
`
`Exhibit List, Page 1
`
`

`
`IPR2016-01734
`ResMed v. Fisher & Paykel
`
`
`
`I. INTRODUCTION AND SUMMARY OF ARGUMENT
`
`Patent Owner Fisher & Paykel Healthcare Limited (“FPH”) is a world leader
`
`and innovator in respiratory therapy devices for critical care and home care use.
`
`U.S. Patent No. 8,443,807 (“the ’807 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 seek inter partes review of Claims 8, 20-21, 26-27 of the ’807
`
`Patent. Before filing the present IPR petition, however, Petitioners filed a
`
`declaratory judgment action in district court challenging the validity of the ’807
`
`Patent. Petitioners’ request to institute an IPR is therefore statutorily barred by 35
`
`U.S.C. § 315(a). In the event that the Board determines that this IPR is not barred,
`
`an IPR should not be instituted because Petitioners have not demonstrated a
`
`reasonable likelihood that the claims are invalid.
`
`Petitioners’ primary prior art reference — Gunaratnam — was considered by
`
`the PTO during prosecution. The PTO addressed the very figure in Gunaratnam
`
`(Figure 135) that Petitioners rely upon in Grounds 1-3. Ex. 1009 at 588. The PTO
`
`also relied upon Figure 135 of Gunaratnam in combination with another reference
`
`— Lovell — as a basis for rejecting some of the pending claims. Id. at 588-89.
`
`That is the same combination that Petitioners rely upon in Ground 3.
`
`-1-
`
`

`
`IPR2016-01734
`ResMed v. Fisher & Paykel
`
`
`Consequently, the Board should exercise its discretion and decline institution
`
`pursuant to 35 U.S.C. § 325(d).
`
`Ground 1 also relies upon an overbroad construction of the “ring-like
`
`connector” in Claim 8. According to Petitioners, virtually any structure with an
`
`opening through it is a “ring-like connector.” However, under the proper
`
`construction of “ring” — “a generally circular band of material” — neither
`
`Gunaratnam nor Ging disclose a “ring-like connector.”
`
`Claim 8 also requires a mask body that includes “two nasal pillows.” Figure
`
`2 (below) of the ’807 Patent illustrates an embodiment that includes nasal pillows.
`
`Nasal pillows (24, 25)
`
`Ex. 1001 at Fig. 2 (annotations added). In use, the nasal pillows are located
`
`beneath the patient’s nose and extend partially within and separately form a seal
`
`
`
`-2-
`
`

`
`IPR2016-01734
`ResMed v. Fisher & Paykel
`
`
`with each of the patient’s nares. Id. at 5:29-33. Figure 20 (below) shows an
`
`example of nasal pillows sealing with a patient’s nares.
`
`Nasal pillows
`(306, 307)
`
`
`
`Id. at Fig. 20 (annotations added). As is evident from the figure above, a force
`
`component that is generally parallel to the patient’s face and directed upwardly
`
`underneath the patient’s nose is required to position the nasal pillows against the
`
`nares and form a seal.
`
`Grounds 1 and 2 hinge upon the alleged obviousness of incorporating a nasal
`
`pillows assembly into the mask shown in Gunaratnam Figure 135 (below).
`
`-3-
`
`

`
`IPR2016-01734
`ResMed v. Fisher & Paykel
`
`
`
`Nasal cushion
`
`
`
`Ex. 1004 at Fig. 135 (annotations and color added). The mask shown in Figure
`
`135 does not have nasal pillows. It includes a nasal cushion, which is an entirely
`
`different type of mask and which uses entirely different forces to properly seal to
`
`the face. Id. ¶ [0403] (identifying Figure 135 as including a nasal cushion).
`
`A nasal cushion is designed to fit over the nose and form a seal around the
`
`outside of the nose. See, e.g., Ex. 1005 (Ging) ¶¶ [0169, 0172, 0174, 0176]
`
`(describing nasal cushion); Ex. 1008 ¶ 70. Figure 1 of Ging (below) shows an
`
`example of a nasal cushion mask and illustrates how the cushion is held against the
`
`face and forms a seal around the nose.
`
`-4-
`
`

`
`IPR2016-01734
`ResMed v. Fisher & Paykel
`
`
`
`Cushion (40)
`
`
`
`Ex. 1005 at Fig. 1 (annotations added), ¶ [0107]. With nasal cushions, a force
`
`component that is generally perpendicular to the face is required to hold the nasal
`
`cushion against the face and form a seal.
`
`Petitioners have not shown that it would have been obvious to modify
`
`Gunaratnam Figure 135 by replacing the nasal cushion with nasal pillows.
`
`Petitioners propose removing the nasal cushion and replacing it with nozzle
`
`assemblies from other embodiments in Gunaratnam. But the nozzle assemblies,
`
`such as shown in Figure 1 of Gunaratnam (below), are significantly and
`
`fundamentally different from the nasal cushion of Gunaratnam Figure 135.
`
`
`
`-5-
`
`

`
`IPR2016-01734
`ResMed v. Fisher & Paykel
`
`
`
`Nozzle assembly (18)
`
`Frame (16)
`
`
`Ex. 1004 at Fig. 1 (annotations added), ¶ [0177]. Petitioners do not provide
`
`sufficient rationale for their proposed redesign.
`
`Gunaratnam does not teach that the nasal cushion shown in Figure 135 could
`
`be replaced with nasal pillows. Due to the substantial differences between cushion
`
`masks and nasal pillows masks, including the different forces required for the
`
`masks to achieve a proper seal, Petitioners have not shown that it is possible to
`
`swap out a nasal cushion in a particular mask design with nasal pillows as they
`
`contend with a reasonable expectation of success. Given the significant
`
`differences between the embodiments Petitioners seek to combine, it is plain that
`
`their picking and choosing features from one embodiment and inserting them into
`
`another is motivated by improper hindsight.
`
`-6-
`
`

`
`IPR2016-01734
`ResMed v. Fisher & Paykel
`
`
`
`
`Ground 2 also fails.
`
` Undoubtedly recognizing that their proposed
`
`construction of “ring-like connector” in Ground 1 is overbroad and unsupported,
`
`Petitioners add yet another reference, McAuley, in Ground 2. Petitioners assert
`
`that McAuley discloses a “ring-like connector” and combine it with Gunaratnam
`
`and Ging. However, Petitioners do not explain how the frame shown in
`
`Gunaratnam Figure 135 could be redesigned as a ring while still maintaining its
`
`functionality. Petitioners also do not provide sufficient reasons why a person of
`
`ordinary skill in the art (“POSITA”) would modify Gunaratnam’s horseshoe-
`
`shaped frame to make it a ring-like connector.
`
` Finally, Ground 3 relies upon the same prior art combination — Lovell and
`
`Gunaratnam — that FPH overcame during prosecution of the ’807 Patent. Claim 8
`
`requires that “the mask assembly is configured to connect to only two side straps.”
`
`Lovell discloses a mask frame that is connected to four straps — two lower straps
`
`and two upper straps. Ex. 1012 at 6:44-7:4. Petitioners contend that it would have
`
`been obvious in view of Gunaratnam to remove two of the straps from Lovell.
`
`However, removing two of the straps from the Lovell mask assembly would
`
`fundamentally alter the way in which the mask functions and it would not have
`
`been obvious to do so.
`
`-7-
`
`

`
`IPR2016-01734
`ResMed v. Fisher & Paykel
`
`
`
`II. THE STATUTE BARS INSTITUTION OF AN
`INTER PARTES REVIEW
`
`Petitioners’ requested IPR may not be instituted because it is barred by
`
`statute. The statute is unequivocal:
`
`An inter partes review may not be instituted if, before the
`date on which the petition for such a review is filed, the
`petitioner or real party in interest filed a civil action
`challenging the validity of a claim of the patent.
`
`35 U.S.C. § 315(a)(1). Before Petitioners filed the instant Petition, they filed a
`
`civil action in the United States District Court for the Southern District of
`
`California challenging the validity of the ’807 Patent. Ex. 1046 (complaint filed
`
`August 16, 2016). The plain language of the statute bars the Petition.
`
`
`
`The Board should not construe Section 315 in a manner contrary to its plain
`
`meaning. As the Supreme Court has explained:
`
`If the statute is clear and unambiguous “that is the end of
`the matter, for the court, as well as the agency, must give
`effect
`to
`the unambiguously expressed
`intent of
`Congress.”
`
`Sullivan v. Stroop, 496 U.S. 478, 482 (1990) (quoting K Mart Corp. v. Cartier,
`
`Inc., 486 U.S. 281, 291-92 (1988)); accord Carcieri v. Salazar, 555 U.S. 379, 387
`
`(2009) (collecting cases). Here, Section 315 leaves no wiggle room. Petitioners
`
`-8-
`
`

`
`IPR2016-01734
`ResMed v. Fisher & Paykel
`
`
`are barred.
`
`A.
`
`Petitioners’ Contrary Construction of Section 315 Is Meritless
`
`Petitioners briefly acknowledge they had previously filed an action
`
`challenging the validity of the ’807 Patent, and then note they dismissed the action
`
`without prejudice. Pet. at 1-2; see also Ex. 1046. Petitioners then argue that their
`
`“action for declaratory judgment regarding the invalidity of the ’807 Patent has no
`
`effect under 35 U.S.C. § 315(a) because it was voluntarily dismissed without
`
`prejudice.” Pet. at 2.
`
`Petitioners filed their declaratory judgment action apparently to ensure their
`
`home forum, the Southern District of California, would be the selected venue for
`
`the parties’ U.S. patent dispute. Petitioners only dismissed their action after
`
`learning they obtained the desired forum because FPH also filed in that forum.
`
`Petitioners should not be permitted to escape the consequences of Section 315
`
`flowing from their procedural maneuvering.
`
`Petitioners apparently contend Section 315(a)(1) includes an implicit,
`
`unstated exception for complaints that are dismissed without prejudice. This,
`
`however, is directly contrary to Sullivan, 496 U.S. at 482, Carcieri, 555 U.S. at
`
`387, and a long line of Supreme Court cases holding that the unambiguous
`
`language of a statute must be faithfully applied. Indeed, Petitioners seek to
`
`completely rewrite Section 315(a)(1) under the apparent guise of interpretation.
`
`-9-
`
`

`
`IPR2016-01734
`ResMed v. Fisher & Paykel
`
`
`The plain language of Section 315(a)(1) unambiguously bars an IPR if the
`
`Petitioners previously “filed a civil action challenging the validity of a claim of the
`
`patent.” 35 U.S.C. § 315(a)(1). Petitioners seek to rewrite this statute to declare
`
`that an IPR is barred if the Petitioners previously “filed a civil action challenging
`
`the validity of a claim of the patent, unless that civil action was dismissed without
`
`prejudice.” There is no legal basis for adding this non-statutory exception to the
`
`unambiguous language of the statute.
`
`B.
`
`Petitioners’ Cited Authorities Are Contrary to Two Lines of Supreme
`Court Precedents
`
`In support of their strained statutory construction, Petitioners cite two
`
`unpublished, non-precedential Board decisions. See Pet. at 2 (citing Macuato
`
`U.S.A. v. BOS GmbH & KG, IPR2012-00004, Paper No. 18 at 15-16 (P.T.A.B. Jan.
`
`24, 2013), and Oracle Corp. v. Click-to-Call Techs. LP, IPR2013-00312, Paper
`
`No. 52 at 12-13 (P.T.A.B. Oct. 28, 2014)). These decisions reason that the Federal
`
`Rules of Civil Procedure and court precedent “treat a dismissal without prejudice
`
`as something that, de jure, never existed.” Oracle, IPR2013-00312, Paper No. 52
`
`-10-
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`

`
`IPR2016-01734
`ResMed v. Fisher & Paykel
`
`
`at 12.1 Thus, these decisions conclude, a dismissal without prejudice “leav[es] the
`
`parties in the same legal position as if the underlying complaint had never been
`
`served.” Id. at 13; see also Macuato, IPR2012-00004, Paper No. 18 at 15-16.
`
`These two non-precedential decisions are unpersuasive for at least two
`
`significant reasons. First, of course, they are both contrary to cases like Sullivan,
`
`496 U.S. at 482, and Carcieri, 555 U.S. at 387, which hold that the plain language
`
`of statutory text must be followed by courts and agencies. The Board in Oracle
`
`and Macuato did not even address the statutory text, much less follow it.
`
`Second, Oracle and Macuato err in assessing the significance of a dismissal
`
`without prejudice under Federal Rule of Civil Procedure 41(a). The Supreme
`
`Court clearly explained the effect of a Rule 41(a) dismissal without prejudice in
`
`Semtek Int’l, Inc. v. Lockheed Martin Corp., 531 U.S. 497, 505 (2001), stating:
`
`The primary meaning of “dismissal without prejudice,” we think, is
`dismissal without barring the plaintiff from returning later, to the
`same court, with the same underlying claim.
`
`
`Id. The Court also quoted favorably the definition of “dismissal without prejudice”
`
`
`1 Following this reasoning, the district court in the parties’ pending litigation
`
`also granted Petitioners’ motion to stay over FHP’s objection that the case should
`
`not be stayed because the IPR petitions were barred under 35 U.S.C. § 315(a)(1).
`
`-11-
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`

`
`IPR2016-01734
`ResMed v. Fisher & Paykel
`
`
`in Black’s Law Dictionary — “removed from the court’s docket in such a way that
`
`the plaintiff may refile the same suit on the same claim.” Id.
`
`In short, by designating their dismissal as being “without prejudice” under
`
`Rule 41(a), Petitioners merely reserved the right to refile the same claim in the
`
`same court at a later date. Petitioners did not and could not nullify the statutory
`
`right that had already accrued to FPH to be free from subsequent petitions for IPR.
`
`It is true that some lower court decisions have loosely described the effect of
`
`a dismissal without prejudice as to “leave the parties as if the action had never been
`
`brought.” Bonneville Assocs. v. Barram, 165 F.3d 1360, 1364 (Fed. Cir. 1999).
`
`This dicta, however, if construed as broadly as Petitioners would do, is inconsistent
`
`with the Supreme Court’s decision in Semtek. Moreover, Bonneville and the other
`
`courts employing this dicta were all merely addressing the procedural effect of a
`
`dismissal without prejudice within the federal court system. None of them was
`
`addressing the effect or lack of effect of a dismissal without prejudice on a
`
`substantive statutory right, such as FPH’s rights under 35 U.S.C. § 315(a).
`
`In addition, the broad dicta of Bonneville, if read in the sweeping fashion
`
`that Petitioners desire, would be plainly wrong on its face. Rule 41(a) itself
`
`provides that a dismissal without prejudice does not “leave the parties as if the
`
`action had never been brought.” Rule 41(a) states that a party who dismisses a
`
`-12-
`
`

`
`IPR2016-01734
`ResMed v. Fisher & Paykel
`
`
`claim without prejudice once may not thereafter dismiss the same claim without
`
`prejudice again. Fed. R. Civ. P. 41(a)(1)(B). Thus, the loose language of
`
`Bonneville cannot be taken to mean that a dismissal without prejudice leaves the
`
`parties as if the action had never been brought for all purposes. Rather, consistent
`
`with Semtek, the language of Bonneville means only that a plaintiff is free to refile
`
`a claim that has been dismissed without prejudice. Indeed, the holding of
`
`Bonneville is that a dismissal without prejudice has no effect beyond this and thus
`
`does not operate to toll the time for refiling an action or an appeal. Bonneville, 165
`
`F.3d at 1364-65.
`
`Finally, the plain language of Rule 41(a) is about dismissal, not filing. Rule
`
`41(a) declares that the dismissal of a complaint is without prejudice under some
`
`circumstances. It does not say that the filing of a complaint is ever without
`
`prejudice. To determine the effect of the filing of a complaint, one must look
`
`elsewhere, in this case to 35 U.S.C. § 315(a).
`
`C.
`
`Petitioners’ Cited Authorities Are Also Contrary to the Rules Enabling
`Act
`
`The two lines of Supreme Court precedents cited above provided reason
`
`enough to reject Oracle and Macuato. Another cardinal principle of federal law,
`
`however, provides an additional reason not to follow these non-precedential
`
`decisions. The Rules Enabling Act declares that the Federal Rules “shall not
`
`-13-
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`

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`IPR2016-01734
`ResMed v. Fisher & Paykel
`
`
`abridge, enlarge or modify any substantive right.” 28 U.S.C. § 2072(b). Thus, any
`
`interpretation of the phrase “dismissal without prejudice” in Rule 41(a) to defeat a
`
`substantive right would violate the Rules Enabling Act.
`
`Yet, that is precisely how Oracle and Macuato construe Rule 41(a). Oracle
`
`and Macuato both hold that the purported right of a plaintiff to dismiss its
`
`complaint without any consequence under Rule 41(a) trumps the substantive right
`
`of a patentee under 35 U.S.C. § 315(a) to be free from subsequent petitions for
`
`inter partes review. Such an interpretation of Rule 41(a) would abridge a
`
`substantive right of patentees under Section 315(a) and thus violate the Rules
`
`Enabling Act.
`
`This is confirmed by the cases interpreting the Rules Enabling Act. For
`
`example, in Semtek, 531 U.S. 497, the issue was whether a Rule 41 dismissal “with
`
`prejudice” had res judicata effect. The defendant argued that the issue was
`
`governed by Rule 41, which specified that the dismissal “operates as an
`
`adjudication upon the merits.” Id. at 501. Thus, the defendant argued, the
`
`dismissal was entitled to res judicata effect. The Supreme Court unanimously
`
`rejected this argument. Id. at 503. The Court concluded that the res judicata effect
`
`of a judgment was a substantive right, and that the defendant’s interpretation of
`
`Rule 41 therefore “would arguably violate the jurisdictional limitation of the Rules
`
`-14-
`
`

`
`IPR2016-01734
`ResMed v. Fisher & Paykel
`
`
`Enabling Act: that the Rules ‘shall not abridge, enlarge or modify any substantive
`
`right.’” Id. (quoting 28 U.S.C. § 2072(b)). In short, Rule 41(a) did not trump
`
`substantive law regarding the res judicata effect of judgments.
`
`Brennan v. Silvergate District Lodge No. 50, 503 F.2d 800 (9th Cir. 1974),
`
`is to the same effect. There, the Secretary of Labor brought an action to set aside a
`
`union election in which Baffone had been elected union president. Id. at 802-03.
`
`Baffone sought to intervene under Rule 23 [now Rule 24] of the Federal Rules of
`
`Civil Procedure. Id. Baffone met the standard for intervention as of right under
`
`the Federal Rules. Id. at 804. However, a substantive labor law statute generally
`
`barred intervention on the side of a union in suits brought by the Secretary of
`
`Labor. Id. (citing 29 U.S.C. § 482(b)). Quoting the Rules Enabling Act, the Ninth
`
`Circuit held that Rule 23 [now Rule 24] could not trump the rights created by
`
`substantive federal labor law. Id. Accordingly, Baffone could not intervene unless
`
`he met the statutory labor law requirements. Id. at 805. See also John Hancock
`
`Life Ins. Co. v. J.P. Morgan Chase & Co., 938 F. Supp. 2d 440, 448 (S.D.N.Y.
`
`2013) (under the Rules Enabling Act, Rule 23’s equitable tolling principles are
`
`trumped by the statute of repose of the Securities Act of 1933).
`
`In sum, the instant Petition is barred under the plain and unambiguous text
`
`of 35 U.S.C. § 315(a)(1).
`
`-15-
`
`

`
`IPR2016-01734
`ResMed v. Fisher & Paykel
`
`
`
`III. BACKGROUND
`
`A. Overview of the ’807 Patent
`
`The ’807 Patent describes masks designed to improve patient comfort and
`
`compliance with CPAP treatment by overcoming disadvantages associated with
`
`conventional nasal masks that were “uncomfortable and cumbersome.” Ex. 1001
`
`at 2:23-27, 2:59-61. One embodiment of the patent is shown in Figure 2 (below).
`
`Headgear (21)
`
`Nasal pillows (24, 25)
`
`Side arm (41)
`
`Mask base (22)
`
`
`Id. at Fig. 2 (annotations added).
`
`The patent describes that the mask includes a mask base 22. Id. at 5:25-40.
`
`In one embodiment, the patent describes the mask base as “a ring or sleeve type
`
`attachment.” Id. at 6:19-23. Figure 5 (below) shows further details of the mask
`
`base.
`
`-16-
`
`

`
`IPR2016-01734
`ResMed v. Fisher & Paykel
`
`
`
`
`
`
`
`Id. at Fig. 5. As shown in Figure 2, the mask base attaches to a mask body 23 and
`
`to a connector 30 that is attached to a tube that provides gas to the mask. Id. at
`
`6:19-45. Figure 7 of the patent further illustrates a mask body 23 and associated
`
`nasal pillows 24, 25.
`
`Nasal pillows
`(24, 25)
`
`Id. at Fig. 7 (annotations added). The mask body 23 includes a lip 28 that is
`
`inserted into the channel 45 of the mask base 22 to connect the two components.
`
`
`
`-17-
`
`

`
`IPR2016-01734
`ResMed v. Fisher & Paykel
`
`
`Id. at 6:26-31. In use, the mask body

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