`
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`Petition for Inter Partes Review
`of U.S. Patent No. 6,631,715
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`CORPAK MEDSYSTEMS, INC. and HALYARD HEALTH, INC,
`Petitioners
`
`v .
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`KIRN MEDICAL DESIGN, L.L.C. and APPLIED MEDICAL TECHNOLOGY,
`INC.,
`Patent Owner.1
`
`
`
`U.S. Patent No. 6,631,715 to Kirn
`
`
`Inter Partes Review No.: IPR2017-01990
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 6,631,715 Under
`35 U.S.C. §§ 311-319 and 37 C.F.R. § 42
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`1 Petitioners note that Applied Medical Technology, Inc. is the exclusive licensee
`
`of the ’715 patent. Additional details are provided infra fn. 2.
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`

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`TABLE OF CONTENTS
`
`Page(s)
`
`I.
`
`INTRODUCTION .......................................................................................... 1
`
`II. OVERVIEW ................................................................................................... 1
`
`A.
`
`B.
`
`The ʼ715 patent ...................................................................................... 1
`
`Background of Nasal Bridles ................................................................ 7
`
`III. STANDING (37 C.F.R. § 41.104(A)); PROCEDURAL
`STATEMENTS .............................................................................................. 9
`
`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(A)(1)) .................................... 9
`
`A.
`
`B.
`
`Each Real Party-in-Interest (37 C.F.R. § 42.8(b)(1)) ............................ 9
`
`Notice of Related Matters (37 C.F.R. § 42.8(b)(2)) .............................. 9
`
`1.
`
`2.
`
`Judicial Matters ........................................................................... 9
`
`Administrative Matters .............................................................10
`
`C.
`
`Designation of Lead and Back-Up Counsel (37 C.F.R.
`§ 42.8(b)(3)) ........................................................................................10
`
`V.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFOR (37 C.F.R. § 42.22(A)) ........................................ 11
`
`VI. THE ʼ715 PATENT AND CLAIM CONSTRUCTION .............................. 11
`
`A.
`
`B.
`
`C.
`
`D.
`
`The ’715 Patent ...................................................................................11
`
`The Priority Date of the ʼ715 Patent ...................................................13
`
`Board’s Prior Decision ........................................................................13
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`Claim Construction..............................................................................14
`
`i
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`VII. PERSON OF ORDINARY SKILL IN THE ART (“POSA”) AND
`STATE OF THE ART .................................................................................. 15
`
`VIII. IDENTIFICATION OF THE CHALLENGE (37 C.F.R. § 42.104(B)) ...... 16
`
`IX.
`
`INVALIDITY ANALYSIS .......................................................................... 17
`
`A.
`
`B.
`
`The Level of Ordinary Skill in the Pertinent Art ................................18
`
`The Scope and Content of the Prior Art ..............................................18
`
`1.
`
`State of the Art ..........................................................................18
`
`a)
`
`b)
`
`c)
`
`d)
`
`Ballantyne .......................................................................18
`
`Simmons .........................................................................25
`
`Izumi ...............................................................................29
`
`Bierman ...........................................................................32
`
`C.
`
`Ground 1: Claim 18 Would Have Been Obvious Over
`Ballantyne in View of Simmons .........................................................36
`
`1.
`
`2.
`
`3.
`
`The Level of Ordinary Skill in the Pertinent Art ......................36
`
`The Scope and Content of the Prior Art ...................................36
`
`Differences Between the Claims and the Prior Art ..................36
`
`D. Ground 2: Claim 18 Would Have Been Obvious Over
`Ballantyne in View of Izumi ...............................................................54
`
`1.
`
`2.
`
`3.
`
`The Level of Ordinary Skill in the Pertinent Art ......................54
`
`The Scope and Content of the Prior Art ...................................55
`
`Differences Between the Claims and the Prior Art ..................55
`
`E.
`
`Ground 3: Claim 18 Would Have Been Obvious Over
`Ballantyne in View of Simmons and Bierman ....................................60
`
`1.
`
`2.
`
`The Level of Ordinary Skill in the Pertinent Art ......................60
`
`The Scope and Content of the Prior Art ...................................60
`
`ii
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`
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`3.
`
`Differences Between the Claims and the Prior Art ..................60
`
`F.
`
`Secondary Considerations of Non-Obviousness .................................68
`
`X.
`
`CONCLUSION ............................................................................................. 69
`
`XI. CERTIFICATE OF WORD COUNT .......................................................... 70
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`iii
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`

`

`
`
`CASES
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Amneal Pharmaceuticals, LLC v. Supernus Pharmaceuticals, Inc., IPR2013-00368
`(Institution Decision, Paper 8) at pp. 12-13 (Dec. 17, 2013) .............................73
`
`Applied Medical Technology, Inc. v. Corpak Medsystems, Inc., 1:16-cv-02190
`(N.D. Ohio) .........................................................................................................11
`
`Cisco Sys., Inc., et al. v. Crossroads Sys., Inc., IPR2014-01544 (Institution
`Decision, Paper 9) at pp. 13-14 (April 3, 2015) .................................................23
`
`Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1570 (Fed. Cir. 1988) . 4
`
`Corpak Medsystems, Inc. et al., v. Kirn Medical Design, L.L.C., IPR2017-00646,
`Paper 9 at 8 (Decision) ............................................................................... 3, 5, 12
`
`Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2144-46 (2016) ................................16
`
`Dow Jones & Co. v. Ablaise Ltd., 606 F.3d 1338, 1340 (Fed. Cir. 2010) ...............20
`
`DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d
`1356, 1368, (Fed. Cir. 2006) ........................................................................ 56, 72
`
`Ethicon Endo-Surgery, Inc. v. Covigien AG, IPR2015-01274 (Final Written
`Decision, Paper 25) at p. 18 (Nov. 30, 2016) .....................................................58
`
`Facebook, Inc. v. TLI Commc’ns, LLC, IPR2015-00778 Paper 17, at 19 (P.T.A.B.,
`Decision Granting Institution, Aug. 28, 2015) ..................................................... 6
`
`Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997) ............. 14, 59
`
`Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17 (1966) .................. 19, 65
`
`Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1334 (Fed. Cir. 2014) ....73
`
`iv
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`

`

`
`
`Husky Injection Molding Systems, Ltd. v. Plastic Engineering & Technical
`Services, Inc., No. IPR2016-00432, slip op. 6-7 (P.T.A.B. June 24, 2016)
`(Paper 10) ..................................................................................................... 21, 34
`
`In re Fout, 675 F.2d 297, 300, (C.C.P.A. 1982) ........................................................ 5
`
`In re Icon Health and Fitness, Inc., 496 F.3d 1374, 1379-80 (Fed. Cir. 2007) ......55
`
`In re Keller, 642 F.2d 413, 425 (Fed. Cir. 1981) ........................................ 58, 64, 72
`
`In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007) ................ 16, 20
`
`Int’l Business Machines Corp. v. Intellectual Ventures I LLC, IPR2015-00302
`(Institution Decision, Paper 8) at pp. 14-15 (June 2, 2015) ...............................23
`
`KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 420 (2007) .......................... 17, 20, 58
`
`Microsoft Corp. v. Parallel Networks Licensing, LLC, IPR2015-00483 (Institution
`Decision, Paper 10) at p. 15 (July 15, 2015) ......................................................22
`
`Microsoft Corp. v. Parallel Networks Licensing, LLC, IPR2015-00486 (Institution
`Decision, Paper 10) at p. 15 (July 15, 2015) ......................................................22
`
`Nestle USA, Inc., v. Steuben Foods, Inc., IPR2014-01235, Paper 12 at 7 (P.T.A.B.,
`Decision Granting Institution, Dec. 22, 2014) ...................................................... 6
`
`Newell Cos., Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988) ............73
`
`Oxford Nanopore Tech. Ltd. v. Univ. of Washington, IPR2015-00057, Paper 28, at
`21 (P.T.A.B., Decision Granting Institution, April 27, 2015) .............................. 7
`
`Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1372 (Fed. Cir. 2008) ..........................73
`
`Praxair Distribution, Inc. v. Ino Therapeautics, LLC, IPR2015-00889 (Institution
`Decision, Paper 14) at pp. 9-10 (Sept. 22, 2015) ................................................22
`
`Praxair Distribution, Inc. v. Ino Therapeautics, LLC, IPR2015-00893 (Institution
`Decision, Paper 14) at pp. 7-8 (Sept. 22, 2015) ..................................................22
`
`v
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`

`

`
`
`Valeo N.A. Inc. et al. v. Magna Electronics, Inc., IPR2014-01206, Paper 13, at 11
`(P.T.A.B. Decision Granting Institution, Dec. 23, 2014) ..................................... 6
`
`STATUTES
`
`35 U.S.C. § 102(b) (pre-AIA) .......................................................................... passim
`
`35 U.S.C. § 103 ........................................................................................................65
`
`OTHER AUTHORITIES
`
`§ 42.10(b) .......................................................................................................... 10, 12
`
`§ 42.63(e) .................................................................................................................10
`
`37 C.F.R. § 41.104(A) .............................................................................................10
`
`37 C.F.R. § 42.100(b) ..............................................................................................16
`
`37 C.F.R. § 42.104(B) ..............................................................................................18
`
`37 C.F.R. § 42.106(a) ...............................................................................................10
`
`37 C.F.R. § 42.22(a) .................................................................................................12
`
`37 C.F.R. § 42.24 .....................................................................................................75
`
`37 C.F.R. § 42.6(d) ..................................................................................................18
`
`37 C.F.R. § 42.8(A)(1) .............................................................................................11
`
`37 C.F.R. § 42.8(b)(1) ..............................................................................................11
`
`37 C.F.R. § 42.8(b)(2) ..............................................................................................11
`
`37 C.F.R. § 42.8(b)(3) ..............................................................................................12
`
`37 C.F.R. § 42.8(b)(4) ..............................................................................................12
`
`
`
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`vi
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`
`
`EXHIBITS
`
`EXHIBIT 1001 U.S. Patent No. 6,631,715
`
`EXHIBIT 1002 U.S. Patent No. 5,185,005 (“Ballantyne”)
`
`EXHIBIT 1003
`
`“A New Nasal Bridle for Securing Nasoentereal Feeding
`Tubes” by Jeffrey A. Meer
`
`EXHIBIT 1004 Declaration of Dr. Terry Layton
`
`EXHIBIT 1005
`
`“Securing of intermediate duration feeding tubes” by W.
`Frederick McGuirt
`
`EXHIBIT 1006
`
`
`“The Bridle: Increasing the Use of Nasoenteric Feedings” by
`Albert Barrocas
`
`EXHIBIT 1007 U.S. Patent No. 5,752,511 (“Simmons”)
`
`EXHIBIT 1008 U.S. Patent No. 5,097,827 (“Izumi”)
`
`EXHIBIT 1009
`
`Patent Owner’s Initial Infringement Contentions
`
`EXHIBIT 1010
`
`“Feeding Tube Anchor” by Albert Levenson
`
`EXHIBIT 1011
`
`PCT International Application Publication No. WO 99/20334
`(“Bierman”)
`
`
`EXHIBIT 1012 Confirmation of Exclusive Licensee Applied Medical
`Technology, Inc.’s Authority to Conduct Inter Partes Review
`
`EXHIBIT 1013
`
`IPR2017-00646, Paper 9 (Decision) (P.T.A.B. July 26, 2017)
`
`vii
`
`

`

`EXHIBIT 1014
`
`IPR2017-00646, Paper 1 (Petition) (P.T.A.B. January 19,
`2017)
`
`EXHIBIT 1015
`
`IPR2017-00646, Paper 7 (Preliminary Response) (P.T.A.B.
`April 28, 2017)
`
`
`
`
`
`
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`viii
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`

`

`
`
`I.
`
`INTRODUCTION
`
`Corpak Medsystems, Inc. and Halyard Health, Inc. (collectively
`
`“Petitioners”) petition for Inter Partes Review (“IPR”) seeking cancellation of
`
`Claim 18 (“challenged claim”) of U.S. Patent No. 6,631,715 to Kirn (“the ʼ715
`
`patent”) (EX1001), which, according to the current records of the USPTO, is
`
`assigned to Applied Medical Technology, Inc. (“AMT” or “Exclusive Licensee”).2
`
`II. OVERVIEW
`
`A. The ʼ715 patent
`
`The ʼ715 patent issued on October 14, 2003 from U.S. Appl. No. 09/939,399
`
`(“the ʼ399 application”), which was filed on August 24, 2001. EX1001, see
`
`
`
`2 Petitioners note that AMT is the exclusive licensee of the ’715 patent and
`
`in prior IPR proceedings Kirn Medical Design, L.L.C. (“Kirn” or “Patent Owner”)
`
`confirmed AMT’s authority to conduct Inter Partes Review. EX1012 at 4, Corpak
`
`Medsystems, Inc. et al., v. Kirn Medical Design, L.L.C., IPR2017-00646
`
`(Exclusive Licensee Applied Medical Technology, Inc.’s Mandatory Notices
`
`Pursuant to 37 C.F.R. § 42.8(a)(2), Paper 5) (February 7, 2017).
`
`
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`LEGAL02/37506098v11
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`EX1004 at ¶ 33.3 The ’715 patent has thirty-two claims. See EX1004 at ¶ 34.
`
`This petition for Inter Partes Review, however, is directed only to a single claim,
`
`Claim 18, the text of which is reproduced below:
`
`18. A method of placing and securing at least one tube
`through a nose into a patient comprising:
`
`inserting the at least one tube into a first or second nare of
`the nose;
`
`inserting an end portion of a flexible member having a
`magnet attached thereto into a first nare of the nose;
`
`inserting a magnetic probe into a second nare of the nose for
`attracting said magnet and said end portion of said flexible
`member;
`
`removing said probe from the second nare of the nose
`thereby retrieving said end portion of said flexible member
`through the second nare of the nose; and
`
`snapping the at least one tube into a channel formed in a
`receiver.
`
`EX1001 at Claim 18; see also EX1004 at ¶ 36.
`
`Claim 18 is generally directed to a method of placing a first tube with a
`
`magnetic element into one of the nasal passages of the patient (referred to in the
`
`claim as a “nare”), retrieving the first tube through the second nasal passage by
`
`
`
`3 The ʼ399 application claims priority to U.S. Provisional Application No.
`
`60/230,525, which was filed on September 1, 2000. Id.
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`LEGAL02/37506098v11
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`2
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`placing a second tube with a corresponding magnetic element into the second nasal
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`passage to magnetically mate with the magnetic element on the first tube, and then
`
`guiding the first tube out through the second nasal passage. EX1004 at ¶ 35. In
`
`addition, Claim 18 recites “snapping the at least one tube into a channel formed in
`
`a receiver,” which as the Board has explained means, “that snapping occurs with
`
`respect to a tube and a channel, based on the express language…” EX1013, Corpak
`
`Medsystems, Inc. et al., v. Kirn Medical Design, L.L.C., IPR2017-00646, Paper 9 at
`
`8 (Decision).4
`
`The medical device to which the method of Claim 18 is directed is generally
`
`known as a “nasal bridle system.” 5 Id. Applications of such medical devices
`
`include uses as feeding tubes, nasogastric tubes, and nasotracheal tubes. EX1001
`
`
`
`4 Petitioners previously filed a petition requesting institution of an IPR of
`
`Claim 18 of the ’715 patent. EX1014. The Board’s prior decision is discussed in
`
`more detail, infra, at Section VI.C.
`
`5 Petitioners note that Claim 18 purportedly covers any “method of placing
`
`and securing at least one tube through a nose into a patient . . . ,” and therefore
`
`covers any device that performs the recited method, and is not limited to any
`
`particular device.
`
`LEGAL02/37506098v11
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`3
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`

`
`
`at 1:15-18; EX1002 at 1:5-18 (U.S. Patent No. 5,185,005 to Ballantyne, referred to
`
`hereinafter as “Ballantyne”); EX1003, Jeffrey A. Meer, A New Nasal Bridle for
`
`Securing Nasoentereal Feeding Tubes, 13 J. Parenteral & Enteral Nutrition, 331,
`
`331-33 (1989); see also EX1004 at ¶ 27.
`
`Claim 18, however, is rendered obvious by the prior art. EX1004 at ¶ 126.
`
`Indeed, even the patentee admitted in the ’715 specification that Ballantyne
`
`discloses most of the elements of Claim 18:
`
`One such method disclosed in U.S. Pat. No. 5,185,005 to
`
`Ballantyne requires a bridle which is pulled into a nare of
`
`a patient’s nose, around the posterior nasal septum, and out
`
`the other nare by a cord attached to the bridle and an
`
`insertion tool. Specifically, first and second installation
`
`tools are inserted into the nares of the patient's nose.
`
`Magnets associated with each tool couple together behind
`
`the posterior nasal septum.
`
`EX1001 at 1:15-32; see also EX1004 at ¶ 60. Constant v. Advanced Micro-
`
`Devices, Inc., 848 F.2d 1560, 1570 (Fed. Cir. 1988) (holding that an applicant’s
`
`admissions regarding prior art are binding); In re Fout, 675 F.2d 297, 300,
`
`(C.C.P.A. 1982) (“Valid prior art may be created by the admissions of the
`
`parties.”).
`
`LEGAL02/37506098v11
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`4
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`

`
`
`Indeed, in its preliminary response to the earlier petition for Inter Partes
`
`Review (IPR2017-00646), AMT did not dispute that Ballantyne taught all but one
`
`element of Claim 18; AMT contested only that Ballantyne did not teach “snapping
`
`the at least one tube into a channel formed in a receiver.” EX1015 Corpak
`
`Medsystems, IPR2017-00646, Paper 7 at 1 (Preliminary Response). The Board
`
`agreed with AMT based on the art submitted and AMT’s proposed construction of
`
`this term and declined to institute IPR2017-00646. EX1013 at 14, 21.
`
`The current petition is not redundant of the prior IPR petition, and although
`
`this petition cites Ballantyne as a reference, it presents different combinations of
`
`references, grounds and arguments to demonstrate that a claim that recites
`
`“snapping the at least one tube into a channel formed in a receiver” would have
`
`been obvious. Valeo N.A. Inc. et al. v. Magna Electronics, Inc., IPR2014-01206,
`
`Paper 13, at 11 (P.T.A.B. Decision Granting Institution, Dec. 23, 2014) (“We are
`
`not persuaded that the art and arguments presented in this Petition are the same or
`
`substantially the same prior art or arguments previously presented to the Office.
`
`For example, none of the grounds of unpatentability in this Petition rely upon
`
`exactly the same combination of prior art as the grounds of unpatentability asserted
`
`against the same claims in the 227 IPR.”); see also Nestle USA, Inc., v. Steuben
`
`Foods, Inc., IPR2014-01235, Paper 12 at 7 (P.T.A.B., Decision Granting
`
`Institution, Dec. 22, 2014) (declining to deny petition under § 325(d) where
`
`LEGAL02/37506098v11
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`5
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`

`

`
`
`petition relied on “combination of references previously not considered and [was]
`
`supported by a declaration previously not considered”); Facebook, Inc. v. TLI
`
`Commc’ns, LLC, IPR2015-00778 Paper 17, at 19 (P.T.A.B., Decision Granting
`
`Institution, Aug. 28, 2015) (“We have compared the prior art and arguments
`
`presented by Petitioner in IPR2014-00566, and by Google Inc. in IPR2015-00283,
`
`with the prior art and arguments presented by Petitioner in this proceeding, and do
`
`not determine that the prior art and arguments presented in either IPR2014-00566
`
`or IPR2015-00283 are the same or substantially the same as the prior art and
`
`arguments presented by Petitioner in this proceeding. The fact that there is overlap
`
`in some respect does not mean the prior art as a whole or the arguments as a whole
`
`are the same or substantially the same.”); Oxford Nanopore Tech. Ltd. v. Univ. of
`
`Washington, IPR2015-00057, Paper 28, at 21 (P.T.A.B., Decision Granting
`
`Institution, April 27, 2015) (“Moreover, as to the challenge to claim 10 based on
`
`the ’782 patent and Butler, Petitioner has not presented substantially the same
`
`arguments as presented in the ’512 Petition, as shown by our determination to
`
`institute a trial in relation to this ground and claim here, in contrast with our prior
`
`decision not to institute a trial based on the ’512 Petition.”). Accordingly,
`
`Petitioners request that its petition be granted and that Claim 18 of the ʼ715 patent
`
`be cancelled.
`
`LEGAL02/37506098v11
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`6
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`
`
`B.
`
`Background of Nasal Bridles
`
`Nasal bridles are nothing new, and, in fact, have been used in the medical
`
`care field since at least 1980 to prevent accidental dislodgement of a nasogastric
`
`tube. Jeffrey A. Meer, A New Nasal Bridle for Securing Nasoentereal Feeding
`
`Tubes, 13 J. Parenteral & Enteral Nutrition, 331, 331 (1989) (EX1003); see also
`
`EX1004 at ¶¶ 26-29. Nasogastric tubes are commonly used to deliver medication
`
`and/or nutrition to hospitalized patients. Id. As Meer explained, dislodgement of
`
`nasogastric tubes was common, occurring in as much as one half of patients. Id.
`
`Dislodgement resulted in many problems such as delayed feeding, increased risk of
`
`aspiration, expenditure of health care professionals’ time, and increased hospital
`
`stay time. Id. Indeed, the earliest designs of nasal bridles were difficult to install,
`
`and thus health care professionals opted for alternative, albeit lesser, means for
`
`securing feeding tubes. Id.
`
`As originally described, a nasal bridle was “a length of material looped
`
`around the patient’s nasal septum and then secured to the feeding tube.” W.
`
`Frederick McGuirt, Securing of intermediate duration feeding tubes, 90
`
`Laryngoscope, 2046-2048 (1980) (EX1005); see also EX1004 at ¶¶ 26-29. One of
`
`the earliest methods of installing the nasal bridle involved inserting a flexible tube
`
`into the nare (used interchangeably with “nostril” herein) of a patient, extracting
`
`the tube from the patient’s mouth, tying umbilical tape to the catheter, and then
`
`LEGAL02/37506098v11
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`7
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`

`

`
`
`removing the catheter from the nostril in order to pull the tape through the nostril.
`
`Id. The catheter is then passed through the other nare and umbilical tape
`
`introduced into the patient’s nasal cavity in the same, aforementioned manner. Id.
`
`The below figures provide an illustration of the installation of this type of nasal
`
`bridle. Id.
`
`
`
`Additional references disclose the installation of a nasal bridle by
`
`introducing the bridle into the patient’s nares, extracting the bridle from the
`
`patient’s mouth, and forming the bridle into a loop ultimately positioned behind the
`
`patient’s nasal septum. EX1006, Albert Barrocas, The bridle: increasing the use of
`
`nasoenteric feedings. 2 Nutritional Support Servs., 8, 8-10 (1982); EX1003 at
`
`LEGAL02/37506098v11
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`8
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`

`

`
`
`331-33; EX1010, Albert Levenson, Feeding Tube Anchor, 5 Nutritional Support
`
`Servs. 8, 40, 42 (1985); see also EX1004 at ¶¶ 26-29.
`
`III. STANDING (37 C.F.R. § 41.104(A)); PROCEDURAL STATEMENTS
`
`Petitioners certify that: (1) the ʼ715 patent is available for IPR; and (2) the
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`Petitioners are not barred or estopped from requesting IPR of any claim of the ʼ715
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`patent on the grounds identified herein. This Petition is filed in accordance with 37
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`C.F.R. § 42.106(a). Concurrently filed herewith are a Power of Attorney for each
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`Petitioner and an Exhibit List pursuant to § 42.10(b) and § 42.63(e), respectively.
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`The required fee is paid through an online credit card, and the office is authorized
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`to charge any fee deficiencies and credit any overpayments to Deposit Acct. No.
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`160605 (Customer ID No. 00826).
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`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(A)(1))
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`A. Each Real Party-in-Interest (37 C.F.R. § 42.8(b)(1))
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`The real parties in interest are Halyard Health, Inc., Medsystems Holdings,
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`Inc., Corpak Medsystems, Inc., and Halyard Sales, LLC.
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`B. Notice of Related Matters (37 C.F.R. § 42.8(b)(2))
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`1.
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`Judicial Matters
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`The ʼ715 patent is currently the subject of the litigation styled Applied
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`Medical Technology, Inc. v. Corpak Medsystems, Inc., 1:16-cv-02190 (N.D. Ohio).
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`2.
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`Administrative Matters
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`The Public Patent Application Information Retrieval (“Public PAIR”)
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`system indicates that the ʼ715 patent issued from the ʼ399 application, which
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`claims priority to Provisional U.S. Application No. 60/230,535, which was filed on
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`September 1, 2000. Public PAIR also indicates that U.S. Patent No. 6,837,237,
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`which issued January 4, 2005, also claims priority to the aforementioned ʼ399
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`application. The ’715 was previously challenged on other grounds in Corpak
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`Medsystems, and the Board denied institution. EX1013.
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`C. Designation of Lead and Back-Up Counsel (37 C.F.R. § 42.8(b)(3))
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`Lead counsel is Richard M. McDermott (Reg. No. 40,720) and back-up
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`counsel are Jitendra Malik Ph.D. (Reg. No. 55,823) and Alissa M. Pacchioli (Reg.
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`No. 74,252). Please direct all correspondence to lead counsel at the following
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`address: 101 S. Tryon St, Ste 4000, Charlotte, NC 28280; telephone 704-444-
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`1000. Pursuant to 37 C.F.R. § 42.10(b), Powers of Attorney are being submitted
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`with this Petition. Petitioners consent to email service at:
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`rick.mcdermott@alston.com, jitty.malik@alston.com, and
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`alissa.pacchioli@alston.com. 37 C.F.R. § 42.8(b)(4).
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`V.
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`STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFOR (37 C.F.R. § 42.22(a))
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`Petitioners request institution of an IPR and cancellation of Claim 18.
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`Petitioners’ full statement of the reasons for the relief requested is set forth in
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`detail below.
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`VI. THE ʼ715 PATENT AND CLAIM CONSTRUCTION
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`A. The ’715 Patent
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`The specification of the ʼ715 patent is allegedly directed to “systems for
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`placing and securing a nasal tube; and more particularly to such a system which
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`utilizes magnets in the placement of a bridle used in combination with a receiver to
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`secure the nasal tube.” EX1001 at 1:8-12; see also EX1004 at ¶ 34. In other
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`words, the ʼ715 patent’s specification purports to describe an apparatus and
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`corresponding method for use in “placing and securing at least one nasal tube in a
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`patient.” EX1001 at 2:21-32; see also EX1004 at ¶ 34.
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`The apparatus described in the specification of the ʼ715 patent is
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`straightforward: It consists of a “flexible member” with a magnet secured at one
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`end, another instrument consisting of a “magnetic probe,” and a “receiver.” Id.;
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`see also EX1004 at ¶ 35. Similarly, the method disclosed in the ʼ715 patent is as
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`straightforward as the disclosed apparatus. Id. The method described in the
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`specification requires insertion of the magnetic end of the flexible member into one
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`nostril and insertion of the magnetic probe into the second nostril so that the
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`magnets mate. EX1001 at 6:30-46; see also EX1004 at ¶ 35. Once the magnets
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`have mated, the magnetic probe is withdrawn from the second nostril and the
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`flexible member is pulled “into the first nare and out through the second nare” and
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`thus “looped around the nasal septum.” EX1001 at 6:61-66; see also EX1004 at ¶
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`35. The magnetic probe and the flexible member are then separated and the end
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`portions of the flexible member and nasal tube are secured in a receiver. EX1001
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`at 7:1-14; see also EX1004 at ¶ 35.
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`Claim 18 recites elements directed to the aforementioned method, which
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`mirrors the disclosure of Ballantyne and adds “snapping the at least one tube into a
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`channel formed in a receiver.” EX1001 at Claim 18; see also EX1004 at ¶ 36.6 As
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`explained in further detail below, in the previous petition for IPR, the Board
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`explained that “snapping the at least one tube into a channel formed in a receiver,”
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`6 The preamble to Claim 18 includes the transition term “comprising.”
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`EX1001 at Claim 18; see also EX1004 at ¶ 37. This means that “other elements
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`may be added and still form a construct within the scope of the claim.” Genentech,
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`Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997) (internal quotations and
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`citations omitted).
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`means “that snapping occurs with respect to a tube and a channel, based on the
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`express language…” EX1013 at 8.
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`B.
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`The Priority Date of the ʼ715 Patent
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`The ʼ715 patent issued from the ʼ399 application, which was filed on August
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`24, 2001. EX1001. The face of the ʼ715 patent claims priority to U.S. Prov. Appl.
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`No. 60/230,535, which was filed on September 1, 2000. Id. AMT, however, has
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`stated in the related patent litigation involving Petitioner Corpak Medsystems, Inc.
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`that Claim 18 of the ʼ715 patent is entitled to priority only to August 24, 2001, the
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`filing date of the ’399 application. EX1009, Patent Owner’s Initial Infringement
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`Contentions at 2; see also EX1004 at ¶ 33. In any event, as described below,
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`whether the correct priority date is September 1, 2000 or August 24, 2001, all of
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`the references relied upon by Petitioners qualify as prior art under 35 U.S.C.
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`§102(b) (pre-AIA). EX1004 at ¶ 33.
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`C. Board’s Prior Decision
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`Petitioners previously filed a petition requesting institution of an IPR of
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`Claim 18 of the ’715 patent. EX1014. The Board denied institution of the IPR.
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`EX1013. The Board’s decision focused on Claim 18’s recitation of “snapping the
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`at least one tube into a channel formed in a receiver.” The Board found that
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`Ballantyne did not disclose snapping a tube into a channel. EX1013 at 16. For the
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`same reasons, the Board held that the prior petition did not establish a reasonable
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`likelihood that Claim 18 is obvious in light of Ballantyne, Ballantyne and the ’448
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`patent, or Ballantyne and the ’199 and ’538 patents. EX1013 at 18-21.
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`D. Claim Construction
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`In an inter partes review, the Board generally interprets a claim term in an
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`unexpired patent according to its broadest reasonable construction in light of the
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`specification of the patent in which it appears. 37 C.F.R. § 42.100(b). In the view
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`of the Petitioners and their expert, Dr. Layton, the limitations of Claim 18 should
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`be given their broadest reasonable interpretation in light of the specification of the
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`ʼ715 patent. See Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2144-46 (2016); see
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`also EX1004 at ¶ 23. In other words, the claim terms should be given their
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`ordinary and customary meaning, as would be understood by one of ordinary skill
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`in the art at the time of the invention, in the context of the entire patent disclosure.
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`In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007); EX1004 at ¶
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`23. As discussed supra, the previously filed petition for IPR was denied and the
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`Board explained that “snapping the at least one tube into a channel formed in a
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`receiver,” as recited by claim 18 means “that snapping occurs with respect to a
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`tube and a channel, based on the express language…” EX1013 at 8. Petitioners
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`apply the same construction herein.
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`VII. PERSON OF ORDINARY SKILL IN THE ART (“POSA”) AND
`STATE OF THE ART
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`A POSA is a hypothetical person who is presumed to be aware of all
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`pertinent art, thinks along conventional wisdom in the art, and is a person of
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`ordinary creativity. KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 420 (2007); see
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`also EX1004 at ¶ 30-32. A POSA of the ʼ715 patent would have had education
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`and/or experience in the biological sciences, engineering, medical device
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`manufacturing, and/or design along with knowledge of the scientific literature in
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`the field. EX1004 at ¶¶ 30-32. Although education and experience levels may
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`vary, a POSA would have had at least a bachelor’s degree in biology,
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`bioengineering, biomedical engineering, zoology or equivalent. Id.
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`A POSA also would have h