`By: Sheila N. Swaroop
`William O. Adams
`Alexander Zeng
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
`Telephone: 949-760-0404
`Facsimile: 949-760-9502
`Email: BoxMIBAL001LP@knobbe.com
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`BALT USA, LLC
`Petitioner,
`
`v.
`
`MICROVENTION, INC.
`Patent Owner.
`
`
`
`
`
`Filed: July 8, 2020
`
`
`
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`
`
`Case No. IPR2020-01259
`U.S. Patent No. 10,076,338
`
`
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`
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 10,076,338
`
`
`
`TABLE OF CONTENTS
`
`Page No.
`
`INTRODUCTION ......................................................................................... 1
`I.
`CLAIM CONSTRUCTION .......................................................................... 5
`II.
`III. LEVEL OF ORDINARY SKILL .................................................................. 6
`IV. THE STATE OF THE ART .......................................................................... 7
`V.
`REASONABLE LIKELIHOOD OF UNPATENTABILITY ....................... 7
`A. Grounds of Challenges ........................................................................ 8
`B.
`Priority of the ’338 Patent ................................................................... 8
`C.
`The Asserted References are Prior Art ................................................ 8
`1.
`U.S. 2006/0052815 (“Fitz”) ...................................................... 8
`2.
`U.S. 6,193,728 (“Ken”) ............................................................. 8
`VI. GROUND I: CLAIMS 1-10 ARE OBVIOUS OVER FITZ
`ALONE .......................................................................................................... 9
`A.
`Introduction to Fitz .............................................................................. 9
`B.
`Claims 1-10 Are Obvious Over Fitz ................................................. 12
`1.
`Claim 1 .................................................................................... 12
`a.
`Preamble: “A detachable implant delivery
`system, comprising.” .................................................... 12
`Limitation 1[i] ............................................................... 12
`Limitation 1[ii] .............................................................. 13
`Limitation 1[iii] ............................................................ 13
`
`b.
`c.
`d.
`
`-i-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`ii.
`
`iii.
`
`2.
`3.
`4.
`5.
`
`Limitation 1[iv] ............................................................. 14
`i.
`“said stretch-resistant member passing
`through a lumen of said microcoil
`being attached at a first location near
`a distal end of said microcoil,” ........................... 15
`“at a second location near a proximal
`end of said microcoil,” ....................................... 18
`“and at a third location near a distal
`end of said delivery device, such that
`said stretch-resistant member is
`located within said heater coil.” ......................... 19
`Limitation 1[v] .............................................................. 21
`f.
`Limitation 1[vi] ............................................................. 23
`g.
`Claims 2, 3 and 6..................................................................... 26
`Claim 4 .................................................................................... 27
`Claim 5 .................................................................................... 28
`Claim 7 .................................................................................... 28
`a.
`Preamble: “A method of detaching a
`microcoil from an implant delivery system,
`comprising.” .................................................................. 28
`Limitation 7[i] ............................................................... 28
`Limitation 7[ii] .............................................................. 29
`Limitation 7[iii] ............................................................ 29
`
`e.
`
`b.
`c.
`d.
`
`-ii-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`Limitation 7[iv] ............................................................. 33
`e.
`Limitation 7[v] .............................................................. 34
`f.
`Limitation 7[vi] ............................................................. 37
`g.
`Limitation 7[vii]............................................................ 38
`h.
`Claim 8 .................................................................................... 40
`6.
`Claims 9 and 10 ....................................................................... 41
`7.
`VII. GROUND II: CLAIMS 1-10 ARE OBVIOUS OVER FITZ IN
`VIEW OF KEN ............................................................................................ 42
`A.
`Introduction to Ken ........................................................................... 43
`B.
`Claims 1-10 Are Obvious over Fitz in view of Ken ......................... 46
`1.
`Claim 1 .................................................................................... 46
`a.
`Preamble: “A detachable implant delivery
`system, comprising.” .................................................... 46
`Limitation 1[i] ............................................................... 46
`Limitation 1[ii] .............................................................. 47
`Limitation 1[iii] ............................................................ 47
`Limitation 1[iv] ............................................................. 47
`i.
`“said stretch-resistant member passing
`through a lumen of said microcoil
`being attached at a first location near
`a distal end of said microcoil,” ........................... 48
`
`b.
`c.
`d.
`e.
`
`-iii-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`ii.
`
`iii.
`
`“at a second location near a proximal
`end of said microcoil,” ....................................... 49
`“and at a third location near a distal
`end of said delivery device, such that
`said stretch-resistant member is
`located within said heater coil.” ......................... 50
`iv. Motivation to Combine Fitz with Ken ............... 50
`v.
`Expectation of Success ....................................... 53
`Limitation 1[v] .............................................................. 56
`f.
`Limitation 1[vi] ............................................................. 56
`g.
`Claims 2, 3 and 6..................................................................... 58
`Claim 4 .................................................................................... 60
`Claim 5 .................................................................................... 61
`Claim 7 .................................................................................... 61
`a.
`Preamble: “A method of detaching a
`microcoil from an implant delivery system,
`comprising.” .................................................................. 61
`Limitation 7[i] ............................................................... 61
`Limitation 7[ii] .............................................................. 61
`Limitation 7[iii] ............................................................ 62
`Limitation 7[iv] ............................................................. 62
`Limitation 7[v] .............................................................. 62
`
`2.
`3.
`4.
`5.
`
`b.
`c.
`d.
`e.
`f.
`
`-iv-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`g.
`
`Limitation 7[vi] ............................................................. 63
`i.
`Motivation to Combine And
`Expectation of Success ....................................... 63
`Limitation 7[vii]............................................................ 64
`h.
`Claim 8 .................................................................................... 65
`6.
`Claims 9 and 10 ....................................................................... 66
`7.
`VIII. NO SECONDARY CONSIDERATIONS .................................................. 67
`IX. DISCRETIONARY FACTORS FAVORING INSTITUTION .................. 67
`X. MANDATORY NOTICES UNDER 37 C.F.R § 42.8(A)(1) ..................... 67
`A.
`Real Party-in-Interest Under 37 C.F.R. § 42.8(b)(1) ........................ 67
`B.
`Related Matters Under 37 C.F.R. § 42.8(b)(2) ................................. 68
`C.
`Lead and Backup Counsel Under 37 C.F.R. § 42.8(b)(3) ................. 68
`D.
`Service Information Under 37 C.F.R. § 42.8(b)(4) ........................... 68
`E.
`Payment of Fees Pursuant to 37 C.F.R. § 42.103 ............................. 69
`XI. ADDITIONAL REQUIREMENTS UNDER 37 C.F.R. §42.104 ............... 69
`XII. CONCLUSION ............................................................................................ 69
`
`
`
`
`
`-v-
`
`
`
`TABLE OF AUTHORITIES
`
`Page No(s).
`
`Comcast Cable Commc’ns, LLC v. Veveo, Inc.,
`IPR2019-00239 Paper 15 (P.T.A.B. July 5, 2019) ............................................. 67
`Microvention, Inc. v. Balt USA, LLC,
`Case No. 8:19-cv-01335-JLS-KES
`(C.D. Cal. filed July 8, 2019, served July 10, 2019) .......................................... 68
`Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co.,
`868 F.3d 1013 (Fed. Cir. 2017) ............................................................................ 5
`
`OTHER AUTHORITIES
`
`§102 ............................................................................................................................ 8
`35 U.S.C. §103 ........................................................................................................... 8
`35 U.S.C. § 282 .......................................................................................................... 5
`37 C.F.R § 42.8 .................................................................................................. 67, 68
`37 C.F.R. § 42.15 ..................................................................................................... 69
`37 C.F.R. § 42.100 ..................................................................................................... 5
`37 C.F.R. § 42.103 ................................................................................................... 69
`37 C.F.R. §42.104 .................................................................................................... 69
`
`
`-vi-
`
`
`
`Balt USA, LLC v. MicroVention, Inc.
`IPR Petition – U.S. Patent No. 10,076,338
`
`TABLE OF EXHIBITS
`
`
`
`Exhibit No. Description
`
`1001
`1002
`1003
`1004
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`1011
`
`1012
`
`1013
`
`U.S. Patent No. 10,076,338
`U.S. Patent Publication No. 2006/0052815 (“Fitz”)
`U.S. Patent No. 6,193,728 (“Ken”)
`Declaration of Marc-Alan Levine
`File History of U.S. Patent No. 10,076,338
`Complaint, Dkt. 1, MicroVention, Inc. v. Balt USA, LLC, No.
`8:19-cv-01335-JLS-KES (C.D. Cal., filed July 8, 2019)
`Summons, Dkt. 8, MicroVention, Inc. v. Balt USA, LLC, No. 8:19-
`cv-01335-JLS-KES (C.D. Cal., filed July 8, 2019)
`Joint Claim Construction Prehearing Statement, Dkt. 31, Mi-
`croVention, Inc. v. Balt USA, LLC, No. 8:19-cv-01335-JLS-KES
`(C.D. Cal., filed July 8, 2019)
`Joint Technology Tutorial for Markman, submitted in MicroVen-
`tion, Inc. v. Balt USA, LLC, No. 8:19-cv-01335-JLS-KES (C.D.
`Cal., filed July 8, 2019)
`Marc-Alan Levine Curriculum Vitae
`Marc-Alan Levine List of Materials Considered
`Balt’s Opening Claim Construction Brief & Supporting Materials,
`Dkt. 33-34, MicroVention, Inc. v. Balt USA, LLC, No. 8:19-cv-
`01335-JLS-KES (C.D. Cal., filed July 8, 2019)
`MVI’s Opening Claim Construction Brief & Supporting Materi-
`als, Dkt. 35, MicroVention, Inc. v. Balt USA, LLC, No. 8:19-cv-
`01335-JLS-KES (C.D. Cal., filed July 8, 2019)
`
`Table of Exhibits, Page 1
`
`
`
`Balt USA, LLC v. MicroVention, Inc.
`IPR Petition – U.S. Patent No. 10,076,338
`
`Exhibit No. Description
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`1025
`1026
`1027
`
`Order Continuing Claim Construction Hearing, Dkt. 41, Mi-
`croVention, Inc. v. Balt USA, LLC, No. 8:19-cv-01335-JLS-KES
`(C.D. Cal., filed July 8, 2019)
`U.S. Patent No. 8,182,506
`Scheduling Order, Dkt. 21, MicroVention, Inc. v. Balt USA, LLC,
`No. 8:19-cv-01335-JLS-KES (C.D. Cal., filed July 8, 2019)
`U.S. Patent No. 7,048,719 (“Monetti”)
`Suzanne R. Morrison, Guglielmi Detachable Coils: An Alterna-
`tive Therapy for Surgically High-Risk Aneurysms, J. NEUROSCI-
`ENCE NURSING, Vol. 29, No. 1, 232-237 (Aug. 1997)
`J.V. Byrne, et al., Treatment by Endovascular Packing with the
`Guglielmi Detachable Coil, in Endovascular Treatment of Intra-
`cranial Aneurysms, 134-165 (1998)
`U.S Patent No. 5,895,385 (“Guglielmi”)
`Cloft, et al., Use of Three-dimensional Guglielmi Detachable
`Coils in the Treatment of Wide-necked Cerebral Aneurysms, AM
`J. NEURORADIOL. 21:1312-1314 (Aug. 2000)
`David Niemann, et al., Anatomically Conformable, Three-Dimen-
`sional, Detachable Platinum Microcoil System for the Treatment
`of Intracranial Aneurysms, AM. J. NEURORADILOGY, 25:813-818
`(May 2004)
`Ferdinand K Hui, et al., A history of detachable coils: 1987-2012,
`J. NEUROVASCULAR SURG. 6:134-138 (2014)
`U.S. Patent No. 6,478,773 (“Gandhi”)
`U.S. Patent Publication No. 2004/0034363 A1 (“Wilson”)
`U.S. Patent Publication No. 2007/0239193 A1 (“Simon”)
`Exhibit Number Not Used
`
`Table of Exhibits, Page 2
`
`
`
`Balt USA, LLC v. MicroVention, Inc.
`IPR Petition – U.S. Patent No. 10,076,338
`
`Exhibit No. Description
`
`1028
`
`Balt’s Responsive Claim Construction Brief, Dkt. 36, MicroVen-
`tion, Inc. v. Balt USA, LLC, No. 8:19-cv-01335-JLS-KES (C.D.
`Cal., filed July 8, 2019)
`
`
`
`Table of Exhibits, Page 3
`
`
`
`Balt USA, LLC v. MicroVention, Inc.
`IPR Petition – U.S. Patent No. 10,076,338
`Balt USA, LLC requests inter partes review of claims 1-10 of Patent No.
`
`10,076,338 (“’338 patent”) (Ex. 1001), purportedly owned by MicroVention, Inc.
`
`(“MVI”).
`
`I.
`
`
`INTRODUCTION
`The ’338 patent is directed to implantable embolic devices (such as micro-
`
`coils) for the treatment of aneurysms. They include a stretch-resistant member that
`
`passes through the microcoil and serves as a tether for connecting the microcoil to a
`
`delivery system.
`
`The ’338 patent contains ten claims, two of which are independent. Those
`
`claims cover a detachable implant delivery system (claim 1 and dependents) and a
`
`method of detaching a microcoil from an implant delivery system (claim 7 and de-
`
`pendents). Each claim is an obvious combination of well-known features from the
`
`prior art. The closest prior art is a patent publication by Fitz. See Ex. 1002 (“Fitz”).
`
`Both named inventors on Fitz are also named inventors on the ’338 patent. Fitz
`
`alone discloses every limitation of the ’338 patent claims. Notably, the Fitz specifi-
`
`cation is almost the same as the ’338 specification. Figure 9 of the ’338 patent was
`
`the only new figure added to Fitz’s prior art specification. See Ex. 1001, Fig. 9; Ex.
`
`1002. However, the description of Figure 9 in the ’338 patent refers back to Fitz on
`
`several occasions, citing to “U.S. patent application number Ser. No. 11/212,830,”
`
`which is the Fitz patent application. Ex. 1001, 16:39-45, 16:54-60. The only other
`
`-1-
`
`
`
`Balt USA, LLC v. MicroVention, Inc.
`IPR Petition – U.S. Patent No. 10,076,338
`new disclosure in the ’338 patent is that related to Figure 9 (id., 15:59-17:13) and
`
`background disclosures (id., 1:42-52). Although the specifications of Fitz and the
`
`’338 patent are almost identical, the ’338 patent does not claim priority back to Fitz,
`
`nor could it, because Fitz published more than one year before the application that
`
`led to the ’338 patent was filed. See Ex. 1001, Ex. 1002.
`
`During prosecution of the application that led to the ’338 patent, the examiner
`
`rejected several pending claims as obvious over Fitz. Ex. 1005, p. 43-52 (2018-01-
`
`25 Non-Final Rejection). Ex. 1004, ¶ 52. In response, the patentee canceled those
`
`rejected claims. Ex. 1005, p. 36-41 (2018-03-22 Amendment); Ex. 1004, ¶ 52. As
`
`demonstrated below, the rejected claim (left) is very similar to the issued, petitioned
`
`’338 patent claim (right). Both recite a tether or stretch-resistant member that at-
`
`taches to the microcoil in two locations and attaches to the delivery device at a third
`
`location, resulting in a configuration of the tether or stretch resistant member having
`
`one section under tension and one section resistant to stretching. Ex. 1004, ¶¶ 52-53.
`
`Rejected Original Claim 1 of the
`’338 Patent Application
`1. A detachable implant delivery sys-
`tem, comprising:
`1.i. a delivery device having a
`distal end and a heater proximate
`said distal end;
`
`
`
`1.ii. a microcoil;
`
`Issued Claim 1 of the ’338 Patent
`(Originally Application Claim 8)
`1. A detachable implant delivery system,
`comprising:
`1.i. delivery device having a heater
`coil proximate a distal end of said de-
`livery device;
`
`1.ii. a microcoil comprising a helical
`wire;
`
`-2-
`
`
`
`Balt USA, LLC v. MicroVention, Inc.
`IPR Petition – U.S. Patent No. 10,076,338
`Rejected Original Claim 1 of the
`’338 Patent Application
`1.iii. a tether connected to said
`microcoil and to said delivery de-
`vice, said tether including:
`
`1.iv.i. a first section extending
`through said microcoil and fixed
`at a distal location of said micro-
`coil;
`1.iv.ii. and a second section ex-
`tending proximally from said first
`section; said second section being
`attached to a proximal location on
`said microcoil
`1.iv.iii. and to a location on said
`delivery device proximal of said
`heater;
`
`1.v. wherein said second section
`of said tether has a higher tension
`than said first section of said
`tether, such that said second sec-
`tion enhances breakage of said
`tether during activation of said
`heater
`
`
`1.vi. and said first section resists
`stretching to retain an original
`configuration of said microcoil.
`
`Ex. 1005 at 37, 126.
`
`Issued Claim 1 of the ’338 Patent
`(Originally Application Claim 8)
`1.iii. and a stretch-resistant member
`characterized by a single monofila-
`ment and connecting said delivery de-
`vice and said microcoil;
`1.iv.i. said stretch-resistant member
`passing through a lumen of said micro-
`coil being attached at a first location
`near a distal end of said microcoil,
`1.iv.ii. at a second location near a
`proximal end of said microcoil,
`
`1.iv.iii. and at a third location near a
`distal end of said delivery device, such
`that said stretch-resistant member is
`located within said heater coil;
`1.v. wherein a first portion of said
`stretch-resistant member is between
`said second location and said third lo-
`cation is tensioned so as to enhance
`breakage upon application of heat by
`said heater coil,
`
`1.vi. and wherein a second portion of
`said stretch-resistant member is iso-
`lated from the tension of said first por-
`tion so as to resist stretching and
`thereby retain an original configura-
`tion of said microcoil.
`
`Although ten claims eventually issued in the ’338 patent, the record is clear
`
`that the examiner failed to appreciate material prior art disclosures. In the Notice of
`
`Allowance, the examiner acknowledged that the “closest prior art of record, Fitz . .
`
`-3-
`
`
`
`Balt USA, LLC v. MicroVention, Inc.
`IPR Petition – U.S. Patent No. 10,076,338
`. in view of Simon . . . discloses a detachable implant delivery system have a delivery
`
`device, a microcoil and a tether [sic] having various tensioned sections and method
`
`for detaching the microcoil from the implant delivery system.” Id., 22. Yet, the
`
`examiner found the “prior art of record does not disclose or fairly suggest either
`
`singly or combination the detachable implant delivery system and method for de-
`
`taching a microcoil from an implant delivery system as presently claimed in claims
`
`8 [issued claim 1] and 14 [issued claim 7], respectively.” Id. This finding is incor-
`
`rect, because Fitz alone discloses the claimed detachable implant delivery system
`
`and method for detaching a microcoil from an implant delivery system. Ex. 1004, ¶
`
`54. Moreover, the examiner failed to apply Ken (Ex. 1003) in combination with
`
`Fitz, which would have rendered the claims obvious. Ex. 1004, ¶ 55.
`
`Fitz, in a single embodiment (Figure 4), discloses almost every element in
`
`claims 1-10 of the ’338 patent. Ex. 1004, ¶¶ 61-140. When Figure 4 and its related
`
`disclosure are combined with Figure 1 and its related disclosure, every element of
`
`these claims is disclosed. Id. Thus, for the reasons discussed herein, claims 1-10
`
`of the ’338 are obvious to a person of ordinary skill in the art (“POSA”) over Fitz
`
`alone. Id.
`
`
`
`Moreover, Fitz in view of Ken also renders the ’338 patent claims obvious to
`
`a POSA. Id., ¶ 141, Ken discloses a tether or stretch resistant member that continues
`
`from the proximal end to distal end of the microcoil, through the lumen, and is
`
`-4-
`
`
`
`Balt USA, LLC v. MicroVention, Inc.
`IPR Petition – U.S. Patent No. 10,076,338
`“loose” or not under tension. Id., ¶ 37-42. To the extent Fitz alone does not render
`
`the petitioned claims obvious, Fitz in view of Ken does so. Id.
`
`
`
`Claims 1-10 should be cancelled based on Fitz and/or Fitz in view of Ken.
`
`II. CLAIM CONSTRUCTION
`Claims are construed using the same standard used in a civil action under 35
`
`U.S.C. § 282(b). 37 C.F.R. § 42.100(b). Claim language is given the meaning it
`
`would have to a POSA at the time the application was filed, in view of the
`
`specification and file history.
`
`The Board need only construe claims to the extent necessary to resolve con-
`
`troversy. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013,
`
`1017 (Fed. Cir. 2017). No term requires express construction here. Four claim terms
`
`from the ’338 patent were offered for construction in the co-pending litigation, in-
`
`cluding:
`
`1. “tensioned so as to enhance breakage upon application of heat by
`said heater coil”
`2. “knot”
`3. “tether that is pre-tensioned”
`4. “a first section of a tether that is pre-tensioned between a first
`location on said implant delivery device so as to enhance break-
`age along said first section of said tether”
`
`Ex. 1008; see also Ex. 1012, 1013, 1028.
`
`
`-5-
`
`
`
`Balt USA, LLC v. MicroVention, Inc.
`IPR Petition – U.S. Patent No. 10,076,338
`The court has not yet construed these terms, and the Markman hearing is not
`
`scheduled until September 22, 2020. Ex. 1013. Although Balt’s proposed con-
`
`structions for these terms should apply in this proceeding, see Ex. 1012, the peti-
`
`tioned claims would have been obvious to a POSA under either party’s proposed
`
`constructions. Ex. 1004, ¶ 59. That is because the parties have construed the dis-
`
`puted terms in the same way as they have construed similar terms in the Fitz disclo-
`
`sure. Id. Fitz is the patent publication that issued as U.S. Patent No. 8,182,506,
`
`which is asserted in the co-pending district court action. See Ex. 1006, ¶ 24.
`
`III. LEVEL OF ORDINARY SKILL
`Petitioner’s analyses are provided from the perspective of a person having
`
`ordinary skill in the relevant art during the relevant time period. For purposes of this
`
`Petition, the relevant art is implantable endovascular devices and delivery systems.
`
`For purposes of this Petition, the relevant time period is July 27, 2007, which is the
`
`earliest alleged priority date of the ’338 patent’s claims.
`
`A person of ordinary skill in the relevant art in or around July 2007 would be
`
`(a) a neurovascular surgeon or interventional radiologist having at least three years
`
`of experience in endovascular embolization procedures; or (b) an engineer with a
`
`Bachelor’s or Master’s degree in biomedical engineering, mechanical engineering,
`
`or a related discipline, with at least two years of experience designing and/or devel-
`
`oping endovascular devices. Ex. 1004, ¶ 19.
`
`-6-
`
`
`
`Balt USA, LLC v. MicroVention, Inc.
`IPR Petition – U.S. Patent No. 10,076,338
`IV. THE STATE OF THE ART
`The ’338 patent is focused primarily on systems and methods for the delivery
`
`of embolic microcoils to neurovascular treatment sites, such as intracranial aneu-
`
`rysms. Ex. 1001 17:14-18:42; Ex. 1004, ¶¶ 21, 45-51. The ’338 patent claims a
`
`detachable implant delivery system and a method for detaching such a system, where
`
`the system includes: (1) a delivery device with a heater coil; (2) a microcoil with a
`
`helical wire; and (3) a stretch-resistant member or tether that passes through the lu-
`
`men of the microcoil to connect on the distal end, wherein one section of the stretch-
`
`resistant member or tether is under tension to enhance breakage and another section
`
`is isolated from tension. Id.
`
`All of the elements of the ’338 patent claims were well-known in the art as of
`
`the priority date. See Ex. 1004, ¶¶ 21-31; see also Ex. 1017-1026. Fitz discloses
`
`every one of these limitations. Ex. 1004, ¶¶ 33-36. Ken discloses many of these
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`limitations, but specifically focuses on the stretch resistant member or tether attach-
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`ing to the proximal end of the microcoil and then continuing through the lumen and
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`connecting to the distal end of the microcoil, such that the stretch resistant member
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`is “loose” within the lumen. Ex. 1004, ¶¶ 37-44.
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`V. REASONABLE LIKELIHOOD OF UNPATENTABILITY
`Petitioner requests the Board cancel claims 1-10 of the ’338 patent for the
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`following reasons.
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`Balt USA, LLC v. MicroVention, Inc.
`IPR Petition – U.S. Patent No. 10,076,338
`A. Grounds of Challenges
`Review is requested for the following grounds of unpatentability.
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`Ground
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`Reference(s)
`
`Basis
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`Challenged Claims
`
`1
`
`2
`
`Fitz
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`35 U.S.C. §103
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`Fitz in view of Ken
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`35 U.S.C. §103
`
`1-10
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`1-10
`
`
`
`B.
`
`Priority of the ’338 Patent
`The application which issued as the ’338 patent was filed on March 25, 2016,
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`as U.S. Application No. 15/081,065, which is a continuation claiming priority to
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`U.S. Application No. 12/180,834, filed on July 28, 2008, now abandoned, which
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`claims priority to U.S. Provisional Application No. 60/952,520, filed on July 27,
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`2007. Ex. 1001. Thus, the earliest possible priority date for all claims of the ’338
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`Patent is July 27, 2007.
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`C. The Asserted References are Prior Art
`1.
`U.S. 2006/0052815 (“Fitz”)
`
`Fitz (Ex. 1002) was published on March 9, 2006, more than one year before
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`the July 27, 2007 priority date for the ’338 Patent. Thus, Fitz is §102(b) prior art.
`
`2.
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`U.S. 6,193,728 (“Ken”)
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`Ken (Ex. 1003) issued as a U.S. patent on February 27, 2001, more than one
`
`year before the July 27, 2007 priority date for the ’338 Patent. Thus, Ken is §102(b)
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`prior art.
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`Balt USA, LLC v. MicroVention, Inc.
`IPR Petition – U.S. Patent No. 10,076,338
`Additional support for this Petition is included in the Declaration of Marc-
`
`Alan Levine (Ex. 1004).
`
`VI. GROUND I: CLAIMS 1-10 ARE OBVIOUS OVER FITZ ALONE
`A.
`Introduction to Fitz
`Fitz’s (Ex. 1002) specification, with few exceptions, mirrors the ’338 specifi-
`
`cation. Ex. 1004, ¶ 46-48. Fitz discloses “an implant delivery and detachment
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`system used to position and deploy implantable devices such as coils.” Ex. 1002,
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`[0005]. Fitz discloses that “the detachment system 300 includes a delivery pusher
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`301 containing a heater 306 that detaches an implant device 302. Detachment sys-
`
`tem 300 also utilizes a tether 310 to couple the implant device 302 to the delivery
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`pusher 301.” Id., [0050]. This is illustrated in Figure 4, reproduced in color below:
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`
`
`Id., Fig. 4 (shaded and annotated), [0024], [0050]-[0055]. The implant can be a
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`microcoil in a helical shape. Id., [0034], [0057]. Figure 4 is described as a “cross
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`sectional side view of a third embodiment of a detachment system,” (Id., [0024]),
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`but the cross sectional view does not continue through the microcoil. Instead, the
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`microcoil is shown as a side view. Ex. 1004, ¶ 34. As a result, any extension of the
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`Balt USA, LLC v. MicroVention, Inc.
`IPR Petition – U.S. Patent No. 10,076,338
`stretch resistant member through the lumen of the microcoil would not be visible in
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`this view. Ex. 1004, ¶ 34.
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`Regarding the tether or stretch resistant member, Figure 1, reproduced below,
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`shows “[t]he coil-type implant device 112 resists unwinding because the stretch re-
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`sistant tether 104 that extends through the lumen of the implant device 112 requires
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`substantially more force to plastically deform than the implant device 112 itself.”
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`Ex. 1002, [0037].
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`
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`Id., Fig. 1 (shaded and annotated). Fitz also states that “[i]n one embodiment where
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`the implant is a coil, the tether may run through the inside lumen of the coil and be
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`attached to the distal end of the coil. This design not only joins the implant to the
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`pusher, but also imparts stretch resistance to the coil without the use of a secondary
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`stretch resistant member.” Id., [0007]. In Figure 4 the “tether 310 is disposed in
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`proximity to the heater 306, having a proximal end fixed within the delivery pusher
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`301 and a distal end coupled to the implant device 302.” Id., [0051]. “The tether
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`310 ties around the proximal end of the implant device 302 to form knot 316.” Id.,
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`Balt USA, LLC v. MicroVention, Inc.
`IPR Petition – U.S. Patent No. 10,076,338
`[0053]. In Figure 4, “tether 310 is disposed in proximity to the heater 306, having a
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`proximal end fixed within the delivery pusher 301 and a distal end coupled to the
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`implant device 302. As current is applied through wires 308 and 309, the heater 306
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`increases in temperature until the tether 310 breaks, releasing the implant device
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`302.” Id., [0051]. Fitz states that “[i]n this embodiment, one end of the tether 310
`
`is attached near the proximal end of the implant device 302 as previously described.
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`The free end of the tether 310 is threaded through a distal portion of the delivery
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`pusher 301 until it reaches an exit point (not shown) of the delivery pusher 301.
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`Tension is applied to the tether 310 in order to store energy in the form of elastic
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`deformation within the tether material by, for example, placing a pre-determined
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`force on the free end of the tether 310 or moving the taunt [sic] tether 310 a pre-
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`determined displacement.” Id., [0054]. Fitz also states that “[w]hen present, the
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`release of potential energy stored in the system operates to apply additional pressure
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`to separate the implant device 302, and the portion of the tether 310 to which the
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`implant device 302 is coupled, away from the heater 306 when the implant device
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`302 is deployed. This advantageously lowers the required detachment time and tem-
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`perature by causing the tether 310 to sever and break.” Id., [0055].
`
`Fitz also discloses several various ways of connecting the tether or stretch
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`resistant member to the distal end of the microcoil: “[the] tether may be joined to the
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`implant and/or the pusher by welding, knot tying, soldering, adhesive bonding, or
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`Balt USA, LLC v. MicroVention, Inc.
`IPR Petition – U.S. Patent No. 10,076,338
`other means known in the art.” Id., [0007]. More specifically, Figure 1 shows “the
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`distal end of the tether 104 may be tied or coupled to the distal end of the implant
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`device 112, or may be melted or otherwise formed into an atraumatic distal end 114.”
`
`Id., [0038].
`
`B. Claims 1-10 Are Obvious Over Fitz
`1.
`Claim 1
`a.
`
`Preamble: “A detachable implant delivery system,
`comprising.”
`
`Fitz discloses “an implant delivery and detachment system used to position
`
`and deploy implantable devices such as coils . . . within a body cavity . . . .” Ex.
`
`1002, [0005].
`
`The preamble is disclosed by Fitz. Ex. 1004 ¶ 62.
`
`b.
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`Limitation 1[i]
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`Limitation 1[i] recites: “a delivery device having a heater coil proximate a
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`distal end of said delivery device.”
`
`Fitz discloses “the detachment system 300 includes a delivery pusher 301 con-
`
`taining a heater 306 that detaches an implant device 302. Detachment system 300
`
`also utilizes a tether 310 to couple the implant device 302 to the delivery pusher
`
`301.” Id., [0050]. “In the cross-sectional view of FIG. 4, a distal end of the delivery
`
`pusher 301 is seen to have a coil-shaped heater 306 that is electrically coupled to
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`electrical wires 308 and 309.” Id., [0051]. The heater coil 306 is very near the distal
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`Balt USA, LLC v. MicroVention, Inc.
`IPR Petition – U.S. Patent No. 10,076,338
`end of the delivery pu