UNITED STATES PATENT AND TRADEMARK OFFICE
`
`______________________
`
`
`
`IN THE UNITED STATES PATENT TRIAL AND APPEAL BOARD
`
`______________________
`
`
`
`ENDOLOGIX, INC.
`Petitioner
`
`v.
`
`LIFEPORT SCIENCES LLC
`Patent Owner
`
`______________________
`
`CASE IPR: 2015-01722
`U.S. PATENT NO. 8,192,482
`______________________
`
`PETITION FOR INTER PARTES REVIEW
`
`
`
`
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box. 1450
`Alexandria, VA 22313-1450
`
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,192,482
`
`Table of Contents
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`PAYMENT OF FEES (37 C.F.R. §§ 42.15 and 42.103) ................................ 1
`
`III. MANDATORY NOTICES (37 C.F.R. § 42.8) ............................................... 1
`
`A.
`
`B.
`
`C.
`
`D.
`
`Real Parties-In-Interest (37 C.F.R. § 42.8(b)(1)) .................................. 1
`
`Related Matters (37 C.F.R. § 42.8(b)(2)) .............................................. 1
`
`Lead and Backup Counsel (37 C.F.R. § 42.8(b)(3)) ............................. 2
`
`Service Information (37 C.F.R. § 42.8(b)(4)) ....................................... 2
`
`IV. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a)) ................................. 3
`
`V.
`
`RELIEF REQUESTED ................................................................................... 3
`
`VI. REASONS FOR THE REQUESTED RELIEF .............................................. 3
`
`A.
`
`B.
`
`Summary of ‘482 Petition ..................................................................... 3
`
`Overview of the Prior Art Specifically Cited Below ............................ 4
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`U.S. Patent No. 8,317,854 (“Ryan”) ........................................... 4
`
`U.S. Patent No. 5,405,377 (“Cragg”) ......................................... 4
`
`U.S. Patent No. 5,064,435 (“Porter”) ......................................... 4
`
`U.S. Patent No. 4,994,071 (“MacGregor”) ................................. 4
`
`U.S. Patent No. 5,135,536 (“Hillstead”) ..................................... 5
`
`U.S. Patent No. 4,733,665 (“Palmaz”) ....................................... 5
`
`U.S. Patent No. 5,370,683 (“Fontaine”) ..................................... 5
`
`U.S. Patent No. 5,707,386 (“Schnepp-Pesch”) ........................... 5
`
`U.S. Patent No. 5,421,955 (“Lau”) ............................................. 6
`
`10. U.S. Patent No. 5,234,457 (“Andersen”) .................................... 6
`
`i
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`

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`Petition for Inter Partes Review of U.S. Patent No. 8,192,482
`
`C.
`
`Background of the Technology and Summary of ‘482 Patent .............. 6
`
`1. Well Known Prior Art Prosthesis Designs ................................. 7
`
`2.
`
`3.
`
`The Patent Owner Only Overcame Previous Rejections By
`Arguing That The Disclosed Non-Helical Design Was
`Novel ......................................................................................... 11
`
`Elements from Helical and Non-Helical Stents Were
`Known To be Interchangeable .................................................. 12
`
`4. Well Known, Interchangeable Prior Art Securing Means ........ 13
`
`Summary of the Prosecution of the ‘482 Patent ................................. 16
`
`The ‘482 Patent Cannot Claim Priority to EP 94400284 or EP
`94401306 ............................................................................................. 16
`
`D.
`
`E.
`
`F.
`
`Related ‘167 Patent IPR and Institution Decision .............................. 18
`
`VII. PERSON OF ORDINARY SKILL IN THE ART ........................................ 18
`
`VIII. CLAIM CONSTRUCTION .......................................................................... 19
`
`A. Additional Terms for Construction ..................................................... 20
`
`1.
`
`“segment” (Claims 2-5,8-9, and 12) ......................................... 20
`
`IX. STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFORE (37 C.F.R. § 42.22(a) AND 42.104(b)) .............. 21
`
`A. Ground 1: Claims 1-9, 12-13, 21-22, and 30 Are Anticipated by
`Ryan ..................................................................................................... 21
`
`B.
`
`C.
`
`Ground 2: Claims 1-9, 12-13, 21-22, and 30 Are Obvious Over
`Ryan ..................................................................................................... 37
`
`Ground 3: Claims 1-9, 12-13, 21-22, and 30 Are Obvious Over
`Ryan In View Of Cragg ...................................................................... 38
`
`D. Ground 4: Claim 2-4, 6-7, and 12 Are Obvious Over Ryan In
`View Of Porter .................................................................................... 40
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`ii
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`Petition for Inter Partes Review of U.S. Patent No. 8,192,482
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`E.
`
`F.
`
`Ground 5: Claims 2, 5, 7-9 Are Obvious Over Ryan In View Of
`MacGregor ........................................................................................... 43
`
`Ground 6: Claims 1-3, 5-6, 12-13, 21, and 30 Are Anticipated by
`Hillstead ............................................................................................... 45
`
`G. Ground 7: Claims 1-3, 5-6, 12-13, 21 and 30 Are Obvious Over
`Hillstead In View Of Palmaz .............................................................. 55
`
`H. Ground 8: Claims 1-9, 12-13, 21-22, and 30 Are Obvious Over
`Hillstead In View Of Palmaz and Ryan .............................................. 57
`
`X.
`
`CONCLUSION .............................................................................................. 60
`
`
`
`iii
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`

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`Petition for Inter Partes Review of U.S. Patent No. 8,192,482
`
`List of Exhibits
`Ex. 1001 U.S. Patent No. 8,192,482 (“‘482 Patent”)
`
`Ex. 1002 Declaration of Richard A. Hillstead, Ph.D
`
`Ex. 1003 Curriculum Vitae of Richard A. Hillstead, Ph.D
`
`Ex. 1004 U.S. Patent No. 8,317,854 (“Ryan”)
`
`Ex. 1005 U.S. Patent No. 5,405,377 (“Cragg”)
`
`Ex. 1006 U.S. Patent No. 5,064,435 (“Porter”)
`
`Ex. 1007 U.S. Patent No. 4,994,071 (“MacGregor”)
`
`Ex. 1008 U.S. Patent No. 5,135,536 (“Hillstead”)
`
`Ex. 1009 U.S. Patent No. 4,733,665 (“Palmaz”)
`
`Ex. 1010 U.S. Patent No. 5,370,683 (“Fontaine”)
`
`Ex. 1011 U.S. Patent No. 5,707,386 (“Schnepp-Pesch”)
`
`Ex. 1012 U.S. Patent No. 5,421,955 (“Lau”)
`
`Ex. 1013 U.S. Patent No. 5,234,457 (“Andersen”)
`
`Ex. 1014
`
`Prosecution History of U.S. Patent No. 8,192,482
`
`Ex. 1015 Amended Complaint in Case No. 1:12-cv-01791-GMS, filed on
`
`August 12, 2014
`
`Ex. 1016
`
`Excerpts from the Deposition of Dr. George Goicoechea on July 8,
`
`2015
`
`Ex. 1017 Board of Patent Appeals and Interferences Decision in Interference
`
`iv
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`Petition for Inter Partes Review of U.S. Patent No. 8,192,482
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`No. 104,192 (April 7, 2000)
`
`Ex. 1018 Memorandum Opinion, Case No. 1:01-cv-2015 (D.D.C. March 31,
`
`2006)
`
`Ex. 1019
`
`Federal Circuit decision in Boston Scientific Scimed, Inc. v. Medtronic
`
`Vascular, Inc., 497 F.3d 1293 (Fed. Cir. 2007)
`
`Ex. 1020 U.S. Patent No. 6,117,167
`
`Ex. 1021
`
`IPR2014-01319, Paper No. 7, Institution Decision (PTAB Feb. 23,
`
`2015)
`
`Ex. 1022
`
`Excerpts from LifePort LLC’s Disclosure of Initial Claim Charts,
`
`dated September 10, 2014
`
`
`
`v
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`

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`Petition for Inter Partes Review of U.S. Patent No. 8,192,482
`
`I.
`
`INTRODUCTION
`Endologix, Inc. (“Petitioner” or “Endologix”) hereby petitions for inter
`
`partes review of claims 1-9, 12-13, 21-22, and 30 of U.S. Patent No. 8,192,482
`
`(“‘482 Patent”) (Ex. 1001) under 35 U.S.C. §§ 311–319 and 37 C.F.R. § 42.
`
`II.
`
`PAYMENT OF FEES (37 C.F.R. §§ 42.15 and 42.103)
`Petitioner authorizes the USPTO to charge the required fees for inter partes
`
`review of 14 claims, and any additional fees, to Deposit Account No. 02–1818.
`
`III. MANDATORY NOTICES (37 C.F.R. § 42.8)
`A. Real Parties-In-Interest (37 C.F.R. § 42.8(b)(1))
`Endologix, located at 2 Musick, Irvine, California 92618, is the real party-in-
`
`interest.
`
`B. Related Matters (37 C.F.R. § 42.8(b)(2))
`The ‘482 Patent is the subject of an infringement lawsuit brought by
`
`LifePort Sciences LLC (“LifePort” or “PO”) against Petitioner in the United States
`
`District Court for the District of Delaware, Case No. 1:12-cv-01791-GMS
`
`(“District Court Case”). The ‘482 Patent was asserted against Endologix on
`
`August 12, 2014, in the Amended Complaint (Dkt. 34) served via the CM/ECF
`
`system after the Court granted LifePort’s Motion to Amend Complaint (Dkt. 33).
`
`See Ex. 1015.
`
`1
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,192,482
`
`C. Lead and Backup Counsel (37 C.F.R. § 42.8(b)(3))
`
`Lead Counsel
`Sanjay K. Murthy
`Reg. No. 45,976
`K&L GATES LLP
`70 W. Madison Street, Suite 3100
`Chicago, IL 60602
`sanjay.murthy@klgates.com
`T: (312) 807-4416
`F: (312) 827-8138
`
`Backup Counsel
`Robert J. Barz
`Pro Hac Vice Authorization
`Requested
`K&L GATES LLP
`70 W. Madison Street, Suite 3100
`Chicago, IL 60602
`robert.barz@klgates.com
`T: (312) 807-4233
`F: (312) 827-1265
`
`Katherine L. Hoffee
`Reg. No. 72,691
`K&L GATES LLP
`70 W. Madison Street, Suite 3100
`Chicago, IL 60602
`katy.hoffee@klgates.com
`T: (312) 807-4325
`F: (312) 345-9987
`
`A power of attorney designating counsel is being filed with this Petition.
`
`Petitioner hereby requests authorization to file a motion under 37 C.F.R. § 42.10(c)
`
`for Back-Up Counsel Robert J. Barz, to appear pro hac vice, as Mr. Barz is an
`
`experienced litigating attorney, and is counsel for Endologix in the pending
`
`District Court Case referred to in Section III.B., and as such has an established
`
`familiarity with the subject matter at issue in this proceeding. Petitioner intends to
`
`file such a motion once authorization is granted.
`
`D.
`
`Service Information (37 C.F.R. § 42.8(b)(4))
`
`Please address all correspondence to the lead counsel at the address shown
`
`2
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,192,482
`
`above. Petitioner also consents to electronic service by email.
`
`IV. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a))
`Petitioner certifies that (1) the ‘482 Patent, issued on June 5, 2012, is
`
`available for inter partes review; (2) under 35 U.S.C. § 315(b), Petitioner is not
`
`barred or estopped from requesting inter partes review of the ‘482 Patent on the
`
`grounds identified herein (see Amneal Pharm., LLC v. Endor Pharm. Inc.,
`
`IPR2014-00360, Paper 15 at 7-10 (PTAB June 27, 2014)); and (3) Petitioner has
`
`not filed a complaint relating to the ‘482 Patent. This Petition is filed in
`
`accordance with 37 C.F.R. § 42.106(a).
`
`V. RELIEF REQUESTED
`Petitioner asks that the Board review the accompanying prior art and
`
`analysis, institute a trial for Inter Partes Review of claims 1-9, 12-13, 21-22, and
`
`30 of the ‘482 Patent, and cancel those claims as invalid under 35 U.S.C. § 102 or
`
`35 U.S.C. § 103.
`
`VI. REASONS FOR THE REQUESTED RELIEF
`A.
`Summary of ‘482 Petition
`Claims 1-9, 12-13, 21-22, and 30 of the ‘482 Patent are anticipated by the
`
`prior art, or at best, cover nothing more than obvious combinations of well known
`
`endoluminal prosthesis designs and/or very well known features of such
`
`endoluminal prostheses. Indeed, the first named inventor testified that the claimed
`
`features added to obtain allowance were merely a matter of “design choice” that
`
`3
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`Petition for Inter Partes Review of U.S. Patent No. 8,192,482
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`required nothing more than “routine engineering.” Ex. 1016 (Goicoechea Dep.) at
`
`144:6-20; see also id. at 139:14-25.
`
`B. Overview of the Prior Art Specifically Cited Below
`1.
`U.S. Patent No. 8,317,854 (“Ryan”)
`U.S. Patent No. 8,317,854 (“Ryan”) (Ex. 1004) was filed on July 19, 1996,
`
`claims priority to June 19, 1994, and issued on November 27, 2012. Ryan is prior
`
`art under 35 U.S.C. § 102(e). Ryan discloses a bifurcated stent with a graft used
`
`for treating aneurysms.
`
`U.S. Patent No. 5,405,377 (“Cragg”)
`
`2.
`U.S. Patent No. 5,405,377 (“Cragg”) (Ex. 1005) was filed on February 21,
`
`1992, and issued on April 11, 1995. Cragg is prior art under 35 U.S.C. § 102(e).
`
`Cragg discloses an intraluminal stent that includes hoops that are connected by
`
`adjacent apices. The stent is compressible and self-expanding.
`
`U.S. Patent No. 5,064,435 (“Porter”)
`
`3.
`U.S. Patent No. 5,064,435 (“Porter”) (Ex. 1006) was filed on June 28, 1990,
`
`and issued on November 12, 1991. Porter is prior art under 35 U.S.C. § 102(b).
`
`Porter discloses a non-helical stent.
`
`U.S. Patent No. 4,994,071 (“MacGregor”)
`
`4.
`U.S. Patent No. 4,994,071 (“MacGregor”) (Ex. 1007) was filed on May 22,
`
`1989, and issued on February 19, 1991. MacGregor is prior art under 35 U.S.C. §
`
`102(b). MacGregor discloses an expandable bifurcated stent that is made of a
`
`4
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`Petition for Inter Partes Review of U.S. Patent No. 8,192,482
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`series of interconnected wire loops.
`
`U.S. Patent No. 5,135,536 (“Hillstead”)
`
`5.
`U.S. Patent No. 5,135,536 (“Hillstead”) (Ex. 1008) was filed on February 5,
`
`1991, and issued on August 4, 1992. Hillstead is prior art under 35 U.S.C. §
`
`102(b). Hillstead discloses a non-helical stent.
`
`U.S. Patent No. 4,733,665 (“Palmaz”)
`
`6.
`U.S. Patent No. 4,733,665 (“Palmaz”) (Ex. 1009) was filed on November 7,
`
`1985, and issued on March 29, 1988. Palmaz is prior art under 35 U.S.C. § 102(b).
`
`Palmaz discloses expandable intraluminal vascular graft that is non-helical in
`
`shape and can be expanded using a balloon.
`
`U.S. Patent No. 5,370,683 (“Fontaine”)
`
`7.
`U.S. Patent No. 5,370,683 (“Fontaine”) (Ex. 1010) was filed on February 4,
`
`1994, claims priority to March 25, 1992, and issued on December 6, 1994.
`
`Fontaine is prior art under 35 U.S.C. § 102(e). Fontaine discloses a vascular stent
`
`for reducing hemodynamic disturbances caused by angioplasty.
`
`U.S. Patent No. 5,707,386 (“Schnepp-Pesch”)
`
`8.
`U.S. Patent No. 5,707,386 (“Schnepp-Pesch”) (Ex. 1011) was a PCT
`
`application filed on January 22, 1994, claims priority to February 4, 1993, and
`
`issued on January 13, 1998. Schnepp-Pesch is prior art under 35 U.S.C. § 102(e).
`
`Schnepp-Pesch discloses a stent that has high flexibility because of successively
`
`arranged hoops in the axial direction which extend over its circumference.
`
`5
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`Petition for Inter Partes Review of U.S. Patent No. 8,192,482
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`U.S. Patent No. 5,421,955 (“Lau”)
`
`9.
`U.S. Patent No. 5,421,955 (“Lau”) (Ex. 1012) was filed on March 17, 1994,
`
`claims priority to October 28, 1991, and issued on June 6, 1995. Lau is prior art
`
`under 35 U.S.C. § 102(e). Lau discloses an expandable stent for implantation in
`
`the body and a method for making such a stent from a single length of wire.
`
`10. U.S. Patent No. 5,234,457 (“Andersen”)
`U.S. Patent No. 5,234,457 (“Andersen”) (Ex. 1013) was filed on October 9,
`
`1991, and issued on August 10, 1993. Andersen is prior art under 35 U.S.C. §
`
`102(b). Andersen discloses a stent assembly, delivery system and method of
`
`manufacture therefor.
`
`C. Background of the Technology and Summary of ‘482 Patent
`The ‘482 Patent describes an endoluminal prosthesis for use in a blood
`
`vessel. ‘482 Patent, 1:14-15; Declaration of Richard A. Hillstead, Ph.D, Ex. 1002,
`
`¶ 22 (hereinafter, “Hillstead Decl.”). For decades before the ‘482 Patent, doctors
`
`had used stents, grafts and prostheses for the treatment of angeological diseases.
`
`Id. A prosthesis is a stent (the wire portion) with a graft (the fabric portion)
`
`covering it. Id. at ¶ 23. A prosthesis is used to provide a prosthetic intraluminal
`
`wall because it allows the blood flow to flow within it. ‘482 Patent, 1:23-25;
`
`Hillstead Decl. ¶ 23. A prosthesis is used to treat an aneurysm by removing the
`
`pressure on a weakened part of an artery, thus reducing the risk of embolism, or of
`
`the natural artery wall bursting. ‘482 Patent, 1:27-29; Hillstead Decl. ¶ 24.
`
`6
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`Petition for Inter Partes Review of U.S. Patent No. 8,192,482
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`1. Well Known Prior Art Prosthesis Designs
`Stents, grafts and prostheses date back to 1980’s. See, e.g., Palmaz;
`
`Hillstead Decl. ¶ 25. By the time of the effective filing date of the ‘482 Patent, a
`
`wide variety of stent designs were well known in the art. The well known stents
`
`were typically tubular and could include extensions, bifurcations, and extensions
`
`for the bifurcations. Hillstead Decl. ¶ 25. The well known tubular structures were
`
`made out of a filament (typically wire) that could take on a variety of patterns to
`
`provide various advantages such as strength, stability, and flexibility. Id.
`
`One way to categorize the well known patterns was to classify a design as
`
`helical or non-helical. Id. at ¶ 26. Both helical and non-helical patterns often took
`
`on a well known zig-zag pattern whereby the wire forming the stent looped around
`
`an axis in a repeating zig-zag pattern to form a cylinder. Id. The ‘482 Patent
`
`explicitly recognized the existence of this well known prior art pattern. ‘482 Patent
`
`at 1:40-59; Hillstead Decl. ¶ 27. The ‘482 Patent also recognized that this prior art
`
`zig-zagging pattern was commonly utilized in prior art helical (e.g., EP-A-
`
`0556850) and non-helical (U.S. Patent No. 4,733,655) stents. Id.
`
`Cragg provides a well known example of a prior art helical design.
`
`
`
`7
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`Petition for Inter Partes Review of U.S. Patent No. 8,192,482
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`Cragg at Fig. 1; Hillstead Decl. ¶ 28. The zig-zaging pattern in Cragg gradually
`
`works its way down the length of the cylinder in helical fashion. Id. The apices of
`
`the zigs and zags are not aligned perpendicular to the longitudinal axis of the stent.
`
`Fontaine also discloses a helical pattern. Id. at ¶ 29. To illustrate, Figure 7 of
`
`Fontaine depicts a partially unwound helical pattern:
`
`Zig-zags are not perpendicular to
`the longitudinal axis; they wind
`to form a helix around the axis
`
`longitudinal axis
`
`Helical Stent
`
`
`
`Fontaine at Fig. 7; Hillstead Decl. ¶ 29.
`
`Non-helical patterns were also very well known at the time. Hillstead Decl.
`
`¶ 30. For example, Hillstead, Palmaz, Ryan, and Schnepp-Pesch all disclose stents
`
`that include non-helical zig-zaging patterns that make a series of loops around the
`
`longitudinal axis, where each loop is in a plane perpendicular to the axis:
`
`8
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`Petition for Inter Partes Review of U.S. Patent No. 8,192,482
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`Well Known Prior Art Non-Helical Stent Designs
`
`Zig-zags/Hoops are perpendicular to the longitudinal
`axis; they do not form a helix around the axis
`
`longitudinal axis
`
`Palmaz
`
`longitudinal axis
`
`Ryan
`
`longitudinal axis
`
`Hillstead
`
`longitudinal axis
`
`Schnepp-Pesch
`
`9
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`Petition for Inter Partes Review of U.S. Patent No. 8,192,482
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`Hillstead at Fig. 2; Palmaz at Fig. 1A; Schnepp-Pesch at Fig.2; Ryan at Fig. 2;
`
`Hillstead Decl. ¶ 30. The ‘482 Patent attempts to claim this well known non-
`
`helical stent design. The background of the specification of the ‘482 Patent
`
`acknowledges both helical and non-helical designs, but the summary of the
`
`invention only focuses on differentiating the alleged invention of the ‘482 Patent
`
`from the well known helical designs without giving credence to the cited non-
`
`helical designs (e.g., Palmaz). Compare ‘482 Patent at 1:48-59 with ‘482 Patent at
`
`3:62-4:7; see also Hillstead Decl. ¶ 31. Specifically, it states: “the wire may be of
`
`an entirely novel configuration, namely one in which the wire forms a plurality of
`
`hoops such that the plane of the circumference of each hoop is substantially
`
`perpendicular to the longitudinal axis of the stent.” ‘482 Patent at 3:63-67.
`
`Like the four prior art examples above,
`the zig-zags/hoops of the ‘482 Patent are
`perpendicular to the longitudinal axis;
`they do not form a helix around the axis
`
`longitudinal axis
`
`‘482 Patent Non-Helical Stent
`
`
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`Petition for Inter Partes Review of U.S. Patent No. 8,192,482
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`This configuration, however, was not novel. As shown above, it was common and
`
`well known in the prior art. Hillstead at Fig. 2; Palmaz at Fig. 1A; Schnepp-Pesch
`
`at Fig.2; Ryan at Fig. 2; Hillstead Decl. ¶ 32. Even assuming, arguendo, that the
`
`design was novel, it still does not qualify as a patentable invention. The prior art
`
`was rife with examples of hoop designs for stents and the inventor himself
`
`characterized the allegedly novel feature as “design choice” and “routine
`
`engineering.” Ex. 1016 (“Goicoechea Dep.”) at 144:6-20.
`
`2.
`
`The Patent Owner Only Overcame Previous Rejections By
`Arguing That The Disclosed Non-Helical Design Was Novel
`
`When the application that became the ‘482 Patent was examined, the PO
`
`argued that the novelty of the alleged invention was its non-helical design. See,
`
`e.g., Ex. 1014, File History at 1247. The PO differentiated the claims of the ‘482
`
`Patent from that relied upon prior art by arguing that they are limited to non-helical
`
`stents. See, e.g., id. (“[claim 1] has been amended to recite, in part, ‘each of said
`
`hoops being non-helical.’ In Cragg and in Fontaine, each of the hoops is not non-
`
`helical.”). The Patent Board recognized PO’s argument that the “non-helical”
`
`configuration was an alleged “novel configuration. Id. at 1933.
`
`Yet, as shown in the well known prior art examples above, and as explained
`
`in detail in the specific challenges below, there was nothing novel about the
`
`claimed “non-helical” hoop stent of the ‘482 Patent. Hillstead Decl. ¶ 33.
`
`Accordingly, the challenges herein establish that at least claims 1-9, 12-13, 21-22,
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`11
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`Petition for Inter Partes Review of U.S. Patent No. 8,192,482
`
`and 30 are unpatentable.
`
`3.
`
`Elements from Helical and Non-Helical Stents Were Known
`To be Interchangeable
`
`The ‘482 Patent specification describes both helical and non-helical
`
`embodiments. ‘482 Patent at 3:62-4:7. Importantly, the ‘482 Patent and the prior
`
`art make clear that well known elements disclosed as part of helical stents could be
`
`simply substituted into non-helical stents. Hillstead Decl. ¶ 33; see also Ex. 1016
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`(“Goicoechea Dep.”) at 144:6-20; see also Ex. 1014, File History at 1693.
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`For example, as shown above, both helical and non-helical prior art stents
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`could have zig-zag patterns whereby adjacent apices abut.
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`Helical Prior Art (Cragg)
`Apices abut and are
`connected/secured
`
`Non- Helical Prior Art (Ryan)
`Apices abut and are
`connected/secured
`
`
`
`Cragg at Fig. 1; Ryan at Fig. 2; Hillstead Decl. ¶ 34. These patterns were well
`
`known in the prior art and, as discussed below, various means for securing abutting
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`apices was also well known in the prior art. Hillstead Decl. ¶¶ 34, 46. Further, it
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`was well known that those securing means were interchangeable not only with one
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`Petition for Inter Partes Review of U.S. Patent No. 8,192,482
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`another, but between helical and non-helical designs. Id. at ¶ 35. Specifically, one
`
`of skill in the art would have been capable of implementing the securing means
`
`from the non-helical design of Cragg into the helical design of Ryan because it
`
`would have been nothing more than a simple substitution of one well known
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`securing means for another well known securing means that would have achieved a
`
`predictable result. Id.
`
`In sum, at the time of the alleged invention of the ‘482 Patent there was
`
`nothing novel about using a helical design, nothing novel about using a non-helical
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`design, and nothing novel about implementing well known prior art elements into
`
`either helical or non-helical designs. Id. at ¶ 36.
`
`4. Well Known, Interchangeable Prior Art Securing Means
`In addition to claiming a non-helical stent design, the ‘482 Patent claims
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`“means for securing an apex of one hoop to an abutting a juxtaposed apex of a
`
`neighboring hoop.” This too was a well known prior art feature of both helical and
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`non-helical stent designs. Id. at ¶ 37.
`
`As briefly described above, it was well known to align the apices of one
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`layer of zig-zags with the apices of an adjacent layer of zig-zags in both helical and
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`non-helical designs. Id. at ¶ 38. It was common to align apices in order to secure
`
`the layers together at the apices where the securing means would be most effective.
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`This practice was well known as early as the 1980s by virtue of, at least, Palmaz.
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`Petition for Inter Partes Review of U.S. Patent No. 8,192,482
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`Palmaz at 6:36-52. Because this practice was so common well before the ‘482
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`Patent, a variety of well known means for securing apices had been established
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`prior to the filing date of the ‘482 Patent. Hillstead Decl. ¶ 39. The various
`
`securing means all shared a common function: to secure an apex of one hoop to an
`
`abutting juxtaposed apex of a neighboring hoop. Id.
`
`The ‘482 Patent recognized that such means for securing were well known
`
`prior art elements at the time of the alleged invention and did not characterize them
`
`as new or novel. Id. at ¶ 40. Specifically, the ‘482 Patent states: “Typically, the
`
`stents of this invention whether of the helical or perpendicular variety, also
`
`comprise a securing means for securing an apex of the sinuous wire in one hoop to
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`a juxtaposed apex of a neighboring hoop so that each hoop is supported by its
`
`neighbors.” ‘482 Patent at 4:21-25.
`
`The following prior art examples not only disclose several of the well known
`
`prior art structures for securing apices, they also recognize the interchangeability
`
`of such structures. Hillstead Decl. ¶ 41.
`
`Palmaz discloses use of “welding, soldering, or gluing” or any other
`
`“conventional manner” for securing apices in order to provide “a relatively high
`
`resistance to radial collapse” and to allow the stent to retain its shape. Palmaz at
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`6:36-49; Hillstead Decl. ¶ 42.
`
`Fontaine discloses using a loop or a staple-like bracket to secure apices in
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`Petition for Inter Partes Review of U.S. Patent No. 8,192,482
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`addition to brazing, welding or gluing: “In practice, the connection between the
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`loop and the filament is slidable along the filament 11, thereby allowing for radial
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`expansion. Although this connection can be easily made using a loop as shown, it
`
`can also be made by, for example, using a bracket. The connector could also be
`
`made by brazing, welding, or gluing the end to the filament.” Fontaine at 4:59-63;
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`Hillstead Decl. ¶ 43.
`
`Cragg discloses using “loops which connect adjacent apices of the wire.”
`
`Cragg at Abstract; Hillstead Decl. ¶ 44. Cragg further discloses “loop members 12
`
`which connect adjacent apices of adjacent helix hoops to help define the tubular
`
`stent. The loop members 12 may connect all or some of the pairs of adjacent
`
`apices.” Cragg at 2:42-47; Hillstead Decl. ¶ 44. This disclosure is further depicted
`
`in the figures of Cragg.
`
`
`
`
`
`
`
`Cragg at Figs. 2-4; Hillstead Decl. ¶ 44.
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`Lau discloses that the apices may be secured integrally or by independent
`
`means: “The interconnecting elements may be formed in a unitary structure with
`
`the expandable cylindrical elements from the same intermediate product, such as a
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`Petition for Inter Partes Review of U.S. Patent No. 8,192,482
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`tubular element, or they may be formed independently and connected by suitable
`
`means, such as by welding or by mechanically securing the ends of the
`
`interconnecting elements to the ends of the expandable cylindrical elements.” Lau
`
`at 2:59-66; Hillstead Decl. ¶ 45.
`
`Andersen discloses that “an improved stent structure that is formed of a self-
`
`expending filament material in loosely interlocked loops.” Andersen at 3:16-18.
`
`Summary of the Prosecution of the ‘482 Patent
`
`D.
`The application that issued as the ‘482 Patent, U.S. Application No.
`
`09/977,826, filed October 15, 2001, is a continuation of U.S. Application No.
`
`09/313,593, now U.S. Patent No. 6,302,906 (“‘906 Patent”), filed May 18, 1999,
`
`which is a continuation of U.S. Application No. 08/662,484, now U.S. Patent No.
`
`5,916,263, filed June 13, 1995, which is a continuation of U.S. Application No.
`
`08/317,763, now U.S. Patent No. 5,609,627, filed Oct. 4, 1994, which is a
`
`continuation of U.S. Application No. 08/312,881, now abandoned, filed Sept. 27,
`
`1994. The examiner did not use Ryan, Hillstead or any other combinations offered
`
`herein as the basis for any rejection. See Ex. 1014, File History.
`
`E.
`
`The ‘482 Patent Cannot Claim Priority to EP 94400284 or EP
`94401306
`
`The ‘482 Patent is a continuation of the ‘906 Patent, which is a continuation
`
`of U.S. Application No. 08/662,484, now U.S. Patent No. 5,916,263, (“‘484
`
`Application”), which is a continuation of U.S. Application No. 08/317,763, now
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`Petition for Inter Partes Review of U.S. Patent No. 8,192,482
`
`U.S. Patent No. 5,609,627 (“‘763 Application”). Another division of the ‘763
`
`Application, U.S. Application No. 08/461,402 (the “‘402 Application,” or
`
`“Goicoechea”), was the subject of an interference before the BPAI, No. 104,192
`
`(“‘192 Interference”). Based on this interference and subsequent district court and
`
`Federal Circuit litigation, it is conclusive that the ‘482 Patent cannot claim priority
`
`to EP 94400284 (“EP ‘284”) or EP 94401306 (“EP ‘306”).
`
`The ‘192 Interference was declared on April 23, 1998, among Goicoechea
`
`and (1) U.S. Application No. 08/463,836 (“the Ryan Patent”), and (2) U.S. Patent
`
`No. 5,575,817 to Eric Martin (“the Martin Patent”).1 In the course of the ‘192
`
`Interference, the BPAI found that the Goicoechea ‘402 Application was not
`
`entitled to claim priority to the MinTec EPO Applications under 35 U.S.C. § 119.
`
`The BPAI determined that because two of the inventors on the Goicoechea ‘402
`
`Application, Michael Dake and Andrew Cragg, did not assign their rights to
`
`MinTec SARL until after the filing of the MinTec EPO Applications, the MinTec
`
`EPO Applications were not filed on Dake’s or Cragg’s behalf as required by 35
`
`U.S.C. § 119, and thus the Goicoechea ‘402 Application could not claim priority to
`
`the MinTec EPO Applications. Ex. 1017, BPAI Decision, April 7, 2000, at 6.
`
`1 Because of corrections of inventorship, Goicoechea is often referred to in the
`
`‘192 Interference as “Cragg,” and Ryan is referred to as “Fogarty.” The Ryan
`
`‘836 application ultimately issued as U.S. Patent No. 8,206,427.
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`Petition for Inter Partes Review of U.S. Patent No. 8,192,482
`
`This determination was affirmed by the United States District Court for the District
`
`of Columbia and the Federal Circuit. Exs. 1018, 1019. Accordingly, all patents in
`
`the Goicoechea patent family that list Dake or Cragg as an inventor cannot claim
`
`priority to the EP applications.
`
`F. Related ‘167 Patent IPR and Institution Decision
`On August 18, 2014, W.L. Gore & Associates, Inc., filed a petition for Inter
`
`Partes Review of U.S. Patent No. 6,117,167 (“‘167 Patent”). The ‘167 Patent
`
`claims priority back to the same application at the ‘482 Patent, U.S. Application
`
`No. 08/312,881, now abandoned, filed Sept. 27, 1994. On February 23, 2015, the
`
`Patent Trial and Appeal Board (“PTAB”) instituted the inter partes review on
`
`claims 1-82 (i.e. all the claims). That proceeding included instituted grounds for
`
`claims similar to the claims of the ‘482 Patent. Compare claim 1 of the ‘482
`
`Patent with claims 35-37 of the ‘167 Patent (Ex. 1020) and IPR2014-01319, Paper
`
`No. 7, Institution Decision at 16 (PTAB Feb. 23, 2015) (Ex. 1021).
`
`VII. PERSON OF ORDINARY SKILL IN THE ART
`A person of ordinary skill in the art is a hypothetical person presumed to
`
`know the relevant prior art. Gnosis S.p.A. v. South Alabama Med. Sci. Found.,
`
`IPR2013-00116, Final Written Decision (Paper 68) at 9. Such a person is of
`
`ordinary creativity, not merely an automaton, and is capable of combining
`
`teachings of the prior art. Id. (citing KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
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`Petition for Inter Partes Review of U.S. Patent No. 8,192,482
`
`420-21 (2007).) Petitioner submits that a person of ordinary skill in the art of the
`
`‘482 Patent as of September 27, 1994, would have had a bachelor of science
`
`degree in mechanical engineering, or the equivalent, or would have had at least
`
`five years of experience in designing stents. Hillstead Decl. ¶¶ 1-20.
`
`VIII. CLAIM CONSTRUCTION
`In the pending district court litigation, the parties agreed to constructions for
`
`some terms in the ‘482 Patent. Normally, a claim in inter partes review is given
`
`the “broadest reasonable construction in light of the specification.” See 37 C.F.R §
`
`42.100(b). However, the ‘482 Patent expired on Sep