UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NUVASIVE, INC.
`Petitioner
`
`WARSAW ORTHOPEDIC, INC.
`Patent Owner
`
`Patent Number: 8,251,997 B2
`Issue Date: August 28, 2012
`Title: METHOD FOR INSERTING AN ARTIFICIAL
`
`IMPLANT BETWEEN TWO ADJACENT VERTEBRAE
`
`ALONG A CORONAL PLANE
`
`Case IPR2013—00208
`
`WARSAW’S PRELIMINARY RESPONSE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NUVASIVE, INC.
`Petitioner
`
`WARSAW ORTHOPEDIC, INC.
`Patent Owner
`
`Patent Number: 8,251,997 B2
`Issue Date: August 28, 2012
`Title: METHOD FOR INSERTING AN ARTIFICIAL
`
`IMPLANT BETWEEN TWO ADJACENT VERTEBRAE
`
`ALONG A CORONAL PLANE
`
`Case IPR2013—00208
`
`WARSAW’S PRELIMINARY RESPONSE
`
`
`
`TABLE OF CONTENTS
`
`I.
`
`INTRODUCTION ........................................................................................... 1
`
`II.
`
`BACKGROUND ............................................................................................. 5
`
`A.
`
`B.
`
`C.
`
`The ’997 Patent Applications ............................................................... 5
`
`Summary of the ’997 Patent Inventions ............................................... 6
`
`Conception and Reduction to Practice of the ’997 Patent
`Inventions .............................................................................................. 8
`
`III.
`
`STANDARD FOR GRANTING INTER PARTES REVIEW ...................... 12
`
`IV.
`
`THE BOARD SHOULD REJECT NUVASIVE’S INAPPROPRIATE
`
`35 U.S.C. §112 WRITTEN DESCRIPTION CHALLENGE
`CHARACTERIZED As A REJECTION UNDER 35 U.S.C. § 103(a)
`PREMISED ON A PRIORITY DISPUTE ................................................... 13
`
`V.
`
`THE PRIOR ART CITED BY NUVASIVE FAILS TO DISCLOSE
`
`INSERTION OF THE CLAIMED LATERAL IMPLANT ......................... 20
`
`A.
`
`The Parties Previously Litigated the Disclosures of Brantigan
`’327 and Michelson ’247 .................................................................... 22
`
`l.
`
`2.
`
`The District Court held by a preponderance of the
`evidence that NuVasive’s key implant art does not
`disclose a lateral implant. ......................................................... 25
`
`The District Court heard extensive testimony that
`NuVasive’s key implant art does not disclose a lateral
`implant. ..................................................................................... 27
`
`B.
`
`Brantigan ’327 Discloses an Anterior Implant that Cannot Meet
`the Implant Limitations of the ”997 Patent. ........................................ 30
`
`l.
`
`2.
`
`NuVasive is collaterally estopped from relitigating the
`disclosures of Brantigan ”327 before the Board....................... 31
`
`Brantigan ’327 expressly teaches away from the implant
`claimed in the ’997 patent. ....................................................... 35
`
`
`
`C. Michelson ’247 Discloses a Posterior Implant that Cannot Meet
`the Implant Limitations of the ’997 Patent. ........................................ 42
`
`VI.
`
`THE REMAINING IMPLANT REFERENCES CITED IN
`
`GROUNDS 5—9 ARE NOT PRIOR ART. ................................................... 47
`
`VII.
`
`THE MCAFEE DECLARATION IS ENTITLED TO LITTLE TO
`
`NO WEIGHT ................................................................................................ 50
`
`VIII.
`
`THE CROCK DECLARATION SHOULD BE DISREGARDED IN
`
`ITS ENTIRETY ............................................................................................ 52
`
`IX.
`
`CONCLUSION ............................................................................................. 54
`
`ii
`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`
`Comair Rotron, Inc. v. Nippon Densan Corp,
`49 F.3d 1535 (Fed. Cir. 1995) .............................................................................. 32
`
`Dayco Procter, Inc. v. Total Containment, Inc,
`329 F.3d 1358 (Fed. Cir. 2003) ............................................................................ 53
`
`Graybill v. US. Postal Serv.,
`782 F.2d 1567 (Fed. Cir. 1986) ............................................................................ 31
`
`In re Baxter Travenol Labs.,
`952 F.2d 388 (Fed. Cir. 1991) .............................................................................. 53
`
`In re Fritch,
`972 F.2d 1260 (Fed. Cir. 1992) ............................................................................ 47
`
`In re NTP, Inc,
`654 F.3d 1268 (Fed. Cir. 2011) ...................................................................... 15, 16
`
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc,
`688 F.3d 1342 (Fed. Cir 2012) ............................................................................. 13
`
`Therasense, Inc. v. Becton, Dickinson & Co.,
`649 F.3d 1276 (Fed. Cir. 2011) ................................................................ 26, 33, 35
`
`Statutes
`
`35 U.S.C. § 102 ....................................................................................... 4, 48, 49, 53
`
`35 U.S.C. § 103 ....................................................................................................... 13
`
`35 U.S.C. § 112 ................................................................................................. 15,19
`
`35 U.S.C. § 120 ....................................................................................................... 14
`
`35 U.S.C. § 311 ................................................................................................ passim
`
`35 U.S.C. § 314 ....................................................................................................... 12
`
`35 U.S.C. § 316 ................................................................................................... 3,12
`
`iii
`
`
`
`Other Authorities
`
`Manual ofPatent Examining Procedure § 2259 ..................................................... 31
`
`Office Patent Trial Practice Guide,
`77 Fed. Reg. 48,756 (Aug. 14, 2012) ........ 7 .................................................... 12, 13
`
`Regulations
`
`37 C.F.R. § 42.1 ....................................................................................................... 33
`
`37 C.F.R. § 42100 ................................................... 33
`
`37 C.F.R. § 42.104 ............................................................................................ passim
`
`37 C.F.R. § 42.108 ................................................................................................... 12
`
`37 C.F.R. § 42.51 ........................................................................................... 3, 22, 30
`
`37 C.F.R. § 42.53 ..................................................................................................... 52
`
`iV
`
`
`
`EXHIBITS
`
`WARSAW2001
`
`Excerpts from Deposition of Dr. Michelson, dated
`November 19, 2010
`
`WARSAWZOOZ
`
`Letter to Dr. Michelson from J. Pafford, dated March 28,
`
`1994.
`
`WARSAW2003
`
`Memorandum from Larry Boyd re: Michelson Devices —
`Interbody Fusion Devices, dated January 26, 1994
`
`WARSAW2004
`
`Dezider Imre Invoice, dated December 26, 1993
`
`WARSAW2005
`
`Memorandum from Larry Boyd re: Meeting with Dr. Gary
`Karlin Michelson, dated January 11, 1994
`
`WARSAW2006
`
`Memorandum from Larry Boyd re: Notes on Threaded
`Dowel Concepts of Dr. Michelson, dated January 11, 1994
`
`WARSAW2007
`
`Letter to Dr. Michelson from L. Boyd, dated January 13,
`1994
`
`WARSAW2008
`
`Excerpts from Trial Testimony - Warsaw Orthopedic, Inc.
`v. Nu Vasive, Inc, Case No. O8—CV«1512 MMA (MDD)
`
`WARSAW2009
`
`License Agreement between Sofamor Danek Group, Inc.
`and Karlin Technology, Inc, dated December 31, 1993
`
`WARSAW2010
`
`US. Patent No. 5,860,973
`
`WARSAW201 1
`
`WARSAWZO 12
`
`Memorandum of Decision Following Bench Trial on
`Inequitable Conduct, Warsaw Orthopedic, Inc. v.
`Nu Vasive, Inc, Case No. 08—CV-1512 MMA (MDD), dated
`
`February 14, 2012
`
`Excerpts from NuVasive’s Reply in Support of Its
`Renewed Motion for Judgment as a Matter of Law or A
`New Trial, Warsaw Orthopedic, Inc. v. Nu Vasive, Inc,
`Case No. 08—CV— 1 5 12 MMA (MDD), dated December 23,
`201 1
`
`
`
`WARSAW20 1 3
`
`WARSAW2014
`
`WARSAW20 1 5
`
`Excerpts from NuVasive's Memorandum of Points and
`Authorities in Support of Its Renewed Motion for Judgment
`as a Matter of Law or a New Trial, Warsaw Orthopedic,
`Inc. v. Nu Vasive, Inc, Case No. 08-CV—1512 MMA
`(MDD), dated October 27, 2011
`
`Excerpts from NuVasive's Closing Argument Regarding
`Inequitable Conduct Committed During the Prosecution of
`the ’973 Patent, Warsaw Orthopedic, Inc. v. Nu Vasive, Inc,
`Case No. 08—CV—1512 MMA (MDD), dated December 23,
`2011
`
`Excerpts from NuVasive's Proposed Findings of Fact and
`Conclusions of Law Regarding the Unenforceability of
`US. Patent No. 5,860,973 for Inequitable Conduct,
`Warsaw Orthopedic, Inc. v. Nu Vasive, Inc, Case No. 08-
`CV-1512 MMA (MDD), dated December 23, 2011
`
`WARSAW201 6
`
`Letter to R. Jansen from P. McAfee, M.D., dated January
`
`16, 1995
`
`WARSAW20 1 7
`
`Excerpts from Deposition of Dr. Bruce E. Van Dam, dated
`January 27, 2011
`
`WARSAW201 8
`
`Baulot, et a1., "Complementary Anterior Spondylodesis by
`Thoracoscopy - Technica1 Note Regarding an
`Observation,” Lyon Surg. 901347—51, November 28, 1994
`
`WARSAW2019
`
`Rosenthal, et a1., "Removal of a Protruded Thoracic Disc
`Using Microsurgica1 Endoscopy,” May 2004
`
`Vi
`
`
`
`I.
`
`INTRODUCTION
`
`NuVasive has filed two petitions for inter partes review of Warsaw’s US.
`
`Patent No. 8,251,997 (the “’997 patent”). The first petition (Case lPR2013—208)
`
`seeks inter partes review of claims 1—8 while the second petition (Case lPR2013-
`
`206) seeks inter partes review of claims 9—30. Patent Owner Warsaw Orthopedic,
`
`Inc. (“Warsaw”) submits that the petitions should be rejected.
`
`Neither petition asserts the claims of the ’997 patent are anticipated by the
`
`prior art. Instead, NuVasive pieces together several multiple-reference
`
`obviousness combinations to argue the ’997 patent is invalid. To prevail on its
`
`petitions NuVasive must show the prior art discloses (i) direct lateral access to an
`
`interbody space, followed by (ii) sequential dilation and (iii) the insertion of an
`
`implant with specific structural limitations. Although NuVasive’s petitions are
`
`deficient on several grounds, this preliminary response focuses on one fundamental
`
`and critical deficiency: NuVasive fails to cite a single prior art reference that
`
`discloses the lateral insertion of an implant with the claimed structural limitations.1
`
`NuVasive’s failure to do so is dispositive and the Board’s review should stop here.
`
`First, NuVasive fails to show that there is a reasonable likelihood of it
`
`prevailing on any challenged claim: NuVasive cannot prove unpatentability by a
`
`1 Every prior art reference NuVasive cites for the alleged disclosure of a lateral
`
`implant was before the examiner during the prosecution of the ’997 patent.
`
`
`
`preponderance of the evidence. Notably, this is not the first time NuVasive has
`
`argued that its key implant references cited in Grounds 14, US. Patent No.
`
`5,192,327 to Brantigan (“Brantigan ’327”) and US. Patent No. 5,015,247 to
`
`Michelson (“Michelson ”247”), disclose a direct lateral implant with the claimed
`
`dimensions. NuVasive argued identical interpretations of these references in jury
`
`and bench trials in a prior lawsuit filed by Warsaw for NuVasive’s infringement of
`
`a related patent having apparatus claims covering the implant, US. Patent No.
`
`5,860,973 (the “”973 patent”), in the United States District Court for the Southern
`
`District of California. There, NuVasive raised the same issues regarding the same
`
`art—whether Brantigan ’327 and Michelson ’247 disclose a lateral spinal implant
`
`with the claimed dimensions. And NuVasive lost that battle on two fronts—both
`
`before the judge in an inequitable conduct proceeding, as well as a jury.
`
`In those two trials, both the judge (sitting as the finder of fact in the
`
`inequitable conduct proceedings and applying the preponderance of the evidence
`
`standard) and a jury rejected NuVasive’s interpretations and found that Brantigan
`
`’327 and Michelson ’247 do not disclose a direct lateral implant. Despite these
`
`prior judgments, NuVasive asserts in its petitions that “there can be no dispute that
`
`Brantigan discloses inserting an implant using a lateral approach.” Petition at 20.
`
`But not only did the District Court and jury “dispute” NuVasive’s interpretation,
`
`they flatly rejected it. Indeed, Dr. Brantigan himself testified during the jury trial
`
`
`
`regarding his patent, and his testimony flatly contradicts NuVasive’s interpretation
`
`of his patent. The jury verdict, District Court’s findings of fact, and testimony in
`
`the two trials regarding the disclosures of Brantigan ’327 and Michelson ’247 are
`
`“relevant information that is inconsistent” with NuVasive’s positions.
`
`In violation of 37 C.F.R. § 42.51(b)(iii), which provides that “a party must
`
`serve relevant information that is inconsistent with a position advanced by the
`
`party during the proceeding concurrent with the filing of the documents or things
`
`that contains the inconsistency,” NuVasive chose, however, to withhold this
`
`information from the Board. And while these findings are not necessarily
`
`dispositive to the entire Petition, they most certainly are relevant. Indeed, and at a
`
`minimum, the doctrine of collateral estoppel precludes NuVasive from re—litigating
`
`identical questions of fact that have been resolved by a finder of fact under the
`
`same burden of proof that applies to NuVasive’s unpatentability challenge. See 35
`
`U.S.C. § 316(e). Accordingly, the Board should decline to institute review of the
`
`’997 patent based upon Grounds 1~—4.
`
`Second, the remaining references that NuVasive cites in Grounds 5~9 for
`
`disclosure of the claimed implant—Baulot (1994), Rosenthal (1994), Michelson
`
`PCT (1994), Michelson ’661 (1995), and Lynn (20l3}—are not prior art to the
`
`invention of the ’997 patent. With respect to Baulot and Rosenthal, while
`
`NuVasive feigns in its petitions to not know whether these references are prior art
`
`
`
`under 35 U.S.C. § 102(a) or (b) because “they were published in 1994,” NuVasive
`
`produced a certified translation of Baulot in the parties’ prior litigation—notably
`
`one that is different from the translation NuVasive submitted in connection with its
`
`petitions—that identifies the publication date as November 1994. Petition at 3.
`
`Similarly, Rosenthal was not published until May 1994. As discussed below, the
`
`”997 patent is entitled to the February 27, 1995 filing date of US. Patent No.
`
`5,772,661 (“Michelson ’661”), with which it shares the identical specification as
`
`filed. Moreover, based upon documentary evidence, as well as testimony from the
`
`parties’ prior trials, none of which NuVasive contradicted during the prior
`
`litigation, Dr. Michelson can establish an invention date for the ’997 patent of no
`
`later than December 1993. Accordingly, these references cannot be prior art under
`
`35 U.S.C. § 102(a) or (b), and the Board should reject Grounds 5-9.
`
`Finally, Ground 9 of NuVasive’s petition is characterized as a rejection
`
`under section 103, but should be rejected as an impermissible section 112 written
`
`description challenge. See ‘35 U.S.C. § 311(b); 37 CPR. § 42.104(b)(2). This
`
`maneuver amounts to an effort on the part of NuVasive to backfill a gaping hole in
`
`its prior art citations: none disclose the length limitations of the claimed implant.
`
`As such, NuVasive attempts to eliminate those limitations by arguing that the ’997
`
`patent claims are not supported by the Michelson ’661 specification, are not
`
`entitled to the filing date of Michelson ’661 , and, therefore, are invalid because of
`
`
`
`alleged intervening art, including the Michelson ’661. But the ’997 patent is a
`
`continuation of the Michelson ’661 patent, and the two share the identical as—filed
`
`specification. Thus, what NuVasive casts as a rejection under 103 predicated on a
`
`priority dispute is, in fact, a section 112 challenge. But this is not the proper forum
`
`for NuVasive’s section 112 written description challenge. And NuVasive’s
`
`attempt to avoid claim limitations for which it has no prior art by circumventing
`
`Congress“ limitation of inter partes review to section 102 and 103 challenges
`
`should be rejected. See 35 U.S.C. § 311(1)); 37 C.F.R. § 42.104(b)(2).
`
`II.
`
`BACKGROUND
`
`A.
`
`The ’997 Patent Applications
`
`The ’997 patent, entitled, “Method For Inserting An Artificial Implant
`
`Between Two Adjacent Vertebrae Along A Coronal Plane,” issued to Dr. Gary K.
`
`Michelson on August 28, 2012 from US. Application No. 13/306,583 (the “’583
`
`application”), filed on November 29, 2011. The application that issued as the ’997
`
`patent was filed as a continuation of US. Application No. 10/371,757, filed on
`
`February 21, 2003, entitled, “Instrumentation For The Endoscopic Correction Of
`
`Spinal Disease” (now US. Patent No. 8,066,705) and US. Application No.
`
`08/480,461 , filed on June 7, 1995, entitled, “Instrumentation For The Surgical
`
`Correction Of Human Thoracic And Lumbar Spinal Disease From The Lateral
`
`Aspect Of The Spine” (now US. Patent No. 7,491,205), which is a divisional of
`
`
`
`Michelson ’661. Furthermore, the application that issued as the ’661 patent was
`
`filed on February 27, 1995 as US. Patent Application No. 08/394,836 (the “’836
`
`application”) and entitled, “Methods And Instrumentation For The Surgical
`
`Correction Of Human Thoracic And Lumbar Spinal Disease From The Antero—
`
`Lateral Aspect Of The Spine.” The ’836 parent application ultimately issued as the
`
`Michelson ’661 patent on June 30, 1998. The as—filed specifications of the ”997
`
`patent and Michelson ’661 patent are, therefore, identical.
`
`Accordingly, and certainly for purposes of these proceedings, the claims of
`
`the ’997 patent are adequately supported by the disclosures of the ’836 parent
`
`application, which has the same specification, and the claims are entitled to an
`
`effective filing date of February 27, 1995.
`
`B.
`
`Summary of the ’997 Patent Inventions
`
`The ’997 patent is directed to methods, instrumentation, and implants for
`
`performing surgery on the spine along its lateral aspect (side) and generally by a
`
`lateral surgical approach, such that the instruments and implants enter the body
`
`from an approach that is other than anterior or posterior and make contact with the
`
`spine along its lateral aspect. NUVASIVE1002 at 3:34—39. These novel methods
`
`for interbody fusion provide for optimal fill of the intervertebral space without
`
`endangering the associated structures and allow for the optimal area of contact
`
`between the implant and the adjacent vertebrae to be fused. Id. at 3: l 8—30. For
`
`
`
`example, the size and structure of the prior art implants are limited by the dural sac
`
`posteriorly and the delicate vital structures anteriorly. Id. at 3:23——26. By contrast,
`
`the claimed methods provide for the insertion of a novel implant of the maximum
`
`possible length across the transverse width of the vertebrae. Id. at ll:3*8. Thus,
`
`as the ’997 patent describes, the implant of the ’997 invention inserted laterally
`
`provides for greater surface area of contact, the largest volume of fusion promoting
`
`material, and the greatest mechanical engagement and thus stability, and is
`
`therefore an improvement upon other methods of implant insertion in facilitating a
`
`successful fusion. Id. at 21 :33—38.
`
`All independent claims of the ’997 patent recite a direct lateral surgical path
`
`to the spine (i.e., a “path having an axis lying in a coronal plane”). 1d. at 22:60—61,
`
`2416—7, 25:31—32, 26:56—57. This surgical path is created by a very specific
`
`process involving three surgical instruments with particular features. For example,
`
`independent claims 9, l7, and 24 all recite a third surgical instrument with at least
`
`one-——and in some claims three—elongated portion at the instrument’s distal end.
`
`Once the surgical path is created, the claims recite the step of inserting an implant
`
`with specific structural limitations into the disc space. This implant must have a
`
`length—from insertion end to trailing end-that is (i) sized to occupy the full or
`
`substantially the full transverse width of adjacent vertebral bodies, (ii) greater than
`
`the depth of the disc space, and (iii) greater than the maximum height of the
`
`
`
`implant. Id. at 23:24—39, 24:49—64, 26:8—24, 28:6-«20. This implant must also
`
`have opposed surfaces with bone engaging projections that are oriented toward
`
`each of the vertebral bodies of the two adjacent vertebrae.
`
`In sum, the claimed methods of the ’997 patent require a precise direct
`
`lateral surgical path, created by specific surgical instruments, through which a
`
`specific lateral implant is inserted. For example, Figure 30 describes an implant
`
`with the claimed length requirements:
`
`
`
`C.
`
`Conception and Reduction to Practice of the ’997 Patent
`Inventions
`
`Dr. Michelson conceived and reduced to practice the invention of the ’997
`
`patent no later than December 26, 1993. Dr. Michelson provided extensive
`
`testimony in the prior litigation on his conception and reduction to practice of his
`
`lateral method and implant, and several documents corroborate this testimony,
`
`none of which was contradicted by NuVasive.
`
`8
`
`
`
`Dr. Michelson testified that he conceived and reduced to practice the ’997
`
`patent’s methods in November or December 1993. WARSAW2001 at 50:23—5 l :9.
`
`In this time frame, Dr. Michelson attended several meetings with Sofamor Danek,
`
`Inc. (“Danek”)2, including NuVasive’s current Chairman of the Board and Chief
`
`Executive Officer, Alex Lukianov, formerly an executive of Danek, to discuss and
`
`negotiate a transaction for various intellectual property assets related to spinal
`
`implants and surgical methods. See WARSAW2002. While at Danek, Mr.
`
`Lukianov was one of the executives responsible for acquiring and developing the
`
`Michelson lateral technology. WARSAW2003 at 1. In December of 1993, Dr.
`
`Michelson demonstrated his translateral spinal implant and instrumentation
`
`technology to Mr. Lukianov and other Danek executives. WARSAWZOOl at
`
`50:23~—51:9, 54z3~l 1, 61:21-62:18. Dr. Michelson testified as follows: “I actually
`
`used the instruments, inserted one of these translateral implants .
`
`.
`
`. [a]nd1
`
`remember that I did it with the second iteration of instruments.” Id. These
`
`instruments were manufactured at Dr. Michelson’s request by his machinist,
`
`Dezider Imre, and are detailed in a December 26, 1993 invoice from Mr. Imre. Id.
`
`at 65: 12—6628. This invoice shows an implant with a 42 mm length and a 24 mm
`
`diameter, an implant driver with a 24 mm diameter, an outer sleeve with a 24 mm
`
`diameter, an inner sleeve with a 21 mm diameter, a distractor with a 24 mm
`
`2 Danek is an affiliate of Warsaw.
`
`
`
`diameter, and a “teethed distractor.” WARSAW2004. A 42 mm implant will
`
`occupy the transverse width of vertebral bodies in the lower thoracic and upper
`
`lumbar region of the spine. See NUVASIVElOOl at 92. As disclosed in the ’997
`
`patent’s specification, Dr. Michelson’s claimed “second surgical instrument”
`
`corresponds to the distractor from Mr. Imre’s invoice and Dr. Michelson’s claimed
`
`“third surgical instrument” corresponds to the outer sleeve. The guide wire
`
`disclosed in the ’997 specification (i.e., the “first surgical instrument”) was well
`
`known in the art and not separately machined by Mr. Imre. See, e.g.,
`
`NUVASIVElOl3 at 4:14—40.
`
`On January ll, 1994, Dr. Michelson met with several executives from
`
`Danek and demonstrated the claimed lateral method of the ’997 patent. Larry
`
`Boyd, then an executive with Danek, wrote a memorandum to Mr. Lukianov,
`
`among others, that memorializes this meeting. WARSAW2005 at 1. At page 8 of
`
`this memorandum, Mr. Boyd writes that Dr. Michelson disclosed a “retroperitoneal
`
`lateral approach to the spine.” Id. at 8. Mr. Boyd continues that “Dr. Michelson
`
`reviewed with us some excellent instrumentation developed for placement of the
`
`threaded dowel via a lateral anterior approach.” Id. This instrumentation included
`
`a “large, bullet—nosed distractor” and an “outer multiple—wedge cannula.” Id.
`
`After insertion of the distractor, “an X—ray is used to confirm that the lateral
`
`position is parallel to the correct plane.” Id.
`
`l0
`
`
`
`In a separate memorandum written on the same day (January 11, 1994), Mr.
`
`Boyd recounted the “basics of the surgical method” disclosed by Dr. Michelson,
`
`which included “distraction is achieved via insertion of the bullet—nosed, long
`
`distractor .
`
`.
`
`. [an] outer sleeve (with engagement teeth) is placed in order to
`
`maintain distraction .
`
`.
`
`. [and then t]he threaded implant is inserted into this hole,
`
`engaging the bone.” WARSAW2006 at 2. On January 13, 1994, Mr. Boyd sent a
`
`letter to Dr. Michelson and expressed that he was “very enthusiastic about moving
`
`forward with the many fusion device concepts” discussed in their meeting.
`
`WARSAW2007 at 1. Mr. Boyd also asked Dr. Michelson to have Mr. Imre (Dr.
`
`Michelson’s machinist) manufacture a set of “Anterior Lateral Implant and
`
`Instruments (24D X 42L size only)” Id. at 2. Another memorandum dated January
`
`26, 1994 to Mr. Lukianov notes that the purchase of the Michelson technology
`
`gave the company access to a “broad range of technology for anterior, posterior,
`
`lateral and laparoscopic surgery of the cervical, thoracic and lumbar spine.”
`
`WARSAW2003 at 1.
`
`Finally, Dr. Michelson testified that Danek had never seen such technology
`
`before their meetings. WARSAW2001 at 68:7—15. At trial, Dr. Michelson
`
`testified that “this is the first time [Mr. Boyd had] ever seen a lateral
`
`retroperitoneal, where you don’t have to move the peritoneum sac.”
`
`WARSAW2009 at 195124—1962. Indeed, Danek was “very excited” about Dr.
`
`11
`
`
`
`Michelson’s technology and moved quickly to acquire it by signing a license
`
`agreement. WARSAWZOOI at 68:7~—15. In this agreement, Dr. Michelson
`
`licensed to Danek, inter alia, an unfiled patent application “entitled or covering the
`
`‘Lateral Discectomy and Interbody Fusion Implants, Instrumentation, and
`
`Method.m 1d.; WARSAW2009 at 23.
`
`NuVasive did not provide any evidence to contradict the foregoing
`
`testimony or documents during the prior litigation. Accordingly, the ’997 patent
`
`claims are entitled to a conception and reduction to practice date of no later than
`
`December 26, 1993.
`
`III.
`
`STANDARD FOR GRANTING INTER PARTES REVIEW
`
`The Board may only grant a petition for inter partes review where “the
`
`information presented in the petition .
`
`.
`
`. shows that there is a reasonable likelihood
`
`that the petitioner would prevail with respect to at least 1 of the claims challenged
`
`in the petition.” 35 U.S.C. § 314(a); 37 C.F.R. § 42.108(c). NuVasive bears the
`
`burden of showing that this statutory threshold has been met. See Office Patent
`
`Trial Practice Guide, 77 Fed. Reg. 48,756, 48,756 (Aug. 14, 2012) (“The Board .
`
`.
`
`.
`
`may institute a trial where the petitioner establishes that the standards for
`
`instituting the requested trial are met .
`
`.
`
`. .”). If interpartes review is granted,
`
`NuVasive also bears the burden of proving unpatentability by a preponderance of
`
`the evidence. 35 U.S.C. § 316(e).
`
`l2
`
`
`
`A party challenging a claim as obvious under 35 U.S.C. § 103 must show
`
`where each claimed limitation is found in the prior art. See, e.g., Kinetic Concepts,
`
`Inc. v. Smith & Nephew, Inc, 688 F.3d 1342, 1361 (Fed. Cir 2012). Failure to do
`
`so defeats a claim of obviousness. Id. The Office Patent Trial Practice Guide
`
`specifies that one of the many responses a patent owner can submit to a petition is
`
`that the prior art lacks a material limitation in all the independent claims. 77 Fed.
`
`Reg. at 48,764. NuVasive fails to cite any prior art that discloses a lateral implant
`
`with the claimed length and structural limitations of the ’997 patent—~ i.e., material
`
`limitations in every claim of the ’997 patent. Accordingly, NuVasive’s petition
`
`should be denied.
`
`IV. THE BOARD SHOULD REJECT NUVASIVE’S INAPPROPRIATE 35
`
`U.S.C. §112 WRITTEN DESCRIPTION CHALLENGE
`CHARACTERIZED AS A REJECTION UNDER 35 U.S.C. § 103(a)
`PREMISED ON A PRIORITY DISPUTE
`
`In Ground 9, NuVasive relies on Michelson ’661 in combination with Lynn
`
`under section 103 for proposing the rejection of claims 1-8. In doing so,
`
`NuVasive is in effect raising challenges to claims 1~—8 under section 112 in Ground
`
`9. NuVasive’s imputed section 112 challenge raised in Ground 9 is brought in
`
`direct violation of 35 U.S.C. § 31103) (and 37 CPR. § 42.104(b)(2)), which
`
`expressly restrict petitions for inter partes review to patentability challenges “that
`
`13
`
`
`
`could be raised under section 102 or 103.” 3 Given that 35 U.S.C. § 311 does not
`
`afford proposed grounds of rejection under section 112 in a petition for inter partes
`
`review, Warsaw requests that Ground 9 be precluded from consideration by the
`
`Board.
`
`According to NuVasive, Ground 9 “is premised upon the conclusion that
`
`claims 1—8 are not entitled to the earliest claimed priority date of the ’997 patent
`
`(Feb. 27, 1995), but instead these claims all recite a claim limitation (‘the length of
`
`said implant being sized to occupy substantially the full transverse width of the
`
`vertebral bodies of the two adjacent vertebrae’) that if interpreted more narrowly
`
`than the broadest reasonable interpretation discussed above, was added no earlier
`
`than the November 29, 2011 filing date of the application that became the ’997
`
`patent.” Petition at 50—51. Given this statement under Ground 9 in the Petition,
`
`NuVasive is, in fact, challenging the claim to priority (presumably under 35 U.S.C.
`
`§ 120) of the ’997 patent by questioning support (presumably under 35 U.S.C. §
`
`3 35 U.S.C. § 311(b) provides that “[a] petitioner in an inter partes review may
`
`request to cancel as unpatentable 1 or more claims of a patent only on a ground
`
`that could be raised under section 102 or- 103 and only on the basis of prior art
`
`consisting of patents or printed publications.”
`
`14
`
`
`
`112) for claims 1—8, with the aim of arguing that the ’997 patent is not entitled to
`
`the priority date (i.e., February 27, 1995) of Michelson ’661.4
`
`As discussed above, the ’997 patent and its priority filing, the Michelson
`
`’661 patent, have identical as—filed specifications. The ’997 patent thus claims
`
`priority to Michelson ’661 as a continuation. There are no continuation—in—part
`
`_ applications in the lineage of the ’997 patent. Furthermore, the ’997 patent shares
`
`its inventorship with Michelson ’661. By questioning support for claims 1~8 from
`
`Michelson ’661 in Ground 9, NuVasive is thus necessarily questioning support for
`
`these claims from the ’997 patent. Accordingly, Ground 9 is wrongly
`
`characterized as a rejection under section 103 premised on a priority dispute. In
`
`actuality, NuVasive is imputing a rejection under section 112 against claims 1—8 of
`
`the ’997 patent in Ground 9.
`
`The scope of petitions for inter partes review under 35 U.S.C. § 311 does
`
`not include rejections under section 112. NuVasive, however, ignores the
`
`applicable statute and tries to justify its approach as analogous to that permitted in
`
`In re NTP, Inc., 654 F.3d 1268 (Fed. Cir. 2011).5 But that decision is not
`
`4 It is interesting to note that Ground 9 does not refer explicitly to either of sections
`
`112 or 120.
`
`5 Warsaw notes NuVasive did not cite this case in its original petition. See Paper 1
`
`at 3—4. Instead, NuVasive cited this case for the first time in its “Corrected
`
`Petition.” See Paper 5 at 3—4. Warsaw submits the addition of caselaw citations is
`
`15
`
`
`
`analogous to the present situation. Contrary to NuVasive’s assertion, the statute
`
`governing these proceedings—~35 U.S.C. § 311(b)———is narrower in scope than the
`
`statutes applicable to reexamination proceedings considered in NTP. Specifically,
`
`35 U.S.C. § 311(b) strictly limits challenges in a petition for interpartes review to
`
`those raised under section 102 or 103, and the imputed section 112 challenge in
`
`Ground 9 does not satisfy 35 U.S.C. § 311(b).
`
`Moreover, NTP was decided August 1, 2011, and the Leahy—Smith America
`
`Invents Act (“AIA”), which included the basis for 35 U.S.C. § 311, was enacted
`
`September 16, 2011. Thus, if Congress had intended to allow challenges under
`
`section 112 in petitions for inter partes review, the AIA could have been passed
`
`with express language stating so. Instead, 35 U.S.C. § 311(b) strictly limits inter
`
`partes petitions to challenges raised under section 102 or 103. Furthermore, if the
`
`Board adopts the imputed 112 challenge raised in Ground 9, the limitations of 35
`
`U.S.C. § 31 1(b) would be rendered meaningless for patents that trace their lineage
`
`through continuation and/or divisional applications. If so, challenges under section
`
`112 could be raised without limit against such patents in petitions for inter partes
`
`review. Such a result would contravene the intent of the statute.
`
`an impermissible “substantive change” made to the original petition. See Paper 3
`
`at 2.
`
`16
`
`
`
`Notably, NuVasive’s resort to a section 112 challenge amounts to an
`
`admission that there is not a single prior art reference that discloses an implant
`
`with a length that occupies substantially the full transverse width of adjacent
`
`vertebral bodies or one that is greater than the depth o
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