Case 3:18-cv-00347-CAB-MDD Document 311 Filed 02/26/21 PageID.30175 Page 1 of 23
`
`
`
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`WILSON SONSINI GOODRICH & ROSATI P.C.
`PAUL D. TRIPODI II (SBN 162380)
`ptripodi@wsgr.com
`WENDY L. DEVINE (SBN 246337)
`wdevine@wsgr.com
`NATALIE J. MORGAN (SBN 211143)
`nmorgan@wsgr.com
`633 West Fifth Street, Suite 1550
`Los Angeles, CA 90071
`Telephone: 323-210-2900
`Fax: 866-974-7329
`Hilgers Graben PLLC
`MICHAEL T. HILGERS (Pro Hac Vice)
`mhilgers@hilgersgraben.com
`575 Fallbrook Blvd, Suite 202
`Lincoln, NE 68521
`Telephone: 402-218-2106
`Fax: 402-413-1880
`Attorneys for Plaintiff NuVasive, Inc.
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA
`SAN DIEGO DIVISION
`NUVASIVE, INC., a Delaware
`)
`Case No. 18-cv-00347-CAB-MDD
`corporation,
`)
`NUVASIVE, INC.’S REPLY IN
`
`)
`SUPPORT OF MOTION FOR
` Plaintiff,
`)
`PARTIAL SUMMARY
`
`)
`JUDGMENT AND MOTION TO
`v.
`)
`EXCLUDE EXPERT OPINIONS
`
`)
`(IMPLANT PATENTS)
`
`)
`ALPHATEC HOLDINGS, INC., a
`)
`
`Delaware corporation, and ALPHATEC
`)
`PER CHAMBERS RULES, NO
`SPINE, INC., a California corporation,
`)
`ORAL ARGUMENT UNLESS
`
`)
`SEPARATELY ORDERED BY THE
` Defendants.
`)
`COURT
`
`
`Judge: Hon. Cathy Ann Bencivengo
`Magistrate Judge: Mitchell D. Dembin
`
`
`
`
`
`)))
`
`NUVA’S REPLY ISO MOT. FOR PARTIAL
`SUMMARY JUDGMENT & MOT. TO EXCLUDE
`
`
`
`
`
`18-cv-00347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 311 Filed 02/26/21 PageID.30176 Page 2 of 23
`
`
`
`
`
`TABLE OF CONTENTS
`
`PAGE(S)
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`B.
`
`C.
`
`B.
`C.
`D.
`
`ALPHATEC’S DECLARATIONS ARE OBJECTIONABLE ...................... 1
`ALPHATEC FAILS TO MEET ITS BURDEN ON
`INDEFINITENESS ......................................................................................... 1
`III. THE PRIORITY DATE IS MARCH 29, 2004 ............................................... 2
`A.
`The Curran Declaration Proves NuVasive was in Possession of
`the Claimed Implant as of the Provisional Filing Date ......................... 2
`Alphatec Fails to Raise Any Genuine Dispute that the
`Provisional Discloses an Implant with the Claimed Dimensions ......... 3
`Alphatec Fails to Raise Any Genuine Dispute that the
`Provisional Discloses an Implant with Radiopaque Markers ............... 4
`D. Alphatec’s Extrinsic Evidence Does Not Create A Factual
`Dispute .................................................................................................. 6
`1.
`NuVasive communications with FDA ........................................ 6
`2.
`The Alphatec IPRs ...................................................................... 6
`IV. THERE WAS NO INVALIDATING EVENT PRIOR TO THE
`CRITICAL DATE ........................................................................................... 7
`V. NO ISSUES OF MATERIAL FACT REGARDING INFRINGEMENT ...... 7
`A.
`The Accused Implants Have Anti-Migration Elements That
`Contact the Interbody Space ................................................................. 8
`The Accused Implants Have a “proximal wall” ................................... 9
`The Battalion Implant Has a “medial support” ................................... 10
`The Accused Implants Have Radiopaque Markers “partially
`positioned in said proximal wall” ....................................................... 11
`The Accused Implants Infringe the Dimension Claim Limitations .... 11
`E.
`Alphatec Manufactured the Titec Coated Implants ............................ 12
`F.
`VI. THE COURT SHOULD GRANT THE MOTION TO EXCLUDE ............ 13
`A. Dr. Sachs’ Speculation About Sales ................................................... 13
`B.
`Untimely Alternative Implant Designs ............................................... 13
`C.
`Untimely Alternative Two-Bladed Retractor Designs........................ 14
`
`I.
`II.
`
`
`
`NUVA’S REPLY ISO MOT. FOR PARTIAL
`SUMMARY JUDGMENT & MOT. TO EXCLUDE
`
`
`
`i
`
`18-cv-00347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 311 Filed 02/26/21 PageID.30177 Page 3 of 23
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`TABLE OF CONTENTS
`(CONTINUED)
`
`PAGE(S)
`D. Dr. Ugone’s Opinions That Are Contrary to Law .............................. 15
`VII. CONCLUSION ............................................................................................. 15
`
`
`
`
`
`
`NUVA’S REPLY ISO MOT. FOR PARTIAL
`SUMMARY JUDGMENT & MOT. TO EXCLUDE
`
`
`
`ii
`
`18-cv-00347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 311 Filed 02/26/21 PageID.30178 Page 4 of 23
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`
`
`
`TABLE OF AUTHORITIES
`
`
`
`
`
`CASES
`
`
`
`
`
` PAGE(S)
`
`AMEX, LLC v. Mopex, Inc.,
`215 F.R.D. 87 (S.D.N.Y. 2002) ....................................................................... 14
`Arlington Indus., Inc. v. Bridgeport Fittings, Inc.,
`632 F.3d 1246 (Fed. Cir. 2011) ....................................................................... 11
`Ball Aerosol & Specialty Container, Inc. v. Ltd. Brands, Inc.,
`555 F.3d 984 (Fed. Cir. 2009) ........................................................................... 9
`DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`469 F.3d 1005 (Fed. Cir. 2006) ......................................................................... 9
`Digit.-Vending Servs. Int’l, LLC v. Univ. of Phx., Inc.,
`672 F.3d 1270 (Fed. Cir. 2012) ....................................................................... 11
`INVISTA N. Am. S.à.r.l. v. M&G USA Corp., No. 11-1007-SLR-CJB,
`2013 U.S. Dist. LEXIS 88633 (D. Del. June 25, 2013) .................................. 14
`Kennedy v. Allied Mutual Insurance Co.,
`952 F.2d 262 (9th Cir. 1991) ............................................................................. 8
`Koito Mfg. Co. v. Turn-Key-Tech, LLC,
`381 F.3d 1142 (Fed. Cir. 2004) ......................................................................... 2
`Lucent Techs. Inc. v. Gateway, Inc.,
`509 F. Supp. 2d 912 (S.D. Cal. 2007) (Fed. Cir. 2008), aff’d, 543
`F.3d 710 ............................................................................................................. 9
`Lucent Techs., Inc. v. Gateway, Inc.,
`580 F.3d 1301 (Fed. Cir. 2009) ....................................................................... 15
`Nautilus, Inc. v. Biosig Instruments, Inc.,
`572 U.S. 898 (2014) ...................................................................................... 1, 2
`New Railhead Mfg., LLC v. Vermeer Mfg. Co.,
`298 F.3d 1290 (Fed. Cir. 2002) ......................................................................... 6
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) ....................................................................... 10
`Tinnus Enters., LLC v. Telebrands Corp., No. 6:16-CV-33-RWS-JDL,
`2016 U.S. Dist. LEXIS 189645 (E.D. Tex. Sept. 29, 2016), aff’d,
`708 F. App’x 1019 (Fed. Cir. 2018) .................................................................. 5
`Typhoon Touch Techs., Inc. v. Dell, Inc.,
`659 F.3d 1376 (Fed. Cir. 2011) ......................................................................... 9
`Zenith Labs., Inc. v. Bristol-Myers Squibb Co.,
`19 F.3d 1418 (Fed. Cir. 1994) ........................................................................... 9
`
`NUVA’S REPLY ISO MOT. FOR PARTIAL
`SUMMARY JUDGMENT & MOT. TO EXCLUDE
`
`
`
`iii
`
`18-cv-00347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 311 Filed 02/26/21 PageID.30179 Page 5 of 23
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` PAGE(S)
`
`TABLE OF AUTHORITIES
`(CONTINUED)
`
`
`STATUTES
`35 U.S.C. § 271(a) ..................................................................................................... 12
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`NUVA’S REPLY ISO MOT. FOR PARTIAL
`SUMMARY JUDGMENT & MOT. TO EXCLUDE
`
`
`
`iv
`
`18-cv-00347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 311 Filed 02/26/21 PageID.30180 Page 6 of 23
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`
`TABLE OF ABBREVIATIONS
`
`U.S. Patent No. 8,361,156 (Doc. No. 110-38, Ex. AL)
`“’156 patent”
`U.S. Patent No. 8,187,334 (Doc. No. 110-48, Ex. AV)
`“’334 patent”
`“Alphatec’s IPRs” Alphatec’s IPR petitions related to the ’156 and ’334
`patents (IPR2019-00362 (Doc. No. 136-1, Ex. A), IPR2019-
`00361 (Doc. No. 136-1, Ex. B), IPR2019-00546 (Doc. No.
`142-3, Ex. A))
`
`Alphatec Holdings, Inc. and Alphatec Spine, Inc.
`“Alphatec”
`“Asserted Claims” Claims 1, 5, 10, 18, and 24 of the ’156 patent; and
`Claims 16 and 18 of the ’334 patent
`Battalion™ Lateral Spacers
`Refers to Exhibits attached to the Declaration of Christiana
`Garrett filed herewith
`
`“Battalion”
`“Ex. __”
`
`Inter Partes Review
`“IPR”
`NuVasive, Inc.
`“NuVasive”
`U.S. Provisional Application No. 60/557,536
`“Provisional”
`Patent Trial and Appeal Board
`“PTAB”
`“Warsaw Patents” U.S. Patent Nos. 6,945,933 (the “’933 patent”), 7,625,379
`(the “’379 patent”), and 8,486,083 (the “’083 patent”)
`Transcript of Deposition of Barton L. Sachs M.D.,
`M.B.A., F.A.C.P.E., F.A.C.H.E. (January 11, 2021)
`Opening Report of Barton L. Sachs, M.D., M.B.A.,
`F.A.C.P.E., F.A.C.H.E. (November 20, 2020)
`Rebuttal Report of Barton L. Sachs, M.D., M.B.A.,
`F.A.C.P.E., F.A.C.H.E. (December 18, 2020)
`The Implant Patents
`
`“Sachs 1/11/21
`Tr.”
`“Sachs 11/20/20
`Rpt.”
`“Sachs Rebuttal
`12/18/20 Rpt.”
`“the ’156 patent
`and ’334 patent”
`“Titec Coated”
`
`Titec Coated LLIF Implants
`
`NUVA’S REPLY ISO MOT. FOR PARTIAL
`SUMMARY JUDGMENT & MOT. TO EXCLUDE
`
`v
`
`18-cv-00347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 311 Filed 02/26/21 PageID.30181 Page 7 of 23
`
`
`
`“Transcend”
`“Youssef 1/13/21
`Tr.”
`
`“Youssef
`11/20/20 Rpt.”
`“Youssef Rebuttal
`12/18/20 Rpt.”
`
`POPR
`“Robinson
`11/4/20 Tr.”
`“Ugone 1/12/21
`Tr.”
`“Aleali 10/30/20
`Tr.”
`
`Transcend™ LIF PEEK Spacer
`Transcript Deposition of Jim Youssef, MD
`(January 13, 2021)
`
`Corrected Opening Expert Report of Jim Youssef, MD,
`and Supporting App. D (November 20, 2020)
`Rebuttal Expert Report of Jim Youssef, MD Regarding
`U.S. Patent Nos. 8,361,156 (’156 Patent) and 8,187,334
`(’187 patent) (December 18, 2020)
`Patent Owner’s Prelim. Response
`Transcript Deposition of Scott Robinson
`(November 4, 2020)
`Transcript Deposition of Keith R. Ugone, Ph.D.
`(January 12, 2021)
`Transcript Deposition of Mike Aleali
`(October 30, 2020)
`
`
`*** All internal citations omitted and emphasis added unless otherwise noted.
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`NUVA’S REPLY ISO MOT. FOR PARTIAL
`SUMMARY JUDGMENT & MOT. TO EXCLUDE
`
`
`
`vi
`
`18-cv-00347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 311 Filed 02/26/21 PageID.30182 Page 8 of 23
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`I.
`
`ALPHATEC’S DECLARATIONS ARE OBJECTIONABLE
`In support of its Opposition, Alphatec submitted declarations from four
`Alphatec employees. (Doc. Nos. 306-1 through 306-19). Two of the declarants—
`Robinson and Aleali—were corporate designees whose untimely declarations
`contradict their prior sworn Rule 30(b)(6) deposition testimony. The other
`declarants—Curran and Howell—are former NuVasive employees who had been at
`NuVasive since the early 2000’s but left for Alphatec in 2017 soon after its
`infringement commenced. Alphatec attempts to use these declarations to fill the
`void left by its discovery failures and those of its own technical expert. To the
`extent that such testimony is admissible, it supports NuVasive, not Alphatec.1
`II. ALPHATEC FAILS TO MEET ITS BURDEN ON INDEFINITENESS
`A conclusion of indefiniteness requires a showing by clear and convincing
`evidence that the claims read in view of the intrinsic evidence fail to inform a
`POSA as to the scope of the invention with “reasonable certainty.” Nautilus, Inc.
`v. Biosig Instruments, Inc., 572 U.S. 898, 910 (2014). In short, Alphatec has not
`explained, much less pointed to the required quantum of evidence, that the claims
`read in view of the intrinsic evidence are indefinite. Instead, Alphatec vaguely
`asserts that it “detailed all the intrinsic evidence” in its motion for summary
`judgment. Doc. No. 306 at 22. A catalog of citations to the text of the patent—
`while ignoring the Figures, the text of the claims, and failing to proffer
`testimony about the understanding of a POSA—is not competent “proof” of
`indefiniteness. The only attempt at this is the conclusory statements in the report of
`Alphatec’s expert witness, Dr. Sachs. Doc. No. 303-14 at 20-22 (¶¶ 329, 334, 335).
`Simply stating a conclusion, however, that the terms are “highly subjective,” “lack
`any objective boundaries,” or “left to the vagaries of any on person’s opinion” is
`argument, not thoughtful opinion, and completely inconsistent with detailed
`
`
`1 As set forth in the “Objections” submitted herewith, much of the content of
`these declarations, particularly of Robinson and Aleali, is incompetent and
`therefore use of these declarations should be limited accordingly.
`1
`18-cv-00347-CAB-MDD
`NUVA’S REPLY ISO MOT. FOR PARTIAL
`SUMMARY JUDGMENT & MOT. TO EXCLUDE
`
`
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 311 Filed 02/26/21 PageID.30183 Page 9 of 23
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`positions taken by Alphatec and its expert in IPR. Koito Mfg. Co. v. Turn-Key-Tech,
`LLC, 381 F.3d 1142, 1152 (Fed. Cir. 2004) (“General and conclusory testimony . . .
`does not suffice as substantial evidence of invalidity.”).
`At its core then, Alphatec’s indefiniteness contentions rest on the legally
`erroneous position that terms of degree are per se indefinite. In support, Alphatec
`relies on Dr. Youssef’s oral responses to Alphatec’s demands that he provide
`boundaries with mathematical precision to the disputed claim terms. As the
`Supreme Court noted in Nautilus, this kind of hypothetical boundary seeking is not
`required under the law:
`Section 112, we have said, entails a delicate balance. On the one hand, the
`definiteness requirement must take into account the inherent limitations of
`language. Some modicum of uncertainty, the Court has recognized, is the price
`of ensuring the appropriate incentives for innovation. One must bear in mind,
`moreover, that patents are “not addressed to lawyers, or even to the public
`generally,” but rather to those skilled in the relevant art.
`572 U.S. at 909. Alphatec cannot carry its indefiniteness burden by seeking
`precision beyond that required by law.
`III. THE PRIORITY DATE IS MARCH 29, 2004
`There is no genuine dispute of fact that the applicable priority date is March
`29, 2004. In contrast to Alphatec’s unsupported arguments, Dr. Youssef opined that
`a POSA reading the Provisional would conclude that, as of March 29, 2004,
`NuVasive was in possession of the spinal fusion implant claimed in the Implant
`Patents, including an implant with “radiopaque markers” that matches the claimed
`dimensions, and a “longitudinal length” that is “greater than [its] maximum
`lateral width.” Doc. No. 110-38 at cl. 1.
`A. The Curran Declaration Proves NuVasive was in Possession of the
`Claimed Implant as of the Provisional Filing Date
`To the extent this Court considers the Curran2 declaration, it fully supports
`NuVasive’s position. Mr. Curran’s declaration and accompanying exhibits show
`
`2 Mr. Curran was a 17-year employee of NuVasive and a named inventor on the
`Implant Patents. After Mr. Miles departure in October 2017, Mr. Curran joined
`Alphatec in December 2017. Tellingly, in its initial disclosures served on April 18,
`2018, Alphatec identified its new Senior Director of Technology Advancement,
`(continued...)
`2
`18-cv-00347-CAB-MDD
`
`NUVA’S REPLY ISO MOT. FOR PARTIAL
`SUMMARY JUDGMENT & MOT. TO EXCLUDE
`
`
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 311 Filed 02/26/21 PageID.30184 Page 10 of 23
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`that the CoRoent spinal implants (a/k/a, “PEEK CR-X” and “PEEK CR-XL”
`cement restrictors) shown and described in the Implant Patents were conceived3 by
`April 28, 2003, in commercial form around February 20044 and “ready for
`widespread availability” by March 2, 2004—all of these dates occurring during
`the one-year grace period in advance of the filing the provisional on March 29,
`2004. Doc. 306-8 at 2, 5 (¶¶ 3, 12). Accordingly, Mr. Curran’s declaration
`confirms that the completed CoRoent implant was finalized and in its commercial
`form when it was shown and described in the Provisional application.
`B. Alphatec Fails to Raise Any Genuine Dispute that the Provisional
`Discloses an Implant with the Claimed Dimensions
`As set forth in NuVasive’s Motion, there is no genuine dispute of fact that a
`POSA reading the Provisional on March 29, 2004 would conclude that NuVasive
`was in possession of an implant meeting each of the claimed limitations. Alphatec
`does not and cannot dispute the following facts:
`i. Just like the claimed implant, the Provisional discloses a long and
`(by comparison) narrower implant with specific, identified
`ranges for each of three dimensions, Doc. No. 110-38 at 27 (5:15-
`19), 30 (12:45-51); Doc. 296-3 at 13 (11:5-15), 32-37 (Figs. 1-3);
`
`ii. Just like the claimed implant, the Provisional discloses a
`proximal-to-distal dimension of the implant that is greater than
`its sidewall-to-sidewall dimension, Doc. No. 110-38 at 27
`(5:15-19); Doc. No. 110-48 at 30 (12:44-54); Doc. No. 296-3 at
`13 (11:5-15), 32-37 (Figs. 1-3).
`
`iii. Just like the claimed implant, the Provisional discloses a spinal fusion implant
`with its longest dimension (25-45mm) that extends from its “proximal side 22”
`
`Mr. Curran, as knowledgeable about “invalidity of U.S. Patent Nos. 8,187,334,
`8,361,156.” As discussed herein, the Curran and Howell declarations are fatal to
`Alphatec’s 102(b) defense. Furthermore, in relation to matters raised by
`NuVasive’s pending Motion to Strike (Doc. No. 296), it is unclear why Alphatec
`took until February of 2021, to provide this information for the first time.
`3 Specifically, Mr. Curran describes the roles that he and a co-inventor, Dr. Luiz
`Pimenta, played in developing the patented CoRoent implants. Doc. 306-8 at 2-3,
`5-6 (¶¶ 3-6, 11). Mr. Curran also points to his “handwritten notes” dated April 28,
`2003, that “highlight[] some of Dr. Pimenta’s contributions to the design of the
`implant.” Id. at 3 (¶ 6). Mr. Curran confirms that the implant described in his
`notes (Ex. B) included “metal spikes,” which are shown in the same configuration
`as the claimed implant. Doc. Nos. 306-8 at 2-3 (¶¶ 3-6); 306-10 at 2.
`4 Mr. Curran states that a CoRoent implant with a “length” of 40mm and 45mm
`and a “width” of 18mm and had been sold to “hospitals and surgeons” by February
`2004. Doc. No. 306-10 at 5-6 (¶¶ 11,14).
`3
`18-cv-00347-CAB-MDD
`NUVA’S REPLY ISO MOT. FOR PARTIAL
`SUMMARY JUDGMENT & MOT. TO EXCLUDE
`
`
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 311 Filed 02/26/21 PageID.30185 Page 11 of 23
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`to its “distal side 16” (i.e., the “proximal-to-distal” direction); Doc. No. 110-38
`at 30 (12:45-51); Doc. No. 296-3 at 15 (13:11-15), 32-37 (Figs. 1-3):
`
`iv. Just like the claimed implant, the Provisional discloses a spinal fusion implant
`with its second-longest dimension (9-18mm) that extends from one “lateral
`side 14” to the other lateral side in a direction generally perpendicular to the
`longer, proximal-to-distal dimension, Doc. No. 110-38 at 30 (12:45-51); Doc.
`No. 296-3 at 15 (13:11-15), 32-37 (Figs. 1-3):
`
`Thus, the only distinction is that the Implant Patents refer to the proximal-to-distal
`dimension as “length” and sidewall-to-sidewall dimensions as “width.” There is no
`dispute, however, about the claim language. The Asserted Claims do not use the
`terms “length” or “width”; instead, they explicitly refer to the relevant dimensions as
`“longitudinal length” defined in the claim as the proximal-to-distal dimension, and
`the “lateral width” defined in the claim as sidewall-to-sidewall.5 Doc. Nos. 110-
`38; 110-48. Even Alphatec’s expert, Dr. Sachs, agrees that the claims utilize this
`convention to identify the long and short dimensions, which is unmistakably shown
`in the Figures of the Provisional. Doc. No. 307-12 at 5 (141:5-14).6
`C. Alphatec Fails to Raise Any Genuine Dispute that the Provisional
`Discloses an Implant with Radiopaque Markers
`The Implant Patents claim a spinal fusion implant with “radiopaque
`markers” in specific locations, and the specification of the Provisional teaches the
`placement of spike elements that can be provided in a “variety of suitable shapes”
`and are “manufactured from any of a variety of suitable materials… preferably
`having radiopaque characteristics.” Doc. No. 296-3 at 17 (15:6-14), 16 (14:11-
`14), 32-37 (Figs. 1-6). Thus, there can be no disagreement that the specification of
`the Provisional expressly contemplates “radiopaque” elements placed in specific
`
`5 It is undisputed that the Provisional discloses an implant whose dimensions
`are identical to the claimed implant, Alphatec ignores that Figures 1-6 in the
`Provisional and Implant Patents are identical.
`6 Alphatec points to other testimony of Dr. Sachs regarding Deposition Exhibit
`9 (Doc. No. 307-11) in order to create the illusion of a factual dispute regarding
`which dimension in the Provisional corresponds to the “longitudinal length” and
`“lateral width” claimed in the Implant Patents. Doc. No. 306 at 27-28 (citing Sachs
`Dep. at 138:14-142:10). But any confusion Dr. Sachs expressed is not about the
`claim language or the Figures, but the color coding used by counsel in annotating
`the text of the Provisional in Deposition Exhibit 9. Doc. No. 307-12 at 6 (144:7-
`16).
`NUVA’S REPLY ISO MOT. FOR PARTIAL
`SUMMARY JUDGMENT & MOT. TO EXCLUDE
`
`4
`
`18-cv-00347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 311 Filed 02/26/21 PageID.30186 Page 12 of 23
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`locations in an implant that will appear on x-ray in those locations. As filed and
`issued, Implant Patents depict the identical implant (Figs. 1-6) and include the exact
`same description of the radiopaque elements.7 Doc. No. 303-30 at 5, 12-13; Doc.
`No. 110-38 at 27 (6:35-41). Thus, it cannot reasonably be disputed that the
`Provisional discloses the “radiopaque markers” limitation. Tinnus Enters., LLC v.
`Telebrands Corp., No. 6:16-CV-33-RWS-JDL, 2016 U.S. Dist. LEXIS 189645, at
`*13-14 (E.D. Tex. Sept. 29, 2016) (concluding priority date of the provisional
`applied in part because “the figure in the [patent in suit] is nearly identical to the
`figure in the provisional application” and both figures depicted claimed limitation),
`aff’d, 708 F. App’x 1019 (Fed. Cir. 2018).
`Alphatec argues that the Provisional does not disclose the “radiopaque
`markers” limitation because the Provisional “does not disclose anti-migration
`spike elements as radiopaque markers to identify the location or orientation of
`the implant.” Doc. No. 306 at 28-29. As noted in NuVasive’s Motion, however,
`even Dr. Sachs concedes that “making the spikes radiopaque would allow
`confirmation that the spikes are serving their intended and repeatedly stated
`function of gripping into the adjacent vertebrae.” Doc. No. 303-1 at 40-41
`(quoting Doc. No. 303-12 at 7-8 (Sachs Rebuttal 12/18/20 Rpt. ¶ 105)). Alphatec
`disagrees with NuVasive’s interpretation of these statements, arguing that the spikes
`serve only a single purpose—as antimigration elements. Doc. No. 306 at 29-30.
`But, as the specification of the Provisional makes clear, the spikes are not only anti-
`migration elements, but also “radiopaque.”8 Thus, the radiopaque elements are
`
`7 As Alphatec concedes, “implant 10” depicted in Figures of the Provisional and
`Implant Patents practices all of the limitations of the Asserted Claims, including the
`“radiopaque marker” limitation. Ex. 26 (Sachs 1/11/21 Tr.) at 126:14-128:15
`(agreeing implant 10 depicted in Figures 1-3 of the ’156 patent “meets . . . the
`elements of the claims of 156”); Doc. No. 110-38 at 5-10; id. at 27 (6:35-38).
`8 In the late 1800’s, the famous Wilhem Roentgen first noticed that a new
`wavelength of “rays” seemed to effortlessly pass through many objects opaque to
`visible light (e.g. books), but were blocked by metal objects, their outline visible on
`the screen. While holding such an object he noted the outline of the bones of his
`hand. As the nature of the rays were unknown, he called them x-rays. Ex. 27 (Dr.
`(continued...)
`5
`18-cv-00347-CAB-MDD
`
`NUVA’S REPLY ISO MOT. FOR PARTIAL
`SUMMARY JUDGMENT & MOT. TO EXCLUDE
`
`
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 311 Filed 02/26/21 PageID.30187 Page 13 of 23
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`indisputably capable of facilitating radiographic visualization.
`D. Alphatec’s Extrinsic Evidence Does Not Create A Factual Dispute
`In an attempt to manufacture a factual dispute, Alphatec relies on two sources
`of extrinsic evidence. However, neither calls into doubt the adequacy of the
`Provisional’s written description of the claimed implant.
`1.
`NuVasive communications with FDA
`In August 2004, in conjunction with NuVasive’s regulatory submission for
`the CoRoent family of implants, an FDA employee, Sergio de del Castillo, wrote to
`NuVasive and noted NuVasive’s engineering drawings showing titanium markers
`and titanium spikes “are not mentioned within the text of the device description,”
`and asked NuVasive to “provide a detailed description of these components.” Doc.
`No. 306-12 at 3. Alphatec claims that request is evidence that a POSA reading the
`Provisional would not readily discern the “radiopaque marker” limitation.
`Alphatec is wrong. First, Mr. de del Castillo’s email relates to a regulatory
`submission that is extrinsic to the Provisional and, thus, not relevant to priority date.
`Second, Alphatec offered no foundation or support whatsoever for its assertion that
`Mr. de del Castillo is skilled (or unskilled) in interpreting the mechanical drawings.
`Therefore, even if his request for additional information were relevant, Alphatec
`identified no reason why the Court should treat Mr. de del Castillo’s email request
`as contradictory to the expert opinions of Dr. Youssef or the plain language of the
`patent specification. Doc. No. 303-27 at 10-13 (¶¶ 106-110); New Railhead Mfg.,
`LLC v. Vermeer Mfg. Co., 298 F.3d 1290, 1295 (Fed. Cir. 2002) (measuring
`adequacy of provisional disclosure from perspective of “those skilled in the art”).
`Thus, Mr. de del Castillo’s request—along with NuVasive’s response—is irrelevant
`to whether the Provisional adequately discloses “radiopaque markers.”
`2.
`The Alphatec IPRs
`Alphatec misrepresents positions taken by the parties in the Alphatec IPRs to
`
`
`Patrick Rock and Dr. Ayush Goel, Wilhelm Roentgen, Radiopaedia.org, Feb. 25,
`2021, https://radiopaedia.org/articles/wilhelm-roentgen-1?lang=us).
`6
`18-cv-00347-CAB-MDD
`NUVA’S REPLY ISO MOT. FOR PARTIAL
`SUMMARY JUDGMENT & MOT. TO EXCLUDE
`
`
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 311 Filed 02/26/21 PageID.30188 Page 14 of 23
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`support its untenable priority contentions. In the Alphatec IPRs, NuVasive
`acknowledged that spikes made of radiopaque material constitute “radiopaque
`markers.” Doc. No. 303-1 at 42 (citing POPR at 60) (“Baccelli teaches that the
`wires in these ducts can be replaced by markers comprising radiopaque spikes
`placed in those same ducts.”); Doc. No. 303-20 at 3. That is entirely consistent with
`NuVasive’s arguments here—it is Alphatec that has changed positions. Alphatec
`now argues that a POSA would not understand radiopaque spikes to serve as
`radiopaque markers. But in the Alphatec IPRs, Alphatec pointed to Baccelli’s
`disclosure of spikes that “can be made of a material that is opaque to X-rays” and
`asserted that this disclosure met the “radiopaque markers” limitation. Doc. No. 136-
`1 at 64 (quoting Baccelli at ¶51). Thus, the Alphatec IPRs fully support NuVasive’s
`position that a POSA would understand that radiopaque spikes in a radiolucent
`implant serve as radiopaque markers. Doc. No. 307-13 at 8-9.
`IV. There Was No Invalidating Event Prior to the Critical Date
`There is no triable issue of fact regarding the prior public use and sale of
`implants within the scope of the claims prior to the critical date. As discussed above
`(Section III. supra), the Implant Patents are entitled to a priority date of March 29,
`2004, and thus a one-year grace period under §102(b) dating back to March 29,
`2003. Mr. Curran’s declaration alleges an April 2003 conception date and that a
`commercial embodiment was not available until February 2004. Doc. No. 306-8 at
`Meanwhile Ms. Howell’s declaration alleges that surgeries involving the patented
`CoRoent XL PEEK implants did not occur until “the end of 2003 and through
`2004”—long after the March 29, 2003 critical date. Doc. No. 306-1 at 3-4.
`Accordingly, both Mr. Curran and Ms. Howell have confirmed that none of the
`allegedly invalidating commercial activity took place more than a year before the
`March 29, 2004 filing date. Therefore, summary judgment of validity is appropriate.
`V. NO ISSUES OF MATERIAL FACT REGARDING INFRINGEMENT
`Alphatec’s Opposition fails to show an issue of fact regarding infringement.
`
`NUVA’S REPLY ISO MOT. FOR PARTIAL
`SUMMARY JUDGMENT & MOT. TO EXCLUDE
`
`18-cv-00347-CAB-MDD
`
`
`
`7
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 311 Filed 02/26/21 PageID.30189 Page 15 of 23
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`A. The Accused Implants Have Anti-Migration Elements That
`Contact the Interbody Space
`Alphatec’s arguments regarding the anti-migration element misrepresent the
`facts and the law. Alphatec illogically argues that its “anti-migration tooth pattern”
`does not prevent migration by contacting the vertebrae. Doc. No. 303-3 at 3; Doc.
`No. 303-4 at 3. This conflicts with Alphatec’s own corporate witness testimony and
`product documentation. Alphatec’s corporate witnesses testified the anti-migration
`elements contact the vertebrae:
`(cid:120) “So ideally, [the anti-migration teeth] makes contact on the very ring of the
`end plate over there. And that essentially more or less – friction keeps the
`cage from migrating.” Doc. No. 303-7 at 9 (90:7-12).
`(cid:120) “And so if the device were to sort of migrate laterally, those teeth would
`come in contact with the ring apophysis. If the implant were to migrate
`anteriorly, again, those teeth would come in contact with the ring apophysis.”
`Doc. No. 303-8 at 10 (73:17-21).
`Alphatec documentation is consistent and indicates that the anti-migration
`elements contact the vertebrae and prevent migration.
`(cid:120) “The device includes rows of teeth on the surface of each end of the device
`which serve to grip the adjacent vertebrae to resist migration and
`expulsion of the device.” Ex. 28 (510K Summary) at
`ATEC_LLIF000966788.
`(cid:120) “[T]eeth on the superior and inferior surfaces, teeth that resist movement.”
`Ex. 29 (Battalion LLIF Implant System) at ATEC_000002273.
`(cid:120) “The implant system shall have unique geometric teeth on the superior and
`inferior surfaces” whose purpose is “to resist migration post-
`implantation.” Doc. No. 303-11 at 3; see also Doc. No. 1-38 at 26 (“as the
`implant is impacted” during the insertion).
`Statements like these in regulatory filings indicate that Alphatec’s contradictory
`declaration is nothing but a sham as defined in Kennedy v. Allied Mutual Insurance
`Co., 952 F.2d 262, 266 (9th Cir. 1991) (“[A] party cannot create an issue of fact