Case 3:08-cv-01512-MMA-MDD Document 451 Filed 12/23/11 Page 1 of 33
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`Todd G. Miller (SBN 163200), miller@fr.com
`Craig E. Countryman (SBN 244601), countryman@fr.com
`Fish & Richardson P.C.
`12390 El Camino Real
`San Diego, CA 92130
`Phone: 858-678-5070/Fax: 858-678-5099
`
`Frank E. Scherkenbach (SBN 142549), scherkenbach@fr.com
`Fish & Richardson P.C.
`One Marina Park Drive
`Boston, MA 02210-1878
`Phone: 617-542-5070/Fax: 617-542-8906
`
`John M. Farrell (SBN 99649), farrell@fr.com
`Jonathan J. Lamberson (SBN 239107), lamberson@fr.com
`Keeley I. Vega (SBN 259928), kvega@fr.com
`Fish & Richardson P.C.
`500 Arguello Street, Suite 500
`Redwood City, CA 94063
`Phone: 650-839-5070/Fax: 650-839-5071
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`Attorneys for Defendant/Counterclaimant/Counterclaim Defendant
`NUVASIVE, INC.
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`UNITED STATES DISTRICT COURT
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`SOUTHERN DISTRICT OF CALIFORNIA
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`WARSAW ORTHOPEDIC, INC.,
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`Plaintiff,
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`v.
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`NUVASIVE, INC.,
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`Defendant.
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`Case No. 3:08-CV-1512 MMA (MDD)
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`NUVASIVE’S PROPOSED FINDINGS OF
`FACT AND CONCLUSIONS OF LAW
`REGARDING THE UNENFORCEABILITY
`OF U.S. PATENT NO. 5,860,973 FOR
`INEQUITABLE CONDUCT
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`
`
`Judge: Hon. Michael M. Anello
`Courtroom: 5, 3rd floor
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`NUVASIVE, INC.,
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`MEDTRONIC SOFAMOR DANEK USA, INC.,
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`Counterclaimant,
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`Counterclaim Defendant.
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`v.
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`AND RELATED COUNTERCLAIMS.
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`Case No. 3:08-CV-1512 MMA (MDD)
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`WARSAW2015
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`Case IPR2013-00206
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`Page 1
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`Case 3:08-cv-01512-MMA-MDD Document 451 Filed 12/23/11 Page 24 of 33
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`states “the plugs can be inserted either anteriorly, posteriorly, or laterally into the vertebral column
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`while mounted on the end of an insertion tool.” [DTX-5909, 2:64-66.]
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`139. The Brantigan ’327 patent describes an implant capable of insertion from a direction
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`other than anterior or posterior (from the front or back of the patient), at Col. 5 lines 30-32, which
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`states “the individual plugs or the stack of plugs can be introduced anteriorly, laterally, or
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`posteriorly depending upon conditions.” [DTX-5909, 5:30-32.]
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`140. The Brantigan ’327 patent teaches both a hemi-oval or half-oval implant designated
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`as “21” (as shown in figure 2, 5, and 12) and also a full oval implant designated as “11” (as shown
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`in figures 1, 10 11, 13, and 14). [DTX-5909.]
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`141. The Brantigan ’327 patent teaches insertion of the hemi-oval implant lateral to the
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`midline of the spine. [DTX-5909 at 2:7-11, FIG 12.]
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`142. The Brantigan ’327 patent teaches lateral insertion (not lateral to the midline) of the
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`full oval implants. The full oval implants are incapable of insertion lateral to the midline of the
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`spine. [DTX-5909 at 6:59-68, FIG 13; IC Trial Tr. at 82:18-84:21.]
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`143. The Brantigan ’327 patent shows that it was not true that at the time the ’973 patent
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`was filed, all known spinal fusion implants were only capable of insertion from the anterior or
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`posterior aspects of the spine. [IC Trial Tr. at 33:10-14.]
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`144. The ’973 patent cites to three of Dr. Brantigan’s four patents, but does not cite to the
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`Brantigan ’327 patent. [PX0326, at Col. 1]
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`145. The Brantigan ’327 patent teaches the insertion of a spinal fusion implant from the
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`lateral aspect of the spine, but the three Brantigan patents cited by Dr. Michelson and his attorneys
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`during the prosecution of the ’973 patent do not. [PX0326 1:51-64.]
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`146. The information disclosure statement filed by Dr. Michelson and his attorneys with
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`the ’973 patent on June 7, 1995 cite to and describe three of Dr. Brantigan’s patents, but do not cite
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`to or describe the Brantigan ’327 patent. [PX0325 at 0044-45.]
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`147. Dr. Michelson testified that it would make sense that he learned of the Brantigan
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`’327 patent by fax. [IC Trial Tr. at 197:14-22 (Michelson).]
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`Case 3:08-cv-01512-MMA-MDD Document 451 Filed 12/23/11 Page 28 of 33
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`172.
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`“Inequitable conduct occurs when a patentee breaches his or her duty to the PTO of
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`“candor, good faith, and honesty.’” Warner-Lambert Co. v. Teva Pharms. USA, Inc., 418 F.3d
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`1326, 1342 (Fed. Cir. 2005).
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`173. The duty is breached by an “affirmative misrepresentation of a material fact,” a
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`“failure to disclose material information,” or a “submission of false material information.” Bristol-
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`Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc., 326 F.3d 1226, 1233 (Fed. Cir. 2003).
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`174. A breach of this duty, when coupled with “an intent to deceive or mislead the PTO,
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`constitutes inequitable conduct.” Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc., 326 F.3d
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`1226, 1233 (Fed. Cir. 2003).
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`175. A patent is unenforceable for inequitable conduct if it is shown, by clear and
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`convincing evidence, that an applicant submitted materially false information or failed to disclose
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`material information to the PTO during prosecution, with an intent to deceive. Molins PLC v.
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`Textron, Inc., 48 F.3d 1172, 1178 (Fed. Cir. 1995).
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`176.
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`“Unlike validity defenses, which are claim specific, see 35 U.S.C. § 288, inequitable
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`conduct regarding any single claim renders the entire patent unenforceable.” Therasense, Inc. v.
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`Becton, Dickinson and Co., 649 F.3d 1276, 1288 (Fed. Cir. 2011).
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`177. The doctrine of inequitable conduct “should only be applied in instances where the
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`patentee's misconduct resulted in the unfair benefit of receiving an unwarranted claim.”
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`Therasense, Inc. v. Becton, Dickinson and Co., 649 F.3d 1276, 1292 (Fed. Cir. 2011) (citations
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`omitted).
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`2.
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`Materiality
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`178.
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`“[A]s a general matter, the materiality required to establish inequitable conduct is
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`but-for materiality.” Therasense, Inc. v. Becton, Dickinson and Co., 649 F.3d 1276, 1291 (Fed. Cir.
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`2011).
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`179.
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`“When an applicant fails to disclose prior art to the PTO, that prior art is but-for
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`material if the PTO would not have allowed a claim had it been aware of the undisclosed prior art.
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`Hence, in assessing the materiality of a withheld reference, the court must determine whether the
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`Case 3:08-cv-01512-MMA-MDD Document 451 Filed 12/23/11 Page 29 of 33
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`PTO would have allowed the claim if it had been aware of the undisclosed reference.” Therasense,
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`Inc. v. Becton, Dickinson and Co., 649 F.3d 1276, 1291 (Fed. Cir. 2011).
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`180.
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` “In making this patentability determination, the court should apply the
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`preponderance of the evidence standard and give claims their broadest reasonable construction.”
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`Therasense, Inc. v. Becton, Dickinson and Co., 649 F.3d 1276, 1291-1292 (Fed. Cir. 2011) (citing
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`Manual of Patent Examining Procedure (“MPEP”) §§ 706, 2111 (8th ed. Rev.8, July 2010)).
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`181.
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`“[E]ven if a district court does not invalidate a claim based on a deliberately
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`withheld reference, the reference may be material if it would have blocked patent issuance under the
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`PTO's different evidentiary standards.” Therasense, Inc. v. Becton, Dickinson and Co., 649 F.3d
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`1276, 1292 (Fed. Cir. 2011) (citing Manual of Patent Examining Procedure (“MPEP”) §§ 706
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`(preponderance of the evidence), 2111 (broadest reasonable construction)).
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`182.
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`“Although but-for materiality generally must be proved to satisfy the materiality
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`prong of inequitable conduct, this court recognizes an exception in cases of affirmative egregious
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`misconduct.” Therasense, Inc. v. Becton, Dickinson and Co., 649 F.3d 1276, 1292 (Fed. Cir. 2011).
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`183.
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`“When the patentee has engaged in affirmative acts of egregious misconduct, such as
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`the filing of an unmistakably false affidavit, the misconduct is material.” Therasense, Inc. v.
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`Becton, Dickinson and Co., 649 F.3d 1276, 1292 (Fed. Cir. 2011) (citing Rohm & Haas Co. v.
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`Crystal Chem. Co., 722 F.2d 1556, 1571 (Fed.Cir.1983) (“there is no room to argue that submission
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`of false affidavits is not material”); Refac Int'l, Ltd. v. Lotus Dev. Corp., 81 F.3d 1576, 1583
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`(Fed.Cir.1996) (finding the intentional omission of declarant's employment with inventor's company
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`rendered the affidavit false and that “[a]ffidavits are inherently material”)). “After all, a patentee is
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`unlikely to go to great lengths to deceive the PTO with a falsehood unless it believes that the
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`falsehood will affect issuance of the patent.” Therasense, 649 F.3d at 1292.
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`184.
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`“A claim for priority is inherently material to patentability because a priority date
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`may determine validity, whether an issue arises in prosecution or later in court challenges to
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`validity” and “[w]hile an active misrepresentation made during prosecution in order to avoid prior
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`art is no doubt ‘highly material,’ a misrepresentation that would not have immediately affected
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`Case 3:08-cv-01512-MMA-MDD Document 451 Filed 12/23/11 Page 32 of 33
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`2.
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`The ’973 Patent is Unenforceable Due to Inequitable Conduct Based on
`the Priority Date Change
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`204. Dr. Michelson’s attorney, Amedeo Ferraro, made false and material statements
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`regarding the priority date during the prosecution of the ’973 patent.
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`205. Dr. Michelson’s attorney, Amedeo Ferraro, committed inequitable conduct during
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`the prosecution of the ’973 patent.
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`206. The ’973 patent is unenforceable due to inequitable conduct during the prosecution
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`of the ’973 patent.
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`3.
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`The ’973 Patent is Unenforceable Due to Inequitable Conduct Based on
`False Statements about the Prior Art
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`207. Dr. Michelson and his attorneys made false statements regarding the prior art during
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`the prosecution of the ’973 patent.
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`208. Dr. Michelson and his attorneys committed inequitable conduct during the
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`prosecution of the ’973 patent.
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`209. The ’973 patent is unenforceable due to inequitable conduct during the prosecution
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`of the ’973 patent.
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`Dated: December 23, 2011
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`FISH & RICHARDSON P.C.
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`By: s/ Todd G. Miller
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`Todd G. Miller
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`Attorneys for Defendant/Counterclaimant/
`Counterclaim Defendant NUVASIVE, INC.
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`Case 3:08-cv-01512-MMA-MDD Document 451 Filed 12/23/11 Page 33 of 33
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a true and correct copy of the above and foregoing
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`document has been served on December 23, 2011 to all counsel of record who are deemed to have
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`consented to electronic service via the Court’s CM/ECF system per Civ LR 5.4(d). Any other
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`counsel of record will be served by U.S. mail or hand delivery.
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`By: s/ Todd G. Miller
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`Todd G. Miller
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