Medtronic, Inc. v Nuvasive, Inc.

Patent Trial and Appeal Board

Apr 8, 2014

12628549 (P.T.A.B. Apr. 8, 2014)

Trials@uspto.gov Paper 10
Tel: 571-272-7822 Entered: April 8, 2014
UNITED STATES PATENT AND TRADEMARK OFFICE
_______________
BEFORE THE PATENT TRIAL AND APPEAL BOARD
_______________
MEDTRONIC, INC.
Petitioner
v.
NUVASIVE, INC.
Patent Owner
_______________

Case IPR2014-00035
Patent 8,000,782
_______________

Before DEBORAH KATZ, SCOTT E. KAMHOLZ,
and DAVID C. McKONE, Administrative Patent Judges.

McKONE, Administrative Patent Judge.

DECISION
Denying Institution of Inter Partes Review
37 C.F.R. § 42.108

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I. INTRODUCTION
A. Background
Medtronic, Inc. (“Petitioner”) filed a Corrected Petition (Paper 6,
“Pet.”) to institute an inter partes review of claims 1, 5, 7-9, 13-18, and 20
of U.S. Patent No. 8,000,782 (Ex. 1015, “the ’782 patent”). See 35 U.S.C.
§ 311. NuVasive, Inc. (“Patent Owner”) filed a Preliminary Response
(Paper 9, “Prelim. Resp.”).
The standard for instituting an inter partes review is set forth in
35 U.S.C. § 314(a), which provides as follows:
THRESHOLD.—The Director may not authorize an
inter partes review to be instituted unless the
Director determines that the information presented
in the petition filed under section 311 and any
response filed under section 313 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.
We determine that the record before us does not demonstrate that
there is a reasonable likelihood that Petitioner would prevail with respect to
at least one challenged claim. We consequently deny the petition and
decline to institute an inter partes review of the ’782 patent.

B. Related Matters
Petitioner has petitioned for an additional inter partes review of
claims 1, 5, 7-9, 13-18, and 20 of the ’782 patent on other grounds,
IPR2014-00034 (which is being entered concurrently with this decision).
Pet. 1; Paper 8 at 2. Patent Owner has asserted the ’782 patent against
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Petitioner in Warsaw Orthopedic Inc. v. NuVasive Inc., Case No. 3:12-cv-
02738-CAB-MDD (S.D. Cal.). Pet. 1; Paper 8 at 2.

C. References Relied Upon
Petitioner relies upon the following prior art references:
Ex. 1001 Smith US 6,679,833 B2 Jan. 20, 2004
(filed Mar. 23, 2001)
Ex. 1002 Obenchain US 5,195,541 Mar. 23, 1993
Ex. 1003 Prass US 6,292,701 B1 Sept. 18, 2001
Ex. 1004 Simonson US 6,159,179 Dec. 12, 2000
Ex. 1005 Mathews US 5,171,279 Dec. 15, 1992
Ex. 1006 Shmulewitz US 6,095,987 Aug. 1, 2000
Ex. 1007 Isley Michael R. Isley et al., Recent
Advances in Intraoperative
Neuromonitoring of Spinal Cord
Function: Pedicle Screw Stimulation
Techniques, vol. 37, no. 2 AM. J.
ELECTRONEURODIAGNOSTIC TECH.,
at 93-126 (June 1997)
Ex. 1008 Epoch 2000 Axon Systems, Inc., Epoch 2000
Neurological Workstation, Food &
Drug Admin. submission under
510(k) No. K971819
Ex. 1009 INS-1 NuVasive, Inc., INS-1 Intraoperative
Nerve Surveillance Sys., Food &
Drug Admin. submission under
510(k) No. K002677 (printed
Aug. 25, 2011)
Ex. 1010 JJB System NuVasive, Inc., Modified INS-1
Intraoperative Nerve Surveillance
System, Food & Drug Admin.
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submission under 510(k) No.
K013215 (printed Dec. 9, 2011)
Ex. 1011 NIM Guide MEDTRONIC XOMED SURGICAL
PRODUCTS, INC., NIM-RESPONSE,
NERVE INTEGRITY MONITOR,
INTRAOPERATIVE EMG MONITOR
USER’S GUIDE (2000)

D. The Asserted Grounds
Petitioner contends that the challenged claims are unpatentable based
on the following specific grounds (Pet. 2-4):
References Basis Claims challenged
JJB System and Obenchain § 103(a) 1, 5
JJB System, Obenchain, and
Mathews
§ 103(a) 7
JJB System, Obenchain, and
Simonson
§ 103(a) 8
JJB System, Obenchain, and Isley § 103(a) 9, 13-18
JJB System, Obenchain, Isley, and
Epoch 2000
§ 103(a) 20
JJB System, Obenchain, Isley, and
NIM Guide
§ 103(a) 17, 18, 20
JJB System, Obenchain, and
Shmulewitz
§ 103(a) 5
JJB System, Obenchain, Isley, NIM
Guide, and Shmulewitz
§ 103(a) 9, 13-18, 20
Smith, INS-1, and Obenchain § 103(a) 1, 7
Smith, INS-1, Obenchain, and Prass § 103(a) 5
Smith, INS-1, Obenchain, and
Simonson
§ 103(a) 8
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Smith, INS-1, Obenchain, Isley, and
Prass
§ 103(a) 9, 13-18, 20
Smith, INS-1, Obenchain, Isley,
Prass, and NIM Guide
§ 103(a) 17, 18, 20
Smith, INS-1, Obenchain, Isley,
Prass, and Epoch 2000
§ 103(a) 17, 18, 20
Smith, INS-1, Obenchain, Prass,
and Shmulewitz
§ 103(a) 5
Smith, INS-1, Obenchain, Prass,
Isley, NIM Guide, and Shmulewitz
§ 103(a) 9, 13-18, 20
For the reasons described below, we decline to institute an inter partes
review of the challenged claims (1, 5, 7-9, 13-18, and 20).

II. ANALYSIS
In its first set of challenges, Petitioner contends that claims 1 and 5 of
the ’782 patent are unpatentable for obviousness over JJB System and
Obenchain. Pet. 19-28. Petitioner further contends that claims 7-9, 13-18,
and 20 are unpatentable for obviousness over JJB System, Obenchain, and
various other references. Id. at 19-38. In its second set of challenges,
Petitioner contends that claims 1 and 7 of the ’782 patent are unpatentable
for obviousness over Smith, INS-1, and Obenchain. Pet. 29-49. Petitioner
further contends that claims 5, 8, 9, 13-18, and 20 are unpatentable for
obviousness over Smith, INS-1, Obenchain, and various other references.
Id. at 29-60. Patent Owner argues that each of the challenges in the Petition
fails because JJB System and INS-1 are not prior art to the ’782 patent.
Prelim. Resp. 19-27.
“A person shall be entitled to a patent unless . . . the invention was
patented or described in a printed publication in this or a foreign country . . .
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more than one year prior to the date of the application for patent . . . .”
35 U.S.C. § 102(b) (pre-Leahy-Smith America Invents Act) (emphasis
added). The Federal Circuit has held that “public accessibility” is the
touchstone in determining whether a reference is a “printed publication”
under Section 102(b). In re Hall, 781 F.2d 897, 898-99 (Fed. Cir. 1986).
“A reference is publicly accessible ‘upon a satisfactory showing that such
document has been disseminated or otherwise made available to the extent
that persons interested and ordinarily skilled in the subject matter or art
exercising reasonable diligence, can locate it . . . .’” Kyocera Wireless Corp.
v. Int’l Trade Comm’n, 545 F.3d 1340, 1350 (Fed. Cir. 2008) (quoting SRI
Int’l, Inc. v. Internet Sec. Sys. Inc., 511 F.3d 1186, 1194 (Fed. Cir. 2008)).
Whether a reference is a printed publication is a legal question based on
underlying factual determinations. Kyocera, 545 F.3d at 1350.
JJB System and INS-1 are both 510(k) premarket notification
submissions made by Patent Owner to the United States Food and Drug
Administration (“FDA”). Ex. 1009 at 2-3; Ex. 1010 at 1, 3. See also
21 C.F.R. § 807.3(p) (“510(k) statement means a statement, made under
section 513(i) of the act, asserting that all information in a premarket
notification submission regarding safety and effectiveness will be made
available within 30 days of request by any person if the device described in
the premarket notification submission is determined to be substantially
equivalent.”). According to Patent Owner, Petitioner obtained JJB System
and INS-1 from the FDA via Freedom of Information Act (“FOIA”) requests
after the filing date of the ’782 patent. Prelim. Resp. 19, 24. On its face,
JJB System indicates that it was requested on December 7, 2011, and printed
on December 9, 2011, after the December 1, 2009, filing date of the ’782
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patent (and after the earlier September 25, 2002, filing date of the PCT
application, to which the ’782 patent claims priority). Ex. 1010 at 1.
Similarly, INS-1 states on its face that it was requested and printed on
August 25, 2011. Ex. 1009 at 1.
Patent Owner argues that it made its 510(k) submissions to the FDA
confidentially and that it had a right to make substantial redactions to the
submissions prior to their public release pursuant to FOIA requests. Prelim.
Resp. 19, 24. According to Patent Owner, the versions of JJB System and
INS-1 obtained from the FDA in 2011 do not reflect the redactions Patent
Owner would have made in October 2001 (approximately one year before
the earliest priority date of the ’782 patent). Prelim. Resp. 20, 25. Patent
Owner argues that Exhibits 1009 and 1010 are not identical to what would
have been available in 2001. Id. Rather, according to Patent Owner,
“[p]lenty of information in the 510(k) submission for the JJB System would
have been confidential in 2001 that was likely no longer confidential in
2011.” Prelim. Resp. 22; see also id. at 25. Patent Owner argues that
concluding that JJB System and INS-1 are prior art because someone, years
later, could obtain them through a FOIA request would be tantamount to
transforming confidential documents into prior art. Id. at 23.

Petitioner argues that JJB System and INS-1 qualify as prior art for
reasons articulated in the Declaration of Lee Grant, a Distinguished
Regulatory Affairs Advisor for Petitioner (“Grant Decl.,” Ex. 1013).
1
Pet. 4.

1
Petitioner’s incorporation of the Grant Declaration as its argument
supporting the prior art status of JJB System and INS-1 is improper.
See 37 C.F.R. § 42.6(a)(3). We have, nevertheless, given this argument and
evidence consideration.
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In his declaration, Mr. Grant provides background information on the FDA’s
database of 510(k) submissions, stating that the FDA accepts a submission,
stamps the submission with a date after the device described in the
submission is cleared for marketing, and publishes a summary of the
submission on its website. Ex. 1013 ¶¶ 9-10. According to Mr. Grant, the
summary includes the device name, the classification, the applicant, and the
product code of the device. Id. ¶ 10. Mr. Grant also states that the FDA
maintains a searchable database of releasable submissions and has done so
since November 1995. Id. ¶¶ 11-13. These statements by Mr. Grant address
whether JJB System and INS-1 would have been sufficiently indexed to
constitute printed publications. See generally Cordis Corp. v. Boston
Scientific Corp., 561 F.3d 1319, 1333 (Fed. Cir. 2009) (“Many of our cases
in this area have concerned publications available in libraries, and the
question has been whether the publication has been sufficiently indexed to
be publicly accessible.”).
Mr. Grant, however, does not address the content of the submissions
that would have been available. Mr. Grant states that 510(k) submissions
have been available to the public through FOIA requests since 1996, but
acknowledges that the submitter is permitted to “redact any portion of the
510(k) the submitter deems confidential.” Ex. 1013 ¶ 14. Based on the
November 13, 2000, and October 16, 2001, dates stamped on the top of the
summary sheets (Ex. 1009 at 2; Ex. 1010 at 1), which Mr. Grant states are
the dates the FDA cleared the submitted devices for marketing (Ex. 1013
¶ 10), and his understanding of FDA procedure, Mr. Grant concludes that
INS-1 would have been available by FOIA request on or before December
31, 2000, and that JJB System would have been available on or before
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November 30, 2001. Ex. 1013 ¶¶ 16-17. Mr. Grant, however, does not
provide any detail as to what portions of the submissions would have been
available in unredacted form.
According to the FDA’s rules, 510(k) submissions are kept
confidential by the FDA at least until certain conditions occur. For example,
21 C.F.R. § 807.95, cited by Mr. Grant (Ex. 1013 ¶¶ 7, 8, 10, 4), specifies
conditions under which the FDA will disclose the existence and the content
of such premarket notification submissions. Part 20 of 21 C.F.R. provides
exemptions from such disclosures. See 21 C.F.R. §§ 20.60-20.67, 807.95(e).
As Patent Owner argues (Prelim. Resp. 19), and Mr. Grant concedes
(Ex. 1013 ¶ 14), the submitter is given an opportunity to redact its
submission prior to the submission being released to the public pursuant to a
FOIA request. Indeed, Epoch 2000, another 510(k) submission, provides an
example letter from the FDA requesting redaction (Ex. 1009 at 2) and the
submitter’s response (Ex. 1009 at 1). Assuming that summaries of INS-1
and JJB System were posted on the FDA’s website by December 31, 2000,
and November 30, 2001, respectively, Patent Owner still would have been
given an opportunity to redact the underlying submissions prior to disclosure
to a member of the public. Despite acknowledging this opportunity to
redact, Petitioner has not directed us to evidence demonstrating that the
portions of INS-1 and JJB System now relied upon by Petitioner would have
escaped redaction.
In short, INS-1 and JJB System are evidence of what was publicly
accessible in 2011, years after the ’782 patent was filed. Petitioner has not
demonstrated that INS-1 and JJB System are representative of what would
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have been publicly accessible in 2000, 2001, or any time prior to the 2011
dates of those documents.
Patent Owner also argues that “importantly, absolutely no copies—
redacted or unredacted—of these 510(k) submissions were ever requested by
the public or otherwise published before September 25, 2002.” Prelim.
Resp. 19. Though actual receipt of information is not required to determine
that the information is prior art, see Constant v. Advanced Micro-Devices,
Inc., 848 F.2d 1560, 1569 (Fed. Cir. 1988) (“[i]f accessibility is proved,
there is no requirement to show that particular members of the public
actually received the information.”), Patent Owner’s argument highlights
that the evidence Petitioner provided is only representative of what was
publicly available in 2011. Petitioner has not and, according to Patent
Owner, cannot introduce submissions requested prior to September 25,
2002, because they do not exist. Accordingly, Petitioner has not
demonstrated what information would have been publically available prior
to September 25, 2002.
On this record, we conclude that Petitioner has not shown that INS-1
and JJB System, as presented in this Petition, qualify as prior art to the ’782
patent.
Because each of the challenges raised in the Petition relies on either
INS-1 or JJB System, Petitioner has not shown that there is a reasonable
likelihood that it would prevail with respect to any of the challenges in the
Petition.

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III. CONCLUSION
Petitioner has not shown that JJB System and INS-1 are prior art to
the ’782 patent. Thus, Petitioner has not shown that there is a reasonable
likelihood that it would prevail with respect to at least one of the claims
challenged in the Petition. The Petition is denied.

IV. ORDER
For the reasons given, it is
ORDERED that the Petition challenging the patentability of claims 1,
5, 7-9, 13-18, and 20 is denied.

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PETITIONER:

Justin J. Oliver
Brian L. Klock
Fitzpatrick, Cella, Harper & Scinto
975 F Street, NW Fourth Floor
Washington, DC 20004

PATENT OWNER:

Stephen R. Schaefer
Michael T. Hawkins
3200 RBC Plaza
60 South Sixth Street
Minneapolis, MN 55402