Medtronic, Inc. v Nuvasive, Inc.

Patent Trial and Appeal Board

Apr 8, 2014

11789284 (P.T.A.B. Apr. 8, 2014)

Trials@uspto.gov Paper 13
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
_______________

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Patent 8,016,767
_______________

Before FRANCISCO C. PRATS, 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 5,
“Pet.”) to institute an inter partes review of claims 1, 2, 4, 5, 10, 15, 17,
and 18 of U.S. Patent No. 8,016,767 (Ex. 1013, “the ’767 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 ’767 patent.

B. Related Matters
Petitioner has petitioned for an additional inter partes review of
claims 1, 2, 4, 5, 10, 15, 17, and 18 of the ’767 patent on other grounds,
IPR2014-00075 (which is being entered concurrently with this decision).
Pet. 1; Paper 8 at 2. Patent Owner has asserted the ’767 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 Cistac DE 100 48 790 A1 Apr. 25, 2002
Ex. 1002 Cistac
1
English Translation of Ex. 1001
Ex. 1003 Obenchain US 5,313,962 May 24, 1994
Ex. 1004 JJB NuVasive, Inc., Modified INS-1
Intraoperative Nerve Surveillance
System, Food & Drug Admin.
submission under 510(k) No.
K013215 (printed Dec. 9, 2011)
Ex. 1005 Koros ’493 US 6,139,493 Oct. 31, 2000
Ex. 1007 Mathews US 5,171,279 Dec. 15, 1992
Ex. 1008 Foley US 5,792,044 Aug. 11, 1998
Ex. 1009 Branch US 6,945,933 B2 Sept. 20, 2005
(filed June 26, 2002)

D. The Asserted Grounds
Petitioner contends that the challenged claims are unpatentable based
on the following specific grounds (Pet. 3-4):
References Basis Claims challenged
Cistac, Obenchain, JJB, and
Koros ’493
§ 103(a) 1, 2, 4, 5, 10, 15, 17,
18
Cistac, Obenchain, JJB,
Koros ’493, Mathews, and Foley
§ 103(a) 1, 2, 4, 5, 10, 15, 17,
18

1
The references to Cistac in the Petition are to the English translation.
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Branch, Obenchain, JJB, and
Koros ’493
§ 103(a) 1, 2, 4, 5, 10, 15, 17,
18
For the reasons described below, we decline to institute an inter partes
review of the challenged claims (1, 2, 4, 5, 10, 15, 17, and 18).

II. ANALYSIS
In its first set of challenges, Petitioner contends that each of the
challenged claims of the ’767 patent is unpatentable for obviousness over
Cistac, Obenchain, JJB, and Koros ’493. Pet. 19-37. In its second set of
challenges, Petitioner contends that each of the challenged claims is
unpatentable for obviousness over Cistac, Obenchain, JJB, Koros ’493,
Mathews, and Foley. Pet. 37-39. In its third set of challenges, Petitioner
contends that each of the challenged claims is unpatentable for obviousness
over Branch, Obenchain, JJB, and Koros ’493. Pet. 40-58. In each of these
grounds, JJB is cited as teaching, inter alia, the nerve sensing features of
independent claim 1, namely:
activating a nerve monitoring system that controls the electrical
stimulation signal output from the stimulation electrode
of the elongate stimulation instrument during delivery of
the elongate stimulation instrument along the lateral,
trans-psoas path to the lumbar spine, the nerve
monitoring system detecting electromyographic (EMG)
activity via a set of EMG sensor electrodes in
communication with muscle myotomes associated with
nerves in the vicinity of the targeted spinal disc; [and]
receiving nerve monitoring information from a video display
device of the nerve monitoring system that
contemporaneously displays: a numeric stimulation
threshold required to obtain the EMG activity in at least
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one of said leg muscle myotomes, and a graphical
representation of a patient, wherein the video display
device is operable to alert a user to at least one of a
presence and absence of a nerve near the elongate
stimulation instrument;
Pet. 30-31, 37, 51-52. No other reference is cited for teaching these features.
Patent Owner argues that each of the challenges in the Petition fails
because JJB is not prior art to the ’767 patent. Prelim. Resp. 16-20.
“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 . . .
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 is a 510(k) premarket notification submission made by Patent
Owner to the United States Food and Drug Administration (“FDA”).
Ex. 1004 at 1-2. 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
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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 from the FDA via a Freedom of Information Act (“FOIA”) request after
the filing date of the ’767 patent. Prelim. Resp. 16. On its face, JJB
indicates that it was requested on December 7, 2011, and printed on
December 9, 2011, after the April 23, 2007, filing date of the ’767 patent
(and after the earlier September 25, 2003, filing date of the provisional
application 60/506,136, to which the ’767 patent claims the benefit).
Ex. 1004 at 1.
Patent Owner argues that it made its 510(k) submission to the FDA
confidentially and that it had a right to make substantial redactions to the
submission prior to its public release pursuant to a FOIA request. Prelim.
Resp. 16-17. According to Patent Owner, the version of JJB obtained from
the FDA in 2011 does not reflect the redactions Patent Owner would have
made in November 2001. Id. at 17-18. Patent Owner argues that Exhibit
1004 is 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 ten years later in 2011.” Id. at 19. Patent
Owner argues that concluding that JJB is prior art because someone, years
later, could obtain it through a FOIA request would be tantamount to
transforming a confidential document into prior art. Id. at 19-20.

Petitioner argues that JJB qualifies as prior art for reasons articulated
in the Declaration of Lee Grant, a Distinguished Regulatory Affairs Advisor
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for Petitioner (“Grant Decl.,” Ex. 1010).
2
Pet. 5. In his declaration,
Mr. Grant provides background information on the FDA’s database of
510(k) submissions, stating that the FDA accepts a 510(k) 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. 1010 ¶¶ 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 would have been indexed sufficiently to constitute a printed
publication. 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 submission
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. 1010 ¶ 14. Based on the
October 16, 2001, date stamped on the top of JJB’s summary sheet
(Ex. 1004 at 2), which Mr. Grant states is the date the FDA cleared the

2
Petitioner’s incorporation of the Grant Declaration as its argument
supporting the prior art status of JJB is improper. See 37 C.F.R.
§ 42.6(a)(3). We have, nevertheless, given this argument and evidence
consideration.
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submitted device for marketing (Ex. 1010 ¶ 10), and his understanding of
FDA procedure, Mr. Grant concludes that JJB would have been available on
or before November 30, 2001. Ex. 1010 ¶ 17. Nevertheless, Mr. Grant 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. 1010 ¶¶ 7, 8, 10, 14), 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. 17), and Mr. Grant concedes
(Ex. 1010 ¶ 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. Assuming that a summary of JJB was posted on the FDA’s
website by November 30, 2001, Patent Owner still would have been given
an opportunity to redact the underlying submission 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
now relied upon by Petitioner would have escaped redaction.
In short, JJB is evidence of what was publicly accessible in 2011,
years after the ’767 patent was filed. Petitioner has not demonstrated that
JJB is representative of what would have been publicly accessible in 2001 or
any time prior to the 2011 date of that document.
Patent Owner also argues that “importantly, absolutely no copies—
redacted or unredacted—of this 510(k) submission [were] ever requested by
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the public or otherwise published before September 23, 2003 (the priority
date of the ’767 patent).” Prelim. Resp. 16. 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 a
submission requested prior to September 23, 2003, because one does not
exist. Accordingly, Petitioner has not demonstrated what information would
have been publically available prior to September 23, 2003.
On this record, we conclude that Petitioner has not shown that JJB, as
presented in this Petition, qualifies as prior art to the ’767 patent.
Because each of the challenges raised in the Petition relies on JJB,
Petitioner has not shown that there is a reasonable likelihood that it would
prevail with respect to any of the challenges in the Petition.

III. CONCLUSION
Petitioner has not shown that JJB is prior art to the ’767 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.

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IV. ORDER
For the reasons given, it is
ORDERED that the Petition challenging the patentability of claims 1,
2, 4, 5, 10, 15, 17, and 18 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