Case IPR2013-00206; U.S. Patent No. 8,251,997
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
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`NUVASIVE, INC.
`Petitioner
`
`v.
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`WARSAW ORTHOPEDIC, INC.
`Patent Owner
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`_____________________________
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`Case IPR2013-00206
`Patent No. 8,251,997
`_____________________________
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`
`
`BRIEF IN RESPONSE TO REMAND FROM
`THE U.S. COURT OF APPEALS FOR THE FEDERAL CIRCUIT
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`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`
`
`NUVASIVE, INC.
`Petitioner
`
`v.
`
`WARSAW ORTHOPEDIC, INC.
`Patent Owner
`
`_____________________________
`
`Case IPR2013-00206
`Patent No. 8,251,997
`_____________________________
`
`
`
`BRIEF IN RESPONSE TO REMAND FROM
`THE U.S. COURT OF APPEALS FOR THE FEDERAL CIRCUIT
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
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`Case IPR2013-00206; U.S. Patent No. 8,251,997
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`TABLE OF CONTENTS
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`I.
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`Disclosure of the “at least two elongated portions” in the ‘997 patent. ........ 2
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`II.
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`Jacobson does not disclose the “positioning…over” recitation of
`independent claim 17. .................................................................................... 4
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`III. The reasoning articulated in the Petition with respect to Jacobson is flawed.
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` IV.
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` Conclusion………………………………………………………………….8
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`Case IPR2013-00206; U.S. Patent No. 8,251,997
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`TABLE OF AUTHORITIES
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`Statutes
`35 U.S.C. § 103(a) .................................................................................................5, 7
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`WARSAW2065
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`WARSAW2066
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`WARSAW2067
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`WARSAW2068
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`Case IPR2013-00206; U.S. Patent No. 8,251,997
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`LIST OF NEW EXHIBITS
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`In re: Warsaw Orthopedic, Inc., Decision of U.S. Court
`of Appeals for the Federal Circuit, Appeal Nos.
`2015-1049 and 2015-1050, decided August 9, 2016.
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`Warsaw Orthopedic, Inc.’s Opening and Response Brief,
`Appeal Nos. 2015-1049, -1050, and -1058, dated May 29,
`2015.
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`NuVasive’s Corrected Opening Brief, Appeal Nos.
`2015-1049, -1050, -1058, dated February 19, 2015.
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`Corrected Brief for Intervenor – Director of the U.S.
`Patent and Trademark Office, Appeal Nos. 2015-1049, -
`1050, -1058, dated July 14, 2015.
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`Case IPR2013-00206; U.S. Patent No. 8,251,997
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`In a Decision dated August 9, 2016 (attached hereto as Exhibit
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`WARSAW2065), the U.S. Court of Appeals for the Federal Circuit (“Federal
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`Circuit”) has remanded claims 17-23 (including independent claim 17) of U.S.
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`Patent No. 8,251,997 (“’997 patent”) to the Board for further consideration in light
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`of U.S. Patent No. 4,545,374 to Jacobson (“Jacobson”).
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`The Federal Circuit indicated that it cannot be readily discerned “that the
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`PTAB’s decision as to the ‘elongated portions’ limitation in claim 17 followed the
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`proper path” to making its decision, because “[t]he PTAB’s affirmative narrative in
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`support of its finding that Jacobson discloses the subject limitation in claim 17
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`consists of a single sentence,” and “[t]he PTAB’s conclusory assertion that Figure
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`5 of Jacobson ‘appears to’ support its finding does not equate to the reasoned
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`explanation needed to support its conclusion.” (Exhibit WARSAW2065 at page
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`13.) As such, the Federal Circuit indicated that this issue is remanded “to the
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`PTAB for additional explanation.” (Exhibit WARSAW2065 at page 14.)
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`In an Order dated November 16, 2016 (“November 2016 Order”), the Board
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`determined that additional briefing was warranted in view of the remand from the
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`Federal Circuit, and indicated that “Patent Owner is authorized to file a brief
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`limited to ten pages for the sole purpose of addressing the ‘elongated portions’
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`limitation of [independent] claim 17,” and “Patent Owner may file as exhibits
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`briefs presented to the Federal Circuit, and may also cite to evidence of record.”
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`1
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`Case IPR2013-00206; U.S. Patent No. 8,251,997
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`(November 2016 Order at pages 2 and 3.) Patent Owner therefore submits this
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`brief to address the “elongated portions” limitation of independent claim 17, and
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`files the briefing presented to the Federal Circuit as Exhibits WARSAW2066,
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`WARSAW2067, and WARSAW2068.
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`Patent Owner submits that, for the following reasons, the Board must reverse
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`the rejection of claim 17 under 35 U.S.C. § 103(a) based on the combination of
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`Jacobson, Leu et al., “Percutaneous fusion of the lumbar spine,” SPINE: State of
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`the Art Reviews, Vol. 6, No. 3, Sep. 1992 (“Leu”), and U.S. Patent No. 5,192,327
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`to Brantigan (“Brantigan”).
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`I.
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`Disclosure of the “at least two elongated portions” in the ’997 patent.
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`Independent claim 17 recites a third surgical instrument having “at least two
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`elongated portions for insertion into the patient, each of said elongated portions
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`having a length, a width, and a thickness, said length of each of said at least two
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`elongated portions being greater than the width and the thickness of said at least
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`two elongated portions, each of said at least two elongated portions have a cross
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`section through the width and the thickness and perpendicular to the length of said
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`at least two elongated portions, respectively, each cross section of said at least two
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`elongated portions having a convex exterior surface, said convex surfaces of each
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`of said at least two elongated portions having the same curvature.”
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`2
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`Case IPR2013-00206; U.S. Patent No. 8,251,997
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`Furthermore, exemplary “at least two elongated portions” are depicted as
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`prongs 149 and 150 formed on extended outer sleeve 140 in Figs. 7, 7A, 9-13, 16-
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`20, and 22 of the ’997 patent. Of these figures of the ’997 patent, Figs. 11 and 12
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`are included below to illustrate the prongs 149 and 150.
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`As discussed in the ’997 patent, “[t]he extended outer sleeve 140 has at its
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`distal end 146…two prongs 149 and 150 sufficiently spaced apart to penetrate and
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`3
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`Case IPR2013-00206; U.S. Patent No. 8,251,997
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`hold fixed the two adjacent vertebrae T7 and T8.” (’997 patent at column 10, lines
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`32-36.) In fact, the ’997 patent only describes and illustrates elongated portions
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`that are spaced apart further than the height of the disc space. (’997 patent at
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`column 10, lines 32-40, column 11, lines 51-57, and column 13, lines 12-17, and
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`Figs. 7, 7A, 9-13, 16-20, and 22.) The spacing between prongs 149 and 150
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`permits the instrument to be positioned above the adjacent vertebrae, as depicted in
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`Figs. 7, 9-13, 16-20, and 22, and as such, provides a clear surgical path to
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`the entire height of the disc space for subsequent insertion of an implant, not just
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`part of the disc space. Independent claim 17 recites “positioning said third surgical
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`instrument such that at least part of one of said at least two elongated portions is
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`over one of the two adjacent vertebrae and at least part of another of said at least
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`two elongated portions is over the other of the two adjacent vertebrae” (emphasis
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`added), hereinafter the “positioning…over” recitation. Thus, the proper
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`construction of the “positioning…over” recitation in light of the specification and
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`drawings of the ’997 patent requires positioning of the at least two elongated
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`portions directly over the adjacent vertebrae.
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`II.
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`Jacobson does not disclose the “positioning…over” recitation of
`independent claim 17.
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`Jacobson discloses anchor wires 14 for anchoring a cannula 11 to the disc.
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`According to Jacobson, “FIG. 6 shows the cannula 11 anchored into a disc with
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`anchor means,” and “[a]s shown, the anchor means is one or more pieces of wire
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`4
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`Case IPR2013-00206; U.S. Patent No. 8,251,997
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`14 which are advanced into the disc capsule so that they will prevent relative
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`shearing movement between the cannula and the disc.” (Jacobson at column 7,
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`lines 3-7.) The positioning of the anchor wires 14 is depicted in Figs. 5 and 6 of
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`Jacobson included below.
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`As depicted in Figs. 5 and 6 and discussed therein, Jacobson’s anchor wires
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`14 are positioned over the disc and disc space, and thus, the anchor wires 14 cannot
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`be positioned over (or even partly) over the adjacent vertebrae as required for the
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`“elongated portions” recited in claim 17 of the ’997 patent. Furthermore, as
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`discussed below, reading Jacobson otherwise does not comport with the proper
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`construction of the “positioning…over” recitation. As such, Jacobson does not
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`disclose the “positioning…over” recitation of independent claim 17.
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`5
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`Case IPR2013-00206; U.S. Patent No. 8,251,997
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`III. The reasoning articulated in the Petition with respect to Jacobson is
`flawed.
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`In its Petition for Inter Partes Review at page 29, the Petitioner contends
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`that “Jacobson discloses that the distally extending tips of the ‘anchor wires’ are
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`‘positioned over’ the adjacent vertebrae, as explicitly depicted in the annotated
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`figure [included below].”
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`To the extent that the Board relied on the Petitioner’s argument and
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`implicitly construed the “positioning…over” recitation to include all of the items
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`indirectly below the anchor wires 14 in Figs. 5 and 6 of Jacobson in the same
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`vertical plane, rather than just the disc and disc space over which the anchor wires
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`14 are actually positioned, Patent Owner submits that such a claim construction is
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`unreasonable and inconsistent with the ’997 patent.
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`6
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`Case IPR2013-00206; U.S. Patent No. 8,251,997
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`First, the ’997 patent, as discussed above, only describes and illustrates
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`elongated portions that are spaced apart further than the height of the disc space,
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`and the spacing between the elongated portions and positioning of the elongated
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`portions above the adjacent vertebrae affords the creation of a clear surgical path to
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`the entire height of the disc space. The same would not be true if positioning over
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`the disc or disc space was sufficient to meet the “positioning…over” recitation
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`based on the theory that vertebrae are buried beneath.
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`Second, the plain language of the “positioning…over” recitation suggests an
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`unobstructed path between two objects. The anchor wires 14 are not positioned
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`over adjacent vertebral bodies, rather they are “positioned over” the disc and disc
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`space. Construing the claim in the manner advanced by Petitioner is as
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`unreasonable as construing the claims such that the elongated portions are
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`“positioned over” the operating table, the operating room floor, or the hospital
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`basement below the operating room.
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`As such, reading the “positioning…over” recitation to include the vertebrae
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`buried beneath the disc and disc space does not comport with the proper
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`7
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`construction thereof.
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`Case IPR2013-00206; U.S. Patent No. 8,251,997
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`IV. Conclusion.
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`Because Jacobson does not disclose the “positioning…over” recitation of
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`independent claim 17, Patent Owner submits that the rejection under 35 U.S.C.
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`§ 103(a) based on the combination of Jacobson, Leu, and Brantigan fails. Thus,
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`independent claim 17 and its dependent claims are patentable.
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`Dated: December 9, 2016
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`Respectfully submitted,
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`
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`/Thomas H. Martin/
`
`Thomas H. Martin
`Registration No. 34,383
`Attorney for Patent Owner
`MARTIN & FERRARO, LLP
`1557 Lake O’Pines Street, NE
`Hartville, Ohio 44632
`Telephone: (330) 877-0700
`Facsimile: (330) 877-2030
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`Case IPR2013-00206; U.S. Patent No. 8,251,997
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`CERTIFICATE OF SERVICE
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`
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`The undersigned hereby certifies that a copy of BRIEF IN RESPONSE TO
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`REMAND FROM THE U.S. COURT OF APPEALS FOR THE FEDERAL
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`CIRCUIT was served in its entirety via electronic mail to APSI@fr.com
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`(referencing Attorney Docket No. 13958-0112IP2) and cc'ing:
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`Stephen R. Schaefer
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`Email: schaefer@fr.com
`
`Michael T. Rosato
`Wilson Sonsini Goodrich & Rosati
`701 Fifth Avenue
`Suite 5100
`Seattle, WA 98104-7036
`Email: mrosato@wsgr.com
`
`Michael T. Hawkins
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`Email: hawkins@fr.com
`
`Paul D. Tripodi II
`Wilson Sonsini Goodrich & Rosati
`633 West Fifth Street
`Suite 1550
`Los Angeles, CA 90071-2005
`Email: ptripodi@wsgr.com
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`Date of Service:
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`December 9, 2016
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`/Thomas H. Martin/
`Signature:
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`Thomas H. Martin, Reg. No. 34,383
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`9
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