Ex Parte 6936051 et al

Patent Trial and Appeal Board

Oct 24, 2013

95000449 (P.T.A.B. Oct. 24, 2013)

UNITED STATES PATENT AND TRADEMARKOFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
95/000,449 03/12/2009 6936051 101.0056-14REX 9875
22882 7590 10/24/2013
MARTIN & FERRARO, LLP
1557 LAKE O'PINES STREET, NE
HARTVILLE, OH 44632
EXAMINER
CLARK, JEANNE MARIE
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
10/24/2013 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

NuVASIVE, INC.,
Requester and Appellant

v.

ZIMMER SPINE, INC.,
Patent Owner and Respondent
____________

Appeal 2012-003391
Reexamination Control 95/000,449
Patent 6,936,051 B2
Technology Center 3900
____________

Before RICHARD E. SCHAFER, SALLY G. LANE, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON REQUEST FOR REHEARING
This is a Request for Rehearing by Patent Owner under § 41.77(b)(2)
(“Req. Reh’g”) of the PTAB Decision of February 26, 2013 (“February 2013
Decision”). Claim 1 and dependent claims 9, 12, and 13 are pending. In the
February 2013 Decision, three new grounds of rejection were set forth over
independent claim 1, and it was left to the Examiner to determine whether
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the new grounds were applicable to dependent claims 9, 12, and 13
(February 2013 Decision 2 and 8). The three new grounds of rejection are as
follows:
A. Claim 1 under 35 U.S.C. § 103(a) based on U.S. Patent No.
5,364,399 to Lowery et al. (“Lowery”) in view of U.S. Patent No. 3,842,825
to Wagner (“Wagner”);
B. Claim 1 under 35 U.S.C. § 103(a) based on U.S. Patent No.
5,888,223 to Bray (“Bray”) in view of U.S. Patent No. 5,397,363 to Gelbard
(“Gelbard”); and
C. Claim 1 under 35 U.S.C. § 103(a) based solely on Bray.
In view of the comments in this Request for Rehearing, and the new
evidence attached to it, we withdraw the rejections.

CLAIM 1
Claim 1 is representative and reads as follows:
1. A plate system adapted for application to the anterior human
cervical spine and for contacting at least a portion of the
anterior aspects of at least two vertebral bodies, said plate
system comprising:
a plate having a longitudinal axis and a length sufficient
to span a disc space and overlap portions of at least two
adjacent cervical vertebral bodies, said plate having a lower
surface for placement against the vertebral bodies and an upper
surface opposite said lower surface, said lower surface being
concave along a substantial portion of the longitudinal axis of
said plate;
at least two bone screw receiving holes extending
through said plate from said upper surface through said lower
surface, each of said bone screw receiving holes having a
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central longitudinal axis and being adapted to receive a bone
screw to attach for engaging said plate to the cervical spine; and
a lock adapted to overlie at least a portion of said at least
two bone screw receiving holes, said lock having an elongated
segment having a width, a length longer than said width, and a
surface adapted to bear against said plate, said lock being
adapted to engage said plate and being adapted to retain at least
two bone screws to said plate when said length of said
elongated segment is generally transverse to the longitudinal
axis of said plate.

A. REJECTION OVER LOWERY AND WAGNER
Claim 1 stands rejected under 35 U.S.C. § 103(a) as obvious in view
of Lowery and Wagner.
Claim 1 is directed to a “plate system adapted for application to the
anterior human cervical spine and for contacting at least a portion of the
anterior aspects of at least two cervical vertebral bodies.” The system
comprises a “plate” which has sufficient length to span two adjacent
vertebral bodies, at least two bone receiving screws extending through the
plate for attaching the plate to the cervical spine and “a lock adapted to
overlie at least a portion of said at least two bone screw receiving holes.”
The lock has “an elongated segment having a width, a length longer than
said width.” The lock is “adapted to retain at least two bone screws to said
plate when said length of said elongated segment is generally transverse to
the longitudinal axis of said plate.”

Lowery
Lowery is said by Requester to describe a plate system comprising a
plate, bone receiving screws, and a lock adapted to overlie the screw holes
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for the bone receiving screws (Requester § 41.77(c) Comments 13). The
following disclosures, listed as findings of fact (“FF”) from Lowery, are
pertinent:
[FF1] Figure 1 of Lowery, reproduced below, shows a cervical
plating system attached to a cervical spine:

[FF2] Figure 1 shows elongated fixation plate 20 instrumented to
cervical vertebra between C3 and C5 vertebrae. The fixation plate 20 is
engaged to the vertebrae by bone engaging screws 20 (Lowery, col. 5, ll. 1-
13).
[FF3] “Screw fixation means 40 is provided to firmly and rigidly fix
certain of the bone engaging screws to the plate.” (Lowery, col. 5, ll. 13-
15.)
[FF4] Figure 5, reproduced below, is an end cross-sectional view of
fixation plate 20:
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[FF5] Figure 5 shows the bone engaging screw 30 passing through
screw bores 27 of fixation plate 20, enlarged head 32 of screw 30, spherical
recess 28 (screw bore recess) of the screw bores 27 in the plate 20, screw
fixation means 40 comprising locking screw 45, fixation bore 41 having
recessed bore 42 into which screw fixation means 40 inserts (Lowery, col. 6,
l. 15 to col. 7, l. 13). The bone engaging screws 30 are shown just prior to
being completely fixed within the fixation plate 20 (id. at col. 6, 39-41).

[FF6]
One important component of the preferred embodiment of the
invention is screw fixation means [40] for clamping the head of
the bone screws to the plate. Pursuant to this invention, the
screw fixation means [40] engaging the plate [20] at its upper
surface to clamp the bone screw heads [32] within recesses [28]
in the plate. Preferably, the bone screws and the screw fixation
means are configured to reside within recesses in the plate [28
and 42] so that these components are flush with or below the
upper surface of the plate. This aspect realizes an advantage
over prior systems which include components projecting above
the fixation plate [20], leading to irritation and trauma of the
surrounding tissue.
(Lowery, col. 2, l. 61 to col. 3, l. 5.)
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[FF7] Lowery teaches that the screw head is flush with the upper
surface of the bone fixation plate 20:
The truncated spherical aspect of the head allows substantially
the entire screw head 32 to rest entirely within the screw bore
recess 28. In this manner, a portion of the screw head 32 is
substantially flush with the upper surface 22 of the plate, while
the remainder of the screw resides below the upper surface
within the recess 28.
(Lowery, col. 6, ll. 33-39.)
[FF8]
As with other cervical implant systems, the present invention
contemplates some means for fixing the bone engaging screws
30 to the fixation plate 20 to prevent the screws from working
loose over time.
(Lowery, col. 6, ll. 53-56.)
[FF9] The screw fixation means 40 includes a threaded fixation bore
41 formed in the plate 20 between the two screw bores 27 at each end of the
plate (Lowery, col. 6, ll. 58-61). The fixation bore 41 includes a recessed
bore 42 which defined from the upper surface 22 of the plate, as shown in
the cross-sectional view of Figure 4 reproduced below (id. at col. 6, ll. 62-
64).

[FF10] Figure 4 shows the recessed bore 42 for the screw fixation
means.
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[FF11] The fixation means 40 has a locking screw 45 (as shown in
Figure 5) (Lowery, col. 7, ll. 1-4)
The locking screw 45 includes a flat head 47 which is thin
enough to reside entirely within the recessed bore portion 42 in
the plate so that the locking screw is not exposed above the
upper surface 22 of the plate.
(Lowery, col. 7, ll. 4-8.)

Wagner
Requester acknowledges that Lowery does not describe a lock having
“an elongated segment having a width, a length longer than said width” as
recited in claim 1 (Requester § 41.77(c) Comments 13). However,
Requester contends that this “feature . . . was well known in the prior art
cervical plate[s].” (Id.) As evidence, Requester cites Wagner which
Requester stated “discloses that it was known to employ an elongate-shaped
plate at an end portion of a bone plate system so as to cover and retain a
plurality of bone screws.” (Id.) Requester reproduced Figure 4 of Wagner:
[FF12]

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[FF13] Figure 4, reproduced above, shows a “hip fixation device.”
(Wagner, col. 2, ll. 10-11.)
[FF14] Figure 4 shows handle portion 3 and bowl portion 4 (Wagner,
col. 2, ll. 38-40), hip screws 10 having square heads 14 (id. at col. 2, ll. 56-
62), and curved ovular plate 16 which fits over bowl portion 4 which, when
washers 25 and nuts 26 are threaded on to bolts 18, produces compression
“on the heads 14 of screws 10 thereby keeping them in place and preventing
them from backing out of the femur.” (Id. at col. 2, l. 63 to col. 3, l. 13.)

Reason to combine
Requester stated:
One of ordinary skill in the art would have been prompted to
modify Lowery’s lock 45 so as to provide an elongate-shaped
cover plate over the end portion of the Lowery’s bone plate (as
taught by Wagner) to thereby cover the Lowery’s bone screw
heads and exert a “positive compression ... on the heads” that
prevents the bone screws from backing out.
(Requester § 41.77(c) Comments 13.)
Requester states that Wagner teaches that other means can be utilized
to attach a cover plate to the underlying bone plate, and “Lowery discloses
that the bone plate includes a recess configured to receive the perimeter of
the lock.” (Requester § 41.77(c) Comments 14.) To support this argument,
written testimony was provided by Dr. Gary L. Lowery (Lowry Declaration
executed May 10, 2011 (“Lowery Decl.”). Dr. Lowery is an orthopedic
surgeon who, at the time the declaration was executed, was Executive Vice
President for Strategic Development at Paradigm Spine LLC (Lowery Decl.
¶ 1). Dr. Lowery stated that he has “actively engaged in the design of
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medical devices and methods related to orthopedics, and specifically have
designed anterior cervical spine plating systems.” (Id.) Dr. Lowery testified
that his employer is not affiliated with the Requester (id. at 2.) Dr. Lowery
also testified that he did not received compensation for his declaration (id.)
Dr. Lowery testified:
[A] person of ordinary skill in the art prior to the alleged
invention of the ‘051 patent would have known that the cover
plate in the resulting combination can be secured to the plate in
a manner that reduces the profile of the anterior cervical plate
system (e.g., selecting particular fasteners and providing
recesses).
(Lowery Decl. ¶ 17)

Patent Owner’s Arguments
Patent Owner identifies the disclosure in Lowery describing that the
bone engaging screws 30 and screw fixation means 40 are designed to reside
within recesses in the plate to avoid irritation and trauma to the surrounding
tissues (FF6, FF9, and FF11; Req. Reh’g 14-15). Patent Owner contends
that
If Lowery was provided with the cover plate 16 of Wagner,
Patent Owner submits that use of the cover plate 16 would
necessarily contravene the inventive concepts of Lowery.
Unlike the head 47 of the locking screw 45, the cover plate 16
would cover the entirety of the heads 32 of the bone engaging
screws 30, and could not be received in the recessed bore 42.
Thus, the cover plate 16 would cover the upper surface 22 of
the plate 20, and by its very nature, project above the plate 20
contrary to the teachings of Lowery.
(Req. Reh’g 15.)
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In addition, Patent Owner argues that bolts 18, washers 25, and nuts
26 would all protrude above the cover plate and extend into the flesh of the
patient to “create all the worst design features that Lowery teaches to avoid.”
(Req. Reh’g 16.) Thus, Patent Owner contends, providing the plate of
Wagner on Lowery would render Lowery “unsuitable for its intended
purpose” (id.). Because the teachings are so divergent, Patent Owner
contends the one of ordinary skill in the art would not look to combine
Lowery and Wagner (id. at 17).

Discussion
We agree with Patent Owner that Lowery’s bone fixation device with
a flush bone engaging screw and screw fixation means screwed into recessed
bores in the bone fixation plate (FF5-FF7 and FF9-FF11) is a substantially
different configuration than the bulky plate described by Wagner, which
comprises washers and nuts (FF12 & FF14) that would project above the
bone plate, a configuration disparaged by Lowery (FF6). Specifically,
Lowery teaches that
Preferably, the bone screws and the screw fixation means are
configured to reside within recesses in the plate so that these
components are flush with or below the upper surface of the
plate. This aspect realizes an advantage over prior systems
which include components projecting above the fixation plate,
leading to irritation and trauma of the surrounding tissue.
(FF6.)
Thus, Wagner’s device has the structure which Lowery specifically
teaches is disadvantageous, providing a disincentive to have incorporated
Wagner’s cover plate and accompanying bolts and washers into Lowery’s
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bone fixation system. “Under the proper legal standard, a reference will
teach away when it suggests that the developments flowing from its
disclosures are unlikely to produce the objective of applicant’s invention. ”
Syntex (USA) LLC v. Apotex, Inc., 407 F.3d 1371, 1380 (Fed. Cir. 2005)
(citations omitted). In this case, one of ordinary skill in the art would have
been discouraged from applying Wagner to Lowery’s bone fixation device,
because it would result in projections into the tissue, contrary to Lowery’s
objective to have a flush, recessed fixation means.
However, even were it true, as testified by Dr. Lowery, that the skilled
artisan “would have known that the cover plate in the resulting combination
can be secured to the plate in a manner that reduces the profile of the
anterior cervical plate system” (Lowery Decl. ¶ 17), the claimed invention
would still not have been obvious to one of ordinary skill in the art. Claim 1
recites that lock is “adapted to retain at least two bone screws to said plate
when said length of said elongated segment is generally transverse to the
longitudinal axis of said plate.” While Wagner’s elongated plate retains the
bone screws when transverse to the longitudinal axis of the plate, it not
“adapted to retain the bone screws” in this position, but could be utilized in
either the transverse or longitudinal position.
For the foregoing reasons, we reverse rejection A based on Lowery
and Wagner.

REJECTIONS BASED ON BRAY
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Under 37 C.F.R. § 1.131, a reference cited under 35 U.S.C. § 103(a)
may be antedated. According to 37 C.F.R. § 1.131 (a), when any claim of a
patent under reexamination is rejected, “the owner of the patent under
reexamination ... may submit an appropriate oath or declaration to establish
invention of the subject matter of the rejected claim prior to the effective
date of the reference or activity on which the rejection is based.” Therefore,
a declaration under 37 C.F.R. § 1.131 can be used to overcome a rejection
under 35 U.S.C. § 103(a) based on prior art considered applicable under 35
U.S.C. § 102(e). Under § 1.131(b), “[t]he showing of facts shall be such, in
character and weight, as to establish reduction to practice prior to the
effective date of the reference, or conception of the invention prior to the
effective date of the reference coupled with due diligence from prior to said
date to a subsequent reduction to practice or to the filing of the application.”
Bray is a continuation of the Bray parent non-provisional application
(U.S. Serial No. 08/764,089) filed December 6, 1996. Both Bray and the
Bray parent application claim priority to the '365 Bray provisional
application (U.S. Provisional Serial No. 60/008,365) filed December 8,
1995. Patent Owner seeks to antedate Bray by establishing practice of the
claimed invention prior to December 8, 1995. Declarations under § 1.131 to
establish such reduction to practice accompanied the Request for Rehearing.
A petition was granted by the Board to have the declarations entered and
considered (Decision on Petitions dated May 17, 2013).
In the Declaration under 37 C.F.R. § 1.131 by the sole inventor of the
’051 patent, Gary K. Michelson, Dr. Michelson testified that the multilock
anterior cervical plate system was reduced to practice prior to December 8,
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1995 (Michelson Decl. §§ 4-6). Dr. Michelson provided drawings that he
testified were created and dated prior to December 8, 1995, which depict all
the features of claim 1 (id. at p. 2-3 (Exhibit 1)).
Dr. Michelson also provided photographs which he testified are of a
“sample of my multilock anterior cervical plate design” . . . made for me,
confidentially, by Neil A. Haworth prior to December 8, 1995.” (Id. at 4.)
Dr. Michelson describes how the photographs show the limitations of the
claim. Page 4 of the photographs clearly depicts in the lower left corner a
photograph of:
a lock adapted to overlie at least a portion of said at least two
bone screw receiving holes, said lock having an elongated
segment having a width, a length longer than said width, and a
surface adapted to bear against said plate, said lock being
adapted to engage said plate and being adapted to retain at least
two bone screws to said plate when said length of said
elongated segment is generally transverse to the longitudinal
axis of said plate.
The lock is shown mounted in the plate with the bone screw
receiving holes as claimed. The plate is shown on pages 1-3 to have a
“lower surface being concave along a substantial portion of the
longitudinal axis of said plate,” as claimed, and the other claimed
features. (Michelson Decl. ¶ 4.)
Declarations were also provide by two declarants, Bradley
Coates and Neil A. Haworth, who testified to have been shown by Dr.
Michelson, prior to December 6, 1995, the multilock anterior cervical
spine system depicted in the photographs of Exhibit 1.
Mr. Bradley Coates, employed by Sofamor Danek (Appendix
C), testified:
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4. Prior to December 6, 1995, Dr. Michelson came to Sofamor
Danek in Memphis and disclosed to me a multilock anterior
plate for use on a human anterior cervical spine that he had
previously designed.

5. At that meeting, prior to December 6, 1995, Dr. Michelson
showed me the multilock anterior cervical plate displayed in the
photographs, attached as Exhibit 1, under the confidentially
provisions of a Non-Disclosure Agreement signed by Dr.
Michelson and John Pafford for Sofamor Danek, attached as
Exhibit 2.

Mr. Neil A. Haworth testified in his declaration that he was
hired by Dr. Michelson prior to December 6, 1995 to make him
samples of his multilock anterior cervical lock (Haworth Decl. 3).
Mr. Haworth testified that he made the multilock cervical plate system
shown in the photographs of Exhibit 2 prior to December 6, 1995 and
that such plate system had all the features recited in the claim (id. at 5-
7).
Based on the evidence provided, we conclude that sufficient
evidence has been provided establishing that the inventor actually
reduced to practice the subject matter of claim 1, antedating Bray.
Because Bray is antedated and not prior art to the claims, we reverse
Rejections B. and C. based on Bray.

REHEARING GRANTED

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PATENT OWNER:

MARTIN & FERRARO, LLP
1557 LAKE O’PINES STREET, NE
HARTVILLE, OH 44632

THIRD PARTY REQUESTER:

FISH AND RICHARDSON, P.C.
P.O. BOX 1022
MINNEAPOLIS, MN 55440-1022

lb