Ex Parte Sweeney

Board of Patent Appeals and Interferences

Sep 25, 2009

10956455 (B.P.A.I. Sep. 25, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte PATRICK J. SWEENEY
____________

Appeal 2009-005030
Application 10/956,455
Technology Center 3700
____________

Decided: September 25, 2009
____________

Before WILLIAM F. PATE III, STEVEN D.A. McCARTHY, and
MICHAEL W. O’NEILL, Administrative Patent Judges.

WILLIAM F. PATE III, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF CASE
This is an appeal from the December 11, 2007 final rejection of
claims 1-20 and 22-25. Claims 21 and 26-35 have been canceled. The
appealed claims are all of the claims remaining in the application. We have
jurisdiction over the appeal under 35 U.S.C. §§ 134 and 6.
The claimed invention is directed to a spinal implant which includes a
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vertebral prosthesis and a spinal fixation device coupled to the prosthesis by
bone screws.
Claim 1, reproduced below, is further illustrative of the claimed
subject matter.
1. A spinal implant system for replacing a damaged
vertebra in a spinal fusion procedure, comprising:

a vertebral prosthesis adapted to be placed at the site of
an excised vertebra between two adjacent vertebrae, the
vertebral prosthesis comprising a shaft having two ends and an
endplate at each end, wherein the shaft is rigid and the
endplates are locked to the shaft to create a rigid structure
suitable for a spinal fusion procedure in which the vertebrae
adjacent to the vertebral prosthesis are fused together with the
vertebral prosthesis as one rigid structure;

a bone screw;

an anchor extending from at least one of the endplates
wherein the anchor is positioned on the endplate such that it is
configured to extend into one of the adjacent vertebrae; and

a spinal fixation device coupled to the prosthesis by the
bone screw, wherein the bone screw is adapted to extend
through at least a portion of one of the adjacent vertebrae.

REFERENCE
The reference of record relied upon by the examiner as evidence of
lack of novelty and obviousness is:
Robioneck US 6,106,557 Aug. 22, 2000

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REJECTIONS
Claims 1-20 and 22-25 stand rejected under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement.
Claims 1-3, 6-10, 13-18, and 22-25 stand rejected under 35 U.S.C.
§ 102 as anticipated by Robioneck.
Claims 4, 5, 11, 12, 19 and 20 stand rejected under 35 U.S.C. § 103 as
unpatentable over Robioneck.

ISSUES
The Examiner states that independent claims 1, 10 and 17 recite that
Appellant’s claimed shaft is rigid and Appellant’s prosthesis is fastened
together to create a rigid structure. According to the Examiner, Appellant’s
originally filed disclosure does not provide written description support for
the rigid claim limitation. Thus, the first issue for consideration on appeal is
whether Appellant has established that the Examiner erred in rejecting
independent claims 1, 10 and 17 as lacking written description support.
With respect to the anticipation rejection of claims 1 and 10,
Appellant argues that the Robioneck reference does not disclose an anchor
extending from one of the endplates configured to extend into one of the
adjacent vertebra. Therefore, the second issue for consideration on appeal is
whether the Appellant has established that the Examiner erred in finding that
Robioneck discloses the claimed anchor.
With respect to the anticipation rejection of claim 17, Appellant
argues that Robioneck is not adjustable. Therefore the third issue for our
consideration is whether the Appellant has established that the Examiner
erred in finding that Robioneck is an adjustable prosthesis.
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With respect to the § 103 rejection of claims 4, 5, 11, 12, 19, and 20,
the Examiner argues that it is well known in the art for bone screws to have
two thread pitches thereon with the thread pitch near the head of the fastener
composed of locking threads to lock the bone screw in position. Therefore,
the final issue for our consideration in this appeal is whether the Appellant
has established that the Examiner erred in concluding that screws comprised
of first and second threaded portions would have been obvious in the context
of the Robioneck disclosure.

FINDINGS OF FACT
Robioneck discloses a spinal implant system for replacing damaged
vertebra in a spinal fusion procedure. The prosthesis is composed of middle
bodies or shafts 10, 12, endplates or end bodies 14 and 16, vertebra body
plates or anchors, 18 and 20, and a fixation device or connection plate 22.
See col. 3, ll. 52-58; Fig. 1. The fixation device 22 and the prosthesis are
connected together by the use of bone screws 102 and distancing screw 92.
See col. 5, ll. 56-61 and col. 5, ll. 44-55. The anchor means 18 and 20
comprise apertures for the bone screws and further comprise spikes 72
which are configured to extend into one of the adjacent vertebra surrounding
the vertebral space where the prosthesis is installed. See col. 5, ll. 27, 28;
col. 6, l. 14. Spikes are best shown in Fig. 9. It appears from Fig. 10 that the
apertures 76, 78 and 74 on the anchors are threaded for bone screws 102.

PRINCIPLES OF LAW
Whether a specification complies with the written description
requirement of 35 U.S.C. § 112, first paragraph, is a question of fact.
Regents of Univ. of Cal. v. Eli Lilly and Co., 119 F.3d 1559, 1566 (Fed. Cir.
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1997), cert. denied, 523 U.S. 1089 (1998)(citing Vas-Cath Inc. v. Mahurkar,
935 F.2d 1555, 1563 (Fed. Cir. 1991)). To fulfill the written description
requirement, a patent specification must describe an invention and do so in
sufficient detail that one skilled in the art can clearly conclude that “the
inventor invented the claimed invention.” Id. (citing Lockwood v. American
Airlines, Inc., 107 F.3d 1565, 1572 (1997) and In re Gosteli, 872 F.2d 1008,
1012 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of
ordinary skill in the art to recognize that [the inventor] invented what is
claimed.”)). Thus, an applicant complies with the written description
requirement “by describing the invention, with all its claimed limitations,
not that which makes it obvious,” and by using “such descriptive means as
words, structures, figures, diagrams, formulas, etc., that set forth the claimed
invention.” Id. (citing Lockwood, 107 F.3d at 1572).
It is important to note that “[t]he invention is, for purposes of the
‘written description’ inquiry, whatever is now claimed.” Vas-Cath, 935 F.2d
at 1564.
The prior art may anticipate a claimed invention, and thereby render it
non-novel, either expressly or inherently. In re Cruciferous Sprout Litig.,
301 F.3d 1343, 1349 (Fed. Cir. 2002). Express anticipation occurs when the
prior art expressly discloses each limitation (i.e., each element) of a claim.
Id. In addition, “[i]t is well settled that a prior art reference may anticipate
when the claim limitations not expressly found in that reference are
nonetheless inherent in it.” Id.
Section 103 forbids issuance of a patent when “the differences
between the subject matter sought to be patented and the prior
art are such that the subject matter as a whole would have been
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obvious at the time the invention was made to a person having
ordinary skill in the art to which said subject matter pertains.”

KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007).
The question of obviousness is resolved on the basis of underlying
factual determinations including (1) the scope and content of the prior art,
(2) any differences between the claimed subject matter and the prior art, (3)
the level of skill in the art, and (4) where in evidence, so-called secondary
considerations. Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966). See
also KSR, 550 U.S. at 406-407 (“While the sequence of these questions
might be reordered in any particular case, the [Graham] factors continue to
define the inquiry that controls.”).

ANALYSIS
As noted in the Principles of Law section above, the question of
whether Appellant has reasonably conveyed possession of the subject matter
of a rigid spinal implant system is a question of fact. The Examiner points
out that the original disclosure does not expressly state that the implant
system is rigid. Appellant points to various places in the Specification
where the Specification states that the system may be used to fuse vertebra
and to create a solid bone in the area that is excised. Appellant also points to
the disclosure that says that the prosthesis can be used to restore normal
height to a portion of the spine. Appellant states that the disclosure of a lock
ring 22 that lock the upper and lower portion together, and the disclosure of
the titanium material of the implant are all facts which in their totality,
points to a rigid structure. To these arguments by Appellant, we also point
to the Figures. and especially Fig. 4 which we believe indicates that the
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prosthesis implant system when installed and fastened together forms a rigid
shaft with a rigid structure. Therefore, on balance, considering Appellant’s
disclosure in its entirety, we believe that the Appellant has established by a
preponderance of evidence, that his original specification conveyed
possession of a rigid shaft and a rigid structure. Therefore, we reverse the
Examiner’s rejection under § 112, first paragraph.
Turning to the rejection of claims 1-3, 6-10, 13-18, and 22-25 under
§ 102, we credit the Examiner’s argument that the presence of spikes 72 on
the anchors or body plates 18, 20, of Robioneck, are a structure that is
configured to extend into one of the adjacent vertebra as in claim 1, or
provide a structure adapted to extend into adjacent vertebra as claimed in
claim 10. We agree with the Examiner that the claimed subject matter does
not require the entire anchor to be in the adjacent vertebra as Appellant
argues.
Appellant notes that his specification states that spikes are
unnecessary. However, spikes are not precluded by Appellant’s claimed
subject matter. In summary, Appellant’s claims 1 and 10 are broad enough
to read on an anchor 18 or 20 wherein a portion of the anchor extends into
the adjacent vertebra. Since spike 72 extends into the adjacent vertebra,
Robioneck meets Appellant’s claims. Furthermore, since Appellant does not
separately argue dependent claims 2, 3, 6-9 and 13-16, we hold that these
claims fall with independent claims 1 and 10 from which they depend.
Turning to the rejection of claim 17, a separately argued independent
claim, we agree with Appellant that Robioneck does not disclose a vertebral
prosthesis wherein the height of the shaft is adjustable after implantation in
the patient. The Examiner’s argument that the device could be somehow
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compressed or deformed after implantation, or that the device could exhibit
expansion through heating are mere speculation. They do not provide
evidence sufficient to support a finding of lack of novelty. Therefore, the
rejection of claims 17, 18, and 22-25 is reversed.
Turning to the rejection of claims 4, 5, 11, 12, 19 and 20 under § 103,
we also reverse the rejection of these claims. We acknowledge the
Examiner’s argument that it is known in the art for bone screws to be
furnished with a second thread pitch to act as locking screws to prevent back
out as well as to keep plates from shifting inside a patient. We further
acknowledge that Robioneck appears to shows that apertures in the anchors
18, 20 are threaded. However, even presupposing that the Examiner’s
double pitch bone screws are well known in the art, it appears that the
anchors 18, 20 of Robioneck mate with the single pitch screws shown in
Robioneck. Presumably if bone screws with two different pitches were
installed in the device of Robioneck, they would be configured to provide a
second pitch near the head to lock the bone screw into the fixation or
connection plate 22 rather than to anchors 18, 20. There does not appear to
be a teaching of changing the thread of the aperture in anchors 18, 20 to
accommodate the second pitch. Thus, Appellant has shown that the
Examiner erred in rejecting claims 4, 5, 11, 12, 19 and 20 under § 103.

CONCLUSIONS
Appellant has established that the Examiner erred in rejecting claims
1-20 and 22-25 under § 112, first paragraph.
Appellant has not established that the Examiner erred in rejecting
1-3, 6-10, 13-16 under 35 U.S.C. § 102.
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Appellant has established that the Examiner erred in rejecting claims
17, 18, and 22-25 under 35 U.S.C. § 102.
The Appellant has established that the Examiner erred in rejecting
claims 4, 5, 11, 12, 19, and 20 under 35 U.S.C. § 103.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv) (2007).

AFFIRMED-IN-PART

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