Ex Parte Reo et al

Patent Trial and Appeal Board

Nov 15, 2017

12434515 (P.T.A.B. Nov. 15, 2017)

UNITED STATES PATENT AND TRADEMARK OFFICE
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.
12/434,515 05/01/2009 Michael L. Reo 1388
109587 7590 11/16/2017
SPINAL KINETICS, Inc.
501 Mercury Drive
Sunnyvale, CA 94085
EXAMINER
JOHANAS, JACQUELINE T
ART UNIT PAPER NUMBER
3733
MAIL DATE DELIVERY MODE
11/16/2017 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
________________

Ex parte MICHAEL L. REO and SHIGERU TANAKA1
________________

Appeal 2016-002236
Application 12/434,515
Technology Center 3700
________________

Before RICHARD M. LEBOVITZ, JOHN G. NEW, and
TIMOTHY G. MAJORS, Administrative Patent Judges.

NEW, Administrative Patent Judge.

DECISION ON APPEAL

1Appellants state that the real party-in-interest is Spinal Kinetics Inc. App.
Br. 3.
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SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 1–39. Specifically, claims 1–7, 10–12,
14–21, 24–26, 28–33, 35–37 and 39 stand rejected as unpatentable under 35
U.S.C. § 103(a) as being obvious over Reo et al. (US 2007/0050033 A1,
March 1, 2007) (“Reo”).
Claims 8, 9, 22, 23, and 34 stand rejected as unpatentable under 35
U.S.C. § 103(a) as being obvious over the combination of Reo and Paes et
al. (US 6,436,142 B1, August 20, 2002) (“Paes”).
Claims 1, 13 15, 27, 30, and 38 stand rejected as unpatentable under
35 U.S.C. § 103(a) as being obvious over the combination of Reo and Slivka
et al. (US 2009/0005873 A1, January 1, 2009) (“Slivka”).
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

NATURE OF THE CLAIMED INVENTION
Appellants’ invention is directed to spinal stabilization devices that
may be introduced into the spine via surgical procedures. Abstract.

REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. An interspinous process spinal stabilization device
implantable between upper and lower spinous processes of
adjacent vertebrae in a spine, the spine having a spinal axis that
is substantially parallel with the spinal cord in the spine, the
device comprising:

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a.) an upper end plate configured to attach to an upper
spinous process with a first fixation structure, and further
configured with a cavity situated opposite from the first fixation
structure, the cavity substantially conforming in shape to a
compressible, elastic, polymeric core member,

b.) a lower end plate configured to attach to a lower
spinous process with a second fixation structure, and further
configured with a cavity situated opposite from the second
fixation structure, the cavity substantially conforming in shape to
the compressible, elastic, polymeric core member,

c.) one or more flexible members selected from the group
consisting of fibers, ribbons, and membranes extending between
the upper end plate and the lower end plate and associating
movement in one end plate with movement in the other end plate,
and

d.) said compressible, elastic, polymeric core member
having a core axis along a core length, the core member having
dimensions perpendicular to the core length that are all shorter
than the core length, the core axis forming an included angle with
the spinal axis greater than about 35° to and including 90°.

App. Br. 30.

ISSUES AND ANALYSES
We decline to adopt the Examiner’s findings of fact and conclusions
that the appealed claims are obvious over the cited prior art. We address the
arguments raised by Appellants below.

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A. Rejection of claims 1–7, 10–12, and 14 over Reo
Issue
Appellants argue that the Examiner erred in finding that Reo, upon
which the Examiner relies, expressly or inherently teaches or suggests that
the Reo end plates are configured to “attach to an upper spinous process [or
to a lower spinous process] with a first [or second] fixation structure” as
recited in the claims. App. Br. 10.

Analysis
The Examiner finds Reo teaches, in relevant part, a spinal stabilization
device (350) which is fully capable of being implanted between upper and
lower spinous processes of adjacent vertebrae in a spine. Final Act. 2. The
Examiner finds Reo teaches that the device (350) comprises: (1) an upper
end plate (352) fully capable of attaching to an upper spinous process with a
first fixation structure (358), and further configured with a cavity (i.e., an
inward-facing concave surface) situated opposite from the first fixation
structure, the cavity substantially conforming in shape to a compressible,
elastic, polymeric core member (356); and (2) a lower end plate (354) which
is fully capable of attaching to a lower spinous process with a second
fixation structure (358), and further configured with a cavity situated
opposite from the second fixation structure, the cavity substantially
conforming in shape to the compressible, elastic, polymeric core member
(356). Id. (citing Reo ¶¶ 131–132; Fig. 13).
Appellants point out that claim 1 recites a device having “an upper
end plate configured to attach to an upper spinous process with a first
fixation structure” and having a similarly described lower end plate
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configured to attach to a lower spinous process. App. Br. 15–16. Appellants
further state that the claim recites that the upper end plate attaches to the
upper spinous process using (“with”) the first fixation member. Id. at 16.
Appellants argue that Reo teaches that its “anchoring fins 111” are “intended
to engage mating grooves that are formed on the surfaces of the upper and
lower vertebral bodies to thereby secure the endplate to its respective
vertebral body.” Id. (citing Reo ¶ 84). Appellants contend that attaching the
Reo device to a spinous process using the “anchoring fin 111” via “mating
grooves” cut into the length of the edge of the spinous process – as taught by
Reo – is at least a bad idea. Id. According to Appellants, the bone
projection known as the spinous process is thin and cutting a groove into the
edge of that bone projection to accommodate Reo’s “anchoring fin 111”
would leave but thin shells of bone along the sides of the “fin.” Id.
Appellants contend that such thin shells would seem to be inadequate to
support an inter-spinous-process device even during the ordinary bending
and twisting actions that human beings partake of every day. Id.
Appellants enlarge upon their theory, arguing that, as a practical
matter, even the step of implanting the Reo device as proposed by the
Examiner ignores several real-life matters. App. Br. 17. Appellants argue,
by way of example, that when a person bends forward, the adjacent spinous
processes in the spine separate from each other in a fanning motion, and
therefore a Reo device implanted as proposed by the Examiner would loosen
from the grooves in the spinous processes. Id. Furthermore, Appellants
argue placing the Reo device into the grooves placed longitudinally in
adjacent spinous processes would require that the supraspinous ligament
running down most of the length of the spine (and other ligaments
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depending upon the site in the back) be severed. Id. Appellants argue that
there is but one implantation pathway into the site proposed by the
Examiner's conjecture, and access to that site is blocked by ligaments. Id.
Appellants also argue that the Examiner erred in alternatively
proposing that the Reo device may be situated such that “anchoring fin 111”
is simply adjacent to the side of the spinous process. App Br. 17.
Appellants contend that the Examiner also proposes that the Reo anchoring
fin “can be held in place with an additional means such as a band or strap.”
Id. Appellants assert that the Examiner thus apparently considers the Reo
device to be “attached” to a spinous process if the “anchoring fin 111”
merely “touches” or “contacts” that spinous bone. Id. at 17–18.
Appellants argue further, the Examiner’s additional proposal of using
some “additional means such as a band or strap” to hold the Reo “anchoring
fins 111” in a touching or contacting relationship with the spinous process
does not satisfy the elements of claim 1. App. Br. 18. Appellants assert that
claim 1 requires a device having “an upper/lower end plate configured to
attach to an upper/lower spinous process with a first/second fixation
structure.” Id. According to Appellants, if the Reo device is inserted such
that the “anchoring fins 111” are only adjacent the spinous process but the
“additional means” have the function of attaching the “anchoring fins 111”
to the pertinent spinous process, then it is the “additional means” that are
“configured to” attach the end plate to the spinous process, not the
“anchoring fins 111.” Id. Appellants thus contend the Examiner has
“radically redefine[d]” the functions of the Reo device and components in a
manner that is inconsistent with the basic argument that the “anchoring fins
111” themselves are “configured to” attach to the spinous processes. Id.
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With respect to Appellants’ argument that the upper end plate and the
lower end plate of Reo are not configured to be attached to an upper and a
lower spinous process, respectively, the Examiner responds that a recitation
of the intended use of the claimed invention must result in a structural
difference to patentably distinguish the claimed invention from the prior art.
Ans. 17–18. The Examiner finds that, if the prior art structure is capable of
performing the intended use, then it meets the claim. Id. at 18. The
Examiner points to Ex parte Masham, 2 USPQ2d 1647, 1647 (BPAI 1987)
in support. Id. at 18.
With respect to Appellants’ argument “that the device of Reo does not
attach directly to the upper and lower spinous processes with the fixation
structures,” the Examiner finds that “the fact that Appellants use their device
for a different purpose does not alter the conclusion that its use in a prior art
device would be prima facie obvious from the purpose disclosed in the
reference.” Ans. 18.
The Examiner further finds, with respect to claim 1, that there is no
structural difference between the device of Reo and Appellants’ claimed
device that precludes the fixation structures of Reo (e.g., element(s) 358 of
Fig. 13) from being attached to the upper and lower spinous processes. Ans.
18. The Examiner finds Appellants have not claimed a medical diagnosis or
treatment regimen for which the claimed device needs function to engage the
adjacent processes. Id. Rather, the Examiner finds, as claimed, Appellants
only require the device be configured to be placed in between spinous
processes with first and second fixation structures configured attached to
upper and lower vertebrae, respectively. Id. at 18–19.
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Contrary to Appellants’ argument that, in order to attach these fixation
structures to the spinous processes, a longitudinal slot must be cut in the
bone or else render the device unsatisfactory for its intended purpose, the
Examiner finds the intended purpose of Reo’s device is to provide a spacer
between adjacent vertebrae, and if the device is placed in an alternate
location in the spine (e.g., between adjacent upper and lower spinous
processes), the device would continue to function to space said vertebrae.
Ans. 19. The Examiner also finds that attaching the device between the
spinous processes would not necessarily require cutting into the spinous
processes for the device to be attached. Id. at 19–20. The Examiner finds
the fixation structures can be placed alongside the processes, in contact with
the spinous processes and the device can be bound or attached to the spinous
processes via means such as a band, strap, ties, adhesive, etc. Id. at 20.
With respect to Appellants’ arguments that Examiner’s interpretation
of the fixation structures “touching” or “contacting” the spinous processes is
an incorrect interpretation of “attaching,” the Examiner finds that such an
interpretation also includes securing the claimed fixation structures to the
processes. App. Br. 20. Therefore, the examples described by the
Examiner, describing how the device of Reo could be placed between
adjacent spinous processes with the fixation structures both contacting and
being secured to said processes via means such as bands, straps, etc.
adequately reads on the claim term “attach.” Id. The Examiner also finds
that the dictionary defines “attach” as “to fasten or affix; join; connect.” Id.
(quoting “attach” at www.dictionary.com). The Examiner therefore finds
that, aside from being secured to spinous processes via means as described
above, the mere touching or contacting of the fixation structures to the
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spinous processes is considered joining, defined as “to bring in contact,
connect, or bring or put together,” thereby also reading on the limitation of
“attaching.” Id. (citing “join” at www.dictionary.com).
We are persuaded by Appellants’ arguments. Claim 1 recites, in
relevant part: “an upper end plate configured to attach to an upper spinous
process with a first fixation structure” and “a lower end plate configured to
attach to a lower spinous process with a second fixation structure.”
Appellants’ Specification provides no explicit definition of the claim term
“configured to attach to a … spinous process” and so we adopt the broadest
reasonable construction of the term. See In re ICON Health & Fitness, Inc.,
496 F.3d 1374, 1379 (Fed. Cir. 2007) (Claims under examination before the
PTO are given their broadest reasonable interpretation consistent with the
specification).
The word “configure” generally means “[t]o design, arrange, set up,
or shape with a view to specific applications or uses.” American Heritage
Dictionary 386 (4th ed. 2000). Based on the record here, we construe the
claim term “configured to attach to a … spinous process” as meaning
“designed, sized, and dimensioned for attachment between the end plate and
the spinous process.” This is consistent with the Board’s past construction
of the term “configured to.” See PPC Broadband, Inc. v. Corning Optical
Communications RF, LLC, 815 F.3d 734, 744–45 (Fed. Cir. 2016)
(“[C]omponents that are shaped or configured to fit one another ‘are sized
and dimensioned to abut one another’”). It is also consistent with the
disclosures of Appellants’ Specification. See Spec. ¶ 11 (“The upper and
lower support structures may be configured to attach directly to the spinous
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processes and may be configured to attach to fixing structures that in turn
fixedly attach directly to the spinous processes”).
Reo is directed to “[p]rosthetic intervertebral discs [that] include
upper and lower endplates separated by a compressible core member.” Reo
Abstr. With respect to the endplates, Reo teaches:
In using the subject discs, the prosthetic disc is fixed to the
vertebral bodies between which it is placed. More specifically,
the upper and lower plates of the subject discs are fixed to the
vertebral body to which they are adjacent. As such, the subject
discs are employed with vertebral body fixation elements during
use.
….
The upper surface of the upper endplate 110 and the lower
surface of the lower endplate 120 are preferably each provided
with a mechanism for securing the endplate to the respective
opposed surfaces of the upper and lower vertebral bodies
between which the prosthetic disc is to be installed. For example,
in FIG. 3, the upper endplate 110 includes a plurality of
anchoring fins 111a–b. The anchoring fins 111a–b are intended
to engage mating grooves that are formed on the surfaces of the
upper and lower vertebral bodies to thereby secure the endplate
to its respective vertebral body …. Each of the anchoring fins
111a-b has a plurality of serrations 112 located on the top edge
of the anchoring fin. The serrations 112 are intended to enhance
the ability of the anchoring fin to engage the vertebral body and
to thereby secure the upper endplate 110 to the spine.

Reo ¶¶ 82, 84. With a respect to another embodiment, Reo teaches:
The upper endplate 352 and lower endplate 354 are
preferably each of a partially cylindrical shape such that the
inward-facing surfaces of each of the endplates are generally
concave, and the outward-facing surfaces of each of the
endplates are generally convex …. In a particularly preferred
embodiment, the upper endplate 352 and lower endplate 354
each have a keel 358 formed on or attached to its upper surface
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and lower surface, respectively. The keels 358 are adapted to
engage the respective vertebral bodies to secure the endplates
against movement upon implantation.

Reo ¶ 132. Reo is thus directed to a prosthetic intervertebral disc
replacement and the endplate structures are designed to engage, via a keel or
fin, a receiving groove or indentation in the vertebral body (i.e., the central
core of the vertebra). The Examiner points to no teaching, nor can we
discern one, by which Reo teaches nor suggests “an … end plate configured
to attach to a[ ] … spinous process with a …fixation structure.” In other
words, in Reo, the endplate engages a groove or indentation in the central
body of the vertebra, rather than attaching to a spinous process with a
fixation structure.
The Examiner finds that a recitation of the intended use of the claimed
invention must result in a structural difference between the claimed
invention and the prior art in order to patentably distinguish the claimed
invention from the prior art. See Ans. 17–18. We find that there is such a
structural difference: an end plate that is configured to, i.e., “designed, sized,
and dimensioned for attachment between the end plate and the spinous
process.” See, e.g., Spec. Fig. 2–3 (depicting end plates 154, 156 with
opposing tabs (162); see also id. Fig. 14.
We find no such structure taught or suggested in Reo. We are further
unpersuaded that the structures cited by the Examiner (e.g., keels 358; see
Reo Fig. 13) are, absent further material modifications, “configured to”
attach to the respective and relatively narrow, cantilever-like upper and
lower spinous processes as recited in Appellants’ claim 1. App. Br. 10;
Spec. Fig. 14 (depicting spinous processes 402 and 404). The Examiner
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hypothesizes that the end plate structures taught by Reo could possibly be
attached to the spinous processes by various routes, but the Examiner
provides no evidentiary support for this beyond mere conjecture – certainly
the Examiner points to no evidence that the serrated fins or keels of the end
plates taught by Reo are “configured to” be attached to a spinous process.
Moreover, to the extent Reo’s structures must be modified for attachment to
occur, the unmodified structures are not “configured to” attach to the
spinous processes as claimed. Rather, the “configured to” language of the
claim requires that “the apparatus as provided must be “capable” of
performing the recited function, not that it might later be modified to
perform that function.” Typhoon Touch Techs., Inc. v. Dell, Inc., 659 F.3d
1376, 1380 (Fed. Cir. 2011) (discussing Microprocessor Enhancement Corp.
v. Texas Instruments, Inc., 520 F.3d 1367 (Fed. Cir. 2008).)
We consequently reverse the Examiner’s rejection of the claims.

B Claims 15–21, 24–26, 28–33, 35–37, and 39
Appellants argue these claims separately, but rely upon essentially the
same arguments presented supra. App. Br. 20–26. For the reasons
explained with respect to those claims, we similarly reverse the Examiner’s
rejection of the claims.

C Claims 8, 9, 22, 23, and 34 over Reo and Paes
Appellants argue these claims separately, but rely upon the same
arguments presented supra. App. Br. 19, 26. For the reasons explained with
respect to those claims, we similarly reverse the Examiner’s rejection of
claims 8 and 9.
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D Claims 1, 13, 15, 27, 30, and 38 over Reo and Slivka
Appellants argue these claims separately, but rely upon the same
arguments presented supra. App. Br. 20, 27. For the reasons explained
with respect to those claims, we similarly reverse the Examiner’s rejection
of claims 1 and 13.

DECISION
The Examiner’s rejection of claims 1–39 as unpatentable under 35
U.S.C. § 103(a) is reversed.

REVERSED