Ex Parte Arramon et al

Patent Trial and Appeal Board

Aug 25, 2017

12435572 (P.T.A.B. Aug. 25, 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.
12/435,572 05/05/2009 Yves Arramon 29850-723.201 3669
143452 7590 08/29/2017
WTT SON SONSTNT OOODRTfTr fr ROSATT/Simnlifv MeHiral
EXAMINER
650 PAGE MILL ROAD
PALO ALTO, CA 94304-1050
WOZNICKI, JACQUELINE
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
08/29/2017 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
patentdocket @ wsgr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte YVES ARRAMON,
MALAN DE VILLIERS, and NEVILLE JANSEN
Appeal 2016-005204
Application 12/43 5,5721
Technology Center 3700
Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to an
intervertebral disc. The Examiner rejected the claims for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
The following rejections are before us for review:
1 Appellants identify Simplify Medical, Incorporated as the real party in
interest.
Appeal 2016-005204
Application 12/435,572
(1) Claims 2, 3, 5—8, 12, and 46-48, under 35 U.S.C. § 103(a), for
obviousness over Hawkins2 and Buchman3 (Ans. 2—7; Non-Final Act. 5—
10);4
(2) Claim 4, under 35 U.S.C. § 103(a), for obviousness over Hawkins,
Buchman, and Carls5 (Ans. 7; Non-Final Act. 10-11);
(3) Claims 9—11, under 35 U.S.C. § 103(a), for obviousness over
Hawkins, Buchman, and Ramirez6 (Ans. 8—10; Non-Final Act. 11—13); and
(4) Claims 2—8, 12, and 46-48, under 35 U.S.C. § 103(a), for
obviousness over Carls, Hawkins, and Buchman (Ans. 10-15; Non-Final
Act. 14—19); and
(5) Claims 9—11, under 35 U.S.C. § 103(a), for obviousness over
Carls, Hawkins, Buchman, and Ramirez (Ans. 16—18; Non-Final Act. 19—
22).
Claim 46, the only independent claim on appeal, is representative and
reads as follows (Appeal Br. 18):
46. An intervertebral disc comprising:
an upper plate having an upper vertebra contacting surface
and a lower bearing surface, wherein the upper plate consists of
polyaryletherketone (PAEK) except for the upper vertebra
contacting surface which is formed at least in part from a metal
for improved bone attachment;
a lower plate having a lower vertebra contacting surface
and an upper bearing surface, wherein the lower plate consists of
polyaryletherketone (PAEK) except for the lower vertebra
2 US 6,793,678 B2 (issued Sept. 21, 2004).
3 US 6,686,437 B2 (issued Feb. 3, 2004).
4 Non-Final Office Action entered December 15, 2004.
5 US 2008/0161930 A1 (published July 3, 2008).
6 US 5,458,641 (issued Oct. 17, 1995).
2
Appeal 2016-005204
Application 12/435,572
contacting surface which is formed at least in part from a metal
for improved bone attachment; and
a core positioned between the upper and lower plates, the
core formed of ceramic and having upper and lower ceramic
surfaces configured to mate with and articulate with respect to
both the bearing surfaces of the upper and lower plates.
OBVIOUSNESS—
HAWKINS AND BUCHMAN
In rejecting claims 2, 3, 5—8, 12, and 46-48 over Hawkins and
Buchman, the Examiner cited Hawkins as disclosing an intervertebral disc
having all of the features of the rejected claims, except for being “silent with
regards to the upper and lower surfaces being formed in part from a metal”
as recited in independent claim 46. Non-Final Act. 6.
The Examiner cited Buchman as evidence that it was known in the art
to place a metal coating on the vertebra-contacting surfaces of devices of the
type described by Hawkins, and reasoned, therefore, that an ordinary artisan
would have considered it obvious to coat the vertebra-contacting surfaces of
Hawkins’s device “as is taught by Buchman in order to improve radiopacity
of the device while maintaining the benefits of having an insert made of
PAEK, such as durability and strength.” Id.
In reiterating the rejection in the Examiner’s Answer, the Examiner
restated the rejection’s reasoning in a different way, contending that it would
have been obvious to apply Buchman’s coating to the vertebra-contacting
surfaces of Hawkins’s device because Buchman’s metal coating was “a
known alternative in the art (to Hawkins’s porous materials Column 9[,]
lines 61-65) for promoting bone in-growth (Column 13[,] lines 36-37, 41-
42).” Ans. 4.
3
Appeal 2016-005204
Application 12/435,572
In addition to traversing the Examiner’s restated rationale (Reply Br.
4—5),7 Appellants contend, for a number of reasons, that the Examiner has
not established that Hawkins and Buchman teach or suggest a device having
all of the features of independent claim 46. Appeal Br. 9—11; Reply Br. 5—7.
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a prima
facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In the present case, Appellants do not persuade us that a
preponderance of the evidence fails to support the Examiner’s conclusion
that the intervertebral disc of claim 46 would have been obvious to an
ordinary artisan.
As required by claim 46, Hawkins discloses an intervertebral disc
composed of three structural components: a core sandwiched between an
upper and a lower plate. Hawkins 2:60-3:25.
As the Examiner found, Hawkins discloses that those components
may be made from a variety of materials, including the ceramic recited in
7 Appellants do not contend that the restated reasoning in the Examiner’s
Answer constitutes a new ground of rejection that has not been properly
designated as such. See Manual of Patent Examining Procedure
§ 1207.03(b) (9th Ed., Rev. 07.2015, Nov. 2015) (explaining that “37
[C.F.R. §] 41.40 sets forth the exclusive procedure for an appellant to
request review of the primary examiner’s failure to designate a rejection as a
new ground of rejection via a petition to the Director under 37 [C.F.R. §]
1.181”).
4
Appeal 2016-005204
Application 12/435,572
claim 46 as composing the core, as well as the PAEK of which the upper and
lower plates of claim 46 consist:
In preferred embodiments, each of the inferior endplate,
superior endplate and core member is manufactured from a
material that possesses the strength and high wear resistance
desired for use as a motion disc component.
These components of the present invention may be made
from any non-resorbable material appropriate for human
surgical implantation, including but not limited to, surgically
appropriate metals, and non-metallic materials, such as carbon
fiber composites, polymers and ceramics.
If a polymer is chosen as a material of construction for a
component, then the polymer is preferably selected from the
group consisting of. . . PAEK ....
Hawkins 8:30-49 (emphases added).
Given Hawkins’s teaching that its endplates and core may be
composed of any type of non-resorbable material, including ceramics and
PAEK, Appellants do not persuade us that the Examiner erred in concluding
that an ordinary artisan had a good reason for, and a reasonable expectation
of success in, using PAEK to form the endplates of Hawkins’s device, and a
ceramic to form the device’s core, as recited in Appellants’ claim 46.
We note, as Appellants contend, that Hawkins does not describe a
specific embodiment having the particular combination of components
composed of the particular materials recited in claim 46. See Reply Br. 6—7
(citing Net Money IN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir.
2008). The rejection at issue here, however, is for obviousness under
§ 103(a), whereas the issue in Net MoneyIN was one of anticipation under
§ 102(a). See, e.g., Net MoneyIN, 545 F.3d at 1362.
5
Appeal 2016-005204
Application 12/435,572
As the Supreme Court has explained, “when a patent ‘simply arranges
old elements with each performing the same function it had been known to
perform’ and yields no more than one would expect from such an
arrangement, the combination is obvious.” KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 417 (2007) (quoting Sakraida v. AgPro, Inc., 425 U.S. 273,
282 (1976)). In the present case, as noted above, Hawkins teaches that
PAEK and ceramics are useful for forming the endplates and core of its
devices. Accordingly, we discern no error in the Examiner’s conclusion that
it would have been obvious to select PAEK to form the endplates, and a
ceramic material to form the core, of Hawkins’s device. We note, moreover,
that Appellants do not identify any unexpected result coming from the
selection of the specific combination of materials and components recited in
claim 46.
We acknowledge claim 46’s recitation that the upper and lower
plates “consist[] of’ PAEK, that is, contain no materials other than PAEK,
except for the metal-containing vertebra-contacting surfaces. Appeal Br. 18.
We acknowledge also Hawkins’s disclosure that “[i]n some
embodiments, the endplates are made from a composite comprising carbon
fiber. Composites comprising carbon fiber are advantageous in that they
typically have a strength and stiffness that is superior to neat polymer
materials such as a polyarylethyl ketone PAEK.” Hawkins 9:27—31. We
acknowledge further that “especially preferred embodiments” {id. at 9:47) of
Hawkins’s device use endplates composed of a carbon fiber/PAEK
composite {id. at 9:47—60).
It is well settled, however, that “in a section 103 inquiry, the fact that
a specific [embodiment] is taught to be preferred is not controlling, since all
6
Appeal 2016-005204
Application 12/435,572
disclosures of the prior art, including unpreferred embodiments, must be
considered.” Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807
(Fed. Cir. 1989) (internal quotation marks and citation omitted).
Thus, although Hawkins might prefer the use of carbon fiber/PAEK
composites due to their superior strength and stiffness as compared to PAEK
alone, Hawkins nonetheless teaches more generally that any of its
components can be made of any type of surgically implantable/non-
resorbable materials, including PAEK, as noted above. See Hawkins 8:30—
49 (quoted above). Appellants do not persuade us, therefore, that Hawkins
teaches away from using PAEK as the sole polymeric component in its
endplates, as required by claim 46.
Appellants also do not persuade us that the Examiner erred in
concluding that an ordinary artisan would have considered it obvious to
provide the vertebra-contacting surfaces of the endplates of Hawkins’s
device with a metal coating, as recited in Appellants’ claim 46. In that
regard, as the Examiner noted, Hawkins discloses that, “in some
embodiments, the outer surfaces of the endplates may have a recess 201
therein. In some embodiments, the recess may be filled with a porous
material (not shown), including osteobiologic materials, adapted for bone
growth.” Hawkins 9:61—65.
Indeed, Hawkins discloses that, in addition to porous materials, a
variety of functionalities may be imparted to the vertebra-contacting surfaces
of its endplates, in order to promote fixation of the device to the patient’s
vertebra through bone ingrowth. See id. at 8:12—17 (“In addition, the
superior surface of this endplate can further comprise features to promote
and secure initial fixation and bony ingrowth including, but not limited to,
7
Appeal 2016-005204
Application 12/435,572
spikes, keels, teeth, projections (such as dovetails), recesses (such as
grooves) and porous coatings”) (emphasis added).
As the Examiner found, Buchman discloses that fixation of an
implanted prosthesis to bone may be achieved by a titanium powder coating
on the surface of a plastic implant:
[Fixation is achieved by creating porous surface of the metal,
that allows bone ingrowth. This is done by technologies such as
plasma spray or coating the metal or plastic with a porous layer
of active calcium phosphate ceramics such as hydroxyapatite or
tricalcium phosphate. A different technology achieves a porous
layer of titanium powder or a titanium net on the plastic.
Buchman 13:36-42 (emphasis added).
Thus, Hawkins discloses the desirability of including bone
ingrowth-promoting porous materials on the vertebra-contacting surfaces of
its devices’ endplates to enhance fixation of the devices to bone, and
Buchman teaches that a useful technique of enhancing fixation of implanted
prostheses was to include a bone-ingrowth promoting porous layer of
titanium on the bone-contacting surface of the device. Appellants do not
persuade us, therefore, that the Examiner erred in finding that an ordinary
artisan had good reason for, and a reasonable expectation of success in,
applying Buchman’s porous titanium coating to the vertebra-contacting
surface of Hawkins’s endplates, as recited in Appellants’ claim 46.
That osteobiologic materials might not have the same properties as a
porous titanium coating (see Reply Br. 5—6) does not persuade us that, as
seen above in the teachings cited by the Examiner, an ordinary artisan would
have recognized that both materials would be useful for promoting fixation
to bone of the vertebra-contacting surfaces of Hawkins’s endplates.
Moreover, as seen above, Buchman’s teaching regarding the use of a porous
8
Appeal 2016-005204
Application 12/435,572
layer of titanium is in the context of achieving fixation to bone (see
Buchman 13:36-42), contrary to Appellants’ contention (see Appeal Br. 15—
16) that Buchman’s teaching regarding the use of a porous layer of titanium
is in the context of application to the articulating surface.
In sum, for the reasons discussed, Appellants do not persuade us that a
preponderance of the evidence fails to support the Examiner’s conclusion
that the intervertebral disc recited in Appellants’ claim 46 would have been
prima facie obvious to an ordinary artisan. We, therefore, affirm the
Examiner’s rejection of claim 46 over Hawkins and Buchman. Because they
were not argued separately, claims 2, 3, 5—8, 12, 47, and 48 fall with claim
46. 37 C.F.R. §41.37(c)(l)(iv).
OBVIOUSNESS—
HAWKINS, BUCHMAN, AND CARLS
In rejecting claim 4, which depends ultimately from claim 46
discussed above, over Hawkins, Buchman, and Carls, the Examiner relied on
the teachings from Hawkins and Buchman discussed above, and cited Carls
as evidence of the obviousness of including, on Hawkins’s device, fins
having the dimensions required by claim 4. Ans. 7; Non-Final Act. 10—11.
Appellants do not specifically contest this rejection. See Appeal Br. 5
(listing contested grounds of rejection); see Reply Br. 2 (same).
Accordingly, because Appellants do not identify, nor do we discern,
error in the Examiner’s prima facie case of obviousness as to claim 4 over
Hawkins, Buchman, and Carls, we affirm the Examiner’s rejection of that
claim over those references.
In a later rejection of claims 2—8, 12, and 46-48 for obviousness over
Carls, Hawkins, and Buchman, the Examiner reasoned that it would have
9
Appeal 2016-005204
Application 12/435,572
been obvious to modify the intervertebral discs described in Carls so that
they would articulate with the core of Carls’s device, as taught in Hawkins.
Ans. 12. The Examiner reasoned further that it would have been obvious to
additionally include, on the vertebra-contacting surfaces of the device, the
titanium coating taught in Buchman, so as to enhance bone ingrowth. Id. at
13.
We affirm this rejection as well. As discussed above, contrary to
Appellants’ assertions (Appeal Br. 15—16; Reply Br. 4—6), we agree with the
Examiner that an ordinary artisan had a good reason for, and a reasonable
expectation of success in, applying Buchman’s porous titanium coating to
the vertebra-contacting surface of Hawkins’s endplates, as recited in
Appellants’ claim 46. Moreover, for the reasons discussed above, that Carls
might not disclose “within the four comers of the document all of the
limitations arranged or combined the same way as recited in the claim”
(Reply Br. 7) in a manner supporting a finding of anticipation, does not
demonstrate that the device recited in claim 46 would have been unobvious.
To the contrary, as discussed above, Hawkins makes it clear that claim 46
recites materials known in the art to be useful for making the precise
intervertebral disc components recited in the claim.
Accordingly, for the reasons discussed, Appellants do not persuade us
that a preponderance of the evidence fails to support the Examiner’s
conclusion that the intervertebral disc recited in Appellants’ claim 46 would
have been prima facie obvious to an ordinary artisan. We, therefore, affirm
the Examiner’s rejection of claim 46 over Carls, Hawkins, and Buchman.
Because they were not argued separately, claims 2—8, 12, 47, and 48 fall
with claim 46. 37 C.F.R. § 41.37(c)(l)(iv).
10
Appeal 2016-005204
Application 12/435,572
OBVIOUSNESS—CLAIMS 9-11
The Examiner rejected claims 9—11 over Hawkins, Buchman, and
Ramirez (Ans. 8—10; Non-Final Act. 11—13), and also over Carls, Hawkins,
Buchman, and Ramirez (Ans. 16—18; Non-Final Act. 19—22).
The Examiner relied on the teachings in Hawkins, Buchman, and
Carls, discussed above, and cited Ramirez as evidence that it would have
been obvious to include, on intervertebral devices such as described in
Hawkins and Carls, metallic inserts configured as recited in claims 9—11,
which depend directly or ultimately from claim 46, discussed above. See id.
As to these rejections, Appellants argue only that “[dependent claims
9-11 are allowable for all the reasons set forth with respect to independent
claim 46 above.” Appeal Br. 11, 16. Accordingly, because Appellants do
not identify, nor do we discern, error in the Examiner’s prima facie case of
obviousness as to claims 9—11 over Hawkins, Buchman, Carls, and Ramirez,
we affirm the Examiner’s rejections of those claims over those references.
SUMMARY
For the reasons discussed, we affirm each of the Examiner’s
rejections.
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
11