Ex Parte Marchand et al

Patent Trial and Appeal Board

Sep 23, 2016

12434465 (P.T.A.B. Sep. 23, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/434,465 0510112009
34263 7590 09/27/2016
O"Melveny & Myers LLP
IP&T Calendar Department LA-1005D
400 South Hope Street
Los Angeles, CA 90071-2899
FIRST NAMED INVENTOR
Philippe Marchand
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
775,988-011 1272
EXAMINER
WEISBERG, AMY REGINA
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
09/27/2016 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):
ipcalendardept@omm.com
cpacheco@omm.com
scarr@omm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PHILIPPE MARCHAND,
BRIAN J. COX, and ROBERT F. ROSENBLUTH
Appeal2014-009854
Application 12/434,465
Technology Center 3700
Before STEFAN STAICOVICI, JAMES P. CALVE, and LEE L. STEPINA,
Administrative Patent Judges.
CAL VE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from the final rejection of
claims 88-101. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
Appeal2014-009854
Application 12/434,465
CLAIMED SUBJECT MATTER
Claim 88, the sole independent claim, is reproduced below.
88. A device for treatment of cerebral aneurysm,
compnsmg:
a self-expanding resilient permeable shell having a
proximal end, a distal end, and a longitudinal axis, the shell
comprising a plurality of elongate resilient filaments having a
braided structure, the number of filaments being between 125
and 180, the plurality of elongate filaments including filaments
of at least two different transverse dimensions, wherein the
plurality of filaments are secured at the proximal and distal ends
thereof,
wherein the permeable shell has a radially constrained
elongated state configured for delivery within a microcatheter
with each filament in the plurality of filaments extending
longitudinally between the proximal and distal ends and
forming a substantially cylindrical configuration, and
wherein the permeable shell has an expanded relaxed
state with a globular, axially shortened configuration relative to
the radially constrained state, each filament forming a smooth
arc between the proximal and distal ends, the permeable shell
having a plurality of openings formed between the braided
filaments.
REJECTIONS
Claims 88-90 and 92-99 are rejected under 35 U.S.C. § 102(e) as
anticipated by, or alternatively under 35 U.S.C. § 103(a) as unpatentable
over, Rosqueta (US 8,142,456 B2, iss. Mar. 27, 2012).
Claim 91 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Rosqueta and Thompson (US 6,342,068 Bl, iss. Jan. 29, 2002).
Claims 100 and 101 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Rosqueta and Calabria (US 2009/0227976 Al, pub. Sept.
10, 2009).
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Appeal2014-009854
Application 12/434,465
ANALYSIS
Claims 88-90 and 92-99 as anticipated or unpatentable over Rosqueta
The Examiner found that Rosqueta discloses the device as claimed
including a plurality of elongate, resilient filaments in the amount of 64, 72,
and upwards and formed in multiple sizes. Final Act. 4. The Examiner also
determined that Rosqueta's disclosed range of 64, 72, and upwards includes
the claimed range of 125-180 filaments so that it would have been obvious
to select the more specific claimed range of 125-180 filaments, particularly
where the prior art recognized the number of filaments as a result effective
variable. Id. at 5.
Appellants argue that the broader range of 64, 72, and upwards that is
disclosed in Rosqueta cannot anticipate the narrower range of between 125
and 180 that is claimed. Appeal Br. 5-9. Appellants argue that the range of
64, 72, and upwards disclosed in Rosqueta does not render the claimed range
of between 125 and 180 obvious given the unexpected results and criticality
of the claimed range. Id. at 10. Appellants cite the Declaration of Charles
M. Strother, M.D. ("Strother Deel.") who states that the number of wires is a
critical feature of the invention and a wire count of 144, which is within the
claimed range, provides superior results to a wire count of 72 wires as
disclosed in Rosqueta and the prior art. Strother Deel. i-f 5. Dr. Strother
declares that devices with 144 wires provide greater consistency in the shape
of the device that is deployed, and the pore sizes of the implants have a
consistent size needed to facilitate thrombus. Id. ff 6-8. Dr. Strother
further declares that a skilled artisan would not have considered increasing
wire count because of concerns that higher wire count would decrease
flexibility, increase stiffness, and collapsed profile. Id. i-f 9.
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Appeal2014-009854
Application 12/434,465
The Examiner does not dispute that the claimed invention produces
unexpected results. Instead, the Examiner contends that Rosqueta's teaching
of wire counts of 64, 72, and upwards "anticipates" the critical and
unexpected results shown by Appellants.
8. Applicant argues that 125-180 filaments are not only critical,
but unexpected. Examiner does not dispute this fact, however
no evidence arguing the limits of "upwards" not including 125-
180 filaments has been provided, and thus Rosqueta also
anticipates these critical and unexpected results as well.
Final Act. 9; see Ans. 6 ("Thus Dr. Strother provides evidence why one
would select 125-180 filaments, however has failed to indicate that such a
range would not be obvious based on Rosqueta's teaching of 64, 72, and
'upwards'."); see also Appeal Br. 10 (citing Examiner's admission).
Anticipation of Claims 88-90 and 92-99
The Examiner has not established by a preponderance of evidence that
Rosqueta's disclosure of a wire count of "64, 72, and upwards" anticipates
the range of filaments of "between 125 and 180" as recited in claim 88. In
circumstances where the prior art discloses a broad range (i.e., from 64 to an
unknown upper limit) that encompasses the claimed range of 125-180, it
must be determined whether the prior art range describes the claimed range
with sufficient specificity to anticipate that range. Atofina v. Great Lakes
Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006) ("Given the considerable
difference between the claimed range and the range in the prior art, no
reasonable fact finder could conclude that the prior art describes the claimed
range with sufficient specificity to anticipate this limitation of the claim.");
MANUAL OF PATENT EXAMINING PROCEDURE§ 2131.03 Section II (9th Ed.
Rev. 7, Nov. 2015) (same).
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Appeal2014-009854
Application 12/434,465
Here, the Examiner has not established with sufficient specificity that
a range of filaments of "64, 72, and upwards" of Rosqueta anticipates a
range of 125-180. The Examiner's finding of anticipation just because
Rosqueta's disclosed range of "e.g. 64, 72, and upwards" "includes the
claimed range of 125-180" (Final Act. 5, 9) is insufficient to show that the
claimed range of 125-180 is anticipated by the larger range disclosed in
Rosqueta. As the Examiner recognizes, the facts of each case determine
whether a larger range anticipates a smaller range that falls within the larger
range. Ans. 2-5. However, the Examiner has not explained why Rosqueta's
larger range describes the claimed range sufficiently to anticipate it. In this
regard, Appellants provide evidence that the claimed range of filaments does
not have the same characteristics as a device with 72 filaments. Strother
Deel. i-fi-1 6-8 (implant with 144 wires provides greater consistency in shape
of the device and size of the pores than an implant with 72 wires). 1
Thus, we do not sustain the rejection of claims 88-90 and 92-99
under 35 U.S.C. § 102(e) as anticipated by Rosqueta.
1 Rosqueta discloses that devices with larger diameters (e.g., 6-12 mm or
more) may use wires in multiples of 64, 72, 96, 128, and 144. Rosqueta,
2:24--26. The disclosure of a species (i.e., 144 wires) that falls within the
claimed range of 125-180 filaments would anticipate that claimed range;
however, this disclosure in Rosqueta was made in provisional application
61/083,957, which was filed on July 28, 2008. Appellants claim priority to
provisional application 61/050, 124, filed May 2, 2008, which discloses a
range of filaments of 10-100 and 60-80 ('957 Spec., 16:7-9) and greater
than 125 and between 80 and 180 ('124 Spec., 19:12-14). The wire counts
in Rosqueta that antedate May 2, 2008 appear in a provisional application
61/046,594 ('594 Spec.), filed on April 21, 2008. That provisional
application disclosed that "[a]t larger diameters (e.g., about 6 to 12 or more),
more wire ends (e.g., 64, 72 and upwards) may be employed informing the
balls." Prov. Spec., 1:9-12, filed Apr. 21, 2008; see Final Act. 3.
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Appeal2014-009854
Application 12/434,465
Obviousness of Claims 88-90 and 92-99
In contrast to the case of anticipation discussed above, a broader range
disclosed in the prior art renders a narrower claimed range that falls within it
prima facie obvious. In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)
("In cases involving overlapping ranges, we and our predecessor court have
consistently held that even a slight overlap in range establishes a prima facie
case of obviousness."); see MANUAL OF PATENT EXAMINING PROCEDURE
§ 2144.05 (9th Ed. Rev. 7, Nov. 2015) (same).
It is equally well-settled that an applicant may rebut a prima facie case
of obviousness by establishing that the claimed range is critical by showing
that the claimed range achieves unexpected results relative to the prior art
range. Peterson, 315 F.3d at 1330. Appellants have introduced evidence of
criticality and unexpected results in this case via the Declaration of Charles
M. Strother, M.D. Dr. Strother declares that Sequent, the real party-in-
interest, "discovered that the number of wires contained in the implants is a
critical factor in the construction of an implant that would meet [the]
requirements" that an implant be safe to deliver and deploy, match, shape,
and size features selected by the physician, and provide pores or openings of
sufficient size and distribution to create thrombosis. Strother Deel. i-fi-1 4-5.
Dr. Strother supports his assertion with evidence of an experiment conducted
to compare these characteristics with a device having 72 wires similar to
Rosqueta and one with 144 wires similar to the claimed range. Id. i15.
Dr. Strother stated that this experiment showed that increasing wire count to
125-180 provided unexpected results in greater consistency in the shape of
the device and pore size as compared to devices with wire counts of 72. Id.
,-r,-r 6-9.
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Appeal2014-009854
Application 12/434,465
The Examiner agrees with Dr. Strother that the claimed range shows
unexpected results as discussed above. See Final Act. 9 ("Applicant argues
that 125-180 filaments are not only critical, but unexpected. Examiner does
not dispute this fact."). Thus, the Examiner has conceded that the claimed
range produces unexpected results as compared to at least part of the prior
art range disclosed in Rosqueta for smaller wire counts. These unexpected
results rebut the Examiner's prima facie case of obviousness based on the
claimed range of 125-180 filaments falling within Rosqueta's larger range
of "64, 72, and upwards." The unexpected results also appear to be fairly
commensurate with the claimed range. Peterson, 315 F.3d at 1330-1331.
For similar reasons, the Examiner's determination that the claimed
range would have been obvious as a routine optimization of result effective
variables for wire count (Final Act. 5) is rebutted by the unexpected results
and criticality of the claimed range. Peterson, 315 F.3d at 1330 (applicant
must show unexpected results for a claimed range where applicant selects a
narrower ranges of variables from broader ranges disclosed in the prior art);
In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) ("Only ifthe 'results of
optimizing a variable' are 'unexpectedly good' can a patent be obtained for
the claimed critical range.") (citations omitted). Although we appreciate the
Examiner's position (Final Act. 5) that the claimed range could have been
obtained through routine optimization, nonetheless, in reviewing the Strother
Deel. the Examiner fails to show that the difference between a device having
72 wire implants and a device having 144 wire implants is a difference in
degree rather than a difference in kind when considering Rosqueta's device
having wire implants of "64, 72, and upwards." See In re Huang, 100 F.3d
135, 139 (Fed. Cir. 1996).
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Appeal2014-009854
Application 12/434,465
More specifically, in reviewing the Strother Deel. the Examiner fails
to consider whether the difference observed between a device with 72 wire
implants and a device with 144 wire implants is expected to be similar to the
difference between a device having 64 wire implants and a device having 72
wire implants, or between a device with 144 wire implants and one with 192
wire implants, so the scope of the unexpected or improved results can be
ascertained relative to the claimed range of 125-180.
For the foregoing reasons, we do not sustain the rejection of claims
88-90 and 92-99 under 35 U.S.C. § 103(a) as unpatentable over Rosqueta.
Claim 91 as unpatentable over Rosqueta and Thompson
Because the Examiner's reliance on Thompson to teach features of
claim 91 for pore size does not cure deficiencies of Rosqueta for claim 88,
from which claim 91 depends, we do not sustain the rejection of claim 91.
Claims 100 and 1 OJ as unpatentable over Rosqueta and Calabria
Because the Examiner's reliance on Calabria to teach features of
claims 100 and 101 for securing adjacent filaments to one another does not
cure deficiencies of Rosqueta for claim 88, from which claims 100 and 101
depend, we do not sustain the rejection of claims 100 and 101.
DECISION
We REVERSE the rejections of claims 88-101.
REVERSED
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