Ex Parte Karabey et al

Patent Trial and Appeal Board

Apr 27, 2017

13556260 (P.T.A.B. Apr. 27, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
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Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/556,260 07/24/2012 Halil I. Karabey H-KN-01532 (10) 7920
77218 7590 05/01/2017
MeHtrnnio Vasionlar - APV Division
EXAMINER
c/o IP Legal Department
3576 Unocal Place
HOUSTON, ELIZABETH
Santa Rosa, CA 95403 ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
05/01/2017 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.
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HALIL I. KARABEY, ANNA G. PRESTEZOG,
MICHAEL S. MIRIZZI, BRIAN FARLEY,
JOHN W. RODRIGUEZ, and RUSSELL B. THOMPSON
Appeal 2014-009997
Application 13/556,260
Technology Center 3700
Before ANNETTE R. REIMERS, JILL D. HILL, and LISA M. GUIJT,
Administrative Patent Judges.
GUIJT, Administrative Patent Judge.
DECISION ON REQUEST FOR REHEARING
Appellants filed a Request for Rehearing, dated February 28, 2017, in
response to the Decision mailed January 3, 2017 (the “Decision”). In the
Decision, the Board affirmed the Examiner’s rejection of claims 1—6, 9—15,
18—28, and 30-32, and designated the affirmance as a new ground of
rejection.
We do not modify the Decision.
Appeal 2014-009997
Application 13/556,260
ANALYSIS
In the Final Office Action1 from which appeal was taken, the
Examiner relied on embodiments in Callister which disclose that the fibrous
member 15 or fibrous mass 42 forms a complex along with tissue ingrowth
or is permeable to allow for tissue ingrowth, for occluding the reproductive
lumen, and therefore, we were persuaded by Appellants’ argument that to
determine that such embodiments would work for their intended purposes
(i.e., occlusion) if the fibrous members were modified to bioabsorb would be
speculative. See Decision 4—6. However, we determined that because
Callister also discloses an embodiment wherein the presence of the fibrous
member is optional and supplemental to a functioning occlusion device,
Appellants’ argument that a biobsorbable fibrous member would cause the
device not to work for its intended purpose was not persuasive. See id. at 6—
7. Because we relied on an embodiment disclosed in Callister that was not
relied on by the Examiner, we designated the affirmance as a new ground of
rejection.
Requests for Rehearing are limited to matters misapprehended or
overlooked by the Board in rendering the original decision. 37 C.F.R.
§41.52. Appellants argue that
the Board misapprehended or overlooked that the apparatus for
occluding a hollow anatomical structure of claim 1 includes,
inter alia, “radially bulked fibers [that] are self-expanding, such
that the implant is . . . self-expandable in the radial direction.” .
. . In the new ground of rejection, the Board relied on a different
embodiment of Callister’s occlusive device than the embodiment
of Callister’s occlusive device relied on by the Examiner.
However, the Board misapprehended or overlooked that the
1 The Final Office Action dated March 14, 2014 (“Final Act.”).
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Application 13/556,260
Examiner’s assertion . . . that Callister in view of Galdonik
allegedly described radially bulked fibers that are self-expanding
was based on the embodiment of Callister relied on by the
Examiner. Accordingly, the Board failed to establish that the
apparatus for occluding a hollow anatomical structure of claim
1, which includes radially bulked fibers that are self-expanding,
such that the implant is self-expandable in the radial direction,
would have been obvious over Callister in view of Gladonik
based on the embodiment of Callister relied on by the Board.
Request 3. Thus, Appellants do not argue that the Examiner’s proposed
modification of the alternative embodiment in Callister relied on by the
Board would fail to result in a device that works for its intended purpose.
Rather, we understand that Appellants are arguing that (i) there is no support
in Callister for a finding of self-expanding fibers as applied to the
embodiment in Callister relied on by the Board; and (ii) there is no support
in Callister or Galdonik, alone or in combination, for a finding that self­
expanding fibers also results in self-expansion of the implant in a radial
direction, as applied to the embodiment in Callister relied on by the Board,
which Appellants contend is a requirement of independent claims 1 and 24.
Regarding whether the record supports a finding of self-expanding
fibers, in the Final Office Action, the Examiner determined that “Callister
discloses the fibers ‘expand’ across the lumen of the vessel.” Final Act. 5
(citing Callister 141). Although this finding was not challenged by
Appellants during the appeal, Appellants now contend that “Callister fails to
disclose or suggest that the fibrous body is self-expanding.” Request 4; see
Appeal Br. 3—12; Reply Br. 2—6. Notwithstanding, the Examiner
alternatively relies on Galdonik for teaching “similar fibers that self-expand
across a vessel lumen, by becoming relatively shorter and relatively thicker,”
and reasons that it would have been obvious “to modify the fibers of
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Application 13/556,260
Callister with the self-expanding nature as taught by Galdonik ... to ensure
the expansion across the vessel as desired by Callister.” Final Act. 5 (citing
Galdonik 1168; Callister H 41, 50).2 The Board implicitly relied on these
findings when designating the affirmance as a new ground. Decision 9 (“We
designate our affirmance as a new ground of rejection ... to the extent we
have relied on passages from the prior art which were not relited upon by the
Examiner.”) Appellants also did not present any arguments during the
appeal proceedings that these findings by the Examiner regarding
Galdonik’s disclosure of self-expanding fibers contained errors (see Appeal
Br. 3—12; Reply Br. 2—6), nor do Appellants challenge this finding in the
Request (see Request 3—9). Instead, Appellants argue in the Request that
Galdonik does not disclose that such self-expanding fibers result in
expansion of the implant. See e.g., id. at 8 (“the cited embodiments of
Galdonik do not describe or suggest self-expansion of a fibrous body that
would necessarily result in the expansion of an implant including the fibrous
body. Instead,. . . Galdonik merely describes that a ‘surface capillary fiber
[SCF] has a configuration to fill a lumen . . . .’”).
Thus, the Board did not misapprehend or overlook that the apparatus
for occluding a hollow anatomical structure of claim 1 includes, inter alia,
fibers that are self-expanding, as argued by Appellants. Rather, the
Examiner’s reasoning to modify Callister’s fibers to be self-expanding, with
respect to either the embodiment relied on by the Examiner or the
2 See also Galdonik 1131 (“device 270 comprises an expanding polymer . .
. for example, a fiber . . . that has shape memory upon heating to body
temperature” such that “released fibers resume their memory shape at the
expanded configuration to fill the vessel.”).
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Application 13/556,260
embodiment relied on by the Board, is equally supported by Galdonik’s
disclosure to use self-expanding fibers to fill the vessel. See Final Act. 5
(“Galdonik teaches similar fibers that self-expand across a vessel lumen,”
and therefore, “it would have been obvious ... to modify the fibers of
Callister with the self-expanding nature as taught by Galdonik ... to ensure
expansion across the vessel as desired by Callister.”)
Regarding Appellants’ second argument, Appellants contend that “the
Board overlooked the fact that Callister does not disclose or even suggest
that its described fibrous body, when disposed within the inner lumen 65 of
the occluding component 61, is ‘self-expanding, such that the implant is . . .
self-expandable in the radial direction ....’” Request 4; see Callister, Fig.
15. In other words, Appellants contend that “the Board has not cited to any
factual basis to support an assertion that a person having ordinary skill in the
art would have understood self-expansion of Callister’s fibrous body 42 to
have resulted in expansion of the occluding device 60 relied on by the
Board. Id. at 5.
Independent claim 1 recites, in relevant part, “an implant. . .
comprising a fibrous mass of. . . fibers . . . ; wherein the . . . fibers are self­
expanding, such that the implant is delivered in a compressed, low-profile
state . . ., and self-expandable in the radial direction . . . .” Appeal Br. 13
(Claims App.). We determine that claim 1 may be read to mean that (i) the
fibers are self-expanding . . . and self-expandable in the radial direction; or
(ii) the fibers are self-expanding, such that the implant is . . . self-expandable
in a radial direction. Notwithstanding, we determine, for the reason stated
infra, that claim 1 does not require the self-expansion of the fibers to cause
the implant to .v^//-expand in the radial direction, as argued by Appellants.
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Accordingly, Appellants’ argument is not commensurate with the scope of
the claim language.
Adopting Appellants’ claim construction, wherein the fibers are self­
expanding, such that the implant is both deliverable in a compressed state
and self-expandable in the radial direction, Callister discloses that helical
coils 62 and 64 are “self-expandable for deployment within a patient’s body
lumen,” and according to the Examiner’s proposed modification, the fibrous
body (not shown in the embodiment of Figure 15) is also self-expanding, in
view of Galdonik. See Callister | 52; Final Act. 5. Thus, the ability of the
fibers themselves to self-expand within the implant allows the implant to be
deliverable in a compressed state, because the fibrous mass within the
implant is capable of also being in an unexpanded state upon delivery, and
the ability of the fibers themselves to self-expand within the implant allows
the implant to be self-expandable in the radial direction, because if the fibers
were not self-expanding, then the implant would have to be delivered in an
expanded state to accommodate the expanded fibers within the implant.
Moreover, the claim requires the implant to be ^//-expanding—not
expanded by the expansion of fibers. In sum, claim 1, as written, does not
require the self-expansion of the fibers to cause the implant to expand (or
more accurately, to .svT/-expand).
The same analysis is equally applicable to the language of
independent claim 24, which recites, in relevant part, “a scaffold ... at least
a section of the scaffold comprising . . . fibers . . . ; wherein the . . . fibers are
self-expanding, such that the scaffold is deliverable in a compressed, low-
profile state . . ., and self-expandable in the radial direction at a treatment
site in the HAS.” Id. at 14—15 (Claims App.).
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For these reasons, we determine that it is immaterial as to whether
“Callister fails to disclose or suggest that... the fibrous body has any
impact on Callister’s occluding device 60 itself,” as argued by Appellants.
Request 4.
Appellants also argue that “neither the Board nor the Examiner has
established that a person having ordinary skill in the art would have
understood the straightened initial configuration of Galdonik’s SCF fibers to
have been radially-bulked fibers, as recited by claim 1,” and further, that
“Galdonik’s fibers that are ‘stretched straight’ are not radially-bulked.”
Request 8. Appellants are presenting this argument for the first time on
appeal in the Request. It is inappropriate, however, for Appellants to discuss
for the first time in a Request for Rehearing matters that could have been
raised in the Appeal Brief. See Ex part Borden, 93 USPQ2d 1473, 1474
(BPAI 2010) (informative decision). Here, we do not have the benefit of the
Examiner’s position on this question. Therefore, we decline to consider this
new argument.
DECISION
We grant the Request to the extent that we have reconsidered the
record. The Request for Rehearing is denied.
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)(l)(iv).
REHEARING DENIED
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