Ex Parte Patadia

Patent Trials and Appeals Board

Apr 8, 2019

11993951 - (D) (P.T.A.B. Apr. 8, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
11/993,951 06/04/2010 Bipin C. Patadia
45200 7590 04/10/2019
K&L Gates LLP-Orange County
1 Park Plaza
Twelfth Floor
IRVINE, CA 92614
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.
1951760-00002 2054
EXAMINER
WEISBERG, AMY REGINA
ART UNIT PAPER NUMBER
3649
NOTIFICATION DATE DELIVERY MODE
04/10/2019 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):
uspatentmail@klgates.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BIPIN C. PATADIA 1
Appeal2017-006446
Application 11/993,951
Technology Center 3700
Before TONI R. SCHEINER, TA WEN CHANG, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHEINER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the non-final rejection
of claims 1-9, 11-20, 22, 23, and 28-30, directed to a system and method
for deploying a stent. The claims have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b ).
We affirm. 2
1 The Real Party in Interest is inventor Bipin C. Patadia. Br. 3.
2 In this decision we refer to the Non-Final Office Action mailed May 16,
2016 ("Non-Final Act."); the Appeal Brief filed October 14, 2016 ("Br.");
and the Examiner's Answer mailed November 9, 2016 ("Ans.).
Appeal2017-006446
Application 11/993 ,951
BACKGROUND
The Specification discloses "proximally-flaring stent and balloon
catheter systems and methods for ... restor[ing] patency to a side branch
and its ostium[3J at a vessel bifurcation where the side branch only can be
approached in the direction of blood flow rather than in the direction
opposite blood flow." Spec. ,r 1. Figures 3A-3C of the Specification,
reproduced below, illustrate deployment of the proximally flaring stent in a
branched vessel:
FIG. 3B
3 "When a vessel branches, the opening to the branched vessel is called an
ostium." Spec. ,r 4.
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Application 11/993 ,951
Figure 3A is a partial cross-sectional view, illustrating the placement of the
proximally flaring stent and balloon catheter system within a side branch of
a branched vessel. Figure 3B illustrates deployment of the stent in the side
branch of the branched vessel after inflation of a first balloon has occurred
and the first balloon has been deflated and removed from the treatment site.
Figure 3C illustrates inflation of a second balloon in the main artery (before
it has been deflated) that completes deployment of the flanged proximal
portion of the proximally flaring stent within the main artery. Spec. ,r,r 34--
36.
STATEMENT OF THE CASE
Claims 1-9, 11-20, 22, 23, and 28-30 are on appeal. Claims 10, 21,
and 24--27 have been cancelled. Claims 1, 13, and 30 are independent.
Claim 1 is representative and reads as follows:
1. A system for deploying a stent, the system comprising:
a proximally-flaring stent having:
(a) a first distal portion;
(b) a first medial region;
( c) a hinge area; and
( d) a flanged proximal portion;
a first balloon catheter having a first inflatable balloon with:
(a) a second distal portion;
(b) a second medial region;
( c) a proximal portion; and
a second, separate balloon catheter having a second inflatable
balloon wherein the second inflatable balloon does not include
a stent;
wherein:
(a) the first balloon is capable of sequential inflation from
the second distal portion through the second medial
region and finally to the proximal portion; and
(b) the proximally-flaring stent's flanged proximal
portion is:
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Application 11/993 ,951
(i) positioned within the first balloon's second
medial region; and
(ii) proximal to the proximally-flaring stent's first
distal portion when mounted on the first inflatable
balloon;and
(iii) deployed by inflating the second inflatable
balloon of the second, separate balloon catheter.
The claims stand rejected under 35 U.S.C. § I03(a) as follows:
Claims 1-6, 8, 9, 11-17, 19-20, 22, 23, and 28-30 as unpatentable
over Kaplan4 and Schaeffer; 5 and
Claims 7 and 18 as unpatentable over Kaplan, Schaeffer, and Tuch. 6
DISCUSSION
Briefly, the Examiner finds that Kaplan discloses all the limitations of
claim 1, with the exception of the "first balloon having a structure capable of
sequential inflation from the second distal portion through the second medial
region and finally to the proximal portion." Non-Final Act. 3-5 ( citing
Kaplan, Figs. 5a, 6a, ,r,r 35, 36). For this limitation, the Examiner turns to
Schaeffer's disclosure of an ostia stent deployment system with "a means for
sequential inflation of a balloon system," wherein the distal section is
expanded before the proximal portion. Id. at 5 ( citing Schaeffer ,r 140).
The Examiner concludes that it would have been obvious for one of
ordinary skill in the art "to use sequential inflation of the balloon system as
4 Kaplan et al., US 2004/0204754 Al, published October 14, 2004 (claiming
priority to Provisional application no. 60/463,075, filed April 14, 2003).
5 Schaeffer, US 2007 /0179592 Al, published August 2, 2007 (claiming
priority to Provisional application no. 60/518,565, filed November 8, 2003).
6 Tuch, U.S. Patent No. 5,624,411, issued April 29, 1997.
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Application 11/993 ,951
taught by Schaeffer ... to provide a more accurate deployment of the flaring
stent at the ostia." Id.
Appellant does not dispute the Examiner's findings with respect to the
scope and content of the prior art; nor does Appellant dispute the Examiner's
conclusion that the claimed invention would have been obvious over the
combined teachings of the prior art. Rather, Appellant contends that "the
[Kaplan and Schaeffer] references cited by the Examiner are not properly
cited as they have been predated by a Declaration under 3 7 C.F .R. § 1.131 "7
(Br. 12) establishing "that the subject matter of the presently pending
claim[ s] was conceived prior to April 14, 2003 and reduced to practice with
appropriate diligence" (id. at 13).
Issue
Thus, the issue raised by both obviousness rejections is whether
Appellant's Declaration under 37 C.F.R. § 1.131 is effective to antedate the
prior art cited against the claims.
Principles of Law
In general, to antedate a reference cited against a claimed invention,
an affidavit or declaration under 37 C.F.R. § 1.131 must establish possession
of either the whole invention claimed or something falling within the claim
(such as a species of a claimed genus) at a time prior to the effective date of
the reference. In re Tanczyn, 347 F.2d 830 (CCPA 1965). Nevertheless,
where the differences between the claimed invention and a reference
disclosure are so small as to render the claims obvious over the reference,
7 Declaration of Bipin Patadia under 37 C.F.R. § 1.131, dated September 23,
2014 ("Deel.").
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Application 11/993 ,951
the affidavit or declaration need only show as much as the reference. In re
Stryker, 435 F.2d 1340, 1342--43 (CCPA 1971).
In addition, to be effective in antedating a reference,
The showing of facts for an oath or a declaration under
paragraph (a) of ... section [ 1.131] shall be such, in character
and weight, as to establish reduction to practice prior to the
effective date of the reference, or conception of the invention
prior to the effective date of the reference coupled with due
diligence from prior to said date to a subsequent reduction to
practice or to the filing of the application.
37 C.F.R. § 1.131(b).
Moreover, a statement that the claimed invention "was diligently
reduced to practice" is not a showing, but a mere pleading. In re Harry, 333
F .2d 920, 923 ( CCP A 1964 ). "It asserts that facts exist but does not tell
what they are or when they occurred," and is, therefore, insufficient. Id.
Analysis
The Examiner contends that Appellant's Declaration under 37 C.F.R.
§ 1.131 is ineffective to overcome the Kaplan and Schaeffer references for
two reasons: (1) "the claimed invention is not shown in the declaration and
the claims are not obvious to one of ordinary skill in] the art" (Ans. 5), and
(2) "[t]he evidence submitted is insufficient to establish diligence from a
date prior to the date of reduction to practice of the Kaplan ... and
Schaeffer" references (id.). We will address the Examiner's contentions in
tum.
Specifically, the Examiner contends "the declaration fails to show the
second balloon acting upon the stent to deploy it" and "[ t ]he declaration also
fails to demonstrate a proximally flaring stent." We disagree with the
Examiner on these two points. Exhibit A of the Declaration shows and
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Application 11/993 ,951
labels a drawing of a stent on a balloon; an arrow connects flanges at one
end of the stent to a drawing showing a different view of the flanges in a
flared condition; and yet another arrow connects that drawing to a drawing
of the stent on the balloon deployed in a branched vessel, with the flanges
deployed in the ostimn of the vessel, and partially flared. Moreover, a
second balloon, without a stent, is visible in the vessel, and we agree with
Appellant that "a skilled artisan would be persuaded with reasonable
certainty that [Appellant] had possession of ... a second balloon catheter,
wherein ... the proximally-flaring stent's flanged proximal portion is
deployed by inflating the second inflatable balloon of the second, separate
balloon catheter." Br. 15.
Nevertheless, claim 1 also requires that "the first balloon is capable of
sequential inflation from the second distal portion through the second medial
region and finally to the proximal portion," and independent claims 13 and
30 have comparable limitations. With respect to this aspect of the claims,
the Examiner contends "sequential inflation is not an inherent quality of all
balloons," but is "a property rendered by a specific structure," and "[m]eans
for sequential inflation cannot be determined from the declaration." Ans. 5.
We agree with the Examiner on this point. Nothing in Exhibit A
illustrates or references sequential inflation of the first balloon. We
acknowledge that, in addition to the drawings in Exhibit A, Appellant
indicates: "I conceived the balloon to be sequentially inflatable from the
distal portion through the medial portion and finally to the proximal
portion." Deel. § 10. This statement, however, is unpersuasive as it is not
accompanied by corroborating evidence of any kind, and moreover, does not
indicate when the balloon was conceived to be sequentially inflatable.
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Application 11/993 ,951
Appellant asserts "if based on a Rule 131 affidavit's facts, one of
ordinary skill in the art would be persuaded that the applicant possessed so
much of the invention as to encompass the reference disclosure, then that
showing should be sufficient to overcome the reference." Br. 15. As
discussed above, however, that is so where the differences between the
claimed invention and a reference disclosure are so small as to render the
claims obvious over the reference. In re Stryker, 435 F.2d at 1342--43.
Here, Appellant has not established that the difference between the claimed
invention and Kaplan's disclosure is so small as to render the claimed
invention obvious over Kaplan. Indeed, Appellant contends "if only one
reference is pre-dated, the remaining reference cannot stand alone to sustain
a primafacie case of obviousness." Br. 12.
Finally, Appellant's statement in the Declaration that "[a]ppropriate
diligence was taken from the date of conception of the invention to filing of
the above-referenced application" is not a showing but a mere pleading. See
In re Harry, 333 F.2d at 923. As it asserts that facts exist, but does not
provide the facts or establish when they occurred, the Declaration is
ineffective to establish the requisite diligence.
Accordingly, we affirm the rejections of the claims under 35 U.S.C.
§ 103(a).
SUMMARY
The rejection of claims 1-6, 8, 9, 11-17, 19-20, 22, 23, and 28-30 as
unpatentable over Kaplan and Schaeffer is affirmed; and
the rejection of claims 7 and 18 as unpatentable over Kaplan,
Schaeffer, and Tuch is affirmed.
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Application 11/993 ,951
TIME PERIOD FOR RESPONSE
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
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