Ex Parte Shabty et al

Board of Patent Appeals and Interferences

Aug 15, 2012

11942865 (B.P.A.I. Aug. 15, 2012)

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.
11/942,865 11/20/2007 Paul Shabty 604650-036 2409
7590 08/15/2012
William H. Honaker, Esq.
DICKINSON WRIGHT PLLC
38525 Woodward Avenue, Suite 2000
Bloomfield Hills, MI 48304-2970
EXAMINER
SIMPSON, SARAH A
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
08/15/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte PAUL SHABTY, ROD A. SHIPMAN,
and ANTHONY Y. VAN HEUGTEN
__________

Appeal 2011-005880
Application 11/942,865
Technology Center 3700
__________

Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and STEPHEN
WALSH, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
Appeal 2010-005880
Application 11/942,865

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STATEMENT OF THE CASE
The claimed invention solves a “need [that] exists to develop a safe
and effective means for sealing the arterial wall following arteriotomy
procedures that allows the patient to quickly return to normal activity.”
(Spec. 2.)
Claim 1 is representative of the claims on appeal and reads as follows:
1. A method of closing an incision having an insertion hole in
a skin and a puncture hole in an artery with an introducer and a catheter
defining first and second lumens in operative communication with first and
second ports and first and second balloons, the second balloon defining at
least one slit therein, said method comprising:
inserting the introducer through the insertion hole and the puncture
hole to extend into the artery,
inserting the catheter and the first and second balloons through the
introducer a sufficient distance to have the first balloon located in the artery,
injecting a fluid into the first port and through the first lumen to
inflate the first balloon in the artery,
withdrawing the catheter with the first balloon being inflated to close
the puncture hole,
removing the introducer from the puncture hole and the insertion hole,
injecting a clotting agent into the second port and through the second
lumen to inflate the second balloon to create a cavity between the insertion
hole and the puncture hole and to create pressure on the inside of the second
balloon,
expanding the slit in the second balloon into an open position as a
result of the pressure of the clotting agent within the second balloon to eject
the clotting agent therefrom and to deflate the second balloon,
deflating the first balloon, and
removing the catheter and the first and second balloons from the puncture
hole in the artery and the insertion hole in the skin.

Cited References

The Examiner relies on the following prior art for reference:

Appeal 2011-005880
Application 11/942,865

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Shaffer et al. US 5,049,132 Sep. 17,1991
Meyers et al. US 5,725,551 Mar. 10,1998

Grounds of Rejection
Claims 1-8 are rejected under 35 U.S.C. 103(a) as being unpatentable
over Myers et al. in view of Shaffer et al.

FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages 3-
7. The following facts are highlighted.

1. Figure 1 of the Specification is reproduced below.

Figure 1 shows an arterial closure device with first balloon 50 and
second balloon 58.

2. Figure 1A of Myers is reproduced below.
Appeal 2011-005880
Application 11/942,865

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Myers, Figure 1A shows arteriotomy closure device with balloon 44 and
second balloon 54.
3. Shaffer teaches that
[a]lso, either before, during, or after the process of inflating
balloon 16, medications such as heparin solution or any other
desired medication or mixtures thereof may be administered
through port 40 and lumen 38 into the space 47 between balloons
16 and 44. Pressure may be applied as necessary, either directly
through port 40 or indirectly by the inflation of balloon 16, causing
the medication to migrate outwardly through the wall of the
balloon 44 to the surrounding tissue.
It can be seen that the catheter of this invention provides great
versatility in that pressure without medication can be applied, or
medication can be applied with pressure, and also medication can
be applied without significant pressure, with sequential
administrations of different kinds of medication being available,
and last minute choices may be made as to the medication to be
administered. All of this is possible with the insertion of a single
catheter. Likewise, medication which is incompatible in some way
with the fluid used to inflate balloon 16 may be provided in a
separated manner, and also the medication may be kept relatively
separate, at least until delivery, from X-ray contrast media or the
like administered to lumen 28 through port 32.

(Col. 6, ll. 19-41.)

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Application 11/942,865

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Discussion
ISSUE
The Examiner concludes that
Myers et al. fail to disclose at least one slit within the second balloon,
injecting a clotting agent comprising a biologically active agent to
inflate the second balloon to expand the slit into an open position as a
result of pressure within the second balloon and to eject the clotting
agent therefrom. Myers et al. teach manual compression of the site
(column 12, lines 55-60), but fail to disclose wherein the second force
is applied by a C-clamp and wherein the insertion hole is dressed in
response to the stoppage of the flow of blood.
However, Shaffer teaches a plurality of equally spaced slits (45a)
disposed downstream from an aperture in a balloon (44) expandable
between an open position and a closed position in response to
inflation of said balloon such that the medication is ejected through
said slit in said open position (figs. 2, 5; columns 6-7, lines 67-68,1-
4). Shaffer further discloses that the therapeutic agent administered
through the slits in the balloon may be a biological adhesive such as
fibrin glue, which is a clotting agent (column 4, lines 8-12).
Given the teachings of Shaffer, it would have been obvious to one of
ordinary skill in the art at the time of the invention to modify the
method of closing a puncture hole of Myers et al. by injecting a
biologically active agent with a clotting agent into the second port to
inflate the second balloon, expanding the slit, and ejecting the clotting
agent. Doing so would enhance controlled delivery as well as use
positive pressure to inject medication to a treatment site, resulting in
less blockage of the medication flow. Lastly, Myers et al. teach
manual compression and it would have been obvious to one of
ordinary skill in the art at the time of the art to modify this step with at
least one finger or a C-clamp. C-clamps and wound dressings are
extremely common and well known in the art. Therefore, clamping
and dressing the wound would have been obvious because a particular
known technique was recognized as part of the ordinary capabilities of
one skilled in the art.

(Ans. 5-6.)

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Application 11/942,865

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Appellants argue that “the present invention teaches and claims the
use of a second balloon 58 that both expands to disrupt surrounding tissue as
well as disperse clotting agent or similar medicine. This is not taught or
suggested by Shaffer or Myers alone or in combination. In fact the Shaffer
reference teaches away from having the medicine dispersing balloon also act
as a pressure balloon due to the pressure generated by the medicine.” (App.
Br. 8.) Appellants argue “that the Examiner's assertions that Shaffer does in
fact teach utilizing pressure in the second balloon to disrupts surrounding
tissues as well as disperse medication is unfounded.” (Id.)
The issue is: Does the cited prior art teach or suggest the invention as
claimed?

PRINCIPLES OF LAW
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
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Application 11/942,865

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A reference may be said to teach away when a person of
ordinary skill, upon reading the reference, would be
discouraged from following the path set out in the reference, or
would be led in a direction divergent from the path that was
taken by the applicant. The degree of teaching away will of
course depend on the particular facts; in general, a reference
will teach away if it suggests that the line of development
flowing from the reference’s disclosure is unlikely to be
productive of the result sought by the applicant.
In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994).

[I]t is elementary that the mere recitation of a newly
discovered function or property, inherently possessed by things
in the prior art, does not cause a claim drawn to those things to
distinguish over the prior art. Additionally, where the Patent
Office has reason to believe that a functional limitation asserted
to be critical for establishing novelty in the claimed subject
matter may, in fact, be an inherent characteristic of the prior art,
it possesses the authority to require the applicant to prove that
the subject matter shown to be in the prior art does not possess
the characteristic relied on.
In re Best, 562 F.2d 1252, 1254-55 (CCPA 1977).

ANALYSIS
We agree with the Examiner’s fact finding, statement of the rejection
and responses to Appellants’ arguments as set forth in the Answer. We find
that the Examiner has provided evidence to support a prima facie case of
obviousness. We provide the following additional comments.
Appellants argue that “the present invention teaches and claims the
use of a second balloon 58 that both expands to disrupt surrounding tissue as
well as disperse clotting agent or similar medicine. This is not taught or
suggested by Shaffer or Myers alone or in combination. In fact the Shaffer
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Application 11/942,865

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reference teaches away from having the medicine dispersing balloon also act
as a pressure balloon due to the pressure generated by the medicine.” (App.
Br. 8.) Appellants argue “that the Examiner's assertions that Shaffer does in
fact teach utilizing pressure in the second balloon to disrupts surrounding
tissues as well as disperse medication is unfounded.” (Id.)
We are not persuaded by Appellants’ arguments. The Examiner
answers these arguments of Appellants, arguing
Shaffer clearly states that "It can be seen that the catheter of this
invention provides great versatility in that pressure without
medication can be applied, or medication can be applied with
pressure, and also medication can be applied without significant
pressure, with sequential administrations of different kinds of
medication being available, and last minute choices may be made as
to the medication to be administered" (column 6, lines 28-35). Thus,
Shaffer does in fact teach that the medicine may be applied with
pressure exerted on the balloon 44. Furthermore, Shaffer teaches that
medication, such as clotting agents (column 4, lines 8-12; wherein
fibrin glue is a clotting agent) may be administered through port 40
into the space 47 between balloons 16 and 44, where pressure may be
applied as necessary.

(Ans. 7.)

Appellants have failed to explain why one of ordinary skill in the art
would not have understood from the above disclosure of Shaffer that
pressure could be applied along with delivery of medication and that such
pressure would have disrupted surrounding tissues. Thus we do not agree
that Appellants have shown that the Shaffer reference teaches away from
having the medicine dispersing balloon also act as a pressure balloon due to
the pressure generated by the medicine. In addition, the Examiner relies on
the disclosure of Meyers for the disclosure of an arteriotomy closure with
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Application 11/942,865

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two balloons, which inherently expands to disrupt surrounding tissue, in the
same manner as that claimed.
The obviousness rejections of claim 1 and separately argued claims 2,
3-7 and 8 are affirmed for the reasons of record.

CONCLUSION OF LAW
The cited references support the Examiner’s obviousness rejection.

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

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