Ex Parte Fulton et al

Board of Patent Appeals and Interferences

Nov 30, 2011

10943434 (B.P.A.I. Nov. 30, 2011)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
10/943,434 09/16/2004 Richard E. Fulton DEV-5431USCNT11 2835
21884 7590 11/30/2011
WELSH FLAXMAN & GITLER LLC
2000 DUKE STREET, SUITE 100
ALEXANDRIA, VA 22314
EXAMINER
SZMAL, BRIAN SCOTT
ART UNIT PAPER NUMBER
3736
MAIL DATE DELIVERY MODE
11/30/2011 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 RICHARD E. FULTON
and WILLIAM RICHARD DUBRUL
__________

Appeal 2010-006220
Application 10/943,434
Technology Center 3736
__________

Before DEMETRA J. MILLS, LORA M. GREEN, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134 from the Examiner’s rejection
of claims 7-14, 22, 38, and 48-54. We have jurisdiction under 35 U.S.C.
§ 6(b).
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STATEMENT OF CASE
The following claims are representative, and read as follows:
7. A method for marking a biopsy cavity comprising the steps of:
providing a bioresorbable body having a radiopaque marker carried by
the bioresorbable body, said bioresorbable body comprising gelatin;
removing a biopsy specimen from the breast of a patient, thereby
creating a biopsy site;
inserting the bioresorbable body into the biopsy site to mark the
location of the biopsy site;
and
testing the biopsy specimen.

13. The method of claim 7, wherein the bioresorbable body swells
upon contact with body fluid.

22. A method for marking a biopsy cavity comprising the steps of:
providing a bioresorbable body having a radiopaque marker carried by
the bioresorbable body, said bioresorbable body comprising polylactic acid;
removing a biopsy specimen from the breast of a patient, thereby
creating a biopsy site;
inserting the bioresorbable body into the biopsy site to mark the
location of the biopsy site;
and
testing the biopsy specimen.

53. The method of claim 38, wherein the bioresorbable body swells
upon contact with body fluid.

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Grounds of Rejection
1. Claims 7-14 are rejected under 35 U.S.C. § 103(a) over Foerster1 in view
of Cragg.2
2. Claims 7-14 are rejected under 35 U.S.C. § 103(a) over Foerster in view
of Nabai.3
3. Claims 22, 38, and 48-52 are rejected under 35 U.S.C. § 103(a) over
Foerster in view of Stinson.4
4. Claims 53 and 54 are rejected under 35 U.S.C. § 103(a) over Foerster in
view of Stinson and Ding.5
FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at
pages 3-7.

Discussion
1. Claims 7-14 are rejected under 35 U.S.C. § 103(a) over Foerster in
view of Cragg.

1 Foerster et al., US 6,228,055 B1, issued May 8, 2001.
2 Cragg et al., US 6,071,301, issued Jun 6, 2000.
3 Nabai et al., US 5,388,588, issued Feb. 14, 1995.
4 Stinson, US 6,174,330 B1, issued Jan. 16, 2001.
5 Ding, US 5,899,935, issued May 4, 1999.
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ISSUE
The Examiner concludes that Foerster teaches each element of the
claimed method except it fails
to disclose the bioresorbable body contains gelatin; the body
swells upon contact with body fluid; and the body swells to
substantially fill the biopsy site.
Cragg et al disclose a means for providing hemostasis of
a biopsy tract and further disclose the bioresorbable body
contains gelatin; the body swells upon contact with body fluid;
and the body swells to substantially fill the biopsy site. See
Column 3, lines 26-29; Column 7, lines 24-28; and Column 8,
lines 49-55.
It would have been obvious to one of ordinary skill in the
art at the time the invention was made to modify the means of
Foerster et al to include the use of a swellable gelatin body, as
per the teachings of Cragg et al, since it is well known in the art
that gelatin is an example of a biocompatible and biodegradable
polymer compound.
(Ans. 3-4).
Appellants argue that Cragg is not concerned with positioning the
pledget at the biopsy site, and does not show marking the biopsy site for
further location. (Br. 9.) Appellants further argue that the Examiner has
failed to show that “Cragg teaches a gelatin as a known material for carrying
a radiopaque marker to a biopsy site or that it would be obvious to modify
Foerster to employ a bioresorbable body carrying a radiopaque marker to a
biopsy site.” (Br. 10.)
The issue is: Has the Examiner provided evidence to support the
conclusion that the claimed subject matter is obvious?

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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).

ANALYSIS
Appellants provide separate argument for claims 7 and 13, which we
address separately. We agree with the Examiner’s fact finding, statement of
the rejection, and responses to Appellants’ arguments as set forth in the
Answer. We provide the following additional comment.
Appellants argue that the Examiner has failed to show that Cragg
teaches gelatin as a known material for carrying a radiopaque marker to a
biopsy site. We are not persuaded. Foerster teaches devices for marking
and defining particular locations in body tissue during biopsy, including
biopsy of the breast. At col. 13, lines 33-36, Foerster teaches that the
markers may be “biocompatible, implantable, and visible using an imaging
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system.” The Examiner relies on Cragg for teaching that gelatin (Gelfoam)
is a well-known biocompatible material for use as a packing material to
control bleeding at a biopsy site. (Col. 1, ll. 34-60; col. 3, ll. 50-53; col. 7,
ll. 24-40.) We agree with the Examiner that it would have been obvious to
one of ordinary skill in the art to substitute one well-known biocompatible
material for use at a biopsy site for another well-known biocompatible
material for use at a biopsy site. “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
at 416 (2007).
With respect to claims 13 and 14, Appellants argue that neither
Foerster nor Cragg teaches the step of the bioresorbable body swelling to fill
the biopsy site. (Br. 10.) We are not convinced by Appellants’ argument.
Cragg teaches that gelatin rapidly expands or swells upon contact with body
fluid at col. 7, ll. 24-36.
We affirm the rejection over Foerster and Cragg for the reasons of
record.

2. Claims 7-14 are rejected under 35 U.S.C. § 103(a) over Foerster in
view of Nabai.
ISSUE
The Examiner finds that Foerster discloses each element of the
claimed method except Foerster fails to disclose that the bioresorbable body
contains gelatin. (Ans. 5.) The Examiner relies on Nabai for disclosing a
means for providing a biopsy wound closure with a bioresorbable body
containing gelatin. (Id.) The Examiner concludes that it would have been
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obvious to include the use of gelatin as a biocompatible and biodegradable
polymer compound in Foerster. (Id.)
Appellants argue that Nabai is concerned with skin biopsies, not
breast biopsies, and that there is no need for radiopaque markers to be used
in conjunction with Nabai. (Br. 11.)
The issue is: Does the cited prior art support the Examiner’s
conclusion that the claimed subject matter is obvious?

ANALYSIS
Appellants provide separate argument for claims 7 and 13, which we
address separately.
We agree with the Examiner’s fact finding, statement of the rejection,
and responses to Appellants’ arguments as set forth in the Answer. We
provide the following additional comment.
Similar to our analysis with respect to Foerster and Cragg, and
notwithstanding the fact that the gelatin material of Nabai is used for a skin
biopsy, we find that Foerster discloses the claimed method for use with
respect to breast biopsies. We agree with the Examiner that it would have
been obvious to one of ordinary skill in the art to substitute one well-known
biocompatible material for use at a biopsy site for another well-known
biocompatible material for use at a biopsy site such as the gelatin disclosed
in Nabai. “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 at 416 (2007).
With respect to claims 13 and 14, Appellants argue that neither
Foerster nor Nabai teaches the step of the bioresorbable body swelling to fill
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the biopsy site. (Br. 11.) We are not convinced by Appellants’ argument.
Nabai teaches that gelatin swells upon contact with body fluid at col. 3,
ll. 43-49. (Ans. 5.)
We affirm the rejection over Foerster and Nabai for the reasons of
record.

3. Claims 22, 38 and 48-527-14 are rejected under 35 U.S.C.
§ 103(a) over Foerster in view of Stinson.
4. Claims 53 and 54 are rejected under 35 U.S.C. § 103(a) over
Foerster in view of Stinson and Ding.

ISSUE
The Examiner finds that Foerster discloses each element of the
claimed method, except Foerster fails to disclose that the bioresorbable body
contains polylactic acid or polyglycolic acid. (Ans. 6.)
The Examiner relies on Stinson for the disclosure of a bioabsorbable,
radiopaque marker that contains polylactic acid or polyglycolic acid. (Id.)
Ding is relied on for the disclosure that polyglycolic acid swells upon
contact with body fluid. (Id.)
Appellants argue that the marker of Stinson is used on a stent and not
used in the manner of Foerster during biopsy. (Ans. 7.) Appellants argue
that just because a material is known does not make it obvious to use in a
method of marking a biopsy cavity.
The issue is: Does the cited prior art support the Examiner’s
conclusion that the claimed subject matter is obvious?

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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
provide the following additional comments.
We agree with the Examiner that it would have been obvious to one of
ordinary skill in the art to substitute one well-known implantable,
biocompatible material for use at a biopsy site for another well-known
implantable biocompatible material. The question of obviousness cannot be
approached on the basis that an artisan having ordinary skill would have
known only what was read in the references, because such artisan must be
presumed to know something about the art apart from what the references
disclose. See In re Jacoby, 309 F.2d 513, 516 (CCPA 1962). Moreover, the
law presumes skill on the part of the artisan rather than the converse. See
In re Sovish, 769 F.2d 738, 742-43 (Fed. Cir. 1985).
Thus, the substitution of polylactic acid of Stinson for a
biocompatible, implantable material described in Foerster is merely the
combination of familiar elements, implantable biocompatible material
according to known methods, and 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 at 416 (2007).
We affirm the rejection over Foerster and Stinson and Ding for the
reasons of record.

CONCLUSION OF LAW
The cited references support the Examiner’s obviousness rejections.
The decision of the Examiner is affirmed.
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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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