Ex Parte Greff

Board of Patent Appeals and Interferences

Nov 9, 2011

10068812 (B.P.A.I. Nov. 9, 2011)

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.
10/068,812 02/04/2002 Richard J. Greff 1001.2216102 8436
11050 7590 11/09/2011
SEAGER, TUFTE & WICKHEM, LLC
1221 Nicollet Avenue
Suite 800
Minneapolis, MN 55403
EXAMINER
GHALI, ISIS A D
ART UNIT PAPER NUMBER
1611
MAIL DATE DELIVERY MODE
11/09/2011 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 J. GREFF
__________

Appeal 2011-007510
Application 10/068,812
Technology Center 1600
__________

Before ERIC GRIMES, MELANIE L. McCOLLUM, and FRANCISCO C.
PRATS, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to cross-
linked gelatin compositions. The Examiner has rejected the claims as
anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
reverse.
STATEMENT OF THE CASE
The Specification discloses that “[c]ross-linked gelatin, often in the
form of gelatin foam, gelatin film or gelatin sponges, has been used as a
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Application 10/068,812

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hemostatic agent … to pack wounds, absorb blood and stop bleeding” (Spec.
3:14-16).
Claims 22-33 and 42 are on appeal. Claim 22 is representative and
reads as follows:
22. A biocompatible, hemostatic, cross-linked gelatin composition
comprising:
a preformed cross-linked gelatin sponge; and
a wetting agent;
wherein the wetting agent decreases hydration time of the gelatin
sponge and the wetting agent is soluble in a non-aqueous solvent;
wherein the wetting agent is coated on at least a substantial portion of
the surface of the preformed gelatin sponge by soaking the preformed gelatin
sponge in a coating solution including the wetting agent and the non-
aqueous solvent.

The Specification discloses that suitable wetting agents “include, for
example, sodium lauryl sulfate, Pluronic F-68, Pluronic F-38, Pluronic P-
105, Pluronic-10R5, Tween 20, Tween 60, Tween 85, Brij 35, Brij 78, Myrj
52, PEG 600, glycerin and the like” (Spec. 12:1-4).
Issue
The Examiner has rejected claims 22-25, 27-30, 32, 33, and 42 under
35 U.S.C. § 102(b) as anticipated by Pawelchak.1 The Examiner has also
rejected claims 26 and 31 under 35 U.S.C. § 103(a): claim 26 in view of
Pawelchak and Yasushi;2 and claim 31 in view of Pawelchak and Song.3
Because the same issue is dispositive for all three of these rejections, we will
consider them together.

1 Pawelchak et al., US 4,292,972, Oct. 6, 1981
2 Yasushi et al., JP 02-182259, July 16, 1990
3 Song et al., EP 568334, Nov. 3, 1993
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The Examiner finds that Pawelchak discloses a “sponge product
comprising hemostatic bioabsorbable cross-linked gelatin foam.… The
product comprises … surface tension modifier including polyoxyethylene
derivatives of sorbitan fatty acid esters, such as Tween 60,” which are
soluble in non-aqueous solvents (Answer 4). The Examiner finds that
Pawelchak’s product can also comprise glycerin, which is soluble in non-
aqueous solvents (id. at 4-5).
The Examiner also finds that Pawelchak discloses a “method of
making the foam by forming [a] dispersion containing aerated foamed
gelatin … and adding the surfactant and/or glycerin to the dispersion,
followed by drying of the dispersion and forming a sponge product” (id. at
5). The Examiner reasons that “[a]dding the surfactant and/or glycerin to the
dispersion containing foamed aerated gelatin meet[s] the limitation of
coating the gelatin with the wetting agent as instantly claimed” (id.).
Appellant contends that Pawelchak’s product does not anticipate
claim 22 because Pawelchak’s sponge was formed by the addition of the
surfactant during formation of the sponge, rather than afterwards as specified
in claim 22, and thus Pawelchak’s method results in a different product
(Appeal Br. 10-11; Reply Br. 3-4).
We agree with Appellant that the Examiner has not adequately shown
that Pawelchak’s gelatin-containing sponge product is the same as the
gelatin sponge composition of claim 22. Pawelchak discloses a foam sponge
product that is prepared by “blending … gelatin, pectin, and sodium
carboxymethylcellulose, adding the mixture to water with agitation so as to
form a colloidal dispersion…, foaming the colloidal dispersion…, and then
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freeze drying” the foam (Pawelchak, col. 2, l. 67 to col. 3, l. 6). Pawelchak
discloses that a “surface tension modifier such as … natural or synthetic
surfactants such as lecithin and polyoxyethylene derivatives of sorbitan fatty
acid esters such as Tween 60 can be added to the colloidal dispersion to
stabilize the gas suspension and enhance the quality of the foam” (id. at col.
4, ll. 47-52). Pawelchak also discloses that “[p]lasticizers such as …
glycerine can be included within the colloidal dispersion” (id. at col. 5, ll.
37-39).
Thus, Pawelchak discloses a gelatin foam product that contains a
wetting agent as recited in claim 22, but the wetting agent is added to the
colloidal dispersion before the foam is generated rather than applied to a
“preformed gelatin sponge by soaking the preformed gelatin sponge in a
coating solution including the wetting agent and the non-aqueous solvent” as
specified in claim 22.
The Examiner reasons that “[a]dding the surfactant to the dispersion
containing foamed aerated gelatin as taught by the reference meet[s] the
limitation of coating the gelatin with the wetting agent by soaking as
instantly claimed by claim 22” (Answer 8).
The Examiner’s reasoning is not persuasive. The claim requires
“soaking the preformed gelatin sponge in a coating solution including the
wetting agent and [a] non-aqueous solvent,” while Pawelchak discloses
adding a surfactant to an aqueous colloidal dispersion of gelatin before the
gelatin sponge has been formed. We do not agree with the Examiner that
Pawelchak discloses the method step recited in claim 22.
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The Examiner also reasons that the process limitations of claim 22 do
not impart patentability because the claimed product appears to be
substantially identical to the prior art product (Answer 9). The Examiner
reasons that, in Pawelchak, “the dispersed surface active agent will
inevitably [be] present on the surface meeting the claimed limitation of
‘coated on at least a substantial portion’” of the surface of the preformed
gelatin sponge (id. at 12).
Appellant argues that the process steps of claim 22 impart structural
features to the gel foam product that patentably distinguish the claimed
product from Pawelchak’s gel foam product (Appeal Br. 8-9, Reply Br. 3-4).
We agree with Appellant that the Examiner has not established that
one of skill in the art would expect the claimed and prior art products to be
the same. Although it may be true that the “Patent Office bears a lesser
burden of proof in making out a case of prima facie obviousness for product-
by-process claims because of their peculiar nature,” Answer 9-10 (citing In
re Fessmann, 489 F.2d 742, 744 (CCPA 1974)), the burden shifts to the
applicant to prove that the products are not the same only when the PTO has
made out a prima facie case that the claimed and prior art products
reasonably appear to be the same. In re Thorpe, 777 F.2d 695, 697 (Fed.
Cir. 1985).
Here, although the Examiner asserts that Pawelchak’s surfactant
would be coated on at least a substantial portion of the surface of its gelatin
sponge, Pawelchak anticipates claim 22 only if its coating is structurally the
same as a coating applied via the process of claim 22. The Examiner has not
provided any evidence or sound technical reasoning to support a conclusion
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that Pawelchak’s product, with surfactant added before formation of the gel
foam, would be structurally the same as a product coated via the process of
claim 22, where the preformed gel sponge is soaked in a surfactant-
containing solution.
“[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of unpatentability.” In
re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). That burden has not been
met in this case. Thus, we reverse the rejection of independent claim 22 and
dependent claims 23-25, 27-30, 32, 33, and 42 under 35 U.S.C. § 102(b).
We also reverse the rejections of claims 26 and 31, which depend
from claim 22. For these rejections, the Examiner relies on Pawelchak, as
discussed above, and provides a second reference to supply dependent claim
limitations. However, as discussed above, the Examiner has not shown that
Pawelchak discloses the composition of claim 22. The Examiner also has
not explained how the other cited references would have made obvious the
limitation that is not disclosed by Pawelchak.
SUMMARY
We reverse the rejection of claims 22-25, 27-30, 32, 33, and 42 under
35 U.S.C. § 102(b), and we reverse the rejections of claims 26 and 31 under
35 U.S.C. § 103(a).

REVERSED

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