Ex Parte Duran et al

Board of Patent Appeals and Interferences

Dec 31, 2002

09103874 (B.P.A.I. Dec. 31, 2002)

The opinion in support of the decision being entered today was
not written for publication and is not binding precedent of the
Board.
Paper No. 27
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte CARLOS M. G. DURAN, DAVID T. CHEUNG
AND DAVID C. PANG
__________
Appeal No. 2003-0233
Application 09/103,874
___________
ON BRIEF
___________
Before PAK, OWENS, and KRATZ, Administrative Patent Judges.
OWENS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal is from the final rejection of claims 18-47,
which are all of the claims remaining in the application.
THE INVENTION
Appeal No. 2003-0233
Application 09/103,874
33. A pliable soft tissue specimen which has been prepared
in a process comprising the steps of:
(1) treating natural soft tissue obtained from a donor with:
(a) liquid compositions of gradually increasing
concentrations of a polar organic solvent or solvents, until
the last of said liquid compositions contains at least
approximately 25% and at most 75% by volume of said solvent,
or mixture of solvents, the balance being water, the solvent
being selected from a group consisting of aliphatic alcohols
having 1 to 3 carbons and other water miscible polar organic
solvents;
(b) thereafter with a second liquid composition of
aqueous glycerol or of low molecular weight polyethylene
glycol having a molecular weight less than approximately
1000D, containing the glycerol or the low molecular weight
polyethylene glycol, or mixtures thereof being in a
concentration range of approximately 10 to 50% by volume,
said second liquid composition also containing approximately
3 - 20% weight by volume polyethylene glycol of a molecular
weight in the range of 6,000 D to 15,000 D and approximately
2 to 75 units per milliliter heparin of a molecular weight
greater than approximately 3KD;
(2) thereafter briefly immersing the soft tissue in an
aqueous heparin solution, and
(3) thereafter freezing the tissue and lyophilizing the
tissue to dryness.
THE REFERENCES
Baumgartner 4,300,243 Nov. 17, 1981
Noishiki et al. (Noishiki) 4,704,131 Nov. 3, 1987
Appeal No. 2003-0233
Application 09/103,874
THE REJECTIONS
The claims stand rejected under 35 U.S.C. § 103 as follows:
claims 18-23, 25-30, 32-38, 40-45 and 47 over Baumgartner in view
of Noishiki, and claims 24, 31, 39 and 46 over Baumgartner in
view of Noishiki and Brendel.
OPINION
We reverse the aforementioned rejections. We need to
address only claim 33, which is the broadest independent claim.1
The appellants’ claims are in product-by-process form.
Hence, the patentability of the claimed invention is determined
based on the product itself, not on the method of making it. See
In re Thorpe, 777 F.2d 695, 697, 227 USPQ 964, 966 (Fed. Cir.
1985) (“If the product in a product-by-process claim is the same
as or obvious from a product of the prior art, the claim is
unpatentable even though the prior art product was made by a
different process.”). Whether a rejection is under 35 U.S.C.
§ 102 or § 103, when the appellants’ product and that of the
prior art appear to be identical or substantially identical, the
Appeal No. 2003-0233
Application 09/103,874
prior art product does not necessarily or inherently possess the
relied-upon characteristics of the appellants’ claimed product.
See In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA
1980); In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34
(CCPA 1977).
Baumgartner discloses a pliable soft tissue specimen which
has been prepared by treating collagenous tissues such as skin,
vessels, nerves, sinews, fasces cartilage and dura mater, with a
dehydration solvent such as ethanol, propanol, methanol,
isopropanol, acetone, methylethylketone or mixtures thereof
(col. 2, lines 33-60). Baumgartner teaches (col. 2, lines 37-
46):
Due to the optimum freeing of fibers and fibrils the
biological material, dura mater for instance, shows in
its histological image a morphological structure very
similar to the native tissue.
Thus properties are obtained which correspond very
well to the properties of the native tissue.
Practically, the elasticity is conserved and the
extensibility is simultaneously quite negligible. The
limit of elasticity amounts, for instance to 1.45 kp.
Noishiki discloses an antithrombotic collagenous medical
Appeal No. 2003-0233
Application 09/103,874
impregnate collagen fibers with protamine, dipping the protamine-
impregnated collagenous material in an aqueous glutaraldehyde
solution to fix the protamine, and then dipping the collagenous
material in an aqueous heparin solution to form a heparinized
collagen material having bonds between the positively charged
protamine and the negatively charged heparin (col. 1, lines 50-
55; col. 2, lines 33-41 and 65-67; col. 3, lines 35-36).
The examiner argues that it would have been obvious to one
of ordinary skill in the art to treat Baumgartner’s collagenous
tissue with heparin to improve the antithrombotic property of the
collagenous tissue as taught by Noishiki (answer, pages 4-5).
In order for a prima facie case of obviousness to be
established, the teachings from the prior art itself must appear
to have suggested the claimed subject matter to one of ordinary
skill in the art. See In re Rinehart, 531 F.2d 1048, 1051, 189
USPQ 143, 147 (CCPA 1976). The mere fact that the prior art
could be modified as proposed by the examiner is not sufficient
to establish a prima facie case of obviousness. See In re
Appeal No. 2003-0233
Application 09/103,874
Fritch, 972 F.2d 1260, 1266, 23 USPQ2d 1780, 1783 (Fed. Cir.
1992).
The examiner has not explained how the applied references
themselves would have led one of ordinary skill in the art to
heparinize Baumgartner’s collagenous material by Noishiki’s
method. A desirable characteristic of Baumgartner’s collagenous
material is that it has properties which correspond very well to
those of the native tissue (col. 2, lines 42-46). The examiner
has not explained why one of ordinary skill in the art would have
reasonably expected Baumgartner’s collagenous material, after
being treated with Noishiki’s protamine, glutaraldehyde and
heparin, to have the properties required by Baumgartner. 3
Nor has the examiner explained how Noishiki would have led
one of ordinary skill in the art to heparinize Baumgartner’s
collagenous material without use of the protamine and
glutaraldehyde. Noishiki indicates that the glutaraldehyde is
essential to fix the protamine, and that the protamine is
essential for bonding to the heparin (col. 2, lines 65-67;
Appeal No. 2003-0233
Application 09/103,874
col. 3, lines 35-36).
The examiner argues that Baumgartner’s collagenous material
differs from that of the appellants only in that Baumgartner’s
collagenous material has not been heparinized (answer, page 6).
Even if, because Baumgartner’s treated collagenous material, like
that of the appellants (specification, page 4, lines 19-22), has
properties corresponding very well to the native tissue, it could
reasonably be considered to appear to be the same or
substantially the same as the appellants’ collagenous material
before being heparinized, the examiner has not established a
prima facie case of obviousness. The reason is that, as
discussed above, the examiner has not established that the
applied references themselves would have led one of ordinary
skill in the art to heparinize Baumgartner’s collagenous
material.
Appeal No. 2003-0233
Application 09/103,874
DECISION
The rejections under 35 U.S.C. § 103 of claims 18-23, 25-30,
32-38, 40-45 and 47 over Baumgartner in view of Noishiki, and
claims 24, 31, 39 and 46 over Baumgartner in view of Noishiki and
Brendel, are reversed.
REVERSED
)
CHUNG K. PAK )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
TERRY J. OWENS )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
PETER F. KRATZ )
Administrative Patent Judge )
Appeal No. 2003-0233
Application 09/103,874
GABOR L. SZEKERES
8141 E. KAISER BLVD
SUITE 112
ANAHEIM, CA 92808
TJO:cae