Ex Parte Mansfield et al

Board of Patent Appeals and Interferences

Mar 17, 2008

09513086 (B.P.A.I. Mar. 17, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte LINDA S. MANSFIELD, MARY G. ROSSANO,
ALICE J. MURPHY, and RUTH A. VRABLE
____________

Appeal 2008-1674
Application 09/513,086
Technology Center 1600
____________

Decided: March 17, 2008
____________

Before ERIC GRIMES, LORA M. GREEN, and RICHARD M. LEBOVITZ
Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s final rejection of claims 4, 13, 46, and 50. We have jurisdiction
under 35 U.S.C. § 6(b). Claims 4 and 13 are representative of the claims on
appeal, and reads as follows:
Appeal 2008-1674
Application 09/513,086

4. A composition consisting of a single naturally occurring 16 (±4) kDa
protein antigen isolated from Sarcocystis neurona and a single naturally
occurring 30 (±4) kDa protein antigen isolated from Sarcocystis neurona in
a pharmaceutically acceptable carrier.

13. A method for treating an equine with Sarcocystis neurona infection,
comprising:
(a) providing a composition consisting of a single naturally occurring
16 (±4) kDa protein antigen isolated from Sarcocystis neurona and a single
naturally occurring 30 (±4) kDa protein antigen isolated from Sarcocystis
neurona in a pharmaceutically acceptable carrier; and
(b) inoculating the equine with the composition to treat the equine
with the Sarcocystis neurona infection.

We reverse.

DISCUSSION
Claims 4, 13, and 46 stand rejected under 35 U.S.C. § 112, first
paragraph, “as containing subject matter which was not described in the
[S]pecification in such a way as to reasonably convey to one skilled in the
relevant art that the inventor(s), at the time the application was filed, had
possession of the claimed invention.” (Ans.1 3.) This is a new matter
rejection (id.).
The Examiner asserts that the terms “isolated” and “naturally
occurring” are not supported by the disclosure as filed (id.). According to
the Examiner, the only support for “isolated” would be in the context of a
recombinant protein (id. at 4). The Examiner further notes that “there is no
literal support for isolating the 16 and 30 kDa proteins directly from
Sarcocystis neurona as a contemplated part of the invention.” (Id.) The

1 All references to the Answer (Ans.) are to the Examiner’s Answer mailed
October 17, 2006.
2
Appeal 2008-1674
Application 09/513,086

Examiner notes moreover that there does not appear to be support for
“naturally occurring,” asserting that “the literal support for this embodiment
can not be found, in particular in the context of an ‘antigen’ versus the
protein itself that exists in nature.” (Id.)
The Examiner notes, however, “that it appears that the [S]pecification
would support inter alia ‘consisting’ since it does contemplate two proteins
in a composition.” (Id. at 3.)
The burden is on the examiner to set forth a prima facie case of
unpatentability. See In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996). The
disclosure as originally filed need not provide “in haec verba support for the
claimed subject matter at issue,” rather, the disclosure should convey to one
skilled in the art that the inventor had possession of the invention at the time
of filing. Purdue Pharma L.P. v. Faulding Pharmaceutical Co., 230 F.3d
1320, 1323 (Fed. Cir. 2000) (citations omitted).
We find that the disclosure as filed would convey to one skilled in the
art that the inventors had possession of a composition consisting of naturally
occurring 16 (±4) kDa protein antigen and naturally occurring 30 (±4) kDa
protein antigen, isolated from Sarcocystis neurona, as well as methods of
using such compositions.
The Specification discloses that an object of the invention is to
provide a vaccine which comprises a 16 (±4) kDa protein antigen and a 30
(±4) kDa of Sarcocystis neurona. (Spec. 10, ll. 25-29.) The Specification
teaches further that the “active immunity is provided by a vaccine that
consists of the isolated 16 (±4) kDa antigen and/or 30 (±4) kDa antigen or
the 16 (±4) kDa antigen and/or 30 (±4) kDa antigen as a fusion
polypeptide.” (Id. at 15, ll. 30-35.) The Specification notes further that in
3
Appeal 2008-1674
Application 09/513,086

one embodiment, “the antigen is a recombinant polypeptide . . . .” (Id. at 5,
ll. 30-31).
As noted by Appellants (App. Br.2 11), Example 1 is drawn to the
production of monoclonal antibodies that recognize the 16 (±4) kDa antigen
and/or 30 (±4) kDa antigen of Sarcocystis neurona (Spec. 33, l. 20). In the
method, Sarcocystis neurona is cultured and merozoites were harvested (Id.
at ll. 25-29). The 16 (±4) kDa antigen and the 30 (±4) kDa antigen “were
purified by methods known to the art for purifying antigens, i.e., the 16 (±4)
kDa antigen and/or 30 (±4) kDa antigen were purified from merozoites by
two-dimensional polyacrylamide gel electrophoresis.” (Id. at ll. 25-34).
Thus, the Specification discloses naturally occurring 16 (±4) kDa
antigen and 30 (±4) kDa antigen isolated from Sarcocystis neurona (Spec.
33). Based on that disclosure, along with the fact that the Specification
teaches that an object of the invention is to provide a vaccine which
comprises a 16 (±4) kDa protein antigen and a 30 (±4) kDa of Sarcocystis
neurona (id. at 10), of which the recombinant form is just one embodiment,
the ordinary artisan would understand that the inventors had possession of
the invention of claims 4, 13, and 46 at the time of filing, and the rejection is
reversed.

Claims 4, 13, and 46 stand rejected under 35 U.S.C. § 112, first
paragraph, for lack of enablement. According to the Examiner, “[t]o the
extent that the claimed compositions and/or methods are not described in the

2 All references to the Appeal Brief (App. Br.) are to the Supplemental Brief,
date stamped June 29, 2006.
4
Appeal 2008-1674
Application 09/513,086

instant disclosure,” they are not enabled as “a disclosure cannot teach one to
make or use something that has not been described.” (Ans. 4.)
Because this rejection is based on the new matter rejection discussed
above, and since we reversed that rejection, we reverse this rejection as well.

Claims 4, 13, 46, and 50 stand rejected under 35 U.S.C. § 112, first
paragraph, “as containing subject matter which was not described in the
[S]pecification in such a way as to reasonably convey to one skilled in the
relevant art that the inventor(s), at the time the application was filed, had
possession of the claimed invention.” (Ans. 5.)
The Examiner asserts that while “Western blots of all of the proteins
of Sarcocystis neurona have been separated on a two dimensional gel
demonstrating multiple spots representing the forms of the proteins that are
naturally occurring . . . , neither the present [S]pecification nor the art of
record at the time of filing has provided any specific information about the
primary sequence of the protein antigens claimed.” (Id.)
The function of the written description requirement of the first
paragraph of 35 U.S.C. § 112 is to ensure that the inventor has possession, as
of the filing date of the application relied on, of the specific subject matter
later claimed by him. In re Wertheim, 541 F.2d 257, 262 (CCPA 1976),
Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319 (Fed. Cir.
2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991). In
establishing a basis for a rejection under the written description requirement,
the Examiner has the initial burden of presenting evidence or reasons why
persons skilled in the art would not recognize in an applicant's disclosure a
5
Appeal 2008-1674
Application 09/513,086

description of the invention defined by the claims. Wertheim, 541 F.2d at
263.
Here, Appellants are not claiming protein antigens of a certain amino
acid sequence, but are claiming compositions and methods that require a
single naturally occurring 16 (±4) kDa protein antigen isolated from
Sarcocystis neurona and a single naturally occurring 30 (±4) kDa protein
antigen isolated from Sarcocystis neurona. As noted by Appellants:
The 16 (±4) and 30 (±4) kDa antigens are described in
the specification by their physical properties, not merely by
their function. The 16 (±4) and 30 (±4) kDa antigens are
described by their source (isolated from Sarcocystis neurona),
by their molecular weight as determined by SDS gel
electrophoresis, by their ability to bind particular antibodies in
antisera from horses infected with Sarcocystis neurona, and by
their ability to bind monoclonal antibodies prepared against
them. These physical properties convey sufficient information
about the antigens to distinguish them from the other proteins
of Sarcocystis neurona.

(App. Br. 17.) Thus, Appellants need not provide an amino acid sequence to
meet the written description requirement of 35 U.S.C. § 112, first paragraph,
and the rejection is reversed.

6
Appeal 2008-1674
Application 09/513,086

CONCLUSION
In summary, we reverse the rejection of claims 4, 13, and 46 under 35
U.S.C. § 112, first paragraph, as containing new matter; the rejection of
claims 4, 13, and 46 stand rejected under 35 U.S.C. § 112, first paragraph,
for lack of enablement; and the rejection of claims 4, 13, 46, and 50 under
35 U.S.C. § 112, first paragraph, for failing to meet the written description
requirement.

REVERSED

Ssc:

MCLEOD & MOYNE, P.C.
2190 COMMONS PARKWAY
OKEMOS, MI 48864
7