Ex Parte Mansfield et al

Board of Patent Appeals and Interferences

Nov 19, 2008

09670096 (B.P.A.I. Nov. 19, 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 2008-5433
Application 09/670,096
Technology Center 1600
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Decided: November 19, 2008
__________

Before ERIC GRIMES, LORA M. GREEN and
RICHARD M. LEVOVITZ, 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 21 and 2.1 We have jurisdiction under
35 U.S.C. § 6(b).

1 This is the second time this application has been before us on appeal. See
Appeal No. 2005-2386, decided May 25, 2006.

Appeal 2008-5433
Application 09/670,096

STATEMENT OF THE CASE
The claims are directed to a method of treating Sarcocystis neurona,
and read as follows:
21. A method for treating an equid infected with Sarcocystis neurona
comprising:
(a) providing a mixture of antibodies against a 16 ±4 kDa antigen and
a 30 ±4 kDa antigen, both of which are specific to Sarcocystis neurona,
wherein the antibodies are selected from the group consisting of polyclonal
antibodies from serum from an animal immunized with the antigen and
monoclonal antibodies from a hybridoma, and wherein the antibodies are in
a pharmaceutically acceptable carrier; and
(b) inoculating the equid with the antibodies in the carrier to treat the
equid.

2. The method composition [sic] of claim 21 wherein the antibodies are
monoclonal antibodies.

The Examiner relies on the following references:
Ed Harlow et al. (Harlow), Antibodies - A Laboratory Manual 285-318
(1988).

Fang Ting Liang et al. (Liang 1997), "Micropreparative High Resolution
Purification of Proteins by a Combination of Sodium Dodecyl Sulfate -
Polyacrylamide Gel Electrophoresis, Isoelectric Focusing, and Membrane
Blotting," 250 ANALYTICAL BIOCHEMISTRY 61-65 (1997).

Fang Ting Liang et al. (Liang 1998), "Evidence that Surface Proteins Sn14
and Sn16 of Sarcocystic neurona Merozoites Are Involved in Infection and
Immunity," 66 INFECTION AND IMMUNITY 5, 1834-38 (1998).

We reverse.
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Application 09/670,096

ISSUE (Obviousness)
The Examiner concludes that claims 21 and 2 are obvious over the
teachings of Liang 1998, Liang 1997, and Harlow.
Appellants contend that the combination would not render obvious a
method of treating an equid infected with Sarcocystis neurona with the
combination of an antibody to the 16kDa antigen and an antibody to the 30
kDa antigen. Thus, the issue on Appeal is: Whether the prior art renders
obvious a method of treating an equid infected with Sarcocystis neurona
with a mixture of an antibody to the 16kDa antigen and an antibody to the 30
kDa antigen?

FINDINGS OF FACT
FF1 The Examiner rejects claims 21 and 2 under 35 U.S.C. § 103(a) as
being obvious over the combination of Liang 1998, Liang 1997, and Harlow
(Ans. 2).
FF2 The Examiner relies on Liang 1998 for teaching “a method of
inhibiting merozoite activity.” (Id. at 3.)
FF3 The Examiner finds that Liang 1998 identified four major immunoblot
bands from the serum and cerebrospinal fluid of horses with neurological
symptoms typical of equine protozoal myeloencephalitis (EPM),
corresponding to 30, 16, 14, and 11kDa proteins (id.). Sarcocystis neurona
is the causative agent of EPM (Liang 1998, Abstract).
FF4 Specifically, Liang 1998 states that serum and CSF samples of horses
with neurological symptoms typical of EPM were “tested for inhibitory
activities on parasite infection by an in vitro neutralization assay.” (Liang
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Application 09/670,096

1998, p. 1834, second column.) From those studies, Liang 1998 found that
“Sn16 [the 16 kDa antigen] and Sn14 [the 14 kDa antigen] may have
important roles during the initial stage of S. neurona infection and that
antibody to Sn14 may be more effective in neutralization [of Sarcocystis
neurona] than antibody to Sn16 [the 16 kDa antigen]. No inhibitory activity
correlating with antibody to Sn30 was noted.” (Id. at 1836, first column
(emphasis added).)
FF5 Liang 1998 concludes that:
Although monoclonal antibodies are often used to study
parasitic proteins, the sera of naturally infected animals have
unique advantages in that they can provide important
information on protectively immunogenic proteins in the
natural host. The parasite may express different proteins at
different stages of in vivo or in vitro development; and some
proteins may be expressed and function essentially only in
vitro. Such proteins would be inappropriate targets for vaccine
development. S. neurona infection of the horse induces
production of antibodies to Sn16 and Sn14, indicating that these
two proteins are expressed in vivo and are strong immunogens
in the horse. Clearly, they warrant further investigation as
candidate antigens for inclusion in vaccines against S. neurona
infection.

(Id. at 1837, second column.)
FF6 Liang 1997 is drawn to the purification of S. neurona antigens (Liang
1997, p. 65, first column), and thus does not add to the teachings of Liang
1998.
FF7 Harlow is cited for teaching the generation of both polyclonal and
monoclonal antibodies (Ans. 4).
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Application 09/670,096

FF8 The Examiner concludes:
It would have been prima facie obvious to one, having
ordinary skill the art at the time the invention was made to
make either monoclonal or polyclonal antibodies to merozoite
surface antigens including 16KD and 30KD because Liang
[1998] taught antibodies to surface antigen can inhibit infection
in neutralization assays. . . . Therefore, an artisan of ordinary
skill would have been motivated to use readily available and
purified surface antigens (Liang . . . 1997) from merozoites
including 16KD and 30 KD as disclosed by the prior art Liang
et al 1998 or Liang et al 1997 with a reasonable expectation of
success for raising antibodies (monoclonal/polyclonal
antibodies) by using well established immunization procedures
. . . .

(Ans. 5.)

PRINCIPLES OF LAW
The question of obviousness is resolved on the basis of underlying
factual determinations including: (1) the scope and content of the prior art;
(2) the level of ordinary skill in the art; (3) the differences between the
claimed invention and the prior art; and (4) secondary considerations of
nonobviousness, if any. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
The Supreme Court has recently emphasized that “the [obviousness] analysis
need not seek out precise teachings directed to the specific subject matter of
the challenged claim, for a court can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.” KSR
Int’l v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007).
However, an invention “composed of several elements is not proved
obvious merely by demonstrating that each of its elements was,
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independently, known in the prior art.” KSR, 127 S. Ct. at 1741. “Often, it
will be necessary . . . to look to interrelated teachings of multiple
[references] . . . and the background knowledge possessed by a person
having ordinary skill in the art, all in order to determine whether there was
an apparent reason to combine the known elements in the fashion
claimed[.]” Id. at 1740-41. “[T]his analysis should be made explicit,” id. at
1741, and it “can be important to identify a reason that would have prompted
a person of ordinary skill in the relevant field to combine the elements in the
way the claimed new invention does.” Id.

ANALYSIS
Appellants argue that Liang 1998 teaches that there is no inhibitory
activity correlated with the antibody to the 30 kDa (Sn30) antigen, and thus
there is no reason for the ordinary artisan to combine an antibody to the
16kDa antigen with antibody to the 30 kDa antigen for the treatment of an
equid infected with Sarcocystis neurona, as required by the method of claim
21.
We agree. As noted by Appellants, Liang 1998 specifically teaches
that “[n]o inhibitory activity correlating with antibody to Sn30 was noted”
(FF4), and the Examiner has not pointed to any reason as to why the
ordinary artisan, faced with that teaching, would have used a mixture of an
antibody to the 16kDa antigen with antibody to the 30 kDa antigen for the
treatment of an equid infected with Sarcocystis neurona. The rejection is
therefore reversed.

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CONCLUSIONS OF LAW
Thus, we conclude that the combination of references relied on by the
Examiner would not have rendered obvious a method of treating an equid
infected with Sarcocystis neurona with the mixture of an antibody to the
16kDa antigen and an antibody to the 30 kDa antigen.

REVERSED

clj

IAN C. McLEOD, P.C.
2190 COMMONS PARKWAY
OKEMOS, MI 48864
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