Ex Parte Bander

Board of Patent Appeals and Interferences

Mar 30, 2006

09929665 (B.P.A.I. Mar. 30, 2006)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES

__________

Ex parte NEIL H. BANDER
___________

Appeal No. 2006-06321
Application No. 09/929,665
________

ON BRIEF2
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Before SCHEINER, MILLS and GRIMES, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL

This appeal involves antibodies that bind prostate specific membrane antigen
(PSMA). The examiner has rejected claims requiring a particular subgenus of anti-
PSMA antibodies as lacking adequate written descriptive support. We have jurisdiction
under 35 U.S.C. § 134. We will reverse this rejection because we find that appellant’s
disclosure conveys with reasonable clarity to those skilled in the art that, as of the filing
date, appellant was in possession of the claimed invention.

1 This appeal is related to appeals in related application nos. 09/357,709 (appeal
no. 2006-0633), 09/357,710 (appeal no. 2006-1520) and 09/929,546 (appeal no. 2006-
0352). We have considered these appeals together.
2 Appellant requested an oral hearing in this case, however, after reviewing the
case, we have determined that an oral hearing will not be necessary and have rendered
a decision based on the record. See 37 CFR §§ 41.47(a),(f).
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BACKGROUND
“PSMA is an integral membrane protein known to have a short intracellular tail
and a long extracellular domain.” Specification, page 9. Various researchers have
reported that “PSMA is prostate-specific and shows increased expression levels in
metastatic sites and in hormone-refractory states” (id.,page 8); that “PSMA is more
strongly expressed in prostate cancer cells relative to cells from the normal prostate or
from a prostate with benign hyperplasia” (id.); and that “PSMA is not found in serum”
(id.). According to appellant, PSMA is “an attractive target for antibody mediated . . .
imaging and therapy of prostate cancer” (id.). However, “antibody molecules do not,
under normal circumstances, cross the cell membrane unless they bind to the
extracellular portion of a molecule and become translocated intracellularly,” thus
antibodies that bind the intracellular portion of PSMA “do[ ] not have access to [the]
antigenic target site in . . . viable cell[s]” and will only bind cells that are already dead
(id., page 9).
The present invention is directed to “biological agents,” in this case, polyclonal or
monoclonal antibodies which bind the extracellular domain of PSMA. Appellant
describes four “particularly preferred” biological agents, monoclonal antibodies E99,
J415, J533 and J591, to be “used alone or as a component in a mixture with other
antibodies or other biological agents to treat or image prostate epithelial cells” (id., page
19). “In a particularly preferred embodiment . . . a first biological agent is conjugated
with a prodrug . . . [and] [t]he prodrug activator is conjugated with a second biological
agent . . . preferably one which binds to a non-competing site” on PSMA. “Whether two
biological agents bind to competing or non-competing binding sites can be determined
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by conventional competitive binding assays” (id., page 27). For example, “[a]
competition study was carried out to determine whether J591, J533, E99, and J415
detected the same or different antigenic sites (epitopes) of [PSMA]” (id., page 37). “The
results indicated that J591, J533, and E99 each interfere, compete, or block binding of
one another but do not block binding of J415 and vice versa” (id., page 38).
DISCUSSION
According to the examiner, “the specification [ ] provides a written description and
indicates possession of a genus of antibodies that bind to the extracellular domain of
PSMA and four species of such monoclonal antibodies, or species of the genus, e.g.
E99, J591, J415, or J533[,]” but does not provide descriptive support for “a subgenus of
antibodies that ‘compete for binding’ to E99, J591, J415, or J533” (Answer, pages 3-4).
Consequently, the examiner has rejected claims 144, 156-168 and 170-210,3 directed
to antibodies that compete with E99, J591, J415, or J533, under the first paragraph of
35 U.S.C. § 112.
Claim 144 is representative of the subject matter on appeal:
144. An isolated antibody or antigen binding portion thereof which competes for
binding to prostate specific membrane antigen (PSMA) with a monoclonal antibody
selected from the group consisting of an E99, a J415, a J533, and a J591 monoclonal

3 Claims 144, 156-168 and 170-210 are the only claims remaining in the
application, claims 1-143, 145-155, 169 and 211-231 having been previously canceled.
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antibody.

Essentially, the examiner’s position is that “antibodies that ‘compete for binding’
to E99, J591, J415, and J533 . . . constitute a separate subgenus” that was not
expressly “recite[d] or reasonably contemplate[d]” in the specification as originally filed
(Answer, page 4). Further, the examiner asserts that the only relevant example in the
specification “reinforce[s] the idea that ‘non-competing’ antibodies are [ ] preferred” (id.,
page 8).
“The ‘written description’ requirement serves a teaching function, . . . in which the
public is given ‘meaningful disclosure in exchange for being excluded from practicing
the invention for a limited period of time.’” University of Rochester v. G.D. Searle & Co.,
Inc., 358 F.3d 916, 922, 69 USPQ2d 1886, 1891 (Fed. Cir. 2004) (citation omitted).
Another “purpose of the ‘written description’ requirement is . . . [to] convey with
reasonable clarity to those skilled in the art that, as of the filing date [ ], [the applicant]
was in possession of the invention.” Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-
64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). See also Enzo Biochem Inc. v. Gen-
Probe Inc., 296 F.3d 1316, 1329, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). The
requirement is satisfied when the specification “set[s] forth enough detail to allow a
person of ordinary skill in the art to understand what is claimed and to recognize that the
inventor invented what is claimed.” University of Rochester, 358 F.3d at 928, 69
USPQ2d at 1896. Whether or not a specification satisfies the requirement is a question
of fact, which must be resolved on a case-by-case basis (Vas-Cath, 935 F.2d at 1562-
63, 19 USPQ2d at 1116).
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Much has been said on both sides of this issue, but we agree with appellant that
the specification describes the disputed subgenus of antibodies, and that this “is not a
close case” (Reply Brief, page 1). The specification describes “a biological agent that
recognizes an extracellular domain of prostate specific membrane antigen”
(Specification, page 11). “Preferred isolated biological agents which recognize an
extracellular domain of prostate specific membrane antigen . . . are isolated antibodies
or binding portions thereof, probes or ligands” (id.). The specification further describes
four “particularly preferred” monoclonal antibodies which bind the extracellular domain
of PSMA (id., page 19). Three of the antibodies, J591, J533, and E99, “interfere,
compete, or block binding of one another” to the same epitope on PSMA, but “do not
block binding of [the fourth antibody,] J415[,] and vice versa” (id., page 38). Moreover,
the specification teaches that “[s]uitable probes or ligands are molecules which bind to
the . . . antigens identified by the monoclonal antibodies of the present invention” (id.,
page 19), i.e., molecules which bind the same epitopes identified by J591, J533, E99
and J415.
Thus, the specification explicitly describes both competing and non-competing
antibodies, and also teaches that other biological agents that bind, or recognize, the
same sites identified by J591, J533, E99 and J415 are suitable for use in the various
methods outlined in the specification. While it is true that the specification does not
explicitly state that other antibodies are included among suitable “molecules which bind
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to the . . . antigens identified by the monoclonal antibodies of the present invention,” we
conclude that appellant’s disclosure as a whole reasonably conveys to one of skill in the
art that appellant was in possession of “[a]n isolated antibody or antigen binding portion
thereof which competes for binding to prostate specific membrane antigen [ ] with a
monoclonal antibody selected from the group consisting of an E99, a J415, a J533 and
a J591 monoclonal antibody” (claim 144), as of the filing date of this application.

The rejection of claims 144, 156-168 and 170-210 under the first paragraph of 35
U.S.C. § 112 is reversed.
REVERSED

)
Toni R. Scheiner )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
)
Demetra J. Mills ) APPEALS AND
Administrative Patent Judge )
) INTERFERENCES
)
)
)
Eric Grimes )
Administrative Patent Judge )
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