Ex Parte Bander

Board of Patent Appeals and Interferences

Mar 31, 2006

09929546 (B.P.A.I. Mar. 31, 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for publication and is not binding precedent of the Board.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. 2006-03521
Application No. 09/929,546
________

ON BRIEF2
__________

Before SCHEINER, MILLS and GRIMES, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL

This appeal involves a method of treating non-prostate cancer by administering
monoclonal 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 09/929,665 (appeal no. 2006-
0632). 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).
Appeal No. 2006-0352
Application No. 09/929,546

Παγε 2
BACKGROUND
“PSMA is an integral membrane protein known to have a short intracellular tail
and a long extracellular domain.” Specification, page 8. Various researchers have
reported that “PSMA is prostate-specific and shows increased expression levels in
metastatic sites and in hormone-refractory states” (id.); 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.). On
the other hand, according to appellant, “the vascular endothelial cells supplying blood to
cancerous tissues . . . express an extracellular domain of [PSMA], irrespective of the
type of cancer involved . . . [while] vascular endothelial cells supplying blood to normal
tissues do not express an extracellular domain of [PSMA]” (id., page 17).
In any case, according to appellant, PSMA is “an attractive target for antibody
mediated . . . imaging and therapy of [ ] cancer” (id., page 8). 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 methods of treating cancer using “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” (id., page 24). “In a
particularly preferred embodiment . . . a first biological agent is conjugated with a
Appeal No. 2006-0352
Application No. 09/929,546

Παγε 3
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
by conventional competitive binding assays” (id., pages 32-33). 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 42). “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 43).
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 allowed claims 58-69, which require antibodies that
bind the extracellular domain of PSMA, or which require monoclonal antibodies E99,
J591, J415, or J533 in particular, but has rejected claims 72, 73, 84-111 and 113, which
require antibodies that compete with E99, J591, J415, or J533, under 35 U.S.C. § 112,
first paragraph.
Claims 58, 67 and 68 are representative of subject matter allowed by the
examiner:
58. A method for treating non-prostate cancer in a subject comprising:
providing an antibody or antigen binding portion thereof which binds to the
extracellular domain of prostate specific membrane antigen; and
administering the antibody or antigen binding portion thereof to a subject in need
of treatment under conditions effective to treat non-prostate cancer.

Appeal No. 2006-0352
Application No. 09/929,546

Παγε 4
67. The method according to claim 58, wherein the antibody is selected from the
group consisting of a monoclonal antibody and a polyclonal antibody.

68. The method according to claim 67, wherein the antibody is a monoclonal
antibody selected from the group consisting of an E99, a J415, a J533, and a J591
monoclonal antibody.

Claim 72 is representative of the subject matter that is the subject of this appeal:
72. The method according to claim 58, wherein the antibody or antigen binding
portion thereof 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 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
Appeal No. 2006-0352
Application No. 09/929,546

Παγε 5
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).
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 “process [which]
involves providing a biological agent which . . . recognizes the extracellular domain of
prostate specific membrane antigen” (Specification, page 9). “Preferred biological
agents for use in the method . . . are antibodies or binding portions thereof, probes or
ligands” (id., page 10 ). The specification further describes four “particularly preferred”
monoclonal antibodies which bind the extracellular domain of PSMA (id., page 24).
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 43). 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 24), i.e., molecules
which bind the 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 claimed
method. While it is true that the specification does not explicitly state that other
antibodies are included among suitable “molecules which bind to the . . . antigens
identified by the monoclonal antibodies of the present invention,” we conclude that
Appeal No. 2006-0352
Application No. 09/929,546

Παγε 6
appellant’s disclosure as a whole reasonably conveys to one of skill in the art that
appellant was in possession of a “method . . . wherein the antibody . . . 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 72), as of the filing date of this application.
The rejection of claims 72, 73, 84-111 and 113 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 )

Appeal No. 2006-0352
Application No. 09/929,546

Παγε 7

Fish & Richardson PC
P.O. Box 1022
Minneapolis MN 55440-1022