Ex parte Cone et al.

Board of Patent Appeals and Interferences

Feb 26, 1999

08011837 (B.P.A.I. Feb. 26, 1999)

Application for patent filed February 1, 1993. 1
According to appellants, the application is a continuation of
Application 07/305,048, filed February 1, 1989, now abandoned.
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THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered
today (1) was not written for publication in a law
journal and (2) is not binding precedent of the Board.
Paper No. 39
UNITED STATES PATENT AND TRADEMARK OFFICE
________________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
________________
Ex parte RICHARD A. CONE and KEVIN J. WHALEY
________________
Appeal No. 95-2710
Application 08/011,8371
________________
ON BRIEF
________________
Before WARREN, OWENS and KRATZ, Administrative Patent Judges.
OWENS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal from the examiner’s final rejection of
claims 52, 54, 55 and 58-62. Claims 1-50, which are the only
other claims remaining in the application, have been withdrawn
Appeal No. 95-2710
Application 08/011,837
According to appellants’ specification (page 16, lines2
29-32), pan semen antibodies are “antibodies that not only
immobilize sperm in semen but also immobilize virtually all
other cells in semen by coaggulating [sic, coagulating] them
with the sperm.”
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from consideration by the examiner as being directed toward a
nonelected invention.
THE INVENTION
Appellants’ claimed invention is directed toward methods
for prophylaxis in a female mammal and for passively
immunizing skin surfaces and mucus epithelial surfaces, by
introducing into the vaginal cavity or uterus of the female
mammal, or applying to the skin or mucus epithelial surfaces,
at least one pan semen antibody which is capable of binding,
directly or indirectly, to cells and pathogens in semen,
thereby trapping the cells and pathogens in semen. 2
Appellants state that the methods are useful for contraception
and prophylaxis against sexually transmitted diseases
(specification, page 1, lines 7-11). Claims 52 and 58 are
illustrative and read as follows:
52. A method of prophylaxis in a female mammal which
comprises continuously introducing into the vaginal cavity or
uterus of said female mammal, over a prolonged period of time
at a controlled rate a prophylactically effective amount of at
Appeal No. 95-2710
Application 08/011,837
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least one pan semen antibody capable of binding, directly or
indirectly, to cells and pathogens in semen, thereby trapping
said cells and pathogens in semen, including sexually
transmitted disease pathogens and cells infected with sexually
transmitted disease pathogens, in mucus secretions present in
said vaginal cavity or uterus;
by means of a biologically compatible prolonged released
carrier therefor,
wherein said at least one pan semen antibody is contacted
with and binds, directly or indirectly, to said cells and
pathogens in semen and thereby effects said trapping.
58. A method of passively immunizing skin surfaces and
mucus epithelial surfaces comprising applying to said surfaces
a pharmaceutical composition comprising
at least one pan semen antibody capable of binding,
directly or indirectly, to viruses and cells in semen, thereby
trapping said cells and viruses in mucus secretions present on
said skin or mucus epithelial surfaces, wherein said antibody
is present in an amount sufficient to effect said trapping,
and
a pharmaceutically acceptable carrier,
under conditions such that said trapping is effected.

THE REFERENCE
Shinzo Isojima et al. (Isojima), “Establishment and
characterization of a human hybridoma secreting monoclonal
antibody with high titers of sperm immobilizing and
agglutinating activities against human seminal plasma”, 10 J.
Reprod. Immunology 67-78 (1987).
THE REJECTIONS
The claims stand rejected as follows: claims 52, 54, 55
Appeal No. 95-2710
Application 08/011,837
We assume that the examiner’s statement that the3
specification is speculative means that the examiner considers
the specification to fail to provide an enabling disclosure.
In the answer (pages 4-5), the examiner erroneously4
includes canceled claim 51 in the rejections under 35 U.S.C.
§§ 101 and 102(b).
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and 58-61 under 35 U.S.C. § 101 as lacking patentable utility;
claims 52, 54, 55 and 58-62 under 35 U.S.C. § 112, first
paragraph, on the ground that the specification is
speculative; claims 52, 54, 55 and 58-61 under 35 U.S.C.3
§ 102(b) as being anticipated by appellants’ admitted prior
art or Isojima.4
OPINION
We have carefully considered all of the arguments
advanced by appellants and the examiner and agree with
appellants that the aforementioned rejections are not well
founded. We therefore do not sustain these rejections.
Rejection under 35 U.S.C. § 101
Before utility is determined, the claims must be
interpreted to define the invention to be tested for utility.
See Raytheon Co. v. Roper Corp., 724 F.2d 951, 956, 220 USPQ
592, 596 (Fed. Cir. 1983), cert denied, 469 U.S. 835 (1984).
Appeal No. 95-2710
Application 08/011,837
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During prosecution, claims are to be given their broadest
reasonable interpretation. See In re Morris, 127 F.3d 1048,
1055, 44 USPQ2d 1023, 1028 (Fed. Cir. 1997); In re Zletz, 893
F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).
Regarding utility, a predecessor of our reviewing court
stated in In re Langer, 503 F.2d 1380, 1391, 183 USPQ 288, 297
(CCPA 1974):
[A] specification which contains a disclosure of
utility which corresponds in scope to the subject
matter sought to be patented must be taken as
sufficient to satisfy the utility requirement of
§ 101 for the entire claimed subject matter unless
there is reason for one skilled in the art to
question the objective truth of the statement of
utility or its scope.
The examiner argues that appellants claim a method for
preventing the sexual transmission of AIDS (answer, page 5).
As indicated by appellants’ specification (page 10, lines 16-
20; page 13, lines 27-35; page 16, line 27 - page 17, line 16;
page 27, lines 11-13), appellants’ claimed methods encompass
binding cells which carry AIDS. The examiner errs, however,
by arguing as though appellants claim methods for treating
AIDS, rather than methods which prevent the transmission of
AIDS (answer, pages 5-6).
Appeal No. 95-2710
Application 08/011,837
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Appellants provide figures which show that appellants’
antibodies agglutinate sperm and other cells (page 8, lines 2-
28; page 17, lines 18-20), and state that all five tested
antibodies coagulated virtually all cells present in semen,
either directly or by binding to factors secreted by the
seminal vesicles (page 17, line 30 - page 18, line 2). Also,
Isojima discloses (page 67) that H6-3C4 has strong sperm
immobilizing and agglutinating activities.
The examiner provides no evidence or sound technical
reason which indicates that one of ordinary skill in the art
would have questioned the objective truth of the statements in
appellants’ specification that their pan semen antibodies bind
to cells and pathogens in semen, including cells that carry
AIDS, thereby trapping the cells and pathogens. Hence, the
examiner has not carried his initial burden of establishing a
prima facie case of lack of utility.
For the above reasons, we do not sustain the rejection
under 35 U.S.C. § 101.
Rejection under 35 U.S.C. § 112, first paragraph
The examiner argues that there is no evidence of record
Appeal No. 95-2710
Application 08/011,837
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of an antibody which can agglutinate sexually transmitted
disease pathogens and sperm (answer, pages 4, 7 and 8).
Appellants argue that their specification discloses five
antibodies which are useful for carrying out the claimed
methods and provides six criteria for screening additional pan
semen antibodies (brief, pages 7-10). The specification,
appellants argue (brief, page 9), discloses at page 16, lines
26-33, antibodies which immobilize sperm and also immobilize
virtually all other cells in semen by coagulating them with
the sperm (see also, reply brief, pages 4-5).
With respect to enablement, a predecessor of our
appellate reviewing court stated in In re Marzocchi, 439 F.2d
220, 223-24, 169 USPQ 367, 369-70 (CCPA 1971):
[A] specification disclosure which contains a
teaching of the manner and process of making and
using the invention in terms which correspond in
scope to those used in describing and defining the
subject matter sought to be patented must be taken
as in compliance with the enabling requirement of
the first paragraph of § 112 unless there is reason
to doubt the objective truth of the statements
contained therein which must be relied on for
enabling support. . . .
. . . .
. . . it is incumbent upon the Patent Office,
Appeal No. 95-2710
Application 08/011,837
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whenever a rejection on this basis is made, to
explain why it doubts the truth or accuracy of any
statement in a supporting disclosure and to back up
assertions of its own with acceptable evidence or
reasoning which is inconsistent with the contested
statement. Otherwise, there would be no need for
the applicant to go to the trouble and expense of
supporting his presumptively accurate disclosure.
The examiner has not carried his initial burden of setting
forth evidence or sound technical reasoning which indicates
that one of ordinary skill in the art would not have been
enabled by appellants’ specification to provide prophylaxis
and passive immunization of skin surfaces and mucus epithelial
surfaces using the disclosed antibodies and other antibodies
selected according to the guidelines in appellants’
specification.
For the above reasons, we do not sustain the rejection
under 35 U.S.C. § 112, first paragraph.
Rejection under 35 U.S.C. § 102(b)
The examiner argues that in appellants’ specification at
page 11, lines 14-23, appellants acknowledge that antibodies
which immobilize sperm, usually by agglutination, were known
in the art (answer, pages 4 and 9). Appellants argue that
they have admitted that certain antibodies were known in the
Appeal No. 95-2710
Application 08/011,837
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art to bind sperm cells in semen, but have not admitted that
pan semen antibodies were known which bind to and trap all
cells and pathogens in semen (brief, page 11). Appellants’
argument is not well taken in view of the fact that the
antibodies used by appellants were known by and obtained from
others (specification, page 12, lines 14-36). Appellants also
argue that they have not admitted that methods were known to
apply a pan semen antibody into the vaginal cavity or uterus
or to skin surfaces or mucus epithelial surfaces (brief, page
11).
The examiner argues that Isojima teaches that H6-3C4,
which is one of the antibodies recited in appellants’ claims
59-61, was known in the art to immobilize sperm and cause
contraception, and that agglutination of pathogenic cells
would be inherent with the administration of the antibody
(answer, page 4). Appellants argue that Isojima does not
disclose an antibody that binds to cells other than sperm
cells or to pathogens in semen (brief, page 12). Appellants’
argument is not persuasive because Isojima discloses H6-3C4
(page 67) which, appellants state (specification, page 17,
lines 30-33), agglutinates virtually all cells present in
Appeal No. 95-2710
Application 08/011,837
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semen. Appellants also argue that Isojima does not disclose
application of a pan semen antibody into the vaginal cavity or
uterus or to the skin surfaces and mucus epithelial surfaces
(brief, page 13).
In order for a claimed invention to be anticipated under
35 U.S.C. § 102(b), all of the elements of the claim must be
found in one reference. See Scripps Clinic & Research Found.
v. Genentech Inc., 927 F.2d 1565, 1576, 18 USPQ2d 1001, 1010
(Fed. Cir. 1991). The examiner has the initial burden of
establishing a prima facie case of anticipation by pointing
out where all of the claim limitations appear in a single
reference. See In re Spada, 911 F.2d 705, 708, 15 USPQ2d
1655, 1657 (Fed. Cir. 1990); In re King, 801 F.2d 1324, 1327,
231 USPQ 136, 138-39 (Fed. Cir. 1986).
Each of appellants’ claims requires a step of applying
the at least one pan semen antibody, either into the vaginal
cavity or uterus of a female mammal or to the skin surfaces
and mucus epithelial surfaces. Appellants do not acknowledge
that this step was known in the art. Also, the examiner does
not point out, and we do not find, where Isojima describes
Appeal No. 95-2710
Application 08/011,837
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such an application step. The examiner’s argument based on Ex
Parte Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Int. 1993)
that “[t]he agglutination of pathogenic cells would be
inherent with the administration of the claimed antibody”
(answer, page 4) is not well founded because the examiner does
not point out where the relied-upon prior art discloses “the
administration of the claimed antibody”. In Novitski, 26
USPQ2d at 1390, the board considered the claimed invention to
be anticipated. In the present case, the examiner does not
indicate where Isojima describes appellants’ claimed methods
within the meaning of 35 U.S.C. § 102(b).
For the above reasons, we find that the examiner has not
carried his burden of establishing a prima facie case of
anticipation of the method recited in any of appellants’
claims. Accordingly, we do not sustain the rejection under 35
U.S.C. § 102(b).
DECISION
The rejections of claims 52, 54, 55 and 58-61 under 35
U.S.C. § 101 as lacking patentable utility, of claims 52, 54,
Appeal No. 95-2710
Application 08/011,837
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55 and 58-62 under 35 U.S.C. § 112, first paragraph, on the
ground that the specification is speculative, and of claims
52, 54,
55 and 58-61 under 35 U.S.C. § 102(b) as being anticipated by
appellants’ admitted prior art or Isojima, are reversed.
REVERSED
CHARLES F. WARREN )
Administrative Patent Judge )
)
)
)
TERRY J. OWENS ) BOARD OF
PATENT
Administrative Patent Judge ) APPEALS AND
) INTERFERENCES
)
)
PETER F. KRATZ )
Administrative Patent Judge )
Appeal No. 95-2710
Application 08/011,837
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