Ex Parte Vesper

Board of Patent Appeals and Interferences

Feb 1, 2010

09866793 (B.P.A.I. Feb. 1, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte STEPHEN JOSEPH VESPER
__________

Appeal 2009-0062201
Application 09/866,793
Technology Center 1600
__________

Decided:2 February 1, 2010
__________

Before TONI R. SCHEINER, DEMETRA J. MILLS, and
FRANCISCO C. PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to methods for
determining if an animal has been exposed to a hemolysin-producing fungus.

1 The United States Environmental Protection Agency is the real party in
interest (App. Br. 1 (entered August 11, 2008)).
2 Oral argument was presented in this case on January 14, 2010.

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The Examiner rejected the claims as anticipated, obvious, lacking adequate
written description, lacking enablement, and being indefinite. We have
jurisdiction under 35 U.S.C. § 6(b).
We reverse the Examiner’s rejections for anticipation, enablement,
and indefiniteness, but affirm the obviousness and written description
rejections.
STATEMENT OF THE CASE
“Hemolysins are molecules that are designated as such because they
have the ability to lyse red blood cells (RBC). It is now recognized that the
biological significance of these toxins goes beyond their lysis of RBC to
their more general ability to form pores in many cells” (Spec. [0008]).
Claims 23-33 are pending and on appeal (App. Br. 3).3 Claims 23, 30,
and 33 are representative and read as follows:
23. A method for determining if an animal has been
exposed to a specific hemolysin-producing fungus, which
hemolysin is species-specific, comprising:
a. contacting a sample from said animal with labeled
antibodies which bind to the hemolysin produced by the fungus
or to active fragments of the hemolysin; and
b. detecting any complex formed between the labeled
antibodies and the hemolysin or active fragments thereof.

30. A method for determining if a building contains a
hemolysin-producing fungus comprising:
a. obtaining a sample from the building;
b. obtaining hemolysin from the sample if hemolysin-
producing fungi are present in the sample;
c. contacting the sample with labeled antibodies
which bind to the fungal hemolysin or to active fragments of
the fungal hemolysin; and

3 Appeal Brief entered August 11, 2008.
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d. detecting any complex formed between the labeled
antibodies and the fungal hemolysin or active fragments
thereof.

33. A method for determining if an animal has been
exposed to a specific hemolysin-producing fungus comprising
detecting the presence of the hemolysin produced by the fungus
in a sample from the animal, the presence of the hemolysin in
the sample indicating that the animal has been exposed to the
hemolysin-producing fungus.

The Examiner cites the following documents as evidence of
unpatentability:
Berg US 6,210,670 B1 Apr. 3, 2001

Moїse Bendayan, Possibilities of False Immunocytochemical Results
Generated by The Use of Monoclonal Antibodies: The Example of the Anti-
proinsulin Antibody, 43 J. HISTOCHEM. AND CYTOCHEM. 881-886 (1995).

Kenneth L. Bost and David W. Pascual, ANTIBODIES AGAINST A
PEPTIDE SEQUENCE WITHIN THE HIV ENVELOPE PROTEIN
CROSSREACTS WITH HUMAN INTERLEUKIN-2, 17 IMMUNOLOGICAL
INVESTIGATIONS 577-586 (1988).

Keiichi Ebina et al., ROLE OF ASP-HEMOLYSIN ON
EXPERIMENTAL ASPERGILLUS INFECTION FOR MICE, 35 JAPANESE
JOURNAL OF MEDICAL SCIENCE AND BIOLOGY 140-141 (1982).

Keiichi Ebina et al., ASP-HEMOLYSIN SIGNIFICANCE AS A
VIRULENCE FACTOR WITH BIOLOGICAL ACTIVITIES FROM
ASPERGILLUS FUMIGATUS, 38 JAPANESE JOURNAL OF MEDICAL
MYCOLOGY 155-160 (1997) (as translated, hereinafter “Ebina ‘97”).

Ed Harlow and David Lane, ANTIBODIES A LABORATORY MANUAL,
Cold Spring Harbor Press Inc., pp. 390-393 (1988).

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Osamu Sakaguchi et al., ROLE AND BIOLOGICAL ACTIVITY OF
HEMOLYTIC TOXIN ON ASPERGILLUS INFECTIONS, 25 JAPANESE
JOURNAL OF MEDICAL MYCOLOGY, 219-224 (1984) (as translated).

Toshihiko Watanabe et al., HOMOLYTIC ACTIVITY OF HUMAN
RED BLOOD CELLS BY CANDIADA SPECIES, 46 JOURNAL OF TOHOKU
UNIVERSITY OF PHARMACOLOGY 145-148 (1999) (as translated).

Katsushi Yokota et al, Studies on the Toxin of Aspergillus fumigatus --
VII. Purification and Some Properties of Hemolytic Toxin (Asp-Hemolysin)
from Culture Filtrates and Mycelia, 21 MICROBIOLOGY IMMUNOLOGY 11-22
(1977).

The following rejections are before us for review:
(1) Claims 23 and 25-29, rejected under 35 U.S.C. § 103(a) as
obvious in view of Sakaguchi and Harlow (Ans. 4-5);4
(2) Claim 33, under 35 U.S.C. § 102(b) as anticipated by Sakaguchi
(Ans. 5-7);
(3) Claims 23-29 and 33, rejected under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement
(Ans. 7);
(4) Claims 30-32, rejected under 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement (Ans. 7-8);
(5) Claims 30-32, rejected under 35 U.S.C. § 112, first paragraph, as
failing to comply with the enablement requirement (Ans. 8-9);
(6) Claims 23-26, rejected under 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement (Ans. 9-10); and
(7) Claims 30-32, rejected under 35 U.S.C. § 112, second paragraph,
as being indefinite (Ans. 10-11).

4 Examiner’s Answer mailed November 17, 2006.
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OBVIOUSNESS
ISSUE
The Examiner cites Sakaguchi as disclosing the antibody-based
detection of Asp-hemolysin “in tissues . . . from a mouse infected with
Aspergillus fumigatus” (Ans. 4). The Examiner finds that Sakaguchi differs
from the claims in that Sakaguchi detects antibody-to-hemolysin binding “by
labeling the second or indirect antibody, rather than the primary or binding
antibody” (id. at 5).
To meet that limitation, the Examiner cites Harlow as disclosing that
“labeling of the primary or binding antibody provides for the advantage of
cleaner signals with lower background” (id.). Based on these teachings the
Examiner concludes that it would have been obvious to label the primary
antibody used Sakaguchi’s hemolysin-detecting method as recited in the
claims (id.).
Appellant contends that the claims are directed to assaying for specific
hemolysin-producing fungi, and that a person skilled in the art “need not be
told in haec verba that each fungus produces a unique hemolysin, because it
is inherent that the hemolysins are unique if one is able to identify different
strains of fungi, which is one object of the present invention” (App. Br. 8).
In contrast, Appellant urges, the “Examiner appears to be confusing
antibody specificity with hemolysin specificity” (id.).
Moreover, Appellant argues, the preamble of claim 23 requires the
practitioner to determine if an animal has been exposed to a hemolysin-
producing fungus (id. at 9). In contrast, Appellant urges, Sakaguchi already
knew that the mouse had been infected with the fungus, as Sakaguchi had
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purposely infected the mouse with the fungus to study the progress of the
infection and tissues involved (id. at 9-10; see also Reply Br. 2-3).5
The Examiner responds that the structure of the Aspergillus fumigatus
hemolysin was known in the art (Ans. 11 (citing Ebina ’97)). Moreover, the
Examiner argues, Sakaguchi “indicates that exposure to a hemolysin
producing strain of Aspergillus fumigatus could be and was detected in
experimental infection by detection of asp-hemolysin from Aspergillus
fumigatus in tissue samples using antibodies that bind the asp-hemolysin”
(id. at 14).
Appellant does not argue the claims subject to this ground of rejection
separately. We select claim 23 as representative of the rejected claims. See
37 C.F.R. § 41.37(c)(1)(vii).
In view of the positions advanced by Appellant and the Examiner, the
issue with respect to this rejection is whether Appellant has shown that the
Examiner erred in concluding that the process recited in claim 23 would
have been obvious to one of ordinary skill viewing the teachings of
Sakaguchi and Harlow.
FINDINGS OF FACT (“FF”)
1. Sakaguchi “describe[s] the results of an experiment to determine
whether or not hemolysin production occurs in mice when infected
experimentally with Aspergillus, whether or not the toxin promoted the
experimental infection, and whether diffusion or obstruction occurred in
various organs and tissues” (Sakaguchi 3). 6

5 Reply Brief entered January 16, 2007.
6 Page numbers refer to those in the translation entered June 19, 2003.
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2. Sakaguchi discloses that viable spores of Aspergillus fumigatus were
intravenously inoculated into mice (id. at 2 (abstract)).
3. Sakaguchi discloses that “viable organisms were detected in the
kidney and brain ten days after challenge and secretion of Asp-hemolysin
from the mycelia was actually observed immunohistochemically in the
tissues using a technique of indirect enzyme labeled antibody (peroxidase
binding IgG antibody)” (id.).
4. Harlow discloses that, when detecting substances of interest in fixed
cells or tissues, “the antibodies can be labeled directly or they can be
detected by using a labeled secondary reagent that will bind specifically to
the primary antibody. Both the direct and indirect detection methods are in
common use” (Harlow 390).
5. Harlow discloses that, while it has certain disadvantages, “[i]n
general, direct labeling of the primary antibody will produce cleaner signals
with lower background.” (Id.)
PRINCIPLES OF LAW
In KSR Int' l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007), the
Supreme Court rejected a “rigid approach” to the obviousness question, and
instead emphasized that “[t]hroughout this Court’s engagement with the
question of obviousness, our cases have set forth an expansive and flexible
approach . . . .”
The Court thus reasoned that the analysis under 35 U.S.C. § 103 “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.” Id. at 418; see
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also id. at 421 (“A person of ordinary skill is . . . a person of ordinary
creativity, not an automaton.”).
During examination the PTO must interpret claims using “the
broadest reasonable meaning of the words in their ordinary usage as they
would be understood by one of ordinary skill in the art, taking into account
whatever enlightenment by way of definitions or otherwise that may be
afforded by the written description contained in the applicant’s
specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
Moreover, “[i]f the claim preamble, when read in the context of the
entire claim, recites limitations of the claim, or, if the claim preamble is
‘necessary to give life, meaning, and vitality’ to the claim, then the claim
preamble should be construed as if in the balance of the claim.” Pitney
Bowes, Inc. v. Hewlett Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999).
On the other hand:
If . . . the body of the claim fully and intrinsically sets forth the
complete invention, including all of its limitations, and the
preamble offers no distinct definition of any of the claimed
invention’s limitations, but rather merely states, for example,
the purpose or intended use of the invention, then the preamble
is of no significance to claim construction because it cannot be
said to constitute or explain a claim limitation.

Id.
ANALYSIS
Appellant’s arguments do not persuade us that the Examiner erred in
concluding that claim 23 encompasses a process that an ordinary artisan
would have considered obvious in view of Sakaguchi and Harlow.
Claim 23 recites a method “for determining if an animal has been
exposed to a specific hemolysin-producing fungus” (emphasis added). The
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determination is made by performing the claimed steps of (a) contacting a
sample from the animal with labeled hemolysin-binding antibodies, and (b)
detecting any complex formed between the labeled antibodies and the
hemolysin.
We agree with Appellant that, giving claim 23 its broadest reasonable
interpretation, the preamble statement that the method determines “if an
animal has been exposed” to a hemolysin-producing fungus does not
encompass processes in which steps (a) and (b) are performed on a subject
that was deliberately infected with the fungus.
We acknowledge that a practitioner might want to verify the degree of
infection in a subject that is known to have been exposed. We do not agree,
however, that it is reasonable to interpret claim 23 as encompassing such a
process.
The preamble explicitly states that the purpose of performing the
claimed steps is to determine “if” a subject has been exposed to a particular
class of fungi. If the claim were interpreted as encompassing processes
where the subject’s exposure status was already known, there would be no
reason to perform the claimed steps. Because the preamble and body of the
claim are tied together in this manner, we do not agree that it is reasonable to
interpret claim 23 as encompassing a process in which steps (a) and (b) are
performed on a subject that was deliberately infected with the fungus.
Even with this claim interpretation, however, Appellant’s arguments
do not persuade us that the Examiner erred in concluding that Sakaguchi
would have suggested the process recited in claim 23 to an ordinary artisan.
We acknowledge that Sakaguchi’s article is a report on the extent and
symptoms of a deliberately caused A. fumigatus infection (FF 1), which as
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stated above, is not encompassed by claim 23. However, the obviousness
analysis is not limited to the explicit disclosures in prior art publications, but
must also take account of what an ordinary artisan would reasonably infer
from those disclosures. KSR, 550 U.S. at 418.
In the instant case, Sakaguchi explicitly discloses that the A. fumigatus
hemolysin, or Asp-hemolysin, can be detected in tissue samples from
exposed animals using antibodies (FF 3). Given that disclosure, an ordinary
artisan would have reasonably inferred that applying Sakaguchi’s antibody
detection methodology to samples from other animals would be useful for
determining if the animal had been exposed to A. fumigatus. Thus, while it
may be true that Sakaguchi does not explicitly describe a process of
determining whether an animal has been exposed to a hemolysin-producing
fungus, Sakaguchi amply suggests such a process, in our view.
We also acknowledge that Sakaguchi does not explicitly state that the
Asp-hemolysin is species-specific to A. fumigatus. As Appellant concedes,
however, “it is inherent that the hemolysins are unique if one is able to
identify different strains of fungi, which is one object of the present
invention” (App. Br. 8).
While it is true that the rationale for a prima facie case of obviousness
cannot be based on an undisclosed inherent prior art property, in the instant
case the conclusion of obviousness is not based on whether Sakaguchi’s
hemolysin is species-specific. Rather, the rationale for practicing the
claimed process is based on the recognition from Sakaguchi that the
hemolysin from A. fumigatus can be detected in tissue samples from exposed
animals using antibodies.
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As Appellant’s arguments do not persuade us that the Examiner erred
in concluding that claim 23 would have been obvious to an ordinary artisan
in view of Sakaguchi and Harlow, we affirm the Examiner’s rejection of
claim 23 over those references. Claims 25-29 fall with claim 23 as they
were not argued separately. See 37 C.F.R. § 41.37(c)(1)(vii).
ANTICIPATION
Claim 33 stands rejected under 35 U.S.C. § 102(b) as anticipated by
Sakaguchi (Ans. 5-7).
Appellant contends that the Examiner’s finding of anticipation is
erroneous because claim 33 is directed to determining if an animal has been
exposed to specific hemolysin-producing fungus, whereas Sakaguchi “knew
that the animals had been exposed to A. fumigatus because the researchers
had infected the animals with A. fumigatus and monitored the progress of the
infection” (App. Br. 10).
The Examiner responds that claim 33 recites a single method step
which is described in Sakaguchi (Ans. 16-17). Thus the Examiner argues,
the “claims require detection of exposure, the fact that the exposure [in
Sakaguchi] was deliberate does not obviate the fact that exposure to a
hemolysin fungus was detected by detection of hemolysin in tissue samples”
(id. at 17).
Appellant has the better position. Claim 33 recites a “method for
determining if an animal has been exposed to a specific hemolysin-
producing fungus” (emphasis added). The determination is made by
detecting the presence of the hemolysin in a sample from the animal.
Similar to the discussion above regarding claim 23, we do not agree
with the Examiner that it is reasonable to interpret claim 33 as encompassing
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processes, like Sakaguchi’s, in which the detecting step is performed on a
subject that has been deliberately infected with the fungus. If the claim were
interpreted as encompassing processes where the subject’s exposure status
was already known, there would be no reason to perform the claimed steps.
Thus, because the Examiner’s anticipation rejection is not based on a
reasonable interpretation of claim 33, we reverse it.
WRITTEN DESCRIPTION -- CLAIMS 23-29 AND 33
ISSUE
Claims 23-29 and 33 stand rejected under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement
(Ans. 7). For reasons unclear, the Examiner also made a separate written
description rejection of claims 23-26 based essentially on the same rationale
(id. at 9-10). As these rejections are cumulative, we consider them together.
The Examiner contends that the recitation in the claims of determining
whether an animal has been exposed to “a specific hemolysin-producing
fungus” encompasses determining whether the animal has been exposed to a
particular species of fungus, that is, that the exposure-detecting method is
“species specific” (Ans. 7).
In contrast, the Examiner argues, “Appellant has not pointed to the
specification by page and line number where written description support for
this claim language can be found. Further, the there is no conception or
written description of any hemolysin being species-specific” (id.).
Moreover, the Examiner urges, “there is no comparison of hemolysins of
different Fungal genera, much less any discussion of different species within
the same genera nor the ability of any antibody to discriminate between
them” (id.).
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Appellant contends that paragraphs [0012] and [0015] of the
Specification disclose that the invention’s objectives include providing
methods of screening animals for exposure to hemolysin-producing fungi
and for identifying strains of such fungi (App. Br. 11). Appellant contends
that if “the hemolysins were not species-specific, the present application
would be inoperable, as it is the specific hemolysins that make it possible to
identify different species of fungi” (id.).
Appellant further contends that, as stated in paragraph [0034], the
claimed test allows a practitioner “to identify the source of the hemolysin in
a human or other animal that has been exposed to such a fungus. Unless the
hemolysin is specific for each hemolysin-producing fungus, this assay would
be worthless other than for a determination that the infection was from a
hemolysin-producing fungus” (Reply Br. 4).
Appellant further contends that, “[w]hile it has not been recited in the
specification in the same manner as claims 23-26 are worded, it is clear that
one skilled in the art would appreciate that hemolysin-producing fungi
produce species-specific hemolysins” (App. Br. 14). Thus, Appellant urges,
a skilled artisan reading the Specification would have recognized “that
hemolysin-producing fungi produce hemolysin that is species specific, so
that individual fungi can be identified. It is respectfully submitted that the
recitation of ‘species-specific hemolysin’ is not new matter, but is an
inherent property of the hemolysin produced by hemolysin producing fungi”
(id. at 15).
Appellant does not argue any of the claims subject to these rejections
separately. We select claim 23 as representative of the rejected claims. See
37 C.F.R. § 41.37(c)(1)(vii).
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Thus, in view of the positions advanced by Appellant and the
Examiner, the issue with respect to these rejections is whether Appellant has
shown that the Examiner erred in finding that the Specification does not
provide adequate descriptive support for the language in claim 23 requiring
the practitioner to determine “if an animal has been exposed to a specific
hemolysin-producing fungus, which hemolysin is species-specific.”
FINDINGS OF FACT
6. The Specification states that “[i]t is an object of the present invention
to provide a method and reagent for screening humans and other animals for
exposure to hemolysin-producing fungi. . . .
It is a further object of the present invention to identify strains of
fungi using an in vitro test” (Spec. [0012]-[0015]).
7. The Specification states:
The present inventor has discovered a method for
purifying fungal hemolysin proteins so that these hemolysin
proteins can be used to demonstrate exposure to fungi for
environmental or medical evaluations, as well as to prepare
vaccines against fungal infection and to produce anti-bacterial
and anti-fungal compositions. These fungal hemolysin proteins
may be present in the blood, urine, saliva, or other measurable
body fluid or material of a human or animal infected with the
fungi. Antibodies produced by any appropriate technique, such
as in rabbits, or monoclonal antibodies, against the hemolysin
protein are used to assay for these proteins. The assay itself can
be of any conventional immunoassay type, such as ELISA,
RIA, etc.

(Id. at [0021].)
8. The Specification discloses that “[b]y growing strains of hemolysin
producing fungi in vitro and isolating the hemolysin, it is now possible to
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use the protein obtained to identify fungi which are isolated from buildings,
homes, schools, and the like” (id. at [0024]).
9. The Specification discloses a process in which conidia of the fungus
Stachybotrys chartarum were cultured, and the hemolysin produced by the
fungus was obtained from fractionated culture medium (id. at [0025]-
[0027]).
Rabbits were immunized with the hemolysin, and anti-hemolysin
antibodies from the immunized rabbits were affinity purified using
immobilized hemolysin (id. at [0030]).
The capacity of the purified antibodies to bind to the hemolysin was
verified in an ELISA in which the hemolysin peptide was coated onto
microliter wells, and then contacted with the anti-hemolysin antibodies and a
second detecting antibody (id. at [0031]).
10. The Specification discloses:
These antibodies to fungal hemolysin can be used in a
conventional immunoassay such as an ELISA to determine if
one has been exposed to strains of fungi which produce
hemolysin. The hemolysin protein itself can be used to
determine if one has produced antibodies in response to
exposure to the fungus.

(Id. at [0032] (as amended January 11, 2002).)
11. The Specification discloses:
The present invention thus provides a method to
determine if a human or other animal has been exposed to a
hemolysin-producing fungus such as Stacybotrys chartarum.
By assaying samples from a human or other animal for
antibodies to a hemolysin-producing fungus, it is now possible
to determine if the human or other animal has been exposed to
such a fungus.

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(Id. at [0033].)
12. The Specification discloses:
Exposure to low levels of hemolysins can lead to
potassium ion depletion in monocytes, which can lead to
activation of interleukin-converting enzyme. This in turn can
lead to rapid and massive release of mature IL-beta. In addition,
T-lymphocytes that leak potassium ions undergo programmed
cell death (apoptosis)[.] For this reason, it is critical to identify
the source of the hemolysin in a human or other animal which
may have been exposed to a hemolysin-producing fungus and
immediately begin appropriate treatment.

(Id. at [0034].)
13. The Specification discloses that “[t]he method of the present invention
is useful for assaying for exposure to or for the presence of any
hemolysin-producing fungal strain. Some nonlimiting examples of these
fungal strains are Stacybotrys chartarum, Aspergillus fumigasus, Candida
albicans and Penicillium chysogenum” (id. at [0035]).
PRINCIPLES OF LAW
As stated in TurboCare Div. of Demag Delaval Turbomachinery
Corp. v. General Elec. Co., 264 F.3d 1111, 1118 (Fed. Cir. 2001):
The written description requirement and its corollary, the new
matter prohibition of 35 U.S.C. § 132, both serve to ensure that
the patent applicant was in full possession of the claimed
subject matter on the application filing date. When the applicant
adds a claim or otherwise amends his specification after the
original filing date . . ., the new claims or other added material
must find support in the original specification.

The test for determining whether a specification is sufficient to
support a particular claim “is whether the disclosure of the application relied
upon ‘reasonably conveys to the artisan that the inventor had possession at
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that time of the later claimed subject matter.’” Ralston Purina Co. v. Far-
Mar-Co, Inc., 772 F.2d 1570, 1575 (Fed. Cir. 1985) (quoting In re Kaslow,
707 F.2d 1366, 1375 (Fed. Cir. 1983)).
Thus, “[i]t is not necessary that the application describe the claim
limitations exactly, but only so clearly that persons of ordinary skill in the
art will recognize from the disclosure that appellants invented processes
including those limitations.” In re Wertheim, 541 F.2d 257, 262 (CCPA
1976) (citation omitted); see also Purdue Pharma L.P. v. Faulding Inc., 230
F.3d 1320, 1323 (Fed. Cir. 2000) (“In order to satisfy the written description
requirement, the disclosure as originally filed does not have to provide in
haec verba support for the claimed subject matter at issue.”).
ANALYSIS
Appellant’s arguments do not persuade us that the Examiner erred in
finding that claim 23 lacks adequate descriptive support in the Specification.
Claim 23 recites “[a] method for determining if an animal has been
exposed to a specific hemolysin-producing fungus, which hemolysin is
species-specific.” Like Appellant and the Examiner, we interpret this
language as requiring the practitioner to determine which particular species
of hemolysin-producing fungus the animal has been exposed to.
In contrast to this requirement, we are convinced that the
Specification would have conveyed to a skilled artisan that Appellant
invented a less specialized method, which merely allows the practitioner to
determine whether an animal has been exposed to hemolysin-producing
fungi in general, without any distinction between species.
For example, the Specification discloses the preparation of antibodies
to only a single hemolysin, the one produced by the fungus Stachybotrys
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chartarum (FF 9). The Specification does not state that the hemolysin is
specific to that species of fungus. The Specification does not state that the
purified antibodies to that hemolysin would be incapable of detecting
hemolysins from other species of fungi.
To the contrary, the Specification explicitly states that “[t]hese
antibodies to fungal hemolysin can be used in a conventional immunoassay
such as an ELISA to determine if one has been exposed to strains of fungi
which produce hemolysin” (Spec. [0032]). Thus, rather than suggesting that
the only antibodies actually prepared by Appellant were specific to S.
chartarum, the Specification states, more generally, that those antibodies
would be useful in determining if a subject had been exposed to
hemolysin-producing fungal strains. Thus, the Specification suggests a
generic applicability for the disclosed antibodies, rather than a species-
specific one.
We acknowledge the Specification’s stated objectives of “screening
humans and other animals for exposure to hemolysin-producing fungi”
(Spec. [0012]), and “identify[ing] strains of fungi using an in vitro test” (id.
at [0015]).
Without any specific disclosure about these methods’ capacities to
distinguish between different species of fungi, however, it is not clear that
the Specification contemplated anything more than the general ability to
detect hemolysin-producing fungi, as opposed to distinguishing between
species. This is particularly true given the Specification’s suggestion that
the antibodies to S. chartarum would be useful in detecting a plurality of
hemolysin-producing strains (id. at [0032]).
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We also acknowledge that the Specification’s disclosure that “it is
critical to identify the source of the hemolysin in a human or other animal
which may have been exposed to a hemolysin-producing fungus and
immediately begin appropriate treatment” (id. at [0034]). However,
Appellant points to no disclosure in the Specification, or other evidence of
record, suggesting that treatment for infection by one species of hemolysin-
producing fungus would be different than treatment for infection by different
fungal species.
Moreover, the next paragraph of the Specification states that “[t]he
method of the present invention is useful for assaying for exposure to or for
the presence of any hemolysin-producing fungal strain. Some nonlimiting
examples of these fungal strains are Stacybotrys chartarum, Aspergillus
fumigasus, Candida albicans and Penicillium chysogenum” (id. at [0035])
(emphasis added).
Given Appellant’s inability to point to a specific statement in the
Specification that the disclosed methods differentiate between different
fungal species, and the suggestion that the S. chartarum antibodies can be
used to detect hemolysins from other “strains” (id. at [0035]) and are
therefore not species-specific, we are convinced that the disclosure of
detecting “any hemolysin-producing fungal strain” (id. at [0035]), would not
have conveyed to a skilled artisan that Appellant invented a method that
allowed a practitioner to determine which particular species of hemolysin-
producing fungus the animal has been exposed to.
Appellant argues that, “[u]nless the hemolysin is specific for each
hemolysin-producing fungus, this assay would be worthless other than for a
determination that the infection was from a hemolysin-producing fungus,”
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and that the Specification therefore would have conveyed to a skilled artisan
that Appellant invented a species-specific identification method (Reply Br.
4). This argument does not persuade us, however, that the Examiner erred in
finding a lack descriptive support for claim 23.
We acknowledge that the Specification must be viewed with the
understanding of a person of ordinary skill in the art. See, e.g., In re
Wertheim, 541 F.2d at 262.
Nonetheless, for the reasons discussed above, we are not convinced
that any of the portions of the Specification cited by Appellant, or related
sections, would have conveyed to a skilled artisan that Appellant invented
anything beyond a generalized method that merely allows the practitioner to
determine whether an animal has been exposed to hemolysin-producing
fungi, without any distinction between species. The fact that a skilled
artisan might have found the disclosed methods useful for purposes beyond
the Specification’s explicit disclosure does not demonstrate that the
Specification contemplated those further uses as part of the invention.
As Appellant’s arguments do not persuade us of error in the
Examiner’s finding of lack of written description with respect to claim 23,
we affirm both of the Examiner’s rejections of that claim under 35 U.S.C. §
112, first paragraph. As claims 24-29 and 33 were not argued separately,
they fall with claim 23. See 37 C.F.R. § 41.37(c)(1)(vii).
WRITTEN DESCRIPTION -- CLAIMS 30-32
ISSUE
Claims 30-32 stand rejected under 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement (Ans. 7-8). The
Examiner finds that, in contrast to claim 30, the portions of the Specification
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relating to screening buildings for hemolysin-producing fungi “do not
provide for the concept of contacting a building sample with a labeled
antibody to detect the hemolysin” (Ans. 8).
Appellant contends that a skilled artisan would have known how to
collect a representative sample from a building, and would also have
recognized that fungal cultures obtained from that sample “could be assayed
in the same manner as samples from bodily fluids” (App. Br. 12). Thus
Appellant argues, a skilled artisan “does not need to have each step spelled
out in excruciating detail, as one skilled in the art can readily ascertain how
to obtain suitable samples and proceed with such an assay” (id. at 12-13).
Appellant does not argue any of the claims subject to these rejections
separately. We select claim 30 as representative of the rejected claims. See
37 C.F.R. § 41.37(c)(1)(vii).
In view of the positions advanced by Appellant and the Examiner, the
issue with respect to this rejection is whether the Examiner erred in finding
that the Specification fails to provide adequate descriptive support for the
method in claim 30, which requires contacting a sample obtained from a
building “with labeled antibodies which bind to the fungal hemolysin or to
active fragments of the fungal hemolysin . . . and . . . detecting any complex
formed between the labeled antibodies and the fungal hemolysin or active
fragments thereof” that might be present in the sample.
FINDINGS OF FACT
14. The Specification discloses:
Many fungi are present in buildings such as offices,
homes, schools, warehouses, etc., but not all fungi adversely
affect humans. To determine if a building holds fungi which are
problematic, i.e., produce hemolysin, a strain of a fungus
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obtained from the building is grown in a synthetic medium such
as tryptic soy broth at a temperature at which the fungus can be
made to grow, generally about 37°C. The culture filtrate is then
applied to a plate, such as a 5% sheep red blood cell blood agar
plate. If the filtrate is shown to be hemolytic, the strain is
problematic and may pose a health risk.
Once a building has been found to contain problematic
fungi, the building is treated to remove or destroy the fungi.
The screening can then be repeated to ensure that the
problematic fungi have been eliminated from the site.

(Spec. [0036]-[0037].)
ANALYSIS
Appellant’s arguments do not persuade us that the Examiner erred in
finding that claim 30 lacks adequate descriptive support in the Specification.
Claim 30 recites a method for determining if a building contains a
hemolysin-producing fungus. The determination is made by performing the
steps of (a) obtaining a sample from the building, (b) obtaining hemolysin
from the sample if hemolysin-producing fungi are present in the sample, (c)
contacting the sample with labeled antibodies which bind to the hemolysin
or active fragments of hemolysin, and (d) detecting any complex formed
between the labeled antibodies and the fungal hemolysin or active fragments
thereof.
As Appellant points out, paragraphs [0036] and [0037] describe the
process by which a sample from a building is testing for contamination by
hemolysin-producing fungi. As the Examiner points out, however, that
disclosure makes no mention of contacting the culture with anti-hemolysin
antibodies. Rather, the hemolysis evidenced by the blood cell agar provides
the indication that the culture contains hemolysins.
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Appellant does not point to any disclosure in the Specification that
links the building sample assay methods to the antibody-based detection
methods used for assaying animal samples. Rather, an overall reading of the
portions of the Specification cited above (FF 6-14) shows that the building
sample assays and animal sample assays are distinct and separate
embodiments.
Thus, while it may be true that Appellant possessed the component
parts of the process recited in claim 30 in separate and distinct embodiments,
we are not convinced that the Specification would have conveyed to a
skilled artisan that Appellant actually invented a process that used those
components in combination, in the manner recited in claim 30. We therefore
affirm the Examiner’s written description rejection of claim 30 under 35
U.S.C § 112, first paragraph.
Because they were not argued separately, claims 31 and 32 fall with
claim 30.
ENABLEMENT -- CLAIMS 30-32
ISSUE
Claims 30-32 stand rejected under 35 U.S.C. § 112, first paragraph, as
failing to comply with the enablement requirement (Ans. 8-9). The
Examiner contends that the Specification does not disclose whether
hemolysins are “readily available on the spore or conidia coat” or whether
“the presence of fungal-hemolysin can be detected in a crude building
sample in the absence of broth culture” (id. at 9).
Thus, the Examiner argues, an ordinary artisan “would have to
determine if the hemolysin was present on the surface of the fungal spores or
conidia before any assessment of the presence or absence in a building
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sample could begin” (id.). Further, the Examiner argues, “even if the spore
surface had the hemolysin present, it is unclear if the method as claim is
sensitive enough to detect the levels present in a crude building sample”
(id.).
Appellant contends that “[o]ne skilled in the art of clinical assays or
assaying for deleterious microorganisms in a building or other such
environment, could read the present specification and readily contrive to
conduct such assay without undue experimentation” (App. Br. 13).
Specifically, Appellant argues, an ordinary artisan would know how to
“obtain samples from a building or other environment, and then, as
described at paragraphs 25 to 32, assay for the presence of fungal
hemolysins in the sample. Paragraph 36, which pertains specifically to
screening fungi in a building, even discloses the culturing technique for
growing the suspected hemolysin-producing fungi” (id.).
In view of the positions advanced by Appellant and the Examiner, the
issue with respect to this rejection is whether Appellant has shown that the
Examiner erred in concluding that an ordinary artisan viewing the present
Specification would have had to resort to undue experimentation to practice
the process recited in claims 30-32.
PRINCIPLES OF LAW
As noted in Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d
1313 (Fed. Cir. 2003):
The enablement requirement is often more indulgent
than the written description requirement. The specification
need not explicitly teach those in the art to make and use the
invention; the requirement is satisfied if, given what they
already know, the specification teaches those in the art enough
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that they can make and use the invention without “undue
experimentation.”

Id. at 1334 (emphasis added).
Thus, “[working] examples are not required to satisfy section 112,
first paragraph.” In re Strahilevitz, 668 F.2d 1229, 1232 (CCPA 1982). For
example, in Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1365 (Fed. Cir.
2006) the court affirmed this Board’s conclusion that claims to a modified
pox virus vaccine were enabled, despite the fact that the specification
focused on viruses other than pox virus, provided no examples directed to
pox virus, and discussed pox virus only in general terms relating to the
inventive disclosure.
ANALYSIS
We agree with Appellant that the Examiner erred in concluding that
the Specification fails to enable claims 30-32.
As noted above, claim 30 recites a method for determining if a
building contains a hemolysin-producing fungus. The determination is made
by performing the steps of (a) obtaining a sample from the building, (b)
obtaining hemolysin from the sample if hemolysin-producing fungi are
present in the sample, (c) contacting the sample with labeled antibodies
which bind to the hemolysin or active fragments of hemolysin, and (d)
detecting any complex formed between the labeled antibodies and the fungal
hemolysin or active fragments thereof.
As also noted above in the discussion regarding the written
description rejection over these same claims, we agree with Appellant that
the component parts of the assay recited in claim 30 are disclosed in the
Specification, albeit not in a manner sufficient to provide adequate
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descriptive support. However, as stated in Amgen Inc. v. Hoechst Marion
Roussel, Inc., 314 F.3d at 1334, “[t]he enablement requirement is often more
indulgent than the written description requirement.”
We conclude that to be the case here. The Specification discloses the
collection of samples from buildings (FF 14), and also discloses methods by
which hemolysin can be obtained from collected samples by culturing the
fungi and getting the hemolysin from the culture supernatant (FF 9). We are
therefore not persuaded that an ordinary artisan would have had to
experiment unduly to practice the process recited in claim 30.
The Examiner’s issue appears to be that the claim recites obtaining
hemolysin from the building sample, whereas the only methods described in
the Specification for obtaining hemolysin from animal or building samples
involves culturing the fungi obtained from the sample (see Ans. 26; see also
FF 9 (culturing S. chartarum conidia to obtain hemolysin in culture filtrate)
and FF 14 (culturing fungi obtained from building sample)).
Thus, the Examiner argues, the “antecedent basis of the claim does
not provide for intermediate strain isolation and culturing steps. The
hemolysin must be obtained from the sample from the building. The strain
isolation and culturing technique is not set forth in the claims” (Ans. 27).
We are not persuaded. While claim 30 may lack the precise wording
preferred by the Examiner, we see nothing that precludes the obtaining step
from involving culturing the collected fungi to obtain the hemolysin. While
this might mean that step (c) requires contacting a cultured sample with
labeled antibodies, we do not agree with the Examiner that this is an
unreasonable interpretation of claim 30.
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As Appellant’s arguments persuade us that the Examiner’s conclusion
of non-enablement with respect to claim 30 is erroneous, we reverse the
Examiner’s enablement rejection of that claim, and its dependents.
INDEFINITENESS
Claims 30-32 stand rejected under 35 U.S.C. § 112, second paragraph,
as being indefinite (Ans. 10-11). The Examiner finds that the preamble of
claim 30 recites a method for determining if a building contains a
hemolysin-producing fungus, whereas step (b) recites “‘obtaining hemolysin
from the sample if hemolysin-producing fungi are present in the sample’”
(id. at 10).
The Examiner concludes that step (b) requires the practitioner to know
that hemolysin is present in the sample, and that step (b) is therefore
inconsistent with the preamble, which requires “measuring an unknown,
where the presence or absence of a hemolysin is unknown. . . . What is the
purpose of performing the assay[?]” (Id. at 10-11.)
Appellant contends that step (b) of claim 30 does not require
knowledge of whether the sample contains hemolysin. We agree.
“A claim is indefinite if, when read in light of the specification, it
does not reasonably apprise those skilled in the art of the scope of the
invention.” Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d at 1342.
Claim 30 recites a method for determining if a building contains a
hemolysin-producing fungus. The steps by which the determination is made
include (a) obtaining a sample from the building, (b) “obtaining hemolysin
from the sample if hemolysin-producing fungi are present in the sample.”
At the outset, we note that the Examiner’s interpretation of claim 30’s
preamble as requiring the use of an unknown sample is entirely inconsistent
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with the interpretation applied in the art rejections, where the Examiner
asserted that the language “determining if” included testing samples whose
exposure status was known (see, e.g. Ans. 16-17).
As to the claim itself, we do not agree that step (b) requires knowing
that hemolysin-fungi are present in the sample. Specifically, if the unknown
sample contains hemolysin-producing fungi, then a step of culturing the
fungi from the sample would allow the practitioner obtain hemolysin from
the sample. Conversely, if the unknown sample does not contain hemolysin-
producing fungi, then a step of culturing the fungi from the sample would
not allow the practitioner obtain hemolysin from the sample.
Thus, because the language in claim 30 would have apprised an
ordinary artisan of the scope of the claim, we reverse the Examiner’s
rejection of claim 30, and its dependents, as being indefinite.

SUMMARY
We affirm the Examiner’s rejection of claims 23 and 25-29 under 35
U.S.C. § 103(a) as obvious in view of Sakaguchi and Harlow.
We reverse the Examiner’s rejection of claim 33 under 35 U.S.C. §
102(b) as anticipated by Sakaguchi.
We affirm the Examiner’s rejection of claims 23-29 and 33 under 35
U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement.
We affirm the Examiner’s rejection of claims 30-32 under 35 U.S.C. §
112, first paragraph, as failing to comply with the written description
requirement.
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We reverse the Examiner’s rejection of claims 30-32 under 35 U.S.C.
§ 112, first paragraph, as failing to comply with the enablement requirement.
We affirm the Examiner’s rejection of claims 23-26 under 35 U.S.C. §
112, first paragraph, as failing to comply with the written description
requirement.
We reverse the Examiner’s rejection of claims 30-32 under 35 U.S.C.
§ 112, second paragraph, as being indefinite.

TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED-IN-PART

cdc

BROWDY AND NEIMARK, P.L.L.C.
624 NINTH STREET, NW
SUITE 300
WASHINGTON DC 20001-5303
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