Ex Parte Jira et al

Board of Patent Appeals and Interferences

Nov 29, 2010

10228280 (B.P.A.I. Nov. 29, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
10/228,280 08/27/2002 Vic Jira 22220-00005-US1 6709
30678 7590 11/29/2010
CONNOLLY BOVE LODGE & HUTZ LLP
1875 EYE STREET, N.W.
SUITE 1100
WASHINGTON, DC 20006
EXAMINER
DEVI, SARVAMANGALA J N
ART UNIT PAPER NUMBER
1645
MAIL DATE DELIVERY MODE
11/29/2010 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte VIC JIRA and VICHAI JIRATHITIKAL
__________

Appeal 2010-007051
Application 10/228,280
Technology Center 1600
__________

Before ERIC GRIMES, FRANCISCO C. PRATS, and
MELANIE L. McCOLLUM, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL1
This appeal under 35 U.S.C. § 134 involves claims to orally
administered fungal vaccines. The Examiner rejected the claims as
anticipated.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm in part.

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
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STATEMENT OF THE CASE
Claims 1, 3, 5, 6, 8-10, and 16-18 stand rejected and appealed (App.
Br. 3-4).2 Claims 1, 3, 5, 10, and 18, the independent claims, are
representative and read as follows:
1. A fungal vaccine comprising one or more
hydrolyzed, dry, heat-inactivated fungal antigens and wherein
at least one of the fungal antigens is effective in producing an
immune response in a host when said vaccine is administered
orally at a dose that is sufficient for preventing or treating
fungal disease in said host.

3. A dry composition for the induction of immunity
to a fungal pathogen in a host in need thereof said composition
comprising a hydrolyzed, dry, heat- inactivated fungal pathogen
formulated for oral delivery.

5. A heat-inactivated immunogen formulated as an
oral pill comprising a hydrolyzed, dry fungal immunogen,
wherein said immunogen upon administration retains the ability
to elicit an immune response to said immunogen in a host.

10. An oral vaccine comprising a dry, heat-inactivated
fungal pathogen which vaccine does not comprise an immune
adjuvant.

18. An oral pill comprising a fungal immunogen
consisting of a dose of a heat-inactivated fungal pathogen,
wherein said fungal immunogen elicits an immune response to
said fungal pathogen upon oral administration without an
immune adjuvant to a mammalian host.

The following rejections are before us for review:

2 Appeal Brief entered September 9, 2009.
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(1) Claims 10 and 18, rejected under 35 U.S.C § 102(b) as anticipated
by Hagiwara3 et al. (Ans. 3-5);
(2) Claims 1 and 3, rejected under 35 U.S.C § 102(b) as anticipated by
Nicoletti4 (Ans. 5-7);
(3) Claims 1, 3, 5, 6, 8, 9, and 16, rejected under 35 U.S.C § 102(b) as
anticipated by Jamas5 et al. (Ans. 7-8); and
(4) Claims 1, 3, 5, 6, 8, 9, and 17, rejected under 35 U.S.C § 102(b) as
anticipated by Otero6 (Ans. 8-10).
ANTICIPATION -- HAGIWARA
ISSUE
The Examiner cites Hagiwara as describing “an orally administrable
tablet (i.e., oral pill), a granule, or a dry powder composition comprising or
consisting of schizophyllan and mycelium (i.e., filamentous fungal antigen)
of the fungus Schizophyllum commune Fries that was subjected to 40°C”
(Ans. 4).
Appellants contend that the Examiner erred in finding that Hagiwara
anticipates claims 10 and 18 because Hagiwara’s vaccine does not contain a
pathogen (App. Br. 20). Specifically, Appellants argue, an “isolated part of
the pathogen does not qualify as a pathogen. Thus, [the polysaccharide]
schizophyllan is not a pathogen” (id.).

3 U.S. Patent No. 5,320,849 (filed Mar. 8, 1993).
4 A. Nicoletti et al., Preliminary Evaluation of Immunoadjuvant Activity of
an Orally Administered Glucan Extracted from Candida albicans, 42
ARZNEIM.FORSCH./DRUG RES. 1246-1250 (1992).
5 U.S. Patent No. 5,817,643 (filed Jun. 6. 1995).
6 M.A. Otero et al., Preparation of an Imitation Soy Sauce from Hydrolyzed
Dried Yeast Candida Utilis, 22 J. FOOD PROCESS. PRESERVAT. 419-432
(1998).
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Appellants do not argue the claims subject to this ground of rejection
separately. We select claim 10 as representative of the rejected claims. See
37 C.F.R. § 41.37(c)(1)(vii).
In view of the positions advanced by Appellants and the Examiner,
the issue with respect to this rejection is whether the evidence of record
supports a finding that Hagiwara discloses a vaccine that contains a fungal
pathogen, as opposed to a purified portion of a fungal pathogen.
FINDINGS OF FACT (“FF”)
1. Hagiwara discloses polysaccharides that activate “immune system-
enhancing ability in the same manner as interferon when . . . administered
into a living body and that achieve[] a remarkable anti-virus effect on
various viruses” (Hagiwara, col. 1, ll. 64-67).
2. Hagiwara discloses that, “[a]s the polysaccharides, there can be
enumerated schizophyllan produced by Schizophyllum commune Fries,
scleroglucan produced by Sclerotium glucanicum and pendulan produced by
Porodisculus pendulus” (id. at col. 2, ll. 1-4).
3. Hagiwara discloses that, “[t]o purify such polysaccharide to a high
degree so that it may be used as a pharmaceutical intended by the present
invention, it is advisable to lower the molecular weight by the
depolymerization of the polysaccharide” (id. at col. 2, ll. 10-14).
4. In Example 5, Hagiwara discloses that “1 kg of culture broth obtained
by cultivating Schizophyllum commune Fries was homogenized as it was,
and the mycelium was fractured and subjected to vacuum drying at 40° C. to
obtain 30 g of light yellow dry powder” (id. at col. 7, ll. 11-15).
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5. Example 5 of Hagiwara further discloses that the “dry powder of this
culture broth . . . [was] orally administered into mice infected with Sendai
virus (5 LD50)” (id. at col. 7, ll. 18-21).
6. Example 5 of Hagiwara further discloses that “all of the non-
administered [control] mice were dead by the 10th day after the virus
infection, but . . . eight of the ten culture broth dry powder-administered
mice were survived even after 14 days from the virus infection” (id. at col. 7,
ll. 22-28).
PRINCIPLES OF LAW
“To anticipate a claim, a prior art reference must disclose every
limitation of the claimed invention, either explicitly or inherently.” In re
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997).
ANALYSIS
Appellants’ only argument regarding this rejection is that claim 10
requires the claimed vaccine to contain an intact pathogen, whereas
Hagiwara’s preparation is a purified polysaccharide (App. Br. 20-21).
Appellants’ argument does not persuade us, however, that Hagiwara fails to
anticipate claim 10.
It might be true that Hagiwara prefers administering its therapeutic
agent as a purified polysaccharide (see FF 3). However, in Example 5, the
example cited by the Examiner (Ans. 4), Hagiwara describes the preparation
of a “dry powder” directly from the culture broth of Schizophyllum
commune, a fungus which is not disputed as being a pathogen (FF 4-6).
Thus, contrary to Appellants’ arguments, Hagiwara discloses a dried
composition that contains an intact fungal pathogen. We therefore affirm
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the Examiner’s rejection of claim 10 as anticipated by Hagiwara, and claim
18 falls with that claim. See 37 C.F.R. § 41.37(c)(1)(vii).
ANTICIPATION -- NICOLETTI
ISSUE
Claims 1 and 3 stand rejected under 35 U.S.C § 102(b) as anticipated
by Nicoletti (Ans. 5-7). The Examiner cites Nicoletti as describing “an oral
Glucan granulate composition (i.e., dry vaccine) for oral delivery comprising
a fungal immunogen or antigen extracted from autoclaved (i.e., heat-
inactivated) and alkali- and acid-extracted (i.e., hydrolysed) Candida
albicans” (id. at 5).
Appellants contend that the Examiner erred in finding that Nicoletti
anticipates the rejected claims because Nicoletti “repeatedly identifies
glucan as an immunoadjuvant, not as a vaccine or antigen” (App. Br. 10).
Because “an immunoadjuvant is not an antigen but an enhancer,” Appellants
argue, “Nicoletti does not disclose all the elements of the claim” (id. at 11).
Appellants further argue that Nicoletti does not anticipate the rejected
claims because Nicoletti administered its composition in the form of a
solution containing the glucan, whereas claims 1 and 3 require the vaccine to
be dry (id.). Appellants also argue that claim 3 requires the vaccine to
contain a pathogen, whereas Nicoletti’s vaccine contains only a glucan
polysaccharide, which is not a pathogen (id. at 13). Moreover, Appellants
argue, because Nicoletti’s glucan is a polysaccharide, it cannot be
inactivated by heat (id. at 14).
The Examiner responds that originally filed claim 11 contemplated
the term “inactivated pathogen” as encompassing parts of a fungus (Ans.
19), and also points out that the definitions advanced by Appellants for the
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term “pathogen” do not exclude Nicoletti’s glucan (id. at 19-20).
Specifically, the Examiner argues, the MedicineNet.com7 webpage
submitted by Appellants includes within the definition of “pathogen” a
“noninfectious agent of disease such as a chemical” (id. at 19).
The Examiner finds, as shown by Hida,8 that the beta-1,3-glucan
polysaccharide from Candida albicans was known in the art to cause
arthritis in mammals (id.). The Examiner therefore reasons that Nicoletti’s
“beta-glucan also qualifies as a polysaccharide noninfectious agent of
arthritis disease” (id.).
In view of the positions advanced by Appellants and the Examiner,
the issue with respect to this rejection is whether the evidence of record
supports the Examiner’s finding that claims 1 and 3 encompass the products
described by Nicoletti.
FINDINGS OF FACT
Claims/Specification
7. Claim 1 recites a vaccine that contains one or more hydrolyzed, dry,
heat-inactivated “fungal antigens.”
8. The Specification states:
The term “immunogen” or “antigen” as used hereinafter
comprises any entity capable of producing a protective antibody
or cell-mediated immunological response against a pathogenic
organism in an animal. The antigen or immunogen can be
whole pathogen or part of the pathogen including any cell
component, a protein, glycoprotein, glycolipid, polysaccharide

7 http://www.medterms.com/script/main/art.asp?articlekey=6383.
8 S. Hida et al., Cell wall beta-glucan derived from Candida albicans acts as
a trigger for autoimmune arthritis in SKG mice, 30 BIOL. PHARM. BULL.
1589-92 (2007) (abstract only (www.pubmed.gov)).
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or lipopolysaccharide which belongs or is associated with the
pathogen, or it may be a polypeptide or other entity which
mimics all or part of such a pathogen or protein, glycoprotein,
glycolipid, polysaccharide or lipopolysaccharide thereof. An
example of fungal polysaccharide is schizophyllan.

(Spec. 12.)
9. Claim 3 recites a dry composition that contains a hydrolyzed, dry,
heat-inactivated “fungal pathogen.”
10. The MedicineNet.com website defines “pathogen” as follows:
Pathogen: An agent of disease. A disease producer. The term
pathogen most commonly is used to refer to infectious
organisms. These include bacteria (such as staph), viruses
(such as HIV), and fungi (such as yeast). Less commonly,
pathogen refers to a noninfectious agent of disease such as a
chemical.

(http://www.medterms.com/script/main/art.asp?articlekey=6383.)
Nicoletti
11. Nicoletti discloses that the “immunoadjuvant activity of an orally
administered glucan (Glucanil®, Gluimmun®) was investigated in mice.
Glucan was extracted from Candida albicans ATCC 20955 and purified by
an alkali-acid and detergent treatment” (Nicoletti 1246 (abstract)).
12. Nicoletti discloses that its glucan improved the immune response of
mice experimentally infected with Candida albicans:
Oral treatment with glucan at 1 mg/mouse/day repeated doses,
starting from 10 days before the experimental infection,
significantly increased polymorphonuclear leukocytes and
peripheral monocytes number. A significant increase in
number and in vitro candidacidal activity was also observed for
alveolar macrophages. The resistance towards systemic
infection with Candida albicans or Staphylococcus aureus
increased, significantly reducing the growth of microorganisms
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in the kidneys of infected animals. Glucan significantly
increased the candidacidal spleen cells activity and synergized
with amphotericin B chemotherapic action.
(Id.)
13. Nicoletti discloses that, in its preparation method, cultured yeast cells
were “resuspended in citric buffer and then treated in autoclave for 3 h.
Cell-wall fraction was repeatedly extracted with hot alkali and acetic acid
and finally treated with a detergent. The product yield is about 14-17 % of
cell dry weight and it contains about 96 % of glucan” by weight (id. at
1247).
14. Nicoletti discloses that, to test the therapeutic properties of its glucan
preparation, “[g]lucan granulate . . . was suspended in saline and orally
administered to animals by gastric catheter” (id. (citations omitted)).
Hida
15. Hida discloses that “SKG mice are a recently established experimental
model for rheumatoid arthritis (RA)” (Hida, abstract).
16. Hida discloses that, because “Beta-glucan (BG) from Laminaria
digitata [and] laminarin (LAM), induced arthritis under SPF conditions, . . .
BG would be a pathogenic factor for arthritis in SKG mice. Therefore, we
prepared BG from Candida albicans, a pathogenic fungus and investigated
whether BG from C. albicans induced arthritis in SKG mice” (id.).
17. Based on its findings that the Candida albicans beta-glucan induced
more severe arthritis in mice as compared to controls and similar
polysaccharides, Hida concluded that “fungal infection may be a factor to
induce and exacerbate autoimmune diseases such as RA” (id.; see also
Hida’s title (“Cell wall beta-glucan derived from Candida albicans acts as a
trigger for autoimmune arthritis in SKG mice”)).
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PRINCIPLES OF LAW
During examination, the PTO must interpret terms in a claim 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).
Thus, while “the PTO must give claims their broadest reasonable
interpretation, this interpretation must be consistent with the one that those
skilled in the art would reach.” In re Cortright, 165 F.3d 1353, 1358 (Fed.
Cir. 1999).
ANALYSIS
Appellants’ arguments do not persuade us that Nicoletti fails to
anticipate claims 1 and 3.
Claim 1 recites a vaccine that contains one or more hydrolyzed, dry,
heat-inactivated “fungal antigens.” As stated in Appellants’ Specification,
the term “antigen” includes a “part of the pathogen including any cell
component, a . . . polysaccharide . . . associated with the pathogen” (Spec.
12 (FF 8)).
Thus, while Nicoletti refers to its yeast-derived glucan polysaccharide
as having “immunoadjuvant activity” (Nicoletti 1246 (FF 11)), Nicoletti’s
glucan nonetheless falls squarely within the definition of “antigen” in
Appellants’ own Specification. Therefore, the fact that Nicoletti refers to its
polysaccharide using language different than Appellants’ does not persuade
us that the polysaccharide itself lacks the attributes required of an antigen by
claim 1.
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Nor are we persuaded that Nicoletti fails to disclose a dry preparation
of that antigen. Specifically, Nicoletti discloses that the orally administered
composition was prepared by suspending a glucan granulate in saline (FF
14).
While we agree that it is reasonable to interpret a saline solution
containing a suspended glucan product as not being dry, Nicoletti
nonetheless discloses that the suspension is prepared from a “[g]lucan
granulate” (Nicoletti 1247 (FF 14)). Given its description as being
granulated, and given that its oral administration via catheter requires
suspension in saline solution, we conclude that it is reasonable to find that
Nicoletti’s glucan granulate was a dry preparation of the glucan, as claim 1
requires.
Moreover, given that Nicoletti’s preparative methods include
autoclaving and acid-alkali treatment steps (FF 13), we also find that
Nicoletti’s glucan meets claim 1’s requirements that the antigen be heat-
inactivated and hydrolyzed. Thus, as Appellants’ arguments do not persuade
us that Nicoletti fails to describe a vaccine having all of the features of claim
1, we affirm the Examiner’s rejection of that claim as anticipated by
Nicoletti.
Regarding claim 3, the principal issue is whether the Examiner
reasonably interpreted the term “fungal pathogen” as encompassing
Nicoletti’s yeast-derived (i.e. fungus-derived) glucan polysaccharide. While
it may be true that the Wikipedia definitions of “pathogen” advanced by
Appellants (App. Br. 13) only include disease-causing organisms as being
pathogens, claim terms must being given their broadest reasonable
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interpretation consistent with the Specification, and also consistent with an
ordinary artisan’s interpretation. In re Cortright, 165 F.3d at 1358.
In the instant case, the Specification does not specifically define
“pathogen,” whereas the Examiner has pointed to evidence, in the form of an
online medical dictionary (FF 10), supporting the proposition that an
ordinary artisan’s broadest reasonable interpretation of “pathogen” includes
disease-causing chemicals in addition to organisms (id.). As Appellants
point to no specific evidence suggesting that an ordinary artisan would have
rejected the MedicineNet.com definition, a preponderance of the evidence
supports the Examiner’s position that the broadest reasonable interpretation
of the term “fungal pathogen” encompasses a fungus-derived chemical, or
portion of a fungus, that causes disease.
As the Examiner points out, Candida albicans beta-1,3-glucans of the
type disclosed by Nicoletti were described in the art as a “pathogenic factor
for arthritis” in a mouse model for autoimmune arthritis (Hida, abstract (FF
16)), and the glucans triggered autoimmune arthritis in those mice (FF 17).
Thus, because Nicoletti’s dried composition, prepared using heat treatment
(autoclave) and acid hydrolysis (FF 13), contains a fungus-derived chemical
described as a pathogenic factor for a disease (FF 16-17), we are not
persuaded that Nicoletti’s composition fails to anticipate claim 3. We
therefore affirm the Examiner’s rejection of claim 3 over Nicoletti.
ANTICIPATION -- JAMAS
ISSUE
Claims 1, 3, 5, 6, 8, 9, and 16 stand rejected under 35 U.S.C § 102(b)
as anticipated by Jamas (Ans. 7-8).
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Appellants contend that the Examiner erred in finding that Jamas
anticipates the rejected claims because Jamas discloses a glucan composition
that is explicitly described as “non-antigenic,” whereas claims 1 and 5,
respectively, require the composition to contain a fungal antigen, or a fungal
immunogen (App. Br. 15-16 (citing Jamas, col. 7, ll. 36-39)). Appellants
further contend that Jamas does not anticipate claim 3 because Jamas
discloses a β-glucan, which “is a component of S. cerevisiae, not a whole
pathogen” as claim 3 requires (id. at 16). Appellants also contend that the
Examiner failed to establish an adequate factual basis for concluding that
Jamas anticipates claims 9 and 16 (id. at 17).
In view of the positions advanced by Appellants and the Examiner,
the issue with respect to this rejection is whether the evidence of record
supports the Examiner’s finding that Jamas anticipates the rejected claims.
FINDINGS OF FACT
18. Jamas discloses “neutral, aqueous soluble β-glucans which exert
potent and specific immunological effects without stimulating the
production of certain cytokines” (Jamas, abstract).
19. More specifically, Jamas discloses that its glucan increases “the
number of neutrophils and monocytes as well as their direct infection
fighting activity (phagocytosis and microbial killing)” whereas it “does not
stimulate the production of biochemical mediators, such as IL-1 and TNF,
that can cause detrimental side effects such as high fever, inflammation,
wasting disease and organ failure” (id. at col. 4, ll. 49-54).
20. Jamas thus discloses that its preparative methods can produce a glucan
that is “is substantially free of protein contamination, is non-antigenic, non-
pyrogenic and is pharmaceutically acceptable for parenteral administration
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to animals and humans. However, if desired, the soluble glucan can be dried
by an appropriate drying method, such as lyophilization, and stored in dry
form” (id. at col. 7, ll. 36-41).
21. Jamas discloses that the “source of the whole glucan particles can be
the broad spectrum of glucan-containing yeast organisms which contain β-
glucans in their cell walls” (id. at col. 5, ll. 20-22).
22. Jamas discloses that its preparative process includes an initial
treatment of the glucans in an “acid solution having a pH of from about 1 to
about 5 and at a temperature of from about 20° to about 100° C.” followed
by separation from the solution, “for example, by centrifugation or filtration.
The pH of the resulting slurry is adjusted with an alkaline compound such as
sodium hydroxide, to a pH of about 7 to about 14. The precipitate is
collected by centrifugation and is boiled in purified water (e.g., USP) for
three hours” (id. at col. 5, l. 43, through col. 6, l. 4).
23. Jamas discloses that the route of administration “can be oral, enteral,
parenteral, intravenous, subcutaneous, intraperitoneal, intramuscular, topical
or intranasal. The form in which the composition will be administered (e.g.,
powder, tablet, capsule, solution, emulsion) will depend upon the route by
which it is administered” (id. at col. 8, ll. 22-27).
24. Jamas discloses that “a single dose will preferably contain
approximately 0.01 to approximately 10 mg of modified glucan per kilogram
of body weight, and preferably from about 0.1 to 2.5 mg/kg” (id. at col. 8, ll.
33-36).
25. Jamas discloses that the yeast-derived glucans of its invention “are
composed of glucose monomers organized as a β(1-3) linked glucopyranose
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backbone with periodic branching via β(1-6) glycosidic linkages” (id. at col.
4, ll. 63-66).
26. Jamas discloses that the “functional activities of yeast β-glucan are
also comparable to those structurally similar carbohydrate polymers isolated
from fungi and plants. These higher molecular weight (1-3)-β-D-glucans
such as schizophyllan, lentinan, krestin, grifolan, and pachyman exhibit
similar immunomodulatory activities” (id. at col. 1, ll. 40-45).
27. Edgington9 discloses that “the ascomycete Saccharomyces cerevisiae
exhibits alternative vegetative growth states referred to as the yeast form and
the filamentous form, and it switches between the two morphologies
depending on specific environmental signals” (Edgington, abstract).
28. The Wikipedia entry for mold10 states that molds include all species of
microscopic “fungi that grow in the form of multicellular filaments, called
hyphae. In contrast, microscopic fungi that grow as single cells are called
yeasts” (http://en.wikipedia.org/wiki/Filamentous_fungi (page 1)).
ANALYSIS
Appellants’ arguments do not persuade us that Jamas fails to
anticipate claims 1 and 5. We note Jamas’ statement that its glucans are
non-antigenic (FF 20). However, that disclosure seems to be directed to the
fact that, despite their potent immunostimulatory activity, Jamas’ glucans do
not elicit negative inflammatory effects, such as fever (see FF 18, 19).

9 N.P. Edgington et al., Control of Saccharomyces cerevisiae filamentous
growth by cyclin-dependent kinase Cdc28, 19 MOL. CELL BIOL. 1369-80
(1999) (PubMed abstract only).
10 http://en.wikipedia.org/wiki/Filamentous_fungi
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Moreover, given that Appellants’ Specification explicitly includes
fungal polysaccharides such as schizophyllan within the definition of antigen
(FF 8), and given Jamas’ disclosure that its yeast glucans are fungal
polysaccharides similar in structure and function to schizophyllan (FF 25,
26), a preponderance of the evidence supports the position that Appellants
are using the term “antigen” in a different way than Jamas uses the term
“antigenic.”
Accordingly, because Appellants’ Specification identifies fungal
polysaccharides as antigens, we agree with the Examiner that Jamas’
yeast/fungus-derived glucans fall within that definition, despite the comment
in Jamas referred to by Appellants. Moreover, given that Jamas’ preparative
methods include heating and acid-alkali treatment steps (FF 22), we also
find that Jamas’ glucan meets the requirements in claims 1 and 5 that the
antigen/immunogen is heat-inactivated and hydrolyzed, respectively.
Thus, as Appellants’ arguments do not persuade us that Jamas fails to
describe a vaccine having all of the features of claims 1 and 5, we affirm the
Examiner’s anticipation rejection of those claims over Jamas. As Appellants
pointed to no specific deficiency in the Examiner’s rejection of claims 6 and
8, and we detect none, those claims fall with claim 5, from which they
depend. See 37 C.F.R. § 41.37(c)(1)(vii).
Regarding claim 3, as noted above, the evidence of record supports
the Examiner’s position that the broadest reasonable interpretation of the
term “fungal pathogen” encompasses a fungus-derived chemical, or portion
of a fungus, that causes disease. As also noted above, β-1,3-glucans of the
type described in Jamas (FF 25, 26) were known to trigger autoimmune
arthritis in mice (FF 16-17).
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Thus, because Jamas’ dried composition (FF 20, 23), prepared using
heat treatment and acid hydrolysis (FF 22), contains a fungus-derived
chemical with a β-1,3-glucan structure known to trigger a disease (FF 16-
17), we are not persuaded that Jamas’ composition fails to anticipate claim
3. We therefore affirm the Examiner’s rejection of claim 3 over Jamas.
We agree with Appellants, however, that Jamas does not anticipate
claim 9, which recites “[t]he immunogen of claim 5 wherein the immunogen
comprised in said pill is between about 0.0000001% to about 20% by
weight.” Specifically, the Examiner finds that the dosage disclosed by
Jamas overlaps the concentration recited in claim 9.
We are not persuaded. Claim 9 limits the oral pill of claim 5 to one
that contains up to 20% of the immunogen. While Jamas discloses a suitable
range of dosages for its glucan (FF 24), the Examiner does not point to, and
we do not see, any disclosure in Jamas describing a dosage form containing
20% or less by weight of the glucan. We therefore reverse the Examiner’s
anticipation rejection of claim 9 over Jamas.
We also reverse the Examiner’s rejection over Jamas of claim 16,
which recites “[t]he immunogen of claim 5 wherein the fungal immunogen
is a filamentous fungal antigen.” It may be true, as the Examiner argues,
that S. cerevisiae has a filamentous form that can be induced by the
appropriate environmental signal (FF 27).
However, as Appellants point out, yeasts are generally not classified
as filamentous fungi (FF 28), and the Examiner has not provided any clear
evidence suggesting that the filamentous form occasionally taken by S.
cerevisiae would cause an ordinary artisan to classify that yeast as a
filamentous fungus. Because a preponderance of the evidence supports
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Appellants’ position, we reverse the Examiner’s anticipation rejection of
claim 16 over Jamas.
ANTICIPATION -- OTERO
ISSUE
Claims 1, 3, 5, 6, 8, 9, and 17 stand rejected under 35 U.S.C § 102(b)
as anticipated by Otero (Ans. 8-10).
Appellants contend that Otero does not anticipate claims 1 and 3
because Otero describes an imitation soy sauce rather than a composition for
inducing immunity (App. Br. 19). Appellants argue that while Otero uses
hydrolysates of the yeast Candida utilis in the soy sauce, the sauce is
susceptible to degradation in the stomach, whereas “the instant invention is
designed to prevent degradation of antigens in the mouth and stomach” (id.).
Thus, Appellants argue, “the vaccine of claim 1 has the property that it
prevents or treats fungal disease. The dry composition of claim 3 has the
property that it induces immunity to a fungal pathogen. For at least this
reason, Otero is misapplied as a reference” (id.).
Appellants further argue that Otero’s sauce is, by definition, not dry,
and that Otero therefore fails to anticipate claims 1 and 3, as well as claims
5, 6, 8, 9, and 17 (id. at 19-20). While Appellants do concede that Otero’s
introductory remarks disclose a dried yeast starting material, Appellants urge
that “it refers to the starting material yeast, not to the imitation soy sauce
which is the [hydrolyzed] product of the article” (id. at 20).
Appellants thus argue this rejection in two groups, the first group
consisting of claims 1 and 3, and the second group consisting of claims 5, 6,
8, 9, and 17. We select claim 1 as representative of the first group and claim
5 as representative of the second group. See 37 C.F.R. § 41.37(c)(1)(vii).
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19

In view of the positions advanced by Appellants and the Examiner,
the issue with respect to this rejection is whether the evidence of record
supports the Examiner’s finding that Otero anticipates claims 1 and 5.
FINDINGS OF FACT
29. Otero prepared an imitation soy sauce by hydrolyzing a dried
preparation of the yeast Candida utilis in hydrochloric acid (Otero 419, 421).
30. After acid hydrolysis, the preparation was assessed for dry matter
content “by dessication [sic] at 105C overnight” (id. at 421).
PRINCIPLES OF LAW
Regarding anticipation rejections, “when the PTO shows sound basis
for believing that the products of the applicant and the prior art are the same,
the applicant has the burden of showing that they are not.” In re Spada, 911
F.2d 705, 708 (Fed. Cir. 1990).
ANALYSIS
Appellants’ arguments do not persuade us that Otero fails to anticipate
either claim 1 or claim 5.
We acknowledge that Otero’s ultimate product is a sauce, which is not
a dried product (FF 29). However, Otero also discloses a desiccated product
prepared by subjecting the acid-hydrolyzed yeast preparation to overnight
treatment at 105 degrees Celsius (FF 30). Thus, as claim 1 requires, Otero
describes an acid-hydrolyzed, dried, heat-treated product obtained from a
fungal culture.
We note that Otero does not disclose that its dried product is capable
of eliciting a protective immune response as claim 1 requires. However,
because the prior art product is made by a process having the claimed steps,
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from the claimed starting material, a sound basis exists to believe that
Otero’s dried product and the claimed dried product are the same, and
Appellants therefore bear the burden of demonstrating a difference between
the two products. In re Spada, 911 F.2d at 708.
In the instant case Appellants have provided no evidence showing that
Otero’s dried product is different than the product recited in claim 1, or lacks
the required functional properties. It might be true that Otero’s sauce is
digested in the digestive tract. Claim 1 does not, however, contain any
limitation excluding such a product.
In sum, because Otero’s dried product is made by a process having the
steps recited in claim 1, from a starting material encompassed by claim 1, a
sound basis exists to believe that Otero’s dried product and the claimed dried
product are the same. Because Appellants have not shown any difference
between the two products, we affirm the Examiner’s rejection of claim 1, as
well as claim 3, which was argued in the same group. See 37 C.F.R.
§ 41.37(c)(1)(vii).
Regarding claim 5, Appellants argue only that “Otero does not
disclose a dry fungal immunogen. Rather, Otero discloses a dry yeast as a
starting material for an industrial process of making imitation soy sauce, but
the yeast is processed in liquids, such as hydrochloric acid” (App. Br. 20
(citing Otero at 422)).
We are not persuaded. As noted above, Otero discloses a dried
product made by treating the acid-hydrolyzed yeast culture at 105 degrees C
overnight (FF 30).
Thus, as Appellants’ arguments do not persuade us that the
Examiner’s anticipation rejection of claim 5 lacks support in the evidence of
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record, we affirm the Examiner’s rejection of that claim over Otero, as well
as claims 6, 8, 9, and 17, which were argued in the same group. See 37
C.F.R. § 41.37(c)(1)(vii).
SUMMARY
We affirm the Examiner’s rejection of claims 10 and 18 under 35
U.S.C § 102(b) as anticipated by Hagiwara.
We also affirm the Examiner’s rejection of claims 1 and 3 as
anticipated by Nicoletti.
We also affirm the Examiner’s anticipation rejection of claims 1, 3, 5,
6, and 8 over Jamas.
However, we reverse the Examiner’s anticipation rejection of claims 9
and 16 over Jamas.
Finally, we affirm the Examiner’s anticipation rejection of claims 1, 3,
5, 6, 8, 9, and 17 over Otero.

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

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