Ex Parte Thanavala

Board of Patent Appeals and Interferences

Jan 12, 2009

09464414 (B.P.A.I. Jan. 12, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte YASMIN THANAVALA
__________

Appeal 2008-4835
Application 09/464,414
Technology Center 1600
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Decided: January 12, 2009
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Before DONALD E. ADAMS, ERIC GRIMES, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to providing
a secondary boosting immune response. The Examiner has rejected the
claims as nonenabled. We have jurisdiction under 35 U.S.C. § 6(b). We
reverse.
Appeal 2008-4835
Application 09/464,414

STATEMENT OF THE CASE
“Pathogenic microorganisms . . . that do not raise a protective enteric
immune response in mammals” are referred to as non-enteric pathogens
(Spec. 1). “‘Non-enteric pathogen antigen’ (NEPA) means an antigen that
will parenterally raise an immune response to a non-enteric pathogen” (id. at
5).
Claims 1-3, 7, 9, 10, and 13 are pending and on appeal. We will focus
on claim 1, the broadest claim on appeal, which reads as follows:
1. A method for providing a secondary boosting immune response
in a mammal to a specific antigen of a non-enteric pathogen (NEPA), the
pathogen being a pathogen that invades through a breach in the skin and that
does not itself enterically raise a primary protective immune response in
mammals in the absence of prior acquired immunity to the pathogen, said
method comprising:
rendering the mammal immunoreceptive to the NEPA by prior
immunization against a non-enteric pathogen containing the NEPA by
vaccination by injection; and
then orally administering the NEPA to the immunoreceptive mammal
by feeding the mammal with transgenic potato containing the NEPA
expressed in the potato to enterically cause a secondary immune response to
the oral administration specific to the NEPA stronger than would be caused
by orally administering the NEPA in the absence of the prior immunization
by injection.
Claims 1-3, 7, 9, 10, and 13 stand rejected under 35 U.S.C. § 112, first
paragraph, “because the specification, while being enabling . . . wherein the
NEPA is hepatitis B surface antigen (HBsAg) . . . , does not reasonably
provide enablement for providing a secondary boosting immune response in
a mammal to any and all NEPAs” (Ans. 4). In particular, the Examiner
finds:
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Application 09/464,414

The specification broadly discloses non-enteric pathogens that
invade the epidermis of mammals via punctures, abrasions, cuts
or other breaches in the skin, e.g., blood transfusions which can
be used as sources of NEPA to raise a protective enteric
immune response in mammals. However, the specification
does not provide sufficient guidance as to how one of ordinary
skill in the art would provide an immune response in a mammal
and/or a human to a NEPA other than the non-enteric pathogen
antigen, hepatitis B surface antigen.
(Id. at 5.)
The Examiner “concedes that one skilled in the art at the time the
invention was made would have known how to make and/or use a plant to
express a viral immunogen (antigen) for the oral administration thereof to
elicit an immunogenic response” (id. at 8). However, the Examiner finds
that Appellant “has not provided sufficient guidance as to how one . . .
would render a mammal immunoreceptive to an antigen of any and all non-
enteric pathogens” (id. at 9).
In particular, the Examiner finds that “the art[s] of virology,
microbiology, and immunology are highly unpredictable” (id. at 10). The
Examiner also finds that “effective immunization treatments for providing
immunological responses in mammals, much less humans, to the disclosed
non-enteric pathogens are moderately rare, controvertible, and in some
instances unsafe; and, therefore, may be unbelievable in the absence of
supporting evidence” (id. at 10-11). In addition, the Examiner finds that
“the state of the art at the time of filing suggests that the functional effect for
rendering a mammal immunoreceptive to any and all NEPAs by prior
immunization via vaccination by injection . . . was atypical or not available”
(id. at 11).
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Appeal 2008-4835
Application 09/464,414

As evidence that the claims are nonenabled, the Examiner refers to the
following references:
Simona Bratu & Larry I. Lutwick, Active immunisation against
human tick-borne diseases, 2 EXPERT. OPIN. BIOL. THER. 187-195 (2002)
(hereinafter “Bratu”);
Richard W. Titball & E. Diane Williamson, Vaccination against
bubonic and pneumonic plague, 19 VACCINE 4175-4184 (2001) (hereinafter
“Titball”);
John R. Stephenson, Genetically Modified Viruses: Vaccines by
Design, 2 CURRENT PHARMACEUTICAL BIOTECHNOLOGY 47-76 (2001)
(hereinafter “Stephenson”); and
Patrizia Farci et al., Lack of Protective Immunity Against Reinfection
with Hepatitis C Virus, 258 SCIENCE 135-140 (1992) (hereinafter “Farci”).
Appellant contends that it “is true that a number of diseases may not
have vaccines with FDA or WHO approval, but it is not true that vaccines do
not exist” (Reply Br. 1-2). Appellant notes that the issue of FDA or WHO
approval “is not the same as whether vaccines can be made by those skilled
in the art against the above diseases” (id. at 2).
ISSUE
Has the Examiner set forth a prima facie case that the Specification
does not enable rendering a mammal immunoreceptive to the claimed NEPA
by prior immunization against a non-enteric pathogen containing the NEPA
by vaccination by injection?
FINDINGS OF FACT
1. The Specification states that “[e]xamples of diseases caused by
non-enteric pathogens are: hepatitis B, hepatitis C, hepatitis delta, yellow
fever, Lassa fever, dengue hemoragic [sic] fever, rabies, tetanus,
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staphylococcus aureous [sic] infections, yaws, relapsing fever, rat bite fever,
bubonic plague, typhoid fever and spotted fever” (Spec. 1).
2. The Specification states that “an immune response to non-
enteric pathogen antigens, e.g., hepatitis B surface antigen ( HBsAg ) may
be obtained when the antigen in a plant material is fed to the animal when
the animal is immunoreceptive to the HBsAg” (id. at 4).
3. The Specification also states that the animal may “be
immunoreceptive due to a prior , e.g. primary, immunization” (id.).
4. In particular, the Specification states that “an animal, e.g. a
human, that previously had a positive response to primary immunization
against hepatitis B, can have a booster response to HBsAg by feeding the
animal the antigen in a plant material” (id.).
5. The Specification also discloses that the primary immunization
may be administered by “parental [sic, parenteral] injection” (id. at 6).
6. Bratu states that “[c]urrently there is no licensed vaccine
available for protection against R. rickettsii,” the causative organism for
Rocky Mountain spotted fever (Bratu 191).
7. Bratu also states:
A formalin-killed, purified R. rickettsii vaccine was developed
from rickettsiae propagated in cell cultures. The vaccine
induces production of serum antibodies as well as a variable
degree of cell-mediated immune responses but studies in both
animals and human volunteers showed that it provides only
partial immunity with a vaccine efficacy reported of
approximately 25%.
(Id.)
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8. Titball states that “[b]oth live attenuated and killed whole cells
vaccines have been used in man [against plague]. . . . Although there is
circumstantial evidence for the efficacy of these vaccines, none have been
subjected to a controlled and randomised clinical trial.” (Titball 4177.)
9. In particular, Titball states that “immunisation with the EV76
[live attenuated] vaccine will provide protection against both bubonic and
pneumonic plague in man. However, the safety of this vaccine in man is
questionable, because the EV76 strain is not avirulent. In studies with mice,
a fatality rate of approximately 1% of [vaccines] has been reported.” (Id.)
Titball also states that “in most countries [the live attenuated vaccine] is not
considered to be suitable for use in humans” (id. at 4175).
10. In addition, Titball states that there “are no definitive clinical
trials which demonstrate the efficacy of killed whole cell vaccines. . . .
However, studies in several animal species have demonstrated protection
against bubonic plague,” although “findings suggest that killed whole cell
vaccines do not induce a response which provides protection against
pneumonic plague.” (Id. at 4177.)
11. Stephenson states that “there is still no commercially available
dengue vaccine” (Stephenson 49).
12. Stephenson also states that there is no commercially available
vaccine for hepatitis C (id. at 49: Table 2).
13. In addition, Stephenson lists several diseases for which there is
a commercially available vaccine. These diseases include hepatitis B,
rabies, and yellow fever. (Id. at 48: Table 1.) Hepatitis B, rabies, and
yellow fever are among the diseases listed in the Specification as
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“[e]xamples of diseases caused by non-enteric pathogens” (Finding of Fact
(FF) 1).
14. Farci states that “evidence indicates that HCV [hepatitis C
virus] infection does not elicit protective immunity against reinfection with
homologous or heterologous strains, which raises concerns for the
development of effective vaccines against HCV” (Farci 135: Abstract).
PRINCIPLES OF LAW
“[T]o be enabling, the specification of a patent must teach those
skilled in the art how to make and use the full scope of the claimed invention
without ‘undue experimentation.’” In re Wright, 999 F.2d 1557, 1561 (Fed.
Cir. 1993).
[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.
In re Marzocchi, 439 F.2d 220, 223 (CCPA 1971). In addition, “a patent
need not teach, and preferably omits, what is well known in the art.”
Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384 (Fed.
Cir. 1986).
“It is [also] well settled that patent applicants are not required to
disclose every species encompassed by their claims, even in an
unpredictable art.” In re Vaeck, 947 F.2d 488, 496 (Fed. Cir. 1991).
Even if some of the claimed combinations were inoperative, the
claims are not necessarily invalid. “It is not a function of the
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claims to specifically exclude . . . possible inoperative
substances. . . .” In re Dinh-Nguyen, 492 F.2d 856, 858-59 . . .
(CCPA 1974). . . . Of course, if the number of inoperative
combinations becomes significant, and in effect forces one of
ordinary skill in the art to experiment unduly in order to
practice the claimed invention, the claims might indeed be
invalid.
Atlas Powder Co. v. E.I. du Pont De Nemours & Co., 750 F.2d 1569, 1576
(Fed. Cir. 1984) (citations omitted). “[S]ufficient disclosure . . . to teach
those of ordinary skill how to make and how to use the invention . . . means
that the disclosure must adequately guide the art worker to determine,
without undue experimentation, which species among all those encompassed
by the claimed genus possess the disclosed utility.” Vaeck, supra.
“[T]he PTO bears an initial burden of setting forth a reasonable
explanation as to why it believes that the scope of protection provided by
that claim is not adequately enabled by the description of the invention
provided in the specification of the application.” Wright, 999 F.2d at 1561-
62. “[T]his includes, of course, providing sufficient reasons for doubting
any assertions in the specification as to the scope of enablement. If the PTO
meets this burden, the burden then shifts to the applicant to provide suitable
proofs indicating that the specification is indeed enabling.” Id. at 1562.
ANALYSIS
The Examiner provides evidence that there are no commercially
available vaccines for some of the diseases indicated in the Specification to
be caused by non-enteric pathogens (FF 6, 9, 11, & 12). However, we agree
with Appellant that evidence that commercially available vaccines are not
available is not evidence that one of ordinary skill in the art would not have
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Application 09/464,414

known how to render mammals immunoreceptive to these NEPAs by prior
immunization against a non-enteric pathogen containing the NEPA by
vaccination by injection (Reply Br. 1-2).
The Examiner also provides evidence indicating that, for one disease
caused by a non-enteric pathogen, hepatitis C, the virus “does not elicit
protective immunity against reinfection with homologous or heterologous
strains, which raises concerns for the development of effective vaccines
against HCV” (FF 14). However, evidence of a possible inoperative
embodiment is not sufficient to render claim 1 nonenabled. “It is not a
function of the claims to specifically exclude . . . possible inoperative
substances.” In re Dinh-Nguyen, 492 F.2d 856, 858-59 (CCPA 1974).
CONCLUSION
The Examiner has not set forth a prima facie case that the
Specification does not enable rendering a mammal immunoreceptive to the
claimed NEPA by prior immunization against a non-enteric pathogen
containing the NEPA by vaccination by injection. We therefore reverse the
enablement rejection of claim 1 and of claims 2, 3, 7, 9, 10, and 13, which
depend from claim 1.

REVERSED

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