Ex Parte Okushin

Board of Patent Appeals and Interferences

Feb 12, 2003

09339239 (B.P.A.I. Feb. 12, 2003)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.
Paper No. 22
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte HIROAKI OKUSHIN
___________
Appeal No. 2002-1728
Application No. 09/339,239
__________
HEARD: January 21, 2003
__________
Before WINTERS, METZ, and ADAMS, Administrative Patent Judges.
WINTERS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal was taken from the examiner's decision rejecting claims 18 through
23 and 25, which are all of the claims remaining in the application.
The Invention
The present invention relates to a therapeutic agent for persistent disappearance
(persistent seronegative) of hepatitis B virus (HBV)-DNA in treating chronic hepatitis B.
More specifically, the invention relates to a method for treating hepatitis B comprising
administering a daily effective dose of
-interferon in a plurality of individual doses
Appeal No. 2002-1728
Application No. 09/339,239
Page 2
which total the daily effective dose.
Claim 18, which is illustrative of the subject matter on appeal, reads as follows:
18. A method for the persistent negation of HBV-DNA or for inducing the
seroconversion of HBe antigen to HBe antibody or for treating hepatitis B comprising
administering a daily effective dose of interferon
(IFN-
) in a plurality of individual
doses which total said daily effective dose.
The Prior Art References
In rejecting the appealed claims under 35 U.S.C. § 103(a), the examiner relies
on the following prior art references:
Eisenberg et al. (Eisenberg), "Preliminary Trial of Recombinant Fibroblast Interferon in
Chronic Hepatitis B Virus Infection," Antimicrobial Agents and Chemotherapy, Vol. 29,
No. 1, pp. 122-126 (1986)
Chiang et al. (Chiang), "Pharmacokinetics and Antiviral Activity of Recombinant Human
Interferon-
ser17 in African Green Monkeys," Journal of Interferon Research, Vol. 13,
pp. 111-120 (1993)
Krogsgaard et al. (Krogsgaard), "Relation Between Treatment Efficacy and Cumulative
Dose of Alpha Interferon in Chronic Hepatitis B," Journal of Hepatology, Vol. 25,
pp. 795-802 (1996)
Park et al. (Park), "Effects of Low Dose, Short Term Recombinant -Interferon Therapy
in Patients with Chronic Hepatitis B," Gastroenterology, Vol. 110, No. 4, p. A1290
(1996)
The Rejection
Claims 18 through 23 and 25 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Krogsgaard, Park, or Eisenberg, either of those "primary" references
considered in view of Chiang.
Deliberations
Our deliberations in this matter have included evaluation and review of the
Appeal No. 2002-1728
Application No. 09/339,239
Page 3
following materials: (1) the instant specification, including all of the claims on appeal;
(2) applicant's Appeal Brief (Paper No. 15) and the Reply Brief (Paper No. 18); (3) the
Examiner's Answer (Paper No. 16); and (4) the above-cited prior art references.
On consideration of the record, including the above-listed materials, we affirm
the examiner's decision rejecting claim 18. However, we reverse the examiner's
decision rejecting claims 19 through 23 and 25.
Discussion
In the Appeal Brief, applicant groups claims 18 and 19 together (Paper No. 15,
section VII. Grouping of Claims). Applicant argues that these claims patentably
distinguish over the combination of Eisenberg and Chiang in view of the following
limitation in dependent claim 19: "wherein the daily effective dose is administered in
two portions for four weeks." (Paper No. 15, page 19, first full paragraph). The
argument is flawed, however, and amounts to a non-sequitur with respect to the
patentability of claim 18 over the combined disclosures of Eisenberg and Chiang. This
follows because the above-quoted limitation in claim 19 does not appear in claim 18. In
other words, applicant's principal argument for the patentability of claim 18 over the
combined disclosures of Eisenberg and Chiang relies on a limitation not in claim 18.
Accordingly, the argument lacks merit.
Eisenberg discloses a method for treating hepatitis B by administering a daily
effective dose of "a new-genetically engineered product,"
ser interferon. Applicant does
not deny that Eisenberg discloses every feature of the subject matter sought to be
Appeal No. 2002-1728
Application No. 09/339,239
Page 4
patented in claim 18 except administration "in a plurality of individual doses which total
said daily effective dose." On this point, we agree with the examiner that it would have
been obvious to modify the method of Eisenberg, per the teachings of Chiang, by
administering
ser interferon "in a plurality of individual doses which total said daily
effective dose." More specifically, it would have been obvious to modify the method of
Eisenberg, per the teachings of Chiang, by administering
ser interferon twice daily. We
are persuaded that a person having ordinary skill, armed with the disclosure of Chiang,
would have found adequate reason, suggestion, or motivation to modify the method of
Eisenberg by administering
ser interferon twice daily; and would have arrived at the
method recited in claim 18. We conclude, therefore, that claim 18 would have been
prima facie obvious in view of the combined disclosures of Eisenberg and Chiang. On
this record, applicant has not presented objective evidence of non-obviousness serving
to rebut the prima facie case.
Applicant appears to acknowledge that a person having ordinary skill in the art
would have been motivated to administer Eisenberg's
ser interferon in twice daily
dosages, per the teachings of Chiang. See the Appeal Brief, Paper No. 15, page 19,
first full paragraph ("one of ordinary skill in the art combining the teachings of Eisenberg
et al. and Chiang et al. would only be motivated to administer the IFN-
ser of Eisenberg
et al. in twice daily dosages for a period of time not exceeding ten days"). Again,
applicant does not set forth any argument in the Appeal Brief, based on a limitation in
claim 18, which would serve to patentably distinguish that claim over the combined
disclosures of Eisenberg and Chiang.
The rejection of claim 18 under 35 U.S.C. § 103(a), to the extent predicated on
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Application No. 09/339,239
Page 5
the combined disclosures of Eisenberg and Chiang, is affirmed.
Claims 19 through 23 and 25, however, stand on different footing.
Claim 19 depends from claim 18 and adds the further limitation "wherein the
daily effective dose is administered in two portions for four weeks." Claim 20 also
depends from claim 18 and adds the limitation "wherein the daily effective dosage of
IFN-
is administered in a plurality of individual doses per day for a predetermined
number of days, and subsequently administered in one portion per day." In our
judgment, the cited prior art is insufficient to support a conclusion of obviousness of
claims containing those limitations. On this record, the examiner has not established
that the combination of Chiang with either Krogsgaard, Park, or Eisenberg would have
led a person having ordinary skill to the specific methods recited in claims 19 and 20.
As indicated, those claims require a specific regimen or protocol for treating hepatitis B.
Claims 21 and 22 depend from claim 19 and add further limitations. Likewise,
claims 23 and 25 depend from "any one of claims 20 to 22," or 23, respectively, and
also add further limitations. Again, the examiner has not established that the
combination of Chiang with either Krogsgaard, Park, or Eisenberg would have led a
person having ordinary skill to the specific methods recited in claims 21 through 23 and
25.
The rejection of claims 19 thorugh 23 and 25 under 35 U.S.C. § 103(a) as
unpatentable over Krogsgaard, Park, or Eisenberg, either of those "primary" references
considered in view of Chiang, is reversed.
Accordingly, the examiner's decision is affirmed-in-part.
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Application No. 09/339,239
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No time period for taking any subsequent action in connection with this appeal
may be extended under 37 CFR § 1.136(a).
AFFIRMED-IN-PART
)
Sherman D. Winters )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Andrew H. Metz )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
Donald E. Adams )
Administrative Patent Judge )
Appeal No. 2002-1728
Application No. 09/339,239
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