Ex parte Furman et al.

Board of Patent Appeals and Interferences

Apr 16, 1999

08054548 (B.P.A.I. Apr. 16, 1999)

Application for patent filed April 27, 1993. According to Appellants, this application is a divisional1
of application 07/846,367, filed March 5, 1992, now U.S. Patent 5,234,913, issued August 10, 1993.
1
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today (1) was not written for
publication in a law journal and (2) is not binding precedent of the Board.
Paper No. 15
UNITED STATES PATENT AND TRADEMARK OFFICE
_____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
_____________
Ex parte PHILLIP A. FURMAN, JR. and GEORGE R. PAINTER, III
_____________
Appeal No. 96-0965
Application 08/054,5481
______________
ON BRIEF
_______________
Before WINTERS, WILLIAM F. SMITH and ROBINSON, Administrative Patent Judges
WINTERS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal was taken from the examiner's decision rejecting claim 8, which is the
only claim pending in the application.
Appeal No. 96-0965
Application 08/054,548
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THE APPEALED CLAIM
The appealed claim reads as follows:
8. A method for inhibiting the replication of the human immunodeficiency
virus which comprises administering to cells containing said virus a first
compound CIS-1-(2-(hydroxymethyl-1,3-oxothiolin-5-yl)-6-fluorocytosine or a
pharmaceutically acceptable salt thereof and a second compound 3'-azido-
3'-deoxythymidine, the first and second compounds being present in an
amount to provide a synergistic combination.
PROCEDURE
The examiner's presentation of this appeal represents somewhat of a procedural
quagmire. In the first place, page 2 of the Examiner's Answer is missing from the record.
Secondly, page 3 of the Answer is internally inconsistent. In section (7), the examiner
expressly states that no prior art references are relied on in rejecting the claim under
appeal. Nevertheless, in section (8), the examiner states that "[t]he following references
are provided in support of the Examiner's position regarding the rejection under 35 U.S.C.
§ 112, first paragraph." The examiner cites these references: Hitchcock, "In Vitro Antiviral
Activity of Didanosine Compared with That of Other Dideoxynucleoside Analogs Against
Laboratory Strains and Clinical Isolates of Human Immunodeficiency Virus", Clinical
Infectious Diseases, vol. 16(Suppl. 1) pgs. S16-S21, published 1993 by the University of
Chicago; Gallicchio et al. ( Gallicchio), "Increased
Appeal No. 96-0965
Application 08/054,548
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Hematopoietic Toxicity Following Administration of Interferon - å With Combination
Dideoxynucleoside Therapy (Zidovudine Plus DDI) Administered in Normal Mice", Life
Sciences, vol. 56 no. 3, pgs. PL71-81 (1995); and "Virus sidesteps convergent therapy",
Treat. Issues, vol. 9, no 1, pg. 6 (Jan. 1995). This is confusing, because it is unclear
whether the examiner is, or is not, relying on prior art references to establish that the
appealed claim is unpatentable.
Adding to the confusion, section (9) of the Examiner's Answer is entitled "Grounds
of rejection", but no grounds of rejection are set froth therein. There, the examiner objects
to the specification under 35 U.S.C. § 112, first paragraph, "as failing to provide an
enabling disclosure for the scope of the invention as claimed". The reasons for this
objection are set forth in the Answer, page 4, first full paragraph. According to the
examiner, Appellants' specification describes the use of both compounds recited in claim
8, in combination, to achieve a synergistic effect in inhibiting HIV in cells in vitro. The
examiner argues, however, that claim 8 is not limited to in vitro use, and that predicting
synergistic efficacy in vivo from Appellants' in vitro results would not have been accepted
by any person skilled in the art. Later, in section (11) of the Examiner's Answer, entitled
"Response to argument", the examiner states
Appeal No. 96-0965
Application 08/054,548
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that "[c]laim 8 is rejected under 35 U.S.C. § 112, first paragraph, for the reasons set
forth in the objection to the specification (emphasis added)." See page 8, second full
paragraph, of the Examiner's Answer.
The Hitchcock , Gallicchio , and "Virus sidesteps convergent therapy" references,
cited above, are not positively included in the statement of the examiner's rejection. As
stated in In re Hoch 428 F.2d 1341, 1342 n.3, 166 USPQ 406, 407, n.3 (CCPA 1970),
Where a reference is relied on to support a rejection, whether or not in a
"minor capacity," there would appear to be no excuse for not positively
including the reference in the statement of the rejection.
Where, as here, the Hitchcock, Gallicchio, and "Virus sidesteps convergent therapy"
references are not included in the statement of rejection under 35 U.S.C. § 112, first
paragraph, and where the examiner expressly states that no prior art references are relied
on in setting forth the rejection, we shall not consider these references further.
In the Final Rejection (paper no. 8), page 2, the examiner rejected claim 8 under 35
U.S.C. § 101 "because the claimed invention has no demonstrated utility for use in vivo."
According to the examiner, the specification teaches that combinations of the compounds
recited in claim 8 have been tested for anti-HIV activity in vitro. The
examiner argued, however, that the claim is not limited to providing a synergistic effect in
Appeal No. 96-0965
Application 08/054,548
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vitro, and that the specification's in vitro results are not correlative or predictive of a
synergistic effect in vivo. However, the examiner does not repeat or refer to the
rejection under 35 U.S.C. § 101 in the Examiner's Answer. The only plausible
interpretation which these facts permit is that the rejection under 35 U.S.C. § 101 has been
dropped. See Paperless Accounting, Inc. v. Bay Area Rapid Transit System, 804 Fd.2d
659, 663, 231 USPQ 649, 652 (Fed. Cir. 1986). The sole issue on appeal is whether the
examiner erred in rejecting claim 8 under 35 U.S.C. § 112, first paragraph, as based on a
non-enabling disclosure.
THE MERITS
The first paragraph of 35 U.S.C. § 112 states that
The specification shall contain a written description of the invention, and of
the manner and process of making and using it, in such full, clear, concise
and exact terms as to enable any person skilled in the art to which it pertains,
or with which it is most nearly connected, to make and use the same, and
shall set forth the best mode contemplated by the inventor of carrying out his
invention (emphasis added).
This provision calls into play the "how-to-make" and "how-to-use" requirements of the
statute. In our judgment, Appellants' specification is replete with information teaching
persons skilled in the art how to make and how to use the claimed invention.
The specification teaches that the first and second compounds recited in claim 8
Appeal No. 96-0965
Application 08/054,548
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may be administered simultaneously or sequentially (page 6, second paragraph;
paragraph bridging pages 6 and 7). In the specification, Appellants teach the optimum
molar ratios of the compounds recited in claim 8 (page 7, second full paragraph).
Appellants also describe suitable dose ranges of the claimed combination (paragraph
bridging pages 7 and 8); suitable modes of administration (page 7, lines 3 through 7; page
8, first full paragraph); and suitable pharmaceutical formulations (page 8, first full
paragraph through page 10, fourth paragraph). In the specification, paragraph bridging
pages 10 and 11, Appellants teach the preparation of zidovudine. Appellants also
describe alternative methods for preparing the other compound recited in claim 8 (pages
11 through 14). Further, Appellants provide detailed information respecting tablet
formulations, capsule formulations, injectable formulations, and intramuscular injection
formulation, a syrup, a suppository, and pessaries (pages 16 through 22). Example 8 in
the specification (page 23) is a working example describing the preparation of 1-(2-
(hydroxymethyl)-1,3-oxathiolan-5-yl)-5-fluorocytosine. Finally, Appellants set forth a
working example describing the in vitro synergistic effect of the compounds recited in
claim 8. (pages 24 and 25).
All in all, we believe that the specification imparts ample information to persons
Appeal No. 96-0965
Application 08/054,548
As previously indicated, the Final Rejection included separate rejections of claim 8 under 352
U.S.C. § 101 and 35 U.S.C. § 112, first paragraph. Both rejections were based on essentially the same
reasoning. In the Examiner's Answer, the examiner dropped the rejection under 35 U.S.C. § 101 and
carried forward the rejection under 35 U.S.C. § 112, first paragraph.
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skilled in the art, enabling them to make and use the claimed invention. Nor does the
examiner directly attack the specification on how-to-make and/or how-to-use
grounds. Rather, it appears that the position espoused by the examiner under 35 U.S.C. §
112, first paragraph, is the very same position dropped under 35 U.S.C. § 101. According
to the examiner, Appellants' specification describes using the claimed composition for
inhibiting HIV cells in vitro; but in vitro data is not predictive of a synergistic effect in vivo.
In other words, the examiner would "backdoor" a rejection of claim 8 under 35 U.S.C. §
101 couched in terms of 35 U.S.C. § 112, first paragraph. 2
The record reflects that (1) the combination of first and second compounds, recited
in claim 8, provides a synergistic effect when tested for anti-HIV activity in vitro
(specification, pages 24 and 25); (2) zidovudine (AZT) is a commercially available
product, known for treating HIV in vivo in humans; (3) the other compound of claim 8 is also
disclosed for use in treating HIV in vivo (U.S. Patent No. 5,210,085, issued May 11, 1993
to Liotta et al.); and (4) parent application Serial No. 07/846,367 issued as
U.S. Patent No. 5,234,913 on August 10, 1993, claiming a pharmaceutical composition
Appeal No. 96-0965
Application 08/054,548
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containing Appellants' first and second compounds and supported by the same
specification which here supports claim 8. In view of the foregoing, we disagree with
the examiner that Appellants' in vitro data is not predictive of a synergistic effect in vivo
for the combination of first and second compounds recited in claim 8.
The rejection of claim 8 under 35 U.S.C. § 112, first paragraph is reversed.
REVERSED
SHERMAN D. WINTERS )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
WILLIAM F. SMITH ) APPEALS AND
Administrative Patent Judge ) INTERFERENCES
)
)
)
DOUGLAS W. ROBINSON )
Administrative Patent Judge )
vsh
Appeal No. 96-0965
Application 08/054,548
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David J. Levy
Global Intellectual Property Dept.
Glaxo Wellcome Inc.
Five Moore Drive
P.O. Box 13398
Research Triangle Park, NC 27709-3398