Ex parte Young et al.

Board of Patent Appeals and Interferences

Sep 21, 1999

07661370 (B.P.A.I. Sep. 21, 1999)

Application for patent filed February 28, 1991.1
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(2) is not binding precedent of the Board.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. 29
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte ELI YOUNG, DEBORAH DAVIS,
JAMES STOREY and GERALD BELTZ
__________
Appeal No. 1995-1933
Application 07/661,3701
__________
ON BRIEF
__________
Before WILLIAM F. SMITH, ELLIS and LORIN, Administrative Patent Judges.
ELLIS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 USC § 134 from the final rejection of claims 2 through 5,
7 through 10, 22 through 28, 54 and 57. Claims 11 through 19, 21, 29 through 53 and 55
have been withdrawn from consideration by the examiner pursuant
Appeal No. 1995-1993
Application 07/661,370
Throughout prosecution the examiner has relied on his own personal translation of2
this reference, but has never obtained a certified translation. Had he done so, the
examiner would have discovered that Kieny has a U.S. patent on the subject matter which
was originally published as WO 87/06260. In our decision, we have relied on the
disclosure of U.S. patent 5,169,763. [Copy attached.]
2
to 37 CFR § 1.142(b). Claims 1, 6, 20 and 56 have been canceled. Claims 2 and 5 are
representative of the subject matter on appeal and read as follows:
2. A substantially pure recombinant FIV 0.4 envelope protein obtained from
cells infected with FIV.
5. A plasmid comprising a DNA sequence coding for a FIV 0.4 envelope
protein.
The references relied on by the examiner are:
Pedersen et al. (Pedersen)5,037,753 Aug. 06, 1991
(effective filing date Aug. 26, 1987)

Watanabe et al. (Watanabe) 4,784, 941 Nov. 15, 1988
O’Connor et al. (O’Connor)0,351,248 Jan. 17, 1990
Kieny et al. (Kieny) WO 87/06260 Oct. 22, 19872
Talbott et al. (Talbott), “Nucleotide Sequence and Genomic Organization of Feline
Immunodeficiency Virus, Proceedings of the National Academy of Sciences, USA,
Vol. 86, pp. 5743-5743 (1989).
Starcich et al. (Starcich), “Identification and Characterization of Conserved and Variable
Regions in the Envelope Gene of HTLV-III/LAV, the Retrovirus of AIDS,” Cell, Vol. 45, pp.
637-48 (1986).
Pauletti et al. (Pauletti), “Application of a Modified Computer Algorithm in Determining
Potential Antigenic Determinants Associated with the AIDS Virus Glycoprotein,”
Analytical Biochemistry, Vol. 151, pp. 540-546 (1985).
Appeal No. 1995-1993
Application 07/661,370
3
Modrow et al. (Modrow), “Computer-Assisted Analysis of Envelope Protein Sequences of
Seven Human Immunodeficiency Virus Isolates: Prediction of Antigenic Epitopes in
Conserved and Variable Regions,” Journal of Virology, Vol. 61, pp. 570-578 (1987).
Colasanti et al. (Colasanti), “The Escherichia coli rep Mutation. X. Consequences of
Increased and Decreased Rep Protein Levels, Molecular and General Genetics, Vol.
209, pp. 382-90 (1987).
The references relied on by the appellants are:
Olmsted et al. (Olmsted I), “Molecular Cloning of Feline Immunodeficiency Virus,”
Proceedings of the National Academy of Sciences, USA, Vol. 86, pp. 2448-2458
(1989).
Olmsted et al. (Olmsted II), “Nucleotide Sequence Analysis of Feline Immunodeficiency
Virus: Genome Organization and Relationship to Other Lentiviruses,”
Proceedings of the National Academy of Sciences, USA, Vol. 86, pp. 8088-92
(1989).
The claims stand rejected as follows:
Claims 2 through 5, 7 through 10, 22 through 28 and 57 stand rejected under
35 USC § 103 as being unpatentable over Talbott, Pedersen and Kieny in view of
Starcich, Pauletti, Modrow, Watanabe and Colasanti.
Claim 54 stands rejected under 35 USC § 103 as being unpatentable over Talbott,
Pedersen, Kieny, Starcich, Pauletti, Modrow, Watanabe and Colasanti in view of
O’Connor.
We have carefully considered the entire record which includes, inter alia, the
specification, the appellants’ brief (Paper No. 27), the examiner’s Answer (Paper No. 28),
and the declaration of Dr. Young (Paper No. 17), and we find ourselves in substantial
Appeal No. 1995-1993
Application 07/661,370
According to the specification, FIV is a member of the family Retroviridae which3
includes human and simian immunodeficiency viruses. Specification, p. 1, lines 24-29.
4
agreement with the appellants’ position. Accordingly, we reverse both rejections.
The present invention is directed to the 0.4 kb envelope protein of feline
immunodeficiency virus (FIV), a plasmid which comprises a DNA sequence encoding3
said protein, an eukaryotic host cell transformed with said plasmid, a method of producing
said protein, a process for making a pharmaceutical composition comprising the amino
acid sequence of said protein and a pharmacologically acceptable carrier, a
pharmaceutical composition comprising said protein, the use of said pharmaceutical
composition for immunizing a cat against FIV, and a kit for detecting FIV antibodies in a
biological sample.
Rejection I
The examiner has premised his conclusion of obviousness on the teachings of
Talbott, Pedersen, and Kieny in view of Starcich, Pauletti, Modrow, Watanabe and
Colasanti. As we understand it, the examiner is proposing two theories by which he
believes the claimed subject matter would have been obvious to one of ordinary skill in the
art. Theory I is primarily based on the combined teachings of Talbott, Pedersen and Kieny
and, Theory II, on the combination of Talbott, Starcich, Pauletti and Modrow. Both theories
hinge on the examiner’s finding that the FIV 0.4 envelope protein and the
Appeal No. 1995-1993
Application 07/661,370
5
HIV gp40 envelope protein are “equivalent” or “strikingly similar.” Answer, pp. 6 and 11.
Turning first to the references used to support Theory I, we find that Talbott teaches
the entire nucleotide sequence (9472 base pairs) and genomic organization of the
Petaluma strain of FIV. Pedersen discloses compositions comprising whole FIV, or
portions thereof. Pedersen further discloses that “Portions of the FTLV [FIV] of particular
interest include the structural and regulatory proteins encoded by the FTLV genome
including the envelope and core proteins, and fragments thereof.” Pedersen, col. 4, lines
24-27. Kieny discloses that the envelope protein of human immunodeficiency virus (HIV,
a.k.a., LAV or HTLV-III) is a promising candidate for developing a vaccine strategy. Kieny,
col. 1, lines 58-61. In Example 17, the portion of the patent relied on by the examiner,
Kieny states that “it may be useful to generate a recombinant vaccinia virus which
expresses the [human] gp40 alone” [emphasis added]. Kieny, col. 17, line 67- col. 18, line
2.
With respect to Theory I the examiner concludes that the DNA sequence encoding
the entire FIV envelope protein, or any fragments thereof, would have been obvious to one
of ordinary skill in the art in view of the combined teachings of Talbott, Pedersen and Kieny
because the claimed sequence is “equivalent to the HIV env polypeptide fragments taught
by Kieny et al., including the carboxyl-proximal gp40, produced by Kieny et al. for vaccine
production, ... [and] ... because Pedersen et al. (‘753) specifically teach that such products
are immunogenic and useful for preparing vaccines... and because Talbott et al. indicate
Appeal No. 1995-1993
Application 07/661,370
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precisely where in an FIV genome the env coding sequence may be found.” Answer, p. 6.
As to Theory II, the examiner’s conclusion of obviousness is based on his finding
that Starcich demonstrates that the env protein of HIV and FIV “share striking similarities.”
Answer, p. 11. The examiner argues that Starcich teaches “the nucleotide and deduced
amino acid sequences of the env gene from five independent HIV isolates, characterizing
hypervariable regions on the basis of deduced polypeptide secondary structure and
observed genetic variation as well as less variable regions and conserved regions on the
same bases [sic, basis].” Answer, p. 8. The examiner further argues that four N-linked
glycosylation sites adjacent to the cysteine pairs are conserved. Id., p. 10. According to
the examiner, “Mere visual comparisons of the deduced amino acid sequences of the
FIV env gene taught by Talbott et al. and of the HIV env gene taught by Starcich et al.
would readily indicate to one of ordinary skill in the art that two mutually conserved cysteine
residues are present in the regions carboxyl-proximal to the mutually conserved proteolytic
processing sites of FIV and HIV, since both pairs of cysteines are approximately 86 amino
acids distant from the conserved cleavage sites and separated by five amino acids in the
HIV isolates and by six in the FIV strain” [emphasis added]. Answer, p. 9. Having made
this finding, the examiner then urges that Pauletti and Modrow demonstrate that antigenic
epitopes present in a region of the HIV env protein correspond to the FIV 0.4 envelope
protein.
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Answer, para. bridging pp. 10-11.
We find both theories unpersuasive.
Here, we find that the examiner has overlooked the fact that the appropriate legal
standard for determining obviousness is whether the applied prior art would have
suggested the claimed invention to one of ordinary skill in the art. With respect to Theory I,
in our review of the Talbott and Pedersen references, the only two references cited in the
rejection which are directed to FIV, we do not find any teaching or suggestion of the FIV
0.4 envelope protein or a DNA sequence which encodes said protein. Nor do we find any
teaching in Kieny, and none has been pointed out by the examiner, that the HIV gp40
peptide is equivalent to the FIV 0.4 envelope protein. As to Theory II and the examiner’s
attempt to relate the teachings of Starcich and Talbott to each other, we find that Starcich
compares different human variants with one another, but that the reference is silent with
respect to the relationship between FIV and HIV. We find that Talbott, on the other hand,
appears to contradict each of the examiner’s theories. That is, Figure 4 of Talbott
suggests that HIV and FIV are phylogenically distinct. Talbott, p. 5746. Thus, in our view,
Talbott suggests that one of ordinary skill in the art would not have expected to find that the
envelope proteins of HIV and FIV are “strikingly similar.”
In fact, overall, we find that the evidence of record overwhelmingly supports a
conclusion which is contrary to the examiner’s unsupported allegation that “mere visual
Appeal No. 1995-1993
Application 07/661,370
A reference provided by the appellants (Paper No. 6; attachment to the Information4
Disclosure Statement) and cited in their Brief. Brief, p. 12.
A reference provided by the appellants in Paper No. 23 and cited in their Brief. 5
Brief, p. 11.
8
inspection” of the HIV and FIV envelope proteins shows that they are “analogous” or
“strikingly similar.” As pointed out by the appellants, the record demonstrates that persons
of ordinary skill in the art would have understood that HIV and FIV are both phylogenically
and antigenically distinct. Brief, pp. 10-13. For example, Pedersen and Olmsted I4
unequivocally state that FIV is not antigenically related to HIV. Pedersen, col. 3, lines 5-8;
Olmsted I, p. 2452, lines, 3-5. In addition, as we discussed above, Talbott suggests that
FIV and HIV are phylogenically distinct. Talbott, p. 5746, Figure 4. Finally, the most
compelling evidence of record which provides a direct comparison of nucleotide and
deduced amino acid sequences of FIV with other lentiviruses, including HIV, has been
ignored by the examiner. We direct attention to Olmsted II wherein it is reported that5
significant sequence identities exist only in the gag and pol genes of FIV and other
lentiviruses. Olmsted II, the abstract. Olmsted II concludes that “In each of the four
analyses, the horizontal distances and branch orders indicate that FIV is more closely
related to the nonprimate lentiviruses (EAIV and visna virus) than to the primate lentiviruses
[HIV and SAIDS].” Olmsted II, p. 8091, col. 2, last para.
Cutting to the chase, the only location on this record, where we find a suggestion
that the FIV 0.4 envelope protein is antigenic, is in the appellants’ specification. Thus, in
Appeal No. 1995-1993
Application 07/661,370
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our view, the examiner has relied on impermissible hindsight in making his determination
of obviousness. In re Fritch, 972 F.2d 1260, 1266, 23 USPQ2d 1780, 1784 (Fed. Cir.
1992) (“It is impermissible to engage in hindsight reconstruction of the claimed invention,
using the applicant’s structure as a template and selecting elements from references to fill
the gaps”); Interconnect Planning Corp. v. Feil, 774 F.2d 1132, 1138, 227 USPQ 543,
547 (Fed. Cir. 1985); W.L. Gore & Assocs. v. Garlock, Inc., 721 F.2d 1540, 1553, 220
USPQ 303, 312-313 (Fed. Cir. 1983), cert. denied,
469 U.S. 851 (1984) (“To imbue one of ordinary skill in the art with knowledge of the
invention in suit, when no prior art reference or references of record convey or suggest that
knowledge, is to fall victim to the insidious effect of a hindsight syndrome wherein that
which only the inventor taught is used against its teacher”). Accordingly, the rejection is
reversed.
Appeal No. 1995-1993
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Rejection II
For the reasons explained above, we do not find that the subject matter of claim 54
would have been obvious to one of ordinary skill in the art over applied prior art. Although
the examiner has additionally applied O’Connor in the second rejection, we do not find that
the reference makes up for the shortcomings previously discussed. O’Connor discloses a
kit for detecting the presence of FIV antibodies in a biological sample; however, he fails to
suggest the use of the FIV 0.4 envelope protein in said kit. Accordingly, rejection II is
reversed.
REVERSED
William F. Smith )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Joan Ellis )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Hubert C. Lorin )
Administrative Patent Judge )
JE/dm
Appeal No. 1995-1993
Application 07/661,370
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