Ex parte Brandazza et al.

Board of Patent Appeals and Interferences

Jan 8, 1998

07536556 (B.P.A.I. Jan. 8, 1998)

Application for patent filed July 11, 1990.1
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publication in a law journal and (2) is not binding precedent of the Board.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. 23
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte ANNA BRANDAZZA,
PAOLO SARMIENTOS,
and GAETANO ORSINI
__________
Appeal No. 94-1484
Application 07/536,5561
__________
ON BRIEF
__________
Before WILLIAM F. SMITH, GRON, and WEIMAR, Administrative Patent Judges.
WILLIAM F. SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of claims 1, 2, 4,
5, 7, and 8. Subsequently, claim 1 was canceled and replaced by claim 9.
Appeal No. 94-1484
Application 07/536,556
In addition, the examiner cites a reference to Kane (Kane et al., “Formation of2
Recombinant Protein Inclusion Bodies in Escherichia coli, TIBTECH, vol. 6, pp. 95-101
(1988)) at page 2 of the Examiner’s Answer. However, the examiner does not rely
upon Kane in the statement of the rejection. Rather, the examiner cites Kane at page 9
of the Examiner’s Answer “for evidentiary purposes only.” As pointed out by the court
in In re Hoch, 428 F.2d 1341, 1342 n.3, 166 USPQ 406, 407 n.3 (CCPA 1970), “[w]here
(continued...)
2
Accordingly, claims 2, 4, 5, and 7 through 9 are presented for consideration in this
appeal.
Claim 9 is illustrative of the subject matter on appeal and reads as follows:
9. A method for the preparation of non-glycosylated pro-UK, characterized in
that non-glycosylated human pro-UK is expressed under the control of the E. coli
promoter Ptrp and the Shine-Dalgarno sequence MS-2 by E. coli B wherein the
sequence comprising the Shine-Dalgarno sequence MS-2, the ATG start codon and the
beginning of the pro-UK gene, flanked upstream by a HindIII site and downstream by a
TaqI site is as follows:
HindIII
5N -AGCTTTAATAGACGCCGGCCATTCAAACATGAGGATTACCCATGAGC
3N -AATTATCTGCGGCCGGTAAGTTTGTACTCCTAATGGGTACTCG
TaqI
AATGAACTTCATCAAGTTCCAT-3N
TTACTTGAAGTAGTTCAAGGTAGC-5N
and said HindIII site is downstream of the promoter Ptrp.
The references relied upon by the examiner are :2
Appeal No. 94-1484
Application 07/536,556
(...continued)2
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.” Accordingly, we have not considered Kane in deciding the issues
presented.
3
Remaut et al. (Remaut), “Inducible High Level Synthesis of Mature Human Fibroblast
Interferon in Escherichia coli”, Nucleic Acids Research, vol. 11, no. 14, pp. 4677-4688,
(1983)
Holmes et al. (Holmes), “Cloning and Expression of the Gene for Pro-urokinase in
Escherichia coli,” Biotechnology, vol. 3, no. 10, pp. 323-29 (1985)
Renhof et al. (Renhof), “Synthesis and Functional Activity of Translation Initiation
Regions in mRNA,” FEBS, vol. 185, no. 2, pp. 277-81 (1985)
Hibino et al. (Hibino), “Enhanced Expression of Human Pro-urokinase cDNA in
Escherichia coli.” Agric. Biol. Chem., vol. 52, no. 2, pp. 329-336 (1988)
Claims 2, 4, 5, and 7 through 9 stand rejected under 35 U.S.C. § 103 as
unpatentable over Holmes in view of Hibino, Remaut, and Renhof. We reverse.
Discussion
By its terms, 35 U.S.C. § 103 requires that obviousness of claimed subject
matter be determined on the basis of the “subject matter as a whole.” Claim 9 on
appeal requires the use of a specific strain of microorganism, E. coli B. The examiner
has not explained where or how any of the four references relied upon, individually or
in combination, teach or suggest the use of E. coli B. Appellants argue this point at
Appeal No. 94-1484
Application 07/536,556
4
page 4 of the Appeal Brief (“the cited references do not disclose or suggest the strain
E. coli B”).
Where as here, the examiner’s patentability determination under 35 U.S.C.
§ 103 has been based on less than the “subject matter as a whole,” the rejection is
legally flawed and cannot be sustained. We recognize that the examiner belatedly
attempted to rectify this error at page 5 of the Examiner’s Answer where, in responding
to appellants’ arguments, the examiner stated that “Appellants have acknowledged,
and it has been argued by the examiner, that E. coli B strains . . . are known and
available to the public . . . .” We first note that the examiner has not relied upon any
evidence in stating the rejection in support of the statement. Second, assuming
arguendo, that E. coli B strains were known at the time of the present invention, that
knowledge does not necessarily mean that the use of those strains would have been
considered obvious by one of ordinary skill in the art in the manner required by the
claims on appeal.
The rejection under 35 U.S.C. § 103 is reversed.
Other Issues
As set forth above, our decision in this appeal has centered upon the failure of
the examiner to properly account for that portion of the claimed subject matter directed
Appeal No. 94-1484
Application 07/536,556
5
to the use of E. coli B. Appellants argued that the use of this particular strain is
significant in the present invention. See, e.g., the first full paragraph of page 5 of the
Appeal Brief. As stated at page 20 of the specification:
The choice of the host strain is also a critical step in the development of
an efficient method of production. It is, in fact, known that insertion of the
same expression plasmid in different strains can lead to very different
expression efficiencies (Harris T.J.R. and Emtage J.S. Microbiological
Sciences, 3, p. 28-31, 1986).
The Harris reference has not been made of record by either appellants or the examiner.
Furthermore, the specification indicates at page 21 that:
For instance, fermentations at high biomass may dramatically be
influenced by the type of host. The present inventors as well as other
groups of researchers have consistently found that E. coli strains of the
type B can be grown more easily than, e.g., K-12 strains. Insertion of the
same expression plasmids, pFC16 or pFC44, in K-12 strains such as
C600 generates recombinant strains, which cannot grow, in fermentators,
as efficiently as the recombinant B strains. In other words, yields of
recombinant non-glycosilated pro-UK are higher from B strains, when
using the same expression plasmids.
Appellants have not made of record any further information regarding the work of the
“other groups of researchers” who found that E. coli B can consistently be grown more
easily than other E. coli strains.
Upon return of the application, appellants and the examiner should take a step
back and re-evaluate the record, paying special attention to that aspect of the claimed
invention which involves the use of E. coli B. If the work of the “other groups of
Appeal No. 94-1484
Application 07/536,556
6
researchers” acknowledged by appellants at page 21 of the specification is prior art, it
would appear to be relevant in determining the patentability of the subject matter on
appeal.
The decision of the examiner is reversed.
REVERSED
William F. Smith )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Teddy S. Gron ) APPEALS AND
Administrative Patent Judge ) INTERFERENCES
)
)
)
Elizabeth C. Weimar )
Administrative Patent Judge )
Appeal No. 94-1484
Application 07/536,556
7
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