Board of Patent Appeals and Interferences
Patent and Trademark Office (P.T.O.)
*1 EX PARTE DAVID V. GOEDDEL AND SIDNEY PESTKA
Appeal No. 580-01
December 16, 1985
Heard: May 15, 1985
Application for Patent filed July 1, 1980, Serial No. 164,986. Microbial Production Of Mature Human Leukocyte Interferons.
George M. Gould et al for appellants
Primary Examiner--Blondel Hazel
Before Blech, Seidleck [FNa1] and Winters
This is an appeal from the final rejection of claims 6, 7, 15 through 17, 19 through 22 and 24 through 31. Claims 1 through 5 and 8 through 12, the only other claims remaining in the case, stand withdrawn from consideration pursuant to 37 CFR 1.142(b) and are thus not before us.
Illustrative of the claimed invention is:
6. A composition of matter comprising a therapeutically active fraction of a polypeptide of about 165-166 amino acids consisting essentially of the amino acid sequence of a mature human leukocyte interferon selected from Le-IF A and Le-IF B, the balance of said composition comprising soluble bacterial protein from which said polypeptide may be purified to a degree sufficient for therapeutic application.
The references relied upon by the Examiner are:
Pestka et al. (Pestka) 4,289,690 Sept. 15, 1981
Torma et al. (Torma), J. Biol. Chem., Vol. 251, No. 16, pp. 4810-4816, 1976.
The references relied upon by appellants:
Levy et al. (Levy), Proc. Natl. Acad. Sci, Vol. 78, No. 10, pp. 6186-6190, 1981.
Gresser, 'Interferon 1981', Vol. 3, (Academic Press, 1981), p. 101-134, p. 126 relied upon.
Rubinstein et al. (Rubinstein), Archives of Biochemistry and Biophysics, Vol. 210, No. 1, pp. 307-318, 1981.
The appealed claims stand rejected under 35 USC 112, first paragraph,
. . . as being based on an insufficient disclosure regarding the deposit requirements for the new microorganism used to produce the products of the instant claims.
On its face, this rejection is not sustainable. The microorganisms employed by appellants to produce the claimed polypeptide are known materials on deposit with the American Type Culture Collection, as indicated at p. 8-9 of the instant disclosure where their accession numbers are set forth.
We cannot subscribe to this holding. Depositing a microorganism in a recognized culture collection bank quite evidently constitutes a convenient way of complying with the statutory requirement. However, it is clearly not the only way by which such can be accomplished. In other words, the procedure found appropriate in In re Argoudelis et al, 58 CCPA 769, 434 F.2d 1390, 168 USPQ 99 (1970), is not absolutely required or mandatory, it is only permissive. Compare In re Lundak, 227 USPQ 90 (CAFC 1985).
*2 Here, appellants in a comprehensive and detailed disclosure have set forth the manner by which the claimed leukocyte interferons may be obtained. One skilled in this art palpably would have no difficulty in following appellants' instructions in order to realize the claimed product starting with known and available precursors. Such is also attested to by affiant Weissbach, an expert in this field of impeccable credentials, in his declaration accompanying the 'Submission in Response to Honorable Board of Appeals Request at Oral Hearing,' submitted May 24, 1985.
The Examiner has advanced no substantive reasons why the instant specification is non-enabling. She urges that (p. 3 of her Answer):
copies verbatim the guidelines set forth in MPEP 608.01p, and refers to Argoudolis.
But this clearly does not rebut appellants' extensive and well reasoned arguments that the disclosure of this case is adequate and sufficient to enable the artisan to practice the claimed invention. Mere broad generalizations and allegations are insufficient for a holding of non-enablement.
The ultimate question in each case manifestly is whether or not it contains a sufficiently explicit disclosure enabling the average routineer in the field to practice an invention claimed therein. Under the facts of this case it is evident to us that the present specification is adequate to comply with Section 112 of the Statute. The Examiner has not given us any specific reasons why we should not so hold.
We also note, as pointed out by appellants, that, in fact, a considerable number of patents have been issued in this field in which no deposit was made.
Accordingly, the rejection of the appealed claims under 35 USC 112, first paragraph, is reversed.
The appealed claims also stand rejected under 35 USC 103
. . . as obvious over the disclosure of Rubinstein et al., Torma and Paucker, and Pestka et al. Each of the references discloses human leukocyte interferons which are not seen to differ in kind from the interferon species of the instant claims.
This rejection on its face, similarly, is not sustainable. The statutory inquiry is obviousness and not 'differ in kind.' Whatever that means, palpably it is not a proper basis for a rejection.
In any event, obviousness, a conclusion of law based upon a fact determination, requires a consideration of (1) the scope and content of the prior art, (2) the differences between the prior art and the claimed invention, (3) the level of ordinary skill in the pertinent art, and (4) additional evidence which may serve as indicia of non-obviousness. Graham v. John Deere Co., 383 US 1, 17, 148 USPQ 459, 467 (US Supreme Court, 1966).
*3 The Examiner has not aided us in evaluating the claimed invention in this required manner. The only substantive statement made by her in support of her rejection is found at p. 4 of her Answer, to wit:
It is noted that Table 2 of Rubinstein at al. shows that there can be variation in the number of amino acid residues of the leukocyte interferon. This may account for the differences in molecular size of the interferon species claimed by appellants. It is noted that appellants' claims are directed to species of human leukocyte interferon polypeptides of 'about' 165-166 amino acids.
Such clearly is inadequate to support the rejection made. Appellants have pointed out in great detail how the claimed synthetic mature human leukocyte interferons prepared by recombinant DNA technology differ from the natural human leukocyte interferons purified from natural sources of the prior art. Appellants also refer us to the above cited literature articles relied upon by them to show further development in this field and which would indicate that the claimed invention would not have been obvious to the artisan. The Examiner has not discussed these literature articles, nor even acknowledged their citation and reliance thereon by appellants although, quite evidently, they are pertinent under consideration (4) of Graham v. John Deere Co., loc. cit.
The mature human leukocyte interferons Le-IF A and Le-IF B, in our view, are adequately defined by being polypeptides of about 165-166 amino acids so as to distinguish over the references adduced by the Examiner. No reasons have been given, nor are apparent to us, which would have motivated the artisan in this field to prepare a 'modified' form of the interferons of the prior art by recombinant DNA technology, the isolated natural proteins of the references being limited to those structures and properties as found. That there can be variations in the number of amino acids in natural leukocyte interferons clearly cannot be basis for a holding of obviousness of those at issue, they being neither taught nor suggested by the references, nor present in their systems.
Although the Examiner has not advanced any rejection of the appealed claims under the judicially created doctrine of double patenting of the obviousness type it is, nevertheless, readily apparent that the claims in copending application S.N. 256,204, filed April 21, 1981 a continuation-in-part of the present case, on appeal and concurrently decided by us, are directed to an invention inclusive of the one at issue herein. Such should be taken into consideration when issuing this case by either having the other application issue on the same date or by the filing of a terminal disclaimer in the appropriate case.
The decision of the Examiner is reversed.
BOARD OF PATENT APPEALS AND INTERFERENCES
James A. Seidleck
Sherman D. Winters
FNa1. Bjorge, Examiner-in-Chief, participated in the oral hearing in this case, but was unavailable at the time a decision was reached. Seidleck, Examiner-in-Chief, was substituted in his place. See In re Dose Corporation, 227 USPQ 1 (CAFC 1985).