Board of Patent Appeals and Interferences
Patent and Trademark Office (P.T.O.)
*1 EX PARTE PAUL STEVENS, KIRSTON E. KOTHS AND BRIAN ISSELL
Appeal No. 90-0644
June 29, 1990
Application for Patent filed August 1, 1986, Serial No. 892,596. Combination Therapy Using Anti-Tumor Monoclonal Antibodies or Immunotoxins with Interleukin-2.
Albert P. Halluin Cetus Corporation
Albert P. Halluin and Gregory J. Giotta for appellants
Primary Examiner--Garnette D. Draper
Before Goldstein, W. Smith and Wiseman
This appeal is from the examiner's final rejection of claims 1, 2, 4 to 8, 11 to 16 and 18 to 22, which are all of the claims remaining in the application. Illustrative claims 1 and 11 are reproduced below.
1. A composition suitable for parenteral or subcutaneous administration to mammalian hosts for therapeutic or prophylactic treatment of cancer comprising a mixture, in pharmacologically effective amounts, of IL-2 from a mammalian species and at least one monoclonal antibody that binds selectively to human breast tumor cells.
11. A method for therapeutic or prophylactic treatment of cancer in mammalian hosts comprising administering to the host a pharmacologically effective amount of IL-2 from a mammalian species and at least one monoclonal antibody that binds selectively to human breast tumor cells.
There are no references relied on by the examiner on appeal.
All of the appealed claims have been finally rejected under 35 U.S.C. 101 and 112 as being based on a disclosure which does not adequately enable the practice of the invention claimed with respect to its asserted utility. We shall affirm this rejection.
In the above statement of the rejection, we have combined two separate grounds of rejection set forth by the examiner under each of the individual statutory sections referred to. We have done so because we believe that there is but a single issue, that which we have expressed above, and that the practice of raising that issue in a rejection under either 35 U.S.C. 101 or 112, or both, has been judicially approved. This fact appears to have been recognized by the examiner herself, in the answer on appeal, in the paragraph bridging pages 10 and 11. In addition to those cases cited by the examiner, see In re Fouche, 439 F.2d 1237, 169 USPQ 429 (CCPA 1971).
As will be evident upon inspection of the claims reproduced above, appellants' invention involves a composition and process for treating cancer. By appellants' express acknowledgement, there is no actual evidence of the effectiveness of the claimed composition and process in achieving that utility. As appellants themselves have characterized it (brief on appeal, paragraph bridging pages 3 and 4), the relevant working example (summarized in Table VIII at page 37 of the specification) reports only an "experimental 'paper' protocol." This characterization is in conformance with the disclosure of the specification itself, which reports that "no work has been actually done confirming such results," with respect to the summary presented in Table VIII (specification, page 37, lines 28 to 29).
*2 The examiner's position is based on the supposition that the facts described above evidence a prima facie case of nonenablement with regard to the disclosed utility in light of all the applicable legal precedents. Where as here, the disclosed utility is the treatment of cancer, we agree with this supposition. The examiner has cited Ex parte Busse, 1 USPQ 2d 1908 (BPAI 1986). In that case, the Board of Patent Appeals and Interferences reviewed the relevant prior decisions of its reviewing court. We shall not repeat those citations here. Suffice it to say that in every cited case the narrow issue involved was whether or not the evidence of record was based on in vivo or in vitro studies which were generally recognized by those of ordinary skill in the art as being reasonably predictive of success in the practical utility under consideration, i.e., human or, at least, mammalian therapy.
The precedents discussed above are relevant only in the broadest sense. To state it in the vernacular, the reported cases illustrate "where the action is." In other words, the justiciable issues concerned what amounts and types of evidence are required to reasonably support assertions of usefulness of compositions and processes for treating cancer. In the present case, by acknowledgement, there is no actual evidence, only speculation, or in appellants' terms, the presentation of an "experimental 'paper' protecol." Appellants have cited no authority which effectively supports their apparent position that no actual evidence at all should be required in a case of the present type and, in the absence of any such authority, their arguments to that effect are of necessity unpersuasive.
The decision of the examiner is affirmed.
No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. 1.136(a). See the final rule notice, 54 F.R. 29548 (July 13, 1989), 1105 O.G. 5 (August 1, 1989).
BOARD OF PATENT APPEALS AND INTERFERENCES
William F. Smith
Thomas G. Wiseman