Board of Patent Appeals and Interferences
Patent and Trademark Office (P.T.O.)
*1 EX PARTE DAVID RUBIN
Appeal No. 86-3466
October 28, 1987
Application for Patent filed March 29, 1984, Serial No. 594,436, is a Continuation of Serial No. 320,088, filed November 10, 1981, abandoned. Cancer Therapy With Interferon.
Roger L. Browdy et al. for appellant
Primary Examiner--Blondel Hazel
Before Sturtevant, Tarring and W. Smith
This is an appeal from the final rejection of all claims in the application, which are claims 1 through 9. Claims 1 and 7 are reproduced here to illustrate the subject matter.
1. A method for improving the effectiveness of interferon in the treatment of neoplastic conditions accompanied by an increase of the patient's serum tyrosinase level substantially above normal, comprising administering an agent for inhibiting tyrosinase in an amount sufficient to substantially inactivate the tyrosinase in the serum of the patient being treated with interferon, and administering the interferon during the time in which the tyrosinase is being inhibited by said agent.
7. In a composition containing interferon and a pharmaceutically acceptable carrier or excipient, the improvement whereby the effectiveness of the interferon is increased, wherein the composition includes an amount of interferon effective for treatment of neoplastic conditions accompanied by an increase in the patient's serum tyrosinase level substantially above normal, and an agent for inhibiting tyrosinase in an amount effective to inactivate the tyosinase [sic] in the serum of the patient.
There are three rejections before us for review. First, all the claims have been rejected under 35 USC 101 and the first paragraph of 35 USC 112 for insufficient proof of utility. Second, all the claims have been rejected under 35 USC 112, first paragraph, as based on a non-enabling disclosure. Finally, the composition claims 7 through 9 have been rejected under 35 USC 103. As evidence of obviousness the examiner relies on the following references:
Chemical Abstracts, Vol. 84, Abstract No. 69303C, (1976).
Nazzaro-Porro et al., Pigment Cell, Vol. 4, pp. 234-243, (1979).
Johnson, R., JAMA, Vol. 245, No. 2, pp. 109-116, (1981).
Lerner, article in Methods in Enzymology, Vol. II, pp. 827-831 (1955).
The examiner improperly failed to list Lerner as a reference, even though clearly she relies on it in her Answer at page 6.
After careful review of the entire record we conclude that each of the rejections must be reversed.
With regard to the rejection of all claims under 101 and the first paragraph of 112, the examiner contends, in effect, that the asserted utility of the invention, to enhance the effectiveness of interferon in treating certain cancer conditions, is per se incredible, i.e. that it must be substantiated by factual evidence of improved activity 'in a complex biological system such as the human body' (Answer, page 4). She expresses disbelief of appellant's statement (specification, page 3) that, because he has proved by an in vitro color test that tyrosinase denatures interferon, it follows that interferon therapeutic activity in vivo is enhanced by inhibiting the serum tyrosinase. Appellant counters that the antineoplastic utility of interferon was known in the art prior to his invention; that his assertions of increasing its effectiveness by administering a compound known to inhibit tyrosinase are 'believable on their face to persons skilled in the art' (Brief, page 8); and that conversely, even if his alleged inhibitor were ineffective, there is no reason to believe that its presence would defeat the known utility of the interferon. His position is well summarized by the following passage in his Brief (page 8, our emphasis):
*2 'The asserted utility in the present specification does not involve incredible statements or statements deemed unlikely to be correct by one skilled in the art in view of contemporary knowledge in the art. The utility asserted in the present specification is that the known effectiveness of interferon in the treatment of certain neoplastic conditions can be improved by the substantially simultaneous administration of another compound which inhibits a substance known to denature interferon.'
We are in full agreement with appellant. The 'contemporary knowledge in the art' has far advanced since the days when any statement of utility in treating cancer was per se 'incredible.' As our reviewing Court observed in In re Jolles, 628 F.2d 1322, 206 USPQ 885 at 890 (CCPA 1980):
'. . . the medical treatment of a specific cancer is not such an inherently unbelievable undertaking or involves such implausible scientific principles as to be considered incredible.'
There is no factual support in this record for the examiner's questioning of the denaturation test reported in the specification. In addition to the color change there discussed, note also that oxidation demand was measured and demonstrated that oxidation took place, further supporting appellant's position. The examiner's attention is directed to In re Langer, 503 F.2d 1380, 183 USPQ 288, especially at 297 (CCPA 1974). The Court there held:
'. . . a specification which contains a disclosure of utility which corresponds in scope to the subject matter sought to be patented must be taken as sufficient to satisfy the utility requirement of § 101 for the entire claimed subject matter unless there is reason for one skilled in the art to question the objective truth of the statement of utility or its scope.'
No reason to doubt 'the objective truth' of the asserted utility having been advanced by the examiner, we accept appellant's disclosure of utility corresponding in scope to the claimed subject matter.
The rejection of all claims under 35 USC 112 as based on a non-enabling disclosure must also be reversed. We point out initially that the very prior art relied on by the examiner teaches a variety of modes of administration of both interferon (the Johnson article) and tyrosinase inhibitors (Nazzaro-Porro et al.); and the Lerner 1955 article demonstrates that methods of monitoring tyrosinase level in the patient's serum have been known in the art for many years. In addition, appellant in his specification (page 5) equates his 'preferred practical procedure for . . . inhibiting tyrosinase' with 'the known treatment for Wilson's disease, which is a rare hereditary disorder.' Thus the examiner's arguments, that the specification fails to teach how the compositions may be administered or how the blood may be monitored to determine effective amounts to be administered, are not only unsupported by evidence supplied by her, but are belied by the evidence on this record.
*3 Finally, with regard to the 103 rejection of claims 7 through 9 each of the three references does indeed teach in general what the examiner asserts it teaches. However, the rejection fails because there is no concept in any of the art relied on, either express or implied, of providing compositions including both interferon and a tyrosinase inhibitor. None of the art teaches increasing the effectiveness of interferon. None of the art teaches inhibiting the patient's serum tyrosinase as it increases concomitantly with the interferon treatment.
In her Answer the examiner for some reason withdrew the rejection of method claims 1 through 6 over the same art, even though her arguments appear equally applicable to them, if applicable at all. We have considered the same art in relation to those claims. Needless to say, our conclusion is the same: the art relied on does not present a prima facie case of obviousness under 103 of the method recited in claims 1 through 6 any more than the art does of the composition claims 7 through 9.
The examiner's decision is accordingly reversed.
BOARD OF PATENT APPEALS AND INTERFERENCES
Henry W. Tarring, III
William F. Smith