Appeal of rejection by the Patent Office Board of Appeals of claims directed to organic compounds, for lack of utility. The specification stated that the claimed compositions were “anti-inflammatory agents, as shown by their effectiveness in treating inflammation of the iris†and also claimed usefulness because the claimed compositions allegedly produced a decrease in vascular permeability and were anti-bacterial agents. The examiner rejected the claims for lack of utility, requiring clear and convincing proof of the safety, effectiveness, and reliability, of the composition and stating that “no tests on human beings have been submitted. Such tests are necessary to establish therapeutic utility in cases of this nature. . . . Experimentation with animals is insufficient.†The Board of Appeals affirmed the examiner’s rejection, agreeing with the examiner’s position with regard to the utility of animal experiment results, and stating that “{a}ny compound which has not been carried beyond {animal} experimentation we think may properly be regarded as of merely speculative or at best potential utility.â€
Notably, the court explicitly did not decide the question of “whether an applicant must, in a situation as is now at bar, provide evidence or proof that claimed compounds are useful for a purpose stated in a patent application,†instead deciding the case based on the evidence presented, which included evidence of usefulness in animals in the form of an affidavit. The court characterized the issue as “whether a test restricted to a laboratory animal is sufficient to satisfy the utility requirement of the statute when a patent application discloses that claimed compounds are useful in the treatment of a condition which can occur both in man and in lower animals, and it is agreed that the disclosure does not exclude the treatment of man.†The court, reversing the Board of Appeals, held that the restriction of tests of the compound to laboratory animals was sufficient to satisfy the utility requirement of 35 U.S.C. § 101. Noting that the “pharmaceutical applications†discussed in the specification were not limited to the treatment of humans, the court stated that the applicant had established by affidavit “that one of his claimed compounds is indeed useful for a purpose alleged in his application. In our opinion, he need do no more to satisfy the requirement of 35 U.S.C. § 101 that the claimed invention be useful.â€
Excerpts and Summaries
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Friday 05 of September, 2008 19:39:47 GMT by Unknown
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Sunday 07 of September, 2008 16:06:50 GMT by Unknown