Name: In re Krimmel
- Item Type: case
- Cite: 292 F.2d 948
- Year: 1961
- Bluebook Cite: In re Krimmel, 292 F.2d 948 (C.C.P.A. 1961).
- Author:
- url: 292 F.2d 948
Summary
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.”
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.”
Excerpts and notes
QUOTE -- {W}e hold that when an applicant for a patent has alleged in his patent application that a new and unobvious chemical compound exhibits some useful pharmaceutical property and when this property has been established by statistically significant tests with ‘standard experimental animals,’ sufficient statutory utility for the compounds has been presented. By ‘standard experimental animals,’ we mean whatever animal is usually used by those skilled in the art to establish the particular pharmaceutical application in question. These may be mice in one case, rabbits in another, chickens in another, and monkeys in another. We hold as we do because it is our firm conviction that one who has taught the public that a compound exhibits some desirable pharmaceutical property in a standard experimental animal has made a significant and useful contribution to the art, even though it may eventually appear that the compound is without value in the treatment of humans.
Dicta -- In dicta, the court discussed the examiner’s requirement that a patent applicant establish the safety, effectiveness, and reliability of his claimed compounds. The examiner and Board cited the case of Isenstead v. Watson, 157 F.Supp. 7 (D.D.C. 1957), a case under 35 U.S.C. § 145 involving a patent application for a medical compound used to test the function of the human liver, as the source of this requirement. The court, in response to the examiner and Board, stated: “Although we have no doubt that the Patent Office has, in the case at bar, acted in good faith and with proper motives, the fact remains that the Patent Office has not been charged by Congress with the task of protecting the public against possible misuse of chemical patents. There is nothing in the patent statute or any other statutes called to our attention which gives the Patent Office the right or the duty to require an applicant to prove that compounds or other materials which he is claiming, and which he has stated are useful for ‘pharmaceutical applications,’ are safe, effective, and reliable for use with humans. It is not for us or the Patent Office to legislate and if the Congress desires to give this responsibility to the Patent Office, it should do so by statute.”
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