In re Novak

Name: In re Novak

• Item Type: case
• Cite: 306 F.2d 924
• Year: 1962
• Bluebook Cite: In re Novak, 306 F.2d 924 (C.C.P.A. 1962).
  
• Author:
• url: 306 F.2d 924
  

Summary

Appeal from decision of the Patent Office Board of Appeals affirming examiner's rejection for lack of utility of claims to carbosymethyl dextranates of organic bases and method for making them. The examiner, in rejecting the claims for lack of utility, stated that “the composition is set forth as therapeutic. In the absence of clear, convincing, scientific evidence that the composition is safe and effective for the purposes set forth, no claim is allowable.” Further, the examiner did not allow the applicants to rely on the safety of organic bases and dextrans to support the safety of their claimed product, requiring the applicants to “prove each and every allegation of utility” and stating that “the applicants cannot rely upon the safety and efficacy of these ingredients, many of which, in reality, are admittedly extremely toxic, to prove the harmlessness and efficacy of their dextranates because the carboxymethyl dextranates are entirely different entities from the carboxymethyl dextran per se and the organic base per se.”

The Board of Appeals agreed with the examiner, stating that the combined organic base and dextran components “are entirely different entities from the individual components and since little prediction is possible in this filed clinical evidence would be a minimum requirement to establish utility.” The court affirmed the board, rejecting the claims for lack of utility.

Excerpts and notes

QUOTE -- We assume that the utility alleged for the claimed products is based on the validity of these statements. In other words, if the claimed products do not have the properties alleged for them or do not function as alleged, then those products will not be useful for the stated purposes, i.e. as drugs, medicaments, and the like in human therapy. In our opinion, when an applicant bases utility for a claimed invention on allegations of the sort made by appellants here, unless one with ordinary skill in the art would accept those allegations as obviously valid and correct, it is proper for the examiner to ask for evidence which substantiates them. Here we find no indication that one skilled in this art would accept without question statements that carboxymethyl dextran has the alleged effects on the functioning of any base, physiologically active or not, and no evidence has been presented to demonstrate that the claimed products do have those effects.

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