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 â€œthe 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.â€ 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 â€œprove each and every allegation of utilityâ€ and stating that â€œthe 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.â€
The Board of Appeals agreed with the examiner, stating that the combined organic base and dextran components â€œare 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.â€ The court affirmed the board, rejecting the claims for lack of utility.
Excerpts and Summaries
Thursday 04 of September, 2008 21:30:14 GMT by Unknown
Sunday 07 of September, 2008 16:07:41 GMT by Unknown