In re Jolles

Name

In re Jolles

Cite

628 F.2d 1322

Year

1980

Bluebook cite

In re Jolles, 628 F.2d 1322 (C.C.P.A. 1980).

Author

URL

628 F.2d 1322

Item Type

case

Summary

Appeal from decision of Patent Office Board of Appeals affirming examiner’s rejection for lack of proof of utility. The invention at issue involved pharmaceutical compositions and methods which the appellant claimed were useful for treatment of acute myeloblastic leukemia in human patients. Two declarations submitted with the patent application reported the results of clinical treatments of human patients with one of the claimed compositions. The doctor making the declarations reported that “complete remission of the disease was achieved in 53 of the {100} patients treated” and concluded that “the specific composition used is an active drug in the treatment of acute myeloblastic leukemia and is a valuable addition to the series of drugs available for such treatment.” Id. at 1324. Two other declarations submitted with the patent application reported the results of experimental tests on laboratory mice. One of the compositions used in the test was the same as the composition used in the clinical treatments. The doctor making the declarations concluded from the tests that the compounds showed “substantial activity against experimental tumours in mice in tests customarily used for the screening of anti-cancer agents of potential utility in the treatment of humans.” Id. All of the compounds tested were structurally related.

The examiner rejected the claims for lack of utility. The examiner required test data that included specific dosages and durations of treatment. Additionally, the examiner stated that the compound used in the human tests was not proven to be safe and effective, because it only worked on 53 patients and 13 patients died during treatment. The examiner concluded that a PHOSITA would not “presume that these novel compounds would be safe and effective for the incredible utility alleged in the absence of verified data substantiating the said allegations of use.”

The board reversed the rejection of the claims to the compounds used in the human clinical tests, but affirmed the rejection of all other claims. First, the board found the only contemplated utility to be in the treatment of humans, and thus stated that the declarations with regard to animal tests were not relevant. The board then found that the declarations showing remissions in 53% of human patients was enough to satisfy the utility requirement of 35 U.S.C. § 101, and noted that claims may be useful despite a lack of safety. Since the human tests were limited to one compound, however, the board found the declarations insufficient to establish the utility of the other claims to related compounds.

The court reversed the board’s rejection of the claims to the related compositions. First, the court found that the board erred in dismissing the declarations with regard to animal tests, finding it “clear that such testing is relevant to utility in humans. Evidence showing substantial activity against experimental tumors in mice in tests customarily used for the screening of anti-cancer agents of potential utility in the treatment of humans is relevant to utility in humans and is not to be disregarded.” Id. at 1327. The court then found the combination of the successful animal tests and the fact that the claimed compounds “have a close structural relationship to daunorubicin and doxorubicin, both known to be useful in cancer chemotherapy” to be enough to establish that “one of ordinary skill in the art would accept appellant's claimed utility in humans as valid and correct.” Id. at 1327-28.

Excerpts and Summaries

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Saturday 20 of September, 2008 16:35:35 GMT
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Saturday 20 of September, 2008 16:35:35 GMT
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