Scott Daniels | August 2, 2010
Requests for reconsideration at the PTO Board are usually hopeless. The Board rarely reverses itself, but it did so earlier today in Ex parte Fisch, a case involving antiestrogen treatment of men, at least with respect to certain dependent claims. Today’s decision also involved the question of what constitutes “a new ground of rejection” by the Board.
Claim 1 of U.S. Patent No. 6,391,920 recites “A method of treating disorders related to androgen deficiency in men comprising administering a selective antiestrogen to men in need of such treating.” Independent claim 4 was substantially the same, except that it defined the disorder as male menopause and did not require that the antiestrogen be “selective.”
In August 2009, the Board affirmed the examiner’s rejection of claims 1-21 as being unpatentable over the MacLean U.S. Patent No. 6,017,964 reference. In doing so, it narrowed the examiner’s construction of the claims. The examiner had found that the claim limitation “androgen deficiency” required a related disorder because all men with an androgen deficiency have a related disorder and all men with a related disorder have an androgen deficiency. In other words, a reference that disclosed androgen deficiency, without referring to a related disorder, would satisfy the limitation. The Board disagreed, finding that the claims require disclosure of both androgen deficiency and a related disorder.
The ‘920 patentee requested reconsideration of the Board’s affirmance of the examiner’s rejection. The patentee also argued that even if the Board agreed that the claims were unpatentable over MacLean, the Board’s analysis constituted “a new ground of rejection” because the Board had construed the claims in a different manner than had the examiner.
The Board’s decision today dealt first with the latter question of whether the analysis constituted a new ground of rejection. It cited In re Kronig as establishing the standard for a “new ground” – whether the patentee had a fair opportunity to react to the “thrust of the rejection.” The Board acknowledged that its construction of the claims differed from the examiner’s, but the Board still found that the “thrust” of its rejection of the claims on the basis of MacLean was the same as the examiner’s. Accordingly, the Board concluded that it had been right in its August 2009 decision to affirm the examiner, rather than to enter a new ground of rejection.
With respect to independent claims 1 and 4, the Board repeated its earlier analysis that MacLean discloses both therapeutic and prophylactic treatment of men with symptoms such as libido loss and pathological conditions such as androgen deficiency, by administration of specific antiestrogens, i.e., tamoxifen analogs. The Board emphasized that it was merely construing the MacLean reference in view of the skill in the art. The Board also stated that an anticipatory reference need not demonstrate utility, but only enable one skilled in the art to practice the claimed invention without undue experimentation. The Board affirmed the rejection of the dependent claims on the basis of similar reasoning.
On the other hand, the Board reversed its rejection of dependent claims 2 and 15 that limited the antiestrogen to clomiphene. Although MacLean disclosed use of clomiphene in the treatment of men with libido loss, the reference did not define that libido loss as resulting from androgen deficiency or male menopause. Thus it was the Board’s more narrow construction of the claims as requiring both androgen deficiency and a related disorder that caused it to reverse the rejection of claims 2 and 15 – MacLean discloses clomiphene in connection with the related disorder of libido loss in men, but not in connection with both androgen deficiency and related disorders.
For the remaining claims 3 and 10-20 that relate to the use of specific compounds, the Board concluded that the examiner had failed to show why they would have been obvious over the cited references and therefore reversed the rejection of those claims.
One finishes reading the Board’s decision with the disquieting impression that there is a contradiction between the Board’s conclusion that the “thrust” of its rejection is the same as the examiner’s, and the Board’s reversal of the rejection of claims 2-3 and 10-20 based in large part on its claim construction that was more narrow than the examiner’s. On the one hand the Board asserts that its analysis is not significantly different from the examiner’s rejection, and on the other, that certain claims rejected by the examiner are now allowable.
In any event, the happy “take-away” is that requests for reconsideration may be time-consuming, but they are not always hopeless.