Ex parte LAWRENCE M. BLATT, HUA TAN and
SCOTT D. SEIWERT
Appeal 2008-6024
Application 11/370,535
Technology Center 1600
Decided: April 27, 2009
1. A method of treating a flavivirus infection in an individual, the method comprising administering to an individual in need thereof an effective amount of an agent that inhibits enzymatic activity of a membrane-bound α-glucosidase, wherein the agent is not an imino sugar.
The Examiner rejected the claims for not being definite, for lacking utility and for not being enabled.
Indefiniteness:
The Examiner alleged that the phrase "wherein the agent is not an imino sugar" was indefinite. Appellants provided exhibits to support their position that imino sugars are recognized by those of skill in the art to be sugars in which the ring oxygen is replaced by a nitrogen atom. The Examiner argued that a compound in a dependent claim "“is arguably ‘an imino sugar’” but the Examiner had no evidence to support this argument. Therefore, the claims were definite.
Utility:
Examiner argued that it lacked utility because treatment included preventing the disease, which is "very unlikely to ever be demonstrated to be possible as a consequence of a medicinal treatment." The Appellants responded by pointing to the definition which included treating symptoms as well. The Board explained, "The Specification defines “treating” as including “completely or partially preventing a disease or symptom thereof” (FF 10); that definition does not require complete, 100% effective prevention of virus infection of any cell of the treated individual. The Examiner has not provided sufficient evidence to support a conclusion that the claimed method would not be useful for “completely or partially preventing a disease or symptom thereof,” as “treating” is defined in the Specification."
Enablement:
The Examiner alleged that the claims were not enabled because it only used an model of flavivirus infection but did not enable treating an HCV infection. The Examiner pointed to a reference that said that the prior art stated, "“validation of the utility of the BVDV surrogate virus model is incomplete, since most of the few drugs that are known to be active against HCV have not been tested against BVDV." However, the rest of the reference stated that although validation was not complete the BVDV model is used by the field and accepted as a model. The Board explained, "Based on that acceptance, persons of skill in the art would expect that a drug that is shown to be effective against BVDV would reasonably be expected to also be effective against HCV."
The Examiner also objected to another claim that used the phrase "and at least one additional therapeutic agent" because it could be an infinite number of agents. The Examiner explained "“reliance on the term ‘at least one’ extends the possible number of ‘additional therapeutic agents’ to infinity, a circumstance which is clearly not enabled by the instant disclosure." The Board reversed finding that this is not sufficient evidence to show that it is not enabled and that the Examiner has not shown that it would require undue experimentation.
The Board Explained:
"The Examiner has provided no reasonable basis for concluding that a person of ordinary skill in the art could not have practiced the method of claim 6 without undue experimentation. The Examiner has posited a potentially inoperative embodiment encompassed by the claim but that by itself does not show nonenablement without evidence that the number of inoperative embodiments is so large that distinguishing between operative and inoperative embodiments would itself require undue experimentation. No such evidence has been presented."
All rejections were reversed.
Full opinion can be found here.
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