Appeal No. 1997-2372
Application 08/083,945
appealed claims as to enable one skilled in the pertinent art to make and use the claimed
invention.
In order to establish a prima facie case of non-enablement, the examiner must
provide a reasonable explanation as to why the scope of protection provided by a claim is
not adequately enabled by the disclosure. See In re Wright, 999 F.2d 1557,
1561-62, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). The threshold step in resolving this
issue is to determine whether the examiner has met his burden of proof by advancing
acceptable reasoning inconsistent with enablement.
In the present case, it is the examiner’s position that the specification does not set
forth sufficient guidance and teachings to enable how to make and/or use fragments,
variants and alleles of the polypeptide corresponding to SEQ ID NO:7 (AAMP-1
polypeptide) without undue experimentation. Examiner’s answer, page 7, lines 21-24. In
addition, the examiner argues that the specification does not enable a method of purifying
heparin by binding to AAMP-1 without undue experimentation and lacks enablement for
recovering heparin from solution which would be implied in a method of purification.
Examiner’s answer, page 5, lines 13-21. We agree with the examiner up to a point.
Factors to be considered by the examiner in determining whether a disclosure
would require undue experimentation have been summarized by the board in Ex parte
Forman, 230 USPO 546, 547 (Bd. Pat. App. & Int. 1986). They include (1) the quantity of
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