Appeal No. 2001-1263 Page 9
Application No. 08/475,955
significant respects. First, the linear epitope must be a peptide of less than 40 amino
acids. Those 39 amino acids then can comprise an amino acid sequence capable of
binding to an autoantibody consisting of the specified La/SSB epitopes.
The examiner’s concern in this rejection is that “there is no specific disclosure as
to what those additional amino acids will to do [sic] antibody binding.” Examiner’s
Answer, page 6. The examiner relies upon Colman for its disclosure that single amino
acid change can “dramatically effect antigen-antibody dynamics.” Id.
If we understand the examiner’s position, it is that it would require undue
experimentation in order to determine which peptides as defined in claim 1 on appeal
possess the required binding property. The question of undue experimentation was
discussed in PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564, 37
USPQ2d 1618, 1623 (Fed. Cir. 1996) as follows:
In unpredictable art areas, this court has refused to find broad generic claims
enabled by specifications that demonstrate the enablement of only one or a few
embodiments and do not demonstrate with reasonable specificity how to make
and use other potential embodiments across the full scope of the claim. See,
e.g., In re Goodman, 11 F.3d 1046, 1050-52, 29 USPQ2d 2010, 2013-15 (Fed.
Cir. 1993); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d. 1200, 1212-14,
18 USPQ2d 1016, 1026-28 (Fed. Cir.), cert. denied, 502 U.S. 856 (1991); In re
Vaeck, 947 F.2d at 496, 20 USPQ2d at 1445. Enablement is lacking in those
cases, the court has explained, because the undescribed embodiments cannot
be made, based on the disclosure in the specification, without undue
experimentation. But the question of undue experimentation is a matter of
degree. The fact that some experimentation is necessary does not preclude
enablement; what is required is that the amount of experimentation “must not be
unduly extensive.” Atlas Powder Co., v. E.I. DuPont De Nemours & Co., 750
F.2d 1569, 1576, 224 USPQ 409, 413 (Fed. Cir. 1984). The Patent and
Trademark Office Board of Appeals summarized the point well when it stated:
The test is not merely quantitative, since a considerable
amount of experimentation is permissible, if it is merely
routine, or if the specification in question provides a
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