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In re Wands - 858 F.2d 731 (Fed. Cir. 1988)

Rule:

Factors to be considered in determining whether a disclosure would require undue experimentation include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.

Facts:

This appeal is from the decision of the Patent and Trademark Office (PTO) Board of Patent Appeals and Interferences (board) affirming the rejection of all remaining claims in appellant's application for a patent, serial No. 188,735, entitled "Immunoassay Utilizing Monoclonal High Affinity IgM Antibodies," which was filed September 19, 1980. The rejection under 35 U.S.C. § 112, first paragraph, is based on the grounds that appellant's written specification would not enable a person skilled in the art to make the monoclonal antibodies that are needed to practice the claimed invention without undue experimentation. Appellants contended that their written specifications fully enabled the practice of their claimed invention in accordance with 35 U.S.C.S. § 112 because the antibodies needed to perform the immunoassays could be made from readily available starting materials using methods that were well known in the antibody art. Respondent alleged that appellant's data presented that the production of antibodies was unpredictable and unreliable and that it would require undue experimentation for one skilled in the art to make the antibodies.

Issue:

Did the PTO Board err, as a matter of law, by sustaining the examiner's rejection for lack of enablement under 35 U.S.C. § 112, first paragraph, of all remaining claims in appellants' patent application, serial No. 188,735?

Answer:

Yes

Conclusion:

The court agreed with appellant, holding that respondent's interpretation of the data was erroneous. Appellant's written disclosure fully enabled the claimed invention. Respondent's classification of the stored cell lines as failures was strained and unduly harsh. Appellant's explanation of its initial failures was reasonable and in view of the fact that the following six fusions were successful, the court concluded that appellant effectively rebutted respondent's challenge to 35 U.S.C.S. § 112.

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