Overcoming Prior Art References Non-Enabling Prior Art References Gary Kunz SPE Art Unit 1616

Prior Art Reference is Presumed to be Enabled When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden shifts to the applicant to provide facts rebutting the presumption of operability. In re Sasse, 629 F.2d 675, 681 (Fed. Cir. 1980) See also MPEP

Meaning of “Enabling Disclosure” is Independent of the Type of Disclosure Level of disclosure required for a prior art reference to be an “enabling disclosure” is the same no matter what type of art is at issue It does not matter whether the prior art is a U.S. patent, foreign patent, or printed publication No basis in 35 USC 102 or 103 for discrimination either in favor of or against prior art references on the basis of nationality In re Moreton, 288 F.2d 708, 711, (CCPA 1961)

35 U.S.C 102 Reference Must Enable Without Undue Experimentation Elan Pharm., Inc. v. Mayo Foundation for Medical and Education Research, 346 F.3d 1051, 1054, (Fed. Cir. 2003) CAFC remanded the case back to the district court for determination of whether the prior art reference enabled persons of ordinary skill in the field to make the desired mutated mouse without undue experimentation,

Reference is Enabling if.... Public was in possession of the claimed invention “Such possession is effected if one of ordinary skill in the art could have combined the publication’s description of the invention with his [or her] own knowledge to make the claimed invention.” In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985)

35 U.S.C. 102 Rejections with Additional References Establishing Enablement An examiner may make a 35 U.S.C. 102 rejection over a reference which teaches every element of the invention but not does enable how to make or use. Secondary references may be used to establish public possession of the method of making and/or using. In re Donohue, 766 F.2d 531, 534 (Fed. Cir. 1985)

When the Reference Only Discloses the Structure of the Compound Lack of enabling disclosure may be established by evidence that attempts to make the compound were unsuccessful. In re Wiggins, 488 F.2d 538, 542 – 543 (CCPA 1973)

When the Reference Only Discloses the Structure of the Compound It is not necessary that an invention disclose under 35 U.S.C. 102 shall have actually been made in order to satisfy the enablement requirement. In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985)

When the Reference Only Discloses the Structure of the Compound In Donohue the examiner made a rejection 35 U.S.C. 102 over a publication which disclosed the compound along with two patents which taught a general process of preparing the specific class of compounds. Applicant provided an affidavit stating that the publication did not actually show the synthesis of the compound—deemed insufficient evidence to overcome rejection under 35 U.S.C. 102

35 U.S.C 103 Rejection Over Obvious Homologs In re Hoeksema, 399 F.2d 269 (CCPA 1968) The examiner rejected a claim to a compound using a patent (De Boer) which disclosed homologs and process of making them. Applicant overcame rejection with affidavit by expert who stated that the process disclosed in the patent could not be used to make the claimed compound.

What Constitutes Enabling Prior Art for Plants? When the claims are directed to plants, the reference combined with the knowledge in the prior art, must enable one of ordinary skill in the art to reproduce the plant. In re LeGrice, 301 F.2d 929 (CCPA 1962) The examiner rejected the claimed rose on the basis of a catalogue which only disclosed pictures of the plant and stated that the person had raised the roses.

What Constitutes Enabling Prior Art for Plants?(cont’d) In LeGrice there was no evidence of commercial availability in enabling form since the asexually reproduced rose could not be reproduced from seed. In contrast in Ex parte Thompson, 24 USPQ2d 1618 (Bd. Pat. App. & Inter. 1992) seeds were commercially available to grow the cotton cultivar.

Pictures May be Enabling Prior Art References Pictures and drawings may be enabling to put the public in the possession of the article pictured. However, the picture must show all of the claimed structural features and how they are put together. Jockmus v. Leviton, 28 F.2d 812 (2d Cir. 1928)

35 U.S.C. 102 Reference does not Require a Patentable Utility “[N]o utility need be disclosed for a reference to be anticipatory of a claim to an old compound.” In re Schoenwald, F.2d 1122, 1124 (Fed. Cir. 1992). It is enough that the claimed compound is taught by the reference.

Summary of Ways to Attack Prior Art References as Non- enabling Establish that the prior art tried and failed to make the compound Provide declaration by an expert that the disclosure of the reference, even with the knowledge in the art, was insufficient to permit the artisan to make the compound.