2121 Prior Art; General Level of Operability Required to Make a Prima Facie Case [R-08.2012]
I. PRIOR ART IS PRESUMED TO BE OPERABLE/ENABLING
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 is on applicant to provide facts rebutting the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). See also MPEP § 716.07.
II. WHAT CONSTITUTES AN “ENABLING DISCLOSURE” DOES NOT DEPEND ON THE TYPE OF PRIOR ART THE DISCLOSURE IS CONTAINED IN
The level of disclosure required within a reference to make it an “enabling disclosure” is the same no matter what type of prior art is at issue. It does not matter whether the prior art reference is a U.S. patent, foreign patent, a printed publication or other. There is no basis in the statute (35 U.S.C. 102 or 103) for discriminating either in favor of or against prior art references on the basis of nationality. In re Moreton, 288 F.2d 708, 129 USPQ 227 (CCPA 1961).
III. EFFICACY IS NOT A REQUIREMENT FOR PRIOR ART ENABLEMENT
A prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation." Impax Labs. Inc. v. Aventis Pharm.Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006). See also MPEP § 2122.
2121.01 Use of Prior Art in Rejections Where Operability is in Question [R-08.2012]
“In determining that quantum of prior art disclosure which is necessary to declare an applicant’s invention ‘not novel’ or ‘anticipated’ within section 102, the stated test is whether a reference contains an ‘enabling disclosure’... .” In reHoeksema, 399 F.2d 269, 158 USPQ 596 (CCPA 1968). The disclosure in an assertedly anticipating reference must provide an enabling disclosure of the desired subject matter; mere naming or description of the subject matter is insufficient, if it cannot be produced without undue experimentation. Elan Pharm., Inc. v. Mayo Found. For Med. Educ. & Research, 346 F.3d 1051, 1054, 68 USPQ2d 1373, 1376 (Fed. Cir. 2003) (At issue was whether a prior art reference enabled one of ordinary skill in the art to produce Elan’s claimed transgenic mouse without undue experimentation. Without a disclosure enabling one skilled in the art to produce a transgenic mouse without undue experimentation, the reference would not be applicable as prior art.). A reference contains an “enabling disclosure” if the public was in possession of the claimed invention before the date of 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, 226 USPQ 619 (Fed. Cir. 1985).
I. 35 U.S.C. 102 REJECTIONS AND ADDITION OF EVIDENCE SHOWING REFERENCE IS OPERABLE
It is possible to make a 35 U.S.C. 102 rejection even if the reference does not itself teach one of ordinary skill how to practice the invention, i.e., how to make or use the article disclosed. If the reference teaches every claimed element of the article, secondary evidence, such as other patents or publications, can be cited to show public possession of the method of making and/or using. In re Donohue, 766 F.2d at 533, 226 USPQ at 621. See MPEP § 2131.01 for more information on 35 U.S.C. 102 rejections using secondary references to show that the primary reference contains an “enabling disclosure.”
II. 35 U.S.C. 103 REJECTIONS AND USE OF INOPERATIVE PRIOR ART
“Even if a reference discloses an inoperative device, it is prior art for all that it teaches.” Beckman Instrumentsv.LKB Produkter AB, 892 F.2d 1547, 1551, 13 USPQ2d 1301, 1304 (Fed. Cir. 1989). Therefore, “a non-enabling reference may qualify as prior art for the purpose of determining obviousness under 35 U.S.C. 103.” Symbol Techs. Inc. v. Opticon Inc., 935 F.2d 1569, 1578, 19 USPQ2d 1241, 1247 (Fed. Cir. 1991).
2121.02 Compounds and Compositions — What Constitutes Enabling Prior Art [R-08.2012]
[Editor Note: This MPEP section is applicable to applications subject to the first inventor to file (FITF) provisions of the AIA except that the relevant date is the "effective filing date" of the claimed invention instead of the "time of the invention" or "date of invention," which are only applicable to applications subject to pre-AIA 35 U.S.C. 102. See 35 U.S.C. 100 (note) and MPEP § 2150 et seq.]
I. ONE OF ORDINARY SKILL IN THE ART MUST BE ABLE TO MAKE OR SYNTHESIZE
Where a process for making the compound is not developed until after the date of invention, the mere naming of a compound in a reference, without more, cannot constitute a description of the compound. In re Hoeksema, 399 F.2d 269, 158 USPQ 596 (CCPA 1968). Note, however, that a reference is presumed operable until applicant provides facts rebutting the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). Therefore, applicant must provide evidence showing that a process for making was not known at the time of the invention. See the following subsection for the evidentiary standard to be applied.
II. A REFERENCE DOES NOT CONTAIN AN “ENABLING DISCLOSURE” IF ATTEMPTS AT MAKING THE COMPOUND OR COMPOSITION WERE UNSUCCESSFUL BEFORE THE DATE OF INVENTION
When a prior art reference merely discloses the structure of the claimed compound, evidence showing that attempts to prepare that compound were unsuccessful before the date of invention will be adequate to show inoperability. In re Wiggins, 488 F.2d 538, 179 USPQ 421 (CCPA 1971). However, the fact that an author of a publication did not attempt to make the compound disclosed, without more, will not overcome a rejection based on that publication. In re Donohue, 766 F.2d 531, 226 USPQ 619 (Fed. Cir. 1985) (In this case, the examiner had made a rejection under pre-AIA 35 U.S.C. 102(b) over a publication, which disclosed the claimed compound, in combination with two patents teaching a general process of making the particular class of compounds. The applicant submitted an affidavit stating that the authors of the publication had not actually synthesized the compound. The court held that the fact that the publication’s author did not synthesize the disclosed compound was immaterial to the question of reference operability. The patents were evidence that synthesis methods were well known. The court distinguished Wiggins, in which a very similar rejection was reversed. In Wiggins, attempts to make the compounds using the prior art methods were all unsuccessful.). Compare In re Hoeksema, 399 F.2d 269, 158 USPQ 596 (CCPA 1968) (A claim to a compound was rejected over a patent to De Boer which disclosed compounds similar in structure to those claimed (obvious homologs) and a process of making these compounds. Applicant responded with an affidavit by an expert named Wiley which stated that there was no indication in the De Boer patent that the process disclosed in De Boer could be used to produce the claimed compound and that he did not believe that the process disclosed in De Boer could be adapted to the production of the claimed compound. The court held that the facts stated in this affidavit were legally sufficient to overcome the rejection and that applicant need not show that all known processes are incapable of producing the claimed compound for this showing would be practically impossible.).
2121.03 Plant Genetics — What Constitutes Enabling Prior Art [R-08.2012]
THOSE OF ORDINARY SKILL MUST BE ABLE TO GROW AND CULTIVATE THE PLANT
When the claims are drawn to plants, the reference, combined with knowledge in the prior art, must enable one of ordinary skill in the art to reproduce the plant. In reLeGrice, 301 F.2d 929, 133 USPQ 365 (CCPA 1962) (National Rose Society Annual of England and various other catalogues showed color pictures of the claimed roses and disclosed that applicant had raised the roses. The publications were published more than 1 year before applicant's filing date. The court held that the publications did not place the rose in the public domain. Information on the grafting process required to reproduce the rose was not included in the publications and such information was necessary for those of ordinary skill in the art (plant breeders) to reproduce the rose.). Compare Ex parteThomson, 24 USPQ2d 1618 (Bd. Pat. App. & Inter. 1992) (Seeds were commercially available more than 1 year prior to applicant’s filing date. One of ordinary skill in the art could grow the claimed cotton cultivar from the commercially available seeds. Thus, the publications describing the cotton cultivar had “enabled disclosures.” The Board distinguished In re LeGrice by finding that the catalogue picture of the rose of In re LeGrice was the only evidence in that case. There was no evidence of commercial availability in enabling form since the asexually reproduced rose could not be reproduced from seed. Therefore, the public would not have possession of the rose by its picture alone, but the public would have possession of the cotton cultivar based on the publications and the availability of the seeds.). In In re Elsner, 381 F.3d 1125, 1126, 72 USPQ2d 1038, 1040 (Fed. Cir. 2004), prior to the critical date of a plant patent application, the plant had been sold in Germany and a foreign Plant Breeder’s Rights (PBR) application for the same plant had been published in the Community Plant Variety Office Official Gazette. The court held that when (i) a publication identifies claimed the plant, (ii) a foreign sale occurs that puts one of ordinary skill in the art in possession of the plant itself, and (iii) such possession permits asexual reproduction of the plant without undue experimentation to one of ordinary skill in the art, then that combination of facts and events directly conveys the essential knowledge of the invention and constitutes a pre-AIA 35 U.S.C. 102(b) statutory bar.Id. at 1129, 72 USPQ2d at 1041. Although the court agreed with the Board that foreign sales may enable an otherwise non-enabling printed publication, the case was remanded for additional fact-finding in order to determine if the foreign sales of the plant were known to be accessible to the skilled artisan and if the skilled artisan could have reproduced the plant asexually after obtaining it without undue experimentation. Id. at 1131, 72 USPQ2d at 1043.
2121.04 Apparatus and Articles — What Constitutes Enabling Prior Art [R-08.2012]
PICTURES MAY CONSTITUTE AN “ENABLING DISCLOSURE”
Pictures and drawings may be sufficiently enabling to put the public in the possession of the article pictured. Therefore, such an enabling picture may be used to reject claims to the article. However, the picture must show all the claimed structural features and how they are put together. Jockmus v. Leviton, 28 F.2d 812 (2d Cir. 1928). See also MPEP § 2125 for a discussion of drawings as prior art.