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2121

2121 Prior Art; General Level of Operability Required to Make a Prima Facie Case [R-6]

 

>I.    < PRIOR ART IS PRESUMED TO BE OPERABLE/ENABLING

GRAVES

LEGRICE

A reference anticipates a claim if it discloses the claimed invention “such that a skilled artisan could take its teachings in combination with his own knowledge of the particular art and be in possession of the invention.” See In re Graves, 69 F.3d 1147, 1152 (Fed. Cir. 1995) (quoting In re LeGrice, 301 F.2d 929, 936 (CCPA 1962)).

See In re Graves, 69 F.3d 1147, 1152 (Fed. Cir. 1995) (citing In re LeGrice, 301 F.2d 929, 936 (CCPA 1962))
(confirming the longstanding interpretation that the teachings of a reference may be taken in combination with knowledge of the skilled artisan to put the artisan in possession of the claimed invention even though the patent does not specifically disclose certain features.).

SASSE

In patent prosecution the examiner is entitled to reject application claims as anticipated by a prior art patent without conducting an inquiry into whether or not that patent is enabled or whether or not it is the claimed material (as opposed to the unclaimed disclosures) in that patent that are at issue. In re Sasse, 629 F.2d 675, 681, 207 USPQ 107, 111 (C.C.P.A.1980) (“[W]hen the PTO cited a disclosure which expressly anticipated the present invention . . . the burden was shifted to the applicant. He had to rebut the presumption of the operability of [the prior art patent] by a preponderance of the evidence.”). The applicant, however, can then overcome that rejection by proving that the relevant disclosures of the prior art patent are not enabled. Id. 
 
In re Sasse, 629 F.2d 675, 681 (CCPA 1980) (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, and the appellant must rebut this presumption with a preponderance of evidence)

>II.    < WHAT CONSTITUTES AN "ENABLING DISCLOSURE" DOES NOT DEPEND ON THE TYPE OF PRIOR ART THE DISCLOSURE IS CONTAINED IN

>III.    EFFICACY IS NOT A REQUIREMENT FOR PRIOR ART ENABLEMENT

IMPAX

Although Andersson might not exemplify an article with both the required particle size and homogenous distribution, “anticipation does not require actual performance of suggestions in a disclosure. Rather, anticipation only requires that those suggestions be enabled to one of skill in the art.” Impax Labs., Inc. v. Aventis Pharms. Inc., 468 F.3d 1366, 1382 (Fed. Cir. 2006).

It has also been held that “proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation.” Impax Labs. Inc. v. Aventis Pharms. Inc., 468 F.3d 1366, 1383 (Fed. Cir. 2006). “Rather, the proper issue is whether the . . . patent is enabling in the sense that it describes the claimed invention sufficiently to enable a person of ordinary skill in the art to carry out the invention.” Id. at 1383.

2121.01 Use of Prior Art in Rejections Where Operability Is in Question [R-3]

ELAN

A reference that is not enabled may not act as anticipatory prior art. Elan Pharm., Inc. v. Mayo Found. For Med. Educ. & Research, 346 F.3d 1051, 1054 (Fed. Cir 2003). 

To benefit from the prior filing date, [a] provisional must provide adequate written description under 35 U. S.C. 112, first paragraph. Trading Technologies Int 'l. v. Espeed, Inc., 595 F.3d 1340, 1359 (Fed. Cir. 2010). Further, "To serve as an anticipating reference, the reference must enable that which it is asserted to anticipate." Elan Pharmaceuticals, Inc. v. Mayo Foundation for Medical Educ. and Research, 346 F.3d 1051, 1054 (Fed. Cir. 2003); see In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985).

I.    35 U.S.C. 102 REJECTIONS AND ADDITION OF EVIDENCE SHOWING REFERENCE IS OPERABLE

II.    35 U.S.C. 103 REJECTIONS AND USE OF INOPERATIVE PRIOR ART

BECKMAN

SYMBOL TECHS

In particular, "a non-enabling reference may qualify as prior art for the purposed of determining obviousness under § 103." Symbol Techs. v. Opticon, Inc., 935 F.2d 1569, 1578 (Fed. Cir. 1991). In this regard, "[e]ven if a reference discloses an inoperative device, it is prior art for all that it teaches." Beckman Instruments, Inc. v. LKB Produkter AB, 892 F.2d 1547, 1551 (Fed.Cir.1989).

However, “[e]ven if a reference discloses an inoperative device, it is prior art for all that it teaches.” Beckman Instruments, Inc. v. LKB Produckter AB, 892 F.2d 1547, 1551 (Fed. Cir. 1989). "While a reference must enable someone to practice the invention in order to anticipate under §102(b), a non-enabling reference may qualify as prior art for the purpose of determining obviousness under § 103." Symbol Tech. v. Opticon, Inc., 935 F.2d 1569, 1578 (Fed. Cir. 1991).
 
2121.02   Compounds and Compositions — What Constitutes Enabling Prior Art [R-3]
 
I.    < ONE OF ORDINARY SKILL IN THE ART MUST BE ABLE TO MAKE OR SYNTHESIZE
>
Prior art in presumed to be enablng, but this presumption can be overcome by evidence that a process for making a claimed composition was unknown in the art at the time of the invention of that composition.  In re Sasse, 629 F.2d 675, 681 (CCPA 1980); In re Hoeksema, 399 F.2d 269, 274 (CCPA 1968).
 
II.    < A REFERENCE DOES NOT CONTAIN AN “ENABLING DISCLOSURE” IF ATTEMPTS AT MAKING THE COMPOUND OR COMPOSITION WERE UNSUCCESSFUL BEFORE THE DATE OF INVENTION
>
 
[F]ailures by those skilled in the art (having possession of the information disclosed by the publication) are strong evidence that the disclosure of the publication was nonenabling. By contrast, the fact that the author of a publication did not attempt to make his disclosed invention does not indicate one way or the other whether the publication would have been enabling.

In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985) (emphasis added).  
 
2121.03   Plant Genetics — What Constitutes Enabling Prior Art [R-3]
 
THOSE OF ORDINARY SKILL MUST BE ABLE TO GROW AND CULTIVATE THE PLANT
 
As with utility patents, “only an ‘enabling’ publication is effective as a bar [under 35 U.S.C. § 102(b)] to a subsequent [plant] patent.” In re LeGrice, 301 F.2d 929, 1138 (CCPA 1962). However, “evidence of [a] foreign sale of a claimed reproducible plant variety may enable an otherwise non-enabled printed publication disclosing that plant, thereby creating a § 102(b) bar.” In re Elsner, 381 F.3d 1125, 1128 (Fed. Cir. 2004). In particular,

 [w]hen a publication identifies the plant that is invented or discovered and a foreign sale occurs that puts one of ordinary skill in the art in possession of the plant itself, which, based on the level of ordinary skill in the art, permits asexual reproduction without undue experimentation, that combination of facts and events so directly conveys the essential knowledge of the invention that the sale combines with the publication to erect a statutory bar.

 Id. at 1129.

“[T]he precise focus of the analysis is not whether the foreign sales are themselves § 102(b) prior art, but whether the publication has placed the claimed invention in the possession of the public before the critical date.” Id. at 1129-30. In this regard, the Elsner court explained that “[t]he foreign sale must not be an obscure, solitary occurrence that would go unnoticed by those skilled in the art. Its availability must have been known in the art, just as a printed publication must be publicly available.” Id. at 1131. In addition, the Elsner court explained that, “even if the interested public would readily know of the foreign sales, those sales [must] enable[ ] one of ordinary skill in the art to reproduce the claimed plants without undue experimentation.” Id.

2121.04   Apparatus and Articles — What Constitutes Enabling Prior Art
 
PICTURES MAY CONSTITUTE AN “ENABLING DISCLOSURE”

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