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2164

2164 The Enablement Requirement [R-2]
 
ARIAD, VAS-CATH
 
Recently, the Court of Appeals for the Federal Circuit decided en banc the scope and purpose of the written description requirement within the first paragraph of 35 U.S.C. § 112. The court reaffirmed that the written description requirement found in the first paragraph of 35 U.S.C. § 112 is separate and distinct from the enablement requirement of that provision. Ariad Pharms., Inc. v. Eli Lilly and Co. , --- F.3d ----, 2010 WL 1007369, at *12 (Fed. Cir. 2010) (citing Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-1563 (Fed. Cir. 1991)).
 
CFMT

“Enablement does not require an inventor to meet lofty standards for success in the commercial marketplace. Title 35 does not require that a patent disclosure enable one of ordinary skill in the art to make and use a perfected, commercially viable embodiment absent a claim limitation to that effect.” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1338 (Fed. Cir. 2003).

HYBRITECH 

Enablement is a legal determination of whether a patent enables one skilled in the art to make and use the claimed invention, is not precluded even if some experimentation is necessary, although the amount of experimentation needed must not be unduly extensive, and is determined as of the filing date of the patent application. . . . . Furthermore, a patent need not teach, and preferably omits, what is well known in the art. Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384, 231 USPQ 81 (Fed. Cir. 1986).  

2164.01 Test of Enablement [R-5]
 
LINDEMANN

The requirement for anticipation that the prior art elements themselves be “arranged as in the claim” means that claims cannot be “treated ... as mere catalogs of separate parts, in disregard of the part-to-part relationships set forth in the claims and that give the claims their meaning.” LindemannMaschinenfabrik GMBH v. Am. Hoist & Derrick Co., 730 F.2d 1452, 1458-59 (Fed. Cir. 1984).

WANDS
 
The test for compliance with the enablement requirement is whether the disclosure, as filed, is sufficiently complete to enable one of ordinary skill in the art to make and use the claimed invention without undue experimentation. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). Some experimentation, even a considerable amount, is not “undue” if, e.g., it is merely routine, or if the specification provides a reasonable amount of guidance as to the direction in which the experimentation should proceed. Id. (quoting Ex parte Jackson, 217 USPQ 804, 807 (Bd. App. 1982)).

VAECK

In determining whether any given disclosure would require undue experimentation to practice the claimed subject matter, the Examiner must consider not only the breadth of the claims, the amount of direction or guidance presented and the presence or absence of working examples, but also the nature of the invention, the state of the prior art, the relative skill of those in the art and the predictability or unpredictability of the art. In re Vaeck, 947 F.2d 488, 495 (Fed. Cir. 1991). 

UNDUE EXPERIMENTATION

ANGSTADT

It is well established that the Examiner has the “burden of giving reasons, supported by the record as a whole, why the [S]pecification is not enabling . . . Showing that the disclosure entails undue experimentation is part of the PTO’s initial burden.” In re Angstadt, 537 F.2d 498, 504 (CCPA 1976). 
 
2164.01(a) Undue Experimentation Factors
 
WANDS
 
The “undue experimentation” analysis involves the consideration of several factors, including: (1) the quantity of experimentation; (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. Wands, 858 F.2d at 737.

WRIGHT BILSTAD CHIRON PPG

The single embodiment would support such a generic claim only if the specification would "reasonably convey to a person skilled in the art that [the inventor] had possession of the claimed subject matter at the time of filing," Bilstad v. Wakalopulos, 386 F.3d 1116, 1125 (Fed. Cir. 2004), and would "enable one of ordinary skill to practice ‘the full scope of the claimed invention,’" Chiron Corp. v. Genentech, Inc., 363 F.3d 1247, 1253 (Fed. Cir. 2004), quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993); PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564 (Fed. Cir. 1996).
 
2164.01(b) How to Make the Claimed Invention
 
2164.01(c) How to Use the Claimed Invention
 
BRANA
 
“[T]he PTO has the initial burden of challenging a presumptively correct assertion of utility in the disclosure.” In re Brana, 51 F.3d 1560, 1566 (Fed. Cir. 1995). Thus, it is “[o]nly after the PTO provides evidence showing that one of ordinary skill in the art would reasonably doubt the asserted utility does the burden shift to the applicant to provide rebuttal evidence sufficient to convince such a person of the invention's asserted utility.” Id.
 
[T]he PTO has the initial burden of challenging a presumptively correct assertion of utility in the disclosure. Only after the PTO provides evidence showing that one of ordinary skill in the art would reasonably doubt the asserted utility does the burden shift to the applicant to provide rebuttal evidence sufficient to convince such a person of the invention’s asserted utility. In re Brana, 51 F.3d 1560, 1566 (Fed. Cir. 1995) (citation omitted).

“Enablement, or utility, is determined as of the application filing date.”
Id. at 1567 n.19. However, post-filing evidence “can be used to substantiate any doubts as to the asserted utility [when it] pertains to the accuracy of a statement already in the specification.” Id.

FISHER
 
In addition, “[i]t is well established that the enablement requirement of § 112 incorporates the utility requirement of § 101.” In re Fisher, 421 F.3d at 1378.
 
2164.02 Working Example
 
BORKOWSKI
 
It is well established that working examples are not required to comply with § 112, first paragraph. In re Borkowski, 422 F.2d 904, 908 (CCPA 1970).

2164.03 Relationship of Predictability of the Art and the Enablement Requirement
 
FISHER
 
Arts based on chemical reactions may be unpredictable. In re Fisher, 427 F.2d 833, 839 (C.C.P.A. 1970). “In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.” Id.
 
2164.04 Burden on the Examiner Under the Enablement Requirement
 
BUNDY
 
[T]he PTO has the initial burden of challenging a presumptively correct assertion of utility in the disclosure. . . . Only after the PTO provides evidence showing that one of ordinary skill in the art would reasonably doubt the asserted utility does the burden shift to the applicant to provide rebuttal evidence sufficient to convince such a person of the invention’s asserted utility. See In re Bundy, 642 F.2d 430, 433 (CCPA 1981).
 
MARZOCCHI

However, the enablement requirement does not require definitive data.  Instead,

a specification disclosure which contains a teaching of the manner and process of making and using the invention in terms which correspond in scope to those used in describing and defining the subject matter sought to be patented must be taken as in compliance with the enabling requirement of the first paragraph of § 112 unless there is reason to doubt the objective truth of the statements contained therein which must be relied on for enabling support.

In re Marzocchi, 439 F.2d 220, 223 (CCPA 1971) (emphasis in original).

WRIGHT, MARZOCCHI
 
When rejecting a claim for lack of enablement, “the [United States Patent and Trademark Office] bears an initial burden of setting forth a reasonable explanation as to why it believes that the scope of protection provided by that claim is not adequately enabled by the description of the invention provided in the specification of the application ….” In re Wright, 999 F.2d 1557, 1561-62 (Fed. Cir. 1993) (citing In re Marzocchi, 439 F.2d 220, 223-24 (CCPA 1971)).
 
“[I]t is incumbent upon the Patent Office . . . to explain why it doubts the truth or accuracy of any statement in a supporting disclosure and to back up assertions of its own with acceptable evidence or reasoning which is inconsistent with the contested statement.” Id. at 224. In other words, the PTO bears an initial burden of setting forth a reasonable explanation as to why it believes that the scope of protection provided by that claim is not adequately enabled by the description of the invention provided in the specification . . . this includes . . . providing sufficient reasons for doubting any assertions in the specification as to the scope of enablement.

In re Wright, 999 F.2d 1557, 1561-1562 (Fed. Cir. 1993).

2164.05 Determination of Enablement Based on Evidence as a Whole

2164.05(a) Specification Must Be Enabling as of the Filing Date
 
HOGAN
 
"Enablement is determined as of the effective filing date of the patent, In re Hogan, 559 F.2d 595, 604 (CCPA 1977)." Plant Genetic Systems, N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1339 (Fed. Cir. 2003). See also Enzo Biochem Inc. v. Calgene Inc., 188 F.3d 1362, 1371 (Fed. Cir. 1999).
 
A later state of the art cannot be relied on as evidence that a claimed invention was not enabled as of its filing date. See In re Hogan, 559 F.2d 595, 606 (CCPA 1977) (“Appellants disclosed, as the only then existing way to make [the claimed ‘solid polymer’], a method of making the crystalline form. To now say that appellants should have disclosed in 1953 the amorphous form which on this record did not exist until 1962, would be to impose an impossible burden on inventors and thus on the patent system.”). 

2164.05(b) Specification Must Be Enabling to Persons Skilled in the Art

2164.06 Quantity of Experimentation
 
WANDS
 
Some experimentation, even a considerable amount, is not “undue” if, e.g., it is merely routine, or if the specification provides a reasonable amount of guidance as to the direction in which the experimentation should proceed. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
 
2164.06(a) Examples of Enablement Issues-Missing Information

UNION PACIFIC

A claim satisfies the definiteness requirement of 35 U.S.C. § 112, second paragraph, when one skilled in the art understands the claim parameters as read in light of the specification. BJ Servs. Co. v. Halliburton Energy Servs., Inc. 338 F.3d 1368, 1372 (Fed. Cir. 2003) (quoting Union Pac. Res. Co. v. Chesapeake Energy Corp., 236 F.3d 684, 692 (Fed. Cir. 2001) (“The definiteness inquiry focuses on whether those skilled in the art would understand the scope of the claim when the claim is read in light of the rest of the specification.”)).

 
2164.06(b) Examples of Enablement Issues - Chemical Cases
 
COLE

SCHULZE

“Argument in the brief does not take the place of evidence in the record.” In re Schulze, 346 F.2d 600, 602 (CCPA 1965) (citing In re Cole, 326 F.2d 769, 773 (CCPA 1964)). 

2164.06(c) Examples of Enablement Issues - Computer Programming Cases [R-5]
 
2164.07 Relationship of Enablement Requirement to Utility Requirement of 35 U.S.C. 101

BRANA

“[T]he PTO has the initial burden of challenging a presumptively correct assertion of utility in the disclosure.” In re Brana, 51 F.3d 1560, 1566 (Fed. Cir. 1995). Thus, it is “[o]nly after the PTO provides evidence showing that one of ordinary skill in the art would reasonably doubt the asserted utility does the burden shift to the applicant to provide rebuttal evidence sufficient to convince such a person of the invention's asserted utility.” Id.
 
[T]he PTO has the initial burden of challenging a presumptively correct assertion of utility in the disclosure. Only after the PTO provides evidence showing that one of ordinary skill in the art would reasonably doubt the asserted utility does the burden shift to the applicant to provide rebuttal evidence sufficient to convince such a person of the invention’s asserted utility. In re Brana, 51 F.3d 1560, 1566 (Fed. Cir. 1995) (citation omitted).

“Enablement, or utility, is determined as of the application filing date.”
Id. at 1567 n.19. However, post-filing evidence “can be used to substantiate any doubts as to the asserted utility [when it] pertains to the accuracy of a statement already in the specification.” Id.

FISHER
 
In addition, “[i]t is well established that the enablement requirement of § 112 incorporates the utility requirement of § 101.” In re Fisher, 421 F.3d at 1378.
 
2164.08 Enablement Commensurate in Scope With the Claims [R-2]

AK STEEL CORP

AK Steel Corp., 344 F.3d at 1244 ("as part of the quid pro quo of the patent bargain, the applicant's specification must enable one of ordinary skill in the art to practice the full scope of the claimed invention").

AMGEN

Further, the Federal Circuit has instructed:

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.

Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir. 2003) (footnotes omitted).

BUCHNER

In re Buchner, 929 F.2d 660, 661 (Fed. Cir. 1991) (A patent need not teach, and preferably omits, what is well known in the art).

GOFFE 

“The mere fact that the claims cover a large number of possible process steps and imaging member materials does not in and of itself make the claims indefinite.” In re Goffe, 188 USPQ 131 (C.C.P.A. 1975), citing In re Skoll, 523 F.2d 1392 (CCPA 1975).

JOHNSON
 
The fact that a claim does not contain further limiting language is a matter of breadth, not indefiniteness. See In re Johnson, 558 F.2d 1008, 1016 n.17 (CCPA 1977).

VAECK

In determining whether any given disclosure would require undue experimentation to practice the claimed subject matter, the Examiner must consider not only the breadth of the claims, the amount of direction or guidance presented and the presence or absence of working examples, but also the nature of the invention, the state of the prior art, the relative skill of those in the art and the predictability or unpredictability of the art. In re Vaeck, 947 F.2d 488, 495 (Fed. Cir. 1991). 
 
2164.08(a) Single Means Claim

HYATT

As the Federal Circuit noted in Hyatt, “[t]he long-recognized problem with a single means claim is that it covers every conceivable means for achieving the stated result, while the specification discloses at most only those means known to the inventor.” 708 F.2d at 714.


2164.08(b) Inoperative Subject Matter

ANGSTADT, ATLAS POWDER

However, it is well settled that a claim does not lack enablement merely because it encompasses inoperative embodiments. See Atlas Powder Co. v. E.I. du Pont De Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984); see also In re Angstadt, 537 F.2d 498 (CCPA 1976).
 
2164.08(c) Critical Feature Not Claimed

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