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]

CALLICRATE

However “a patent specification may sufficiently enable a feature under § 112, ¶ 1, even if only the background section provides the enabling disclosure.” Callicrate v. Wadsworth Mfg., Inc., 427 F.3d 1361, 1374 (Fed. Cir. 2005).

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).

MINERALS

The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Minerals Separation v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).

TELETRONICS

The test for enablement is whether a person of ordinary skill in the art "could make or use the invention from the disclosures in the patent coupled with information known in the art without undue experimentation." United States v. Telectronics, Inc., 857 F.2d 778, 785 (Fed. Cir. 1988).

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).

When interpreting claims, all limitations must be given effect. See In re Angstadt, 537 F.2d 498, 501 (CCPA 1976) (“we must give effect to all claim limitations”).

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

For questions of enablement, the Federal Circuit has held that “the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993) (emphasis added).

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

BRESLOW

We are aware of no legal authority requiring that a specification enable a final product when a claim is directed to a transitory product. Rather, the Manual of Patent Examining Procedure (“MPEP”) instructs that “for unstable and transitory chemical intermediates, the ‘how to make’ requirement [of 35 U.S.C. § 112, first paragraph] does not require that the applicant teach how to make the claimed product in stable, permanent or isolatable form.” MPEP § 2164.01(b) (9th ed.) (July 2015 revision) (citing In re Breslow, 616 F.2d 516, 521 (CCPA 1980) (reversing rejections under 35 U.S.C. §§ 101 and 112, first paragraph, for lack of enablement and holding that chemical intermediates are patentable compositions of matter under § 101 even if they are “transitory, unstable, and non-isolatable”).

...

In this case, as in Breslow, the claimed golf ball cover, while temporary, does exist. Breslow, 616 F.2d at 518, 521 (the court noting that in the enablement rejection, the board “was too literal about the need for the artisan to be in possession of the claimed compounds in the sense of hold them for a time in his hands in a ‘reasonable stable’ form”)

FISHER

See In re Fisher, 427 F.2d 833, 839 (CCPA 1970) ("In cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific laws.")

SPECTRA-PHYSICS

Appellant cites Spectra-Physics, Inc. v. Coherent, Inc., which states:

If an invention pertains to an art where the results are predictable, . . . a broad claim can be enabled by disclosure of a single embodiment . . . and is not invalid for lack of enablement simply because it read on another embodiment of the invention which is inadequately disclosed. Id. (citing 827 F.2d 1524, 1533 (Fed. Cir. 1987) (internal citations omitted)).

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).

“[T]here is no magical relation between the number of representative examples and the breadth of the claims; the number and variety of examples are irrelevant if the disclosure is ‘enabling.’” In re Borkowski, 422 F.2d 904, 910 (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.

VICKERS, COOK2, ETHICON

A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526–27 (CCPA 1944); In re Cook, 439 F.2d 730, 734 (CCPA 1971).

See Ethicon Endo-Surgery, Inc. v. U.S. SurgicalCorp., 93 F.3d 1572, 1582 n.7 (Fed. Cir. 1996), citing In re Vickers, 141 F.2d 522, 525 (CCPA 1944) (“an applicant . . . is generally allowed claims, when the art permits, which cover more than the specific embodiment shown” (emphasis omitted)).

2164.04 Burden on the Examiner Under the Enablement Requirement

BOWEN

Cf. In re Bowen, 492 F.2d 859, 862 (Cust. & Pat. App. 1974) (“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.”).

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

LINDEMANN

Moreover, the Examiner does not sufficiently explain how the applied prior art as a whole suggests the desirability of the Marshall-Dean-Floyd combination. See Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick Co., 730 F.2d 1452, 1462 (Fed. Cir. 1984) ("The claimed invention must be considered as a whole, and the question is whether there is something in the prior art as a whole to suggest the desirability, and thus the obviousness, of making the combination.")

WRIGHT

Declarations fail in their purpose when they merely make unsupported conclusory statements. See in re Wright, 999 F.2d 1557, 1563 (Fed. Cir. 1993) and In re Brandstadter, 484 F.2d 1395, 1405 (CCPA 1973).

2164.05(a) Specification Must Be Enabling as of the Filing Date

GUNN

Feldman 2010, van Holten, and Vierboom are post filing date art. However, references that are published “after the filing date of appellant’s application . . . are not, therefore, evidence of subject matter known to ‘any person skilled in the art’ as required by 35 U.S.C. § 112, paragraph 1.” In re Gunn, 537 F.2d 1123, 1128 (CCPA 1976).

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

I. ELECTRICAL AND MECHANICAL DEVICES OR PROCESSES

MAGSIL

[a] generic recitation of an algorithm is clearly not enabling for all types of algorithms, given the complexities associated with the differing types of algorithms. MagSil Corp. v. Hitachi Global Storage Technologies, Inc., 687 F.3d 1377, 103 USPQ2d 1769 (Fed. Cir. 2012)

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.”)).

“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 [S]pecification. Even if the written description does not enable the claims, the claim language itself may still be definite.” Union Pacific Resources Co. v. Chesapeake Energy Corp., 236 F.3d 684, 692, (Fed. Cir. 2001) (citation omitted).

II. MICROORGANISMS

III. DRUG CASES

2164.06(b) Examples of Enablement Issues - Chemical Cases

I. SEVERAL DECISIONS RULING THAT THE DISCLOSURE WAS NONENABLING

(A) ENZO

In order for the specification to be enabling, it “must adequately disclose the claimed invention so as to enable a person skilled in the art to practice the invention at the time the application was filed without undue experimentation.” In re Swartz, 232 F.3d 862, 863 (Fed. Cir. 2000) citing, Enzo-Biochem, Inc. v Calgene, Inc., 188 F.3d 1362, 1371–72 (Fed. Cir. 1999).

Whether making and using the claimed invention would have required undue experimentation, such that claims were not sufficiently enabled by the Specification, is a legal conclusion based upon underlying facts. In re Goodman, 11 F.3d 1046, 1049–50 (Fed. Cir. 1993).

II. SEVERAL DECISIONS RULING THAT THE DISCLOSURE WAS ENABLING

III. AFFIDAVIT PRACTICE (37 CFR 1.132)

IV. REFERENCING PRIOR ART DOCUMENTS

V. ARGUMENTS OF COUNSEL

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]

BRANDSTADTER

2164.07 Relationship of Enablement Requirement to Utility Requirement of 35 U.S.C. 101

I. WHEN UTILITY REQUIREMENT IS NOT SATISFIED

A.Not Useful or Operative

B.Burden on the Examiner

Examiner Has Initial Burden To Show That One of Ordinary Skill in the Art Would Reasonably Doubt the Asserted Utility

BRANA

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.

SWARTZ

“To satisfy the enablement requirement of § 112, ¶ 1, a patent application must adequately disclose the claimed invention so as to enable a person skilled in the art to practice the invention at the time the application was filed without undue experimentation.” In re Swartz, 232 F.3d 862, 863 (Fed. Cir. 2000)

C.Rebuttal by Applicant

II. WHEN UTILITY REQUIREMENT IS SATISFIED

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).

But “it is the function of the specification, not the claims, to set forth the ‘practical limits of operation’ of an invention.” In re Johnson, 558 F.2d 1008, 1017 (CCPA 1977) (citing In re Rainer, 305 F.2d 505, 509 (CCPA 1962)). In other words, contrary to the Examiner’s assertions, “[o]ne does not look to claims to find out how to practice the invention they define, but to the specification.” Id. (citing Roberts, 470 F.2d at 1403; In re Fuetterer, 319 F.2d 259 (CCPA 1963)).

PLANT GENETC

However, it is well settled that the “use of later publications as evidence of the state of art existing on the filing date of an application” is permissible (id.). See Plant Genetic Systems, N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1344 (Fed. Cir. 2003) (“Report of a first success after 1987 indicates failure or difficulty in or before 1987.

VAECK

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).

ATLAS POWDER

Even if some of the claimed combinations were inoperative, the claims are not necessarily invalid. "It is not a function of the claims to specifically exclude ... possible inoperative substances...." Of course, if the number of inoperative combinations becomes significant, and in effect forces one of ordinary skill in the art to experiment unduly in order to practice the claimed invention, the claims might indeed be invalid.

Atlas Powder Co. v. E.I. du Pont De Nemours & Co., 750 F.2d 1569, 1576-77 (Fed. Cir. 1984) (quoting In re Dinh-Nguyen, 492 F.2d 856, 858-59 (CCPA 1974) (emphasis omitted)).

2164.08(c) Critical Feature Not Claimed