2161 Three Separate Requirements for Specification Under 35 U.S.C. 112, First Paragraph

THE SPECIFICATION MUST INCLUDE A WRITTEN DESCRIPTION OF THE INVENTION, ENABLEMENT, AND BEST MODE OF CARRYING OUT THE CLAIMED INVENTION

35 U.S.C. 112(a) (applicable to applications filed on or after September 16, 2012) provides:

(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.

The first paragraph of pre-AIA 35 U.S.C. 112 (applicable to applications filed before September 16, 2012) provides:

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best modecontemplated by the inventor of carrying out his invention. [emphasis added].

35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph require that the specification include the following:

• • (A) A written description of the invention;

  • (B) The manner and process of making and using the invention (the enablement requirement); and

  • (C) The best mode contemplated by the inventor of carrying out his invention.

II. THE THREE REQUIREMENTS ARE SEPARATE AND DISTINCT FROM EACH OTHER

ARMBRUSTER

As the predecessor to our reviewing court stated in In re Armbruster, 512 F.2d 676, 677 (CCPA 1975):

[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.

(quoting In re Marzocchi, 439 F.2d 220 (CCPA 1971)).

“Section 112 does not require that a specification convince persons skilled in the art that the assertions therein are correct.” In re Armbruster, 512 F.2d 676, 678 (CCPA 1975).

THE THREE REQUIREMENTS ARE SEPARATE AND DISTINCT FROM EACH OTHER

2161.01 Computer Programming, Computer Implemented Inventions, and 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph [R-10.2019]

DETERMINING WHETHER THERE IS ADEQUATE WRITTEN DESCRIPTION FOR A COMPUTER-IMPLEMENTED FUNCTIONAL CLAIM LIMITATION

ARIAD

See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (“[T]he test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.”).

The test for written description is that it "must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed." [Ariad, 598 F.3d at 1351 (citation and quotations omitted).] The disclosure must "convey[] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." [Id.]

FIERS

Fiers v. Revel, 984 F.2d 1164, 1170 (Fed. Cir. 1993) (rejecting the argument that “only similar language in the specification or original claims is necessary to satisfy the written description requirement”)

HERSCHLER

The test for determining compliance with the written description requirement is whether the disclosure of the application as originally filed reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter, rather than the presence or absence of literal support in the specification for the claim language. In re Herschler, 591 F.2d 693, 700 (CCPA 1979); In re Edwards, 568 F.2d 1349, 1351-52 (CCPA 1978).

KASLOW

“The test for determining compliance with the written description requirement is whether the disclosure of the application as originally filed reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter, rather than the presence or absence of literal support in the specification for the claim language.” In re Kaslow, 707 F.2d 1366, 1375 (Fed. Cir. 1983)

It is well established that the content of the drawings may also be considered in determining compliance with the written description requirement. See, e.g., In re Kaslow, 707 F. 2d 1366, 1375 (Fed. Cir. 1983).

LIZARDTECH

LizardTech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346 (Fed. Cir. 2005) (a description of a single embodiment "does not entitle the inventor" to broad claims).

VASUDEVAN

“For computer-implemented functional claims, the determination of the sufficiency of the disclosure will require an inquiry into the sufficiency of both the disclosed hardware and the disclosed software (i.e., “how [the claimed function] is achieved . . .), due to the interrelationship and interdependence of computer hardware and software.” Vasudevan Software, Inc. v. Microstrategy, Inc., 782 F.3d 671, 683 (Fed. Cir. 2015). “The written description requirement is not met if the specification merely describes a ‘desired result.” Id. at 682 (citing Ariad, 598 F.3d at 1349).

II. BEST MODE

CHEMCAST

A best mode analysis requires first determining whether, at the time of filing the application, the inventor knew of a mode of practicing the claimed invention that the inventor considered to be better than any other, which is a wholly subjective inquiry. Chemcast Corp. v. Arco Indus. Corp., 913 F.2d 923, 927–28 (Fed. Cir. 1990). If the inventor in fact contemplated a preferred mode, the second part of the analysis compares what the inventor knew to what the inventor disclosed, i.e., whether the inventor concealed the preferred mode from the public. Id. at 928.

GAY

The requirement that a best mode violation requires intentional concealment was set forth in In re Gay, 309 F.2d 769, 772 (CCPA 1962) where this court’s predecessor explained, “Manifestly, the sole purpose of [the best mode requirement] is to restrain inventors from applying for patents while at the same time concealing from the public preferred embodiments of their inventions which they have in fact conceived.”

III. ENABLEMENT

ALZA

However, one “cannot simply rely on the knowledge of a person of ordinary skill to serve as a substitute for the missing information in the specification.” ALZA Corp. v. Andrx Pharms., LLC, 603 F.3d 935, 941 (Fed. Cir. 2010).

Although extrinsic evidence will not substitute for a basic enabling disclosure, it can be used to show what was well known in the art or prove that undue experimentation was not required. See ALZA Corp. v. Andrx Pharm., LLC, 603 F.3d 935, 940 (Fed.Cir.2010) (“the rule that a specification need not disclose what is well known in the art is merely a rule of supplementation, not a substitute for a basic enabling disclosure.”); In re Strahilevitz, 668 F.2d 1229, 1232 (Fed. Cir. 1982) (finding that the appellant properly relied on literature citations to establish both the level of ordinary skill in the art and the fact that the techniques necessary to practice his invention were known in the art.); In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988) (holding that declaratory evidence showing experimentation was not undue effectively rebutted the examiner’s enablement challenge).

"While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention. That requirement has not been met in this specification" with regard to differentiation to form insulin producing cells for any vertebrate species other than Xenopus for the reasons given above. see Genentech, Inc. v. Novo NordiskA/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997).