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
The first paragraph of 35 U.S.C. 112 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 mode contemplated by the inventor of carrying out his invention. [emphasis added].
This section of the statute requires 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.
THE THREE REQUIREMENTS ARE SEPARATE AND DISTINCT FROM EACH OTHER
The written description requirement is separate and distinct from the enablement requirement. In reBarker, 559 F.2d 588, 194 USPQ 470 (CCPA 1977), cert. denied, 434 U.S. 1064 (1978); Vas-Cath, Inc.v.Mahurkar, 935 F.2d 1555, 1562, 19 USPQ2d 1111, 1115 (Fed. Cir. 1991) (While acknowledging that some of its cases concerning the written description requirement and the enablement requirement are confusing, the Federal Circuit reaffirmed that under 35 U.S.C. 112, first paragraph, the written description requirement is separate and distinct from the enablement requirement and gave an example thereof.). An invention may be described without the disclosure being enabling (e.g., a chemical compound for which there is no disclosed or apparent method of making), and a disclosure could be enabling without describing the invention (e.g., a specification describing a method of making and using a paint composition made of functionally defined ingredients within broad ranges would be enabling for formulations falling within the description but would not describe any specific formulation). See In reArmbruster, 512 F.2d 676, 677, 185 USPQ 152, 153 (CCPA 1975) (“[A] specification which ‘describes’ does not necessarily also ‘enable’ one skilled in the art to make or use the claimed invention.”). Best mode is a separate and distinct requirement from the enablement requirement. In reNewton, 414 F.2d 1400, 163 USPQ 34 (CCPA 1969).
2161.01 Computer Programming and 35 U.S.C. 112 ** , First Paragraph [R-9]>
The statutory requirements for computer-implemented inventions are the same as for all inventions, such as the subject matter eligibility and utility requirements under 35 U.S.C. 101 , the definiteness requirement of 35 U.S.C. 112, second paragraph, the three separate and distinct requirements of 35 U.S.C. 112, first paragraph, the novelty requirement of 35 U.S.C. 102, and nonobviousness requirement of 35 U.S.C. 103 . For determining whether claimed subject matter complies with the subject matter eligibility requirement of 35 U.S.C. 101 , examiners should consult MPEP §2106. For determining whether claimed subject matter complies with the utility requirement of 35 U.S.C. 101 , examiners should consult the “Guidelines for Examination of Applications for Compliance with the Utility Requirement” set forth in MPEP § 2107. For determining whether claimed subject matter complies with the written description requirement of 35 U.S.C. 112, first paragraph, examiners should consult the “Computer Programming and 35 U.S.C. 112, First Paragraph, Guidelines” set forth in MPEP §2161.01 and the “Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, paragraph 1, ‘Written Description’ Requirement” set forth in MPEP §2163 . For determining whether claimed subject matter complies with the enablement requirement of 35 U.S.C. 112, first paragraph, examiners should consult the enablement guidelines set forth in MPEP §2164 et seq., including the “Examples of Enablement Issues – Computer Programming Cases” set forth in MPEP §2164.06(c) and “Enablement Commensurate in Scope With the Claims” set forth in MPEP §2164.08 . For determining whether the claims comply with the nonobviousness requirement of 35 U.S.C. 103 , examiners should use the “Examination Guidelines for Determining Obviousness Under 35 U.S.C. 103 ” set forth in MPEP §2141. Nevertheless, computer-implemented inventions have certain unique examination issues, especially those that are claimed using functional language that is not limited to a specific structure. This section provides supplemental information to assist examiners in examining computer-implemented functional claim limitations. See MPEP §2181(II)(B) and §2181(IV) for information regarding means (or step) plus function limitations that invoke 35 U.S.C. 112, sixth paragraph.<
I. ** > DETERMINING WHETHER THERE IS ADEQUATE WRITTEN DESCRIPTION FOR A COMPUTER-IMPLEMENTED FUNCTIONAL CLAIM LIMITATION
The first paragraph of 35 U.S.C. 112 contains a written description requirement that is separate and distinct from the enablement requirement. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, ___ (Fed. Cir. 2010) (en banc). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111, ___ (Fed. Cir. 1991). Specifically, the specification must describe the claimed invention in a manner understandable to a person of ordinary skill in the art and show that the inventor actually invented the claimed invention. Vas-Cath, 935 F.2d at 1562-63; Ariad, 598 F.3d at 1351. The function of the written description requirement is to ensure that the inventor had possession of, as of the filing date of the application relied on, the specific subject matter later claimed by him or her; how the specification accomplishes this is not material. In re Herschler, 591 F.2d 693, 700-01, 200 USPQ 711, 717 (CCPA 1979) and further reiterated in In re Kaslow, 707 F.2d 1366, 217 USPQ 1089 (Fed. Cir. 1983). See also MPEP § 2163 - § 2163.04.
The written description requirement of 35 U.S.C. 112, first paragraph applies to all claims including original claims that are part of the disclosure as filed. Ariad, 598 F.3d at 1349. As stated by the Federal Circuit, “[a]lthough many original claims will satisfy the written description requirement, certain claims may not.” Ariad, 598 F.3d at 1349; see also LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 1343-46, 76 USPQ2d 1724, ___ (Fed. Cir. 2005); Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, ___ (Fed. Cir. 1997). For instance, generic claim language in the original disclosure does not satisfy the written description requirement if it fails to support the scope of the genus claimed. Ariad, 598 F.3d at 1350; Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, ___ (Fed. Cir. 2002) (holding that generic claim language appearing in ipsis verbis in the original specification did not satisfy the written description requirement because it failed to support the scope of the genus claimed); Fiers v. Revel, 984 F.2d 1164, 1170, 25 USPQ2d 1601, ___ (Fed. Cir. 1993) (rejecting the argument that “only similar language in the specification or original claims is necessary to satisfy the written description requirement”). For example, in LizardTech, the claim was directed to a method of compressing digital images using seamless discrete wavelet transformation (“DWT”). The court found that the claim covered all ways of performing DWT-based compression processes that lead to a seamless DWT because there were no limitations as to how the seamless DWT was to be accomplished. LizardTech, 424 F.3d at 1346 (“[T]he description of one method for creating a seamless DWT does not entitle the inventor . . . to claim any and all means for achieving that objective.”). However, the specification provided only one method for creating a seamless DWT, and there was no evidence that the specification contemplated a more generic way of creating a seamless array of DWT coefficients. Therefore, the written description requirement was not satisfied in this case because the specification did not provide sufficient evidence that the inventor invented the generic claim. LizardTech, 424 F.3d at 1346.
In addition, original claims may fail to satisfy the written description requirement when the invention is claimed and described in functional language but the specification does not sufficiently identify how the invention achieves the claimed function. Ariad, 598 F.3d at 1349 (“[A]n adequate written description of a claimed genus requires more than a generic statement of an invention’s boundaries.”) (citing Eli Lilly, 119 F.3d at 1568). In Ariad, the court recognized the problem of using functional claim language without providing in the specification examples of species that achieve the claimed function:
The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus. Ariad, 598 F.3d at 1349.
The level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. Ariad, 598 F.3d at 1351; Capon v. Eshhar, 418 F.3d 1349, 1357-58, 76 USPQ2d 1078, ___ (Fed. Cir. 2005). Computer-implemented inventions are often disclosed and claimed in terms of their functionality. This is because writing computer programming code for software to perform specific functions is normally within the skill of the art once those functions have been adequately disclosed. Fonar Corp. v. General Elec. Co., 107 F.3d 1543, 1549, 41 USPQ2d 1801, ___ (Fed. Cir. 1997). Nevertheless, for computer-implemented inventions, the determination of the sufficiency of disclosure will require an inquiry into both the sufficiency of the disclosed hardware as well as the disclosed software due to the interrelationship and interdependence of computer hardware and software. For instance, in In re Hayes Microcomputer Products, the written description requirement was satisfied because the specification disclosed the specific type of microcomputer used in the claimed invention as well as the necessary steps for implementing the claimed function. The disclosure was in sufficient detail such that one skilled in the art would know how to program the microprocessor to perform the necessary steps described in the specification. In re Hayes Microcomputer Prods., Inc. Patent Litigation, 982 F.2d 1527, 1533-34, 25 USPQ2d 1241, ___ (Fed. Cir. 1992). Two additional observations made by the Federal Circuit in Hayes are important. First, the Federal Circuit stressed that the written description requirement was satisfied because the particular steps, i.e., algorithm, necessary to perform the claimed function were “described in the specification.” Hayes, 982 F.2d at 1534 (emphasis in original). Second, the Court acknowledged that the level of detail required for the written description requirement to be met is case specific. Hayes, 982 F.2d at 1534.
When examining computer-implemented functional claims, examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter. Specifically, if one skilled in the art would know how to program the disclosed computer to perform the necessary steps described in the specification to achieve the claimed function and the inventor was in possession of that knowledge, the written description requirement would be satisfied. Hayes, 982 F.2d at 1534. If the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention including how to program the disclosed computer to perform the claimed function, a rejection under 35 U.S.C. 112, first paragraph for lack of written description must be made. For more information regarding the written description requirement, see MPEP §2161.01- §2163.07(b).<
II. BEST MODE
The purpose of the best mode requirement is to “restrain inventors from applying for patents while at the same time concealing from the public the preferred embodiments of their inventions which they have in fact conceived.” In re Gay, 309 F.2d 769, 772, 135 USPQ 311, 315 (CCPA 1962). Only evidence of concealment, “whether accidental or intentional,” is considered in judging the adequacy of the disclosure for compliance with the best mode requirement. Spectra-Physics, Inc. v. Coherent, Inc.,827 F.2d 1524, 1535, 3 USPQ 2d 1737, 1745 (Fed. Cir. 1987). That evidence, in order to result in affirmance of a best mode rejection, must tend to show that the quality of an applicant’s best mode disclosure is so poor as to effectively result in concealment.” In re Sherwood, 613 F.2d 809, 816-817, 204 USPQ 537, 544 (CCPA 1980). Also, see White Consol. Indus. v. Vega Servo-Control Inc., 214 USPQ 796, 824 (S.D. Mich. 1982), aff’d on related grounds, 713 F.2d 788, 218 USPQ 961 (Fed. Cir. 1983). See also MPEP § 2165 - § 2165.04.
There are two factual inquiries to be made in determining whether a specification satisfies the best mode requirement. First, there must be a subjective determination as to whether at the time the application was filed, the inventor knew of a best mode of practicing the invention. Second, if the inventor had a best mode of practicing the invention in mind, there must be an objective determination as to whether that best mode was disclosed in sufficient detail to allow one skilled in the art to practice it. Fonar Corp. v. General Electric Co., 107 F.3d 1543, 41 USPQ2d 1801, 1804 (Fed. Cir. 1997); Chemcast Corp. v. Arco Industries, 913 F.2d 923, 927-28, 16 USPQ2d 1033, 1036 (Fed. Cir. 1990). “As a general rule, where software constitutes part of a best mode of carrying out an invention, description of such a best mode is satisfied by a disclosure of the functions of the software. This is because, normally, writing code for such software is within the skill of the art, not requiring undue experimentation, once its functions have been disclosed. . . . [F]low charts or source code listings are not a requirement for adequately disclosing the functions of software.” Fonar Corp., 107 F.3d at 1549, 41 USPQ2d at 1805 (citations omitted).
III. * > DETERMINING WHETHER THE FULL SCOPE OF A COMPUTER-IMPLEMENTED FUNCTIONAL CLAIM LIMITATION IS ENABLED
To satisfy the enablement requirement of 35 U.S.C. 112, first paragraph, the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without “undue experimentation.” See, e.g., In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, ___ (Fed. Cir. 1993); In re Wands, 858 F.2d 731, 736-37, 8 USPQ2d 1400, ___ (Fed. Cir. 1988). In In re Wands, the court set forth the following factors to consider when determining whether undue experimentation is needed: (1) the breadth of the claims; (2) the nature of the invention; (3) the state of the prior art; (4) the level of one of ordinary skill; (5) the level of predictability in the art; (6) the amount of direction provided by the inventor; (7) the existence of working examples; and (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. Wands, 858 F.2d at 737. The undue experimentation determination is not a single factual determination. Rather, it is a conclusion reached by weighing all the factual considerations. Wands, 858 F.2d at 737.<
When basing a rejection on the failure of the applicant’s disclosure to meet the enablement provisions of the first paragraph of 35 U.S.C. 112, USPTO personnel must establish on the record a reasonable basis for questioning the adequacy of the disclosure to enable a person of ordinary skill in the art to make and use the claimed invention without resorting to undue experimentation. See In re Brown, 477 F.2d 946, 177 USPQ 691 (CCPA 1973); In re Ghiron, 442 F.2d 985, 169 USPQ 723 (CCPA 1971). Once USPTO personnel have advanced a reasonable basis for questioning the adequacy of the disclosure, it becomes incumbent on the applicant to rebut that challenge and factually demonstrate that his or her application disclosure is in fact sufficient. See In re Doyle, 482 F.2d 1385, 1392, 179 USPQ 227, 232 (CCPA 1973); In re Scarbrough, 500 F.2d 560, 566, 182 USPQ 298, 302 (CCPA 1974); In re Ghiron, supra. See also MPEP § 2106, paragraph V.B.2 and § 2164 - § 2164.08(c).>
Functional claim language may render the claims broad when the claim is not limited to any particular structure for performing the claimed function. In re Swinehart, 439 F.2d 210, 213, 169 USPQ 226, ___ (CCPA 1971). Since such a claim covers all devices which perform the recited function, there is a concern regarding whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought by the claim. Swinehart, 439 F.2d at 213; AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244, 68 USPQ2d 1280, ___ (Fed. Cir. 2003); In re Moore, 439 F.2d 1232, 1236, 169 USPQ 236, ___ (CCPA 1971). Applicants who present broad claim language must ensure the claims are fully enabled. Specifically, the scope of the claims must be less than or equal to the scope of the enablement provided by the specification. Sitrick v. Dreamworks, LLC, 516 F.3d 993, 999, 85 USPQ2d 1826, ___ (Fed. Cir. 2008) (“The scope of the claims must be less than or equal to the scope of the enablement to ensure that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims.”) (quotation omitted).
For example, the claims in Sitrick were directed to “integrating” or “substituting” a user’s audio signal or visual image into a pre-existing video game or movie. While the claims covered both video games and movies, the specification only taught the skilled artisan how to substitute and integrate user images into video games. The Federal Circuit held that the specification failed to enable the full scope of the claims because the skilled artisan could not substitute a user image for a preexisting character image in movies without undue experimentation. Specifically, the court recognized that one skilled in the art could not apply the teachings of the specification regarding video games to movies, because movies, unlike video games, do not have easily separable character functions. Because the specification did not teach how the substitution and integration of character functions for a user image would be accomplished in movies, the claims were not enabled. Sitrick, 516 F.3d at 999-1001.
Although the specification need not teach what is well known in the art, applicant cannot rely on the knowledge of one skilled in the art to supply information that is required to enable the novel aspect of the claimed invention, when the enabling knowledge is in fact not known in the art. ALZA Corp. v. Andrx Pharms., LLC, 603 F.3d 935, 941, 94 USPQ2d 1823, ___ (Fed. Cir. 2010) (“ALZA was required to provide an adequate enabling disclosure in the specification; it cannot simply rely on the knowledge of a person of ordinary skill to serve as a substitute for the missing information in the specification.”); Auto. Techs. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 1283, 84 USPQ2d 1108, ___ (Fed. Cir. 2007) (“Although the knowledge of one skilled in the art is indeed relevant, the novel aspect of an invention must be enabled in the patent.”). The Federal Circuit has stated that “‘[i]t is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement.’” Auto. Techs., 501 F.3d at 1283 (quoting Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366, 42 USPQ2d 1001, ___ (Fed. Cir. 1997)). 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.” Genentech, 108 F.3d at 1366; see also ALZA Corp., 603 F.3d at 940-41. Therefore, the specification must contain the information necessary to enable the novel aspects of the claimed invention. ALZA Corp., 603 F.3d at 941; Auto. Techs., 501 F.3d at 1283-84 (“[T]he ‘omission of minor details does not cause a specification to fail to meet the enablement requirement. However, when there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required.’”) (quoting Genentech, 108 F.3d at 1366). For instance, in Auto. Techs., the claim limitation “means responsive to the motion of said mass” was construed to include both mechanical side impact sensors and electronic side impact sensors for performing the function of initiating an occupant protection apparatus. Auto. Techs., 501 F.3d at 1282. The specification did not disclose any discussion of the details or circuitry involved in the electronic side impact sensor, and thus, it failed to apprise one of ordinary skill how to make and use the electronic sensor. Since the novel aspect of the invention was side impact sensors, the patentee could not rely on the knowledge of one skilled in the art to supply the missing information. Auto. Techs., 501 F.3d at 1283.
A rejection under 35 U.S.C. 112, first paragraph for lack of enablement must be made when the specification does not enable the full scope of the claim. USPTO personnel should establish a reasonable basis to question the enablement provided for the claimed invention and provide reasons for the uncertainty of the enablement. For more information regarding the enablement requirement, see MPEP §§ 2164.01(a)-2164.08(c), e.g., 2164.06(c) on examples of computer programming cases. <