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2161 Three Separate Requirements for Specification Under 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph [R-07.2015]

I. 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 mode contemplated 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

The written description requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1341, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc) (If Congress had intended enablement to be the sole description requirement of § 112, first paragraph, the statute would have been written differently.) 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.); In re Barker, 559 F.2d 588, 194 USPQ 470 (CCPA 1977), cert. denied, 434 U.S. 1064 (1978). See also, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-685, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015) (reversing and remanding the district court's grant of summary judgment of invalidity for lack of an adequate written description and lack of enablement because there were genuine issues of material fact regarding 1) whether the claims had sufficient written description support (“[t]he fact that . . . the specification do[es] not speak in haec verba of accessing ‘disparate databases’ does not eliminate as a genuine issue of material fact that the existence of at least some discussion, and therefore, possession, of the accessing of disparate databases, as claimed”); and 2) whether the claims were enabled (“the effort it took the inventor to reduce the invention to practice does not conclusively show lack of enablement”). 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, Computer Implemented Inventions, and 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph [R-07.2022]

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 (see MPEP §§ 2106 and 2107, respectively), the novelty requirement of 35 U.S.C. 102, the nonobviousness requirement of 35 U.S.C. 103, the definiteness requirement of 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, and the three separate and distinct requirements of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. In addition, claims with computer-implemented functional claim limitations may invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. See MPEP § 2181, subsection II.B, and § 2181, subsection IV. for information regarding means- (or step-) plus- function limitations.

Even if a claim is not construed as a means-plus- function limitation under 35 U.S.C. 112(f), computer-implemented functional claim language must still be evaluated for sufficient disclosure under the written description and enablement requirements of 35 U.S.C. 112(a).

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

The 35 U.S.C. 112(a) or first paragraph of pre-AIA 35 U.S.C. 112 contains a written description requirement that is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (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 at the time of filing. Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345, 54 USPQ2d 1915, 1917 (Fed. Cir. 2000) (“The purpose of [the written description requirement] is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification”); LizardTech Inc. v. Earth Resource Mapping Inc., 424 F.3d 1336, 1345, 76 USPQ2d 1724, 1732 (Fed. Cir. 2005) (“Whether the flaw in the specification is regarded as a failure to demonstrate that the patentee [inventor] possessed the full scope of the invention recited in [the claim] or a failure to enable the full breadth of that claim, the specification provides inadequate support for the claim under [§ 112(a)]”); cf. id. (“A claim will not be invalidated on [§] 112 grounds simply because the embodiments of the specification do not contain examples explicitly covering the full scope of the claim language.”). While “[t]here is no special rule for supporting a genus by the disclosure of a species,” the Federal Circuit has stated that “[w]hether the genus is supported vel non depends upon the state of the art and the nature and breadth of the genus.” Hynix Semiconductor Inc. v. Rambus Inc., 645 F.3d 1336, 1352, 98 USPQ2d 1711, 1724 (Fed. Cir. 2011); id. (further explaining that “so long as disclosure of the species is sufficient to convey to one skilled in the art that the inventor possessed the subject matter of the genus, the genus will be supported by an adequate written description.”). See also Rivera v. Int'l Trade Comm’n, 857 F.3d 1315, 1319-21, 123 USPQ2d 1059, 1061-62 (Fed. Cir. 2017) (affirming the Commission’s findings that “the specification did not provide the necessary written description support for the full breadth of the asserted claims,” where the claims were broadly drawn to a “container . . . adapted to hold brewing material” while the specification disclosed only a “pod adapter assembly” or “receptacle” designed to hold a “pod”).

Specifically, the specification must describe the claimed invention in a manner understandable to a person of ordinary skill in the art in a way that shows that the inventor actually invented the claimed invention at the time of filing. Id.;Ariad, 598 F.3d at 1351, 94 USPQ2d at 1172. The function of the written description requirement is to ensure that the inventor had possession of the specific subject matter later claimed as of the filing date of the application relied on; how the specification accomplishes this is not material. In re Herschler, 591 F.2d 693, 700-01, 200 USPQ 711, 717 (CCPA 1979), 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(a) or pre-AIA 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, 94 USPQ2d at 1170. As stated by the Federal Circuit, “[a]lthough many original claims will satisfy the written description requirement, certain claims may not.” Id. at 1349, 94 USPQ2d at 1170-71; see also LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 1343-46, 76 USPQ2d 1724, 1730-33 (Fed. Cir. 2005); Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1405-06 (Fed. Cir. 1997)(“The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention.”). Problems satisfying the written description requirement for original claims often occur when claim language is generic or functional, or both. Ariad, 593 F.3d at 1349, 94 USPQ2d at 1171 ("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 [inventor] has made a generic invention that achieves the claimed result and do so by showing that the applicant [inventor] has invented species sufficient to support a claim to the functionally-defined genus.").

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 1349-50, 94 USPQ2d at 1171 (“[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, 43 USPQ2d at 1405-06); Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (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, 1606 (Fed. Cir. 1993) (rejecting the argument that “only similar language in the specification or original claims is necessary to satisfy the written description requirement”).

The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 “merely by clearly describing one embodiment of the thing claimed.” LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). The issue is whether a person skilled in the art would understand the inventor to have invented, and been in possession of, the invention as broadly claimed. In LizardTech, claims to a generic method of making a seamless discrete wavelet transformation (DWT) were held invalid under 35 U.S.C. 112, first paragraph, because the specification taught only one particular method for making a seamless DWT and there was no evidence that the specification contemplated a more generic method. “[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.” LizardTech, 424 F.3d at 1346, 76 USPQ2d at 1733.

Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.

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, 94 USPQ2d at 1172; Capon v. Eshhar, 418 F.3d 1349, 1357-58, 76 USPQ2d 1078, 1083-84 (Fed. Cir. 2005). Computer-implemented inventions are often disclosed and claimed in terms of their functionality. For computer-implemented inventions, the determination of the sufficiency of disclosure will require an inquiry into the sufficiency of both the disclosed hardware and the disclosed software due to the interrelationship and interdependence of computer hardware and software. The critical inquiry 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. Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 682. 114 USPQ2d 1349, 1356 (citing Ariad Pharm., Inc. V. Eli Lilly & Co, 598 F.3d 1336, 1351, 94 USPQ2d 1161, 1172 (Fed. Cir. 2010) in the context of determining possession of a claimed means of accessing disparate databases).

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 possessed the claimed subject matter at the time of filing. An algorithm is defined, for example, as “a finite sequence of steps for solving a logical or mathematical problem or performing a task.” Microsoft Computer Dictionary (5th ed., 2002). Applicant may “express that algorithm in any understandable terms including as a mathematical formula, in prose, or as a flow chart, or in any other manner that provides sufficient structure.” Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1340, 86 USPQ2d 1609, 1623 (Fed. Cir. 2008) (internal citation omitted). It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015) (reversing and remanding the district court’s grant of summary judgment of invalidity for lack of adequate written description where there were genuine issues of material fact regarding “whether the specification show[ed] possession by the inventor of how accessing disparate databases is achieved”). 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 a rejection under 35 U.S.C. 112(a) or pre-AIA 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 § 2162- § 2163.07(b). If the specification does not provide a disclosure of sufficient corresponding structure, materials, or acts that perform the entire claimed function of a means- (or step-) plus- function limitation in a claim under 35 U.S.C. 112(f) or the sixth paragraph of pre-AIA 35 U.S.C. 112, "the applicant has in effect failed to particularly point out and distinctly claim the invention" as required by the 35 U.S.C. 112(b) [or the second paragraph of pre-AIA 35 U.S.C. 112]. In re Donaldson Co., 16 F.3d 1189, 1195, 29 USPQ2d 1845, 1850 (Fed. Cir. 1994) (en banc). A rejection under 35 U.S.C. 112(b) or the second paragraph of pre-AIA 35 U.S.C. 112 must be made in addition to the written description rejection. See also MPEP § 2181, subsection II.B.2(a).

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 USPQ2d 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 [inventor's] best mode disclosure is so poor as to effectively result in concealment." In re Sherwood, 613 F.2d 809, 816, 204 USPQ 537, 544 (CCPA 1980)(emphasis omitted); 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 the inventor knew of a best mode of practicing the invention at the time the application was filed. 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. Gen. Elect. Co., 107 F.3d 1543, 41 USPQ2d 1801, 1804 (Fed. Cir. 1997); Chemcast Corp. v. Arco Indus., 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(a) or pre-AIA 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, 1513 (Fed. Cir. 1993); In re Wands, 858 F.2d 731, 736-37, 8 USPQ2d 1400, 1402 (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, 8 USPQ2d 1404. The undue experimentation determination is not a single factual determination; rather, it is a conclusion reached by weighing all the factual considerations. Id.

All questions of enablement under 35 U.S.C. 112(a) are evaluated against the claimed subject matter with the focus of the examination inquiry being whether everything within the scope of the claim is enabled. Accordingly, examiners should determine what each claim recites and what subject matter is encompassed by the claim when the claim is considered as a whole and not analyze the claim elements individually.

When basing a rejection on the failure of the applicant’s disclosure to meet the enablement provisions of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 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 the application disclosure is 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 §§ 2164 - 2164.08(c).

When a claim is not limited to any particular structure for performing a recited function and does not invoke 35 U.S.C. 112(f), any claim language reciting the ability to perform a function per se would typically be construed broadly to cover any and all embodiments that perform the recited function. Because such a claim encompasses all devices or structures that perform the recited function, there is a concern regarding whether the applicant's disclosure sufficiently enables the full scope of protection sought by the claim. In re Swinehart, 439 F.2d 210, 213, 169 USPQ 226, 229 (CCPA 1971); AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244, 68 USPQ2d 1280, 1287 (Fed. Cir. 2003); In re Moore, 439 F.2d 1232, 1236, 169 USPQ 236, 239 (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, 1830 (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, 85 USPQ2d at 1830-32.

In MagSil Corp. v. Hitachi Global Storage Techs., Inc. 687 F.3d 1377, 103 USPQ2d 1769 (Fed. Cir. 2012), the Federal Circuit stated that “a patentee chooses broad claim language at the peril of losing any claim that cannot be enabled across its full scope of coverage,” finding “one skilled in the art could not have taken the disclosure in the specification regarding ‘change in the resistance by at least 10% at room temperature’ and achieved a change in resistance in the full scope of that term without undue experimentation." 687 F.3d at 1381-82, 103 USPQ2d at 1771. "Thus, the specification enabled a marginal advance over the prior art, but did not enable at the time of filing a tunnel junction of resistive changes reaching even up to 20%, let alone the more recent achievements above 600%.” The court held that the “claims [were] invalid for lack of enablement because their broad scope [was] not reasonably supported by the scope of enablement in the specification.” 687 F.3d at 1381-1382, 1384, 103 USPQ2d at 1771, 1772, 1774 (“MagSil did not fully enable its broad claim scope. Therefore, it cannot claim an exclusive right to exclude later tri-layer tunnel junctions that greatly exceed a 10% resistive change.”). See also Convolve, Inc. v. Compaq Computer Corp., 527 Fed. App'x 910, 931 (Fed. Cir. 2013) (non-precedential), quoting MagSil Corp.)(affirming grant of summary judgment of invalidity due to lack of enablement where the patentee “[b]y choosing such broad claim language, ... put itself ‘at the peril of losing any claim that cannot be enabled across its full scope of coverage.’”).

The specification need not teach what is well known in the art. However, 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, 1827 (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, 1114-15 (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. Technologies, 501 F.3d at 1283, 84 USPQ2d at 1115 (quoting Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366, 42 USPQ2d 1001, 1005 (Fed. Cir. 1997)). See also Idenix Pharms. LLC v. Gilead Scis. Inc., 941 F.3d 1149, 1159-61, 2019 USPQ 2d 415844 (Fed. Cir. 2019). 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, 42 USPQ2d 1005; see also ALZA Corp., 603 F.3d at 940-41, 94 USPQ2d at 1827. Therefore, the specification must contain the information necessary to enable the novel aspects of the claimed invention. Id. at 941, 94 USPQ2d at 1827; Auto. Technologies, 501 F.3d at 1283-84, 84 USPQ2d at 1115 (“[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, 42 USPQ2d at 1005). For instance, in Auto. Technologies, 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. Technologies, 501 F.3d at 1282, 84 USPQ2d at 1114. The specification did not include any discussion of the details or circuitry involved in the electronic side impact sensor and thus, failed to apprise one of ordinary skill how to make and use the electronic sensor. Because 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. Technologies, 501 F.3d at 1283, 84 USPQ2d at 1114.

Not everything necessary to practice the invention need be disclosed. Trs. of Bos. Univ. v. Everlight Elecs. Co., LTD., 896 F.3d 1357, 1364, 127 USPQ2d 1609, 1614 (Fed. Cir. 2018) (explaining that while “the specification must enable the full scope of the claimed invention[,]” “[t]his is not to say that the specification must expressly spell out every possible iteration of every claim.”). For instance, “‘a specification need not disclose what is well known in the art.’” Id. (quoting Genentech, Inc.v. Novo Nordisk A/S, 108 F.3d 1361, 1366, 42 USPQ2d 1001, 1005 (Fed. Cir. 1997)); see also AK Steel Corp. v. Sollac & Ugine, 344 F.3d 1234, 1244, 68 USPQ2d 1280, 1287 (Fed. Cir. 2003). This is of particular importance with respect to computer-implemented inventions due to the high level of skill in the art and the similarly high level of predictability in generating programs to achieve an intended result without undue experimentation. See MPEP § 2164.08.

The Federal Circuit has repeatedly held that 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 Trs. of Bos. Univ., 896 F.3d at 1364 (“‘The scope of enablement . . . is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation.’” (quoting Nat’l Recovery Techs., Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1196 (Fed. Cir. 1999))). For example, in Sitrick v. Dreamworks, LLC, 516 F.3d 993 (Fed. Cir. 2008), the claims at issue were directed to “integrating” or “substituting” a user’s audio signal or visual image into a pre-existing video game or movie. Id. at 995-97. 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. Id. at 1000. The Federal Circuit held that the specification “did not enable the full scope of the asserted claims” because “one skilled in the art could not take the disclosure in the specification with respect to substitution or integration of user images in video games and substitute a user image for a pre- existing character image in movies without undue experimentation.” Id.

A rejection under 35 U.S.C. 112(a) or pre-AIA 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), especially, MPEP § 2164.06(c) for examples of computer programming cases. See also MPEP § 2181, subsection IV.

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