The Substantive Requirements for a Patent- Eligibility, Anticipation and Obviousness

A person is entitled to obtain a patent for a new and useful “process, machine, manufacture, or composition of matter” or improvement, subject to the requirements of 35 U.S.C. §§101, 102, 103 and 112.[i]

Utility, under 35 U.S.C. §101, has been interpreted by the U.S. Supreme Court to act as a threshold test to determine if an invention can be patented.[ii] The threshold requires the invention fit into one of four categories, i.e. “process, machine, manufacture, or composition of matter”, and not fall into any of exception, “laws of nature, physical phenomena, and abstract ideas.”[iii] Courts are directed to determine if claims cover one of the judicial exceptions, and if so, then determine if the claims add significantly more elements than just the exception.[iv] A common test used to determine if an invention is eligible for a patent is the machine or transformation test.[v]

Anticipation, under 35 U.S.C. §102 precludes patenting of an invention if

The claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention[.][vi]

This anticipation requirement demands every element of a claim to be present in the reference supporting a refusal for anticipation[vii] meaning that every element of the claim must be found in a single prior art reference for an application to be rejected for anticipation.[viii]  Further, the prior art must enable, or describe, “the claimed invention sufficiently to enable a person of ordinary skill in the art to carry out the invention[.]”[ix] As such, satisfying this requirement typically is the easiest of the substantive refusals to satisfy.

Obviousness, as stated in 35 U.S.C. §103, requires

if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.

A common concern relates to what it means for an invention to be “obvious”. While the definition has not been overly helpful,[x] the U.S. Supreme Court has provided some factors that are pertinent in determining obviousness versus non-obviousness, namely,

(1) determining the scope and content of the references in the field (prior art);

(2) differences between the references and the claims;

(3) the level of skill in the field (ordinary skill in the art);

(4) any secondary considerations, like commercial success of the invention (that relates to the inventive aspect of the product), unsolved need in the field, and failure of others.[xi]

An obviousness rejection requires a showing that knowledge in the respective field would lead a person of ordinary skill in that field to the invention.  This is done, at least in part, through references that evidence what was known at a given time, showing the background knowledge in the field and/or the technological in the reference.[xii] While a single reference can be relied upon for rejecting a patent application for obviousness, it is common for multiple references to be strung together to form a refusal to patent the invention. However, in doing so, the references must show some rationale or motivation to combine the references, with a reasonable expectation of success in integrating the concepts in the references together to meet the claimed invention.[xiii] The motivation to combine can take into account the demands known in the field or marketplace,[xiv] a need or problem known in the field and addressed by a reference can provide motivation,[xv] as well as “known-technique[s]” in the field, meaning a technique used to improve one device that is applicated to improve similar devices in the same way.[xvi] However, it is important to note that the solution does not need to be the best solution, just a suitable option for the problem.[xvii]

Because obviousness is a somewhat amorphous requirement, it is typically more difficult to anticipate and address than anticipation.  However, comparative studies, information showing the limitations in the field, or other information showing limitations in the prior art are useful in limiting obviousness refusals or addressing the refusals.

The substantive requirements under 35 U.S.C. §112 require the specification,[xviii] i.e. the body of the application, to provide information on how to make and use the invention, and describe the best manner of accomplishing the invention.[xix] The written description requirement provides that a specification must provide enough detail to allow someone in the field to reasonably determine the inventor had possession of the invention as claimed.[xx] This is a factual consideration, based on the knowledge in the field and the invention.[xxi] Enablement requires the specification to explain to a person working in the field how to make and use the invention without requiring “undue experimentation”.[xxii] This can be accomplished through broad terminology and discussion or various illustrative examples.[xxiii] The scope of the claims must be reasonably correlated to the enablement[xxiv] and the written description.[xxv]


[i] See, Diamond v. Chakrabarty, 447 U.S. 303, 308 (1980) (citing to 35 U.S.C. §101); 35 U.S.C. §102(a) (“person shall be entitled to a patent unless…”).

[ii] Bilski v. Kappos, 561 U.S. 593, 601-602, 130 S.Ct. 3218, 3225 (2010).

[iii] Bilski v. Kappos, 561 U.S. 593, 601-602, 130 S.Ct. 3218, 3225 (citing Diamond v. Chakrabarty, 447 U.S. 303, 309, 100 S.Ct. 2204).

[iv] Alice Corp. Pty. Ltd. V. CLS Bank Int’l, 573 U.S. 208, 217-218, 110 U.S.P.Q.2d 1976, 1981 (2014).

[v] Bilski v. Kappos, 561 U.S. 593, 604, 95 USPQ2d 1001, 1007 (2010).

[vi] 35 U.S.C. §102(a)(1).

[vii] Verdegaal Bros. v. Union Oil Co. of Cali­fornia, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987)).

[viii] Verdegaal Bros. v. Union Oil of California, 814 F.2d 628, 631 (Fed. Cir. 1987).

[ix] Impax Labortatories, Inc. v. Aventis Pharmceuticals, Inc., 468 F.3d 1366, 1383 (Fed. Cir. 2006).

[x] See, Dann v. Johnston, 425 U.S. 219, 230, 189 USPQ 257, 261 (1976) (Stating the obviousness test looks to “whether the difference between the prior art and the subject matter in question “is a difference sufficient to render the claimed subject matter unobvious to one skilled in the applicable art. . . .””). 

[xi] Graham v. John Deere Co., 383 U.S. 1, 17-18, 148 USPQ 459 (1966).

[xii] Netflix, Inc., No. 2022-1083 at 9 (Fed. Cir., Mar. 1, 2023) (citing EWP Corp. v. Reliance Universal Inc., 755 F.2d 898, 907 (Fed. Cir. 1985); In re Applied Materials, Inc., 692 F.3d 1289, 1298 (Fed. Cir. 2012); In re Kahn, 441 F.3d 977, 990 (Fed. Cir. 2006)).

[xiii] Netflix, Inc. v. DIVX, LLC, No. 2022-1083, slip opinion at 7 (Fed. Cir., Mar. 1, 2023) (citing Procter & Gamble Co. v. Teva Pharmaceuticals USA, Inc., 566 F.3d 989, 994 (Fed. Cir. 2009). See also, Intel Corp. v. PACT XPP Schweiz AG, No. 2022-1037, slip opinion at 7 (Fed. Cir., Mar. 13, 2023) (citing PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1193 (Fed. Cir. 2014)).

[xiv] KSR Int’l Co.,127 S.Ct 1727 at 1740.

[xv] Intel Corp. v. PACT XPP Schweiz AG, 61 F.4th 1373, 1380-1, 2023 U.S.P.Q.2d 297 (Fed. Cir. 2023).

[xvi] Id.

[xvii] Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 800 (Fed. Cir. 2021) (quoting Par Pharmaceuticals, 773 F.3d at 1197–98); see also In re Mouttet, 686 F.3d 1322, 1334 (Fed. Cir. 2012); Kahn, 441 F.3d at 990)).

[xviii] There are non-substantive requirements under this title, requiring the application to end in claims that adequately define the scope of the subject matter claimed.

[xix] 35 U.S.C. §112(a).

[xx] See, Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Fujikawa v. Wattanasin, 93 F.3d 1559, 1570, 39 U.S.P.Q.2d 1895 (Fed. Cir. 1996).

[xxi] In re Wake Pure Chemical Indus. Ltd., 4 Fed.Appx. 853, 854 (Fed. Cir. 2001)(unpublished opinion)

[xxii] In re Vaeck, 947 F.2d 488, 495, 20 U.S.P.Q.2d 1438 (Fed. Cir. 1991) (citing In re Wands, 858 F.2d 731, 737, 8 U.S.P.Q.2d 1400, 1404 (Fed. Cir. 1988).

[xxiii] In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510 (Fed. Cir. 1993).

[xxiv] See, In re Vaeck, 947 F.2d at 495.

[xxv] Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 U.S.P.Q.2d 1895 (Fed. Cir. 1996).

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