There are two criteria for determining subject matter eligibility under 35 U.S.C. 101 and both must be satisfied. The claimed invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception, as defined below. The following two step analysis is used to evaluate these criteria.I. THE FOUR CATEGORIES OF STATUTORY SUBJECT MATTER
Step 1: Is the claim directed to one of the four patent-eligible subject matter categories: process, machine, manufacture, or composition of matter? The subject matter of the claim must be directed to one of the four subject matter categories. If it is not, the claim is not eligible for patent protection and should be rejected under 35 U.S.C. 101, for at least this reason. A summary of the four categories of invention, as they have been defined by the courts, are:
- i. Process – an act, or a series of acts or steps. See Gottschalk v. Benson, 409 U.S. 63, 70, 175 USPQ 673, 676 (1972) ("A process is a mode of treatment of certain materials to produce a given result. It is an act, or a series of acts, performed upon the subject-matter to be transformed and reduced to a different state or thing." (emphasis added) (quoting Cochrane v. Deener, 94 U.S. 780, 788, 24 L. Ed. 139, 1877 Dec. Comm'r Pat. 242 (1876))); NTP, Inc. v. Research in Motion, Ltd., 418 F.3d 1282, 1316, 75 USPQ2d 1763, 1791 (Fed. Cir. 2005) ("[A] process is a series of acts." (quoting Minton v. Natl. Ass’n. of Securities Dealers, 336 F.3d 1373, 336 F.3d 1373, 1378, 67 USPQ2d 1614, 1681 (Fed. Cir. 2003))). See also 35 U.S.C. 100(b); Bilski v. Kappos, 561 U.S. 593, 130 S. Ct. 3218, 95 USPQ2d 1001 (2010).
- ii. Machine – a concrete thing, consisting of parts, or of certain devices and combination of devices. Burr v. Duryee, 68 U.S. (1 Wall.) 531, 570, 17 L. Ed. 650 (1863). This includes every mechanical device or combination of mechanical powers and devices to perform some function and produce a certain effect or result. Corning v. Burden, 56 U.S. 252, 267, 14 L. Ed. 683 (1854).
- iii. Manufacture – an article produced from raw or prepared materials by giving to these materials new forms, qualities, properties, or combinations, whether by hand labor or by machinery. Diamond v. Chakrabarty, 447 U.S. 303, 308, 206 USPQ 193, 197 (1980) (emphasis added) (quoting Am. Fruit Growers, Inc. v. Brogdex Co., 283 U.S. 1, 11, 51 S. Ct. 328, 75 L. Ed. 801, 1931 (Dec. Comm'r Pat. 711 (1931))).
- iv. Composition of matter – all compositions of two or more substances and all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids, for example. Chakrabarty, 447 U.S. at 308, 206 USPQ at 197.
- i. transitory forms of signal transmission (for example, a propagating electrical or electromagnetic signal per se), In re Nuijten, 500 F.3d 1346, 1357, 84 USPQ2d 1495, 1503 (Fed. Cir. 2007);
- ii. a human per se, The Leahy-Smith America Invents Act (AIA), Public Law 112-29, sec. 33, 125 Stat. 284 (September 16, 2011);
- iii. a legal contractual agreement between two parties, see In re Ferguson, 558 F.3d 1359, 1364, 90 USPQ2d 1035, 1039-40 (Fed. Cir. 2009) (cert. denied);
- iv. a computer program per se, Gottschalk v. Benson, 409 U.S. at 72, 175 USPQ at 676-77;
- v. a company, Ferguson, 558 F.3d at 1366, 90 USPQ at 1040;
- vi. a mere arrangement of printed matter, In re Miller, 418 F.2d 1392, 1396, 164 USPQ 46, 49 (CCPA 1969); and
- vii. data per se, Digitech Image Tech., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1720 (Fed. Cir. 2014).
A claim that covers both statutory and non-statutory embodiments (under the broadest reasonable interpretation of the claim when read in light of the specification and in view of one skilled in the art) embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter. Such claims fail the first step (Step 1: NO) and should be rejected under 35 U.S.C. 101, for at least this reason.
For example, machine readable media can encompass non-statutory transitory forms of signal transmission, such as, a propagating electrical or electromagnetic signal per se. See In re Nuijten, 500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007). When the broadest reasonable interpretation of machine readable media in light of the specification as it would be interpreted by one of ordinary skill in the art encompasses transitory forms of signal transmission, a rejection under 35 U.S.C. 101 as failing to claim statutory subject matter would be appropriate. Thus, a claim to a computer readable medium that can be a compact disc or a carrier wave covers a non-statutory embodiment and therefore should be rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
If the claimed invention is clearly not within one of the four categories, then a rejection under 35 U.S.C. 101 must be made indicating that the claimed invention is directed to non-statutory subject matter. Form paragraphs 7.05 and 7.05.01 should be used; see MPEP § 706.03(a). However, when the claim fails under Step 1 and it appears from applicant’s disclosure that the claim could be amended to be directed to a statutory category, Step 2 below should still be conducted.II. JUDICIAL EXCEPTIONS TO THE FOUR CATEGORIES
Step 2: Does the claim wholly embrace a judicially recognized exception, which includes laws of nature, natural phenomena, and abstract ideas? Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. _, 134 S. Ct. 2347, 2354, 110 USPQ2d 1976, 1980 (2014) (citing Association for Molecular Pathology v. Myriad Genetics, Inc. 569 U.S. _, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972, 1979 (2013)). See also Bilski v. Kappos, 561 U.S.593, 601, 130 S. Ct. 3218, 3225, 95 USPQ2d 1001, 1005-06 (2010) (stating “The Court's precedents provide three specific exceptions to § 1.1's broad patent-eligibility principles: ‘laws of nature, physical phenomena, and abstract ideas.’”) (quoting Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, 197 (1980)).
Determining that a claim falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter) does not end the eligibility analysis because claims directed to nothing more than abstract ideas (such as mathematical algorithms), natural phenomena, and laws of nature are not eligible for patent protection. Diamond v. Diehr, 450 U.S. 175, 185, 209 USPQ 1, 7 (1981); accord, e.g., Chakrabarty, 447 U.S. at 309, 206 USPQ at 197; Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978); Benson, 409 U.S. at 67-68, 175 USPQ at 675.
In addition to the terms "laws of nature," "natural phenomena," and "abstract ideas," judicially recognized exceptions have been described using various other terms, including "physical phenomena," "scientific principles," "systems that depend on human intelligence alone," "disembodied concepts," "mental processes" and "disembodied mathematical algorithms and formulas," for example. The exceptions reflect the courts’ view that the basic tools of scientific and technological work are not patentable. “A principle, in the abstract, is a fundamental truth; an original cause; a motive; these cannot be patented, as no one can claim in either of them an exclusive right.” Le Roy v. Tatham,55 U.S. (14 How.) 156, 175 (1852). Instead, such “manifestations of laws of nature” are “part of the storehouse of knowledge,” “free to all men and reserved exclusively to none.” Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948).
Thus, “a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter” under Section 101. Chakrabarty, 447 U.S. at 309, 206 USPQ at 197. “Likewise, Einstein could not patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity.” Id. Nor can one patent “a novel and useful mathematical formula,” Flook, 437 U.S. at 585, 198 USPQ at 195; electromagnetism or steam power, O’Reilly v. Morse, 56 U.S. (15 How.) 62, 113-114 (1853); or “[t]he qualities of... bacteria,... the heat of the sun, electricity, or the qualities of metals,” Funk, 333 U.S. at 130, 76 USPQ at 281; see Le Roy, 55 U.S. (14 How.) at 175.Analysis Of Subject Matter Eligibility
While abstract ideas, natural phenomena, and laws of nature are not eligible for patenting, methods and products employing abstract ideas, natural phenomena, and laws of nature to perform a real-world function may well be. Thus, if a claim is directed to a judicial exception, it must be analyzed to determine whether the elements of the claim, considered both individually and as an ordered combination, are sufficient to ensure that the claim as a whole amounts to significantly more than the exception itself - this has been termed a search for an inventive concept. Alice Corp., 134 S. Ct. at 2357, 110 USPQ2d at 1981. This analysis considers whether the claim as a whole is for a particular application of an abstract idea, natural phenomenon, or law of nature, as opposed to the abstract idea, natural phenomenon, or law of nature itself. Mayo Collaborative Serv. v. Prometheus Labs., Inc., 566 U.S. _, 132 S. Ct. 1289, 1293-94, 101 USPQ2d 1961, 1965-66 (2012) (citing Diehr, 450 U.S. at 187, 209 USPQ at 7).
For a detailed discussion of the analysis required to determine whether a claim is directed to patent-eligible subject matter, see the 2014 Interim Guidance on Patent Subject Matter Eligibility, 79 Fed. Reg. 74618 (December 16, 2014) and related materials available at www.uspto.gov /patent/laws-and-regulations/examination-policy/2014- interim-guidance-subject-matter-eligibility-0.III. Establish on the Record a Prima Facie Case
USPTO personnel should review the totality of the evidence (e.g., the specification, claims, relevant prior art) before reaching a conclusion with regard to whether the claimed invention sets forth patent eligible subject matter. USPTO personnel must reach a conclusion as to whether it is more likely than not that the claimed invention as a whole either falls outside of one of the enumerated statutory classes or within one of the exceptions to statutory subject matter. “The examiner bears the initial burden … of presenting a prima facie case of unpatentability.” In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992). If the record as a whole suggests that it is more likely than not that the claimed invention would be considered significantly more than an abstract idea, natural phenomenon, or law of nature, then USPTO personnel should not reject the claim.
After USPTO personnel identify and explain in the record the reasons why a claim is for an abstract idea, natural phenomenon, or law of nature without significantly more, then the burden shifts to the applicant to either amend the claim or make a showing of why the claim is eligible for patent protection. See, e.g., In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed. Cir. 1995).
Under the principles of compact prosecution, regardless of whether a rejection under 35 U.S.C. 101 is made based on lack of subject matter eligibility, a complete examination should be made for every claim under each of the other patentability requirements: 35 U.S.C. 102, 103, 112, and 101 (utility, inventorship and double patenting) and non-statutory double patenting. Thus, Office personnel should state all non-cumulative reasons and bases for rejecting claims in the first Office action.