Section 401.2 - DefinitionsIn addition to the definitions in 35 U.S.C. 201 , as used in this part-
(a) The term funding agreement means any contract, grant, or cooperative agreement entered into between any Federal agency, other than the Tennessee Valley Authority, and any contractor for the performance of experimental, developmental, or research work funded in whole or in part by the Federal government. This term also includes any assignment, substitution of parties, or subcontract of any type entered into for the performance of experimental, developmental, or research work under a funding agreement as defined in the first sentence of this paragraph.(b) The term contractor means any person, small business firm or nonprofit organization, or, as set forth in section 1, paragraph (b)(4) of Executive Order 12591, as amended, any business firm regardless of size, which is a party to a funding agreement.(c) The term invention means any invention or discovery which is or may be patentable or otherwise protectable under Title 35 of the United States Code, or any novel variety of plant which is or may be protectable under the Plant Variety Protection Act (7 U.S.C. 2321 et seq.).(d) The term subject invention means any invention of a contractor conceived or first actually reduced to practice in the performance of work under a funding agreement; provided that in the case of a variety of plant, the date of determination (as defined in section 41(d) of the Plant Variety Protection Act, 7 U.S.C. 2401(d) ) must also occur during the period of contract performance.(e) The term practical application means to manufacture in the case of a composition of product, to practice in the case of a process or method, or to operate in the case of a machine or system; and, in each case, under such conditions as to establish that the invention is being utilized and that its benefits are, to the extent permitted by law or government regulations, available to the public on reasonable terms.(f) The term made when used in relation to any invention means the conception or first actual reduction to practice of such invention.(g) The term small business firm means a small business concern as defined at section 2 of Pub. L. 85-536 (15 U.S.C. 632 ) and implementing regulations of the Administrator of the Small Business Administration. For the purpose of this part, the size standards for small business concerns involved in government procurement and subcontracting at 13 CFR 121.5 will be used.(h) The term nonprofit organization means universities and other institutions of higher education or an organization of the type described in section 501(c)(3) of the Internal Revenue Code of 1954 (26 U.S.C. 501(c) and exempt from taxation under section 501(a) of the Internal Revenue Code (26 U.S.C. 501(a) ) or any nonprofit scientific or educational organization qualified under a state nonprofit organization statute.(i) The term Chapter 18 means Chapter 18 of Title 35 of the United States Code.(j) The term Secretary means the Director of the National Institute of Standards and Technology.(k) The term electronically filed means any submission of information transmitted by an electronic system.(l) The term electronic system means a software-based system approved by the agency for the transmission of information.(m) The term patent application or "application for patent" may be the following:(1) A United States provisional application as defined in 37 CFR 1.9(a)(2) and filed under 35 U.S.C. 111(b) ; or(2) A United States nonprovisional application as defined in 37 CFR 1.9(a)(3) and filed under 35 U.S.C. 111(a) ; or(3) A patent application filed in a foreign country or an international patent office; or(4) An application for a Plant Variety Protection certificate.(n) The term initial patent application means, as to a given subject invention: (1) The first United States provisional application as defined in 37 CFR 1.9(a)(2) and filed under 35 U.S.C. 111(b) ; or(2) The first United States nonprovisional application as defined in 37 CFR 1.9(a)(3) and filed under 35 U.S.C. 111(a) ; or(3) The first patent application filed under the Patent Cooperation Treaty as defined in 37 CFR 1.9(b) ; or(4) The first application for a Plant Variety Protection certificate.(o) The term statutory period means the one-year period before the effective filing date of a claimed invention in a patent application during which exceptions to prior art exist per 35 U.S.C. 102(b) as amended by the Leahy-Smith America Invents Act, Public Law 112-29 .52 FR 8554, Mar. 18, 1987, as amended at 60 FR 41812, Aug. 14, 1995; 78 FR 4766 , Jan. 23, 2013; 83 FR 15958 , Apr. 13, 2018; 88 FR 17735 , Mar. 24, 2023 83 FR 15958 , 5/14/2018; 88 FR 17735 , 4/24/2023