r/title-35-PATENTS wiki — defined terms

“USMCA country” applies in that section

the term “USMCA country” has the meaning given that term in section 3 of the United States-Mexico-Canada Agreement Implementation Act ( 19 U.S.C. 4502 ); and;

“WTO member country” applies in that section

the term “WTO member country” has the meaning given that term in section 2(10) of the Uruguay Round Agreements Act ( 19 U.S.C. 3501(10) ).

“eligible entity” applies in that section

the term “eligible entity” means an entity that— (1) submits an application under subsection (d) for a patent that addresses a humanitarian issue; and (2) meets the requirements specified by the Director. (b) Establishment .— There is established a competition, to be held not less frequently than biennially, to award eligible entities certificates that can be redeemed to accelerate one of the following matters: (1) An ex parte reexamination proceeding, including 1 appeal to the Patent Trial and Appeal Board from that proceeding. (2) An application for a patent, including 1 appeal to the Patent Trial and Appeal Board from that application.

“claimed invention” applies throughout this title

The term “claimed invention” means the subject matter defined by a claim in a patent or an application for a patent.

“coinventor” applies throughout this title

The terms “joint inventor” and “coinventor” mean any 1 of the individuals who invented or discovered the subject matter of a joint invention.;

“invention” applies throughout this title

The term “invention” means invention or discovery.;

“inventor” applies throughout this title

The term “inventor” means the individual or, if a joint invention, the individuals collectively who invented or discovered the subject matter of the invention.;

“joint inventor” applies throughout this title

The terms “joint inventor” and “coinventor” mean any 1 of the individuals who invented or discovered the subject matter of a joint invention.;

“joint research agreement” applies throughout this title

The term “joint research agreement” means a written contract, grant, or cooperative agreement entered into by 2 or more persons or entities for the performance of experimental, developmental, or research work in the field of the claimed invention.

“process” applies throughout this title

The term “process” means process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.;

“third-party requester” applies throughout this title

The term “third-party requester” means a person requesting ex parte reexamination under section 302 who is not the patent owner.;

“this country” applies throughout this title

The terms “United States” and “this country” mean the United States of America, its territories and possessions. (d) The word “patentee” includes not only the patentee to whom the patent was issued but also the successors in title to the patentee.;

“United States” applies throughout this title

The terms “United States” and “this country” mean the United States of America, its territories and possessions. (d) The word “patentee” includes not only the patentee to whom the patent was issued but also the successors in title to the patentee.;

“UPOV Contracting Party” applies in that section

the term “UPOV Contracting Party” means a member of the International Convention for the Protection of New Varieties of Plants.

“WTO member country” applies in that section

the term “WTO member country” has the same meaning as the term is defined in section 104(b)(2); and;

“micro entity” applies throughout this title

the term “micro entity” means an applicant who makes a certification that the applicant— (1) qualifies as a small entity, as defined in regulations issued by the Director; (2) has not been named as an inventor on more than 4 previously filed patent applications, other than applications filed in another country, provisional applications under section 111(b), or international applications filed under the treaty defined in section 351(a) for which the basic national fee under section 41(a) was not paid; (3) did not, in the calendar year preceding the calendar year in which the applicable fee is being paid, have a gross income, as defined in section 61(a) of the Internal Revenue Code of 1986, …

“business day” applies in that section

the term “business day” means any Monday, Tuesday, Wednesday, Thursday, or Friday, excluding any legal holiday under section 6103 of title 5 . (2) (A) Within 60 days of the submittal of an application for extension of the term of a patent under paragraph (1), the Director shall notify— (i) the Secretary of Agriculture if the patent claims a drug product or a method of using or manufacturing a drug product and the drug product is subject to the Virus-Serum-Toxin Act, and (ii) the Secretary of Health and Human Services if the patent claims any other drug product, a medical device, or a food additive or color additive or a method of using or manufacturing such a product, device, or additive …

“covered date” applies in that section

the term “covered date” means the later of— (A) the date an application is approved— (i) under section 351(a)(2)(C) of the Public Health Service Act; or (ii) under section 505(b) or 512(c) of the Federal Food, Drug, and Cosmetic Act; (B) the date an application is conditionally approved under section 571(b) of the Federal Food, Drug, and Cosmetic Act; (C) the date a request for indexing is granted under section 572(d) of the Federal Food, Drug, and Cosmetic Act; or (D) the date of issuance of the interim final rule controlling the drug under section 201(j) of the Controlled Substances Act.

“drug product” applies in that section

The term “drug product” means the active ingredient of— (A) a new drug, antibiotic drug, or human biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act), or (B) a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Virus-Serum-Toxin Act) which is not primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques, including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient.;

“due diligence” applies in that section

the term “due diligence” means that degree of attention, continuous directed effort, and timeliness as may reasonably be expected from, and are ordinarily exercised by, a person during a regulatory review period. (4) An application for the extension of the term of a patent is subject to the disclosure requirements prescribed by the Director.

“informal hearing” applies in that section

The term “informal hearing” has the meaning prescribed for such term by section 201(y) 2 of the Federal Food, Drug, and Cosmetic Act.;

“major health or environmental effects test” applies in that section

The term “major health or environmental effects test” means a test which is reasonably related to the evaluation of the health or environmental effects of a product, which requires at least six months to conduct, and the data from which is submitted to receive permission for commercial marketing or use. Periods of analysis or evaluation of test results are not to be included in determining if the conduct of a test required at least six months. (4) (A) Any reference to section 351 is a reference to section 351 of the Public Health Service Act. (B) Any reference to section 503, 505, 512, or 515 is a reference to section 503, 505, 512, or 515 of the Federal Food, Drug, and Cosmetic Act.

“patent” applies in that section

The term “patent” means a patent issued by the United States Patent and Trademark Office. (7) The term “date of enactment” as used in this section means September 24, 1984 , for a human drug product, a medical device, food additive, or color additive. (8) The term “date of enactment” as used in this section means the date of enactment of the Generic Animal Drug and Patent Term Restoration Act for an animal drug or a veterinary biological product.

“product” applies in that section

the term “product” includes an approved product. (c) The term of a patent eligible for extension under subsection (a) shall be extended by the time equal to the regulatory review period for the approved product which period occurs after the date the patent is issued, except that— (1) each period of the regulatory review period shall be reduced by any period determined under subsection (d)(2)(B) during which the applicant for the patent extension did not act with due diligence during such period of the regulatory review period; (2) after any reduction required by paragraph (1), the period of extension shall include only one-half of the time remaining in the periods described in paragraphs …

“contractor” applies throughout its chapter

The term “contractor” means any person, small business firm, or nonprofit organization that is a party to a funding agreement.;

“Federal agency” applies throughout its chapter

The term “Federal agency” means any executive agency as defined in section 105 of title 5 , and the military departments as defined by section 102 of title 5 .;

“funding agreement” applies throughout its chapter

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. Such term 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 herein defined.;

“invention” applies throughout its chapter

The term “invention” means any invention or discovery which is or may be patentable or otherwise protectable under this title 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.).;

“nonprofit organization” applies throughout its chapter

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 1986 ( 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.

“practical application” applies throughout its chapter

The term “practical application” means to manufacture in the case of a composition or 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. (g) The term “made” when used in relation to any invention means the conception or first actual reduction to practice of such invention.;

“small business firm” applies throughout its chapter

The term “small business firm” means a small business concern as defined at section 2 of Public Law 85–536 ( 15 U.S.C. 632 ) and implementing regulations of the Administrator of the Small Business Administration.;

“subject invention” applies throughout its chapter

The term “subject invention” means any invention of the 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) 1 of the Plant Variety Protection Act ( 7 U.S.C. 2401(d) )) must also occur during the period of contract performance.;

“whoever” applies in that section

the term “whoever” includes any State, any instrumentality of a State, and any officer or employee of a State or instrumentality of a State acting in his official capacity. Any State, and any such instrumentality, officer, or employee, shall be subject to the provisions of this title in the same manner and to the same extent as any nongovernmental entity. (i) As used in this section, an “offer for sale” or an “offer to sell” by a person other than the patentee, or any designee of the patentee, is that in which the sale will occur before the expiration of the term of the patent.

“body” applies in that section

the term “body” shall mean a human body, organ or cadaver, or a nonhuman animal used in medical research or instruction directly relating to the treatment of humans. (F) the term “patented use of a composition of matter” does not include a claim for a method of performing a medical or surgical procedure on a body that recites the use of a composition of matter where the use of that composition of matter does not directly contribute to achievement of the objective of the claimed method.;

“medical activity” applies in that section

the term “medical activity” means the performance of a medical or surgical procedure on a body, but shall not include (i) the use of a patented machine, manufacture, or composition of matter in violation of such patent, (ii) the practice of a patented use of a composition of matter in violation of such patent, or (iii) the practice of a process in violation of a biotechnology patent.;

“medical practitioner” applies in that section

the term “medical practitioner” means any natural person who is licensed by a State to provide the medical activity described in subsection (c)(1) or who is acting under the direction of such person in the performance of the medical activity.;

“professional affiliation” applies in that section

the term “professional affiliation” shall mean staff privileges, medical staff membership, employment or contractual relationship, partnership or ownership interest, academic appointment, or other affiliation under which a medical practitioner provides the medical activity on behalf of, or in association with, the health care entity.;

“related health care entity” applies in that section

the term “related health care entity” shall mean an entity with which a medical practitioner has a professional affiliation under which the medical practitioner performs the medical activity, including but not limited to a nursing home, hospital, university, medical school, health maintenance organization, group medical practice, or a medical clinic.;

“State” applies in that section

the term “State” shall mean any State or territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico. (3) This subsection does not apply to the activities of any person, or employee or agent of such person (regardless of whether such person is a tax exempt organization under section 501(c) of the Internal Revenue Code), who is engaged in the commercial development, manufacture, sale, importation, or distribution of a machine, manufacture, or composition of matter or the provision of pharmacy or clinical laboratory services (other than clinical laboratory services provided in a physician’s office), where such activities are: (A) directly related to the …

“invention promoter” applies in that section

the term “invention promoter” means any person, firm, partnership, corporation, or other entity who offers to perform or performs invention promotion services for, or on behalf of, a customer, and who holds itself out through advertising in any mass media as providing such services, but does not include— (A) any department or agency of the Federal Government or of a State or local government; (B) any nonprofit, charitable, scientific, or educational organization, qualified under applicable State law or described under section 170(b)(1)(A) of the Internal Revenue Code of 1986; (C) any person or entity involved in the evaluation to determine commercial potential of, or offering to license or …

“invention promotion services” applies in that section

the term “invention promotion services” means the procurement or attempted procurement for a customer of a firm, corporation, or other entity to develop and market products or services that include the invention of the customer. (d) Records of Complaints.— (1) Release of complaints .— The Commissioner of Patents shall make all complaints received by the Patent and Trademark Office involving invention promoters publicly available, together with any response of the invention promoters. The Commissioner of Patents shall notify the invention promoter of a complaint and provide a reasonable opportunity to reply prior to making such complaint publicly available.

“international application” applies throughout its part

The term “international application” means an application filed under the treaty.;

“international application designating the United States” applies throughout its part

The term “international application designating the United States” means an international application specifying the United States as a country in which a patent is sought, regardless where such international application is filed.;

“international application originating in the United States” applies throughout its part

The term “international application originating in the United States” means an international application filed in the Patent and Trademark Office when it is acting as a Receiving Office under the treaty, irrespective of whether or not the United States has been designated in that international application.;

“International Bureau” applies throughout its part

The term “International Bureau” means the international intergovernmental organization which is recognized as the coordinating body under the treaty and the Regulations. (i) Terms and expressions not defined in this part are to be taken in the sense indicated by the treaty and the Regulations.

“International Preliminary Examining Authority” applies throughout its part

The terms “International Searching Authority” and “International Preliminary Examining Authority” mean a national patent office or intergovernmental organization as appointed under the treaty which processes international applications as prescribed by the treaty and the Regulations.;

“International Searching Authority” applies throughout its part

The terms “International Searching Authority” and “International Preliminary Examining Authority” mean a national patent office or intergovernmental organization as appointed under the treaty which processes international applications as prescribed by the treaty and the Regulations.;

“Receiving Office” applies throughout its part

The term “Receiving Office” means a national patent office or intergovernmental organization which receives and processes international applications as prescribed by the treaty and the Regulations.;

“treaty” applies throughout its part

The term “treaty” means the Patent Cooperation Treaty done at Washington, on June 19, 1970 . (b) The term “Regulations”, when capitalized, means the Regulations under the treaty, done at Washington on the same date as the treaty. The term “regulations”, when not capitalized, means the regulations established by the Director under this title.;

“effective registration date” applies throughout its part

the term “effective registration date” means the date of international registration determined by the International Bureau under the treaty;

“International Bureau” applies throughout its part

the term “International Bureau” means the international intergovernmental organization that is recognized as the coordinating body under the treaty and the Regulations;

“international design application” applies throughout its part

the term “international design application” means an application for international registration; and;

“international registration” applies throughout its part

the term “international registration” means the international registration of an industrial design filed under the treaty. (b) Rule of Construction .— Terms and expressions not defined in this part are to be taken in the sense indicated by the treaty and the Regulations.

“regulations” applies throughout its part

the term “regulations”— (A) when capitalized, means the Common Regulations under the treaty; and (B) when not capitalized, means the regulations established by the Director under this title; (3) the terms “designation”, “designating”, and “designate” refer to a request that an international registration have effect in a Contracting Party to the treaty;

“treaty” applies throughout its part

the term “treaty” means the Geneva Act of the Hague Agreement Concerning the International Registration of Industrial Designs adopted at Geneva on July 2, 1999 ;