justicedao/patent-legal-corpus huggingface dataset:
37 CFR 1.705 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Patent term adjustment determination.

§ 1.705 Patent term adjustment determination. (a) The patent will include notification of any patent term adjustment under 35 U.S.C. 154(b). (b) Any request for reconsideration of the patent term adjustment indicated on the patent must be by way of an application for patent term adjustment filed no later than two months from the date the patent was granted. This two-month time period may be extended under the provisions of § 1.136(a). An application for patent term adjustment under this section must be accompanied by: (1) The fee set forth in § 1.18(e); and (2) A statement of the facts involved, specifying: (i) The correct patent term adjustment and the basis or bases under § 1.702 for the adjustment; (ii) The relevant dates as specified in §§ 1.703(a) through (e) for which an adjustment is sought and the adjustment as specified in § 1.703(f) to which the patent is entitled; (iii) Whether the patent is subject to a terminal disclaimer and any expiration date specified in the terminal disclaimer; and (iv)(A) Any circumstances during the prosecution of the application resulting in the patent that constitute a failure to engage in reasonable efforts to conclude processing or examination of such application as set forth in § 1.704; or (B) That there were no circumstances constituting a failure to engage in reasonable efforts to conclude processing or examination of such application as set forth in § 1.704. (c) Any request for reinstatement of all or part of the period of adjustment reduced pursuant to § 1.704(b) for failing to reply to a rejection, objection, argument, or other request within three months of the date of mailing of the Office communication notifying the applicant of the rejection, objection, argument, or other request must be filed prior to the issuance of the patent. This time period is not extendable. Any request for reinstatement of all or part of the period of adjustment reduced pursuant to § 1.704(b) under this paragraph must also be accompanied by: (1) The fee set forth in § 1.18(f); and (2) A showing to the satisfaction of the Director that, in spite of all due care, the applicant was unable to reply to the rejection, objection, argument, or other request within three months of the date of mailing of the Office communication notifying the applicant of the rejection, objection, argument, or other request. The Office shall not grant any request for reinstatement for more than three additional months for each reply beyond three months from the date of mailing of the Office communication notifying the applicant of the rejection, objection, argument, or other request. (d) No submission or petition on behalf of a third party concerning patent term adjustment under 35 U.S.C. 154(b) will be considered by the Office. Any such submission or petition will be returned to the third party, or otherwise disposed of, at the convenience of the Office. [65 FR 56394, Sept. 18, 2000, as amended at 69 FR 21711, Apr. 22, 2004; 78 FR 19420, Apr. 1, 2013]
37 CFR 1.710 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Patents subject to extension of the patent term.

§ 1.710 Patents subject to extension of the patent term. (a) A patent is eligible for extension of the patent term if the patent claims a product as defined in paragraph (b) of this section, either alone or in combination with other ingredients that read on a composition that received permission for commercial marketing or use, or a method of using such a product, or a method of manufacturing such a product, and meets all other conditions and requirements of this subpart. (b) The term product referred to in paragraph (a) of this section means— (1) The active ingredient of a new human 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) including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient; or (2) The active ingredient of 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) that is not primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes including 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; or (3) Any medical device, food additive, or color additive subject to regulation under the Federal Food, Drug, and Cosmetic Act. [54 FR 30379, July 20, 1989]
37 CFR 1.72 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Title and abstract.

§ 1.72 Title and abstract. (a) The title of the invention may not exceed 500 characters in length and must be as short and specific as possible. Characters that cannot be captured and recorded in the Office's automated information systems may not be reflected in the Office's records in such systems or in documents created by the Office. Unless the title is supplied in an application data sheet (§ 1.76), the title of the invention should appear as a heading on the first page of the specification. (b) A brief abstract of the technical disclosure in the specification must commence on a separate sheet, preferably following the claims, under the heading “Abstract” or “Abstract of the Disclosure.” The sheet or sheets presenting the abstract may not include other parts of the application or other material. The abstract must be as concise as the disclosure permits, preferably not exceeding 150 words in length. The purpose of the abstract is to enable the Office and the public generally to determine quickly from a cursory inspection the nature and gist of the technical disclosure. [65 FR 54667, Sept. 8, 2000, as amended at 65 FR 57054, Sept. 20, 2000; 68 FR 38628, June 30, 2003; 78 FR 62402, Oct. 21, 2013]
37 CFR 1.730 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Applicant for extension of patent term; signature requirements.

§ 1.730 Applicant for extension of patent term; signature requirements. (a) Any application for extension of a patent term must be submitted by the owner of record of the patent or its agent and must comply with the requirements of § 1.740. (b) If the application is submitted by the patent owner, the application must be signed either by: (1) The patent owner in compliance with § 3.73(c) of this chapter; or (2) A registered practitioner on behalf of the patent owner. (c) If the application is submitted on behalf of the patent owner by an agent of the patent owner (e.g., a licensee of the patent owner), the application must be signed by a registered practitioner on behalf of the agent. The Office may require proof that the agent is authorized to act on behalf of the patent owner. (d) If the application is signed by a registered practitioner, the Office may require proof that the practitioner is authorized to act on behalf of the patent owner or agent of the patent owner. [65 FR 54679, Sept. 8, 2000, as amended at 77 FR 48825, Aug. 14, 2012]
37 CFR 1.73 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Summary of the invention.

§ 1.73 Summary of the invention. A brief summary of the invention indicating its nature and substance, which may include a statement of the object of the invention, should precede the detailed description. Such summary should, when set forth, be commensurate with the invention as claimed and any object recited should be that of the invention as claimed.
37 CFR 1.741 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Complete application given a filing date; petition procedure.

§ 1.741 Complete application given a filing date; petition procedure. (a) The filing date of an application for extension of a patent term is the date on which a complete application is received in the Office via the USPTO patent electronic filing system or filed pursuant to the procedure set forth in § 1.8(a)(1)(i)(C) and (a)(1)(ii). A complete application must include: (1) An identification of the approved product; (2) An identification of each Federal statute under which regulatory review occurred; (3) An identification of the patent for which an extension is being sought; (4) An identification of each claim of the patent which claims the approved product or a method of using or manufacturing the approved product; (5) Sufficient information to enable the Director to determine under subsections (a) and (b) of 35 U.S.C. 156 the eligibility of a patent for extension, and the rights that will be derived from the extension, and information to enable the Director and the Secretary of Health and Human Services or the Secretary of Agriculture to determine the length of the regulatory review period; and (6) A brief description of the activities undertaken by the marketing applicant during the applicable regulatory review period with respect to the approved product and the significant dates applicable to such activities. (b) If an application for extension of patent term is incomplete under this section, the Office will so notify the applicant. If applicant requests review of a notice that an application is incomplete, or review of the filing date accorded an application under this section, applicant must file a petition pursuant to this paragraph accompanied by the fee set forth in § 1.17(f) within two months of the mail date of the notice that the application is incomplete, or the notice according the filing date complained of. Unless the notice indicates otherwise, this time period may be extended under the provisions of § 1.136. [52 FR 9394, Mar. 24, 1987, as amended at 59 FR 54503, Oct. 22, 1993; 61 FR 64028, Dec. 3, 1996; 65 FR 54680, Sept. 8, 2000; 69 FR 56546, Sept. 21, 2004; 88 FR 13033, Mar. 2, 2023]
37 CFR 1.74 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Reference to drawings.

§ 1.74 Reference to drawings. When there are drawings, there shall be a brief description of the several views of the drawings and the detailed description of the invention shall refer to the different views by specifying the numbers of the figures and to the different parts by use of reference letters or numerals (preferably the latter).
37 CFR 1.750 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Determination of eligibility for extension of patent term.

§ 1.750 Determination of eligibility for extension of patent term. A determination as to whether a patent is eligible for extension may be made by the Director solely on the basis of the representations contained in the application for extension filed in compliance with § 1.740 or § 1.790. This determination may be delegated to appropriate Patent and Trademark Office officials and may be made at any time before the certificate of extension is issued. The Director or other appropriate officials may require from applicant further information or make such independent inquiries as desired before a final determination is made on whether a patent is eligible for extension. In an application for extension filed in compliance with § 1.740, a notice will be mailed to applicant containing the determination as to the eligibility of the patent for extension and the period of time of the extension, if any. This notice shall constitute the final determination as to the eligibility and any period of extension of the patent. A single request for reconsideration of a final determination may be made if filed by the applicant within such time as may be set in the notice of final determination or, if no time is set, within one month from the date of the final determination. The time periods set forth herein are subject to the provisions of § 1.136. [60 FR 25618, May 12, 1995]
37 CFR 1.760 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Interim extension of patent term under 35 U.S.C. 156(e)(2).

§ 1.760 Interim extension of patent term under 35 U.S.C. 156(e)(2). An applicant who has filed a formal application for extension in compliance with § 1.740 may request one or more interim extensions for periods of up to one year each pending a final determination on the application pursuant to § 1.750. Any such request should be filed at least three months prior to the expiration date of the patent. The Director may issue interim extensions, without a request by the applicant, for periods of up to one year each until a final determination is made. The patent owner or agent will be notified when an interim extension is granted and notice of the extension will be published in the Official Gazette of the United States Patent and Trademark Office. The notice will be recorded in the official file of the patent and will be considered as part of the original patent. In no event will the interim extensions granted under this section be longer than the maximum period for extension to which the applicant would be eligible. [65 FR 54680, Sept. 8, 2000]
37 CFR 1.770 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Express withdrawal of application for extension of patent term.

§ 1.770 Express withdrawal of application for extension of patent term. An application for extension of patent term may be expressly withdrawn before a determination is made pursuant to § 1.750 by filing in the Office a written declaration of withdrawal signed by the owner of record of the patent or its agent. An application may not be expressly withdrawn after the date permitted for reply to the final determination on the application. An express withdrawal pursuant to this section is effective when acknowledged in writing by the Office. The filing of an express withdrawal pursuant to this section and its acceptance by the Office does not entitle applicant to a refund of the filing fee (§ 1.20(j)) or any portion thereof. [62 FR 53201, Oct. 10, 1997, as amended at 88 FR 13033, Mar. 2, 2023]
37 CFR 1.77 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Arrangement of application elements.

§ 1.77 Arrangement of application elements. (a) The elements of the application, if applicable, should appear in the following order: (1) Utility application transmittal form. (2) Fee transmittal form. (3) Application data sheet (see § 1.76). (4) Specification. (5) Drawings. (6) The inventor's oath or declaration. (b) The specification should include the following sections in order: (1) Title of the invention, which may be accompanied by an introductory portion stating the name, citizenship, and residence of the applicant (unless included in the application data sheet). (2) Cross-reference to related applications. (3) Statement regarding federally sponsored research or development. (4) The names of the parties to a joint research agreement. (5) An incorporation by reference statement regarding the material in: (i) One or more ASCII plain text files, submitted via the USPTO patent electronic filing system or on one or more read-only optical discs ( see § 1.52(e)(8)), identifying the names of each file, the date of creation of each file, and the size of each file in bytes, for the following document types: (A) A “Computer Program Listing Appendix” ( see § 1.96(c)); (B) A “Sequence Listing” ( see § 1.821(c)); or (C) “Large Tables” ( see § 1.58(c)). (ii) An XML file for a “Sequence Listing XML” ( see § 1.831(a)), submitted via the USPTO patent electronic filing system or on one or more read-only optical discs ( see § 1.52(e)(8)), identifying the names of each file, the date of creation of each file, and the size of each file in bytes. (6) Statement regarding prior disclosures by the inventor or a joint inventor. (7) Background of the invention. (8) Brief summary of the invention. (9) Brief description of the several views of the drawing. (10) Detailed description of the invention. (11) A claim or claims. (12) Abstract of the disclosure. (13) “Sequence Listing,” required by § 1.821(c), that is submitted as a Portable Document Format (PDF) file (as set forth in § 1.821(c)(2)) via the USPTO patent electronic filing system or on physical sheets of paper (as set forth in § 1.821(c)(3)). (c) The text of the specification sections defined in paragraphs (b)(1) through (b)(12) of this section, if applicable, should be preceded by a section heading in uppercase and without underlining or bold type. [65 FR 54668, Sept. 8, 2000, as amended at 70 FR 1823, Jan. 11, 2005; 77 FR 48820, Aug. 14, 2012; 78 FR 11055, Feb. 14, 2013; 86 FR 57047, Oct. 14, 2021; 86 FR 73985, Dec. 29, 2021; 87 FR 30817, May 20, 2022]
37 CFR 1.780 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Certificate or order of extension of patent term.

§ 1.780 Certificate or order of extension of patent term. If a determination is made pursuant to § 1.750 that a patent is eligible for extension and that the term of the patent is to be extended, a certificate of extension, under seal, or an order granting interim extension under 35 U.S.C. 156(d)(5), will be issued to the applicant for the extension of the patent term. Such certificate or order will be recorded in the official file of the patent and will be considered as part of the original patent. Notification of the issuance of the certificate or order of extension will be published in the Official Gazette of the United States Patent and Trademark Office. Notification of the issuance of the order granting an interim extension under 35 U.S.C. 156(d)(5), including the identity of the product currently under regulatory review, will be published in the Official Gazette of the United States Patent and Trademark Office and in the Federal Register. No certificate of, or order granting, an extension will be issued if the term of the patent cannot be extended, even though the patent is otherwise determined to be eligible for extension. In such situations, the final determination made pursuant to § 1.750 will indicate that no certificate or order will issue. [65 FR 54680, Sept. 8, 2000]
37 CFR 1.785 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Multiple applications for extension of term of the same patent or of different patents for the same regulatory review period for a product.

§ 1.785 Multiple applications for extension of term of the same patent or of different patents for the same regulatory review period for a product. (a) Only one patent may be extended for a regulatory review period for any product (§ 1.720(h)). If more than one application for extension of the same patent is filed, the certificate of extension of patent term, if appropriate, will be issued based upon the first filed application for extension. (b) If more than one application for extension is filed by a single applicant which seeks the extension of the term of two or more patents based upon the same regulatory review period, and the patents are otherwise eligible for extension pursuant to the requirements of this subpart, in the absence of an election by the applicant, the certificate of extension of patent term, if appropriate, will be issued upon the application for extension of the patent term having the earliest date of issuance of those patents for which extension is sought. (c) If an application for extension is filed which seeks the extension of the term of a patent based upon the same regulatory review period as that relied upon in one or more applications for extension pursuant to the requirements of this subpart, the certificate of extension of patent term will be issued on the application only if the patent owner or its agent is the holder of the regulatory approval granted with respect to the regulatory review period. (d) An application for extension shall be considered complete and formal regardless of whether it contains the identification of the holder of the regulatory approval granted with respect to the regulatory review period. When an application contains such information, or is amended to contain such information, it will be considered in determining whether an application is eligible for an extension under this section. A request may be made of any applicant to supply such information within a non-extendable period of not less than one month whenever multiple applications for extension of more than one patent are received and rely upon the same regulatory review period. Failure to provide such information within the period for reply set shall be regarded as conclusively establishing that the applicant is not the holder of the regulatory approval. (e) Determinations made under this section shall be included in the notice of final determination of eligibility for extension of the patent term pursuant to § 1.750 and shall be regarded as part of that determination. [60 FR 25618, May 12, 1995, as amended at 62 FR 53201, Oct. 10, 1997]
37 CFR 1.790 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Interim extension of patent term under 35 U.S.C. 156(d)(5).

§ 1.790 Interim extension of patent term under 35 U.S.C. 156(d)(5). (a) An owner of record of a patent or its agent who reasonably expects that the applicable regulatory review period, described in 35 U.S.C. 156(g)(1)(B)(ii), (2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or (5)(B)(ii), that began for a product that is the subject of such patent may extend beyond the expiration of the patent term in effect may submit one or more applications for interim extensions for periods of up to one year each. In no event will the interim extensions granted under this section be longer than the maximum period of extension to which the applicant would be entitled under 35 U.S.C. 156(c). (b) Any application for interim extension under this section must be filed using the USPTO patent electronic filing system in accordance with the USPTO patent electronic filing system requirements. (c) Complete initial applications for interim extension under this section must: (1) Be filed during the period beginning 6 months and ending 15 days before the patent term is due to expire, and include a statement that the initial application is being submitted within the period and an identification of the date of the last day on which the initial application could be submitted; (2) Include all of the information required for a formal application under § 1.740 and a complete application under § 1.741, except as follows: (i) Paragraphs (a)(1), (2), (4), and (6) through (15) of §§ 1.740 and 1.741 shall be read in the context of a product currently undergoing regulatory review; and (ii) Paragraphs (a)(3) and (5) of § 1.740 are not applicable to an application for interim extension under this section; and (3) Include a statement that the applicable regulatory review period, described in 35 U.S.C. 156(g)(1)(B)(ii), (2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or (5)(B)(ii), has begun for the product that is the subject of the patent. (d) Each subsequent application for interim extension: (1) Must be filed during the period beginning 60 days before and ending 30 days before the expiration of the preceding interim extension and include a statement that it is being submitted within the period and an identification of the date of the last day on which it could be submitted; (2) May be limited in content to a request for a subsequent interim extension along with any materials or information required under §§ 1.740 and 1.741 that are not present in the preceding interim extension application; and (3) Must include a statement that the applicable regulatory review period, described in 35 U.S.C. 156(g)(1)(B)(ii), (2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or (5)(B)(ii), has not been completed. [88 FR 13033, Mar. 2, 2023]