justicedao/patent-legal-corpus huggingface dataset:
37 CFR 1.791 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Termination of interim extension granted prior to regulatory approval of a product for commercial marketing or use.

§ 1.791 Termination of interim extension granted prior to regulatory approval of a product for commercial marketing or use. Any interim extension granted under 35 U.S.C. 156(d)(5) terminates at the end of the 60-day period beginning on the date on which the product involved receives permission for commercial marketing or use. If within that 60-day period the patent owner or its agent files an application for extension under §§ 1.740 and 1.741 including any additional information required under 35 U.S.C. 156(d)(1) not contained in the application for interim extension, the patent shall be further extended in accordance with the provisions of 35 U.S.C. 156. [60 FR 25619, May 12, 1995]
37 CFR 1.7 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Times for taking action; Expiration on Saturday, Sunday or Federal holiday.

§ 1.7 Times for taking action; Expiration on Saturday, Sunday or Federal holiday. (a) Whenever periods of time are specified in this part in days, calendar days are intended. When the day, or the last day fixed by statute or by or under this part for taking any action or paying any fee in the United States Patent and Trademark Office falls on Saturday, Sunday, or on a Federal holiday within the District of Columbia, the action may be taken, or the fee paid, on the next succeeding business day which is not a Saturday, Sunday, or a Federal holiday. See § 90.3 of this chapter for time for appeal or for commencing civil action. (b) If the day that is twelve months after the filing date of a provisional application under 35 U.S.C. 111(b) and § 1.53(c) falls on Saturday, Sunday, or on a Federal holiday within the District of Columbia, the period of pendency shall be extended to the next succeeding secular or business day which is not a Saturday, Sunday, or a Federal holiday. [65 FR 14871, Mar. 20, 2000, as amended at 78 FR 62395, Oct. 21, 2013]
37 CFR 1.801 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Biological material.

§ 1.801 Biological material. For the purposes of these regulations pertaining to the deposit of biological material for purposes of patents for inventions under 35 U.S.C. 101, the term biological material shall include material that is capable of self-replication either directly or indirectly. Representative examples include bacteria, fungi including yeast, algae, protozoa, eukaryotic cells, cell lines, hybridomas, plasmids, viruses, plant tissue cells, lichens and seeds. Viruses, vectors, cell organelles and other non-living material existing in and reproducible from a living cell may be deposited by deposit of the host cell capable of reproducing the non-living material.
37 CFR 1.802 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Need or opportunity to make a deposit.

§ 1.802 Need or opportunity to make a deposit. (a) Where an invention is, or relies on, a biological material, the disclosure may include reference to a deposit of such biological material. (b) Biological material need not be deposited unless access to such material is necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112. If a deposit is necessary, it shall be acceptable if made in accordance with these regulations. Biological material need not be deposited, inter alia, if it is known and readily avaliable to the public or can be made or isolated without undue experimentation. Once deposited in a depository complying with these regulations, a biological material will be considered to be readily available even though some requirement of law or regulation of the United States or of the country in which the depository institution is located permits access to the material only under conditions imposed for safety, public health or similar reasons. (c) The reference to a biological material in a specification disclosure or the actual deposit of such material by an applicant or patent owner does not create any presumption that such material is necessary to satisfy 35 U.S.C. 112 or that deposit in accordance with these regulations is or was required.
37 CFR 1.803 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Acceptable depository.

§ 1.803 Acceptable depository. (a) A deposit shall be recognized for the purposes of these regulations if made in (1) Any International Depositary Authority (IDA) as established under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, or (2) Any other depository recognized to be suitable by the Office. Suitability will be determined by the Director on the basis of the administrative and technical competence, and agreement of the depository to comply with the terms and conditions applicable to deposits for patent purposes. The Director may seek the advice of impartial consultants on the suitability of a depository. The depository must: (i) Have a continuous existence; (ii) Exist independent of the control of the depositor; (iii) Possess the staff and facilities sufficient to examine the viability of a deposit and store the deposit in a manner which ensures that it is kept viable and uncontaminated; (iv) Provide for sufficient safety measures to minimize the risk of losing biological material deposited with it; (v) Be impartial and objective; (vi) Furnish samples of the deposited material in an expeditious and proper manner; and (vii) Promptly notify depositors of its inability to furnish samples, and the reasons why. (b) A depository seeking status under paragraph (a)(2) of this section must direct a communication to the Director which shall: (1) Indicate the name and address of the depository to which the communication relates; (2) Contain detailed information as to the capacity of the depository to comply with the requirements of paragraph (a)(2) of this section, including information on its legal status, scientific standing, staff and facilities; (3) Indicate that the depository intends to be available, for the purposes of deposit, to any depositor under these same conditions; (4) Where the depository intends to accept for deposit only certain kinds of biological material, specify such kinds; (5) Indicate the amount of any fees that the depository will, upon acquiring the status of suitable depository under paragraph (a)(2) of this section, charge for storage, viability statements and furnishings of samples of the deposit. (c) A depository having status under paragraph (a)(2) of this section limited to certain kinds of biological material may extend such status to additional kinds of biological material by directing a communication to the Director in accordance with paragraph (b) of this section. If a previous communication under paragraph (b) of this section is of record, items in common with the previous communication may be incorporated by reference. (d) Once a depository is recognized to be suitable by the Director or has defaulted or discontinued its performance under this section, notice thereof will be published in the Office Gazette of the Patent and Trademark Office.
37 CFR 1.804 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Time of making an original deposit.

§ 1.804 Time of making an original deposit. (a) Whenever a biological material is specifically identified in an application for patent as filed, an original deposit thereof may be made at any time before filing the application for patent or, subject to § 1.809, during pendency of the application for patent. (b) When the original deposit is made after the effective filing date of an application for patent, the applicant must promptly submit a statement from a person in a position to corroborate the fact, stating that the biological material which is deposited is a biological material specifically identified in the application as filed. [54 FR 34880, Aug. 22, 1989, as amended at 62 FR 53202, Oct. 10, 1997]
37 CFR 1.806 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Term of deposit.

§ 1.806 Term of deposit. A deposit made before or during pendency of an application for patent shall be made for a term of at least thirty (30) years and at least five (5) years after the most recent request for the furnishing of a sample of the deposit was received by the depository. In any case, samples must be stored under agreements that would make them available beyond the enforceable life of the patent for which the deposit was made.
37 CFR 1.807 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Viability of deposit.

§ 1.807 Viability of deposit. (a) A deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of deposit and during the term of deposit. Viability may be tested by the depository. The test must conclude only that the deposited material is capable of reproduction. No evidence is necessarily required regarding the ability of the deposited material to perform any function described in the patent application. (b) A viability statement for each deposit of a biological material defined in paragraph (a) of this section not made under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure must be filed in the application and must contain: (1) The name and address of the depository; (2) The name and address of the depositor; (3) The date of deposit; (4) The identity of the deposit and the accession number given by the depository; (5) The date of the viability test; (6) The procedures used to obtain a sample if the test is not done by the depository; and (7) A statement that the deposit is capable of reproduction. (c) If a viability test indicates that the deposit is not viable upon receipt, or the examiner cannot, for scientific or other valid reasons, accept the statement of viability received from the applicant, the examiner shall proceed as if no deposit has been made. The examiner will accept the conclusion set forth in a viability statement issued by a depository recognized under § 1.803(a).
37 CFR 1.808 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Furnishing of samples.

§ 1.808 Furnishing of samples. (a) A deposit must be made under conditions that assure that: (1) Access to the deposit will be available during pendency of the patent application making reference to the deposit to one determined by the Director to be entitled thereto under § 1.14 and 35 U.S.C. 122, and (2) Subject to paragraph (b) of this section, all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent. (b) The depositor may contract with the depository to require that samples of a deposited biological material shall be furnished only if a request for a sample, during the term of the patent: (1) Is in writing or other tangible form and dated; (2) Contains the name and address of the requesting party and the accession number of the deposit; and (3) Is communicated in writing by the depository to the depositor along with the date on which the sample was furnished and the name and address of the party to whom the sample was furnished. (c) Upon request made to the Office, the Office will certify whether a deposit has been stated to have been made under conditions which make it available to the public as of the issue date of the patent grant provided the request contains: (1) The name and address of the depository; (2) The accession number given to the deposit; (3) The patent number and issue date of the patent referring to the deposit; and (4) The name and address of the requesting party.
37 CFR 1.809 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Examination procedures.

§ 1.809 Examination procedures. (a) The examiner shall determine pursuant to § 1.104 in each application for patent, application for reissue patent or reexamination proceeding if a deposit is needed, and if needed, if a deposit actually made is acceptable for patent purposes. If a deposit is needed and has not been made or replaced or supplemented in accordance with these regulations, the examiner, where appropriate, shall reject the affected claims under the appropriate provision of 35 U.S.C. 112, explaining why a deposit is needed and/or why a deposit actually made cannot be accepted. (b) The applicant for patent or patent owner shall reply to a rejection under paragraph (a) of this section by— (1) In the case of an applicant for patent, either making an acceptable original, replacement, or supplemental deposit, or assuring the Office in writing that an acceptable deposit will be made; or, in the case of a patent owner, requesting a certificate of correction of the patent which meets the terms of paragraphs (b) and (c) of § 1.805, or (2) Arguing why a deposit is not needed under the circumstances of the application or patent considered and/or why a deposit actually made should be accepted. Other replies to the examiner's action shall be considered nonresponsive. The rejection will be repeated until either paragraph (b)(1) of this section is satisfied or the examiner is convinced that a deposit is not needed. (c) If an application for patent is otherwise in condition for allowance except for a needed deposit and the Office has received a written assurance that an acceptable deposit will be made, the Office may notify the applicant in a notice of allowability and set a three-month period of time from the mailing date of the notice of allowability within which the deposit must be made in order to avoid abandonment. This time period is not extendable under § 1.136 ( see § 1.136(c)). (d) For each deposit made pursuant to these regulations, the specification shall contain: (1) The accession number for the deposit; (2) The date of the deposit; (3) A description of the deposited biological material sufficient to specifically identify it and to permit examination; and (4) The name and address of the depository. (e) Any amendment required by paragraphs (d)(1), (d)(2) or (d)(4) of this section must be filed before or with the payment of the issue fee (see § 1.312). [54 FR 34880, Aug. 22, 1989, as amended at 66 FR 21092, Apr. 27, 2001; 78 FR 62408, Oct. 21, 2013]
37 CFR 1.81 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Drawings required in patent application.

§ 1.81 Drawings required in patent application. (a) The applicant for a patent is required to furnish a drawing of the invention where necessary for the understanding of the subject matter sought to be patented. Since corrections are the responsibility of the applicant, the original drawing(s) should be retained by the applicant for any necessary future correction. (b) Drawings may include illustrations which facilitate an understanding of the invention (for example, flow sheets in cases of processes, and diagrammatic views). (c) Whenever the nature of the subject matter sought to be patented admits of illustration by a drawing without its being necessary for the understanding of the subject matter and the applicant has not furnished such a drawing, the examiner will require its submission within a time period of not less than two months from the date of the sending of a notice thereof. (d) Drawings submitted after the filing date of the application may not be used to overcome any insufficiency of the specification due to lack of an enabling disclosure or otherwise inadequate disclosure therein, or to supplement the original disclosure thereof for the purpose of interpretation of the scope of any claim. [43 FR 4015, Jan. 31, 1978, as amended at 53 FR 47808, Nov. 28, 1988; 77 FR 48821, Aug. 14, 2012; 78 FR 62404, Oct. 21, 2013]
37 CFR 1.823 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Requirements for content of a “Sequence Listing” part of the specification.

§ 1.823 Requirements for content of a “Sequence Listing” part of the specification. (a) The “Sequence Listing” must comply with the following: (1) The order and presentation of the items of information in the “Sequence Listing” shall conform to the arrangement in appendix G to this subpart. The submission of those items of information designated with an “M” is mandatory. The submission of those items of information designated with an “O” is optional. (2) Each item of information shall begin on a new line, with the numeric identifier enclosed in angle brackets, as shown in appendix G to this subpart. (3) Set forth numeric identifiers <110> through <170> at the beginning of the “Sequence Listing.” (4) Include each disclosed nucleotide and/or amino acid sequence, as defined in § 1.821(a). (5) Assign a separate sequence identifier to each sequence, beginning with 1 and increasing sequentially by integers, and include the sequence identifier in numeric identifier <210>. (6) Use the code “000” in place of the sequence where no sequence is present for a sequence identifier. (7) Include the total number of SEQ ID NOs in numeric identifier <160>, as defined in appendix G to this subpart, whether followed by a sequence or by the code “000.” (8) Must not contain more than 74 characters per line. (b)(1) Unless paragraph (b)(2) of this section applies, if the “Sequence Listing” required by § 1.821(c) is submitted as an ASCII plain text file via the USPTO patent electronic filing system or on a read-only optical disc, in compliance with § 1.52(e), then the specification must contain a statement in a separate paragraph (see § 1.77(b)(5)) that incorporates by reference the material in the ASCII plain text file identifying: (i) The name of the file; (ii) The date of creation; and (iii) The size of the file in bytes. (2) If the “Sequence Listing” required by § 1.821(c) is submitted as an ASCII plain text file via the USPTO patent electronic filing system or on a read-only optical disc, in compliance with § 1.52(e) for an international application during the international stage, then incorporation by reference of the material in the ASCII plain text file is not required. (3) A “Sequence Listing” required by § 1.821(c) that is submitted as a PDF file (§ 1.821(c)(2)) via the USPTO patent electronic filing system or on physical sheets of paper (§ 1.821(c)(3)), setting forth the nucleotide and/or amino acid sequence and associated information in accordance with paragraph (a) of this section: (i) Must begin on a new page; (ii) Must be titled “Sequence Listing”; (iii) Must not include material other than the “Sequence Listing” itself; (iv) Must have sheets containing no more than 66 lines, with each line containing no more than 74 characters; (v) Should have sheets numbered independently of the numbering of the remainder of the application; and (vi) Should use a fixed-width font exclusively throughout. [86 FR 57050, Oct. 14, 2021]
37 CFR 1.824 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Form and format for a nucleotide and/or amino acid sequence submission as an ASCII plain text file.

§ 1.824 Form and format for a nucleotide and/or amino acid sequence submission as an ASCII plain text file. (a) A “Sequence Listing” under § 1.821(c)(1) and the CRF required by § 1.821(e) submitted as an ASCII plain text file may be created by any means, such as text editors, nucleotide/amino acid sequence editors, or other custom computer programs; however, the ASCII plain text file must conform to the following requirements: (1) Must have the following compatibilities: (i) Computer compatibility: PC or Mac®; and (ii) Operating system compatibility: MS-DOS®, MS-Windows®, Mac OS®, or Unix®/Linux®. (2) Must be in ASCII plain text, where: (i) All printable characters (including the space character) are permitted; and (ii) No nonprintable (ASCII control) characters are permitted, except ASCII CRLF or LF as line terminators. (3) Must be named as *.txt, where “*” is one character or a combination of characters limited to upper- or lowercase letters, numbers, hyphens, and underscores and does not exceed 60 characters in total, excluding the extension. No spaces or other types of characters are permitted in the file name. (4) Must contain no more than 74 printable characters in each line. (5) Pagination is not permitted; the ASCII plain text file must be one continuous file, with no “hard page break” codes and no page numbering. (b) The ASCII plain text file must contain a copy of a single “Sequence Listing” in a single file and be submitted either: (1) Electronically via the USPTO patent electronic filing system, where the file must not exceed 100 MB, and file compression is not permitted; or (2) On a read-only optical disc(s), in compliance with § 1.52(e), where: (i) A file that is not compressed must be contained on a single read-only optical disc; (ii) The file may be compressed using WinZip®, 7-Zip, or Unix®/Linux® Zip; (iii) A compressed file must not be self-extracting; and (iv) A compressed ASCII plain text file that does not fit on a single read-only optical disc may be split into multiple file parts, in accordance with the target read-only optical disc size, and labeled in compliance with § 1.52(e)(5)(vi). [86 FR 57051, Oct. 14, 2021]
37 CFR 1.833 — Rules of Practice in Patent Cases
Current through: 2024-07-01

Requirements for a “Sequence Listing XML” for nucleotide and/or amino acid sequences as part of a patent application filed on or after July 1, 2022.

§ 1.833 Requirements for a “Sequence Listing XML” for nucleotide and/or amino acid sequences as part of a patent application filed on or after July 1, 2022. (a) The “Sequence Listing XML” as required by § 1.831(a) must be presented as a single file in XML 1.0 encoded using Unicode UTF-8, where the character set complies with paragraphs 40 and 41 and Annex IV of WIPO Standard ST.26 (incorporated by reference, see § 1.839). (b) The “Sequence Listing XML” presented in accordance with paragraph (a) of this section must further: (1) Be valid according to the Document Type Definition (DTD) as presented in WIPO Standard ST.26, Annex II. (2) Comply with the requirements of WIPO Standard ST.26 to include: (i) An XML declaration as defined in paragraph 39(a) of WIPO Standard ST.26; (ii) A document type (DOCTYPE) declaration as defined in paragraph 39(b) of WIPO Standard ST.26; (iii) A root element as defined in paragraph 43 of WIPO Standard ST.26; (iv) A general information part that complies with the requirements of paragraphs 45, 47, and 48, as applicable, of WIPO Standard ST.26; and (v) A sequence data part that complies with the requirements of paragraphs 50-55, 57, 58, 60-69, 71-78, 80-87, 89-98, and 100, as applicable, of WIPO Standard ST.26 representing the nucleotide and/or amino acid sequences according to § 1.832. (3) Include an INSDQualifier__value element with a value in English for any language-dependent free text qualifier as defined by paragraphs 76 and 85-87 of WIPO Standard ST.26, and as required by § 1.52(b)(1)(ii). [87 FR 30818, May 20, 2022]