DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete. The incorporation by reference paragraph must contain the size of the XML file in bytes.
Required response - Applicant must:
• Provide a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claim 6i s objected to because of the following informalities: “Adeno virus-associated vector” should read “adeno-associated virus vector”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: “is used introduce: should read “is used to introduce”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Applicant fails to distinctly claim the subject matter. “A tag-free CM1 polypeptide” or “CM1tf polypeptide” is not defined within the claims or the specification. In the Specification, SEQ ID NOs: 3 (amino acid) and 4 (nucleic acid) seem to be what is claimed, but as the sequences are not part of the claims, it is unclear.
It is also unclear the difference, if any, between “a tag-free CM1 polypeptide” and “CM1tf polypeptide” as within the Specification no delineation is made. This is especially unclear as the Specification defines “[t]he term "tag-free" as that term modifies a polypeptide refers to a polypeptide lacking extra amino acid information that is not native to the polypeptide” (0041). This suggests that even a single extra amino acid residue added to the sequence would make the polypeptide no longer “tag-free” meaning both “a tag-free CM1 polypeptide” and “CM1tf polypeptide” both only claim a polypeptide sequence that consists of SEQ ID NO: 3 only with no substitutions or additions.
Claim 2 recites the limitation "the ubiquitin polypeptide variant nucleic acid sequence" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 3-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 17/952,252 (reference application/conflicting claims). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to a tag-free CM1 polypeptide.
Regarding instant claims 3-4, conflicting claims 1-2 recite an isolated polypeptide wherein then ubiquitin polypeptide variant comprises the sequence of SEQ ID NO: 482, which is the SEQ ID for the polypeptide sequence of CM1tf.
Claims 1 and 2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 17/952,252 in view of Presnell, et al. (Nucleic Acids Res 1988 Mar 11;16(5);1693-702, hereinafter “Presnell”).
The rejection of claims 3-4 is set forth above. The conflicting claims do not recite an isolated nucleic acid sequence that encodes for a tag-free CM1 polypeptide. However, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the conflicting claims with the teachings of Presnell resulting in a nucleic acid sequence that encodes a tag-free CM1 polypeptide because Presnell teaches reverse translation, wherein a nucleic acid sequence can be determined from an amino acid sequence (Abstract). Presnell provides motivation to modify the conflicting claims by teaching that reverse translation facilitates the use of modular mutagenesis (Abstract).
Claims 5-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, and 31 of copending Application No. 17/952,252 in view of Wang, et al. (Cell Volume 181, Issue 1, 2 April 2020, pages 136-150, hereinafter “Wang”).
The rejections of claims 1-4 are set forth above. Regarding instant claims 5-7, conflicting claims 1-2 recite an isolated polypeptide wherein then ubiquitin polypeptide variant comprises the sequence of SEQ ID NO: 482, which is the SEQ ID for the polypeptide sequence of CM1tf. The conflicting claim 31 recites a method of increasing homologous recombination in a cell by introducing the isolated polypeptide of claim 1.
The conflicting claims do not recite nucleic acid donor template introduced into the cell or wherein an AAV is used to introduce the donor template. However, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the conflicting claims with the teachings of Wang resulting introducing both the nucleic acid donor template into the cell using an AAV along with the polypeptide because Wang teaches using AAV vectors to infect cells to provide donor templates (pg. 140 column 1). Wang provides motivation to modify the conflicting claims by teaching that these strategies are used in HDR-mediated strategies (pg. 140 column 1).
Claims 3-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of copending Application No. 19/033,845 (reference application/conflicting claims). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to a tag-free CM1 polypeptide.
Regarding instant claims 3-4, conflicting claims 1 and 4 recite an isolated polypeptide wherein then ubiquitin polypeptide variant comprises the sequence of SEQ ID NO: 1, which is the SEQ ID for the polypeptide sequence of CM1tf (named Ubv-A in the reference application).
Claims 1 and 2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of copending Application No. 19/033,845 in view of Presnell.
The rejection of claims 3-4 is set forth above. The conflicting claims do not recite an isolated nucleic acid sequence that encodes for a tag-free CM1 polypeptide. However, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the conflicting claims with the teachings of Presnell resulting in a nucleic acid sequence that encodes a tag-free CM1 polypeptide because Presnell teaches reverse translation, wherein a nucleic acid sequence can be determined from an amino acid sequence (Abstract). Presnell provides motivation to modify the conflicting claims by teaching that reverse translation facilitates the use of modular mutagenesis (Abstract).
Claims 5-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 13-16, and 20 of copending Application No. 19/033,845 in view of Wang.
The rejections of claims 1-4 are set forth above. Regarding instant claims 5-7, conflicting claims 1-4 recite an isolated polypeptide wherein then ubiquitin polypeptide variant comprises the sequence of SEQ ID NO: 1, which is the SEQ ID for the polypeptide sequence of CM1tf. The conflicting claims 13-16 recite a method of enhancing HDR in a cell by introducing an isolated polypeptide wherein then ubiquitin polypeptide variant comprises the sequence of SEQ ID NO: 1, which is the SEQ ID for the polypeptide sequence of CM1tf (named Ubv-A in the reference application). Reference claim 20 recites introducing into the cell a donor DNA template.
The conflicting claims do not recite wherein an AAV is used to introduce the donor template. However, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the conflicting claims with the teachings of Wang resulting introducing both the nucleic acid donor template into the cell using an AAV along with the polypeptide because Wang teaches using AAV vectors to infect cells to provide donor templates (pg. 140 column 1). Wang provides motivation to modify the conflicting claims by teaching that these strategies are used in HDR-mediated strategies (pg. 140 column 1).
Claims 3-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of copending Application No. 18/613,719 (reference application/conflicting claims). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to a tag-free CM1 polypeptide.
Regarding instant claims 3-4, conflicting claims 1 and 6 recite a ubiquitin polypeptide variant corresponding to the sequence of SEQ ID NO: 1, which is the SEQ ID for the polypeptide sequence of CM1tf.
Claims 1-2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of copending Application No. 18/613,719 (reference application/conflicting claims). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to a nucleic acid sequence that encodes tag-free CM1 polypeptide.
Regarding instant claims 1-2, conflicting claims 1 and 6 recite a ubiquitin polypeptide variant corresponding to the sequence of SEQ ID NO: 31, which is the SEQ ID for the a the nucleic acid sequence that encodes the polypeptide of CM1tf.
Claims 5-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of copending Application No. 18/613,719 in view of Wang.
The rejections of claims 1-4 are set forth above. Regarding instant claims 5-7, conflicting claims 1 and 5 recite a method of improving HDR in a cell by transfecting an isolated polypeptide wherein then ubiquitin polypeptide variant comprises the sequence of SEQ ID NO: 1, which is the SEQ ID for the polypeptide sequence of CM1tf (named Ubv-A in the reference application).
The conflicting claims do not recite nucleic acid donor template introduced into the cell or wherein an AAV is used to introduce the donor template. However, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the conflicting claims with the teachings of Wang resulting introducing both the nucleic acid donor template into the cell using an AAV along with the polypeptide because Wang teaches using AAV vectors to infect cells to provide donor templates (pg. 140 column 1). Wang provides motivation to modify the conflicting claims by teaching that these strategies are used in HDR-mediated strategies (pg. 140 column 1).
This is a provisional nonstatutory double patenting rejection.
Conclusion
NO CLAIMS ARE ALLOWED
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cassandra Senn Grizer whose telephone number is (571)272-2292. The examiner can normally be reached M-Th 0630 - 1700 ET.
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/CASSANDRA SENN GRIZER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672