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 .
This action is in response to the amendment filed 03/02/2026, in which claims 1, 3, 7, 12, 14 and 16 were amended, claim 2 was canceled, claims 97-101 were newly added and claim 17 was previously withdrawn due to a restriction required mailed 10/02/2025. Claims 1, 3, 7, 12, 14, 16 and 97-101 are currently pending.
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claim 98 been renumbered 99, misnumbered claim 99 has been renumbered as claim 100 and misnumbered claim 100 has been renumbered as claim 101.
It is noted that the amendment to the claims filed on 03/02/2026 does not comply with the requirements of 37 CFR 1.121(c) because Claim 1 was changed from “into a target sequence” to “”to a target sequence” without markings as well as Claim 3 contains amendments without proper markings: (i) “target polynucleotide” was changed to “target polypeptide” without markings; and (ii) “Initiation of Mutagenic retrohoming” was deleted. However, in the interest of compact prosecution, the amendment to the claims has been entered.
Applicant’s arguments have been thoroughly reviewed, but are not persuasive for the
reasons that follow. Any rejection and objections not reiterated in this action have been
withdrawn. This action is NON-FINAL.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," 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 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) 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") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) 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 of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiency - The ASCII .txt file purported to contain the computer readable form (CRF) copy of the "Sequence Listing" filed with this application in accordance with 37 CFR 1.821(c)(1) has been found to be damaged, unreadable, or otherwise contains an error as indicated on document "Computer Readable Form (CRF) for Sequence Listing - Defective" dated 3/3/2026.
Required response – Applicant must provide:
a replacement "Sequence Listing" in the form of an ASCII plain text file under 37 CFR 1.821(c)(1) as provided for in 37 CFR 1.825(b)(1)(i), together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(b)(3);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
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;
OR
A "Sequence Listing" part of the disclosure, as described above in item 1 c) or 1 d) as provided for in 37 CFR 1.825(b)(1)(ii) or 1.825(b)(1)(iii); together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
When the "Sequence Listing" part of the disclosure is submitted according to item 1 c), or 1 d) above, Applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) as required by 37 CFR 1.825(b)(6); and
a statement according to item 2) a) or b) above.
Drawings
Nucleotide and/or Amino Acid Sequence Disclosures
The previous objection to the drawings for not including sequence identifiers on figure 7 has been withdrawn due to Applicant’s filing of substitute drawings filed on 03/02/2026.
Claim Objections
Claim 1, 3, 7, 97 and 98 are objected to because of the following informalities:
Claim 1 include periods within the body of the claim. MPEP 608.01(m) states, “Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations.”
Claim 3 includes abbreviations without the term spelled out in the first instance. Specifically, “IMH region” should be amended to recite “Initiation of Mutagenic Homing (IMH) region”.
Claim 3 recites target “polypeptide” and it should be amended to recite target “polynucleotide”.
Claim 7 includes abbreviations without the term spelled out in the first instance. Specifically, “Zn”, “CRISPR-Cas”, “TALEN” and “TALE” are abbreviations that are not spelled out at the first instance within the claims.
Claim 97 include periods within the body of the claim. MPEP 608.01(m) states, “Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations.”
Claim 97 recites the phrase “the Cas protein” where it should be amended to recite “the CRISPR-Cas nuclease” in order to stay consistent with previous claim limitations.
Claim 97 does not have a period at the end of the claim. MPEP 608.01(m) states, “Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations.”
Claim 98 recites the phrase “the Cas protein” where it should be amended to recite “the CRISPR-Cas nuclease” in order to stay consistent with previous claim limitations.
Appropriate correction is required.
Furthermore, claims 12, 14, 16 and 101, which depends from claim 14, all depend from claim 1 and are objected to for the same reason applied to claim 1.
Response to Amendments - Claim Objections
The previous objection to claim 7 has been withdrawn in view of Applicant’s amendments to the claim filed on 03/02/2026.
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 7 and 97-100 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.
Claim 7 contains the trademark/trade name TALEN. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe transcription activator-like effector nuclease and, accordingly, the identification/description is indefinite.
Response to Amendments - Claim Rejections - 35 USC § 112
The previous rejection of claim 2 under 35 U.S.C. 112(a) has been withdrawn in view of Applicant’s cancellation of the claim filed on 03/02/2026.
The previous rejection of claim 12 under 35 U.S.C. 112(a) has been withdrawn in view of Applicant’s amendments to the claim filed on 03/02/2026.
Claim Rejections - 35 USC § 102
The previous rejection of claims 1, 2, 7, 12, 14 and 16 under 35 U.S.C. 102(a)(1)/(a)(2) has been withdrawn in view of Applicant’s amendments to the claims filed on 03/02/2026.
Claim Rejections - 35 USC § 103
The previous rejection of claims 1-3, 7 and 14 under 35 U.S.C. 103 has been withdrawn in view of Applicant’s amendments to the claims filed on 03/02/2026.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ROSE LIPPOLIS whose telephone number is (703)756-5450. The examiner can normally be reached Monday-Friday, 8:00am to 5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JENNIFER A DUNSTON can be reached at (571) 272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALEXANDRA ROSE LIPPOLIS/Examiner, Art Unit 1637
/Jennifer Dunston/Supervisory Patent Examiner, Art Unit 1637
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