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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-17 in the reply filed on 05/12/2026 is acknowledged. The traversal is on the ground(s) that claim 18 has been amended to depend from claim 1 and claim 20 has been amended to recite the corresponding technical feature of claim 1. This is not found persuasive because this application was not filed under 35 USC 371 but is a Continuation. Lack of Unity practice is not germane.
The requirement is still deemed proper and is therefore made FINAL.
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/12/2026.
Claim Objections
Claim 1 is objected to because of the following informalities: At the last line, the phrase “sequence of the DNA fragment A is set forth in SEQ ID NO:2” should read “sequence of the DNA fragment A is the sequence set forth by SEQ ID NO:2” . Appropriate correction is required.
Claim 11 is objected to because of the following informalities: The phrase “the 5’ homology arm is shown in positions 1-120 of SEQ ID NO:2” should read “the 5’ homology arm is the sequence set forth at positions 1-120 of SEQ ID NO:2” . Appropriate correction is required.
Claim 12 is objected to because of the following informalities: The phrase “the 3’ homology arm is shown in positions 157-306 of SEQ ID NO:2” should read “the 3’ homology arm is the sequence set forth at positions 157-306 of SEQ ID NO:2” . Appropriate correction is required.
Claim 13 is objected to because of the following informalities: The phrase “the specific recognition sequence of the ligase A is shown in positions 133-147 of SEQ ID NO:2” should read “the specific recognition sequence of the ligase A is the sequence set forth at positions 133-147 of SEQ ID NO:2” . Appropriate correction is required.
Claim 15 is objected to because of the following informalities: The phrase “the sequence of the Cas9 mRNA is shown in SEQ ID NO:3” should read “the sequence of the Cas9 mRNA is the sequence set forth by SEQ ID NO:3”. 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.
The previous rejection of claims 10-17 are rejected under 35 U.S.C. 112(b) is withdrawn in light of the amendments to the claims.
Claims 1,11-13,15-17 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.
Claim 1 is unclear in recitation of “wherein the target sequence cleaved by the Cas9 nuclease”. There is no recitation of target sequence or Cas9 nuclease prior to this wherein clause. Thus, the phrase lacks clear antecedent basis.
Claim 1 is also unclear with regard to how the final wherein clause fits within the context of the claim. There is no active method step using the recited homologous recombination vector.
The remaining claims are unclear by virtue of their dependency from claim 1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The rejections under 35 USC 102 and 103 are withdrawn in light of Applicant’s amendments to the claims and Remarks at page 9. Applicant has argues that there is nothing on the record to point the person of ordinary skill in the art to the specifically recited insertion and there is nothing to support that insertion of a universal coupling interface at this specific location would not affect the function of the antibody.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALARIE BERTOGLIO whose telephone number is (571)272-0725. The examiner can normally be reached M-F 6AM-2:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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VALARIE E. BERTOGLIO, Ph.D.
Examiner
Art Unit 1632
/VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632
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