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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 7-13 and 16 in the reply filed on 08/07/2026 is acknowledged.
Claims 1-6, 14-15, 18-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/07/2026.
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 7-13 and 16 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.
Claims 7-10 recite the term “preferably”. It is not clear if the recitation following the term is a part of the claim or not, therefore metes and bounds of the claims are unclear.
Claims 11-13 and 16 are rejected based on their dependency on claims 7-10.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 13 is rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 13 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The broadest reasonable interpretation of the term "cell" embraces a human having the cell. It is suggested to amend the claim to recite "An isolated recombinant host cell" to avoid the claim embracing a human organism.
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(s) 7-13, 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaulich et al (US 2019/0330616, October 2019).
Concerning claims 7 and 16 Kaulich disclose gRNA mutants as shown in Figure 2D (see Figure 2D and paragraph [0080]). Claim 7 describes claimed gRNA as product-by-process and is not limited to the manipulation of recited steps, but only the structure implied by the steps (see MPEP 2113, I), thus gRNAs from Figure 2D satisfy structural requirements of such product. Limitation of the claim 7 following “preferably” recitation are interpreted as not required by the claim. It is inherent that synthetic gRNAs are present in at least water or buffer, therefore compositions of such gRNAs are inherently disclosed.
Concerning claims 8 and 9 gRNA mutants disclosed by Kaulich are 28 nucleotides long and have mutations on either end of guide sequence, satisfying structural requirements of claims 8 and 9 (see Figure 2D). Limitation of the claims following “preferably” and “optionally” recitations are interpreted as not required by the claim.
Concerning claim 10 gRNA mutants disclosed by Kaulich comprise substitutions of 1 to 10 nucleotides (see Figure 2D).
Concerning claims 11 and 12 Kaulich disclose vectors comprising polynucleotides encoding gRNA mutants (see paragraph [0031]).
Concerning claim 13 Kaulich disclose cells comprising vectors comprising polynucleotides encoding gRNA mutants (see paragraph [0038]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EKATERINA POLIAKOVA whose telephone number is (571)270-5257. The examiner can normally be reached Mon-Fri 8-5.
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637
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