DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to the communication filed 2-29-24.
Claim 76 is pending in the instant application.
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 76 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claimed invention is directed to products of nature. The claim is drawn to a gRNA and a class 2, Type V CRISPR protein which are capable of forming a ribonuclear protein complex (RNP) exhibiting at least one or more improved characteristics compared an RNP of reference proteins of SEQ ID No. 1, 2 or 3, and a gRNA comprising SEQ ID No. 4 or 5. The claims do not include any elements that add significantly more to any judicial exceptions, and do not include features that demonstrate that the recited products are markedly different from what exists in nature. The molecules perform in their natural way, serve the ends nature originally provided, and act quite independently of any effort of patentee. There are no marked differences in the function or structure of these naturally occurring molecules, and their characteristics do not change from that occurring in nature.
In sum when the relevant factors are analyzed, they weigh toward ineligibility under 35 U.S.C. 101. Therefore, the claims are non-statutory, and the rejection under 35 U.S.C. 101 is appropriate.
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.
Claim 76 is 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.
The claim recites the phrase “exhibiting at least one or more improved characteristics”. It is unclear what “improved characteristics” embody, rendering the claim vague and indefinite.
Appropriate clarification/correction is required.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 76 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The breadth of the claims:
The claim is drawn to a gRNA and a class 2, Type V CRISPR protein together which are capable of forming a ribonuclear protein complex (RNP) exhibiting at least one or more improved characteristics compared to an RNP of reference proteins of SEQ ID No. 1, 2 or 3, and a gRNA comprising SEQ ID No. 4 or 5..
Teachings in the specification:
The specification at, e.g., ¶¶ 0052, 0056-0060, 0076, 0133, 0169, 0181, 0191, 0215 and 0254, describe subsets of CasX variants with increased on-target activity and without off-target cleavage; improved biochemical cleavage of a subset of mutants with varying spacer lengths, improvements in EC50 values, increased binding affinity to the target gene, increased editing specificity, increased target strand loading, increased resistance to nuclease activity, and reduced off target folding intermediates. It is unclear which mutants exhibit which of these desired characteristics.
The specification and claim do not adequately describe the broad genus of improved characteristics claimed, and/or fail to provide a representative number of species, and do not indicate what distinguishing attributes are concisely shared by the members of the genus.
For the reasons stated above, the instant rejection for lacking adequate written description is proper.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 76 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Doudna et al (WO 2020/041456).
Doudna et al (WO 2020/041456) teach gRNA and a class 2, Type V CRISPR protein, together which are capable of forming a ribonuclear protein complex (RNP) exhibiting at least one or more improved characteristics compared an RNP of reference proteins of SEQ ID No. 1, 2 or 3, and a gRNA comprising SEQ ID No. 4 or 5. Doudna teach CasX variants with increased on-target activity and without off-target cleavage; improved biochemical cleavage of mutants with varying spacer lengths, improvements in EC50 values, increased binding affinity to the target gene, increased editing specificity, increased target strand loading, increased resistance to nuclease activity, and reduced off target folding intermediates (see entire document, esp. the Abstract, Summary on page 2, figures 9-17, ¶¶ 0049-0070, 0083, 0084, 0092, 0105-0108, 0112, 0119, 0121, 0123, 0127, 0128, 0146, claims 1-25).
Claim(s) 76 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Nagy, E. (WO 2019/084148).
Nagy, E (WO 2019/084148) teach gRNA and a class 2, Type V CRISPR protein, together which are capable of forming a ribonuclear protein complex (RNP) exhibiting at least one or more improved characteristics compared with an RNP of reference proteins of SEQ ID No. 1, 2 or 3, and a gRNA comprising SEQ ID No. 4 or 5 (see entire document, esp. the Abstract, Background on page 1, ¶¶ 0014, 0017, 0019, 0037, 0038, 0146, 0147, 0185-0187, claims 5-9).
Conclusion
Certain papers related to this application may be submitted to Art Unit 1637 by facsimile transmission. The faxing of such papers must conform with the notices published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 C.F.R. ' 1.6(d)). The official fax telephone number for the Group is 571-273-8300. NOTE: If Applicant does submit a paper by fax, the original signed copy should be retained by applicant or applicant's representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED so as to avoid the processing of duplicate papers in the Office.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jane Zara whose telephone number is (571) 272-0765. The examiner’s office hours are generally Monday-Friday, 10:30am - 7pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jennifer Dunston, can be reached on (571)-272-2916. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (703) 308-0196.
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Jane Zara
12-18-25
/JANE J ZARA/Primary Examiner, Art Unit 1637