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
Claims 2, 3, 6, 7, 9, 10, 15, and 35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/29/2026.
Claim Rejections - 35 USC § 112
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.
Claims 1, 8, 4, 11, 13, 18, and 31 are 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims are drawn to polypeptides and polynucleotides that code for mutant forms of ERCas12a. The independent claim requires undefined mutations, wherein the ERCas12a possesses “improved” nuclease activity compared to the wild-type. Later, dependent claims, broadly describe potential mutations in terms of point mutations, and homology to certain SEQ ID NOs. Based upon the base claim, all mutations must result in improved nuclease activity. All sequences that have reasonably shown improved activity are provided in Table 2 of the instant specification, and are also defined by SEQ ID NOs 3-210. As such, it can reasonably be inferred that the Applicant had possession of all embodiments defined in Table 2 and the provided sequences. However, the claims are not limited to these embodiments, the claims are drawn to any mutations that lead to improved activity.
Although it is clear that the Applicant had possession of a certain cross-section of the claimed limitations, the Applicant only shows particular mutations that lead to improved activity, the Applicant has not show other mutations that would result in improved activity. For example, when looking at the point mutations provided in Table 2, while this does show possession of some of the embodiments provided in claims 4 and 13, it does not reasonably show improved activity for more than one amino acid substitution. If more than one of the amino acids is mutated from claims 4 or 13, it provides for innumerable more embodiments, wherein it is unclear if that Applicant was in possession. This variability is further underscored in claim 11, wherein the claim is limited to a certain amount of homology to SEQ ID NO 2; the claim requires that the unknown sequence can possess as little as 95% homology to SEQ ID NO 2. Based upon the fact that the claimed sequence requires “improved nuclease activity,” it is unclear if the Applicant was in possession of a reasonable number of embodiments to show possession of the entire genus. Furthermore, since it is unclear if the Applicant was in possession of the claimed genus, the claims required the skilled artisan to create the claimed invention based upon the claims. There would be an immense burden on the skilled artisan to create sequences with improved nuclease activity.
For the analysis of these claims, under 35 USC 112(a) Written Description, the Applicant is directed to the USPTO website, wherein 35 USC 112(a) Written Description is analyzed with respect to inventions drawn to sequences. Briefly, if the functional limitation is removed from the claims, the Written Description rejections would likely be withdrawn.
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, 4, 5, 8, 11-14, 16-18 and 32 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.
The term “improved” in claims 1, 8 and 32 is a relative term which renders the claim indefinite. The term “improved” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what specific criteria the Applicant considers for the claimed nuclease to be considered “improved” over the wild-type. For example, it is unclear if “improved” is drawn to kinetics, or substrate specificity.
All claims that claim dependence on 1, 8, or 32 are also rejected insofar as they are dependent on a rejected claim, and do not further improve the clarity of the claim scope.
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.
Claims 1, 8, 18, and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Begemann, et al (US Pat. 2017/0233756). Bergman provides for a sequence that has one more amino acid mutations compared to the wild-type. This is demonstrated in SEQ ID NO 111. Bergmann suggests that these mutations provide for improvements. See paragraph [0016] [0037] [0068] [0074]. As such, Begemann directly reads upon the base claim.
With respect to claim 1, Begemann teaches the claimed polypeptide.
With respect to claims 8 and 18, Begemann describes the nucleotide sequence, wherein the sequence can provide a vector. Furthermore, if the amino acid sequence is known, the polynucleotide sequence would necessarily be known. See paragraph [0087] [0088].
With respect to claim 32, Begemann teaches the claimed method. See paragraph [0001] [0007].
Allowable Subject Matter
Although claims 5, 12, 14, 16 and 17 are rejected, they include allowable subject matter. If the issues regarding the 35 USC 112 rejections are resolved, these claims would likely be allowable. If the Applicant wants other named sequences, these would need further search and consideration.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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, Melenie Gordon can be reached at 571-272-8037. 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.
/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651
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