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 .
Claim Status
Claims 1-10, 17-20, 22, 28-31 are pending.
Claims 1-8 are withdrawn from consideration.
Claims 9-10, 17-20, 22, 28-31 are examined on the merits.
Response to Arguments - Claim Rejections - 35 USC § 102
Applicant's amendments and arguments filed 7 July 2025 have overcome the rejection of record.
Claim Rejections - 35 USC § 112
Lack of Written Description
The following is a quotation 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.
Claims 9-10, 17-20, 22, 28-30 remain rejected and claim 31 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 claims are broadly drawn to products comprising a type V Cas-alpha polypeptide having DNA binding activity comprising the motifs GxxxG, ExL, CxnC, and Cxn(C or H) wherein N=2 to11.
It does not seem that the recited motifs alone are sufficient to confer DNA binding ability or even be considered a type V Cas nuclease. It is critical to recognize that the none of the claims require an overall identity to a single SEQ ID NO that encodes a full-length Cas-alpha endonuclease. Without such a scaffold, the potential structures encompassed by the broad scope of the claims is quite amorphous. The Examiner does recognize that the RuvC subdomains are required that their approximate location relative to one another is specified. This is not nearly enough structural limitations being claimed for a poorly characterized class of Cas endonucleases. Claim 9 states that polypeptide can be up to 799 amino acids in length. A total of 8 amino acids are specified by the recited RuvC subdomains. This means that about 1% of the polypeptide is specified.
The instant disclosure describes many putative Cas endonuclease that have been identified by in silico means (Example 1). Functional assays were conducted to confirm function of the putative nuclease and determine their PAM motif preferences in subsequent examples.
These descriptions are insufficient, because despite the extensive examples, they do not overcome the extreme breadth (nearly limitless) of the claims.
Given the broad scope of the claimed genus, the lack of working examples and the failure to describe the structures required to confer the claimed function, one of skill in the art would not have recognized that Applicant was in possession of the claimed genus at the time of filing.
Response to Arguments - Lack of Written Description
Applicant's arguments filed 7 July 2025 have been fully considered but they are not persuasive.
Applicant urges that the claims have been amended to more closely claim the RuvC subdomains and as currently claimed, no longer encompass the APOBEC deaminase that was previously cited.
This argument is not persuasive, because the claims still recite very few structural limitations, to the point that it would be nearly impossible to adequately describe such a large an amorphous scope.
Conclusion
No claims are allowed. THIS ACTION IS MADE FINAL. 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 extension fee 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 MATTHEW R KEOGH whose telephone number is (571)272-2960. The examiner can normally be reached M-Th 7-4:30, half day on Fridays.
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, Amjad Abraham can be reached on 571-270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
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