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 .
Status of the Claims
Claims 1-2, 4-9, 11-16, and 18-20 are pending and examined herein.
Claims 3, 10, and 17 are canceled.
Priority
As detailed on the 19 November 2020 filing receipt, the application claims priority as early as 19 November 2020. At this point in examination, all claims have been interpreted as being accorded this priority date as the effective filing date.
Withdrawal / Revision of Objections and/or Rejections
The objection to claims 1, 8, and 15 is withdrawn in view of amendment to recite the meaning of TFBS as transcription factor binding site. The rejection under 35 USC 101 is withdrawn in view of amendment to recite editing the gene using a gene editing tool, which is understood as a modification of an actual gene in view of the remarks (pg. 14, second paragraph), thus realizing the improvement with an element in addition to the abstract ideas. The following rejections are either maintained or newly applied and constitute the full set of rejections for the instant claims.
Claim Rejections - 35 USC § 112(a)
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 8-9, 11-16, and 18-20 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. Independent claims 8 and 15, directed to a computer-readable medium and computer system respectively, recite “editing an actual gene using a gene editing tool to remove a target feature according to the set of target features.” The specification, while disclosing support for gene editing tools (pg. 4, paragraph [12]), does not disclose support for how a computer system comprising processors and storage or a computer program can using a gene editing tool such as CRISPR to edit an actual gene. Therefore, the claims are considered to lack written description support in the specification for this element. Claims 9, 11-14, 16, and 18-20 are rejected on similar grounds.
Claims 1-2, 4-9, 11-16, and 18-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for some applications of a gene editing tool, such as CRISPR, to perform editing a gene to remove a target feature, where a target feature is the number of occurrences of a nucleotide string in each gene and promoter, in some genes, does not reasonably provide enablement for doing so in any gene, which is the scope of the independent claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims. For instance, Uddin (Frontiers in Oncology 10(1387): 17 pgs., 2020; newly cited) teaches CRISPR is limited by the requirements for a protospacer adjacent motif (PAM) near the target site (pg. 6, col. 1, last paragraph). Given such a limitation does not appear to contemplated in the claims or specification, it is not clear that the application to virtually any gene with the features (that is, the breadth of the claims), the predictability of use of CRISPR given requirement of a PAM, and thus require experimentation to determine if the editing tool would work on the selection of virtually any gene as recited by the claims. Therefore, in view of In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1998) and MPEP 2164, it is questionable whether the invention is enabled for editing any gene using a gene editing tool.
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.
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/R.J.K./Examiner, Art Unit 1685
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685
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