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 Application/Amendment/Claims
This Office action is in response to the communications filed on December 29, 2025.
Currently, claims 1, 3, 7, 9, and 16-25 are pending in the instant application. Claims 3 and 17-24 are withdrawn from further consideration as being drawn to nonelected species, there being no allowable generic or linking claim. Accordingly, claims 1, 7, 9, 16, and 25 are under examination on the merits in the instant application.
The following rejections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
Response to Arguments and Amendments
Withdrawn Rejections
Any rejections/objections not repeated in this Office action are hereby withdrawn.
Maintained Rejections
Claim Rejections - 35 USC § 112
Claims 1, 7, 9, 16, and 25 remain rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement for the reasons as set forth in the Office action mailed on September 29, 2025 and for the reasons set forth below.
Applicant's arguments filed on December 29, 2025 have been fully considered but they are not persuasive. Applicant argues that the claims as currently amended comply with the written description requirement by pointing out paragraphs 0085-0087. Contrary to applicant’s argument, as noted in the last Office action, see pages 6-7, the specification regarding the in vitro embodiment at best describes an in vitro method pertaining to a TP53-KO RKO (colorectal cancer) cell or a TP53-KO hESC (human embryonic stem cell) that is resistant to cisplatin, which is not related to the instantly claimed TP53-KO ovarian cancer cell that is resistant to a therapeutic agent including cisplatin. There is no adequate written description support in the specification that teaches TP53-KO ovarian cancer cells are resistant to the genus of “therapeutic agent” including the number of different species (e.g., Bleomycin sulfate, Osimertinib, Uracil mustard) recited in claim 9 and the cisplatin specifically claimed in claim 25, wherein the resistant TP53-KO ovarian cancer cells are resensitized upon the ZNF207-targeting sgRNAs. As explained in the last Office action, the idea pertaining to TP53-muated ovarian cancer cells, ZNF207, and platinum compounds is merely and purely speculative based on “published datasets”. That is, there is no experimental, scientific validation pertaining to the claimed method, wherein the mere speculation is far from reasonably conveying that the instant co-inventors had possession of the instantly claimed subject matter, which does require the known, proven nexus between the claimed cell type, the claimed sgRNAs, and the claimed therapeutic agent.
Further, as pointed out in the last Office action, SEQ ID NO:8 and SEQ ID NO:9 claimed to be “sgRNAs” targeting ZNF207 (see claim 16) are disclosed as “primers” used in “realtime quantitative PCR”. Applicant did not point out where in the specification SEQ ID NOs:8-9 are described as being “sgRNAs” and where in the specification SEQ ID NOs:8-9 are shown to have the sgRNA function providing indels in the ZNF207 gene by the CRISPR/Cas mechanism in a TP53-KO ovarian cancer cell, which is resensitized to a therapeutic agent upon the contact of the sgRNAs comprising SEQ ID NO:8 or SEQ ID NO:9 or combination thereof.
Accordingly, this rejection is maintained.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 7, 9, 16, and 25 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.
Claim 1 recites the limitation "the ovarian cancer cell comprising Cas9" in line 5. There is insufficient antecedent basis for this limitation in the claim. Note that “an ovarian cancer cell” in line 2 is not “an ovarian cancer cell comprising Cas9”.
Claim 1 recites “an ovarian cancer cell comprising a knockout of TP53” in line 7. It is unclear whether this “ovarian cancer cell” in line 7 is same as or different from the “ovarian cancer cell” recited in line 2 and/or line 5.
Since claims 7, 9, 16, and 25 depend directly from claim 1, claims 7, 9, 16, and 25 are also deemed indefinite for the reasons stated above.
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RAM SHUKLA can be reached at 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANA H SHIN/Primary Examiner, Art Unit 1635