DETAILED ACTION
The amendment submitted on July 1, 2025 has been entered. Claims 18-29 are pend-ing in the application and remain rejected for the reasons set forth below. No claim is allowed.
Withdrawn Rejections
The rejection of claims 18-29 for double patenting over Patent No. 11,364,243 B2 is withdrawn in view of the terminal disclaimer submitted on July 1, 2025.
Response to Arguments
Applicant argues that the amended claims are “novel” because the references “fail to disclose, either alone or in combination, all the limitations of claim 18.” See applicant’s Remarks, submitted July 1, 2025, at pp. 6-8. As a general matter, the examiner notes that the word “novel” is typically used in the context of anticipation, not nonobviousness. See MPEP 2131 (“A claimed invention may be rejected under 35 U.S.C. 102 when the invention is anticipated (or is ‘not novel’) over a disclosure that is available as prior art.”). Applicant’s argument that the claims are “novel” appears to confuse whether the claims are rejected under § 102 or § 103. The claims remain rejected for obviousness under § 103. In any case, applicant’s argument is simply that the references do not disclose all of the limitations of the claims, but applicant does not explain what specific limitation is not taught. It is appli-cant’s burden to “point[] out the specific distinctions believed to render the claims patent-able over the references in presenting arguments in support of … amendments.” See MPEP 714.02. Applicant has not specifically pointed out how the amendments overcome the rejection. Applicant’s arguments have been fully considered but are not persuasive. The rejection is therefore maintained.
Maintained Rejections Claim Rejections – 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obvious-ness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: (1) determining the scope and contents of the prior art; (2) ascertaining the differences between the prior art and the claims at issue; (3) resolv-ing the level of ordinary skill in the pertinent art; and (4) considering objective evidence present in the application indicating obviousness or nonobviousness. See MPEP1 2141 et seq.
Claims 18-20, 22-26, and 28-29 remain rejected under 35 U.S.C. 103 as being unpatentable over Mizuarai (US 2012/0157342 A1) in view of Eicheler (J. Histochem. Cytochem. 2002;50(2): 197-204) and Olivier (Cold Spring Harb. Perspect. Biol. 2010;2(1):a001008).
Mizuarai (cited in the prior action) discloses methods for identifying whether a patient with a cancer mediated by a dysfunctional or aberrant p532 is likely to respond to treatment with a WEE1 inhibitor (para. 0001). WEE1 inhibition specifically causes cell death in p53-negative tumors and thereby selectively sensitizes p53-deficient tumors to different chemo-therapies (para. 0006). Biomarkers used to predict the response to treatment include genetic markers, such as gene amplification and genetic mutations, as well as gene-expres-sion markers (para. 0008). Any clinically relevant tissue sample, such as a tumor biopsy, can be used as the source of the biomarkers (para. 0048). The example WEE1 inhibitor referred to in the reference as “Compound A” (see “Test Compound” at para. 0141) is the exact same compound3 recited in instant claim 20. Cancers amenable to treat-ment with a WEE1 inhibitor include ovarian cancer and lung cancer (para. 0133), which meets the limitations of claims 22-24. Examples of anti-cancer agent used in a combination treatment with the WEE1 inhibitor include 5-fluorouracil (5-FU), carboplatin, gemcitabine, and so forth (para. 0137), which meets the limitations of claims 25-26.
The difference between the prior art and the claims at issue is that, although Mizuarai discloses assaying “genetic markers,” it does not specifically disclose the claimed gene mutations.
Eicheler (cited in the prior action), however, discloses (p. 199) that frameshift muta-tions for P53 were known in the prior art, which suggests amended4 limitation “a” in the list of mutations recited in claim 18. Similarly, Olivier (also cited in the prior action) discloses that many different frameshift and nonsense mutations of TP53 were known in the prior art (see, e.g., Fig. 2 at p. 3 and the discussion thereof). Olivier further discloses that examples of known mutations include R248W (p. 7), S241F (p. 7) C277F (p. 7), C176F (p. 7), H179R (p. 7), R175H (p. 9), and R273H (p. 9), among numerous other mutations recited in claim 19.
It would have been prima facie obvious to one of ordinary skill in the art to look up mutations of TP53 known in the prior art (e.g., Eicheler and Olivier) when assaying the “genetic markers” taught by Mizuarai and thereby arrive at subject matter within the scope of the instant claims. While Mizuarai generally discloses testing biomarkers that “include genetic markers (e.g., nuclear aberrations [such as micronuclei], gene amplification, and mutation), gene-expression markers (e.g., mRNA up- or down-regulation)” and so forth (para. 0008), it does not include detailed information about known mutations. It is implicit in Mizuarai that those of skill in the art would be competent to look up such information for themselves. Eicheler and Olivier are cited as evidence that various mutations listed in claims 18-19 were known in the prior art.
Finally, one would have viewed the subject matter of claims 28-29, that one drug could be administered before the other drug or vice versa, as being a matter of common sense.
Claims 21 and 27 remain rejected under 35 U.S.C. 103 as being unpatentable over Mizuarai, Eicheler, and Olivier as applied above, and further in view of Bamba (US 2011/0135601 A1).
The disclosures of Mizuarai, Eicheler, and Olivier are relied upon as set forth above. The difference between the prior art and the claims at issue is that none of these references specifically discloses the WEE1 inhibitor recited in claim 21. Bamba (cited in the prior action), however, discloses that this compound5 was yet another WEE1 inhibitor known in the prior art. See Example 1 in Bamba at para. 0770. Generally, one would have viewed substituting one WEE1 inhibitor for another WEE1 inhibitor that is also known in the prior art as being a matter of routine experimentation and therefore prima facie obvious. See MPEP 2144.06(II) (substituting equivalents known for the same purpose). By substituting “Exam-ple 1” as taught by Bamba for “Compound A” disclosed in Mizuarai, one arrives at subject matter within the scope of claim 21.
With respect to claim 27, Bamba recognizes that combination therapy with carboplatin (para. 0285 and 0315) and paclitaxel (para. 0283 and 0313) were known in the prior art.
Conclusion
THIS ACTION IS MADE FINAL. See MPEP 706.07 (Final Rejection). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statu-tory 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 Theodore R. Howell whose telephone number is 571-270-5993. The examiner can normally be reached Monday through Thursday, 7:00 am - 6:00 pm (Eastern Time). The examiner is generally not available on Fridays. Examiner interviews are available via telephone and video conferencing using an Office-supplied web-based collab-oration tool. To schedule an interview, applicant is encouraged to use the USPTO Auto-mated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Theodore R. Howell/ Primary Examiner, Art Unit 1628
September 10, 2025
1 Manual of Patent Examining Procedure (MPEP), Latest Revision November 2024 [R-01.2024]
2 “TP53” referred to in the instant claims is the gene that encodes the protein “p53” that is discussed is Mizuarai (see applicant’s own specification at p. 2, ll. 27-28).
3 This compound (CAS Reg. No. 955365-80-7) is generally known in the prior art as “adavosertib.” See Example 53 in WO 2007/126128.
4 The rejection is therefore maintained notwithstanding the amendment to claim 18 to delete “a stop codon mutation prior to codon 306.”
5 CAS Reg. No. 1092793-92-4, generally known in the prior art as “MK-3652.”