DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
The present Application, filed December 8, 2022, is a national stage entry under 35 U.S.C. § 371 of International Patent Application No. PCT/US2021/036680, filed June 9, 2021, which claims priority to U.S. Provisional Patent Application No. 63/037,112, filed June 10, 2020.
A Note on the Claims
It is noted that in the claim set filed on October 7, 2025, canceled claim 46 is not shown. All claims, including all canceled claims, should be shown in all future claim sets.
Status of the Claims
In the amendment filed October 7, 2025, claim 2 is canceled and claims 3-5, 8, 10-11, 14-16, 21-22, 24, 26, 33, 40-41, and 44 are amended. claims 6-7, 9, 12-13, 17-20, 23, 25, 27-32, 34-38, 42-43, and 45-46 were previously canceled. Claims 1, 3-5, 8, 10-11, 14-16, 21-22, 24, 26, 33, 39, 40-41, and 44 are currently pending.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on July 10, 2023 and October 7, 2025 are acknowledged.
Previous Rejections and/or Objections
Any objections and/or rejections raised in the previous Office Action but not reiterated below are considered to have been withdrawn.
Claim Rejections - 35 USC § 112(b) – Maintained in Part
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.
Claim 44 is indefinite:
Claim 44 is 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 44 is indefinite for reciting, “wherein the cancer is characterized by a reduction or absence of MTAP gene expression, the absence of the MTAP gene, reduced level of MTAP protein, or reduced function of MTAP protein,” because a person of ordinary skill in the art could not reasonably determine the metes and bounds of this limitation. It would be unclear whether a cancer of the claim is any cancer described in the instant specification or in the art as commonly demonstrating the recited “reduction or absence” etc., or whether such identification requires an individualized determination, such as performance of an unrecited assay to measure the recited “reduction or absence,” etc.
It is noted that this rejection is substantially a repetition of the rejection for indefiniteness of claim 44 assessed in the Office Action of June 13, 2025. While Applicant’s Remarks of October 7, 2025 (pg. 10, first paragraph) suggest that the amendment to claim 44 rendered this rejection moot, it does not. The amendment caused claim 44 to recite a list of cancers, via dependency from claim 41, but the uncertainty remains. In particular, if all cancers recited in claim 41 meet the requirement of claim 44, then claim 44 would fail to further limit claim 41 from which it depends. If all cancers recited in claim 41 do not meet the requirement of claim 44, then it would be unclear how one would distinguish those that do meet the requirement of claim 44 from those that do not. For example, it would be unclear how one would determine a “reduced function of MTAP protein,” in terms of whether such determination would be on a per-patient basis, what would constitute the baseline from which such reduction would be evaluated, what degree of potential reduction would be considered sufficiently significant to constitute an actual reduction, how activity would be assayed, etc.
Claim Rejections - 35 USC § 102 – Newly Made in View of Amendment
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, 3, 10, 15, 21, 33, and 40-41 are anticipated by Geuns-Meyer:
Claims 1, 3, 10, 15, 21, 33, and 40-41 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by U.S. Patent No. 7,880,000 to Geuns-Meyer et al. (hereinafter, “Geuns-Meyer”).
Claim 1 recites a compound of Formula (I),
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where the variable groups are as defined
Geuns-Meyer teaches compounds of a formula I as protein kinase modulators (Abstract):
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Geuns-Meyer teaches Example 75 (4-(2-fluoro-pyridin-3-yl)-6,7-dimethoxy-quinazoline, col. 94, lines 37-67):
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which is a compound of instant claim 1, where R1 and R2 are methoxy; X1 is a bond and R6 is H; X is N and Z is CH; R3 is fluoro (halo) and n is one.
With respect to claim 3, Z is CH in Example 75 of Geuns-Meyer. With respect to claim 10, R3 is halo in Example 75 of Geuns-Meyer. With respect to claim 15, instant n is one in Example 75 of Geuns-Meyer. With respect to claim 21, R6 is H in Example 75 of Geuns-Meyer. Claim 33 specifies a narrower set of alternatives for variable group Rc, when present, but does not require that Rc be present. As such, Example 75 of Geuns-Meyer, in which instant Rc is not present, anticipates claim 33 for the same reasons that it anticipates claim 1.
With respect to claim 40, Geuns-Meyer teaches incorporation of the disclosed compounds, along with pharmaceutically-acceptable carriers, in pharmaceutical compositions (col. 851, lines 53-58). With respect to claim 41, Geuns-Meyer teaches a method of treating breast cancer in a subject, the method comprising administering to a subject an effective amount of a disclosed compound (e.g. claim 17).
Claims 1, 4-5, 8, 11, 14, 26, and 33 are anticipated by Herdewijn:
Claims 1, 4-5, 8, 11, 14, 26, and 33 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by U.S. Patent No. 8,338,435 to Herdewijn et al. (hereinafter, “Herdewijn”).
Herdewijn teaches di-, tri- and tetra-substituted pyrido(3,2-d)pyrimidine derivatives as antiviral agents (Abstract). In one example, Herdewijn teaches 6-chloro-4-(pyrid-2-yl)-pyrido[3,2-d]pyrimidin-2-ylamine (col. 51, line 53, contained within Examples 86 to 225):
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which is a compound of instant claim 1, where R1 is chloro (halo) and R2 is H, or vice-versa; Z is N; X1 is a bond and R6 is amino (-NRaRb where Ra and Rb are each H); and n is zero.
With respect to claim 4, in the exemplary compound of Herdewijn, instant Z is N. With respect to claims 5 and 8, R1 can be regarded as chloro (halo) if R2 is regarded as H. With respect to claims 11 and 14, each of these specifies a narrower set of alternatives for group R3, but does not require that R3 be present (that n be greater than zero). As such, these claims are anticipated by the exemplary compound of Herdewijn, in which instant n is zero, for the same reason that claim 1 is anticipated. With respect to claim 16, in the exemplary compound of Herdewijn, instant n is zero. With respect to claim 26, in the exemplary compound of Herdewijn, instant R6 is amino (-NRaRb where Ra and Rb are each H). Claim 33 specifies a narrower set of alternatives for variable group Rc, when present, but does not require that Rc be present. As such, Example 75 of Geuns-Meyer, in which instant Rc is not present, anticipates claim 33 for the same reasons that it anticipates claim 1.
Claims 1, 3, 8 11, 14, 22, and 33 are anticipated by Morimoto:
Claims 1, 3, 8 11, 14, 22, and 33 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2011/0166135 to Morimoto et al. (hereinafter, “Morimoto”).
Morimoto teaches aromatic nitrogen-containing 6-membered ring compounds as PDE10 inhibitors (Abstract). Morimoto teaches, inter alia, Reference Example 4, 4-pyridin-2-ylquinazolin-2-carbaldehyde (paragraphs [0432]-[0439]):
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which is a compound of instant claim 1, where R1 and R2 are H; Z is CH; X1 is a bond and R6 is formyl (-C(O)Rd where Rd is H); and n is zero.
With respect to claim 3, Z is CH in Reference Example 4 of Morimoto. With respect to claim 8, instant R2 in Reference Example 4 of Morimoto is H. With respect to claims 11 and 14, each of these specifies a narrower set of alternatives for group R3, but does not require that R3 be present (that n be greater than zero). As such, these claims are anticipated by Reference Example 4 of Morimoto, in which instant n is zero, for the same reason that claim 1 is anticipated. With respect to claim 22, instant R6 is formyl (-C(O)Rd where Rd is H) in Reference Example 4 of Morimoto. Claim 33 specifies a narrower set of alternatives for variable group Rc, when present, but does not require that Rc be present. As such, Reference Example 4 of Morimoto, in which instant Rc is not present, anticipates claim 33 for the same reasons that it anticipates claim 1.
Claims 1, 3, 8 11, 14, 24, and 33 are anticipated by Lafferty:
Claims 1, 3, 8 11, 14, 24, and 33 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by the non-patent publication, The preparation and properties of certain pyridylpyrimidines and bidiazines as potential chelating agents for iron(II), J. Org. Chem., 32, pgs. 1591-1596 (1967) by Lafferty et al. (hereinafter, “Lafferty”).
Lafferty teaches, inter alia, synthesis and testing of a series of pyridylpyrimidines for their ability to form stable chelates with iron(II) (Abstract). Lafferty teaches the synthesis of 2,4-Bis(2-pyridyl)pyrimidine (compound XX) - see pg. 1595, right column, eighth full paragraph, and pg. 1592, Scheme III:
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or
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which is a compound of instant claim 1, where R1 and R2 are H; Z is CH; X1 is a bond and R6 is pyridyl (6-membered heteroaryl ring having 1 heteroatom ring vertex that is N); and n is zero.
With respect to claim 3, Z is CH in compound XX of Lafferty. With respect to claim 8, instant R2 in compound XX of Lafferty is H. With respect to claims 11 and 14, each of these specifies a narrower set of alternatives for group R3, but does not require that R3 be present (that n be greater than zero). As such, these claims are anticipated by compound XX of Lafferty, in which instant n is zero, for the same reason that claim 1 is anticipated. With respect to claim 24, instant R6 is pyridyl (6-membered heteroaryl ring having 1 heteroatom ring vertex that is N) in compound XX of Lafferty. Claim 33 specifies a narrower set of alternatives for variable group Rc, when present, but does not require that Rc be present. As such, compound XX of Lafferty, in which instant Rc is not present, anticipates claim 33 for the same reasons that it anticipates claim 1.
Allowable Subject Matter
Claim 39 is allowed.
Conclusion
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.
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/ALEXANDER K. SHOWALTER/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629