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 .
DETAILED ACTION
Claims 1-7, 12-14, 20-22, 24, 26, 27 and 30 are pending in the application. Claims 1-7 and 12-14 are rejected. Claims 20-22, 24, 26, 27 and 30 are withdrawn from further consideration.
Response to Amendment / Argument
On pages 14 and 15 of the response filed June 9th, 2026, Applicant traverses the rejection of claims under 35 USC 102(a)(1) over CAS Registry No. 1069738-72-2. Applicant argues that the reference is not enabling since the prior art “provides no information on how such a compound could be synthesized” and “fails to provide any scheme by which DB4 could theoretically be synthesized.” The instant specification similarly lacks any such disclosure. The only disclosures concerning synthesis appear to be found on pages 52 and 54 including the following on page 52:
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There do not appear to be any “general schemes” in the instant specification and the disclosure on page 54 merely cites general references and textbooks. Therefore, the specification appears to rely upon general knowledge in the art as sufficient to enable preparation of the prior art compound. Regardless, 37 CFR 1.56(a) notes:
[…] Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section. […]
37 CFR 1.56(b) states:
(b) Under this section, information is material to patentability when it is not cumulative to information already of record or being made of record in the application, and
(1) It establishes, by itself or in combination with other information, a prima facie case of unpatentability of a claim; or
(2) It refutes, or is inconsistent with, a position the applicant takes in:
(i) Opposing an argument of unpatentability relied on by the Office, or
(ii) Asserting an argument of patentability.
The remarks filed June 9th, 2026 take the position that “CAS at best discloses that a compound with the structure of DB4 may exist….” The position taken in the remarks appears to be that prior to the instant filing, it was not necessarily known whether DB4 existed. The specification describes the results of in silico screening on page 83 as follows:
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The section above refers to obtaining 25 compounds from Chembridge. The specification then states that hit compounds were screened as follows on page 83:
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The section above refers to 25 hit compounds resulting in DB4 (the instant elected species) being the most active. Unless the 25 compounds cited in line 9 are different from the 25 hit compounds cited in line 13 (and recited in Figure 2 including DB4), the specification takes the position that DB4 was known prior to the instant filing and could be acquired from Chembridge. Whether compound DB4 (to the knowledge of any individual delineated in 37 CFR 1.56(c)) was known prior to the instant filing and/or acquirable from a commercial supplier would appear to qualify as information material to patentability since it would refute a position opposing unpatentability or establish by itself unpatentability. Since the arguments of counsel are not considered evidence outweighing the instant specification, the remarks filed June 9th, 2026 are not found persuasive.
All other objections and rejections made in the previous Office Action that do not appear below have been overcome by Applicant's amendments to the claims. Therefore, arguments pertaining to these objections and rejections will not be addressed.
Election/Restrictions
The instant claims are being examined according to MPEP 803.02 where examination (in view of Applicant’s amendment to overcome previously cited prior art) has been extended to include 3-(5-(3-acetylphenyl)-2-phenyl-1H-imidazol-4-yl)-4-cyclopropyl-1H-1,2,4-triazol-5(4H)-one, which species is not allowable.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 1069738-72-2, which entered STN on November 2nd, 2008.
CAS Registry No. 1069738-72-2 is drawn to the compound having the following formula:
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The compound above is recited as the first compound in instant claim 5 and corresponds to Applicant’s elected species. The compound is embraced by Formula (I) where Xa is S, Ra and Rb are substituted alkyl and Rc is substituted heterocycloalkyl. The compound is further embraced by claim 2 (first option for Ra-Xa where n is 1 and Ra1 is chloro, Rb is the third option and Rc is the first option where Rc1 is heteroaryl alkyl), claim 3 (Formula (Ia)), and claim 4. Regarding instant claims 6 and 7, these claims define embodiments within generic options of a parent claim that do not apply to the elected species and therefore do not exclude the elected species. Regarding instant claim 12, this claim only requires the presence of the compound itself, which is taught by the prior art.
Claim(s) 1 and 12 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by U.S. Patent PGPub No. 2017/0360756 A1 by Brown et al.
The prior art teaches 3-(5-(3-acetylphenyl)-2-phenyl-1H-imidazol-4-yl)-4-cyclopropyl-1H-1,2,4-triazol-5(4H)-one on page 32 as Example 1:
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The compound corresponds to variables of instant claim 1 where Xa is O, Ra is hydrogen, Rb cycloalkyl and Rc is substituted heteroaryl. Regarding the fact that the prior art compound is depicted as a tautomer (at the instant -Xa-Ra and adjacent carbon and -N= ring positions), the instant specification states on page 53 (lines 11 and 12) that “All tautomers are included within the scope of the compounds presented herein.” Regarding instant claim 12, the instant claim only requires the presence of the compound itself.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness 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.
Claim(s) 1 and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent PGPub No. 2017/0360756 A1 by Brown et al.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Brown et al. teach compounds of the following general formula as BET inhibitors (abstract):
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The prior art further teaches that the compounds can be used in the treatment of cancer (see, for instance, page 48, claim 98 of the prior art). As an example of the genus, the prior art teaches 3-(5-(3-acetylphenyl)-2-phenyl-1H-imidazol-4-yl)-4-cyclopropyl-1H-1,2,4-triazol-5(4H)-one on page 32 as Example 1:
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The compound corresponds to variables of instant claim 1 where Xa is O, Ra is hydrogen, Rb cycloalkyl and Rc is substituted heteroaryl. Regarding the fact that the prior art compound is depicted as a tautomer (at the instant -Xa-Ra and adjacent carbon and -N= ring positions), the instant specification states on page 53 (lines 11 and 12) that “All tautomers are included within the scope of the compounds presented herein.” Regarding instant claim 12, the instant claim only requires the presence of the compound itself.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art anticipates instant claims 1 and 12 where anticipation is the epitome of obviousness. Instant claims 13 and 14 encompass a composition where the prior art compound is combined with olaparib.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Brown et al. teach combinations with other therapies including cancer therapies as follows on page 22:
[0211] In one embodiment, because of potential synergy or additive effects between BET inhibitors and other cancer therapy, BET inhibitor compounds of Formula I or Formula Ia, stereoisomers, tautomers, pharmaceutically acceptable salts, or hydrates thereof, or compositions comprising one or more of those compounds may be combined with other therapies, chemotherapeutic agents, or anti-proliferative agents to treat human cancer and other proliferative disorders. The list of therapeutic agents which can be combined with BET inhibitors in cancer treatment includes, but is not limited to, ABT-737, Azacitidine (Vidaza), AZD1152 (Barasertib), AZD2281 (Olaparib), […].
The prior art teaches combinations with olaparib. It would have been prima facie obvious for one of ordinary skill in the art at the time the invention was made to combine two compounds known in the prior art which are taught to be useful for the same purpose. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose ....[T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Thus, the skilled artisan would reasonably expect success in this combination. A person having ordinary skill in the art would have at least been motivated to test combinations with the individual examples of the prior art genus and the individual examples of cancer therapies including olaparib.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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