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 .
Claim Status
Claims 1-4, 10-11, 16-17, 19, 22-23, 25-31, 33 and 35 are pending. Claims 31 and 33 are withdrawn. Claims 1-3, 10-11, 16-17, 19, and 28-30 are rejected. Claims 4, 22-23, 25-27, and 35 are objected to.
Election/Restrictions
Applicant’s election without traverse of Group I and the elected species C123 in the reply filed on September 8th, 2026 is acknowledged.
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicant’s elected species appears free of the art. Therefore, according to MPEP 803.02: should the elected species be found allowable, the examination of the Markush-type claim will be extended. If the examination is extended and a non-elected species found not allowable, the Markush-type claim shall be rejected and claims to the non-elected invention held withdrawn from further consideration. The examination of the Markush-type claims has been extended to include the scope of claims 3-4, 16-17, 19, 22-23, 25-28 and the scope of claims 1-2, 10-11 and 29 where the compound is one of the following:
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or
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These species of which are not allowable. Any subject matter discussed outside this scope was discovered incidental to the expanded search and is presented in the interest of compact prosecution.
As a non-elected species has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention are held withdrawn from further consideration. Examination has been limited to claims embracing the elected species which are claims 1-4, 10-11, 16-17, 19, 22-23, 25-30, and 35. Claims 1-4, 10-11, 16-17, 19, 22-23, 25-30, and 35 have been examined to the extent that they are readable on the elected embodiment and the above identified nonelected species. Since the nonelected species have not been found allowable, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
Claims 31 and 33 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on September 27th, 2023, January 31st, 2024, and June 3rd, 2024. It is noted, however, that applicant has not filed a certified copy of the followings applications as required by 37 CFR 1.55.: PCT/CN23/122071, PCT/CN24/74987, PCT/CN24/96981.
For the purposes of search and examination the earliest priority date for the instant claims is September 26th, 2024.
Claim Objections
Claims 3, 4, 22 and 29 are objected to because of the following informalities:
Claim 3 recites the limitation "3-oxa-8-azabicyclo[3.2.1]octany" in lines 12-13 where “octany” should read “octanyl”.
Claim 4 recites the following moiety where the iodine substituent is obscured by the bond connecting it to the piperidine ring:
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Likewise, claim 29 recites the following compound where the iodine substituent is obscured:
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Claims 3, 22, and 23 recite two instances of duplicate tetrahydrofuranyl such as shown below:
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Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-3, 10-11, 16-17 and 19 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.
Claims 1, 2, 11, and 19 recite instances of 4-membered heteroaryl or “heteroaryl ring of 4 to 12 members” and it is unclear what rings would be embraced by 4-membered heteroaryl.
Claim 3 recites the limitation "said…3-oxa-8-azabicyclo[3.2.1]octany[l]" in line 12. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 is further rejected as it recites the limitation "said…C1-8alkyl-C3-8cycloalkyl" in line 12. There is insufficient antecedent basis for this limitation in the claim.
Claims 10-11 and 16-17 are rejected for failing to obviate the indefiniteness of the claims from which they depend.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 28 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 28 recites the compound of claim 23 wherein two R1d attached to the same atom form tetrahydropyranyl however claim 23 only provides for tetrahydrofuranyl.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-2, 10-11, and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 2059058-49-8, which entered Registry on January 5th, 2017.
CAS Registry No. 2059058-49-8 is drawn to 1-Cyclohexyl-2-methyl-N-[[2-(trifluoromethyl)phenyl]sulfonyl]-1H-benzimidazole-5-carboxamide, which has the following structure:
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The compound above reads on instant claims 1-2, 10-11, and 30 where
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, R6-R8 are each hydrogen, R10 is C1alkyl, R12A is C6 cycloalkyl, R2-R5 are each hydrogen, and R1 is haloC1alkyl.
Regarding instant claim(s) 30, which is drawn to a pharmaceutical composition comprising the compound and a pharmaceutically acceptable excipient, the CAS Registry entry includes predicted properties including mass and molar solubilities at varying pH values. MPEP 2131.02 states:
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015)
In this situation, a person having ordinary skill in the art in viewing the properties of the Registry entry would envisage a composition with the compound and water, which is a pharmaceutically acceptable excipient.
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) 29 is rejected under 35 U.S.C. 103 as being unpatentable over WO2024189598 A2 by Hearn et al.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art teaches (title) “acylsulfonamide KAT6A inhibitors” and discloses the following KAT6A inhibitor (page 24):
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Compound 20 is analogous to compound C23 of instant claim 29 however the prior art compound possesses a methyl substituent where the instant compound has hydrogen:
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Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art compound and instant compound C23 differ by a hydrogen/methyl substituent.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Hearn et al. disclose the following genus of KAT6A inhibitors which embraces the instant compound and compound 20 of the prior art (page 2):
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The prior art genus encompasses compounds wherein n is 0, i.e., the methyl substituent of compound 20 is absent.
“Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.” In re Deuel 34 USPQ2d 1210 at 1214. Furthermore MPEP 2144.09 (II) states: “Compounds which are […] homologs (…) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).” It is well established that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Wood, 199 U.S.P.Q. 137 (C.C.P.A. 1978) and In re Lohr, 137 U.S.P.Q. 548, 549 (C.C.P.A. 1963).
The motivation to make a substitution of an alkyl group for a hydrogen stems from the fact that a person having ordinary skill in the art would expect that the compounds would have the same utility as the compounds taught by the prior art. In the interest of generating additional compounds that have the same utility as the compounds taught by the prior art, a person having ordinary skill in the art would seek to make additional compounds that are most closely related to compounds specifically taught by the prior art that have been demonstrated to have the desired utility. The replacement of an alkyl group for hydrogen falls under the well-established doctrine of homology, which assumes that homologous compounds are likely to have similar properties. Therefore, the instantly claimed compound which differs by hydrogen/alkyl, over the compound of the prior art is unpatentable absent a showing of unexpected results. MPEP 2144.09 (VIII) states “A prima facie case of obviousness based on structural similarity is rebuttable by proof that the claimed compounds possess unexpectedly advantageous or superior properties. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963).”
Allowable Subject Matter
Claims 22-23, 25-27, and 35 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 4 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and corrected to eliminate the informality discussed above.
Closest Prior Art
The closest prior art with regards to instant claims 3-4, 16-17, 19, 22-23, and 25-28 is WO 2025/016317 A1 by Wang et al. The prior art discloses acyl sulfonamide compounds and their uses in medicine. Prior art compounds such as compound 008 are analogous to those of the instant claims by having a core sulfonamide structure, a phenyl ring substituted by methoxy and tert-butyl and a bicyclic ring corresponding to
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(page 217):
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However, the prior art does not disclose any compounds where this ring is attached to the sulfonamide at the carbon required by the instant claims. Furthermore, the prior art genus only supports compounds in this orientation (page 1):
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Wang et al. provide no motivation or guidance for modifying the prior art compounds in a manner that would result in compounds embraced by the instant claims therefore the prior art neither anticipates nor renders obvious the instant claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLI A CHICKS whose telephone number is (571)270-0582. The examiner can normally be reached M-Th 7 a.m.- 5 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at (571)272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A.C./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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