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 11-13. 23-29 and 34-36 are pending in the present application file.
AMENDMENTS
The amendments filed 12/15/2025 have been acknowledged and entered in the present application file.
Election/Restrictions
Applicant’s election of Group I (claims 11-13, 24 and 27-29; directed to compound having the structure of Formula III) and a species of present formula (III) without traverse in the reply filed December 15, 2025 is acknowledged.
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species of present formula (I) appears free of the prior 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species found not allowable, the Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. The examination of the Markush-type claims has been extended to include the species cited below under 35 U.S.C. 102, which are not allowable.
As a non-elected species has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention held withdrawn from further consideration. Claims 11-13, 24 and 27 have been examined to the extent that they embrace and are readable on the elected embodiment and the above identified nonelected species. Since the nonelected species has been found not allowable, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
Claims 23, 25-26, 28-29 and 34-36 do not read on the presently searched and examined subject matter. Therefore, claims 23, 25-26, 28-29 and 34-36 are withdrawn from consideration by the Examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
Claim Rejections - 35 USC § 112
Claims 11-13, 24 and 27 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of Formula III is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
The core structure of the presently claimed genus is
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wherein each of the X1, X2, X3, X4, X5, X6, ring A and ring B can include various permutations of carbocyclic or heterocyclic structures which are not sufficiently described to convey a structural similarity and the presently claimed utility until the identity of each of these variables is known.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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 11-12, 24 and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No 831189-36-7 (which entered STN February 15, 2005).
CAS Registry No 831189-36-7 is drawn to α-[[2,5-Dimethyl-1-(2-pyridinyl)-1H-pyrrol-3-yl]methylene]-6-methoxy-1H-benzimidazole-2-acetonitrile, which has the following structure:
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CAS Registry No 831189-36-7 corresponds to a compound of present formula (III) where,
X1 is CR1
R1 is hydrogen
X2 is CR2
R2 is hydrogen
X3 is CR3
R3 is C1 alkoxy
X4 is CR4
R4 is hydrogen
X5 is N
X6 is NR6
R6 is hydrogen
R10 is hydrogen
R9 is cyano
Ring A is a pyrrole ring optionally substituted with 2 R11
R11 is C1 alkyl
Ring B is a pyridine ring
The Registry structure would be embraced by a compound of present claims 11-12 and 27.
Regarding present claim 24, which is drawn to a pharmaceutical composition comprising the compound in a pharmaceutically acceptable vehicle or support, 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 at once envisage a composition with the compound and water, which is a pharmaceutically acceptable vehicle.
Claims 11-12, 24 and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No 1287413-34-6 (which entered STN April 29, 2011).
CAS Registry No 1287413-34-6 is drawn to α-[[2,5-Dimethyl-1-(5-methyl-3-isoxazolyl)-1H-pyrrol-3-yl]methylene]-1H-benzimidazole-2-acetonitrile, which has the following structure:
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CAS Registry No 1287413-34-6 corresponds to a compound of present formula (III) where,
X1 is CR1
R1 is hydrogen
X2 is CR2
R2 is hydrogen
X3 is CR3
R3 is C1 alkoxy
X4 is CR4
R4 is hydrogen
X5 is N
X6 is NR6
R6 is hydrogen
R10 is hydrogen
R9 is cyano
Ring A is a pyrrole ring optionally substituted with 2 R11
R11 is C1 alkyl
Ring B is a pyridine ring
The Registry structure would be embraced by a compound of present claims 11-12 and 27.
Regarding present claim 24, which is drawn to a pharmaceutical composition comprising the compound in a pharmaceutically acceptable vehicle or support, 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 at once envisage a composition with the compound and water, which is a pharmaceutically acceptable vehicle.
Conclusion
Claims 11-12, 24 and 27 are rejected
Claims 23, 25-26, 28-29 and 34-36 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626