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
Status of the Claims
Claims 1, 8-20 and 25-33 currently pending. Claims 26-29 are withdrawn. Claims 1, 8-10, 14, 17, 20, 25 and 32-33 are rejected. Claims 11-13, 15-16 and 30-31 are objected to. Claims 18 and 19 are allowed.
Response to Amendment/Arguments
The amendment filed 01/30/2026 is compliant with the requirements of 37 CFR 1.121(c), accordingly the amendment has been entered. Applicant’s arguments have been fully considered and are addressed below:
Objection to the Claims
The objection of claim 18 for informalities has been overcome by the amendment correcting said informalities. The objection has been withdrawn.
35 USC § 112 Rejections
The rejection of claims 5 under 35 USC 112 has been overcome by cancelling said claim. The rejection has been withdrawn.
35 USC § 102 Rejection
The rejections of claims 1-17, 20 and 25 under 35 USC 102 for being anticipated by 1) Biswas et al. in WO 2012177893, 2) CAS Registry No. 1061128-34-4, and 3) PubChem CID 131927238 has been overcome by the amendments to said claims. The rejection has been withdrawn.
Scope of the Elected Invention
In accordance with the MPEP 803.02, examination of the Markush-type claims has been extended, as necessitated by amendment, to the species of claims 18-19 and 30-33 and the full scope of Formula (I) of claim 1, which was not found allowable over the prior art.
Claims 26-29 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
New Claim Objection
Claim 15 is objected to because of the following informalities:
improper grouping. Applicant may wish to amend the claim to delete “independently selected from the group consisting of: 2)”
Appropriate correction is required.
New 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.
Claims 17 and 32-33 are rejected under 35 U.S.C. 112(d) 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 17 does not properly depend from parent claim 1 wherein A is substituted with one to five substituents, however parent claim 1 states that A is substituted with one to three substituents. Since claim 17 includes limitations beyond the scope of claim 1, claim 17 does not properly depend. Applicant may overcome the rejection by, for instance, amending claim 17 to state that A is substituted with one to three substituents.
Claims 32 and 33, which both depend from claim 1, are drawn to compounds that are not embraced by Formula (I) of claim 1. Specifically, the compounds wherein the A and/or B rings may be substituted with -CF3 are outside the scope of Formula I. Applicant may overcome the rejection by, for instance, canceling claims 32 and 33.
New 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.
(1 of 2) Claims 1, 8-10, 14, 20 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 1301578-13-1, which entered STN May 27, 2011.
CAS Registry No. 1301578-13-1 recites the compound
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326
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which reads on the instant formula
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243
401
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of claim 1 wherein:
A is phenyl substituted with one Ra wherein Ra is -(CH2)p-OC1alkyl wherein p = 0;
B is phenyl substituted with one Rb wherein Rb is -(CH2)q-OC1alkyl wherein p = 0;
R1 is C2 alkyl substituted with three Rc groups wherein Rc is halo (fluoro); and
R2, R3, R4, R5, R6, R7 and R8 are each hydrogen. See also claims 8-10 and 14.
Regarding instant claim 20 drawn to a pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier, the CAS Registry entry includes predicted properties including bioconcentration factors at varying pH values. See 1301578-13-1_STN_and_CAS_Entries, pages 2-3. 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 carrier. Therefore, claim 20 is anticipated by the prior art.
Regarding instant claim 25 drawn to the compound “for use in therapy,” the claim is interpreted as a product claim with an intended use which does not carry patentable weight. Therefore, claim 25 is anticipated by the prior art.
(2 of 2) Claims 1, 8-10, 14, 20 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 1388431-52-4, which entered STN August 9, 2012.
CAS Registry No. 1388431-52-4 recites the compound
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286
303
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which reads on the instant formula
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243
401
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of claim 1 wherein:
A is phenyl substituted with one Ra wherein Ra is -(CH2)p-OC1alkyl wherein p = 0;
B is phenyl substituted with one Rb wherein Rb is -(CH2)q-OC1alkyl wherein p = 0;
R1 is C2 alkyl; and
R2, R3, R4, R5, R6, R7 and R8 are each hydrogen. See also claims 8-10 and 14.
Regarding instant claim 20 drawn to a pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier, the CAS Registry entry includes predicted properties including bioconcentration factors at varying pH values. See 1388431-52-4_STN_and_CAS_Entries, pages 2-3. 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 carrier. Therefore, claim 20 is anticipated by the prior art.
Regarding instant claim 25 drawn to the compound “for use in therapy,” the claim is interpreted as a product claim with an intended use which does not carry patentable weight. Therefore, claim 25 is anticipated by the prior art.
Allowable Subject Matter
Claims 18 and 19 are allowed.
Claims 11-13, 15-16 and 30-31 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.
Biswas et al. in WO 2012177893, as cited in the IDS dated 7/11/2024, appears to be the closest prior art. While compound 163, which has the chemical structure
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168
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and nearly reads on instant formula I except that the A and B rings of the presently claimed formula may not be substituted with -CF3 groups. Additionally, the prior art does not teach the species present in claims 18 and 19, nor does the prior art provide any motivation or suggestion for modifying compound 163 in such a way as to identify said compounds.
Conclusion
Claims 1, 8-10, 14, 17, 20, 25 and 32-33 are rejected. Claims 11-13, 15-16 and 30-31 are objected to. Claims 18 and 19 are allowed.
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 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 date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jalisa H. Ferguson whose telephone number is (703)756-1489. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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/J.H.F./Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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