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 .
Status of the Claims
Claims 1-18 are pending. Claims 1-12 and 17 are withdrawn. Claims 13-16 and 18 are rejected.
Election/Restrictions
Applicant's election of Group II (claims 9-16 and 18) and of the elected species of Formula (VI) without traverse in the reply filed on 12/29/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 13-16 and 18 read on Applicant’s species election of Formula (VI). Examination of the elected invention was conducted in accordance with the MPEP 803.02.
The elected species is not allowable in view of the prior art; therefore, examination of the Markush-type claim has not been extended.
Since art was found on the elected species, subject matter not embraced by the elected embodiment is therefore withdrawn from further consideration. Claims 1-12 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Priority
This application claims benefit to PRO 63/352,054 filed 06/14/2022.
Information Disclosure Statement
The information disclosure statement (IDS) dated 09/30/2025 has been considered.
Claim Objections
Claim 13 is objected to because of the following informality:
the second “a” in line 2 should be deleted.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 16 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 16 recites “The pharmaceutical composition according to claim 5…". There is insufficient antecedent basis for this limitation in claim 5. Applicant may overcome the rejection by, for example, amending claim 16 so that it depends from claim 13 which is drawn to a pharmaceutical composition.
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 14 and 16 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 14 does not properly depend from claim 13 wherein R21 is C1-8 alkyl substituted with phenyl wherein the phenyl is optionally substituted with a 5- to 10-memebred heteroaryl because claim 13 does not include a limitation for R21 wherein an alkyl may be substituted with a phenyl which is further substituted with a heteroaryl. Applicant may overcome the rejection by, for example, amending claim 14 such that the alkyl-phenyl may not be further substituted with a 5- to 10-membered heteroaryl.
Claim 16 is drawn to a pharmaceutical composition of claim 5, however claim 5 does not recite a pharmaceutical composition. Applicant may overcome the rejection by, for example, amending claim 16 so that it depends from claim 13.
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.
Claims 13-16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry entry 1048518-53-1, which entered STN 09/11/2008. CAS Registry entry 1048518-53-1 discloses the compound
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, which is identical to compound WMA-RV6 of claim 16 and reads on instant formula (VI) of claims 13-15 wherein:
X is C(R22)(R23) wherein R22 and R23 are each H;
Z is N;
R1 and R3 are H;
R20 is N(R4)C(=O)-R14, wherein R4 is H and R14 is C6 aryl (phenyl) substituted with C1 alkyl; and
R21 is C1 alkyl substituted with C6 aryl (phenyl) substituted with C1 alkyl.
Regarding instant claim 18 drawn to a pharmaceutical composition comprising the elected compound species and a pharmaceutically acceptable carrier, the CAS Registry entry includes predicted properties including bioconcentration factors at varying pH values, see page 3. MPEP 2131.02 (III) 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 18 is anticipated by the prior art.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.H.F./Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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