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 – 2, 6 – 78, 81 and 83 – 101 are pending.
Claims 1 – 2, 7, 10 – 12, 14 – 15, 28, 31 – 32, 50, 52 – 54, 56, 58, 60, 65, 72, 81, 85, 91, 97 – 98 and 100 are rejected.
Claims 6, 8 – 9, 13, 16 – 27, 29 – 30, 33 – 49, 51, 55, 57, 59, 61 – 64, 66 – 71, 73 – 78, 83 – 84, 86 – 90, 92 – 96, 99 and 101 are withdrawn.
Response to Applicant’s Remarks
Applicant’s amendments/remarks filed on June 29, 2026 have been fully considered.
The rejection under 35 U.S.C. §112(b) of claims 1 – 2, 7, 10 – 12, 14 – 15, 28, 31 – 32, 50 and 100 (claims 3 and 5 are cancelled) is withdrawn in view of amendments to delete the term “-CH” from the scope of X1, X2 and X4.
The rejection under 35 U.S.C. §112(b) of claims 53 – 54, 56, 58, 60, 62, 65, 72, 81, 85 and 91 (claim 82 is cancelled) is withdrawn in view of amendments to delete the term “-CH” from the scope of X1, X2 and X4.
The rejection under 35 U.S.C. §112(d) of claim 52 is withdrawn in view of amendment to delete the compound.
The rejection under 35 U.S.C. §102(a)(1)/102(a)(2) of claims 1 – 2, 7, 10 – 12, 14, 28, 31 – 32, 50, 53 – 54, 56, 58, 60, 62, 65, 72, 81, 85, 91, 97 – 98 and 100 (claims 3, 5 and 82 are cancelled) is withdrawn in view of amendments to delete the limitation, wherein R5 is heteroaromatic.
Examination: Applicant’s amendments necessitate extending the search. However, upon further consideration, it is noted that Applicant’s elected Compound 3 is not allowable over the prior art. Examination of the Markush-type claim has not been further extended to the complete scope of the claims. Claims 6, 8 – 9, 13, 16 – 27, 29 – 30, 33 – 49, 51, 55, 57, 59, 61 – 64, 66 – 71, 73 – 78, 83 – 84, 86 – 90, 92 – 96, 99 and 101 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/ species, there being no allowable generic or linking claim.
A 2nd Non-Final action is being issued to address a new rejection under 35 U.S.C. 102(a)(1) of claims 1 – 2, 7, 10 – 12, 14 – 15, 28, 31 – 32, 50, 52 – 54, 56, 58, 60, 65, 72, 81, 85, 91, 97 – 98 and 100 as being anticipated by CAS Registry Number 1894024-80-6 (Entered STN date: April 20, 2016).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on June 12, 2026, July 1, 2026 and August 10, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement are being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, page 3, lines 5-6: The limitation “Y1 and Y2 are each independently… -CO2R8, - NR10R11” is grammatically incorrect because it does not recite proper conjunction “or” for the group of alternatives. In order to overcome the objection, Applicant may amend to recite the limitation as follows: “Y1 and Y2 are each independently… -CO2R8, or - NR10R11”.
Appropriate correction is required.
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, 7, 10 – 12, 14 – 15, 28, 31 – 32, 50, 52 – 54, 56, 58, 60, 65, 72, 81, 85, 91, 97 – 98 and 100 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry RN 1894024-80-6 (Entered STN date: April 20, 2016).
CAS Registry RN 1894024-80-6 teach the compound as presented below:
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207
314
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. See, e.g., pg. 1.
The compound anticipates the instant claims as presented below:
Claims 1 – 2, 7, 10 – 12, 14 – 15, 28, 31 – 32, and 50, directed to a compound of Formula (I-C):
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354
414
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, wherein:
Y1 – Y2 are each hydrogen (H),
Both R1s and R2s are each H,
X1 – X4 are each -C,
A1 and A2 are each a bond,
R3 – R4 and R6 are each H,
R5 is heteroaromatic (thienyl ring), and
R7 is
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205
209
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, wherein both R1 and R2 are each H, and
n is 1.
Claim 52, wherein the compound is:
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178
178
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. See, page 7, left column, 2nd row.
Claims 53 – 54, 56, 58, 60, 65, 72, 81, 85, 91, 97 – 98, directed to a compound of Formula (I-B):
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352
549
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, wherein:
A1 and A2 are each a bond,
R1 and R2 are each H,
X is -CH,
R3 is absent, and
R4 is H, and
R5 is heteroaromatic (thienyl ring).
Claim 97, wherein the compound is:
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178
178
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. See, page 17, left column, 1st row.
Claim 98, wherein the compound is:
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196
196
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. See, page 18, left column, 1st row.
With respect to claim 100, the experimental and predicted properties of CAS RN 1894024-80-6 discloses mass and molar solubilities at varying pH values of a composition comprising 2 grams of said compound in 1 Liter of unbuffered water (0.010 mol/L). See Mass solubility data, e.g., page 2, lines 36-38 and 51-53. 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. Water is considered a pharmaceutically acceptable carrier.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sagar Patel whose telephone number is (571)272-1317. The examiner can normally be reached Monday - Friday: 9am to 5pm EST.
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/Sagar Patel/Examiner, Art Unit 1626
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626
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