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 .
Priority
The instant application, filed 01/20/2023, is a Continuation of PCT/US21/42644, filed 07/21/2021, which claims domestic priority to U.S. Application No. 63/054,767, filed 07/21/2020.
Preliminary Amendments and Claim Status
The preliminary amendment filed on 10/10/2025 is acknowledged and entered.
Claim 119 is amended;
Claims 1-118 are cancelled;
Claims 119-138 are pending and are under prosecution.
Information Disclosure Statement
The Information Disclosure Statement filed on 05/19/2023, 01/19/2024, 05/21/2024, and 06/12/2025 are acknowledged and found to be in compliance with the provisions of 37 CFR § 1.97. Accordingly, the information disclosure statements are considered.
Restriction/Election
Applicant’s election without traverse of Group I in the reply filed on 10/10/2025 is acknowledged. Furthermore, the election of compound 457 as a particular species of a compound of Formula (III-C) is also acknowledged.
In accordance with the MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
As per MPEP § 803.02, the Examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species, compound 457 (Figure 1) makes a contribution over the prior art of record. Therefore, according to MPEP § 803.02: should the elected species appear allowable, the search of the Markush-type claim will be extended. The Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. It has been determined that the entire scope claimed is not patentable.
Figure 1. Elected Species
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Figure 1. Compound 457, CAS Registry Number RN 2758549-73-2
Status of Claims
Claims 119-138 are pending in the instant application. Applicant has elected compound 457 as a specific species of Formula (III-C), which is encompassed by claims 119, 125, and 133. Upon examination, the elected species has been found to be free of the prior art of record. Accordingly, the search has been expanded pursuant to MPEP § 803.02 to include an additional species, compound 439—encompassed by claims 119, 125, 126, 130, and 133. As such, claims 120-124, 127-129, 131, 132, and 134-138 are withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species. Therefore, claims 119, 125, 126, 130, and 133 read on an elected invention and species subject to examination and are therefore under consideration in the instant application, and examined on the merits as such.
Claim Rejections - 35 U.S.C. § 103
The following is a quotation of pre-AIA 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.
Claims 119, 125, 126, 130, and 133 are rejected under 35 U.S.C. § 103 as being unpatentable over Saiah et al. (WO 2019241789 A1, published December 19, 2025, cited on applicant IDS dated 05/19/2023),
The instant claims are drawn to a compound of Formula (III-C), specifically examined as compound number 439 in accordance with MPEP § 803.02: as the compound to which the Markush-type claim has been extended, and a pharmaceutically composition thereof.
Saiah teaches a compound of Formula (III) (claim 12), wherein R1 is a C4 hydrocarbon wherein one of the methylene units are replaced by -O- (claim 1). Saiah further teaches a composition comprising a pharmaceutically acceptable carrier (claim 17).
Figure 2. Structural comparison of instantly claimed Formula (III-C) and prior art compound
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Figure 2. a) Instantly claimed Formula (III-C); b) Prior Art Formula (III); c) Instantly claimed species
The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. However, it would have been prima facie obvious to make the combination since all the claimed elements were explicitly taught within the prior art and a person having ordinary skill in the art would have been motivated to combined the elements as instantly claimed by known methods with no change in their respective functions, and the combination yields nothing more than predictable results (see MPEP § 2143 (I)(A)).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Figure 3. Structural comparison of instantly claimed Formula (III-C) and patented Formula (X)
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Figure 3. a) Instantly claimed Formula (III-C); b) Patented Formula (X); c) Instantly claimed species
Claims 119, 125, 126, 130, and 133 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-15, and 17 of U.S. Patent No. US 11603377 B2, (cited on applicant IDS dated 05/19/2023). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims drawn to a compound of Formula (X) renders obvious the instantly claimed compound no. 439 (see Figure 3) wherein,
Wherein L is C2 alkylene
R1 is OH
R2 and R3 are C1 alkoxy
R4 is
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(see patented claims 1, 14, 15, and 17)
R5 is OH
R6 and R7 come together to form a carbonyl
Regarding claim 7, R25 of R4 is substituted C2 alkyl
Regarding claims 8 and 9, R25 is substituted OH
Regarding claim 10, D is -O-, G is -O-, y is 1-3, and V is hydrogen
Regarding claim 11, R25 is -D-(CH2-CH2-G)y-V, D is -O-, G is -O-, y is 1, and V is hydrogen
Regarding claim 12, R′ and R″ are hydrogen
Regarding claim 13, z is 2
Correspondence
No claim is allowed.
Any inquiry concerning this or earlier communications from the examiner should be directed to Sophia P. Hirakis whose telephone number is +1 (571) 272-0118. The examiner can normally be reached within the hours of 5:00 am to 5:00pm EST, Monday through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached on +1 (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is +1 (571) 273-8300.
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/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623