DETAILED ACTION
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 1-8, 10, 13, 14, 21, 25, 59, and 61-66 are pending. Claims 9, 11, 12, 15-20, 22-24, 26-58, and 60 are cancelled. Examiner previously required a restriction (dated September 11, 2025). In response, Applicant elected, without traverse, Group I which encompasses claims 1-8, 10, 13, 14, 21, 25, 61, 62, 65, and 66. Accordingly, claims 59, 63, and 64 are withdrawn.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/IB2021/000708, filed on October 20, 2021. This application also claims the benefits of U.S. Provisional Application No. 63/094,808, filed on October 21, 2020.
In this office action, Examiner used the effective filing date of the International patent application PCT/IB2021/000708 (i.e., October 20, 2021) as the effective filing date of the instant application (explanation provided in the non-final rejection dated 01/27/2026).
Election/Restrictions
As a reminder, Applicant elected, without traverse, Group I which corresponds to claims 1-8, 10, 13, 14, 21, 25, 61, 62, 65, and 66. Applicant also elected the following species:
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and indicated that this compound may read on claim 21. The elected species was not found in the prior art and, thus, the search was expanded.
Specification - Disclosure
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this office action has been withdrawn or rendered moot in view of applicant' s amendments and/or remarks.
Claim Objections
Claim 10 is objected to because of the following informalities:
In claim 10, to be concise and avoid repetition:
“… each substituent being independently selected from the group consisting of thiol, … cycloalkyl, heterocycloalkyl, and heterocycloalkyl”
should read
“… each substituent being independently selected from the group consisting of thiol, … cycloalkyl, and heterocycloalkyl”
Appropriate correction is required.
------------------------- Maintained/Added Rejection ----------------------------
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.
Claims 1-8, 10, 13, 14, 21, 25, 61, 62, 65, and 66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-5, 7-11, 13-20 of U.S. Patent No. 10,875,845 B2 (‘845B2)
as recited in the non-final rejection dated 01/27/2026
claim 1 of U.S. Patent No. 11,634,411 B2 (‘411 B2)
as recited in the non-final rejection dated 01/27/2026
claims 45-53, 55, 57-61, and 64 of U.S. Patent Application No. 18/119,248 (‘248)
as recited in the non-final rejection dated 01/27/2026
claims 53, 59, and 61 in ‘248 are now cancelled; claims 70 and 71 of ‘248 are newly added claims.
the instant claims are also provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 65 and 67-71 of ‘248 in this action.
Although the claims at issue are not identical, they are not patentably distinct from each other because there is overlap between the instant claims and the claim sets from the granted patents and the co-pending application.
For example, claim 1 of ‘845B2 is directed to a compound of the following structure:
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. The region outlined in the box with the solid lines correspond to Lz = -(C=O)O(CR8R9)z- of the compound of instant claim 1 wherein z = 1; R8 = H or unsubstituted C1-3 alkyl; and R9 = H. Furthermore, when X = bond and R9 = substituted alkyl or substituted heteroalkyl in Formula (III) of ‘845B2 (see region outlined in the box with dashed lines above), that corresponds to R = substituted alkyl or substituted heteroalkyl in the compound of instant claim 1. Although the compounds claimed in ‘845B2 are enantiomers of the compound of instant claim 1, it would have been obvious to one of ordinary skill in the art to prepare and evaluate the opposite enantiomer of the patented compound (as well as prepare and evaluate a pharmaceutical composition comprising the opposite enantiomer and a pharmaceutically acceptable excipient), particularly because individual stereoisomers were known to be routinely investigated for their biological properties. Moreover, both the claims of ‘845B2 and the instant claims (identified above) recite use of the respective compounds for the same therapeutic use: treating ocular diseases (see title of ‘845B2 and the instant application).
Therefore, claims 1-8, 10, 13, 14, 21, 61, 62, and 66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-11, and 13-20 of U.S. Patent No. 10,875,845 B2 (‘845B2).
Claim 1 of U.S. Patent No. 11,634,411 B2 (‘411 B2) is directed to a compound having the structure of Formula (Ia) as shown below:
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.
Upon comparing claim 1 of ‘411B2 with instant claims 1-8, 10, 13, 14, 21, 25, 61, 62, 65, and 66, a POSITA would recognize that the scope of claim 1 of ‘411B2 overlaps with the scope of instant claims 1-8, 10, 13, 14, 21, 25, 61, 62, 65, and 66.
Claims 45-52, 55, 57, 58, 60, and 70 of ‘248 are directed to a compound having the structure of Formula (Id) as shown below:
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.
Upon comparing claims 45-52, 55, 57, 58, 60, and 70 of ‘248 with instant claims 1-8, 10, 13, 14, 21, 25, 61, 62, and 66, a POSITA would recognize that the scope of claims 45-52, 55, 57, 58, 60, and 70 of ‘248 overlaps with the scope of instant claims 1-8, 10, 13, 14, 21, 61, 62, and 66.
Claims 65, 67-69, and 71 of ‘248 are directed to a compound having the following structure:
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.
Upon comparing claims 65, 67-69, and 71 of ‘248 with instant claims 1-8, 10, 13, 14, 21, 61, 62, and 66, a POSITA would recognize that the scope of claims 65, 67-69, and 71 of ‘248 overlaps with the scope of instant claims 1-8, 10, 13, 14, 21, 61, 62, and 66.
Although claim 64 of ‘248 is directed to a method of treating a dermal or an ophthalmic disease or disorder in an individual in need thereof, comprising administering to the individual a composition comprising a compound of claim 45, the claim nevertheless renders the instant claims not patentably distinct. Specifically, the method of claim 64 of ‘248 necessarily requires the compound of claim 45, which encompasses compounds falling within the scope of the instant claims. Furthermore, the compound recited in the instant claims has the same therapeutic use: for treating ocular diseases. Accordingly, instant claims 1-8, 10, 13, 14, 21, 61, 62, and 66 do not define a patentably distinct invention over claim 64 of ‘248.
Conclusion
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN ROMERO whose telephone number is (571)272-6478. The examiner can normally be reached M-F 9:30 AM - 6:00 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY H. MURRAY can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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