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
This Office Action is in response to Applicant's Restriction Requirement remarks filed on November 25, 2025. Claim(s) 1, 3-5, 7, 9, 13, 16, 18, 20, 22, 24-26, 30, 31, 35-40, and 52-56 are pending. Applicant's election of Group I drawn to a compound of Formula I and election of species of compound:
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without traverse of the restriction requirement in the reply is acknowledged. The requirement is deemed proper and is therefore made FINAL. The elected species was found free of the art, therefore the search was expanded Formula I in its entirety. The species election is hereby withdrawn. Claim(s) 1, 3-5, 7, 9, 13, 16, 18, 20, 22, 24-26, 30, 31, 35-40, and 52-56 are examined herein insofar as they read on the elected invention.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 3-5, 7, 9, 13, 16, 18, 20, 22, 24-26, 30, 31, 35-40, and 52-56 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 3, 7, 9, 18, 20, 21, 30, 31, 37, 40-43, 54, and 58-62 of copending Application No. 18/858,868. Although the conflicting claims are not identical, they are not patentably distinct from each other. The instant claims are drawn to compounds of formula I. The copending claims employ Formula I in the same scope for the treatment of fibrosis. The copending claims embrace the instant claims.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 1, 3-5, 7, 9, 13, 16, 18, 20, 22, 24-26, 30, 31, 35-40, and 52-56 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 3, 7, 9, 18, 20, 21, 30, 31, 37, 40-41, 47, and 54-58 of copending Application No. 18/858,861. Although the conflicting claims are not identical, they are not patentably distinct from each other. The instant claims are drawn to compounds of formula I. The copending claims employ Formula I in the same scope for the treatment of neuropathy. The copending claims embrace the instant claims.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 1, 3-5, 7, 9, 13, 16, 18, 20, 22, 24-26, 30, 31, 35-40, and 52-56 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 3, 7, 9, 18, 20, 21, 30, 31, 37, 40-41, 45, and 64-68 of copending Application No. 18/858,864. Although the conflicting claims are not identical, they are not patentably distinct from each other. The instant claims are drawn to compounds of formula I. The copending claims employ Formula I in the same scope for the treatment of a neuroinflammatory condition. The copending claims embrace the instant claims.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 1, 3-5, 7, 9, 13, 16, 18, 20, 22, 24-26, 30, 31, 35-40, and 52-56 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 3, 4, 7, 9, 13, 18, 20, 22, 24, 30, 31, 32, 35, 37, 39, 40, 43-53 of copending Application No. 18/716,404. Although the conflicting claims are not identical, they are not patentably distinct from each other. The instant claims are drawn to compounds of formula I. The copending claims employ Formula I in the same scope for the treatment of mild cognitive impairment. The copending claims embrace the instant claims.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
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, 7, 13, 31, 35, 36, and 40 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Shiota (US 2019/0055249) of record (IDS 7/31/25, PG PUB #1).
Shiota teaches compounds of formula I and pharmaceutical compositions thereof (page 1, column 2, [0013]-[0018]).
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The formula above embraces the compounds of the instant claims when L is a bond, R4 is Ph, R3 is C6 arylalkyl, R2 and R7 are oxo, R1a and R1b are H and benzyl, R6 is H, and n is 0 therefore no R5, thereby meeting the limitations of claims 1, 7, 13, 31, 35, 36, 37, and 40.
Claims 1, 7, 13, 31, 35, 36, and 37 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by CAS RN 2089298-25-7.
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The formula above embraces the compounds of the instant claims when L is a bond, R4 is Ph, R3 is C10 arylalkyl, R2 and R7 are oxo, R1a and R1b are H and benzyl, R6 is H, and n is 0 therefore no R5, thereby meeting the limitations of claims 1, 7, 13, 31, 35, 36, and 37.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-5, 7, 9, 13, 16, 18, 20, 22, 24-26, 30, 31, 35-38, and 40 are rejected under 35 U.S.C. 103 as being obvious over Masliah (WO 2008/157425) of record (IDS 9/8/23, Foreign Patent # 6).
Masliah teaches compounds of formula II and pharmaceutical formulations thereof (page 48, claim 4).
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Masliah teaches "heteroaromatic" and "heteroaryl" refer to such monocyclic or fused bicyclic ring systems which contain as ring members one or more heteroatoms selected from O, S and N. The inclusion of a heteroatom permits aromaticity in 5-membered rings as well as 6-membered rings. Typical heteroaromatic systems include monocyclic C5-C6 aromatic groups such as pyridyl, pyrimidyl, pyrazinyl, pyridazinyl, triazinyl, thienyl, furanyl, pyrrolyl, pyrazolyl, thiazolyl, isothiazolyl, oxazolyl, isoxazolyl, imidazolyl, triazolyl, thiadiazolyl, oxadiazolyl, and tetrazolyl rings, and the fused bicyclic moieties formed by fusing one of these monocyclic groups with a phenyl ring or with any of the heteroaromatic monocyclic groups to form a C8-C10 bicyclic group such as indolyl, benzimidazolyl, indazolyl, benzotriazolyl, isoquinolinyl, quinolinyl, benzothiazolyl, benzofuranyl, benzothienyl, benzisoxazolyl, 5 pyrazolopyridyl, quinazolinyl, quinoxalinyl, cinnolinyl, and the like (page 22-23, bridging ¶).
Masliah teaches aryl and heteroaryl moieties may be substituted with a variety of substituents which are known in the art. In alternative aspects, substituents include, but are not limited to, halo, C1- C8 alkyl, -NO2, -CN, -OR', -SR', -COOR', -C(O)NR'2, and -NR'2, where each R' independently represents H, C1-C4 alkyl or C5-C12 arylalkyl, or a heteroform of one of these (page 23, lines 13-16).
Masliah teaches a generic group of compounds which embraces applicants’ claimed compounds (see definitions above). The claims differ from the reference by reciting specific species and a more limited genus than the reference. However, it would have been obvious to one having ordinary skill in the art at the time of the invention to select any of the species of the genus taught by the reference, including those instantly claimed, because the skilled chemist would have the reasonable expectation that any of the species of the genus would have similar properties and, thus, the same use as taught for the genus as a whole. One of ordinary skill in the art would have been motivated to select the claimed compounds from the genus in the reference since such compounds would have been suggested by the reference as a whole. It has been held that a prior art disclosed genus of useful compounds is sufficient to render prima facie obvious a species falling within a genus. In re Susi, 440 F.2d 442, 169 USPQ 423, 425 (CCPA 1971), followed by the Federal Circuit in Merck & Co. v. Biocraft Laboratories, 847 F.2d 804, 10 USPQ 2d 1843, 1846 (Fed. Cir. 1989).
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Conclusion
Claims 1, 3-5, 7, 9, 13, 16, 18, 20, 22, 24-26, 30, 31, 35-40, and 52-56 are not allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sahar Javanmard whose telephone number is (571)270-32800-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SAHAR JAVANMARD/Primary Examiner, Art Unit 1627