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 .
DETAILED ACTION
The office acknowledges Applicants filing of the claim amendments on 8/27/2024. Claims 13-16, 21-22 has been amended. For the sake of compact prosecution attorney of record, Tolga Gulmen was contacted regarding the restriction election of groups/species on Aug 10 2026. Applicants elected Group I compound claims, the compound of claim 12 and HCC as species for examination. Claims 1-22 are pending. The elected compound is free of prior art. Therefore the scope of the subject matter was extended or broadened pursuant to MPEP 803.02. The following species will be examined:
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Claims 1-2, 4, 6, 7, 9-11, 13 read on the elected group and species. Claims 3, 5, 8, 14-22 are withdrawn from further consideration pursuant to 37 C.F.R. 1.142(b), as being drawn to non-elected subject matter. The claims corresponding to the elected subject matter are 1-2, 4, 6, 7, 9-11, 13 and are herein acted on the merits.
Application Priority
This application filed 08/27/2024 is a National Stage entry of PCT/US2023/ 063382, International Filing Date: 02/27/2023, PCT/US2023/063382 Claims Priority from Provisional Application 63314470, filed 02/27/2022.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 8/27/2024, 01/07/2025, and 2/12/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to
Group I, claim(s) 1-13 are drawn to compounds, and its pharmaceutical composition:
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Group II, claim(s) 14-22 are drawn to a method of modulating hOAT, or reducing activity of an hOAT expressed by a human cancer, method of treating cancer.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-II lack unity of invention because even though the inventions of these groups require the technical feature of a composition comprising compound of claim 1 and this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Silverman et al. (IDS: WO 2017062942 A2). Silverman teach a compound of claim 1.
Unity of invention links the various inventions together by sharing a common special technical feature in each invention. However, when the special technical feature is not a contribution over the prior art, the various inventions may be restricted from each other.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144.
Applicants are required to elect a single group for examination, e.g. Group I.
Election of Species
This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows:
Compounds of formula of claim 1
Diseases to be treated
The species listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, the species lack the same or corresponding special technical features for the following reasons: (i) The species lack unity because the shared common technical feature is not a contribution over the prior art. The compound of claim I can be arrived from the prior art and hence it cannot be considered a special technical feature. (ii) As to the diseases there are hundreds of types of cancer(s). Disease states herein claimed do not flow from a single biochemical lesion, but form a range of physiological activities. Therefore the species election is proper, as they do not share a contribution over prior art. See MPEP 1850 and 37 CFR 1.475. Because the inventions lack unity for the reasons given above restriction for examination purpose as indicated is proper.
Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election. Applicant is required to elect a single compound, e.g. Example 1 compound and a disease to be treated for e.g. heart failure.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, the following claim(s) are generic: 1, 2, 9, 13-17, 21.
The election of species may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention or species.
Should applicant traverse on the ground that the inventions or species have unity of invention (37 CFR 1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 of the other invention.
During a telephone communication with Attorney Tolga Gulmen on 8/12/2026, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-13 and the species, compound of claim 12 and HCC as species for examination. Affirmation of this election must be made by applicant in replying to this Office action. Claims 3, 5, 8, 14-22 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Rejections - 35 USC § 102/103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Silverman et al. (IDS: WO 2017062942 A2).
Silverman teach the following compounds:
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Further taught in [0018],
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Silverman further teach composition for GABA- AT inactivation, inhibition or modulation and/or treatment of an addiction and associated indications (for e.g. treating hepatocellular carcinoma) comprising the cyclopentene carboxylic acid compounds comprising a carrier (see title, abstract, [0013-15]).
If in the above formula R1 is H and R2 is F or R1 is F and R2 is H, the following compound and its salt (HCl) are derived.
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(Salt)
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(Silverman) (Instantly claimed compound)
Thus Silverman anticipates claim 1. As to claim 4, the Silverman teach R1 and R2 can be selected from H or F (X =F and Y=H as in instant claim 4) and thus anticipated.
Claim(s) 1, 2, 4, 6-7, 9-11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Silverman et al. (IDS: WO 2017062942 A2).
Silverman teachings discussed as above.
From Silverman a skilled artisan would have found it obvious to arrive at the following compound with carboxylate and ammonium moiety.
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A person skilled in the art would have been motivated to arrive at the compound(s) with a reasonable expectation of success and to use it as gaba aminotransferase inactivator, for e.g. treating hepatocellular carcinoma. Thus claims 1-2, 6-7, 11 are addressed. As to claim 4, the Silverman teach R1 and R2 can be selected from H or F. As to claim 12, it is within the skill of an artisan to arrive at the pharmaceutical composition comprising the instantly claimed compound with a carrier from Silverman to use it in therapeutic applications.
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, 2, 6-7, 9-11, 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7,9-33 of U.S. 9670141 (‘141)
The instant claims are directed to:
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’141 reference claims are directed to:
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The instantly claimed compound of claim 1, (in particular compound of claim 6) is anticipated by the reference claims teachings (In reference claim 1 or claim 7, when R1=H and R2=F). Thus claims 1, 6-7, 11 are addressed. Claims 2, 9-10 and 13 are anticipated by reference claims 1, 4-6.
Claims 1, 6-7, 11, 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of US 9603820 (‘820).
The instant claims as above.
The reference claims are directed to:
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If in claim 1, R1=H and R2=F or R1=F and R2=H, then the compound of claims 1, 6-7, 11 are anticipated.
As to claim 13, it is within the skill of an artisan to add a pharmaceutical carrier to the compound and arrive at the pharmaceutical composition for oral administration, e.g. tablet.
Note: ODP rejections over other co-pending application(s) or patents are not made because the claims are examined based on the election of groups/species (includes but not limited to, ODP rejections over US 1078153 and US 10632088).
Allowable Subject Matter
Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to UMAMAHESWARI RAMACHANDRAN whose telephone number is (571)272-9926. The examiner can normally be reached M-F- 8:30-5:00 PM (PST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 5712705239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/ docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Umamaheswari Ramachandran/ Primary Examiner, Art Unit 1627
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