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 23-38 are pending. Claims 24 and 26-38 are withdrawn. Claim 25 is objected. Claim 23 is rejected.
Election/Restriction Requirement
Restriction to one of the following inventions is required under 35 U.S.C. 121:
Group I. Claims 23-31, drawn to a group of compounds, classified in various subclasses of CPC C07D.
Group II. Claims 32-38, drawn to a method of using a CHD1L inhibitor, classified in CPC A61P.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the process of Group II can be practiced with materially different products. For example, treatment of TCF-transcription driven cancers can be treated with TCF inhibitor FH535,
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. This inhibitor is a sulfonamide, which is
materially different than the compounds claimed. See Handeli et al. Mol. Cancer. Ther. 2008, 7, 521-529 at 523.
Restriction for examination purposes as indicated is proper because all these inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because at least the following reason(s) apply:
The inventions have acquired a separate status in the art in view of their different classification as noted above;
The inventions have acquired a separate status in the art due to their recognized divergent subject matter, since Group I pertains to small organic molecules and Group II pertains to the practice of medicine; and
The inventions require a different field of search (e.g., searching different classes /subclasses or electronic resources, or employing different search strategies or search queries).
Traversal of Restriction Requirement
The election of an invention may be made with or without traverse. To reserve 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 upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should 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. In either instance, 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(a) of the other invention.
Election of Species
This application contains claims directed to the following patentably distinct species: Compounds of claim 23 (for Group I) and CHD1L inhibitors (for Group II). See claims 23 and 37 for example.
The species are independent or distinct because the species as claimed have a materially different design which imparts to each compound a different chemical reactivity and pharmacokinetic profile, resulting in different in vitro and in vivo effects. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable.
There is a search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
The species require a different field of search (e.g., searching different classes /subclasses
or electronic resources, or employing different search strategies or search queries), since the species are classified throughout various classes of CPC C07D.
Traversal of Election Requirement
The election 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 election of species 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 species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
Rejoinder
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.
Telephonic Election
During a telephone conversation with Dr. Victoria Cheng on May 13, 2025 a provisional election was made to prosecute the invention of Group I (claims 23-31) with a species election of the compound of claim 25. Affirmation of this election must be made by applicant in replying to this Office action.
Claims 23 and 25 read on the elected species,
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. Examination of the elected invention was conducted in accordance with the MPEP 803.02:
Following election, the Markush-type claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability. If the Markush-type claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush-type claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration.
On the other hand, should the examiner determine that the elected species is allowable, the examination of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the Markush-type claim with respect to a nonelected species, the Markush-type claim shall be rejected and claims to the nonelected species would be held withdrawn from further consideration.
The elected species appears allowable in view of the prior art; therefore, examination of the Markush-type claim has been extended to include the species
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. Since art was found on these nonelected species, subject matter not embraced by the elected embodiment or the above-identified nonelected species is therefore withdrawn from further consideration. Claims 24 and 26-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Priority
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The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/994,259, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) for claim 23. The ‘259 application does not provide support for the compounds claimed except for the following:
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and
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. See, e.g., pages 46-51.
The 63/139,394 application provides support for some of the compounds that did not appear in the ‘259 application, but not for the following:
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. See, e.g., pages 79-86.
The application, PCT/US2021/023981, provides support for some of the compounds that did not appear in the ‘259 and/or ‘394 application, but does not provide support for the compound
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. This compound finds support in the prior-filed application,
Application No. 63/250,803 as compound number 114 (p. 132). Since the ‘803 application was filed on September 30, 2021, this is the effective filing date accorded to claim 23. Claim 25 is supported by the ‘394 application and, therefore, has an effective filing date of January 20, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 27, 2024 was in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. Accordingly, the IDS has been considered by the examiner and a signed copy is enclosed herewith.
Claim Objections
Claim 23 is objected to for the following informalities: the compound
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appears twice in the claim (page 2 and page 3). 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.
Claim 23 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abbott et al. Mol. Cancer. Ther. 2020, 19, 1598-1612 (pub. August 4, 2020).
Abbott et al. teaches the following anticipatory compounds in Figure A (p. 1606):
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. These compounds are identical to the following claimed compounds on page 3:
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.
Allowable Subject Matter
Claim 25 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L AGUIRRE whose telephone number is (571)272-5592. The examiner can normally be reached 10 am-6 pm EDT.
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, JOSEPH K McKANE can be reached on 571-272-0699. 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.
/AMANDA L. AGUIRRE/ Primary Examiner, Art Unit 1626
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