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 .1
Status of Claims
Claims 1,3-5,8-10,13-15,18,20,23,25,28,30,33,36 and 47 are pending.
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 elect a single invention to which the claims must be restricted.
Group I, claims 1,3-5,8-10,13-15,18,20,23,25,28,30,33,36,44, drawn to a compound of formula I, (S)-1-(1-acryloylpiperidin-3-yl)-2-fluoro-5,6, 7,8,9,10-hexahydro-cyclohepta[b]indole-4-carboxamide, aka Compound I (see paragraph 7 of the specification), aka Cinsebrutinib
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Group II, claim 47, drawn to a method for treating a disease or condition modulated by Bruton's tyrosine kinase inhibition.
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 and II lack unity of invention because even though the inventions of these groups require the technical feature of Compound I, aka Cinsebrutinib, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of WO2021207549A1 (WO 549), aka reference D1 from the Written Opinion of PCT/US2022/047050, the International Application this examined application is a 371 National Stage Application thereof.
Starting at page 106 to page 111 of WO 549, Example 5-6 discloses the synthesis of the claimed compound 1, aka (S)-1-(1-acryloylpiperidin-3-yl)-2-fluoro-5,6, 7,8,9,10-hexahydro-cyclohepta[b]indole-4-carboxamide, aka Cinsebrutinib, as an off white solid. WO 549 does not state if Example 5-6 (aka claimed Compound 1) if the off white solid is crystalline or not.
Despite this, example 2 of the specification (paragraph 49) discloses the starting material to be used for polymorph screening is a rod-like crystal. Because WO 549 teaches the ONLY known method for synthesizing the claimed compound 1 (Cinsebrutinib), the synthesis of Compound 1 from WO 549 must be a rod-like crystal and therefore, the claimed solid crystalline form of Compound 1, thus destroying novelty.
During a telephone conversation with Dr. James Malecha on April 16, 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1,3-5,8-10,13-15,18,20,23,25,28,30,33,36 and 44 (directed to solid crystalline forms and a pharmaceutical composition thereof). Affirmation of this election must be made by applicant in replying to this Office action. Claim 47 (Group II) is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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).
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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Sept 9 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. US20220009920A1, the US published equivalent of cited prior art, WO 2021207549A1 has been cited by the Examiner on the PTO-892 form.
Claim Objections
Claims 3-5, 8-10, 13-15, 18, 20, 23, 25, 28, 30, and 33 are 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.
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 and 36 are rejected under 35 U.S.C. 102(a)(1) as anticipated by WO 2021207549A13 (WO 549), published Oct 14 2021.4
Claim 1 is directed to a solid crystalline form of compound 1, aka (S)-1-(1-acryloylpiperidin-3-yl)-2-fluoro-5,6,7,8,9,10-hexahydro-cyclohepta[b]indole-4-carboxamide, aka Cinsebrutinib, where claim 36 is a pharmaceutical composition comprising the crystalline form of claim 1.
Starting at page 106 to page 111 of WO 549, Example 5-6 discloses the synthesis of claimed compound 1, as an off white solid. WO 549 does not state if Example 5-6 (aka claimed Compound 1) if the off white solid is crystalline or not.
Despite this, example 2 of the examined specification (paragraph 49) discloses the starting material to be used for polymorph screening is a rod-like crystal. Because WO 549 teaches the ONLY known method for synthesizing the claimed compound 1 (Cinsebrutinib), the synthesis of Compound 1 from WO 549 must be a rod-like crystal and therefore, the claimed solid crystalline form of Compound 1.
Regarding claim 36, WO 549 teaches a pharmaceutical composition of its compounds. See claims 28-29.
Claim Rejections - 35 USC § 103
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 44 is rejected under 35 U.S.C. 103 as being unpatentable over WO2021207549A1.
Starting at page 106 to page 111 of WO 549, Example 5-6 discloses the synthesis of claimed compound 1, as an off white solid. Note that claim 44 is not limited to a solid crystalline form of compound 1 as the balance of the examined claims.
Regarding claim 44, WO 549 teaches a pharmaceutical composition of its compounds. See claims 28-29.
While teaching the claimed pharmaceutical composition comprising a crystalline solid of compound 1, WO 549 does not necessarily recite the claim 44 amounts of 1-25 mg of compound 1.
However, WO 549 teaches doses of its claimed compounds in amounts of 1mg/ml and/or 10 mg/kg dosed to subjects, where based on these concentrations, it would be routine for a person having ordinary skill in the art (PHOSITA) to adjust these concentrations to arrive at the claimed range of claim 44.
Prior to the filing of the instant application a PHOSITA following the teachings of WO 546 would have found it prima facie obvious to arrive at the claimed range following the teachings disclosing a pharmaceutical composition comprising compound 1 in the taught concentrations. See MPEP 2143 (e), choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success.
Conclusion and Correspondence
In summary, no claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can be reached M-F.
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, Adam C. Milligan can be reached at (571) 270-7674. 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.
/WILLIAM Y LEE/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
1 CONTINUING DATA
This application is a 371 of PCT/US2022/047050 10/18/2022
PCT/US2022/047050 has PRO 63/393,163 07/28/2022
PCT/US2022/047050 has PRO 63/257,509 10/19/2021
This application has published as US 20250243176 A1.
2 CAS Reg. No. 2724962-58-5
2-Fluoro-5,6,7,8,9,10-hexahydro-1-[(3S)-1-(1-oxo-2-propen-1-yl)-3-piperidinyl]cyclohept[b]indole-4-carboxamide (ACI)
Cinsebrutinib
3 Current Assignee GB005 Inc
Inventors: Craig Alan COBURN, Dange Vijay Kumar, Luis Antonio Lopez, Daniel John Buzard
4 Earliest claimed priority of this examined application is 10/19/2021.
Applicant: Vidya Therapeutics, Inc, Encinitas, CA, UNITED STATES
Inventors: Beili Zhang. Fahmi AL-AQRABI
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