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
Note this is a second non-final rejection.
Claims 1-23 and 27-28 are pending in the instant application.
Claim 1 is amended.
Claims 6-7 and 21-23 are cancelled.
Claims 1-5, 8-20, and 27-28 are examined herein.
Priority
The instant application claims benefit of priority to U.S. Provisional Application No. 62/958056, filed on 07 January 2020 and PCT/US2020/065798, filed on 18 December 2020. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 07 January 2020.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 20 September 2022, 03 October 2022, 09 April 2024, are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Arguments
The amendment filed on 25 August 2025 has been entered.
In view of applicant cancellation of claims 21-23, the 112(a) written description rejection of record is withdrawn.
With respect to the Improper Markush, applicant amendment is considered but not found to be persuasive. There is still an insufficient representation of the claimed genus. The rejection is amended below.
Additionally new objections, 112(b), and 102 rejections are below.
All rejections and objections not found below have been withdrawn.
MAINTAINED REJECTIONS
Improper Markush
Claims 1-5, 8-20, and 27-28 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of V and X are improper because the alternatives defined by the Markush grouping do not share both a single structural similarity, as there is no common core, and a common use, as the specification fails to use a combination of these variables for the use as BTK inhibitors.
The possible substitution patterns set forth in claim 1 create a genus of compounds that spans classifications due to the changing core. Without a representative number of structures, expressing the range of variability, disclosed in the specification or shown in the prior art, the instant application does not show all the possible structure subtypes to be functionally equivalent and have a common use.
Claim 20 depicts the instant embodiments of the claimed genus. Under the assumption that V is two ring atoms from the -Y-B(OR)2 substituent counterclockwise and X is two ring atoms from the -Y-B(OR)2 substituent clockwise; there are four structures (pictured below) where X is CR12R13 and two of these structures (first two on left) are the only representation where V is NR8. All other structures depict X as NR11 and V as CR9R10. All embodiments where X is NR11, R11 is only hydrogen. There are 11 different substituent groups presented for R11 alone, which leads to over 200 different combinations of substituents. Disclosing 1 possibility is not representative of the genus. Likewise for V, when V is NR8, R8 is only recited as H, with no representation of the other 200 possibilities claimed. When V is CR9R10, R9 is always H and R10 forms a ring with R4 twice and a bridge with R6 once, for every other instance R10 is H.
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A proper Markush would be a representation of the claimed compounds. As depicted the overwhelming majority of compounds recite X as NH and V as CH.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
NEW REJECTIONS
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claims 17-20, and 6 have been renumbered to claims 16-20. As claim 16 is missing from the claims sheet, claim 17 is renumbered to Claim 16. Claim 18 is renumbered to Claim 17. Claim 19 is renumbered to Claim 18. Claim 20 is renumbered to Claim 19. Claim 6 is renumbered to Claim 20. The renumbering matches the previously presented claims filed on 27 June 2022.
Claim 20 objected to because of the following informalities:
Claim 20 recites the compound
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. The R8 substituent is missing. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4 and renumbered claim 20 (currently numbered 6) is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Renumbered claim 20 recites the limitation "
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." There is insufficient antecedent basis for this limitation in the claim as Z has been amended to no longer include -CH2 as a substituent.
Renumbered claim 20 recites the limitation “
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.” There is insufficient antecedent basis for this limitation. Claim 1 depicts a bond between Y and the ring carbon to which it attaches. If the cyclopropyl is the Y substituent, there is no antecedent basis for the missing methylene or the lack of an R7 substituent. If the cyclopropyl is R7 and Y taken together, there is also no antecedent basis for this possibility recited in claim 1. Claim 4 has not been included in this rejection as the attachment point of the cyclopropyl as guided by claim 1 would be to the carbon of the ring.
Claim Rejections - 35 USC § 102
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 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(s) 1, 2, and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ortiz et al. (Tetrahedron. 2005;61(7):1699-1707).
Regarding claims 1, 2, and 5, Ortiz teaches the compound 11 (page 1701), or cyclopentylmethylboronic acid (pictured below). This compound is a species of the instant genus when R1 is H; R2 is H; R3 is H; R4 is H; R5 is H; R6 is H; R7 is H; V is CR9R10, wherein R9 is H and R10 is H; X is CR12R13, wherein R12 is H and R13 is H; Y is C1 alkyl; and Z is a bond.
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Conclusion
Claims 1-5, 8-20, and 27-28 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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