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 Claims
Claims 1-3, 14-15, 24-25, 34-39, 56-59, 66-69, 82-85, 89-92, 127-128, 133, 135, 141 and 143 are pending in the instant application. Claims 1, 14, 15, 34-39, 66-69, 128, 133, 135, 141 and 143 are amended and claims 4-13, 16-23, 26-33, 40-55, 60-65, 70-81, 86-88, 93-126, 129-132, 134, 136-140 and 142 are cancelled via the amendment filed March 26th, 2024.
Priority
This application is a continuation of PCT/US2022/033667, filed June 15th, 2022, which claims priority to 63/263,878, filed November 10th, 2021 and 63/211,353, filed June 16th, 2021.
Information Disclosure Statement
The Information Disclosure Statement filed 05/21/2024 was considered by the Examiner.
Restriction/Election
Applicant’s election without traverse of “compound D18” to prosecute the invention of Group I, drawn to a compound of Formula (I) or a pharmaceutical composition thereof, in the reply filed on May 31st, 2026 is acknowledged.
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species of the compound D18 appears allowable. Therefore, according to MPEP 803.02: should the elected species be found allowable, the examination of the Markush-type claim will be extended. If the examination is extended and a non-elected species found not allowable, the Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. The examination of the Markush-type claims has been extended to include the scope of claims 15, 25, 37-38, 68, 84, 91 and 127, as well as structural species:
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Since a non-elected species has been found not allowable, examination has been limited to claims directed to the elected species, which are presently claims 1, 3, 15, 25, 37-38, 68, 84, 91, 127 and 128. Claims 1, 3, 15, 25, 37-38, 68, 84, 91, 127 and 128 have been examined to the extent that they are readable on the elected embodiment and the above identified nonelected species. Since the nonelected species has been found not allowable, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
Claims 2,14,24,34-36,39,56-59,66,69,82-83,85,89-90,92,133,135,141 and 143 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention or species. Election was made without traverse in reply filed May 31st, 2026.
Claim Rejections - 35 USC § 112(b)
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 1, 3, 15, 25, 37-38, 68, 84, 91 and 128 are 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.
Claim 1 is drawn to a genus of bifunctional compounds of Formula (I), shown below:
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Claim 1 further defines elements R1, R2, R3, R4A, R4B, A and RE in specific chemical terms, while defining the element L only with the statement that “L is a linker”. No structure is provided in claim 1 with regard to the “linker” L.
The instant Specification includes the word “linker” 13 times (pages 2, 25, 68 and 98-99). On page 2, the structure of Formula (I) is provided in the same manner as instant claim 1, with only the proviso that “L is a linker” (paragraph [0006]). On page 68, the Specification provides that “In certain embodiments, L is a linker having the structure of -ZL-(RL-ZL)-“, with further definitions of the elements ZL and RL provided therein (paragraph [00158]). Given that the definition is only provided for “certain embodiments”, a person of ordinary skill in the art would not assume that these limitations apply to instant claim 1.
Given that the linker can be any molecule that accomplishes a molecular linkage between the two ligands, claim 1 is rendered indefinite because a POSITA would not be able to surmise what structure is not within the scope of a linker for claim 1, and therefore what overall molecular structure(s) is/are not in scope of the genus of Formula (I) of claim 1. Claims 3, 15, 25, 37-38, 68, 84, 91 and 128 depend directly or indirectly from claim 1 and each of these claims is indefinite because none of these claims provides structure for the linker “L”.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1, 3 and 128 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Weiss et al (US 2023/0122219 A1, which claims priority to 63/042,831, filed June 23rd, 2020).
Weiss teaches the following compound (page 100, which finds priority on page 118, Table 1 of the priority document):
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Regarding claim 1, this compound is embraced by instant formula (I), wherein R1 is hydrogen, R2 is C2 alkyl, R3 is hydrogen, R4A is R4, wherein R4 is hydrogen, R4B is -A-L-RE, A is a bond, L is a molecule that accomplishes a molecular linkage between two ligands, RE is
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, wherein ZE is a heteroarylene, YE is a bond, XE is C(RE2), wherein RE2 is hydrogen, m is 1 and RE1 is hydrogen.
Regarding claim 3, the above compound is of structure Formula (III).
Regarding claim 128, Weiss teaches a pharmaceutical composition comprising the above compound and a pharmaceutically acceptable carrier, adjuvant or vehicle (claim 7).
Allowable Subject Matter
Claims 127 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Grace Kuckla whose telephone number is (703)756-5610. The examiner can normally be reached Monday-Friday 7:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A 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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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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