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 .
Priority
This application is a national stage application under 35 U.S.C. § 371 of International Application No. PCT/US2022/074387, filed 08/01/2022, which claims the priority benefit of PRO Application No. 63/352,063, filed 06/14/2022 and PRO Application No. 63/228,303 filed 08/02/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/31/2024, and 06/02/2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of the Application
Claims 1-2, 6, 11, 16-17, 21-23, 25-28, 30-39, 41-44 and 46-72 are currently pending in this application and under examination. Claims 3-5, 7-10, 18-20, 24, 29, 40, and 45 have been cancelled by applicant without prejudice or disclaimer.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The use of the term “Keytruda” (pg. 78), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 68-72 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.
The term “characterized” in claim 68, line 1 is a relative term which renders the claim indefinite. The term “characterized” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The limitations of instant claim 68 do not provide a person of ordinary skill in the art a suitable definition of what is encompassed by “a disease or disorder characterized by aberrant B-cell lymphoma 6 (BCL6) activity”.
This rejection may be overcome by cancelling the claim or amending the language of the claim limitations to remove the term “characterized”.
Claims 69-72 are also rejected for being dependent on a rejected claim.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The limitations of instant claims 1-2, 6, 11, 16-17, 21-23, 25-28, 30-39, 41-44 and 46-67 make a contribution over Berlin (WO202/1077010) the closest prior art of record. Berlin teaches the compound of formula:
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127
234
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, which can be regarded as the closest prior art and differs from applicants compound of formula I where X2 is independently CH2, S, CHF, CHC1, CHOH, or CF2, and the methyl group adjacent to X2. Berlin also does not fairly teach or suggest to one of ordinary skill the compound of applicant’s formula I of the instant claims.
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109
201
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Applicant’s Formula I (Above)
Conclusion
Claims 1-2, 6, 11, 16-17, 21-23, 25-28, 30-39, 41-44 and 46-67 are allowable, claims 68-72 are rejected.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNESTO VALLE JR whose telephone number is (703)756-5356. The examiner can normally be reached 0730-1700 M-F EST, 1st Friday off.
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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.
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/E.V./Examiner, Art Unit 1623
/SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623