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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 29 October 2025 has been entered.
Status of the Claims
Claims 1, 17, 19, 22, 24-27, 30, and 32-36 are pending in the instant application.
Claim 1 is amended.
Claims 26 and 27 are cancelled.
Claims 1, 17, 19, 22, 24-25, 30, and 32-36 are examined herein.
Priority
The instant application claims benefit of priority to U.S. Provisional Application No. 62900557, filed on 15 September 2019 and PCT/IB2020/000745, filed on 14 September 2020. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 15 September 2019.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 9 May 2022, 10 March 2023, 13 December 2023, 23 February 2024, 26 July 2024, 19 February 2025, 05 June 2025, and 29 October 2025 are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Arguments
The amendment filed on 19 February 2025 has been entered.
In view of Applicant’s arguments the 103 rejection of record is withdrawn.
In addition new objections and 112(a) rejections are necessitated by amendment and request for continued examination.
All rejections and objections not found below have been withdrawn.
NEW REJECTIONS
Claim Objections
Applicant is advised that should claim 17 be found allowable, claim 33 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 17, 19, 22, 24-25, 30, and 32-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the method of treating a solid tumor in a subject comprising administering 5-(3,6-dibromo-9H-carbazol-9-yl)-N,N,N-trimethylpentan-1-aminium. The specification provides the method of administering the 5-(3,6-dibromo-9H-carbazol-9-yl)-N,N,N-trimethylpentan-1-aminium in the treatment of solid tumors derived only from the A549 cell line, known to model human lung adenocarcinoma. No other cell lines are disclosed in the specification. As the dependent claims do not remedy the issue they are subject to the rejection as well.
One of ordinary skill in the art would not be able to determine the scope of treatable solid tumors based on the specification. The specification does not provide a structure-function correlation between the instant compound and the targeted solid tumors. There is no mechanism of action described in the specification, just the reduction of tumor volume in tumors of the A549 cell line. Within pharmaceutics, the art of cancer therapeutics is well known to be unpredictable due to the differing etiologies and mechanisms of action for particular cancers. There are more than 200 known cancers, with around 90% of these being solid tumor cancers; treatment applicable to one is unlikely to be applicable to another. Bianchi et al. (Current Opinion in Cell Biology. 2020; 63:135-143) attributes this unpredictability to tissue specificity, noting most cancer driver genes are mutated in a tissue-dependent manner, which affects therapeutic response (page 135). Edelman et al. (J Thorac Oncol. 2019;14(10):1853–1859) present a study of palbociclib, a CDK 4/6 inhibitor and standard first-line treatment in breast cancer, in patients with squamous non-small cell lung cancer (NSCLC) with CDK/cyclin abnormalities. Edelman concludes no significant activity against sqNSCLC. And further brings light to the unpredictability of cancer therapeutics by noting abemaciclib, another CDK 4/6 inhibitor used in breast cancer treatment, has shown partial activity in non-squamous carcinoma.
Additionally, one cell line is not an adequate representation of the over 200 possible cancers. A representative number of species demonstrating the cytotoxic effects of 5-(3,6-dibromo-9H-carbazol-9-yl)-N,N,N-trimethylpentan-1-aminium would provide one skilled in the art with a scope of solid tumors capable oof being treated by the instant compound. However, as the specification does not provide any structure-function correlation to support the bounds of treatable solid tumor, nor are there a representative number of examples presented in the instant specification, this suggests the applicant is not in possession of the knowledge of solid tumors can be treated with 5-(3,6-dibromo-9H-carbazol-9-yl)-N,N,N-trimethylpentan-1-aminium.
In conclusion, there is no structure-function correlation between what solid tumors the instant compound can and cannot treat. Without the correlation between structure and function or an adequate representation of species being treated by the instant compound, the instant invention fails to comply with the written description requirement.
Conclusion
Claims 1, 17, 19, 22, 24-25, 30, and 32-36 are rejected.
Claim 33 is objected to.
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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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621