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 .
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.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-14 and 17-20), in the reply filed on 4 June 2026, is acknowledged.
Applicant’s election without traverse of their elected species of genus formula I, in the reply filed on 4 June 2026, is acknowledged.
Applicants provided a compliant species election of:
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, wherein R1 and R2 join together to make a 5-membered ring; R3 is H; A is propylene (C3alkylene; claim 11: “n” is 3); R4 is alkylamino; and each of the two R5 are methoxy.
Applicants’ elected species is free of the prior art.
The Examiner extended the Markush search to the full scope of genus formula I of instant claims 1 and 11 but did not find any prior art.
Therefore, the Election of Species Requirement of 6 April 2026, is withdrawn, as all claims are free of the prior art.
In the interests of compact prosecution, the Examiner has rejoined non-elected Group II claims 15-16 and examined these claims in this Office Action. The Restriction Requirement of 6 April 2026, is withdrawn accordingly.
Current Status of 18/618,496
This Office Action is responsive to the amended claims of 4 June 2026.
Claims 1-20 have been examined on the merits. Claims 1-14 and 16-20 are previously presented. Claim 15 is currently amended.
Priority
The instant application’s effective filing date is 2 May 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 27 March 2024, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 15 is objected to as it contains a phrase: “or a pharmaceutical composition comprising one or more compounds of claim 1”. This phrase is duplicative with the phrase immediately preceding it drawn to “a composition comprising a therapeutically effective amount of one or more compounds of claim 1”. The first phrase is drawn to a composition (which has medicinal qualities and hence is a “pharmaceutical composition”). So, why is the latter phrase included? Please strike the duplicative latter phrase to render moot this objection.
Claim 16 is similarly objected to as it refers back to claim 15 but does not remedy the rationale underpinning the basis for objecting to claim 15.
Claim 17 is objected to as the illustrations should be incorporated into the claim. Right now, they are floating in space and come after the period at the end of claim 17, thereby looking unattached to claim 17.
Claims 18-20 are similarly objected to as these claims refer back to claim 17 but do not remedy the rationale underpinning the basis for objecting to claim 17.
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 1-20 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.
The limitations “C1-C6alkenyl” and “C1-C6alkynyl” within variable R5 of claims 1 and 11 render the metes and bounds of claims 1 and 11 undefined (hence rendering claims 1 and 11 indefinite under 35 USC 112(b)). The artisan is not certain how a C1alkenyl and a C1alkynyl can exist (hence the claims 1 and 11 are indefinite given the uncertainty) since an “alkenyl” is understood by the artisan to be a double bond between at least two carbon atoms AND an “alkynyl” is understood by the artisan to be a triple bond between at least two carbon atoms.
Claims 2-10 and 12-20 are similarly rejected as indefinite under 35 USC 112(b) since these claims refer back to claims 1 and/or 11 but do not remedy the rationale underpinning the basis for rejecting claims 1 and/or 11.
To render this rejection moot: please revise to: -- (C2 [[C1]]-C6alkynyl) -- and -- (C2 [[C1]]-C6alkenyl) -- within variable R5 of all (emphasis) the rejected claims, above.
Claim 8 recites the limitation "wherein R1 and R2 are taken together to form a -CH2-". There is insufficient antecedent basis for this limitation in the claim.
As drafted, the limitation "wherein R1 and R2 are taken together to form a -CH2-" renders the metes and bounds of claim 8 undefined (hence rendering claim 8 indefinite under 35 USC 112(b)) since the artisan does not know where antecedent basis can be found for permitting "R1 and R2 are taken together to form a -CH2-". Claim 1 permits either 1) R1 and R2 to be separate embodiments OR 2) permits R1 and R2 are taken together to form a 5-membered or 6-membered ring.
Note that claim 19 is similarly rejected as indefinite under 35 USC 112(b) for the same rationale. Claim 20 is similarly rejected as indefinite under 35 USC 112(b) since it refers back to claim 19 but does not remedy the rationale underpinning the basis for rejecting claim 19.
Please strike "wherein R1 and R2 are taken together to form a -CH2-" from claims 8 and 19 to render moot this rejection.
Claim 8 recites the limitations: "heteroaryloxy" and “trialkylammonium”. There is insufficient antecedent basis for this limitation in the claim.
As drafted, the limitations "heteroaryloxy" and “trialkylammonium” for variable R4 of claim 8 render the metes and bounds of the claim undefined (hence rendering claim 8 indefinite under 35 USC 112(b)): the artisan does not know where antecedent basis for "heteroaryloxy" and “trialkylammonium” can be found within R4 of claim 1. Please strike these limitations to render moot this rejection.
Claim 11, drawn to “A is (CH3)n wherein n is 2 to 3” is a limitation that renders the metes and bounds of the claim undefined (hence rendering claim 11 indefinite under 35 USC 112(b)). The artisan does not know how the terminal substituent -CH3 can be attached to the N- of the core ring compound of formula I and also attached to itself 2-3 times while keeping a stable valence of 4 for carbon. The variable A of claim 11 acts as an alkylene bridge and hence it should be revised to -- -(CH2)n - -- .
Claims 12-14 are similarly rejected as indefinite under 35 USC 112(b) since these claims refer back to claim 11 but do not remedy the rationale underpinning the basis for rejecting claim 11.
Thus, don’t Applicants really intend -- –(CH2)n- -- ? Please revise accordingly to render moot this rejection.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7-8 and 19-20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Dependent claim 7, drawn to twelve (12) distinct alternative embodiments of variable R4, fails to further limit (emphasis) the identical (emphasis) twelve alternative embodiments of variable R4 of claim 1. A dependent claim must refer back to the parent claim AND further limit it. Thus, claim 7 is rejected under 35 USC 112(d). Canceling claim 7 can render moot this rejection.
Dependent claim 8 recites the limitation "wherein R1 and R2 are taken together to form a -CH2-". This fails to properly further limit R1 and R2 of parent claim 1 which permits either 1) R1 and R2 to be separate embodiments OR 2) permits R1 and R2 are taken together to form a 5-membered or 6-membered ring. Thus, claim 8 is rejected under 35 USC 112(d). Please strike "wherein R1 and R2 are taken together to form a -CH2-" from claim 8 to render moot this rejection.
Note that claim 19 is similarly rejected under 35 USC 112(d) for the same rationale.
Claim 20 is similarly rejected under 35 USC 112(d) since it refers back to claim 19 but does not remedy the rationale underpinning the basis for rejecting claim 19.
Dependent claim 8 recites the limitations: "heteroaryloxy" and “trialkylammonium”. This fails to properly further limit R4 of parent claim 1, which does not permit either "heteroaryloxy" and “trialkylammonium”. Thus, claim 8 is rejected under 35 USC 112(d). Please strike these limitations to render moot this rejection.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-20 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-20 (21 March 2024 claim-set) of co-pending Application No. 18/694,168 (reference application). Reference claims 1-10 are directed to the same scope of genus formula I (identical wording, too; the reference claim 9 compounds are identically disclosed within instant claim 9) as instant claims 1-10. The wording and scope of reference claims 11-14 are also identical to that of instant claims 11-14. Also, the wording and scope of reference claims 15-20 are identical to that of instant claims 15-20.
A non-statutory double patent rejection could be necessitated in the Final Office Action based on any Applicant claim amendments designed to overcome this statutory double patent rejection. If and when a non-statutory double patent rejection is made, then, a terminal disclaimer could render moot that non-statutory double patent rejection.
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Conclusion
No claims are presently allowable as written.
There is no known prior art reference that either teaches or anticipates a genus formula I of instant claims 1 and 11.
The reference HAN (Han, Yichen, et al. “Design, Synthesis, and Investigation of the Pharmacokinetics and Anticancer Activities of Indenoisoquinoline Derivatives That Stabilize the G-Quadruplex in the MYC Promoter and Inhibit Topoisomerase I.” J. Med. Chem. (26 April 2024), 67, pp. 7006-7032), discloses the compound:
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(page 7007), wherein: each of the two R5 is methoxy; “A” is propylene (C3-alkylene); R4 is heterocyclyl; R3 is H; and R1 and R2 together with the atoms to which they are attached form a 5-membered ring.
However, HAN is a close art but not a prior art reference since it was published 26 April 2024, which is after the instant application’s effective filing date of 2 May 2022.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew D Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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