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 in the reply filed on 3 April 2026, is acknowledged.
Applicants’ provided a compliant species election of:
PNG
media_image1.png
134
240
media_image1.png
Greyscale
, which is a species of instant claims’ 1, 11, and 15 genus formula I, wherein: R5 represents two methoxy substituents; R4 is isopropylamino (an “alkylamino”); variable “A” represents propylene (an “alkylene”) wherein “n” is 3; R3 is hydrogen (H); and R1 and R2 together with the atoms to which they are attached form a 5-membered ring.
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, 11, and 15, but did not find any prior art.
Therefore, the Election of Species Requirement of 1 April 2026, is withdrawn, as all claims are free of the prior art.
All claims have been examined on the merits.
Current Status of 18/694,168
This Office Action is responsive to the original claims of 21 March 2024.
Original claims 1-20 have been examined on the merits.
Priority
The instant application’s effective filing date is 2 May 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 21 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 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 limitation “(C1-C6)alkenyl” of variable R5 of claim 1 renders the metes and bounds of claim 1 undefined (hence rendering claim 1 indefinite under 35 USC 112(b)). The artisan does not know what a C1alkenyl is since “alkenyls” are understood as a minimum of two carbon atoms joined by a double bond. Thus, a C1alkenyl does not exist and is therefore indefinite. The “(C1-C6)alkynyl” for variable R5 of claim 1 is similarly rejected as indefinite under 35 USC 112(b): an “alkynyl” is at a minimum two carbon atoms joined by a triple bond. Thus, the artisan does not know what a C1alkynyl is; Applicants should strike C1alkenyl and C1alkynyl from all (emphasis) claims to render moot this rejection.
Claims 2-10 and 17-20 are similarly rejected as indefinite since these claims refer back to claim 1 but do not remedy the rationale underpinning the basis for rejecting claim 1.
Similarly, claim 11 is rejected under 35 USC 112(b) indefiniteness given the presence of C1alkenyl and C1alkynyl in variable R5 for the same rationale as above. Furthermore, claims 12-14 are similarly indefinite since these claims refer back to claim 11 but do not remedy the rationale underpinning the basis for rejecting claim 11.
Moreover, claim 15 is rejected under 35 USC 112(b) indefiniteness given the presence of C1alkenyl and C1alkynyl in variable R5 for the same rationale as above. Moreover, claim 16 is similarly rejected as indefinite since this claim refers back to claim 15 but does not remedy the rationale underpinning the basis for rejecting claim 15.
Applicants should strike C1alkenyl and C1alkynyl from all (emphasis) claims to render moot these rejections.
Claim 8 recites the limitations "R1 and R2 are taken together to form -CH2-". Moreover, variable R4 of claim 8 is “heteroaryloxy”, “heteroarylamino”, “heteroarylalkylaminoalkylamino”, and “trialkylammonium”. There is insufficient antecedent basis for these limitations in the claim. Thus, claim 8 is rejected under 35 USC 112(b) indefiniteness. As drafted, these limitations lack antecedent basis to variables in parent claim 1. Claim 1 does not permit "R1 and R2 are taken together to form -CH2-" Rather, claim 1 only permits "R1 and R2 are taken together to form a 5- or 6-membered ring”. Moreover, claim 1 does not permit R4 to be “heteroaryloxy”, “heteroarylamino”, “heteroarylalkylaminoalkylamino”, and “trialkylammonium”. Claims 19 and 20, drawn to the limitations "R1 and R2 are taken together to form -CH2-" lacks antecedent basis to claim 1 for the same rationale: that claim 1 only permits limitations "R1 and R2 are taken together to form a 5- membered or 6-membered ring”. Hence, claims 19-20 are rejected as indefinite under 35 USC 112(b).
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 8, 14, 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 8 recites the limitations "R1 and R2 are taken together to form -CH2-". Moreover, claim 8 also recites variable R4 is “heteroaryloxy”, “heteroarylamino”, “heteroarylalkylaminoalkylamino”, and “trialkylammonium”. These limitations cause dependent claim 8 to be rejected under 35 USC 112(d). These limitations do not further limit R1, R2, and R4, respectively in parent claim 1. Claim 1 does not permit "R1 and R2 are taken together to form -CH2-" Rather, claim 1 only permits "R1 and R2 are taken together to form a 5- or 6-membered ring”. Moreover, claim 1 does not permit R4 to be “heteroaryloxy”, “heteroarylamino”, “heteroarylalkylaminoalkylamino”, and “trialkylammonium”. Dependent claims 19 and 20, drawn to the limitations "R1 and R2 are taken together to form -CH2-" also are rejected under 35 USC 112(d) for the same rationale: that claim 1 only permits limitations "R1 and R2 are taken together to form a 5- membered or 6-membered ring”.
Dependent claim 14, drawn to “the composition comprising a compound of formula I, or salt, hydrate, or solvate thereof”, fails to further limit claim 11, drawn to same. The scope of claim 14 is identical to that of claim 11, and thus fails to further limit claim 11. Thus, claim 14 is rejected under 35 USC 112(d).
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
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-20 of co-pending Application No. 18/618,496 (reference application). The reference amended claims of 4 June 2026 and the instant original claims of 21 March 2024 were used to write this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims. For example, the reference claim 9 compound 1:
PNG
media_image2.png
150
270
media_image2.png
Greyscale
, anticipates the compound 1
PNG
media_image2.png
150
270
media_image2.png
Greyscale
of instant claim 9, drawn to same; said compound also anticipates the instant claim 1 genus formula I wherein: R5 represents two methoxy substituents; R4 is heteroaryl; variable “A” represents propylene (an “alkylene”) wherein “n” is 3; R3 is hydrogen (H); and R1 and R2 together with the atoms to which they are attached form a 5-membered ring.
Furthermore, the reference claims 1-20 anticipate the instant claims 1-20, drawn to same.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are presently allowable as written.
The instant claims 1, 11, and 15 are free of the prior art.
There is no known prior art reference that either teaches or anticipates a compound of genus formula I of instant claims 1, 11, and 15.
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. (2024), 67, pp. 7006-7032), discloses the compound LMP400:
PNG
media_image3.png
138
200
media_image3.png
Greyscale
(page 7007), which is a species of genus formula I, wherein: R5 represents two methoxy substituents; R4 is heterocyclyl; variable “A” represents propylene (an “alkylene”) wherein “n” is 3; R3 is hydrogen (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 as it was published on April 26, 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
Prosecution Insights