Detailed Action
The present office action is in response to the amendments filed on 17 Apr 2026.
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
Claims 1, 4-5, 9-13, 15, 21-22, 24-25, and 43-44 of the pending application have been examined on the merits. Acknowledgement is made of the amendments filed 17 Apr 2026. Acknowledgement is made of the cancelation of claims 2-3, 6-8, 14, 16-20, 23, and 26-42.
Priority
The instant application retains the priority date of 30 Jul 2019.
Response to Applicant Arguments
Acknowledgement is made of the amendments filed 17 Apr 2026.
Applicant’s arguments filed 17 Apr 2026, with respect to the rejection(s) of claim(s) 1, 4-5, 9-13, 15, 21, 25, and 43-44 under obviousness-type nonstatutory double patenting over U.S. Patent No. 12,187,742 (provided in IDS 02/19/25), hereinafter ‘742, further in view of Patani et al. (Chem Rev, 1996, 96:3147-3176; provided in the office action mailed 29 Dec 2025), hereinafter Patani, have been fully considered but are not persuasive.
Applicant argues on page 6 of the remarks that there is no motivation to modify the reference compound in the rejection. Applicant argues that the selection of one compound out of over fifty compounds in claim 9 does not have a rational basis when faced with the extensive list of compounds and there is no reason to suggest the selection of this compound over the other compounds.
This is not persuasive. Patani teaches the motivation to create the species suggested by the genus of reference claim 1 and can be easily achieved by modifying the compounds of claim 9. Examiner picked the reference compound as an example, but the person having ordinary skill in the art can modify the compounds of the reference claims to be species of the instant genus. There is nothing in ‘742 or Patani that teaches away from modifying the reference compounds to match the claims.
Applicant further argues there is nothing that suggests fluorine could or should be added at the particular position of the instant claims and that there is no motivation to select fluorine (pg. 7).
This is not persuasive. As stated in the office action mailed 29 Dec 2025, homologs of sufficiently close structural similarity have a presumed expectation of similar properties. See MPEP § 2144.09(I)-(II). Further, there is no showing of unexpected properties by modification of the specific position of fluorine and it would be within the skill of the artisan to modify the compounds and arrive at the species of the instant claims. Patani also provides motivation to select fluorine as found in the office action mailed 29 Dec 2025.
Applicant argues that there is no motivation to modify the reference compound by replacing propylene with ethylene and that this is not obvious in view of the compounds of claim 9 (pg. 7).
As stated in the office action mailed 29 Dec 2025, homologs of sufficiently close structural similarity have a presumed expectation of similar properties and a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. See MPEP § 2144.09(I)-(II).
Lastly, applicant argues that the difference between the claimed compounds and the reference compounds impart surprising improvements and cites a single compound’s results to show these improvements (pg. 8).
This is not persuasive. Applicant has not shown that the specific modifications are the reason for the improvement of the compound and does not provide adequate controls to show the difference in activity for the experiments disclosed in the specification and figures.
In light of the discussion above, the rejection of claims 1, 4-5, 9-13, 15, 21, 25, and 43-44 under nonstatutory double patenting, as obvious over ‘742 and Patani, is maintained for the reasons of record.
Regarding the rejection of claims 1, 4-5, 9-13, 15, 21, 25, and 43-44 under anticipatory-type nonstatutory double patenting over copending Application No. 18/263,998, applicant’s arguments filed 17 Apr 2026 have been fully considered but they are not persuasive. Applicant argues that since the instant application’s patent term filing date, 30 Jul 2020, predates the reference application’s patent term filing date, 02 Feb 2022, and that the rejection over the reference patent is the only rejection remaining in the instant application, the rejection should be withdrawn according to MPEP § 804(I)(B)(1)(b)(i). This is not persuasive because the rejection over ‘998 is not the only rejection remaining (see “Double Patenting” below) and thus the rejection is maintained.
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, 4-5, 9-13, 15, 21-22, 24-25, and 43-44 are rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claim 1 of ‘742, further in view of Patani. Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims teach compounds of formula (IA) (claim 1):
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The instant claims further claim pharmaceutical compositions comprising compounds of formula (IA) and a pharmaceutically acceptable excipient (claim 25 and claim 44).
‘742 teaches compounds of reference formula (I) (reference claim 1):
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And further limits the reference formula to species which include the compound below (reference claim 9):
Name
Structure
N-(2-(3-(Dimethylamino)propoxy)-5-(3'-methyl-2'-oxo-2',3'-dihydrospiro[cyclobutane-1,1'-pyrrolo[2,3-c]quinolin]-8'-yl)pyridin-3-yl)methanesulfonamide
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‘742 further teaches a pharmaceutical composition comprising compounds of reference claim 1 and a pharmaceutically acceptable carrier or excipient. The reference compound differs from the instantly claimed formula (I) in having a propyl group where the instant variable L is limited to an ethylene group and having a H where the instant variable R3 is limited to a halogen or optionally substituted C1-3 alkyl.
Patani teaches that bioisosterism represents one approach used by the medicinal chemist for the rational modification of lead compounds into safe and more clinically effective agents and the concept of bioisosterism is often considered to be qualitative and intuitive (pg. 3147, columns 1-2). Patani teaches the substitution of hydrogen by fluorine is one of the more commonly employed monovalent isosteric replacements (pg. 3149, column 1). Patani also teaches that the ability of fluorine to replace hydrogen is an effective method of exploring the affinity of an agent to the target site by virtue of its greater electronegativity while other parameters such as steric size and lipophilicity are maintained (pg. 3150, column 1).
MPEP § 2144.09(II) states, “homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possesses similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).”
By following the teachings of ‘742 and Patani, a person of ordinary skill in the art would be lead to modify the reference compound by adding a fluorine in place of H, as taught by Patani. The artisan would know these atoms to be bioisosteres and would further be motivated to substitute fluorine for a hydrogen to explore the affinity of an agent to the target site by virtue of its greater electronegativity while other parameters such as steric size and lipophilicity are maintained.
Further, the motivation to make the instantly claimed compounds derives from the expectation that structurally similar compounds, such as compounds which have a propyl group in place of an ethyl group as in this case, would possess similar activity with potential for better bioavailability and lower side effects. There would be a reasonable expectation of success in producing and using the instantly claimed compounds in view of the compounds taught by ‘742.
Claims 1, 4-5, 9-13, 15, 21, 25, and 43-44 are provisionally rejected on the ground of anticipatory-type nonstatutory double patenting as being unpatentable over claims 1 and 9 of copending Application No. 18/263,998 (reference application), hereinafter ‘998. Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claims 1, 4-5, 9-13, 15, 21, 25, and 43-44 are directed towards compounds which include the instantly elected species (below):
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'998 claims a method of treating cancer comprising administering a compound of Formula (Ia-1) (below) to a subject that has received or is receiving an anti-tumor immune checkpoint inhibitor and a radiotherapy (reference claims 1 and 9).
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The compound of reference Formula (Ia-1) is the same compound as the instantly elected species. By claiming a method of treating cancer in a subject in need by administering a compound of Formula (Ia-1), ‘998 inherently shows possession of the compound and so anticipates the instantly elected compound.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew 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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/J.D.M./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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