Detailed Action
The present office action is in response to the amendments filed on 07 Aug 2025.
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 07 Aug 2025. Acknowledgement is made of the cancelation of claims 2-3, 6-8, 14, 16-20, 23, and 26-42.
Priority
Applicants identify the instant application, Serial #: 17/586,277, filed 27 Jan 2022, as a Continuation of International Patent Application #: PCT/US2020/044322, filed 30 Jul 2020, which claims priority from U.S. Provisional Application #: 62/883,325, filed 06 Aug 2019, and foreign priority from Foreign Application #: CN201910695148.4, filed 30 Jul 2019.
Response to Applicant Elections
Applicant’s election without traverse of Group I and the following compound:
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in the reply filed on 19 Feb 2025 is acknowledged. No prior art was returned in searching this compound. Examiner expanded the Markush search to include the full scope of the generic claim, including withdrawn claims 22 and 24 which are currently rejoined.
Response to Applicant Arguments
Acknowledgement is made of the amendments filed 07 Aug 2025.
The rejection of claim 1 under 35 U.S.C. § 112(b) is rendered moot following applicant amendments.
The rejection of claim(s) 1, 4-5, 9-13, 15, 21, 25, and 43-44 under anticipatory-type nonstatutory double patenting over copending Application No. 18/945,747 is rendered moot following abandonment of the copending application.
Applicant’s arguments, see pgs. 6-7, filed 07 Aug 2025, with respect to the rejection(s) of claim(s) 1, 4-5, 9-13, 15, 21, 25, and 43-44 under anticipatory-type nonstatutory double patenting over U.S. Patent No. 12,187,742 (provided in IDS 02/19/25), hereinafter ‘742, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a different interpretation of ‘742 under a new grounds of anticipatory-type nonstatutory double patenting. Previously, examiner argued a person having ordinary skill in the art could “at once envisage” the instantly elected compound using the specification of ‘742. Upon further consideration, ‘742 includes species which make obvious the compounds of the generic claims, meaning there is no need for the artisan to use the specification to envisage the compounds of the instant claims.
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 anticipated over ‘742 is amended 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 07 Aug 2025 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 U.S. Patent No. 12,187,742 (provided in IDS 02/19/2025), hereinafter ‘742, further in view of Patani et al. (Chem Rev, 1996, 96:3147-3176). 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.
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