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 .
Priority
Applicant's claim for the benefit of a prior-filed application, Application N° 63/602,041, filed 22 November, 2023, under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10 April, 2025 is acknowledged and has been considered.
Status of the Application
Receipt is acknowledged of Applicant's claimed invention, filed 15 May, 2025, in the matter of Application N° 18/953,578. Said documents have been entered on the record.
Claims 19, 23, 27, 29, 31, 35, 41, 48, 51, 54-55, 66-67, 74-75, 78, 82, 88-89, 93, 96-97, 100, 103, 105-106, 109 and 115-119 are amended. Claims 2-6, 8, 10-18, 20-22, 24-26, 28, 30, 32-34, 36-37, 39-40, 42-47, 49-50, 52-53, 56-65, 68-73, 76-77, 79-81, 83-87, 90-92, 94-95, 98-99, 101-102, 104, 107-108, 110 and 123-130 are canceled. No new matter was introduced.
Thus, Claims 1, 7, 9, 19, 23, 27, 29, 31, 35, 38, 41, 48, 51, 54-55, 66-67, 74-75, 78, 82, 88-89, 93, 96-97, 100, 103, 105-106, 109 and 111-122 represent all claims currently under consideration.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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, 7, 9, 19, 23, 27, 29, 31, 35, 38, 41, 48, 51, 54-55, 66-67, 74-75, 78, 82, 88-89, 93, 96-97, 100, 103, 105-106, 109 and 111-122 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, 7, 9, 19, 23, 27, 29, 31, 35-36, 38, 41, 48, 51, 54-55, 63, 67, 74-75, 78, 82, 88-89, 96-98, 100-103, 105-106, 109 and 111-122 of copending Application No. 18/953,485 in view of Ritchie and MacDonald (European Journal of Medicinal Chemistry 124, 2016, 1057-1068.)
The claims of the copending application recite compounds according to Formula I and Formula II, pharmaceutical compositions comprising compounds of Formula I, and methods employing compounds of Formula I, which are substantially the same as the corresponding compounds, compositions and methods presently claimed. The claimed compounds share the same bicyclic heterocyclic core and substantially identical substituent definitions and structural variables. The claimed compounds differ principally in the position of attachment of the otherwise identically defined R4-, R5-, and R6-containing side chain to a ring heteroatom of the bicyclic heterocyclic core. The structural requirements and definitions of R4, R5, and R6 within the side chain are otherwise the same in the respective claims. This difference in attachment position correspondingly results in the differing nomenclature of the bicyclic ring system recited in the respective claims.
The relationship between the claimed compounds is further illustrated below by side-by-side comparisons of representative species corresponding to Formula I and Formula II.
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Instant Claim 113 (Formula I):
N-(2-(7-ethyl-5-oxo-8-(2-oxo-2-((4-(trifluoromethyl)phenyl)amino)ethyl)-2-phenyl-5,8-dihydroimidazo[1,2-a]pyrimidin-6-yl)phenyl)acrylamide
‘485 Claim 113 (Formula I):
N-(2-(7-ethyl-5-oxo-1-(2-oxo-2-((4-(trifluoromethyl)phenyl)amino)ethyl)-2-phenyl-1,5-dihydroimidazo[1 ,2-a]pyrimidin-6-yl)phenyl)acrylamide
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Instant Claim 114 (Formula II):
N-(2-(7-ethyl-8-(2-((4-fluorophenyl)amino )-2-oxoethyl)-2-methyl-5-oxo-6-phenyl-5,8-dihydroimidazo[1,2-a]pyrimidin-3-yl)phenyl)acrylamide
‘485 Claim 114 (Formula II):
N-(2-(7-ethyl-1-(2-((4-fluorophenyl)amino )-2-oxoethyl)-2-methyl-5-oxo-6-phenyl-1,5-dihydroimidazo[1,2-a]pyrimidin-3-yl)phenyl)acrylamide
As illustrated above, the corresponding species retain the same substituents and side-chain structure, with the pertinent structural difference being the position at which the R4-, R5-, and R6-containing side chain is attached to the bicyclic heterocyclic core.
Ritchie and MacDonald (2016) teach that individual regioisomers of heterocyclic compounds may exhibit different drug-relevant properties and that consideration of available regioisomers permits medicinal chemists to select compounds having desirable properties during medicinal-chemistry optimization, demonstrating that investigation of alternative regioisomeric arrangements of heterocyclic compounds was a known strategy for evaluating and optimizing drug-relevant properties (2016, Abstract, Table 1 and 2, Conclusion).
Accordingly, one of ordinary skill in the art, having the compounds claimed in the copending application, would have been motivated to investigate the alternative positional attachment of the R4-, R5-, and R6-containing side chain to the bicyclic heterocyclic core as a part of routine medicinal-chemistry optimization, in order to evaluate the effect of the alternative regioisomeric arrangement on drug-relevant properties. The presently claimed compounds therefore represent an obvious positional variation of the compounds claimed in the copending application.
With respect to the specifically recited species recited in claims 113 and 114 (the same claim numbers in both applications) the overlapping species differ in the same manner, namely, in the position of attachment of the otherwise corresponding R4-, R5-, and R6-containing side chain to the bicyclic heterocyclic core. The remaining structural features of the corresponding species are otherwise the same. As illustrated above, the presently claimed species represent the corresponding regioisomeric forms of the overlapping species claimed in the copending application. For the reasons discussed above, the presently claimed species would likewise have been obvious positional variations of the overlapping species claimed in the copending application.
The pharmaceutical composition claim (Claim 115 in both applications) and method claims (Claims 116-122 in both applications) similarly do not render the claimed subject matter patentably distinct. These claims recite, respectively, pharmaceutical compositions comprising and methods employing the Formula I compounds discussed above, and otherwise recite subject matter that is the same or substantially the same as that recited in the corresponding claims of the copending application. Because the underlying Formula I compounds would have been obvious positional variants of the compounds claimed in the copending application, the corresponding pharmaceutical compositions and methods likewise would have been obvious variants absent a further patentable distinction.
Therefore, the presently claimed compounds of Formula I and Formula II, the specifically recited overlapping species thereof, and the claimed pharmaceutical compositions and methods are not patentably distinct from the corresponding subject matter claimed in the copending application.
This is a provisional nonstatutory double patenting rejection.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.M.N./ Examiner, Art Unit 1627
/SARAH PIHONAK/ Primary Examiner, Art Unit 1627
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