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 . Claims 1-13, file December 01, 2025 are currently pending.
CHANGE OF EXAMINER
Note that the examiner has changed from Examiner Daniel Carcanague to George Kosturko. Please make all your responses and interview requests to Examiner George Kosturko.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/01/2025 has been entered.
Status of Claims
As indicated in the Office Action of 04/10/2025, claims 2-8 and 12 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim and claim 11 was withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. Election was made with traverse in the reply filed on 03/13/2025. Claims 1, 9-10 and 13 are the subject matter of this Office Action.
Response to Amendment
Applicant’s amendments, filed 12/01/2025 is acknowledged. Applicant has amended the genus of R1 for Formulas (I)-(III) as follows: wherein R1 is a C3-C10 hydrocarbyl comprising at least one nitrogen heteroatom, with the proviso that (i) R1 is not pyrrolidin-1-yl in formula (I), (ii) R1 is not an aryl C3- C10 hydrocarbyl in formula (I) and formula (II), (iii) R1 is not a C5 hydrocarbyl that forms an 8-methyl-8-azabicyclo[3,2.1]octan-3-yl in formula (III), (iv) R1 is not a C6 hydrocarbyl that forms an octahydro-2H-quinolizin-2-yl in formula (III), (v) the at least one nitrogen heteroatom is the only heteroatom of R1 unless R1 includes an epoxy moiety, [[and ]](vi) R1 does not include an amide, and (vii) R1 is a bicyclo C3-C10 hydrocarbyl in formula (III);wherein when R1 comprises a cyclic group in formula (I), an atom of the cyclic group is directly bonded to the alpha carbon; wherein R2, R3, R4, R5, and R6 are independently selected from the group consisting of hydrogen, methyl, methoxy, hydroxy, a first halogen, and a C1-C6 hydrocarbyl comprising a covalent bond between R2 and R3, R3 and R4, R4 and R5, or R5 and R6; wherein X is selected from the group consisting of hydrogen, methyl, ethyl, hydroxy, and a second halogen;
In view of Applicant’s amendments, the pending 35 U.S.C 102(a)(1) rejection of claims 1, 10 and 13 by Giovannini (SynLett 1996 pages 1001-1003) is withdrawn. In addition, the pending 35 U.S.C 102(a)(1) rejection of claims 1, 9-10 and 13 by Duncan (J. Med. Chem Vol. 13 pages 1-6 published 1970) is also withdrawn. Applicant's arguments, filed 01/22/2013 have been fully considered. Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and objections presently being applied to the instant application.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 10 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lutz (J. Org. Chem. Vol. 12 pages 617-703 published 1947).
Lutz (J. Org. Chem. Vol. 12 pages 617-703 published 1947) teaches compounds of Formula (I). Embraced within the teachings of Lutz is compound XXXVB which comprises the following structural limitations: R2, R3, R5 and R6 are each independently H, R4 is halogen, R1 is a C5 hydrocarbyl with one nitrogen (piperidine) and X is CH3 (page 650).
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Regarding claim 10, Lutz teaches formulating said compound as a pharmaceutical composition further comprising the pharmaceutically acceptable carrier in a assay to identify the potency of said compound on inhibiting malaria pathogenesis (pages 653-654). Regarding claim 13, R1 is not an 8-methyl-8-azabicyclo[3.2.1]octanyl ring.
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, 9-10 and 13 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 11-42 of U.S. Patent No. 11,912,705.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following. Claims 1-9 and 11-42 of U.S. Patent 11,912,705 embrace compounds of Formulas (I)-(III) which include the following compound
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Which reads on the following claimed limitations: R2-R6 are each independently H, R1 is a C5 hydrocarbyl with one nitrogen (piperidine) and X is OH (claims 1, 5). Claims 11, 15-16 and 39-42 of U.S. Patent 11,902,705 embrace compounds of Formula (III) wherein R1 is bicyclo C3-C10 hydrocarbyl.
Conclusion
In view of the rejections set forth above, no claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE W KOSTURKO whose telephone number is (571)270-5903. The examiner can normally be reached M-F 9:00-5:30.
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/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621