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 6 July 2026, is acknowledged.
Applicants provided a compliant species election of compound 208:
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, which is a species of genus formula I of instant claim 1, wherein: Y is -CH2 (-CR10R10’ wherein R10 and R10’ are each H); Z is -CH (-C R12 wherein R12 is H); R6 is H; Ra and Rb are each H; Ring B is phenyl (a “monocyclic aromatic”) substituted with halogens: fluorine and chlorine, and further substituted with heteroaryl pyridine; and wherein the pyridine is further substituted with ethoxy (an “alkoxy”).
The Examiner found no prior art against the elected species.
The Examiner extended the Markush search to the full scope of instant claim 1 but did not find any prior art.
Therefore, the Election of Species Requirement of 6 May 2026, is withdrawn, as all claims are free of the prior art.
All claims have been examined on the merits.
Current Status of 18/699,825
This Office Action is responsive to the amended claims of 6 July 2026.
Claims 1-27, 32, 44, and 48 have been examined on the merits. Claims 1-2, 7, 9-13, 19, and 22 are original. Claims 3-6, 8, 14-18, 20-21, 23-27, 32, and 44 are previously presented. Claim 48 is new.
Priority
The effective filing date is 18 October 2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 18 August 2026; 12 May 2026; 23 May 2024; and 10 April 2024, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Dependent claims 2-27 are objected to because these dependent claims do not begin with “The”. An independent claim must begin with -- A -- or -- An -- and a dependent claim must begin with -- The -- . Please revise accordingly.
Claim 11 is objected to since the moieties of R3 lack commas separating one moiety from another in the list of moieties. Please add commas between each moiety and the article -- or -- between the last two moieties to render moot this objection.
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 5, 8-10, 15-16, 19-20, 22-23, and 26-27 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 “preferably” within claim 5 renders the metes and bounds of the claim undefined (hence rendering claim 5 indefinite under 35 USC 112(b)) as the artisan is not certain if the limitations following “preferably” are merely exemplary or are required limitations of the claim. Claims 8-10, 15-16, and 19-20 are similarly rejected as indefinite under 35 USC 112(b) for the same rationale.
Please delete “preferably” to render moot this rejection.
Claim 22 recites X1 as being R1 and X4 as R4 wherein R1 and R4 are both H. This is interpreted as meaning that X1 and X4 are both H. However, in context of formula Ib (claim 22 depends on claim 21 which depends on claim 18) the limitation X1 and X4 are both H renders the metes and bounds of claim 22 undefined (hence rendering claim 22 indefinite under 35 USC 112(b)). Hydrogen cannot be at the node of the 5- or 6-membered heteroaromatic group of claim 1’s ring B; rather, only carbon, N, or another heteroatom with appropriate valence can be. Don’t Applicants really intend for claim 22 to say: -- wherein R1 and R4 are both -CH or N -- ? Claim 23 is indefinite under 35 USC 112(b) for a similar rationale: that the halogens Cl and Br cannot be at nodal positions; rather, halogens can only be substituents.
Claim 26 contains the limitation “including” which renders the metes and bounds of claim 26 undefined (hence rendering claim 26 indefinite under 35 USC 112(b)). The artisan does not know if the limitations following “including” are merely exemplary or are required limitations of the claim.
Claim 27 recites the limitation "
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". There is insufficient antecedent basis for this limitation in the claim and hence this renders the metes and bounds of claim 27 undefined (hence rendering claim 27 indefinite under 35 USC 112(b)).
Per the illustration, above, formula If lacks antecedent basis to genus formula I of instant claim 1 at least because it is missing an oxo (=O) where the R11 is currently.
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.
Claim 27 is 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 27, drawn to a compound of formula If:
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, fails to properly further limit the genus formula I of instant claim 1, at least because If has R11 whereas genus formula I has an oxo (=O) at the same locale. Hence, claim 27 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 1-7, 9-11, 15-17, 24-25, and 27 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-2, 7, 10, 12, 16, 18, 22, 26-27, 30-33, 35, 38, 40, 45, and 47 of co-pending Application No. 19/164,564 (reference application). The reference amended claims of 22 July 2026 and the instant amended claims of 6 July 2026 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, reference claim 31 compound 1:
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, or a pharmaceutically acceptable salt or solvate thereof, anticipates instant claim 1 genus formula I, wherein: Y is -CH2 (-CR10R10’ wherein R10 and R10’ are each H); Z is -CH (-CR12 wherein R12 is H); R6 is H; Ra and Rb are each H; Ring B is phenyl (a “monocyclic aromatic”) substituted with halogens: fluorine and chlorine, and further substituted with bicyclic heteroaromatic group. This also anticipates instant claims 2-7, 9-11, 15-17, 24-25, and 27.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 12-14, 18, 21, are objected to for informalities, see, above.
Claims 32, 44, and 48 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 1-11, 15-17, 19-20, and 22-27 are not presently allowable as written.
There is no known prior art reference that either teaches or anticipates a compound of genus formula I of instant claim 1.
The reference SCHULTZ (Schultz, Danielle and Wolfe, John P. “Intramolecular Alkene Carboamination Reactions for the Synthesis of Enantiomerically Enriched Tropane Derivatives.” Org. Lett. (2011), Vol. 13, No. 11, pp. 2962-2965, provided by Applicants and referenced in IDS of 10 April 2024), discloses the compound:
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(Scheme 4 on page 2965).
However, this compound is distinct from the instant claimed invention.
Thus, the reference SCHULTZ is a close art but not a prior art reference.
The co-pending 18/866,010 is drawn to a distinct compound/invention and hence is not a double patent reference.
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.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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