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 .
Detailed Action
Information Disclosure Statement
The IDS assertion fee has been reconsidered. The IDS filed 05/14/2025 have been considered.
The IDS submitted 02/03/2026 have been considered.
State of Claims
Claims currently pending are claims 1-13, 15, 18, 20-23, 26, and 28-30.
Claims currently withdrawn are claims 15, 18, 20-23, 26, and 28-30.
Claims currently under examination are claim 1-13.
New Objections
Claim 1 states “each R3 independently represents halo or C1-6 alkyl, C2-6 alkenyl, or…”. Similar use of “or” is found regarding Rb (“H or C1-6 alkyl…or C2-6 alkynyl”), and Ra1. The use of “or” in these instances is improper and should be removed.
There is semi-colon in claim 1, regarding Rb and Rc and/or Rf and Rg, which is not needed. Claim 1 states “which ring optionally is substituted by one or more groups independently selected from halo; C1-3…”. See l. 21 of claim 1.
Use of the phrase “as appropriate” in claim 1, regarding the limitation “m represents 0 to 11” is improper.
Claims 2-3 use the phrase “as defined herein”. The phrase should state “as defined in claim 1”.
Maintained Rejection
Non-Statutory 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 and 6-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 13-15 of U.S. Patent No. 11,427,539. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claims a compound, a composition, a kit, and a method of preparing the following compound (claim 1 shown in its entirety).
Reference Patent Claim 1
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The critical difference between the instant compound and the reference compound is that the reference compound has only one methyl group anywhere on the nitrogen-containing ring where the instant compound requires two at a specific carbon.
Reference claim 41 specifies that an R1 group is adjacent to the nitrogen on the nitrogen-containing ring which matches where the instant compound requires two R1 groups.
Applicants, in their arguments against the 103 rejection, argued that putting a methyl group where no substituent had appeared before is not a situation of a “homolog”.
First, the exact name used is not controlling. It is the nature of the structural relationship that matters. And second, there is no reason to use as narrow a definition as applicants are using. This exact point was made in In re Druey, 138 USPQ 39, which noted that both narrower and broader definitions for the term homolog and employed: "We need not decide here whether the compounds in question are properly labeled homologues. It appears to us from the authorities cited by the solicitor and appellants that the term homologue is used by chemists at times in a broad sense, and at other times in a more narrow or strict sense. The name used to designate the relationship between related compound is not necessarily controlling; it is the closeness of that relationship which is indicative of the obviousness or unobviousness of the new compound.” Note that in In re Lohr, 137 USPQ 548, at page 550, the non-methylated form was specifically called a “lower homolog”, and in In re Magerlein, 202 USPQ 473, adding two methyl groups at one position was also called a homolog.
A similar argument applies here. The compounds share the same core structure, substituents, and even have similar substituent placing (adjacent to the nitrogen on the specific ring system). The only difference is the presence of an additional methyl group in the instant compound where the reference compound contains only one methyl, as stated above. Therefore one of ordinary skill in the art would find the instant compounds obvious over the reference compounds.
Response to Arguments
The affidavit received 02/03/2026 includes data indicating that there is an enhanced effect on bioavailability when the compound contains a gem-methyl group next to the amine of the heterocyclic ring system compared to the reference compounds. See direct comparison below.
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However, the information in the affidavit does not support an enhanced synergistic effect for the full scope of claim 1.
For example, the compound of Formula I is shown below.
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Claim 1 states “ring A represents 4- to 8-membered heterocycloalkyl”.
The affidavit does not show increased bioavailability for compounds with ring sizes larger than 6-membered rings.
Examples 4-6 provided in the affidavit differ from the reference compounds in that the halogen position is changed from meta- to ortho- substituted. Two of the compounds were not tested in humans.
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Additionally, examples 7 and 8 in the affidavit show similar bioavailability in Hep Human to that of the present compound 11 and 10 above (entry 1 and 5, respectfully).
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The examiner acknowledges that there are improved effects. However, this improvement has not been shown for the full scope of the claim.
Allowable Subject Matter
Claim 5 is 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.
Conclusions
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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/L.G./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624