The following action replaces the action mailed 06/04/2026 to correct an error on the office action summary form.
DETAILED ACTION
Status of Application
The response filed 02/17/2026 has been received, entered and carefully considered. The response affects the instant application accordingly:
An amendment to the specification has been submitted for Scheme 1 and Scheme 4.
A 130 declaration by Christian Melander is submitted.
Applicant had previously elected Group I for the examination with the election of species of
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1-(2-(5-bromo-1H-indol-3-yl)ethyl)-3-(4-bromo-3,5-dichlorophenyl)urea which was expanded to include
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and
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.
Due to restriction, based on election of Group I and the elected/expanded species above, claims 2, 11-16, 18-30 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-30 are pending.
Claims 1, 3-10, 17 are present for examination at this time.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant invokes the 102(b)(2)(c) exception for the prior art of Melander et al. (U.S. Pat. Pub. 2022/0356147) with the statement that Melander was subject to an obligation of assignment to the same entity as the instant claimed invention no later than the effective filing date of the present application; wherein Melander et al. is no longer prior art and the rejections based on Melander et al. are withdrawn.
All grounds not addressed in the action are withdrawn either by 102(b)(2)(c) exception for common assignment or specification amendment.
Specification
Applicant has submitted amendments to the specification for Scheme 1 and Scheme 4. The amendments cite [183] and [186] of the specification as originally for support but these paragraphs are to Example 5 and 7 which does not support for the amendments. Review of the U.S. Pat. Publication of the application which is U.S. Pat. Pub. 2023/0131376 appears to provide the support for the amendment, including the sections for the formation of those compounds of 1a-d, 6a-d, 8a and 8d with 9a and 9d, 8b and 8c and 8e with 9b and 9c and 9e.
The amendment to the specification is accepted and the objection is withdrawn.
It is noted to Applicant however that none of the schemes 1-4 appear to support for compounds 12a-e which are from indoles of 5-aminoindole (i.e.
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12b) and compounds 13a-e (i.e.
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13d) which are from indoles of 6-aminoindole and the compounds do not fall within formula I.
As the specification is amended with content that was not present in the parent PCT, the priority has changed as addressed below.
Priority
As the specification is amended to include a Scheme 1 and Scheme 4 not present in the PCT; this application now repeats a substantial portion of parent PCT of PCT/US2020/028484, filed 04/16/2020, and adds disclosure not presented in the prior PCT application. Because this application names the inventor or at least one joint inventor named in the prior application, it may constitute a continuation-in-part of the prior application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
The instant examined claims have content that goes back to the PCT/US2020/028484 wherein the priority date of the examined claims are to 04/16/2020.
Standing Grounds of Rejection
Claim Rejections - 35 USC § 102
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 –
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.
Claims 1, 3-10, 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Minrovic et al. (Second-Generation Tryptamine Derivatives Potently Sensitize Colistin Resistant Bacteria to Colistin).
Rejection:
Minrovic et al. teaches treating a gram-negative bacterial infection (A. baumannii 4106, multidrug resistant with a mcr gene (mcr-1)) comprising administering to a subject (moth larva/worms) a combination of colistin (polymyxin antibiotic, 50mg/kg) and compound 9e
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(a compound of instant formula I, 50mg/kg) that was effective to inhibit the infection (47% survival verses 7% (colistin alone) and 0% (compound 9e alone), (page 831 Col. 2 last paragraph-Page 832 Col. 1 last paragraph)). Minrovic et al. also teaches that compounds
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and
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are effective in combination with colistin to potentiate colistin for treating gram-negative bacteria (Table 2 and 5, Page 830-831, see full document specifically areas cited).
All the critical elements are taught by the cited reference and thus the claims are anticipated.
Response to Arguments:
Applicant's arguments are centered on the assertion that the Minrovic et al. is conceived and disclosed by the same join inventor of the present application and the other coauthors did not contribute to the conception of the claimed invention cited the declaration and that it is excluded under 102(b)(1)(a). This is fully considered but not persuasive as the 130 declaration by Christian Melander invokes a 102(b)(2) exception (item 8 of the declaration) which is incorrect as it applies to 102(a)(2) rejections with regards to disclosures in applications and patents; but the Minrovic et al. is under 35 U.S.C. 102(a)(1) wherein the 102(b)(2) exception does not apply. Therein Minrovic et al. remains prior art.
Accordingly, the rejection stand.
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, 3-10, 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 26-27 of copending Application No. 17/771896 in view of Minrovic et al. (Second-Generation Tryptamine Derivatives Potently Sensitize Colistin Resistant Bacteria to Colistin).
The copending claims are directed to the treatment of a bacterial infection in a subject in need thereof with the administration of a compound of Formula I with an antibiotic, wherein the antibiotic is colistin (copending claim 26) and the bacterial infection is a multidrug resistant gram-negative bacteria (copending claim 27).
The copending claims do not recite the inclusion of a compound of the instant claims but is directed to the treatment of a bacterial infection (i.e. gram-negative bacteria) with an antibiotic like colistin.
Minrovic et al. teaches that colistin is useful in the treatment of a gram-negative bacterial infection like A. baumannii (multidrug resistant with a mcr gene (mcr-1)) and that treatment with colistin is improved when combined with compound 9e
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(a compound of instant formula I) as it was effective to inhibit the infection (47% survival verses 7% (colistin alone) and 0% (compound 9e alone), (page 831 Col. 2 last paragraph-Page 832 Col. 1 last paragraph)). Minrovic et al. also teaches that compounds
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and
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are effective in combination with colistin to potentiate colistin for treating gram-negative bacteria (Table 2 and 5, Page 830-831).
Wherein it would be obvious before the effective filing date of the claimed invention incorporate compound 9e
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as suggested by Minrovic et al. and produced the claimed invention; as it is prima facie obvious to incorporate a compound for its known and additive effect on colistin for treating the bacterial infection with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments:
Applicant's arguments are those directed to Minrovic et al. which are addressed above.
Accordingly, the rejection stand.
Conclusion
Claims 1, 3-10, 17 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
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