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
Claims 42-48 are currently pending.
Election/Restriction
Applicant’s election without traverse of Group III (Claims 42 and now 43-48, drawn to polyamides) and the elected species
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in the reply filed on 8/06/2026 is acknowledged.
Claims 44-45 and 47-48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to unelected species, there being no allowable generic or linking claim. Thus, Claims 42-43 and 46 are being examined on the merits herein.
The requirement is deemed proper and is therefore made final.
Specification
The specification is objected to because the titular compound of Step 11 in Para 170 recites “affordamido”. It appears that this group should instead be “amido” and that the word “afford” was mistakenly inserted within the long chemical name.
The objection is made on the following grounds: the preceding intermediate of Step 10 recites
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instead of
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, the compounds only differing by a methyl rather than any amide-type functional group. Further, the starting material of subsequent Step 12, which should be the same as that intermediate formed in Step 11, uses the following to refer to said starting material/Step 11 compound:
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. Further, “affordamido” has no apparent chemical meaning.
Appropriate correction throughout the specification is required for each instance of this misnaming. (See also Para 171 at least.)
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 42 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 42 includes the following compounds:
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. Only the methyl ester versions of the above compounds are disclosed before applicant’s amendments filed 9/16/2024. Intermediate 36 is described as follows on Page 6 of the specification:
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wherein
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. However, no specific embodiment supports the claimed acid intermediates. Again, only methyl ester versions are disclosed in Scheme 1 of the specification on Page 56:
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, whereas the carboxylic acid forms of the specific intermediates lack support before the above date. Therefore, applicant did not have possession of the scope of the claimed invention at the time of filing. This is a new matter situation.
It is noted, however, that the following compounds
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are all supported by the disclosure of the earliest provisional application: US Prov. App. No. 63229235 filed 08/04/2021 (See Para 169).
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.
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 –
(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 42-43 and 46 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ansari (WO2021158707, published 8/12/2021, filed 2/03/2021, claiming priority to US Provisional App. Nos. 62/969,644 and 63/135,476 which are filed 2/03/2020 and 1/08/2021, respectively; 6/16/2025 IDS).
102(a)(2): The applied reference has a common assignee, applicant, and/or joint inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Ansari teaches Methyl 4-[4-(3-aminopropanamido)-1-methylimidazole-2-amido]-1-methylpyrrole-2-carboxylate hydrochloride or
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as claimed (Page 99, Step 5; See Page 97, Scheme 1). Ansari also teaches the following compounds: Methyl 1-methyl-4-[1-methyl-4-(3-[[1-methyl-4-(1-methylimidazole 2-amido)pyrrol-2-yl]formamido]propanamido)imidazole-2-amido]pyrrole-2-carboxylate
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and, the elected species, 1-methyl-4-[1-methyl-4-(3-[[1-methyl-4-(1-methylimidazole-2-amido)pyrrol-2-yl]formamido]propanamido)imidazole-2-afford[sic]amido]pyrrole-2-carboxylic acid
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(Pages 100-101, Steps 10-11; See Page 97, Scheme 1).
Claims 42-43 and 46 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jeffries (WO 2022126000, published 6/16/2022, filed 12/11/2021, claiming priority to US Provisional App. No. 63/124,592 which is filed 12/11/2020).
102(a)(2): The applied reference has a common assignee, applicant, and/or joint inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Jeffries teaches Methyl 4-[4-(3-aminopropanamido)-1-methylimidazole-2-amido]-1-methylpyrrole-2-carboxylate hydrochloride (INT60-022-201) or
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as claimed (Page 214, Step 5; See Page 213, Scheme 25). Jeffries also teaches the following compounds: methyl 1-methyl-4-[1-methyl-4-(3-[[1-methyl-4-(1-methylimidazole 2-amido)pyrrol-2-yl]formamido]propanamido)imidazole-2-amido]pyrrole-2-carboxylate (INT61-001-102)
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and, the elected species, 1-methyl-4-[1-methyl-4-(3-[[1-methyl-4-(1-methylimidazole-2-amido)pyrrol-2-yl]formamido]propanamido)imidazole-2-afford[sic]amido]pyrrole-2-carboxylic acid (INT61-001-103)
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(Page 219, Steps 5-6; See Page 217, Scheme 26).
Claims 42-43 and 46 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shah (WO2022150555, published 7/14/2022, filed 1/07/2022, claiming priority to US Provisional App. No. 63/135,427 which is filed 1/08/2020).
102(a)(2): The applied reference has a common assignee, applicant, and/or joint inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Shah teaches Methyl 4-[4-(3-aminopropanamido)-1-methylimidazole-2-amido]-1-methylpyrrole-2-carboxylate hydrochloride or
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as claimed (Page 175, Step 5; See Page 173, Scheme 1). Shah also teaches the following compounds: methyl 1-methyl-4-[1-methyl-4-(3-[[1-methyl-4-(1-methylimidazole 2-amido)pyrrol-2-yl]formamido]propanamido)imidazole-2-amido]pyrrole-2-carboxylate
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and, the elected species, 1-methyl-4-[1-methyl-4-(3-[[1-methyl-4-(1-methylimidazole-2-amido)pyrrol-2-yl]formamido]propanamido)imidazole-2-afford[sic]amido]pyrrole-2-carboxylic acid
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(Page 176-177, Steps 10-11; See Page 173, Scheme 1).
Conclusion
No claim is allowable.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 8:30am - 4:30pm EST.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
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