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 .
Status of Claims
The preliminary amendment filed on 20 February 2025 amends claims 1, 10, 23, 52, 56, 71, 82, 87, 97, 101, 103, 120, 121, 124, 128-129, 144, and 147, and cancel claims 2-8, 11-16, 18-22, 25-32, 34-51, 53-55, 57-59, 62-70, 72-81, 83-86, 89-96, 98-100, 102, 104-119, 122-123, 125-127, 130-143, 145-146, and 148-154.
Claims 1, 9-10, 17, 23-24, 33, 52, 56, 60-61, 71, 82, 87-88, 97, 101, 103, 120-121, 124, 128-129, 144, and 147 are pending.
Priority
This application, filed on 5 July 2024, claims benefit under 35 U.S.C. 119 or 365, and is a
National Stage entry from International Application No. PCT/US23/10176, filed 5 January 2023, which claims the benefit of US Provisional Application No. 63/297,124, filed on 6 January 2022.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) filed on 20 February 2025 and 12 September 2025 have been acknowledged and considered.
Specification Objections
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means,” “said,” and “comprising” should be avoided. The word “comprising” is mentioned in the abstract, appropriate correction is requested.
Claim Rejections - 35 USC § 112(b)
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 1, 9-10, 17, 23-24, 33, 52, 56, 60-61, 71, 82, 87-88, 97, 101, 103, 120-121, 124, 128-129, 144, and 147 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.
Regarding claims 1, 9-10, 17, 33, 60-61, 71, 101, 103, 120, and 144, the phrase “a salt (e.g., pharmaceutically acceptable salt) thereof” renders the claim indefinite because it is unclear whether the term in the parenthetical “e.g., pharmaceutically acceptable salt” is a limitation of the claimed invention. See MPEP § 2173.05(d). Claims 23-24 52, 56 82, 87-88, 97 121, 124, 128-129 and 147 do not remedy the indefinite language in the aforementioned claims, and by virtue of their dependency are rejected.
Claim 101 is 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 written description and the claims are separate statutory requirements. Under modern claim practice, claims must stand alone to define an invention. Ex parte Fressola, 27 USPQ2d 1608 (BPAI 1993). Claim 101 recites “Table 2 or Table 3” to describe the compounds claimed without providing a chemical structure or nomenclature for each compound. As a result, one of ordinary skill in the art must refer back to the specification to understand what the claimed invention
Appropriate correction is required.
Art Made of Record but not Applied
Claims 1, 9-10, 17, 23-24, 33, 52, 56, 60-61, 71, 82, 87-88, 97, 101, 103, 120-121, 124, 128-129, 144, and 147 contain allowable subject matter relative to the prior art.
The closest prior art is WO2022261154 (claiming benefit of US Provisional App. No. 63/208,662 filed 09 June 2021) (“Barda”), which discloses compounds of Formula I
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. The preferred example compounds in Table 2 of Barda are similar in structure to the species described in the instant specification. For example, compound 63 defined in Table 3 of the instant specification shares a similar structure with the 2nd entry in the 1st column of Table 2 of Barda (both compounds shown below). The substituents of the Barda compound, with respect to the R1 and R3-5 positions of the instant claims, are either identical or read on the limitations of the genera provided in the instant claims. However, the ether group positioned opposite a nitrogen atom on the bicyclic ring of the compound 63 is not disclosed in Barda, which has a heterocyclic group at that position. There is no suggestion to make modifications to substitute the heterocyclic ring containing N atoms in Barda, for ethers substituted with substituted or unsubstituted mono- or bicyclic heterocycles to arrive at the claimed invention. Accordingly, claims 1, 9-10, 17, 23-24, 33, 52, 56, 60-61, 71, 82, 87-88, 97, 101, 103, 120-121, 124, 128-129, 144, and 147 are novel and nonobvious over Barda.
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[AltContent: textbox (Barda)][AltContent: textbox (63)]
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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, 17, 23-24, 33, 52, 56, 60-61, 71, 82, 87-88, 97, 101, 103, 120-121, 124, 128-129, 144, and 147 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-9, 27, 52, 60-61, 71, 77, 86, 103, 107, 109, 122-124, 128-129, and 142-143 of copending Application No. 18/726,865 (‘865). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘865 anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 of ‘865 recites:
“A compound according to Formula I:
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…”
Claim 1 is further limited in the substituents R2 and R3 wherein, “R2 is a 4-6 membered heterocycle containing one or more nitrogen atoms, wherein the heterocycle is substituted with one or more E and 0-4 R8…” and “R3 is selected from H, -OR10, AND C1-6alkyl…” The instant claims recite, “…R2 as a 4-11 membered heterocycle containing one or more nitrogen atoms, wherein the heterocycle is unsubstituted or is substituted with one or more R8…” and “…R3 is H…” Claim 1 of ‘865 encompasses the limitations of instant claim 1.
Claim 8 of ‘865 recites the same compound of Formula IA with the same substitutions of Rg and Rh as instant claim 9, except for ‘865 comprises a substituent E. Claim 8 of ‘865 encompasses instant claim 9.
Claim 9 of ‘865 recites compounds of Formula IA1-3, whereas instant claim 10 includes the aforementioned compounds and IA4-5. The compounds in claim 9 of ‘865 are encompassed by instant claim 10.
Claim 27 of ‘865 and instant claim 33 share the same exact structure.
Claim 52 of ‘865 and instant claim 56 share the same substituent with the same substitution limitations.
Claim 60 of ‘865 encompasses instant claim 60 by virtue of the additional R2 and R3 substituents in ‘865.
Claims 61 and 71 of ‘865 and instant claims 61 and 71 share the same exact structure with the same limitations.
Claim 103 of ‘865 and instant claim 97 share the same exact structure with same limitations.
Claim 107 of ‘865 and instant claim 101 share the same limitations.
Claim 109 of ‘865 recites a pharmaceutical composition compromising a compound of claim 1 or a salt and a pharmaceutically acceptable excipient, whereas instant claim 103 recites the same but includes the ester, tautomer, prodrug, zwitterionic and stereoisomeric forms of compound 1. Instant claim 103 encompasses claim 109 of ‘865.
Claims 122, 124, 128, 129, and 147 of ‘865 recite the same method limitations as instant claims 120, 124, 128, 129, and 147, respectively.
Conclusion
Claims 23-24 52, 56 82, 87-88, 97 121, 124, 128-129 and 147 are allowable.
Claims 1, 9-10, 17, 33, 60-61, 71, 101, 103, 120, and 144 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAHIL CHANDER AGGARWAL whose telephone number is (571)272-7755. The examiner can normally be reached 7am-5pm.
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, Adam C Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAHIL CHANDER AGGARWAL/ Examiner, Art Unit 1623
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621
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