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 .
Priority
This application is a national stage application under 35 U.S.C. § 371 of International Application No. PCT/US21/19184, filed 02/23/2021, which claims the priority benefit of PRO Application No. 62/980,790, filed 02/24/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on dates 09/14/2023, 09/15/2023,
09/18/2023, 09/30/2024 were filed in compliance with the provisions of 37 CFR 1.97.
Accordingly, the information disclosure statements are being considered by the examiner.
Further, the relevance of the foreign patent document WO202027202 reference 27, dated
2020-08-06 on the IDS dated 09/14/2023, could not be determined and appears to include
typographical errors or missing digit. Clarification is required before consideration.
Status of claims
Claims 1-3, 5-6, 15-18, 25, 32-33, 35-37, 43-44, 47-49, 55-57, 61-62, and 74-76 are pending in this application. Claims 4, 7-14, 19-24, 26-31, 34, 38-42, 45-46, 50-54, 58-60, and 63-73 have been cancelled by applicant without prejudice or disclaimer. New claims 74-76 have been added.
Applicant’s arguments, filed 02/18/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 102
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.
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 74 and 76 are rejected under 35 U.S.C. 102(a)(l) as being anticipated by CAplus Registry Number: RN 1518319-09-9, [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 1518319-09-9, Entered STN: 13 Jan 2014].
Registry number 1518319-09-9 anticipates the structural limitations of instant claims 74 and 76 where R4 is Aryl, Y is bond, R8 is a C1 alkyl, R3 and R11 are H, X is CR7 wherein R7 is H and where R1 is N(R6)2 wherein R6 is H.
Registry number 1518319-09-9 is available as prior art as of 13 Jan 2014, the date it was indexed into the REGISTRY database.
Regarding the compositions of claim 76, comprising the anticipatory compounds and an excipient, the Registry entry for Registry no. 1518319-09-9 discloses a mass solubility of 0.02 g/L, in unbuffered water at pH 8.71. This teaching of water anticipates the claimed composition, wherein the compounds are present with an excipient (i.e., water).
See MPEP § 2128 “Printed Publications” as prior art. An electronic publication, including an on-line database or Internet publication, is considered to be a “printed publication” within the meaning of 35 U.S.C. § 102 (a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981): since this date represents the date that each compound entered the REGISTRY database on STN, this represents the date that each compound was made accessible to the public.
It is further noted that for the purposes of determining if a reference is a “printed publication,” MPEP § 2128 (I) states the following:
A reference is proven to be a "printed publication" "upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it." In re Wyer, 655 F.2d 221, 210 USPQ 790 (CCPA 1981) (quoting I.C.E. Corp. v. Armco Steel Corp., 250 F. Supp. 738, 743, 148 USPQ 537, 540 (SDNY 1966)) ("We agree that ‘printed publication’ should be approached as a unitary concept.
where “prior art disclosures…on an on-line database are considered to be publicly available as of the date the item was publicly posted.” Since each of the database entries above lists the date that each compound was entered into the on-line database, the compounds were made publicly available as of that date in each citation.
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Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: applicants formula I of the instant claims makes a contribution over the prior art of CAplus Registry Number: RN 1518319-09-9, [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 1518319-09-9, Entered STN: 13 Jan 2014].
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RN 1518319-09-9 (Left) Applicants formula I (Right)
The compound of RN 1518319-09-9 differs from applicants formula I of claim 1 wherein Y is bond. The CAplus Registry Number: RN 1518319-09-9 entry does not fairly teach or suggest Y as a heteroarylene as is disclosed in instant claim 1.
Conclusion
1-3, 5-6, 15-18, 25, 32-33, 35-37, 43-44, 47-49, 55-57, 61-62, and 75 are allowable, Claims 74 and 76 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNESTO VALLE JR whose telephone number is (703)756-5356. The examiner can normally be reached 0730-1700 M-F EST, 1st Friday off.
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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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/E.V./Examiner, Art Unit 1623
/SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623