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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/18/2026 has been entered.
Response to Amendment
The amendments received 02/18/2026 have been entered. Claims 1-2, 4-6, 13-17, 46, 48-51, and 53-57 are pending. Applicant’s amendments have overcome the rejections under 35 U.S.C. 112(d) and the rejection of claims 46, 48-51 and 53-56 under 35 U.S.C. 112(a) new matter over the term “halogen” as previously set forth in the Office Action mailed 08/18/2025.
Information Disclosure Statement
The Information Disclosure Statement filed on 02/19/2026 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of list of references cited from the IDS is included with this Office Action.
Specification
The amendment filed 02/18/2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: Applicant has corrected instances of "halide" to "halogen". However, "halogen" was not disclosed at the time of filing, nor does the recitation of Cl, F, and Br as preferred "halides" constitute as adequate description of halogens. Halogen also includes I, At, and Ts, none of which are adequately disclosed or suggested by the instant specification. Moreover, Applicant has added “which may be optionally substituted with one or more halogens” which was not adequately disclosed at the time of filing for the same reasons regarding correction to “halogen” as above, and because the disclosure of particular examples does not constitute adequate disclosure of each and every C1-C6 alkyl, attached at any location on R2, substituted by any number and type of halogen.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claims 1 and 57 are objected to because of the following informalities:
Claim 1: “general formula (I)” should read “formula (I)”;
Claim 1 does not end in a period;
Claim 57: “Z3485538338” is listed with the first compound on page 27 of the claims as filed, however, no other compounds in claim 57 are listed with their associated “Z” numbers as identifiers.
Appropriate correction is required.
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.
Claims 1-2, 4-6, 13-17, 46, and 48-50 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for enantiomers, diastereomers, and pharmaceutically acceptable salts, does not reasonably provide enablement for hydrates or solvates. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
The instant claims are drawn to compounds of formula (I) and hydrates and solvates thereof. However, the working examples presented in the instant specification fail to produce a solvate or hydrate, nor is sufficient guidance provided in the instant specification such that one of ordinary skill in the art would be apprised what solvates or hydrates could be formed. Solvates and hydrates are known in the art to be unpredictable, despite a high level of skill (that of a synthetic chemist with a PhD), and cannot be simply willed into existence. As stated in Morton International Inc. v. Cardinal Chemical Co., 28 USPQ2d 1190 “The specification purports to teach, with over fifty examples, the preparation of the claimed compounds with the required connectivity.” Hence, applicants must show that solvates and hydrates of the claimed compounds can be made, or limit the claims accordingly.
Claims 1-2, 4-6, 13-17, 46, 48-51, and 53-56 are 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.
The instant claims have been amended as below.
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Applicant’s amendments to the claims constitute as new matter. No disclosure of the above genus can be found as of the time of filing. While the instant disclosure is replete with recitations of “OXA is 1,3-oxazolyl and the group R1-S-CH2 is bound to C2 of the 1,3-oxazolyl and the group R2 is bound to C4 of the 1,3-oxazolyl”, no genus is disclosed where R2 is bound to C5. The species disclosed in the instant specification, furthermore, do not constitute as an adequate written description of a broader genus. For example, there is no evidence to suggest that Applicant had contemplated a compound of formula (I) wherein OXA is 1,3-oxazolyl, R1 is 1,3,5-triazine substituted once with methyl and once with ter-butyl, and R2 is phenyl substituted by F and methyl, wherein R2 is bound to C5 of the oxazolyl, to name one of thousands of compounds encompassed by claims 1, 46, and 52. Applicant may amend the claims to be directed toward the particular species within the claimed genus, however, Applicant has not sufficiently demonstrated possession of the genus as a whole.
Additionally, Examiner notes that Applicant states that the discrepancy between R2 being connected at C4 versus C5 of the 1,3-oxazolyl is due to typographical error (Remarks, p. 25). MPEP 2163(I)(B), “An amendment to correct an obvious error does not constitute new matter where the ordinary artisan would not only recognize the existence of the error in the specification, but also recognize the appropriate correction. In re Oda, 443 F.2d 1200, 170 USPQ 268 (CCPA 1971).” This is not the instant case. See, for example, the equivalent patent granted by the EPO, EP 3956323 B1, wherein claim 1 is drawn to 1,3-oxazolyl and R2 is bound to C4 of the 1,3-oxazolyl. It is therefore unclear whether Applicant truly intended to seek patent rights for the instantly claimed invention as amended and merely made a typographical error at the time of filing.
Claims 1-2, 4-6, and 13-17 are 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.
Applicant has amended the claims to recite “halogen” instead of “halide”. However, "halogen" was not disclosed at the time of filing, nor does the recitation of Cl, F, and Br as preferred "halides" constitute as adequate description of halogens. Halogen also includes I, At, and Ts, none of which are adequately disclosed or suggested by the instant specification. Examiner suggests correcting “halogen” to “Cl, Br, and F”.
Moreover, Applicant has added “which may be optionally substituted with one or more halogens” which was not adequately disclosed at the time of filing for the same reasons regarding correction to “halogen” as above, and because the disclosure of particular examples (cited in Remarks, p. 24) does not constitute adequate disclosure of each and every C1-C6 alkyl, attached at any location on R2, substituted by any number and type of halogen. Applicant is required to delete the new matter.
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 1-2, 4-6, 13-17, 46, 48-51, and 53-57 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 269 of copending Application No. 18/032,963 (reference application, now allowed). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 269 recites compounds that are within the scope of, and therefore anticipate, the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 02/18/2026 have been fully considered but they are not persuasive.
35 U.S.C. 112(a) – “R2 is bound to C5”
Regarding the rejection of claims 1-2, 4-6, 13-17, 46, 48-51, and 53-56 under 35 U.S.C. 112(a) new matter, Applicant argues that Examiner’s position contradicts the earlier Office Action (mailed 12/27/2024) which stated “all of the species disclosed wherein OXA is 1,3-oxazolyl connect to R2 at C5 of the 1,3-oxazolyl” (p. 6). This is not persuasive. Examiner’s observation that the species disclosed were substituted at C5 of the 1,3-oxazolyl is not equivalent to acknowledging, and does not indicate, that the disclosure provides adequate written description of a genus of formula (I) wherein OXA is 1,3-oxazolyl and connects to R2 at C5 of the 1,3-oxazolyl. Recent case law Tronzo v. Biomet 47 USPQ2d 1829 states that a species in a prior application does not provide written description to a generic claim.
Moreover, a claimed genus may be supported by description of a representative number of species. Per MPEP 2163.05, “A ‘representative number of species’ means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).” The subgenus of Scheme 1-3 (see p. 31-32 of Remarks) and the disclosed species are not representative of the entire genus of formula (I) (in any of claims 1, 46, or 51), wherein both the aforementioned subgenus and species require that at least one carbon of the triazinyl be substituted by amino. No subgenus or species are set forth in the instant disclosure which implicitly or explicitly suggests compounds within the genus of formula (I) wherein the triazinyl is not substituted by at least one amino.
As a representative number of species that reflect the variety of substituents within the genus of formula (I) are not adequately disclosed, the claims lack written description for the genus of formula (I) and the rejection is maintained.
35 U.S.C. 112(a) – “halogen” vs. “halide”
In the Remarks filed 02/18/2026, Applicant argues that the term “halogen” is considered an obsolete term in German/European usage of the term “halide”, and that the negatively charged ions of the halogens are also called “halides” (p. 34 of Remarks). This is not persuasive.
First, Applicant points to a Wikipedia article in German and its English translation, which allegedly states that the term “haloide” translates to English as “halogen” and states “The obsolete term is halogens”. Yet the remainder of the article is replete with the use of the term “halogen”, such as “halogen hydrides” and “organic compounds containing halogens”. It is unclear whether the translation provided by Applicant is correct as “halogene” also translates to halogen. In fact, the same German article machine translated by the Examiner yields “haloids” as the English translation of “haloide” (see attached).
Regardless, the article provided Applicant does not support their argument. While Applicant points to an excerpt of the article that reads “the singly negatively charged ions of the halogens… are referred to as halide ions (also halides for short)” this argument fails in that the instant invention is directed toward covalently bonded compounds, not ionic compounds. Thus, even if singly negatively charged ions of halogens may be referred to as “halides”, the halogens listed in the instant claims (F, Cl, Br) are not ions and would therefore not be called halides. Nowhere in the article provided by Applicant are halogens in covalent compounds referred to as “halides”, and only in reference to the compound as a whole is the term “covalent halides” used (see first page of English translation provided by Applicant).
As such, Applicant’s arguments are not persuasive as it would not be understood that the translation of the term for “halide” in German would be equivalent to “halogen” in English. The rejection is maintained.
Allowable Subject Matter
Claim 57 is objected to but is free of the art. The closest prior art is RN 2361706-39-8, 927366-09-4, and 927366-07-2 (CHEMCATS, STN).
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The compounds are not disclosed with an intended use or function, such that it would not be obvious for one of ordinary skill in the art to modify the compounds to arrive at the invention of claim 57.
Conclusion
Claims 1-2, 4-6, 13-17, 46, 48-51, and 53-56 are rejected. Claim 57 is objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
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, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.E.B./Examiner, Art Unit 1624 05/21/2026
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
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