DETAILED ACTION
All rejections and objections not mention below have been withdrawn.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/09/2025 has been entered.
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
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Applications No. 62/965,371 and 63/094,741, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. A claim by claim analysis indicated that the compounds of claim 49 are not fully supported by the priority documents and thus claim 49 receives a priority date of 01/25/2021. The rest of the claims were given a priority date of 01/24/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/08/2023, 12/04/2023, 03/04/2024, 10/22/2024, 04/01/2025, 08/14/2025 and 09/05/2025 are being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 15 does not properly further limit claim 2 from which it depends because claim 2 also requires J1=CH. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1, 2, 3, 7, 9, 10, 13, 15, 17, 18, 20, 21, 25, 28, 30, 31, 34, 35 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by STN (STN, ACS CAS 922131-18-8 REGISTRY, Entered STN: 20 Feb 2007).
The reference STN, ACS CAS 922131-18-8 REGISTRY teaches the following compound, wherein X=CH2, n=2, R1=H, J1=CH, J2=J3=CH, R2=H, Z=O, R5=CF3, R3=R4=aryl. This anticipates claims 1, 2, 3, 7, 9, 10, 13, 15, 17, 18, 20, 21, 25, 28, 30, 31, 34, 35.
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Claim(s) 1, 2, 9, 11, 15, 17, 18, 20, 21, 25, 28, 30, 31, 34, 35 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by STN (STN, ACS CAS 1594408-93-1 REGISTRY, Entered STN: 30 Apr 2014).
The reference STN, ACS CAS 1594408-93-1 REGISTRY teaches the following compound, wherein X=CH2, n=2, R1=H, J1=CH, J2=J3=CH, R2=H, Z=O, R5=CH3, R3=R4= 6-member heteroaryl, R100=optionally substituted alkyl. This anticipates claims 1, 2, 9, 11, 15, 17, 18, 20, 21, 25, 28, 30, 31, 34, 35.
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Claim(s) 1, 2, 7, 8, 9, 10, 15, 17, 18, 20, 21, 25, 28, 30, 31, 34, 35 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by STN (STN, ACS CAS 1209570-11-5 REGISTRY, Entered STN: 14 Mar 2010).
The reference STN, ACS CAS 1209570-11-5 REGISTRY teaches the following compound, wherein X=CH2, n=2, R1=H, J1=CH, J2=J3=CH, R2=H, Z=O, R5=CH3, R3=R4= aryl, R100= alkyl. This anticipates claims 1, 2, 7, 8, 9, 10, 15, 17, 18, 20, 21, 25, 28, 30, 31, 34, 35.
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Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 2, and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over MAKITA (MAKITA et al., CA-3048602-A1, 2018).
The reference MAKITA teaches the following general formula wherein R1=H(reference claim 1).
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The reference MAKITA teaches the following lead compound (page 128), wherein X=CH and X=C-cyclopropyl, n=2, R1=Ethyl, J1=CH, J2=J3=CH, R2=Me, Z=O, R5=Me, R3=R4=aryl and “When a the compound represented by the formula [1] is used as medicament, pharmaceutical aids that are commonly used in formulation, such as excipients, carriers and diluents, may be mixed into the compound, as appropriate”[0130]. This helps to teach claim 1, 2 and 50.
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The reference MAKITA does not teach a specific compound wherein R1=H (all claims), however, the general formula teaches wherein R1=H.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified MAKITA to produce the compounds and compositions of the instant claims because the only necessary changes is from ethyl to H for R1 from the lead compound this would be obvious to do because the general formula of the reference suggest this change, as only one of two general options, and thus one would have a reasonable expectation of success. One would be motivated to do so because the structures would be very similar and thus have a reasonable expectation to treat the diseases mentioned in the reference. A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
Claim(s) 1, 2, and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over
STN (STN, ACS CAS 1209570-11-5 REGISTRY, Entered STN: 14 Mar 2010).
The reference STN, ACS CAS 1209570-11-5 REGISTRY teaches the following compound, wherein X=CH2, n=2, R1=H, J1=CH, J2=J3=CH, R2=H, Z=O, R5=CH3, R3=R4= aryl, R100= alkyl. This anticipates claims 1, 2, 7, 8, 9, 10, 15, 17, 18, 20, 21, 25, 28, 30, 31, 34, 35.
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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 1-4, 7-11, 13, 17-18, 20-21, 25, 28, 30-31, 34-36 and 49-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-60 of copending Application No. 19/122,953.
The application ‘953 claims:
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This helps to teach claims 1-4, 7-11, 13, 17-18, 20-21, 23, 25, 28, 29-31, 34-35 and 49-51.
The application ‘953 does not teach the exact formula of instant claims 1-2 but does teach compounds that would be included in claims 1-2. The application ‘953 does not teach the exact formula of instant claims 3-4, 7-11, 13, 17-18, 20, 21, 23, 25, 28, 29-31, 34-35, 49-51 but they are overlapped in reference formula I or IV.
It would have been prima facie obvious to one of ordinary skill in the art to have modified the compounds and formula of application ‘953 to achieve compounds and formulas of the instant invention because application has a lead compound that is included in instant formula (I)
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and the reference formulas teach the necessary modifications to achieve the other compounds and formulas of the instant invention. One would have a reasonable expectation of making these compounds because they have been claimed as successful compounds by the reference application and one would have a motivation to do so to treat the disease described by the reference application.
This is a provisional nonstatutory double patenting rejection.
Claim 1-4, 7-11, 13, 15-18, 20-21, 25, 28, 30-31, 34-36 and 50 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-30 of copending Application No. 18/746,835 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The application ‘835 claims the following(page 229 and 27 ), wherein X=CH2, n=2, R1=H, J1=CH, J2=N, J3=CH, R2=H, Z=O, R5=CH2CH3, R3=R4= heteroaryl:
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This anticipates claims 1-4, 9-11, 13, 15-16, 20-21, 25, 28, 30-31.
The application ‘835 claims the following:
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This anticipates claim 7, 8, 34, 35, 36.
The application ‘835 claims the following:
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This anticipates claim 17-18.
The application ‘835 claims the following:
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This anticipates claim 50.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 3, 4, 7, 8, 9, 11, 13, 15, 17, 18, 20, 21, 25, 28, 30, 31, 34, 35, 36, 49, 50, 51 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12054475 B2.
The patent ‘475 claims:
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The patent ‘475 teaches “The present disclosure is further based, in part, on the discovery that various compounds described herein can potently and/or selectively inhibit one or more ALDH enzymes such as ALDH1a3 and/or ALDH1a2, can inhibit the retinoid pathway activation, and can treat various diseases such as cancer and Type 2 Diabetes”(column 2).A compound claim can be used to reject a method claim if the utility is disclosed in the specification. See Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F. 3d 1381, 1385 (CAFC 2010). See also MPEP § 804(II)(B)(2)(a).
The patent ‘475 does not teach J1=CH or the specific compounds of claim 49, however the only difference between the reference compound and the instant claimed compound is two methyl groups replacing H.
It would have been prima facie obvious to one of ordinary skill in the art to have modified patent ‘475 to achieve the instant compounds because they only differ in two methyl groups replacing H (see reference claim 26 and instant compound 63). One would have a reasonable expectation of success because one of the methyl is suggested by the generic reference formula for R20 and the other methyl is not a significant change in the structure and thus one of ordinary skill in the art would have a reasonable expectation that the similar structure would give the compound a similar function and thus would be motivated to make the new compound to treat the same diseases as the original structure. It is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C. P.A. 1963).
Claims 1, 2, 3, 7, 8, 9, 11, 15, 17, 18, 20, 21, 25, 28, 30, 31, 34, 35, 36, 49, 50 and 51 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. US 12162855 B2.
The patent ‘855 claims:
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The patent ‘855 teaches “Provided herein are compounds, compositions and methods for treating cancers, for example, metastatic cancers (e.g., a metastatic breast cancer, such as a basal-like breast cancer, a HER-2 positive breast cancer), chemoresistant cancers (e.g., cancers resistant to paclitaxel and/or doxorubicin) in a subject in need thereof”(page 1).A compound claim can be used to reject a method claim if the utility is disclosed in the specification. See Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F. 3d 1381, 1385 (CAFC 2010). See also MPEP § 804(II)(B)(2)(a).
The patent ‘855 the specific compounds of claim 49, however the only difference between the reference compound and the instant claimed compound is one methyl group replacing H.
It would have been prima facie obvious to one of ordinary skill in the art to have modified patent ‘855 to achieve the instant compounds because they only differ in one methyl group replacing H (see reference claim 1 and instant compound 64). One would have a reasonable expectation of success because the methyl is not a significant change in the structure and thus one of ordinary skill in the art would have a reasonable expectation that the similar structure would give the compound a similar function and thus would be motivated to make the new compound to treat the same diseases as the original structure. It is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C. P.A. 1963).
Response to Arguments
Applicant’s arguments with respect to all claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Double Patenting
Applicant's arguments filed 12/09/2025 have been fully considered but they are not persuasive. The applicant argues that:
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This argument was found to be unpersuasive because is only true if it is the only rejection remaining since this is not the case it is not persuasive.
Additionally, the arguments that changing a H to methyl make the new compound new and nonobvious are not persuasive because: it is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C. P.A. 1963).
Allowable Subject Matter
Claim 19 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1, 2, 3, 4, 7, 8, 9, 10, 11, 13, 15, 16, 17, 18, 20, 21, 25, 28, 30, 31, 34, 35, 36, 49, 50 and 51 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON AZAR SALAMATIAN whose telephone number is (703)756-4584. The examiner can normally be reached Mon-Thurs 7:30am-5pm EST Friday 7:30-4pm EST (every other Friday off).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A.S./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627