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All rejections and objections not mention below have been withdrawn.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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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, 09/05/2025 and 06/08/2026 are being considered by the examiner.
Claim Objections – New due to Amendments
Claims 1, 7-are objected to because of the following informalities: floating "; and" instead of a period at the end of the claim. Appropriate correction is required.
Claims 1, 7-9, 13, 16-19, 20-21, 25, 28, 30, 31, 34, 35-36 and 50 are objected to because of the following informalities: carbon-linked and carbon linked are used these should be consistent. Appropriate correction is required.
Claim Rejections - 35 USC § 112 -New due to Amendments
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, 7-9, 13, 16-19, 20-21, 25, 28, 30, 31, 34, 35-36 and 50 are rejected as failing to define the invention in the manner required by 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
The claim(s) must be in one sentence form only. See period added in the third line on page 4.
Claims 1, 7-9, 13, 16-19, 20-21, 25, 28, 30, 31, 34, 35-36 and 50 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.
The claim language “carbon-linked” is indefinite and one of ordinary skill in the art would not know the scope of the claims 1, 7-9, 13, 16-18, 20-21, 25, 28, 30, 31, 34, 35-36 and 50. It is unclear for example if this is meant to encompass two groups linked by a carbon chain, or two groups bound through one or two carbon atoms within the groups themselves. For the purpose of examining the broadest reasonable interpretation was used, which would be to understand carbon-linked as any of the above interpretations.
The variables p is not mentioned in relation to how they would connect to formula I thus claims 1, 7-9, 13, 16-18, 20-21, 25, 28, 30, 31, 34, 35-36 and 50 are indefinite as one of ordinary skill in the art would not know how they would attach. For the purposes of examination the broadest reasonable interpretation is if the groups can attach anywhere on formula I.
Claims 1, 7- recites the limitation "the aryl" in line 1 of page 3. There is insufficient antecedent basis for this limitation in the claim. It is unclear if it refers to just the aryl in option (ii) or both options (ii) and (i) because it is in option (ii) but it refers to the level of the two option by pointing out just the 6-membered heteroaryl and the aryl and no other options so in that case it is likely referring to both options (i) and (ii). For the broadest reasonable interpretation both options are assumed to be referred to.
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.
Claims 13 and 34 are 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 34 improperly broaden claim 1 from which it depends because it includes a double bond for the X location which has been amended out of claim 1. Claim 13 is rejected because the amendment requires the R5 to be attached to formula I through C while claim 13 improperly broadens claim 1 to include O groups as well. 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 – NEW due to Amendments
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 –
Claim(s) 1, 7, 8, 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 1295307-72-0 REGISTRY, 16 May 2011) .
The reference STN, ACS CAS 1295307-72-0 REGISTRY teaches the following compound, wherein X=CH2, n=2, R1=H, J1=CH, J2=J3=CH, R2=H, Z=O, R3=R4=aryl with a substituted aryl further substituted with R100=CF3, R5=H. This anticipates claims 1, 7, 8, 17, 18, 20, 21, 25, 28, 30, 31, 34, 35.
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Claim(s) 1, 9, 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 1299870-19-1 REGISTRY, 24 May 2011) .
The reference STN, ACS CAS 1299870-19-1 REGISTRY teaches the following compound, wherein X=CH2, n=2, R1=H, J1=CH, J2=J3=CH, R2=H, Z=O, R3=R4=6-memebered heteroaryl with a substituted aryl further substituted with R100=Br, R5=Me. This anticipates claims 1, 9, 17, 18, 20, 21, 25, 28, 30, 31, 34, 35.
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Claim(s) 1, 13, 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 1317299-48-1 REGISTRY, 14 August 2011) .
The reference STN, ACS CAS 1317299-48-1 REGISTRY teaches the following compound, wherein X=CH2, n=2, R1=H, J1=CH, J2=J3=CH, R2=H, Z=O, R3=R4=6-memebered aryl with a substituted heteroaryl, R5=OMe, R100=Cl. This anticipates claims 1, 13, 17, 18, 20, 21, 25, 28, 30, 31, 34, 35.
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Double Patenting- updated due to Amendments and IDS
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, 7-8, 17-18, 20-21, 25, 28, 30, 31, 34, 35 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2, 4-11, 14-16, 18, 27-29, 37-39 of copending Application No. 19/122,953 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The application ‘953 claims:
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This anticipates claims 1, 7-8, 17-18, 20-21, 25, 28, 30, 31, 34, 35.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 7-8, 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 claims 1-2, 4-11, 14-16, 18, 27-29, 37-39 of copending Application No. 19/122,953.
The application ‘953 claims:
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The specification of the reference application teaches the use of these compounds for treatment of diseases including cancer ([006] and abstract). Thus it would be obvious to make pharmaceutical composition for delivery to treat cancer. 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).
This helps to teach claims 1, 7-9, 13, 17-18, 20-21, 25, 28, 30-31, 34-36 and 49-51.
The application ‘953 does not teach the specific compounds of claims 36 or 49 or the methods or compositions of claims 50-51.
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 the application has a lead compound that is included in instant formula (I)
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. One would have a motivation to do so to treat the disease described by the reference application. Additionally, the lead compound
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, only differs from the compounds of claim 49 by two methyl groups. Furthermore,
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only differs from the compounds of claim 36 by one methyl group Further, 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). Given that applicant did not provide unexpected or unobvious results of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to substitute the H group for a Me. 2144.08(II)(A)(4)(c). One would have a reasonable expectation of success because methyl for H are minor changes in structure. The same logic holds for substituting a Me for an H group.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 17-18, 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 wherein X=CH2, n=2, R1=H, J1=CMe, J2=CH, J3=CH, R2=H, Z=O, R3=R4= heteroaryl:
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This helps to teach claims 1, 17-18, 20-21, 25, 28, 30-31, 34-35-36 and 50.
The application ‘835 claims the following:
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The application ‘835 claims the following:
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This helps to teach claims 1, 17-18, 20-21, 25, 28, 30-31, 34-35-36 and 50.
The application ‘835 does not teach J1=CH in a specific compound all claims.
It would have been prima facie obvious to one of ordinary skill in the art to have modified the compounds and formula of application ‘835 to achieve compounds and formulas of the instant invention because the application has a lead compound that is included in instant formula (I)
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. One would have a motivation to do so to treat the disease described by the reference application. Additionally, the lead compound
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, only differs from the compounds the instant claims by one methyl group. Further, 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). Given that applicant did not provide unexpected or unobvious results of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to substitute the H group for a Me. 2144.08(II)(A)(4)(c). One would have a reasonable expectation of success because methyl for H are minor changes in structure. The same logic holds for substituting a Me for an H group.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 49 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 19/529,564 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The application ‘564 claims:
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This compound only differs from the compound 53 of instant claim 49 by two methyl groups.
It would have been prima facie obvious to one of ordinary skill in the art to have modified application ‘564 to achieve the instant compounds because they only differ in two methyl groups replacing H (see reference claim 15 and instant compound 53). One would have a reasonable expectation of success because one of the methyl is suggested by the generic reference formula to be H 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). The same logic holds for substituting a Me for an H group.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 17-18, 20-21, 25, 28, 30-31, 34-36, 49, 50, and 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 one 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 one methyl groups replacing H (see reference claim 29 and instant compound 59 and instant claim 1 optionally substituted carbon -linked heterocyclyl). One would have a reasonable expectation of success because one of the methyl is suggested to be H by the generic reference formula for R22 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). The same logic holds for substituting a Me for an H group.
Claims 49, 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 32 is the connection of amide group to the fused ring.
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 the location of the amide connection to the fused ring (see reference claim 1 and instant compound 32). One would have a reasonable expectation of success because 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. MPEP § 2144.09(II) also states position isomers are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In addition, the Court has stated that “[i]f a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” KSR, 127 S.Ct. at 1740.
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 06/08/2026 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 the new amendment makes the instant claim allowable over the double patenting rejections is not persuasive because due to the new amendment the rejections have been updated to account for this new limitation.
Conclusion
Claims 1, 7-9, 13, 16-19, 20-21, 25, 28, 30, 31, 34, 35-36 and 49-51 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.
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 06/08/2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON AZAR HASTINGS 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).
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, 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.H./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
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