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 .
DETAILED ACTION
Election/Restrictions and Status of the Claims
Applicant’s election without traverse of Group I, comprising claims 24-30, as well as “Formula 4” as the single specific MRTF A inhibitor and “cisplatin” as the single specific anticancer drug in the response filed on March 23rd 2026 is acknowledged. Claims 24-37 are pending. Claims 31-37 are withdrawn from further consideration as being directed towards nonelected inventions. Claims 24-30 are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements filed on April 6th 2026, March 23rd 2026, and August 17th 2023 are in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
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.
Claim 24 and its dependent claims, 25-28 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.
Claim 24 recites the limitation "A method for treating the resistance of an anticancer drug or enhancing the sensitivity of an anticancer drug in a subject.” The claimed patient population of “subjects,” is interpreted as “any subject” (MPEP 2111.02). As such, the patient population in the context of the claimed method can be divided into four distinct populations:
Subjects who have previously received an anticancer drug and have developed a resistance to said anticancer drug.
Subjects who have previously received an anticancer drug and would have enhanced sensitivity to the drug upon administration of the method of claim 24.
Subjects who have NOT previously received an anticancer drug and have developed a resistance to said anticancer drug.
Subjects who have NOT previously received an anticancer drug and would have enhanced sensitivity to the drug upon administration of the method of claim 24.
Of these four patient populations, three have full support in the application, being:
Subjects who have previously received an anticancer drug and have developed a resistance to said anticancer drug.
Subjects who have previously received an anticancer drug and would have enhanced sensitivity to the drug upon administration of the method of claim 24.
Subjects who have NOT previously received an anticancer drug and would have enhanced sensitivity to the drug upon administration of the method of claim 24.
However, there is insufficient antecedent for the fourth patient population:
Subjects who have NOT previously received an anticancer drug and have developed a resistance to said anticancer drug.
As one cannot develop a resistance to an anticancer drug without having previously received said drug, there is insufficient antecedent basis to support the claimed patient population, and claim 24 and its dependent claims 25-28 are indefinite.
Note that as claims 29-30 require administration of the anticancer drug, the 112(b) rejection does not apply.
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 24-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Larsen (US 2016/0145251 A1 published on May 26th 2016).
Claims 24-26 are directed towards a method of treating resistance to/ enhancing the sensitivity of an anticancer drug via administration of the myocardin-related transcription factor A (MRTF A) inhibitor,
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to a subject.
It is noted that the described patient population of “a subject” is non-limiting and thus is directed towards the administration to any subject. See MPEP 2111.02:
"[A] claim preamble has the import that the claim as a whole suggests for it." Bell Communications Research, Inc. v. Vitalink Communications Corp., 55 F.3d 615, 620, 34 USPQ2d 1816, 1820 (Fed. Cir. 1995). "If the claim preamble, when read in the context of the entire claim, recites limitations of the claim, or, if the claim preamble is ‘necessary to give life, meaning, and vitality’ to the claim, then the claim preamble should be construed as if in the balance of the claim." Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165-66 (Fed. Cir. 1999). See also Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333, 68 USPQ2d 1154, 1158 (Fed. Cir. 2003) (In considering the effect of the preamble in a claim directed to a method of treating or preventing pernicious anemia in humans by administering a certain vitamin preparation to "a human in need thereof," the court held that the claims’ recitation of a patient or a human "in need" gives life and meaning to the preamble’s statement of purpose.).
Larsen teaches the treatment of cancers and other various diseases (Larsen, pg. 106, claims 31, 40) with the compound. As such, Larsen teaches administration of the drug to an equivalent patient population of “subjects,” and is anticipatory of claims 24-26.
Claim 27 limits the anticancer drug of claim 24 (i.e. the drug which has an increase in sensitivity after administration of the MRTF A inhibitor) to one selected from cisplatin, carboplatin, and oxaliplatin. It is noted that this limitation is only limiting to the effect of the method and not to the method itself (i.e. the claim would be interpreted as: “A method for treating the resistance of cisplatin, carboplatin, or oxaliplatin, or enhancing the sensitivity of cisplatin, carboplatin, or oxaliplatin, comprising administering an effective amount of an MRTF A inhibitor to a subject”). As the patient population receiving administration still remains “a subject,” Larsen is anticipatory of claim 27.
Claim Rejections - 35 USC § 103
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.
Claims 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen in view of Xu (Xu et al., MRTF-A can activate Nrf2 to increase the resistance to doxorubicin. Oncotarget. 2017 Jan 31;8(5):8436-8446).
Claim 28 is directed towards the method of claim 24, wherein the anticancer drug is also administered. For the teachings of Larsen as they relate to claim 24, see the above 102 rejection over Larsen. Regarding the combination therapy of the MRTF A inhibitor and an additional anticancer drug, one of ordinary skill in the art would have had a reasonable expectation of success in administering such a therapy, because MRTF A activation is known in the art to increase resistance to certain chemotherapeutic drugs. See Xu, who demonstrates that the activation of MRTF A in HeLa cells increases resistance of the cells to doxorubicin:
We found that the sensitivity of tumor cells with MRTF-A over expression to doxorubicin was significantly lower than that of normal tumor cells, and the up-regulation of anti-apoptotic genes and genes about drug resistance were also observed. However, when MRTF-A was disturbed, the above tendency was the opposite. All these showed that MRTF-A could increase the resistance of tumor cells.
[Xu, pg. 7]
Thereby, one of ordinary skill in the art would have a reasonable expectation of success in:
Decreasing resistance/increasing sensitivity of cancer cells to doxorubicin via administration of Larsen’s MRTF A inhibitor
Administering the doxorubicin as a chemotherapeutic agent to treat the cancer
As such, the combination therapy of the MRTF A inhibitor and doxorubicin, and consequently claim 28, is prima facie obvious.
Claim 29 is directed towards claim 28, wherein the anticancer drug administered is selected from a group that includes doxorubicin. Claim 29 is thereby prima facie obvious for the same reasons as claim 28.
Claims 30 is rejected under 35 U.S.C. 103 as being unpatentable over Larsen in view of Xu and in further view of Wang (Wang et al., MBNL1 regulates resistance of HeLa cells to cisplatin via Nrf2, Biochemical and Biophysical Research Communications, Volume 522, Issue 3, 2020, Pages 763-769).
Claim 30 is directed towards the method of claim 29 wherien the anticancer drug is selected from the group consisting of cisplatin, carboplatin, and oxaliplatin. For the teachings of Larsen and Xu as they are relevant to claim 29, see the above 103 rejection for claim 29. Regarding the platinum-based anticancer drug, one of ordinary skill in the art would have had a reasonable expectation of success in administering cisplatin alongside the MRTF A inhibitor because the regulation of cisplatin resistance is known in the art to be regulated in a manner similar to that of doxorubicin resistance (see the above 103 rejection for claim 28). See Wang, who demonstrates that the MBNL1 splicing protein causes an upregulation of Nrf2 degradation and that such degradation increases the sensitivity of HeLa cells to cisplatin.
Based on sequencing data mining, we predicted that MBNL1 might be involved in the occurrence and poor prognosis of cervical cancer, and verified that MBNL1 could regulate the resistance of HeLa cells to cisplatin via Nrf2.
[Wang, Abstract]
In HeLa cells with MBNL1 overexpressed, MTT was used to detect the sensitivity of cells to cisplatin. The results showed that MBNL1 overexpression could increase the resistance of HeLa to cisplatin (Fig. 2 A). When MBNL1 was silenced, HeLa cells’ sensitivity to cisplatin reduced correspondingly, (Fig. 2 B). Subsequently, some genes’ expression levels related to drug resistance were detected with real time RT-PCR and western in MBNL1 overexpressed or silenced HeLa cells (Fig. 2 E-H). It is worth noting that MBNL1 does not regulate the mRNA level of Nrf2, but can inhibit the protein level of Nrf2 (Fig. 2 E-H). To explore whether MBNL1 regulates HeLa cells’ resistance through Nrf2, shRNAs of Nrf2 were used to silence the expression of endogenous Nrf2. Then, MTT results showed MBNL1 could not regulate the sensitivity of HeLa cells to cisplatin, in the condition of Nrf2 was silenced (Fig. 2 I). Therefore, the above data preliminarily confirmed that MBNL1 could increase HeLa cells’ sensitivity to cisplatin through Nrf2.
[Wang, pg. 764-765, Results]
That is to say, the mechanism by which cisplatin resistance is regulated is by the degradation of Nrf2, and an upregulation of Nrf2 results in an increase in cisplatin sensitivity.
Regarding Xu, Xu demonstrates that MRTF A promotes the expression of Nrf2, thus increasing doxorubicin resistance, and that MRTF A has no effect on doxorubicin resistance when Nrf2 is knocked down (Xu, pg. 3). Thus, one of ordinary skill in the art would have a reasonable expectation of success in:
Administering the MRTF A inhibitor, expecting it to act in an opposite manner of the MRTF A protein, and thus promoting the degradation of Nrf2
Recognizing that the degradation of Nrf2 promotes sensitivity of cancer cells to cisplatin
Administering the cisplatin as a chemotherapeutic agent to treat the cancer
As such, the combination therapy of the MRTF A inhibitor and cisplatin, and consequently claim 30, is prima facie obvious.
Nonstatutory 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 24-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13, 16, and 26-28 of U.S. Patent No. 12,653,816 (reference patent; as of yet unpublished—note the claim rejections will be over the claims as listed in the claim set of Application No. 18/259,944 filed on December 30th 2025). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches a combination therapy of MRTF A inhibitors identical to those of the instant application, administered alongside additional drugs, such as cisplatin, to a patient population with stem-like subtype gastric cancer (encompassed by applicant’s patient population of “subjects”).
Conclusion
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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