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 .
Applicant’s amendments, filed 3/06/2026, is acknowledged.
Claims 2-6, 8-15, and 22 are cancelled.
Claims 1, 7, and 16-21 are currently pending.
Newly amended claim 16 is withdrawn, and claims 19-21 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions and/or Species.
Claims 1, 7, 17, and 18 are under examination as reading on a method of improving immune function in a cancer patient comprising administration of relacorilant and a taxane.
In view of the amendments and remarks filed on 3/06/2026, the following rejections remain.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 7, 17, and 18 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Hunt (U.S. PGPub 20180280378, on IDS filed 7/15/2022, in Office Action mailed 12/11/2025) as evidenced by Greenstein et al. (J Clin Oncol 38, 3091-3091(2020) doi: 10.1200/JCO.2020.38.15_suppl.3091, in Office Action mailed 12/11/2025). This is a new ground of rejection necessitated by Applicant’s amendments.
Applicant has amended instant claim 1 to recite a method of improving immune function in a cancer patient comprising administration of relacorilant/CORT125134 and a chemotherapeutic, wherein the improved immune function comprises a increase in CD3 T-cells, a decrease in Treg cells, a decrease in IL-10, and/or increased IFNγ.
Hunt teaches (Abstract): “…methods comprise administering to the subject an effective amount of a non-steroidal selective glucocorticoid receptor modulator (SGRM) and an effective amount of a chemotherapeutic…”
Hunt additionally teaches methods of treating a subject with cervical cancer with a combination of paclitaxel and CORT125134 (i.e., relacorilant; Example 2, Fig. 1, ¶[0137]): “Reducing Implanted Cervical Cancer Tumor Growth in Mice Using the Combination Therapy of CART125134 and Paclitaxel”. Hunt further teaches methods of treating a solid tumor comprising administration of nab-paclitaxel as the taxane (i.e., the limitations of instant claims 17 and 18; Hunt Claim 5).
Regarding the limitations “improving immune function” and the other function limitations recited in instant claims 1 and 7, Hunt is silent on the properties, However these functional limitations are considered inherent properties of the method of treatment comprising administration of relacorilant and nab-paclitaxel.
To support the position that the functional limitations recited in the claims are an inherent property of a method of treatment comprising administration of relacorilant and nab-paclitaxel, Greenstein et al. is provided as an evidentiary reference. Greenstein et al. teaches that a method of treating cancer comprising administration of relacorilant and nab-paclitaxel leads to an improvement in immune function in patients (Results): “Relacorilant Improves Immune Activity in Patients with Durable Response”. Patients with solid tumors that were treated with relacorilant and nab-paclitaxel had increased CD3+ T-cell counts 8 days after treatment (Fig. 11), and increased IFNγ on day 15 (Fig. 11 and Results): “Plasma cytokine levels: Increase in IFNγ (P=0.03)”, meeting the functional limitations recited in claims 1 and 7.
When a claim recites using an old composition or structure (e.g., method of treatment comprising administration of nab-paclitaxel and relacorilant) and the use is directed to a result or property of that composition or structure (properties recited in claims 1 and 7) then the claim is anticipated. See MPEP 2112.02. Also, see Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc. 58 USPQ2d 1508 (CA FC 2001); Ex parte Novitski 26 USPQ 1389 (BPAI 1993); Mehl/Biophile International Corp. V. Milgraum, 52 USPQ2d 1303 (Fed. Cir. 1999); Atlas Powder Co. V. IRECO, 51 USPQ2d 1943 (Fed. Cir. 1999).
The Courts have held that there is no requirement that those of ordinary skill in the art know of the inherent property. See MPEP 2131.01(d) and MPEP 2112 - 2113.
Applicant’s arguments, filed 3/06/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that Greenstein et al. is not a prior art and Hunt does not teach the functional limitations recited in claims 1 and 7.
However, it is Examiner’s position that these functional results are an inherent property of a method of treating cancer comprising administration of relacorilant and nab-paclitaxel. Greenstein et al. is not used as a prior art for the purposes of rejection, this is used as an evidentiary reference to support the positions that these functional results are an inherent property of this method, which is taught by Hunt.
Hunt et al. teaches a method of treating cancer comprising administration of relacorilant and nab-paclitaxel (see supra). The difference in the method of treatment encompassed by the instant claims and the method of treatment taught by Hunt are patient outcomes resulting from use of this method (“improving immune function”, “increased CD3+ cells”, “decreased numbers of Treg cells”, “decreased IL-10”, and/or “increased IFNγ”; and “improved after 1 or more days”), and thus the claim is anticipated. See the discussion of inherent properties supra.
Claims 1, 7, 17, and 18 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Clinical trial NCT0276981 (Version 20180313, clinicaltrials.gov/study/NCT02762981, in Office Action mailed on 12/11/2025), as evidenced by Greenstein et al. (supra). (J Clin Oncol 38, 3091-3091(2020) doi: 10.1200/JCO.2020.38.15_suppl.3091). This is a new ground of rejection necessitated by Applicant’s amendments.
NCT0276981 teaches a method of treating solid tumors in cancer patients comprising administration of a combination of CORT125134 (i.e., relacorilant) and nab-paclitaxel (“Brief Title” and “Arms and Interventions”, emphasis added):
“[s]tudy to Evaluate CORT125134 in Combination With Nab-paclitaxel in Patients With Solid Tumors…[p]atients will be treated with CORT125134 in combination with nab-paclitaxel at escalating dose levels”.
NCT0276981 additionally teaches that CORT125134 is a GR antagonist (“Brief Summary”): “…CORT125134, a novel glucocorticoid receptor (GR) antagonist…”
Thus, NCT0276981 teaches the limitations of instant claims 1, 17, and 18.
Regarding the limitations “improving immune function” and the other functional limitations recited in instant claims 1 and 7, NCT0276981 is silent on these properties, these are considered inherent properties of the method of treatment comprising administration of the compounds nab-paclitaxel and relacorilant for the reasons discussed in the first 35 USC 102 rejection supra.
The reference teachings anticipate the claimed invention.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1, 7, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over WO2017151613 (in Office Action mailed 12/11/2025) in view of Clinical Trial NCT02752685 (version 11/28/2018, clinicaltrials.gov/study/NCT12752685, in Office Action mailed 12/11/2025), as evidenced by Greenstein et al. (J Clin Oncol 38, 3091-3091(2020) doi: 10.1200/JCO.2020.38.15_suppl.3091, in Office Action mailed 12/11/2025, supra). This is a new ground of rejection necessitated by Applicant’s amendment.
WO2017151613 teaches methods of treating breast cancer (i.e. “a solid tumor) in a subject comprising administration of CORT125134 (i.e., relacorilant) and the anti-PD-1 immune checkpoint antibody pembrolizumab (Example 6). Imaging indicated that the tumor size in a patient had reduced by more than 20% (Example 6 ¶[0188]).
NCT02752685, in the same field of endeavor, teaches a combination therapy of nab-paclitaxel and pembrolizumab to treat breast cancer in patients (“Brief Summary” section).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have combined the breast cancer therapies involving the checkpoint inhibitor pembrolizumab taught by WO2017151613 and NCT02752685 to make a therapy comprising pembrolizumab, nab-paclitaxel, and relacorilant to treat breast cancer with a reasonable expectation of success, as all the references are concerning cancer therapies involving checkpoint inhibitors to treat breast cancer. One would have been motivated to make this change to treat breast cancer with a combination therapy of all three compounds to enhance the potency of the anti-cancer therapy.
Additionally, it is prima facie obvious to combine two compositions each of which is taught by prior art to be useful for same purpose in order to form third composition that is to be used for very same purpose; idea of combining them flows logically from their having been individually taught in prior art. In re Kerkhoven, 205 USPQ 1069, CCPA 1980. See MPEP 2144.06. In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
Regarding the functional limitations recited in claims 1 and 7, these method outcomes are considered to be inherent properties of the combination therapy taught by WO2017151613 in view of NCT0272685. To support the position that the functional limitations recited in the claims are an inherent property of a method of treatment comprising administration of relacorilant and nab-paclitaxel, Greenstein et al. is provided as an evidentiary reference. Greenstein et al. teaches that a method of treating cancer comprising administration of relacorilant and nab-paclitaxel leads to an improvement in immune function in patients (Results): “Relacorilant Improves Immune Activity in Patients with Durable Response”. Patients with solid tumors that were treated with relacorilant and nab-paclitaxel had increased CD3+ T-cell counts 8 days after treatment (Fig. 11), and increased IFNγ on day 15 (Fig. 11 and Results): “Plasma cytokine levels: Increase in IFNγ (P=0.03)”, meeting the functional limitations recited in claims 1 and 7.
Additionally, the functions recited in the wherein clauses of the claims flow naturally from the teachings of the prior art. (citing Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985 (“The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.”), and Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999) (“[T]he discovery of... a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer.”)).
An obvious formulation cannot become nonobvious simply by measuring and claiming an activity of the formulation in a particular context, “because ‘[t]o hold otherwise would allow any formulation—no matter how obvious—to become patentable merely by testing and claiming an inherent property.’” Persion Pharm., slip op. at 13 (Fed. Cir. Dec. 27, 2019) (citing Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344, 1354 (Fed. Cir. 2012)); see also Gen. Elec. Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242, 249 (1945) (“It is not invention to perceive that the product which others had discovered had qualities they failed to detect.”).
Applicant’s arguments, filed 3/06/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that WO2017151613 fails to teach all elements of the recited method of treatment (Remarks pg. 10): “…WO2017151613 lacks any mention or discussion of paclitaxel, or nab-paclitaxel, or taxanes. However, the present claimed methods require a chemotherapeutic agents comprising a taxane.” Applicant further argues that WO2017151613 does not teach the function outcomes recited in the instant claims (Remarks pg. 10-11).
Applicant argues that NCT02752685 also fails to teach the methods outcome limitations of the recited method of treatment (Remarks pg. 11): “…NCT0275685, entitled…, fails to provide or to suggest elements missing from WO2017151613…”
Applicant further argues that the combination of the references does not teach the methods functional outcomes (Remarks pg. 12): “…both WO2017151613 and NCT0272685 lack at least the claim aelements of administration of both relacorilant and a chemotherapeutic agent comprising a taxane; of comparing levels of CD3+ cells, TregS cells, IL-10, and IFNγ…”
This has been found to be not convincing.
In response to applicant’s arguments against the references individually, one cannot show non-obviousness by attacking references individually where the rejections are based on combination of references. See MPEP 2145. Contrary to applicant’s arguments against the references individually, note that One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. Where an applicant’s reply establishes that each of the applied references fails to teach a limitation and addresses the combined teachings and/or suggestions of the applied prior art, the reply as a whole does not attack the references individually as the phrase is used in Keller and reliance on Keller would not be appropriate. This is because "[T]he test for obviousness is what the combined teachings of the references would have suggested to [a PHOSITA]." In re Mouttet, 686 F.3d 1322, 1333, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012). See MPEP 2145 IV.
It is noted that in considering the disclosure of a reference, it is proper to take into account not only specific teaching of the reference but also the inferences which one skilled in the art would be reasonably be expected to draw therefrom. In re Preda, 401 F.2d 825, 159 USPQ 342, 344 (CCPA 1968). See MPEP 2144.01.
Furthermore, specific statements in the references themselves which would spell out the claimed invention are not necessary to show obviousness, since questions of obviousness involves not only what references expressly teach, but what they would collectively suggest to one of ordinary skill in the art. See CTS Corp. v. Electro Materials Corp. of America 202 USPQ 22 (DC SNY ); and In re Burckel 201 USPQ 67 (CCPA). In re Burckel is cited in MPEP 716.02.
Here, given the teachings of WO2017151613 teaching a method of treating breast cancer in a subject comprising administration of CORT125134; and NCT02752685 teaching a method of treating breast cancer comprising administration of nab-paclitaxel, the ordinary artisan at the time of the invention would have had a reasonable expectation of success to combine these therapies to try to make a combination therapy that is more potent at treating breast cancer than the individual therapies alone.
Additionally, in response to Applicant’s arguments that the combined references do not teach the functional outcomes recited in the instant claims, it is Examiner’s positions that these functional outcomes are inherent properties of the method taught by the combined references of WO2017151613 and NCT02752685, as evidenced by Greenstein et al., as discussed supra. An obvious formulation cannot become nonobvious simply by measuring and claiming an activity of the formulation in a particular context, “because ‘[t]o hold otherwise would allow any formulation—no matter how obvious—to become patentable merely by testing and claiming an inherent property.’” Persion Pharm., slip op. at 13 (Fed. Cir. Dec. 27, 2019) (citing Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344, 1354 (Fed. Cir. 2012)); see also Gen. Elec. Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242, 249 (1945) (“It is not invention to perceive that the product which others had discovered had qualities they failed to detect.”).
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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, 7, 17, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,440,487 (Pat '487, in Office Action mailed on 12/11/2025), as evidenced by Greenstein et al. (J Clin Oncol 38, 3091-3091(2020). Doi:10.1200/JCO.2020.38.15_suppl.3091, in Office Action mailed on 12/11/2025, supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendment.
Pat ‘487 claims a method of reducing neutrophil-to-lymphocyte ratio (i.e., “improving immune function”) in a cancer patient with a solid tumor comprising administration of relacorilant (claim 1) and nab-paclitaxel (i.e., the limitations of instant claims 1, 17, and 18; Pat ‘487 claim 19).
Regarding the limitations “improving immune function” and the other functional limitations recited in instant claims 1, 7, and 22, Pat ‘487 is silent on these properties. However, these functional limitations are considered inherent properties of the method of treatment comprising administration of the compounds relacorilant and nab-paclitaxel for the same reasons discussed in the 35 U.S.C. § 102 rejection supra.
Applicant’s arguments, filed 3/06/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that Greenstein et al. is not a prior art, and Pat ‘487 does not claim the same function outcomes as the instant application (Remarks pg. 13-14). However, these arguments have been found to be not convincing for the same reasons discussed in the 35 U.S.C. § 102 rejection supra.
The invention encompassed by Pat ‘487, as evidenced by Greenstein et al., anticipates the claimed invention.
Claims 1, 7, 17, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,234,971 (Pat ‘971, in Office Action mailed on 12/11/2025), as evidenced by Greenstein et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendment.
Pat ‘971 claims methods of treating cancer in a subject (claim 1) comprising administration of a nab-paclitaxel (claim 24) and relacorilant (claim 2). Pat ‘971 additionally defines cancers/tumors to include solid tumors such as carcinomas and adenocarcinomas (Col. 12, lines 48-56).
Pat ‘971, as evidenced by Greenstein et al., anticipates the invention encompassed by the instant claims for the same reasons discussed for Pat ‘487 supra.
Applicant’s arguments, filed 3/06/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that Greenstein et al. is not a prior art, and Pat ‘971 does not claim the same function outcomes as the instant application (Remarks pg. 14). However, these arguments have been found to be not convincing for the same reasons discussed in the 35 U.S.C. § 102 rejection supra.
Pat ‘971, as evidenced by Greenstein et al., anticipates the invention encompassed by the instant claims.
Claims 1, 7, 17, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,285,145 (Pat ‘145, in Office Action mailed on 12/11/2025), as evidenced by Greenstein et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendment.
Pat ‘145 claims a method of treating cancer in a subject comprising administration of relacorilant and paclitaxel (claim 1), including nab-paclitaxel (claim 4), and treating solid tumors (claim 22).
Pat ‘145, as evidenced by Greenstein et al., anticipates the invention encompassed by the instant claims for the same reasons discussed for Pat ‘487 supra.
Applicant’s arguments, filed 3/06/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that Greenstein et al. is not a prior art, and Pat ‘145 does not claim the same function outcomes as the instant application (Remarks pg. 14). However, these arguments have been found to be not convincing for the same reasons discussed in the 35 U.S.C. § 102 rejection supra.
Pat ‘145, as evidenced by Greenstein et al., anticipates the invention encompassed by the instant claims.
Claims 1, 7, 17, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,389,432 (Pat ‘432, in Office Action mailed on 12/11/2025), as evidenced by Greenstein et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendment.
Pat ‘432 claims methods of treating cancer in a subject comprising administration of relacorilant and a chemotherapy (claim 1), wherein the chemotherapy is nab-paclitaxel (claim 19). Pat ‘432 additionally defines cancers/tumors to include solid tumors such as carcinomas and adenocarcinomas (Col. 12, lines 11-20).
Pat ‘432, as evidenced by Greenstein et al., anticipates the invention encompassed by the instant claims for the same reasons discussed for Pat ‘487 supra.
Applicant’s arguments, filed 3/06/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that Greenstein et al. is not a prior art, and Pat ‘432 does not claim the same function outcomes as the instant application (Remarks pg. 13-14). However, these arguments have been found to be not convincing for the same reasons discussed in the 35 U.S.C. § 102 rejection supra.
Pat ‘432, as evidenced by Greenstein et al., anticipates the invention encompassed by the instant claims.
Claims 1, 7, 17, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,944,617 (Pat ‘617, in Office Action mailed on 12/11/2025), as evidenced by Greenstein et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendment.
Pat ‘617 claims a method of treating cancer in a subject comprising administration of relacorilant and paclitaxel (claim 1), including nab-paclitaxel (claim 4), and treating solid tumors (claim 7).
Pat ‘617, as evidenced by Greenstein et al., anticipates the invention encompassed by the instant claims for the same reasons discussed for Pat ‘487 supra.
Applicant’s arguments, filed 3/06/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that Greenstein et al. is not a prior art, and Pat ‘617 does not claim the same function outcomes as the instant application (Remarks pg. 15). However, these arguments have been found to be not convincing for the same reasons discussed in the 35 U.S.C. § 102 rejection supra.
Pat ‘617, as evidenced by Greenstein et al., anticipates the invention encompassed by the instant claims.
Claims 1, 7, 17, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,109,272 (Pat ‘272, in Office Action mailed on 12/11/2025), as evidenced by Greenstein et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendment.
Pat ‘272 claims a method of treating cervical cancer (i.e., “a solid tumor) in a subject comprising administration of relacorilant and nab-paclitaxel (claim 1).
Pat ‘272, as evidenced by Greenstein et al., anticipates the invention encompassed by the instant claims for the same reasons discussed for Pat ‘487 supra.
Applicant’s arguments, filed 3/06/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that Greenstein et al. is not a prior art, and Pat ‘272 does not claim the same function outcomes as the instant application (Remarks pg. 15). However, these arguments have been found to be not convincing for the same reasons discussed in the 35 U.S.C. § 102 rejection supra.
Pat ‘272, as evidenced by Greenstein et al., anticipates the invention encompassed by the instant claims.
Claims 1, 7, 17, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,980,797 (Pat ‘797, in Office Action mailed on 12/11/2025) in view of Soliman (Onco Targets Ther. 2016 Dec 21;10:101-112. doi: 10.2147/OTT.S122974, in Office Action mailed on 12/11/2025), as evidenced by Greenstein (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendment.
Pat ‘797 claims a method of treating a solid tumor in a cancer patient comprising administration of a checkpoint inhibitor (i.e., “a cancer treatment”) and a selective glucocorticoid receptor antagonist (claim 1), including relacorilant (CORT125134; Pat ‘797 claim 6).
Pat ‘797 does not claim methods of treatment comprising administration of relacorilant and nab-paclitaxel (i.e., the limitations of instant claims 1, 17, and 18), or the functional limitations of instant claims 1 and 7.
Soliman, in the same field of endeavor, teaches chemotherapy agents can act to “prime” the immune system of cancer patients that can help elicit a T-cell response when used prior to or in conjunction with a checkpoint inhibitor (pg. 103, “Chemotherapy in combination with checkpoint inhibitors”). Soliman further teaches that multiple studies have demonstrated that a combination of chemotherapy and checkpoint inhibition improved outcomes (pg. 106): “[t]aken together, these trials indicate that giving chemotherapy before immunotherapy lead sot better outcomes…”
Soliman further teaches that nab-paclitaxel combined with checkpoint inhibitors led to augmented antitumor responses in solid tumors (pg. 107): “…early data suggests that nab-paclitaxel-based therapy may augment the antitumor activity of these agents.”
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have modified the invention of Pat ‘797 in view of Soliman to make a method of treating a solid tumor comprising administration of a checkpoint inhibitor, relacorilant, and nab-paclitaxel with a reasonable expectation of success, as both references are teaching methods of treating solid tumors in patients. One would have been motivated to make this change to enhance the anti-tumor effect of the administered checkpoint inhibitors by using nab-paclitaxel. Additionally, it is prima facie obvious to combine two compositions each of which is taught by prior art to be useful for same purpose in order to form third composition that is to be used for very same purpose; idea of combining them flows logically from their having been individually taught in prior art. In re Kerkhoven, 205 USPQ 1069, CCPA 1980. See MPEP 2144.06. In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
Regarding the functional limitations recited in claims 1 and 7, these are considered inherent properties of the method of treatment taught by Pat ‘797 in view of Soliman, as evidenced by Greenstein, for the same reasons discussed in the 35 U.S.C. § 103 rejection supra.
Applicant’s arguments, filed 3/06/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that, and Pat ‘797 nor Soliman claim the same functional outcomes as the instant application (Remarks pg. 15-16). However, these arguments have been found to be not convincing for the same reasons discussed in the 35 U.S.C. § 103 rejection supra.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘797 in view of Soliman, as evidenced by Greenstein et al.
Claims 1, 7, 17, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12,171,760 (Pat ‘760, in Office Action mailed on 12/11/2025) in view of Soliman (supra), as evidenced by Greenstein (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendment.
Pat ‘760 claims methods of treating cancers, including prostate cancer (i.e., “a solid tumor”; claim 5), comprising administration of CORT125134 (i.e., relacorilant) and a checkpoint inhibitor (claim 1). Thus, Pat ‘760 claims the limitations of instant claims 1, 8, and 9.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘760 in view of Soliman, as evidenced by Greenstein et al. for the same reasons discussed for Pat ‘797 supra.
Applicant’s arguments, filed 3/06/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that, and Pat ‘760 nor Soliman claim the same functional outcomes as the instant application (Remarks pg. 16). However, these arguments have been found to be not convincing for the same reasons discussed in the 35 U.S.C. § 103 rejection supra.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘760 in view of Soliman, as evidenced by Greenstein et al.
Claims 1, 7, 17, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No 12,616,685 (Pat ‘685, in Office Action mailed on 12/11/2025 as Application 17/330,987), as evidenced by Greenstein et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendment.
Copending Application 17/330,987 has been patented as Patent No. 12,616,685 since the mailing of the last office action.
Pat ‘685 claims methods of treating cancer comprising administration of relacorilant (claim 1), further comprising nab-paclitaxel (claim 7), wherein the cancer is ovarian cancer (i.e., “a solid tumor”; claim 6).
Pat ‘685, as evidenced by Greenstein et al. anticipates the invention encompassed by the instant claims for the same reasons discussed for Pat ‘487 supra.
Applicant’s arguments, filed 3/06/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that Greenstein et al. is not a prior art, and Pat ‘685 does not claim the same function outcomes as the instant application (Remarks pg. 17). However, these arguments have been found to be not convincing for the same reasons discussed in the 35 U.S.C. § 102 rejection supra.
Pat ‘685, as evidenced by Greenstein et al., anticipates the invention encompassed by the instant claims.
Claims 1, 7, 17, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No 12,589,094 (Pat ‘094), as evidenced by Greenstein et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendment.
Pat ‘094 claims methods of treating a solid tumor comprising administration of nab-paclitaxel and relacorilant (claims 1 and 4).
Pat ‘094, as evidenced by Greenstein et al. anticipates the invention encompassed by the instant claims for the same reasons discussed for Pat ‘487 supra.
Claims 1, 7, 17, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 18/460,226 (App ‘226, in Office Action mailed on 12/11/2025), as evidenced by Greenstein et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendment.
App ‘226 claims methods of treating cancer comprising administration of a SGRM and a cancer therapy (claim 1), including ovarian cancer (i.e., “a solid tumor”; claim 3), wherein the SGRM is relacorilant (claim 4), and the cancer therapy is nab-paclitaxel (claim 5).
App ‘226, as evidenced by Greenstein et al. anticipates the invention encompassed by the instant claims for the same reasons discussed for Pat ‘487 supra.
Applicant’s arguments, filed 3/06/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that Greenstein et al. is not a prior art, and App ‘226 does not claim the same function outcomes as the instant application (Remarks pg. 16-17). However, these arguments have been found to be not convincing for the same reasons discussed in the 35 U.S.C. § 102 rejection supra.
App ‘226, as evidenced by Greenstein et al., anticipates the invention encompassed by the instant claims. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 7, 17, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-7, 11-15, and 21-30 of copending Application No. 18/797,328 (App ‘328, in Office Action mailed on 12/11/2025), as evidenced by Greenstein et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendment.
App ‘328 claims methods of treating cancer comprising administration of relacorilant and a cancer therapy (claim 1), including ovarian cancer (i.e., “a solid tumor”; claim 3), wherein the cancer therapy is nab-paclitaxel (claim 5).
App ‘328, as evidenced by Greenstein et al. anticipates the invention encompassed by the instant claims for the same reasons discussed for Pat ‘487 supra.
Applicant’s arguments, filed 3/06/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that Greenstein et al. is not a prior art, and App ‘328 does not claim the same function outcomes as the instant application (Remarks pg. 17). However, these arguments have been found to be not convincing for the same reasons discussed in the 35 U.S.C. § 102 rejection supra.
App ‘328, as evidenced by Greenstein et al., anticipates the invention encompassed by the instant claims. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 7, 17, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 7, 9, 11, 13, and 35 of copending Application No. 17/792,675 (App ‘675, in Office Action mailed on 12/11/2025), as evidenced by Greenstein et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendment.
App ‘675 claims methods of treating adrenocortical carcinoma (i.e., “a solid tumor”) an SGRM (claim 1), wherein the SGRM is relacorilant (claim 11), and the method further comprises administration of nab-paclitaxel (claim 9).
App ‘675, as evidenced by Greenstein et al. anticipates the invention encompassed by the instant claims for the same reasons discussed for Pat ‘487 supra.
Applicant’s arguments, filed 3/06/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that Greenstein et al. is not a prior art, and App ‘675 does not claim the same function outcomes as the instant application (Remarks pg. 17). However, these arguments have been found to be not convincing for the same reasons discussed in the 35 U.S.C. § 102 rejection supra.
App ‘675, as evidenced by Greenstein et al., anticipates the invention encompassed by the instant claims. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 7, 17, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 12-15, and 19-29 of copending Application No. 18/940,632 (App ‘632, in Office Action mailed on 12/11/2025) in view of Soliman (supra), as evidenced by Greenstein et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendment.
App ‘632 claims methods of treating cancer comprising administration of CORT125134 (i.e., relacorilant) and a checkpoint inhibitor (claim 1), including solid tumors such as breast cancer and prostate cancer (claim 13).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘632 in view of Soliman, as evidenced by Greenstein et al., for the same reasons discussed for Pat ‘797 supra.
Applicant’s arguments, filed 3/06/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that neither App ‘632 nor Soliman claim the same functional outcomes as the instant application (Remarks pg. 18). However, these arguments have been found to be not convincing for the same reasons discussed in the 35 U.S.C. § 103 rejection supra.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘632 in view of Soliman, as evidenced by Greenstein et al. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 7, 17, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18/670,160 (App ‘160, in Office Action mailed on 12/11/2025) in view of Demeure et al. (Ann Surg. 2012 Jan;255(1):140-6. doi: 10.1097/SLA.0b013e3182402d21, in Office Action mailed on 12/11/2025). This is a new ground of rejection necessitated by Applicant’s amendment.
App ‘160 claims methods of treating an adrenal gland tumor (i.e., “a solid tumor”) in a subject comprising administration of SGRMs (claim 1), including relacorilant (claim 2).
App ‘160 does not claim a combination therapy comprising nab-paclitaxel and relacorilant, nor the function limitations recited in instant claims 1, 7, and 22.
Demeure et al., in the same field of endeavor, teaches nab-paclitaxel as a potential treatment for adrenocortical cancer (i.e., an “adrenal gland tumor”; Title). Demeure et al. teaches that nab-paclitaxel is effective at reducing adrenal gland tumor cells in two mouse xenograft models (“In vitro and in vivo data” section and Figure 2).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant application, to have combined the adrenal gland tumor therapies of App ‘160 and Demeure et al. to make a combination therapy of both compounds to treat the tumors. It is prima facie obvious to combine two compositions each of which is taught by prior art to be useful for same purpose in order to form third composition that is to be used for very same purpose; idea of combining them flows logically from their having been individually taught in prior art. In re Kerkhoven, 205 USPQ 1069, CCPA 1980. See MPEP 2144.06. In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
Regarding the functional limitations recited in claims 1 and 7, these are considered inherent properties of the method of treatment taught by App ‘160 in view of Soliman, as evidenced by Greenstein, for the same reasons discussed in the 35 U.S.C. § 103 rejection supra.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘160 in view of Demeure et al. in absence of evidence to the contrary. This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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.
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/ALEC JON PETERS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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