DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant's election with traverse of Group I (claims 1-13) with species, (SGRM): relacorilant; (cancer therapeutics): a. taxane; and (disease/disorder): a. cancer in the reply filed on June 3, 2026 is acknowledged. The traversal is on the ground(s) that “…for at least the reason that claims 1-13 and claims 14-30 encompass related and overlapping subject matter, such that search and examination of all claims together would be more efficient and better use of USPTO resources than would search and examination of claims 14-30 separately from search and examination of claims 1-13.”, see Remarks, page 2. This is not found persuasive because as noted in the Requirement mailed April 22, 2026, the two different methods are down to materially different designs and method endpoints. Moreover, the species differ in functional properties and composition.
The requirement is still deemed proper and is therefore made FINAL.
3. Claims 1-30 are pending.
Claims 8, 9, 11 and 14-30, drawn to non-elected species and non-elected inventions are withdrawn from examination.
Claims 1-7, 10, 12 and 13 are examined on the merits with species,
(SGRM): relacorilant; (cancer therapeutics): a. taxane; and (disease/disorder): a. cancer.
Claim Rejections - 35 USC § 101
4. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
5. The claimed invention (claims 1-7, 10, 12 and 13) is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because they read on a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract) without significantly more.
The claimed invention (claims 1-7, 10, 12 and 13) is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract) without significantly more. The claim(s) recite(s) method for identifying cancer patients that are likely to benefit from the administration of a selective glucocorticoid receptor modulator (SGRM), elected species relacorilant and a cancer therapeutic based upon the difference in the measure of RNA encoding a gene selected from CDKN1C, TNFSF17, BRIP1, PDK1, CLEC10A, FRP3, CCR2, LILRB4 or CD86 between the cancer patient’s baseline level and a sample from said patient, wherein a change of said RNA level that is at least 40% as compared to the baseline level identifies the cancer patient as likely to benefit from the said administration, thereby proceeding to further administration of the treatment modality and hence treating said identified cancer patient.
The judicial exception is not integrated into a practical application because a biological sample assessed for a baseline measure and/or before and after the administration of a treatment modality required to use the correlation does not add a meaningful limitation to the method as they are insignificant extra-solution activity. Moreover, the cancer therapeutic is not named and the claims do not set forth any conditions, nor circumstances when there is no change in the RNA level or the change is less than 40%. These situations, as well as the cited claimed invention are not integrated into a practical application. The claim(s) do/does not include additional elements that are sufficient to amount to significantly more than the judicial exception because it does not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
The analysis as set forth in the 2019 Guidance is as follows:
Step 1: Yes, claims are drawn to a method which is one of the four statutory categories, a process.
Step 2A, prong 1: Yes, the claims recite/describe/set forth a judicial exception. The claim describes the relationship between the level of RNA encoding a gene before and after the administration of a SGRM and a cancer therapeutic and likelihood of the cancer patient benefiting from the treatment modality when a change of said RNA level is at least 40% as compared to the baseline level identifies the cancer patient as one, whom will benefit from the treatment modality and continuing the treatment. The claims describe the relationship between the difference in RNA encoding genes within the baseline sample compared with a sample obtained from the cancer patient after treatment, wherein a change in the RNA level that is at least 40% between the two sets of samples is predictive of outcome or response to treatment.
Step 2A, prong 2: No, the judicial exception is not integrated into a practical application. The claims do not rely on or use the exception here. Once the baseline RNA level is assessed and there is a change in the post-treatment sample of at least 40% when evaluating differences in level, the cancer patient is identified as likely to benefit from said treatment and the administration of the SGRM and cancer therapeutic should continue thereby the identified patient is suggested to benefit from the treatments. There are no additional elements or combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
Step 2B: There is no inventive concept present in the clams. The steps of analyzing, measuring and determining RNA encoding gene levels in a cancer patient’s biological sample before and after treatment with a SGRM and a cancer therapeutic is established by well understood, routine conventional methods, and in addition they are pre-solution activity, i.e. data gathering necessary to perform the correlation. The following claims and steps inform one of ordinary skilled in the art, the level(s) of RNA encoding gene(s) between two different samples from the cancer patient at two different time points, before cancer treatment and after cancer is indicative of the impact of the cancer treatment, as well as the outcome of the treatment and response to said treatment. The claims do not recite additional elements that amount to significantly more than the judicial exception. Accordingly, these claims are not be eligible under step 2A or step 2B.
Claims 1-7, 10, 12 and 13 are drawn to a non-statutory method having a "natural principle" as a limiting element or step without reciting additional elements/steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself. In the instant case, the "natural principle" is: detecting differences in RNA levels between samples before and after cancer treatments ascertained at a designated level is indicative of benefit from the SGRM and any cancer therapeutic with the continuance of the treatment modality. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because assaying for candidate cancer biomarkers does not add significantly more and is not an inventive concept. Because methods for making such determinations were well known in the art, these steps simply tell researchers to engage in well-understood, routine, conventional activity previously engaged in by scientists in the field. Such activities are normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such law. Detection of RNA levels by standard technology has been observed by applicant but not engineered by applicant. The claims do not add significantly more to the natural phenomenon because the claims do not require a novel reagent, novel apparatus or incorporate a novel treatment based on the correlation.
A claim that focuses on use of a natural principle must also include additional elements or steps to show that the inventor has practically applied, and added something significant to, the natural principle itself. See Mayo, 101 USPQ2d at 1966. A recited element such as “identifying” and “measuring” based on the natural principle imposes no meaningful limit on the performance of the claimed invention. As set forth the claims do not impose meaningful limits on the performance of the claimed invention. Patents cannot be obtained on subject matter identified by the courts as being exempted from eligibility (i.e., laws of nature, natural phenomenon, and abstract ideas). Further, the active method steps are conventional and routine in the art for the reasons stated above and the claims do not amount to significantly more than the recited natural principle. The claims do not "practically apply" the natural principle; rather, the claims "simply inform" the natural principle to one performing routine active method steps and do not amount to significantly more than the natural principle itself. Thus, the technology used by the instant claims is well-known in the art and does not contribute significantly more to the judicial exception. See the 2019 Revised Patent Subject Matter Eligibility Guidance and Federal Register https://www.federalregister.gov/documents/2019/10/18/2019-22782/october-2019-patent-eligibility-guidance-update; and FDsys.gov.
Claim Rejections - 35 USC § 103
6. 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.
7. Claim(s) 1-7, 10, 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunt, et al., US 2020/0147073 A1 (published May 14, 2020), and further in view of Poussin et al., US 2019/0244677 A1 (published August 8, 2019), He et al., (Journal Cell Mol. Med. 25: 3391-3399, online 9 April 2021) and Stampone et al. (Int. J. Mol. Sci. 19(4): 1-24, published 2 April 2018). Hunt teaches treating cancers, ovarian and prostate with a combination of therapies, including non-steroidal selective glucocorticoid receptor modulator (SGRM) with a chemotherapeutic agent, see page 1, sections 0008, 0009 and 0011; page 3, sections 0017 and 0023; and segment I. on page 16. The SGRM is CORT125134, relacorilant with the same chemical name and structure as cited in claim 4 spanning pages 48 and 49 of claim set submitted September 1, 2021, see page 3, section 0017. The chemotherapeutic agent is a taxane including nab-paclitaxel, see page 1, section 0009; and section 0163 bridging pages 15 and 16.
Hunt teaches assaying expression of tumor-specific biomarkers, “…measuring the expression levels of a tumor-specific genetic marker…” including mRNA of the [genetic] marker…” isolated from a patient’s blood sample, see page 17, sections 0172 and 0173. Absent evidence to the contrary the blood sample is whole blood.
“Typically the levels of the tumor-specific genetic marker are measured in multiple samples taken over time of the combination therapy of the invention, and a decrease in levels correlates with a reduction in tumor load.”, see page 17, section 0173.
Hunt does teach assessing hallmarks of effective and beneficial treatment after the administration of the combinatorial treatment, see page 17, sections 0176 and 0177.
Hunt does not teach identifying a patient with cancer likely to benefit from administration of SGRM and cancer therapeutic, wherein the RNA encodes the genes, Cyclin-dependent kinase inhibitor 1C (CDKN1C) and C-type lectin domain family 10, member A (CLEC10A) was measured before said combinatorial treatment and after combinatorial treatment, wherein a change of said RNA level that is at least 40% as compared to the sample before the treatment or at baseline identifies the cancer patient as likely to benefit from administration of said combinatorial treatment and continuing said administration of the SGRM and the cancer therapeutic to said patient identified as likely to benefit from said treatment, thereby treating said identified cancer patient.
Poussin teaches methods for assessing genes within a data set including CDKN1C and CLEC10A amongst other genes in a subject’s sample, whole blood, see page 8, sections 0087-0091; and page 12, section 0125. He teaches CLEC10A RNA was assayed via expression profiling data and the expression level of this molecule affects organ systems including ovarian and pancreatic and a prognostic biomarker correlated with clinical pathologic features, see page 3391; page 3392, segment 2.1; page 3398, column (col.) 1, 2nd paragraph; and entire document. And Stampone teaches CDKN1C also known p57Kip2 is able to be measured in several different cancers including pancreatic adenocarcinomas, prostate cancer and ovarian cancers, see page 11, segment 3.2.; and entire document.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assay at different time points the RNA encoding genes, CDKN1C and CLEC10A in diverse cancer cell types with glucocorticoid receptor (GR) mediated signaling pathways, which is known to influence cancer treatment, see Hunt, Background and Summary spanning pages 1-3; and both He and Stampone in their entirety. One of ordinary skill in the art would have been motivated to assay biomarkers in different cell types, measure the RNA encoding the biomarker genes to accurately profile the gene expression products of interest before and after SGRM treatment to determine fi the glucocorticoid signaling had a positive or negative effect with a reasonable expectation of success exemplified in the said prior art documents, particularly, Hunt, see all documents in their entirety.
Moreover, one of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success exemplified in all prior art documents, wherein these molecules are predictors of prognosis and avail themselves as immunotherapy targets, see all documents in their entirety.
Conclusion
8. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
- Colombo, et al. Selective glucocorticoid receptor modulation reveals a new role for CLEC10A in patients with solid tumors [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 3434.
9. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however she can generally be reached 8AM-8PM, Monday through Friday.
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, Julie Wu can be reached on 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
17 July 2026
/Alana Harris Dent/Primary Examiner, Art Unit 1643
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