DETAILED ACTION
This office action is in response to applicant’s filing dated August 7, 2026.
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 .
Status of Claims
Claims 1-5, 9-16, 19-24, and 28-30 are pending in the instant application. Acknowledgement is made of Applicant's amendments filed February 16, 2024. Claims 6-8, 17, 18, 25-27 were previously canceled.
Advisory Note
Claims 6-8, 17, 18, 25-27 have the status identifier of (canceled) and the text is marked through. In the response filed February 16, 2024, claims 6-8, 17, 18, 25-27 were indicated to stand canceled.
37 C.F.R. 1.121(c) states:
Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
When claim text shall not be presented; canceling a claim.
(i) No claim text shall be presented for any claim in the claim listing with the status of "canceled" or "not entered."
(ii) Cancellation of a claim shall be effected by an instruction to cancel a particular claim number. Identifying the status of a claim in the claim listing as "canceled" will constitute an instruction to cancel the claim.
In the instant case, to prevent delays in prosecution, the Examiner has accepted the amendment with the improperly canceled claims since the amendment otherwise complies with 37 CFR 1.121. Applicant should delete the text of the canceled claims in future responses.
Election/Restrictions
Applicant's election with traverse of Group I, drawn to a method of treating a patient suffering from a disorder selected from a liver disorder, cancer, a fungal infection, a bacterial infection, a viral infection, an inflammatory disease or condition, a cardiovascular disease, an endocrine condition, and a kidney disease, and combinations thereof, without adverse effects on the liver of said patient comprising administering to the patient an effective amount of relacorilant to treat said disorder without adverse effects on the liver of the patient, classified in different classes depending on the disorder in the reply filed on August 7, 2026 is acknowledged. The traversal is on the ground(s) that search and examination of all disorders and formulations at the same time would reduce or eliminate needless redundancies and duplication of effort that might occur if sequential searches were undertaken for individual disorders and formulations. This is not found persuasive because:
As set forth previously on the record, chemical compounds are defined by a unique set of physical and chemical properties. For example, a search for the compound, hydroxyurea, a ribonucleotide reductase inhibitor:
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would not retrieve prior art for the compound methyldopa, an alpha-2 agonist:
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or the compound, ritonavir, a protease inhibitor:
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or the compound, clarithromycin, a macrolide antibiotic:
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Similarly, the disorder species require different fields of search because each disorder has a mutually exclusive etiology and pathophysiology and is drawn to a different patient population. As set forth in the previous Office Action, there is a serious search and/or examination burden for the patentably distinct species because the species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
The requirement is still deemed proper and is therefore made FINAL.
Claims 12-16, 19-24, and 28-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on August 7, 2026.
Applicant's election with traverse of a liver disorder, nonalcoholic fatty liver disease (NAFLD) as the elected disorder and a formulation species further comprising clarithromycin in the reply filed on August 7, 2026 is acknowledged. The traversal has been addressed above.
Claims 3 and 5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on August 7, 2026.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1, 2, 4, and 9-11 are presently under examination as they relate to the elected species: nonalcoholic fatty liver disease and clarithromycin.
Priority
The present application is a DIV of US Application No. 18/199,624 filed May 19, 2023, which claims benefit of US Provisional Application No. 63/344,308 filed on May 20, 2022.
Drawings
Acknowledgement is made of the drawings received on February 16, 2024. These drawings are acceptable.
Claim Rejections - 35 USC § 112
Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 9-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating Cushing’s syndrome and non-alcoholic fatty liver disease comprising administering to the patient an effective amount of relacorilant, does not reasonably provide enablement for a method of treating any of the distinct disorders of claim 1 (any liver disorder, any cancer, any fungal infection, any bacterial infection, any viral infection, any inflammatory disease or condition, any cardiovascular disease, any endocrine condition, or any kidney disease) comprising administering relacorilant alone or in combination with any additional pharmaceutical composition without limit (instant claim 9), any CYP3A inhibitor of claim 10 or any of the structurally and functionally disparate drugs of claim 11. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. This is a scope of enablement rejection.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the quantity of experimentation necessary,
2- the amount of direction or guidance provided,
3- the presence or absence of working examples,
4- the nature of the invention,
5- the state of the prior art,
6- the relative skill of those in the art,
7- the predictability of the art, and
8- the breadth of the claims
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention, state and predictability of the art, and relative skill of those in the art
The invention relates to a method of treating a liver disorder, cancer, a fungal infection, a bacterial infection, a viral infection, an inflammatory disease or condition, a cardiovascular disease, an endocrine condition, and a kidney disease comprising administering to the patient an effective amount of relacorilant.
The relative skill of those in the art is high, generally that of an M.D. or Ph.D. The artisan using Applicant’s invention would generally be a physician with a M.D. degree and several years of experience.
The factor is outweighed, however, by the unpredictable nature of the art. It is well established that “the scope of enablement varies with the degree of unpredictability of the factors involved” and physiological activity is considered to be an unpredictable factor. See In re Fisher, 166 USPQ 18, at 24 (In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved); Nationwide Chemical Corporation, et. al. v. Wright, et. al., 192 USPQ 95 (one skilled in chemical and biological arts cannot always reasonably predict how different chemical compounds and elements might behave under varying circumstances); Ex parte Sudilovsky 21 USPQ2d 1702 (Applicant’s invention concerns pharmaceutical activity. Because there is no evidence of record of analogous activity for similar compounds, the art is relatively unpredictable); In re Wright 27 USPQ2d 1510 (the physiological activity of RNA viruses was sufficiently unpredictable that success in developing specific avian vaccine was uncertain). As illustrative of the state of the art, the examiner cites Gura et al (Science, 1997, 278:1041-1042, cited in the IDS filed February 16, 2024), Johnson et al. (British Journal of Cancer, 2001, 84:1424-1431, cited in the IDS filed February 16, 2024), and Kunnumakkara et al (Experimental Biology and Medicine, 2019; 244:663-689, cited in the IDS filed February 16, 2024).
Gura et al., cited for evidentiary purposes, teaches that researchers face the problem of sifting through potential anticancer agents to find ones promising enough to make human clinical trials worthwhile and further teach that since formal screening began in 1955, many thousands of drugs have shown activity in either cell or animal models, but only 39 have actually been shown useful for chemotherapy (see page 1041, first and second paragraph). Also, with regard to unpredictability, Johnson et al., also cited for evidentiary purposes, teach that the in vivo activity of 39 different agents in a particular histology in a tumor model did not correlate to activity in the same human cancer (see Results on page 1426). In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. Further, the mode of action of anticancer agents is often unknown or very unpredictable and administration of such agents is often accompanied by undesirable side effects.
Furthermore, with regard to unpredictability, Kunnumakkara teaches cancer is a group of more than 200 neoplastic diseases caused by diverse deregulated cell signaling cascades (page 633, left, 1st paragraph); consumption of tobacco and alcohol, obesity, insufficient physical activity, exposure to ultraviolet radiation, and various dietary factors which include insufficient fruit, non-starchy vegetables, and fiber; red/processed meat are predicted to be strongly associated with the risk of diverse cancer types; cancer occurs as a result of the dysregulation of as many as 500 different genes which may happen over a very long duration of time (20–30 years) till the symptoms become apparent (page 633, right, last bridge paragraph). Kunnumakkara further teaches there exists a missing connection between preclinical data and clinical findings; although, a significantly huge amount of money is spent in the pre-clinical settings for target validation and drug optimization, most of the therapies fail in the clinical trials till date; this can be due to the reason that the models used in the pre-clinical setting are not the adequate ones to effectively mimic human responses (page 664, right, 2nd paragraph); although highly convenient, cancer cell line models are associated with several limitations as well; for example, existence of genomic instability which may result in differences between the original tumor and the respective cell line, culture conditions that can alter the morphology, gene expression pattern, genomic profile, cellular pathways and culture environment from that of the original tumor, loss of natural tumor heterogeneity; the generic transformations that occur upon culturing of the cancer cells are not restored when regrown in vivo; and cancer cells in the in vitro condition grow in absence of stroma which include lymphatic vessels and blood, associated fibroblasts and immune cells, and lack a complex extracellular matrix; therefore, in vitro data often exhibits fundamental mismatch with those obtained from clinical findings and hence this can be regarded as one prime reason behind the failure of novel drug development (page 665, last bridge paragraph). Kunnumakkara teaches the foremost shortcomings of the use of animal models are their inability to recapitulate the link between the tumor and its microenvironment completely and the requisite of an immunocompromised host; basically, these animal models do not have the ability to reflect all the features of human cancer impeccably. Kunnumakkara teaches despite the advances in understanding of cancer biology and deriving different novel therapeutic targets, the translation of these understanding into therapies is poor due to higher failure rate (90%). The high failure rate could be due to non-consideration of factors such as clinical translation, drug delivery, drug pharmacokinetics, pre-clinical models, and tumor physiology, which are critical factors.
These articles plainly demonstrate that the art of developing and testing anticancer drugs, particularly for use in humans, is extremely unpredictable, particularly in the case of a single compound or genus of compounds being used to treat any and all solid tumor cancers. Cancer is a subset of inflammatory disease and thus the art of developing and testing drugs to treat inflammatory disease, particularly for use in humans, is extremely unpredictable, particularly in the case of a single compound or genus of compounds being used to treat any and all inflammatory diseases.
2. The breadth of the claims
Claims 1 and 9-11 are very broad in terms of the type of diseases being treated: all types of liver disorders, cancers, fungal infections, bacterial infections, viral infections, inflammatory diseases or conditions, cardiovascular diseases, endocrine conditions, and kidney diseases are claimed to be treated with relacorilant. Claims 9 and 11 are very broad in terms of compounds utilized to treat any of the diverse diseases encompassed by the list above to combine with relacorilant including any additional pharmaceutical composition without limit (instant claim 9), any CYP3A inhibitor of claim 10 or any of the structurally and functionally disparate drugs of claim 11.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides data for the administration of relacorilant and itraconazole in healthy subjects (Example 2) and administration of relacorilant to treat subjects having endogenous Cushing’s syndrome and impaired glucose tolerance and/or hypertension (Example 3). The cited art (see rejections below) establishes that relacorilant is known in the art for treating non-alcoholic fatty liver disease.
The specification provides no particular direction or guidance for determining the particular administration regimens (e.g., timing, administration routes, etc.) necessary to treat all of the various disorders recited in claim 1, particularly in humans. At best, an “effective amount” is defined as “amount of a drug or pharmaceutical agent that will elicit the biological or medical response of a tissue, a system, animal or human that is being sought by a researcher, veterinarian, medical doctor or other clinician” (paragraph [086]). While experimentation is presented for treatment of relacorilant for treating Cushing’s syndrome and relacorilant and itraconazole treatment of healthy subjects, there is no experimentation or mechanism of action presented or discussed in the specification regarding treatment of all the disorders recited in claim 1 that are not Cushing’s syndrome or treatment of Cushing’s syndrome with relacorilant in combination with all the drugs encompassed by claims 9-11.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art (as discussed supra) and in the absence of experimental evidence commensurate in scope with the claims, the skilled artisan would not accept that relacorilant alone or in combination with any of the structurally and functionally different compounds of claims 9-11 could be predictably used as treatment for all liver disorders, all cancers, all fungal infections, all bacterial infections, all viral infections, all inflammatory diseases or conditions, all cardiovascular diseases, all endocrine conditions, and all kidney diseases.
Genentech Inc. vs. Nova Nordisk states, "[A] patent is not a hunting license. It is not a reward for a search but a compensation for its successful conclusion and 'patent protection' is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable" (42 USPQ 2d 1001, Fed. Circuit 1997).
As noted above, none of the experimentation provided is drawn to the treatment of any disorder that is not Cushing’s syndrome. A review of the state of the art fails to reveal that relacorilant is therapeutic for the treatment of any of the disorders recited in claim 1, except for Cushing’s syndrome and non-alcoholic fatty liver disease. Determining if relacorilant is useful to treat any particular disease state recited in claim 1 would require synthesis of the compound, formulation into a suitable dosage form, and subjecting it to clinical trials or to testing in an assay known to correlate to clinical efficacy of such treatment. This is undue experimentation given the limited guidance and direction provided by Applicants. As noted supra, even in vitro and in vivo assays do not always correlate to efficacy in humans and are not generally predictive of clinical efficacy.
Accordingly, the instant claims do not comply with the enablement requirement of 35 U.S.C. 112(a), since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
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 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nieman et al (WO 2020/190351 A1).
Regarding claims 1 and 2, Nieman teaches a method of ameliorating a disorder of insulin sensitivity, which comprises administering an amount of one or more glucocorticoid receptor antagonists to a patient in need thereof effective to ameliorate said disorder, and which method is effected under non-rescue conditions (claim 1), wherein said disorder of insulin insensitivity is non-alcoholic fatty liver disease (claim 2), wherein said one or more glucocorticoid receptor antagonists are non-steroidal (claim 8), wherein the nonsteroidal GR antagonist is relacorilant (claim 9).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Nieman et al (WO 2020/190351 A1) as applied to claims 1 and 2 above, and further in view of Hunt et al (WO 2019/236487 A1).
As set forth above, Nieman teaches a method of treating non-alcoholic fatty liver disease in a patient in need thereof comprising administering an effective amount of one or more glucocorticoid receptor antagonists, including the claimed relacorilant, to a patient in need thereof. Nieman does not teach the nonalcoholic fatty liver disease is nonalcoholic steatohepatitis.
However, Hunt teaches a method of treating a disorder or condition through antagonizing a glucocorticoid receptor, the method comprising administering to a subject in need of such treatment a compound of formula (I), wherein the disorder or condition is nonalcoholic fatty liver disease and/or nonalcoholic steatohepatitis. Hunt teaches compounds of formula (I) are GR modulators [0049]; and in an exemplary embodiment, the GR modulator is an antagonist of GR activity (also referred to herein as "a glucocorticoid receptor antagonist") [0154]. Thus, Hunt establishes that GR antagonists are useful for treating nonalcoholic fatty liver disease and/or nonalcoholic steatohepatitis.
As such, since Nieman teaches a method of treating non-alcoholic fatty liver disease in a patient in need thereof comprising administering an effective amount of a glucocorticoid receptor antagonists, relacorilant, to a patient in need thereof, and since Hunt establishes that GR antagonists are useful for treating nonalcoholic fatty liver disease and/or nonalcoholic steatohepatitis, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of treating non-alcoholic fatty liver disease taught by Nieman to treat nonalcoholic steatohepatitis with an expectation of success, since the prior art establishes that relacorilant is a GR antagonist and GR antagonists are useful for treating nonalcoholic fatty liver disease and nonalcoholic steatohepatitis.
Taken together, all this would result in the practice of the method of claim 4 with a reasonable expectation of success.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Nieman et al (WO 2020/190351 A1) as applied to claims 1 and 2 above, and further in view of Maharshi et al ( Gastroenterology Report, 2020; 8(2):104–110) and Flavell et al (WO 2016/033439 A2).
Nieman teaches all the limitations of claims 9-11 (see above 102 rejection), except wherein the method comprises administering a further pharmaceutical composition wherein the further pharmaceutical composition comprises the elected clarithromycin.
However, Maharshi teaches IR (insulin resistance has been shown to play a pivotal role in the pathogenesis and progression of NAFLD (non-alcoholic fatty liver disease); Helicobacter pylori infection is also one of the proposed mechanisms for pathogenesis and/or progression of NAFLD; a higher prevalence of NAFLD is seen in H. pylori-positive persons than those who are negative; Helicobacter pylori infection has been linked to IR as well (page 109, left, 3rd paragraph).
Moreover, Flavell teaches a method of treating an inflammatory disease or disorder associated with a secretory antibody-bound bacteria in the microbiota of a subject in need thereof, the method comprising administering to the subject at least one therapy to diminish the number of at least one strain of at least one species of bacteria that is over represented in the microbiota of the subject (claim 52); wherein the at least one therapy is at least on antibiotic (claim 53); wherein the strain of bacteria is Helicobacter spp (claim 58); wherein the inflammatory disease is non-alcoholic fatty liver disease (NAFLD) (claim 60) and the at least on antibiotic is clarithromycin (claim 63).
As such, since Nieman teaches a method of treating non-alcoholic fatty liver disease in a patient in need thereof comprising administering an effective amount of a glucocorticoid receptor antagonists, relacorilant, to a patient in need thereof, since Maharshi teaches IR (insulin resistance has been shown to play a pivotal role in the pathogenesis and progression of NAFLD (non-alcoholic fatty liver disease); Helicobacter pylori infection is also one of the proposed mechanisms for pathogenesis and/or progression of NAFLD; a higher prevalence of NAFLD is seen in H. pylori-positive persons than those who are negative; Helicobacter pylori infection has been linked to IR; and since Flavell teaches that clarithromycin is an antibiotic useful for treating NAFLD associated with Helicobacter bacteria, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the references so as to administer relacorilant to treat NAFLD as taught by Nieman to further administer clarithromycin taught by Flavell with an expectation of success, since the prior art establishes that IR (insulin resistance has been shown to play a pivotal role in the pathogenesis and progression of NAFLD (non-alcoholic fatty liver disease); Helicobacter pylori infection is also one of the proposed mechanisms for pathogenesis and/or progression of NAFLD; a higher prevalence of NAFLD is seen in H. pylori-positive persons than those who are negative; Helicobacter pylori infection has been linked to IR.
One would have been motivated to do so because of each of the compounds have been individually taught in the prior art to be useful for treating NAFLD. Moreover, the instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two agents each of which is taught by the prior art to be useful for the very same purpose. The idea of combining them flows logically from having been individually taught in the prior art. Applying the same logic to the instant claims, one of ordinary skill in the art would have been imbued with at least a reasonable expectation of success that by combining relacorilant with clarithromycin, one would have achieved a composition useful for treating NAFLD.
Taken together, all this would result in the practice of the method of claims 9-11 with a reasonable expectation of success.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33 and 40 of U.S. Patent No. 12,152,028. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The previously allowed claims are directed to a method of treating fatty liver disease comprising administering to a subject in need thereof a therapeutically effective amount of a composition comprising a compound of Formula (I) (claims 33 and 40).
The instant claim is directed to a method of treating a patient suffering from a liver disorder comprising administering to the patent an effective amount of relacorilant.
Relacorilant and the compound of formula (I) are compounds having the same structure.
Thus, the method of the previously allowed claims anticipates the method of the instant claim.
Claims 1, 2, 4, and 9-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33 and 40 of U.S. Patent No. 12,152,028 in view of Nieman et al (WO 2020/190351 A1) as applied to claims 1 and 2 above, and further in view of Hunt et al (WO 2019/236487 A1), Maharshi et al ( Gastroenterology Report, 2020; 8(2):104–110), and Flavell et al (WO 2016/033439 A2).
The previously allowed claims are directed to a method of treating fatty liver disease comprising administering to a subject in need thereof a therapeutically effective amount of a composition comprising a compound of Formula (I) (claims 33 and 40). The specification of the previously allowed claims teaches fatty liver disease refers to a disease or a pathological condition caused by, at least in part, abnormal hepatic lipid deposits and includes alcoholic fatty liver disease.
The instant claim is directed to a method of treating a patient suffering from a liver disorder comprising administering to the patent an effective amount of relacorilant.
The previously allowed claims do not explicitly disclose non-alcoholic fatty liver disease. However, as set forth above, Nieman teaches a method of treating non-alcoholic fatty liver disease in a patient in need thereof comprising administering an effective amount of one or more glucocorticoid receptor antagonists, including the claimed relacorilant, to a patient in need thereof.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to arrive at the method of the instant claims from the previously allowed claims in view of the teachings of Nieman since Nieman teaches relacorilant is useful for treating non-alcoholic fatty liver disease.
The previously allowed claims do not explicitly teach the nonalcoholic fatty liver disease is nonalcoholic steatohepatitis.
However, as set forth above, Hunt establishes that GR antagonists are useful for treating nonalcoholic fatty liver disease and/or nonalcoholic steatohepatitis.
As such, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of liver disease of the previously allowed claims to treat nonalcoholic steatohepatitis with an expectation of success, since the prior art establishes that relacorilant is a GR antagonist and GR antagonists are useful for treating nonalcoholic fatty liver disease and nonalcoholic steatohepatitis.
The previously allowed claims do not explicitly teach the method comprises administering a further pharmaceutical composition wherein the further pharmaceutical composition comprises the elected clarithromycin.
However, as set forth above, Nieman teaches non-alcoholic fatty liver disease is a disorder of insulin sensitivity and relacorilant is useful for treating non-alcoholic fatty liver disease.
AS set forth above, Maharshi teaches IR (insulin resistance has been shown to play a pivotal role in the pathogenesis and progression of NAFLD (non-alcoholic fatty liver disease); Helicobacter pylori infection is also one of the proposed mechanisms for pathogenesis and/or progression of NAFLD; a higher prevalence of NAFLD is seen in H. pylori-positive persons than those who are negative; Helicobacter pylori infection has been linked to IR as well (page 109, left, 3rd paragraph).
As set forth above, Flavell teaches a method of treating non-alcoholic fatty liver disease (NAFLD) comprising administering clarithromycin.
As such, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of liver disease of the previously allowed claims to administer relacorilant to treat NAFLD as taught by Nieman to and to further administer clarithromycin taught by Flavell with an expectation of success, since the prior art establishes that IR (insulin resistance has been shown to play a pivotal role in the pathogenesis and progression of NAFLD (non-alcoholic fatty liver disease); Helicobacter pylori infection is also one of the proposed mechanisms for pathogenesis and/or progression of NAFLD; a higher prevalence of NAFLD is seen in H. pylori-positive persons than those who are negative; Helicobacter pylori infection has been linked to IR.
One would have been motivated to do so because of each of the compounds have been individually taught in the prior art to be useful for treating NAFLD. Moreover, the instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two agents each of which is taught by the prior art to be useful for the very same purpose. The idea of combining them flows logically from having been individually taught in the prior art. Applying the same logic to the instant claims, one of ordinary skill in the art would have been imbued with at least a reasonable expectation of success that by combining relacorilant with clarithromycin, one would have achieved a composition useful for treating NAFLD.
Conclusion
Claims 1, 2, 4, and 9-11 are rejected.
No claim is allowed.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628
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