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 .
FINAL ACTION
Priority
Instant application 18/009,537 filed on 12/09/2022 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
The amendment filled on 03/03/2026 has been entered.
Claims 463,466,469-470,472-473,475,478,481-482,484-487,489,492-493,497-498,500,503-504,507-508,510,513-514,518-519,521,524-525,528,530-532,534-536,538-539,541-542,544-545 and 547 are pending.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/07/2023, 09/27/2024, 05/30/2025, 10/10/2025 and 03/03/2026 were in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Arguments/Amendments/Declaration under 37 CFR § 1.132
The amendment filled on 03/03/2026 has been entered.
Applicant’s arguments filed 03/03/2026 and the declaration under 37 CFR § 1.132 by Julia Sturgeon filed 03/03/2026 have been fully considered.
Regarding instant claims 528, 530, 531, 532, 534, 535, 536, 538, 539, 541, 542, 544, 545 and 547 Applicant’s arguments are persuasive.
Applicant submitted that:
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Further, Applicant submitted:
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In view of the unexpected results, the rejections of claims 528, 530, 531, 532, 534, 535, 536, 538, 539, 541, 542, 544, 545 and 547 are withdrawn.
Claims 528, 530, 531, 532, 534, 535, 536, 538, 539, 541, 542, 544, 545 and 547 are allowed.
However, claims 463, 466, 469-470, 472-473, 475, 478, 481-482, 484-487, 489, 492-493, 497-498, 500, 503-504, 507-508, 510, 513-514, 518-519, 521 and 524-525 are not commensurate in scope with the surprising results.
The above claims allow for starting the treatment any time during the day, including administering the first dose in the evening. It should be noted that the limitation of doubling the dose in the evening is not present in those claims.
As, evidenced by Harvard Health Publishing (HarvardHealthOnline+, October 1, 2023):
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Since the above claims allow for administering the larger dose in the morning, therefore, the 103 rejections and the double patenting rejections are maintained for those claims.
Further, it should be noted that Application 19/216,847 has been abandoned. Therefore, the provisional double patenting rejection over Application 19/216,847 is withdrawn.
Claim Interpretation
The instant claims recite a compound of Formula (I).
As evidenced by MedKoo Cat#: 522656 ( https://www.medkoo.com/products/8261, printed 11/22/2025) The compound of instant formula (I) is known as crinecerfont, also known as SSR125543.
MedKoo teaches “Crinecerfont, also known as SSR125543, is a potent, selective, and orally active corticotropin-releasing factor 1 receptor (CRF1) antagonist (pKi values of 8.73 and 9.08 for human cloned or native CRF1 receptors, respectively). SSR125543 attenuates long-term cognitive deficit induced by acute inescapable stress in mice, independently from the hypothalamic pituitary adrenal axis. SSR125543 prevents stress-induced cognitive deficit associated with hippocampal dysfunction”
GRIGORIADIS (WO-2015112642-A1) teaches the structure and chemical name of the compound of instant Formula (I) (SSR-125543) (see page 14, fist compound):
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The above references are only used to confirm the name and structure of the compound recited in instant Formula (I).
The term “administering twice daily” has been interpreted as twice in 24 hours.
As evidenced by Harvard Health Publishing (HarvardHealthOnline+, October 1, 2023):
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The term “administering twice daily” allows for starting treatments any time during the day, including administering the first dose in the evening and the second dose in the morning.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 463, 466, 469-470, 472-473, 475, 478, 481-482, 484-487, 489, 492-493, 497-498, 500, 503-504, 507-508, 510, 513-514, 518-519, 521 and 524-525 are rejected under 35 U.S.C. 103 as being unpatentable over Tushla (Todd Tushla (Investors), Neurocrine Biosciences Reports Positive Phase II Data for Crinecerfont in Adults with Congenital Adrenal Hyperplasia at ENDO Online 2020, SAN DIEGO, June 8, 2020) in view of GRIGORIADIS (WO-2015112642-A1) evidenced by WHO (World Health Organization reference, 2007 – weight charts for Girls and Boys 5 to 10 years old) and evidenced by World Data Info (Average Sizes of Man and Woman (https://www.worlddata.info/average-bodyheight.php, printed 11/22/2025).
Tushla teaches “Positive Phase II Data for Crinecerfont in Adults with Congenital Adrenal Hyperplasia at ENDO Online 2020” (see title).
Tushla teaches” Classic CAH is a genetic disorder, in which an enzyme deficiency alters the production of adrenal steroids. Because of this deficiency, the adrenal glands fail to produce enough cortisol and, sometimes, aldosterone, resulting in a potentially life-threatening condition. The lack of cortisol stimulates the release of high levels of adrenocorticotropic hormone (ACTH) from the pituitary gland, leading to excessive adrenal androgen levels. These levels can lead to virilization, menstrual irregularities, hirsutism, acne in females and accelerated growth and precocious puberty in childhood (resulting in short stature and fertility problems in both males and females).
Corticosteroids, the current standard of care, are used both to correct the endogenous cortisol deficiency and to reduce the high ACTH levels and androgen excess. However, the dose and duration of glucocorticoids required to suppress ACTH are often well above the normal physiological level of cortisol, which can result in serious complications typical of iatrogenic Cushing's syndrome, including metabolic issues, bone loss, growth impairment, and infection risk.”
Tushla teaches “Crinecerfont treatment produced meaningful reductions in elevated adrenocorticotropic hormone (ACTH) and 17-hydroxyprogesterone (17-OHP) levels (by 54% to 75%) at all doses studied, together with a dose-related decrease in androstenedione (A4) levels, ranging from 21% to 64% (Figure1). At the highest dose of crinecerfont (100 mg twice daily), 75% of patients showed a response of at least 50% reduction from baseline for each of the three hormone markers at day 14 (Table 1)”.
Tushla teaches concurrent treatment with crinecerfont and glucocorticoid:” Crinecerfont is a novel, potent, selective, oral, non-steroidal corticotropin-releasing factor type 1 (CRF1) receptor antagonist under evaluation for the treatment of classic CAH. The blockade of CRF receptors in the pituitary has been shown to decrease the release of adrenocorticotropic hormone (ACTH), which in turn decreases the production of adrenal androgens, and potentially the symptoms associated with CAH. Lowering ACTH and adrenal androgen levels could reduce the amount of glucocorticoid treatment necessary for disease control and thus could avoid the complications associated with long-term supraphysiologic glucocorticoid therapy.”
Tushla teaches "We are pleased that crinecerfont was effective in producing a meaningful, dose-related reduction of adrenal androgens and other key biomarkers of disease in patients with classic CAH and was well tolerated in this study," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences."In addition, data from the study was successful in identifying an effective dosing regimen for further evaluation in a single, global registration study in adults with classic CAH. We hope to demonstrate that crinecerfont is a valuable, non-steroidal, treatment option for patients to manage the
burdensome symptoms of classic CAH, while also reducing the need for chronic supraphysiologic dosing with glucocorticoids."
Tushla teaches administration with meals: “The Phase II open-label, multiple-dose, dose-finding study assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of crinecerfont in 18 adults with classic 21-hydroxylase deficiency CAH. The study's sequential-cohort design evaluated four crinecerfont oral dosing regimens: 50 mg at bedtime (Cohort 1; n=8); 100 mg at bedtime (Cohort 2; n=7); 100 mg once-daily with an evening meal (Cohort 3; n=8); and 100 mg twice-daily with meals (Cohort 4; n=8).”
It should be noted that Tushla teaches administration with meals (plural), thus, one of ordinary skill would understand that the term “meals” include morning and evening meals since most people eat breakfasts and suppers every day.
Tushla does not teach the first daily administration is less than the amount of the second administration and Tushla is silent about the specific glucocorticoid, dexamethasone. Tushla is also silent about a pediatric subject.
MPEP 2144.05 II. states: "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation."
In addition, GRIGORIADIS teaches the compound of instant Formula (I) (SSR-125543) for treatment of CAH (see page 14, fist compound):
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GRIGORIADIS teaches optimal doses may be determined using experimental models familiar to those having ordinary skill in the art (see page 24):
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further optimize the method disclosed by Tushla and GRIGORIADIS and use it for the same purpose.
Regarding the specific glucocorticoid, dexamethasone, GRIGORIADIS teaches:
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It should be noted that GRIGORIADIS teaches about adults (“fully grown subject”) and pediatric subject (“a subject who is growing patient with CAH”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use glucocorticoid in combination with compound of Formula (I) for treatment of CAH in adults and children.
Regarding patients’ selection based on weigh.
As evidenced by WHO (see charts -weight-for age 5 to 10) most children weight between 10 kg to 20 kg. It should be noted that weigh of a pediatric patient (a subject who is growing) change with age.
As evidenced by World Data Info the average weight of an adult is above 55 kg (table).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method disclosed by Tushla and GRIGORIADIS for patients from 10 kg to 20 kg, 20 kg to 55kg and weights greater than or equal to 55 kg. MPEP 2144.05 II. states: "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” It should be noted that GRIGORIADIS teaches optimal doses may be determined using experimental models familiar to those having ordinary skill in the art. The level of the compound that is administered to a subject may be monitored by determining the level of the compound in biological fluid. It should be noted that GRIGORIADIS teaches about adults (“fully grown subject”) and pediatric subject (“a subject who is growing patient with CAH”).
Claims 463, 466, 469-470, 472-473, 475, 478, 481-482, 484-487, 489, 492-493, 497-498, 500, 503-504, 507-508, 510, 513-514, 518-519, 521 and 524-525 are rejected under 35 U.S.C. 103 as being unpatentable over Tushla (Todd Tushla (Investors), Neurocrine Biosciences Reports Positive Phase II Data for Crinecerfont in Adults with Congenital Adrenal Hyperplasia at ENDO Online 2020, SAN DIEGO, June 8, 2020) in view of GRIGORIADIS (WO-2015112642-A1) and further in view of Rivkees (Hindawi Publishing Corporation International Journal of Pediatric Endocrinology Volume 2010, Article ID 569680, 7 pages doi:10.1155/2010/569680).
Although all claims directed to administration with morning and evening meals had been rejected above, additional rationale is presented below.
The teachings of Tushla and GRIGORIADIS have been discuses above and those teachings are incorporated herein by reference.
Tushla teaches administration with meals.
Tushla does not explicitly teaches about morning meals.
Rivkees teaches dexamethasone in treatmants of CAH in children (pediatric subjects) (see title and abstract):
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Rivkees teaches circulating hormone level change at different times of a day (page 6, left column, last paragraph):
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Regarding morning treatments, Rivkees teaches that nighttime dosing of dexamethasone may be associated with overtreatment, thus the morning is the favored time for administration (see page 6, left column last full paragraph)
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Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the glucocorticoid in combination with compound of Formula (I) with morning meals for the same purpose in adults and children with CAH. MPEP 2144.05 II. states: "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." Based on the teachings of Rivkees, the skilled artisan would have been motivated to administer the treatment with a morning meal to prevent an overtreatment.
Claims 463, 466, 469-470, 472-473, 475, 478, 481-482, 484-487, 489, 492-493, 497-498, 500, 503-504, 507-508, 510, 513-514, 518-519, 521 and 524-525 are rejected under 35 U.S.C. 103 as being unpatentable over GRIGORIADIS (WO-2015112642-A1) evidenced by World Health Organization (2007 WHO reference – weight charts for Girls and Boys 5 to 10 years old) and evidenced by World Data Info (Average Sizes of Man and Woman (https://www.worlddata.info/average-bodyheight.php, printed 11/22/2025).
The teachings of GRIGORIADIS have been disclosed above and those teachings are incorporated herein by reference.
GRIGORIADIS teaches the compound of instant Formula (I) (SSR-125543) (see page 14, fist compound):
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GRIGORIADIS teaches dose range (see page 24):
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GRIGORIADIS teaches administrations prior to sleep (see page 25):
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GRIGORIADIS teaches concurrent treatment with crinecerfont and glucocorticoid:
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GRIGORIADIS does not teach the first daily administration is less than the amount of the second administration.
However, GRIGORIADIS teaches (see pages 24/25):
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MPEP 2144.05 II. states: "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation."
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the method disclosed by GRIGORIADIS by routine experimentation. Since GRIGORIADIS teaches about adults (“fully grown subject”) and pediatric subject (“a subject who is growing patient with CAH”), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use glucocorticoid in combination with compound of Formula (I) for treatment of CAH in adults and children. As evidenced by WHO most children weight between 10 kg to 20 kg. As evidenced by Word Data, the average weight of an adult is above 55 kg. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method disclosed by GRIGORIADIS for patients from 10 kg to 20 kg, 20 kg to 55kg and for patients with weights greater than or equal to 55 kg. It should be noted that GRIGORIADIS teaches optimal doses may be determined using experimental models familiar to those having ordinary skill in the art. The level of the compound that is administered to a subject may be monitored by determining the level of the compound in biological fluid.
Claims 463, 466, 469-470, 472-473, 475, 478, 481-482, 484-487, 489, 492-493, 497-498, 500, 503-504, 507-508, 510, 513-514, 518-519, 521 and 524-525 are rejected under 35 U.S.C. 103 as being unpatentable over GRIGORIADIS (WO-2015112642-A1) evidenced by World Health Organization (2007 WHO reference – weight charts for Girls and Boys 5 to 10 years old) and evidenced by World Data Info (Average Sizes of Man and Woman (https://www.worlddata.info/average-bodyheight.php, printed 11/22/2025) in view of Rivkees (Hindawi Publishing Corporation International Journal of Pediatric Endocrinology Volume 2010, Article ID 569680, 7 pages doi:10.1155/2010/569680) and in view of Koziolek (M. Koziolek, F. Schneider, M. Grimm, C. Modeb, A. Seekamp, T. Roustom, W. Siegmund, W. Weitschies, Intragastric pH and pressure profiles after intake ofthe high-caloric, high-fat meal as used for food effect studies, J. Controlled Release 220 (2015) 71–78).
Although all claims have been rejected above, additional rejection of claims directed to morning administration with a meal and evening administration with a meal is presented below.
The teachings of GRIGORIADIS have been discussed above and are incorporated herein by reference.
GRIGORIADIS does not explicitly teaches about a morning administration or about an administration with a meal.
Rivkees teaches dexamethasone in the treatment of CAH (see title and abstract):
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Rivkees teaches (page 6, left column, last paragraph):
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Regarding morning treatments, Rivkees teaches that nighttime dosing of dexamethasone is associated with overtreatment (see page 6, left column last full paragraph)
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Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the specific glucocorticoid, dexamethasone in combination with compound of Formula (I) for the same purpose in adults and children with CAH. MPEP 2144.05 II. states: "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." Further, based on the teachings of Rivkees, the skilled artisan would have been motivated to administer the treatment in the morning to prevent an overtreatment.
Regarding administration in a fed state, Koziolek teaches drug absorption can be altered by administration in a fed state (see page 72):
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Since GRIGORIADIS teaches:
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MPEP 2144.05 II. A states: "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation."
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the method disclosed by GRIGORIADIS by a routine experimentation. Since GRIGORIADIS teaches about adults (“fully grown subject”) and pediatric subject (“a subject who is growing patient with CAH”), therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use glucocorticoid in combination with the compound of Formula (I) for treatment of CAH in adults and children. As evidenced by WHO most children weight between 10 kg to 20 kg. As evidenced the average with of an adult is above 55 kg. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method disclosed by GRIGORIADIS for patients from 10 kg to 20 kg, 20 kg to 55kg and for patients with weights greater than or equal to 55 kg. It should be noted that GRIGORIADIS teaches optimal doses may be determined using experimental models familiar to those having ordinary skill in the art. The level of the compound that is administered to a subject may be monitored by determining the level of the compound in biological fluid.
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 463, 466, 469-470, 472-473, 475, 478, 481-482, 484-487, 489, 492-493, 497-498, 500, 503-504, 507-508, 510, 513-514, 518-519, 521 and 524-525 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11311544 (application number 17/393,555) in view of GRIGORIADIS (WO-2015112642-A1).
Claims of U.S. Patent No. 11311544 recite compound of instant Formula (I) (also known as SSR-125543) and glucocorticoid (including dexamethasone, see claim 5) for treatment of adults and children with CAH (including classical CAH, see claim 14).
Claims of U.S. Patent No. 11311544 recite the dose of glucocorticoid is decreased following administration of compound of instant formula (I) (SSR-125543):
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The claims of US 11311544 do not recite the first daily administration is less than the amount of the second administration.
However, GRIGORIADIS teaches (see pages 24/25):
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Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the method recited in claims of US 11311544 by routine experimentations. MPEP 2144.05 II. states: "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”
Claims 463, 466, 469-470, 472-473, 475, 478, 481-482, 484-487, 489, 492-493, 497-498, 500, 503-504, 507-508, 510, 513-514, 518-519, 521 and 524-525 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-5 of U.S. Patent No. 10905690 (application number 16/227,127) in view of Rivkees (Hindawi Publishing Corporation International Journal of Pediatric Endocrinology Volume 2010, Article ID 569680, 7 pages doi:10.1155/2010/569680) and in view of Koziolek (M. Koziolek, F. Schneider, M. Grimm, C. Modeb, A. Seekamp, T. Roustom, W. Siegmund, W. Weitschies, Intragastric pH and pressure profiles after intake ofthe high-caloric, high-fat meal as used for food effect studies, J. Controlled Release 220 (2015) 71–78).
The claims of US 10905690 recite:
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The claims of U.S. Patent No 10905690 do not recite treatment with glucocorticoid and are silent about an administration routine.
However, the use of glucocorticoids is well-established in treatments of CAH.
Regarding glucocorticoid, Rivkees teaches dexamethasone in the treatment of CAH (see title and abstract):
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Rivkees teaches (page 6, left column, last paragraph):
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Regarding morning treatments, Rivkees teaches that nighttime dosing of dexamethasone is associated with overtreatments, thus the morning is the favored time for administration (see page 6, left column last full paragraph):
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Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the specific glucocorticoid, dexamethasone in combination with compound of Formula (I) for the same purpose. MPEP 2144.05 II. states: "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." Further, based on the teachings of Rivkees, the skilled artisan would have been motivated to administer the treatment in the morning to prevent overtreatments.
Regarding administration in a fed state, Koziolek teaches drug absorption can be altered by administration in a fed state (see page 72):
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Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use compound of Formula (I) in combination with dexamethasone. The use of dexamethasone is well-established in treatments of CAH.
Further, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the method recited in claims of U.S. Patent No. 10905690 by routine experimentation. MPEP 2144.05 II. states: "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”
Claims 463, 466, 469-470, 472-473, 475, 478, 481-482, 484-487, 489, 492-493, 497-498, 500, 503-504, 507-508, 510, 513-514, 518-519, 521 and 524-525 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 11730739 (application number 17/074,845) in view of GRIGORIADIS (WO-2015112642-A1).
The claims of U.S. Patent No. 11730739 recite:
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372
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101
379
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57
383
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256
376
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The claims of U.S. Patent No. 11730739 do not recite the first daily administration is less than the amount of the second administration.
However, GRIGORIADIS teaches (see pages 24/25):
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the method recited in claims of U.S. Patent No. 11730739 by routine experimentations. MPEP 2144.05 II. states: "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”
Claims 463, 466, 469-470, 472-473, 475, 478, 481-482, 484-487, 489, 492-493, 497-498, 500, 503-504, 507-508, 510, 513-514, 518-519, 521 and 524-525 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-18 of U.S. Patent No. 12128033 (application number 18/604,836) in view of GRIGORIADIS (WO-2015112642-A1) and in view of Rivkees (Hindawi Publishing Corporation International Journal of Pediatric Endocrinology Volume 2010, Article ID 569680, 7 pages doi:10.1155/2010/569680).
The claims of U.S. Patent No. 12128033 recite a method of treating CAH comprising compound (I) (99.7% e.e%) and glucocorticoid:
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The claims of U.S. Patent No 12128033 do not recite the first daily administration is less than the amount of the second administration. Further, the claims of U.S. Patent No. US 12128033 do not recite the specific glucocorticoid - dexamethasone.
However, the use of dexamethasone is well-established in treatments of CAH.
Rivkees teaches dexamethasone in treatments of CAH (see title and abstract):
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Rivkees teaches (page 6, left column, last paragraph):
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Regarding morning treatments, Rivkees teaches that nighttime dosing of dexamethasone is associated with overtreatments, thus the morning is the favored time for administration (see page 6, left column last full paragraph):
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Regarding administration regime, GRIGORIADIS teaches (see pages 24/25):
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Therefore, it would have been prima face obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the specific glucocorticoid, dexamethasone, in combination with compound of Formula (I) for the same purpose. MPEP 2144.05 II. states: "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." Further, based on the teachings of Rivkees, the skilled artisan would have been motivated to administer the treatment in the morning to prevent an overtreatment.
Claims 463, 466, 469-470, 472-473, 475, 478, 481-482, 484-487, 489, 492-493, 497-498, 500, 503-504, 507-508, 510, 513-514, 518-519, 521 and 524-525 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22-51 of copending Application No. 18/222,011 (final rejection mailed 01/16/2025) in view of GRIGORIADIS (WO-2015112642-A1).
This is a provisional nonstatutory double patenting rejection.
The claims of copending Application No. 18/222,011 recite:
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The claims of copending Application No. 18/222,011 do not recite the first daily administration is less than the amount of the second administration.
However, GRIGORIADIS teaches concurrent treatment with crinecerfont and glucocorticoid (see page 27):
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Further, GRIGORIADIS teaches:
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the compound of Formula (I) in combination with dexamethasone. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the method recited in claims of copending Application No. 18/222,011 by routine experimentation. MPEP 2144.05 II. states: "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”
Conclusion
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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/I.S./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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