DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Application Status
2. Applicant’s response, submitted March 18, 2026, has been reviewed by the examiner.
3. Claims 51-78 are present in the application.
4. Claims 75-78, (drawn to methods of use) were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
5. Applicant previously elected the species of compound 18R:
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, which is readable on claims 51, 52, 54-57, 62, 63, 65-67, 71 and 73. The non-elected compound species remain withdrawn from consideration.
6. Claims 51, 52, 54-57, 62, 63, 65-67, 71 and 73 are under examination with the elected species and are the subject of this office action.
Specification
7. Applicant’s corrected abstract, which identifies the chemical compounds recited in the claims, is sufficient to overcome the previous objection. Accordingly the previous objection to the abstract is withdrawn.
Previous Double Patenting Rejections
8. Claims 51, 52, 54-57, 62, 63, 65-67, 71 and 73 were previously provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, and 7-10 of copending Application No. 18/572,861 (reference application).
9. In view of Applicant’s argument that the only pending rejection in the present application is the provisional non-statutory rejection over a later-filed application, pursuant to MPEP 808IB1(b)(I), the previous double patenting rejection of claims
51, 52, 54-57, 62, 63, 65-67, 71 and 73 is withdrawn.
Election/Restrictions
10. Claims 51, 52, 54-57, 62, 63, 65-67, 71 and 73 are directed to an allowable product. Therefore the non-elected compound species are hereby rejoined for examination, i.e., Compound 18S is herein rejoined, such that claims 51-74 are fully examined for patentability.
11. After a thorough search, claims are 51-74 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 75-78, directed to the process of using the allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
12. Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on September 18, 2024 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Objections
13. Claims 51-78 are objected to because of the following informalities:
in claims 51-53, 62-65, and 75-78, the nomenclature used to define compound 18R differs from that used to defined compound 18S, i.e., in compound 18R, chirality is indicated at the stereocenter on the pyridinone ring, but it is not indicated in the same stereocenter in Compound 18S. It is also noted that the amino-methyl group in Compound 18R is notated “-NH-Me”, however the same group is notated “-NH—” in Compound 18S.
It is recommended that the same nomenclature is employed among all compounds recited in the claims, for consistency and clarity of the record.
14. Claims 54-61 and 66-74 are objected to as being dependent on and including all of the limitations of objected claims 51-53, 62-65, and 75-78.
New Claim Rejections - 35 USC § 112(a)
15. 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.
16. Claims 75-78 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 depression and anxiety comprising administering compound 18, compound 18R or compound 18S to a subject in need thereof, does not reasonably provide enablement for a method of treating the other disorders embraced by “a mood disorder, an anxiety disorder, or a substance use disorder, and any symptom or disorders associated therewith in a subject in need thereof.” 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.
17. The standard for determining whether the Specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? As recognized by the court in In re Wands, 858 F.2d 731 (Fed. Cir. 1988), that is still the standard to be applied, determined by consideration of the Wands factors (MPEP 2164.01(A)); namely, nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art, predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered, with the most relevant factors discussed below.
18. Nature of the Invention: As stated in MPEP 2164.05(a), “[t]he initial inquiry” for determining whether the Specification is enabling “is into the nature of the invention, i.e., the subject matter to which the claimed invention pertains.”
19. In the instant case, the claimed invention pertains to a method of treating depression, anxious depression, any mood disorder(s), any anxiety disorder(s), or any substance use disorder, and any symptom or disorders associated therewith in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a compound of the formula 18 or a pharmaceutically acceptable salt thereof, or a compound of the formula 18R or a pharmaceutically acceptable salt thereof, or a compound of the formula 18S or a pharmaceutically acceptable salt thereof.
20. The State of the Prior Art and the Level of Predictability in the Art: As stated in MPEP 2164.05(a), “[t]he state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains” and, as stated in MPEP 2164.05(b), “[t]he relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed.”
As discussed above, the instantly claimed invention pertains a method a method of treating depression, anxious depression, any mood disorder(s), any anxiety disorder(s), or any substance use disorder, and any symptom or disorders associated therewith in a subject in need thereof.
21. The state of the art regarding depression is that symptoms caused by major depression can vary from person to person. Depression with specific features include anxious distress — depression with unusual restlessness or worry about possible events or loss of control; mixed features — simultaneous depression and mania, which includes elevated self-esteem, talking too much and increased energy; melancholic features — severe depression with lack of response to something that used to bring pleasure and associated with early morning awakening, worsened mood in the morning, major changes in appetite, and feelings of guilt, agitation or sluggishness; atypical features — depression that includes the ability to temporarily be cheered by happy events, increased appetite, excessive need for sleep, sensitivity to rejection, and a heavy feeling in the arms or legs; psychotic features — depression accompanied by delusions or hallucinations, which may involve personal inadequacy or other negative themes; catatonia — depression that includes motor activity that involves either uncontrollable and purposeless movement or fixed and inflexible posture; peripartum onset — depression that occurs during pregnancy or in the weeks or months after delivery (postpartum); seasonal pattern — depression related to changes in seasons and reduced exposure to sunlight; and other disorders that cause depression symptoms including Bipolar I and II disorders; cyclothymic disorder; disruptive mood dysregulation disorder; persistent depressive disorder; premenstrual dysphoric disorder; and depression caused by the use of recreational drugs, some prescribed medications or another medical condition. Appropriate treatment relies on an accurate diagnosis and includes selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs); atypical antidepressants; tricyclic antidepressants; monoamine oxidase inhibitors (MAOIs, which can have serious side effects and require a strict diet because of dangerous (or even deadly) interactions with foods); as well as other medications such as mood stabilizers or antipsychotics, anti-anxiety drugs and stimulant medications (see webpage printout of Depression (major depressive disorder) - Diagnosis and treatment - Mayo Clinic).
22. The state of the art regarding anxiety disorders is that several types of anxiety disorders exist including agoraphobia; anxiety disorder due to a medical condition; generalized anxiety disorder; panic disorder; selective mutism; separation anxiety disorder; social anxiety disorder (social phobia); specific phobias; substance-induced anxiety disorder; and other types of anxiety disorders. Anxiety can be linked to a medical cause, wherein medical problems that can be linked to anxiety include: heart disease, diabetes, thyroid problems, such as hyperthyroidism, respiratory disorders, such as chronic obstructive pulmonary disease (COPD) and asthma, drug misuse or withdrawal, withdrawal from alcohol, anti-anxiety medications (benzodiazepines) or other medications, chronic pain or irritable bowel syndrome, rare tumors that produce certain fight-or-flight hormones, and/or a side effect of certain medications. Treatment involves psychotherapy and medications including certain antidepressants, anti-anxiety drugs, sedatives, and/or beta-blockers (see webpage printout of Anxiety disorders - Symptoms and causes - Mayo Clinic).
23. The state of the art regarding mood disorders are divided into two major groups: depressive disorders and bipolar disorders. Depressive disorders include: major depression; seasonal affective disorder; persistent depressive disorder; disruptive mood dysregulation disorder; premenstrual dysphoric disorder; depression related to a medical condition; and depression related to substance or medicine use. Bipolar disorder types include: Bipolar I disorder; Bipolar II disorder; cyclothymia; bipolar related to a medical condition including Cushing's disease, multiple sclerosis, stroke and traumatic brain injury can cause bipolar mania or hypomania; as well as bipolar related to the use of certain substances. Treatment is disorder and symptom-dependent and includes talk therapy and/or medication, as well as brain stimulation therapies including transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT) (see webpage printout of Mood disorders - Symptoms and causes - Mayo Clinic).
24. The state of the art regarding substance abuse is that substance use disorders embrace the use and misuse of alcohol; tobacco, e-cigarettes and vaping; illicit drugs (e.g., stimulants including methamphetamine and cocaine; as well as fake prescription pills which can include fentanyl); prescription medications (e.g., opioids, including illicit opioids, wherein overdose can be life threatening; other pain relievers, stimulants including ADHD medication; or sedatives/tranquilizers for anxiety or sleep); and marijuana and/or CBD, each of which is extremely complex, potentially life-threatening and can be extraordinarily difficult to treat. People with substance use disorders (SUDs) are at particular risk for developing one or more primary conditions or chronic diseases. Treatment of substance use disorder is dependent upon the substance(s) itself and any comorbid condition(s), wherein the use of medications (approved by FDA), in combination with counseling and behavioral therapies, is the most successful approach. Medications are clinically driven and tailored to meet each patient’s needs, and for some, medications can help sustain recovery (see webpage printout of About Substance Use - Alcohol, Marijuana, CBD, Vaping, and Opioids | SAMHSA, updated March 10, 2026).
25. The state of the art regarding the instant arylcyclohexylamine derivatives (i.e., fluorinated ketamine analogs) is that Wang et al. teach the clinical effectiveness of ketamine in anesthesia, pain, and depression (page 904, right column, second to last paragraph), and teach that “therapeutic applications for ketamine have recently expanded to include severe and treatment-resistant major depression, with rapid and sustained response” (page 898, right column, first paragraph). Wang et al. go on to teach the advantages of fluorinated ketamine analogs, wherein the halogen substitution optimizes drug adsorption, distribution, recognition and selectivity (page 903, right column, last paragraph). Therefore one skilled in the art would reasonably assume that the instant fluorinated ketamine analogs would have similar pharmacokinetic and pharmacological properties to ketamine, i.e., its antidepressant effects.
26. As such, one of skill in the art would be unable to fully predict the therapeutic effects of administering a fluorinated ketamine analog for the treatment of the full scope of disorders embraced by the claims including depression, anxious depression, any mood disorder, any anxiety disorder, any substance use disorder, and any symptoms or disorders associated therewith, let alone the multitude of disorders disclosed above and as embraced by the instant claims. This unpredictability is certainly true in the case of treating the above listed disorders which, as disclosed by each of the refences above, are complex and varied in etiology as well as severity of pathology.
27. There is no question Applicant’s instant arylcyclohexylamine derivatives may play a role in future methods of treating certain of the aforementioned disorders (i.e., depression and/or anxiety). What is disputed is the claim that the recited method could be employed by one skilled in the art at the effective filing date of the claimed invention and used as treatments for any/ all of the disorders embraced by the claims, without undue experimentation. There is simply no evidence to be found in the literature suggesting that Applicant’s compositions are capable of being used in the manner recited. In essence, there is no absolute predictability in pharmacology, even with compounds whose properties have been determined, despite the extraordinarily high skill possessed by the ordinary artisan.
28. The Relative Skill of those in the Art: The level of skill in the art of one tasked with treating any depressive/ anxiety disorder(s), mood disorders, and substance use disorders is high, i.e., neurologists and physicians represent one of ordinary skill in the art.
29. The Amount of Direction Provided by the Inventor / Existence of Working Examples: The amount of direction provided by the Applicant is considered to be determined by the Specification and the working examples. In the instant case, the Specification provides plasma PK parameters following the administration of select compounds at various dosage amounts in Examples 21-26 and Tables 2-10 (Specification at pages 154-185), including the racemate 18rac, but fails to demonstrate pK data for the enantiomers 18R or 18S. Applicant demonstrates binding affinity and uptake inhibition of a few dozen disclosed compounds in Tables 11 and 14, including the racemate 18rac, but fails to demonstrate binding affinity for the instantly recited enantiomers 18R or 18S.
Applicant provides a few in vivo working example demonstrating the antidepressive effects of compound 35, compound 35R, and compound 35S on behavioral tests after chronic social defeat stress (CSDS) in mice (Example 29); the antidepressive effects of compounds 2rac and 14rac in the forced swim test (FST) in mice (Example 30); the antidepressive effects of compound 14rac in the forced swim test (FST) in mice (Example 31); and the effects of additional disclosed compounds 114, 114R, 11S, 11R, 19S, 19R, 29rac, and 27rac, (Examples 32 and 34); the effects of compound 14S and 14R in a conditioned place preference mode of abuse liability in mice (Example 33). The Specification fails to disclose any working examples of the administration of compound 18, compound 18R, or compound 18S, for the treatment of any disease whatsoever.
30. Scope or Breadth of the Claims: As stated in MPEP 2164.01(c), “[w]hen a compound or composition claim is limited by a particular use, enablement of that claim should be evaluated based on that limitation.” Thus, as stated in MPEP 2164.08, “[t]he focus of the examination inquiry is whether everything within the scope of the claim is enabled” (emphasis added). The Federal Circuit has repeatedly held that “the specification 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 (Fed. Cir. 1993) (emphasis added).
31. At the same time, however, it is also recognized that not everything necessary to practice the invention need be disclosed. Nor is it necessary that an Applicant test all the embodiments of his invention. In re Angstadt, 537 F.2d 498 (CCPA 1976) (emphasis added). In fact, as stated by the court in In re Buchner, 929 F.2d 660 (Fed. Cir. 1991), a patent need not teach, and preferably omits, what is well known in the art.
32. Accordingly, for purposes of enablement, the relevant concern is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate in scope with the protection sought by the claims. Thus, while “a patent application is entitled to claim his invention generically” it is necessary that “he provide a disclosure sufficient to enable one skilled in the art to carry out the invention commensurate with the scope of his claims.” Amgen, Inc, v. Chugai Pharmaceutical Co., Ltd. (Fed. Cir. 1991). As noted by the court in In re Fisher, 427 F.2d 833 (CCPA 1970), the scope of enablement must bear a “reasonable correlation” to the scope of the claims. As stated in MPEP 2164.08, resolution of this concern requires two stages of inquiry: “[t]he first is to determine how broad the claim is with respect to the disclosure. The entire claim must be considered. The second inquiry is to determine if one skilled in the art is enabled to make and use the entire scope of the claim without undue experimentation”.
33. As to the first inquiry, as discussed above, the claims are drawn to a method of treating depression, anxious depression, any mood disorder(s), any anxiety disorder(s), or any substance use disorder, and any symptom or disorders associated therewith in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a compound of the formula 18 or a pharmaceutically acceptable salt thereof, or a compound of the formula 18R or a pharmaceutically acceptable salt thereof, or a compound of the formula 18S or a pharmaceutically acceptable salt thereof. Applicant provides a non-limiting list of psychiatric disorders embraced by the instant claims, embracing an extremely broad scope of largely unrelated pathologies that are complex in etiology and often difficult to diagnose, let alone treat:
“Depressive Disorders, e.g., Major Depressive Disorder, Persistent Depressive Disorder, Postpartum Depression, Premenstrual Dysphoric Disorder, Seasonal Affective Disorder, Psychotic Depression, Disruptive Mood Dysregulation Disorder, Substance/Medication-Induced Depressive Disorder, and Depressive Disorder Due to Another Medical Condition.
[0218] Also provided herein are compounds, methods, and compositions useful for treating refractory depression, e.g., patients suffering from a depressive disorder that does not, and/or has not, responded to adequate courses of at least one, or at least two, other antidepressant compounds or therapeutics. As used herein "depressive disorder" encompasses refractory depression.
[0219] In some embodiments, the compounds, methods, and compositions may be used to treat a psychiatric disorder including Bipolar and Related Disorders, e.g., Bipolar I Disorder, Bipolar II Disorder, Cyclothymic Disorder, Substance/Medication-Induced Bipolar and Related Disorder, and Bipolar and Related Disorder Due to Another Medical Condition.
[0220] In some embodiments, the compounds, methods, and compositions may be used to treat a psychiatric disorder including Substance-Related Disorders, e.g., preventing a substance use craving, diminishing a substance use craving, and/or facilitating substance use cessation or withdrawal. Substance use disorders involve abuse of psychoactive compounds such as alcohol, caffeine, cannabis, inhalants, opioids, sedatives, hypnotics, anxiolytics, stimulants, nicotine and tobacco. As used herein "substance" or "substances" are psychoactive compounds which can be addictive such as alcohol, caffeine, cannabis, hallucinogens, inhalants, opioids, sedatives,
hypnotics, anxiolytics, stimulants, nicotine and tobacco. For example, the methods and compositions may be used to facilitate smoking cessation or cessation of opioid use.
[0221] In some embodiments, the compounds, methods, and compositions may be used to treat a psychiatric disorder including Anxiety Disorders, e.g., Separation Anxiety Disorder, Selective Mutism, Specific Phobia, Social Anxiety Disorder (Social Phobia), Panic Disorder, Panic Attack, Agoraphobia, Generalized Anxiety Disorder, Substance/Medication-Induced Anxiety Disorder, and Anxiety Disorder Due to Another Medical Condition.”
(Paragraphs [0217]-[0221]).
34. Thus, considering that “any mood disorder(s), any anxiety disorder(s), or any substance use disorder, and any symptom or disorders associated therewith in a subject in need thereof,” encompasses thousands of possible unrelated disorders including attention disorders, mood disorders, neurological disorders, neurocognitive disorders, developmental disorders, psychiatric disorders, cardiovascular disorders, inflammatory disorders, and sleep disorders, it is evident that the claims are broad. Yet, as discussed above, the instant Specification discloses only a few working examples of the anti-depressant-like effects of a few disclosed compounds in mice and rats (Examples 29-32, 34 and 37) and the effects of a few disclosed compounds in a model of opioid abuse in mice (Example 33).
35. As such, the claims are extremely broad with respect to the disclosure. The second inquiry is discussed in detail below.
36. Amount of Experimentation Necessary: In view of all of the foregoing, at the time the invention was made, it would have required undue experimentation to practice the entire scope of the invention as claimed. As discussed above, the claims are drawn to a method of treating depression, anxious depression, any mood disorder(s), any anxiety disorder(s), or any substance use disorder, and any symptom or disorders associated therewith in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a compound of the formula 18 or a pharmaceutically acceptable salt thereof, or a compound of the formula 18R or a pharmaceutically acceptable salt thereof, or a compound of the formula 18S or a pharmaceutically acceptable salt thereof. Since identifying any disorder(s) which involve a lack of motivation or cognitive engagement and is capable of being treated by administering a composition comprising psilocybin or psilocin is extremely complex, the nature of the instant invention considered to be one of extreme complexity. In the instant case, this complexity is exacerbated by the challenges of treating comorbid disorders (see above paragraphs 21-24) as well as the extreme breath embraced by the claims (see above paragraphs 32-34). Although the relative skill of those in the art to which the invention pertains is high, the state of the art and unpredictability within the art is such that even the most talented artisan could not reasonably predict which of the thousands of disorders encompassed by the claims would be treatable based on the limited disclosure of a few working examples of the anti-depressive effects of a few disclosed compounds, and the ability of a few disclosed compounds to treat opioid abuse, and no working examples of Applicant’s instantly recited compound 18, compound 18R and/or compound 18S. That is, the only way one skilled in the art is enabled to use the entire scope of the claim based on the instant disclosure entails undue experimentation.
37. To overcome this rejection, Applicant should narrow the scope of the claims such that they bear a reasonable correlation with the disclosure.
New Double Patenting Rejections
38. 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.
39. Claims 75-78 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-16 of copending Application No. 18/572,861 (reference application).
40. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite the following:
Instant claim 75 is drawn to a method of treating depression, anxious depression, a mood disorder, an anxiety disorder, or a substance use disorder and any symptom or disorders associated therewith in a subject in need thereof, the method comprising administering to the subject in need thereof an effective amount of the compound of the formula:
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or a compound of the formula:
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, or a compound of the formula:
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or a pharmaceutically acceptable salt thereof.
Instant claim 76 is drawn to the method of claim 75 and limits wherein the compound is:
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or a pharmaceutically acceptable salt thereof.
Instant claim 77 is drawn to the method of claim 75 and limits wherein the compound is:
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or a pharmaceutically acceptable salt thereof.
Instant claim 78 is drawn to the method of claim 75 and limits wherein the compound is:
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or a pharmaceutically acceptable salt thereof.
41. U.S. Application No. 18/572,861 recites the following method in claims 11-16:
11. A method of treating depression, anxious depression, a mood disorder, an anxiety disorder, or a substance use disorder and any symptom or disorders associated therewith in a subject in need thereof, the method comprising administering to the subject in need thereof an effective amount of a compound or composition of any one of claims 1-10,
[i.e., a compound selected from
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and
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].
12. The method of claim 11, wherein the compound or composition is orally administered.
13. A method of treating depression or anxious depression in a subject in need thereof, the method comprising administering to the subject in need thereof an effective amount of a compound or composition of any one of claims 1-10.
14. The method of claim 13, wherein the compound or composition is orally administered.
15. A method of treating depression, anxious depression, a mood disorder, an anxiety disorder, or a substance use disorder and any symptom or disorders associated therewith in a subject in need thereof, the method comprising administering to the subject in need thereof an effective amount of a compound selected from the group consisting of:
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or a pharmaceutically acceptable salt thereof.
16. The method of claim 15, wherein the compound or composition is orally administered.
42. As such, co-pending U.S. Application No. 18/572,861 recites the same method treating depression, anxious depression, a mood disorder, an anxiety disorder, or a substance use disorder and any symptom or disorders associated therewith in a subject in need thereof method of use comprising administering the same fluorinated ketamine analog compound, its R-enantiomer, and its S-enantiomer, that are presently recited in the instant claims.
43. As such, claims 75-78 are prima facie obvious over claims 11-16 of U.S. Appl No. 18/572,861.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
44. Claims 51-78 are pending in the application. Claims 75-78 are rejected. Claims 51-78 are objected to. No claim is currently allowable.
45. Rejoinder of the method claims filed in Applicant's amendment of September 24, 2025 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.
46. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached Monday-Friday 8:30AM-5PM EST.
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, Amy L Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANET L COPPINS/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
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