DETAILED ACTION
This office action is in response to applicant’s filling dated January 7, 2025.
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 18-25 are pending in the instant application. Acknowledgement is made of Applicant’s amendments filed January 7, 2025. Acknowledgement is made of Applicant’s addition of claims 18-25; and cancelation of claims 1-17.
Priority
The present application is a 371 of PCT/IB2022/060011 filed on October 18, 2022 which claims benefit of domestic priority to 63/256,728 filed on October 18, 2021.
Claim Rejections - 35 USC § 112
Written Description
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 30-32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The Written Description Guidelines for examination of patent applications indicates, "the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical characteristics and/or other chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show applicant was in possession of the claimed genus." (Federal register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001, see especially page 1106 column 3) and (see MPEP 2164).
Claim 30 is drawn to a method of treating depression comprising administering a therapeutically effective amount of 2-FDCK and at least one additional antidepressant. Thus, the claims encompass a broad genus of compounds which can act as an antidepressant with no structural components of the compound. Antidepressants can be any sort of chemical species, including a myriad of native chemical species in the body and an innumerable number of uninvented compounds, which can treat depression with no limit to safety, synergistic effects with 2-FDCK, and pharmacological mechanism of action. Similarly claim 31 is drawn to a method of treating depression comprising 2-FDCK and at least one antidepressant selected from the group consisting of mono-amine oxidase inhibitors, tricyclics, serotonin reuptake inhibitors, serotonin noradrenergic reuptake inhibitors, noradrenergic and specific serotonergic agents, and atypical antidepressants. In addition, Claim 32, recites a method of treating depression comprising 2-FDCK and at least one additional antidepressant, potentially selected from a generic neurokinin receptor antagonist. Thus, the various claims encompass various broad genuses of compounds such as “antidepressant,” “mono-amine oxidase inhibitors,” “tricyclics,” “serotonin reuptake inhibitors,” “serotonin noradrenergic reuptake inhibitors,” “noradrenergic and specific serotonergic agents,” “atypical antidepressants,” and “neurokinin receptor antagonists.” Thus, the claims encompass multiple genuses of molecules which function as an antidepressant with no other defined structural components to be administered with 2-FDCK which may be pharmaceutically safe and effective against depression.
In a review of the instant specification, the specification does not appear to provide guidance as to what structural components are critical to the desired function (see below). The specification discloses various compounds antidepressants such as imipramine, amitriptyline, desipramine, nortriptyline, doxepin, protriptyline, trimipramine, maprotiline, amoxapine, trazodone, bupropion, chlomipramine, fluoxetine, duloxetine, escitalopram, citalopram, sertraline, paroxetine, fluvoxamine, nefazadone, venlafaxine, milnacipran, reboxetine, lithium, mirtazapine, phenelzine, tranylcypromine, moclobemide, Kava-Kava, St. John's Wart, S- adenosylmethionine, thyrotropin releasing hormone, and triiodothyronine which can be used in combination with 2-FDCK for treating depression. Despite the breadth of different compounds recited, the specification does not give evidence that 2-FDCK will act efficaciously with all types of known, unknown, and future antidepressants, mono-amine oxidase inhibitors, tricyclics, serotonin reuptake inhibitors, serotonin noradrenergic reuptake inhibitors, noradrenergic and specific serotonergic agents, atypical antidepressants, and neurokinin receptor antagonists. Because there are an innumerably large number of bio-molecules/compounds within the scope of the generic claims, it would require extensive manpower to make and test each compound to determine which compound would possess the recited properties (i.e., synergistically act with 2-FDCK to treat depression) and be useful in the instantly claimed method.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
"To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966." Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163. The MPEP does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
In the instant case, the claims are drawn to a method of treating depression comprising administering a therapeutically effective amount of 2-FDCK and at least one additional antidepressant to the subject.
The claims are generic, broadly reciting genuses of “antidepressant,” “mono-amine oxidase inhibitors,” “tricyclics,” “serotonin reuptake inhibitors,” “serotonin noradrenergic reuptake inhibitors,” “noradrenergic and specific serotonergic agents,” “atypical antidepressants,” and “neurokinin receptor antagonists.” As stated supra, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that claims 30-32 are broad and generic, with respect to all possible compounds encompassed by the claims.
Applicant has failed to show that they were in possession of all the diverse compounds encompassed by “antidepressant,” “mono-amine oxidase inhibitors,” “tricyclics,” “serotonin reuptake inhibitors,” “serotonin noradrenergic reuptake inhibitors,” “noradrenergic and specific serotonergic agents,” “atypical antidepressants,” and “neurokinin receptor antagonists.” In the specifications, the applicant discloses various antidepressants such as imipramine, amitriptyline, desipramine, nortriptyline, doxepin, protriptyline, trimipramine, maprotiline, amoxapine, trazodone, bupropion, chlomipramine, fluoxetine, duloxetine, escitalopram, citalopram, sertraline, paroxetine, fluvoxamine, nefazadone, venlafaxine, milnacipran, reboxetine, lithium, mirtazapine, phenelzine, tranylcypromine, moclobemide, Kava-Kava, St. John's Wart, S- adenosylmethionine, thyrotropin releasing hormone, and triiodothyronine which can be used in combination with 2-FDCK for treating depression.
As there are an innumerably large number of potential antidepressants, mono-amine oxidase inhibitors, tricyclics, serotonin reuptake inhibitors, serotonin noradrenergic reuptake inhibitors, noradrenergic and specific serotonergic agents, atypical antidepressants, and neurokinin receptor antagonists, it would require extensive manpower to make and test each compound to determine which compound would possess the recited properties (i.e., treat depression in combination with 2-FDCK) and be useful in the instantly claimed compositions. Only reciting various well-known antidepressants cannot be viewed as being reasonably representative of the entire genuses in its claimed scope.
Given the broad scope of the claimed subject matter, Applicant has not provided sufficient written description that would allow the skilled in the art to recognize a method of treating depression comprising administering a therapeutically effective amount of 2-FDCK with a generic antidepressants, mono-amine oxidase inhibitors, tricyclics, serotonin reuptake inhibitors, serotonin noradrenergic reuptake inhibitors, noradrenergic and specific serotonergic agents, atypical antidepressants, and neurokinin receptor antagonists claimed in claims 30-32.
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)(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 18-29 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kruegel et al. (WO 2021134086 A1, effective filing date December 26, 2019, provided in the IDS dated April 16, 2024.).
Regarding Claim 18, Kruegel teaches a method treating depression in a subject in need thereof comprising administering to the subject in need thereof an effective amount of an isolated, substantially enantiomerically pure compound represented by Compound 35R (claim 20; which reads on Claim 18 in the instant application):
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Compound 35R is an R-stereoisomer of instantly claimed 2-FDCK as evidenced by the instant application (see paragraph [23]). Thus, Kruegel anticipates the method of claim 18.
Regarding Claim 19, Kreugel teaches that arylcyclohexylamine derivative compounds (including 2-FDCK listed as compound 35R) are useful for treating treatment-refractory depression (pp 99, paragraph 0218; which reads on claim 19 in the instant application). Thus, Kruegel anticipates the method of claim 19.
Regarding Claims 20-23, Kreugel teaches exemplifications where the arylcyclohexylamine derivative compounds (including 2-FDCK listed as compound 35R) are administered in dosages of 0.25 or 0.5 mg/kg (which read on claims 20-21 in the instant application) or administered to the subject in a total amount of 50 mg (which reads on claims 22-23 and 29 in the instant application) (pp 103, paragraph 0239).
Regarding claim 28 and 29, Kreugel further teaches that arylcyclohexylamine derivative compounds (including 2-FDCK listed as compound 35R) can be administered to a patient in discrete unit dosage form solid compositions for treating depression (pp 109, paragraph 0283; which reads on claim 28 in the instant application). As set forth above,
MPEP 2131.03 states:
"[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)). In the instant case, an amount of at least 0.25 or 0.5 mg/kg falls within the instant claimed range of claims 20-21 and thus anticipates the claimed ranges of claims 20-21. Similarly, an amount of 50 mg falls within the instant claimed range of claims 22-23 and 29, and thus anticipates the claimed ranges of claims 22-23 and 29.
Thus, Kruegel anticipates the method of claims 20-23 and 28-29.
Regarding Claim 24, Kreugel teaches that arylcyclohexylamine derivative compounds (including 2-FDCK listed as compound 35R) can form compositions with additional auxiliary agents such as carriers for treating depression (pp 109, paragraph 0282; which reads on claim 24 in the instant application). Thus, Kruegel anticipates the method of claim 24.
Regarding Claims 25-27, Kruegel teaches that the pharmaceutical compositions comprising arylcyclohexylamine derivative compounds (including 2-FDCK listed as compound 35R) would be suitable for parenteral/intravenous (which reads on claim 25 in the instant application), nasal (which reads on claim 26 in the instant application), and oral (which reads on claim 26 in the instant application) administration to treat depression (pp 109, paragraph 0281). Thus, Kruegel anticipates the method of claims 25-27.
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 30-33 are rejected under 35 U.S.C. 103 as being unpatentable over Kruegel et al. (WO 2021134086 A1, effective filing date December 26, 2019, provided in the IDS dated April 16, 2024) as applied to claims 18-29 above, further in view of Katz et al. (U, Katz, R.B. et al. “Concurrent use of Ketamine and Monoamide Oxidase Inhibitors in the Treatment of Depression: Letter to the Editor”, General Hospital Psychiatry (2018) pp. 62-63).
In regards to claims 30-33, the teachings of Kruegel are set forth above and applied as before. In addition, Kruegel teaches that racemic ketamine has a high affinity for the N-methyl-D-aspartate receptor (NMDAR), which leads to potent disassociate effects and ketamine’s addictive properties (pp 1, paragraphs 1-2). Kruegel teaches that compound 35 (2-FDCK), has a higher Ki for NMDAR and thus a lower bonding affinity, making 2-FDCK much less addictive than ketamine (pp. 186, table 11).
Kruegel does not expressly teach the method of treating depression with a therapeutically effective amount of 2-FDCK further comprising the use of at least one antidepressant.
However, Katz teaches the use of ketamine in conjunction with the mono-amine oxidase inhibitor antidepressant phenelzine to treat a patient with Major Depressive Disorder (pp. 63, table 1).
Since Katz teaches that ketamine can be used efficaciously with the mono-amine oxidase inhibitor antidepressant phenelzine to treat depression and Kruegel teaches that 2-FDCK is a ketamine derivative which could be used to treat depression, at the time of the invention it would have been prima facie obvious for a person of ordinary skill in the art to substitute ketamine for 2-FDCK with a reasonable expectation of success. The skilled artisan would have been motivated to substitute ketamine for 2-FDCK based on a teaching from Kruegel that 2-FDCK is a ketamine derivative with a lower binding affinity for the NMDAR receptor, thereby making 2-FDCK less addictive and less likely to abused than ketamine.
As such, claims 34-35 are rendered obvious by Kruegel in view of Katz.
Claims 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Kruegel et al. (WO 2021134086 A1, effective filing date December 26, 2019, provided in the IDS dated April 16, 2024.) as applied to claims 18-29 above, further in view of FDA Staff (V, FDA Staff. “Spravato”, Drugs at FDA (2019) pp. 1-40).
Regarding claims 34-35, he teachings of Kruegel are set forth above and applied as before. In addition, Kruegel teaches that racemic ketamine has a high affinity for the N-methyl-D-aspartate receptor (NMDAR), which leads to potent disassociate effects and ketamine’s addictive properties requiring medical professional oversight (pp 1, paragraphs 1-2). Kruegel teaches that compound 35 (2-FDCK), has a higher Ki for NMDAR and thus a lower bonding affinity, making 2-FDCK much less addictive than ketamine (pp. 186, table 11).
Kruegel does not expressly teach the 2-FDCK is self-administered or administered under the direction of a professional.
However, FDA Staff teach that the Spravato nasal solution comprising the arylcyclohexylamine derivative antidepressant esketamine is FDA approved for the treatment of treatment resistant depression (pp. 1, paragraph 1-3). FDA Staff further teaches that Spravato is available in unit dose cartons containing two 28 mg nasal spray devices providing 56 mg of Spravato per dose (pp 35, paragraph 3). FDA Staff also teach that Spravato is self-administered under the direction and supervision of a healthcare provider expert (pp. 30, paragraph 1).
Since Kruegel teaches a method of treating depression with the arylcyclohexylamine derivative antidepressant 2-FDCK, and since FDA Staff teaches that the arylcyclohexylamine derivative antidepressant esketamine can be self-administered under the direction and supervision of a healthcare provider professional to treat depression, at the time of the invention it would have been prima facie obvious for a person of ordinary skill in the art to substitute one known arylcyclohexylamine antidepressant (esketamine) for another molecule of the same class inducing depression along the same pathway (2-FDCK) with a reasonable expectation of success. The skilled artisan would have been motivated to replace ketamine with 2-FDCK based on the teaching of Kruegel that 2-FDCK is a ketamine analogue with a lower binding affinity for the NMDAR receptor, which causes 2-FDCK to be less addictive than ketamine and thus require less medical professional oversight.
As such, claims 34-35 are rendered obvious by Kruegel in view of FDA Staff.
Claims 18, 20-23 and 30-33 are rejected under 35 U.S.C. 103 as being unpatentable over Katz et al. (U, Katz, R.B. et al. “Concurrent use of Ketamine and Monoamide Oxidase Inhibitors in the Treatment of Depression: Letter to the Editor”, General Hospital Psychiatry (2018) pp. 62-63) in view of Moghimi et al. (W, Moghimi, A. et al. “Synthesis of 2-(2-Fluorophenyl)-2-methylamino-Cyclohexanone as a New Ketamine Derivative”, Synthetic Communications (2014) pp. 2021-2022).
Regarding claim 18, Katz teaches a method of treating Major Depressive Disorder comprising administering ketamine to the subject (pp. 63, table 1).
Katz fails to teach a method of treating Major Depressive Disorder comprising 2-FDCK.
However, Moghimi et al. teaches that 2-FDCK is a ketamine analogue and a potential pharmaceutical alternative with fewer side effects which shows advantages over ketamine in terms of effective dose and recovery time (pp. 2021, abstract; pp. 2022, paragraphs 1-2).
It would have been prima facia obvious for a person of ordinary skill in the art before the effective filling date of the claimed invention to develop of treating depression comprising administering to a subject in need thereof a therapeutically effective amount of 2-FDCK. This is as Katz teaches a method of treating major depressive disorder comprising ketamine, and Moghimi teaches that 2-FDCK is a chemical analogue of ketamine and which preliminary data shows, exhibits similar pharmacological effects to ketamine making it a potentially viable alternative. The skilled artisan would have been motivated to make the substitution of ketamine and 2-FDCK based off of the teaching of Moghimi that 2-FDCK exhibits superior effective dose and recovery times as compared to ketamine in animal studies.
Regarding claims 20-23, Katz teaches that ketamine was administered to the subjects in dosage amounts ranging from 0.5 mg/kg to 1.5 mg/kg and 25 mg – 75 mg (pp. 63, table 1). As 2-FDCK is a known ketamine analogue with analogous antidepressant qualities as ketamine, it would have been prima facia obvious to one of ordinary skill in the art to utilize the known ketamine concentrations and amounts as taught by Katz as a starting point for optimizing the amount of 2-FDCK administered to the patient since ketamine and 2-FDCK are structurally similar compounds with similar pharmacological activity and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
As such, claims 20-23 are rendered obvious by Katz in view of Moghimi.
Regarding claims 30-33, Katz teaches the use of ketamine in conjunction with the mono-amine oxidase inhibitor antidepressant phenelzine to treat a patient with Major Depressive Disorder (pp. 63, table 1).
As such, claims 30-33 are rendered obvious by Katz in view of Moghimi.
Claims 19, 24-26, 28-29, and 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Katz and Moghimi as applied to claims 18, 20-25 and 30-33 above, and further in view of FDA Staff (V, FDA Staff. “Spravato”, Drugs at FDA (2019) pp. 1-40).
Katz and Moghimi teach all the limitations of claims 24, 28-29, and 34-35 (see above 103), except wherein the 2-FDCK is administered to treat treatment-resistant depression, it is administered intranasally with at least one pharmaceutically acceptable carrier, in a unit dose form between 1 mg to 1000 mg, it is self-administered, and it is administered under the direction of a professional.
However, FDA Staff teach that the Spravato nasal solution comprising the arylcyclohexylamine derivative antidepressant esketamine is FDA approved for the treatment of treatment resistant depression (pp. 1, paragraph 1-3). FDA Staff further teaches that Spravato is available in unit dose cartons containing two 28 mg nasal spray devices providing 56 mg of Spravato per dose (pp 35, paragraph 3). FDA Staff also teach that Spravato is self-administered under the direction and supervision of a healthcare provider expert (pp. 30, paragraph 1).
Regarding claim 19, FDA Staff teaches a method of treating treatment-resistant depression comprising administering to the subject a therapeutically effective dose of ketamine. It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date to modify the method of treating treatment-resistant depression to substitute ketamine for 2-FDCK based off of a teaching of Moghimi that 2-FDCK is a ketamine analogue and a potential pharmacological alternative (pp. 2022, paragraph 1-2) and that it that 2-FDCK exhibits superior effective dose and recovery time qualities than Ketamine (pp. 2021, abstract).
As such, claim 19 is rendered obvious by FDA Staff in view of Moghimi and Katz.
Regarding claim 24 and 26, FDA Staff teaches that Spravato nasal solution, comprising the arylcyclohexylamine derivative antidepressant esketamine, is FDA approved for the treatment of treatment resistant depression further comprises water as a pharmaceutically acceptable carrier (pp. 25, paragraph 1). FDA Staff also recites that Spravato administers esketamine to the subject intranasally (pp. 1, paragraphs 1-3).
Regarding claim 25, Katz teaches that ketamine was administered to the patient via an infusion (i.e. intravenously) (pp. 62, paragraph 6).
As such, claims 24-26 are rendered obvious by FDA Staff in view of Moghimi and Katz.
Regarding claims 28-29, FDA Staff further teaches that Spravato is available in unit dose cartons containing two 28 mg nasal spray devices providing 56 mg of Spravato per dose (pp 35, paragraph 3). As set forth above,
MPEP 2131.03 states:
"[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)). In the instant case, an amount of at 56 mg falls within the instant claimed range of claim 29 and thus renders obvious the claimed ranges of claims 29.
As such, claims 28-29 are rendered obvious by FDA Staff in view of Moghimi and Katz.
Regarding claims 34-35, FDA staff teaches that Spravato is self-administered under the direction and supervision of a healthcare provider expert (pp. 30, paragraph 1).
As such, claims 34-35 are rendered obvious by FDA Staff in view of Moghimi and Katz.
Claims 19, 24-25, 27-29, and 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Katz and Moghimi as applied to claims 18, 20-25 and 30-33 above, and further in view of Shirawi et al. (X, Shirawi, M. I. A. et al. “Oral Ketamine in Treatment-Resistant Depression”, Journal of Clinical Psychopharmacology (2017) pp. 464-465).
Katz and Moghimi teach all the limitations of claims 19, 24, and 27 (see above 103), except wherein the 2-FDCK is administered to treat treatment-resistant depression, it is administered orally with at least one pharmaceutically acceptable carrier, in a unit dose form between 1 mg to 1000 mg, it is self-administered, and it is administered under the direction of a professional.
Katz and Moghimi teach all the limitations of claims 24, 28-29, and 34-35 (see above 103), except wherein the 2-FDCK is administered to treat treatment-resistant depression, it is administered intranasally with at least one pharmaceutically acceptable carrier, in a unit dose form between 1 mg to 1000 mg, it is self-administered, and it is administered under the direction of a professional.
Shirawi teaches a method of treating treatment-resistant depression comprising administering ketamine orally to the subject in need (pp. 464, paragraph 1). Shirawi further teaches that the ketamine was compounded to form pills for oral administration and that these pills had standardized dosages (unit doses) of 25 mg per capsule (pp. 465, paragraph 8). Shirawi also teaches that the ketamine pills were administered with an initially dose under professional supervision at the clinic with subsequent doses self-administered at home during nighttime (pp. 465, paragraph 8).
Regarding claim 19, Shirawi teaches a method of treating treatment-resistant depression comprising administering to the subject a therapeutically effective dose of ketamine. It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date to modify the method of treating treatment-resistant depression to substitute ketamine for 2-FDCK based off of a teaching of Moghimi that 2-FDCK is a ketamine analogue and a potential pharmacological alternative (pp. 2022, paragraph 1-2) and that it that 2-FDCK exhibits superior effective dose and recovery time qualities than Ketamine (pp. 2021, abstract).
As such, claim 19 is rendered obvious by Shirawi in view of Moghimi and Katz.
Regarding claim 24 and 27, Shirawi teaches a method of treating treatment-resistant depression comprising administering ketamine orally to the subject in pill form, where the pills were compounded for oral administration (therefore inherently requiring a carrier) (pp. 465, paragraph 8).
Regarding claim 25, Katz teaches that ketamine was administered to the patient via an infusion (i.e. intravenously) (pp. 62, paragraph 6).
As such, claims 24-25 and 27 are rendered obvious by Shirawi in view of Moghimi and Katz.
Regarding claims 28-29, Shirawi further teaches that teaches that the ketamine was compounded to form pills for oral administration and that these pills had standardized dosages (unit doses) of 25 mg per capsule (pp. 465, paragraph 8). As set forth above,
MPEP 2131.03 states:
"[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)). In the instant case, an amount of at 25 mg falls within the instant claimed range of claim 29 and thus renders obvious the claimed ranges of claims 29.
As such, claims 28-29 are rendered obvious by Shirawi in view of Moghimi and Katz.
Regarding claims 34-35, Shirawi teaches that the initial dose of ketamine is self-administered under the direction and supervision of a healthcare provider expert and subsequent doses were self-administered at the patient’s home (pp. 465, paragraph 8).
As such, claims 34-35 are rendered obvious by Shirawi in view of Moghimi and Katz.
Conclusion
Claims 18-35 are rejected and no claim is allowed.
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/A.R.U./Examiner, Art Unit 1628
/Rayna Rodriguez/Primary Examiner, Art Unit 1628
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