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 .
Status of the Claims
Claims 1-4, 7-13, and 16-21 are pending.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Instant application is a U.S. National Stage Entry of PCT/GB2022/051608, filed 06/23/2022. PCT/GB2022/051608 claims priority of foreign application GB2109022.0, filed 06/23/2021. Therefore, the effective filing date is 06/23/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/21/2023 and 01/12/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 3, 4, 7, 8, 10-13, 16-18, 20, and 21 are objected to because of the following informalities:
Claims 3, 4, 10-13, 16, 20 and 21 read “…naltrexone, or a metabolite or analogue thereof…”. This should instead read “…naltrexone, a metabolite thereof, or the analogue thereof…” (emphasis added), since “analogue” is referencing the list of analogues in either claim 1 or claim 2.
Claims 7 and 17 read “…YM-31636, or metabolites thereof and combinations thereof” and should read “…YM-31636, a metabolite thereof, and combinations thereof”, in order to be in the singular form.
Claims 8 and 18 read “…and the metabolites thereof” and should read “…or a metabolite thereof”, in order to be in the singular form.
Claims 10, 11, 20, and 21 read “…is to be administered…” and should read “…is administered…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 7-13, and 16-21 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 major depressive disorder comprising administering ketamine and naltrexone, does not reasonably provide enablement for enablement for the treatment of any cognitive or neurological disorder comprising administering naltrexone, analogues, or metabolites thereof, and a 5-HT agonist or metabolites 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.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: (a) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor or joint inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. {See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986); and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988)}.
The above factors, regarding the present invention, are summarized as follows:
Breadth of the claims
The breadth of the claim includes a method of treating a cognitive or neurological disorder in a patient, comprising administering a naltrexone, a metabolite or analogue thereof, and a 5-HT agonist or metabolite thereof.
Nature of the invention
The nature of the invention is performance of a method of treating a cognitive or neurological disorder in a patient, comprising administering a naltrexone, a metabolite or analogue thereof, and a 5-HT agonist or metabolite thereof.
State of the prior art
No single drug has been discovered that is effective in treating the myriad of cognitive and neurological diseases in a patient, including, but not limited to, Alzheimer's disease, dementia, motor neuron disease (MND), depression, psychosis, anxiety, obsessive compulsive disorder (OCD), post-traumatic stress disorder (PTSD), paranoia, panic attacks or flashbacks. See In re Hokum, 226 USPQ 353 (ComrPats 1985).
The state of the prior art teaches that ketamine may be used to treat major depressive disorder, and Yoon et al. (WO 2018075481 A1), on page 35, teaches that ketamine in combination with naltrexone decreased depressive symptoms in major depressive disorder. However, no prior art reference teaches that naltrexone or any metabolite or analogue thereof in combination with any 5-HT agonist or metabolite thereof is capable of treating any neurological or cognitive disorder.
Level of one of ordinary skill in the art
The artisans performing the inventor’s or joint inventor’s method of treating a neurological or cognitive disorder in a patient, comprising administering a naltrexone or any metabolite or analogue thereof in combination with any 5-HT agonist, would be a collaborative team of synthetic chemists and/or health practitioners, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience.
Level of predictability in the art
Synthetic organic chemistry is quite unpredictable. See In re Marzocchi and Horton 169 USPQ at 367 ¶3. Similarly, it is well established that “[T]he scope of enablement varies inversely with the degree of unpredictability of the factors involved, and physiological activity is generally considered to be an unpredictable factor”. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
Amount of direction provided by the inventor
The invention lacks direction with respect to making and/or using (performing) a method of treating a neurological or cognitive disorder in a patient, comprising administering naltrexone or any metabolite or analogue thereof in combination with any 5-HT agonist.
Existence of working examples
The disclosure is insufficient to allow extrapolation of the limited examples to enable performing the instantly recited method of treating any neurological or cognitive disorder in a patient, comprising administering naltrexone or any metabolite or analogue thereof in combination with any 5-HT agonist.
Similarly, according to the specification, naltrexone or any metabolite or analogue thereof in combination with any 5-HT agonist is capable of treating any neurological or cognitive disorder in a patient, including, but not limited to, Alzheimer's disease, dementia, motor neuron disease (MND), depression, psychosis, anxiety, obsessive compulsive disorder (OCD), post-traumatic stress disorder (PTSD), paranoia, panic attacks or flashbacks.
However, the specification fails to set forth any convincing in vitro and/or in vivo assays corroborating the alleged activity in association with any of the aforementioned diseases. The specification does not provide examples for the treatment of any neurological or cognitive disorder. There is insufficient disclosure to reasonably conclude that the method of any neurological or cognitive disorder in a patient, comprising administering naltrexone or any metabolite or analogue thereof in combination with any 5-HT agonist, as recited, would contribute to treatment of any the aforementioned disorders. The inventor or joint inventor has neither provided convincing data for any patient population, nor indicated any art recognized correlation between the disclosed data and the breadth of the claim.
Quantity of experimentation needed
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the invention was filed, would not have taught one skilled in the art how to make and/or use (perform) the full scope of the claimed invention without undue experimentation. See In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
One skilled in the art, such as a medical doctor, would be required to perform hundreds of clinical trials and in vivo or in vitro assays in order to determine which of the indefinite number of naltrexone analogues and metabolites in combination with the indefinite number of 5-HT agonists would be capable of treating which neurological and cognitive disorders. Even in vitro and in vivo assays do not always correlate to efficacy in humans and are not generally predictive of clinical efficacy.
The determination that undue experimentation would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. See In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404. These factual considerations are discussed comprehensively in MPEP § 2164.08 (scope or breadth of the claims), § 2164.05(a) (nature of the invention and state of the prior art), § 2164.05(b) (level of one of ordinary skill), § 2164.03 (level of predictability in the art and amount of direction provided by the inventor or joint inventor), § 2164.02 (the existence of working examples) and § 2164.06 (quantity of experimentation needed to make or use the invention based on the content of the disclosure).
Based on a preponderance of the evidence presented herein, the conclusion that the inventor or joint inventor is insufficiently enabled for a method of treating a neurological or cognitive disorder in a patient, comprising administering naltrexone or any metabolite or analogue thereof in combination with any 5-HT agonist, is clearly justified.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 7-13, and 16-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1-4, 7, 8, 10-13, 16-18, 20, and 21, the metes and bounds of the “metabolite(s) thereof” are unclear because research is required and one skilled in the art cannot say which derivative is the active metabolite and which one is not. The specification, on page 5, uses open language such as “such as” to give non-limiting examples of naltrexone metabolites. No examples are given for metabolites of the 5-HT agonist. Neither the 5-HT agonist nor the naltrexone metabolites are given a defined structure. This rejection would be overcome by defining which metabolites are included in the invention or by removing the term “metabolite(s)”. Claims 9 and 19 are rejected as being dependent upon a rejected claim and failing to give structure to the “metabolite(s)”.
The inventor or joint inventor should note that claims 1-4, 9-13, 16, and 19-21 are reach-through claims. The claim attempts to obtain protection for subject matter that is prophetic and/or has yet to be invented (e.g., 5-HT agonists that have not yet been invented). Similarly, the metes and bounds of 5-HT agonists, specifically 5-HT agonists shown to be capable of treating neurological and cognitive conditions, are not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification, on pages 7-8, lists preferred embodiments of the 5-HT agonists including, but not limited to, “psilocybin, psilocin, mescaline, lysergic acid diethylamide (LSD), ketamine, salvinorin A, ibotenic acid, muscimol, N,N-dimethyltryptamine (DMT), 3,4-methylenedioxy-methamphetamine (MDMA), methyldiethanolamine, also known as N-methyl diethanolamine (MDEA), 3,4- methylenedioxy amphetamine (M DA), 4-Bromo-2,5-dimethoxyphenethyl- amine (2C-B); 1-(8-Bromo-2,3,6,7-tetra-hydrobenzo[1,2-b;4,5-b']difuran-4-yl)2- amino-ethane (2C-B-fly); 4-Ethyl-2,5-dimethoxyphenethylamine (2C-E); 4-Ethyl- thio-2,5-dimethoxy phenethylamine (2C-T-2); 4-Ethylthio-2,5-dimethoxy- amphetamine (ALEPH-2); 4-Ethylthio-2,5-dimethoxyphenylbutylamine (4C-T- 2); 2,5-Dimethoxy-4-ethoxyamphetamine (MEM); 2,4,5-Trimethox-amphetamine (TMA-2); 3,4,5-Trimethoxamphetamine (TMA); 2,5-Dimethoxy-4-bromo-amphetamine (DOB); 2,5-Dimethoxy-4-iodo-amphetamine (DOI); 2,5-Dimethoxy- 4-methylamphetamine (DOM); 2,5-Dimethoxy-4-ethylamphet-amine (DOET); 5-Methoxy-N,N-dimethyl-tryptamine (5-MeO-DMT); N,N-Dipropyltryptamine (DPT);5-Methoxy-N-methyl-N-isopropyltryptamine (5-MeO-MIPT); N,N- Diisopropyltryptamine (DIPT); 5-Methoxy-N,N-diiso-propyltryptamine (5-MeO-DIPT); 6-Fluoro-N,N-dimethyltryptamine (6-fluoro-DMT); lisuride; ibogaine; cis-2a; RR-2b; SS-2c; 2-Ethyl-5-methoxy-N,N-dimethyl-tryptamine (EMDT), serotonin hydrochloride, m-chlorophenylbiguanide hydrochloride, N-methylquipazine dimaleate, PSEM 895, quipazine dimaleate, RS56812 hydrochloride, serotonin hydrochloride, SR7227 hydrochloride, 1-phenylbiguanide hydrochloride, cereulide, 2-methyl-5-HT, alpha-methyltryptamine, bufotenin, chlorophenylbiguanide, ibogaine, varenicline, YM-31636, or metabolites thereof and combinations thereof. More preferably the agonist of a 5-HT2A, 5-HT2B or 5-HT2C receptor is psilocybin, ketamine, MDMA, LSD and the metabolites thereof.”. However, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments, including, but not limited to, the above listed compounds. Consequently, the method for the treatment of a neurological or cognitive condition, the method comprising administering a 5-HT agonist, has been rendered indefinite by the use of the reach-through protocol. The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Rejections - 35 U.S.C. § 112(a), to overcome this rejection.
Regarding claim 2, the phrase “intended to be” renders the claims indefinite, because it is unclear how one would determine whether a patient is “intended to be” administered a 5-HT agonist. Additionally, if a patient was “intended to be” administered a 5-HT agonist, but then was not administered a 5-HT agonist, it is unclear if this scenario reads on the instant claims, and what the metes and bounds of the method involve in such a case. This rejection would be overcome by removing “intended to be” from the claims. Claims 12, 13, 16-19 are rejected as being dependent upon a rejected claim and failing to specify that the 5-HT agonist is administered.
Claims 8 and 18 recites the limitation “the metabolites”, in reference to the 5-HT agonist. There is insufficient antecedent basis for this limitation in the claim. This rejection would be overcome by removing “the metabolites” from claims 8 and 18, or by amending claims 1 and 2, from which these claims depend, to read “…an agonist of a 5-hydroxytryptamine (5-HT) receptor subtype…or a metabolite thereof” (emphasis added).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10 teaches that the patient naltrexone or the analogue thereof “is to be administered prior to the administration of the agonist…”. However, claim 1 already teaches that the patient is “pre-treated with naltrexone”. Therefore, claim 10 fails to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 7-13, and 17-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoon et al. (WO 2018075481 A1), cited by Applicant in the IDS.
Yoon et al. teaches, in claims 16 and 27, a method of treating major depressive disorder comprising administering ketamine and naltrexone. Yoon et al. teaches, in Example 1, a method of treating major depressive disorder in patients comprising pre-treatment with 380 mg naltrexone and treatment with ketamine 2 days after the treatment with naltrexone (see Table 1), as in instant claims 1, 2, 7-11, and 17-21.
It is taught, in claim 19, that the compounds are co-administered, as in instant claim 3. The route of administration is taught, in claim 23 and on page 21 line 27, to include oral administration in the form of a tablet or capsule, as in instant claims 12 and 13.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 4 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Yoon et al. (WO 2018075481 A1), cited by Applicant in the IDS, as applied to claims 1-3, 7-13, and 17-21 above.
Yoon et al. teaches a method of treating major depressive disorder comprising pre-treatment with naltrexone and administration of ketamine. See above rejection.
Yoon et al. fails to teach an embodiment where the naltrexone is administered in an amount of 0.01-50 mg.
However, Yoon et al. teaches, on page 16 lines 6-8, that the naltrexone may be administered orally from about 10 mg to about 100 mg. MPEP 2144.05 I states: “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997)”.
Therefore, instant claims 4 and 16 are rendered prima facie obvious by the teachings of Yoon et al., since the amount of naltrexone taught overlaps with the instant claims.
Additionally, Yoon et al. teaches, on pages 26-27, that “[T]he therapeutically effective amount or dose of a compound of the present invention depends on the age, sex and weight of the patient, the current medical condition of the patient and the progression of a disease or disorder contemplated in the invention. The skilled artisan is able to determine appropriate dosages depending on these and other factors.” MPEP 2144.05 II A states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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 re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”.
Therefore, the specific dosage amount of naltrexone is not patentably new subject matter, since this would be routine optimization conducted by one of ordinary skill in the art, and since Yoon et al. teaches that the effective amount or dose is dependent on a variety of factors.
Nonstatutory 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 1-4, 7-13, and 16-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 2, 4, 8, and 12-14 of copending Application No. 18/572,637 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1, 2, 12, and 13 of Application ‘637 teach a method of treating a cognitive or neurological disorder, including Alzheimer’s, PTSD, OCD, MND, depression, psychosis, anxiety, paranoia, panic attacks, and flashbacks comprising administering 0.01-10 mg naltrexone and a 5-HT agonist, as in instant claims 1-4, 9, 16, and 19. The 5-HT agonists of reference claim 4 reads on the agonists of instant claims 7, 8, 17, and 18. The administration methods of reference claims 8 and 14 reads on the formulation and administration techniques of instant claims 10-13, 20, and 21.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 7-13, and 16-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-4, 7-13, and 16-21 of copending Application No. 18/572,651 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1, 2, 7-9, 17-19, of Application ‘651 teach a method of treating a neurological or cognitive disorder comprising administering naltrexone and a 5-HT agonist, as in instant claims 1 and 2. The method includes the neurological and cognitive disorders listed in instant claims 9 and 19, and the 5-HT agonists listed in instant claims 7, 8, 17, and 18. The administration methods of reference claims 3, 4, 10-13, 16, 20 and 21 read directly on instant claims 3, 4, 10-13, 16, 20, and 21.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-4, 7-13, and 16-21 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RILLA M SAMSELL whose telephone number is (703)756-5841. The examiner can normally be reached Monday-Friday, 7-3.
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, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/R.M.S./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624