DETAILED ACTION
This office action is in response to applicant’s filing dated July 1, 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 115-144 are pending in the instant application. Acknowledgement is made of Applicant's amendments filed July 1, 2025. Acknowledgement is made of Applicant's cancelation of claims 1-114; and addition of new claims 115-144.
Claims 115-144 are presently under examination.
Priority
The present application is a 371 of PCT/EP2023/057857 filed on March 27, 2023, which claims benefit of foreign priority to EP 22000083.0 and EP 22000086.3 filed on March 27, 2022 and EP 23153995.8, and EP 23153939.6 filed on January 30, 2023.
Information Disclosure Statement
In the instant application, it is duly noted that Applicant has submitted an information disclosure statement on January 15, 2025 with a total of over 1500+ references. While the Examiner has made every effort to thoroughly review these references, one could have very well overlooked a pertinent document. Accordingly, the information disclosure statement is being considered by the examiner to the extent possible, except where marked with a strikethrough.
As noted by the court, applicant has an obligation to call the most pertinent prior art to the attention of the Patent Office in a proper fashion. Burying one reference amongst a large number of other IDS references is like citing nothing. See Penn Yan Boats, Inc. v. Sea Lark Boats Inc., 359 F. Supp 948, 175 USPQ 260 (S.D. Fla. 1972; Golden Valley Microwave Foods Inc. v. Weaver Popcorn Co. Inc., 24 USPQ2d 1801 (U.S. Dist. N. Dist. IN 1992). Accordingly, the information disclosure statement is being considered by the examiner to the extent possible, except where marked with a strikethrough.
The information disclosure statement (IDS) submitted on February 27, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner, except where marked with a strikethrough.
The information disclosure statements filed March 28, 2025; April 30, 2025; May 30, 2025; June 30, 2025; July 31, 2025; August 29, 2025; September 26, 2025; October 31, 2025; December 15, 2025; January 21, 2026; and February 23, 2026 fail to comply with the provisions of 37 CFR 1.97(a) because they lack the appropriate size fee set forth in 37 CFR 1.17(v). It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: 5-Methoxy-N,N-DimethylTrytamine (5-MeO-DMT) for the Treatment of Anxiety.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 115-117, 122-125, 129, 133-137, and 141-144 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Terwey et al (WO 2020/169850 A1, cited in the IDS filed January 15, 2025).
Regarding claims 115, Terwey teaches embodiments related to the treatment of anxiety disorder (page 45, last line); 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof for use in treating a patient who is diagnosed with anxiety disorder by a licensed professional in accordance with accepted medical practice (page 46, 1.), wherein a dosage of about 4 mg to about 20 mg 5-MeO-DMT is administered (page 46, 10.). A dosage of about 4 mg to about 20 mg 5-MeO-DMT reads on an effective amount as evidenced by instant claim 129, which depends from claim 115 and thus further limits the limitations of claim 115.
Regarding claim 116, anxiety disorder reads on mental or nervous system disorder.
Regarding claim 117, Terwey teaches wherein the patient is diagnosed with a treatment-resistant form of anxiety disorder (page 46, 5.).
Regarding claims 122, 124, 125, and 143, Terwey teaches wherein a clinical response, as assessed by at least 50% improvement of the BAI (Beck Anxiety Inventory) or HAM-A (Hamilton Anxiety Scale) score, compared to the respective score prior to treatment, occurs not later than about 2 hours after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof (page 49, 27). Reduction in score no later than about 2 hours after the last administration of 5-MeO-DMT reads on reduction of anxiety is observed on day 1 after the last administration of 5-MeO-DMT.
Regarding claim 123, Terwey teaches wherein there is a clinical response, as assessed by at least 75% improvement of the BAI or HAM-A score, compared to the respective score prior to treatment, on day 7 after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof (page 49, 30.)
Regarding claim 129, Terwey teaches wherein a dosage of about 4 mg to about 20 mg 5-MeO-DMT is administered (page 46, 10.).
Regarding claims 133 and 134, Terwey teaches wherein the 5-MeO-DMT is administered in a dosage from about 2 mg to about 8 mg for a first administration, and then increased, unless the patient has already experienced a peak psychedelic experience, to a dosage from about 8 mg to about 14 mg for a second administration, and then increased, unless the patient has already experienced a peak psychedelic experience, to a dosage from about 14 mg to about 20 mg for a third administration, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT (page 47, 13.).
Regarding claims 135 and 136, Terwey teaches wherein the first dosage of 5-MeO-DMT is about 6 mg, the second dosage of 5-MeO-DMT is about 12 mg, and the third dosage of 5-MeO-DMT is about 18 mg; or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT (page 47, 14.).
Regarding claims 137, Terwey teaches wherein the interval between two administrations is not less than 1 hour and not more than 24 hours, such as about 2 to 4 hours (page 47, 15.).
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 amounts taught by Terwey falls within the instant claimed ranges of claims 129 and 133-137 and thus anticipates the claimed ranges of claims 129 and 133-137.
Regarding claim 141, Terwey teaches wherein the 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via inhalation (page 48, 18.).
Regarding claim 142, Terwey teaches preferably the active compound is administered nasally (page 17, 2nd paragraph).
Regarding claim 144, Terwey teaches wherein the 5-MeO-DMT or salt thereof is administered at a dose or in a dosage regimen that causes the patient to experience a peak psychedelic experience (page 46, 9.).
Thus, the teachings of Terwey anticipate the method of claims 115-117, 122-125, 129, 133-137, and 141-144.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 118-121, 126-128, 130-132, and 138-140 is/are rejected under 35 U.S.C. 103 as being unpatentable over Terwey et al (WO 2020/169850 A1, cited in the IDS filed January 15, 2025) as applied to claims 115-117, 122-125, 129, 133-137, and 141-144 above.
Terwey teaches all the limitations of claims 118-120 (see 102 rejection above), except wherein the patient is suffering from a disorder characterized by depressive episodes associated with the anxiety, is suffering from a current major depressive episode, or is suffering from major depression disorder associated with the anxiety.
However, Terwey teaches embodiments relating to the treatment of major depressive disorder with suicidal ideation with intent or with imminent risk for suicide (page 95, last paragraph) and 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof for use in treating a patient who is diagnosed with major depressive disorder by a licensed professional in accordance with accepted medical practice, and who also has suicidal ideation with intent or has imminent risk for suicide, as diagnosed by a licensed professional in accordance with accepted medical practice (page 95, 1.); wherein the 5-MeO-DMT or salt thereof is administered at a dose or in a dosage regimen that causes the patient to experience a peak psychedelic experience (page 96, 6.); wherein a dosage of about 4 mg to about 20 mg 5-MeO-DMT is administered (page 96, 7.); wherein the 5-MeO-DMT is administered in a dosage from about 2 mg to about 8 mg for a first administration, and then increased, unless the patient has already experienced a peak psychedelic experience, to a dosage from about 8 mg to about 14 mg for a second administration, and then increased, unless the patient has already experienced a peak psychedelic experience, to a dosage from about 14 mg to about 20 mg for a third administration, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT (page 97, 10.); wherein the 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via inhalation (page 97, 15.). Moreover, Terwey teaches treating anxiety in a subject suffers in addition from suicidal ideation (page 46, 1 and 6).
As such, since Terwey teaches a method of treating anxiety comprising administering an effective amount 5-MeO-DMT in a dosage that causes a patient to experience a peak psychedelic experience and in addition suffers from suicidal ideation, and since Terwey further teaches that 5-MeO-DMT in the same amounts and dosages that cause a patient to experience a peak psychedelic experience is useful for treating major depressive disorder with suicidal ideation, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of treating anxiety associated with major depressive disorder with an expectation of success, since the prior art establishes that 5-MeO-DMT is useful for treating anxiety and major depressive disorder.
Moreover, regarding claim 121, Terwey teaches the disclosed methods are useful for treating treatment-resistant form of anxiety disorder (claim 46, 5.) and treating major depressive disorder with suicidal ideation wherein the patient is diagnosed with a treatment-resistant form of major depressive disorder (page 96, 5.). It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of treating anxiety associated with major depressive disorder wherein the patient suffering from MDD suffers from a treatment resistant form of the disorder with an expectation of success, since the prior art establishes that 5-MeO-DMT is useful for treating treatment-resistant form anxiety and major depressive disorder.
Taken together, all this would result in the practice of the method of claims 118-121 with a reasonable expectation of success.
Regarding claims 126-128, Terwey does not explicitly teach that use of Clinical Global Impression -Severity (CGI-S) score for measuring improvement in the anxiety disorder. However, Terwey does teach the use of Clinical Global Impression - Improvement (CGI-I) score (page 48, 23.). Moreover, Terwey teaches "Clinical response" includes, but is not limited to, improvements on rating scales such as the Clinical Global Impression – Severity scale (CGI-S) and the Clinical Global Impression - Improvement scale (CGI-I) and further includes HAM-D for major depressive disorder and persistent depressive disorder, anxiety symptoms e.g. as measured by the Beck Anxiety Inventory (BAI) and the Hamilton Anxiety Scale (HAM-A) (page 16, last bridge paragraph). Thus, Terwey establishes that CGI-I and CGI-S are alternatively useful for measuring clinical response for major depression and anxiety. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to utilize either the CGI-I or CGI-S scales for measuring clinical response in view of the teachings of Terwey.
Taken together, all this would result in the practice of the method of claims 126-128 with a reasonable expectation of success.
Regarding claims 130-132, Terwey teaches 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof for use in treating a patient who is diagnosed with anxiety disorder by a licensed professional in accordance with accepted medical practice (page 46, 1.); wherein the 5-MeO-DMT or salt thereof is administered in a first dosage amount for a first administration; and the 5-MeO-DMT or salt thereof is administered in zero to six subsequent administrations; wherein each subsequent administration uses a dosage amount higher than the previous administration unless the patient experiences a peak psychedelic experience (page 47, 12.).
Regarding claim 138, Terwey teaches wherein the interval between two administrations is not less than 1 hour and not more than 24 hours, such as about 2 to 4 hours (page 47, 15.).
MPEP 2144.05 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). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
Regarding claim 139, Terwey teaches wherein the occurrence of a peak psychedelic experience is identified through achievement of at least 60% of the maximum possible score in each of the four subscales (mystical, positive mood, transcendence of time and space, and ineffability) of the 30-item revised Mystical Experience Questionnaire (MEQ30) (page 51, 44.)
Regarding claim 140, Terwey teaches wherein the occurrence of a peak psychedelic experience is identified through achievement of a Peak Psychedelic Experience Questionnaire (PPEQ) Total Score of at least 75 (page 47, 17).
Taken together, all this would result in the practice of the method of claims 130-132 and 138-140 with a reasonable expectation of success.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 115-144 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 33-68 of copending Application No. 18/850,394 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a method for treating anxiety in a patient comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the patient is suffering from a disorder characterized by depressive episodes associated with the anxiety, wherein the patient is suffering from major depressive disorder (MDD) associated with the anxiety.
The copending claims are directed to a method for treating a mental or nervous system disorder in a breastfeeding mother comprising administering an effective amount of 5-Methoxy-N,N-dimethyltryptamine (5-MeO- DMT) or a pharmaceutically acceptable salt thereof, wherein treatment leads to improvement of anxiety; wherein the disorder characterized by depressive episodes is Major Depressive Disorder (MDD). Improvement of the disorder is measured with CGI-S score. The copending claims also are directed to the same doses and dosing regimens.
Thus, the method of the copending claims would anticipate the method of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 115-144 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 284-314 of copending Application No. 18/851,343 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a method for treating anxiety in a patient comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the patient is also suffering from a mental or nervous system disorder, wherein the patient is suffering from a disorder characterized by depressive episodes associated with the anxiety, wherein the patient is suffering from a current major depressive episode.
The copending claims are directed to a method for treating bipolar disorder in a patient comprising administering an effective amount of 5-Methoxy-N,N-dimethyltryptamine (5-MeO- DMT) or a pharmaceutically acceptable salt thereof, wherein the bipolar disorder is bipolar II disorder and wherein the patient is suffering from a current major depressive episode, wherein treatment leads to improvement of anxiety; wherein the disorder characterized by depressive episodes is Major Depressive Disorder (MDD). The copending claims also are directed to the same doses and dosing regimens.
Thus, the method of the copending claims would anticipate the method of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 115-144 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-85 of copending Application No. 18/373,906 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a method for treating anxiety in a patient comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the patient is also suffering from a mental or nervous system disorder.
The copending claims are directed to a method for treatment of a mental or nervous disorder in a breastfeeding mother comprising administering an effective amount of 5-Methoxy-N,N-dimethyltryptamine (5-MeO- DMT) or a pharmaceutically acceptable salt thereof, wherein the patient suffers from a mental or nervous system disorders involving anxiety symptoms and wherein treatment reduces or eliminates symptoms of anxiety. The copending claims also are directed to the same doses and dosing regimens.
Thus, the method of the copending claims would anticipate the method of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 115-144 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 33-62 of copending Application No. 18/851,329 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a method for treating anxiety in a patient comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the patient is also suffering from a mental or nervous system disorder.
The copending claims are directed to a method for treatment of a mental or nervous disorder in a breastfeeding mother comprising administering an effective amount of 5-Methoxy-N,N-dimethyltryptamine (5-MeO- DMT) or a pharmaceutically acceptable salt thereof, wherein the disorder is a disorder characterized by depressive episodes, wherein the disorder is major depressive disorder or anxiety disorder, wherein treatment wherein treatment leads to improvement in anxiety.
Thus, the method of the copending claims would anticipate the method of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 115-144 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-87 of copending Application No. 18/373,914 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a method for treating anxiety in a patient comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the patient is also suffering from a mental or nervous system disorder.
The copending claims are directed to a method for treatment of a mental or nervous disorder in a breastfeeding mother comprising administering an effective amount of 5-Methoxy-N,N-dimethyltryptamine (5-MeO- DMT) or a pharmaceutically acceptable salt thereof, wherein the patient suffers from a mental or nervous system disorders involving anxiety symptoms and wherein treatment reduces or eliminates symptoms of anxiety. The copending claims also are directed to the same doses and dosing regimens.
Thus, the method of the copending claims would anticipate the method of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 115-144 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 114-137 of copending Application No. 18/851,294 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a method for treating anxiety in a patient comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the patient is suffering from a disorder characterized by depressive episodes associated with the anxiety, wherein the patient is suffering from major depressive disorder (MDD) associated with the anxiety.
The copending claims are directed to a method for treating anxiety in a patient comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via an intravenous, intramuscular or subcutaneous route, wherein the patient is also suffering from a mental or nervous system disorder, wherein the mental or nervous system disorder is a treatment-resistant form of the mental or nervous system disorder, wherein the patient is suffering from a disorder characterized by depressive episodes associated with the anxiety, wherein the patient is suffering from a current major depressive episode, wherein the patient is suffering from major depressive disorder (MDD) associated with the anxiety.
Thus, the method of the copending claims would anticipate the method of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 115-144 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-16, 23-35, 38-41, 46, 47, and 92-112 of copending Application No. 18/851,346(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a method for treating anxiety in a patient comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the patient is suffering from a disorder characterized by depressive episodes associated with the anxiety, wherein the patient is suffering from major depressive disorder (MDD) associated with the anxiety.
The copending claims are directed to for use in treating a patient suffering from sleep disturbance, wherein the 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via an intravenous, intramuscular or subcutaneous route, wherein the patient is suffering from a mental or nervous system disorder characterized by depressive episode including major depressive disorder and generalized anxiety disorder.
Thus, the method of the copending claims would anticipate the method of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 115-144 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 283-305 of copending Application No. 18/851,336 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a method for treating anxiety in a patient comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the patient is also suffering from a mental or nervous system disorder, wherein the patient is suffering from a disorder characterized by depressive episodes associated with the anxiety, wherein the patient is suffering from a current major depressive episode.
The copending claims are directed to a method for treating bipolar disorder in a patient comprising administering an effective amount of 5-Methoxy-N,N-dimethyltryptamine (5-MeO- DMT) or a pharmaceutically acceptable salt thereof, wherein the bipolar disorder is bipolar II disorder and wherein the patient is suffering from a current major depressive episode, wherein treatment leads to improvement of anxiety; wherein the disorder characterized by depressive episodes is Major Depressive Disorder (MDD).
Thus, the method of the copending claims would anticipate the method of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 115-144 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628
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