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 1-85 are pending in the instant application.
Priority
Acknowledgement is made of Applicant’s claim for foreign priority based on the EP22000083.0, EP22000086.3, EP23153995.8, and EP23153939.6 applications filed on March 27th, 2022, March 27th, 2022, January 30th, 2023, and January 30th, 2023, respectively.
Information Disclosure Statement
The Information Disclosure Statements filed on December 15th, 2025, October 31st, 2025, September 26th, 2025, August 29th, 2025, July 31st, 2025, June 30th, 2025, May 30th, 2025, April 30th, 2025, March 28th, 2025, February 27th, 2025, January 31st, 2025, December 27th, 2024, November 26th, 2024, October 28th, 2024, September 27th, 2024, August 26th, 2024, July 23rd, 2024, and January 23rd, 2024 have been fully considered, except where marked with a strikethrough.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
The abstract of the disclosure is objected to because the abstract is fewer than 50 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 1-48 and 52-85 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 treating postpartum depression, does not reasonably provide enablement for treatment of any mental or nervous system disorder. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims, (2) The nature of the invention, (3) The state of the prior art, (4) The level of one of ordinary skill, (5) The level of predictability in the art, (6) The amount of direction provided by the inventor, (7) The existence of working examples and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Nature of the invention:
The invention is drawn to a method of treatment of a mental or nervous system disorder in a breastfeeding mother.
Breadth of the invention:
The scope of the claimed invention is very broad. As claimed, the invention is drawn to treating any mental or nervous system disorder. This encompasses a myriad of conditions, known presently, but could also include disorders discovered or classified years from now as mental or nervous system disorders. Can an Applicant simply “reach through” and obtain patent protection from disorders not yet known, or disorders presently known, later reclassified as a mental or nervous system disorder? The genus of mental or nervous system disorder encompasses an array of distinct disorders with mutually exclusive etiologies and responsiveness to treatments.
State of the prior art and predictability in the art:
With respect to pharmaceutical treatment of mental disorders, Stern et. al. (“Prediction of Response to Drug Therapy in Psychiatric Disorders”, Focus, Vol 17, 2019; hereinafter referred to as Stern) represents the state of the prior art.
At Page 294, Third Paragraph of the Second Column, Stern teaches psychiatric disorders are prevalent and heterogeneous disorders. Further, at the Second Paragraph of the First Column at Page 295, Stern teaches many psychiatric disorders demonstrate pleiotropy whereby a single gene is identified as the cause of multiple disorders. Stern states, “The main conclusion when it comes to treatment selection is that the origin of each disorder is so complex that no single treatment is best for these disorders; the whole genetic, epigenetic and environmental background should be taken into account.”
Further, at the Last Paragraph of the First Column at Page 295, Stern states, “The diversity of available drugs today for psychiatric disorders alone shows the difficulty of finding the right treatment for the right patient. The mechanism by which these drugs act is usually not well understood. Each drug carries a long list of side effects, so when an ineffective drug is prescribed, not only is it a waste of time for the patient whose symptoms do not improve, but there are also the side effects that act on other systems, sometimes causing long-lasting and irreversible damage.” Further, by example, Stern teaches that 30% of schizophrenic patients will have no response to drugs intended to treat schizophrenia, while an additional 30-40% of patients will have a partial response, and 30% of the responders will relapse. For bipolar disorder, only 30% of patients will fully respond to treatment. For major depression, only 30-50% of patients have full remission of symptoms with treatment.
Taken together, this demonstrates a lack of predictability in the treatment of mental disorders. The complex origins of mental disorders, as taught by Stern, in view of the lack of predictability of treatment establishes the standard by which enablement must be demonstrated.
The invention is directed toward medicine and is therefore physiological in nature. It is well established that “the 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).
In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F. 2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F. 2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F. 2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
Level of ordinary skill in the art:
An ordinary artisan in the area of drug development would have experience in synthesizing chemical compounds for particular activities. The synthesis of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can be employed, developing a therapeutic method, as claimed, prior to synthesizing and testing compounds is generally not well-known or routine, given the complexity of certain biological systems.
The amount of direction provided and working examples:
Beginning at Page 254 of the instant specification, at Example 1, Applicant has sufficiently disclosed a method for the preparation of an aerosol dispersion containing 5-MeO-DMT, suitable for use for administration of 5-MeO-DMT by inhalation.
Beginning at Page 255 of the instant specification, at Example 2, Applicant has sufficiently disclosed the preparation of 5-MeO-DMT in high purity, noting impurities below 0.10%.
At Page 256 of the instant specification, at Example 3, Applicant has sufficiently disclosed the preparation of a 5-MeO-DMT hydrobromide salt.
Beginning at Page 256 of the instant specification, at Example 4, Applicant has sufficiently disclosed a method for determining dissociation constants and mean inhibition constants for 5-MeO-DMT against 5-HT1A and 5-HT2A, and has disclosed these values for 5-MeO-DMT.
Beginning at Page 259 of the instant specification, at Example 5, Applicant discloses results from a clinical trial wherein 5-MeO-DMT was administered to patients with treatment-resistant major depressive disorder. Notably, this example is silent with respect to whether any of the patients in the trial were breastfeeding mothers. As the instant claims draw a distinction between a human patient and a breastfeeding mother, this example is insufficient to be extrapolated to determine efficacy in the treatment of breastfeeding mothers.
Beginning at Page 263 of the instant specification, at Example 6, Applicant discloses pharmacokinetic properties of 5-MeO-DMT and bufotenine.
At Page 264 of the instant specification, at Example 7, Applicant discloses toxicological tsting data of 5-Meo_DMT.
At Page 265 of the instant specification, at Example 8, Applicant discloses binding data of 5-MeO-DMT in human plasma proteins.
Beginning at Page 265 of the instant specification, at Example 9, Applicant discloses metabolic data of 5-MeO-DMT in humans.
Beginning at Page 268, at Example 12, Applicant discloses the efficacy of 5-MeO-DMT administered via inhalation in treating postpartum depression.
Beginning at Page 281, at Example 13, Applicant outlines the plans for a clinical trial for evaluating the efficacy of administration of 5-MeO-DMT by inhalation in treating bipolar II disorder. As no results from such a trial have been disclosed, however, treatment of bipolar II is then speculative, and sufficient disclosure has not been provided to enable the instant invention for the treatment of bipolar II disorder.
Quantity of experimentation needed to use the invention based on the content of the disclosure:
The quantity of experimentation needed is undue experimentation. As referenced above, a person having ordinary skill in the art would need not only to identify and/or develop suitable protocols to evaluate the efficacy of administration of 5-MeO-DMT in treating a mental or central nervous system disorder in a breastfeeding mother, but would also need to employ these methods, with no assurance of success. In light of the unpredictable nature of treatment of psychiatric disorders, the disclosure provided is not enabling for the scope of the claims as recited.
Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person having ordinary skill in the art would have to engage in undue experimentation to determine suitable prodrugs of the compounds in the instant claims, with no assurance of success.
Claim Rejections - 35 USC § 112
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, 23, and 37-48 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.
Claim 1 is rendered indefinite due to the recitation of the limitation “wherein the patient is advised to temporarily cease breastfeeding.” The term “temporarily” does not reasonably convey to a person having ordinary skill in the art the metes and bounds of this limitation. Clarification is required.
Claim 23 is rendered indefinite due to the recitation of the limitation “predetermined thresholds”, as this phrase is not defined such that a person having ordinary skill in the art would readily understand the metes and bounds of this limitation. Appropriate clarification is required.
Claims 37-48 are rendered indefinite due to the recitation of the limitation “by pumping and discarding breastmilk for an appropriate period of time or by a combination of these measures”, as the phrase “an appropriate period of time” is not defined such that a person having ordinary skill in the art would readily understand the metes and bounds of this limitation. Appropriate clarification is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 23-46 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 23 recites the limitation of “any expressed breast milk is discarded as long as the concentrations of 5-MeO-DMT and/or 5-MIAA in breast milk will exceed predetermined thresholds”, with dependent Claims 24-36 providing ranges of such thresholds. This step is a judicial exception because it is an abstract idea insofar that it amounts to a mental process. Per MPEP 2106.04(a)(2), III., “The courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper” to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). As the Federal Circuit explained, “methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas the ‘basic tools of scientific and technological work’ that are open to all.’” 654 F. 3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409, U.S. 63, 175 USPQ 673 (1972)).” This judicial exception is not integrated into a practical application because it amounts to nothing more than interpreting data. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no process is positively recited in which concentrations of 5-MeO-DMT and/or 5-MIAA in breast milk do not exceed predetermined thresholds is to be performed.
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.
Claims 1-22 and 49-85 are rejected under 35 U.S.C. 103 as being unpatentable over Davis et. al. (“5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) used in a naturalistic group setting is associated with unintended improvements in depression and anxiety”, The American Journal of Drug and Alcohol Abuse, 2019; cited on Applicant’s Information Disclosure Statement filed January 23rd, 2024; hereinafter referred to as Davis) in view of Eberhard-Gran et. al. (“Use of Psychotropic Medications in Treating Mood Disorders during Lactation – Practical Recommendations”, CNS Drugs, 2006; hereinafter referred to as Eberhard-Gran).
At the Abstract, Davis teaches administration of 5-MeO-DMT resulted in improvement in depression and anxiety symptoms. Further, it is taught at the abstract that the structured procedures and guiding dose and administration of 5-MeO-DMT are similar to procedures used in clinical trials. In the group examined, most respondents reported improvement in depression/anxiety.
At Page 166, Davis states, under Discussion, “The present study suggests that 5-MeO-DMT administered in a naturalistic group setting is associated with improvements in depression and anxiety among a sample of individuals using 5-MeO-DMT for spiritual purposes. For example, approximately 80% of respondents with anxiety or depression in this sample reported improvements in these conditions after using 5-MeO-DMT.”
At Page 162, Last Paragraph, Davis teaches administration of 5-MeO-DMT via inhalation.
At Page 163, First Paragraph, Davis teaches administration in doses between 5-7 mg, 8-12 mg, or 13-15mg+.
Davis does not teach administration of 5-MeO-DMT to a breastfeeding mother, wherein the patient is advised to temporarily cease breastfeeding.
At the Abstract, Eberhard-Gran states, “Infant drug exposure is, however, generally higher during pregnancy through placental passage than through breast milk.”
At Page 192, under Treatment Recommendations, Eberhard-Gran states, “Historically, depressed mothers have been advised against breastfeeding while receiving treatment with anti-depressants and mood-stabilizing agents.”
Applying KSR exemplary rationale C, it would have been obvious to a person of ordinary skill in the art to advise a breastfeeding mother to cease breastfeeding to administer 5-MeO-DMT, known in the art to treat depression, as Eberhard-Gran establishes standard practice in the art is to advise breastfeeding mothers to cease breastfeeding while being treated for depression.
Regarding the doses recited at Claims 1 and 72-78, the aforementioned doses taught by Davis fall within these ranges. Per MPEP 2144.05, I., “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)”.
Regarding the limitations regarding “MADRS score”, “HAM-D score”, “BIMF”, “HAM-A score”, “PSQI”, “MEQ30”, “OBN”, “ASC, and/or “PES” at Claims 50-54, 57-61, 63-67, and 79-80, the prior art is silent with respect to a patient reporting the recited parameters according to each of these scores/metrics. However, these scores/metrics will naturally flow from the method made obvious by the prior art, since the same compound, 5-MeO-DMT, is being administered to the same subjects in the same dosage amounts. In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding specific metrics/scores of regarding “MADRS score”, “HAM-D score”, “BIMF”, “HAM-A score”, “PSQI”, “MEQ30”, “OBN”, “ASC, and/or “PES” as recited at Claims 50-54, 57-61, 63-67, and 79-80, by practicing the method made obvious by the prior art, administering 5-MeO-DMT to treat anxiety/depression, one will also be achieving these metrics, even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage of administering 5-MeO-DMT.
MPEP 2145, II. states, “The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious. Ex parte Obiaya, 227 USPQ 58, 60.”
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 1-22 and 69-78 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33-35, 39-41, 46-48, 50, 52, 54—58, and 60-68 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 both claim sets are drawn to the administration of 5-MeO-DMT to treat a mental or nervous system disorder in a breastfeeding disorder.
The aforementioned claims of the reference application differ from the instant claims in that the instant claims recite the additional limitation of the patient being advised to temporarily cease breastfeeding. This additional limitation, however, does not make the instant claims patentably distinct from the claims of the reference application, as the broadest reasonable interpretation of the reference claims would reasonably include treatment of a breastfeeding mother that has been advised to temporarily cease breastfeeding.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-22, and 49-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 10-17 of copending Application No. 18/851,356 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the reference claims are drawn to the administration of 5-MeO-DMT for the treatment of postpartum depression.
The aforementioned reference claims differ from the instant claims in that the instant claims specify the patient is a breastfeeding mother, and are more broadly directed at the treatment of a mental or central system disorder. Instant Claim 49, however, is directed to the treatment of postpartum depression. Therefore, the instant claims read on the aforementioned reference claims, as in the broadest reasonable interpretation, a patient, as claimed in the reference application can include breastfeeding mothers, as required by the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-22 and 49-51 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 49 of copending Application No. 18/851,322 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the reference application are drawn to the administration of 5-MeO-DMT for the treatment of postpartum depression.
Reference Claim 49 differs from the instant claims in that the instant claims specify the patient is a breastfeeding mother, and are more broadly directed at the treatment of a mental or central system disorder. Instant Claim 49, however, is directed to the treatment of postpartum depression. Therefore, the instant claims read on reference Claim 49, as the broadest reasonable interpretation of a patient includes breastfeeding mothers, as recited in the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-80 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-86 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 both the instant claims and the reference claims are drawn to administration of 5-MeO-DMT to treat a mental or nervous system disorder in a breastfeeding mother.
The reference claims differ from the instant claims in that the reference claims require administration of 5-MeO-DMT via intravenous, intramuscular, or a subcutaneous route. Instant Claim 1 is silent with respect to the route of administration. Therefore, the broadest reasonable interpretation of instant claim 1 would allow for administration of 5-MeO-DMT to treat a mental or nervous system disorder in a breastfeeding mother by any of the intravenous, intramuscular, or subcutaneous routes.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-22 and 49-51 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/373,904 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the reference application are drawn to the administration of 5-MeO-DMT for the treatment of postpartum depression.
Reference Claim 1 differs from the instant claims in that the instant claims specify the patient is a breastfeeding mother, and are more broadly directed at the treatment of a mental or central system disorder. Instant Claim 49, however, is directed to the treatment of postpartum depression. Therefore, the instant claims read on reference Claim 1, as the broadest reasonable interpretation of a patient includes breastfeeding mothers, as recited in the instant application. Further, reference Claim 1 differs from the instant Claims in that it requires administration of 5-MeO-DMT via intravenous, intramuscular, or a subcutaneous route. Instant Claim 1 is silent with respect to the route of administration. Therefore, the broadest reasonable interpretation of instant claim 1 would allow for administration of 5-MeO-DMT by any of the intravenous, intramuscular, or subcutaneous routes.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-22, 55, and 69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33-34, 53-62 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 both the instant claims and the reference claims are drawn to administration of 5-MeO-DMT to treat a mental or nervous system disorder in a breastfeeding mother.
The reference claims differ from the instant claims in that the reference claims require administration of 5-MeO-DMT via intravenous, intramuscular, or a subcutaneous route. Instant Claim 1 is silent with respect to the route of administration. Therefore, the broadest reasonable interpretation of instant claim 1 would allow for administration of 5-MeO-DMT to treat a mental or nervous system disorder in a breastfeeding mother by any of the intravenous, intramuscular, or subcutaneous routes.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 283 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 and the reference claim are both drawn to treating a mental disorder by administering 5-MeO-DMT.
The reference claims differ from the instant claims in that the patient being treated is not required to be a breastfeeding mother, and the treatment is more narrowly directed to treatment of bipolar II disorder in a patient that is suffering from a current major depressive episode, where the 5-MeO-DMT is administered via an intravenous, intramuscular, or subcutaneous route. The instant claim 1 is silent with respect to mode of administration. Therefore, the broadest reasonable interpretation of instant Claim 1 would allow for intravenous, intramuscular, or subcutaneous routes of administration of 5-MeO-DMT. Further, treating a breastfeeding mother for bipolar II disorder currently suffering a major depressive episode would read on both instant Claim 1 and reference claim 283.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 114 and 135 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 both the instant claims and the reference claims are directed to treating a mental disorder in a patient by administering 5-MeO-DMT.
The claims differ in that the reference claims are more narrowly directed to treating anxiety by administering 5-MeO-DMT via an intravenous, intramuscular, or subcutaneous route. The instant claims are directed to treating a mental disorder in a breastfeeding mother, and are silent with respect to the route of administration of 5-MeO-DMT. Therefore, the broadest reasonable interpretation of instant Claim 1 would allow for any route of administration of 5-MeO-DMT, and treating a breastfeeding mother for anxiety would read on both the instant claims and the reference claims, as the broadest reasonable interpretation of patient as recited in the reference claims would include a breastfeeding mother.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 49-51, and 69-85 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9-12, and 19-36 of copending Application No. 18/373,903 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and reference claims are both drawn to treating postpartum depression by administering 5-MeO-DMT.
While instant Claim 1 is silent with respect to treating postpartum depression as claimed in reference Claim 1, instant Claim 49 recites treatment of postpartum depression. Therefore, the instant claims and reference claims are not patentably distinct, as they are drawn to overlapping subject matter insofar that the instant claims and reference claims are drawn to treating postpartum depression by administering 5-MeO-DMT. The instant claims differ from the reference claims in that the instant claims are more narrowly directed to treatment of a breastfeeding mother. The broadest interpretation of Claim 1 of the reference application, however, would include a breastfeeding mother as a patient suitable for treatment of postpartum depression via the claimed method. Therefore, the practice of the instant claims would read on the reference claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 284 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 Claim and the reference claim are both drawn to treating a mental disorder in a patient by administering 5-MeO-DMT.
The reference claim differs from the instant Claim in that the reference claim is more narrowly directed to treating a patient having bipolar II disorder. The instant claim is more narrowly directed to treating a patient that is a breastfeeding mother. The broadest reasonable interpretation of the reference claim, however, would include treatment of a breastfeeding mother. Therefore, the reference claim and the instant claim are drawn to overlapping subject matter, as administration of 5-MeO-DMT to a breastfeeding mother to treat bipolar II disorder would read on both the instant and reference claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 115-116 of copending Application No. 18/850,348 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant Claims and reference claims are both drawn to the treatment of a mental disorder comprising administering 5-MeO-DMT.
The instant claims and reference claims differ insofar that the reference claims are more narrowly directed to treatment of anxiety, while more broadly being directed at treating a patient. The instant claims are more broadly directed to treating any mental or central nervous system disorder, but more narrowly directed to treating a patient that is a breastfeeding mother. Treatment of anxiety in a breastfeeding mother comprising administering 5-MeO-DMT would read on both the reference claims and instant Claim 1. Therefore, the claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/675,914 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claim and instant claim are both drawn to the treatment of a mental disorder comprising administration of 5-MeO-DMT.
The reference claim differs from the instant claim insofar that the reference claim is more narrowly directed to treating a treatment-resistant form of major depressive disorder, and is more broadly directed to treatment of a patient. Instant Claim 1 is broadly directed to the treatment of a mental or nervous system disorder, but more narrowly directed to treatment of a breastfeeding mother. Treatment of a breastfeeding mother for treatment-resistant major depressive disorder would read on both the instant and reference claims. Therefore, these claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/679,917 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and reference claims are both drawn to treatment of a mental disorder comprising administration of 5-MeO-DMT.
The reference claim differs from the instant claim in that it is more narrowly directed to the treatment of major depressive disorder via administration through an intravenous, intramuscular, or subcutaneous route. The instant application is more broadly directed to treatment of a mental or central nervous system disorder, and is silent with respect to the route of administration. Therefore, administration via intravenous, intramuscular, or subcutaneous routes would read on the instant claim. Further, the instant claim differs from the reference claim in that it is more narrowly directed to the treatment of a breastfeeding mother. The broadest reasonable interpretation of a patient in the reference application, however, would include breastfeeding mothers. In other words, treatment of major depressive disorder in a breastfeeding mother by administering 5-MeO-DMT would read on both the instant and reference claims, and therefore they are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-85 are rejected.
No claim is allowed.
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/D.J.B./ Examiner, Art Unit 1624
/JEFFREY H MURRAY/ Supervisory Patent Examiner, Art Unit 1624