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. Information Disclosure Statement The information disclosure statement (IDS) submitted on 12/28/2023 , is in compliance with the provisions of 37 CFR 1.97 an d 37 CFR 1.98. The IDS documents were considered. A signed copy of Form PTO-1449 is enclosed herewith. Priority This Application filed on 12/28/2023 , claims priority to U.S. Provisional Application No. 63/ 477,780 , filed on 12/29/2022 . Status of the Claims Claims 1-16 are pending. Claim Objections Claims 1-15 are objected to under 37 CFR 1.71(a) because of the following informalities: Claims 1-15 recite the limitation “D- BetaHydroxyButyric acid”, “Psilocybin”, “Psilocin”, “ Norpsilocin ” “ Aeruginascin ” , “ Baeocystin ” , “ Norbaeocystin ” , “ Bufotenin ” , and “ Bufotenidine ” , etc., which are inappropriately capitalized and should be respectively, “D- betahydroxybutyric acid”, “psilocybin”, “psilocin”, “ norpsilocin ” “ a eruginascin ” , “ b aeocystin ” , “ n orbaeocystin ” , “ b ufotenin ” , and “ b ufotenidine ”. Appropriate correction is required. Claim Rejections - 35 USC § 112 -2 nd Paragraph 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 appl icant regards as his invention. Claim s 1- 16 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. Claims 2-8 depend from claim 1 and are therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, for the reasons set forth below. Claims 10-13 depend from claim 9 and are therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, for the reasons set forth below. Claims 12-13 depend from claim 10 and are therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, for the reasons set forth below. Claims 15-16 depend from claim 14 and are therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, for the reasons set forth below. As per MPEP 2173.02, “[d] uring prosecution, applicant has an opportunity and a duty to amend ambiguous claims to clearly and precisely define the metes and bounds of the claimed invention. The claim places the public on notice of the scope of the patentee’s right to exclude (emphasis added). See, e.g., Johnson & Johnston Assoc. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052, 62 USPQ2d 1225, 1228 (Fed. Cir. 2002) ( en banc).” If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is appropriate (emphasis added). See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993). Claim 1 recites the limitation “ Readministering free D- BetaHydroxyButyric acid until depressive symptoms are reduced ” , however, a person skilled in the art cannot reasonably determine the meets and bounds of the limitation in the claim. This is because it is unclear to one skilled in the art as to whether the “ until depressive symptoms are reduced ” recited in line 5, is: i ) referring to an additional reduction in depressive symptoms resulting from the “ Readministering free D- BetaHydroxyButyric acid ” ; or ii) including a reduction in depressive symptoms resulting from the “ Administering a therapeutic amount of free D- BetaHydroxyButyric acid ” recited in line 3 , since claim 1 fails to make it clear that the “ Administering a therapeutic amount of free D- BetaHydroxyButyric acid ” recited in line 3 would not reduce depressive symptoms. Furthermore, the recited “ until depressive symptoms are reduced ”, is vague in that there is no baseline or threshold defined by the claim or instant specification, for establishing the level (s) from which the depressive symptoms are to be reduced . The specification does not provide a standard for ascertaining the requisite degree. Accordingly, without guidelines in the specification for how one skilled in the art can reasonably determine the baseline or threshold level(s) from which the depressive symptoms are to be reduced , one of ordinary skill in the art would not be able to draw a clear boundary between what is and is not covered by the claims. Appropriate correction is required. Each of c laims 3- 8 and 16, recites psilocybin derivative substance (claims 3-5 ) , psilocybin derivative material (claims 6-8) and psilocybin novel prodrug derivatives (NPDs) of psilocin (claim 16), however, one skilled in the art cannot reasonably determine the meets and bounds of these limitations in the claims. This is because it is not clear to the skilled artisan as to the chemical structure(s) that are intended to be encompassed by the claimed genus of “ psilocybin derivativ e substance ”, “ psilocybin derivative material ” and “ psilocybin novel prodrug derivatives (NPDs) of psilocin ” . Thus, a person skilled in the art would not be able to draw a clear boundary between what is and is not covered by the claims. Appropriate correction is required. Claim 9 recites that a ketone level monitor is for a mental health subject in need thereof, however, it is unclear as to what the “ glucose monitor ” and “ Free D- BetaHydroxyButyric Acid therapeutic dose ”, are for. Thus, a person skilled in the art would not be able to draw a clear boundary between what is and is not covered by the claims. For the purpose of examination, the Examiner is interpretating claim 9 as “ A depression management system comprising a ketone level monitor, a glucose monitor and a therapeutic dose of free D - betahydroxybutyric acid ”. Appropriate correction is required. Claim 10 recites the limitation “ free D - BetaHydroxyButyric acid admi nistered ” in lines 1-2 . There is insufficient antecedent basis for this limitation in the claim. Claim 10 lacks antecedent basis because claim 9 from which claim 10 depends, fails to recite the limitation of “ administering free D- BetaHydroxyButyric acid ”. Appropriate correction is required. Claim 14 is rendered indefinite for reciting “ A therapeutic compound comprising ”, because the term “ compound ”, refer s to a specific chemical entity, and therefore, cannot “ compris e or comprising ” . Claim 14 is directed to a product (a therapeutic compound), but, claim 14 also recites “ administered ”, which appears to indicate a process of using the therapeutic compound. It is unclear to one skilled in the art as to whether the phrase “ administered ”, is referring to a process step, because claim 14 recites a product . A person skilled in the art cannot reasonably determine whether claim 14 is a composition or a process claim. This is indefinite because the claim recites both a product (a therapeutic compound) and a process of using the product ( “ administered ”). Please see MPEP § 2713.05(p)(II). It is recommended that Applicants amend claim 14 to recite “ A therapeutic composition comprising 5g-30 g of D- betahydroxybutyric acid and a therapeutic amount of a psychoactive substance selected from the group consisting of psilocybin, peyote and LSD ” , in order to overcome the rejection . Appropriate correction is required. Claim 15 recites “ comprising ”, to describe a Markush group of psilocybin derivatives. The transitional term " comprising ", is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. Please see MPEP § 2111.03. However, a person skilled in the art cannot reasonably determine the meets and bounds of the recited limitation, because it is unclear to one skilled in the art as to psilocybin derivatives are included. Thus, one of ordinary skill in the art would not be able to draw a clear boundary between what is and is not covered by the claims. The recitation of “ comprising ”, is an improper Markush language which should be in alternative language, i.e., “ selected from the group consisting of ...” A claim element defined by selection from a group of alternatives (a Markush grouping) requires selection from a closed group "consisting of" (rather than "comprising" or "including") the alternative members. Please see MPEP § 803.02 and MPEP § 2111.03. It is recommended that Applicants amend claim 15 to recite “ The therapeutic composition of claim 14, additionally comprising a psilocybin derivative selected from the group consisting psilocin, norpsilocin , aeruginascin , baeocystin , norbaeocystin , bufotenin , and bufotenidine ” , in order to overcome the rejection. Appropriate correction is required. This lack of clarity makes it impossible to ascertain with reasonable precision when that claim is infringed and when it is not. Lacking such clarity, the skilled artisan would not be reasonably apprised of the metes and bounds of the subject matter for which Applicants seek patent protection. Rather, a subjective interpretation of the claimed language would be required. However, as such is deemed inconsistent with the tenor and express language of 35 U.S.C. § 112, second paragraph, the claims are deemed properly rejected. Claim Rejections - 35 USC § 112 -1 st Paragraph 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. Claim s 3-8 and 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claimed invention : Claims 3-8 and 16 claim molecules without any description or a reasonable reference and/or guidance to a chemical structure. Each of claims 3-8 and 16, recites psilocybin derivative substance (claims 3-5), psilocybin derivative material (claims 6-8) and psilocybin novel prodrug derivatives (NPDs) of psilocin (claim 16). There is insufficient written description for these claim limitations in the disclosure. M.P.E.P. § 2163 states: “ An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention…one must define a compound by ‘whatever characteristics sufficiently distinguish it’. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process .” The Supporting Disclosure : Each of the claimed genus of “ psilocybin derivative substance (claims 3-5), psilocybin derivative material (claims 6-8) and psilocybin novel prodrug derivatives (NPDs) of psilocin (claim 16) ”, requires a definite chemical structure or formula. However, in the instant case, the recited “ psilocybin derivative substance, psilocybin derivative material and psilocybin novel prodrug derivatives (NPDs) of psilocin”, lack chemical structural information for what they are and chemical structures are highly variant and encompass a myriad of possibilities. Furthermore, there is no description of structural characteristics that are required for the recited “ psilocybin derivative substance, psilocybin derivative material and psilocybin novel prodrug derivatives (NPDs) of psilocin” . The specification provides insufficient written description to support the genus encompassed by the claimed “ psilocybin derivative substance, psilocybin derivative material and psilocybin novel prodrug derivatives (NPDs) of psilocin” . Accordingly, the claims fail to meet the requirements of 35 U.S.C. 112, first paragraph, and is, thus, properly rejected. Appropriate corrections are required. 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. Claim s 9-10 are rejected under 35 U.S.C. 10 2(a)(1) as being anticipated by Schroeder et al (hereinafter “Schroeder”, U.S. Pub. No. 20210322350, published 10/21/2021) . Regarding claims 9, Schroeder (see reference claim 11), teaches: Regarding claim 10, Schroeder teaches , wherein the amount of D-β-hydroxybutyric acid administer ed is 10 g (see ¶ 0066) , which is within the claimed range of “ between 5 grams and 30 grams of free D- BetaHydroxyButyric acid ”, recited in claim 10. A specific example in the prior art which is within a claimed range anticipates the range. Please MPEP § 2131.03. 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 . Claim s 1-2 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Pan et al (hereinafter “Pan”, Behavioural Pharmacology , 2020, 31, 322-332) in view of : i ) Zheng et al (hereinafter “ Zheng ”, Metabolomics , 2011, 7, 413-423); ii) Yao et al (hereinafter “Yao”, Applied Microbiology & Biotechnology , 2021, 105, 6229-6243) ; and iii) Schroeder et al (hereinafter “Schroeder”, U.S. Pub. No. 20210322350, published 10/21/2021) . By way of a background, Applicants’ invention is drawn to a method of treating depression with D-β - hydroxybutyric acid ( D B HBA) , alone or in combination with a psychoactive compound. DBHBA is the natural form that is generated endogenously. Please see e.g., ¶s 0001 and 0008 of the specification. Under the broadest reasonable interpretation (BRI), consistent with the specification , Applicants’ invention, is being interpreted as a method for managing depression symptom in a subject in need thereof, comprising administering to the subject, a therapeutic amount of DBHBA. Similar to Applicants’ invention (see discussions above) , Pan (see abstract), teaches a method for treating depression in mice model of depression, comprising administering the mice, 300 mg/kg of β-hydroxybutyrate (BHB) and measuring the effect of BHB on immobility time in the tail suspension test (TST) and forced swim test (FST). Please see abstract, Table 1, Figures 1-5 and discussions therein. A 70 kg human subject in need thereof, would require 21 kg of BHB (300 mg/kg x 70 kg). The BHB was purchased from Sigma ( catalog number 54965, see page 323), which is a sodium salt of racemic (DL) BHBA . The disclosure of TST and FST is interpreted as assessing depressive symptoms. Pan differs from the claimed invention only insofar as Pan is not explicit in disclosing: i ) assessing ketone levels (claims 1 and 9) ; ii) monitoring glucose (claim 9) ; and i i i) administering D BHBA (claims 1 and 9) . However, the claimed invention would have been obvious over Pan, because at the time of the instant invention, it was known in the art that: i ) depression is associated with low levels ketone and glucose ; and ii) exogenous D BHBA can be employed for increasing endogenous D BHBA levels. For example: i ) S imilar to Pan (see discussions above), Zheng (see page 416, Figure 1 and Table 1), teaches depressive rats characterized by low levels of glucose and ketone bodies (BHB and acetoacetate). The disclosure of low levels of glucose and ketone is interpreted as monitoring glucose and ketone levels. ii) Similar to Pan (see discussions above), Yao (see abstract, page 6231 and Figure 1), discloses that exogenous BHB supplements can be present in the form of salt s, ester s or free acid . Salts are usually composed of mixed D and L isomers, whereby the L-BHB is not naturally produced by the body, and its presence in non-racemic d/l-3HB tends to delay the onset of ketosis. Another drawback of a salt form is the increased likelihood of excessive salt consumption which can cause adverse effects such as salt-induced hypertension and severe gastrointestinal (GI) side effects, which was likely to be due to excessive mineral consumption. Please see abstract and page 6231. With respect to the esters, major downside is that an ester needs to be hydrolyzed before releasing the free acid , hence may cause a slight delay in onset of consumption to the direct absorption of the free acid (see abstract and page 6231). Use of exogenous DBHBA can induce a faster increase in endogenous DBHBA compared to the use of salt or ester forms (see abstract, pages 6231 and 6233). iii) Schroeder (see reference claim 11), teaches: Accordingly, at the time of the instant invention, a person skilled in the art would have envisaged a method for treating depression in a subject in need thereof, with exogenous DHBA, from the Pan, Zheng, Yao and Schroeder disclosures. One skilled in the art would have had with a reasonable expectation that the administration of the DBHA would treat depression in the subject. The skilled artisan would have considered employing exogenous DBHA, in order to induce a faster increase in endogenous DBHA and for the advantage of avoiding the side effects or major downside associated with employing salts or esters (see discussions above). Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02. The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc. , 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02). Regarding claim s 2 and 10, Schroeder teaches, wherein the amount of D-β-hydroxybutyric acid administered is 10 g (see ¶ 0066) , which is within a claimed range anticipates the range of “ between 5 grams and 30 grams of free D- BetaHydroxyButyric acid ”, recited in claims 2 and 10 . A specific example in the prior art which is within a claimed range anticipates the range. Please MPEP § 2131.03. Therefore, claims 1-2 and 9-10 are obvious over Pan, Zheng, Yao and Schroeder. In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references. FILLIN "Enter where the motivation for the rejection is found, either in the reference(s), or in the knowledge generally available to one of ordinary skill in the art \* MERGEFORMAT Claim s 1-2 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Tung et al (hereinafter “Tung”, U.S. Pub. No. 20210008018, published 01/14/2021) in view of: i ) Zheng ( Metabolomics , 2011); ii) Yao ( Applied Microbiology & Biotechnology , 2021); and iii) Schroeder (U.S. Pub. No. 20210322350). Similar to the Applicants’ invention (see discussions above), Tung (see ¶s 0002-0004 and 0040-0041 ), discloses that decreased levels of brain-derived neurotrophic factor (BDNF), are associated with depression . E ndogenous DBHBA have been shown to increase levels of BNDF and alleviate depressio n . Tung (see e.g., ¶s 0030-003 4 and 0318-0320 ) , discloses a method for treating a disease or condition responsive to increased levels of BDNF (e.g., depression) , comprising administering a therapeutically effective amount of a compound of Formula I : or a pharamaceutically acceptable sa lt or an ester threreof. A compound of Formula I is exogenous compound DBHDA, wherein each of R 1 , R 2 , Y 1a , Y 1b , Y 1c , Y 2 , Y 3a and Y 3b = H (see ¶s 0031-0033). An effective amount of a compound of Formula I , can range from 1-60 g/day or from 5-30 g/day or from 10-20 g/day (see ¶ 0310). Tung differs from the claimed invention only insofar as Pan is not explicit in disclosing: i ) assessing ketone levels (claims 1 and 9); and ii) monitoring glucose (claim 9) . However, the claimed invention would have been obvious over Tung , because at the time of the instant invention, it was known in the art that: i ) depression is associated with low levels ketone and glucose; For example: i ) Similar to Tung (see discussions above), Zheng (see page 416, Figure 1 and Table 1), teaches depressive rats characterized by low levels of glucose and ketone bodies (BHB and acetoacetate). The disclosure of low levels of glucose and ketone is interpreted as monitoring glucose and ketone levels. ii) Similar to Tung (see discussions above), Yao (see abstract, page 6231 and Figure 1), discloses that exogenous BHB supplements can be present in the form of salts, esters or free acid. Salts are usually composed of mixed D and L isomers, whereby the L-BHB is not naturally produced by the body, and its presence in non-racemic d/l-3HB tends to delay the onset of ketosis. Another drawback of a salt form is the increased likelihood of excessive salt consumption which can cause adverse effects such as salt-induced hypertension and severe gastrointestinal (GI) side effects, which was likely to be due to excessive mineral consumption. Please see abstract and page 6231. With respect to the esters, major downside is that an ester needs to be hydrolyzed before releasing the free acid, hence may cause a slight delay in onset of consumption to the direct absorption of the free acid (see abstract and page 6231). Use of exogenous DBHBA can induce a faster increase in endogenous DBHBA compared to the use of salt or ester forms (see abstract, pages 6231 and 6233). iii) Schroeder (see reference claim 11), teaches: Accordingly, at the time of the instant invention, a person skilled in the art would have envisaged a method for treating depression in a subject in need thereof, with exogenous DHBA, from the Tung , Zheng, Yao and Schroeder disclosures. One skilled in the art would have had with a reasonable expectation that the administration of the DBHA would treat depression in the subject. The skilled artisan would have considered employing exogenous DBHA, in order to induce a faster increase in endogenous DBHA and for the advantage of avoiding the side effects or major downside associated with employing salts or esters (see discussions above). Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02. The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc. , 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02). Regarding claims 2 and 10, Tung teaches DBHBA can range from 10-20 g (see discussions above), and Schroeder teaches, wherein the amount of D-β-hydroxybutyric acid administered is 10 g (see ¶ 0066), each of which is within the claimed range of “ between 5 grams and 30 grams of free D- BetaHydroxyButyric acid ”, recited in claims 2 and 10. A specific example in the prior art which is within a claimed range anticipates the range. Please MPEP § 2131.03. Therefore, claims 1-2 and 9-10 are obvious over Tung , Zheng, Yao and Schroeder. In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references. FILLIN "Enter where the motivation for the rejection is found, either in the reference(s), or in the knowledge generally available to one of ordinary skill in the art \* MERGEFORMAT Claim s 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Pan ( Behavioural Pharmacology , 2020) in view of: i ) Zheng ( Metabolomics , 2011); ii) Yao ( Applied Microbiology & Biotechnology , 2021); and iii) Schroeder (U.S. Pub. No. 20210322350), as applied to claims 1-2 and 9-10 above and further in view of Griffiths et al (hereinafter “Griffiths” J. Psychopharmacology , 2016, 30(12), 1181-1197) . The limitation of claims 1-2, 9-10, as well as the corresponding teach ings of Pan, Zheng, Yao and Schroeder are described above and hereby incorporated into the instant rejections. The invention of claims 3-8 and 11-16 are similar to claims 1 and 9 respectively. However, claims 3-8 and 11-16 differ from claims 1 and 9 in that claims 3-8 and 11-16 require DBHBA in combination with psilocybin or a psilocybin derived compound . Pan teaches that combination therapy comprising BHB and an antidepressant (fluoxetine), at doses that do not produce pharmacological effects for either drug, was found to produce similar antidepressant effects in mice , which indicates that BHB-anti depressant co-treatment may be a potential strategy for depression treatment (see page 329) . Pan, Zheng, Yao and Schroeder differ from the claimed invention only insofar as the cited references do not combine to explicitly disclose a psilocybin derived compound as an antidepressant. However, the claimed invention would have been obvious over Pan, Zheng, Yao and Schroeder , because at the time of the instant invention, psilocybin or a psilocybin derived compound was known in the art as an antidepressant . For example, Griffiths teaches a method of treating depression with psilocybin (see abstract), which is metabolized to psilocin (see page 1195) . Accordingly, at the time of the instant invention, a person skilled in the art would have envisaged a method for treating depression in a subject in need thereof, with a combination of exogenous DHBA and an antidepressant (e.g., psilocybin or psilocin), from the Pan, Zheng, Yao, Schroeder and Griffiths disclosures. One skilled in the art would have had with a reasonable expectation that the administration of a combination therapy comprising, for example, DBHA and psilocybin would enhance the therapeutic efficacy, when compared to a therapy comprising either DBHBA alone or psilocybin alone. treat depression in the subject. Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02. The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc. , 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02). Regarding claims 4-5, the recited dosage scheduling is a result effective variable that would have been routinely determined and optimized in the pharmaceutical art. Furthermore, MPEP § 2144.05(II)(B), states that “after KSR , the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.” Regarding claim s 7 and 12 , Griffiths teaches 22 mg psilocybin (see abstract), which is within the claimed range of between 10-30 mg psilocybin , recited in claims 7 and 1 2 . A specific example in the prior art which is within a claimed range anticipates the range. Please MPEP § 2131.03. Regarding claims 8 and 13, Griffiths teaches 1 mg psilocybin (see abstract), which is within the claimed range of approximately 0.1-1 mg psilocybin , recited in claims 8 and 13. A specific example in the prior art which is within a claimed range anticipates the range. Please MPEP § 2131.03. Regarding claim 14, Schroeder teaches, wherein the amount of D-β-hydroxybutyric acid administered is 10 g (see discussions above), which is within the claimed range of 5-30 g DB H BA, recited in claim 14 . A specific example in the prior art which is within a claimed range anticipates the range. Please MPEP § 2131.03. In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references. Claim s 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Tung (U.S. Pub. No. 20210008018) in view of: i ) Zheng ( Metabolomics , 2011); ii) Yao ( Applied Microbiology & Biotechnology , 2021); and iii) Schroeder (U.S. Pub. No. 20210322350), as applied to claims 1-2 and 9-10 above and further in view of Griffiths ( J. Psychopharmacology , 2016, 30(12), 1181-1197). The limitation of claims 1-2, 9-10, as well as the corresponding teachings of Tung, Zheng, Yao and Schroeder are described above and hereby incorporated into the instant rejections. The invention of claims 3-8 and 11-16 are similar to claims 1 and 9 respectively. However, claims 3-8 and 11-16 differ from claims 1 and 9 in that claims 3-8 and 11-16 require DBHBA in combination with psilocybin or a psilocybin derived compound. Tung discloses that an embodiment of the invention further comprises one or more additional therapeutic agent useful for treating a disease or condition such as depression (see e.g., ¶s 0303-0304 ). Tung , Zheng, Yao and Schroeder differ from the claimed invention only insofar as the cited references do not combine to explicitly disclose a psilocybin derived compound as an antidepressant. However, the claimed invention would have been obvious over Tung , Zheng, Yao and Schroeder, because at the time of the instant invention, psilocybin or a psilocybin derived compound was known in the art as an antidepressant. For example, Griffiths teaches a method of treating depression with psilocybin (see abstract), which is metabolized to psilocin (see page 1195). Accordingly, at the time of the instant invention, a person skilled in the art would have envisaged a method for treating depression in a subject in need thereof, with a combination of exogenous DHBA and an antidepressant (e.g., psilocybin or psilocin), from the Tung , Zheng, Yao, Schroeder and Griffiths disclosures. One skilled in the art would have had with a reasonable expectation that the administration of a combination therapy comprising, for example, DBHA and psilocybin would enhance the therapeutic efficacy, when compared to a therapy comprising either DBHBA alone or psilocybin alone. treat depression in the subject. Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02. The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc. , 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02). Regarding claims 4-5, the recited dosage scheduling is a result effective variable that would have been routinely determined and optimized in the pharmaceutical art. Furthermore, MPEP § 2144.05(II)(B), states that “after KSR , the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.” Regarding claims 7 and 12, Griffiths teaches 22 mg psilocybin (see abstract), which is within the claimed range of between 10-30 mg psilocybin , recited in claims 7 and 12. A specific example in the prior art which is within a claimed range anticipates the range. Please MPEP § 2131.03. Regarding claims 8 and 13, Griffiths teaches 1 mg psilocybin (see abstract), which is within the claimed range of approximately 0.1-1 mg psilocybin , recited in claims 8 and 13. A specific example in the prior art which is within a claimed range anticipates the range. Please MPEP § 2131.03. Regarding claim 14, Tung teaches DBHBA can range from 10-20 g (see discussions above), and Schroeder teaches, wherein the amount of DBHBA administered is 10 g (see discussions above), each of which is within the claimed range of 5-30 g DB H BA, recited in claim 14 . A specific example in the prior art which is within a claimed range anticipates the range. Please MPEP § 2131.03. In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references. FILLIN "Enter where the motivation for the rejection is found, either in the reference(s), or in the knowledge generally available to one of ordinary skill in the art \* MERGEFORMAT Non-Statutory Obviousness-Type 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp . Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. patent application No s: 1) 17/002,691 (‘ 691 application) ; 2) 18/401,445; 3) 18/419,229; and 4) 19/334,835, in view of Tung (U.S. Pub. No. 20210008018) . The corresponding teachings of Tung are described above and hereby incorporated into the instant rejections. Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the instant application and the reference U.S. Applications are similarly drawn to a method of using exogenous DBHBA . For example, the claims of the instant application (e.g., instant claim 1 ), are drawn to a method for treating depression with exogenous DBHBA , whereas, the claims of the U.S. Application No. 17/002,691 (‘691 application), are directed to a method of administering exogenous DBHBA to a patient in need thereof . Although the ‘691 application is not explicit in claiming a method for treating depression with DBHBA, the selection of a method for treating depression from the ‘691 application embodiment would have been obvious in view of Tung. Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusions No claim is allowable. If Applicants should amend the claims, a complete and responsive reply will clearly identify where support can be found in the disclosure for each amendment. Applicants should point to the page and line numbers of the application corresponding to each amendment, and provide any statements that might help to identify support for the claimed invention ( e.g., if the amendment is not supported in ipsis verbis , clarification on the record may be helpful) . Should the Applicants present new claims, Applicants should clearly identify where support can be found in the disclosure. 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 Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020 . The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST) . If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /IBRAHIM D BORI/ Examiner, Art Unit 1629 /JEFFREY S LUNDGREN/ Supervisory Patent Examiner, Art Unit 1629