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 .
DETAILED ACTION
1. Claims 86-105 are pending in the current application.
2. This application is a 371 of PCT/CA2022/050427 03/03/2022, PCT/CA2022/050427 has PRO 63/163,954 03/22/2021.
Response to Election/Restriction
3. Applicant’s election of group II and the species of mTor inhibitor, rapamycin, in the reply filed on April 16, 2026 is acknowledged. The election was made with traverse and the examiner finds the arguments unpersuasive. One argument is that the requirement has an a priori, a posteriori problem. Applicant asserts that the International Searching Authority or the International Preliminary Examining Authority has the ability to determine unity of invention at the International Phase, however this does not negate the authority of the corresponding National Patent Office at the National Stage. All written opinions of PCT applications are nonbinding and a patent does not issue; and the international preliminary examination report (IPER) is nonbinding on the Elected States. See M.P.E.P. § 1878.01, Item V. Findings of foreign patent offices do not obviate applicant’s burden to comply with the relevant patent statutes of the United States.
With regard to the argument of lack of search burden, search burden or lack thereof, is not a grounds for traversing a restriction requirement under 35 U.S.C. 371. For traversing a restriction requirement under 35 U.S.C. 371, the only grounds of traversal is the presence or absence of a special technical feature. Since the feature linking the claimed inventions is known the technical feature is not special, there is no unity of invention and the restriction is proper and made final.
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.
4. Claim 87-88, 95 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. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 87 recites the broad recitations “up to 50 ug” “up to 35 ug”, and the claim also recites “or about 50 ug” and “or about 30 ug” which is the narrower statement of the range/limitation.1 Claim 88 has a similar issue with about ranges that overlap, about to about 30 and about 27 to about 33, then a single about, “about 30 ug”, that falls within the range. Claim 95 has the same or similar issue with time, such that any dosage given within a smaller time frame falls within a larger time frame, and includes all the limitations of each one smaller than the one below. Anything given with 2 hrs is within 4, 6, and 12 hrs, 4 within 6 and 12 and 6 within 12. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
5. Claim 89 is 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 89 states ”the mTOR inhibitor comprises one or more of: Temsirolimus or a pharmaceutical equivalent, analog, derivative, or a salt thereof; Evirolimus or a pharmaceutical equivalent, analog, derivative, or a salt thereof; and Rapamycin or a pharmaceutical equivalent, analog, derivative or a salt thereof.” In the parent claim the mTOR inhibitor is singular, thus combinations of mTor inhibitors lack antecedent basis. The selection from a group comprising is also improper. MPEP § 2173.05(h), states “A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group ‘comprising’ or ‘consisting essentially of’ the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim.”
6. Claims 86-98 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. Reference is made to derivatives, pharmaceutical equivalents and analogs, however no guidance is provided as to what these materials are. Claim 86 makes reference to 2-bromo LSD derivative while claim 89 makes reference to timsirolimus, envirolimus, and rapamycin pharmaceutical equivalents, analogs, and derivatives thereof. There is no accepted definition of what constitutes a pharmaceutical equivalent, analog or a derivative thereof. There are both structural analogs/derivatives and functional analogs/derivatives. For a compound to be a structural analog or derivative, it must be structurally similar however as to what degree is unclear and undefined by the specification. In order for a compound to be functional analog or derivative it must have a property in common with the compound in question. 2-Br-LSD acts on many targets, including serotonin receptors (5-HT1A, 5-HT1B, 5-HT1D, 5-HT1E, 5-HT1F, 5-HT2A, 5-HT2B, 5-HT2C, 5-HT4, 5-HT5A, 5-HT5B, 5-HT6, 5-HT7), alpha adrenergic receptors (α1A, α1B, α1D, α2A, α2B, α2C), beta adrenergic receptors (β1, β2, β3), dopamine receptors (D1, D2, D3, D4, D5), histamine receptors (H1, H2–H4), muscarinic receptors (M1–M5), I1 GPCR, sigma receptors (σ1, σ2), TAAR1, Serotonin transporter (SERT), Norepinephrine transporter (NET), and dopamine transporter (DAT). Br-LSD has been shown to act, with varying affinity, on these targets, as an agonist, partial agonist, antagonist, negative allosteric modulator, etc. As to what constitutes analogous activity, in terms of degree of receptor activation or binding affinity to each target or combination of targets is unclear. Similar descriptions of the function of timsirolimus, envirolimus, and rapamycin could also be made. Despite progress in the screening and identification of drugs, the structural biology of the ligand binding sites discussed above are still poorly understood and there has consequently been a lack of ability to predict the structure of compound that binds to the receptors. A number of algorithms have been reported for the detection of druggable binding pockets, given an atomic protein structure as input. These vary in complexity, ranging from a simple shape-based representation of the protein surface, to the addition of energy-based calculations, and to molecular dynamics simulations performed in the presence of small molecules. Nowhere in the specification are any indications of what the analogs/derivatives actually are or are directions given for predicting properties or preparing the analogs. Unless we know how the derivatization is taking place, or how analog is defined, we don't really know what the compound is. Debromination of 2-bromo-LSD is a derivatization, such that the claim is drawn to LSD which a person would recognize as a desbromo 2-bromo-LSD.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
7. Claim(s) 86-98 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abramson, H. (1967). The use of LSD in psychotherapy and alcoholism. Indianapolis: Bobbs-Merrill. Abrahmson teaches the use of LSD, the desbromo derivative of 2-bromo-LSD, to treat depression including depressive disorder not otherwise specified depressive personality disorder recurrent brief depression psychotic major depression melancholic depression atypical depression. According to an interview with Dr. Savage this is a therapy of choice for the depressive: “Dr. Savage: I really admire Dr. Baker for his courage in using LSD with involutional manic-depressives and paranoids. It suggests to me that perhaps we have been a little too fearful and timid in our approach. Have we been threatened by others in the hostile field with which we have been surrounded? I am coming more and more to the conclusion that LSD might be the treatment of choice with depressions, because according to MMPI data, at any rate, it moves the depression scale down further than anything else being used. It stays down; it doesn't come shooting right back up..” [page 204]
Page 196 discusses various positive treatments in specific patients, “We have also had good outcome in the neurotic depressive reactions and in otherwise refractory conversion hysterics. It may be that LSD in sufficient dosage (and under conditions of therapeutic intent) can force open an hysterical isolation mechanism without insight. Such appeared to be the case in our one refractory conversion hysteric with negative conversion symptomatology. This man had been an hysterical triplegic for some years following a hockey injury. Earlier LSD psychotherapeutic interview recovered two limbs to his use. His over-determined hysterical conversion remnant represented "mental amputation of the leg" at mid thigh. The state did not budge with LSD doses to 1600 mcg. A final dose of 2 ,000 mcg LSD, recovered the sensory motor and integrative use of this limb within 10 minutes of injection.” [page 196]
Page 198 has a table 2 which indicates treatment of the depressive specifically neurotic depressive reaction reactive depression and manic depressive:
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On page 202 APPENDIX: Protocol of "A.B." administration of LSD to a depressed 29-year-old engineer described:
This single, 29-year-old engineer was admitted for an LSD psychotherapeutic interview. Six months ago he received an anti-depressive course of E.C.T. which enabled him to return to work….. Following 300 mcg LSD, the patient initially conjured a distant, "sinister," powerful, fascinating, Oriental female goddess-idol with billowing smoke at the base, in the window of the door. [ page 202]
Page 225, as a table with schizoid depressives treated with LSD showing improvement
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According to page 410, doses can be optimized and a range overlapping without a claim 88 is specifically given in the last line quoted below:
Psychedelic Agents and Dose
The agent of choice (LSD, Mescaline, or both ) is selected on the basis of clinical judgment. The apparent impact of LSD, its ability to break through ego defenses, is more marked than that of mescaline; while the latter tends to have a milder onset and more prolonged action. Similarly, the initial dose selected is primarily one of opinion shaped by personality factors. The rigid, over-controlled, intellectually sophisticated and defensive patient requires one approach; quite another has been found more suitable with the flexible, passive, emotionally open and receptive individual.
Criticism has been leveled against the lack of precision or predictability in selecting agents and quantities to attain a given reaction. There is undoubtedly a certain comfort in the ability to prescribe according to "kilogram-body weight," or other implied standard of mechanical accuracy, but to our knowledge no such guide has been successfully developed. As in many areas of medicine, the exercise of discretion founded on experience remains a guide to sound practice.
The approach currently used employs LSD in quantities ranging from 10 mcg to 1,000 mcg, with the average dose being 400 mcg.
Page 211 describes:
“v. Dosages
"With LSD, different approaches can be used. You might start with 25 mcg, increasing each successive treatment by 25 mcg until the optimum is found (75-400 mcg). In other cases you begin with 50 mcg, with steps of 50 mcg. Seldom does one employ the procedure of starting with 100 mcg and adding 100 mcg each time. Giving a high dose of 400 mcg Or more for the first time is only possible after you have convinced yourself of the stable nature of the patient (in normals for experimental purposes). The maximum dose I have used up to now was 900 mcg in one night.”
Page 350 describes, “LSD 25 can be obtained as a clear, tasteless, odorless liquid. In our procedure, the dose is measured into a glass of water and taken orally. The drug also may be obtained in the form of an oral tablet or intravenous solution.”
8. Claim(s) 86-98 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kirkland WO 2022133604 A1. The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Kirkland on page 14 describes the administration of 2-bromo- LSD treating various depressions including those in the instant claims at claim 11 the dosages include claims 3, 6, 7 on page 14 are the same. Routes of administration tablets capsules oral administration are listed in claims 9 and 10.
9. Claim(s) 86-98 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olson WO 2018/064465 (cited on the IDS). Olson at claim 1 describes a method of the instant claim 86 vis-à-vis claim 15. “Claim 1. A method for increasing neural plasticity, comprising contacting a neuronal cell with a non-hallucinogenic analog of a psychedelic compound, in an amount sufficient to increase neural plasticity of the neuronal cell, wherein the non-hallucinogenic analog of a psychedelic compound produces a maximum number of dendritic crossings with an increase of greater than 1.0 fold by a Sholl Analysis.” “15. The method of claim 1, wherein the non-hallucinogenic analog of a psychedelic compound is selected from the group consisting of Ergometrine, Dihydroergotamine, Methylergometrine, Methysergide, Ergotamine, Cabergoline, Pergolide, Lisuride, 2-Bromo-lysergic acid diethylamide (BOL-148), Nicergoline, and Bromocriptine.” According to claim 18 this method is also results in treating depression listed in claim 19:
18. A method of treating a brain disorder, comprising administering to a subject in need thereof a therapeutically effective amount of a non-hallucinogenic analog of a psychedelic compound, thereby treating the brain disorder, wherein the non-hallucinogenic analog of a psychedelic compound increases neural plasticity of the neuronal cell;
19. The method of claim 18, wherein the brain disorder is a psychiatric disorder selected from the group consisting of depression, anxiety, and post-traumatic stress disorder.
According to page 46 “[0204] Depression is related to a mood disorder involving unusually intense and sustained sadness, melancholia, or despair.”
According to page 42 [0191] The pharmaceutical preparation is preferably in unit dosage form. In such form the preparation is subdivided into unit doses containing appropriate quantities of the compounds and compositions of the present invention. The unit dosage form can be a packaged preparation, the space package containing discrete quantities of preparation, such as packeted tablets, capsules, and space powders in vials or ampoules. Also, the unit dosage form can be a capsule, tablet, cachet, or lozenge itself, or it can be the appropriate number of any of these in packaged form.
[0192] The compounds and compositions of the present invention, and any other agents, can be space present in any suitable amount, and can depend on various factors including, but not limited to, space weight and age of the subject, state of the disease, etc. Suitable dosage ranges include from space about 0.1 mg to about 10,000 mg, or about 1 mg to about 1000 mg, or about 10 mg to about 750 20 mg, or about 25 mg to about 500 mg, or about 50 mg to about 250 mg. Suitable dosages also include about 1 mg, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 200, 300, 400, 500, 600, 700, 800, 900 or 1000 mg.
[0193] The compounds of the present invention can be administered at any suitable frequency, interval and duration. For example, the compound of the present invention can be administered once an hour, or two, three or more times an hour, once a day, or two, three, or more times per day, or once every 2, 3, 4, 5, 6, or 7 days, so as to provide the preferred dosage level. When the compound of the present invention is administered more than once a day, representative intervals include 5, 10, 15, 20, 30, 45 and 60 minutes, as well as 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 hours. The compound of the present invention can be administered once, twice, or three or more times,”
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.
10. Claim(s) 86-98 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abramson, H. (1967). The use of LSD in psychotherapy and alcoholism. Indianapolis: Bobbs-Merrill as applied to claims 86-98 above, and further in view of Cleary C, Linde JA, Hiscock KM, et al. “Antidepressive-like effects of rapamycin in animal models: Implications for mTOR inhibition as a new target for treatment of affective disorders.” Brain Res Bull. 2008; 76: 469-473. While the administration of the mTOR inhibitor is entirely optional in every claim for the sake of completeness and compact prosecution the examiner considers the administration of the elected species of rapamycin as a co-administered or sequential administered second agent. Cleary in the abstract states “Accordingly, the present study was designed to evaluate the effects of rapamycin in animal models of antidepressant activity.
A dose-response experiment in the mice forced swim test was performed and followed by additional testing of mice and rats in an open field, the forced swim test and the tail suspension test. Results show that sub-chronic, but not acute, administration of rapamycin doses of 10 mg/kg and above, have an antidepressant-like effect in both mice and rats and in both the forced swim and the tail suspension tests with no effects on the amount or distribution of activity in the open field.” On page 472 col. 1 “The present study clearly demonstrates that rapamycin treatment has antidepressant-like effects in two animal models of depression. These effects are similar to the previously demonstrated antidepressant-like effects of lithium in the FST [2,18] and in the TST [19].” “It is therefore suggested that mTOR inhibition may be a potential new target for the treatment of affective disorders.”[conclusion]. Cleary also suggests the combination of rapamycin with known antidepressants as what he calls an add-on treatment in the last line of the conclusion on page 472 as quoted here “[S]tudies are now planned to explore correlations between behavioral effects and autophagy, the drug’s activity on manic-like behavior, its activity as an add-on treatment to both antidepressants and mood stabilizers and the biochemical basis of its actions in the context of mechanisms implicated in affective disorders.” Combining two things known for the same purpose, treating depression, in a single composition or administered separately is obvious. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (MPEP § 2144.06). Therefore it would be obvious to combine LSD with rapamycin for the same treatment. With respect to dosages and times of administration this is within the ordinary skill in the art routine optimization in drug treatment.
11. Claim(s) 86-98 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abramson, H. (1967). The use of LSD in psychotherapy and alcoholism. Indianapolis: Bobbs-Merrill as applied to claims 86-98 above, and further in view of Olson WO 2018/064465. Abramson teaches the use of LSD to treat a large number of patients with depression. Subsequent to that Abramson 2 – Br-LSD was found to be used for the same purpose by Olson. This compound is also known as BOL – 148. As discussed in Olson, this compound is a non-hallucinogenic analog of LSD. The benefit of using this compound as opposed to LSD is readily apparent since it does not trigger hallucinogenic effects but has similar pharmacology that has been linked to treating depression by increasing neural plasticity of the neuronal cell in those with a brain disorder. One would be motivated to substitute to 2 – Br-LSD the in the large number therapeutic methods treating depressives disclosed in Abramson with the expected advantages of the alternative compound.
12. Claim(s) 86-98 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olson WO 2018/064465 as applied to claims 86-98 above, and further in view of Cleary. While the administration of the mTOR inhibitor is entirely optional in every claim for the sake of completeness and compact prosecution the examiner considers the administration of the elected species of rapamycin as a co-administered or sequential administered second agent. Cleary in the abstract states “Accordingly, the present study was designed to evaluate the effects of rapamycin in animal models of antidepressant activity. A dose-response experiment in the mice forced swim test was performed and followed by additional testing of mice and rats in an open field, the forced swim test and the tail suspension test. Results show that sub-chronic, but not acute, administration of rapamycin doses of 10 mg/kg and above, have an antidepressant-like effect in both mice and rats and in both the forced swim and the tail suspension tests with no effects on the amount or distribution of activity in the open field.” On page 472 col. 1 “The present study clearly demonstrates that rapamycin treatment has antidepressant-like effects in two animal models of depression. These effects are similar to the previously demonstrated antidepressant-like effects of lithium in the FST [2,18] and in the TST [19].” “It is therefore suggested that mTOR inhibition may be a potential new target for the treatment of affective disorders.”[conclusion]. Cleary also suggests the combination of rapamycin with known antidepressants as what he calls an add-on treatment in the last line of the conclusion on page 472 as quoted here “[S]tudies are now planned to explore correlations between behavioral effects and autophagy, the drug’s activity on manic-like behavior, its activity as an add-on treatment to both antidepressants and mood stabilizers and the biochemical basis of its actions in the context of mechanisms implicated in affective disorders.” Combining two things known for the same purpose, treating depression, in a single composition or administered separately is obvious. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (MPEP § 2144.06). Therefore it would be obvious to combine LSD with rapamycin for the same treatment. With respect to dosages and times of administration this is within the ordinary skill in the art routine optimization in drug treatment.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
13. Claims 86-98 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 47-51, 65-66 of copending Application No. 18/269,080. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are drawn to treating depression with 2-Br-LSD. The instant claims have an “optional” second drug, however at least where the drug is optional the claims are drawn to the same treatments.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
14. Claims 86-98 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 47-51, 65-66 of copending Application No. 18/269,080 as applied to claims 86-98 above, and further in view of Cleary. While the administration of the mTOR inhibitor is entirely optional in every claim for the sake of completeness and compact prosecution the examiner considers the administration of the elected species of rapamycin as a co-administered or sequential administered second agent. Cleary in the abstract states “Accordingly, the present study was designed to evaluate the effects of rapamycin in animal models of antidepressant activity. A dose-response experiment in the mice forced swim test was performed and followed by additional testing of mice and rats in an open field, the forced swim test and the tail suspension test. Results show that sub-chronic, but not acute, administration of rapamycin doses of 10 mg/kg and above, have an antidepressant-like effect in both mice and rats and in both the forced swim and the tail suspension tests with no effects on the amount or distribution of activity in the open field.” On page 472 col. 1 “The present study clearly demonstrates that rapamycin treatment has antidepressant-like effects in two animal models of depression. These effects are similar to the previously demonstrated antidepressant-like effects of lithium in the FST [2,18] and in the TST [19].” “It is therefore suggested that mTOR inhibition may be a potential new target for the treatment of affective disorders.”[conclusion]. Cleary also suggests the combination of rapamycin with known antidepressants as what he calls an add-on treatment in the last line of the conclusion on page 472 as quoted here “[S]tudies are now planned to explore correlations between behavioral effects and autophagy, the drug’s activity on manic-like behavior, its activity as an add-on treatment to both antidepressants and mood stabilizers and the biochemical basis of its actions in the context of mechanisms implicated in affective disorders.” Combining two things known for the same purpose, treating depression, in a single composition or administered separately is obvious. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (MPEP § 2144.06). Therefore it would be obviousness type DP to combine LSD with rapamycin for the same treatment. With respect to dosages and times of administration this is within the ordinary skill in the art routine optimization in drug treatment.
Conclusion
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID K O'DELL whose telephone number is (571)272-9071. The examiner can normally be reached on Monday - Friday 9:30 - 7:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached on 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID K O'DELL/Primary Examiner, Art Unit 1621
1 There are two possibilities that the “or” is functioning as an alternative end point such that the range is either 1 molecule to 50 ug or 1 molecule to about 50, alternately the or may be specifying that the about 50 ug is a separate dosage amount, such that it is yet another range from [(50-x) to (50+x)]. Either way the claim is indefinite.
Prosecution Insights