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
The preliminary amendment filed 02/18/2025, cancelled claims 7-10, 19, 21-23, 25-28, 30-31 and 34-43.
Claims 1-6, 11-18, 20, 24, 29, and 32-33 are pending and examined on the merits herein.
Priority
This application claims the following priority:
PNG
media_image1.png
84
667
media_image1.png
Greyscale
Claim Rejections - 35 USC § 112(b)
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 1-6, 11-18, 20, 24, 29, and 32-33 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.
-In claim 1, regarding the phrase “a crystalline form of psilocin and psilocybin,” it is not clear if this phrase means a composition comprising a single crystal comprising psilocin and psilocybin, or if it means a composition comprising a crystal of psilocin, or a crystal of psilocybin, or a single crystal comprising both psilocin and psilocybin.
-In claim 2, the phrase “the crystalline form is co-crystal Form A” renders the claim indefinite. The instant specification does not definitely define “co-crystal Form A,” but merely recites XRPD peaks that a “co-crystal Form A” can have (see for example [0018]-[0020], [0045], [0173], and [0184]-[0186]). [0018] states that co-crystal form A may be characterized by a XRPD pattern including a significant peak at a 2theta angle of about 10.2. [0019] states that
PNG
media_image2.png
78
626
media_image2.png
Greyscale
. [0020] states that co-crystal Form A is characterized by a XRPD pattern comprising a significant peak at a 2theta angle of about 10.1 and about 19.16. As such, the metes and bounds of the phrase “co-crystal Form A” are unclear.
In view of compact prosecution, for the purpose of applying prior art, any co-crystal comprising psilocin and psilocybin is interpreted as meeting the limitation of “co-crystal Form A.”
-The term “significant” in claims 3-6 is a relative term which renders the claim indefinite. The term “significant” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what baseline is being utilized to characterize a peak as “significant” in comparison to one that is “not significant.”
In view of compact prosecution, for the purpose of applying prior art, “a significant peak” is interpreted as any peak in an XRPD pattern. It is further pointed out that the instant specification does not provide any XRPD pattern.
-Claim 11 is indefinite because it is not clear if “a salt formed between psilocin and psilocybin,” is a salt of the co-crystal Form A (i.e., a salt of co-crystal of psilocin and psilocybin) or if the co-crystal is formed such that a salt literally formed between the psilocin and psilocybin crystals.
-In claim 14, the phraases “grief related disorder,” “loss-related disorders,” “end of life related disorders,” and “cancer disorders” render the claim indefinite. It is not clear if a “loss related disorder” is the same as a “grief related disorder,” i.e., they phrases are synonyms, or if “loss related disorder” and “grief related disorder” are distinct disorders. It is not clear if “end of life related disorders” are diseases/conditions that cause death, such as pneumonia or cancer, or if “end of life related disorders,” are some type of disorder that is distinct from the disease/condition that is causing the end of life, i.e., death. Further, it is not clear if “cancer disorders” are cancers, themselves, or if they are some type of disorder that that can result from having cancer, such as depression or nausea.
-Claim 18 recites the limitation "the BDNF activity" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is further pointed out that the first mention of BDNF in the claims should be recited as “brain-derived neurotrophic factor (BDNF).”
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 11-18, 20, 24, 29, and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over WO2019/073,379 to Londesbrough (published 2019, PTO-892) in view of Nelson (Augmentation treatment in major depressive disorder: focus on aripiprazole, published 2008, PTO-892).
Londesbrough teaches a co-crystal of psilocybin-psilocin Polymorph A, wherein the crystal comprises psilocybin and psilocin at a level of 1% or less, as an impurity ([0037], [0045], [0084]), and wherein the XRPD pattern for Polymorph A include a peak at a 2theta angle of 10.1 and 19.4 (the 19.4 of Londesbrough is taught as ±0.1, i.e., 19.3, which is about 19.16, as instantly claimed; see [0041] of the instant specification for the definition of “about”) ([0049]). See also psilocybin polymorph B ([0074]-[0075]).
Londesbrough teaches polymorph A for the treatment of depression, and especially drug resistant depression by administering to a subject in need thereof, an effective dose of polymorph A ([00119]-[00122]; claims 21, 24, 25).
While Londesbrough teaches a method of treating depression by administering a co-crystal of psilocybin and psilocin, it differs from that of instant claim 1 in that it does not teach an atypical antipsychotic.
Nelson teaches major depressive disorder as a disabling psychiatric condition for which effective treatment remains an outstanding need, wherein two-thirds of patients fail to achieve remission with initial treatment. As a result, a range of augmentation and combination strategies are used to improve outcomes for patients. Nelson teaches that adjunctive therapy with atypical antipsychotics has beneficial antidepressant effects in the absence of psychotic symptoms, wherein aripiprazole has shown efficacy as an augmentation option with antidepressant therapy (abstract).
It would have been prima facie obvious to one ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to add aripiprazole, to the method of Londesbrough, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-Londesbrough teaches its methods for the treatment of depression, and especially for drug resistant depression,
-Nelson teaches aripiprazole as an augmentation option with antidepressant therapy, wherein the aripiprazole augments antidepressant efficacy (pg. 943, Col. 1), increases remission rates (pg. 943, Col. 2), and greatly improves the Clinical Global Impression of Severity and Improvement scores, and
-"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), MPEP 2144.06.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a more potent and/or therapeutically effective method of treating depression.
Regarding claims 2-4, Londesbrough teaches a co-crystal of psilocybin-psilocin Polymorph A, wherein the crystal comprises psilocybin and psilocin at a level of 1% or less, as an impurity ([0037], [0045], [0084]), and wherein the XRPD pattern includes peaks at 2theta angles of 10.1 and 19.4 (the 19.4 of Londesbrough is taught as ±0.1, i.e., 19.3, which is about 19.16, as instantly claimed; see [0041] of the instant specification for the definition of “about”) ([0049]).
Regarding claim 11, Londesbrough teaches salts of its of its crystals ([00148]).
Regarding claims 12-13, Nelson teaches aripiprazole.
Regarding claims 14-16, the combination of Londesbrough and Nelson teaches a method of treating depression, which is a mental health disorder and a cognitive disorder.
Regarding claims 17-18, 20, 24, and 29, MPEP 2111.04 states, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
In the instant case, the wherein clauses expresses the desired result of the positive step of administering therapeutically effective amounts of a co-crystal of psilocin and psilocybin having XRPD peaks at 10.1 and 19.16, and aripiprazole, an atypical antipsychotic, to a patient in need of such treatment, such as a patient with depression. Since the combination of Londesbrough and Nelson teach this method, these limitations are met. See also MPEP 2112.02.
Regarding claims 32-33, while the combination of Londesbrough and Nelson do not teach simultaneous or sequential administration of the psilocybin-psilocin co-crystal and aripiprazole, it would have been prima facie obvious to an ordinary skilled artisan, prior to the effective filing date of the instantly claimed invention, to modify the administration of the aripiprazole, to either simultaneous or sequential administration, to predictably achieve a method that is optimized for therapeutic efficacy in the treatment of depression; "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
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/apply/applying-online/eterminal-disclaimer.
Claims 1-6, 12-18, 20, 24, 29, and 32-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,280,068 (PTO-892) in view of Nelson (Augmentation treatment in major depressive disorder: focus on aripiprazole, published 2008, PTO-892).
‘068 claims a method of increasing the number of neuronal progenitor cells or increasing BDNF levels, in a subject in need thereof comprising administering to the subject a co-crystal Form A of psilocin and psilocybin having a 2theta angle of 10.1 and 19.6.
The specification of ‘068 teaches increasing the number of neuronal progenitor cells and BDNF levels as treating mental health disorders or central nervous system disorders (Col. 2, line 62-Col. 4, line 35; Col. 8, line 34-Col. 9, line 30).
Regarding claims 1 and 12-16, while ‘068 teaches a method of treating depression by administering co-crystal Form A of psilocybin and psilocin, it differs from that of instant claim 1 in that it does not teach an atypical antipsychotic.
Nelson is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to add aripiprazole, to the method of ‘068, to arrive at instant claims 1 and 12-16. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-‘068 teaches its methods as increasing the number of neuronal progenitor cells and increasing BDNF levels, which treat depression,
-Nelson teaches aripiprazole as an augmentation option with antidepressant therapy, wherein the aripiprazole augments antidepressant efficacy (pg. 943, Col. 1), increases remission rates (pg. 943, Col. 2) and greatly improves the Clinical Global Impression of Severity and Improvement scores, and
-"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), MPEP 2144.06.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a more potent and/or therapeutically effective method of treating depression.
Regarding instant claims 2-6, see claims 1-2 and 7-8 of ‘068.
Regarding claims 17-18, see claim 2 of ‘068.
Regarding claim 20, see claim 1 of ‘068.
Regarding claim 29, see claim 9 of ‘068.
Further regarding claims 17-18, 20, and 29, and regarding claim 24, MPEP 2111.04 states, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
In the instant case, the wherein clauses expresses the desired result of the positive step of administering a therapeutically effective amount of a co-crystal Form A of psilocin and psilocybin with 2theta peaks at 10.1 and 19.16, and aripiprazole, an atypical antipsychotic, to a patient in need of such treatment, such as a patient with depression. Since the combination of ‘068 and Nelson teach this method, these limitations are met. See also MPEP 2112.02.
Regarding claims 32-33, while the combination of ‘068 and Nelson do not teach simultaneous or sequential administration of the crystal and aripiprazole, it would have been prima facie obvious to an ordinary skilled artisan, prior to the effective filing date of the instantly claimed invention, to modify the administration to either simultaneous or sequential, to predictably achieve a method that is optimized for therapeutic efficacy; "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
Claims 1-6, 12-18, 20, 24, 29, and 32-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,049,447 (PTO-892) in view of Nelson (Augmentation treatment in major depressive disorder: focus on aripiprazole, published 2008, PTO-892).
‘447 claims a composition comprising a co-crystal Form A of psilocin and psilocybin having a 2theta angle of 10.1 and 19.6.
Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”.
‘447 teaches its compositions for the treatment of depression (Col. 14, line 36-Col. 16, line 15).
Regarding claims 1 and 12-16, while ‘447 teaches a method of treating depression by administering co-crystal Form A of psilocybin and psilocin, it differs from that of instant claim 1 in that it does not teach an atypical antipsychotic.
Nelson is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to add aripiprazole, to the method of ‘447, to arrive at instant claims 1 and 12-16. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-‘447 teaches it compositions in methods of treating depression,
-Nelson teaches aripiprazole as an augmentation option with antidepressant therapy, wherein the aripiprazole augments antidepressant efficacy (pg. 943, Col. 1), increases remission rates (pg. 943, Col. 2) and greatly improves the Clinical Global Impression of Severity and Improvement scores, and
-"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), MPEP 2144.06.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a more potent and/or therapeutically effective method of treating depression.
Regarding instant claims 2-6, see claims 1-3, 9-12 of ‘447.
Regarding claims 17-18, 20, 24, and 29, MPEP 2111.04 states, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
In the instant case, the wherein clauses expresses the desired result of the positive step of administering a co-crystal Form A of psilocin and psilocybin with 2theta peaks at 10.1 and 19.16, and aripiprazole, an atypical antipsychotic, to a patient in need of such treatment, such as a patient with depression. Since the combination of ‘447 and Nelson teach this method, these limitations are met. See also MPEP 2112.02.
Regarding claims 32-33, while the combination of ‘447 and Nelson do not teach simultaneous or sequential administration of the crystal and aripiprazole, it would have been prima facie obvious to an ordinary skilled artisan, prior to the effective filing date of the instantly claimed invention, to modify the administration to either simultaneous or sequential, to predictably achieve a method that is optimized for therapeutic efficacy; "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
Claims 1-6, 12-18, 20, 24, 29, and 32-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,667,607 (PTO-892) in view of Nelson (Augmentation treatment in major depressive disorder: focus on aripiprazole, published 2008, PTO-892).
‘607 claims a composition comprising a co-crystal Form A of psilocin and psilocybin having a 2theta angle of 10.1, 19.6, 14.54, 16.5, 13.44, 23.42, and 8.62 (claims 1, 7).
Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”.
‘607 teaches its compositions for the treatment of depression (Col. 17, line 9-Col. 18, line 56).
Regarding claims 1 and 12-16, while ‘607 teaches a method of treating depression by administering co-crystal Form A of psilocybin and psilocin, it differs from that of instant claim 1 in that it does not teach an atypical antipsychotic.
Nelson is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to add aripiprazole, to the method of ‘607, to arrive at instant claims 1 and 12-16. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-‘607 teaches it compositions in methods of treating depression,
-Nelson teaches aripiprazole as an augmentation option with antidepressant therapy, wherein the aripiprazole augments antidepressant efficacy (pg. 943, Col. 1), increases remission rates (pg. 943, Col. 2) and greatly improves the Clinical Global Impression of Severity and Improvement scores, and
-"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), MPEP 2144.06.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a more potent and/or therapeutically effective method of treating depression.
Regarding instant claims 2-6, see claims 1-2, 7-9, 12 of ‘607.
Regarding claims 17-18, 20, 24, and 29, MPEP 2111.04 states, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
In the instant case, the wherein clauses expresses the desired result of the positive step of administering a co-crystal Form A of psilocin and psilocybin with 2theta peaks at 110.1, 19.6, 14.54, 16.5, 13.44, 23.42, and 8.62, and aripiprazole, an atypical antipsychotic, to a patient in need of such treatment, such as a patient with depression. Since the combination of ‘607 and Nelson teach this method, these limitations are met.
Regarding claims 32-33, while the combination of ‘607 and Nelson do not teach simultaneous or sequential administration of the crystal and aripiprazole, it would have been prima facie obvious to an ordinary skilled artisan, prior to the effective filing date of the instantly claimed invention, to modify the administration to either simultaneous or sequential, to predictably achieve a method that is optimized for therapeutic efficacy; "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
Claims 1-6, 12-18, 20, 24, 29, and 32-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,351,554 (PTO-892) in view of Nelson (Augmentation treatment in major depressive disorder: focus on aripiprazole, published 2008, PTO-892).
‘554 claims a method of treating or ameliorating a disease or disorder comprising administering to a subject crystal Form A of psilocin and psilocybin having a 2theta angle of 10.1 and 19.6 (claims 1), wherein the disease or disorder is a mental health disorder or a central nervous system disorder, such as depression (claims 9-18).
Regarding claims 1 and 12-16, while ‘554 teaches a method of treating depression by administering co-crystal Form A of psilocybin and psilocin, it differs from that of instant claims 1 and 12-16 in that it does not teach an atypical antipsychotic.
Nelson is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to add aripiprazole, to the method of ‘554, to arrive at instant claims 1 and 12-16. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-‘554 teaches it compositions in methods of treating depression,
-Nelson teaches aripiprazole as an augmentation option with antidepressant therapy, wherein the aripiprazole augments antidepressant efficacy (pg. 943, Col. 1), increases remission rates (pg. 943, Col. 2) and greatly improves the Clinical Global Impression of Severity and Improvement scores, and
-"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), MPEP 2144.06.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a more potent and/or therapeutically effective method of treating depression.
Regarding instant claims 2-6, see claims 1-3 of ‘554.
Regarding claims 17-18, 20, 24, and 29, MPEP 2111.04 states, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
In the instant case, the wherein clauses expresses the desired result of the positive step of administering a co-crystal Form A of psilocin and psilocybin with 2theta peaks at 110.1 and aripiprazole, an atypical antipsychotic, to a patient in need of such treatment, such as a patient with depression. Since the combination of ‘554 and Nelson teach this method, these limitations are met. See also MPEP 2112.02.e
Regarding claims 32-33, while the combination of ‘554 and Nelson do not teach simultaneous or sequential administration of the crystal and aripiprazole, it would have been prima facie obvious to an ordinary skilled artisan, prior to the effective filing date of the instantly claimed invention, to modify the administration to either simultaneous or sequential, to predictably achieve a method that is optimized for therapeutic efficacy; "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
Claims 1-6, 11-18, 20, 24, 29, and 32-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 73-76, 80-81, 86, 109-110, 112-113 of copending Application No. 18/877,636 (claim set dated 10/31/2025) in view of Nelson (Augmentation treatment in major depressive disorder: focus on aripiprazole, published 2008, PTO-892).
‘636 claims a method of stimulating neurogenesis or neurite growth comprising administering a crystalline Form A of psilocin and psilocybin having XRPD peaks at a 2theta angle of about 10.1 and about 19.16 (claim 73), wherein its methods treating Alzheimer’s stroke, depression and other diseases (claim 76).
‘636 claims administration of a 2nd pharmaceutically active compound, such as an anti-depressive compounds (claims 109-110).
Regarding claims 1 and 12-16, while ‘636 teaches a method of treating depression by administering co-crystal Form A of psilocybin and psilocin and an anti-depressive compound, it differs from that of instant claim 1 in that it does not teach an atypical antipsychotic.
Nelson is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select aripiprazole as the anti-depressive compound in the method of ‘636, to arrive at instant claims 1 and 12-16. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-‘636 teaches it compositions in methods of treating depression,
-Nelson teaches aripiprazole as an augmentation option with antidepressant therapy, wherein the aripiprazole augments antidepressant efficacy (pg. 943, Col. 1), increasing remission rates (pg. 943, Col. 2) and greatly improving the Clinical Global Impression of Severity and Improvement scores, and
-"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), MPEP 2144.06.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a more potent and/or therapeutically effective method of treating depression.
Regarding claims 2-6, see claims 73, 80-81 of ‘636.
Regarding claim 11, see claim 86 of ‘636.
Regarding claims 17-18, 20, 24, and 29, MPEP 2111.04 states, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
In the instant case, the wherein clauses expresses the desired result of the positive step of administering a co-crystal Form A of psilocin and psilocybin with 2theta peaks at 10.1 and 19.6, and aripiprazole, an atypical antipsychotic, to a patient in need of such treatment, such as a patient with depression. Since the combination of ‘636 and Nelson teach this method, these limitations are met. See also MPEP 2112.02.
Regarding claims 32-33, ‘636 claims simultaneous and sequential administration (claims 112-113).
This is a provisional nonstatutory double patenting rejection.
Claims 1-6, 12-18, 20, 24, 29, and 32-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of copending Application No. 19/183,492 (claim set dated 04/18/2025) in view of Nelson (Augmentation treatment in major depressive disorder: focus on aripiprazole, published 2008, PTO-892).
‘492 claims a method of treating a disease or disorder or a method of decreasing neuroinflammation, in a subject in need thereof comprising administering a co-crystal Form A of psilocin and psilocybin having XRPD peaks at a 2theta angle of about 10.1 and about 19.16 (claims 1-2), wherein its methods treat mental health disorders and central nervous system disorders, such as depression (claims 5-15)
Regarding claims 1 and 12-16, while ‘492 claims a method of treating depression by administering co-crystal Form A of psilocybin and psilocin and an anti-depressive compound, it differs from that of instant claim 1 in that it does not teach an atypical antipsychotic.
Nelson is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select aripiprazole as the anti-depressive compound in the method of ‘492, to arrive at instant claims 1 and 12-16. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-‘492 teaches it compositions in methods of treating depression,
-Nelson teaches aripiprazole as an augmentation option with antidepressant therapy, wherein the aripiprazole augments antidepressant efficacy (pg. 943, Col. 1), increases remission rates (pg. 943, Col. 2) and greatly improves the Clinical Global Impression of Severity and Improvement scores, and
-"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), MPEP 2144.06. See also MPEP 2112.02.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a more potent and/or therapeutically effective method of treating depression.
Regarding claims 2-6, see claims 1-4 of ‘492.
Regarding claims 17-18, see claims 16, 18, 21-22 of ‘492.
Regarding claims 17-18, 20, 24, and 29, MPEP 2111.04 states, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
In the instant case, the wherein clauses expresses the desired result of the positive step of administering a co-crystal Form A of psilocin and psilocybin with 2theta peaks at 10.1 and 19.6, and aripiprazole, an atypical antipsychotic, to a patient in need of such treatment, such as a patient with depression. Since the combination of ‘492 and Nelson teach this method, these limitations are met.
Regarding claims 32-33, while the combination of ‘492 and Nelson do not teach simultaneous or sequential administration of the crystal and aripiprazole, it would have been prima facie obvious to an ordinary skilled artisan, prior to the effective filing date of the instantly claimed invention, to modify the administration to either simultaneous or sequential, to predictably achieve a method that is optimized for therapeutic efficacy; "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
This is a provisional nonstatutory double patenting rejection.
Free of the Prior Art
Claims 5-6 are free of the prior art. The closest prior art is WO2019/073,379 to Londesbrough (published 2019, PTO-892) which teaches a co-crystal of psilocybin-psilocin Polymorph A, ([0037], [0045], [0084]), wherein the XRPD pattern for Polymorph A includes a peak at 2theta angles of 10.1 and 19.4 (the 19.4 of Londesbrough is taught as ±0.1, i.e., 19.3, which is about 19.16, as instantly claimed; see [0041] of the instant specification for the definition of “about”) ([0049]). See also psilocybin polymorph B ([0074]-[0075]). However, Londesbrough differs from that of in instant claims 5-6 in that it does not teach the 2theta angles recited in claims 5-6.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAUREN WELLS/Primary Examiner, Art Unit 1622
Prosecution Insights