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
This action is in response to papers filed August 1, 2025. Applicant’s reply to the restriction/election requirement of June 24, 2025 has been entered. Claims 10, 16, 19, 27-30, 33-35, 37, 42, 49, 59, 65, 71, and 76-78 have been amended; claims 2-9, 11-15, 17, 18, 20-26, 31, 32, 36, 38-41, 43-48, 50-58, 60-64, 66-70, and 72-75 have been canceled; and no claims have been newly added. Claims 1, 10, 16, 19, 27-30, 33-35, 37, 42, 49, 59, 65, 71, and 76-78 are pending in the application.
Priority
Applicant’s claim for the benefit of prior-filed WIPO International Application No. PCT/US2021/044032, filed July 30, 2021 under 35 U.S.C. 365(c), which claims the benefit of prior-filed U.S. Provisional Patent Application No. 63/060,577, filed August 3, 2020 under 35 U.S.C. 119(e), is acknowledged.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 10, 16, 19, 27-30, 33-35, and 37, is acknowledged. Applicant’s elections of i) “SEQ ID NO 1 (KRSS)” as the species of first CNS homing peptide sequence, ii) “aspirin” as the species of NSAID, iii) “aspirin in blood” as the species which has a Cmax of 2-12 µg/mL, iv) “aspirin in blood” as the species which has a Tmax of 10-150 minutes, v) “aspirin in blood” as the species which has an elimination half life of 20-200 minutes, vi) “aspirin” as the species which has a Cmax in the CNS that is 50-150% of the Cmax in the blood, vii) “intravenous administration” as the species of route of administration, viii) “SEQ ID NO 2 (PGESS)” as the species of second CNS homing peptide sequence, and ix) “multiple sclerosis” as the species of disease are all also acknowledged. The Examiner has determined that claims 1, 10, 16, 19, 27-30, 33-35, and 37 read on the elected subject matter.
Accordingly, claims 42, 49, 59, 65, 71, 76-78 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected subject matter, there being no allowable generic or linking claim.
Applicant timely traversed the restriction (election) requirement in the reply filed on August 1, 2025. Claims 1, 10, 16, 19, 27-30, 33-35, and 37 are under examination.
Abstract
The abstract of the disclosure is objected to because of the following:
1. The abstract should be a concise summary of the key technical aspects of the invention which are new to the art to which the invention pertains. If the invention is a composition, the abstract should recite the key requite ingredients. If the invention is a method, the abstract should recite the key requisite active steps.
2. The abstract merely informs the reader in a broad and generic manner that the invention pertains to methods, compositions, and kits for treating a disease. These are generally not new to the art at all by any stretch of the imagination, and have been known for thousands of years. The abstract further introduces an “embodiment” of a composition. However, the “embodiment” appears to be the full scope of the actual invention, and should be presented accordingly. Further, while the abstract introduces “methods” for treating a disease, the abstract does not properly recite the key requisite active steps.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 27-30, and 33-35 objected to because of the following:
i) In claim 1, there is an extraneous colon between “comprising” and “administering”; and there should be a comma between “nonsteroidal” and “anti-inflammatory”.
ii) In claims 27, there should be a semicolon rather than a comma between each of the first three recitations “12 µg/ml” and “and/or”.
iii) In claims 28, there should be a semicolon rather than a comma between each of the first three recitations “150 minutes” and “and/or”.
iv) In claims 29, there should be a semicolon rather than a comma between each of the first three recitations “200 minutes” and “and/or”.
v) In claim 30, there should be a semicolon rather than a comma between “of the subject” and “and/or”.
vi) In claim 33, there should be a semicolon rather than a comma between “are administered alone” and “and/or wherein the maximum concentration of psilocybin”.
vii) In claim 34, there should be a semicolon rather than a comma between “are administered alone” and “and/or wherein the time to reach maximum concentration”.
viii) In claim 35, there should be a semicolon rather than a comma between “of the CNS homing peptide” and “and/or wherein the elimination half-life of psilocybin”
Appropriate correction is required.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 10, 16, 19, 27-30, 33-35, and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7, 9, 10, 12, 14-16, 19-24, 33, and 56 of copending Application No. 18/004,633, in view of Petcavich (WIPO International Application Pub. No. WO 2019/246532).
Applicant’s elected subject matter is directed to a method of treating multiple sclerosis in a subject in need thereof comprising intravenously administering to the subject a therapeutically effective amount of a composition comprising the peptide KRSS, aspirin, and psilocybin; wherein the molar or weight ratio of the peptide to the aspirin or psilocybin is 1:10 to 10:1.
Claims 1-3, 7, 9, 10, 12, 14-16, 19-24, 33, and 56 of copending Application No. 18/004,633 disclose a method of treating e.g. a neuroinflammatory disease in a subject in need thereof comprising administering to the subject a therapeutically effective amount of a composition comprising a CNS homing peptide, aspirin, and psilocybin; wherein the molar or weight ratio of the peptide to the aspirin or psilocybin is 1:10 to 10:1.
Petcavich discloses a method of treating e.g. multiple sclerosis in a subject in need thereof comprising administering to the subject a therapeutically effectively amount of a composition comprising e.g. psilocybin; wherein the method induces neuron dendritic and synaptic genesis to thus recover and restore dendritic and synaptic neuron connections.
Although the claims at issue are not identical, they are not patentably distinct from each other because the disclosure of copending Application No. 18/004,633 defines neuroinflammatory disease as including within its scope e.g. multiple sclerosis; defines “administering” as including within its scope e.g. intravenous administration; and provides that SEQ ID NO 1-22 includes the peptide sequence KRSS.
Moreover, Since Petcavich discloses that a method of treating a neuroinflammatory disease such as e.g. multiple sclerosis in a subject in need thereof can advantageously further comprise administering to the subject a therapeutically effectively amount of e.g. psilocybin; wherein the psilocybin induces neuron dendritic and synaptic genesis to thus recover and restore dendritic and synaptic neuron connections; one of ordinary skill in the art would thus be motivated to further include psilocybin in the composition of claims 1-3, 7, 9, 10, 12, 14-16, 19-24, 33, and 56 of copending Application No. 18/004,633, with the reasonable expectation that when the resulting composition is administered to a subject in need of treatment of a neuroinflammatory disease such as e.g. multiple sclerosis, the method will successfully treat the multiple sclerosis by attenuating the underlying neuro-inflammation and also by inducing neuron dendritic and synaptic genesis to thus recover and restore dendritic and synaptic neuron connections.
This is a provisional nonstatutory double patenting rejection.
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, 10, 16, 19, 27-30, 33-35, and 37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 stipulates the active step of administering a “first” pharmaceutical composition that comprises a “first” CNS homing peptide. Designating a “first” means there is a “second” and perhaps a “third” and so forth. But, claim 1 does not appear to ever expressly disclose a “second” pharmaceutical composition, or even a “second” CNS homing peptide. One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter. Perhaps the first pharmaceutical composition includes the CNS homing peptide and the NSAID, and the second pharmaceutical composition is a separate composition that includes the psilocybin?
Claim 10 stipulates in a wherein clause that “the CNS homing peptide is indirectly associated with the NSAID and/or psilocybin”. The phrase “indirectly associated with” is not defined by the claim, and one of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed subject matter. Does “indirectly associated with” mean the CNS homing peptide is in the same composition with the NSAID? Or what?
Claims 27, 28, and 29 stipulate a Cmax, Tmax, and elimination half-life, respectively, of the NSAID or the psilocybin in “cells, tissues, organs, and/or environment thereof”, which renders the claim indefinite for the following reasons:
1. The claim recites at least one broad limitation (e.g. organ) together with a narrower limitation (e.g. cells) that fall within the broader limitation in the alternative in the same claim, which is indefinite.
2. Organs and tissues are generally composed of cells and extracellular space. The extracellular space within a particular tissue or organ could be considered the “environment” of the cells within the tissue or organ. However, one of ordinary skill in the art cannot definitively ascertain the “environment thereof” of a tissue or organ of the CNS. For example, what constitutes the “environment thereof” of the brain? If anything, the “environment thereof” of the brain is not the brain itself, but some structure or space beyond the brain itself, which is undefined. Moreover, to compound the indefiniteness, the “environment thereof” is plural, implying there are multiple environments. Does the “environment thereof” of the brain include blood vessels and the blood therein that supply the brain? If so, it is noted that the claim already provides for the Cmax, Tmax and elimination half-life values in the blood.
Claim 30 stipulates in a wherein clause that the Cmax of the NSAID or the psilocybin in “cells, tissues, organs, and/or environment thereof” of the CNS is about 50-150% of the Cmax in the blood, which renders the claim indefinite for the following reasons:
1. The claim recites at least one broad limitation (e.g. organ) together with a narrower limitation (e.g. cells) that fall within the broader limitation in the alternative in the same claim, which is indefinite.
2. Organs and tissues are generally composed of cells and extracellular space. The extracellular space within a particular tissue or organ could be considered the “environment” of the cells within the tissue or organ. However, one of ordinary skill in the art cannot definitively ascertain the “environment thereof” of a tissue or organ of the CNS. For example, what constitutes the “environment thereof” of the brain? If anything, the “environment thereof” of the brain is not the brain itself, but some structure or space beyond the brain itself, which is undefined. Moreover, to compound the indefiniteness, the “environment thereof” is plural, implying there are multiple environments.
3. One of ordinary skill in the art cannot definitively ascertain whether the “environment thereof” of the brain include blood vessels and the blood therein that supply the brain? If so, claim 30 would provide that the Cmax of the NSAID or the psilocybin in the blood supplying the brain is 50-150% of the Cmax in the blood, which is incongruous.
Claims 33-35 stipulate that the Cmax, Tmax, and elimination half-life of respectively, of the NSAID or of the psilocybin in “cells, tissues, organs, and/or environment thereof” of the CNS is 50-150% of the Cmax, Tmax, and elimination half-life, respectively, of the NSAID or of the psilocybin in “cells, tissues, organs, and/or environment thereof” of the CNS when the NSAID and/or psilocybin are administered in the absence of the CNS homing peptide or are administered alone, which renders the claim indefinite for the following reasons:
1. The stipulation that “the Cmax, Tmax, and elimination half-life of respectively, of the NSAID or of the psilocybin in cells, tissues, organs, and/or environment thereof of the CNS is 50-150% of the Cmax, Tmax, and elimination half-life, respectively, of the NSAID or of the psilocybin in cells, tissues, organs, and/or environment thereof of the CNS” appears to be incongruous.
2. Claims 33-35 each depend from claim 1, which appears to require that the CNS homing peptide, the NSAID, and the psilocybin are to all be administered together. However, claims 33-35 appear to require or at least provide that the NSAID and/or psilocybin can be administered in the absence of the CNS homing peptide. One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
3. Claim 1 makes explicit reference to a “first” composition, but never expressly discloses any “second” composition. In view of this ambiguity, one of ordinary skill in the art cannot definitively ascertain whether claims 33-35 somehow are attempting to provide for a “second” composition, and that one composition can contain the NSAID alone, or the NSAID and the psilocybin alone, without the CNS homing peptide.
Claims 10, 16, 19, 27-30, 33-35, and 37 are (also) indefinite for depending from an indefinite claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 10, 16, 19, 27-30, 33-35, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Moudgil et al. (U.S. Patent Application Pub. No. 2019/0359651), in view of Petcavich (WIPO International Application Pub. No. WO 2019/246532).
Applicant Claims
Applicant’s elected subject matter is directed to a method of treating multiple sclerosis in a subject in need thereof comprising intravenously administering to the subject a therapeutically effective amount of a composition comprising the peptide KRSS, aspirin, and psilocybin; wherein the molar or weight ratio of the peptide to the aspirin or psilocybin is 1:10 to 10:1.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Moudgil et al. disclose a method of treating e.g. multiple sclerosis in a subject in need thereof comprising e.g. intravenously administering to the subject a therapeutically effectively amount of a composition comprising e.g. the CNS homing peptide KRSS and e.g. aspirin (see abstract; paragraphs 0008, 0010, 0011, 0028, 0043, 0044, 0046, 0055, 0058, 0066, 0084, 0093, 0094, 0100, 0106, 0123, 0125, and 0126).
Petcavich discloses a method of treating e.g. multiple sclerosis in a subject in need thereof comprising administering to the subject a therapeutically effectively amount of a composition comprising e.g. psilocybin; wherein the method induces neuron dendritic and synaptic genesis to thus recover and restore dendritic and synaptic neuron connections.
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Moudgil et al. do not explicitly disclose that the composition being administered to treat multiple sclerosis further contains psilocybin. This deficiency is cured by the teachings of Petcavich.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Moudgil et al. and Petcavich, outlined supra, to devise Applicant’s presently claimed method.
Moudgil et al. disclose a method of treating e.g. multiple sclerosis in a subject in need thereof comprising e.g. intravenously administering to the subject a therapeutically effectively amount of a composition comprising e.g. the CNS homing peptide KRSS and e.g. aspirin. Since Petcavich discloses that a method of treating e.g. multiple sclerosis in a subject in need thereof can advantageously further comprise administering to the subject a therapeutically effectively amount of e.g. psilocybin; wherein the psilocybin induces neuron dendritic and synaptic genesis to thus recover and restore dendritic and synaptic neuron connections; one of ordinary skill in the art would thus be motivated to further include psilocybin in the Moudgil et al. composition, with the reasonable expectation that when the resulting composition when administered to a subject in need of treatment of multiple sclerosis, will successfully treat the multiple sclerosis by attenuating the underlying neuro-inflammation and also by inducing neuron dendritic and synaptic genesis to thus recover and restore dendritic and synaptic neuron connections.
Moreover, Moudgil et al. disclose than an “effective amount” of the homing peptide and also an “effective amount” of the therapeutic agent, e.g. aspirin, are to be administered for the treatment of multiple sclerosis in a subject (see e.g. paragraph 0028). As Moudgil et al. make crystal clear in paragraph [0095]; “a pharmacologically effective dose can be determined by one of ordinary skill in the art and by methods known to one of ordinary skill in the art”. Indeed, the optimal dose for the peptide and for the aspirin will depend on the subject being treated, the particulars of the disease involved, and other factors. Nevertheless, as Moudgil et al. expressly teach, one of ordinary skill in the art can arrive at the optimal effective doses for both the peptide and the therapeutic agent, in moles or in weight, that should be included in the composition being administered. As a result, one of ordinary skill in the art would thus be able to arrive at a peptide to aspirin molar or weight ratio of 1:10 to 10:1.
One of ordinary skill in the art, in following the teachings of the cited prior art, would thus arrive at the presently claimed method of treating multiple sclerosis in a subject in need thereof, with the active step of intravenously administering to the subject a therapeutically effective amount of a composition comprising the peptide KRSS, aspirin, and psilocybin; wherein the molar or weight ratio of the peptide to the aspirin or psilocybin is 1:10 to 10:1. Since the method one of ordinary skill in the art would thus arrive at is the same as the claimed method, the properties must be the same as well, including the pharmacokinetic properties, e.g. of claims 27-30 and 33-35, after administering the composition to the subject with multiple sclerosis.
In light of the foregoing 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. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617