DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Claims 1-7 are pending
Claims 1-7 are under consideration in the instant office action.
Priority
This application claims benefit of U.S. Provisional Application No. 63/183,771 filed on 05/04/2021 and U.S. Application No. 17/734,102 filed on 05/01/2022.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (Role of sigma-1 receptors in neurodegenerative diseases, Journal of Pharmacological Sciences, 2015, 127, pp. 17-29) in view of Brammer et al. (Interactions between 3,4-ethylenedioxymethamphetamine and σ1 receptors, European Journal of Pharmacology, 2006, pp. 141-145).
Nguyen et al. is drawn towards the role of sigma-1 receptors in neurodegenerative diseases (see abstract). Nguyen et al. teaches that “Of note, neuro-inflammation is a significant contributor in the pathophysiology of Parkinson's disease, and treatment with PRE084 also attenuated M1 microglial responses induced by 6-hydroxydopamnie lesions (60). Along with alleviating neuro-inflammation, sigma-1 receptors may also attenuate dopamine-induced toxicity in Parkinson's disease (35).” (pg. 23, left column, first and second paragraph).
Nguyen et al. does not teach administering 3,4-methylenedioxymethamphetamine (MDMA) for the treatment of a movement disorder.
Brammer et al. is drawn towards interactions between MDMA and σ1 receptors (see abstract). Brammer et al. teaches “the ability of MDMA to interact with σ receptors with similar affinities to its better recognized interactions with serotonin and dopamine transporters. Similar to other psychomotor stimulants such as cocaine and methamphetamine, MDMA has a better affinity for the σ1 compared to the σ2 subtype” (pg. 144, right column, third paragraph). Brammer et al. teaches the administration of MDMA in an amount of 0-50 mg/kg in a single dose (pg. 143, left column, second paragraph).
It would have been obvious to one of ordinary skill in the art to treat a movement disorder comprising administering a composition consisting of a psychedelic, as suggested by Brammer et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since Brammer et al. teaches that MDMA can modulate sigma-1 signaling, which can aid in the treatment of Parkinson’s diseases as taught by Nguyen et al., with a reasonable expectation of success absent evidence of criticality of the particular steps.
Regarding claims 4-7, when the composition recitations are met, the desired properties are met, as any component that materially affects the composition and its properties would have to be present in the claim to be commensurate in scope (i.e. claim 4). Additionally, when the composition is delivered in the same manner as claimed, the effects of the composition would be the same such as the therapeutic profile, as they are a direct result of the components of the composition and the mode of administration which are met by the art, whereby the resulting properties and effects would intrinsically be met. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that 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)). (MPEP 2111.04 I).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 9-21 of copending Application No. 17/734,102.
Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims both recite similar methods of treating a movement disorder comprising administering LSD or MDMA. Application No. 17/734,102 is drawn towards a method of treating a movement disorder comprising administering LSD or MDMA. Application No. 17/734,102 recites administering LSD at a dosage of 10-1000 µg or MDMA at a dosage of about 25 mg/kg (claim 1).
Application No. 17/734,102 does not recite administering the same genus of psychedelics for the treatment of a movement disorder.
It would have been obvious to one of ordinary skill in the art to treat a movement disorder by administering a psychedelic including LSD or MDMA, as suggested by Application No. 17/734,102, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since Application No. 17/734,102 does disclose that LSD or MDMA can be administered for the treatment of a movement disorder (claim 3), with a reasonable expectation of success absent evidence of criticality of the particular steps.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1-7 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691