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 .
Claims 78-112 are before the Examiner.
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:
Claims 78-112 are rejected under 35 U.S.C. 103 as being unpatentable over WO2020169851 (hereinafter D1), US20220062238 (hereinafter D2), Manlin, Journal of psychedelic studies, 2020, 4(2), 104-113 (hereinafter D3); Ielyseieva, "Microdosing Moms: Psilocybin & Postpartum Depression Relief- Truffle Report 29 October 2021 pages 1-10, (herein after D1-XP093059408), Clayton, "Field Trip Health Ltd. to Pursue Treatment Resistant Depression and Postpartum Depression as Indications for FT-104 - Psychedelicalpha", 9 September 2021 (2021-09-09), pages 1-10, (herein after D2-XP093059426) and Jairaj, J Psychopharmacol. 2022 May 30;36(8):920–93.
D1 (page 1, last two paragraphs - page 2, paragraph 6; page 13, paragraph 3; example 2; claims) discloses 5-MeO-DMT for use in treating mental disorders, in particular major depressive disorder, persistent depressive disorder, anxiety disorder, posttraumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorder and psychoactive substance abuse, in particular treatment- resistant form of major depressive disorder (TRD). The administration is mentioned therein to be i.v., i.m. or s.c. (see p. 13, par. 3). It is noted that the depression is evaluated with the same MADRS and HAM-D scores as defined in the current claims. Also see claims 1-33; and Example 2. D1 not only provides a structurally similar and similar class of compound to psilocybin, it is noted that D1 teaches the benefit in patients with treatment resistant major depressive disorder, including similar improvements in the assessment scales and items assessed, as alledged by the application as filed. Further it would appear that post-partum depression in the case of the patient tested, was diagnosed with major depressive disorder with peri-partum onset. Thus the skilled person would have an expectation of success when using 5-MeO-DMT as an alternative to psilocybin.
The difference of the instant base claim 1 with D1 is the treatment of a particular type of depression, namely postpartum depression (PPD). Thus, the problem underlying the instant method can only be seen in the provision of a particular depression type postpartum depression (PPD), alternative to those already mentioned in D1, that can be treated with 5-MeO-DMT.
D2 (page 1, paragraph 0006; page 5, paragraph 0080-0083; page 7, paragraph
0093; page 11, paragraph 0140) teaches pharmaceutical formulations comprising a dimethyltryptamine DMT compound, suitable for injection, for use in the treatment of psychiatric or neurological disorders. One of the DMT compounds mentioned therein is 5-MeO-DMT. The psychiatric or neurological disorders include post-partum depression.
Therefore, the person skilled in the art would expect that 5-MeO-DMT is also effective in the particular type of depression PPD. Consequently, the subject-matter of base claim 78 is considered obvious in the light of D1 in combination with D2.
D1-XP093059408 discloses the effects of psilocybin microdosing for relieving the symptoms of post-partum depression. Psilocybin is disclosed to represent an alternative to traditional treatment e.g. with antidepressants.
D2-XP093059426 discloses the announcement of Field Trip Health to test a psychedelic compound, called FT-104 for the treatment of treatment-resistant depression and postpartum depression. FT-104 is a next-generation psychedelic synthetic serotonin-2A (5-HT2A) agonist having a serotonin 2A potency similar to psilocybin, expected to produce a reliably shorter duration of psychoactivity than psilocybin and with high bioavailability after administration. No disclosure of 5-MeO-DMT.
The only example in the application as filed relating to post-partum depression is Example 12. According to the Example 12, out of 15 patients, only one patient diagnosed with postpartum depression has been treated, whereby 5-MeO-DMT was administered via inhalation at a nominal dose of 6mg followed by 12mg. Several assessments according to MADRS/BPRS and BIMF were made and the results presented in Tables 9-11. In addition it is reported that this patient was diagnosed with major depressive disorder with peri-partum onset. Various items were assessed but it is not clear in some cases, whether an improvement was seen. The applicant also states on pg. 91 "while the patient's baseline scores for some items reflected absence of the symptom (reduced appetite, concentration difficulties, suicidal thoughts), items with scores reflecting severe symptoms (e.g. reduced sleep, inner tension) saw remarkable improvement".
Thus overall it would appear that only for very specific items, an effect of 5-MeO-DMT was seen, and only in 1 specific patient which may not be considered statistically significant. In addition there is no data demonstrating a technical effect linked to the use of 5-MeO-DMT over psilocybin.
According to Jairaj there is increasing evidence for safety, and encouraging signals for efficacy, of psilocybin in the treatment of MDD. Psilocybin has been shown to catalyse a sense of ‘reconnection’ in participants with MDD. This effect in PPD, by fostering a sense of ‘reconnection’ for the mother, may allow for improved mood and maternal sensitivity towards the infant, which can positively impact maternal role gratification and the mother-infant relationship. See Results (page 920).
As per MPEP 2143 Examples of Basic Requirements of a Prima Facie Case of Obviousness [R-01.2024], section under I. Examples of rationales that may support a conclusion of obviousness include: Simple substitution of one known element for another to obtain predictable results.
Also note that Examination guidelines as to the position taken is also predicated on the following:
The recited active ingredient is well-known 5-MeO-DMT is a very powerful, naturally occurring psychedelic. It works on the brain's serotonin system. As such the compound and its inherent biological property are well-known. The new use for an old compound must be novel as to the use directed and unobvious. The new use (if any) must account for the possibility that the underlying mechanism for the new therapy is the same mechanism that allows for a prior art treatment using the same compound (or its obvious version). The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the applicants had merely found a new property of the compound and such a discovery did not constitute a new use. As MPEP 2112 Requirements of Rejection Based on Inherency; Burden of Proof [R-10.2019], "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer."
Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art.
Dependent claims 79-104 are either known from D1 or for which no particular technical effect has been shown in the present application that can support the presence of an inventive step. That the MADRS (Montgomery-Åsberg Depression Rating Scale) is a clinical tool used by doctors to measure the severity of depression. It evaluates 10 symptoms, such as sadness, sleep, and pessimistic thoughts is well-known. See Jairaj Table 1 at page 923, Also see Jairaj page 921 column B, for teachings of routes of administration of for PPD. These correspond to the limitations of claims with regards to claims 79-88, 97-99, 104-106, 109-110. For example, with respect to claim 90-96, 100-106, (routes of administration) D3 (abstract; page 105, column 1, paragraph 1) highlights that, compared to vaporization, the i.m. route of administering 5-MeO-DMT is associated with lower and less doses, lower frequencies of reporting reactivation, a higher frequency of physical tension release, and a slower onset of acute effects. Applicant is encouraged to use word search technique to locate for specific limitations of the claims in the cited documents. Also see Jairaj at page 921 top of column A for motivation.
Accordingly, the claims do not recite an unobvious distinction over the prior art. Further, a reference is relevant not only for what it expressly teaches, but also for what it would have conveyed to one of ordinary skill in the art. See In re Opprecht, 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode, 193 USPQ 12 (CCPA 1976). In light of the foregoing discussion, the Examiner finds that the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made, in view of the cited references and the knowledge generally available in the art. Accordingly, the claims are rejected under 35 U.S.C. § 103.
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 78-112 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of copending Application No. 18373903 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because there is extensive overlap in the conflicting claims.
Base claim 1 can also be regarded as being genus of the instant base claim 78.
The active ingredient and the patient and disease treated are the same in both cases.
Note that the entirety of prior art references cited in rejection under Claim Rejections - 35 USC § 103 is used here in the obviousness analysis as per Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Simply Applicant is encouraged to place on record that these references are not in the rejection statement here. Simply copying and pasting what is/are already in the same office action are not done here to avoid redundancy.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 78-112 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-87 of copending Application No. 18373914 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because there is extensive overlap in the conflicting claims.
Base claim 1 can also be regarded as being genus of the instant base claim 78.
The active ingredient and the patient and disease treated are the same in both cases.
The patient in 18373914 is breast-feeding. By definition, postpartum depression (PPD) is a serious mood disorder that can begin during pregnancy or within the first year after childbirth.
Note that the entirety of prior art references cited in rejection under Claim Rejections - 35 USC § 103 is used here in the obviousness analysis as per Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Applicant is encouraged to place on record that these references are not in the rejection statement here. Simply copying and pasting what is/are already in the same office action are not done here to avoid redundancy.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Feldman, Understanding ‘Evergreening’ : Making Minor Modifications Of Existing
Medications To Extend Protections, Health Affairs June 2022 41:6, 801-804
Dwivedi, Evergreening: A deceptive device in patent rights, Technology in Society 32 (2010) 324–330.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
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