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 .
Claim Objections
Claims 18-19 are objected to because of the following informalities:
Claim 18 does not end in a period (see MPEP §608.01(m), “Each claim begins with a capital letter and ends with a period.”).
Claim 19 states “A method of activating a 5-HT2A receptor in a cell comprising effecting the administration to said cell of an effective amount of a compound according to claim 1” (emphasis added) which appears have a grammatical error and should read “A method of activating a 5-HT2A receptor in a cell comprising administering to said cell.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a) Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 17-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating a psychiatric disorder susceptible to 5-HT2A receptor activation, does not reasonably provide enablement for treating any psychiatric disorder, depressive disorder, anxiety disorder, substance use disorder, or “any symptom or disorder associated therewith” (see also 35 U.S.C. 112(b) Rejection below). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the nature of the invention,
2- the breadth of the claims,
3- the state of the prior art,
4- the predictability of the art,
5- the amount of direction or guidance provided
6- the presence or absence of working examples,
7- the quantity of experimentation necessary, and
8- the relative skill of those in the art.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Undue experimentation is required by one skilled in the art to determine enablement of the instant disclosure as claimed due to the following:
The nature of the invention (1) and the breadth of the claims (2)
The nature of the invention and breadth of claims is the treatment or prophylaxis of a psychiatric disorder broadly (claim 17) or the disorders listed in claim 18 (a depressive disorder, an anxiety disorder, or a substance use disorder), and potentially any symptom of the disorders (see 35 USC 112(b) Rejection below).
The specification defines “treatment” as “obtaining beneficial or desired results, including clinical results” including “not worsening” and “prophylactic” (see instant spec. at p. 25 line 11 – p. 26 line 2).
The specification defines “subject” as “all members of the animal kingdom including mammals” (see instant spec. at p. 25 lines 8-10).
The specification does not appear to define or clarify “any symptom or disorder associated therewith”.
The specification contemplates a very large and diverse spans of psychiatric disorders ranging from postpartum depression to bipolar disorder to agoraphobia to acute stress disorder (see instant spec. at pp. 57-66).
Furthermore since subjects include animals and humans and treatment includes prophylaxis and “not worsening”, the broadest reasonable interpretation includes a patient population of anyone.
The state (3) and predictability (4) of the art
MPEP § 2164.05(a) states if a publication demonstrates that those of ordinary skill in the art would not find that a particular invention was not enabled years after the filing date, the publication would be evidence that the claimed invention was not possible at the time of filing.
In regards to unpredictability in targeting 5-HT2A for treating a psychiatric disorder, Jukić1 teaches:
“Pimavanserin is an FDA-approved atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis, whereas glemanserin (MDL-11,939) was found ineffective and did not reach the market” (emphasis added, see Jukić at p. 100 right col. ¶2)
“…glemanserin and pimavanserin are referred to as selective 5-HT2A antagonists; however, while glemanserin blocked both 5-HT2A-Gq and 5-HT2A-Gi1 signaling pathways, pimavanserin blocked 5-HT2A-Gq and exhibited inverse agonism on 5-HT2A-Gi1 signaling pathway” (emphasis added, see Jukić at p. 101 left col. ¶1)
“…these findings are correlative in their nature…” (emphasis added, see Jukić at p. 101 left col. ¶2)
“2,5-Dimethoxy-4-iodoamphetamine (DOI) is a potent LSD-like hallucinogen, whereas pergolide does not exhibit as strong hallucinogenic properties as DOI. While DOI activated both 5-HT2A-Gq and 5-HT2A-Gi1 signaling pathways, pergolide activated only the 5-HT2A-Gq and not 5-HT2A-Gi1 signaling pathway. All the activations were abolished with glemanserin to ensure that they arise from the activation of 5-HT2A and not any other receptor, since DOI and pergolide are not selective 5-HT2A drugs.” (emphasis added, see Jukić at p. 101 left col. ¶2).
“it has been established long time ago that the 5-HT2A receptor also activates the β-arrestin pathway in addition to the already mentioned Gq and Gi1 pathways” (emphasis added, see Jukić at p. 101 left col. ¶2).
Jukić thus teaches that targeting 5-HT2A is complicated and unpredictable due to selectivity differences (5-HT2A vs other 5-HT2 receptors), downstream signaling differences (arrestin vs Gq and Gi1), agonism vs antagonism effects, and knowledge gaps in in vivo vs clinical trial results (e.g. glemanserin).
The prior art provides enablement for treating a psychiatric disorder susceptible to 5-HT2A receptor activation.
The amount of direction or guidance provided (5) and the presence or absence of working examples (6)
The specification provides the following embodiments:
5-HT2A receptor binding assays, screened 39 compound species with a range of low (e.g. 1200) to high (e.g. 0.35) binding affinities (see instant spec. at pp. 154-156 Table 1).
5-HT receptor subtypes functional activity assay, screened 43 compound species against 5-HT2A, 5-HT2B, 5-HT2C, and 5-HT1A receptors with a range of low (>10,000 or NC) to high (1.40) potency (see instant spec. at pp. 159-161 Table 3).
Head twitch response in mice, screened 1 compound in a manual HTR assay in mice (see instant spec. at p. 163 Table 4); screened 8 compound species in an automated HTR assay in mice (see instant spec. at p. 165 Table 5).
The specification provides enablement for treating a psychiatric disorder susceptible to 5-HT2A receptor activation.
Nowhere in the specification is it explained how such “symptoms or disorder associated therewith” are to be treated through the administration of the claimed compounds.
Therefore, the full scope of treatment in the methods of claim(s) 17-18 are not enabled.
The quantity of experimentation necessary (7) and the relative skill of those in the art (8)
The relative skill of those in the art is high, generally that of an M.D. or Ph.D. Because of the unknown predictability in the art (as discussed above) and in the absence of experimental evidence commensurate in scope with the claims, the skilled artisan would not accept that compounds of the instantly claimed genus could be used as treatments for any psychiatric disorder or “associated disorder” or symptom.
As noted above, little experimentation provided is drawn to treatment and prophylaxis of diseases listed in claim 18. A review of the state of the art fails to show 5-HT2A agonists are useful as therapeutic treatment as claimed (e.g. any psychiatric disorder). Determining if compounds of the claimed genus would be therapeutic for any particular disease state would require careful analysis and replicability of a composition comprising a compound of the claimed genus, formulation into a suitable dosage form, assay testing to correlate clinical efficacy, identifying off-targets and biased signaling effects (e.g. arrestin vs Gq and Gi1), subjecting to animal trials, and subjecting to clinical trials.
All this is undue experimentation given the limited guidance and direction provided by Applicants.
Conclusion
Accordingly, the inventions of claims 17-18 do not comply with the enablement requirement of 35 U.S.C 112, first paragraph, since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation with no assurance of success.
Suggested Amendment
Examiner suggests amending the claims as follows:
Claim 17. A method of treating a psychiatric disorder susceptible to 5-HT2A receptor activation in a subject comprising administering to said subject an effective amount of a compound according to claim 1.
Claim 18. The method according to claim 17 wherein the psychiatric disorder is a depressive disorder, an anxiety disorder, or a substance use disorder.
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 2, 14, 18 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 2 recites the limitation “wherein heteroaryl and aryl groups may be unsubstituted or substituted with…” and “alkyl, alkenyl, and alkynyl groups may be substituted or unsubstituted with…” and “cycloalkyl and 3-6 membered heterocyclyl may be unsubstituted or substituted with…”. It is unclear which heteroaryl, aryl, alkyl, alkenyl, alkynyl, cycloalkyl, and heterocyclyl groups the limitation is referring to. Moreover, the core of the compound of claim 1 is a substituted heteroaryl with a substituent (ethylamine) that does not appear to fall into claim 2’s substituent options for heteroaryls, and R6 may be benzyl and it is unclear if the phenyl moiety of an R6 benzyl is included in claim 2’s narrowing for “aryl” substituents. The claim should be amended to specify which R#s and groups the claim is referring to (e.g. wherein the heteroaryl, aryl, alkyl, alkenyl, alkynyl, cycloalkyl, or heterocyclyl of R1 is unsubstituted). For the purposes of applying art, claim 2 is construed as if an R1-R5 has a heteroaryl, aryl, alkyl, alkenyl, alkynyl, cycloalkyl, or heterocyclyl group, it may be unsubstituted, or if substituted, limited to the substituents listed in claim 2.
Claim 14 recites the limitation “wherein all heteroaryl, aryl, alkyl, alkenyl, alkynyl, cycloalkyl, and heterocyclyl groups are unsubstituted” (emphasis added). There is insufficient antecedent basis for this limitation in the claim. It is unclear which heteroaryl, aryl, alkyl, alkenyl, alkynyl, cycloalkyl, and heterocyclyl groups the limitation is referring to. Moreover, the core of the compound of claim 1 is a substituted heteroaryl and cannot be unsubstituted, and R6 may be benzyl and it is unclear if the phenyl moiety of an R6 benzyl is included in this narrowing for “aryl”. The claim should be amended to specify which R#s and groups the claim is referring to (e.g. wherein the heteroaryl, aryl, alkyl, alkenyl, alkynyl, cycloalkyl, or heterocyclyl of R1 is unsubstituted). For the purposes of applying art, claim 14 is construed as if an R1-R5 has a heteroaryl, aryl, alkyl, alkenyl, alkynyl, cycloalkyl, or heterocyclyl group, it must be unsubstituted.
Claim 18 recites “wherein the psychiatric disorder is a depressive disorder, an anxiety disorder, or a substance use disorder and any symptom or disorder associated therewith” (emphasis added). The metes and bounds of the limitation are unclear: What additional disorders associated with the already claimed disorder classes are included? What symptoms are included or excluded? What if a subject is experiencing a symptom shared by multiple psychiatric disorders? What if the symptom overlaps with a psychiatric disorder symptom but the subject does not have a psychiatric disorder? For the purposes of applying art, claim 18 is construed as simply “wherein the psychiatric disorder is a depressive disorder, an anxiety disorder, or a substance use disorder.”
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-9, 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN2.
Regarding claims 1-2, 9, 11-12, and a compound of the instant genus, STN teaches CAS# 2706-56-1 which reads on the instantly claimed genus when R1-R6 are H.
CAS# 2706-56-1
Instant Genus
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Regarding claims 1-3 and a compound of the instant genus, STN teaches CAS# 194658-15-6 which reads on the instantly claimed genus when R1-R3 are H, R4 is alkoxy specifically methoxy, R5-R6 are H.
CAS# 194658-15-6
Instant Genus
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Regarding claims 1-2, 11, 13-14 and a compound of the instant genus, STN teaches CAS# 6312-25-0 which reads on the instantly claimed genus when R1-R5 are H and R6 is benzyl.
CAS# 6312-25-0
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Regarding claims 1-2, 6, 8-9, 11-12, 14 and a compound of the instant genus, STN teaches CAS# 885277-36-1 which reads on the instantly claimed genus when R2-R6 are H and R1 is CF3.
CAS# 885277-36-1
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Regarding claims 1-9, 11-12, 14, and a compound of the instant genus, STN teaches CAS# 1785610-75-4 which reads on the instantly claimed genus when R1 is C1-C6 alkyl specifically methyl, R2-R3 are H, R4 is alkoxy specifically methoxy, R5-R6 are H.
CAS# 1785610-75-4
Instant Genus
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Regarding instant claims 1-2, 6, 8, 11, 13, 14, and a compound of the instant genus, STN teaches CAS# 2315505-60-1 which reads on the instantly claimed genus when R1 is C1-C6 alkyl specifically methyl, R2 is OR7 and R7 is H also known as hydroxyl, R3 is C1-C8 alkyl specifically methyl, R4 is C1-C8 alkyl specifically methyl, R5 is H, and R6 is benzyl.
CAS# 2315505-60-1
Instant Genus
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Claim(s) 1-2, 9, 11-14, 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 3,574,221 to Hankovszky et. al.3
Regarding instant claims 1-2, 9, 11-14 and a compound of the instant genus, Hankovszky teaches compounds of Formula I (see Hankovszky at col. 1 lines 40-45) such as CAS# 22540-55-2 (see Hankovszky at col. 4 first table).
CAS# 22540-55-2
Hankovszky Formula I
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CAS# 22540-55-2 reads on the instantly claimed genus when R1-R5 are H, R6 is a benzyl substituted with one R6a and R6a is hydroxyl.
Regarding instant claim 16 and a pharmaceutical composition, Hankovszky teaches the disclosed compounds are analgesics with tranquillo-sedative activity (see Hankovszky at col. 4 second table and ¶2). Hankovszky teaches the disclosed compounds can be formulated with a carrier, binder, filler, and/or flavoring agent (see Hankovszky at col. 2 lines 67-72). Hankovszky teaches the disclosed compounds may be formulated as oral compositions (see Hankovszky at col. 3 line 3).
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.
Claim(s) 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Hankovszky as applied to claims 1-2, 9, 11-14, 16 above and in further view of Childress et. al.4
Regarding claims 17-18 and a method of treating a psychiatric disorder, Hankovszky teaches the disclosed compounds exhibit better tranquillo-sedative effect compared to trimetozine or meprobamate (see Hankovszky at col. 1 lines 63-72).
The prior art differs from the instant claims as follows: While Hankovszky teaches the disclosed compounds are tranquillo-sedatives comparable to trimetozine or meprobamate, Hankovszky does not specify a method of treating a psychiatric disorder by administering to a patient.
However,
Regarding a psychiatric disorder, Childress teaches compounds that are anti-psychotic and anti-anxiety agents (see Childress at Title). Childress teaches trimetozine is a tranquilizer without hypnotic or anticonvulsant properties (see Childress at p. 8 5 and at p. 9 Compound XXXIV).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Regarding a psychiatric disorder, per MPEP § 2144.07, a prima facie case of obviousness exists for the selection of a known material based on its suitability for its intended use. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). The prior art compares a known sedative anti-anxiety medication (trimetozine, taught by Childress and Hankovszky) to the pyridinyl compounds with sedative properties such as CAS# 22540-55-2 (as taught by Hankovszky). It would have been obvious to an artisan to select a sedative such as CAS# 22540-55- taught by the prior art as a suitable alternative for the functionally similar trimetozine for treating anxiety because the prior art teaches the pyridinyl compounds such as CAS# 22540-55-2 have improved properties over trimetozine.
Regarding administering a therapeutically effective amount, it would have been obvious to an artisan to administer a therapeutically effective amount of a known compound (such as CAS# 22540-55-2, as taught by Hankovszky) to treat a known disorder (anxiety, as taught by Childress) in order to perform its intended use (sedate a subject, as taught by Hankovszky).
Furthermore, it is well-within the ordinary skill in art to incorporate one known sedative in lieu of another in a method of treating anxiety.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
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 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-49 of copending Application No. 19/579,0295 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The applicable analysis for Nonstatutory Double Patenting is set forth in MPEP § 804(II), and specifically MPEP § 804(II)(B). MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis. The instant analysis is an anticipation analysis.
Regarding instant claim 1, App’029 appears to claim the same or a significantly overlapping genus as instant claim 1 (App’029 claim 1). App’029 appears to further limit R1-R6 which do not appear to be excluded by the instant genus (App’029 claims 19-44).
App’029 Claim 1 Genus
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Regarding instant claims 2, App’029 appears to further limit heteroaryl, aryl, alkyl, alkenyl, alkynyl, cycloalkyl, heterocyclyl groups (App’029 claims 2-5) which are not excluded by the instant genus.
Regarding instant claim 3, App’029 appears to claim the same limitations (App’029 claim 6).
Regarding instant claim 4, App’029 appears to claim the same limitations (App’029 claim 7).
Regarding instant claim 5, App’029 appears to claim the same limitations (App’029 claim 8).
Regarding instant claim 6, App’029 appears to claim the same limitations (App’029 claim 9).
Regarding instant claim 7, App’029 appears to claim the same limitations (App’029 claim 10).
Regarding instant claim 8, App’029 appears to claim the same limitations (App’029 claim 11).
Regarding instant claim 9, App’029 appears to claim the same limitations (App’029 claim 12).
Regarding instant claim 10, App’029 appears to claim the same limitations (App’029 claim 13).
Regarding instant claim 11, App’029 claims significantly overlapping limitations (R5 is methyl, ethyl) (App’029 claim 14) and the same limitations (App’029 claim 15).
Regarding instant claim 12, App’029 appears to claim the same limitations (App’029 claim 16).
Regarding instant claim 13, App’029 appears to claim the same limitations (App’029 claim 17).
Regarding instant claim 14, App’029 appears to claim the same limitations (App’029 claim 18).
Regarding instant claim 15, App’029 claims species also instantly claimed (App’029 claim 45).
App’029 Claim 45 Exemplary Species
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Regarding instant claim 16 and a composition, App’029 also claims a pharmaceutical composition comprising a pharmaceutically effective amount of a compound of the claimed genus and a pharmaceutically acceptable carrier (App’029 claim 46).
Regarding instant claims 17-18 and a method of treating a psychiatric disorder, App’029 also claims a method of treating a psychiatric disorder in a subject comprising administering to said subject an effective amount of a compound of the claimed genus (App’029 claim 47). App’029 further claims wherein the psychiatric disorder is a depressive disorder, an anxiety disorder, or a substance use disorder and any symptom or disorder therewith (App’029 claim 48).
Regarding instant claim 19 and a method of activating a 5-HT2A receptor, App’029 also claims a method of activating a 5-HT2A receptor in a cell comprising effecting the administration to said cell of an effective amount of a compound of the claimed genus (App’029 claim 49).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 10, 15 are included in the provisional NSDP rejection, but following a terminal disclaimer, would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art to claims 10 (R3 and R4 are required to be methoxy) and 15 (fully defined species) is Acuña-Castillo et. al.6 Acuña-Castillo teaches phenylethylamine compounds for targeting 5-HT2A receptors (see Acuña-Castillo at Title and at p. 511 Figure 1).
Acuña-Castillo Genus
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The prior art differs from the instant claims as follows: While Acuña-Castillo teaches structurally similar compounds for a similar purpose, the prior art genus notably differs from the instant genus in the phenyl vs pyridinyl core.
Pyridine is an aromatic heterocycle whereas phenyl is an aromatic carbocycle. It would not be obvious to an artisan to make such a modification with a reasonable expectation of success because of their different electronic properties. In addition, as discussed in the scope of enablement rejection, in regards to a method comprising compounds of claims 10 or 15, Jukić teaches unpredictability in the art of targeting 5-HT2A receptors.
Conclusion
Claims 18-19 are objected to.
Claims 1-19 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA J REILLY whose telephone number is (703)756-5669. The examiner can normally be reached 9:00 am - 5:00 pm EST M-F.
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/SOPHIA REILLY/Examiner, Art Unit 1627
1 Jukić, M. "Can Gi1 biased 5-HT2A inverse agonists improve the treatment of psychosis?" European Neuropsychopharmacology 2020, 37, 100-101. DOI: 10.1016/j.euroneuro.2020.06.012. Hereinafter Jukić.
2 Hereinafter “STN” is referring to the following CAS Registry Number entries, retrieved from an STN database:
CAS 2706-56-1. CAS Registry File Accessed September 14, 2026 from STN, entered into STN November 16, 1984.
CAS 194658-15-6. CAS Registry File Accessed September 14, 2026 from STN, entered into STN September 30, 1997.
CAS 6312-25-0. CAS Registry File Accessed September 14, 2026 from STN, entered into STN November 16, 1984.
CAS 885277-36-1. CAS Registry File Accessed September 14, 2026 from STN, entered into STN May 23, 2006.
CAS 1785610-75-4. CAS Registry File Accessed September 14, 2026 from STN, entered into STN June 21, 2015.
CAS 2315505-60-1. CAS Registry File Accessed September 14, 2026 from STN, entered into STN May 24, 2019.
3 Patented April 6, 1971. Hereinafter Hankovszky.
4 Childress et. al. "Chapter 1. Antipsychotic and Anti-anxiety Agents" Annual Reports in Medicinal Chemistry, Academic Press, 1966, Vol. 1, 1-11. DOI: 10.1016/S0065-7743(08)60048-2. Hereinafter Childress.
5 371 of PCT/US2024/051877 filed October 18, 2024. Hereinafter App’029.
6 Acuña-Castillo et. al. "Differences in potency and efficacy of a series of phenylisopropylamine/phenylethylamine pairs at 5-HT2A and 5-HT2C receptors." Br J Pharmacol 2002, 136, 510–519. DOI: 10.1038/sj.bjp.0704747. Hereinafter Acuña-Castillo.
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