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 .
Priority
This application, filed 06/05/2023 is a National Stage entry of PCT/EP2021/084484, International Filing Date: 12/07/2021. PCT/EP2021/084484 claims foreign priority to 20306508.1, filed 12/07/2020. A certified copy of the foreign priority application is of record.
Status of Claims
Claims 16-34 are currently pending, claims 1-15 have been canceled.
Claims 16-34 were examined and are rejected.
Claim Rejections-35 USC § 112
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.
Claim 20 is 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 20 depends directly from claim 19 and recites R5 as optionally being CF3. However, claim 19 doesn’t recite the option of the C1-3 alkyl group of R5 as being fluorinated. There is insufficient antecedent basis for this limitation in the claim, and the claim is indefinite.
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) 16-19, 21-22, and 25-27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et. al., Psychiatry Investigation, vol. 7(3), pp. 220-223, publ. 2010.
Kim discloses a case series of aripiprazole augmentation in individuals afflicted with pervasive developmental disorders (title & abstract). In particular, Kim discloses treatment of individuals with autistic disorder and Asperger’s disorder, wherein the individuals are concomitantly treated with chlorpromazine (abbreviated as CPZ), wherein the individuals are 17 years of age and 15 years of age, respectively, i.e., adolescents (see Table 1, pp. 222-223; see patient M/17 and M/15). The chemical structure of chlorpromazine is well-known in the art and is included within formula (I), having X=-CH2-; R1=chloro; R2=hydrogen; n=1; and R3, R4=both methyl. Kim therefore anticipates the claims.
Claim(s) 16, 19, 23, 25-27, and 33-34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Young et. al., WO 2009001040 A2, publ. 12/31/2008.
Young discloses the treatment of depression in a subject comprising administering dacemazine (abstract; p. 10, lines 9-11). Dacemazine is included within formula (I) having X=C(O); n=0; R1, R2=both hydrogen; and R3, R4=both methyl, and depression meets the claim limitation of a neuropsychiatric disorder. Young discloses administration of the compound either orally, intravenously, or intraperitoneally (p. 14, lines 8-9; p. 15, line 24-p. 16, line 3). Young therefore anticipates the claims.
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.
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.
Claim(s) 16, 19, 21-30, and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Syrov et. al., WO 2019022639 A1, publ. 1/31/2019, cited in an IDS.
Syrov et. al. teaches pharmaceutical compositions comprising alimemazine tartrate (abstract; para [0001]); alimemazine tartrate is another name for trimeprazine tartrate. Trimeprazine tartrate meets the limitation of formula (I) of the instant claims, having X=-CH2; n=1; R1=hydrogen; R2=methyl; and R3, R4=both methyl, in the form of the tartaric acid salt. Syrov teaches alimemazine tartrate as an antipsychotic drug having antihistamine, antispasmodic, serotonin blocking, and sedative effects (para [0005]). Syrov teaches a pharmaceutical composition comprising alimemazine tartrate, lactose, hydroxypropyl methylcellulose, pregelatinized starch, magnesium stearate, and colloidal silicon dioxide as having prolonged action (para [0008], [0011], [0015]). Syrov teaches the composition in the form of a capsule or tablet, for oral or rectal administration (para [0022], [0031]). Syrov further teaches the composition to be used for treating various conditions, including dementia due to anxiety disorder, schizophrenia, obsessive compulsive disorder, anorexia nervosa, in addition to other psychiatric disorders (para [0034]); dementia due to anxiety disorder, schizophrenia, obsessive compulsive disorder, and anorexia nervosa all meet the limitation of a neuropsychiatric disorder. As human adults are well-known in the art to be afflicted with these conditions, treatment of a human adult in need of treatment for a neuropsychiatric disorder comprising administering trimeprazine tartrate in the composition taught by Syrov would have been prima facie obvious in view of the above teachings. Syrov additionally doesn’t teach or suggest another active agent is needed for treatment, therefore, it would have been prima facie obvious to have administered trimeprazine tartrate in the composition taught by Syrov, wherein this compound is the sole active ingredient. Therefore, the method of the instant claims would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims, in consideration of the guidance of Syrov.
Claim(s) 16 and 19-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dreyfuss et. al., US 20060135509 A1, publ. 6/22/2006.
Dreyfuss et. al. teaches a method of treating neurological diseases and disorders with a compound that replaces or enhances the function of the survival motor neuron (SMN) gene product (abstract; para [0002], [0011]). Dreyfuss teaches conditions to be treated including neurological and psychiatric diseases and disorders, such as dementia, depression, psychosis, alcoholism, schizophrenia, anorexia nervosa, and bipolar disorder, among others (para [0010], [0015]). Dreyfuss particularly exemplifies the following compounds (para [0019], see compounds 14 and 17):
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. The first shown compound, compound 14, meets the limitation of trimeprazine, included within formula (I) having X=-CH2-; R1=hydrogen; R2=methyl; n=1; R3, R4=both methyl. The second compound, compound 17, is included within formula (I) having X=-CH2-; R1=-CO-R5; R5=methyl; n=0; R3, R4=both methyl. Dreyfuss further teaches the compounds in the form of their pharmaceutically acceptable salts, including tartaric acid (para [0040]); therefore, trimeprazine tartrate would have been included within the teachings of Dreyfuss. Dreyfuss teaches the compounds administered in pharmaceutical compositions via a variety of routes, including intraperitoneal or orally (para [0039], [0044]). Dreyfuss further teaches the effective daily dose of compound to range from about 0.1 mg to about 2000 mg., more preferably between about 0.5 to about 60 mg., but that the selected dose will depend upon a variety of factors and can be adjusted by a physician or veterinarian, for administration to an animal or human being (para [0050-0052], [0054]).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have treated a neuropsychiatric disorder in a subject in need thereof, such as dementia, depression, alcoholism, psychosis, schizophrenia, anorexia nervosa, and bipolar disorder comprising administering a compound of formula (I), selected from trimeprazine or trimeprazine tartrate, or compound 17 as shown in Dreyfuss before the effective filing date of the claims. Dreyfuss teaches treating neurological diseases and disorders with a compound that replaces or enhances the function of the survival motor neuron (SMN) gene product, and exemplifies compounds 14 and 17 as discussed above, and more specifically neuropsychiatric disorders such as dementia, alcoholism, depression, psychosis, schizophrenia, anorexia nervosa, and bipolar disorder. Dreyfuss further teaches oral or intraperitoneal administration, and a preferred dose range between 0.5-60 mg/day, but that this dose can be adjusted by a physician or veterinarian based on a variety of factors. Therefore, it would have been prima facie obvious to have administered a compound of formula (I) by oral or intraperitoneal delivery to treat a neuropsychiatric disorder in a subject, including a human subject, and have had a reasonable expectation of success. Although Dreyfuss doesn’t explicitly teach the dose range from 0.01 to 0.50 mg/kg BW as recited by instant claim 31, Dreyfuss does provide guidance for a daily dose from about 0.1 mg to about 2000 mg., more preferably between about 0.5 to about 60 mg., and that the selected dose will depend upon a variety of factors and can be adjusted by a physician or veterinarian. As such, one of ordinary skill in the art would have arrived at the range recited in instant claim 31, in the absence of evidence showing the criticality of this range. See MPEP 2144.05(II): Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, while neuropsychiatric disorders such as dementia, alcoholism, depression, psychosis, schizophrenia, anorexia nervosa, and bipolar disorder are well-known in the art to afflict human adults, it would have been prima facie obvious to have administered a compound of formula (I), either trimeprazine or compound 17 above, to a human adult in need of treatment for a neuropsychiatric disorder. As Dreyfuss doesn’t teach combination therapy is required, it would have been prima facie obvious to have arrived at the claimed method of treatment, wherein trimeprazine is administered in a pharmaceutical composition as the sole active ingredient, as recited by instant claim 30.
Information Disclosure Statement
The IDS filed on 6/5/2023 has been considered.
Conclusion
Claims 16-34 were examined and are rejected.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/ Primary Examiner, Art Unit 1627