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 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.
Claims 1 – 2, 6, and 10 – 16 are rejected under 35 U.S.C. 103 as being unpatentable over International Publication Number WO 2006/048294 A1 to Kalkman et. al. (herein after Kalkman’294; cited on the IDS dated April 20th, 2023) in view of Stein et. al. ((2008), Social Anxiety Disorder, Lancet, 371, 1115 – 1125).
Regarding claims 1 – 2, 6, and 10 – 16, Kalkman’294 teach combination suitable for the treatment of psychiatric disorders (page 1 lines 3 – 4) which includes anxiety disorders (page 1 lines 20 – 21). Specifically, Kalkman’294 teach the administration of at least one nicotinic acetylcholine alpha 7 receptor agonist with at least one compounds selected from a list (page 1 lines 6 – 10). In particular, Kalkman’294 teach (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane (claims 1, 6, and 15) as the preferred nicotinic acetylcholine alpha 7 receptor agonist (page 6 line 27). Moreover, Kalkman’294 teach that the effective dosage of each of the active ingredients employed in the combination of the invention, which includes the nicotinic acetylcholine alpha 7 receptor agonist (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane, may vary depending on the particular compound or pharmaceutical composition employed, the mode of administration, the severity of the condition being treated; thus, a physician, clinician or veterinarian of ordinary skill can readily determine and prescribe the effective amount of the single active ingredients required to prevent (claim 15), counter or arrest the progress of the condition (page 21 lines 16 – 23).
Now while the prior art of Kalkman’294 teach the use of compounds of the disclosure in methods for treating anxiety; Kalkman’294 fails to specific teach a method for treating or preventing public speaking anxiety (claims 1 and 15) or a method of treating social anxiety disorder (SAD) (claim 6).
Nevertheless, Stein et. al. teach that anxiety disorders are the most pervasive class of mental disorders, with a 12-month prevalence in the community of about 18% (page 1115 column 1 paragraph 1). Furthermore, Stein et. al. teach that Social anxiety disorder (also known as social phobia) is classified in the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV; panel 1) and in the International Classification of Diseases 10 (ICD-10; panel 2) as a phobic (anxiety) disorder, alongside agoraphobia and specific phobias (from which it was first distinguished only 40 years ago4) (page 1115 column 1 paragraph 1). Additionally, Stein et. al. teach that individuals with social anxiety disorder invariably experience intense emotional or physical symptoms, or both (eg, fear, heart racing (claims 11 – 12), sweating, trembling, trouble concentrating (claims 13 – 14))(page 1115 column 1 paragraph 2).
Also, Stein et. al. teach that although people with generalized social anxiety disorder (claim 6) can fear and avoid specific performance situations such as public speaking (claims 1 – 2, 10, and 15), their social fears and avoidance extend far beyond that relatively common sphere of concern (page 1115 column 2 paragraph 1). Thus, Stein et. al. teach that the genus of anxiety disorders includes the species social anxiety disorders. Furthermore, Stein et. al. teach that anxiety around public speaking is one fear that someone with social anxiety experiences. Moreover, Stein et. al. teach that in seminal trials comparing drug treatment versus cognitive behavioral therapy in social anxiety disorder suggested that drugs can have faster effects, but the effects of cognitive behavioral therapy might last longer (page 1120 column 1 paragraph 2). Still, Stein et. al. teach that the choice to begin one modality rather than another, or to use combined treatment, therefore often relies on clinical judgment about individual patients (eg, drug treatment might be advisable in a patient who was too anxious or depressed to begin psychotherapy, or did not complete psychotherapy homework) (page 1120 column 1 paragraph 2).
Regarding claim 1, recitation for a method of treatment of an individual suffering from public speaking anxiety; as taught above in the prior art of Stein et. al. the fear of public speaking is one of the anxieties that are present for an individual that suffers from SAD. Hence given that the relative skill of one of ordinary skill in the pharmaceutical arts is relatively high it would have been with in the purview of such artisan to treat the public speaking anxiety through treating SAD since the prior art of Stein et. al, suggest overlap between these two anxieties.
Moreover, regarding claim 15, recitation for preventing a manifestation of one or more symptoms of public speaking anxiety in an individual comprising administering the (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane; as stated above, Kalkman’294 teach that the effective dosage of each of the active ingredients employed may vary depending on the particular compound or pharmaceutical composition employed, the mode of administration, the severity of the condition being treated; thus, a physician, clinician or veterinarian of ordinary skill can readily determine and prescribe the effective amount of the single active ingredients required to prevent (claim 15), counter or arrest the progress of the condition (page 21 lines 16 – 23). Furthermore, the prior art of Stein et. al. teach that the choice to begin one modality rather than another, or to use combined treatment, therefore often relies on clinical judgment about individual patients (eg, drug treatment might be advisable in a patient who was too anxious or depressed to begin psychotherapy, or did not complete psychotherapy homework) (page 1120 column 1 paragraph 2). Thus taking both the prior art teachings and given that the relative skill of one of ordinary skill in the pharmaceutical arts is relatively high it would have been obvious to administer (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane prior to public speaking to prevent the anxiety and the physical/cognitive effects.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Kalkman’294, that is to use agonist (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane to treat anxiety in view of Stein et. al., that is to treat or prevent public speaking anxiety and treat social anxiety disorder. One of ordinary skill in the art would have been motivated to make this modification to improve the mental health of individual suffering from these anxieties. One of ordinary skill in the art would have had a reasonable expectation of success because in seminal trials comparing drug treatment versus cognitive behavioral therapy in social anxiety disorder suggested that drugs can have faster effects.
Claims 4, 8, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over International Publication Number WO 2006/048294 A1 to Kalkman et. al. (herein after Kalkman’294; cited on the IDS dated April 20th, 2023) and Stein et. al. ((2008), Social Anxiety Disorder, Lancet, 371, 1115 – 1125) as applied to claims 1 – 2, 6, and 10 – 16 above, and further in view of Fuentes-Rodriguez et. al. ((2018), Exploring the role of the DSM-5 performance-only specifier in adolescents with social anxiety disorder, Psychiatry Research, 270, 1033 – 1038).
The teachings of Kalkman’294 and Stein et. al. as they relate to claims 1, 6, and 15, from which claims 4, 8, and 19 depend, are given previously in this office action and are fully incorporated here.
However, the prior art of Kalkman’294 and Stein et. al. fail to teach a method wherein the individual suffers from SAD-performance only (SAD-PO) (claims 4, 8, and 19).
Nevertheless, Fuentes-Rodriguez et. al. teach that social anxiety disorder (SAD) is characterized by “marked fear or anxiety about one or more social situations in which the individual is exposed to possible scrutiny by others” (page 1033 column 1 paragraph 1). Moreover, Fuentes-Rodriguez et. al. teach that based on the limited supporting evidence for the generalized subtype and data substantiating that social anxiety symptomatology appears to fall along a continuum of severity, the DSM-5 Anxiety, Obsessive-Compulsive Spectrum, Posttraumatic, and Dissociative Disorders Work Group suggested the usefulness of a specifier (page 1033 column 1 paragraph 1). Furthermore, Fuentes-Rodriguez et. al. teach that as a result, the DSM-5 added the performance-only specifier to characterize individuals whose anxiety is limited to speaking or performing in public, emphasizing a narrower range of the condition in a subgroup of persons (page 1033 column 1 paragraph 1).
Fuentes-Rodriguez et. al. teach that there is ongoing debate as to whether “performance only” specifiers may represent a discrete entity, distinct from those with broader social fears, or if specifiers are likely to evidence milder social anxiety symptomatology, in line with a dimensional conceptualization of social anxiety disorder (page 1036 column 2 paragraph 5). Furthermore, Fuentes-Rodriguez et. al. teach that the present study examined whether performance-only specifier adolescents exhibited differences in terms of gender, age of onset, comorbidity rates, social anxiety, depression and well-being scores compared to the group that included adolescents with performance anxiety only and adolescents with interaction anxiety (full spectrum of SAD), and adolescents free of any diagnosis (healthy controls)(page 1036 column 2 paragraph 6).
Thus Fuentes-Rodriguez et. al. teach that the performance-only specifier may correspond to a mild form of social anxiety disorder (page 1037 column 1 paragraph 2). Specifically, Fuentes-Rodriguez et. al. teach that the limited impact on the depressive measure, behavioral social anxiety subscales, and health-related quality of life dimensions calls into question the clinical usefulness of the SAD specifier, namely the performance-only specifier, has low prevalence and that it merely reflects an indicator of severity and not a different diagnostic entity (page 1037 column 1 paragraph 3).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Kalkman’294, that is to use (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane to treat anxiety in view of Stein et. al., that is to treat or prevent public speaking anxiety and treat social anxiety disorder, in further view of Fuentes-Rodriguez et. al., to treat SAD-performance only. One of ordinary skill in the art would have been motivated to make this modification to improve the mental health of individual suffering from these anxieties. One of ordinary skill in the art would have had a reasonable expectation of success because SAD-performance only was found to correspond to a mild form of social anxiety disorder. Moreover, as taught above there was no significant different between SAD and SAD-performance only in regards to the depressive measure, behavioral social anxiety subscales, and health-related quality of life dimensions for adolescent patients.
Claims 21 – 22, 24 – 25, and 70 – 71 are rejected under 35 U.S.C. 103 as being unpatentable over International Publication Number WO 2006/048294 A1 to Kalkman et. al. (herein after Kalkman’294; cited on the IDS dated April 20th, 2023) and Stein et. al. ((2008), Social Anxiety Disorder, Lancet, 371, 1115 – 1125) as applied to claims 1 – 2, 6, and 10 – 16 above, and further in view of European Patent Application EP 2742940 A1 to Trinius (herein after Trinius’940; cited on the IDS dated April 20th, 2023).
The teachings of Kalkman’294 and Stein et. al. as they relate to claims 1, 6, and 15, from which claims 21 – 22, 24 – 25, and 70 – 71 depend, are given previously in this office action and are fully incorporated here.
However, the prior art of Kalkman’294 and Stein et. al. fail to teach a method wherein the dose is from about 0.007 mg/kg to about 10 mg/kg (claim 21); wherein the dose is about 0.5 mg, about 2 mg, about 2.5 mg, about 10 mg, about 15 mg, about 75 mg, about 100 mg, about 200 mg, or about 700 mg (claims 22, and 70 – 71); wherein the compound is (R)-3-(6-p-tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane in mono-fumarate acid addition salt form (claim 24); and wherein the compound is orally administered in a solid immediate release form comprising the compound and one or more pharmaceutically acceptable excipients (claims 25, and 70 – 71).
Nevertheless, Trinius’940 teach an administration unit comprising a fumarate (claim 24), maleate, chloride, phosphate, succinate or malonate salt of (R)-3-(6-(4-methylphenyl)-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane (abstract). Trinius’940 teach in embodiment 1 the mono-fumarate salt of (R)-3-{6-(4-methylphenyl)-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane in crystalline form may be produced from isopropyl alcohol when one equivalent fumaric acid (claim 24) is used (page 6 paragraph 0012 lines 37 – 41). Moreover, Trinius’940 teach that the abbreviation {drug1 a}= fumarate salt of (R)-3-(6-(4-methylphenyl)-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane (page 4 paragraph 0009 line 48).
Additionally, Trinius’940 teach a preferred embodiment for the administration of a therapeutically effective amount of {drug1a} as 50 mg to 100 mg (claims 22, and 70 – 71) (page 52 paragraph 0072 lines 33 – 35) and 5 mg/kg body weight to 10 mg/kg body weight (claim 21)(page 60 paragraph 0151 line 5). Furthermore, Trinius’940 teach a preferred embodiment for oral administration (page 56 paragraph 0099 lines 13 – 14), selected from the group consisting of tablets, capsules, effervescent tablets, orodispersible tablets, dragees, sachets, drops, suspensions, and powders (page 56 paragraph 0100 lines 15 – 16). Moreover, Trinius’940 teach a preferred embodiment wherein the formulation provides immediate release of {drug1} which encompasses {drug1a} (page 55 paragraph 0094 line 49). Likewise, Trinius’940 teach a preferred embodiment wherein the administration unit comprises one or more excipients independently selected from the group consisting of antiadherents, binders, disintegrants, fillers, diluents, flavors, colors, lubricants, glidants, sorbents, surfactants, preservatives and sweeteners (page 58 paragraph 0132 lines 41 – 43). Thus Trinius’940 suggest the administration of {drug1a} as in a solid dosage form that can immediately release the medication.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Kalkman’294, that is to use (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane to treat anxiety in view of Stein et. al., that is to treat or prevent public speaking anxiety and treat social anxiety disorder, in further view of Trinius’940, that is to administer the (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane at the dosages and in the dosage form as recited above. One of ordinary skill in the art would have been motivated to make this modification to improve the mental health of individual suffering from these anxieties. One of ordinary skill in the art would have had a reasonable expectation of success because in seminal trials comparing drug treatment versus cognitive behavioral therapy in social anxiety disorder suggested that drugs can have faster effects.
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 – 2, 4, 6, 8, 10 – 17, 19, 21 – 22, 24 – 25, and 70 – 71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 3, and 5 – 20 of copending Application No. 18/527638 to Polymeropoulos et. al. (reference application; herein after Polymeropoulos’638).
Although the claims at issue are not identical, they are not patentably distinct from each other because both copending Polymeropoulos’638 and the instant application direct to the scope of methods of treating an individual suffering from or susceptible to acute anxiety wherein the cause is social anxiety disorder (SAD), SAD-performance only (SADPO), public speaking anxiety (PSA) independent of SAD diagnosis, public speaking anxiety as a presenting symptom of social anxiety disorder (SAD), public speaking anxiety as a presenting symptom of SAD-performance only (SAD-PO), performance anxiety, procedural anxiety, and an acute phobia comprising the administration of (R)-3-(6-p-tolylpyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane (reference claim 1; instant claims 1, 6, and 15).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 – 2, 4, 6, 8, 10 – 17, 19, 21 – 22, 24 – 25, and 70 – 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 2, and 6 – 8 of U.S. Patent No. US 9828642 B2 to Feuerbach et. al. (herein after Feuerbach’642) in view of Stein et. al. ((2008), Social Anxiety Disorder, Lancet, 371, 1115 – 1125), Trinius (herein after Trinius’940; cited on the IDS dated April 20th, 2023), and Fuentes-Rodriguez et. al. ((2018), Exploring the role of the DSM-5 performance-only specifier in adolescents with social anxiety disorder, Psychiatry Research, 270, 1033 – 1038).
Feuerbach’642 recite a therapeutic method of increasing the cognitive skills of an individual and/or treating a cognitive impairment, psychotic and/or neurodegenerative disorder, the therapeutic method comprising: administering a therapeutically effective amount of an alpha 7 nicotinic acetylcholine receptor activator to the individual, wherein the individual has been selected according to a method comprising the steps of: obtaining the genotype of the individual at the genetic locus of the human cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2) gene; and determining that the individual's CYP1A2 genotype includes (i) a homozygous SNP genotype of rs2069514-A/A, or (ii) a heterozygous SNP genotype of rs2069514-A/G, or (iii) a SNP fanning a haplotype with said SNP genotypes or a SNP in the same linkage disequilibrium with said SNP genotypes (reference claim 1); wherein the alpha 7 nicotinic acetylcholine receptor activator is a compound of formula (I)
PNG
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wherein L1-4 and A1 are defined (reference claim 2); wherein the alpha 7 nicotinic acetylcholine receptor activator of formula (I) is (R)-3-(6-p-tolylpyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane in free base or acid addition salt form (reference claim 6); wherein the alpha 7 nicotinic acetylcholine receptor activator of formula (I) is (R)-3-(6-p-tolylpyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane, in fumarate salt form (reference claim 7); wherein the alpha 7 nicotinic acetylcholine receptor activator of formula (I) is (R)-3-(6-p-tolylpyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane, in mono-fumarate salt form (reference claim 8).
Now while Feuerbach’642 recite a method for treating a psychotic disorder; Kalkman’294 fails to recite a method for treating or preventing public speaking anxiety (instant claims 1 and 15) or a method of treating social anxiety disorder (SAD) (instant claim 6).
The teachings of Stein et. al., Trinius’940, and Fuentes-Rodriguez et. al. as they relate to the prior art rejection of instant claims 1 – 2, 4, 6, 8, 10 – 17, 19, 21 – 22, 24 – 25, and 70 – 71, are given previously in this office action and are fully incorporated here.
Therefore it would have been obvious to one of ordinary skill in the art to modify the invention of Feuerbach’642 for a method of treating a psychotic disorder comprising administering R)-3-(6-p-tolylpyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane in view of Stein et. al. , that is to treat the anxiety disorders public speaking anxiety and social anxiety disorder in further view of Trinius’940, that is to administer the (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane at the dosages and in the dosage form as recited above and Fuentes-Rodriguez et. al., to treat SAD-performance only. One of ordinary skill in the art would have been motivated to make this modification to improve the mental health of individual suffering from these anxieties. One of ordinary skill in the art would have had a reasonable expectation of success because in seminal trials comparing drug treatment versus cognitive behavioral therapy in social anxiety disorder suggested that drugs can have faster effects. One of ordinary skill in the art would have been motivated to make this modification to improve the mental health of individual suffering from these anxieties. Additionally, one of ordinary skill in the art would have had a reasonable expectation of success because SAD-performance only was found to correspond to a mild form of social anxiety disorder. Moreover, as taught above there was no significant different between SAD and SAD-performance only in regards to the depressive measure, behavioral social anxiety subscales, and health-related quality of life dimensions for adolescent patients.
Claims 1 – 2, 4, 6, 8, 10 – 17, 19, 21 – 22, 24 – 25, and 70 – 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4 and 8 of U.S. Patent No. US Patent No. US 11359241 B2 to Feuerbach et. al. (herein after Feuerbach’241) in view of Stein et. al. ((2008), Social Anxiety Disorder, Lancet, 371, 1115 – 1125), Trinius (herein after Trinius’940; cited on the IDS dated April 20th, 2023), and Fuentes-Rodriguez et. al. ((2018), Exploring the role of the DSM-5 performance-only specifier in adolescents with social anxiety disorder, Psychiatry Research, 270, 1033 – 1038).
Feuerbach’241 recite method for treatment of a selected individual suffering from a psychotic disorder, the method comprising: using one of sequence-specific primer (SSP) typing, sequence-specific oligonucleotide (SSO) typing, sequence based typing (SBT), or DNA amplification, detecting, in the individual's genotype, the presence of: (i) the CYP1A2 SNP rs2069514-A (SEQ ID NO.I), or (ii) the CYP1A2 SNPrs2069514-G (SEQ ID NO. 2), or (iii) a SNP forming a haplotype with said SNPs or a SNP in the same linkage disequilibrium with said SNPs by using at least one oligonucleotide that specifically hybridizes with specific regions on the nucleic acid molecule carrying said SNP or SNPs; and wherein the individual is selected for treatment based on a determination that the individual's genotype includes: (i) a homozygous SNP genotype of rs2069514-A/A, or (ii) a heterozygous SNP genotype of rs2069514-A/G, or (iii) a SNP forming a haplotype with said SNP genotypes or a SNP in the same linkage disequilibrium with said SNP genotypes; and administering a therapeutically effective amount of the alpha 7 nicotinic acetylcholine receptor activator to the selected individual (reference claim 4); wherein the alpha 7 nicotinic acetylcholine receptor activator of formula (I) is (R)-3-(6-p-tolylpyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane in free base form or in acid addition salt form (reference claim 8; instant claim 24).
Now while Feuerbach’241 recite a method for treating a psychotic disorder; Kalkman’294 fails to recite a method for treating or preventing public speaking anxiety (instant claims 1 and 15) or a method of treating social anxiety disorder (SAD) (instant claim 6).
The teachings of Stein et. al., Trinius’940, and Fuentes-Rodriguez et. al. as they relate to the prior art rejection of instant claims 1 – 2, 4, 6, 8, 10 – 17, 19, 21 – 22, 24 – 25, and 70 – 71, are given previously in this office action and are fully incorporated here.
Therefore it would have been obvious to one of ordinary skill in the art to modify the invention of Feuerbach’241 for a method of treating a psychotic disorder comprising administering R)-3-(6-p-tolylpyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane in view of Stein et. al. , that is to treat the anxiety disorders public speaking anxiety and social anxiety disorder in further view of Trinius’940, that is to administer the (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane at the dosages and in the dosage form as recited above, and Fuentes-Rodriguez et. al., to treat SAD-performance only. One of ordinary skill in the art would have been motivated to make this modification to improve the mental health of individual suffering from these anxieties. One of ordinary skill in the art would have had a reasonable expectation of success because in seminal trials comparing drug treatment versus cognitive behavioral therapy in social anxiety disorder suggested that drugs can have faster effects. One of ordinary skill in the art would have been motivated to make this modification to improve the mental health of individual suffering from these anxieties. Additionally, one of ordinary skill in the art would have had a reasonable expectation of success because SAD-performance only was found to correspond to a mild form of social anxiety disorder. Moreover, as taught above there was no significant different between SAD and SAD-performance only in regards to the depressive measure, behavioral social anxiety subscales, and health-related quality of life dimensions for adolescent patients.
Conclusion
Claims 1 – 2, 4, 6, 8, 10 – 17, 19, 21 – 22, 24 – 25, and 70 – 71 are rejected.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627