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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/06/2023 and 07/25/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink (see, for example [0003], line 9) and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of the terms CHIRALPACK® and CHIRACEL®, which are trade names or a marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Status of the Claims
Claims 1-3, 5, 8-9, 17, 23, 27-31, 34-35, 44-45, 50-53, 60, and 64-65 are pending in this application. Claims 4, 6-7, 10-16, 18-22, 24-26, 32-33, 36-43, 46-49, 54-59, and 61-63 have been cancelled by Applicant.
Claim Objections
Claim 64 is objected to because of the following informalities:
Claim 64 recites the limitation: “to antagonize 5-HT2A, 5-HT7, or 5-HT2A and 5-HT7”. The comma between the first “5-HT2A, 5-HT7” should be replaced by “or” OR the limitation should be condensed to recite “to antagonize 5-HT2A and/or 5-HT7”.
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 5, 8, 17, 23, and 50-52 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Malen et al. (US 4496557 – cited in IDS, Pub. Date: Jan. 29, 1985) (“Malen”).
Regarding claims 1-2, 5, 8, 17, and 23, Malen discloses the compounds of Formula 1 and 2 below (col. 1 and 13-14; and claim 1), wherein for Formula 1, n can be 1 (as in preferred embodiments of Formula 2); R1-2 (corresponding to instant R1-2) can be can independently be H or alkyl; and X and Y (corresponding to instant R4) can be H, halogen, lower alkyl, alkoxy, or -CF3
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Regarding claim 50, Melen claims a pharmaceutical composition comprising their compounds and an excipient (Melen’s claims 6-7).
Regarding claim 51, Melen claims a pharmaceutical composition comprising at least one of their compounds and an excipient. Therefore, when Melen’s composition can comprise two or more of their antidepressant compounds, thus anticipating the instant claim of one or more additional therapeutic agents (Melen’s claim 8).
Regarding claim 52, Melen claims a method of treating depression (a neurological or psychiatric disorder) comprising administration of an effective amount of their compounds (Melen’s claim 8).
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.
Claims 3, 9, 27-31, 34-35, and 44-45 are rejected under 35 U.S.C. 103 as being unpatentable over Malen et al. (US 4496557 – cited in IDS) (“Malen”); as applied to claims 1-2, 5, 8, 17, 23, and 50-52; in view of Meanwell et al. (J. Med. Chem. 2011, 54, 2529–2591) (“Meanwell”).
The teachings of Malen are disclosed in the 102-section above and incorporated herein.
Malen further teaches their compounds as psychotropic substances which exhibit antidepressant and anxiolytic effects on the central nervous system (col. 10, lines 7-12).
Regarding claims 27-28, Malen discloses their compounds 1 and 2 above, wherein stereochemistry has not been specified. With respect to stereoisomerism, it is noted that in Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293 (Fed. Cir. 2007), the court also relied on the settled principle that in chemical cases, structural similarity can provide the necessary reason to modify prior art teachings. The Federal Circuit also addressed the kind of teaching that would be sufficient in the absence of an explicitly stated prior art-based motivation, explaining that an expectation of similar properties in light of the prior art can be sufficient, even without an explicit teaching that the compound will have a particular utility. The Federal Circuit cautioned that requiring such a clearly stated motivation in the prior art to isolate 5(S) ramipril ran counter to the Supreme Court' s decision in KSR. The court stated: [r]equiring an explicit teaching to purify the 5(S) stereoisomer from a mixture in which it is the active ingredient is precisely the sort of rigid application of the TSM test that was criticized in KSR. Id. at 1301 (See MPEP 2143). Thus, Malen’s disclosure reads on the instant claims.
Regarding claims 3 and 29-30, while Malen’s compounds correspond to instant X2 being CH and X1 being -O-, or with both of X2 and X1 being -O-, as required by the instant claims, Applicant is advised that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. In re Norris, 179 F.2d. 970, 84 USPQ 458 (CCPA 1970). Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results. In re Finely, 81 USPQ 383 (CCPA 1949); 84 USPQ 458 (CCPA 1950).
Regarding claim 31, Malen discloses their compounds 1 and 2 above wherein the group corresponding to instant R3 is H.
Regarding claim 44, Malen discloses their compounds 1 and 2 above wherein the group corresponding to instant R2 can be lower alkyl (reading on methyl).
While Malen does not teach their compounds wherein the group corresponding to instant X2 is -O-, the teachings of Meanwell are relied upon to leverage these differences.
Meanwell teaches that the design of bioisosteres frequently introduces structural changes that can be beneficial depending on the context, with size, shape, electronic distribution, polarizability, dipole, polarity, lipophilicity, and pKa potentially playing key contributing roles in molecular recognition and mimicry. In the contemporary practice of medicinal chemistry, the development and application of bioisosteres have been adopted as a fundamental tactical approach useful to address a number of aspects associated with the design and development of drug candidates (abstract). Meanwell also discloses -CH--2-, -NH-, and -O- are all classical divalent bioisosteres; and H and F are classical monovalent bioisosteres (Table 1). Meanwell further teaches that several examples in the literature demonstrate advantages with N for CH substitution in benzene rings (starting on page 2541, col. 2, bottom; and Table 24). Meanwell discloses this substitution stabilizes lead compounds and drugs by making phenyl moieties less susceptible to oxidation (such as hydroxylation), thus resulting in improved metabolic stability and increased solubility.
Therefore, regarding instant claims 3, 27-31, and 44-45, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by Malen’s disclosed formulae in view of Meanwell; In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). See MPEP 2144.08. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of antidepressants disclosed by Malen, in view of Meanwell’s teachings that -CH2-, -O-, and -NH- are divalent bioisosteres. Accordingly, one having ordinary skill in the art would have been motivated to substitute the A group in Malen’s compounds (defined as either -CH2- or -NH-) for an -O-, to arrive at the instant invention; and/or one would have been also been motivated to substitute the -O- corresponding to instant X1 in Malen’s compounds for a -CH2- to arrive at the instant compounds in view of Meanwell’s disclosures.
Applicant is advised that similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Linter, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972) (see MPEP 2144.08(d)).
Further regarding claim 45, the compound below is particularly obvious in view of Malen’s disclosure in view of Meanwell:
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Regarding instant claims 9, 34-35, and 45, Meanwell further teaches that several examples in the literature demonstrate advantages with N for CH substitution in benzene rings (starting on page 2541, col. 2, bottom; and Table 24). Meanwell discloses this substitution stabilizes lead compounds and drugs by making phenyl moieties less susceptible to oxidation (such as hydroxylation), thus resulting in improved metabolic stability and increased solubility
Therefore, regarding claims 9, 34-35, and 45, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by Malen’s disclosed formulae in view of Meanwell. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of antidepressants disclosed by Malen, in view of Meanwell’s teachings that N for CH substitution in a phenyl ring is an obvious substitution, which results in improved metabolic stability and solubility of lead compounds and drugs. Accordingly, one having ordinary skill in the art would have been motivated to substitute a CH on one of the phenyls in Malen’s compounds for a N to arrive at the instant invention.
Further regarding claim 45, the compounds below are particularly obvious in view of these disclosures:
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Claims 53 and 65 are under 35 U.S.C. 103 as being unpatentable over Malen et al. (US 4496557 – cited in IDS) (“Malen”); as applied to claims 1-2, 5, 8, 17, 23, and 50-52; in view of McCormack et al. (WO 2010/035047 A1) (“McCormack”); further in view of Beckmann et al. (Frontiers in Physiology, 2014, 5, Article 331, 14 pages) “(Beckmann”).
The teachings of Malen are disclosed in the 102-section above and incorporated herein.
Malen further teaches their compounds as psychotropic substances which exhibit antidepressant and anxiolytic effects on the central nervous system (col. 10, lines 7-12).
While Malen does not specifically teach: (i) treatment of schizophrenia, bipolar disorder, etc. (claim 53); the teachings of McCormick and Beckmann are relied upon for these disclosures.
McCormick teaches their related compounds of Formula I below as acid sphingomyelinase (ASM) inhibitors. McCormack’s compounds encompass Malen’s compounds when X is
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, wherein R11 can be H (corresponding to instant X1 being O or -CR3); Y is independently -C(R12)2, wherein R12 can be H; R1-8 (corresponding to R4 when instant Y1-8 are CR4) can be H, halogen, -CN, -OH, etc.; R9-10 can be H or alkyl; and n can be 1. McCormack’s general structure encompasses Malen’s compounds as well as the instant compounds; thus, McCormack suggests that Malen’s compounds are ASM inhibitors.
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Applicant is reminded that similar properties may normally be presumed when compounds are very close in structure. (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious.
Beckmann teaches that the ability of tricyclic antidepressants to inhibit acid sphingomyelinase (ASM) was discovered in the 70’s; that ASM and ceramide were shown to play a crucial role in a wide range of diseases, including Alzheimer’s disease (AD), and major depression. Beckmann further teaches that the potential to block ceramide by inhibiting ASM is a new therapeutic approach for the treatment of these conditions
Therefore, regarding claim 53, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to administer Malen’s antidepressants for the treatment of neurological or psychiatric disorders, such as AD and major depression in view of McCormack and Beckmann. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Malen’s disclosure of their tricyclic antidepressant compounds, which are encompassed by McCormack’s general Formula of ASM inhibitors; further in view of Beckmann’s teaching that ASM inhibitors can block ceramide, thus providing a therapeutic pathway to treat AD and major depression.
Regarding claim 65, Beckmann teaches amitriptyline and fluoxetine as additional ASM inhibitors administered together to reduce ceramide levels in the hippocampus of mice, resulting in increased neurogenesis, neuronal maturation, and survival of neurons (page 7, col. 1, para. 1). Thus, it would have been obvious to one of ordinary skill prior to the effective filing of the claimed invention to administer Malen’s tricyclic antidepressants; taught by McCormack to be ASM inhibitors, in combination with another ASM inhibitors like amitriptyline or fluoxetine.
Applicant is advised that the courts have found that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art (In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).” See MPEP2144.06. It is therefore obvious to provide a mixture of the two agents.
Claims 60 and 64 are rejected under 35 U.S.C. 103 as being unpatentable over Malen et al. (US 4496557 – cited in IDS) (“Malen”); as applied to claims 1-2, 5, 8, 17, 23, and 50-52; in view of Gainetdinov et al. (Pharmacol. Rev., 2018, 70, 549-620) (“Gainetdinov”); and Celada et al. (Rev. Psychiatr. Neurosci. 2004, 29, 252-265).
The teachings of Malen are disclosed in the 102-section above and incorporated herein.
Malen further teaches their compounds as psychotropic substances which exhibit antidepressant and anxiolytic effects on the central nervous system (col. 10, lines 7-12).
While Malen does not teach inhibition of TAAR1, 5-HT2A and/or 5-HT7 with their compounds (claims 60 and 64); the teachings of Gainetdinov and Celada are relied upon for these disclosures.
Gainetdinov teaches that TAAR1 has been identified as a novel therapeutic target for depression (abstract, col. 2).
Celada teaches that selective serotonin reuptake inhibitors (SSRI) are the most frequently prescribed antidepressants; which rapidly block serotonin reuptake (5-HT). Celada discloses that blockade of 5-HT-2A seems to improve the clinical effects of SSRIs (abstract).
Applicant is advised that 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, as well as a method of using them for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the inventors had merely found a new property of the compound and such a discovery did not constitute a new use. See MPEP 2112.02(II).
In the present case, Applicant claims a method of use that is directed to an intrinsic property of Malen’s compounds that was not previously disclosed. The claims are drawn to a method of agonizing/ antagonizing TAAR1 and 5-HT2A. Both TAAR1 and 5-HT2A are known targets for the treatment of depression, as taught by Gainetdinov and Celada. Treatment of depression is the same intended use disclosed by Malen for their compounds. Therefore, the claims are directed to a result or property of Malen’s compounds.
Applicant is further advised that products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). 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.
Claims 1-3, 5, 8, 17, 23, 27-31, 44-45, and 50-51 are rejected under 35 U.S.C. 103 as being unpatentable over McCormack et al. (WO 2010/035047 A1) (“McCormack”).
Regarding claims 1, 29, and 45, McCormack discloses their compounds of Formula I below as acid sphingomyelinase (ASM) and as “tricyclic antidepressants” (see pages 1 and 10), reading on the intended use of the instant compounds. McCormack’s compounds render the instant compounds obvious when X is
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, wherein R11 can be H (corresponding to instant X1 being O or -CR3); Y is independently -O- or -C(R12)2, wherein R12 can be H; R1-8 (corresponding to R4 when instant Y1-8 are CR4) can be H, halogen, -CN, -OH, etc.; R9-10 can be H or alkyl; and n can be 1.
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While McCormack does not disclose specific preferred embodiments that match the instant compounds, their broad genus of encompasses the instantly claimed subgenus.
Therefore, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by McCormick’s disclosed formula. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by McCormick. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the claims.
Regarding claims 2-3, 5, and 30-31, McCormick discloses their general formula above, wherein X is
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, wherein R11 can be H (corresponding to instant X1 being O or -CR3 and R3 being H); Y is independently -O- or -C(R12)2, wherein R12 can be H (corresponding to instant X2 being O or -CR3 and R3 being H). This, McCormick discloses their compounds wherein the groups corresponding to instant X1 and X2 are independently -O- or CH2.
Regarding claims 8 and 17, McCormick discloses their general formula above, wherein the groups corresponding to instant Y1-8 are CR4, wherein their group corresponding to instant R4 can be H, halogen, -CN, etc.
Regarding claims 23 and 44, McCormick discloses their general formula above, wherein the groups corresponding to instant R1-2 can be H or C1-10 alkyl.
Regarding claims 27-28, with respect to stereoisomerism, Applicant is reminded that in Aventis Pharma Deutschland v. Lupin Ltd., the court also relied on the settled principle that in chemical cases, structural similarity can provide the necessary reason to modify prior art teachings. The Federal Circuit also addressed the kind of teaching that would be sufficient in the absence of an explicitly stated prior art-based motivation, explaining that an expectation of similar properties in light of the prior art can be sufficient, even without an explicit teaching that the compound will have a particular utility. The Federal Circuit cautioned that requiring such a clearly stated motivation in the prior art to isolate 5(S) ramipril ran counter to the Supreme Court' s decision in KSR. The court stated: [r]equiring an explicit teaching to purify the 5(S) stereoisomer from a mixture in which it is the active ingredient is precisely the sort of rigid application of the TSM test that was criticized in KSR. Thus, the claimed compounds are obvious in view of the cited art.
Regarding claim 45, the compound below is particularly obvious in view of McCormick’s teachings above:
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Regarding claims 50-51, McCormick claims pharmaceutical compositions comprising their compounds, an NO-donor (reading on additional therapeutic agent) and an excipient (McCormick’s claims 1 and 15).
Claims 9, 34-35, and 45 are rejected under 35 U.S.C. 103 as being unpatentable over McCormack et al. (WO 2010/035047 A1) (“McCormack”); as applied to claims 1-3, 5, 8, 17, 23, 27-31, 44-45, and 50-51; in view of Meanwell et al. (J. Med. Chem. 2011, 54, 2529–2591) (“Meanwell”).
The teachings of McCormick are disclosed above and incorporated herein.
While McCormick does not teach their compounds wherein a CH on a phenyl ring has been substituted for N; the teachings of Meanwell are relied upon to leverage these differences.
Meanwell teaches that the design of bioisosteres frequently introduces structural changes that can be beneficial depending on the context, with size, shape, electronic distribution, polarizability, dipole, polarity, lipophilicity, and pKa potentially playing key contributing roles in molecular recognition and mimicry. In the contemporary practice of medicinal chemistry, the development and application of bioisosteres have been adopted as a fundamental tactical approach useful to address a number of aspects associated with the design and development of drug candidates (abstract). Meanwell further teaches that several examples in the literature demonstrate advantages with N for CH substitution in benzene rings (starting on page 2541, col. 2, bottom; and Table 24). Meanwell discloses this substitution stabilizes lead compounds and drugs by making phenyl moieties less susceptible to oxidation (such as hydroxylation), thus resulting in improved metabolic stability and increased solubility.
Therefore, regarding instant claims 9, 34-35, and 45, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by McCormick’s disclosed formulae in view of Meanwell. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of antidepressants disclosed by McCormick, in view of Meanwell’s teachings that N for CH substitution in a phenyl ring is an obvious substitution, which results in improved metabolic stability and solubility of lead compounds and drugs. Accordingly, one having ordinary skill in the art would have been motivated to substitute a CH on one of the phenyls in McCormick’s compounds for a N to arrive at the instant invention.
Further regarding claim 45, the compounds below are particularly obvious in view of the disclosures above:
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Claims 52-53 and 65 are rejected under 35 U.S.C. 103 as being unpatentable over McCormack et al. (WO 2010/035047 A1) (“McCormack”); as applied to claims 1-3, 5, 8, 17, 23, 27-31, 44-45, and 50-51; in view of Beckmann et al. (Frontiers in Physiology, 2014, 5, Article 331, 14 pages) “(Beckmann”).
The teachings of McCormack are disclosed above and incorporated herein.
McCormack teaches their compounds as acid sphingomyelinase (ASM) inhibitors (pages 1 and 10).
While McCormack doesn’t teach treatment of neurological or psychiatric diseases, like bipolar, Parkinson’s (PD), Alzheimer’s (AD), etc. (claims 52-53 and 65); the teachings of Beckmann are relied upon for these disclosures.
Beckmann teaches that the ability of tricyclic antidepressants to inhibit acid sphingomyelinase (ASM) was discovered in the 70’s; that ASM and ceramide were shown to play a crucial role in a wide range of diseases, including Alzheimer’s disease (AD), and major depression. Beckmann further teaches that the potential to block ceramide by inhibiting ASM is a new therapeutic approach for the treatment of these conditions
Therefore, regarding claims 52-53, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to administer McCormack’s compounds for the treatment of neurological or psychiatric disorders, such as AD and major depression in view of Beckmann. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of McCormack’s disclosure of their ASM inhibitors and pharmaceutical compositions thereof; further in view of Beckmann’s teaching that ASM inhibitors can block ceramide, thus providing a therapeutic pathway to treat AD and major depression.
Regarding claim 65, Beckmann teaches amitriptyline and fluoxetine as additional ASM inhibitors administered together to reduce ceramide levels in the hippocampus of mice, resulting in increased neurogenesis, neuronal maturation, and survival of neurons (page 7, col. 1, para. 1). Thus, it would have been obvious to one of ordinary skill prior to the effective filing of the claimed invention to administer McCormack’s ASM inhibitors in combination with another ASM inhibitors like amitriptyline or fluoxetine.
Applicant is reminded that the courts have found that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art. It is therefore obvious to provide a mixture of the two agents.
Claims 60 and 64 are rejected under 35 U.S.C. 103 as being unpatentable over McCormack et al. (WO 2010/035047 A1) (“McCormack”); in view of Beckmann et al. (Frontiers in Physiology, 2014, 5, Article 331, 14 pages) “(Beckmann”); as applied to claims 52-52 and 65; further in view of Gainetdinov et al. (Pharmacol. Rev., 2018, 70, 549-620) (“Gainetdinov”); and Celada et al. (Rev. Psychiatr. Neurosci. 2004, 29, 252-265).
The teachings of McCormack and Beckmann are disclosed above and incorporated herein.
While McCormack in view of Beckmann does not teach inhibition of TAAR1, 5-HT2A and/or 5-HT7 with their compounds (claims 60 and 64); the teachings of Gainetdinov and Celada are relied upon for these disclosures.
Gainetdinov teaches that TAAR1 has been identified as a novel therapeutic target for schizophrenia, depression, and addiction (abstract, col. 2).
Celada teaches that selective serotonin reuptake inhibitors (SSRI) are the most frequently prescribed antidepressants; which rapidly block serotonin reuptake (5-HT). Celada discloses that blockade of 5-HT-2A seems to improve the clinical effects of SSRIs (abstract).
Applicant is reminded that 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. 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. (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, as well as a method of using them for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the inventors had merely found a new property of the compound and such a discovery did not constitute a new use. See MPEP 2112.02(II).
In the present case, Applicant claims a method of use that is directed to an intrinsic property of McCormack’s compounds that was not previously disclosed. Both TAAR1 and 5-HT2A are known targets for the treatment of depression, as taught by Gainetdinov and Celada. Treatment of depression is the same use of McCormack’s compounds in view of Beckmann. Therefore, the claims are directed to a result or property of McCormack in view of Beckmann’s compounds.
Applicant is further advised that products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). 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.
Conclusion
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627