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 .
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was noted at page 7 first full paragraph of the previous action.
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.
Claim(s) 9-15, 30-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ortega US9181198; Vankayalapati US8987335; Peter, Trends in Molecular Medicine, 2011, vol. 17, no. 7, pages 372-379; Jeste, American Psychiatric Association, Diagnostic and Statistical Manual of Mental, DSM-5, Fifth Edition, 2013 and Ballard, Nat Rev Neurol 5, 245–255 (2009). .
Ortega teaches in Ortega claim 58, a method of treating a neurological disease or disorder, wherein said neurological disease or disorder is selected from Alzheimer's disease, Huntington disease, Parkinson's disease, Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, or Dementia with Lewy Bodies, the method comprising administering, to a subject in need of such treatment, the active ingredient, compound of dependent claim 14, the elected species, of claimed method.
Disclosure with respect to the inherent property of the compound as lysine specific demethylase-1 (LSD1) inhibitor, activity appears about 170 times in Ortega’s disclosure.
The following is noted with respect to instant disclosure with respect to the inherent property:
As per US 8987335 column 5 line 24. The terms "LSD1" and "lysine-specific demethylase 1" can be used interchangeably and refer to a histone demethylase encoded by the KDM1A gene. So well-known is that KDM1A (lysine specific demethylase-1, or LSD1) is a critical enzyme that regulates gene expression by removing methyl groups from histones (H3K4me1/2), acting as a key epigenetic regulator of development and differentiation, that conspicuously absent in the instant disclosure is any reference to this inherent property or is the term LSD1 or any disclosure with respect to relationship of the recited KDM1A inhibition and LSD1.
Similarly, the terms ‘behavior alteration’ (claim 9), ‘social behavior alteration’ (claim 10), ‘social withdrawal" (claims 11) and ‘aggressiveness’ (claims 12)) are disclosed in the specification (with examples, not with any specific definition) with broad meaning such that overlap with each other these diseases are linked and underlying the claimed conditions.
According to Peter, under section ‘Molecular Mechanisms of histone (lysine) methylation’, starting on at bottom of page 373, column B, on to page 374, lysine-specific KDM1 (LSD1/KDM1A), contains an amine oxidase domain and requires flavin adenine dinucleotide as a cofactor to demethylate di- and monomethylated lysine’s At page 375 column B Peter teaches KDMs’s role in cognition and neuropsychiatric disease and at page 377 bottom of column B, teach that LSD1 inhibitors for mood and psychosis spectrum disorders to become novel therapeutics for neuropsychiatric diseases.
According to Jeste, disorders of aggression qualify as psychological disorders: The Diagnostic and Statistical Manual-5 (DSM-5) and International Statistical Classification of Diseases and Related Health Problems (ICD-10), which are the manuals used by psychologists, psychiatrists, and other mental health professionals to classify disorders and make diagnoses. A psychological disorder is defined as a persistent pattern of behavior, thoughts, and feelings.
Further according to Ballard titled, Management of agitation and aggression associated with Alzheimer disease, Agitation and aggression are frequently occurring and distressing behavioral and psychological symptoms of dementia (BPSD), further these symptoms are disturbing for individuals with Alzheimer disease, commonly confer risk to the patient and others, and present a major management challenge for clinicians.
The instant active ingredient and it is inherent biochemical property (claims 9, 14, 15) are taught by Ortega. The inherent biochemical property of (inhibiting LSD1/KDM1A) of the active ingredient, in turn in view of the teachings of Peter, Jeste and Ballard teach its use for treating neuropsychiatric diseases of claims 10-12, for human of claim 13 and orally (see Ortega column 54, lines 16-30). The limitations of dependent claims 32-42 are reiteration of claims 9-13.
Thus all the claimed elements (active ingredient, relationship of its inherent biochemical property to the recited disease states) are known in art when taken together with the teachings of Ortega, Peter, Jeste and Ballard. As such there is reasonable expectation of success in arriving at the limitations of instant claims. Therefore, nothing unobvious is seen in the claims.
The position taken is also predicated on the following with respect to claims for ‘new for an old compound’:
The new use for an old compound must be novel as to the use directed and unobvious. The new use (if any) must account for the possibility that the underlying mechanism for the new therapy is the same mechanism that allows for a prior art treatment using the same compound (or its obvious version).
The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the applicants had merely found a new property of the compound and such a discovery did not constitute a new use. As MPEP 2112 Requirements of Rejection Based on Inherency; Burden of Proof [R-10.2019], "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer."
The art made of record and not relied upon is considered pertinent to applicant's disclosure.
Maes, Methods of Treating Behavior Alternations US20200323828;
Peedicayila, Vafidemstat: a lysine-specific demethylase 1A inhibitor that shows promise for treating neuropsychiatric disorders, Epigenet Rep. 2025 ; 3(1): . doi:10.1080/28361512.2025.2552947.
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 9-15, 31-42 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9-15 of U.S. Patent No. 9181198 in view of Ballard, Nat Rev Neurol 5, 245–255 (2009)., Although the claims at issue are not identical, they are not patentably distinct from each other as explained below:
Claims of 9181198:
20. A method of treating a neurological disease or disorder, wherein said neurological disease or disorder is selected from depression, Alzheimer's disease, Huntington disease, Parkinson's disease, Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, or Dementia with Lewy Bodies, the method comprising administering, to a subject in need of such treatment, the compound of claim 1.
21. The method of claim 20 wherein said compound is selected from: 4′-((trans)-2-((2-aminothiazol-5-yl)methylamino)cyclopropyl)biphenyl-3-ol
58. A method of treating a neurological disease or disorder, wherein said neurological disease or disorder is selected from Alzheimer's disease, Huntington disease, Parkinson's disease, Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, or Dementia with Lewy Bodies, the method comprising administering, to a subject in need of such treatment, the compound of claim 25.
59. The method of claim 58 wherein said compound is selected from: (−) 5-(((trans)-2-(4-(benzyloxy)phenyl)cyclopropylamino)methyl)-1,3,4-oxadiazol-2-amine
60. A method of treating a neurological disease or disorder, wherein said neurological disease or disorder is selected from Alzheimer's disease, Huntington disease, Parkinson's disease, Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, or Dementia with Lewy Bodies, the method comprising administering, to a subject in need of such treatment.
The compounds/active ingredients of the above method claims 9181198, are LSD1 inhibiters. The compounds/active ingredients of the instant method claims are KDM1A inhibitors. That these refer to same inherent biochemical property is as per Peter teachings. (see below).
The active ingredient of instant claim 14 is the active ingredient in claims of 9181198, see claim 59. The preamble of instant base claim 9 (from which instant claim 14 depends on) is drawn to KDM!A inhibitor.
According to Peter at page lysine-specific KDM1 (LSD1/KDM1A), contains an amine oxidase domain and requires flavin adenine dinucleotide as a cofactor to demethylate di- and monomethylated lysines At page 375 column B Peter teaches KDms role in role in cognition and neuropsychiatric disease and at page 377 bottom of column B, teach at the minimum suggests, LSD1 inhibitors for mood and psychosis spectrum disorders to become novel therapeutics for neuropsychiatric diseases.
According to Jeste, disorders of aggression qualify as psychological disorders: The Diagnostic and Statistical Manual-5 (DSM-5) and International Statistical Classification of Diseases and Related Health Problems (ICD-10), which are the manuals used by psychologists, psychiatrists, and other mental health professionals to classify disorders and make diagnoses. A psychological disorder is defined as a persistent pattern of behavior, thoughts, and feelings.
Further according to Ballard titled, Management of agitation and aggression associated with Alzheimer disease, Agitation and aggression are frequently occurring and distressing behavioral and psychological symptoms of dementia (BPSD), further these symptoms are disturbing for individuals with Alzheimer disease, commonly confer risk to the patient and others, and present a major management challenge for clinicians.
As such there is extensive overlap between the method of instant claims ahd the method claims of 20, 21, 58-60 of 9181198 in the context of the teachings of Peter, Jeste and Ballard.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Feldman, Understanding ‘Evergreening’ : Making Minor Modifications Of Existing Medications To Extend Protections, Health Affairs June 2022 41:6, 801-804
Dwivedi, Evergreening: A deceptive device in patent rights, Technology in Society 32, (2010) 324–330.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
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