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 .
Response to Arguments
Claim Rejections - 35 USC § 103
Applicant’s response from 7/3/2026 is acknowledged. Applicant’s arguments have been carefully considered, but have not been found to be persuasive.
First, Applicant has argued against the number of compounds claimed in Coma- 739, and because the claims recite that what is claimed is a combination of at least two compounds, Applicant has done a math estimating that the unique two-compound combination is 271,953. Applicant has further argued that Coma teaches treating 69 unique neurological disorders.
The Examiner responds that Applicant’s arguments have inappropriately turned Coma on its head. Starting with the issue of the so-characterized by Applicant “unique neurological disorders”, it is noted that the disclosure of Coma specifically relates to one specific category- that of neurodegenerative diseases, the list of which is known. Applicant’s claimed spinal muscular atrophy is simply one known neurodegenerative disease. It is also one, which is disclosed and claimed in Coma.
Further, Applicant’s independent claim 1 does not even require a combination. It solely requires haloperidol. The transitional phrase is “comprising”, which is open-ended, and does not preclude the presence of any other compound. Moreover, Applicant has no data of synergy, to the extent that it also claims additional compounds, in e.g. claims 5 and 6. Nor has Applicant argued any unexpected results over the prior art of record. Unlike that, Coma actually tested, and found its combinations to be synergistic, or at minimum additive, and that includes testing with a combination of compounds claimed by Applicant. See, e.g. Table 1, which specifically discloses “List of drugs that when combined in combinations of at least two compounds, score positive for having additive or synergistic effects for treating neurological diseases, specifically neurodegenerative diseases”. “[0046] A final group of drug combinations was obtained. High TPMS scores obtained by drug combinations with high individual prediction degree (prediction value equal or higher than 0.02), and high additive or synergistic degree by the highest single agent (HAS) model, were obtained for any combinations of at least two compounds as described in TABLE 1. Each of the drugs showed a specific score for each one of the four pathophysiological mechanisms or motives of neurodegenerative diseases described above: Amyloid pathology, Tau pathology, Oxidative Stress and Neuronal dysfunction and death.”
For the foregoing reasons, the Examiner maintains that Coma renders Applicant’s claims prima facie obvious, and that Applicant’s arguments have failed to overcome the prima facie obvious by way of either argument or data.
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 1-5, 7-13, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over US 20130116215 to Coma et al. (“Coma”, of record).
Coma relates to novel pharmaceutical combinations useful for the treatment of neurological diseases, specifically neurodegenerative diseases, which demonstrate additive or synergistic effect in silico and in vivo. (Abstract).
Coma claims a pharmaceutical composition comprising a therapeutically-effective amount of at least two or more compounds or an acceptable salt thereof, selected from the group including moxifloxacin and haloperidol (claim 1), further comprising at least one pharmaceutically acceptable carrier (claim 8). Coma claims a method of treating a neurological disease in a patient comprising administering to the patient in need of such treatment a therapeutically effective amount of a pharmaceutical composition according to claims 1 and 8 (claim 10), where is the disease is, inter alia, Spinal Muscular Atrophies of Childhood, and other neurodegenerative diseases (claims 12 and 11, [0053]). The pharmaceutical compositions may be specially formulated for oral administration. ([0061]). Per Coma, the active agents of the combination therapy are administered sequentially in either order or simultaneously. ([0090]). “Spinal Muscular Atrophies of Childhood” falls within the definition of SMA type I-III, according to Applicant’s Table 1.
The disclosure encompasses haloperidol lactate. ([0086] A "pharmaceutically-acceptable derivative" denotes any salt, ester of a compound of this invention, or any other compound which upon administration to a patient is capable of providing (directly or indirectly) a compound of this invention, or a metabolite or residue thereof. [0087] The term "pharmaceutically-acceptable salts" embraces salts commonly used to form alkali metal salts and to form addition salts of free acids or free bases. Appropriate organic acids may be selected from lactic acid.).
Thus, since Coma discloses the same compounds in therapeutically effective amounts, and for the treatment of the same disease, they will have the same effect o increasing full length functional SMN protein levels.
Coma does not specifically disclose the claimed molar ration of haloperidol: moxifloxacin of Applicant’s claims 13 and 17, but does provides that the compounds are used in “therapeutically affective amount” for the treatment of spinal muscular atrophy, and as further defined in ([0084]). Coma further discloses that: “[0085] Actual dosage levels of active ingredients in the pharmaceutical compositions of this invention can be varied so as to obtain an amount of the active compound(s) which is effective to achieve the desired therapeutic response for a particular patient, compositions, and mode of administration. The selected dosage level will depend upon the activity of the particular compound, the route of administration, the severity of the condition being treated, and the condition and prior medical history of the patient being treated.” Accordingly, it would have been obvious to a person of skill in the art before the effective filing date of the claimed invention to optimize the amounts, guided by the desire to achieve an optimal therapeutic effect with no side effects.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over US 20130116215 to Coma et al. (“Coma”, of record), as applied to claims 1-5, 7-13, 16 and 17 in the 35 U.S.C. 103 rejection above, and further in view of US 20170239225 A1 to Androphy et al. (“Androphy”, of record).
Coma is discussed in the 35 U.S.C. 103 rejection above.
Coma does not specifically additional administration of nusinersen, per Applicant’s claim 6.
Androphy relates to compositions and methods for treatment of spinal muscular atrophy (SMA). In certain embodiments, compounds are provided that increase full-length survival of motor neuron (SMN) protein production by an SMN2 gene. (Abstract).
Androphy claims a method of treating spinal muscular atrophy in a subject in need thereof, the method comprising administering a composition comprising SMN2 splicing compound and a SMN2 transcription enhancer, wherein the splicing compound is selected from nusinersen. (claims 25, 14 and 15).
Accordingly, it would have been obvious to a person of skill in the art before the effective filing date of the claimed invention to combine the teachings of Coma and Androphy in order to practice Applicant’s claimed invention with a reasonable expectation of success. The skilled artisan would have been motivated to do so, because nusinersen is a known in the art compound for the treatment of SMN, as disclosed by Androphy, in addition to haloperidol and moxifloxacin, as taught by Coma as known agents for the treatment of the same disease.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SVETLANA M IVANOVA whose telephone number is (571)270-3277. The examiner can normally be reached 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SVETLANA M IVANOVA/ Primary Examiner, Art Unit 1627
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