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 .
Applicant’s amendments filed 7/23/2025 have been entered.
The outstanding double patenting rejections are withdrawn in view of the terminal disclaimer filed 7/23/2025.
The outstanding rejection under 35 USC 112 is withdrawn in view of the amendments filed 7/23/2025.
Claims 1-66 are pending.
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 1-66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 17/706,210 (‘210) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘210 teaches a method of employing a treated 3α-OH-5β-pregnan-20-one composition in a method of treating depression, PPD and epilepsy (see claims 20, 21, and 26). ‘210 teaches the composition comprising various lipophilic and hydrophilic additives (see claims 24, 27). ‘210 teaches the pharmacokinetic properties of the composition (see claims 12-13, 23, 25). ‘210 teaches the dosage and amount of the active in the composition as 10-600mg (see claim 19).
‘210 does not expressly teach the exact herein claimed resulting Cmax values.
It would have been obvious to one of ordinary skill in the art at the time of filing to employ treated 3α-OH-5β-pregnan-20-one, in the herein claimed dosage, in a method of treating depression. Although the method of ‘210 does not expressly teach the herein claimed pharmacokinetic properties, the method utilizes the same compound, patients, and the same lipophilic and hydrophilic excipients. Therefore, the Cmax the dissolution profile, and the resulting effects as recited in the claims would be considered as inherently present in the method.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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) 1-66 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2016/040322 (‘322). All of the references are of record in the related patent application 18/908,278.
‘322 teaches the use of neuroactive steroid including allopregnanolone, such as via oral route of administration, useful in a method of treating CNS disorders such as epilepsy and depression (see claims 91, 92; [age 50, third paragraph). ‘322 teaches the plasma concentration of from 10 nM to up to 300nM can be achieved (see claims 23-26). Administered dosage can be up to 0.01 to 20 mg/kg (see page 68, last paragraph). ‘322 teaches the final serum level could reach up to 1500ng/mL (see page 74 last paragraph). ‘322 teaches the various dosing regimen and titration dosing (see page 4, last paragraph bridging page 7, second paragraph). ‘322 teaches various carriers such as a solvent or dispersion medium containing or comprising, for example, water (e.g., Water for Injection, USP), ethanol, one or more polyols (e.g., glycerol, propylene glycol, and liquid polyethylene glycol), oils, such as vegetable oils (e.g., peanut oil, corn oil, sesame oil, etc.), and combinations thereof (see page 72, 4th paragraph). ‘322 teaches various surfactants can be used. These surfactants may be anionic, cationic, amphoteric or nonionic surface active agents. Suitable anionic surfactants include, but are not limited to, those containing or comprising carboxylate, sulfonate and sulfate ions. Examples of anionic surfactants include sodium, potassium, ammonium of long chain alkyl sulfonates and alkyl aryl sulfonates such as sodium dodecylbenzene sulfonate; dialkyl sodium suliosuccinates, such as sodium dodecylbenzene sulfonate; dialkyl sodium suliosuccinates, such as sodium bis-(2-ethylthioxyl)-sulfosuccinate; and alkyl sulfates such as sodium lauryl sulfate. Cationic surfactants include, but are not limited to, quaternary ammonium compounds such as benzalkonium chloride, benzethonium chloride, cetrimonium bromide, stearyl dimethylbenzyl ammonium chloride, polyoxyethylene and coconut amine. Examples of nonionic surfactants include ethylene glycol monostearate, propylene glycol myristate, glyceryl monostearate, glyceryl stearate, polyglyceryl-4- oleate, sorbitan acylate, sucrose acylate, PEG-150 laurate, PEG-400 monolaurate, polyoxyethylene monolaurate, polysorbates, polyoxyethylene octylphenylether, PEG-1000 cetyl ether, polyoxyethylene tridecyl ether, polypropylene glycol butyl ether, Poloxamer® 401, stearoyl monoisopropanolamide, and polyoxyethylene hydrogenated tallow amide. Examples of amphoteric surfactants include sodium N- dodecyl-β-alanine, sodium N-lauryl-β-iminodipropionate, myristoamphoacetate, lauryl betaine and lauryl sulfobetaine. (see page 72, last paragraph bridging page 73, first paragraph).
‘322 does not expressly teach the herein claimed dosage of allopregnanolone. ‘322 does not expressly teach the pharmacokinetic properties of the administration of allopregnanolone.
It would have been obvious to one of ordinary skill in the art to employ the herein dosage of allopregnanolone in the method of treating tremor and/or postpartum depression.
One of ordinary skill in the art would have been motivated to employ the herein dosage of allopregnanolone in the method of treating tremor and/or postpartum depression. The optimization of result effect parameters (dosage range, dosing regimens) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[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). Since the ‘322 teaches the serum concentration that encompasses the one recited in the claims, prima facie case of obviousness exists. It is also noted that the dosage clearly corelated to the dosage administered by the patient.
In addition, the pharmacokinetic properties (such as the Cmax the dissolution profile, and the resulting effects) of the method are considered a resulting effect of allopregnanolone administration because the method of ‘322 utilizes the same compound, patients, and the same lipophilic and hydrophilic excipients, for treating the same diseases.
Applicants' attention is directed to Ex parte Novitski, 26 USPQ2d 1389 (BOPA 1993) illustrating anticipation resulting from inherent use, absent a haec verba recitation for such utility. In the instant application, as in Ex parte Novitski, supra, the claims are directed to preventing a malady or disease with old and well known compounds or compositions. It is now well settled law that administering compounds inherently possessing a protective utility anticipates claims directed to such protective use. Arguments that such protective use is not set forth haec verba are not probative. Prior use for the same utility clearly anticipates such utility, absent limitations distancing the proffered claims from the inherent anticipated use. Attempts to distance claims from anticipated utilities with specification limitations will not be successful. At page 1391, Ex parte Novitski, supra, the Board said "We are mindful that, during the patent examination, pending claims must be interpreted as broadly as their terms reasonably allow. In re Zletz, 893 F.2d 319, 13 USPQ2d 1320 (Fed. Cir. 1989). As often stated by the CCPA, "we will not read into claims in pending applications limitations from the specification." In re Winkhaus, 52 F.2d 637, 188 USPQ 219 (CCPA 1975).". In the instant application, Applicants' failure to distance the proffered claims from the recited pharmacokinetic properties, renders such claim limitations as inherently present in the cited prior art’s method.
Response to Arguments
Applicant's arguments filed 7/23/2025 averring the cited prior art’s failure to teach or suggest the recited pharmacokinetic properties have been fully considered but they are not persuasive. As discussed above, ‘322 utilizes the same compound, patients, and the same lipophilic and hydrophilic excipients, for treating the same diseases. The independent claims do not recite any limitations to distance the teachings of ‘322. As the matter of fact, the independent claims do not recite any specific carriers or dosages of the NAS compound. The examiner notes that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).” MPEP2112.01. In the instant case, the cited prior art utilizes the same compound, patients, and the same lipophilic and hydrophilic excipients, for treating the same diseases.
Applicant’s arguments with regard to the optimization of the dosage discussed, have been considered, but are not found persuasive. As discussed above, the examiner notes that the dosage was only recited in some of the depending claims. Such recited dosage can be optimized because the cited prior art teaches the target serum concentration of the active and the dosage relates to the serum concentration. Therefore, absent evidence to the contrary, the dosages and amount of the active adjustment would be considered obvious as routine optimization for maximum effectiveness and minimize side effects.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/SAN MING R HUI/ Primary Examiner, Art Unit 1627