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 .
Priority
This application is a Continuation of Application No. 16/840,561 filed on April 08,2019, which claims priority to Provisional Application No. 62/830,830, filed on 04/08/2019.
Status of Claims
Claims 1-20 are pending and under examination.
Free of prior art
The closest prior arts are Saniova (J Neural Transm (2004) 111: 511-514) Huang (PLOS One, January 2014, vol. 9, Issue, pages 1-14), and Brenner (J Neurol (1989) 236: 153-156).
Saniova and PK-Merz® Infusion collectively do not teach amantadine hydrochloride amantadine hydrochloride in the amount of 0.1 mg/ml to about 10 mg/ml, and intravenous
administration. Moreover, Saniova and PK-Merz® Infusion collectively do not teach mild
traumatic brain injury and mild traumatic brain injury the is caused by stroke or an accident.
Huang teaches a method for treating mild to severe traumatic brain injury in a rat
subject comprising administering subcutaneously a mini-pump comprising amantadine
hydrochloride. (See Abstract and page 2; right column, fourth paragraph.) Moreover, Huang
teaches amantadine has emerged in the literature as a medication with potential benefits for
patients with head injuries and has been used in basic animal studies and clinical trials [8].
Preliminary studies have shown that amantadine hydrochloride accelerates functional recovery
during the active treatment of patients with brain injuries. (See page 2; left column, second
paragraph.)
Brenner teaches intravenous administration of amantadine has been shown to be a
quick-acting and highly effective method for treating patients with Parkinson’s disease. (See
Abstract.) Moreover, Brenner teaches treatment initially consisted of a daily infusion of 200 mg
amantadine sulphate (500ml PK-Merz) between 8.00 and 11.00 a.m. over a period of 10 days.
On the 10th day 3 × 1 tablet (100 mg) was additionally administered. From the 11th day on 3 ×
2 tablets were administered for 6 months. (See page 153; right column, second paragraph.)
None of the cited prior art references teach or suggest intravenous administration of amantadine or a pharmaceutically acceptable salt thereof at a dose of about 200 mg to about 400 mg once or twice daily, at a rate of about 15 mg/hr to about 135 mg/hr, and a volume of about 100 mg to about 1000 ml for treating traumatic brain injury in a human patient.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,707,439B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
The U.S. patent claims teach a method of treating traumatic brain injury (TBI) mild and severe in a human subject comprising intravenously administering a composition consisting of a pharmacologically effective amount of amantadine or a pharmaceutically acceptable salt thereof in sterile water and wherein the composition is free of any other excipients, the composition has a volume of about 100 ml to about 1000 ml and the composition is administered once or twice daily at a daily dose of about 200 mg to about 400 mg amantadine or a pharmaceutically acceptable salt thereof at a rate of about 15 mg/hr to about 135 mg/hr. (See claims 1, 3 and 4.) Moreover, the U.S. patent claims teach the method comprising: (i) a first period of administrating of the composition consisting of about 200 mg to about 400 mg of amantadine hydrochloride in sterile water at a rate of about 15 mg/hr to about 135 mg/hr of amantadine hydrochloride, (ii) followed by a second period without administration of amantadine hydrochloride, and (iii) followed by a third period of administrating of the composition consisting of about 200 mg to about 400 mg of amantadine hydrochloride in sterile water at a rate of about 15 mg/hr to about 135 mg/hr of amantadine hydrochloride, whereby the administration comprises twice daily administration of the composition. (See claim 20.) The traumatic brain injury is caused by a stroke or an accident and the composition is administered in combination with other neuroprotective and/or anti-inflammatory compounds. (See claims 6 and 9.) The U.S. patent claims teach
The method of the U.S patent claims anticipate the instant claims.
Conclusion
Claims 1-20 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEAN P CORNET whose telephone number is (571)270-7669. The examiner can normally be reached Monday-Thursday from 7.00am-5.30pm.
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/JEAN P CORNET/Primary Examiner, Art Unit 1628