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 .
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 82-101 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,213,953 B2 (‘953). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘953 patent discloses a pharmaceutical composition comprising: a first release portion comprising an active agent in a range of about 20% to about 40% (w/w) of a total amount of the active agent in the composition; a second release portion comprising the active agent in a range of about 60% to about 80% (w/w) of the total amount of the active agent in the composition; and a rate controlling agent, wherein the rate controlling agent is selected from the group consisting of a water-soluble excipient, a water-insoluble excipient, a water permeable excipient, and a combination thereof, and wherein the rate controlling agent is present in a weight ratio of the active agent in the second release portion of the composition to the rate controlling agent of about 1:1 to about 1:30 (w/w); wherein the in vitro release rate of the active agent, measured by an in vitro dissolution test comprises (i) a first release that is relatively fast and (ii) a second release, wherein the second release does not include a second rise in release rate that takes place about 5 hours to about 10 hours after start of the in vitro dissolution test, wherein the active agent is selected from the group consisting of midodrine, a pharmaceutically acceptable salt of midodrine, desglymidodrine, a pharmaceutically acceptable salt of desglymidodrine, and any combination thereof; and wherein the second release comprises a second rise in release rate that takes place about 2 to about 4.5 hours after start of the in vitro dissolution test. Method for treating orthostatic hypotension or postural orthostatic tachycardia syndrome (POTS) in a subject is found in claim 16-17.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to obtain the claimed invention given the claims of the ‘953 patent, because the ‘953 patent discloses a fast release and an extended release portions comprising midrodrine.
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.
Claims 82-101 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sundgreen et al. US 2002/0147232 A1.
Sundgreen teaches a kit that comprises i) a package comprising at least a first and a second pharmaceutical composition, wherein the first composition is designed to release the desglymidodrine relatively fast in order to obtain a relatively fast onset of the therapeutic effect and the second composition is in the form of a controlled release composition (cf. a co-pending patent application by the same Applicant) which is designed to give a release pattern as described below in order to utilize the possibility of having the active drug substance absorbed not only in the upper part of the gastrointestinal tract but also during its passage through colon, the first and the second composition may be of the same kind, e.g. in the form of tablets or capsules or they may be in the form of two different types of pharmaceutical compositions e.g. the first composition may be in the form of plain tablets or a nasal spray and the second composition may be in the form of controlled release tablets or capsules, and ii) a pharmaceutical composition which include a first and a second part, wherein the first part is designed to release desglymidodrine relatively fast in order to obtain a relatively fast onset of the therapeutic effect and the second part is a controlled release part (cf. a co-pending patent application by the same Applicant) which is designed to give a release pattern as described below in order to utlize the possibility of having the active drug substance absorbed not only in the upper part of the gastrointestinal tract but also during its passage through colon, and the first and the second part are presented in the form of a single composition such as, e.g. in the form of a tablet, a capsule (e.g. containing pellets which may be the same or different), sachets, or powders. In a kit according to the invention, the composition (or part) intended for relatively fast release contains desglymidodrine as the active substance and the composition (or part) intended for controlled release contains desglymidodrine or midodrine or a combination thereof. Interesting compositions of the invention are those, which are designed to release desglymidodrine relatively fast in order to obtain a relatively fast onset of action, i.e an action within 1-2 min after administration such as, e.g. within about 3 min. within about 4 min, within about 5 min, within about 7.5 min, within about 10 min within about 12.5 min or within about 15 min after administration. See paragraphs 0184-0189 and 0236-0242. Paragraphs 0246-0250 disclose at least three release profiles with the first release being fast release, second release being a slower and steady release with no second rise (plasma concentration which is relatively constant), and a third release with second rise in release of active agent. Method for treating orthostatic hypotension is found in claim 59. Active agents can be the same or different in the first and second portions and can be midodrine or desglymidodrine is found in the abstract, claims and paragraph 0237. Midodrine is a prodrug labeled for treatment of orthostatic hypotension. After absorption it is readily metabolized to desglymidodrine that acts as an agonist at the peripheral .alpha.-1 receptors in the smooth muscles of arteries and veins, but has no direct central nervous or cardiac effects. Its main effect is to increase the vascular tone thus increasing the total peripheral resistance and rising blood pressure. The presser effect of midodrine is manifest within 20 to 90 minutes after oral administration of a single dose. This pressor effect usually persists for 3 to 6 hours. Doses used in clinical practise (10 mg t.i.d.) significantly increase standing blood pressure, thus alleviating symptoms of orthostatic hypotension. See paragraph 0749.
Claims 82-101 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Skinhoj et al. US 7,070,803 B2.
Skinhoj teaches a controlled release pharmaceutical composition for oral use containing midodrine and/or active metabolite, desglymidodrine, and pharmaceutically excipients. See abstract and columns 17-20. The composition is formulated into a multilayer tablet having different release profiles including an immediate release layer. See columns 15-16. Dosing range from 2.5-50 mg is found in column 15. The claimed release profiles can be found in the Figures, the Examples and disclosure on columns 5-12. Method for treating a patient suffering from orthostatic hypotension and/or urinary incontinence, the method comprising administering an effective amount of midodrine and/or desglymidodrine in the form of a controlled release composition is found in claims 24-27.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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