Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Detailed Action
Previous Rejections
Applicants' arguments, filed 08/12/25 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Nonstatutory Double Patenting Rejection
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 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10, 028,912. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite a method to administer therapeutic and/or diagnostic agents to an animal subject which method comprises administering to said subject a reconstituted formulation of a lyophilized gel-phase liposomal composition, wherein the lyophilized gel-phase composition has been reconstituted in a pharmaceutical carrier, which lyophilized composition comprises: (a) gel-phase liposomes that exhibit a melting phase temperature (Tc) of at least 37°C, wherein the liposome membrane of said liposomes comprises no more than 20 mol % cholesterol and at least 1 mol % of a phosphatidylglycerol (PG) or a phosphatidylinositol (PI) or both, wherein at least two therapeutic and/or diagnostic agents are stably associated with said liposomes, wherein at least one of said agents is amphipathic or hydrophilic; and; (b) a cryoprotectant external to said liposomes; and wherein said liposomes contain substantially no internal cryoprotectant, and wherein when said lyophilized gel-phase liposomal composition is reconstituted in said pharmaceutical carrier, the mean diameter of the liposomes is maintained as compared to said composition prior to lyophilization and said agents are substantially retained in the liposomes. The composition in patented claims are for administration and therefore, instant method claims are deemed obvious over the patented composition claims. The claims in said patent and instant claims are obvious variants.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims1-17 of U.S. Patent No. 10,166,184. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim 1 is drawn to the same lyophilized gel-phase liposomal composition containing at least two therapeutic and/or diagnostic agents reciting specific liposome forming phospholipids and cholesterol and the dependent claims reciting instantly claimed DSPC. A lyophilized gel-phase liposomal composition, which composition comprises: (a) gel-phase liposomes that exhibit a melting phase temperature (T.sub.c) of at least 37° C. and wherein the liposome membrane of said liposomes comprises no more than 20 mol % cholesterol and at least 1 mol % of a phosphatidylglycerol (PG) or a phosphatidylinositol (PI) or both; and wherein at least two therapeutic and/or diagnostic agents are stably associated with said liposomes wherein at least one of said agents is amphipathic or hydrophilic; and; (b) a cryoprotectant external to said liposomes; and wherein said liposomes contain less than 50 mM internal cryoprotectant, and wherein when said lyophilized gel-phase liposomal composition is reconstituted in a pharmaceutical carrier, the mean diameter of the liposomes is maintained as compared to said composition prior to lyophilization and said agents are substantially retained in the liposomes. The composition in patented claims are for administration and therefore, instant method claims are deemed obvious over the patented composition claims. The claims in said patent and instant claims are obvious variants.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims1-15 of U.S. Patent No. 10,835,492. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite a lyophilized gel-phase liposomal composition, which composition comprises: (a) gel-phase liposomes that exhibit a melting phase temperature (T.sub.c) of at least 37° C. and wherein the liposome membrane of said liposomes comprises no more than 20 mol % cholesterol and at least 1 mol % of a phosphatidylglycerol (PG) or a phosphatidylinositol (PI) or both; and wherein at least two therapeutic and/or diagnostic agents are stably associated with said liposomes wherein at least one of said agents is amphipathic or hydrophilic; and; (b) a cryoprotectant external to said liposomes; and wherein said liposomes contain less than 50 mM internal cryoprotectant, and wherein when said lyophilized gel-phase liposomal composition is reconstituted in a pharmaceutical carrier, the mean diameter of the liposomes is maintained as compared to said composition prior to lyophilization and said agents are substantially retained in the liposomes. They are not patentably distinct from each other because the claims in said patent and instant claims are drawn to a method of administering the same lyophilized liposomal composition; the patented claims recite ‘substantially no internal cryoprotectant and are generic with respect to the lipids making up the liposomes and since liposome bilayer can be formed using any phospholipid, instant claims and patented claims are obvious variants.
The rejections are maintained pending submission of terminal disclaimer.
Action is final
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SNIGDHA MAEWALL whose telephone number is (571)272-6197. The examiner can normally be reached Monday thru Friday; 8:30 AM to 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Frederick Krass can be reached on 571-272-0580. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612