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 04/16/26 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of (U.S. Patent No. 10, 028,912) in view of Wong et al. (US PG Pub. 2006/0110441A1).
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 is 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 each liposome comprises no more than 20 mol % cholesterol and at least 1 mol % of a phosphatidylglycerol (PG) or a phosphatidylinositol (PI) or a combination thereof, wherein at least two therapeutic and/or diagnostic agents are encapsulated in each liposome, wherein at least one of said agents is amphipathic or hydrophilic; and; (b) a cryoprotectant in an amount of from about 100mM to about 500nmexternal to said liposomes; and wherein an internal medium said liposomes contains 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. The patent does not teach the amount of cryoprotectant.
Wong et al. teaches any suitable concentration of cryoprotectant may be used in the present invention including about 5% to about 15% (w/v). A preferred cryoprotectant is 10% sucrose. It will be appreciated that the ratio of cryoprotectant to lipid may be more important than the concentration of the cryoprotectant. Preferably, the weight ratio of cryoprotectant to lipid is from about 0.5:1 at 200 mM lipid in 10% sucrose to about 100:1 at 1 mM lipid in 10% sucrose. Preferable ratios of lipid to cryoprotectant include 2:1 to 1:100. An exemplary embodiment includes about 175 mM lipid and 10% sucrose as cryoprotectant in a ratio of about 1.4:1, see [0062]. In one embodiment, the aqueous solution added to the dry film includes a cryoprotectant. In this manner, the cryoprotectant is present in the liposome internal aqueous space as well as in the aqueous medium. It will be appreciated that where it is desired for the cryoprotectant to be present only in the internal aqueous space of the liposomes, the external aqueous medium may be changed. It will further be appreciated that where it is desired that the cryoprotectant be present only in the external aqueous medium, the cryoprotectant may be added to the aqueous medium after hydration of the liposomes. It will be appreciated that the cryoprotectant may be added to achieve a desired molar ratio of cryoprotectant to lipid. In one embodiment, the cryoprotectant is present in a molar ratio of about 0-600 (based on 20% sucrose to 1 mM lipid) cryoprotectant to lipid, see [0070].
It would have been obvious to one of ordinary skill to have manipulated the amount as provided by Wong et al. into the patented cryoprotectant used during lyophilized liposome formulations and methods. One of ordinary skill would have been motivated to do so because Wong while teaching lyophilized liposomes provides for the use of cryoprotectant and their amounts.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims1-17 of (U.S. Patent No. 10,166,184) in view of Wong et al. (US PG Pub. 2006/0110441A1).
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 is 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 each liposome comprises no more than 20 mol % cholesterol and at least 1 mol % of a phosphatidylglycerol (PG) or a phosphatidylinositol (PI) or a combination thereof, wherein at least two therapeutic and/or diagnostic agents are encapsulated in each liposome, wherein at least one of said agents is amphipathic or hydrophilic; and; (b) a cryoprotectant in an amount of from about 100mM to about 500nmexternal to said liposomes; and wherein an internal medium said liposomes contains 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. Regarding the amount of cryoprotectant, Wong et al. teaches any suitable concentration of cryoprotectant may be used in the present invention including about 5% to about 15% (w/v). A preferred cryoprotectant is 10% sucrose. It will be appreciated that the ratio of cryoprotectant to lipid may be more important than the concentration of the cryoprotectant. Preferably, the weight ratio of cryoprotectant to lipid is from about 0.5:1 at 200 mM lipid in 10% sucrose to about 100:1 at 1 mM lipid in 10% sucrose. Preferable ratios of lipid to cryoprotectant include 2:1 to 1:100. An exemplary embodiment includes about 175 mM lipid and 10% sucrose as cryoprotectant in a ratio of about 1.4:1, see [0062]. In one embodiment, the aqueous solution added to the dry film includes a cryoprotectant. In this manner, the cryoprotectant is present in the liposome internal aqueous space as well as in the aqueous medium. It will be appreciated that where it is desired for the cryoprotectant to be present only in the internal aqueous space of the liposomes, the external aqueous medium may be changed. It will further be appreciated that where it is desired that the cryoprotectant be present only in the external aqueous medium, the cryoprotectant may be added to the aqueous medium after hydration of the liposomes. It will be appreciated that the cryoprotectant may be added to achieve a desired molar ratio of cryoprotectant to lipid. In one embodiment, the cryoprotectant is present in a molar ratio of about 0-600 (based on 20% sucrose to 1 mM lipid) cryoprotectant to lipid, see [0070].
It would have been obvious to one of ordinary skill to have manipulated the amount as provided by Wong et al. into the patented cryoprotectant used during lyophilized liposome formulations and methods. One of ordinary skill would have been motivated to do so because Wong while teaching lyophilized liposomes provides for the use of cryoprotectant and their amounts.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims1-15 of (U.S. Patent No. 10,835,492) in view of Wong et al. (US PG Pub. 2006/0110441A1).
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. Regarding the amount of cryoprotectant, Wong et al. teaches any suitable concentration of cryoprotectant may be used in the present invention including about 5% to about 15% (w/v). A preferred cryoprotectant is 10% sucrose. It will be appreciated that the ratio of cryoprotectant to lipid may be more important than the concentration of the cryoprotectant. Preferably, the weight ratio of cryoprotectant to lipid is from about 0.5:1 at 200 mM lipid in 10% sucrose to about 100:1 at 1 mM lipid in 10% sucrose. Preferable ratios of lipid to cryoprotectant include 2:1 to 1:100. An exemplary embodiment includes about 175 mM lipid and 10% sucrose as cryoprotectant in a ratio of about 1.4:1, see [0062]. In one embodiment, the aqueous solution added to the dry film includes a cryoprotectant. In this manner, the cryoprotectant is present in the liposome internal aqueous space as well as in the aqueous medium. It will be appreciated that where it is desired for the cryoprotectant to be present only in the internal aqueous space of the liposomes, the external aqueous medium may be changed. It will further be appreciated that where it is desired that the cryoprotectant be present only in the external aqueous medium, the cryoprotectant may be added to the aqueous medium after hydration of the liposomes. It will be appreciated that the cryoprotectant may be added to achieve a desired molar ratio of cryoprotectant to lipid. In one embodiment, the cryoprotectant is present in a molar ratio of about 0-600 (based on 20% sucrose to 1 mM lipid) cryoprotectant to lipid, see [0070].
It would have been obvious to one of ordinary skill to have manipulated the amount as provided by Wong et al. into the patented cryoprotectant used during lyophilized liposome formulations and methods. One of ordinary skill would have been motivated to do so because Wong while teaching lyophilized liposomes provides for the use of cryoprotectant and their amounts.
The rejections are maintained pending submission of terminal disclaimer. Arguments are moot in view of the new rejections made above necessitated by claim amendments.
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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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612
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