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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over WO 96/15774 (WO ‘774) in combination with Andreasen (US 2014/0112979) and Morrison (US 5,827,531).
WO ’774 discloses a method of making nanosized liposomes containing phospholipids using supercritical fluid (page 6, lines 28-30, page 8, lines 5-8, page 9, lines 20-24, page 15, lines23-28) for encapsulating hydrophobic active agents using an apparatus (Abstract). The method involves dissolving the phospholipids in the supercritical fluid with or without the entrainer and adding the aqueous medium, de-pressurizing the contents. The sizes of the formed liposomes are also controlled with pressures (lowering the pressures and the nozzle sizes (Figures, Examples and claims). The hydrophobic drugs taught are bryostatin-1, camptothecins, toxoids and cisplatin (page 5, lines 14-18). The cosolvents and entrainers (ethanol) which are added to phospholipids and aqueous phases (page 6, lines, lines 28-30), lines 19-25, page 14, line 27).
WO ’774 does not teach step b, ‘freezing and thawing’ of the formed liposomes; (instant step e) or a step in microgravity.
Anreasen discloses a process of preparation of liposomes using supercritical fluid technology (Abstract, 0001, 0076, 0091 and Example 2). According to Andreasen that the freezing and thawing of sonicated phospholipid mixtures produces liposomes with large trapping capacity is known in the art of liposomes (0110).
Morrison discloses methods of forming multi-lamellar liposomes under the conditions of microgravity (Abstract, col. 3, line 30 through col. 4, line 42, col. 5, lines 9-32, col. 12, lines 43-64, Examples, Examples I and II).
It would have been obvious to one of ordinary skill in the art to introduce a step of freezing and thawing after the formation of liposomes taught by WO ’774, with a reasonable expectation of success since Andreasen teaches that such a method to increase the trapping capacity of liposomes is known in the art.
The encapsulation of water-soluble active agents, as recited in claim 20, would also have been obvious to one of ordinary skill in the art.
One or ordinary skill in the art would be motivated to prepare the liposomes in a microgravity environment, with a reasonable expectation of success since Morrison teaches that liposomes can also be prepared under microgravity conditions.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over WO 96/15774 (WO ‘774) in combination with Andreasen (US 2014/0112979) and Morrison (US 5,827,531), the combination further in view of Frederiksen (Journal of Pharmaceutical Sciences (1997).
The teachings of WO ‘774, Morrison and Andreasen are discussed above. They do not teach the encapsulation of a water-soluble active agent prepared by the method using supercritical carbon dioxide.
Fredericksen teaches encapsulation of a water-soluble active agent prepared by the method using supercritical carbon dioxide (see Abstract and Experimental section).
It would have been obvious to one of ordinary skill in the art, with a reasonable expectation of success, to encapsulate a hydrophilic active agent prepared by the process of WO ‘773, using the method of Fredericksen since liposomes can encapsulate both hydrophobic and hydrophilic compounds.
Non-Statutory 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 the claims of U.S. Patent No. 5,776,486 (‘486) in view of WO 96/15774 (WO ‘774), Andreasen (US 2014/0112979), Morrison (US 5,827,531), and Frederiksen (Journal of Pharmaceutical Sciences (1997). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘486 does not teach the addition of an alcohol fluid, the step of freezing and thawing, or adjusting the gravity. The secondary references are discussed above for teaching all the missing steps and it would have been obvious to incorporate known encapsulation steps into the process in patent ‘486.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri (9am-6pm + mid-day flex).
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612