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 .
Applicant’s amendments filed 4/30/2025 have been entered.
Claims 1, 3-21 are pending.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 3-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 102370619 (‘619) in view of WO2007/089931 (‘931), both references are of record in IDS filed 9/6/2023. Google English translation of CN102370619 will be provided.
‘619 teaches an emulsion composition comprising a local anesthetics, including ropivacine, in a concentration of 1-100g/liter (see page 2, middle of the page; also claims 3 and 8). ‘619 also teaches an oil phase comprising a vegetable oil such as soybean oil (see page 2, sixth paragraph from the bottom; also claim 5); as well as an emulsifiers includes various phospholipids and lecithin, especially soybean lecithin (see page 2, fifth paragraph from the bottom and claim 6). ‘619 teaches water used as the aqueous phase (see page 3, first paragraph and claim 8). ‘619 also teaches the pH of the composition as 5.5-9.0 (see claim 8). ‘619 also teaches the pH adjusting agents including sodium hydroxide and hydrochloric acid (see claim 9).
The examiner notes that:
- wherein the concentration of local anesthetic is between: 0.1% (1,000 mg in 1,000 mL) and 10% (100,000 mg in 1,000 mL), which overlaps with the instantly claimed range of: no more than 4%,
- wherein the concentration of vegetable oil (i.e. soybean oil) is between 0% and 30% (300,000 mg in 1,000 mL), the concentration of the emulsifier (i.e. lecithin) is between 0.1% (1,000 mg in 1,000 mL) and 2% (20,000 mg in 1,000 mL) (see page 2, last 3 lines through page 3, first 6 lines). As such, the so-called oil phase (lecithin plus vegetable oil) comprises between 0.1% (0% plus 0.1%) and 32% (30% plus 2%), which overlaps with the instantly claimed range of: about 20% and 99.8%.
and the lecithin: vegetable oil ratio is between: infinite (when the vegetable oil is 0%) and 0.0033:1 (when lecithin is 0.1% and vegetable oil is 30%), which overlaps with the instantly claimed range: between 2:1 and 5:4.
‘619 does not expressly teach sesame oil. ‘619 does not expressly teach the use of organic solvent. ‘619 does not expressly teach the particle size.
‘931 teaches pharmaceutical formulations as emulsions of pharmaceutically active agents which are poorly water-soluble active agents, as an oil-in-water emulsion comprising oil droplets in an aqueous medium, wherein:
1- the poorly water-soluble agent can be for example an anesthetic agent (see page 4, line 17; page 19, line 20; page 20, line 2 and also lidocaine in particular (see page 21, line 20).
2- the formulation comprises an oil phase which comprises: a) a vegetable oil like: sesame oil, soybean oil, olive oil, etc. (see page 26, lines 4-9) and b) a phospholipid like lecithin (see page 27, line 30 through page 28, line 12),
3- the formulation comprises an aqueous phase (see page 3, line 16)
4- the emulsion containing a “bulking agent” to protect the emulsion and such agent include polyethylene glycol (page 32, line 21).
‘931 teaches the droplet size of 105-150nm so that the composition can be sterilization via filtration (see page 11, line 25).
It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate sesame oil and polyethylene glycol in the emulsion composition. It would have been obvious to one of ordinary skill in the art at the time of filing to formulate the composition to have a particle size of less than 0.2 micron.
One of ordinary skill in the art would have been motivated to incorporate sesame oil and polyethylene glycol in the emulsion composition because it is well-known sesame oil can be used as the oil phase in emulsion composition. As for polyethylene glycol, it can provide the enhanced stability to the emulsion.
One of ordinary skill in the art would have been motivated to formulate the composition to have a particle size of less than 0.2 micron because with a small particle size, the emulsion composition would be able to sterilize using filtration.
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, 3-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,992,483 (‘483). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘483 teaches a ropivacaine emulsion composition comprising about 2.55% w/w ropivacaine HCl monohydrate; about 52% w/w soy lecithin; about 0.02% w/w EDTA disodium dihydrate; about 8% w/w ethanol; about 36% w/w sesame oil; and about 0.1% w/w L-cysteine (see claim 26)
The scope of ‘483 is narrower than that of the instant case. This is an anticipatory type of obviousness double patenting rejection.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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/SAN MING R HUI/ Primary Examiner, Art Unit 1627