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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 03/16/2026 is acknowledged.
Claims 10-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Groups II and III there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/16/2026.
Status of Claims
Preliminary amendment filed on 03/12/2024 is acknowledged.
Claims 18-19 are cancelled. Claims 3-9 and 15 are amended.
Claims 10-17 are withdrawn without traverse for being drawn to nonelected groups.
Claims 1-17 are pending. Claims 1-9 are being examined herein on the merits.
Information Disclosure Statement
The information disclosure statement (IDS), filed on 03/12/2024, is in compliance with the
provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the
Examiner.
Priority
This instant application 18691309 is a 371 of PCT/US222/077727, filed on 10/07/2022, which claims benefit of 63/253929, filed on 10/08/2021.
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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Dillard et al. (WO9915152, 04/01/1999, IDS of 03/12/2024), in view of Garti et al. WO2017002117, 01/05/2017, PTO-892).
Dillard throughout the reference teaches medical lubricant lipid emulsions comprising lipid, surfactant, co- surfactant, and water (e.g., Claim 1), wherein lipid is an oil consisting of vegetable oils such as olive oil, sunflower oil, soybean oil, etc. and medium chain triglycerides, surfactant is a phospholipid, and co-surfactant is bile salt (e.g., Claims 2-4).
Regarding instant claims 1, 3-4 and 6-8, Dillard exemplifies a medical lubricant lipid emulsion (Claims 22-23) comprising:
a) 5 to 40 g/100 mL lipid, including olive oil at a concentration of between about 15 and about 25 g/100 mL emulsion (overlapping with oil range from about 1 to about 40 g/100 mL in instant claim 1; corresponding to olive oil in instant claim 3),
b) 0.3 to 3 g/100 mL surfactant phospholipid which includes egg yolk phospholipid (known as a source of natural lecithin), or at a concentration between about 0.6 and about 1.8 g/100 mL emulsion (overlapping with phospholipid sunflower lecithin range from about 0.3 g/100 mL to about 3 g/100 mL in instant claim 1),
c) 0.04 to 4.0 g/100 mL co-surfactant bile salt, including sodium deoxycholate at a concentration of between about 0.2 and about 0.8 g/100 mL emulsion (overlapping with co-surfactant from about 0.1 to 10 g/100 mL in instant claim 1; corresponding to sodium deoxycholate in instant claim 4; corresponding to range from about 6 to about 6.5 g/100 mL in instant claim 7),
d) 1 to 30 g/100 mL cryogenic agent, including glycerin at a concentration between about 2 and about 20 g/100 mL emulsion (overlapping with cryogenic agent from about 0.1 to about 10 g/100 mL in instant claim 1; corresponding to glycerin in instant claim 6),
e) 0.01 and about 1 g/100 mL of amino acid buffer, including L-histidine and
f) water for injection (corresponding to aqueous liquid in instant claim 1, and pharmaceutically acceptable liquid in instant claim 8).
Regarding instant claim 2, Dillard teaches that the medical lubricant lipid emulsion can further comprise disodium EDTA (e.g., Claim 18; Claim 25), which can be at 0.014% (0.5 mM) (equivalent to 0.014 g/100 mL) in the emulsion (e.g., Pg. 7, Line 27; Pg. 12, Line 31) (falling within the range from about 0.001 to about 0.1g/100 mL in instant claim 2). MPEP 2112.01.II states "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable, as indicated in MPEP 2112.01.II. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. For this instance, being an antimicrobial preservative is a mutual property that cannot be separated from the compound disodium EDTA, which has been taught by prior art. MPEP 2131.03.I states that "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023).
Regarding instant claim 9, Dillard teaches that the medical lubricant lipid emulsion has a mean droplet size less than about 1 micro meter (e.g., Claim 21), most preferably less than about 0.5 micrometer (e.g., Pg. 3, Lines 15-16), equal to less than 1000 nm, preferably less than about 500 nm.
Dillard does not teach sunflower lecithin as recited in instant claim 1, or co-surfactant as polysorbate 80 as recited in instant claim 5.
Garti throughout the reference teaches novel dilutable delivery systems and propofol microemulsions suitable for intravenous delivery of propofol (e.g., Abstract), comprising an oil phase in the form of oil droplets dispersed in an aqueous diluent continuous phase, wherein the oil phase comprises propofol, a polysorbate, at least one solvent, at least one co-surfactant, and at least one co-solvent, the oil droplets having a size of at most 20 nm (about 10 and 20 nm, Pg 50, Claim 12) in the continuous phase, and the microemulsion being suitable for parenteral administration (e.g., Pg. 49, Claim 1; Pg. 50, Claim 9; Pg. 8, middle).
Garti teaches that the solvent can include olive oil, soybean oil, canola oil, cotton oil, sunflower oil, corn oil, etc. (e.g., Pg. 10, bottom), co-surfactant can include lecithins and phospholipids (e.g., Pg. 51, Claim 17; Pg. 11, top), such as sunflower lecithin, egg lecithin, rapeseed lecithin, soy lecithin, etc. (e.g., Pg. 12, top), and polysorbate can be polysorbate 40 (Tween 40), polysorbate 60 (Tween 60), polysorbate 80 (Tween 80) as hydrophilic surfactants in the formulation (e.g., Pg. 7, bottom), and co-solvent can be ethanol, propanol, glycerol (e.g., Pg. 51, Claim 19). Garti exemplifies using Tween-80 (or polysorbate 80) at concentration of 7.578 % and 8.593% in formulation IV and III (e.g., Pg. 26, Table 4-2).
It would have been prima facie obvious for a person with ordinary skills in the art prior to filing date to incorporate Garti’s teaching of sunflower lecithin and polysorbate 80 into the formulation of Dillard to arrive at current invention. Because both compositions are suitable microemulsions with safe ingredients for pharmaceutical injections, it would have motivated artisans in the field to swap egg yok phospholipid in Dillard with sunflower lecithin, or select polysorbate 80 for reasonable expectation of success. It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, the oil amount, phospholipid surfactant amount, co-surfactant (e.g., sodium deoxycholate) amount, cryogenic agent amount, antimicrobial preservative amount all overlap with those taught by prior art. Although polysorbate 80 amount range does not overlap with the co-surfactant amount range taught by Dillard, Garti exemplifies higher polysorbate 80 amounts, it would have motivated artisans to adjust, optimize and explore higher co-surfactant amount ranges that that in Dillard based on Garti’s teaching. “It would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Conclusion
No claim is allowed.
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/DX.Z./ Examiner, Art Unit 1616
/SUE X LIU/ Supervisory Patent Examiner, Art Unit 1616
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