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 .
DETAILED ACTION
The amendment filed 10/28/2025 has been entered. Claim 2 has been cancelled. Claims 1, and 3-16 are pending and under examination.
Response to Arguments
With respect to the rejection of claims 1 and 3-16 under 35 USC 103, Applicant's arguments filed 10/28/2025 have been fully considered but they are not persuasive. Applicant argues that Aoe does not teach injecting molten lipids directly into a liquid having a temperature of 20˚C or higher and lower than a melting point of the lipids. However, the claim recites injecting molten lipids directly into a liquid…wherein the liquid has a temperature lower than the melting point of the lipids.
In response, Aoe teaches spraying the oil and fat composition, which is dissolved by heating (i.e., the lipids are molten), from an inner tube of an air atomizing nozzle (equivalent to the liquid supply port of the two-fluid nozzle) while simultaneously ventilating pressured air from the external tube of the air atomizing nozzle (equivalent to the gas supply port of the two-fluid nozzle) to produce fine droplets. Aoe teaches that the droplets come in contact with a substance, that may be liquid at 0˚-25˚C. Aoe teaches an example using soybean oil, which has a melting temperature of 70˚C. Therefore, if the soybean oil was atomized into a liquid with a temperature of 0˚-25˚C, said liquid would have a temperature lower than the melting point of the lipids.
Applicant argues that the Vg/Vf ratio of Aoe is different than that of the instant claim. However, as stated, the selection of specific flow velocities would be a routine matter of optimization on the part of the artisan of ordinary skill (see MPEP§ 2144.05 II), said artisan recognizing that flow velocities would affect lipid droplet size.
Applicant’s remaining arguments with respect to claims 1 and 3-16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
(NEW REJECTION NECESSICATED BY AMENDMENT)
Claims 1 and 3-16 are rejected under 35 U.S.C. 103 as being unpatentable over Aoe et al., (U.S. Patent No. 5,514,406, previously cited) in view of Park et al., (WO03/079990A2) and Sato et al., (EP 2,899,264 B1, previously cited), as evidenced by Sigma Aldrich (Converting from Flow Velocity to Volumetric Flow Rates) and Morlino et al., 2023 (Cupriavidus necator as a platform for polyhydroxyalkanoate production: An overview of strains, metabolism, and modeling approaches).
Regarding claim 1, Aoe teaches a method of powdering an oil/fat (i.e., lipids) composition using a spray cooling method using an atomizer such as a double-fluid nozzle type of atomizer (Column 3, lines 30-35). Aoe teaches spraying the oil and fat composition, which is dissolved by heating (i.e., the lipids are molten), from an inner tube of an air atomizing nozzle (equivalent to the liquid supply port of the two-fluid nozzle) while simultaneously ventilating pressured air from the external tube of the air atomizing nozzle (equivalent to the gas supply port of the two-fluid nozzle) to produce fine droplets (Column 3, lines 47-55). Aoe teaches that the droplets come in contact with a substance, that may be liquid such as water or alcohol at 0˚-25˚C, so that they are cooled and solidified (Column 3, lines 54-58).
Aoe teaches an example (Example 1), in which hydrogenated soybean oil (melting point 70˚C) was maintained at 90˚C, and was sprayed from an inner tube of an air atomizing nozzle, and pressurized air heated at 90˚C was sprayed from an external tube of the air atomizing nozzle (Column 4, Example 1). Therefore, it is construed that the two-fluid nozzle of Aoe was heated to 90˚C, which is 20˚ higher than the melting point of the soybean oil. If the soybean oil was injected into a liquid at 0˚-25˚C the liquid would have a lower temperature than the melting point of the oil.
Volume median diameter, or D50, is defined in the art as the median droplet size, therefore, it is interpreted that average particle size is synonymous with volume median diameter. Aoe teaches that the nozzle diameter was 8 mm (Column 3, line 50), and Example 1 teaches a particle size of 15 µm (Column 4, lines 44-46). Therefore, it is considered that the D50/Nd ratio of Example 1 of Aoe would be approximately 0.0019 (15 µm/8000 µm). Although this median droplet size (D50) differs from that of the instant claim, the selection of median droplet size would have been a routine matter of optimization on the part of the artisan of ordinary skill (see MPEP§ 2144.05 II), said artisan recognizing that median droplet size would affect the stability of the lipid-based formulations.
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It is interpreted that “injection linear velocity” is synonymous with flow velocity. To calculate flow velocity from flow rate, the following formula, as evidenced by Sigma Aldrich, may be used:
A circular column cross-sectional area is πr2 where r = radius in cm. Aoe teaches a lipid flow rate of 1.5 L/min wherein the diameter of the nozzle from which the lipid flows is 8 mm, i.e., the radius is 0.4 cm (Column 3, lines 49-51). Aoe teaches a gas flow rate of 90 L/min, wherein the diameter of the nozzle from which the gas flows is 25 mm, i.e., the radius is 1.25cm (Column 3, lines 52-53). Therefore, the lipid flow velocity taught by Aoe would be approximately 178926 cm/h (1500 mL/min x 60/ π(0.4 cm)2), while the gas flow velocity of Aoe would be approximately 110078 cm/h (90000 mL/min x 60/ π(1.25 cm)2), i.e., a Vg/Vf ratio of 6.14. Although this velocity differs from that of the instant claim, the selection of specific flow velocities would be a routine matter of optimization on the part of the artisan of ordinary skill (see MPEP§ 2144.05 II), said artisan recognizing that flow velocities would affect lipid droplet size.
Aoe does not teach that the lipids have a water solubility of 10 g/L or less at 25˚C or that the gas and liquid supply ports of the two-fluid nozzle, i.e., the atomizer, located in the liquid, i.e., submerged.
However, Park teaches a method of generating drug-containing microcapsules using an atomizer submerged in a collection bath consisting of water (Example 5; Figure 3).
However, Sato teaches a method of culturing microorganisms using lipids having low solubility in media as a carbon source (para. [0019]). Sato teaches that the lipid preferably has a water solubility at 25˚C of 10 g/L or less (para. [0022]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have atomized lipids, as taught by Aoe, with a water solubility of 10 g/L or less at 25˚C, as taught by Sato, by submerging the atomizer nozzle, which contains the gas and liquid supply ports, in a liquid, as taught by Park. One of ordinary skill in the art would have been motivated to do so because Sato teaches that emulsions containing said lipids are very stable and teaches that said emulsions allow microorganisms to suitably assimilate lipids having high melting points and low solubility (para. [0019]). One of ordinary skill would have been motivated to submerge the atomizer into the aqueous collection bath because Park teaches that submerging allows for immediate solvent exchange between the microparticles and the bath (p. 7, para. 2). One of ordinary skill in the art would have had a reasonable expectation of success because Aoe and Park are in the same field of endeavor of atomization of biological materials and Aoe and Sato are in the same field of endeavor of development of lipid-containing nutritional products.
Regarding claim 3, Aoe teaches an average particle size of 15 µm (Example 1).
Regarding claim 4, Aoe teaches that the method is useful for obtaining an atomized oil/fat composition with a narrow particle size distribution (Column 4, lines 35-37). Therefore, it is interpreted that if a lipid with a water solubility of 10 g/L or less at 25˚C, as taught by Sato, is atomized using the method of Aoe, then the span in particle size distribution would inherently be between 0.5-3.0.
Regarding claim 5, Aoe teaches that the melting point of the soybean oil is 70˚C (Example 1).
Regarding claim 6, Sato teaches that an exemplary oil may be palm oil (para. [0039]).
Regarding claim 7, Aoe teaches that the pressurized air, i.e., the gas, was heated to 90˚C (Example 1), which is higher than the melting point of the soybean oil and is less than 200˚C.
Regarding claim 8, Aoe teaches that the gas is air (Example 1).
Regarding claim 9, Aoe teaches that soybean oil with a melting point of 70˚C was maintained at 90˚C (Example 1).
Regarding claim 10, Aoe teaches that the lipids may be cooled and solidified. Aoe teaches the atomization of soybean oil (Example 1). Aoe does not teach that the atomized oil may be used in a microbial culture solution. However, Sato teaches a method of producing a lipid-containing emulsion for culturing microorganisms (para. [0034], para. [0035]), and teaches that a suitable oil for the emulsion may be soybean oil (para. [0039]). Therefore, it would have been obvious to one of ordinary skill in the art to atomize the soybean oil of Aoe into the microbial culture solution of Sato instead of the liquid such as water or alcohol, because the end product of Aoe is capable of supporting microbial growth, as taught by Sato (para. [0039]).
Regarding claim 11, Sato teaches that bacteria to be cultured with the lipid emulsion may be Cupriavidus necator (para. [0028]), which produces polyhydroxyalkanoates, as evidenced by Morlino (Abstract).
Regarding claim 12, Aoe teaches preparing lipid particles from soybean oil according to the method of instant claim 1, while Sato teaches a method of producing a lipid-containing emulsion for culturing microorganisms wherein the lipid has water solubility of 10 g/L or less at 25˚C (para. [0022], para. [0034], para. [0035]). Sato teaches that a suitable oil for the emulsion may be soybean oil (para. [0039]). Therefore, it would have been obvious to one of ordinary skill in the art to have cultured microorganisms in lipid-containing culture solution, as taught by Sato, using atomized lipids prepared by the method taught by Aoe and Park, as the end product of Aoe is capable of supporting microbial growth, as taught by Sato (para. [0039])
Regarding claim 13, as stated, Aoe teaches that the melted lipid droplets may come into contact with a liquid, such as alcohol or water at 0-25˚C (Column 3, lines 55-57). Although the temperature differs from that of the instant claim, MPEP§ 2144.05 II states: “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. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.")” The selection of a specific liquid temperature would have been a routine matter of optimization on the part of the artisan of ordinary skill, said artisan recognizing that liquid temperature would affect lipid solidification.
Regarding claims 14 and 16, Sato teaches that the lipid may be palm fatty acid distillate (para. [0066]).
Regarding claim 15, Sato teaches a culture temperature of 30˚C (para. [0076]). Although the temperature differs from the temperature of the instant claim, 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, as stated in MPEP§ 2144.05 II which is discussed above. The selection of specific culture medium temperatures would have been a routine matter of optimization on the part of the artisan of ordinary skill, said artisan recognizing that culture medium temperature would affect microorganism growth.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL EMILY MARTIN whose telephone number is (703)756-1416. The examiner can normally be reached M-Th 8:30-16:00, F 8:30-10:00 EST.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/RACHEL EMILY MARTIN/Examiner, Art Unit 1657