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 Objections
Claim 1 is objected to because of the following informalities: the claim utilizes inconsistent verb tenses. The claim states “Stirring until the cyclodextrin forming a coating layer” in this case “stirring until” and “forming” are used together improperly. Additionally, the claim states “perform a secondary emulsification” in this case “perform” and “emulsification” are used together improperly. Appropriate correction is required.
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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Tang et al. (herein referred to as Tang, CN 113647627 A) in view of Arakawa et al. (herein referred to as Arakawa, US 20100055191 A1) and Haneda et al. (herein referred to as Haneda, JP 2013209493 A). With evidentiary evidence for Claim 4 from Microfluidics (“M700 Microfluidizer® Processor”).
With regard to Claim 1, Tang teaches a method for manufacturing a functional oil powder (abstract). Tang teaches mixing an emulsifier in a functional oil and stirring until the functional oil is emulsified to form an emulsified solution ([n0017]). Tang teaches adding the cyclodextrin to the emulsified solution and stirring until the cyclodextrin forms a coting layer (i.e., wall materials) on a surface of the functional oil contained in the emulsified solution, thereby forming a modified emulsified solution ([n0006], [n0016], [n0018]). Tang teaches the modified emulsified solution is emulsified a second time to obtain a primary emulsion which is subsequently homogenized wherein the homogenized solution comprises 8%-45% cyclodextrin (i.e., small molecule filler), 20%-70% functional oil, and 0.2% to 2% emulsifier ([n0007], [n0019]). Tang teaches the homogeneous solution is spray dried to obtained the functional oil powder ([n0019]).
It is important to note that Tang teaches an emulsifier in a range of 0.2% to 2% which is smaller than the claimed range of 55% to 85%.
Arakawa teaches a powder composition of a functional oil material which can contain a functional oil ([0030]-[0032]), cyclodextrin ([0161]-[0163]), and an emulsifier ([0105]-[0106]). Arakawa teaches the total amount of emulsifier to be used in the invention may be in a range of from 10 to 1,000% by mass based on the oil phase containing the functional oil component ([0123]). Arakawa teaches when the amount falls within the above range, emulsion stability of the emulsion composition can be made satisfactory ([0123]).
It would have been obvious to one with ordinary skill in the art to modify Tang in view of Arakawa to increase the amount of emulsifier, as demonstrated by Arakawa, to ensure the emulsion stability is satisfactory.
Tang is silent to the second emulsion being done via a microfluidic device.
Arakawa teaches a powder composition of a functional oil material is obtained by drying an emulsion composition comprising at least one functional oil component (abstract). Arakawa teaches useful mechanical emulsification apparatuses for reducing the particle size include various commercially available high-pressure homogenizers such as a microfluidizer ([0175]).
Arakawa imparts reasoning for obviousness because the teaching shows that the claimed microfluidic device was known to create an emulsion in the process of making a functional oil powder and was published at the time of filing, which means it was within the general skill of one with ordinary skill in the art to select a miucrofluidic device, because it would have been obvious to one with skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious. In addition, it would be advantageous to modify Tang in view of Arakawa to utilize a microfluidic device to reduce the particle size.
Wang teaches precise control over desired features of emulsions is vital to template synthesis of controllable application-oriented microparticles with advanced functions. Wang teaches the recent progress on microfluidic emulsification techniques for controllable emulsion production and functional microparticle synthesis (abstract). Wang teaches emulsion droplets made via a microfluidic device have controllable features such as size, shape, composition and structure, enable template synthesis of versatile advanced microparticles with desired functions for myriad applications (Conclusion).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Tang to utilize a microfluidic device for the second emulsion as taught by Wang to control the size, shape, composition and structure of the microparticles while enabling template synthesis of versatile particles with desired functions.
In addition, Tang teaches the homogenous solution is spray dried but is silent to the solution being lyophilized.
Haneda teaches a powdered oil and fat and method of manufacturing ([0001]). Haneda teaches freeze drying (lyophilization) or spray drying the emulsion to form a powder ([0039]). Haneda teaches freeze drying the oils and fats contained in the emulsion are not exposed to high temperatures, so oxidation of the oils and fats can be effectively prevented, and as a result, high-quality powdered oils and fats can be produced ([0039]).
Therefore, it would have been obvious to one with ordinary skill in the art to modify Tang in view of Haneda to substitute spray drying for freeze drying because they are both suitable for the intended use and freeze drying advantageously prevents oxidation of the oils and results in a high quality powdered oil composition.
With regard to Claim 2, Tang teaches the functional oil comprises fish oil ([n0012).
With regard to Claim 3, Tang teaches after adding the cyclodextrin in the emulsified solution, the stirring is performed at 50-70℃ ([n0018]). See MPEP 2144.05(I) which states In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In addition MPEP 2144.05(I) states similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.
With regard to Claim 4, Tang is silent to the pressure of the microfluidic device.
Arakawa teaches the particle size of the emulsion composition can be adjusted by controlling the components of the emulsion composition, or by controlling other factors such as the stirring conditions (shearing force, temperature and pressure) in the production method of the emulsion composition and the oil phase/water phase ratio ([0203]). It is important to note that Arakawa teaches that when a high-pressure homogenizer is used in the invention, the processing pressure is preferably 50 MPa (i.e., ~493 atm) or more ([0180]). Arakawa teaches using a Microfluidizer manufactured by Microfluidics ([0175]). Looking at the product specifications, models can operate up to 30,000 psi (i.e., 0-30,000 psi) and the manufacturer teaches the machine can process at a wide range of pressures a flows (See Microfluidics). Thus one with ordinary skill in the art would have reasonable expectation of success to formulate the claimed range through route experimentation because the microfluidizer can operate at the claimed pressure range and through routine optimization one would be able to achieve the desired particle size.
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Tang in view of Arakawa to utilize a microfluidizer, such as the Microfluidizer manufactured by Microfluidics, at pressure within the operating parameters of the Microfluidizer in order to achieve the desired particle size of the emulsion. See MPEP 2144.05(II) "[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)
With regard to Claim 5, Tang is silent to the flow rate of the microfluidic device.
Arakawa teaches the particle size of the emulsion composition can be adjusted by controlling the components of the emulsion composition, or by controlling other factors such as the stirring conditions (shearing force, temperature and pressure) in the production method of the emulsion composition and the oil phase/water phase ratio ([0203]). One with ordinary skill in the art would recognize stirring conditions and shearing forces are directly related to the flow rate when using a microfluidic device. See MPEP 2144.05(II) which teaches "[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).
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Tang in view of Arakawa to utilize a microfluidic device wherein stirring conditions such as shear force (which is a direct result of the flow rate) can be controlled to achieve the desired particle size.
With regard to Claims 6 and 7, Tang is silent to the temperature of the second emulsification step with the microfluidic device.
Arakawa teaches the temperature condition at emulsification (i.e., high-pressure homogenization via a microfluidizer [0173]-[0175]) dispersion in the invention is not particularly limited. The temperature is preferably from 10 to 100℃ from the standpoint of stability of the functional oil component. A preferred temperature range may be appropriately selected in accordance with the melting point of the functional oil component to be used, and the like ([0179]).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Tang in view of Arakawa to utilize a temperature from 10 to 100℃ for the second emulsification with the microfluidic device to be appropriately aligned with the melting point of the functional oil being used to support stability of the functional oil component. See MPEP 2144.05(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With regard to Claims 8-11, the combination of the above references clearly teach the claimed method. Thus, per MPEP 2112.01(I), Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Therefore, the properties, such as storage period and water activity, of the product made via the method taught above would inherently be identical or substantially identically to the claimed properties because the product is produce by identical or substantially identical processes and therefore the properties applicant discloses and/or claimed would necessarily be present.
Conclusion
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/K.I.D./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792