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 .
Status of the Application
The status of the claims stands as follows:
Pending claims: 1-12
Currently rejected claims: 1-12
Allowed claims: None
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
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 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over McClements et al. (U.S. 2008/0044543 A1) in view of Toledo-Madrid et al. (Toledo-Madrid et al., “Microencapsulation of Purple Cactus Pear Fruit (Opuntia ficus indica) Extract by the Combined Method W/O/W Double Emulsion-Spray Drying and Conventional Spray Drying: A Comparative Study,” Processes 2018, 6, 189, 1-18).
Regarding claim 1, McClements et al. discloses a method for producing a W/O/W emulsion ([0010]), the method comprising:
preparing a first aqueous phase ([0022]);
adding the aqueous phase to an oil phase to obtain a W/O emulsion ([0022], [0050]), where the oil phase comprises a highly unsaturated fatty acid ([0017], fish oil);
obtaining a second aqueous phase by dissolving a protein in water ([0023]); and
obtaining a W/O/W emulsion by mixing the W/O emulsion with the second aqueous phase ([0022], [0060]).
McClements et al. does not specifically disclose (i) the first aqueous phase as comprising from 15-50% water-soluble antioxidant dissolved, (ii) the protein as being in an amount of 3-45 mass%; (iii) obtaining a powdered oil/fat containing from 5-30 mass% of the highly unsaturated fatty acid by spray-drying the W/O/W emulsion, or (iv) the protein as being vegetable protein that has a protein content in a solid content of ≥70mass%, and NSI of 80 or more, and an area ratio having 2,000-20,000 Da of 45-90%.
Regarding the spray drying step, Toledo-Madrid et al. discloses spray drying of W/O/W emulsions in order to prolong stability and improve handling (pp. 15-16, 4. Conclusions).
It would have been obvious to one having ordinary skill in the art to spray dry the W/O/W emulsion obtained from McClements et al. First, McClements et al. indicates that the W/O/W emulsions are resistant to stresses caused by food product utilization techniques, including drying ([0011]), which suggests that drying may be a suitable subsequent processing step. A skilled practitioner would be motivated to consult Toledo-Madrid et al. for further instruction regarding suitable drying processes. Since Toledo-Madrid et al. teaches that spray drying a W/O/W emulsion may prolong stability and improve handling (pp. 15-16, 4. Conclusions), a skilled practitioner would find spray drying the W/O/W emulsion of McClements et al. to be obvious.
Regarding the addition of the antioxidant, McClements et al. discloses that each phase may comprise components that are soluble therein, including antioxidants ([0019]). Toledo-Madrid et al. more specifically teaches that the spray-dried W/O/W emulsion is useful for microencapsulating antioxidant material as a controlled-delivery vehicle (Abstract). A skilled practitioner would thus find the inclusion of a water-soluble antioxidant into the first aqueous phase to be obvious.
As for the addition of vegetable protein material F that satisfies the claimed requirements, McClements et al. discloses broadly that proteins may be added as surface active components ([0023]) and further discloses vegetable proteins ([0016]), which renders the addition of any protein material that imparts such functionality obvious. The addition of vegetable protein material that has a protein content in a solid content of ≥70mass%, and NSI of 80 or more, and an area ratio having 2,000-20,000 Da of 45-90% would thus be obvious, especially since no effect of the protein is required, no amount of the second aqueous phase is required, and the exclusion of other protein material that may overwhelm any effect of vegetable protein material F is not required.
As for the claimed concentrations of antioxidant in the first aqueous phase and vegetable protein material F in the second aqueous phase, MPEP 2144.05 II A 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.” The concentrations of the antioxidant in the first aqueous phase and vegetable protein material F in the second aqueous phase apply only to intermediate aqueous solutions but no concentrations are claimed for either aqueous material in the finished emulsion, such that apparently any amounts of the aqueous phases may be added. The concentrations of 15-50 mass% antioxidant in the first aqueous phase and 3-45 mass% of vegetable protein material F in the second aqueous phase thus cannot be said to be critical and are consequently deemed obvious. Further, the indication in McClements et al. that proteins may be added in a “functionally-effective amount” ([0023]) indicates that suitable concentrations may be readily determined by a skilled practitioner, wherein no concentration would be deemed non-obvious.
As for the claimed concentration of highly unsaturated fatty acid in the spray dried powder, MPEP 2144.05 II A again applies, where the concentration of a component will not support patentability unless the concentration is shown to be critical. The lack of specificity regarding the composition of the “highly unsaturated fatty acid”, the lack of any required effect, and the lack of limitations requiring the composition of the remaining 95-70 mass% of powdered oil/fat to comprise any particular fatty acid profile all weigh against the claimed concentration of 5-30% highly unsaturated fatty acid in the powdered oil/fat being critical. The claimed concentration of 5-30% highly unsaturated fatty acid is thus deemed obvious.
As for claim 2, McClements et al. discloses the particle diameter of the first aqueous phase as being 500 nm or less (specifically, less than about 1 µm, or 1,000 nm, which encompasses the claimed range) ([0044]).
As for claim 3, McClements et al. discloses the first aqueous phase as further comprising a carbohydrate (i.e., polysaccharides) ([0016]).
Regarding claim 4, McClements et al. discloses a method for producing a W/O/W emulsion ([0010]), the method comprising:
preparing a first aqueous phase ([0022]);
adding the aqueous phase to an oil phase to obtain a W/O emulsion ([0022], [0050]), where the oil phase comprises a highly unsaturated fatty acid ([0017], fish oil);
obtaining a second aqueous phase by dissolving a protein in water ([0023]); and
obtaining a W/O/W emulsion by mixing the W/O emulsion with the second aqueous phase ([0022], [0060]).
McClements et al. does not specifically disclose (i) the first aqueous phase as comprising from 15-50% water-soluble antioxidant dissolved, (ii) the protein as being in an amount of 3-45 mass%; (iii) obtaining a powdered oil/fat containing from 5-30 mass% of the highly unsaturated fatty acid by spray-drying the W/O/W emulsion, (iv) the protein as being vegetable protein that has a protein content in a solid content of ≥70mass%, and NSI of 80 or more, and an area ratio having 2,000-20,000 Da of 45-90%, or (v) the method as being for suppressing generation of off-flavors due to oxidation in a powdered oil/fat containing a highly unsaturated fatty acid.
Regarding the spray drying step, Toledo-Madrid et al. discloses spray drying of W/O/W emulsions in order to prolong stability and improve handling (pp. 15-16, 4. Conclusions).
It would have been obvious to one having ordinary skill in the art to spray dry the W/O/W emulsion obtained from McClements et al. First, McClements et al. indicates that the W/O/W emulsions are resistant to stresses caused by food product utilization techniques, including drying ([0011]), which suggests that drying may be a suitable subsequent processing step. A skilled practitioner would be motivated to consult Toledo-Madrid et al. for further instruction regarding suitable drying processes. Since Toledo-Madrid et al. teaches that spray drying a W/O/W emulsion may prolong stability and improve handling (pp. 15-16, 4. Conclusions), a skilled practitioner would find spray drying the W/O/W emulsion of McClements et al. to be obvious.
Regarding the addition of the antioxidant, McClements et al. discloses that each phase may comprise components that are soluble therein, including antioxidants ([0019]). Toledo-Madrid et al. more specifically teaches that the spray-dried W/O/W emulsion is useful for microencapsulating antioxidant material as a controlled-delivery vehicle (Abstract). A skilled practitioner would thus find the inclusion of a water-soluble antioxidant into the first aqueous phase to be obvious.
As for the addition of vegetable protein material F that satisfies the claimed requirements, McClements et al. discloses broadly that proteins may be added as surface active components ([0023]) and further discloses vegetable proteins ([0016]), which renders the addition of any protein material that imparts such functionality obvious. The addition of vegetable protein material that has a protein content in a solid content of ≥70mass%, and NSI of 80 or more, and an area ratio having 2,000-20,000 Da of 45-90% would thus be obvious, especially since no effect of the protein is required, no amount of the second aqueous phase is required, and the exclusion of other protein material that may overwhelm any effect of vegetable protein material F is not required.
As for the claimed concentrations of antioxidant in the first aqueous phase and vegetable protein material F in the second aqueous phase, MPEP 2144.05 II A 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.” The concentrations of the antioxidant in the first aqueous phase and vegetable protein material F in the second aqueous phase apply only to intermediate aqueous solutions but no concentrations are claimed for either aqueous material in the finished emulsion, such that apparently any amounts of the aqueous phases may be added. The concentrations of 15-50 mass% antioxidant in the first aqueous phase and 3-45 mass% of vegetable protein material F in the second aqueous phase thus cannot be said to be critical and are consequently deemed obvious. Further, the indication in McClements et al. that proteins may be added in a “functionally-effective amount” ([0023]) indicates that suitable concentrations may be readily determined by a skilled practitioner, wherein no concentration would be deemed non-obvious.
As for the claimed concentration of highly unsaturated fatty acid in the spray dried powder, MPEP 2144.05 II A again applies, where the concentration of a component will not support patentability unless the concentration is shown to be critical. The lack of specificity regarding the composition of the “highly unsaturated fatty acid”, the lack of any required effect, and the lack of limitations requiring the composition of the remaining 95-70 mass% of powdered oil/fat to comprise any particular fatty acid profile all weigh against the claimed concentration of 5-30% highly unsaturated fatty acid in the powdered oil/fat being critical. The claimed concentration of 5-30% highly unsaturated fatty acid is thus deemed obvious.
The limitation that the method is “for suppressing generation of off-flavors due to oxidation in a powdered oil and/or fat containing a highly unsaturated fatty acid” is a statement of intended use. Such statements must be “evaluated to determine whether the recited purpose or intended use results in a structural difference...between the claimed invention and the prior art.” MPEP 2111.02 II. In the present instance, no difference can be ascertained between the claim and the prior art as related to the intended effect of the method because the references disclose a method that is capable of performing the claimed intended use. The claimed method, including the intended purpose of suppressing generation of off-flavors, is thus considered obvious to a skilled practitioner.
As for claim 5, McClements et al. discloses the particle diameter of the first aqueous phase as being 500 nm or less (specifically, less than about 1 µm, or 1,000 nm, which encompasses the claimed range) ([0044]).
As for claim 6, McClements et al. discloses the first aqueous phase as further comprising a carbohydrate (i.e., polysaccharides) ([0016]).
Regarding claim 7, the claimed powdered oil/fat corresponds to the product that would be produced according to the method of claim 1, as well as further requiring that the product comprises 5-60 mass% of vegetable protein material F. The method of claim 1 was shown to be obvious, and consequently, the product obtained by the method would be obvious according to the same rationale. The claimed vegetable protein concentration is broader than that claimed in the method of claim 1, including higher concentration from the range of 30-60 mass%, but the higher concentrations would simply be achieved due to evaporation of water upon spray drying. The claimed concentration range thus does not materially alter the claimed composition from what would be obtained via the method of claim 1. As such, the claimed powdered oil/fat is considered obvious to a skilled practitioner.
As for claim 8, McClements et al. discloses the particle diameter of the first aqueous phase as being 500 nm or less (specifically, less than about 1 µm, or 1,000 nm, which encompasses the claimed range) ([0044]).
As for claim 9, McClements et al. discloses the first aqueous phase as further comprising a carbohydrate (i.e., polysaccharides) ([0016]).
As for claim 10, McClements et al. discloses the first aqueous phase as further comprising a carbohydrate (i.e., polysaccharides) ([0016]).
As for claim 11, McClements et al. discloses the first aqueous phase as further comprising a carbohydrate (i.e., polysaccharides) ([0016]).
As for claim 12, McClements et al. discloses the first aqueous phase as further comprising a carbohydrate (i.e., polysaccharides) ([0016]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY P MORNHINWEG whose telephone number is (571)270-5272. The examiner can normally be reached 8:30AM-5:00PM.
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/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793
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