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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/02/2026 has been entered.
Status of the Claims
Receipt of Remarks/Amendments filed on 01/02/2026 is acknowledged. Claim 16 is new. Claims 1 and 9 have been amended. Claims 1-16 are presented for examination on the merits for patentability.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/02/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement was considered by the Examiner.
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.
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 1-13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Bromley P. (EP2563164 B1; Of record), hereinafter Bromley, as evidenced by Phase Diagram (Of record), and PubChem Lauric Acid (Of record).
Regarding Claim 1 component (i), Bromley cites studies of lyophilized nanoemulsions and dispersion concentrates and expressly teaches compositions which are oil-in-water nanoemulsions ([0006]-[0011], [0077]). The concentrates contain one or more non-polar compound such as PUPAs, mono/diglycerides, lauric acid, palmitic acid, and stearic acid [0235]. Bromley also teaches flavoring agent such as lemon oil [0340].
Regarding the drop size having a d50 greater than 1 micron but less than 20 microns, Bromley teaches the droplet size up to about 1000 nm, which touches the claimed range (Claim 1; [0078], [0107]). A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05.
Regarding Claim 1 components (ii) and (iii), Bromley teaches that powder forms of the composition are obtained by converting the nanoemulsion concentrate into a powder using well-known methods such as spray-drying and/or milling [0344]. In general, spray drying is used to dry a heated liquid by passing it through hot gas; as the material is atomized (sprayed), the surface tension causes a uniform spherical particle to form, which is passed through the cooling chamber and hardens into a solid intact sphere [0349].
While Bromley does not expressly teach the melting peak temperature of the dispersed phase, one skilled in the art would know from general chemistry knowledge that at above the melting peak temperature the phase changes from solid to liquid and liquid to gas, and vice versa at below the melting peak temperature. See Phase Diagram figure. Therefore, one of ordinary skill in the art would know that dispersing at a higher temperature above melting peak temperature would allow more mixing of the components in the different phases because to obtain a dispersion, the dispersed phase has to be capable of being dispersed, i.e. to disperse an oil into an aqueous liquid, the oil needs to be above the melting temperature in order to be distributed throughout the liquid continuous phase because otherwise it would be in solid form and will settle out of the liquid continuous phase. One of ordinary skill in the art would also know that drying at a higher temperature above melting peak temperature would ensure better removal of moisture, and that cooling below the melting peak temperature would maximize the powder obtained.
Regarding Claim 2, Bromley renders obvious the lipid mixture comprising plant-based fat and a flavor oil by teaching i) non-polar compounds such as monoglycerides, diglycerides, palmitic acid, lauric acid, and stearic acid etc. [0235], and ii) flavor oil such as wintergreen oil, sweet birch oil, citrus oils, and lemon oil as exemplary of flavoring agent ([0211], [0340]). The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). MPEP 2144.07.
Regarding Claim 3, Bromley teaches that the powder form of the composition can be obtained using well-known methods such as spray-drying [0344]. Bromley expressly describes spray drying liquid nanoemulsion compositions to form powder compositions [0349]-[0353].
Regarding Claim 4 requirement of the weight ratio between the plant-based fat and the flavor oil or the perfume oil in being between 5:95 to 95:5, Bromley teaches that the amount of non-polar compound in the concentrate typically is between 5 % and 10 % by weight, of the concentrate [0014]; the concentration of flavoring agent added to the provided concentrates is less than 5%, typically less than 1% [0341]. By Examiner’s calculation, this amounts to 5:5 to 10:1 ratio which overlaps with the instantly claimed ratio. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding Claim 5, because Bromley teaches non-polar compounds such as monoglycerides, diglycerides, palmitic acid, lauric acid, and stearic acid etc., the claim is obvious [0235].
Regarding Claim 6, because Bromley teaches the same plant-based fat monoglycerides, diglycerides, palmitic acid, lauric acid, and stearic acid etc. as instantly claimed, the plant-based fat must necessarily have the same characteristics claimed, i.e. melting peak temperature ranging between 20°C and 80˚C, as the property is not severable from the composition. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed.
Regarding Claim 7, Bromley teaches inclusion of excipients, and in one particular example, the excipients are selected from any one or more of maltodextrin and gum acacia [0345]. The maltodextrin reads on the carrier claimed.
Regarding Claim 8, Bromley teaches inclusion of co-surfactants (emulsifiers), expressly claiming that the liquid nanoemulsion concentrate further comprises a blend of gums as an emulsion stabiliser ([0268], Claim 23). Bromley teaches the emulsifiers instantly claimed by teaching quillaja saponin [0417], [0422]; and lecithin as exemplary phospholipid emulsifier ([0105], [0324]).
Regarding Claim 9, Bromley has taught the powdered form of the composition comprising a maltodextrin, a lecithin emulsifier, and the plant-based fat and flavor oil. Bromley does not expressly teach a powdered composition having: 20°C<Tm<70°C; and 15°C<Tso%<60°C; and 20°C<T9s%<80°C as claimed. However, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007). Because Bromley teaches the same components as instantly claimed, e.g. lauric acid which is a solid plant-based fat with Tm at 43.8 ˚C, which is within the claimed temperature range (See PubChem Lauric Acid), the composition arising from the teaching of Bromley must necessarily have the same characteristics as that instantly claimed because the property is not severable from the composition. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed.
Regarding recitation of “wherein the powdered composition comprises granules having an average size of greater than 100 microns”, Bromley forming the powders by spray drying, wherein the heated liquid is dried, and atomized using spray nozzles in a cooling tower or chamber, forming uniform spherical particle to form [0349]. The spray dried particles can be between at or about 0.5 microns and at or about 100 microns, which touches the claimed range. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05. As such, Claim 16 is also rendered obvious.
Regarding Claim 10, Bromley teaches some examples wherein the concentrate contains more than one non-polar active ingredient, and wherein the total amount of non-polar active ingredient(s) is between at or about 5 % and 10 % of the weight of the concentrate, which overlaps with the claimed range [0030]. While Bromley does not expressly teach that this concentration range is in the powder form, Bromley has taught that the conversion of nanoemulsion concentrate into a powder form [0344].
Regarding Claim 11, Bromley teaches a typical example of a concentrate including at least one surfactant at a starting concentration of between 16 % to about 30 %, by weight (w/w) of the concentrate [0203]. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. Additionally, Bromley teaches phosphatidylcholine (lecithin) as one co-surfactant that may be included at less than or equal to 1 % by weight (w/w) of the concentrate [0324].
Regarding Claim 12, Bromley teaches maltodextrin excipient, which is a carrier according to the instant disclosure (Specification, p. 8). Bromley teaches the typical concentration of the excipients is between about 50 % and 85 % of the free flowing powder [0347].
Regarding Claim 13, Bromley discloses that its compositions and methods are useful for preparing foods and beverages that contain additives, such as nutraceuticals, pharmaceuticals and supplements [0005].
Claim 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bromley as applies to Claims 1, 9 and 13 above, and in view of Kumar et al. (Critical reviews in food science and nutrition 57.5 (2017): 923-932; Of record), hereinafter Kumar.
Bromley has taught the suitability of its powder composition in foods and beverages that contain additives [0005]. However, Bromley is silent on the vegetable protein and meat/fish analogues.
Kumar recognizes the cost of meat production and the need to fabricate protein-rich food from plant sources, with simulated texture, flavor and value (pp. 923-924). Kumar teaches that the interest in meat analogues with vegetable proteins are cited to be due to health and nutritional benefits, environmental considerations, religious beliefs, and animal rights reasons (p. 925, L. Col., 1st paragraph).
Regarding Claims 14-15, Kumar teaches that vegetable proteins are currently the main source of material for meat analogues, with soybeans being the cheapest common source of protein material (p. 925, L. Col., 2nd paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Kumar to that of Bromley, and make a meat analogue comprising vegetable protein according to Kumar containing the fat composition of Bromley with flavor oil, and suitable for food. One would have been motivated to do so to obtain more options for meat analogues in the market.
Response to Remarks:
Applicant admits that Bromley teaches that clear compositions require a droplet particle size of 1000 nm or less, and further argues that in order to have the desired clarity, the nanoemulsion concentrates should have a particle size of less than about 200 nm. Applicant relates that one of ordinary skill in the art would not be motivated to adjust the diameter/particle size of the nanoemulsion concentrates of Bromley because doing so would render the nanoemulsion concentrates unsatisfactory for the intended purpose of making liquid dilution compositions that have the desired clarity. Similarly, Applicant argues that Bromley teaches that the desired particle size is less than at or about 1 micron, and one of ordinary skill in the art would not be motivated to adjust the particle size of the powder form to be greater than 100 microns because doing so would render the powder unsatisfactory for the intended purpose.
The Examiner considered the arguments but was not persuaded. Firstly, Applicant admits that Bromley teaches that clear compositions require a droplet particle size of up to about 1000 nm, while Bromley teaches droplet particle size of 200nm or less is desired; that powder particle size of greater than 100 microns is desired. Applicant is reminded that a preferred or exemplified embodiment does not constitute a teaching away from other embodiments disclosed within the four corners of the reference, including non-preferred embodiments. Applicant is reminded that the disclosure of a reference must be considered as expansively as is reasonably possible to determine the full scope of the disclosure and, as a result, is most certainly not limited to that which is preferred and/or exemplified. Thus, the fact that other droplet and powder particle sizes are preferred does not negate or direct the artisan away from the broader teaching of the reference, which expressly provides for, and, thus, clearly contemplates a droplet particle size of about 1000 nm and powder particle size of about 100 microns, which touches the ranges in the instant claims. Even if the reference fails to prove clarity using a working example, the reference Bromley applied under 35 U.S.C. 103(a) constitute prior art for all they teach. See MPEP §2121.01 (II), which states, “Therefore, ‘a non-enabling reference may qualify as prior art for the purpose of determining obviousness under 35 U.S.C. 103.’ Symbol Techs. Inc. v. Opticon Inc., 935 F.2d 1569, 1578, 19 USPQ2d 1241, 1247 (Fed. Cir. 1991).”
Conclusion
No claims are allowed.
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 JANICE Y SILVERMAN whose telephone number is (571)272-2038. The examiner can normally be reached M-F, 10-6 EST.
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/J.Y.S./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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