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 Claims
Receipt of Remarks/Amendments filed on 09/09/2026 is acknowledged. Claims 17-18 are new. Claims 1-18 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Rejection(s) not reiterated from the previous Office Action are hereby withdrawn.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.
Modified Rejection As Necessitated by the Amendment Filed 09/09/2026
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.
Claims 17-18 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 Verkoeijen et al. (CN 107080145 A, machine translated in IP.com), hereinafter Verkoeijen.
Bromley teaches embodiments where non-polar active ingredient are between 5-10%, and embodiments where in oil amounts are between 1-6% ([0030], [0034]). 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 the amount of carrier, Bromley does not teach the claimed amount of carrier
in Claims 17 and 18, Bromley teaches the concentration of excipients, selected from one or more of maltodextrin and gum acacia, to typically be from 50-85%, which is outside the claimed range [0345]-[0347].
Verkoeijen is in the same field and teaches spray-dried particulate emulsion comprising a non-lipid carrier at 40-95%, an oil phase at 5-60%, and water from 0-5% (Abstract). Verkoeijen also teaches that typically, composition of the invention includes about from 0.1 mass % to about 90 mass % oil-in-water emulsion and from about 10 mass % to about 99.9 mass % carrier (p. 10, 7th paragraph). Suitable carriers in the composition are those which substantially does not dissolve in the oil-in-water emulsion, preferably starch or modified starch such as maltodextrin or a glucose syrup or mono-, di- or oligosaccharides, which make it compatible with Bromley (p. 9, 5th to 8th paragraphs).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine Bromley and Verkoeijen and optimize the amount of carrier based on the teachings of Bromley and Verkoeijen for typical amounts of carriers in spray-dried emulsion compositions. An improvement in the art would have been obvious if “it is likely the product not of innovation but of ordinary skill and common sense.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). Finding workable or optimal ranges is generally understood as within the capabilities of the ordinary artisan. See Pfizer Inc. v. Apotex Inc., 82 USPQ2d 1321 (Fed. Cir. 2007) (discovery of an optimum value of a variable in a known process is usually obvious.). The idea that optimizing an ordinary variable does not by itself constitute a patentable advance was also stated in In re Geisler, 43 USPQ2d 1362: “…“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). Only if the “results of optimizing a variable” are “unexpectedly good” can a patent be obtained for the claimed critical range. In re Antonie, 559 F.2d 618, 620, 195 USPQ 6, 8 (CCPA 1977); see also In re Dillon , 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed.Cir. 1990) (in banc).” Note MPEP §2144.05(II)(A) on this issue. Likewise, optimization of a range or other variable within the claims flows from the “normal desire of scientists or artisans to improve upon what is already generally known.” In re Peterson, 65 USPQ2d 1379, 1382.
See also In re Boesch, 617 F.2d 272, 276 (C.C.P.A. 1980): “[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.”; In re Esterhoy, 440 F.2d 1386, 1389 (C.C.P.A. 1971): “The conditions recited in the claims appear to us to be only optimum and easily ascertained by routine experimentation.”; In re Swentzel, 219 F.2d 216, 219 (C.C.P.A. 1955): “the determination of that desired size under the present circumstances involves nothing more than routine experimentation and exercise of the judgment of one skilled in the art.”; In re Swain, 156 F.2d 246, 247-48 (C.C.P.A. 1946): “In the absence of a proper showing of an unexpected and superior result over the disclosure of the prior art, no invention is involved in a result obtained by experimentation.” See also In re Kulling, 14 USPQ2d 1056 and In re Malagari, 182 USPQ 549, 553.
Note that this applies even if the prior art range is very broad. In In re Waymouth and Koury, 182 USPQ 290, the prior art range was 0.0000001 to 1.3 (called “extremely broad”); the claims were 0.08 to 0.75. The court stated, “In order to show an unexpected result, we do not believe that the lamp must be inoperable over other ranges, but rather that over the claimed critical range, there be a difference in kind, rather than in degree.”
As is stated in Iron Grip Barbell Co. v. USA Sports, Inc., 73 USPQ2d 1225, 1228 “[W]here there is a range disclosed in the prior art, and the claimed invention falls within that range, there is a presumption of obviousness.” Note similar language in In re Cooper, 57 USPQ 117, 119-120 and Ormco Corp. v. Align Tech., Inc., 79 U.S.P.Q.2d 1931, 1940. To overcome this prima facie case of obviousness applicants must show “that the claimed range achieves unexpected results relative to the prior art range.” (Peterson).
Response to Remarks:
Applicant argues Bromley discloses a drop size of “less than about 1000 nm” [0107], which is not greater than 1 micron, as required by the present claim, and that without more, does not establish obviousness because one skilled in the art would not have pursued increase in droplet size. Applicant appears to contend that this is because Bromley teaches nanoemulsion with desired clarity that is dependent on lower particle size. Applicant states that “Bromley does not teach that its 1000 nm upper endpoint is approximate, flexible, or otherwise subject to extension beyond that endpoint.”
The Examiner considered the arguments but was not persuaded. As noted in the previous Office Action response to remarks, Bromley teaches that clear compositions require a droplet particle size of up to about 1000 nm, which indicates flexibility and approximation, and not a finite endpoint. 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. The MPEP is clear with regards to its obviousness guidance on ranges. 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. 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. 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).”
Furthermore, even if the exact range claimed of “greater than 1 micron and less than 20 microns” is not disclosed by Bromley, it is generally noted that differences in sizes do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such size range 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). Given that applicant did not point out the criticality of drop size range of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to determine where in a disclosed set of ranges is the optimum drop size. NOTE: MPEP 2144.05.
Finding workable or optimal ranges is generally understood as within the capabilities of the ordinary artisan. See Pfizer Inc. v. Apotex Inc., 82 USPQ2d 1321 (Fed. Cir. 2007) (discovery of an optimum value of a variable in a known process is usually obvious.). The idea that optimizing an ordinary variable does not by itself constitute a patentable advance was also stated in In re Geisler, 43 USPQ2d 1362: “…“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). Only if the “results of optimizing a variable” are “unexpectedly good” can a patent be obtained for the claimed critical range. In re Antonie, 559 F.2d 618, 620, 195 USPQ 6, 8 (CCPA 1977); see also In re Dillon, 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed.Cir. 1990) (in banc).” Note MPEP §2144.05(II)(A) on this issue. Likewise, optimization of a range or other variable within the claims flows from the “normal desire of scientists or artisans to improve upon what is already generally known.” In re Peterson, 65 USPQ2d 1379, 1382.
See also In re Boesch, 617 F.2d 272, 276 (C.C.P.A. 1980): “[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.”; In re Esterhoy, 440 F.2d 1386, 1389 (C.C.P.A. 1971): “The conditions recited in the claims appear to us to be only optimum and easily ascertained by routine experimentation.”; In re Swentzel, 219 F.2d 216, 219 (C.C.P.A. 1955): “the determination of that desired size under the present circumstances involves nothing more than routine experimentation and exercise of the judgment of one skilled in the art.”; In re Swain, 156 F.2d 246, 247-48 (C.C.P.A. 1946): “In the absence of a proper showing of an unexpected and superior result over the disclosure of the prior art, no invention is involved in a result obtained by experimentation.” See also In re Kulling, 14 USPQ2d 1056 and In re Malagari, 182 USPQ 549, 553.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Udomrati et al. (Food Hydrocolloids 44 (2015) 23e31), hereinafter Udomrati. Udomrati teaches the preparation of esterified maltodextrins by enzymatic esterification of maltodextrin with dextrose equivalent (DE) of 16 (DE16) and 9 (DE9) and three fatty acids: decanoic acid (C-10), lauric acid (C-12) and palmitic acid (C-16), wherein 5% and 35% esterified maltodextrin DE16 palmitate were adsorbed on the surface of the oil droplets and evaluated for critical flocculation concentration (CFC) of Tween 80 (Abstract). The amount of carrier overlaps with the claimed range, but Udomrati does not teach the claimed droplet size but rather larger sizes of oil droplets (p. 24, L. Col., 2nd paragraph).
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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