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 Status
Claims 2-5, 7, 11-12, 14-18, 21, 23 and 26-27 are pending.
Claims 2 and 14-16 are currently amended.
Claims 1, 6, 8-10, 13, 19-20, 22, 24-25 and 28-31 have been canceled.
Claims 21, 23 and 26-27 are withdrawn.
Claims 2-5, 7, 11-12 and 14-18 are currently under consideration.
Claims 2-5, 7, 11-12 and 14-18 are rejected.
Acknowledgement of Receipt
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/10/2025 has been entered.
Withdrawn Objections
In light of the new amendments to claims 14 and 16 the objections to claims 14 and 16 are withdrawn.
Claim Objections
Claim 5 is objected to because of the following informalities: the small case letter “u” of line 2 of claim 5 in “um” appears to be a typo. The Examiner notes that Applicants’ instant specification does not disclose microns (i.e., µm). Applicants are made aware that the copying and pasting of complex files that contain embedded images, animations, or intricate formatting, may result in data loss or formatting inconsistencies.
Claim 21 is objected to because of the following informalities: The claim number should be followed by the appropriate status identifier in parenthesis, e.g., “(Withdrawn)”. Appropriate correction is required.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. § 103 (a) are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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. Applicants are 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.
Applicant Claims
The instant claims are directed to a particle consisting of a core a plant oil encapsulated in an amphiphilic shell, wherein said amphiphilic shell comprises an amphiphilic plant protein and a hydrophobic compound and wherein said core comprises a plant oil, wherein the w/w ratio of said hydrophobic compound to said plant protein ranges from 0.01:1 to 1:1, and wherein the w/w ratio of said plant protein to said plant oil ranges from 0.1:1 to 10:1; wherein said hydrophobic compound is a curcuminoid and wherein said amphiphilic plant protein is a potato protein (PP) (claim 2); wherein said shell consists of the hydrophobic compound and said PP (claim 3); wherein said shell is a single layer shell (claim 4); wherein said particle is a microparticle having an average particles size between 1 and 20um (claim 5); wherein said plant oil is selected from the group consisting of: an olive oil, a triglyceride oil, a terpenoid oil, a sunflower oil, a nut oil, a peanut oil, a soy oil, a rapeseed oil, a sesame oil, a palm oil, a cocoa butter, a rice oil, a wheat germ oil, a citrus oil, limonene or any combination thereof (claim 7); Applicants further claim that said plant oil comprises olive oil (claim 11) wherein a w/w ratio of said curcuminoid to said olive oil is between 0.1:1 and 1:1; and wherein a w/w ratio of said PP to said olive oil is between 3:1 and 1:3 (claim 12).
The instant claims are also directed to a particle consisting of a hydrophobic core and an amphiphilic shell, wherein said hydrophobic core consists of a hydrophobic compound or of the hydrophobic compound and a plant oil, wherein said amphiphilic shell comprises a first layer and a second layer, wherein said first layer comprises a low molecular weight surfactant and said second layer comprises an amphiphilic plant protein, wherein the w/w ratio of said amphiphilic plant protein to said surfactant ranges from 1:1 to 500:1, and wherein the w/w ratio of said hydrophobic compound to said surfactant ranges from 0.01:1 to 1:10 of said particle, wherein said amphiphilic shell consists of said amphiphilic plant protein and said surfactant; wherein said hydrophobic compound has a low solubility in plant oil (claim 14); wherein said hydrophobic compound is selected from the group consisting of: carotenoid, a flavonoid, a phytosterol, an antioxidant, a phytoestrogen, a polyphenol, and anthocyanin or any combination thereof (claim 15); wherein said hydrophobic compound is selected from the group consisting of: a phenolic acid, a tannin, a stilbene, a curcuminoid, a coumarin, a lignan, a quinone, or any combination thereof; and wherein said surfactant comprises lecithin (claim 16). wherein hydrophobic compound comprises curcumin, astaxanthin (AX) or both (claim 17); wherein said amphiphilic plant protein is a potato protein (PP) wherein said first layer consists of the surfactant and said second layer consists of the amphiphilic plant protein; and wherein the surfactant is lecithin (claim 18).
Claims 2-5 and 7 are rejected under 35 U.S.C. 103 as being obvious over Livney (US 2016/0220502 A1, pub. 08/04/2016) in view of Harel et al. (US 2016/0038428 A1, pub. 02/11/2016) evidenced by Cambridge Polymer Group (“Fatty Acid and Triglyceride Analysis: Linseed Oil” 10/06/2017) herein referenced Livney, Harel, and Cambridge.
Livney discloses a nanoparticle made of a potato protein (PP) and a hydrophobic bioactive compound bound to the potato protein (title, abstract, [0011], claim 1). Livney discloses that the bioactive compound may be an oil-soluble vitamin, a polyunsaturated fatty acid or its ester, an antioxidant, a phytochemical, an omega-3 fatty acid, or its esters, or any combination thereof ([0011], claim 3, 19). See also paragraphs [0029], [0031-0032] specifically in which the bioactive is a carotenoid ([0032]). Livney discloses a nanoparticle (or a plurality of nanoparticles) comprises: (a) a potato protein; and (b) a bioactive compound bound to the potato protein ([0024], claim 1, 12). Livney discloses the nanocapsule or nanoparticle as having a structure which comprises a nano-vesicular system that is formed in a core-shell arrangement ([0026]).
Applicants describe curcuminoids to include curcumin (see Spec., [0116]). Applicants provide exemplary oil-soluble hydrophobic compounds to include a carotenoid, a natural phenol (e.g., resveratrol), hydrophobic vitamin A, D, E, K, a cannabinoid, polyunsaturated fatty acid (e.g., omega-3 fatty acid), a phytosterol, and curcumin (see Spec., [0111]). Notably Livney discloses carotenoids in examples i.e., Vitamin D, however, this is not to read on the claimed bioactive curcuminoid.
Regarding curcuminoid as the bioactive, Harel is provided.
Harel discloses a composition comprising hydrophobic droplets coated by a shell and dispersed in a matrix and a consumable product comprising the composition (abstract). The hydrophobic droplets comprise a hydrophobic compound, the shell comprises an irreversibly denatured protein, and the matrix comprises a protein, a starch, and a polysaccharide (title, abstract, claim 1). Harel teaches a ratio between the protein and the hydrophobic compound that is from 0.1:1 to 1:1 by weight ([0009]) and that the proteins may be corn zein proteins and vegetable proteins ([0010]). The hydrophobic compound may be a biologically active or bioactive agent to include vitamins, antibiotics, carotenoids, plant extracts, fruit extracts, vegetable extracts, antioxidants, lipids, steroids, phytochemicals and drugs ([0028]). Harel discloses that the composition may further comprise resveratrol, quercetin, carotenoids (e.g., α-, β-, and γ-carotene, astaxanthin), curcuminoids, and polyphenols ([0030], claim 11). Harel teaches that the hydrophobic droplets may further comprise an edible oil selected from the group consisting of vegetable oils which may be selected from the group consisting of flaxseed oil, and oil comprising an omega-3 fatty acid or a conjugated linoleic acid ([0034]). Harel teaches hydrophobic compounds to include soluble vitamins, (e.g., Vit A, D, E, and K), tocotrienols, carotenoids, xanthophylls (e.g., astaxanthin) ([0035]).
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to combine the teaching of curcuminoids from Harel in the nanoparticle of Livney with expected results. Given that Harel and Livney both share the same objective to encapsulate bioactive(s) in a plant-based shell and as Harel cites Livney (see Harel, [0037]), their teachings of flaxseed oil, carotenoids, and ratios of protein to hydrophobic compound all overlap. One would be motivated to combine Harel and Livney because Livney provides results that show potato protein prevents the hydrophobic compound from degrading ([0113-0116] see degradation studies).
Regarding the hydrophobic compound to plant protein (0.01:1 to 1:1); plant protein to plant oil (0.1:1 to 10:1), Livney teaches lipid to potato protein concentration ratio 20:1 to 1:20 ([0030]), potato protein at a concentration of 0.1-100 g/L ([0014], [0088], claim 28), and bioactive compound from 0.1 microgram/ml to 1 mg/ml ([0046], claim 16).
Livney teaches a plant (i.e., potato) protein to plant oil (i.e., vitamin) ratio ranging from 0.1:0.0001 to 1,000:1 (0.1-1,000 mg/ml of potato protein; 0.0001-1 mg/ml bioactive/oil) which encompasses a 1:1 ratio which falls within the claimed range. MPEP 2144.05 states that a prima facie case of obviousness exists in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art.
Livney teaches a diameter of 10 nm to 100 nm (i.e., 0.01 to 0.1 µm) ([0033], claim 6).
Livney teaches flax seed oil as the bioactive compound ([0031]). As evidenced by Cambridge, flax seed oil, also known as linseed oil, is a triglyceride oil.
Claims 11-12 and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Livney in view of Harel evidenced by Cambridge as applied to claims 2-5 and 7 above, further in view of Shi et al. (US 2013/0315831, pub. 11/28/2013) herein referenced Shi.
The teachings of Livney, Harel, and Cambridge above are incorporated herein.
Livney discloses that the nanocapsule may encapsulate an inner liquid core, a solid core, or a partly liquid and partly solid core ([0026]).
Olive oil is not disclosed in Livney.
Shi discloses a particle comprising an aqueous core; a first amphiphilic layer surrounding the aqueous core; and a polymeric matrix surrounding the first amphiphilic layer (abstract, [0007], claim 1 ). Shi teaches curcumin (i.e., a curcuminoid) in paragraph [0121], and olive oil in paragraph [0201].
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to incorporate the olive oil of Shi in the core taught by Livney in view of Harel with expected results. One would be motivated to do so because Shi teaches that the aqueous core may contain lipids ([0045]). In addition, Shi teaches olive oil as a pharmaceutically acceptable carrier ([0201]).
As mentioned above, Livney discloses the bioactive compound at 0.1 µm/ml to 1 mg/ml; 0.5 mg/ml to 5 mg/ml ([0046]) and the ratio of lipid to potato protein is 20:1 to 1:20 ([0030]). Livney does not teach a ratio of bioactive compound to an (encapsulated) oil. However, substituting the lipid of Livney in view of Harel with the olive oil of Shi would provide ratios that overlap with the claimed range(s). MPEP 2144.05 states that where 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.
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to incorporate the olive oil of Shi in the core taught by Livney in view of Harel with expected results. Both Shi and Livney focus on encapsulation efficiency and controlling, e.g., slowing release (see Shi [0024], [0053] and Livney [0027], [0077]). One would be motivated to do so because Shi teaches that the encapsulation of multiple agents improves particle stability and high loading efficiency ([0006]). Likewise, Livney teaches a combination of compounds comprising the bioactive ([0026], [0029]).
Regarding claims 14-18, looking to Applicants’ specification, a double-layered shell is described as comprising a first inner layer (i.e., surrounding the core) which comprises a surfactant, and a second outer layer comprising a plant protein (see Spec., [093]).
Livney does not mention more than one layer.
Regarding the hydrophobic core, Shi discloses a particle with an aqueous core that may contain a nucleic acid surrounded by an inner lipid layer where the hydrophobic portions of the inner lipids interact with a polymeric shell ([0045-0047]).
Regarding the second layer, Shi discloses the core of the particle being surrounded by an amphiphilic layer while this amphiphilic layer is surrounded by a polymer matrix (claims 1, 2) and that surrounding the matrix is an optional second amphiphilic layer ([0007], [0010], [0018], claim 2).
Regarding the first layer comprising surfactant, Shi teaches that any or all of the following may include one or more active agents: core, first amphiphilic layer, polymeric matrix, and second amphiphilic layer, ([0007]). Either the first or second amphiphilic layer, or both, can be mono- or multilayered ([0009]). The first amphiphilic compound can be a naturally derived lipid, or surfactant ([0009], [0019]). Figure 1D depicts an exemplary particle formulation where the polymeric shell is surrounded by an outer surfactant (e.g., polyvinyl alcohol) layer ([0047], [0062]). While Livney mentions that the core may be devoid of a surfactant or is substantially free of a surfactant ([0027]), nevertheless, the use of surfactants is not prohibitive.
Regarding the newly added low molecular weight surfactant, Shi teaches sodium lauryl sulfate and magnesium stearate ([0202]).
Regarding the second layer comprising plant protein, Livney teaches a nanoshell consisting of potato protein ([0011], [0024], [0092], Examples 1-2, claims 1, 12, 22). Potato protein isolates (PPI) are touted by Livney as being highly functional, having excellent solubility and good emulsifying and foaming abilities ([0007]). Livney underscores the benefits of utilizing potato protein in this context to include economic advantages, ample availability, nutritional value, and its Generally Recognized as Safe (GRAS) designation ([0007]). In light of these teachings, a skilled artisan would be motivated to use potato protein as the plant protein in the second layer of Shi, absent evidence to the contrary.
Regarding the amphiphilic plant protein to surfactant (1:1 to 500:1), Livney teaches potato protein at a concentration of 0.1 to 100 g/L ([0014], claim 28) and typically at a concentration of 0.7 to 1.5 g/L ([0088]). Livney teaches that in some embodiments, the w/v of a subject compound, more preferably from about 0.1% to about 2.0% ([0079]). Looking to Fig. 1D of Shi, surfactant surrounds the polymer shell while outer lipid (e.g., lecithin, i.e., surfactant) and is taught as an amphiphilic lipid to form an amphiphilic layer ([0046], [0061]). Shi discloses that the particles comprise 5% to 20% lipid (by weight) ([0061]). Here the prior art teaches a range of plant protein to surfactant that falls within the claimed range.
Regarding the hydrophobic compound to surfactant ratio, Livney’s disclosure of the bioactive compound is present at a concentration of 0.1 µg/ml to 1 mg/ml (claim 16) along with Shi’s teaching of lipid (i.e., surfactant) overlaps the claimed range (i.e., 0.01:1 to 1:10). MPEP 2144.05 states that where 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.
Regarding the plant protein and surfactant in the shell, Shi shows that the lecithin forms a phospholipid bilayer having the hydrophilic (polar) heads and hydrophobic tails ([0061]). Thus, a skilled artisan would immediately consider plant protein of Livney and lecithin of Shi because the non-covalent interactions between lecithin and plant protein are well known in the art. Shi clearly teaches lecithin in the second amphiphilic layer ([0009], [0044], [0061], claim 26), and underscores its versatility for use in other delivery devices since lecithin is a natural lipid with FDA approval ([0061]).
Regarding low solubility, looking to the instant specification, Applicants describe the hydrophobic compound as having a low solubility in the plant oil and examples are phenolic compounds, tannins, stilbenes, curcuminoids, coumarins, lignans, quinones (see Spec., [015]). The prior art meets the limitation by teaching curcuminoid (see Shi [0121], Harel claim 11). Livney describes the bioactive compound as a compound having maximal aqueous solubility below 1 g/l ([0011], [0028], claims 2, 18). MPEP § 2112.01 states that if a composition is physically the same, it must have the same properties. Thus, the properties recited in claims are presumed to be present in any composition that meets the structural requirements of the claims, absent evidence to the contrary.
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to combine the teachings of Livney in further view of Shi with expected results. One would be motivated to do so because Shi teaches that within the layers of the particle there can be other layers. Shi teaches that having more than one component within the layers with respect to amphiphilic compounds advantageously improves encapsulation yields and release control ([0024]). Shi provides a particle that has advantages of both polymer- and lipid-based nanoparticles ([0043]). Shi teaches that hydrophobic portions of inner lipids non-covalently interact with the active ([0045]).
Regarding claim 15, Livney teaches that the bioactive compound is a carotenoid ([0032-0033]), phytochemical ([0029], claims 3, 19), and phytosterol ([0031]).
Regarding claim 16, Livney teaches a phytochemical as the bioactive compound ([0029], claims 3, 19) which encompasses polyphenols.
Regarding claim 17, Livney teaches that the bioactive is a carotenoid ([0032]).
Regarding claim 18, Livney teaches potato protein ( [0024], claims 1, 12, 22).
Response to Arguments
Applicant's arguments filed 09/10/2025 have been fully considered but they are not persuasive.
35 U.S.C. § 103 – Livney, Harel, and Helson (instant claim 2)
Applicants argue that Livney’s homogeneous particle containing potato protein (PP) and bioactive is irrelevant and that Livney’s nano-capsule where the core contains bioactive and the nanoshell comprises PP does not teach the bioactive in the shell (see Remarks, pg. 6, para. 6).
The Examiner in response, respectfully disagrees because an optional particle does not take away from the prior art teaching of PP in the shell just as MPEP states that language that suggests or makes optional and does not require does not limit the claim to a particular structure or limit the scope of a claim or claim limitation. Applicants’ remarks about the bioactive bound to the potato protein nanoshell would be known by any skilled artisan to be understood as the hydrogen “bonding” interactions common between such components i.e., hydrophobic amino acids of the protein and the hydrophobic bioactive.
Harel is brought in to teach curcuminoids, in addition Harel teaches astaxanthin ([0014], [0030], [0035], claim 11). Given that Harel and Livney share the objective to encapsulate bioactive(s) in a plant-based shell, Harel cites Livney (see paragraph [0037]) and both references provide teachings of flaxseed oil, carotenoids, and ratios of protein to hydrophobic compound that overlap. One would be motivated to combine Harel and Livney because Livney provides results that show potato protein prevents the hydrophobic compound from degrading ([0116]). Here the combined art renders the claim obvious to have a particle wherein curcuminoid is present with the potato protein in the shell.
Applicants argue that Harel teaches encapsulating the hydrophobic compound and requires particles to be "dispersed in a matrix" (i.e. solid protein/ polysaccharide medium) which fails to teach "free standing" particles without matrix, as instantly claimed (see Remarks, pg. 7, para. 1).
In response, the claims as presented do not recite free standing particles and do not exclude a matrix, in fact, a core-shell encapsulation matrices are well known in the art. To reiterate, Harel is provided to teach curcuminoids.
Applicants argue that Helson teaches curcuminoid in the core (see Remarks, pg. 7, para. 3).
Helson is no longer used.
35 U.S.C. § 103 – Livney, Harel, and Shi (instant claim 14)
Applicants argue that the references do not teach (i) hydrophobic core consisting of a hydrophobic compound or of the hydrophobic compound and a plant oil; (ii) amphiphilic shell consisting of the plant protein and a low molecular weight surfactant, (iii) a multi-layered shell, wherein the 1st and 2nd shell layers have different compositions and (iv) the amphiphilic shell encapsulates a hydrophobic compound (see Remarks, pg. 7, para. 6). Applicants further argue that Livney does not teach the low-molecular weight surfactant with the disclosure of a polymer in the shell, citing paragraph [0025] (see Remarks, pg. 7, para. 7).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., (i) consisting of plant protein …) are not recited in the rejected claim(s). Lines 3-5 of rejected claim 14 recites comprising language. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims.
In response to the low molecular weight surfactant, Shi is provided to teach a first layer amphiphilic compound can be a naturally derived lipid, or surfactant ([0009], [0019]). Shi teaches sodium lauryl sulfate and magnesium stearate ([0202]) to read on the low molecular weight surfactant.
Applicants argue that Harel does not teach the instantly claimed 2-layers shell and rather teaches emulsion stability even without emulsifier or surfactant citing paragraph [0024] (see Remarks, pg. 8, para. ). Applicants argue that Shi does not teach a layered shell, is solely directed to an aqueous core, and is silent regarding "hydrophobic core consists of a hydrophobic compound or of the hydrophobic compound and a plant oil.”
Shi discloses the core of the particle being surrounded by an amphiphilic layer whilst this amphiphilic layer is surrounded by a polymer matrix (claims 1, 2) and that surrounding the polymeric matrix is an optional second amphiphilic layer ([0007], [0010], [0018], claim 2). Any or all of the following may include one or more active agents: core, first amphiphilic layer, polymeric matrix, and second amphiphilic layer, ([0007]). Either the first or second amphiphilic layer, or both, can be mono- or multilayered ([0009]).
For these reasons, Applicants’ arguments are found unpersuasive.
Conclusion
Claims 2-5, 7, 11-12, 14-18 and 21 are rejected; no claims are currently allowable.
The Examiner asks Applicant to provide support for the amendments in the application disclosure by referencing page numbers, paragraphs, figures, etc. for the sake of compact prosecution.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Karen Ketcham whose telephone number is (571) 270-5896. The examiner can normally be reached 900-500 ET.
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/Karen Ketcham/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614