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 .
DETAILED ACTION
Claims 1-20 are currently pending and the claims as originally filed on 10/20/2025 are acknowledged.
Election/Restriction
Applicants’ elections of the following species are acknowledged: ‘microcrystalline cellulose’ for a first filler; ‘gum Arabic” for a second filler; ‘hydroxycellulosepropyl’ for a third filler; ‘xanthan gum’ for fifth filler; and ‘ashwagandha’ for a first active agent; and ‘caffeine’ for a second active agent, which elections are reading on claims 1-6, 8-16, 18, and 20.
However, the combination of the elected species is found to be free of art. Thus, the Examiner extends the search and examination to a non-elected species or group of species that falls within the scope of a proper Markush grouping that includes the elected species.
As a result, claims 1-20 are being examined.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The seven (7) information disclosure statements (IDS) submitted on 04/17/2023; 11/08/2023; 01/19/2024; 07/01/2024; 01/07/2025; 04/07/2025; and 09/12/2025 were filed before the mailing date of the instant first action on the merits. The submissions thereof are in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statements have been considered by the examiner, and signed and initialed copies are enclosed herewith.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: claims 1-16 and 18-20 are not found in the specification.
Claim Objections
Claims 1, 3, 7 and 20 are objected to minor informalities:
Each of claims 1 and 20 recites “the fourth phase comprising: a fifth filler …” The specification does not disclose “fifth filler”. Although the applicant can have their own lexicographer, claim 1 is not copacetic with the other phases/fillers, and that is, claim 1 is not internally consistent. Appropriate correction is respectfully requested.
Claim 3 recites “a plurality of emulsifying agents selected from the group consisting of an extract of Quillaja … sphingomyelin, and cardiolipin … or combinations thereof. However, claim 3 is written in improper Markush format. Applicant can write a proper Markush format (selected from the group consisting of A, B and C) or alternative form of “selected from A, B, or C”.
Claim 7 recites “the second filler is selected from the group consisting of short-chain triglycerides … polyethylene glycol, and vegetable oil (line 3), … hydroxy propyl methyl cellulose or combinations thereof (in last line). However, claim 7 is written in improper Markush format. Applicant can write a proper Markush format (selected from the group consisting of A, B and C) or alternative form of “selected from A, B, or C”.
Appropriate correction is requested.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 10, 12, 13, 19 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Each of claims 3 and 20 contains the trademark/trade name “Tween and Span”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name of instant claims 3 and 20 does not identify or describe the goods associated with the trademark or trade name. Accordingly, the identification/description led by Tween or Span is indefinite.
Claim 10 recites “the fifth phase” in line 5, but which lacks sufficient antecedent basis because base claim 1 does not require a fifth phase.
Claim 12 recites “the fourth filler” in line 2, but which lacks sufficient antecedent basis because base claim 1 does not require a fourth filler.
Thus, until the 112(b) rejection against claims 10 and 12 is resolved, the prior art rejection thereof is hold in abeyance.
Claim 13 recites “the additive is spray-dried to obtain a population of beads…” However, claim 13 is directed to a composition of matter, and but claim 13 recites active step of spray-dried in the composition of matter claim. That is, the composition claim cannot have active step. In this context, see analogous situation with apparatus/method steps. MPEP 2173.05(p)(II): “A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b). Thus, claim 13 using active step is indefinite. For examination purpose, claim 13 is seen as the additive in the form of beads having Z-average diameter between 100 and 900 microns”.
Claim 19 recites “Lactobacillus delbrueckii (bulgaricus)” in lines 8-9. However, such limitation using parentheses is vague and indefinite. It is unclear whether the limitation in parentheses is mean to be limitation in this claim or whether it is only suggestion/example. Please note that parenthetical expression is not permissible which do not contribute the clearness or exactness in stating applicant’s invention ((Ex parte Cahill, 1893 C. D., 78; 63 O. G., 2125).
Appropriate correction is requested.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-9, 11 and 13-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moaseri (US10,945,953B1, publication date: 2021-03-16).
Please note that the embodiment of claim 1 reciting “an additive comprising a first phase to a fifth phase” does not appear to be expressly supported by the provisional application nos. 63/244105 (filing date: 09/14/2021), 63/321596 (filing date: 3/18/2022), and 63/356169 (filing date: 06/28/2022). Thus, the effective filing date of the instant application is actual US filing 09/14/2022.
Applicant claims the below claim 1 filed on 10/20/2025:
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Prior Art
Moaseri discloses a food and beverage additive, the additive including: a first phase including a first filler; a second phase including a second filler; and a third phase including a third filler; and a fourth phase including a fifth filler and a first active ingredient (col. 71 – Group C:1 and col. 77- Group G:1) (instant claim 1); the third phase further includes the first active ingredient (col. 77 – Group G:2) (instant claim 2); the additive further includes a plurality of emulsifying agents selected from Quillaja, Tween 20, Tween 40, Tween 45, Tween 60, Tween 65, Tween 80, Tween 81 and Tween 85, polyglyceryl, gum acacia, Polyglycerol polyricinoleate, Span 85, Span 65, Span 83, Span 80, Span 60, Span 40, Xanthan gum, sorbitol, mannitol, glycerol, sodium alginate, or combinations thereof (col. 77 - Group G:3)(instant claim 3); wherein every one of the first, the second, the third, the fourth and the fifth phases a portion of plurality of emulsifying agents ([0376] – Group G:4)(instant claim 4); wherein the first and third phases are water insoluble; and the second and fourth phases are aqueous phases(col. 77- Group G:5)(instant claim 5); wherein the second and fourth phases are water insoluble; and the first and third phases are aqueous phases (col. 77 – Group G:6) (instant claim 6); wherein the second filler is selected from selected from the group consisting of short-chain triglycerides, medium-chain triglycerides, long-chain triglycerides, medium-chain partial glycerides, polyoxyethylated fatty alcohols, polyethylene glycol, and vegetable oil, shellac, methyl cellulose, hydroxy propyl cellulose, hydroxypropyl-methyl cellulose, ethyl methyl cellulose, carboxy methyl cellulose, ethyl cellulose, microcrystalline cellulose, cellulose, hypro mellose, hydroxyl propyl methyl cellulose, or combinations thereof (col. 77- Group G:7) (instant claim 7); wherein the fifth filler is selected from is selected from the group consisting of alginic acid, sodium alginate, potassium alginate, calcium alginate, agar, guar gum, and xanthan gum (elected species)(col. 77 – Group G:8)(instant claim 8); wherein the fourth phase further includes a second active ingredient (col. 77-Group G:9) wherein the second active ingredient includes cannabinoid, hemp, cannabis, Echinacea purpurea, basil, oregano, bacopa, etc. (col. 78 - Group G: 19) that is not soluble in the fifth filler such as alginic acid, sodium alginate, potassium alginate, calcium alginate, agar, guar gum, and xanthan gum (col. 77- Group G:8)(instant claim 9); wherein the weight ratio of the second phase to the first phase is from 1:1.5 to 1:5; the weight ratio of the third phase to the second phase is from 1:1.5 to 1:5; the weight ratio of the fourth phase to the third phase is from 1:1.5 to 1:5; and the weight ratio of the fifth phase to the fourth phase is from 1:1.5 to 1:5 (col. 78- Group G:10); wherein the first filler has a melting point that is above 45C (col. 78 - Group G: 11 and Group C:18)(instant claim 11); wherein at least three of the first, the second, the third, the fourth, and the fifth fillers retard the release of the first active ingredient after consumption (col. 78 – Group G:12); wherein the additive is spray dried to obtain a population of beads, wherein: the population of beads has a Z-average diameter less than 500 microns (col. 78 - Group G:14)(instant claim 13); wherein at least 10% by weight of the first active ingredient is not released within 2 hours after consumption (col. 78 - Group G:17)(instant claim 14); wherein the first filler do not break down in an aqueous solution with a pH above 5.5 (col. 78 – Group G:18)(instant claim 15); wherein the first filler do not break down in an aqueous solution with a pH in the range of 2.0 to 5.0 (col. 78 – Group C:17)(instant claim 16); wherein the first filler comprises: a wax is selected from the group consisting of bees wax, carnauba wax, rice bran wax, camauba wax, candelilla wax, or combinations thereof (col. 78 – Group G:19)(instant claim 17); wherein the first active ingredient includes probiotics, caffeine, Dynamine, hemp, Cannabis, Echinacea purpurea, Echinacea angustifolia, Echinacea pallida, Acmella oleracea, Helichrysum umbraculigerum, Radula marginata, kava, black truffle, Syzygium aromaticum, Rosmarinus oficinalis, basil, oregano, lavender, true cinnamon, malabathrum, Cananga odorata, Riboflavin, Theanine, Ginkgo biloba, Bacopa, and Rhodiola rosea Extract (col. 78 – Group G:20), and ashwagandha ([0223]) (instant claim 18); and wherein the first plurality of active ingredients is selected from the group consisting of hemp, Cannabis, Echinacea purpurea, Echinacea angustifolia, Echinacea pallida, Acmella oleracea, Helichrysum umbraculigerum, Radula marginata, kava, black truffle, Syzygium aromaticum, Rosmarinus oficinalis, basil, oregano, lavender, true cinnamon, malabathrum, Cananga odorata, Riboflavin, Theanine, Ginkgo biloba, Bacopa, and Rhodiola rosea Extract (col. 78: Group G:20)(instant claim 19).
In light of the foregoing, instant claims 1-9, 11 and 13-19 are anticipated by Moaseri.
Claims 1-5, 7, 9, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Doucet et al. (US2014/0154191A1).
Applicant claims the above instant claim 1:
Prior Art
Doucet discloses use of cosmetic compositions in the form of e.g., emulsion ([0041]) comprising dermatological active ingredients, emulsifying agents, antioxidant, surfactant, pigments, preservatives, emollients, perfumes, stabilizers, humectants, sunscreen filters, silicone oils, gel formers, pH regulators tec. ([0026]-[0037]) wherein the compositions additionally dermatological or cosmetic auxiliaries such as water, vitamins, other plant extracts, phospholipid, fatty acids, plant oils, waxes, biotechnological extracts ([0038]); wherein the active ingredients include UVA or UVB filters or both such as 4-amino benzoic acid derivatives, butyl-methoxybenzoylmethane, etc. ([0045]-[0046]) and Pisum Sativum (pea) extract and the gel formers include xanthan gum, carrageenan, acacia gum, guar gum, alginate, HPMC, HEC, CMC, polyacrylate, etc. ([0043]); the emulsion include multiple emulsions, micro/nano emulsions in the form of W/O, O/W, W/Si, Si/W, W/O/W, O/W/O, O/W/Si and W/Si/W emulsions (O=Oil, W=Water, Si=Silicone) ([0041]); wherein the suitable emulsifiers for multiple emulsions include tribehenin PEG-20 esters, PEG-12 dimethicone crosspolymer, polyglyceryl-6-dioleate, cyclopentasiloxane, PEG-8 caprylic/capric glyceride, sorbitan monoester and diester of C6-22 reading on the claimed Span (([0058] and [0060]); as the cosmetic auxiliaries, the composition can contain waxes ([0062]); the oil phase can contain C18-26 triglycerides, etc. ([0057]).
The below embodiment refers to multiple emulsions SPF 25-30:
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In the above Table, Phase A contain soctocrylene, ethylhexyl palmitate, isopropyl palmitate, stearic acid, tribehenin PEG-20 esters, TiO2, etc. wherein the ethylhexyl palmitate, isopropyl palmitate and stearic acid read on the claimed first filler, and tribehenin PEG-20 esters and isopropyl palmitate reads on the claimed plural emulsifying agent, these components are not soluble in water and Phase A reads on the claimed first phase; Phase B contains water, EDTA, glycerin, propylene glycol, HPMC, etc. wherein the EDTA, propylene glycol and HPMC read on the claimed second filler, and the glycerin reads on the claimed emulsifying agent and these components are water-soluble phase and Phase B reads on the claimed second phase; Phase C contains 8.0% cyclopentasiloxane reading on the claimed emulsifying agent and 0.7% phenoxyethanol reading on the claimed filler and/or active agent, and Phase C having 8% cyclopentasiloxane reads on the claimed water-insoluble and thus Phase C reads on the claimed third phase; and Phase D contains RPF complex of plant extracts reading on the claimed second active agent not water-soluble, mixture of vitamin E and C which reads on the claimed first active agent, triethanolamine, perfume, water wherein the said RPF and mixture of vitamin read on the claimed active agent and triehanoamine and perfume read on the claimed fifth filler and Phase D reads on the aqueous and reads on the claimed fourth phase ([0073]) (instant claims 1-5, 7 and 9).
In light of the foregoing, instant claims 1-5, 7 and 9 are anticipated by Doucet.
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.
Claims 1-9, 11, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Doucet et al. (US2014/0154191A1) as applied to instant claims 1-5, 7 and 9.
Applicant claims as noted above.
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a additives for cosmetic, food, beverage, supplement, and/or nutraceutical research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art (MPEP 2141.01);
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02); and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
Doucet was discussed with respect to claims 1-5, 7 and 9 as noted above.
Doucet further discloses the composition can be multiple emulsion in the form of W/OW, O/W/O ([0041]) and therefore, it would be obvious to modify multiple phases with aqueous first/third phases and non-aqueous second/fourth phases from the standpoint of the ordinary artisan (instant claim 6).
Doucet discloses a gel-forming agent such as e.g. carbomer, xanthan gum, carrageenan, acacia gum, guar gum, agar-agar, alginates, etc. ([0043]) and thus the gel-forming agent is seen as the filler, and thus, it may be further contained in Phase D (instant claim 8).
Doucet teaches stearic acid in the Phase A, which has a melting point of 67-69C as evidenced by the attached Stearic Acid SDS obtained from ThermoFisher (2014-06-02, pp. 1-8) that overlaps the instant range of above 45C. Further it is general that the cosmetic product is kept and stored at room temperature as evidenced by Krave Beauty, “Should I refrigerate my skincare?”, 2019, pp. 1-3 including page 2, and accordingly such stearic acid filler is higher than the storage room temperature (instant claim 11).
Doucet does not release/no break-down properties of instant claims 14-16. In this case, the Examiner interprets “after consumption” in claim 14 as “after application” the product. Since Doucet discloses the same multiple-phase structure and components thereof, such properties would be implicit because properties and product are not separable. see MPEP 2112.01 II.COMPOSITION CLAIMS — IF THE COMPOSITION IS PHYSICALLY THE SAME, IT MUST HAVE THE SAME PROPERTIES “Products of identical chemical composition cannot have mutually exclusive properties. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).” (instant claims 14-16).
Doucet discloses wax such as beeswax, carnauba wax, candelilla wax, etc. can be used in the composition as the cosmetic auxiliaries ([0038] and [0057] and [0062]). Doucet teaches Phase A is water-insoluble and thus, it would be obvious to place the wax filler in that Phase A (instant claim 17).
In light of the foregoing, instant claims 1-9, 11 and 14-17 are obvious over Doucet.
Claims 13 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Doucet et al. (US2014/0154191A1) in view of Waugh et al. (US2019/0105261A1, IDS of 01/07/2025).
Doucet does not expressly teach beads having certain Z-average diameter of instant claim 13 and the first active ingredients of instant claims 18-19. However, the deficiencies are cured by Wough
Wough discloses a cosmetic composition containing one or more active ingredients, ECM component of hyaluronic acid, collagen, elastin, etc. (abstract); and the composition further comprises Echinacea Purpurea, Saccharomyces cerevisiae, etc. ([0092]), antigen such as streptococcus, ([0098]), nicotinic acid (=vitamin B); and the composition may be a dry powder comprising micronized particles encapsulating active agent and other ingredient, and the microparticles has a diameter of 0.1 to 10 microns ([0160] and [0249]) which is considered microspheres or beads.
Although Wough does not expressly teach the Z-average diameter of beads of instant claim 13, Wough teaches the composition in the form of powder having microparticles. Therefore, it would be obvious to optimize or increase smaller micron size of Wough to the claimed range depending on the intended purpose, type of formulation, etc., in the absence of criticality of the claimed range. It is well-established in U.S. patent law that merely changing the size, weight, or proportions of an existing article is typically considered a matter of routine design choice and not ordinarily the basis for a patentable invention. See In re Rose, 105 USPQ237 (C.C.P.A.1955) (instant claim 13).
Further, it would have been obvious to modify or replace the active agent of Doucet with Echinacea purpurea, nicotinic acid and Saccharomyces cerevisiae as a matter of design or choice and such choice would have yielded no more than predictable results of enhanced cosmetic properties of the composition as taught by Waugh (instant claims 18-19).
In light of the foregoing, instant claims 13 and 18-19 are obvious over Doucet in view of Waugh.
Conclusion
All examined claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/ Primary Examiner, Art Unit 1613