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, 2, 7, 8, 13, 15, 21, 22, 25, 26, 28, 29, 30, 37 and 49-59 are pending in Claim Set filed 2/17/2026.
Claims 53-59 are newly added.
Claims 1, 2, 7, 8, 13, 15, 21 and 22 have been amended.
Applicants elected without traverse Group I: claims 1, 2, 7, 8, 11, 13, 15, 22 and 25-30. The species election has been extended to include unelected species. The species election has been extended to include the genus of: lignin particles and tannins, and the surfactant species election has been extended to include: phosphatidylcholine, phosphatidylethanolamine, phosphatidylglycerol, phosphatidylserine, phosphatidylinositol, cardiolipin, and the derivatives of these phospholipids and polyethylene oxide. Phospholipids (surfactants) are recited in instant claim 7 and disclosed in the Specification para. [28].
The elected species to sodium lignosulfonate and polyglyceryl-2-dipolyhydroxy stearate surfactant is deemed free of the prior art (claims 22, 25, 26, 28).
The rejections presented below incorporate the extended species.
Claims 21, 37, 49-55, 58 and 59 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claims 3-6, 9-12, 14, 16-20, 23, 24, 27, 31-36 and 38-48 are cancelled.
Herein, claims 1, 2, 7, 8, 13, 15, 22, 25, 26, 28, 29, 30, 56 and 57 are for examination.
Notice Regarding Claims
Applicants are reminded that appropriate claim identifiers of pending claims are required during the prosecution of Instant Application.
Claims 58-59 of Claim Set filed 2/17/2026 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Proper Claim Identifiers for Claims 58-59 of Claim Set filed 2/17/2026 are shown below:
MPEP 714 C. Amendments to the Claims
Status Identifiers: The current status of all of the claims in the application, including any previously canceled or withdrawn claims, must be given. Status is indicated in a parenthetical expression following the claim number by one of the following status identifiers: (original), (currently amended), (previously presented), (canceled), (withdrawn), (new), or (not entered). The status identifier (withdrawn – currently amended) is also acceptable for a withdrawn claim that is being currently amended.
Claims 58-59 are withdrawn, but are indicated in the Claim Set filed 2/17/2026 as (Previously presented).
Any non-elected claims that are being withdrawn must have the status identifier (Withdrawn).
Any future claims must have the proper status identifiers in accordance with MPEP 714 Amendments to the claims II C (A).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/25/2025, 9/29/2025, 2/17/2026 and 2/17/2026 has been considered by the examiner and an initialed copy of the IDS is included with the mailing of this office action.
Withdrawn Objection
The objection to claim 15 is withdrawn in view of the amendments to the claim.
Maintained Rejections
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The rejection of claims 1, 2, 7, 8, 13, 15, 22, 25, 26, 28, 29, 30, 56 and 57 on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 and 15 of U.S. Patent No. 11,155,683 (herein ‘683) is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because Instant Claims and ‘683 claims are directed to common subject matter.
Instant Claims are directed to 1. A dispersion comprising a composition and a lipophilic carrier, the composition comprising phenolic polymer particles, and a surfactant, on and surrounding each phenolic polymer particle of the phenolic polymer particles, wherein the phenolic polymer particles are in the solid state and the phenolic polymer is a water-soluble polymer; 2. The composition dispersion of claim 1, wherein the phenolic polymer particles comprise a substance selected from the group consisting of lignins, humates, tannins, botanical extracts containing water soluble and/or water dispersible components, and combinations thereof; 7. The composition dispersion of claim 1, wherein the surfactant comprises a substance selected from the group consisting of fatty alcohols and polyols, fatty acids, polyglyceryl esters, polyglyceryl polyesters, polyesters with affinic hydroxyl, amine or amide groups, polyurethanes with affinic hydroxyl, amine or amide groups, polyamides with affinic hydroxyl, amine or amide groups, polyacrylates with affinic hydroxyl, amine or amide groups, phosphate esters, polymeric phosphoric acid salts, phospholipids, ceramides, sphingosines, combinations thereof, copolymers thereof, and cross-polymers thereof; 8.The composition dispersion of claim 1, wherein the phenolic polymer particles have a particle size of 0.1 to 1.0 microns (µm); 13. The dispersion of claim 1, wherein the carrier vehicle comprises a substance selected from the group consisting of triglycerides, esters, natural oils and butters, alkanes, silicones and combinations thereof; 15. The dispersion of claim 1, wherein the phenolic polymer particles are present in an amount of 0.1-75.0% by weight, and the surfactant is present in an amount of 1.0-100.0% of the mass of the phenolic polymer particles; 22. A dispersion, comprising: sodium lignosulfonate particles,a surfactant, on and surrounding each sodium lianosulfonate particle of the sodium lignosulfonate particles, and a carrier vehicle comprising an oil phase, wherein the sodium lignosulfonate particles have a particle size of 0.1-1.0 microns, the sodium lignosulfonate particles with the surfactant are lipophilic and are present in the oil phase of the dispersion, and the sodium lignosulfonate particles are in the solid state; 25. The dispersion of claim 22, wherein the surfactant comprises polyglyceryl-2 dipolyhydroxystearate,the carrier vehicle comprises caprylic/capric triglycerides,the sodium lignosulfonate is present in an amount of 1.0-40.0% by weight, and the polyglyceryl-2 dipolyhydroxystearate is present in an amount of 15.0-50.0% by weight; 26. The dispersion of claim 25, wherein the dispersion is super photostable; 28. The dispersion of claim 25, wherein the dispersion passes the free radical quenching test; 29. A sunscreen composition, comprising:the dispersion of the dispersion of a UV radiation protectant; 30. The sunscreen composition of claim 29, wherein the UV radiation protectant is selected from the group consisting of zinc oxide (ZnO), titanium dioxide (TiO2), p-aminobenzoic acid (PABA), padimate O, phenylbenzimidazole sulfonic acid, cinoxate (2-ethoxyethyl p-methoxycinnamate), dioxybenzone (benzophenone-8), oxybenzone (benzophenone-3), homosalate (homomethyl salicylate), menthyl anthranilate (meradimate), octocrylene (2-cyano-3,3-diphenyl acrylic acid), octyl methoxycinnamate (octinoxate), octyl salicylate (2-ethylhexyl salicylate), sulisobenzone (2-hydroxy-4-methoxybenzophenone-5-sulfonic acid, 3-benzoyl-4-hydroxy-6- methoxybenzenesulfonic acid, benzophenone-4), trolamine salicylate (triethanolamine salicylate), avobenzone (1-(4-methoxyphenyl)-3-(4-tert-butylphenyl)propane-1,3-dione),ecamsule (terephthalylidene dicamphor sulfonic acid), cerium oxide (CeO2), drometrizole trisiloxane, bis-ethylhexyloxyphenol methoxyphenyl triazine, bisoctrizole and combinations thereof; 56. A composition, comprising: phenolic polymer particles, and a surfactant, on and surrounding each phenolic polymer particle of the phenolic polymer particles, wherein the phenolic polymer particles are in the solid state, the phenolic polymer is a water-soluble polymer, and the surfactant comprises a substance selected from the group consisting of fatty alcohols and polyols, fatty acids, polyglyceryl esters, polyglyceryl polyesters, polyesters with affinic hydroxyl, amine or amide groups, polyurethanes with affinic hydroxyl, amine or amide groups, polyamides with affinic hydroxyl, amine or amide groups, polyacrylates with affinic hydroxyl, amine or amide groups, phosphate esters, polymeric phosphoric acid salts, ceramides, sphingosines, combinations thereof, copolymers thereof, and cross-polymers thereof; 57. A dispersion, comprising: the composition of the composition of a lipophilic carrier vehicle.
‘683 claims are directed to 1) A composition, comprising: phenolic polymer particles, and a surfactant, on the phenolic polymer particles, wherein the composition is very water resistant; 2) wherein the phenolic polymer particles comprise a substance selected from the group consisting of lignins, humates, tannins, botanical extracts containing water soluble and/or water dispersible components, and combinations thereof; 3) wherein the surfactant comprises a substance selected from the group consisting of fatty alcohols and polyols, fatty acids, polyglyceryl esters, polyglyceryl polyesters, polyesters with affinic hydroxyl, amine or amide groups, polyurethanes with affinic hydroxyl, amine or amide groups, polyamides with affinic hydroxyl, amine or amide groups, polyacrylates with affinic hydroxyl, amine or amide groups, phosphate esters, polymeric phosphoric acid salts, phospholipids, ceramides, sphingosines, combinations thereof, copolymers thereof, and cross-polymers thereof; 4) wherein the phenolic polymer particles have a particle size of 0.001-10.0 microns (μm). 5) A dispersion, comprising: the composition of claim 1, and a carrier vehicle; 6) wherein the carrier vehicle comprises a substance selected from the group consisting of triglycerides, esters, natural oils and butters, alkanes, silicones and combinations thereof; 7) wherein the phenolic polymer particles are present in an amount of 0.1-75.0% by weight, and the surfactant is present in an amount of 1.0-100.0% of the mass of the phenolic polymer particles. 8) A dispersion, comprising: sodium lignosulfonate particles, a surfactant on the sodium lignosulfonate particles, and a lipophilic cosmetically-acceptable fluid, wherein the sodium lignosulfonate particles have a particle size of 0.1-1.0 microns, the dispersion is pourable, and the dispersion is very water resistant; 9) wherein the surfactant comprises polyglyceryl-2-dipolyhydroxystearate, the carrier vehicle comprises caprylic/capric triglycerides, the sodium lignosulfonate is present in an amount of 1.0-40.0% by weight, and the polyglyceryl-2 dipolyhydroxystearate is present in an amount of 15.0-50.0% by weight; 10) wherein the dispersion is super photostable; 11) wherein the dispersion passes the free radical quenching test. 12) A sunscreen composition, comprising: the composition of claim 1, and a UV radiation protectant; 13) The sunscreen composition of claim 12, wherein the UV radiation protectant is selected from the group consisting of zinc oxide (ZnO), titanium dioxide (TiO2), p-aminobenzoic acid (PABA), padimate O, phenylbenzimidazole sulfonic acid, cinoxate (2-ethoxyethyl p-methoxycinnamate), dioxybenzone (benzophenone-8), oxybenzone (benzophenone-3), homosalate (homomethyl salicylate), menthyl anthranilate (meradimate), octocrylene (2-cyano-3,3-diphenyl acrylic acid), octyl methoxycinnamate (octinoxate), octyl salicylate (2-ethylhexyl salicylate), sulisobenzone (2-hydroxy-4-methoxybenzophenone-5-sulfonic acid, 3-benzoyl-4-hydroxy-6-methoxybenzenesulfonic acid, benzophenone-4), trolamine salicylate (triethanolamine salicylate), avobenzone (1-(4-methoxyphenyl)-3-(4-tertbutylphenyl) propane-1,3-dione), ecamsule (terephthalylidene dicamphor sulfonic acid), cerium oxide (CeO.sub.2), drometrizole trisiloxane, bis-ethylhexyloxyphenol methoxyphenyl triazine, bisoctrizole and combinations thereof; 15) Lipophilic phenolic polymer particles, wherein the lipophilic phenolic polymer particles are very water resistant.
The ‘683 claims differ from Instant Claims in that the ;683 claims do not recite a surfactant on and surrounding each phenolic polymer particles; wherein the phenolic polymer particles are in the solid state.
However, ‘683 claims recite particles that are phenolic polymer particles of which are lipophilic and very water resistant wherein the surfactant is on the phenolic polymer. Thus, it would necessarily follow the surfactant is on and surrounds the phenolic polymer particles in order for the particles to be lipophilic and that the particle that are surrounded by the surfactant are in a solid state having a reasonable expectation of success.
Therefore, the claimed invention is directed to the same invention or is an obvious variation of the invention claimed in the ‘683 claims.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned Patent '683 discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 1 00(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was
made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 1 00(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Response to Arguments
Applicants argue that the rejection of the claims under the doctrine of obviousness-type double patenting over U.S. Patent No. 11,155,683 ("the '683 patent") has been obviated by the filing of an appropriate terminal disclaimer herewith. Withdrawal of this ground of rejection is requested.
Applicant’s arguments have been fully considered but they are not persuasive, because the Terminal Disclaimer form is illegible: The Applicant name and 100 is cut off. Therefore, Disclaimer filed 2/17/2026 is ‘Disapproved’ and The Double Patenting rejection as set forth above is maintained. Office requests Applicant to send in a more legible copy.
Maintained Rejections
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 of this title, 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 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or
nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The rejection of claims 1, 2, 7, 13, 15, 29, 30, 56 and 57 under 35 U.S.C. 103 as being unpatentable over Kaufman et al (USP 9925149) [Kaufman] in view of Chung et al (Tannins and Human Health: A Review, Critical Reviews in Food Science and Nutrition, p.421, 1998) is maintained.
Regarding claims 1, 2, 7, 13, 15, 29, 30, 56 and 57,
Kaufman teaches lipid structured nanoparticles that encapsulate one or nutraceutical supplements, of which are provided as solid lipid nanoparticles (col.4, lns.10-84). Kaufman teaches lipid structured nanoparticles are ‘solid lipid nanoparticles’ that are in a solid form and are synthesized from natural lipid surfactants and contain an encapsulated inner core phase. Kaufman teaches that solid lipid nanoparticles provide controlled release, efficient targeting, and stability to its cargo or payload (col.5, lns.41-45). Kaufman teaches the lipid surfactants are phospholipids that include phosphatidylcholine, phosphatidylethanolamine, phosphatidylglycerol, phosphatidylserine, phosphatidylinositol, cardiolipin, and the derivatives of these phospholipids (col.5, lns.55-67). Kaufman teaches that the lipid structured nanoparticles made from the phospholipids encapsulate one or nutraceutical supplements, wherein the nutraceutical supplements comprise phenolic compounds, e.g., tannins (col.4, lns.10-84; col.5, lns.1-21).
Further, Kaufman teaches lipid structured nanoparticles are ‘Lipid emulsion nanoparticles’ that are dispersed particle droplets created from natural lipids that possess an outer phospholipid layer and an encapsulated inner lipid core.
Kaufman teaches that the lipid structured nanoparticle assemblies may be dispersed in a solvent and carrier fluid during formulation, wherein the solvent is silicone oil (recited in claim 13). (col.5, lns.50-54). Further, Kaufman teaches that the lipid structured nanoparticles comprise nutraceutical factors that protect against UV solar radiation (cols.20-21), wherein it would have been well within the purview of one skilled in the art to provide a UV protectant as claimed in claim 30 having a reasonable expectation of success.
Kaufman teaches the nutraceutical supplements is present in the formulation at about 1-60 wt% and the phospholipids are present in the formulation at about 28-37 wt% (col.22), of which overlaps with the claimed amounts. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05.
Kaufman differs from the claims in that the documents do not teach that the phenolic polymer, e.g., tannin, is water soluble.
However, Chung cures the deficiencies.
Chung teaches Tannins (commonly referred to as tannic acid) are water-soluble polyphenols (Abstract). Moreover, Chung teaches tannin molecules have also been shown to reduce the mutagenic activity of a number of mutagens. Many carcinogens and/or mutagens produce oxygen-free radicals for interaction with cellular macromolecules. The anticarcinogenic and antimutagenic potentials of tannins is related to their antioxidative property, which is important in protecting cellular oxidative damage, including lipid peroxidation. Chung teaches the antimicrobial activities of tannins are well documented. The growth of many fungi, yeasts, bacteria, and viruses was inhibited by tannins. Moreover, tannic acid (tannins) was inhibitory to foodborne bacteria, aquatic bacteria, and off-flavor-producing microorganisms. Chung teaches that the antimicrobial property of tannic acid (tannins) can also be used in food processing to increase the shelf-life of certain foods, such as catfish fillets. Moreover, Chung teaches tannins are known to exert other physiological effects, such as to accelerate blood clotting, reduce blood pressure, decrease the serum lipid level, produce liver necrosis, and modulate immunoresponses. (Abstract; see entire document).
It would have been prima facie obvious to one skilled in the art that tannins are water soluble in the teachings of Chung. Moreover, one skilled would have been motivated to select tannins to provide structured nanoparticles that encapsulate tannin as one of nutraceutical supplements as taught by Kaufman., because tannins as taught by Chung have been shown to reduce the mutagenic activity of a number of mutagens, moreover, tannins have antimicrobial properties, such as, inhibition of yeasts, bacteria, and viruses, foodborne bacteria, aquatic bacteria, and off-flavor-producing microorganisms. Chung teaches that the antimicrobial property of tannic acid (tannins) can also be used in food processing to increase the shelf-life of certain foods, such as catfish fillets.
All the claimed elements herein are 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.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide instantly claimed antimicrobial composition and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, in the absence of evidence to the contrary, the claimed invention as a whole would have been obvious to one of ordinary skill as evidenced by Kaufman and Chung, as a whole.
The rejection of claim 8 under 35 U.S.C. 103 as being unpatentable Kaufman et al (USP 9925149) [Kaufman] in view of Chung et al (Tannins and Human Health: A Review, Critical Reviews in Food Science and Nutrition, p.421, 1998) as applied to claims 1, 2, 7, 13, 15, 29, 30, 56 and 57 above and further in view of Antwi-Boasiako et al (Tannin extraction from the barks of three tropical hardwoods for the production of adhesives, Journal of Applied Sciences Research, p. 2959, 2012) is maintained.
The teachings of Kaufman and Chung, as a whole, are described above.
Kaufman and Chung differ from the claims in that the documents do not teach that the phenolic polymer particles have a particle size of 0.1 to 10 microns.
However, Antwi-Boasiako cures the deficiency.
Antwi-Boasiako teaches tannin particles of 0.5 microns that can readily be obtained from plant bark (Abstract, p.2960; see entire document)
One skilled in the art would have been motivated to use nanoparticles (500 nm = 0.5 microns) because Kaufman teaches lipid structured nanoparticles that encapsulate nutraceutical supplements, e.g., tannins. Thus, one skilled in the art would have been motivated to look to Antwi-Boasiako to obtain tannin (phenolic polymer particles) that are suitable to be encapsulated using lipid surfactants that are phospholipids in accordance with the teachings of the cited prior art.
All the claimed elements herein are 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.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide instantly claimed antimicrobial composition and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, in the absence of evidence to the contrary, the claimed invention as a whole would have been obvious to one of ordinary skill as evidenced by Kaufman and Chung, as a whole.
Response to Arguments
Applicants argue: Kaufman describes nanoparticle compositions as carriers of nutraceutical Factors across cell membranes and biological barriers. Kaufman notes that "[m]any nutraceuticals that contain antioxidant ingredients may be unstable, poorly water soluble. and poorly distributed in vivo. Kaufman describes the challenges of oral administration of ocular nutrients through the GI tract. including the hydrophobicity of many ocular nutrients, making them insoluble in aqueous solutions, and thereby demonstrating slow or incomplete dissolution in the GI tract (coL11, lines 60-67), Kaufman further explains that the insolubility, hydrophobic nature, size, shape, or molecular structure of an ocular nutraceutical can severely inhibit passage across blood-ocular barriers and delivery to ocular tissues. To address this problem, Kaufman prepares a lipid structural nanoparticle carrier system to deliver the nutraceuticals into mammals. A nutraceutical factor includes any of a large variety of compounds, including phenolic compounds such as tannins and lignins. Tannins is a broad class that includes water insoluble members (see, for example, Serrano et al, 2009, which states that tannins such as proanthocyanldins are not soluble in water, at S318. right column). Note: Applicants did not specifically indicate the paragraph where in S318, right column, teaches proanthocyanldins are not soluble in water.
Examiner has selected (shown below) the subject matter in Serrano et al, 2009, S318, right column, that appears to be relevant to Applicants arguments (show below)
Proanthocyanidin oligomer absorption in the small intestine has been studied by several authors. In Caco-2 cells, Deprez et al. [130) observed that (+)-catechin and a proanthocyanidin dimer and trimer had similar permeability coefficients, close to that of mannitol, a marker of paracellular transport. In contrast, permeability of a proanthocyanidin oligomer with an average polymerization of six (MW = 1740) was approximately ten times lower. These results suggest that proanthocyanidin trimers and dimers could be absorbed in vivo and that polymer bioavailability is limited in the gut lumen [130]. Early studies from Jimenez-Ramsey et al. [131] demonstrated that proanthocyanidins soluble in water and ethanol are absorbed from the intestinal tract of chicks and are extensively distributed in all tissues and plasma, while proanthocyanidin fractions soluble in aqueous acetone but insoluble in water and ethanol are not bioavailable at all. Other studies have corroborated these findings. For example, Tanaka et al. [132] were able to measure the absorption of orally administered procyanidin B2 and procyanidin B3 in rat plasma. Baba et al. [133] likewise observed absorption and excretion in the urine of procyanidin B2 in rats, where a portion of the procyanidin B2 was degraded internally to (-)-epicatechin and to the conjugated and/or methlylated (-)-epicatechin metabolite. Indirect evidence suggests that at least some of the actions of proanthocyanidins are in part due to its absorption in the small intestine.
Applicants argue: The phenolic polymer nanoparticles of Kaufman are designed to improve bioavailability of poorly water soluble ingredients, and there would be no reason to select water-soluble tannins disclosed in Chung for use in the nanoparticles of Kaufman to facilitate tannins crossing cell membranes and biological barriers. A person of ordinary skill in the art seeking to improve bioavailability of nutraceuticals that are poorly water soluble would have no reason to select the water-soluble tannins of Chung. For use in the nanoparticles of Kaufman. Antwi-Boasiako js cumulative of Chung in describing tannins as water soluble, and does not cure the deficiency of Kaufman and Chung to provide a reason why a person of ordinary skill would select tannins for use in the nanoparticles of Kaufman. Chung describes tannins as water-soluble polyphenols (Abstract). Chung describes tannins as "nutritionally undesirable. Chung states that tannins are responsible for decreases in feed intake, growth rate, feed efficiency, net metabolizable energy. protein digestibility, damages to mucosal lining of the gastrointestinal tract, alteration of excretion of certain cations, and increased excretion of proteins and essential amino acids, (id., middle right column). Chung also describes tannins carcinogenic, for example, with respect to liver cancer. Chung is silent as to requiring a carrier for tannins to cross cell membranes and biological barriers. Antwi-Boasiako describes the extraction of water-soluble tannins from plant bark (Abstract 2962}. Antwi-Boasiako is silent also requiring a carrier for tannins to cross cell membranes and biological barriers.
Applicant’s arguments have been fully considered but they are not persuasive, because the teachings of Serrano imply that proanthocyanidins (trimers and dimers) are soluble in water, whereas, proanthocyanidin fractions (i.e., average polymerization of six (MW = 1740) are soluble in aqueous acetone but insoluble in water and ethanol are not bioavailable at all. Furthermore, the instant claims recite the transitional phrase ‘comprising’ and are open ended and do not exclude additional, unrecited elements or method steps. See, e.g. Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004). Accordingly, the teachings of Serrano comprise proanthocyanidins that are water-soluble and water-insoluble.
Kaufman teaches solid lipid nanoparticles as well as lipid emulsion nanoparticles carriers that are formed from phosphatidylcholine are superior dermal carriers. Interestingly, phosphatidylcholine shows properties which are similar to the properties of ceramides. It integrates in the skin barrier layers, and just like the ceramides, it is very resistant against exogenous substances. Nanoparticles, which contain phosphatidylcholine as a raw material, are very well integrated by the bilayers of the stratum corneum. Because a lipid structured nanoparticle composition can be formed with non-toxic and non-irritant lipids like phosphatidylcholine of GRAS status, they are well suited for use on damaged or inflamed skin, and may reduce the irritancy of some agents because of their controlled release properties. The small particle size diameter a solid lipid nanoparticle carrier (<60 nm) helps ensure close contact to the stratum corneum and compounds encapsulated in lipids improve selective delivery to skin layers. Solid lipid nanoparticles possess a solid matrix, which has the potential to modulate the active compounds release over a prolonged period with a reduced rate of systemic absorption (col.14, lns.6-24). In particular, Kaufman teaches the encapsulated material may have dissimilar molecular structures and physical properties. The differences in physical properties can include hydrophobic and hydrophilic moieties (col.2, lns.22-25). Specifically, Kaufman teaches nutritional supplements include phenolic compounds, e.g., tannins, lignins, and anthrocyanins (col.4, lns.65-67 to col.5, lns.6-7). Notably, nutritional supplements such as lignins and anthrocyanins are known to be water-soluble. Thus, one skilled in the art would have reasonably recognized that the teachings of Kaufman include the ‘tannins’ that are water-soluble tannins, absence evidence to the contrary. Notably, specification at para. [09] states that the term ‘phenolic polymer’ means a water-soluble polymer that includes a plurality of OH-substituted phenyl groups. Examples of phenolic polymers include lignins and tannins. Where an explicit definition is provided by the applicant for a term, that definition will control interpretation of the term as it is used in the claim. Toro Co. v. White Consolidated Industries Inc., 199 F.3d 1295, 1301, 53 USPQ2d 1065, 1069 (Fed. Cir. 1999) (meaning of words used in a claim is not construed in a “lexicographic vacuum, but in the context of the specification and drawings.”) (see MPEP 2106 C). In addition, tannins are recited in claim 2. Further, Phospholipids are recited in claim 7, along with phosphate ester in claim 56 (i.e., phospholipids are best classified as phosphate esters). Likely so, Applicants do not dispute the use of phospholipids as a surfactant, since Kaufman unquestionably teaches phospholipids are superior dermal carriers. Noteworthy, Instant Claim 29 comprising the dispersion of 13 (dependent on the dispersion of claim 1) is specifically directed to a sunscreen composition. Thus, one skilled in the art would have been motivated to use phospholipids as a surfactant to be on or surround each tannin particle in a sunscreen composition having a reasonable expectation of success to enhance the delivery of a ‘tannin’ in a sunscreen composition.
Herein, the rejections are based on the combination of references; accordingly, one cannot show nonobviousness by attacking the references individually. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicant is reminded that obviousness does not require absolute predictability In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976).
Although, Kaufman does not teach that the phenolic polymer, e.g., tannin, is preferably water soluble. However, Chung teaches the many advantages of using water soluble ‘tannins’ (i.e., Chung cures the deficiencies).
Especially obvious, Tannins are water-soluble polyphenols as taught by Chung. Moreover, Chung teaches tannin molecules have been shown to reduce the mutagenic activity of a number of mutagens, where many carcinogens and/or mutagens produce oxygen-free radicals for interaction with cellular macromolecules. The anticarcinogenic and antimutagenic potentials of tannins is related to their antioxidative property, which is important in protecting cellular oxidative damage, including lipid peroxidation. Furthermore, Chung teaches (in part) the antimicrobial activities of tannins are well documented. The growth of many fungi, yeasts, bacteria, and viruses was inhibited by tannins. Accordingly, Chung makes clear the many beneficial inherent properties of tannins. Thus, one skilled in the art would have been motivated to provide a dispersion comprising phospholipids as a surfactant to be on and surround each phenolic polymer particle to deliver ‘tannins’ comprising a release over a prolonged period with a reduced rate of systemic absorption, wherein the composition would necessarily be suitable for use in a sunscreen (i.e., protect cellular oxidative damage) having a reasonable expectation of success. Additionally, the teachings of Antwi-Boasiako are described to demonstrate the tannin particles of 0.5 microns, in combination with the teachings of Kaufman and Chung, as a whole.
The rejections are based on the combination of references: Kaufman, Chung and Antwi-Boasiako, as a whole. One cannot show nonobviousness by attacking the references individually. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The issue here is whether the teachings of Kaufman and Chung, as a whole, suggest and provide sufficient motivation to one of ordinary skill to include water soluble tannins in a composition comprising a surfactant and a phenolic polymer that is water soluble. As described above, the teachings of Kaufmam yield preferences to using phospholipids, wherein the lipid structured nanoparticles possess an outer phospholipid layer used to incorporate, e.g., tannins, wherein the phospholipids can be used to deliver ‘tannins’ in a prolonged period with a reduced rate of systemic absorption. In combination with the teaching of Chung, one of ordinary skill in the art would have preferentially selected water-soluble tannins in view of the many favorable physiological and therapeutic characteristics of water-soluble tannins. Furthermore, as described above, instant claims recite the transitional phrase ‘comprising’ and are open ended and do not exclude additional, unrecited elements or method steps. See, e.g. Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) (‘like the term ‘comprising,’ the term ‘containing’ is open-ended.). Thus, even if both water soluble and water insoluble tannin are included in the ‘tannins’ as taught by Kaufman, the claims do not exclude phenolic polymers that are water soluble and water insoluble tannins. Further, Kaufman teaches the disclosure teaches a universal platform for encapsulation of a broad range of unique and/or multiple species of nutraceuticals, and nutraceuticals having different molecular structures and physical properties without requiring changing the basic chemistry (col.2., lns.53-58). Moreover, Kaufman teaches the product is administered across the dermal and epidermal barriers (col.2., lns.60-67; col.5, lns.22-32; col.8, lns.42-53; See entire document). Especially, Kaufman teaches solid lipid nanoparticles as well as lipid emulsion nanoparticles carriers that are formed from phosphatidylcholine are superior dermal carriers, wherein the use of phospholipids is well suited for use damaged and inflamed skin and may reduce irritancy of some agents due to their controlled release properties (col.14, lns.6-19).
Regardless of what rationale is applied in a rejection for obviousness, every prior art reference is good for everything it teaches, not just the invention it describes or claims, and the combined teachings of the prior art as a whole must be considered. See EWP Corp v. Reliance Universal, Inc., 755 F.2d 898, 907 (Fed. Cir. 1985). Further, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclo-sure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971) MPEP 2123 Section II. Accordingly, one skilled in the art at the time of the invention would not be expected to rely only on: e.g., oral administration of ocular nutrients through the GI tract. Since a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), 493 U.S. 975 (1989) MPEP 2123 Section I.
Applicant is reminded that obviousness does not require absolute predictability In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). In the instant case, Applicants have failed to provide evidence showing there was no reasonable expectation of success.
Conclusions
No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
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/T.W./ Examiner, Art Unit 1619
/SARAH ALAWADI/ Primary Examiner, Art Unit 1619
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