DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/16/2026 has been entered.
Formal Matters
Receipt of Applicant’s response dated 01/16/2026 is acknowledged.
Claims 1 and 9-21 are pending.
Claims 2-8 are canceled.
Claims 20-21 are new.
Claim 1 is amended.
Claims 10-19 remain withdrawn from consideration as being drawn to a nonelected invention.
New claims 20-21 are withdrawn from consideration as being drawn to nonelected species (i.e., each of these claims do not recite the combination of a chelating agent being trisodium ethylenediamine disuccinate and an antioxidant being tocopherol).
Claims 1 and 9 are under consideration in the instant Office action to the extent of the elected species, i.e., the at least one avenanthramide or analogue thereof is avenanthramide L and the at least two avenanthramide stabilizers is the combination of trisodium ethylenediamine disuccinate and tocopherol.
Information Disclosure Statement
The information disclosure statement (IDS) filed 12/17/2025 has been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
OBJECTIONS/REJECTIONS WITHDRAWN
Specification
The objection to the abstract set forth in the Office action dated 10/16/2025 is hereby withdrawn in light of Applicant’s amendment to the abstract.
Claim Rejections - 35 USC § 112(b)
The rejection of claim 8 set forth in the Office action dated 10/16/2025 is hereby withdrawn in light of Applicant’s cancelation of claim 8.
Claim Rejections - 35 USC § 112(d)
The rejection of claim 8 set forth in the Office action dated 10/16/2025 is hereby withdrawn in light of Applicant’s cancelation of claim 8.
Claim Rejections - 35 USC § 102
The anticipation rejection of claims 1, 5, and 7-8 over Sweeney et al set forth in the Office action dated 10/16/2025 is hereby withdrawn in light of Applicant’s amendments to the claims and in favor of the new grounds of rejection set forth below.
Claim Rejections - 35 USC § 103
The obviousness rejection of claims 1, 5, and 7-9 over Sweeney et al set forth in the Office action dated 10/16/2025 is hereby withdrawn in light of Applicant’s amendments to the claims and in favor of the new grounds of rejection set forth below.
Double Patenting
The nonstatutory double patenting provisional rejection of claims 1, 5, and 7-9 over claims 1, 2, 5, 10-12, 16, and 17 of copending Application No. 17/909,343 in view of Sweeney et al set forth in the Office action dated 10/16/2025 is hereby withdrawn in light of Applicant’s amendments to the claims and in favor of the new grounds of rejection set forth below.
NEW GROUNDS OF OBJECTION/REJECTION
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code at least on Page 12 of the specification (See below table on Page 12).
Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 9 recites "the at least one avenanthramide or analogue thereof" and depends on claim 1 which recites "at least one avenanthramide selected from the group consisting of avenanthramides A, B, C, G, H, K, L, and R and dihydroavenanthramide D". Because claim 1 limits the at least one avenanthramide to the group consisting of avenanthramides A, B, C, G, H, K, L, and R and dihydroavenanthramide D, but claim 9 recites the broader scope of the at least one avenanthramide including any and all analogues of the at least one avenanthramide, claim 9 is rejected for failing to further limit the subject matter of claim 1 and for failing to include all of the limitations of claim 1.
The Examiner suggests amending "the at least one avenanthramide or analogue thereof" in claim 9 to "the at least one avenanthramide" in order to overcome this rejection.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sweeney et al (US 9,636,292 B2, published 05/02/2017, cited in Notice of References Cited dated 03/10/2025).
Sweeney et al teach a topical skin care composition for the treatment and prevention of skin damage due to environmental factors (See entire document, e.g., Abstract).
Sweeney et al exemplify two compositions, a topical cream composition for day use and a topical cream composition for night use, each comprising 0.250% Avena sativa (oat) kernel flour, 0.100% trisodium ethylenediamine disuccinate, 1.000% of the combination of Oryza sativa (rice) bran extract, Rosmarinus officinalis (rosemary) leaf extract, Heliantus annuus (sunflower) seed oil, and tocopherol, and 1.000% of the combination of Avena sativa (oat) extract, water, glycerin, and potassium sorbate, where percent is based on the total weight of the composition (See Tables 1 and 2 in Col. 8-10).
Because each of the topical cream composition for day use and the topical cream composition for night use of Sweeney et al comprises Avena sativa, each of the topical cream composition for day use and the topical cream composition for night use of Sweeney et al necessarily comprise avenanthramide L, as evidenced by Par. [0009], [0039]-[0040], [0043] and [0045] of the instant specification.
Thus, the topical cream compositions for day and night use of Sweeney et al read on instant claim 1 to the extent of the elected species.
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.
The factual inquiries 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.
Claims 1 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney et al (US 9,636,292 B2, published 05/02/2017, cited in Notice of References Cited dated 03/10/2025).
The exemplified topical skin care compositions of Sweeney et al have been discussed supra. The instant rejection, however, applies the general teachings of Sweeney et al in a rejection of instant claims 1 and 9 distinct from the above rejection under 35 USC 102 of instant claim 1.
Sweeney et al teach a topical skin care composition for the treatment and prevention of skin damage due to environmental factors (See entire document, e.g., Abstract).
The topical skin care composition comprises an oat avenanthramide extract and an all-natural anti-oxidant complex composed of rice extract, rosemary extract, sunflower extract and natural tocopherols (e.g., Col. 1 Lines 33-44).
The oat avenanthramide extract has been found to be a natural anti-oxidant and anti-irritant that protects from UV exposure and reduces redness, inflammation and itching of the skin (e.g., Col. 5 Lines 10-13). One source of the oat avenanthramide extract is CP Oat Avenanthramide Extract 902-3043 sold by Ceapro, Inc., which includes Avena sativa (oat) extract, water, glycerin and potassium sorbate (e.g., Col. 5 Lines 8-16), which necessarily comprises avenanthramide L as evidenced by Par. [0009], [0039]-[0040], [0043] and [0045] of the instant specification. The oat avenanthramide extract is present in the compositions in an amount ranging from 0.1% to 3.0% by weight of the composition (e.g., Col. 5 Lines 17-20).
The all-natural anti-oxidant complex has been found to protect natural oils of the skin from oxidative degradation (e.g., Col. 7 Lines 40-42). One source of the all-natural anti-oxidant complex is Bottanessential RRST sold by Botanigenics (USA), which includes Oryza sativa (rice) bran extract, Rosmarinus officinalis (rosemary) leaf extract, Heliantus annuus (sunflower) seed oil, and tocopherol (e.g., Col. 7 Lines 42-46). The all-natural anti-oxidant complex is present in an amount ranging from 0.1% to 2.0% by weight of the composition (e.g., Col. 7 Lines 47-50).
Other optional ingredients for topical application include trisodium ethylenediamine disuccinate used as a chelating agent (e.g., Col. 8 Lines 20-27). Trisodium ethylenediamine disuccinate is used in exemplified topical skin care compositions at 0.100% based on the weight of the composition (e.g., Col. 8 Table 1, Col. 10 Table 2).
Based on the teachings of Sweeney et al, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide a topical skin care composition comprising the oat avenanthramide extract being CP Oat Avenanthramide Extract 902-3043 (which comprises avenanthramide L) from 0.1% to 3.0%, the all-natural anti-oxidant complex being Bottanessential RRST (which comprises tocopherol) from 0.1% to 2.0%, and trisodium ethylenediamine disuccinate as a chelating agent at 0.100%, where percent is based on the weight of the composition. One of ordinary skill in the art would have been motivated to do so in order to provide a topical skin care composition, using commercially available ingredients, that protects from UV exposure and reduces redness, inflammation and itching of the skin and protects the natural oils of the skin from oxidative degradation. There would have been a reasonable expectation of success because Sweeney et al teach the compatibility of these ingredients in these amounts in a topical skin care composition for the treatment and prevention of skin damage due to environmental factors.
The topical skin care composition of Sweeney et al comprising from 0.1% to 2.0% of Bottanessential RRST (which comprises tocopherol) as the all-natural anti-oxidant complex and 0.100% of trisodium ethylenediamine disuccinate necessarily has a content of tocopherol and trisodium ethylenediamine disuccinate that overlaps with the range of 0.02 to 0.5 wt% required by instant claim 9. A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)).
Thus, the teachings of Sweeney render obvious instant claims 1 and 9 to the extent of the elected species.
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).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 10-12, 16-17, and 21 of copending Application No. 17/909,343 (hereafter ‘343) in view of Sweeney et al (US 9,636,292 B2, published 05/02/2017, cited in Notice of References Cited dated 03/10/2025).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant claims 1 and 9 recite a composition comprising: at least one avenanthramide selected from the group consisting of avenanthramides A, B, C, G, H, K, L, and R and dihydroavenanthramide D; and at least two avenanthramide stabilizers, wherein the at least two avenanthramide stabilizers comprise a chelating agent and an organic carboxylic acid; or a chelating agent and an antioxidant; or an organic carboxylic acid and an antioxidant; or a chelating agent, an organic carboxylic acid, and an antioxidant. wherein the chelatinq agent, when present, is selected from the qroup consisting of EDTA and its salts, phvtic acid, tetrasodium glutamate diacetate, trisodium ethylenediamine disuccinate, sodium citrate, potassium citrate, sodium phvtate, sodium qluconate, calcium qluconate, caprylhydroxamic acid, qalactaric acid, qalacturonic acid, sodium metaphosphate, sodium polvitaconate, disodium etidronate and trisodium methylqlycinediacetic acid; wherein the organic carboxylic acid, when present, is selected from the qroup consisting of gluconic acid, glyceric acid, glycolic acid, isocitric acid, lactic acid, malic acid, citric acid, mandelic acid, azelaic acid, anisic acid, ectoin, ferulic acid, folic acid, levulinic acid, niacin, sebacic acid, salicylic acid, sorbic acid, tartaric acid, 2-hydroxyoctanoic acid, 2-hydroxydecanoic acid, salts of the foregoing, mixtures of the foregoing, and gluconolactone; and wherein the antioxidant, when present, is selected from the group consistinq of 4-hydroxyacetophenone, ascorbic acid, 6-paradol, uric acid, butylhydroxytoluol (BHT), butylhydroxyanisol (BHA), ascorbyl palmitate, ascorbyl phosphate and salts thereof, carnosine, sodium ascorbate, rutin, tocopherol, tocopheryl acetate, ubiquinone, tropolone and allantoin, wherein the composition comprises 0.0001 to 5.0 wt% of the at least one avenanthramide or analogue thereof; and 0.02 to 0.5 wt% of the at least two avenanthramide stabilizers, based on the total weight of the composition.
Claims 1-2, 10-12, 16-17, and 21 of ‘343 recite a composition comprising: 0.0001 to 1.0 wt% of at least one avenanthramide or an analogue thereof; and 0.005 to 2.0 wt% of 4-hydroxyacetophenone, based on the total weight of the composition, wherein the ratio of the amount of the at least one avenanthramide to the amount of 4-hydroxyacetophenone is in a range of 1:1 to 1:50, or wherein the ratio of the amount of the at least one avenanthramide analogue to the amount of 4-hydroxyacetophenone is in a range of 1:0.2 to 1:30, wherein the at least one avenanthramide is selected from the group consisting of avenanthramides A, B, C, G, H, K, L, and R, and mixtures thereof or the group consisting of avenanthramide A and avenanthramide L, and the composition further comprising one or more active substances selected from the group consisting of skin-moisturising or moisture-retaining substances, cooling agents, osmolytes, keratological substances, nurturing substances, anti-inflammatory, antibacterial or antimycotic substances, substances having a reddening- alleviating or itch-alleviating action, lenitive substances, cosmetically or pharmaceutically acceptable excipients selected from the group consisting of antioxidants, preservatives, (metal) chelating agents, penetration enhancers, surface-active substances, emulsifiers, perfume oils, anti-foaming agents, colorants, pigments having a colouring action, thickeners, plasticisers, fats, oils, waxes or other conventional components of a cosmetic composition, such as alcohols, polyols, polymers, foam stabilisers, electrolytes, organic solvents or silicone derivatives, and thereof, and a food, food supplement, or cosmetic, pharmaceutical or veterinary preparation comprising the composition in an amount of 0.0001 to 5.0 % by weight of the composition and further comprising one or more active substances selected from the group of skin-moisturising and/or moisture-retaining substances, cooling agents, osmolytes, keratological substances, nurturing substances, anti-inflammatory, antibacterial or antimycotic substances, substances having a reddening-alleviating or itch- alleviating action, lenitive substances, mixtures of the foregoing, and cosmetically or pharmaceutically acceptable excipients selected from the group of antioxidants, preservatives, chelating agents, penetration enhancers, surface-active substances, emulsifiers, perfume oils, anti-foaming agents, colorants, pigments having a colouring action, thickeners, plasticisers, fats, oils, waxes, alcohols, polyols, polymers, foam stabilisers, electrolytes, organic solvents, silicone derivatives, and mixtures of these.
Claims 1-2, 10-12, 16-17, and 21 of ‘343 do not recite the chelating agent being trisodium ethylenediamine disuccinate, the antioxidant being tocopherol, or the chelating agent and antioxidant being present in the composition from 0.02 to 0.5 wt% based on the total weight of the composition.
These deficiencies are made up for in the teaching of Sweeney et al, which has been discussed in detail supra.
It would have been prima facie obvious to one of ordinary skill in the art to provide the composition of claims 1-2, 10-12, 16-17, and 21 of ‘343 comprising Bottanessential RRST (which comprises tocopherol) as the antioxidant from 0.1% to 2.0% and trisodium ethylenediamine disuccinate as the chelating agent at 0.100%, where percent is based on the weight of the composition. One of ordinary skill in the art would have been motivated to do so because Sweeney et al teach that Bottanessential RRST is a source of an all-natural anti-oxidant complex that has been found to protect natural oils of the skin from oxidative degradation (e.g., Col. 7 Lines 37-46) and teach that trisodium ethylenediamine disuccinate is a compatible chelating agent with a topical skin care composition comprising an oat avenanthramide extract for the treatment and prevention of skin damage due to environmental factors (e.g., Abstract, Col. 8 Table 1, Col. 10 Table 2).
Thus, claims 1-2, 10-12, 16-17, and 21 of ‘343 render obvious instant claims 1 and 9 to the extent of the elected species.
Claims 1 and 9 are directed to an invention not patentably distinct from claims 1-2, 10-12, 16-17, and 21 of commonly assigned copending Application No. 17/909,343. Specifically, see above.
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 copending Application No. 17/909,343, 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. 100(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. 100(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.
Claims 1 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 10-11, and 15 of copending Application No. 17/909,340 (hereafter ‘340) in view of Sweeney et al (US 9,636,292 B2, published 05/02/2017, cited in Notice of References Cited dated 03/10/2025).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant claims 1 and 9 recite a composition comprising: at least one avenanthramide selected from the group consisting of avenanthramides A, B, C, G, H, K, L, and R and dihydroavenanthramide D; and at least two avenanthramide stabilizers, wherein the at least two avenanthramide stabilizers comprise a chelating agent and an organic carboxylic acid; or a chelating agent and an antioxidant; or an organic carboxylic acid and an antioxidant; or a chelating agent, an organic carboxylic acid, and an antioxidant. wherein the chelatinq agent, when present, is selected from the qroup consisting of EDTA and its salts, phvtic acid, tetrasodium glutamate diacetate, trisodium ethylenediamine disuccinate, sodium citrate, potassium citrate, sodium phvtate, sodium qluconate, calcium qluconate, caprylhydroxamic acid, qalactaric acid, qalacturonic acid, sodium metaphosphate, sodium polvitaconate, disodium etidronate and trisodium methylqlycinediacetic acid; wherein the organic carboxylic acid, when present, is selected from the qroup consisting of gluconic acid, glyceric acid, glycolic acid, isocitric acid, lactic acid, malic acid, citric acid, mandelic acid, azelaic acid, anisic acid, ectoin, ferulic acid, folic acid, levulinic acid, niacin, sebacic acid, salicylic acid, sorbic acid, tartaric acid, 2-hydroxyoctanoic acid, 2-hydroxydecanoic acid, salts of the foregoing, mixtures of the foregoing, and gluconolactone; and wherein the antioxidant, when present, is selected from the group consistinq of 4-hydroxyacetophenone, ascorbic acid, 6-paradol, uric acid, butylhydroxytoluol (BHT), butylhydroxyanisol (BHA), ascorbyl palmitate, ascorbyl phosphate and salts thereof, carnosine, sodium ascorbate, rutin, tocopherol, tocopheryl acetate, ubiquinone, tropolone and allantoin, wherein the composition comprises 0.0001 to 5.0 wt% of the at least one avenanthramide or analogue thereof; and 0.02 to 0.5 wt% of the at least two avenanthramide stabilizers, based on the total weight of the composition.
Claims 1, 4, 10-11, and 15 of ‘340 recite a composition comprising: avenanthramide L; and a penetration enhancer comprising a diol, wherein the composition comprises 0.0001 to 5.0 wt% or 0.001 to 1.0 wt% of avenanthramide L, and 0.01 to 10.0 wt% of the penetration enhancer based on the total weight of the composition, and a cosmetic or pharmaceutical preparation comprising the composition and further comprising one or more active substances selected from the group consisting of skin-moisturising and/or moisture-retaining substances, cooling agents, osmolytes, keratological substances, nurturing substances, anti-inflammatory, antibacterial or antimycotic substances, substances having a reddening-alleviating or itch-alleviating action, lenitive substances, mixtures of the foregoing, cosmetically or pharmaceutically acceptable excipients selected from the group consisting of antioxidants, preservatives, chelating agents, surface-active substances, emulsifiers, perfume oils, anti-foaming agents, colorants, pigments having a colouring action, thickeners, plasticisers, fats, oils, waxes, alcohols, polyols, polymers, foam stabilisers, electrolytes, organic solvents, silicone derivatives, and a mixture of any of the foregoing.
Claims 1, 4, 10-11, and 15 of ‘340 do not recite the chelating agent being trisodium ethylenediamine disuccinate, the antioxidant being tocopherol, or the chelating agent and antioxidant being present in the composition from 0.02 to 0.5 wt% based on the total weight of the composition.
These deficiencies are made up for in the teaching of Sweeney et al, which has been discussed in detail supra.
It would have been prima facie obvious to one of ordinary skill in the art to provide the composition of claims 1, 4, 10-11, and 15 of ‘340 comprising Bottanessential RRST (which comprises tocopherol) as the antioxidant from 0.1% to 2.0% and trisodium ethylenediamine disuccinate as the chelating agent at 0.100%, where percent is based on the weight of the composition. One of ordinary skill in the art would have been motivated to do so because Sweeney et al teach that Bottanessential RRST is a source of an all-natural anti-oxidant complex that has been found to protect natural oils of the skin from oxidative degradation (e.g., Col. 7 Lines 37-46) and teach that trisodium ethylenediamine disuccinate is a compatible chelating agent with a topical skin care composition comprising an oat avenanthramide extract for the treatment and prevention of skin damage due to environmental factors (e.g., Abstract, Col. 8 Table 1, Col. 10 Table 2).
Thus, claims 1, 4, 10-11, and 15 of ‘340 render obvious instant claims 1 and 9 to the extent of the elected species.
Claims 1 and 9 are directed to an invention not patentably distinct from claims 1, 4, 10-11, and 15 of commonly assigned copending Application No. 17/909,340. Specifically, see above.
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 copending Application No. 17/909,340, 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. 100(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. 100(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 Applicant’s Arguments
Applicant’s arguments filed on 01/16/2026 have been considered.
Regarding the rejection under 35 USC 102 set forth in the Office action dated 10/16/2025, Applicant argues that Sweeney in view of the present specification does not establish that the exemplary compositions described in Tables 1 and 2 necessarily contain an avenanthramide, let alone avenanthramide L. Applicant argues that Sweeney describes oat extracts but does not describe or identify any specific avenanthramides that are allegedly present in any particular oat extract. Applicant argues that the specification does not teach that any particular avenanthramide is necessarily present in the oat extract of the Sweeney compositions.
The above argument has been fully considered by the Examiner but are not found persuasive because Sweeney et al teach two compositions, a topical cream composition for day use and a topical cream composition for night use, each comprising 0.250% Avena sativa (oat) kernel flour, 0.100% trisodium ethylenediamine disuccinate, 1.000% of the combination of Oryza sativa (rice) bran extract, Rosmarinus officinalis (rosemary) leaf extract, Heliantus annuus (sunflower) seed oil, and tocopherol, and 1.000% of the combination of Avena sativa (oat) extract, water, glycerin, and potassium sorbate, where percent is based on the total weight of the composition. The Examiner agrees that Sweeney et al do not describe or identify the avenanthramides present in the compositions and that the instant specification does not teach the avenanthramides present in the compositions of Sweeney et al, however the instant specification does provide evidence that the compositions of Sweeney et al necessarily comprise avenanthramide L. In addition to Par. [0043] and [0045] which were pointed to in the rejection under 35 USC 102 set forth in the Office action dated 10/16/2025, the Examiner further points to Par. [0009] of the instant specification which states that “avenanthramides… are a group of naturally occurring phenolic amides in oats, both A. sativa and A. nuda… Oats contain a unique group of approximately 40 different types of [avenanthramides], which are present in both oat grains and leaves, Par. [0039] of the instant specification which states that “within the context of the present invention, the term "avenanthramide(s)" (anthranilic acid amides) is understood to mean a member of a group of phenolic alkaloids, i.e. naturally occurring avenanthramide(s), found mainly in oats (Avena sativa)” and Par. [0040] of the instant specification which states that “the avenanthramides of the composition of the present invention are naturally found in and can be isolated and purified from oats. The two main species of oats are Avena sativa L. and Avena nuda L.” Par. [0043] presents a table of said naturally occurring avenanthramides. Therefore, the instant specification clearly provides evidence for the compositions of Sweeney et al necessarily comprise the naturally occurring avenanthramides including avenanthramide L because the compositions of Sweeney et al comprise Avena sativa.
Regarding the rejection under 35 USC 103 set forth in the Office action dated 10/16/2025, Applicant argues that the instant specification simply lists avenanthramides that can be obtained or isolated from oats of the genus Avena, including A. sativa and A. nuda, and the specification does not teach that any particular avenanthramide, let alone avenanthramide L, is necessarily present in all oat-derived extracts, such as the Ceapro, Inc., Avena sativa extract described in Sweeney. Applicant argues that Sweeney in view of the present specification does not teach that the oat extract necessarily contains any particular avenanthramide, let alone avenanthramide L. Applicant argues the present application demonstrates benefits to selecting an avenanthramide and at least two avenanthramide stabilizers as claimed that would not have
been predicted based on the disclosure of Sweeney. Sweeney describes many ingredients
that can be present in the topical compositions disclosed therein but does not provide
motivation to particularly select an avenanthramide in combination with at least two
avenanthramide stabilizers as claimed with any expectation of a benefit. Regarding the benefits of the present application, Applicant argues the present application demonstrates synergistic benefits to stability of avenanthramides resulting from formulating with at least two avenanthramide stabilizers as claimed and points to stability tests of avenanthramide C and avenanthramide B.
The above arguments have been fully considered by the Examiner but are not found persuasive because, firstly, Sweeney et al as evidenced by the instant specification does teach that the oat extract necessarily contains avenanthramide L. The composition of Sweeney et al comprises CP Oat Avenanthramide Extract 902-3043 sold by Ceapro, Inc., which includes Avena sativa (oat) extract, water, glycerin and potassium sorbate. For the same reasons as discussed in response to the rejection under 35 USC 102 above (See discussion of Par. [0009] and [0039]-[0040] of the instant specification), the instant specification clearly provides evidence for the composition of Sweeney et al necessarily comprising the naturally occurring avenanthramides including avenanthramide L because the composition of Sweeney et al comprises Avena sativa. The arguments regarding synergistic benefits have been considered but are not found persuasive because the instant claims are being examined to the extent of the elected species, which includes the at least one avenanthramide or analogue thereof is avenanthramide L, and therefore, arguments regarding the stability of avenanthramide C and avenanthramide B are not applicable. Further, the arguments regarding Sweeney not teaching said benefits have been considered but are not found persuasive because it is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). The argument regarding Sweeney et al describing many ingredients for which the rejection under 35 USC 103 picks from has been considered but is not found persuasive because it is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands (Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985)).
Applicant’s arguments regarding new claims 20-21 are moot as each of new claims 20-21 are withdrawn as being drawn to nonelected species.
Regarding the provisional double patenting rejection set forth in the Office action dated 10/16/2025 over copending application ‘343, Applicant argues that claims of ‘343 recite a composition comprising an avenanthramide or analogue thereof and 4-hydroxyacetophenone and none of the cited claims recite a composition comprising at least two avenanthramide stabilizers of the types recited in amended claim 1, let alone at least two of the specific stabilizers recited in amended claim 1. Applicant argues that even if the 4-hydroxyacetophenone of the '343 application were considered to be an avenanthramide stabilizer, the cited claims of the '343 application do not disclose or suggest a composition comprising at least two avenanthramide stabilizers comprising a chelating agent and an organic carboxylic acid, or a chelating agent and an antioxidant, or an organic carboxylic acid and an antioxidant, or a chelating agent, an organic carboxylic acid, and an antioxidant, as claimed. Applicant argues that Sweeney does not remedy the deficiencies of the '343 application as Sweeney does not disclose or suggest a composition comprising at least two avenanthramide stabilizers as claimed. Applicant argues that the present application demonstrates synergistic benefits to oxidative stability of avenanthramides resulting from formulating with at least two avenanthramide stabilizers as claimed, whereas the cited claims of the '343 application in view of Sweeney do not provide motivation to select at least two avenanthramide stabilizers as claimed with any expectation of such a benefit.
The above argument has been fully considered by the Examiner but are not found persuasive because, firstly, the rejection does not rely on the basis that 4-hydroxyacetophenone of the '343 application is an avenanthramide stabilizer. As can be seen in the above rejection, the claims of ‘343 recite that the composition may comprise pharmaceutically acceptable excipients selected from a group including antioxidants and chelating agents, however do not recite suitable antioxidants or chelating agents, which is cured by the teaching of Sweeney et al. The basis of the rejection is that it would have been prima facie obvious to one of ordinary skill in the art to provide the composition of claims 1-2, 10-12, 16-17, and 21 of ‘343 comprising Bottanessential RRST (which comprises tocopherol) as the antioxidant from 0.1% to 2.0% and trisodium ethylenediamine disuccinate as the chelating agent at 0.100%, where percent is based on the weight of the composition. One of ordinary skill in the art would have been motivated to do so because Sweeney et al teach that Bottanessential RRST is a source of an all-natural anti-oxidant complex that has been found to protect natural oils of the skin from oxidative degradation and teach that trisodium ethylenediamine disuccinate is a compatible chelating agent with a topical skin care composition comprising an oat avenanthramide extract for the treatment and prevention of skin damage due to environmental factors. The argument regarding the cited claims of the '343 application in view of Sweeney not teaching synergistic benefits demonstrated in the present application has been considered but is not found persuasive because it is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991).
Conclusion
No claims are allowable.
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/K.E.O./Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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