DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
Status of Claims
The amendment, filed on 22 October 2025, is acknowledged.
Claim 11 has been amended.
Claims 1-4 have been cancelled.
New claims 21-23 have been added.
Claims 9, 15, and 17-19 were previously withdrawn from consideration as being drawn to a nonelected invention in the Office Action mailed on 22 May 2025.
Claims 5-8, 10-14, 16, and 20-23 are pending and under consideration in the instant Office Action, to the extent of the following previously elected species:
the condition treated is the prevention and/or treatment of sensitive skin;
the specific additional component in the avenanthramide L composition is panthenol; and
the specific excipient in the avenanthramide L composition is citric acid.
Objections Withdrawn
Objections to Claims
Applicant’s amendment to claim 11, submitted on 22 October 2025, has overcome the objection to the claim set forth in the Office Action mailed on 22 May 2025. Applicant’s cancellation of claims 1 and 4 have rendered moot the objections to the claims set forth in the Office Action mailed on 22 May 2025. Accordingly, the relevant objections are withdrawn.
Rejections Withdrawn
Rejections pursuant to 35 U.S.C. § 112
The rejections of claims 1-4 under 35 U.S.C. § 112 are withdrawn in view of Applicant’s cancellation of the claims.
Rejections pursuant to 35 U.S.C. § 102
The rejection of claims 1-4 under 35 U.S.C. § 102 is withdrawn in view of Applicant’s cancellation of the claims.
Rejections pursuant to 35 U.S.C. § 103
The rejection of claims 1-4 under 35 U.S.C. § 103 is withdrawn in view of Applicant’s cancellation of the claims.
Maintained Rejections
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.
Claims 5-8, 10-11, 14, 16, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Redmond et al. (European Patent No. EP 1 522 304 B1, published on 15 July 2009, hereafter referred to as Redmond) as evidenced by the specification.
Redmond teaches compositions that comprise oat extracts having utility in the personal care, cosmetics, and pharmaceutical industries because the compositions are “useful as anti-irritants, anti-oxidants and skin-protection agents applied to the skin” (para. [0001]). Oat extracts and colloidal oatmeal suspensions are taught by Redmond to be historically used in the treatment of atopic dermatitis, or long-term inflammation of the skin, and the active ingredients in the oat are described as “desirable to extract…in order to facilitate the use of the grain in medicinal and cosmetic applications” (para. [0002]). The active ingredients in the extract are taught to be the group of anthranilic acid derivatives called avenanthramides, which comprises “more than 36 naturally occurring” compounds and “are unique to cereal grains” (para. [0048]). Three specific avenanthramide compounds in the extract, AF-1, AF-2, and AF-6, are shown in Figure 1 and correspond to avenanthramide L, M, and N, respectively, as evidenced by the specification (see Table 1).
The method taught by Redmond to extract the compounds of interest from oats involves milling whole oats, extracting the resulting oatmeal with a solvent, adjusting the pH, and filtering through a membrane (para. [0028]). In a surprising finding, Redmond taught a higher yield of avenanthramides from the extraction of whole oat rather than bran fractions (para. [0026]). The whole oat used in the teachings of Richmond is from the species Avena sativa (para. [0002]). The solvent used to extract avenanthramides “favorably comprises water and a primary alcohol”, with a preferred mixture taught to comprise water and ethanol (para. [0034]). The composition comprising avenanthramides extracted from oats are taught to be used as a “dermatological cosmetic product, in particular for use in the treatment of sensitive skin and/or redness” (claims 1 and 4). Taken together, these teachings anticipate the invention of instant claims 5-8, 10-11, 14, and 20.
Instant claim 16 recites a method comprising the use of avenanthramide L, or an oat extract comprising avenanthramide L, as an antagonist of the neurokinin-1 receptor NK1R. The ability of avenanthramide L to act as an antagonist is an inherent feature of the compound and recitation of these abilities does not make instant claim 16 patentably distinct. MPEP § 2112 provides guidelines on inherency and states that “something that is old does not become patentable upon the discovery of a new property”. In Atlas Powder Co. v. IRECO Inc., the U.S. Court of Appeals for the Federal Circuit stated that “the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Further, the MPEP states in § 2112.II. that the “inherent feature need not be recognized at the relevant time”.
The above guidelines on inherency apply to the teachings of Redmond, which teaches the application of a composition comprising oat extracts containing AF-1, which is necessarily avenanthramide L (as evidenced by Table 1 and para. [0068] of the instant specification, supra), to the skin and would therefore necessarily have the identical functions of serving as an antagonist of NK1R. Redmond is silent on the ability of avenanthramides, including avenanthramide AF-1, to act as an antagonist to NK1R, but the ability of anthranilic acid derivatives to act as an antagonist is the discovery of a new property and a “scientific explanation for the prior art’s function”, and therefore does not render the teachings of Redmond patentably new to the Applicant. The Applicant acknowledged in para. [0107] and [0118] that these properties were surprising newly discovered properties. Therefore, despite Redmond being silent on avenanthramides acting as antagonists, their teachings anticipate the method of instant claim 16.
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 5-8, 10-14, 16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Redmond (European Patent No. EP 1 522 304 B1, published on 15 July 2009) in view of Schmaus et al. (U.S. Patent Application Publication No. US 2016/0008297 A1, published on 14 January 2016, hereafter referred to as Schmaus).
Redmond teaches the above.
Redmond does not teach their topical composition to comprise citric acid as an antioxidant nor panthenol as a moisturizer regulator. These deficiencies are offset by the teachings of Schmaus.
Schmaus teaches compositions comprising specific compounds for “preventing, reducing or alleviating itchy skin condition(s) and/or as a PAR-2 antagonist…in particular for topical administration, preferably cosmetic or pharmaceutical compositions, in particular for preventing, reducing or alleviating one or more itchy skin conditions” (Abstract). Itchiness of the skin is taught to be “one of the most common disturbing skin conditions and can have high influence on life quality” and is stated to be a neurological phenomenon with diverse receptors involved, including histamine 1-4, NK1, and PAR-2 receptors, in addition to their mediators, and an impaired epidermal barrier (para. [0006]). The invention of Schmaus is directed to antagonizing PAR-2 receptors because of evidence that PAR-2 signaling is directly involved in skin itchiness in patients (para. [0006]).
The topical compositions taught by Schmaus comprise a PAR-2 antagonist of the formula Formula 1 (para. [0015]), in addition to additional substances selected from (i) further anti-itch compounds, (ii) steroidal anti-inflammatory substances, (iii) non-steroidal anti-inflammatory substances, (iv) natural or naturally occurring anti-inflammatory substances, (v) skin care agents, (vi) skin moisture retention regulators or skin repair agents, (vii) cooling agents, and (viii) additional receptor antagonists (para. [0042-0050]). Among the (iv) natural or naturally occurring anti-inflammatory substances that may be included in the composition are extracts from oats, further specified to be avenanthramides, natural and non-natural, in the (v) skin care agents (para. [0046-0047], [0116-0117], and [0125-0126], claims 36-37). Skin care agents of interest are taught to be panthenol, which is described as a skin moisture retention regulator, and one of the additional receptor antagonists is taught to be an NK1 antagonist (para. [0048], [0050], [0118], and [0120], claim 36). Further, the alpha-hydroxy acid citric acid is taught by Schmaus to act as an antioxidant and may be included in a preferred formulation (para. [0048], [0050], [0118], [0127], and [0157], claim 37).
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing date of the instant application, to modify the teachings of Redmond with the teachings of Schmaus to arrive at the claimed invention because combining prior art elements according to known methods yields predictable results. An artisan would be motivated to combine the teachings of Redmond and Schmaus because the former does not teach the components of their topical composition, other than avenanthramides, for treating sensitive skin in humans. Schmaus teaches additional components that can be included in a topical composition for treating sensitive skin, including the skin moisture retention regulator panthenol, the antioxidant citric acid, and a number of receptor antagonists that have utility in treating skin conditions. Among these receptor antagonists are oat extracts and the specified compounds natural and non-natural avenanthramides, as well as the PAR-2 receptor agonist of formula 1. Citric acid would be desirable for an artisan to include in the composition taught by Redmond because it would prevent undesirable oxidation of the composition, possibly leading to decomposition, and panthenol would aid in moisturizing skin, which is desirable in a skin treatment composition. An artisan would be further motivated to select avenanthramides from oat extracts as additional receptor agonists alongside the PAR-2 agonist of formula 1 because Redmond specifically teaches their effectiveness in treating the skin conditions that are the focus of Schamus’s teachings.
Schmaus further teaches a number of example formulations, including the percent composition of individual components, which are absent from the teachings of Redmond. The combination of these teachings would enable an artisan to formulate a topical composition, comprising avenanthramide AF-1 (avenanthramide L, as evidenced by Table 1 of the instant specification) and additional avenanthramides, for the treatment of sensitive skin. As a result, there is a reasonable expectation of success in arriving at the claimed invention in view of the teachings of Redmond and Schmaus.
Response to Arguments
The Applicant’s arguments, filed on 22 October 2025, have been fully considered but are not persuasive.
In para. 1 of pg. 7 of the remarks, Applicant argues that Redmond “fails to disclose an embodiment that incorporates all elements of claim 5 or claim 6”. The Examiner disagrees, as claims 5 and 6 both recite methods of using avenanthramide L or an oat extract comprising the compound “comprising administering the avenanthramide L or an oat extract comprising avenanthramide L to a subject in need thereof”. As discussed above, Redmond teaches an oat extract comprising avenanthramide AF-1 and that the extract can be used as a dermatological product for the treatment of skin.
Applicant also argues on pg. 7 that because Redmond discloses three embodiments of Figure 1 (AF-1, AF-2, and AF-6, reproduced below) with the variable “n” rather than a defined number of ethylene groups, the teachings do not anticipate a specific species, in the instant case avenanthramide L. Applicant references MPEP § 2131 (III) (interpreted as MPEP § 2131.02.III.) and states that for anticipation to exist, “one of ordinary skill in the art must be able to draw the structural formula or write the name of each of the compounds included in the generic formula” (bold added for emphasis).
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Figure 1, reproduced from Redmond.
Below is Formula 1, reproduced from pg. 10 of the instant specification:
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According to para. [0068] of the instant specification, avenanthramide L, using the non-Collins abbreviation, is a compound of Formula 1 in which R1=R3=OH, R2=R4=H, and n=2, with CAS no. 172549-38-1. This is equivalent to a compound of AF-1 in Figure 1 from Redmond above with n=2.
Additionally, the text quoted from MPEP § 2131.02.III. by the Applicant is regarding In re Petering, 301 F.2d 676, 681(CCPA 1962), and omits relevant information from the MPEP regarding the writings of the Court:
In In re Petering, the prior art disclosed a generic chemical formula "wherein X, Y, Z, P, and R'- represent either hydrogen or alkyl radicals, R a side chain containing an OH group." The court held that this formula, without more, could not anticipate a claim to 7-methyl-9-[d, l'-ribityl]-isoalloxazine because the generic formula encompassed a vast number and perhaps even an infinite number of compounds. However, the reference also disclosed preferred substituents for X, Y, Z, P, R, and R' as follows: where X, P, and R' are hydrogen, where Y and Z may be hydrogen or methyl, and where R is one of eight specific isoalloxazines. The court determined that this more limited generic class consisted of about 20 compounds. The limited number of compounds covered by the preferred formula in combination with the fact that the number of substituents was low at each site, the ring positions were limited, and there was a large unchanging structural nucleus, resulted in a finding that the reference sufficiently described "each of the various permutations here involved as fully as if he had drawn each structural formula or had written each name." The claimed compound was 1 of these 20 compounds. Therefore, the reference "described" the claimed compound and the reference anticipated the claims (bold added for emphasis).
Because Redmond teaches identical substituents for R1, R2, R3, and R4, as well as the same structural nucleus, and only the number of linking ethylene groups “n” may vary, the Redmond reference is determined to anticipate the claimed compound avenanthramide L.
Applicant further argues on pg. 7 that Redmond does not describe the use of avenanthramide L in any compositions or methods nor attribute any benefit to the use “of any specific compound, let alone avenanthramide L”. This is not found persuasive for the same reason above - in brief, Redmond teaches a composition comprising oat extracts, in which compound AF-1 exists. Redmond also explicitly teaches that a composition comprising the oat extract can be used as a dermatological product for the treatment of skin, which is determined to be a benefit to the user.
In para. 3 of pg. 9, Applicant argues that the Schmaus reference does not remedy deficiencies with the Redmond reference because it is “silent with respect to any other specific avenanthramides or avenanthramide analogs, let alone avenanthramide L”. Applicant also argues that Schmaus does not teach any benefits from the inclusion of avenanthramides. The argument regarding the deficiencies of Redmond is not found persuasive for the reasons above, and the argument regarding avenanthramide L and its benefits are an argument against the Schmaus reference individually, which cannot show nonobviousness where the rejections are based on combinations of references. 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 Schmaus reference is used for its teachings that a composition for treatment of a user’s skin would advantageously comprise panthenol, citric acid, and other beneficial receptor antagonists that are known to have utility in skin treatment, and not for a teaching of the specific compound avenanthramide L.
From the penultimate para. of pg. 9 to the penultimate para. of pg. 10, Applicant states that they have “advantageously found that avenanthramide L exhibited marked activity against the neurokinin-1 receptor (NK1R)” and discusses its activity, concluding that because the Redmond and Schmaus references do not teach this activity, there is no motivation to select avenanthramide L for use in the methods as claimed. As stated in the Non-Final Office Action, mailed on 22 May 2025, and repeated here in brief, application of an oat extract composition comprising avenanthramide L is taught by Redmond to treat irritated skin and inherently acts as an antagonist and/or induces protein expression. “Something that is old does not become patentable upon the discovery of a new property”, see MPEP § 2112.I. In Atlas Powder Co. v. IRECO Inc., the U.S. Court of Appeals for the Federal Circuit stated that “the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). The Applicant finding a mechanism for avenanthramide soothing the skin of a user following application does not render the composition patentably new.
New Grounds of Rejection
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this section can be found above.
Claims 21-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Redmond (European Patent No. EP 1 522 304 B1, published on 15 July 2009) as evidenced by the specification.
Redmond has been described above.
Instant claims 21-23 recite methods comprising the use of avenanthramide L, or an oat extract comprising avenanthramide L, for inducing the expression of small heat shock proteins (sHSPs) sHSP27 (HSPB1, HSPB2, HSPB3) or aB-crystallin (CRYAB/HSPB5), CD44, or biliverdin reductase B (BLVRB). The ability of avenanthramide L to induce protein expression is an inherent feature of the compound and recitation of these abilities does not make instant claims 21-23 patentably distinct. MPEP § 2112 provides guidelines on inherency and states in § 2112.I. that “something that is old does not become patentable upon the discovery of a new property”. In Atlas Powder Co. v. IRECO Inc., the U.S. Court of Appeals for the Federal Circuit stated that “the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Further, the MPEP states in § 2112.II. that the “inherent feature need not be recognized at the relevant time”.
The above guidelines on inherency apply to the teachings of Redmond, which teaches the application of a composition comprising oat extracts containing AF-1, which is necessarily avenanthramide L (as evidenced by Table 1 and para. [0068] of the instant specification, supra), to the skin and would therefore necessarily have the identical functions of inducing the expression of sHSPs sHSP27 (HSPB1, HSPB2, HSPB3) or aB-crystallin (CRYAB/HSPB5), CD44, or BLVRB. Redmond is silent on the ability of avenanthramides, including avenanthramide AF-1, to induce the expression of proteins, but the ability of the anthranilic acid derivatives to induce the expression of proteins is the discovery of a new property and a “scientific explanation for the prior art’s function”, and therefore does not render the teachings of Redmond patentably new to the Applicant. The Applicant acknowledged in para. [0107] and [0118] that these properties were surprising newly discovered properties. Therefore, despite Redmond being silent on avenanthramides inducing protein expression, their teachings anticipate the method of instant claims 21-23.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.J.S./
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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