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 .
Response to Election/Restriction
Applicant’s election without traverse of Group 1, claims 1-8, 10-14, 16, and 20, in the reply filed on 16 April 2025, is acknowledged. The species elected are the prevention and/or treatment of sensitive skin, panthenol, and citric acid.
Status of Claims
The preliminary amendment, filed on 6 September 2022, is acknowledged. Claims 1-16 and 18 are amended.
New claims 19-20 are added.
Claims 1-20 are pending in the instant application.
Claims 9, 15, and 17-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 16 April 2025.
Claims 1-8, 10-14, 16, and 20 are under consideration in the instant Office Action, to the extent of the following 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.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 2 December 2022, 6 December 2023, 14 December 2023, and 4 April 2024, were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1, 4 and 11 are objected to because of the following informalities:
Claim 4 currently recites “of the method of claim 6” in the first line of the claim. The Examiner believes the word “of” should not have been added during amendments and the word “the” should be capitalized so the claim reads “The method of claim 6”.
Claim 11 currently recites “at least one naturally occuring analogue avenanthramide” in the third and fourth lines of the claim. The claim should read “at least one naturally occurring analogue of avenanthramide”.
Claim 11 currently recites “at least one non-naturally occurring analogue avenanthramide” in the final line of the claim. The claim should read “at least one non-naturally occurring analogue of avenanthramide”.
Applicant is advised that should claim 16 be found allowable, claim 1 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the “expression of BLVRB” in the third line of the claim. There is no explanation of the meaning of this abbreviation in the claim and the language is therefore indefinite. The first use of an abbreviation in a claim should be preceded by the full definition of the abbreviation, as in claim 2 regarding sHSPs, followed by the abbreviation in parentheses, and subsequent uses of the term can use the shortened abbreviation. Applicant can overcome this rejection by writing the full definition of “BLVRB” when it is first recited in the instant claims.
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.
Claims 1-4 are 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.
Claims 1-4 depend from claim 6, a succeeding claim. A series of singular dependent claims is permissible in which a dependent claim refers to a preceding claim which, in turn, refers to another preceding claim.
A claim which depends from a dependent claim should not be separated by any claim which does not also depend from said dependent claim. It should be kept in mind that a dependent claim may refer to any preceding independent claim. In general, applicant's sequence will not be changed. See MPEP § 608.01(n)(III).
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.
Claims 1-8, 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 claims 1-4 and 16 recite methods comprising the use of Avenanthramide L, or an oat extract comprising Avenanthramide L, as an antagonist of the neurokinin-1 receptor NK1R, for inducing the expression of small heat shock proteins (sHSPs) sHSP27 (HSPB1, HSPB2, HSPB3) or aB-crystallin (CRYAB/HSPB5), CD44, or BLVRB. The ability of Avenanthramide L to act as an antagonist or induce protein expression is an inherent feature of the compound and recitation of these abilities does not make instant claims 1-4 and 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 of the specification, supra), to the skin and would therefore necessarily have the identical functions of serving as an antagonist of NK1R or 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 act as an antagonist to NK1R or induce the expression of proteins, but the ability of the anthranilic acid derivatives to act as an antagonist and 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 acting as antagonists or inducing protein expression, their teachings anticipate the invention of instant claims 1-4 and 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 1-8, 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN J. STEINKE whose telephone number is (571) 272-3396. The examiner can normally be reached Monday - Friday, 09:00 - 17:00 ET.
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/S.J.S./Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619