DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Request for Continued Examination (RCE), Amendments and Remarks, filed 31 August 2026, in the matter of Application N° 18/042,679. Said documents have been entered on the record. The Examiner further acknowledges the following:
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicants’ submission filed on 31 August 2026 has been entered.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
No claims have been added or canceled.
Claims 17 and 26 have been amended. Both claims have been amended to recite “an effective amount of an oil derived from akenes of Silybum marianum (L.) Gaertn as active ingredient. [emphasis added] Claim 26 is additionally amended to recite that the cosmetic composition is free of silymarin. [emphasis added]
Both amendments are supported and add no new matter.
Thus, claims 17-31 continue to represent all claims currently under consideration.
Information Disclosure Statement
No new Information Disclosure Statement(s) (IDS) have been filed for consideration.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 30 April 2026 since the art that was previously cited continues to read on the amended and previously recited limitations.
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 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. Applicants are 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 17-31 are rejected under 35 U.S.C. 103 as being unpatentable over Saurat et al. (US Pre-Grant Publication Nº 2019/0175677 A1).
The instantly amended invention of claim 17 is directed to a method for increasing the epidermal barrier function (i.e., providing added protection) to the skin, comprising administering to a person in need thereof, an effective amount of an oil derived from the achenes of Silybum marianum (L.) Gaertn, wherein the oil is free of silymarin. [emphasis added] Independent claim 26 recites the same limitations with the additional limitation of the oil being in combination with at least one cosmetically acceptable excipient.
Saurat discloses a method for the treatment of acne, seborrhea, rosacea and/or seborrheic dermatitis comprising the administration to a subject in need thereof an effective quantity of a Silybum marianum (L.) Gaertn. achene extract (see e.g., claims 30, 42, 45 and 46). Claim 38 teaches Applicants’ instantly claimed product by process method steps and is therefore considered to teach a method of preparing an oil extract of Silybum marianum (L.) Gaertn. that is then formulated into the cosmetic composition disclosed in claims 42 and 45. The limitations of claim 45 are considered to meet the limitations of instant claim 26 and 31 in view of MPEP §2144.05(I).
Claim 43 discloses that the cosmetic formulations of claim 42 are intended for topical application.
Disclosure in ¶[0071]-¶[0075] of different excipients are considered to meet the intended treatment limitations presented in claims 18-21 and 27-30. Therein, such agents as moisturizing agents are taught as being included in the practiced compositions. Such an agent is considered to protect against water loss and moisturize the skin. Also, UV filters are compounds that block and absorb ultraviolet light in order to protect skin from the sun’s harmful UV, thereby protecting it from such effects as itching, tightness, redness and irritation (e.g., sunburn).
Based on the combined teachings of the references, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition and arriving at the recited method of treatment. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 17-31 under 35 USC 103(a) as being unpatentable over the teachings of Saurat et al. have been fully considered, but they are not persuasive.
Applicants traverse the rejection on the same premises as previously argued, namely that Saurat does not provide teaching or suggestion for increasing epidermal barrier function, and that the reference fails to teach or suggest the administered silymarin-free oil for the claimed purpose.
Regarding the former, Applicants again traverse the Examiner’s interpretation of “decreasing and/or increasing an epidermal barrier function” and reiterate that refers to the physiological protective function of the epidermis.
The Examiner again points out that Applicants’ definition for this is inclusive of such functions as supporting skin hydration, maintaining permeability, and protecting the skin from external stressors. It is respectfully maintained that formulations that moisturize and protect the skin from UV exposure, fall squarely within the instant definition and claimed methods.
Contrary to the assertion, the Examiner’s conclusion is supported by Saurat.
The Examiner concurs that Saurat does not describe the recited function or method in the exact terms used by Applicants in the response. However, it is maintained that the composition of the claimed methods is taught and suggested and topically administered to treat the skin in a manner that is consistent with “increasing a barrier function”.
In response to Applicants’ assertion that “[t]he mere disclosure of moisturizing activity, UV protection, or treatment of dermatological disease does not establish that Saurat teaches preventing decrease in and/or increasing epidermal barrier function as presently claimed,” the Examiner respectfully directs Applicants’ to such disclosures as ¶[0071]-¶[0073], which discloses additional excipients that will accomplish these very tasks when formulated with the Silybum marianum achene extract. See also ¶[0174] (Example 2).
Thus, contrary to the assertion, Applicants’ argument that the Examiner’s conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Saurat discloses cosmetic formulations which would present the ordinarily skilled artisan with a reasonable expectation of achieving the method as instantly claimed.
Applicants’ second position, it is stated that “the Examiner notes that the prior wording of the claim did not expressly specify whether the administered composition consisted solely of the silymarin-free oil or merely comprised such oil.”
With respect to this observation, the Examiner maintains that the amendments to claims 17 and 26 have not changed the interpretation of record. Applicants further attest that “the present application demonstrates that the silymarin-free oil itself provides the claimed effect on epidermal barrier function.”
The Examiner again maintains that the scope of the composition recited in the instant method is not commensurate in scope. Applicants’ composition of the recited methods simply does not exclude the presence of other excipients or additives from being combined with the claimed extract. Saurat discloses such formulations as well as the effects of applying such compositions to the skin of a given user.
Applicants’ final remarks are directed again to the assertion that Saurat provides no motivation to eliminate silymarin from the practiced compositions, despite acknowledging the disclosure of the reference.
The Examiner maintains that Saurat does teach and suggest producing an oil extract from the achenes of Silybum marianum that contain less than 0.2% or even less than 0.1% by weight of silymarin. Applicants acknowledge this teaching on the record. The Examiner respectfully submits that such a teaching would have motivated the skilled artisan to minimize the presence of silymarin in the practiced compositions with silymarin-free extracts being optimal.
Applicants’ arguments, for the above reasons, are found unpersuasive. Said rejection is therefore maintained.
Art of Interest Cited
A further brief search of the prior art by the Examiner has resulted in the following document which is also considered to minimally render obvious the instant claims: Mady et al. (Drug Design, Development and Therapy; 2016) reports on a study performed that evaluated silymarin pluronic-lecithin organogels for treating atopic dermatitis (see e.g., Title; Abstract). The reference is not considered to teach the administered composition of the instant invention. However, study does report on the use of compositions that are free of silymarin demonstrating some of the same topical relief as the silymarin-loaded organogels (see pg. 1108, paragraph bridging to pg. 1109). The passage additionally discusses that this could be explained by the fact that first line treatment of AD is hydration of the skin by using an emollient, and this hydration effect was provided by the base.
What this state-of-the-art discussion is considered to teach is that silymarin-free compositions (i.e., Saurat’s formulation) would still produce the intended effect despite not expressly disclosing the absence of silymarin (i.e., less than 0.1 wt% silymarin).
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
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