DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Request for Continued Examination (RCE), Amendments and Remarks, filed 6 January 2026, in the matter of Application N° 18/042,679. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 20 is discussed as having been canceled.
Claim 17 is noted as having been amended to add the limitation that the applied “oil is free of silymarin” and support for the amendment is “found in now-canceled claim 20.”
Contrary to the foregoing, the Examiner observes that claim 20 is neither canceled, nor does it recite any language which would be considered to support the newly presented limitation that now resides in claim 17. The limitation is addressed herein (see New Rejections).
No new claims have been added.
Thus, claims 17-31 continue to represent all claims currently under consideration.
Information Disclosure Statement
One new Information Disclosure Statement (IDS) filed 5 December 2025 is acknowledged and has been considered.
Withdrawn Rejections
Rejections over Jean
Both the previously maintained anticipation and obviousness rejections over the teachings of Jean (WO 01/13879 A1) are hereby withdrawn in view of Applicants’ amendment to claim 17.
New Rejections
Applicants’ amendment has necessitated the following ground of rejection:
Claim Rejections - 35 USC §112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 17-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention.
As amended, claim 17 now recites:
“A cosmetic method for preventing a decrease in and/or increasing the epidermal barrier function, comprising the administration to a person in need thereof, of an effective amount of an oil derived from akenes of Silybum marianum (L.) Gaertn, wherein the oil is free of silymarin.” [emphasis added to reflect newly added limitation]
Applicants’ response, as reflected above, asserts that “support for [the amendment] can be found in now-canceled claim 20.”
Claim 20, also as mentioned above, has not been canceled and continues to recite the following:
“The method according to claim 17, for improving the skin repair by reinforcing or restoring the barrier function, by increasing the level of total ceramides in the skin.”
The Examiner submits that the claim states nothing with respect to the administered composition, including the absence of silymarin from it.
Having further fully considered the originally-filed specification and claims, the Examiner again finds no support for the added limitation. Specifically, in considering the resulting property of the claimed method, the Examiner notes that the instant specification refers to increasing the total ceramides using the composition prepared in Example 1 (see Spec., pg. 20, lines 14-16). Example 1 has been reviewed (see Spec., pg. 15, lines 19-22). While it is noted as being a method for preparing an oil composition, the Examiner submits that it is silent as to the amount of silymarin present in such a preparation.
Further consideration of the state of the art, notably such teachings as Jean (WO 01/13879 A1; of record), reveal that compositions prepared from the achenes of Silybum Marianum through the application of high-pressure, cold-press filtration, as instantly performed in Example 1, fail to remove silymarin. Applicants’ remarks reflect as much and the Examiner has withdrawn the previous rejections on the basis of this distinction.
Thus, it is respectfully advanced that Applicants’ amendment to the applied composition constitutes new matter.
Consistent with MPEP §2163.06(I), the Examiner will still consider the subject matter of the amended claim in considering rejections based on the prior art since there exists the possibility that Applicants may potentially overcome the new matter rejection.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 6 October 2025 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 grounds that “the claims have been amended to clarify that the extract used in the claimed methods is free of silymarin.”
Regarding the teachings of Saurat, Applicants thus posit that “Saurat likewise does not disclose or suggest a silymarin-free extract” and that “the cited prior art teaches toward the presence of silymarin and away from the claimed silymarin-free extract,” and that “[t]here is no teaching, suggestion, or motivation that would have led a person of skill in the art to modify the cited [reference] to arrive at the claimed subject matter as amended.”
Addressing instant independent claim 26 first, the Examiner respectfully submits that Applicants’ response fails to overcome the rejection to claims 26-31, specifically since no such amendment has been made to the claim. Empirically, this rejection is maintained.
Secondly, Applicants’ addition of new matter notwithstanding, claims 17-25 remain rejected over the teachings of Saurat since the reference does, in fact, teach and suggest silymarin-free extracts prepared from Silybum marianum (L.) Gaertn. Paragraph [0008], for instance, discloses the same method as presented by instant Example 1. Though the method of preparation is not at issue, the Examiner submits that the same scope of disclosure is present, namely that no discussion is present regarding the quantification of silymarin in the preparation. Furthermore, Saurat does guide the skilled artisan towards preparing compositions that contain minimal amounts of silymarin in the applied compositions. Therein, ¶[00141]-¶[0021] and ¶[0030] all disclose that “[a] further subject-matter of the invention relates to a method for preparing a Silybum marianum (L.) Gaertn. achene extract comprising less than 0.2%, preferably less than 0.1% by weight of silymarin with respect to the weight of the dry extract comprising a step for extracting an oil obtained from Silybum marianum (L.) Gaertn. achenes”.
The Examiner submits that the foregoing disclosure minimally suggests that the prepared compositions of the practiced method are inclusive of those that are free of silymarin. Additionally, the downward preference for less silymarin in the prepared composition further suggests to the person of ordinary skill in the art that a composition containing no silymarin is most preferred.
Applicants’ arguments, for the above reasons, are found unpersuasive. Said rejection is therefore maintained.
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