DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Remarks and Affidavit under 37 CFR §1.132 (herein “Rule 132”), filed 16 April 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 .
No additions, amendments, or cancellations have been made to the previously filed claims. No new matter has been added.
Thus, claims 17-31 continue to represent all claims currently under consideration.
Information Disclosure Statement
No new Information Disclosure Statements (IDS) have been filed for consideration.
Withdrawn Rejections
Rejection under 35 USC 112
Applicants’ remarks and Rule 132 affidavit have been fully considered, as well as the cited passages in the published application. The Affidavit is a ten-year old report of a gas chromatographic sample analysis of “an oil sample” provided by Applicants. Therein, the sample was analyzed for sterol, fatty acid, and glyceride content. Though the sterol analysis reported out an “unidentified” component of <0.1%, Applicants attest that the sample contains no silymarin. Based on these results, Applicants conclude that a coproduct of silymarin extraction can be free of silymarin.
The Examiner notes further that Applicants do not mention in the affidavit what method was undertaken to obtain the oil sample (e.g., instant Example 1).
Applicants’ remarks however, state that “[a]s described, Example 1 separates the oil from the remainder of the extract, with the silymarin residing in the non-oil fraction.”
Based on this, and the other cited passages, the Examiner withdraws the new matter rejection as Applicants’ instant disclosure appears to establish that cold pressing achenes of Silybum marianum can produce an oil that is devoid of silymarin.
Maintained Rejections
The following rejection is maintained from the previous Office Correspondence dated 16 January 2026 since the art that was previously cited continues to read on the amended/newly cited 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 continue their traversal the rejection on the grounds that the instant claims required the administration of an extract that is free of silymarin. It is also again asserted that Saurat neither teaches nor suggests preparing an extract of Silybum marianum (L.) Gaertn. that is free of silymarin.
It is argued that Saurat employs hydrotropic, aqueous solutions, subcritical water, or organic solvents that are not miscible with oil in order to remove the oil fraction from the sample (see e.g., ¶[0008] and claim 38).
Applicants additionally allege that the differences between claim 17 and Saurat are substantial, such that the present claims require use of the oil derived from the achenes whereas Saurat is alleged to exclude it.
The Examiner respectfully continues to disagree and maintains the rejection for the reasons already of record.
At the outset, the Examiner submits that Applicants’ claimed method is directed to a of treatment and not a method for preparing the administered composition. Secondly, Applicants’ cited Example 1 and Rule 132 Affidavit establish that extracts obtained from the achenes of Silybum marianum (L.) Gaertn. can be free of silymarin. [emphasis added to reflect Applicants’ sworn statement]
Looking to instant Example 1, the Examiner notes that the instant specification supports the following method regarding obtaining the “silymarin-free” oil:
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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.”
As previously argued, the same scope of method is at issue; both oils of the instant and disclosed inventions are acquired via cold pressing.
Saurat discloses achieving an extract that contains less than 0.2% by weight and preferably less than 0.1% by weight of silymarin. This minimally suggests to the ordinarily skilled artisan that a composition containing as little silymarin as possible is most desirable. Furthermore, looking past the method disclosed in claim 38, Saurat’s Example 1 describes two methods for producing the practiced and administered extract. Methods A is shown as depicting what is known in the art and as resulting in the production of an extract with a high silymarin content. Method B, however, employs a cold pressing method to produce an extract having a low silymarin content. See ¶[0095]-¶[0108].
What is understood about the process of Method A is that it too produces an oil that ideally contains little to no silymarin. Paragraph [0160] states that Method A favors the extraction of polar compounds, and in particular silymarin flavonolignans, whereas Method B favors the extraction of lipophilic compounds such as free fatty acids, sterols, tocopherols and other apolar compounds. Both methods separate polar from apolar compounds and seek to separate silymarin from the extracted oil. Method B, like Applicants’ relied upon method, cold presses the oil to acquire its product.
Claim 23 of Saurat discloses a method for treating conditions of the skin comprising the administration of an extract of Silybum marianum (L.) Gaertn. containing less than 0.2 wt% silymarin, preferably less than 0.1% by weight (see e.g., ¶[0011]). As discussed above, Saurat clearly looks to minimize the presence of silymarin and also employs cold pressing of the extract to obtain it.
Applicants next argue that Saurat contains no teaching, suggestion, or motivation to retain or isolate the oil fraction nor to use it for improving epidermal barrier function, and that it in fact teaches away from the instantly claimed invention by deliberately removing the oil and focusing on suitable compositions for treating conditions with excess lipids.
The Examiner disagrees.
Claims 30-35 disclose the preparation of an achene extract that contains less than 0.2 wt% silymarin and does include beta-sitosterol free linoleic acid, free fatty acids, and tocopherols. Claim 42 discloses a pharmaceutical composition comprising the composition prepared by claim 30 and claim 46 discloses a method of treatment using the disclosed pharmaceutical composition.
Applicants’ arguments, for the above reasons, are found unpersuasive. Said rejection is therefore maintained.
All claims under consideration remain rejected; no claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicants are 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 extension fee 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.
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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