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 .
Priority
The instant application is the national stage entry of PCT/JP2022/037897 filed 11 October 2022. Acknowledgement is made of the Applicant’s claim of foreign priority to application JP2021-168413 filed 13 October 2021.
Examiner's Note
Applicant's amendments and arguments filed 27 August 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant's response, filed 27 August 2026, it is noted that claims 31-32 have been amended and claims 37-41 newly added. Support can be found in the claims as originally filed. No new matter has been added.
Status of the Claims
Claims 31-41 are pending.
Claims 31-41 are rejected.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 31-36 are rejected under 35 U.S.C. 103 as being unpatentable over Couzy et al. (US 7,479,286) in view of Ishikawa et al. (US 2006/0029643) in view of Tamer et al. (Dermatol Pract Concept 2018;8(2):4). Couzy teaches a food composition intended for improving skin health and for preventing or regulating the growth of skin pathogens and microflora, wherein the composition comprises anti-microbial fatty acids (abstract). The fatty acid may be a-linolenic acid and may be in amounts of at least 5%, or amounts sufficient to improve or maintain skin health (col 2, lns 21-30; col 3, lns 5-7). Couzy teaches that a-linolenic is known to inhibit inflammatory reactions on the skin (col 1, lns 48-51). Couzy also teaches their invention as being active against S. aureus, S. intermedius, and Malassezia pachydermatis, the latter which is a yeast known to cause seborrheic dermatitis (col 2, lns 15-20). The concentration of a-linolenic acid can be increased by dietary means (col 10, lns 37-40). The purpose the dietary lipids, in addition to improving skin health, is to maintain an adequate barrier function of the skin (col 3, lns 26-29). There can be situations where the barrier function of the skin becomes insufficient due to changes in physiological, environmental, or pathological conditions and the skin can adapt by increasing skin lipids (col 1, lns 35-40).
Couzy does not teach wherein the composition further comprises diacylglycerol nor does it teach the claimed concentrations.
Ishikawa teaches a food containing a glycosylated ceramide and a diacylglycerol [0010]. The diacylglycerol, when incorporated in a food with the ceramide, increases the amount of ceramide in the stratum corneum and thus remarkably improves the barrier function of the skin [0024]. The diacylglycerol can be incorporated in concentration from 0.01-20% [0026].
Tamer teaches that Malassezia is the main causative agent of seborrheic dermatitis, however S. aureus may also play a role (abstract).
It would have been prima facie obvious to prepare the oral composition of Couzy comprising a-linolenic acid for the improvement of skin health wherein the a-linolenic acid is present in amounts of at least 5%. Moreover, it would have been obvious to combine the oral food product of Ishikawa, which comprises diacylglycerol and glycosylated ceramide, into the oral product of Couzy. Since Couzy teaches that there can be situations where the barrier function of the skin becomes insufficient due to changes in physiological, environmental, or pathological conditions and that increasing skin lipids help correct this situation, it would have been obvious to modify the oral dosage to include a barrier function improving agent like diacylglycerol. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).
Regarding the amount of diacylglycerol, Ishikawa teaches a range of from 0.01-20%, however due to the ability of diacylglycerol to improve the skin barrier function, it would have been obvious to optimize the amounts thereof. That being said and in lieu of objective evidence of unexpected results, the concentration of diacylglycerol can be viewed as a variable which achieves the recognized result of successfully improving the skin barrier function. The optimum or workable range of diacylglycerol concentration can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Appellants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of diacylglycerol concentration nonobvious.
The skilled artisan would have found it obvious to take the composition of Couzy and Ishikawa and use it in a method of treating skin inflammation, such as seborrheic dermatitis as caused by M. pachydermatis, in a subject in need thereof, as well as a method of improving the skin barrier function based on the known properties of diacylglycerol and the desired outcome of the composition of Couzy. Claims 31-36 are accordingly rejected as obvious in view of the prior art.
Claims 31-41 are rejected under 35 U.S.C. 103 as being unpatentable over Couzy et al. (US 7,479,286) in view of Ishikawa et al. (US 2006/0029643) in view of Tamer et al. (Dermatol Pract Concept 2018;8(2):4) in view of Fukumoto et al. (US 2004/0115233) as evidenced by Cleveland Clinic (https://my.clevelandclinic.org/health/diseases/23408-baby-eczema).
Couzy, Ishikawa, and Tamer, as applied supra, are herein applied in their entirety for the teachings of a composition comprising a-linolenic acid and diacylglycerol.
Couzy does not teach wherein the patient population further comprises those with atopic dermatitis, contact dermatitis, asteatotic eczema, or infantile eczema.
Fukumoto teaches that a-linolenic acid is an effective agent proven to be effective in oral administration therapy of atopic dermatitis and asteatosis [0019, 0022].
Cleveland Clinic evidences that baby eczema (infantile eczema) is the same as atopic dermatitis (pg 1, ¶1).
It would have been prima facie obvious to take the composition of Couzy and Ishikawa and use it in a method of treating skin inflammation, such as seborrheic dermatitis as caused by M. pachydermatis, in a subject in need thereof, as well as a method of improving the skin barrier function based on the known properties of diacylglycerol and the desired outcome of the composition of Couzy. The skin inflammation can further be any condition caused by the bacteria targeted by Couzy or any condition cured by the inclusion of a-linolenic acid. The cited prior art teaches that the composition of Couzy would be effective against Malassezia pachydermatis, which are known to be a cause of seborrheic dermatitis. Moreover, a-linolenic acid is known to be effective at treating atopic dermatitis and asteatosis, which is interpreted as being asteatotic eczema. Atopic dermatitis is the same as infantile eczema. Regarding contact dermatitis, this condition is typically caused by an outside trigger, however since the prior art composition comprising a-linolenic acid is known to be effective against other forms of dermatitis, there is a reasonable expectation of success for treating all forms of dermatitis. As such, instant claims 31-41 are obvious in view of the prior art.
Response to Arguments
Applicant's arguments filed 27 August 2026 have been fully considered but they are not persuasive. The Applicant argues, on page 5 of their remarks, that the underlying mechanism of Ishikawa is different from Couzy, therefore there would be no motivation to combine.
In response, Couzy teaches that there can be situations where the barrier function of the skin becomes insufficient due to changes in physiological, environmental, or pathological conditions and that increasing skin lipids help correct this situation. As such, it would have been obvious to modify the oral dosage to include a barrier function improving agent like diacylglycerol which is taught in Ishikawa. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07). Any difference in mechanism between the two references is not relevant as the prior art motivation is in the suggestion that Ishikawa can improve the method of Couzy by the inclusion of diacylglycerol.
The Applicant argues, on page 5 of their remarks, that it is clear that diacylglycerol alone does not contribute to skin barrier function, but rather it must be included along with a glycosylated ceramide. Moreover, the Applicant argues that the effective fatty acids in Ishikawa are lauric acid and palmitoleic acid, not a-linolenic acid.
In response, the instant claims are open-ended and do not forbid the further inclusion of any agents. As such, the skilled artisan would have found it obvious to include diacylglycerol along with any necessary agents such as glycosylated ceramide in order to improve the function of Couzy. In addition, alternative fatty acids can be included along with a-linolenic acid.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW S ROSENTHAL whose telephone number is (571)272-6276. The examiner can normally be reached M-F 8-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
