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 .
Applicant’s amendment and reply field October 7, 2025 have been received and entered into the case. Claim 2 is canceled; claims 1 and 2 – 11 are pending and have been considered on the merits. All arguments have been fully considered.
Specification
Previous objections to the disclosure are withdrawn due to grammar and spelling corrections.
Claim Objections
Previous objections to the claims are withdrawn due to grammar and spelling corrections.
Claim Rejections - 35 USC § 112
Previous rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn due to reciting an active step in claim 1 and removing the range with in a range limitations.
Claim Rejections - 35 USC § 102
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 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.
(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 and 3 are rejected under 35 U.S.C. 102a1 and 102a2 as being anticipated by Powell (US 2016/0120781).
Regarding claim 1, Powel teaches a skin care composition comprising ergothioneine and trehalose and a method of making the composition by combining the components together (0071, example 4, claims, figures 9, 10). Combining the components of Powel is interpreted as contacting the ergothioneine with trehalose. Although the reference does not teach the step of contacting the components results in improved thermostability of ergothioneine, the method step is the same. Thus, in making the composition Powel, one is also inherently improving thermostability of ergothioneine. Moreover, the claimed function must be inherent to the reference composition. 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. Thus the claiming of a new use, functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (MPEP 2112)
Regarding claim 3, the claim further defines a characteristic of hyaluronic acid (HA) which is not required by the claim language since the HA is an alternative to trehalose.
Therefore, the reference anticipates the claimed subject matter.
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.
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 4 – 11 are rejected under 35 U.S.C. 103 as being unpatentable over Powell (US 2016/0120781) in view of Essendoubi et al. (2015).
Regarding claims 4 – 7, Powell teaches a skin care composition comprising hyaluronic acid (HA), trehalose and ergothioneine (0071, example 4, claims, figures 9, 10). The HA (sodium hyaluronate) is present at 0.05 – 0.1% and the trehalose is present at 1 – 4% (figures 9, 10) the ratio of which include 1:10, falling within the claimed ratio of 1:99 to 50:50 or 1:10.
Powell does not teach the composition wherein the HA has the claimed molecular weight. However, Essendoubi teaches that hyaluronic acid with lower molecular weights penetrate skin more readily (abstract) and that such lower molecular weight HA is desirable for skin care compositions (abstract, p.1 – 2). Specifically, Essendoubi teaches HA with a molecular weight of 20 kDa (abstract, p.2, 3) and demonstrates that decreasing molecular weight HA increases skin permeation, significantly improving skin hydration and wrinkle depth (p.6). In this regard, at the time the claims were filed, one of ordinary skill in the art would have been motivated to use hyaluronic acid having a low molecular weight in the skin care compositions of Powell for the known advantages of skin penetration and hydration and with a reasonable expectation for successfully obtaining effective skin care compositions.
Although Powell does not teach the recited use of hyaluronic acid and/or trehalose to stabilize ergothioneine or using the composition as an auxiliary agent, these limitations are interpreted as intended use limitations. The intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112).
Regarding claims 8 - 10, Powell teaches a skin care composition comprising hyaluronic acid (HA), trehalose and ergothioneine (0071, example 4, claims, figures 9, 10). The ergothioneine is included at 0.1 – 70%, the HA is present at 0.05 – 0.1% and the trehalose is present at 1 – 4% (figures 9, 10) the ratio of which include 1:10, falling within the claimed ratio of 1:99 to 50:50 or 1:10. Although Powell does not teach the claimed amounts of each component, generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." (MPEP 2144.05 IIA). In the instant case, the components were all well known and used in cosmetic compositions as disclosed by Powell, and as such, it would have been well within the purview of one of ordinary skill in the art to optimize the amounts thereof as a matter of routine practice and with a reasonable expectation for successfully obtaining an effective skin care composition.
Further, Powell does not teach the composition wherein the HA has the claimed molecular weight. However, Essendoubi teaches that hyaluronic acid with lower molecular weights penetrate skin more readily (abstract) and that such lower molecular weight HA is desirable for skin care compositions (abstract, p.1 – 2). Specifically, Essendoubi teaches HA with a molecular weight of 20 kDa (abstract, p.2, 3) and demonstrates that decreasing molecular weight HA increases skin permeation, significantly improving skin hydration and wrinkle depth (p.6). In this regard, at the time the claims were filed, one of ordinary skill in the art would have been motivated to use hyaluronic acid having a low molecular weight in the skin care compositions of Powell for the known advantages of skin penetration and hydration and with a reasonable expectation for successfully obtaining effective skin care compositions.
Regarding claim 11, the compositions have antioxidant activity (0032, 0070, example 4, claims 66, 67).
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant argues that Powell does not teach or suggest that HA with the claimed molecular weight and/or trehalose can improve thermostability of ergothioneine; that the claimed method results in significant and unexpected improvements to stability of ergothioneine, particularly when spray drying ergothioneine fermentation broth; and that Tables 1 and 2 show the content of ergothioneine is significantly higher than other products.
However, these arguments fail to persuade.
Regarding the argument that the combination of HA and trehalose unexpectedly improves thermostability of ergothioneine, it is noted that claims 1 and 3 do not require both HA and trehalose to be included in the method. Instead, HA and trehalose are recited as alternatives in a method of contacting ergothioneine therewith. Additionally, the claims fail to recite a method for increasing thermostability of ergothioneine during spray drying. Thus, the argument is not commensurate in scope with the claimed method. Notwithstanding, the tables on which applicant relies for unexpected results does not provide objective evidence of an unexpected result. Rather, the tables show results of various adjuvants and nothing more.
Applicant argues that Powell does not teach compositions comprising HA with the claimed molecular weight; Essendoubi is drawn to skin penetration of HA; they do not teach the claimed ratio of components; and neither reference teaches HA stabilizes ergothioneine and are therefore non-analogous. Finally, applicant argues that the composition demonstrates significantly higher antioxidant activity than ergothioneine alone.
However, these arguments fail to persuade.
Regarding the claimed compositions, it is iterated that even though Powell does not teach the composition wherein the HA has the claimed molecular weight, Essendoubi teaches that hyaluronic acid with lower molecular weights penetrate skin more readily (abstract) and that such lower molecular weight HA is desirable for skin care compositions (abstract, p.1 – 2) for the advantage of increased skin permeation, significantly improving skin hydration and wrinkle depth (p.6). Therefore, it is maintained that at the time the claims were filed, one of ordinary skill in the art would have been motivated to use hyaluronic acid having a low molecular weight in the skin care compositions of Powell for the known advantages of skin penetration and hydration and with a reasonable expectation for successfully obtaining effective skin care compositions.
Regarding the claimed amounts, it is iterated that differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. Applicant has not shown by argument or evidence that the claimed ratios are critical for a specific purpose.
Regarding the argument that the references do not teach the intended use, it is iterated that intended use of the claimed composition does not patentably distinguish the composition since such undisclosed use is inherent in the reference composition and the intended use does not create a structural difference between the claimed composition and the composition of the prior art. Additionally, claims 8 – 11 do not require any particular use.
Regarding the argument that the composition demonstrates significantly higher antioxidant activity than ergothioneine alone, no evidence has been made of record to support applicant’s assertion of unexpected results. Arguments presented by applicant cannot take the place of evidence in the record (MPEP 2145 I). Objective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results (MPEP 716.01(c)).
No claims are allowed.
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 RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUTH A DAVIS/ Primary Examiner, Art Unit 1699