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 filed March 3, 2026; and the IDS filed January 8, 2026 have been received and entered into the case. Claims 4, 11 and 29 are canceled; claims 1 – 3, 5, 7 – 9, 21 – 22, 25, 31 – 33, 35 – 36, 43, 51 are pending; claims 36, 43, 51are withdrawn; claims 1 – 3, 5, 7 – 9, 21 – 22, 25, 31 – 33 and 35 have been considered on the merits. All arguments have been fully considered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 8, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8 and 35 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 8, line 3, the recitation of “comprising” renders the claim indefinite as it is unclear if the phrase intends to recite a Markush group wherein the additional antioxidant must be selected from the recited elements, or if the phrase is open ended to include any additional antioxidant. Clarification is required.
Claim 35 is drawn to a topical composition, however is rendered indefinite for reciting “an antioxidant system” because it is unclear what must be included to meet a “system.” The term is not defined by the specification or claim language and its general meaning implies multiple structures working together having different functions. Moreover, it is unclear what other components with different functions are required to meet an antioxidant “system” other than an antioxidant. Applicant may overcome this rejection by replacing “system” with “component.”
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.
Claims 1 – 3, 5, 7 – 9, 21 – 22, 25, 31 – 33 and 35 remain rejected under 35 U.S.C. 103 as being unpatentable over Aliyar et al. (US 2015/0141389) in view of Perricone et al. (US 2017/0189326).
Regarding claims 1, 2, 5 and 31, Aliyar teaches topical drug delivery formulations comprising occlusive agents such as silicon-based components and at least one active to be delivered through the skin for therapeutic or cosmetic purposes (abstract, 0056, 0069). Active agents include proteases (proteolytic enzymes) such as papain and bromelain (0065) and antioxidants (0052). The formulation may be prepared with or without water, which includes less than 10% or less than 8% water (0080, examples 1-6).
Aliyar does not teach the composition wherein the active antioxidant is green tea polyphenols. However, Aliyar teaches active agents to be delivered include antiaging agents (0063) or plant extracts such as oolong (green) tea extract (0066). Perricone teaches topical compositions comprising antioxidants, specifically green tea catechins (polyphenols), for the purpose of treating aging skin (antiaging agents) (abstract), wherein the green tea catechins include epicatechin, epigallocatechin, epicatechin gallate, gallocatechin gallate and epigallocatechin gallate (0007, 0027, claims). At the time the claims were filed one of ordinary skill in the art would have been motivated to include the claimed green tea catechins as the active agent in the delivery formulation of Aliyar since they were well known and used antioxidants and antiaging agents delivered through the skin for therapeutic and cosmetic purposes, and with a reasonable expectation for successfully obtaining an effective topical composition.
Aliyar does not teach the composition comprising the claimed amount of enzyme. However, the reference teaches the compositions are typically applied to treat scars (0029). In this regard, the active components can be added in amounts effective for its relevant purpose, or treating scars, and are interpreted as result effective variables. As such, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to optimize the concentration of actives (or enzymes) as a matter of routine practice and experimentation, and with a reasonable expectation for successfully obtaining an effective topical composition.
Regarding claim 3, Aliyar teaches the compositions are typically applied to treat scars (0029). In this regard, the active components can be added in amounts effective for its relevant purpose, or treating scars, and are interpreted as result effective variables.
Regarding claim 7, Aliyar does not teach the claimed amount of antioxidants. However, Perricone teaches including antioxidants at varying amounts depending on the nature of condition to be treated, severity and user’s skin type, with typical amounts ranging from 0.121 – 6.05% (0015), which includes the claimed ranged. In following the teachings of the combined prior art at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to optimize the amount of antioxidants according to these factors and with a reasonable expectation for successfully obtaining an effective topical composition for treating skin.
Regarding claims 8 – 9, Aliyar teaches additional antioxidants may be included in the compositions, such as glutathione, tocopherol, allantoin (0052, 0064); while Perricone teaches including caffeic acid, tocopherol (0021, 0044).
Regarding claim 21, Aliyar teaches including stabilizing agents (0072) and a silicone organic elastomer blend included in a silicone or organic carrier fluid such as isodecylneopentanoate, dimethicone/bis-isobutyl propylene glycol cross polymer, polyethylene glycol-12 dimethicone/bis-isobutyl propylene glycol-20 cross polymer and combinations thereof (0007).
Regarding claim 25, Aliyar teaches other active agents may be included such as sunscreens, antibiotics, steroids or hydroquinone (0052, 0058, 0062, claims).
Regarding claim 32, neither Aliyar nor Perricone require urea in the compositions, which is less than about 8% urea.
Regarding claims 33 and 35, Aliyar teaches the compositions may be homogenous suspensions (0079).
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 there is no motivation to include the claimed amount of enzyme because the prior art does not recognize the functional relationship between the enzyme and green tea polyphenols, or that the enzyme is not a recognized result effective variable. Specifically in that the green tea polyphenols act as a soothing agent of the enzyme treatment. Applicant argues that the prior art does not teach including the antioxidant component to soothe skin, increase patient compliance and overall efficacy of treatment, or that the antioxidant counteracts irritation.
However, these arguments fail to persuade for the following reasons.
Regarding the motivation to include the claimed amount of enzyme, the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant (MPEP 2144 IV). In other words, Aliyar specifically teaches active agents in the composition include the claimed enzymes and antioxidants (0052, 0065) and that the compositions are effective to treat various skin conditions. In this regard, the active agents are identified/recognized result effective variables, making it obvious to one of ordinary skill in the art to optimize the amount thereof as a matter of standard practice with a reasonable expectation for successfully obtaining an effective topical drug.
Regarding the argument that the prior art does not recognize the effect of the antioxidant, the fact that applicant uses the antioxidant for a different purpose does not alter the conclusion that its use in a prior art composition would have been prima facie obvious from the purpose disclosed in the references (MPEP 2144 IV). The assertion that the antioxidant increases efficacy of the “treatment” is not supported by objective evidence made of record. Arguments presented by applicant cannot take the place of evidence in the record (MPEP 2145 I).
Therefore, absent evidence of an unexpected result or advantage, the claims remain rejected.
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).
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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
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