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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/09/2026 has been entered.
Response to Amendment
The Amendment filed 06/09/2026 has been entered. Applicant’s amendments are in response to in the Final Office Action mailed 03/09/2026. Applicant’s claims have been amended in the following manner: independent claim 1 has been modified by inclusion of included “in an amount of 0.001 wt% to 0.3 wt%, based on total weight of the topical composition” to characterize the proteolytic enzymes (i.e., it represents a narrower amount range compared to the 0 wt% to 1 wt% of the now-cancelled claim 8 from the previous claim set). Thus, a new ground of rejection is prompted by the amendment (i.e., introduction of the Fein reference).
The following objections/rejections are withdrawn: none.
The Examiner further acknowledges the following:
Claims 1, 5-7, 12, 15-17, 20-22, 31, 33-34, 37, and 40-41 are pending.
Claims 33-34, 37, and 40-41 are withdrawn from consideration as directed to non-elected inventions.
Claims 1, 5-7, 12, 15-17, 20-22, and 31 are presented for examination and rejected as set forth below.
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 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.
Claims 1, 5-7, 12, 15-17, 20-22, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Vromen (US20040081681A1), as evidenced by Terrisse (US20140031305A1), and in further view of Fein (US20030026794A1), White (Oxidative Medicine and Cellular Longevity, 2012), Vishnupad (US20020111281A1), and Applechem (Sensogel 200, 2018).
Applicant’s claims are directed to a topical composition comprising an occlusion forming agent comprising glycerin and a binding agent; one or more proteolytic enzymes in an amount of 0.001 wt% to 0.3 wt%, based on total weight of the topical composition; and an antioxidant system comprising green tea polyphenols species, wherein the antioxidant system is 0.2-1.0 wt% based on the total weight of the composition; wherein the topical composition has less than 10 wt.% added water, based on total weight of the topical composition.
In independent claims 1 and 5, note that the topical composition is considered to comprise glycerin and/or a binding agent, generally (i.e., these ingredients do not need to be pre-associated before incorporation into composition) because a composition’s patentable weight is based on the product and not the process in which it forms. The “occlusion forming agent” only requires something with occlusive function within the composition as a limitation. Similarly, the “antioxidant system” is considered a mixture comprising green tea polyphenols that overall imparts antioxidant function to the “topical composition” of claims 1 and 5 (where Applicant describes that the polyphenols have antioxidant activity in the Specification [0062]).
Note the requirement of use on a scar (i.e., an intended use), as specified in instant claim 5, is not a meaningful limitation in terms of the instant composition (where the structure of the composition itself defines patentability).
Vromen teaches topical delivery of bioactive agents that is non-irritating to the skin (abstract) for the treatment of a wide variety of dermatological conditions (i.e., any abnormality of the skin, which would include scars) such as scabs and wounds [0037].
Regarding claim 1, 5-7, 15, 17, and 20: Vromen discloses anhydrous (<10 wt% water) compositions (Vromen – claim 1), comprising the carrier glycerin (reads on claim 15), polyols, and/or propylene glycol (Vromen – claim 4), compounds from green tea in an amount of 1-10 wt% [0032], and papain (reads on proteolytic enzyme of instant claims 1, 5-6, etc.) in preferably 1-7 wt% (while 1-7 wt% is a preferable range, Vromen does not teach away from concentrations that are higher and/or lower than this range) [0035]. Furthermore, Vromen demonstrates formulations where 0.3% or 0.6% antioxidant amount in a composition is obvious (Table 1, [046]).
Vromen teaches that papain and bromelain are exfoliating enzymes that behave as an exfoliant to eliminate dead cells without killing living cells [0035], which is cosmetically desirable for scars and wound healing. Thus, they are established as a result-effective variable that a person of ordinary skill in the art would routinely optimize in order to promote exfoliation and/or eliminate dead skin cells. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where 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). Therefore, a PHOSITA would establish the minimal amount of ingredient required that would still achieve the desired effect of exfoliation and/or elimination of dead skin cells. In support of this, Vromen does not teach a lower limit of enzyme required to achieve an effect; furthermore, the 1 to 7 wt% represents only a preferred embodiment.
With respect to claim 17 and 22, Vromen teaches the carrier ([0021]) propylene glycol in 10 wt% (Table 1, [0046]). As evidenced by Terrisse, propylene glycol and polyols are considered binding agents [0122-0125]; thus, meeting the binding agent requirement of claim 1 and 17.
Vromen also teaches the beneficial use of occlusive agents as obvious to prevent the formulation from escaping the exterior of the skin (Vromen – claims 68-71), reading on the occlusive functionality within the composition.
Regarding claim 12: Vromen teaches the antioxidant d-tocopherol in 0.6 wt% [0046] (Vromen – claim 108). Vromen teaches this antioxidant within a larger discussion of antioxidants as “bioactive substances” (Vromen – claim 34-37), (where a subset is “biological additives”, where green tea compounds are found within that subset [0032]), where the purpose of Vromen’s formulation is to topically deliver bioactive substances to the skin in a non-irritating way (abstract).
In summary, Vromen teaches the elements of the instant invention (within the context of a topical formulation to deliver bioactive agents for percutaneous absorption and is non-irritating to the skin). Furthermore, Vromen does not teach a lower limit of exfoliating enzyme required to achieve the desired effect, and that the disclosed 1 to 7 wt% represents only a preferred embodiment, where lesser amounts would also achieve an exfoliating effect. However, Vromen does not teach the explicit instant amount range of 0.001-0.3 wt% (instant claims 1 and 5), the specific compounds of the green tea (i.e., the polyphenols) (instant claims 1 and 5), the glycerin amount (instant claim 16), the carrier (solvent) dimethicone (instant claim 21), and the specified viscosity (instant claim 31).
Fein teaches selective enzyme treatment of skin conditions (abstract), in the form of creams, ointments, lotions, etc. (Fein – claim 15) for topical application (Fein – claim 10), including compositions comprising papain and/or bromelain in 1×10−5% w/v to 10% w/v (Fein – instant claim 11), encompassing the amended instant amount range of 0.01-0.3 wt% (instant claims 1 and 5). With regard to the numerical range, note that "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003) (see 2144.05(I)). Fein teaches these amounts of papain and/or bromelain are effective to exfoliate skin [0003-0008]. Specifically, Fein provides examples of topical cream with 0.2% papain [0066] and a topical ointment with 0.1% papain [0068], that additionally read on the instant amount range (instant claims 1 and 5).
White teaches green tea to contain various polyphenols such as epigallocatechin-3-gallate and epicatechin-3-gallate (reads on claim 1 and 5) that can be extracted from green tea and function as antioxidants (abstract, Figure 1). White teaches the green tea polyphenols have protective effects with topical application to skin (abstract, pg 1, ‘introduction’).
Vishnupad teaches anhydrous compositions (similarly to Applicant’s compositions, as stated in the Specification [0074] and Table 1, [0175]), where Vishnupad demonstrates the combination of 97-99 wt% glycerin (reads on the glycerin amount of instant claim 16) in combination with a viscosity enhancing ingredient (Table 6), teaching this combination provides substantially anhydrous compositions having a viscosity greater than 1000 centipoise (e.g., a viscosity of 10,000 to 1,000,000 cps (reads on claim 31) (Vishnupad – claim 12)) that can deliver beneficial agents unstable in aqueous systems and provide a cosmetic with desired viscosity and thickness [0005-0006].
Applechem teaches dimethicone (reads on claim 21) and Sensogel 200 (pg 8), in which Sensogel is a demonstrated as a binding agent in Applicant’s specification (Table 1, [0175]). Applechem teaches Sensogel 200 to make thin spray formulas to thick butter cosmetics by adjusting the usage rate (pg 1) (or amount of ingredient), thus causing it to be an ingredient as person of ordinary skill in the art would optimize the amount of in order to obtain the desired final product consistency. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where 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). Applechem also teaches high viscosity butters at 620,000 cps (reads on claim 31) (pg 8), and Sensogel 200 contributes to the rich look of a thick smoothie and has better feel compared to traditional body butters (pg 8).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Vromen to use the specific amounts of proteolytic enzyme taught by Fein, because Fein teaches these amounts are suitable to exfoliate skin [0003-0008]. Specifically, Fein provides examples of topical cream with 0.2% papain [0066] and a topical ointment with 0.1% papain [0068].
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Vromen to use the specific polyphenols taught by White in place of the general teachings of Vromen of using compounds from green tea and/or antioxidants. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Not only does Vromen have a teaching of using bioactive substances from green tea [0032], but Vromen also teaches the general value of incorporating antioxidants as bioactive substances into topical formulations (Vromen – claims 34-37). These green tea polyphenols that protect the skin are taught by White as antioxidants in topical application (abstract, introduction).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Vromen to apply high amounts of glycerin, as taught by Vishnupad, because this allows stable delivery of beneficial active agents, while maintaining a desired viscosity and thickness [0005-0006].
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Vromen to incorporate Sensogel 200, dimethicone, and a high viscosity because that would allow for design of the appropriate final formulation based on viscosity with improvements on formulations on the market (i.e., Sensogel 200 is discussed as a superior ingredient vs. popular thickeners to achieve this on pg 1, and in comparison to acrylamide thickeners and competitor B thickening agent on pg 6), as taught by Applechem, and Vromen generally teaches topical formulations (abstract) that can include viscosity modifying agents and carriers (Table 1).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 5-7, 12, 15-17, 20-22, and 31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over, and in further view of Vishnupad (US20020111281A1), as evidenced by Terrisse (US20140031305A1), and Applechem (Sensogel 200, 2018):
claims 1-5, 7-9, 11, 21-22, 25, 29, 31-33, 35-36, 43, 51 of copending Application No. 18/038,576 (reference application)
Although the claims at issue are not identical, they are not patentably distinct from each other because all claim sets teach a composition comprising an occlusion forming agent, proteolytic enzymes, and an antioxidant system comprising green tea polyphenols. The copending applications differ only by the specific occlusion forming agent.
This is remedied by Vishnupad teaches an anhydrous composition comprising solvents such as glycerin and propylene glycol or PEG (Vishnupad – claim 15) in amounts of 97-99%, etc. (Table 7), but generally without limitation in amount [0010]. As evidenced by Terrisse, propylene glycol or PEG are considered binding agents [0122-0125]. Also, Applechem teaches Sensogel 200, which is a thickener (pg 8), in which Sensogel is an appropriate binding agent according to Applicant’s specification (Table 1, [0175]). One of ordinary skill in the art would have been motivated to modify the teachings of the copending application because glycerin works with binding agents in viscous and thickened anhydrous formulations, and Sensogel 200 can thicken topical formulations for better feel and appearance (i.e., similarly to the logic used to combined references in the 103 rejections above).
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicants arguments, see pg 6-8, filed 06/09/2026, with respect to the 103 rejection of claims 1, 5-8, 12, 15-17, 20-22, and 31 under rejection have been fully considered but they are not persuasive. The 103 rejection has been modified with respect to amendments made to the claim set (i.e., see the teachings of Fein reference). Arguments based on the narrowed proteolytic enzyme range of 0.001-0.3 wt% are considered moot (i.e., they are now addressed by Fein in the 103 rejection). However, arguments of significance will be addressed when identified.
On page 6-7, Applicant claims amounts far lower than Vromen’s preferred recited range (i.e., 1-7 wt%) were found to act as an exfoliant (i.e., to digest the skin). In response to this argument, the Examiner points to the newly incorporated reference of Fein (prompted by amendment), whereby Fein teaches selective enzyme treatment of skin conditions (abstract), in the form of creams, ointments, lotions, etc. (Fein – claim 15) for topical application (Fein – claim 10), including compositions comprising papain and/or bromelain at 1×10−5% w/v to about 10% w/v (Fein – instant claim 11), encompassing the amended instant amount range of 0.01-0.3 wt% (instant claims 1 and 5). With regard to the numerical range, note that "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003) (see 2144.05(I)). Thus, Fein teaches the above amounts are suitable to exfoliate skin [0003-0008]. Specifically, Fein provides examples of topical cream with 0.2% papain [0066] and a topical ointment with 0.1% papain [0068], that additionally read on the instant amount range (instant claims 1 and 5).
Note that Vromen does not teach away from concentrations that are higher and/or lower than the “preferred” 1-7 wt% range [0035], and Vromen also teaches the same mechanism of the exfoliant enzymes as Fein. In order to teach away from a proposed modification, the art must “criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). The Vromen reference does not criticize, discredit, or otherwise discourage the modification proposed by the Examiner (i.e., lower amounts of exfoliating enzyme), that incorporates Fein’s teaching of lower effective amounts of papain and/or bromelain in topical cosmetics, for effective skin exfoliation [0003-0008].
On page 8, Applicant request abeyance of the double patenting rejection, which is fine.
On page 8, Applicant concludes. The claims remain under rejection, as obvious, per the 103 rejection.
Correspondence
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/R.P./Examiner, Art Unit 1614 6/29/2026
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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