DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed 11/13/2025 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Rejections - 35 USC § 112, Second Paragraph
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.
Claim 21 is 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.
Claim 21 recites the limitation “said hydrophobic hazardous agents" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. To overcome this rejection, the limitation can be changed to “said hazardous agents” as introduced in claim 1.
Claim Rejections - 35 USC § 103 (New, Necessitated by Amendment)
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 1-5, 7-13, 16-21, 23, 33-37 are rejected under 35 U.S.C. 103 as being as being obvious over Dodd et al. (US 6,344,218 B1) in view of Clark et al. (US 6,103,245), Van Den Plas et al. (WO 2008/012107 A2), and Barry (US 2012/0039832 A1), and as evidenced by Dai et al. (Chemosphere, 2020: 251: 126074).
Regarding claims 1, 7, 21, 34-35, and 37 Dodd discloses a composition for sanitizing skin surfaces (abstract) with an emollient, such as polyethylene glycol (Col 10, lines 50-51), in an amount of 0.5-50 wt.% (Col 10, lines 63-66), an odor controlling agent, such as activated charcoal/carbon (Col 2, lines 5-6; Col 7, lines 30-31), in an amount of 0.1-10 wt.% (Col 5, lines 54-58), and water (Col 10, lines 31-37). Dodd does not require the use of penetration enhancers.
Dodd does not disclose the composition further includes a phyllosilicate, such as bentonite, in an amount of 1 to 40 wt.%, that the molecular weight of the polyethylene glycol is at least 1 kDa or that the activated carbon has a particle size in a range of between 3 and 50 µM.
Clark teaches a topical composition for the skin with bentonite (abstract; Col 7, lines 33-36), in an amount of 0.0005 to 50 wt.% (Col 6, lines 27-31). Clark teaches that bentonite is capable of microbial adsorption which inhibits microbial activity (Col 6, lines 39-41).
Since Dodd generally teaches a composition for the skin, it would have been prima facie obvious to one of ordinary skill in the art to include bentonite, within the teachings of Dodd, in the amount taught by Clark because Clark teaches this amount of bentonite in a composition for the skin. An ordinarily skilled artisan would be motivated to use bentonite because Clark teaches that bentonite is capable of microbial adsorption which inhibits microbial activity (Col 6, lines 39-41).
The combined teachings of Dodd and Clark do not disclose that that the molecular weight of the polyethylene glycol is at least 1 kDa or that the activated carbon has a particle size in a range of between 3 and 50 µM.
Van Den Plas teaches the use of polyethylene glycol with molecular weights from 200 to 1500 Da (0.2-1.5 kDa) for topical application (abstract; pg. 13, lines 26-29). Van Den Plas teaches that polyethylene glycol with this molecular weight is beneficial for the reduction of inflammation and to reduce or prevent scarring on the skin (pg. 16, lines 14-24; abstract).
Since Dodd generally teaches a composition for the skin with polyethylene glycol, it would have been prima facie obvious to one of ordinary skill in the art to include polyethylene glycol with molecular weights from 200 to 1500 Da, within the teachings of Dodd, because Van Den Plas teaches polyethylene glycol with this molecular weight in a composition for the skin. An ordinarily skilled artisan would be motivated to use polyethylene glycol with a molecular weight from 200 to 1500 Da because Van Den Plas teaches that polyethylene glycol with this molecular weight is beneficial for the reduction of inflammation and to reduce or prevent scarring on the skin (pg. 16, lines 14-24; abstract).
The combined teachings of Dodd, Clark, and Van Den Plas do not disclose that the activated carbon has a particle size in a range of between 3 and 50 µM.
Barry teaches a topical composition (abstract) that includes activated carbon with a size from 3 microns to 500 microns [0030]. Barry teaches that this size of activated carbon can be obtained from commercial sources and has substantial adsorbent surface area and pore cavity [0030].
Since Dodd generally teaches a composition for the skin with activated carbon, it would have been prima facie obvious to one of ordinary skill in the art to include activated carbon with a size from 3-500 microns, within the teachings of Dodd, because Barry teaches activated carbon with this size in a composition for the skin. An ordinarily skilled artisan would be motivated to use this size of activated carbon because Barry teaches that this size of activated carbon can be obtained from commercial sources and has substantial adsorbent surface area and pore cavity [0030].
Further regarding the claim 1 limitation of “for decontamination of skin from hazardous agents”, and the claim 34 limitation of “decontamination of skin from polycyclic aromatic hydrocarbons” it would be reasonably expected that the composition of the combined teachings of the prior art would decontaminate the skin from hazardous agents, such as polycyclic aromatic hydrocarbons (PAHs). Dodd teaches that the compositions of the disclosure sanitize, disinfect, and remove contamination on skin surfaces (abstract; Col 25, lines 8-18) and Clark teaches that bentonite inhibits microbial activity (Col 6, lines 39-41). Furthermore, as evidenced by Dai, bentonite has been widely used for the removal of PAHs (pg. 2, left column, second full paragraph). Therefore, it would be reasonably expected that a composition containing bentonite (which would have been prima facie obvious to include within the composition of Dodd, as discussed above) would decontaminate the skin from the hydrophobic hazardous agent, polycyclic aromatic hydrocarbons.
Regarding the amounts of the individual components, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05 A.
Claims 2-3 are rendered prima facie obvious because Dodd discloses polyethylene glycol (Col 10, lines 50-51).
Claims 4-5 are rendered prima facie obvious because an ordinarily skilled artisan would be motivated to use bentonite, as taught by Clark, as previously discussed.
Claims 8-10 are rendered prima facie obvious because Dodd discloses carboxymethyl cellulose as a thickener (Col 11, line 36), in an amount of 0.01 to 10 wt.% (Col 12, lines 9-11). Dodd further discloses phenoxy ethanol (Col 15, line 49), as a perfume, in an amount of 0-0.5 wt.% (Col 14, lines 9-11). A prima facie case of obviousness exists because of overlap, as previously discussed.
Claims 11-13 and 36 are rendered prima facie obvious because Dodd discloses an emollient, such as polyethylene glycol (Col 10, lines 50-51), in an amount of 0.5-50 wt.% (Col 10, lines 63-66), an odor controlling agent, such as activated charcoal/carbon (Col 2, lines 5-6), in an amount of 0.1-10 wt.% (Col 5, lines 54-58), a preservative in an amount of 0.0002% to 0.2 wt.% (Col 20, lines 34-36), a thickener, such as carboxymethyl cellulose (Col 11, line 36), in an amount of 0.01 to 10 wt.% (Col 12, lines 9-11), and water (Col 10, lines 31-37). It would have been prima facie obvious to include bentonite, as taught by Clark, within the composition of Dodd as previously discussed. Clark taught bentonite in an amount of 0.0005 to 50 wt.% (Col 6, lines 27-31). A prima facie case of obviousness exists because of overlap, as previously discussed.
Claims 16 and 17 are rendered prima facie obvious because Dodd discloses the buffering agent, sodium carbonate, can be added to the composition (Col 6, lines 29-30).
Claim 18 is rendered prima facie obvious because the compositions taught by Dodd do not require surfactants (surfactants are optional; Col 16, line 55).
Claim 19 is rendered prima facie obvious because the compositions taught by Dodd do not require any of the listed compounds (full document).
Regarding claim 20, while the composition “not affecting the barrier function of the skin” is not explicitly disclosed, a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because the combined teachings of the prior art disclose a composition that is to be applied to the skin with the same components, overlapping with the claimed amounts, as previously discussed, (i.e., polyethylene glycol, bentonite, carbon-based powder), the properties the applicant discloses and/or claims are necessarily present (i.e., does not affect barrier function).
Claim 23 is rendered prima facie obvious because Dodd discloses the composition is preferably a gel (Col 5, lines 52-53).
Claim 33 is rendered prima facie obvious because Dodd discloses activated charcoal/carbon (Col 2, lines 5-6; Col 7, lines 30-31).
Response to Arguments
Applicant's arguments filed 11/13/2025 have been fully considered but they are not persuasive, and will be addressed insofar as they apply the new ground of rejection.
Applicant argues that a person of ordinary skill in the art seeking to solve the problem of effectively decontaminating the skin from harmful or hazardous substances would not be led to Dodd as Dodd focuses on skin sanitizing paired with cosmetic elimination of unpleasant odors.
The Examiner disagrees. Dodd teaches that the compositions of the disclosure sanitize, disinfect, and remove contamination on skin surfaces (abstract; Col 25, lines 8-18) and is analogous art to the instant invention because the reference is from the same field of endeavor as the claimed invention as both are concerned with compositions for the skin. See MPEP 2414.01(a).I.
Applicant argues that Dodd discourages the use of activated carbon in skin formulations as activated carbon is not preferred.
The Examiner disagrees. Patents are relevant as prior art for all that they contain and nonpreferred or alternative embodiments constitute prior art. See MPEP 2123. Dodd teaches that the compositions of the disclosure are “skin sanitizing and deodorizing compositions” comprising activated carbon (Col 1, line 60 – Col 2, line 5). Therefore, even if activated carbon is not preferred for the composition for the skin, it is explicitly listed as a component in a skin sanitizing and deodorizing composition and is therefore taught by Dodd. Additionally, Barry teaches a topical composition (abstract) that includes activated carbon with the claimed particle size [0030]. Therefore, the prior art does not teach away from the use of activated carbon in a topical composition.
Applicant argues that Dodd provides no teaching about whether carbon is suitable for removing hazardous substances or what concentration would be effective for such a purpose and there is no indication that PEG could serve as a multifunctional agent for removing contaminants from the skin.
The Examiner disagrees. There is nothing in the instant claims requiring that the carbon-based powder or PEG, specifically, is decontaminating the skin, only that the intended use of the composition as a whole is to decontaminate the skin from hazardous substances. It would be reasonably expected that the composition of the combined teaching of the prior art would decontaminate the skin from hazardous agents, such as polycyclic aromatic hydrocarbons (PAHs). Dodd teaches that the compositions of the disclosure sanitize, disinfect, and remove contamination on skin surfaces (abstract; Col 25, lines 8-18) and Clark teaches that bentonite inhibits microbial activity (Col 6, lines 39-41). Furthermore, as evidenced by Dai, bentonite has been widely used for the removal of PAHs (pg. 2, left column, second full paragraph). Therefore, it would be reasonably expected that a composition containing bentonite (which would have been prima facie obvious to include within the composition of Dodd, as discussed above) would decontaminate the skin from the hydrophobic hazardous agent, polycyclic aromatic hydrocarbons.
Applicant argues that Dodd explicitly states that certain PEG derivates, such as polyethylene glycol stearate and distearate are not preferred in cyclodextrin-containing compositions and that formulations which proved to be effective for sanitizing containing PEG were always combined with ethanol which leads one of ordinary skill in the art away from the invention.
The Examiner disagrees. Dodd teaches polyethylene glycol as a useful emollient in the composition (pg. 10, lines 50-51) and does not require the use of ethanol within the compositions of the disclosure. Additionally, there is nothing limiting the use of ethanol in the instant claims.
Applicant argues that the teachings of Clark are not combinable with those of Dodd because the two compositions serve different technical purposes with Dodd targeting sanitizing odor and cosmetic stability and Clark focusing on microbial inhibition.
The Examiner disagrees. Dodd is combinable with Clark because both are concerned with compositions for the skin. Since both Dodd and Clark generally teaches a composition for the skin, it would have been prima facie obvious to one of ordinary skill in the art to include bentonite, within the teachings of Dodd, in the amount taught by Clark because Clark teaches this amount of bentonite in a composition for the skin. An ordinarily skilled artisan would be motivated to use bentonite because Clark teaches that bentonite is capable of microbial adsorption which inhibits microbial activity (Col 6, lines 39-41).
Analysis of Alleged Unexpected Results
Applicant argues that the present claims define a specifically optimized composition in which a phyllosilicate, such as bentonite, and activated carbon act synergistically rather than competitively. Applicant states that the resulting formulation achieves highly effective decontamination of hazardous compounds from the skin, which is unexpected over the prior art. The Examiner is directed to the results shown in Table 2 on pg. 22 of the instant specification.
The Examiner has fully reviewed and considered the unexpected results alleged by the applicant (Table 2). Skin samples contaminated with CdSe quantum dot particles were treated with different decontamination compositions including PEG (31 wt.%), water (42 wt.%), activated carbon (9 wt.%), kaolin (9 wt.%), and bentonite (9 wt.%).
The compositions containing a combination of PEG (31 wt.%), water (42 wt.%), activated carbon (9 wt.%), kaolin (9 wt.%), and bentonite (9 wt.%) were highly effective in removing CdSe quantum dot decontamination from the skin.
These results are unexpected over the prior art.
However, the claims are not “commensurate in scope” with the showing. See MPEP § 716.02(d). It is unclear that a comparative composition containing these specific components and in these specific percentages would be reasonably representative of compositions containing other classes of polymers (e.g., different than PEG), different phyllosilicates (e.g., other than the combination of kaolin and bentonite) in differing amounts to decontaminate the skin from other hazardous agents (e.g., other than CdSe quantum dots) falling within the broader scope currently claimed.
Claim 6 is rejected under 35 U.S.C. 103 as being as being obvious over Dodd et al. (US 6,344,218 B1) in view of Clark et al. (US 6,103,245), Van Den Plas et al. (WO 2008/012107 A2), and Barry (US 2012/0039832 A1) and as evidenced by Dai et al. (Chemosphere, 2020: 251: 126074) and further as evidenced by Calgon Carbon (CPG®).
The 35 U.S.C. 103 rejection over Dodd in view of Clark, Van Den Plas, and Barry, and evidenced by Dai was previously discussed.
Dodd discloses the activated carbon is available as Calgon-Type CPG® (Col 7, lines 31-33).
As evidenced by Calgon Carbon, CPG is made from bituminous coal (pg. 1, left column, bottom paragraph).
Response to Arguments
Applicant's arguments filed 11/13/2025 have been fully considered but they are not persuasive.
Applicant argues that Calgon Carbon does not cure any of the deficiencies of Dodd, Clark, or Dai.
The Examiner disagrees because the prior art is not deficient expected where Calgon Carbon provides evidence that the activated carbon taught by Dodd is made from bituminous coal.
Claims 14-15 are rejected under 35 U.S.C. 103 as being as being obvious over Dodd et al. (US 6,344,218 B1) in view of Clark et al. (US 6,103,245), Van Den Plas et al. (WO 2008/012107 A2), and Barry (US 2012/0039832 A1), and as evidenced by Dai et al. (Chemosphere, 2020: 251: 126074) and further in view of Heber et al. (US 2010/0255076 A1).
The 35 U.S.C. 103 rejection over Dodd in view of Clark, Van Den Plas, and Barry, and evidenced by Dai was previously discussed.
Dodd does not disclose the composition includes an agent for the skin, such as glucomannan, as recited in claims 14 and 15.
Heber teaches a formulation for the skin with glucomannan (Abstract). Heber teaches that when glucomannan is applied to the skin it attracts fibroblasts and stimulates production of collagen to provide augmentation, regeneration or healing of the treated skin [0012].
Since the combined teachings of the prior art generally teach a composition for the skin, it would have been prima facie obvious to one of ordinary skill in the art to include glucomannan, within the teachings of the prior art, because Heber teaches a formulation for the skin with glucomannan. An ordinarily skilled artisan would be motivated to include glucomannan because Heber teaches that when glucomannan is applied to the skin it attracts fibroblasts and stimulates production of collagen to provide augmentation, regeneration or healing of the treated skin [0012].
Response to Arguments
Applicant's arguments filed 11/13/2025 have been fully considered but they are not persuasive.
Applicant argues that Heber does not cure any of the deficiencies of Dodd, Clark, or Dai.
The Examiner disagrees because the prior art is not deficient expected where Heber teaches glucomannan.
Applicant also argues that Heber is non-analogous art.
The Examiner disagrees. Heber is analogous art because Heber also teaches a formulation for the skin (Abstract).
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 1-21, 23, and 33-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 and 17-18 of U.S. Patent Application No. 18/839,363 in view of Barry (US 2012/0039832 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The copending claims recite all of the features recited for the instant claims expect that the carbon-based powder has a particle size in a range of between 3 and 50 µM.
Barry teaches a topical composition (abstract) that includes activated carbon with a size from 3 microns to 500 microns [0030]. Barry teaches that this size of activated carbon can be obtained from commercial sources and has substantial adsorbent surface area and pore cavity [0030].
An ordinarily skilled artisan would be motivated to use this size of activated carbon within the copending claims because Barry teaches that this size of activated carbon can be obtained from commercial sources and has substantial adsorbent surface area and pore cavity [0030].
The weight percentages of each component, as recited in the instant claims, would be achieved by one of ordinary skill in the art through routine optimization. See MPEP 2144.05(II)(A).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Terminal Disclaimer
The terminal disclaimer filed on 11/13/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 18/839,363 has been reviewed and is NOT accepted.
The terminal disclaimer recites the incorrect filing date of 18/839,363. The terminal disclaimer needs to be resubmitted with the correct filing date to be accepted. No fee is required.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashlee E Wertz whose telephone number is (571)270-7663. The examiner can normally be reached Monday - Friday, 8 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHLEE E WERTZ/Examiner , Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612