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 .
Claims Status
Claims 3-4, 6,7,11-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claims 1-2, 5, 8-10 and 18 are under current examination directed to the elected composition of: creams, having a combination of hydrogen peroxide with trichloroacetic acid.
Applicants' arguments and amendments filed on 11/20/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Information Disclosure Statements
Information Disclosure Statement (IDS) filed on 02/03/2026 has been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
New rejections in view of claim amendments
Claim Rejections - 35 USC § 112(d)-failure to further limit
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5, 8-9 and 18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 5 recites that the molar ratio between trichloroacetic acid and hydrogen peroxide is 4.34-4.74, however claim 1 has already been amended to require this ratio, therefore claim 5 does not further limit claim 1.
Claim 8 recites that the hydrogen peroxide aqueous solution is a 5-31% aqueous solution. However, claim 1 has been amended to recite a 29-31% aqueous hydrogen peroxide in a concentration by weight ranging from 0.01-5%. Thus, claim 8 broadens the aqueous hydrogen peroxide concentration and does not further limit claim 1.
Claim 9 recites compositions according to claim 1 having a pH value from 2.6 to 3.6. However, claim 1 has been amended to already recite a pH value of from 2.6 to 3.6 and thus claim 9 does not further limit claim 1.
Claim 18 recites compositions according to claim 1 wherein the hydrogen peroxide aqueous solution is a 29-31% aqueous solution. However, claim 1 already requires a 29-31% aqueous solution and thus claim 18 does not further limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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 1-2, 5,8, 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Johansen et al. (United States patent Publication 20020137655) in view of Skin Aesthetics (PRX-T33 is the latest innovative skin rejuvenator- publication date online of 11/2020) and Cox et al. (WO2017013448).
Johansen et al. teach compositions having a source of hydrogen peroxide and as source of carboxylic acid, see claim 1. The composition treats bacteria or fungi for disinfecting skin wounds, and can comprise cosmetic creams, see paragraphs [0152]-[0154]. Examples of carboxylic acids include trichloroacetic acid (TCA), see paragraph [0048]. The source of carboxylic acid which includes trichloroacetic acid can be present from 0.001-1000mM (millimolar), see paragraphs [0048] and [0050]. The hydrogen peroxide can comprise 0.01-1000mM, see paragraph [0037]. The composition can be ready to use or a concentrated product having a pH from 2-11, see paragraph [0060] and can comprise water, see paragraph [0059]. The Molar ratio is suggested to be 1:1. Since the mM amount of trichloroacetic acid is from 0.001-1000nm (0.000001 to 1 molar) and the mM amount of hydrogen peroxide is 0.01-1000mM, the molar ratio between trichloroacetic acid and hydrogen peroxide overlaps and thus renders obvious the claimed range of 4.34-4.74. In water, for aqueous solutions wt%= mM x Mw/10,000. Therefore the weight percent of hydrogen peroxide is about 10x-5 to 3.401 weight percent. For trichloroacetic acid, this about 0.00001634% to about 16.34% by weight. These amounts overlap and render obvious the claimed range. The pH of the composition includes a range of 2 to 11 which overlaps and renders obvious the instantly claimed range of 2.6-3.6, see paragraph [0060].
Though Johansen does not exemplify a claimed range for hydrogen peroxide and TCA, from the teachings of Skin Aesthetics, a combination of 1% hydrogen peroxide with 33% TCA is taught to be advantageous because this combination regenerates skin without use of needles or skin peeling. The hydrogen peroxide neutralizes the caustic effect of TCA and the combination increases the stimulation of new collagen and elastin.
It would have been prima facie obvious to combine the hydrogen peroxide and TCA taught by Johansen in overlapping ranges because Johansen teaches overlapping ranges for the concentration of each. In addition, an ordinary skilled artisan would have been motivated to adjust the concentration of TCA and make the combination of 33% TCA with 1% hydrogen peroxide in view of this combination taught by Skin Aesthetic providing advantageous skin rejuvenation and stimulation of new collagen and elastin.
There would have been a reasonable expectation of success given Johansen teaches a combination of TCA with hydrogen peroxide useful for cosmetic skin products.
With regards to the molecular ratio one of ordinary skill in the art in view of the teachings of Johansen would have adjusted the amount of hydrogen peroxide and TCA to achieve the desired ratios as Johansen teaches overlapping molar amounts and that the combination provides for disinfection of microbial growth and is useful in cream products.
Generally, differences in concentration will not support the patentably 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The modified Johansen does not teach a 29-31% w/w aqueous hydrogen peroxide.
Cox et al. teach compositions which comprise hydrogen peroxide and can take the form of creams, see page 2, lines 1-5, claims 2, 126 and entire document. The formulation can comprise 10-60 w/w of aqueous solvent or from about 19-20% ww/ of water, see page 20, lines 1-24.
It would have been prima facie obvious to provide the composition of Johansen as a 29-31% aqueous solution for the hydrogen peroxide. Doing so is merely adjusting the concentration of water that is present. One of ordinary skill in the art would have been motivated to do so because per Cox et al., hydrogen peroxide solutions can take the form of cream and can comprise no more than 30% water or from 109-19% water. A person of ordinary skill in the art would have had a reasonable expectation of success in adjusting the concentration of water as the composition of Johannsen is already taught to be diluted to a suitable concentration with water, see paragraph [0059]+. Furthermore, Johannessen’s composition is inclusive of up to 70% water, see example embodiment to detergent at paragraph [0181].
Generally, differences in concentration will not support the patentably 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim Objections
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Remarks
Applicants argue that the synergic action of the components of the formulation allows for surprising healing activity (specification page 4, lines 25-26). The claimed composition accelerates healing of traumatic skin and mucosal lesions. Applicants argue that the Johansen composition does not describe Applicants invention as Johansen only provides for compositions which are capable of exhibiting excellent oxidizing, bleaching and antimicrobial activity when combined with carboxylic acid. The applications of Johansen are cooling water, laundry rinse water, oil systems, preservation of wood, latex, adhesives, paper, textiles, plastics, caulking, feed, preservation for foods, beverages cosmetics, contact lens solutions and enzyme formulations. The invention treats acne, and skin infections., in antiperspirants, deodorants, foot baths and forth cleaning and disinfecting contact lenses, hard surfaces and wounds bruises and the like. Applicants argue that thus the compositions of Johansen are too harsh for wand healing compositions as claimed and do not provide synergistic results.
Examiner respectfully submits that regarding the synergistic action, it is unclear which combination Applicants are referring to demonstrate synergism. Page 4 discloses synergism but does not provide any evidence of synergism within the ranges disclosed for each component. Furthermore, synergism does not appear to be shown for the lower amounts 0.08% of trichloroacetic acid and a 29-31% w/w aqueous solution of 0.01% trichloroperoxyacetic acid. Furthermore, Johanson teaches improved antimicrobial activity, thus applying the composition of Johanson would provide an improved antimicrobial effect, see paragraph [0129]. Applicants’ arguments that Johanson would not be suitable for wound healing is considered unpersuasive because at paragraph [0154], Johanson expressly teaches that the invention is suitable for treating skin infections and wounds.
Rejoinder
Examiner respectfully submits that several withdrawn claims are presently ineligible for rejoinder due to potential 112 issues. For example, claim 4 requires chloroacetic acid which was amended out from claim 1. Furthermore, it is respectfully submitted that claim 17 recites an improper Markush for the conditions being treated. Examiner suggests to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. See MPEP § 821.04.
Conclusion
The amendment to the claims necessitated new grounds of rejections. 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).
Currently, no claims are allowed and all claims are rejected.
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 extension fee 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 SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619