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. DETAILED ACTION Pursuant to the amendment dated 12/ 30 /2025 , claim s 1-15 were amended. C laims 1-15 are pending in the instant application and are examined on the merits herein. Priority The instant application is a PCT Patent Application No. PCT/EP2021/078390 filed on 10/14/2021 and claims foreign priority to EPO 20201865.1 filed on 10/14/2020. Withdrawn Rejections Applicant’s amendment, filed on 12/ 30 /2025, with respect to the rejection of claim 4 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second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, has been fully considered and is persuasive. Applicant has amended claim 4 to add the conjunctional phrase “and” clarifying that all components are required to be present in the instant invention . The rejection is hereby withdrawn . Applicant’s amendment, filed on 12/ 30 /2025, with respect to the rejection of claim s 6-9 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, has been fully considered and is persuasive. Applicant has amended claim s 1 and 6-9 to be method claims . The rejection is hereby withdrawn . Applicant’s amendment, filed on 12/ 30 /2025, with respect to the rejection of claim 15 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, has been fully considered and is persuasive. Applicant has amended claim 15 to be a method claim . The rejection is hereby withdrawn . Applicant’s amendment, filed on 12/ 30 /2025, with respect to the rejection of claim 15 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter , has been fully considered and is persuasive. Applicant has amended claim 15 to be a method claim . The rejection is hereby withdrawn . Applicant’s amendment, filed on 12/ 30 /2025, with respect to the rejection of claims 1- 13 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the enablement requirement, has been fully considered and is persuasive. Applicant has amended claim 1 to remove the phrase “preventing”. The rejection is hereby withdrawn . Applicant’s amendment, filed on 12/ 30 /2025, with respect to the rejection of claim 14 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the enablement requirement, has been fully considered and is persuasive. Applicant has amended claim 1 4 from “prevention of epidermolysis bullosa” to “treating epidermolysis bullosa” . The rejection is hereby withdrawn . Applicant’s amendment, filed on 12/ 30 /2025 , with respect to the rejection of claim s 5, 7 and 9 under 35 U.S.C. 102(a)( 1 ) an d 102(1)(2) as being anticipated by Marteinsson et al. (WO 2018/130951 A1, published 07/19/2018, see IDS dated 02/24/2025) has been fully considered and is persuasive . Applicant has amended independent claim 1 to be a method claim and Marteinsson does not exemplify the method wherein the composition also comprises a disinfectant, Marteinsson does not exemplify the method wherein the composition is applied on skin that is not injured, and Marteinsson does not exemplify the method wherein the skin has been previously sterilized . The rejection is hereby withdrawn . Applicant’s amendment, filed on 12/ 30 /2025 , with respect to the rejection of claim s 14 and 15 under 35 U.S.C. 102(a)( 1 ) and 102(1)(2) as being anticipated by Marteinsson et al. (WO 2018/130951 A1, published 07/19/2018, see IDS dated 02/24/2025) has been fully considered and is persuasive . Applicant has amended independent claim 1 to be a method claim and Marteinsson does not exemplify the method of treating epidermolysis bullosa and Marteinsson does not exemplify the method of preventing microbes from settling on surfaces of protective gear . The rejection is hereby withdrawn . Rejections Necessitated by Amendment The following are new ground(s) necessitated by Appl icants' amendment, filed on 12/ 30 /2025 , wherein instant independent claim s 1 , 14, and 15 were amended to alter the breadth and scope of th e claim, and wherein the remaining pending claims 2-13 depend from said independent claim 1 . New and Maintained Grounds of Rejection Claim Rejections - 35 USC § 102 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim s 1-3, 6 , 8 and 10- 1 3 are rejected under 35 U.S.C. 102 (a)(1) and 102(a)(2) as being anticipated by Marteinsson et al. ( WO 2018/130951 A 1, published 07/19/2018 , see IDS dated 02/24/2025 ) . Marteinsson is drawn to chitosan-containing formulations (abstract). The chitosan-containing formulations can be used in a variety of ways, e.g., for the targeted treatment of wounds, aches and pains, skin inflammation due to insect bites, bedsores, ulcers, and the like (paragraph 0055). Marteinsson teaches an aqueous chitosan-containing formulation comprising chitosan and an amount of at least one acid effect to enhance the solubility of said chitosan in deionized water, and an amount of deionized water effecting, in the presence of said acid, to solubilize said chitosan, wherein said aqueous chitosan-containing formulation is suitable for administration to a subject in need thereof (claim 1). The acid may be lactic acid (claim 14). Marteinsson teaches a method for treating a skin condition in a subject in need ther e of with chitosan, wherein the chitosan is applied in the form of a solution which may be applied by spr a ying or dipping to cover and protect superficial wounds or temporary skin defects/damage/irritation/inflammation and promote healing, to reduce skin inflammation, or provide a sealing and protective barrier with antimicrobial properties (claim 33). Regarding claim 10, this claim depends from instant claim 1 and recited additional limitations of the allergy. However, instant claim 1 recites the alternative limitations that the method may reduce skin irritation, allergy, and or an infectious disease. Thus , the limitation of instant claim 10 is met by the prior art teaching the reduction of a skin irritation. Regarding claims 12 and 13, these claims depend from instant claim 1 and recited additional limitations of the infectious disease. However, instant claim 1 recites the alternative limitations that the method may reduce skin irritation, allergy, and or an infectious disease. Thus, the limitations of instant claims 12 and 13 are met by the prior art teaching the reduction of a skin irritation. Claim 14 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Maki et al. (WO 2016/004212 A1, published 01/07/2016, PTO-892). Maki is drawn to hydrogels for treating and ameliorating wounds and methods for making and using them (title). Maki teaches pharmaceutical compositions comprising a hydrogel and active ingredients (abstract). Maki teaches that the composition is in liquid form (claim 1). Maki teaches that the hydrogel comprises a chitosan (claim 4). Maki teaches a method for treating a skin wound caused by Epidermolysis Bullosa with the composition comprising the chitosan hydrogel (claim 9). Accordingly, the claim is anticipated by the prior art. Claim 1 5 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Sabesan ( WO 2005012630 A2 , published 02/10/2005 , PTO-892). Sabesan is drawn to antimicrobial ballistic fabrics and protective articles. S a besan teaches methods for producing antimicrobial ballistic fabrics and protective apparel comprising aramid, polybenzazole or high-performance polyethylene, which articles are rendered antimicrobial by a chitosan agent, thereby preventing the development of odor and fungal and bacterial growth (abstrac t ). The method for rendering antimicrobial an article comprising aramid or polybenzazole antimicrobial, comprising the sequential steps: (a) providing the article comprising aramid or polybenzazole ; (b) contacting said article with water; (c) optionally, contacting the article with a basic solution; (d) contacting the article produced in step (b) or step (c) with a solution comprising a chitosan agent selected from the group consisting of chitosan, chitosan salts and chitosan derivatives (claim 1). S a besan exemplifies the reduction of bacterial growth of an inoculated chitosan treated protective fabric compared to an inoculated untreated protective fabric (Example 1, page 14 and Figure 1). Accordingly, the claim is anticipated by the prior art. 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. Claims 1 , 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable Marteinsson et al. ( WO 2018/130951 A 1, published 07/19/2018 , see IDS dated 02/24/2025 ) . Claim 1 is rejected as discussed above. Marteinsson does not exemplify the composition comprising both glycolic acid or lactic acid. Marteinsson does not teach wherein the composition further comprises a disinfectant. Marteinsson further teaches that the chitosan composition may contain any two or more of the organic acids including glycolic acid and lactic acid (claim 13). The chitosan is present at a concentration between about 0.1% and about 10% by weight based on the weight of said formulation (claim 3). Marteinsson teaches that composition comprising an amount of acid is at least about 10% of the weight of the chitosan which would be 0.01% to about 1% by weight (claim 9). Marteinsson further teaches the composition may comprise one or more iodophors to enhance the antimicrobial spectrum (paragraph 0048). Regarding claim 5, the instant specification states that the disinfectant may be an iodine compound and that the iodine compounds includes compounds which release iodine and are synonymous to iodophors (instant specification page 34). Therefore, an iodophor to enhance the antimicrobial spectrum would meet the limitation of a disinfectant. It would have been prima facie obvious before the effective filing date of the claimed invention to optimize the concentration within the range disclosed by Marteinsson to arrive at the claimed invention. It would have been prima facie obvious for a person of ordinary skill in the art to optimize the concentration within the range disclosed because Marteinsson teaches an aqueous composition comprising about 0.1% to about 10% by weight chitosan and about 0.01% to about 1% by weight acid selected from two or more of glycolic acid and lactic acid. One of ordinary skill in the art would have a reasonable expectation of success because Marteinsson teaches a composition comprising chitosan, glycolic acid and lactic acid and in the concentration range of instant claim 4. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim , 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff , 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature 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.” In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). It would have been prima facie obvious before the effective filing date of the claimed invention to modify the composition taught by Marteinsson to further comprise a disinfectant such as an iodophor to arrive at the claimed invention. It would have been prima facie obvious for a person of ordinary skill in the art to modify the composition to further comprise a disinfectant such as an iodophor because Marteinsson teaches the chitosan-containing composition may comprise an iodophor to enhance the antimicrobial spectrum. One of ordinary skill in the art would have a reasonable expectation of success because Marteinsson teaches the addition of the iodophor to the chitosan-containing composition. Claims 1 , 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable Vanangamudi et al. ( US 20170080013 A1 , published 03-23-2017 , see PTO-892 ) . Vanangamudi is drawn to compositions comprising hydrocortisone acetate and chitosan and treatment of dermatological conditions including but not limited to healing wounds and treatment of dermatitis (abstract). Vanangamudi teaches that t he compositions are particularly useful for the treatment of skin inflammation, dermatitis, and allergic conditions. Vanangamudi teaches that the chitosan in the composition functions as a film forming, biocompatible, non-allergenic biopolymer, protecting the skin by acting as a barrier and that the composition acts as a skin protectant and inhibits the mobility of pathogens from one site to another (paragraph 0047). The novel compositions described herein enable the efficient delivery of active therapeutic agents to penetrate intact skin, to improve skin regeneration and rejuvenation, as well as wound healing (paragraph 0104) . The formulations of topical administration may include liquids (claim 54). The composition may be a pharmaceutical composition (claim 52). Vanangamudi teaches that the compositions are applied after thorough cleansing and drying the skin area (paragraph 0110). Vana n gamudi does not exemplify a method of inhibiting skin irritation or a contact allergy such as dermatitis by applying a pharmaceutical composition comprising chitosan. It would have been pr ima facie obvious before the effective filing date of the claimed invention to select a composition comprising chitosan and apply it to intact skin to inhibit a contact allergy such as dermatitis as taught by Vana n gamudi to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to select a composition comprising chitosan and apply it to intact skin to inhibit a contact allergy because Vana n gamudi teaches that a pharmaceutical composition comprising chitosan that may be used on intact skin to inhibit dermatitis. One of ordinary skill in the art would have a reasonable expectation of success because Vana n gamudi teaches that chitosan in the composition acts as a film forming barrier. Response to Arguments Applicant's arguments filed 12/ 30 /2025 have been fully considered in so much as they apply to the amended claims but they are not persuasive. Regarding the 112(a) rejection over instant claim 14, a pplicant argues that the examples show that the pharmaceutical composition comprising chitosan can both heal the symptoms of epidermolysis bullosa and also form a protective film that prevents further mechanical stress on the skin (specification, pages 52-53 and 84-85). Thus, the disclosed pharmaceutical composition can prevent at least one symptom of epidermolysis bullosa. The argument is not persuasive. Mechanical stress on the skin is not a symptom of epidermolysis bullosa. Further, instant example 8 (specification pages 84-85) does not support that all mechanical stress was prevented. Applicant argues that Marteinsson does not disclose or suggest reducing skin irritation, allergy and/or infectious disease by administering a pharmaceutical composition comprising chitosan in a liquid dosage form . The argument is not persuasive. Marteinsson discloses the use of the composition comprising chitosan for the treatment of skin irritation and that the composition may be in the form of a solution. As instant claim 1 recites the alternative limitations that the method may reduce skin irritation, allergy, and / or an infectious disease, meeting the limitation of reducing skin irritation meets the limitations for instant claim 1. Conclusion No claims are allowed. 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. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration t ool. To schedule an interview, a pplicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA SCHACHERMEYER whose telephone number is (703) 756-5337 . The examiner can normally be reached on M-F 9 :00 AM – 3:30 PM EST . If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached on (571) 270-5241 . The fax phone number for the organization where this application or procee ding is assigned is 571-273-8300 . Information regarding the status of an application may be obtained from Patent Center and the Private Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from Patent Center or Private PAIR. Status information for unpublished applications is available through Patent Center and Private PAIR to authorized users only. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). /SAMANTHA LYNN SCHACHERMEYER/ Examiner, Art Unit 1693 /SCARLETT Y GOON/ Supervisory Patent Examiner, Art Unit 1693