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 .
Any References cited but not appearing in any current Form 892 may be found in previous Form 892’s or IDS’s.
Response to Amendment
The amendment to the claims filed on 02/18/2026 has been entered.
In the amendment, claims 1, 17 and 19 are amended. Claims 5-6, 12-16, 18 and 23-25 are cancelled. Claims 1-4, 7-11, 17, 19-22 and 26 are currently pending.
The cancellation of claim 12 renders the 112b rejection to claim 12 moot.
The cancellation of claim 13, renders the 112b rejection to claim 13 moot.
The cancellation of claim 15 renders the 112b rejection to claim 15 moot.
The amendment to claim 17 overcomes the 112b rejection to claim 17.
The cancellation of claim 18 renders the 112b rejection to claim 18 moot.
The amendment to claim 19 overcomes the 112b rejection with regard to claim 19.
Response to Arguments
Applicant’s arguments, see pages 5-8, filed 02/18/2026, with respect to the rejection(s) of claim(s) 1 under 102 and have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly cited Chawrai (US 2016/0128944) in view of newly cited XU (US 2022/0387610) in view of newly cited Askill (US 2003/0031717) and in further view of newly cited Pigg (US 2015/0320605).
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 recites “A method comprising applying: a) applying…b) applying…c)applying….” It is suggested that the first occurrence of applying is deleted for clarification.
Claim 7 is objected to because of the following informalities: claim 7, part a) recites “biding site” instead of --binding site--.
Claim 26 is objected to because of the following informalities: claim 26 recites “sit” instead of --site--.
Appropriate correction is required.
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.
Claim(s) 1-4, 7-11, and 19-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chawrai (US 2016/0128944) in view of XU (US 2022/0387610) in view of Askill (US 2003/0031717) and in further view of Pigg (US 2015/0320605).
Regarding claim 1, Chawrai discloses a method ([0002], methods of use) comprising applying: a) applying a biocide to a target area and then applying dodecane to the target area; b) applying a nonpolar dodecane to a target area and then applying a biocide to the target area; or c) applying a mixture ([0017], a particle comprising a core comprising an active agent and a coating layer comprising a cationic molecule on the core) comprising a peptidomimetic and dodecane to a target area ([0046], the active agent can be selected from the group including peptidomimetic, nucleic acids, nucleic acids analogs and derivatives; [0099] to [0100, the coating layer of the active agent [peptidomimetic] is a lipid and a cationic molecule, and an example of a cationic molecule is 1,4,7,10-tetrazacyclododecane, thus the mixture is a peptidomimetic and dodecane; [0177], [0174], the composition can be a cream, oil, lotion, serum and in some embodiments the composition comprising the particles disclosed herein is an antifungal, antibacterial, anti-inflammatory, anti-aging, anti-wrinkle, or skin whitening or skin bleaching composition; NOTE: the composition is in one example used to treat skin suffering from an infectious or diseased condition thus a target area is for example, skin to which the mixture is applied).
Chawrai does not explicitly disclose that the peptidomimetic is a biocide, the biocide being a microbial efflux pump inhibitor, wherein for any of the disjunctive steps listed above, the biocide and dodecane are contained in a covering and the covering is applied to the target area, and the covering comprises a material selected from the group consisting of films, tapes, foams, and woven or non-woven fabrics coated with acrylate, silicone or synthetic rubber and mixtures thereof.
XU teaches an analogous method (Abstract, [0012], method of treating a patient) comprising applying an analogous peptidomimetic to a target area ([0087], [0101], topical application which implies application to the skin), peptidomimetic being a biocide and a microbial efflux pump inhibitor ([0065], In some embodiments, the antibiotic molecule is an efflux pump inhibitor (EPI). The efflux pump inhibitor (EPI) may be a peptidomimetic compound; [0066], In certain embodiments, the efflux pump inhibitor is selected from the group consisting of phenylalanine arginyl β-naphthylamide [PaβN; MC-207,110]; NOTE: Applicant’s specification, [0021] and Applicant’s claim 10 provide phenylalanine arginyl β-naphthylamide is provided as an example of a biocide being a microbial efflux pump inhibitor and thus XU which teaches use of phenylalanine arginyl β-naphthylamide as the peptidomimetic used, teaches a biocide and a microbial efflux pump inhibitor).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the peptidomemetric of the method of claim 1 of Chawrai is a biocide, the biocide being a microbial efflux pump inhibitor, as taught by XU, in order to provide an improved method that has a mixture that works as an antibiotic via efflux pump inhibition (XU, [0065]).
Chawrai in view of XU discloses the invention as described above.
Chawrai in view of XU does not disclose wherein for any of the disjunctive steps listed above, the biocide and dodecane are contained in a covering and the covering is applied to the target area, and the covering comprises a material selected from the group consisting of films, tapes, foams, and woven or non-woven fabrics coated with acrylate, silicone or synthetic rubber and mixtures thereof.
Askill teaches an analogous method of applying an analogous a biocide to an analogous target area ([0016], topical antibiotic preparations in cream or lotion form), wherein the analogous mixture is contained in a covering and the covering is applied to the target area ([0016], layers or covers such as dressings over the ointments).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide to the method of Chawrai in view of XU that for any of the disjunctive steps listed above, the biocide and dodecane are contained in a covering and the covering is applied to the target area, as taught by Askill, in order to provide an improved method that prevents topical ointments from being easily rubbed off (Askill, [0016]).
Chawrai in view of XU and in further view of Askill disclose the invention as described above.
The combination fails to disclose the covering comprises a material selected from the group consisting of films, tapes, foams, and woven or non-woven fabrics coated with acrylate, silicone or synthetic rubber and mixtures thereof.
Pigg teaches an analogous covering ([0041], dressing) applied to an analogous target area ([0002], wound and skin), the covering comprising a material selected from the group consisting of films ([0041], film substrate), tapes, foams, and woven or non-woven fabrics coated with acrylate, silicone or synthetic rubber and mixtures thereof ([0005]; [0041], film substrate coated with a suitable fluid silicone precursor mixture).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the covering of the method of Chawrai in view of XU and in further view of Askill comprises a material selected from the group consisting of films, tapes, foams, and woven or non-woven fabrics coated with acrylate, silicone or synthetic rubber and mixtures thereof, as taught by Pigg, in order to provide an improved method that facilitates providing a weakly adhering wound facing layer and that inhibits leakage of wound fluid through edges of the dressing (Pigg, [0013]).
Regarding claim 2, Chawrai in view of XU, in view of Askill and in further view of Pigg discloses the invention as described above with regard to claim 1.
Chawrai further discloses wherein said target area is an exterior or interior surface of a mammal ([0177], skin care composition are material applied topically to treat skin suffering from infectious diseases; [0171], the composition is administered to mammals and preferably humans).
Regarding claim 3, Chawrai in view of XU, in view of Askill and in further view of Pigg discloses the invention as described above with regard to claim 2.
Chawrai further discloses wherein said target area is the skin ([0177], skin]), eye and/or ear of said mammal ([0171]).
Regarding claim 4, Chawrai in view of XU, in view of Askill and in further view of Pigg discloses the invention as described above with regard to claim 2.
Chawrai further discloses wherein said mammal is a human (see rejection to claim 2 above).
Regarding claim 7, Chawrai in view of XU, in view of Askill and in further view of Pigg discloses the invention as described above with regard to claim 1.
The combination further discloses wherein said microbial efflux pump inhibitor is selected from the group consisting of: a) a compound configured to competitively bind to a biding site of the efflux pump,wherein the efflux pump is of the resistance nodulation division family; b) a compound configured to competitively bind to a binding site of the efflux pump, wherein the efflux pump is of the major facilitator superfamily; c) a compound configured to competitively bind to a binding site of the efflux pump, wherein the efflux pump is of the ATP-binding cassette superfamily; d) a molecule having a structure configured to recognize, interact, and block the efflux pump (per Applicant’s specification at [0021] phenylalanine arginyl β-naphthylamide is a molecule having a structure configured to recognize, interact, and block the efflux pump and Chawrai discloses a peptidomimetic and Xu teaches the peptidomimetic is phenylalanine arginyl β-naphthylamide, see claim 1 rejection, thus the limitation is met as Applicant discloses phenylalanine arginyl β-naphthylamide is having a structure configured to recognize, interact, and block the efflux pump); e) a molecule that is configured to bind and block efflux pumps or porins within the cellular membranes; and f) a molecule that binds allostericly to an efflux pump, preferably said molecule that binds allostericly to an efflux pump is an allosteric inhibitor.
Regarding claim 8, Chawrai in view of XU, in view of Askill and in further view of Pigg discloses the invention as described above with regard to claim 7.
The combination further discloses wherein said molecule having a structure configured to recognize, interact, and block the efflux pump is selected from the group consisting of a pyridopyrimidine, an arylpiperazine, an arylpiperidine, peptidomimetic (per Applicant’s specification at [0021], a molecule having a structure configured to recognize, interact, and block the efflux pump, is a peptidomimetic and is phenylalanine arginyl β-naphthylamide, and Chawrai discloses a peptidomimetic and XU teaches the peptidomimetic is phenylalanine arginyl β-naphthylamide, see claim 1 rejection, and claim 7 rejection above, thus the combination discloses that the molecule having a structure configured to recognize, interact, and block the efflux pump is a peptidomimetic) and mixtures thereof, and said molecule that is configured to bind and block efflux pumps or porins within the cellular membranes is selected from the group consisting of biorecognition elements, antibodies, nanobodies, aptamers and mixtures thereof.
Regarding claim 9, Chawrai in view of XU, in view of Askill and in further view of Pigg discloses the invention as described above with regard to claim 8.
The combination further discloses wherein said peptidomimetic is a c-capped dipeptide (Applicant’s specification at [0021] and Applicant’s claim 11, provides that phenylalanine arginyl β-naphthylamide is a c-capped dipeptide, and the combination teaches the peptidomimetic is phenylalanine arginyl β-naphthylamide, see the claim 1 rejection, thus said peptidomimetic is a c-capped dipeptide) and said aptamer is a nucleic acid.
Regarding claim 10, Chawrai in view of XU, in view of Askill and in further view of Pigg discloses the invention as described above with regard to claim 9.
The combination further discloses wherein said c-capped dipeptide is a dipeptide compound (Applicant’s specification at [0021] discloses phenylalanine arginyl β-naphthylamide is a c-capped dipeptide, and the c-capped dipeptide is preferably a dipeptide compound, and claim 11 recites said dipeptide compound is phenylalanine arginyl β-naphthylamide, and the combination discloses the peptidomimetic of Chawrai is a phenylalanine arginyl β-naphthylamide as taught by XU and thus discloses that it is a c-capped dipeptide and the c-capped dipeptide is a dipeptide compound).
Regarding claim 11, Chawrai in view of XU, in view of Askill and in further view of Pigg discloses the invention as described above with regard to claim 10.
The combination further discloses wherein said dipeptide compound is Phe-Arg-p- napthylamide and analogs thereof (the combination discloses the peptidomimetic of Chawrai is a phenylalanine arginyl β-naphthylamide as taught by XU, see rejection to claim 1) or a diamine-containing peptide and analogs thereof.
Regarding claim 19, Chawrai in view of XU, in view of Askill and in further view of Pigg discloses the invention as described above with regard to claim 1.
XU further teaches wherein the target area is infected with bacteria or fungi ([0087], topical administration implies the target area is skin; [0066], bacteria/Pseudomonas aeruginosa).
Regarding claim 20, Chawrai in view of XU, in view of Askill and in further view of Pigg discloses the invention as described above with regard to claim 19.
XU further teaches wherein said bacteria is a Gram-negative bacteria or Gram-positive bacteria (Applicant’s specification at [0027] and claim 21 indicates the bacteria is Pseudomonas aeruginosa as an example of the bacteria that is either gram positive or gram negative; XU teaches [0066], bacteria/Pseudomonas aeruginosa; also NOTE: bacteria is inherently gram positive or gram negative thus teaches a gram negative or gram positive bacteria) and said fungi is a filamentous fungus or yeast.
Regarding claim 21 Chawrai in view of XU, in view of Askill and in further view of Pigg discloses the invention as described above with regard to claim 20.
XU further teaches wherein said bacteria is a Pseudomonad or Acinetobacter (pplicant’s specification at [0027] indicates Pseudomonas aeruginosa is a Pseudomonad; XU teaches [0066], bacteria/Pseudomonas aeruginosa and thus teaches a Pseudomonad), and fungus is a Candida group yeast.
Regarding claim 22 Chawrai in view of XU, in view of Askill and in further view of Pigg discloses the invention as described above with regard to claim 21.
XU further teaches wherein said wherein said bacteria is Pseudomonas aeruginosa (XU teaches [0066], bacteria/Pseudomonas aeruginosa), Acinetobacter baumannii, and said fungus is Candida albicans.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chawrai (US 2016/0128944) in view of XU (US 2022/0387610) in view of Askill (US 2003/0031717) and in further view of Pigg (US 2015/0320605) as applied to claim 1 above, and further in view of Webb (US 2023/0248798).
Regarding claim 17, Chawrai in view of XU, in view of Askill and in further view of Pigg as described above with regard to claim 1.
Chawrai further discloses wherein said biocide and/or said nonpolar solvent are in the form of a cream ([0177], [0174], the composition can be a cream, oil, lotion, serum NOTE: it is inherent that the cream has a viscosity).
The combination does not disclose wherein the biocide and/or dodecane are in the form of a cream or gel, and each cream or gel has, independently, a viscosity of from 0.5 cP to 250,000 cP.
Webb teaches an analogous biocide ([0062]) in the form of a cream ([0071]), preferably each cream, has independently a viscosity from about 0.5 cP to about 250,000 cP ([0071]; NOTE: the cream has a viscosity of from about 30000 cP to about 100000cP which falls within the claimed range).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the biocide and/or said nonpolar solvent that are in the form of a cream or gel, in the method of Chawrai in view of XU, in view of Askill and in further view of Pigg has, independently, a viscosity from 0.5 cP to 250,000 cP as taught by Webb, in order to provide an improved method that facilitates providing a topical skin composition and a desired composition form (Webb, [0071], [0070]).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chawrai (US 2016/0128944) in view of XU (US 2022/0387610) in view of Askill (US 2003/0031717) and in further view of Pigg (US 2015/0320605) as applied to claim 1 above, and further in view of Nelson (US 2004/0204378).
Regarding claim 26, Chawrai in view of XU, in view of Askill and in further view of Pigg discloses the invention as described above with regard to claim 1.
The combination does not disclose wherein said application to said target site occurs before said target sit is infected.
Nelson teaches an analogous method ([0108]) comprising applying: applying a mixture ([0108];[0150]; NOTE: the mixture that is applied includes the efflux pump inhibitor and a drug which is resistant to microbes as well as a pharmaceutically accepted carrier and they are applied simultaneously) comprising a biocide ([0108]; [0098]]; [0034]; NOTE: the efflux pump inhibitor treats an infection caused by a microbe and is thus a biocide as it may be antibacterial on its own), wherein said application to said target site occurs before said target sit is infected ([0114]).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that said application to said target site of the method of Chawrai in view of XU, in view of Askill and in further view of Pigg occurs before said target sit is infected, as taught by Nelson, in order to provide an improved method that facilitates prophylactic treatment of a subject (Nelson, [0114]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Publication 2011/0065771 discloses a method comprising applying: applying a mixture comprising a biocide and dodecane to a target area, said the biocide being a microbial efflux pump inhibitor ([0064], aptamers used; [0152], [0172]; preparations are antimicrobial; [0140] to [0141], formulations may be prepared with micelles which include sodium dodecane).
US Patent No. 6211349 to Dale discloses a method comprising applying: applying a mixture comprising a biocide and dodecane to a target area, said the biocide being a microbial efflux pump inhibitor (col. 12, line 60 to col. 13, line 67; col. 14, line 50 to col. 15, line 28; col. 16, line 31 to col. 17, line 54; col. 2, lines 9-11).
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.
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/G.M./Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786
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