DETAILED ACTION
RESPONSE TO AMENDMENT
1. Receipt of Applicants’ amendments/remarks filed 7/1/2026 are acknowledged.
INFORMATION DISCLOSURE STATEMENT
2. No new Information Disclosure Statement has been submitted for review.
WITHDRAWN REJECTIONS
3. Rejections not reiterated from previous Office Actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections- 35 USC § 103
4. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 27-31 and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Stack (US 20080044479) in view of Patel et al. (WO 2007120608), GP 2587894, Carnell et al. (US Patent 8815952) and Pedersen et al. (US 20150272124).
Stack (US 20080044479) (hereinafter Stack) discloses a composition comprising water, chlorhexidine digluconate, cetyl alcohol, propylene glycol (1,2 propane diol a C3 alcohol) and triethanolamine (Example 1 table 1, para 0036). The chlorohexidine is present in an amount of 0.1-7 wt % (e.g., at least 0.05 wt %). Stack discloses the formulations can comprise a mixture of solvents. In some embodiments the formulation can comprise about 75 % PG and 25 % water (para 0132). The formulations include acrylic polymers (para 0030). The formulation includes use of chelating agents (e.g., VERSENE 100 (para 0032).
Stack does not disclose the chelating agent of claims 27 and 43. Patel et al. (WO 2007120608) (hereinafter Patel et al.) disclose chelating agents (disodium EDTA) can heighten the susceptibility of bacteria and other organisms to the antiseptic effects of the anti-microbial agent, thereby rendering the composition more effective in combating and/or preventing infection without the necessity of increasing the levels of the anti-microbial agent contained therein (para 0023). Disodium EDTA has the formation constant of claim 27 as disclosed in the instant specification. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include chelating agents such as disodium EDTA in the compositions of Stack. One would have been motivated to heighten the susceptibility of bacteria to the antiseptic effects of the anti-microbial agent.
Patel et al. (WO 2007120608) (hereinafter Patel et al.) disclose chelating agents (disodium EDTA) can heighten the susceptibility of bacteria and other organisms to the antiseptic effects of the anti-microbial agent, thereby rendering the composition more effective in combating and/or preventing infection without the necessity of increasing the levels of the anti-microbial agent contained therein (para 0023). Disodium EDTA has the formation constant of claim 27 as disclosed in the instant specification. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include chelating agents such as disodium EDTA in the compositions of Stack. One would have been motivated to heighten the susceptibility of bacteria to the antiseptic effects of the anti-microbial agent.
Stack does not disclose the chelating agent is present in an amount of 25 ppm to 100 ppm.
GP 2587894 disclose sanitization compositions containing a chelating agent of at least 0.01 % (100 ppm) (page 4,lines 17-20). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to optimize the amount of chelating agent. One would have been motivated to add the desired amount of chelating agent to enhance the effectiveness of the antimicrobial agent.
Stack does not disclose trisodium HEDTA.
Carnell et al. (US Patent 8815952) (hereinafter Carnell et al.) disclose chelating agents such as disodium EDTA or trisodium HEDTA (col. 3, line 62-col. 4 line 36).
Pedersen et al. (US 20150272124) (hereinafter Pedersen et al.) disclose a chelating agent is a molecule capable of coordinating (binding) the metal ions commonly found in water sources to prevent the metal ions from interfering with the action of other ingredients and Examples include EDTA (para 0098-0099).These can be present from 10 ppm to 20,000 ppm (claim 26).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute the disodium EDTA for trisodium HEDTA as taught in Carnell et al. and Peterson et al. One would have been motivated to do so because simple substitution of one known element for another would obtain predictable results as both are art recognized chelating agents. The amounts of chelating agent that may be present overlaps with the claimed ppm.
5. Claims 27-38 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Modak et al. (US 20200352991) in view of Patel et al. (WO 2007120608), Huang et al. (US 20070048345), GP 2587894-as cited on the IDS, Carnell et al. (US Patent 8815952) and Pedersen et al. (US 20150272124).
Modak et al. (US 20200352991) (hereinafter Modak et al.) disclose film forming formulations with antimicrobial agents for inhibiting bacterial growth (abstract). The reference teaches the compositions can contain solvents such as ethanol from 20 to 80 % (para 0170) and that the compositions contain water from 1 to 90 % (para 0171). The compositions contain chlorhexidine 1 % (para 0190, 0333). Chlorhexidine glucanate is disclosed (tables of Ex 15 and Ex 16). Moda et al. disclose that cellulose polymers include cellulose in amounts from 0.1 to 5 % (para 0070).
Modak et al. does not disclose chelating agents.
Patel et al. (WO 2007120608) (hereinafter Patel et al.) disclose chelating agents (disodium EDTA) can heighten the susceptibility of bacteria and other organisms to the antiseptic effects of the anti-microbial agent, thereby rendering the composition more effective in combating and/or preventing infection without the necessity of increasing the levels of the anti-microbial agent contained therein (para 0023). Disodium EDTA has the formation constant of claim 27 as disclosed in the instant specification. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include chelating agents such as disodium EDTA in the compositions of Modak et al. One would have been motivated to heighten the susceptibility of bacteria to the antiseptic effects of the anti-microbial agent.
Modak et al. disclose chlorhexidine and its salts and chlorhexidine gluconate does not disclose chlorhexidine digluconate.
Huang et al. (US 20070048345) (hereinafter Huang et al.) disclose biocides include chlorhexidine gluconate and chlorhexidine digluconate (para 0010). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute the chlorhexidine gluconate for chlorhexidine digluconate. One would have bene motived to do so because both are biguanide compounds used as biocides and simple substitution of one antimicrobial for another would yield predictable results.
Modak et al. does not disclose the chelating agent is present in an amount of 25 ppm to 100 ppm.
GP 2587894 disclose sanitization compositions containing a chelating agent of at least 0.01 % (100 ppm) (page 4,lines 17-20). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to optimize the amount of chelating agent. One would have been motivated to add the desired amount of chelating agent to enhance the effectiveness of the antimicrobial agent.
Modak et al. does not disclose trisodium HEDTA.
Carnell et al. (US Patent 8815952) (hereinafter Carnell et al.) disclose chelating agents such as disodium EDTA or trisodium HEDTA (col. 3, line 62-col. 4 line 36).
Pedersen et al. (US 20150272124) (hereinafter Pedersen et al.) disclose a chelating agent is a molecule capable of coordinating (binding) the metal ions commonly found in water sources to prevent the metal ions from interfering with the action of other ingredients and Examples include EDTA (para 0098-0099).These can be present from 10 ppm to 20,000 ppm (claim 26).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute the disodium EDTA for trisodium HEDTA as taught in Carnell et al. and Peterson et al. One would have been motivated to do so because simple substitution of one known element for another would obtain predictable results as both are art recognized chelating agents. The amounts of chelating agent that may be present overlaps with the claimed ppm.
6. Claims 27 and 44-45 are rejected under 35 U.S.C. 103 as being unpatentable over Modak et al. (US 20200352991) in view of Patel et al. (WO 2007120608) and Huang et al. (US 20070048345), GP 2587894-as cited on the IDS, Carnell et al. (US Patent 8815952) and Pedersen et al. (US 20150272124) as applied to claims 27-38 and 49 above, and further in view of Hobbs et al. (US 20100282409).
Modak et al. does not disclose emollient esters. Hobbs et al. (US 20100292409) (hereinafter Hobbs et al.) disclose antimicrobial compositions that contain emollient esters that further provide enhanced antimicrobial efficacy (para 0118). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to further include emollient esters in the composition of Modak. One would have been motivated to do so to further provide for enhanced antimicrobial efficacy.
RESPONSE TO ARGUMENTS
7. Applicants’ arguments have been fully considered and are not persuasive for the reasons below.
Applicants argue that Stack teaches amount of chelating agent 0.1 % which is 1000 ppm and 10-fold greater than the maximum in claim 27 which is 100 ppm.
In response, the Examiner respectfully submits that Applicants are arguing the references individually and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Patel et al. GP 2587894, Carnell et al., and Pedersen et al. were relied upon to address the concentration. Pedersen et al. clearly discloses chelating agents can be present from 10-20000 ppm.
Applicants argue that chelating agents in Navjeet, Carnell and Pedersen are for topical antiseptic uses. A person of skill in the art would not be motivated based on these references to add a chelating agent disclosed in an amount to the compositions of Modak since they are coatings for medical devices.
In response, the Examiner respectfully submits that this argument is not found persuasive because Modak discloses that the film forming compositions act like a bandage and can eliminate the need for a separate bandage to cover a wound (para 0058). Modak defines “medical device” as any instrument, apparatus or other article that can be inserted into, or otherwise contacted with, the body of a patient, for diagnosis, treatment, prevention or monitoring of a disease, injury or medical condition (para 0053). The methods apply to treating minor wounds (para 0054). Surface wounds include wound to the surface of the patient’s body, e.g., skin (para 0048 and 0059). The paragraphs demonstrate application to the skin. Application of a wound dressing to a patient’s skin would be considered topical. Furthermore, Modak et al. disclose “ in certain exemplary embodiments, the present technology is directed to a hydrophobic film forming would healing topical cream or gel containing one or more wound healing agents” (para 0196). Therefore, the compositions are also applied topically.
Applicants argue that Hobbs defines emollients as materials which are capable of maintaining or improving the moisture level, compliance, or appearance of the skin when used repeatedly and Modak is directed to film forming compositions for coating medical devices.
In response, the Examiner respectfully submits that Modak defines “medical device” as any instrument, apparatus or other article that can be inserted into, or otherwise contacted with, the body of a patient, for diagnosis, treatment, prevention or monitoring of a disease, injury or medical condition (para 0053). The methods apply to treating minor wounds (para 0054). Surface wounds include wound to the surface of the patient’s body, e.g., skin (para 0048 and 0059). The paragraphs demonstrate application to the skin. Application of a wound dressing to a patient’s skin would be considered topical. Furthermore, Modak et al. disclose “ in certain exemplary embodiments, the present technology is directed to a hydrophobic film forming would healing topical cream or gel containing one or more wound healing agents” (para 0196). Therefore, the compositions are also applied topically.
CONCLUSION
8. THIS ACTION IS MADE FINAL. 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
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Danah Al-Awadi/
Primary Examiner, Art Unit 1615
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