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 .
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) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenblatt in view of US Pre-Grant Publication 2010/0256576 to Aggarwal et al. (Aggarwal).
Regarding claim 1, Rosenblatt teaches the provision of wipes (paragraph 33) which may have various compositions therein, including e.g. 3% tetrasodium EDTA (paragraphs 14, 81), ethanol (1-30%, see paragraph 24), and chlorhexidine (paragraph 28). Rosenblatt does not teach the use of pH of at least 9.5. Aggarwal teaches that a disinfectant solution for a catheter may have a pH of 8-12 (paragraph 58). Aggarwal teaches that this pH is subject to routine experimentation in view of a particular application (paragraph 57). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a composition having a pH of at least 9.5 as taught by Aggarwal in the wipes of Rosenblatt in order to adapt it for use with catheters. With respect to the first and second wipes and compositions, such wipes are obvious as the mere duplication of the wipes above (the examiner notes the first wipe does not exclude the use of chlorhexidine).
Regarding claim 2, Rosenblatt teaches an overlapping range (1-30%, paragraph 24).
Regarding claim 3, Rosenblatt teaches 3% tetrasodium EDTA (paragraphs 14, 81).
Regarding claim 4, Rosenblatt teaches that the composition may include
Regarding claim 5, Rosenblatt teaches an overlapping range (1-30%).
Regarding claims 6-8, Rosenblatt does not explicitly teach a concentration of chlorhexidine. However, Rosenblatt does explicitly teach a range of antibiotic (minocycline, 0.05%-0.2%, paragraph 15). As such, Rosenblatt is aware that the concentration of antibiotic in the composition is a result effective variable determining efficacy in sterilization and minimization of biofilm. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to optimize the range of concentration of chlorhexidine as the routine optimization of a known result effective variable (see MPEP 2144.05). The tetrasodium EDTA and ethanol concentrations in claims 7-8 are discussed above with respect to claims 2-5.
Regarding claim 9, Rosenblatt teaches the use of wipes for catheter sterilization (see e.g. paragraph 11). Such a process includes the cleaning solution exuding from the wipe, as commonly understood in the art.
Regarding claims 10-12, Rosenblatt teaches suitability for use with catheters (paragraph 11).
Rosenblatt teaches peripheral lines (paragraph 31), solution chambers (see e.g. paragraph 20, the examiner notes that “a solution chamber” is broad and reads on essentially any container), the solution which may additionally include taurolidine (see paragraph 27). Rosenblatt does not explicitly teach at least 1% taurolidine. However, Rosenblatt does explicitly teach a range of antibiotic inclusion (minocycline, 0.05%-0.2%, paragraph 15), which is the role filled by taurolidine (per paragraph 27). As such, Rosenblatt is aware that the concentration of antibiotic in the composition is a result effective variable determining efficacy in sterilization and minimization of biofilm. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to optimize the range of Taurolidine as the routine optimization of a known result effective variable (MPEP 2144.05). Rosenblatt does not teach the use of pH of at least 9.5. Aggarwal teaches that a disinfectant solution for a catheter may have a pH of 8-12 (paragraph 58). Aggarwal teaches that this pH is subject to routine experimentation in view of a particular application (paragraph 57). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a composition having a pH of at least 9.5 as taught by Aggarwal in the wipes of Rosenblatt in order to adapt it for use with catheters.
Regarding claim 14, Rosenblatt teaches that the composition may have tetrasodium EDTA, ethanol, and taurolidine or chlorhexidine, but does not specifically teach that separate and different compositions may be provided in a kit. Aggarwal teaches that different formulations of a composition may have different additives for different parallel applications (see e.g. paragraph 62). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide different formulations of the composition of Rosenblatt in a kit in order to use the composition in different parallel applications.
Response to Arguments
Applicant's arguments filed 23 January 2026 have been fully considered but they are not persuasive.
Applicant’s argument that Rosenblatt teaches away from the present combination is not persuasive. While Rosenblatt teaches a different pH and that pH > 8.5 can be detrimental, this teaching relates to use in the bloodstream, rather than on an externally utilized wipe. There is no evidence of record suggesting that the proposed usage of the substance would be problematic. Accordingly, the examiner holds that Rosenblatt does not substantively teach away from the combination with Aggarwal.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 17 April 2026
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