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 .
Election/Restrictions
Claims 20-36 were withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/30/24.
The requirement was deemed proper and was previously made FINAL.
Claim Rejections - 35 USC § 103
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.
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 17-19 and 40-47 are rejected under 35 U.S.C. 103 as being unpatentable over Beyenal et al (11229714) in view of Hou et al (2009/0291844). Beyenal discloses the use of a flexible biocompatible fabric substrate having two electrodes (e.g. figures 1-3, col. 5, lines 50-59, col. 9, lines 1-10, etc.) as being a fabric with electrodes, that uses a battery/cells (e.g. col. 1, line 51, col. 6, lines 20-25, etc.) to produce hydrogen peroxide, where the production is approximately 2 mM/hr, and for a 24 hour period approximately 45 mM (e.g. col. 12, lines 53-57 etc.) to be used on and applied to wounds to therapeutically treat the wounds to inhibit or disrupt a biofilm in the wound (e.g. abstract, etc.), where the substrate is wetted before use or during use with wound exudate or saline (e.g. the substrate contains the saline, col. 4, lines 55-57, exudate containing the water for hydrogen peroxide production, col. 5, lines 1-4, etc.).
As to the new claim limitation of the “hydrogen peroxide for killing the bacteria population at a rate of 2.5% CFU/umol H2O2” where the bacteria is E. Coli, the applicant states in their disclosure in paragraph 93 that due to tests applying H2O2 to E. Coli, this results in E. Coli bacteria being killed at a rate of 2.5%CFU/umol of H2O2. As Beyenal produces 2mM/hr of H2O2 or 45mM of H2O2 over a 24 hour period, his system and method will necessarily result in killing the E. Coli bacteria population at a rate of 2.5% CFU/umol H2O2 since this is what the applicant states occurs when H2O2 is produced and applied to E. Coli, and/or since Beyenal produces 2mM/hr or 45mM of H2O2 over a 24 hour period to be applied therapeutically to wounds.
Beyenal does not disclose the substrate to be polyester, the electrodes printed or woven in the substrate, the anode and/or cathode comprising a catalyst for the production of the hydrogen peroxide, and the catalyst is selected for the formation of hydrogen peroxide over water, such that the hydrogen peroxide is formed with at least 10 times greater Faradaic efficiency than water.
Hou discloses the use of at least a pair of electrodes with a catalyst (e.g. figures 2, 8, 9, abstract, paras. 10, 24, 96, copper/Cu, etc.) connected to a battery to provide current/voltage to the electrodes (e.g. para. 25, etc.) to produce hydrogen peroxide (e.g. paras. 14, 17, 23, etc.) where the electrodes are printed on/woven in a biocompatible substrate (e.g. paras. 34, 35, etc.) such as made of polyester and Cu/copper (e.g. para. 96, table 1, etc.) where the substrate is used for bacteria or viruses (e.g. para. 30, etc.). For claim 40, Hou uses the water to produce the hydrogen peroxide and therefore would have selective formation of hydrogen peroxide over water, such as 10 times (in the alternative, see the 103 rejection below). It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the hydrogen peroxide generation system and method as taught by Beyenal, with the substrate to be polyester, the electrodes printed or woven in the substrate, the anode and/or cathode comprising a catalyst for the production of the hydrogen peroxide, and the catalyst is selected for the formation of hydrogen peroxide over water, such that the hydrogen peroxide is formed with at least 10 times greater Faradaic efficiency than water, such as taught by Hou, since it would provide the predictable results of: an flexible and comfortable fabric for use on the patient; an inexpensive and/or quickly manufactured technique for attaching electrodes to the substrate; providing a way to facilitate the production of hydrogen peroxide and/or generate a higher concentration of hydrogen peroxide; and focusing on the production of hydrogen peroxide to inhibit or disrupt the biofilms, using the water provided, without producing the undesirable production of water.
Claims 37-39, and in the alternative claim 40, are rejected under 35 U.S.C. 103 as being unpatentable over Beyenal in view of Hou (i.e. “modified Beyenal”) in view of Parasher et al (2012/0020872). Modified Beyenal discloses the use of the electrode and catalyst made of copper but does not disclose the catalyst comprising nanoparticles having a particle size of 10 nm to 500 nm, and in the alternative the catalyst is selective for the formation of hydrogen peroxide over water, such that the hydrogen peroxide is formed with at least 10 times greater Faradaic efficiency than water. Parasher discloses with sufficient specificity the use of 20 nm and 50 nm sized nanoparticles as a catalyst, and the catalyst is selective for the formation of hydrogen peroxide over water, such that the hydrogen peroxide is formed with at least 10 times greater Faradaic efficiency than water (e.g. 67-69, para. 49, etc.), to provide a commercially viable way to produce hydrogen peroxide while avoiding the undesired production of water. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the system and method as taught by modified Beyenal, with the catalyst comprising nanoparticles having a particle size of 10 nm to 500 nm (such as 20 nm or 50 nm) and the catalyst is selective for the formation of hydrogen peroxide over water, such that the hydrogen peroxide is formed with at least 10 times greater Faradaic efficiency than water (such as 67-69), as taught by Parasher, since it would provide the predictable results of providing a commercially viable way to produce hydrogen peroxide while avoiding the undesired production of water.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot in view of the new grounds of rejection necessitated by amendment.
Conclusion
The prior art of Paluszcyk made of record is considered pertinent to applicant's disclosure and shows some of the well-known in the art elements.
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 George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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/George R Evanisko/Primary Examiner, Art Unit 3792 5/5/26
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