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 .
Applicant’s arguments filed 2/3/2026 has been entered. Claims 31-38, 43-52 and 54-59 are pending. Claims 31-38, 49-52, 54 and 55 are withdrawn. Claims 43-48 and 56-59 are under examination.
Maintained 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.
Claims 43-45, 47, 48 and 56-59 are rejected under 35 U.S.C. 103 as being unpatentable over Burke (US 2017/0215427; published August 3, 2017) in view of Brennan et al. (US 2007/0228064; published October 4, 2007) and Polykarpov et al. (US 2007/0116910; published May 24, 2007) in further view of Western (US 7022945) and Branz et al. (US 2001/0030492; published October 18, 2001).
Applicant’s Invention
Applicant claims a method of disinfecting skin comprising:
storing a plurality of packages in a storage environment at a temperature from 30 to 65 ˚C,
removing a package comprising a sealed container which contains at least one wipe, from a storage environment having an above-ambient temperature,
removing the wipe from the package, and
applying the wipe to skin, wherein each package comprises a sealed container which contains at least one wipe and the wipe comprises a nonwoven cloth comprising fibers having a denier from 2.6-3.7 and a cleansing composition disposed on the cloth comprising chlorhexidine gluconate in a sufficient amount to reduce pathogens present on skin, a monohydric alcohol in an amount to provide a defoaming effect, a wetting agent and water and wherein the container comprises a polymeric vapor barrier film permitting no greater than a 1.6% reduction of moisture content of a wipe during storage at 51.7 degrees for 250 hours.
Determination of the scope and the content of the prior art
(MPEP 2141.01)
With respect to claims 43-45, 47, 48 and 56-59 of the instant application, Burke et al. teach a wipe for killing spores comprising an absorbent sheet holding an aqueous composition and a sealed package containing the sheet, wherein the aqueous composition comprises water, an antimicrobial agent and a peroxide. Burke et al. also teach a process for killing spores with the wipe (abstract). The wipe is used to kill spores on human skin by wiping the spores from the skin [0044-45]. The absorbent material holds the aqueous composition and is contained within a sealed package of non-porous sheets that are hermetically sealed [0024]. The absorbent sheet may comprise a non-woven material [0025]. The sealed package has an air and liquid impermeable construction made of aluminum foil, plastic sheet, coated paper or a combinations of two non-porous sheets sealed together [0026]. The sheets comprise 0.001-5% antimicrobial agent by weight of the aqueous composition [0028]. The antimicrobial agent may comprise an isopropanol (isopropyl alcohol), benzalkonium chloride, chlorhexidine gluconate and a mixture of two or more thereof [0033]. The aqueous composition further comprises wetting agents and foaming agents including polyalkylene glycols (which encompasses polypropylene glycol) [0038].
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
Burke et al. does not teach a wipe comprising nonwoven cloth with plural fibers having a denier in the range of 2.6 to 3.7. It is for this reason that Brennan et al. is joined.
Brennan et al. teach pre-moistened wipes comprising two layers of nonwoven fibers with average denier of about 2.5 to about 6 (abstract). The wipes are pre-moistened with a liquid composition that are suitable for cleaning babies and adults and are packaged in moisture impervious containers or wrappers [0049]. Synthetic fibers with large fiber denier of 1 to 6, preferably from 2.5 to 4, allow larger particles to be trapped and captured within the wipe for good cleaning characteristics [0063].
With respect to claim 43, Burke et al. and Brennan et al. do not teach the container has a polymeric vapor barrier film permitting no greater than a 1.6% reduction of moisture content of the wipe at 51.7 degrees Celsius for 250 hours, however the specification teach reduction of moisture content can be calculated and that polymeric films, foils of aluminum and paper coated with polymers or metallic films that are laminated and fixed together inherently possess these properties [0014]. Burke et al. teach that the sealed package may have an air and liquid impermeable construction made of aluminum foil, plastic sheet, coated paper or a combinations thereof and may be made of two non-porous sheets with common peripheral edges sealed together [0014].
With respect to claim 44, Burke et al. and Brennan et al. do not teach the vapor barrier film has a water vapor transmission rate of greater than 0.9 g/m2/24 hours at 37.8 degrees Celsius and 100% humidity.
With respect to claim 45, Burke al. and Brennan et al. do not teach the vapor barrier film having an oxygen transmission rate of no greater than 0.4 cc/m2/24 hours at 22.8 degrees Celsius and 0 % humidity.
With respect to claim 47, Burke al. and Brennan et al. do not teach the vapor barrier film comprises a barrier layer laminated to a support film.
With respect to claim 48, Burke al. and Brennan et al. do not teach the support film comprises a linear low-density polyethylene film and the barrier layer comprises a polyethylene terephthalate film. It is for this reason that Polykarpov et al. is joined.
Polykarpov et al. teach a multilayer laminated structure for use in flexible laminate packaging as a sealing layer (abstract). The structures are no more than 500 microns thick [0021]. The laminated structure contains at least on barrier layer and has an oxygen transmission rate of no more than 5 cm3/m2/24 hrs. at 25 degrees C and a moisture vapor transmission rate of no more than 2 cm3/m2/24 hrs. at 40 degrees C [0052-53]. The barrier films are formulated from poly(ethylene terephthalate) and the polymeric films include low-density polyethylene films [0054]. The structures also include a heat sealable layer, laminated to the barrier layer via an adhesive, which also blocks the transmission of oxygen and water vapor and has a thickness of 5-50 microns [0060-66; 0079-92]. The products may include a clear film to form an abrasion-resistant surface, preferably from poly(ethylene terephthalate) with a thickness of 5-50 microns [0066]. The structures are used to form packaging for wipes [0130].
Since, Burke et al., Brennan et al. and Polykarpov et al. all teach that sealed packages for wipes that possess air and liquid impermeable polymers one or ordinary skill would expect similar properties at different humidity rates. Polykarpov et al. teach the claimed water vapor transmission rate and oxygen transmission rate were known to be obtained for multilayer laminated structures. Although silent to rates of humidity of 100% or 0%, as specified for the water vapor transmission rate and oxygen transmission rate, respectively, the container would have been expected to possess these properties since the materials used for the barrier layer and support film are taught by Polykarpov et al. to be used to make sealed packages for wipes.
With respect to claims 43-45, 47, 48 and 57-59, Burke et al., Brennan et al. and Polykarpov et al. do not teach a storage environment at a temperature from 30 to 65 ˚C. With respect to claim 56, Burke et al., Brennan et al. and Polykarpov et al. do not teach that a storage environment is a warming cabinet including at least one shelf and a heater. It is for this reason that Western and Branz et al. are joined.
Western teaches a portable baby wipe warmer and container comprising a container for storing baby wipes, a heat source thermally coupled to the container and a temperature regulating component coupled to the heat source for regulating the heat provided to the container (abstract). The invention provides a reliable means for heating wipes at a controlled temperature so that warm wipes can be provided on the go to clean an infant without the annoying effect caused by the sensation of a cold wipe against the skin (column 1, lines 24-35). The temperature of the environment ranges from 100-180˚F (37.7-82.22˚C) (column 1, lines 55-60).
Branz et al. teaches cabinets wherein the environment inside the cabinet is controlled and warming cabinets with swing door access to the temperature controlled compartments [0002]. The cabinets have improved environmental control for storing foodstuffs and other items requiring a controlled environment [0004]. Chemical reagents are examples of items the must be stored where temperature can be controlled and the warming cabinets are configured for the storage of the items that need to be kept at temperatures above the temperature of the immediate environment [0028]. The compartments within the cabinet include flat, horizontally extending shelves which subdivide the inside of the environmentally controlled compartment [0029].
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
Burke et al., Brennan et al. Polykarpov et al. and Western all teach articles of manufacture for the storage of wipes. Burke et al., Western and Branz et al. are all related to containers comprising chemical reagents. It would have been prima facie obvious to one of ordinary skill to combine the teachings of Burke et al., Brennan et al., Polykarpov et al., Western and Branz et al. to include wipes with fibers with denier of 2.6 to 3.7 with a reasonable expectation of success. One of ordinary skill would have been motivated before the time of filing to combine the teachings of Burke et al., Brennan et al., Polykarpov et al., Western and Branz et al. to include fibers with denier of 2.6 to 3.7 because Brennan et al. teach that fibers with denier of 1-6, preferably 2.5-5, allow for particles to be captured and trapped and therefore aid in cleansing skin.
It would have been prima facie obvious to one of ordinary skill to combine the teachings of Burke et al., Brennan et al., Polykarpov et al., Western and Branz et al. and include a storage environment with a temperature ranging from 30 to 65 ˚C. One of ordinary skill would have been motivated before the time of filing to store wipes at this temperature because Western teach that warming wipes is desired to avoid the sensation of a cold wipe against the skin and temperature of the warmers heat to temperatures of from 100 to 180 ˚F which encompasses temperatures of from 37.7-82.22 ˚C and Branz et al. teach warming cabinets are used to store items that need to be kept at temperatures above the temperature of the immediate environment.
It would have been prima facie obvious to one of ordinary skill to combine the teachings of Burke et al., Brennan et al., Polykarpov et al., Western and Branz et al. and include a storage environment that is a warming cabinet including at least one shelf and a heater with a reasonable expectation of success. One of ordinary skill would have been motivated at the time of filing to store wipes in a warming cabinet because Western teach that warming wipes is desired to avoid the sensation of a cold wipe against the skin and Branz et al. teach warming cabinets comprising flat, horizontally extending shelves which are used to store items that need to be kept at temperatures above the temperature of the immediate environment.
Furthermore, it would have been facie obvious to one of ordinary skill to combine the teachings of Burke et al., Brennan et al., Polykarpov et al., Western and Branz et al. and include vapor barrier film comprising a barrier layer laminated to a support film with a reasonable expectation of success. One of ordinary skill would have been motivated before the time of filing to combine the teachings of Burke et al., Brennan et al., Polykarpov et al., Western and Branz et al. because Polykarpov et al. teaches the use of the multilaminate flexible packages comprising a poly(ethylene terephthalate) barrier layer and low-density polyethylene films are known to aid in storing wipes and inhibit oxygen and water vapor transmission due to the lamination process.
Claim 46 is rejected under 35 U.S.C. 103(a) as being unpatentable over Burke (US 2017/0215427; published August 3, 2017) in view of Brennan et al. (US 2007/0228064; published October 4, 2007) and in combination with Polykarpov et al. (US 2007/0116910; published May 24, 2007) in further view of Western (US 7022945) and Branz et al. (US 2001/0030492; published October 18, 2001), as applied to claims 43-45, 47, 48, and 56-59 in further view of Durden et al. (US 2002/0106399; published August 8, 2002).
Applicant’s Invention
Applicant claims a method of disinfecting skin comprising:
storing a plurality of packages in a storage environment at a temperature from 30 to 65 ˚C,
removing a package comprising a sealed container which contains at least one wipe, from a storage environment having an above-ambient temperature,
removing the wipe from the package, and
applying the wipe to skin, wherein each package comprises a sealed container which contains at least one wipe and the wipe comprises a nonwoven cloth comprising fibers having a denier from 2.6-3.7 and a cleansing composition disposed on the cloth comprising chlorhexidine gluconate in a sufficient amount to reduce pathogens present on skin, a monohydric alcohol in an amount to provide a defoaming effect, a wetting agent and water and wherein the container comprises a polymeric vapor barrier film permitting no greater than a 1.6% reduction of moisture content of a wipe during storage at 51.7 degrees for 250 hours.
Determination of the scope and the content of the prior art
(MPEP 2141.01)
The teachings of Burke et al., Brennan et al., Polykarpov et al., Western and Branz et al. are addressed in the above 103 rejection.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
Burke et al., Brennan et al., Polykarpov et al., Western and Branz et al. do not teach that the cleansing composition comprises dimethicone, glycerin and propylene glycol in combination with chlorhexidine gluconate and benzalkonium chloride. It is for this reason that Durden et al. is joined.
Durden teach wipes impregnated with a composition having alcohol and one or more ingredients that mitigate against the unpleasant effects of high-concentration alcohol (abstract). The antimicrobial wipes are designed to be used on human skin and are effective against viruses, bacteria and other harmful germs [0015]. The wipe is comprised of nonwoven sheets and the alcohol used includes isopropanol [0016-18]. Skin conditioners include glycerin and dimethicones which provide a pleasant after-feel on the skin [0022]. Preferred other ingredient include propylene glycol, dimethicone and glycerin together with the alcohol in a single formulation [0030].
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
Burke et al. and Durden teach antimicrobial wipes comprising liquid formulations. Therefore, it would have been prima facie obvious to one of ordinary skill to combine the teachings of Burke et al., Brennan et al., Polykarpov et al., Western, Branz et al. and Durden and include an antimicrobial wipe composition comprising chlorhexidine gluconate, benzalkonium chloride, dimethicone, glycerin and propylene glycol with a reasonable expectation of success. One of ordinary skill would have been motivated before the time of filing to combine the teachings of Burke et al., Brennan et al., Polykarpov et al., Western, Branz et al. and to include dimethicone, glycerin and propylene glycol because Durden teach that dimethicone, glycerin and propylene glycol aid providing a pleasant after-feel to skin and are widely known compounds used as additional formulation ingredients in antimicrobial wipes.
Response to Arguments
Applicant's arguments filed 2/3/2026 have been fully considered but they are not persuasive.
Applicant first argues that Burke and Brennan are not concerned with storage at elevated temperature, Polykarpov is not concerned with the storage of wipes and Western does not recognize the need for long term storage of wipes and actually teaches way from what is claimed. The Examiner is not persuaded by this argument because the claims are drawn to a method of disinfecting skin, however, the claims require additional limitations to the structure of the packaging, the cloth, the cleansing composition and a container which encompass different classification and search fields. Due to this the references render the claims prima facie obvious because Burke et al., Brennan et al. Polykarpov et al. and Western all teach articles of manufacture for the storage of wipes.
Applicant further argues that Branz and Durden are not relevant to the rejection so the combination of references is implausible and would not yield the claimed rejection. The Examiner is not persuaded by this argument because Western teaches storing wipes at a temperature environment ranging from 37.7-82.22˚C (column 1, lines 55-60) and Branz et al. teach storage of the items that need to be kept at temperatures above the temperature of the immediate environment in warming cabinets was known before the time of filing [0028]. Additionally, Durden teach wipes impregnated with a composition comprising propylene glycol, dimethicone and glycerin together with the alcohol in a single formulation mitigate against the unpleasant effects of high-concentration alcohol [0030]. Burke et al., Western and Branz et al. are all related to containers comprising chemical reagents. Therefore, one of ordinary skill would have been motivated to combine the references with a reasonable expectation of success.
Conclusion
No claims allowed.
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.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
DANIELLE D. JOHNSON
Examiner
Art Unit 1617
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