DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Claims 1-2, 5-6, 10-12, 15-16, 20-22 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Voorhees (US 2017/0189225) in view of PROVENCAL (US 2018/0056097).
Regarding claim 1-2, Voorhees discloses a pad for targeted temperature management ("TTM"), comprising: a multilayered pad body (fig.3; pad 10) including: a conduit layer (fig.3; flexible base member 14) including one or more conduits configured to convey a fluid through the conduit layer (fig.3, see also [0035]); an impermeable film (fig.3; flexible film layer 15) over the conduit layer configured to retain the fluid in the conduit layer when the fluid is conveyed through the conduit layer (fig.3, see also [0032]); and an adherable layer (fig.3; flexible hydrogel layer 16, see also [0032]) over the impermeable film configured to adhere to a body portion of a patient [0032]. However, Voorhees does not specifically disclose one or more comfort-enhancing features integrated into the pad for mitigating or eliminating skin irritation along at least edges around the pad and wherein the edges around the pad are chamfered for enhanced comfort.
PROVENCAL teaches an apparatus that includes a coverall garment having a plurality of pads. The pads include beveled edge for facilitating pad placement for improved comfort of the user [0123]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the device of Voorhees with one or more comfort-enhancing features integrated into the pad and wherein the edges of the pad are chamfered as taught by PROVENCAL for the purpose of improving ergonomics/comfort.
Regarding claim 5, Voorhees/ PROVENCAL teaches the pad of claim 1, wherein the conduit layer includes a perimetrical wall and one or more inner walls extending from the conduit layer toward the impermeable film (fig.2 and 4 of Voorhees), the perimetrical wall and the one-or-more inner walls forming the one-or-more conduits (fig.2 and 4, see also [0035]) of the conduit layer (fig.2 and 4, see also [0035] of Voorhees).
Regarding claim 6, Voorhees/ PROVENCAL teaches the pad of claim 1, wherein the conduit layer includes a plurality of protrusions (fig.3-4C of Voorhees) extending from the conduit layer toward the impermeable film (fig.2 and 4, see also [0037]-[0038] of Voorhees), the protrusion configured to promote even flow of the fluid when the fluid is conveyed through the conduit layer ([0037]-[0038] of Voorhees).
Regarding claim 10, Voorhees/ PROVENCAL teaches the pad of claim 1, further comprising one or more inlets (fig.3; inlet port 12a, see also [0035] of Voorhees) configured for charging the conduit layer with the fluid and one or more outlets (fig.2-4; outlet port 12b, see also [0035] of Voorhees) configured for discharging the fluid from the conduit layer ([0035] of Voorhees).
Regarding claim 11-12 and 21-22, Voorhees discloses a system/method for targeted temperature management ("TTM"), comprising: a control module (fig.7; Heat exchanger 23 and controller 50) including a hydraulic system having: a chiller evaporator (fig.6; evaporator/chiller 234) configured for chilling a fluid to produce a chilled fluid ([0055]-[0056]); one or more outlets configured for discharging the chilled fluid from the hydraulic system (fig.6; outlet port 34); and one or more inlets (fig.6; inlet port 33) configured for charging the hydraulic system with the fluid to continue to produce the chilled fluid [0053]; and a pad (fig.3; pad 10) including: a multilayered pad body (fig.3; medical pad 10) having: a conduit layer (fig.3; flexible base member 14) including one or more conduits (plurality of rib members 14a) configured to convey the chilled fluid through the conduit layer [0035]; an impermeable film over the conduit layer configured to retain the chilled fluid in the conduit layer (flexible film layer 15); and an adherable layer (fig.3; hydrogel layer 16) over the impermeable film configured to adhere to a body portion of a patient [0032]. However, Voorhees does not specifically disclose one or more comfort-enhancing features integrated into the pad for mitigating or eliminating skin irritation along at least edges around the pad and wherein the edges around the pad are chamfered for enhanced comfort.
PROVENCAL teaches an apparatus that includes a coverall garment having a plurality of pads. The pads include beveled edge (around) for facilitating pad placement for improved comfort of the user [0123]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the device of Voorhees with one or more comfort-enhancing features integrated into the pad and wherein the edges around the pad are chamfered as taught by PROVENCAL for the purpose of improving ergonomics/comfort.
Regarding claim 15, Voorhees/ PROVENCAL teaches the system of claim 1, wherein the conduit layer includes a perimetrical wall (fig.2 and 4) and one or more inner walls extending from the conduit layer toward the impermeable film (fig.2 and 4), the perimetrical wall and the one-or-more inner walls forming the one-or-more conduits of the conduit layer (fig.2 and 4, see also [0035] of Voorhees).
Regarding claim 16, Voorhees/ PROVENCAL teaches the system of claim 1, wherein the conduit layer includes a plurality of protrusions extending from the conduit layer toward the impermeable film, the protrusions configured to promote even flow of the chilled fluid (fig.2 and 4, see also [0037]-[0038] of Voorhees).
Regarding claim 20, Voorhees/ PROVENCAL teaches the system of claim 11 further comprising one or more inlets (fig.3; inlet port 12a, see also [0035]) configured for charging the conduit layer with the fluid and one or more outlets (fig.2-4; outlet port 12b, see also [0035]) configured for discharging the fluid from the conduit layer [0035].
Regarding claim 26, Voorhees/ PROVENCAL teaches the method of claim 21, wherein connecting the inlet of the pad to the hydraulic system of the control module includes connecting the inlet to an outlet of the hydraulic system in parallel with one or more other pads of the system and connecting the outlet of the pad to the hydraulic system of the control module includes connecting the outlet to an inlet of the hydraulic system in parallel with the one-or-more other pads of the system (fig.6, see also [0052] of Voorhees).
Claims 9, 19 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Voorhees et al. (US 2017/0189225) in view of PROVENCAL et al. (US 2018/0056097) in further view of Sinha et al. (US 2020/0129326).
Regarding claim 9, 19 and 25, Voorhees/ PROVENCAL does not teach wherein each layer of the multilayered pad body is transparent, thereby allowing visual inspection for skin irritation under the pad and along the edges of the pad.
Sinha teaches a thermal blanket with multiple layers (fig.5). Sinha teaches the layers being transparent that can provide visual transparency of the patient (abstract). Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the device of Voorhees/ PROVENCAL with transparent muti-layers as taught by Sinha for the purpose of patient safety. Furthermore, it would have been obvious to one having ordinary skill in the art at the time the Application was effectively filed to have layers made of any material including transparent material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the amendment necessitated a new ground of rejection.
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 TIGIST S DEMIE whose telephone number is (571)270-5345. The examiner can normally be reached Monday-Friday 8am-5Pm.
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794
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