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
Applicant’s election without traverse of Group II (Claims 16-24) in the reply filed on 12/30/2025 is acknowledged.
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.
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.
Claim(s) 16, 18-20, 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voorhees (US 20140214138 A1) in view of Quinn (US 20180263748 A1).
Regarding claim 16, Voorhees teaches targeted temperature management ("TTM") (Fig 3; medical pad 300), comprising: one or more pads for TTM (Fig 13; medical pad 300), each pad of the one-or-more pads including: a multilayered ([0045] The medical pad includes a plurality of layers) pad body including: a conduit layer ([0077] The intermediate layer 340 and interface layer 350 may be provided to define a circulation layer (e.g., channels 352; see FIG. 4B) therebetween, wherein a first thermal-exchange fluid may flow into and out of such circulation layer via fluid circulation lines 380a, 380b) including one or more conduits configured to convey a temperature-controlled fluid ([0077]) as a supply fluid from a hydraulic system and convey a return fluid back to the hydraulic system (Fig 4A; fluid circulation lines 380a, 380b); and a patient-interfacing layer over the conduit layer (Fig 4A; containment layer 330) configured for placement on a portion of a patient's body ([0081] In one approach, the chambers 332 and indentations 334 may be arranged in rows and columns to facilitate flexure of the medical pad along the indentations 334 for conformal engagement of medical pad 300 with a patient), the patient-interfacing layer having a patient-facing side including a plurality of wells (Fig 4; chambers 332) configured to hold a thermally conductive medium ([0077] Further, the intermediate layer 340 and containment layer 330 may be provided to define a fluid containment layer therebetween for containing a second thermal-exchange fluid disposed in, for example, one or more chambers 332) (((([0080] at least a portion of a second thermal-exchange fluid contained by the containment layer overlying the central portion 308 of the pad may be contained by the plurality of depressions 342 and the plurality of chambers 332 defining the containment layer); an applicator including the thermally conductive medium for addition of the thermally conductive medium to the wells ([0088] Additionally, containment layer 330 may include one or more opening(s) 337 for receipt of fill port 304 therethrough, as shown in FIG. 4A) ([0087] Further, top layer 320 may include one or more opening(s) 347 for receipt of a fill port 304 therethrough, as shown in FIG. 4A, for selective use in flowing a second thermal-exchange fluid into the containment layer (e.g., during assembly of medical pad 300)); and packaging around the one-or-more pads and the applicator ([0083] Top layer 320 may be provided to define an insulative layer, or air space, between the top layer 320 and containment layer 330) ([0087] Further, top layer 320 may include one or more opening(s) 347 for receipt of a fill port 304 therethrough).
Voorhees fails to fully teach a pad package and packaging around the one-or-more pads and the applicator.
However, Quinn teaches a pad package ([0053] According to other embodiments of the invention, one or more poultice application pads according to the invention may be held either individually, or in a stack, within a container in sealed relation from atmosphere (i.e., in an airtight container) to physically protect the application pads from damage during shipment and/or storage, and to maintain the desired level of moisture within the poultice application pad over extended periods of time following initial manufacture and packaging) and packaging around the one-or-more pads and the applicator ([0053] Most preferably, the container is vacuum sealed at the factory to maintain the level of moisture within the poultice mixture within close tolerances over an extended period of time so as to extend the shelf-life of the poultice application pads packaged therein. While the poultice application pads for some applications may be packaged individually according to this aspect of the invention, preferably, the container is sized and otherwise adapted to hold a stack of four poultice application pads). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Voorhees to include a pad package and packaging around the one-or-more pads and the applicator. Doing so protects the pad from outside damage during shipment or storage (Quinn [0053]).
Regarding claim 18, Voorhees teaches the pad package of claim 16, wherein the wells are interconnected ([0080] the chambers 332 and depressions 342 may be disposed in opposed, face-to-face relation for fluid communication therebetween. In this regard, at least a portion of a second thermal-exchange fluid contained by the containment layer overlying the central portion 308 of the pad may be contained by the plurality of depressions 342 and the plurality of chambers 332 defining the containment layer).
Regarding claim 19, Voorhees teaches the pad package of claim 16, wherein the thermally conductive medium includes a polymer, a gel, or a fatty substance ([0102] the second thermal-exchange fluid may comprise liquid of a gel material. In one approach, a cellulose gel material may be utilized that is flowable into the containment layer and curable to assume a shape-holding state within the containment layer. For example, a carboxmethyl cellulose (CMC) gel may be utilized that includes aluminum acetate to crosslink the CMC and form a shape-holding gel).
Regarding claim 20, Voorhees teaches the pad package of claim 16, wherein the thermally conductive medium includes a solid-particle additive including metal flakes, metal-oxide particles, salt particles, or carbon particles ([0102] the second thermal-exchange fluid may comprise liquid of a gel material. In one approach, a cellulose gel material may be utilized that is flowable into the containment layer and curable to assume a shape-holding state within the containment layer. For example, a carboxmethyl cellulose (CMC) gel may be utilized that includes aluminum acetate to crosslink the CMC and form a shape-holding gel).
Regarding claim 22, Voorhees teaches the pad package of claim 16, the pad body further including an impermeable film between the patient-interfacing layer and the conduit layer configured to retain the temperature-controlled fluid in the conduit layer (Fig 4B; [0077] The intermediate layer 340 and interface layer 350 may be provided to define a circulation layer (e.g., channels 352; see FIG. 4B) therebetween, wherein a first thermal-exchange fluid may flow into and out of such circulation layer via fluid circulation lines 380a, 380b. Further, the intermediate layer 340 and containment layer 330 may be provided to define a fluid containment layer therebetween for containing a second thermal-exchange fluid disposed in, for example, one or more chambers 332. FIG. 4B, also illustrates a sheet-like interface layer 350 having a top surface disposed adjacent to the bottom surface of the intermediate layer 340) ([0058] a structure 214 (e.g., comprising a polymer-based material) may define the dimple matrix with channels 212 sealably provided between the structure 214 (e.g., top surface of fluid circulation layer) and a sheet-like layer 215 (e.g., bottom surface of fluid circulation layer). Typically, the structure 214 is formed of a sheet layer of a non-permeable material (e.g., polymer-based material)) ([0058] when the sheet-like layer 215 is disposed over the bottom surface of the structure 214, a top surface of the sheet-like layer 215 is juxtaposed against the projections 220. Thus, the spaces between the projections 220 and the sheet-like layer 215 define the channels 212 and the circulation layer 116).
Regarding claim 23, Voorhees teaches the pad package of claim 16, each pad of the one-or-more pads further including: a pad inlet connector including a pad inlet configured for charging the conduit layer with the supply fluid (Fig 3; fluid inlet port 302a); and a pad outlet connector including a pad outlet configured for discharging the return fluid from the conduit layer (Fig 3; a fluid outlet port 302b).
Regarding claim 24, Voorhees teaches the pad package of claim 23, further comprising one or more secondary fluid delivery lines ("FDLs") corresponding in number to the one-or-more pads (Fig 10; [0105] The medical pad is connected with the fluid circulating system 600 using pad-connector pairs 612), each secondary FDL of the one-or-more secondary FDLs configured to convey the supply fluid from the hydraulic system (Fig 10; inlet 620) and convey the return fluid back to the hydraulic system (Fig 10; outlet 622), each secondary FDL of the one-or-more secondary FDLs split at a pad-connecting end of the secondary FDL ([0105] The medical pad is connected with the fluid circulating system 600 using pad-connector pairs 612), and the pad-connecting end of the secondary FDL including a pair of secondary FDL connectors ([0105] The medical pad is connected with the fluid circulating system 600 using pad-connector pairs 612) including a secondary FDL outlet connector configured to fluidly connect to the pad inlet connector and a secondary FDL inlet connector configured to fluidly connect to the pad outlet connector (Fig 10; [0105] Each pad-connector pair 612 includes an inlet connector 612A for connection with an inlet 620 of the medical pad 610 and an outlet connector 612B for connection with an outlet 622 of the medical pad 610).
Claim(s) 17 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voorhees (US 20140214138 A1) in view of Quinn (US 20180263748 A1).
Regarding claim 17, Voorhees teaches the pad package of claim 16, wherein the wells are square-packed rectangular wells (Fig 1 and 4), hexagonally packed circular wells, or hexagonally packed hexagonal wells ([0047] In a specific embodiment in which the chambers 108 are thus provided in a generally rectangular configuration and each have substantially the same size and shape, the containment layer 104 may thus have a waffle-shaped configuration, but this is not a requirement of the invention. In other embodiments, the sizes of the chambers 108 may differ and the chambers 108 may be organized in other than a rectangular configuration, particularly as might be suitable for application to specific portions of the body or for specialized applications). It would have been an obvious matter of design choice to make the different portions of the wells of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 21, Voorhees teaches the pad package of claim 16, each pad of the one-or-more pads further comprising a release liner over the patient-interfacing layer ([0079] The patient interface layer 350 may further include a removable liner or bottom layer 360 that may be readily removed from the adhesive surface of the interface layer 350 at the time of placement of medical pad 300 on a given patient for contact cooling (e.g., direct adhesive engagement with the skin of a patient)), the release liner configured to expose the wells when the release liner is removed for subsequent addition of the thermally conductive medium to the wells ([0087] top layer 320 may include one or more opening(s) 347 for receipt of a fill port 304 therethrough, as shown in FIG. 4A, for selective use in flowing a second thermal-exchange fluid into the containment layer (e.g., during assembly of medical pad 300)) ([0096] Such interconnection may occur subsequent to or prior to interconnection of the top layer 320, containment layer 330, and intermediate layer 340. As may be appreciated, the enlarged end 309 of fill port 304 may be disposed between intermediate layer 340 and containment layer, with tubular portion positioned through openings 347, and 337, prior to such interconnection). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the release liner configured to expose the wells when the release liner is removed for subsequent addition of the thermally conductive medium to the wells, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179. Wherein this case, the assembly of the separate layers would allow filling of the wells prior to application.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794