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 III (claims 15-22) in the reply filed on 12/30/2025 is acknowledged.
Response to Amendment
Acknowledgement is made to cancel claim 16.
The amendments under 37 CFR 1.132 filed 04/29/2026 is insufficient to overcome the rejection of claim 15 based upon being rejected under 35 U.S.C. 103 as being unpatentable over Voorhees (US 20140214138 A1) in view of Lennox (US 20100137951 A1) as set forth in the last Office action because:
Voorhees teaches the connector (Fig 3; connector 382a and 382b are interconnected at connector 384) comprises a first lumen for transporting TTM fluid to the fluid containing layer and a second lumen for transporting TTM fluid away from the fluid containing layer ([0077] a first thermal-exchange fluid may flow into and out of such circulation layer via fluid circulation lines 380a, 380b) ([0075] a connector device 384 may be provided at the second ends of the first and second fluid circulation lines 380a, 380b for interconnection with the fluid control system) ([0099] Further, when patient cooling is desired via thermal exchange between a first thermal-exchange fluid circulated through medical pad 300 and a patient, connectors 382a, 382b of fluid circulation lines 380a, 380b may be interconnected to ports 302a, 302b, and connector 384 may be interconnected to a fluid circulation control system, wherein the first thermal-exchange fluid may be circulated through circulation layer of medical pad 300 to achieve patient cooling in tandem with or independent from patient cooling via the second thermal-exchange fluid (e.g., during and after the second thermal-exchange fluid warms)).
Response to Arguments
Applicant's arguments filed 04/29/2026 have been fully considered but they are not persuasive.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references Voorhees (US 20140214138 A1) and Lennox (US 20100137951 A1), the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Voorhees teaches a snap fit connector to connect the fluid to the pad. Lennox teaches that the fluid inlet and the fluid outlet each include a swivel joint configured to allow rotation of an inlet connector relative to the head-cooling device ([0019]). The addition of a swivel joint keeps the main purpose of the connector taught by Voorhees and therefore not changing the principle of operation of Voorhees.
Voorhees teaches a connector 384 that comprises the inlet and outlet fluid lines connected to the pad. First lumen 380a and second lumen 380b provide inlet and outlet flow of fluid to the pad. Further, connectors 382a, 382b of fluid circulation lines 380a, 380b may be interconnected to ports 302a, 302b, and connector 384 may be interconnected to a fluid circulation control system ([0099]). The parts of the connectors and fluid lines are all interconnected in which a single connector 384 comprises lumens 380a and 380b.
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) 15, 17, 20, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voorhees (US 20140214138 A1) in view of Lennox (US 20100137951 A1).
Regarding claim 15, Voorhees teaches a thermal pad for facilitating thermal energy transfer between a targeted temperature management (TTM) fluid and a patient ([abstract] The fluid circulation layer is for containing a first thermal-exchange fluid circulatable therethrough, with the medical pad being operable for thermal exchange between the first thermal-exchange fluid and a patient through a first side of the fluid circulation layer), the pad comprising: a fluid containing layer (Fig 5; containment layer 330) configured to: receive a TTM fluid from a TTM fluid source via a fluid line extending between the fluid source and the thermal pad (Fig 5; [0077] a first thermal-exchange fluid may flow into and out of such circulation layer via fluid circulation lines 380a, 380b), contain the TTM fluid (Fig 4; containment layer 330), and circulate the TTM fluid within the fluid containing layer to facilitate thermal energy transfer between the TTM fluid and the patient ([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); and a connector attached to the fluid containing layer, the connector defining a fluid port of the fluid containing layer ([0089] fluid flow may occur between inlet port 302a and outlet port 302b), wherein: the connector is configured to couple to a corresponding fluid line connector to establish fluid communication between the fluid containing layer and the fluid line ([0093] outlet port 302b and connector 382b may be configured in a manner analogous to inlet port 302a and connector 882a described above), and the connector (Fig 3; connector 382a and 382b are interconnected at connector 384) comprises a first lumen for transporting TTM fluid to the fluid containing layer and a second lumen for transporting TTM fluid away from the fluid containing layer ([0077] a first thermal-exchange fluid may flow into and out of such circulation layer via fluid circulation lines 380a, 380b) ([0075] a connector device 384 may be provided at the second ends of the first and second fluid circulation lines 380a, 380b for interconnection with the fluid control system) ([0099] Further, when patient cooling is desired via thermal exchange between a first thermal-exchange fluid circulated through medical pad 300 and a patient, connectors 382a, 382b of fluid circulation lines 380a, 380b may be interconnected to ports 302a, 302b, and connector 384 may be interconnected to a fluid circulation control system, wherein the first thermal-exchange fluid may be circulated through circulation layer of medical pad 300 to achieve patient cooling in tandem with or independent from patient cooling via the second thermal-exchange fluid (e.g., during and after the second thermal-exchange fluid warms)).
Voorhees fails to fully teach the connector is configured to swivel with respect to the corresponding fluid line connector.
However, Lennox teaches the connector is configured to swivel with respect to the corresponding fluid line connector ([0019] In one arrangement, the fluid inlet and the fluid outlet each include a swivel joint configured to allow rotation of an inlet connector relative to the head-cooling device. The swivel joints, therefore, minimize kinking of an umbilical connecting the head-cooling device to a console (e.g., a console having a positive gage pressure source and a negative gage pressure source) during operation). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Voorhees to include the connector is configured to swivel with respect to the corresponding fluid line connector. Doing so allows for the rotation of the cooling device in relation to the fluid lines for various placement/ orientation when in use.
Regarding claim 17, Voorhees teaches the thermal pad of claim 15, wherein the connector is configured to couple to the corresponding fluid line connector via a snap fit ([0093] FIG. 7B, tubular portion 307 may be configured together with connector 382a for one-way, snap-fit interconnection. For such purposes, a top end of tubular portion 307 may be sized to receive a tubular port 385 at connector 382a. Further, tubular portion may be provided with an inwardly protruding lip 307a. In turn, first tubular port 385 may have a tapered end portion 385a and adjacent recess for snap-fit receipt of the lip 307a of the tubular portion 307 of the inlet port 302a).
Regarding claim 20, Voorhees teaches the thermal pad of claim 15, further comprising a second connector attached to the fluid containing layer (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. Both the inlet and outlet connections may be made with flexible tubing or similar structure suitable for fluidic connection. Merely by way of illustration, the embodiment shown includes six pad-connector pairs 612 to permit connection of six medical pads 610 with the fluid circulating system 600. But it should be appreciated that the invention is not limited by the number of pad-connector pairs 612 and that different embodiments might have a greater or lesser number of pad-connector pairs 612) ([0105] Each inlet connector 612A of the pad-connector pairs 612 is connected via an inlet feeder line 618 to a main inlet connector 614, and each outlet connector 612B of the pad-connector pairs 612 is connected via an outlet feeder line 620 to a main outlet connector 616), the second connector defining a second fluid port of the fluid containing layer (Fig 10; [0105]), wherein the second connector is configured to: couple to a second corresponding fluid line connector of a second fluid line to establish fluid communication between the fluid containing layer and the second fluid line via a lumen of the second connector (Fig 10; [0089] fluid flow may occur between inlet port 302a and outlet port 302b), and swivel with respect to the second corresponding fluid line connector when the second connector is coupled to the second corresponding fluid line connector ([0093] FIG. 7B, tubular portion 307 may be configured together with connector 382a for one-way, snap-fit interconnection. For such purposes, a top end of tubular portion 307 may be sized to receive a tubular port 385 at connector 382a. Further, tubular portion may be provided with an inwardly protruding lip 307a. In turn, first tubular port 385 may have a tapered end portion 385a and adjacent recess for snap-fit receipt of the lip 307a of the tubular portion 307 of the inlet port 302a).
Voorhees fails to fully teach swivel with respect to the second corresponding fluid line connector when the second connector is coupled to the second corresponding fluid line connector.
However, Lennox teaches and swivel with respect to the second corresponding fluid line connector when the second connector is coupled to the second corresponding fluid line connector (0019] In one arrangement, the fluid inlet and the fluid outlet each include a swivel joint configured to allow rotation of an inlet connector relative to the head-cooling device. The swivel joints, therefore, minimize kinking of an umbilical connecting the head-cooling device to a console (e.g., a console having a positive gage pressure source and a negative gage pressure source) during operation). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Voorhees to include and swivel with respect to the second corresponding fluid line connector when the second connector is coupled to the second corresponding fluid line connector. Doing so allows for the rotation of the cooling device in relation to the fluid lines for various placement/orientation when in use. Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include a the second connector defining a second fluid port of the fluid containing layer; a second corresponding fluid line connector of a second fluid line, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 22, Voorhees teaches the thermal pad of claim 20, further comprising a third connector attached to the fluid containing layer (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. Both the inlet and outlet connections may be made with flexible tubing or similar structure suitable for fluidic connection. Merely by way of illustration, the embodiment shown includes six pad-connector pairs 612 to permit connection of six medical pads 610 with the fluid circulating system 600. But it should be appreciated that the invention is not limited by the number of pad-connector pairs 612 and that different embodiments might have a greater or lesser number of pad-connector pairs 612) ([0105] Each inlet connector 612A of the pad-connector pairs 612 is connected via an inlet feeder line 618 to a main inlet connector 614, and each outlet connector 612B of the pad-connector pairs 612 is connected via an outlet feeder line 620 to a main outlet connector 616), the third connector defining a third fluid port of the fluid containing layer (Fig 10; [0105]), wherein the third connector is configured to: couple to a third corresponding fluid line connector (Fig 10; [0089] fluid flow may occur between inlet port 302a and outlet port 302b).
Voorhees fails to fully teach swivel with respect to the third corresponding fluid line connector when the third connector is coupled to the third corresponding fluid line connector.
However, Lennox teaches a swivel with respect to the third corresponding fluid line connector when the third connector is coupled to the third corresponding fluid line connector (0019] In one arrangement, the fluid inlet and the fluid outlet each include a swivel joint configured to allow rotation of an inlet connector relative to the head-cooling device. The swivel joints, therefore, minimize kinking of an umbilical connecting the head-cooling device to a console (e.g., a console having a positive gage pressure source and a negative gage pressure source) during operation). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Voorhees to include a swivel with respect to the third corresponding fluid line connector when the third connector is coupled to the third corresponding fluid line connector. Doing so allows for the rotation of the cooling device in relation to the fluid lines for various placement/orientation when in use. Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include a third connector defining a third fluid port of the fluid containing layer, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim(s) 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voorhees (US 20140214138 A1) in view of Lennox (US 20100137951 A1), further in view of Beardall (US 20130238043 A1).
Regarding claim 18, Voorhees teaches the thermal pad of claim 15, wherein the connector comprises an annular sealing surface ([0091] enlarged end 305 includes a disk portion 305a, an aperture 305b and stand-off members 305c projecting away from disk portion 305a about aperture 305b. Inlet port 302a may be of a sufficiently rigid construction (e.g., comprising an integral, molded plastic material), such that stand-off members 305c maintain a desired layer-to-layer spacing for fluid flow at aperture 305b) ([0092] inlet port 302a comprises a tubular portion 307 in fluid communication with aperture 305b. As may be appreciated, tubular portion 307 may be sized to fit through openings 345 of the intermediate layer 340. Further, tubular portion 307 may be configured for selective interconnection with connector 382a), but fails to fully teach configured to facilitate a fluid seal between the connector and the corresponding fluid line connector.
However, Beardall teaches wherein the connector comprises an annular sealing surface configured to facilitate a fluid seal between the connector and the corresponding fluid line connector ([0042] FIGS. 6A-6B show some embodiments in which the probe device 10 comprises an internal fluid chamber 40, an ingress line 45, and an egress line 50. Additionally, to ensure that the internal chamber 40 is fluid tight, FIGS. 6A-6B show that, in some embodiments, the probe device 10 comprises one or more gaskets 44, barriers 46, O-rings 48). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Voorhees to include wherein the connector comprises an annular sealing surface configured to facilitate a fluid seal between the connector and the corresponding fluid line connector. Doing so allows for the seal to prevent against leaking between the inlet/outlet connectors when fluid is moving between.
Regarding claim 19, Voorhees teaches the thermal pad of claim 15, wherein the connector comprises a second annular sealing surface ([0092] inlet port 302a comprises a tubular portion 307 in fluid communication with aperture 305b. As may be appreciated, tubular portion 307 may be sized to fit through openings 345 of the intermediate layer 340. Further, tubular portion 307 may be configured for selective interconnection with connector 382a) ([0093] outlet port 302b and connector 382b may be configured in a manner analogous to inlet port 302a and connector 882a described above, respectively), but fails to fully teach configured to facilitate a second fluid seal between the connector and the corresponding fluid line connector.
However, Beardall teaches wherein the connector comprises a second annular sealing surface configured to facilitate a second fluid seal between the connector and the corresponding fluid line connector ([0042] FIGS. 6A-6B show some embodiments in which the probe device 10 comprises an internal fluid chamber 40, an ingress line 45, and an egress line 50. Additionally, to ensure that the internal chamber 40 is fluid tight, FIGS. 6A-6B show that, in some embodiments, the probe device 10 comprises one or more gaskets 44, barriers 46, O-rings 48). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Voorhees to include wherein the connector comprises a second annular sealing surface configured to facilitate a second fluid seal between the connector and the corresponding fluid line connector. Doing so allows for the seal to prevent against leaking between the inlet/outlet connectors when fluid is moving between.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voorhees (US 20140214138 A1) in view of Lennox (US 20100137951 A1), further in view of Yoskowitz (US 20180140407 A1).
Regarding claim 21, Voorhees teaches the thermal pad of claim 20, but fails to fully teach wherein the second connector comprises a septum extending across the lumen of the second connector to seal the lumen of the second connector, and wherein the septum is configured to be ruptured when the second connector is coupled to the second corresponding fluid line connector.
However, Yoskowitz teaches wherein the second connector comprises a septum extending across the lumen of the second connector to seal the lumen of the second connector, and wherein the septum is configured to be ruptured when the second connector is coupled to the second corresponding fluid line connector ([0104] no valves are used and instead one or more flaps secured by adhesive or the like covers the conduits until a suitable pressure is applied which then opens or breaks the flap material to allow flow of the cooling medium). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Voorhees to include wherein the second connector comprises a septum extending across the lumen of the second connector to seal the lumen of the second connector, and wherein the septum is configured to be ruptured when the second connector is coupled to the second corresponding fluid line connector. Doing so allows for the second connector to remain sealed until it is time for fluid to move through it and for preventing unwanted fluid to enter.
Conclusion
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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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