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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/08/2026 has been entered.
Response to Amendment
The amendment filed 05/11/2026 has been entered. Claims 14-17, 20-21 & 32-33 remain pending in the application. Applicant’s amendments to the claims have overcome the objections and rejections previously set forth in the Final Office Action mailed 03/09/2026.
Response to Arguments
Applicant's arguments with respect to claims 14-17, 20-21 & 32-33 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The claim amendments changed the scope of the claimed invention. See new grounds for rejection below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 14-17, 21-22 & 32-33 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 recites the limitation "the rotatable actuator" in lines 27 & 31-32. There is insufficient antecedent basis for this limitation in the claim. Examiner believes this is a typo and should be the “rotatable member”, in which for examination are being treated as the same element.
Claims 15-17, 21-22 & 32-33 are rejected based on their dependency on independent claim 14.
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.
Claim 14, 16-17, 21-22 & 32 are rejected under 35 U.S.C 103 as being unpatentable over Schaefer et al. (US 20160022477) and Lennox et al. (US 20040158303) herein referred to as Lennox in further view of Lewis (US 20150231009) herein referred to as Lewis.
Regarding Claim 14, Schaefer discloses a medical pad for exchanging thermal energy between a targeted temperature management (TTM) fluid and a patient (Paragraph [0031]; wherein thermal contrast therapy include circulating fluid from a thermal contrast therapy device through a treatment pad, the treatment pad having been applied to a patient), the pad comprising: a pad portion configured for placement on the patient (Figure 8b, 810 & 812), the pad portion defining: a patient facing side (Figure 8, 810); and a top side disposed opposite the patient facing side (Figure 8b, 812); a fluid delivery conduit extending away from the pad portion (Figure 8a, 804), the fluid delivery conduit including a delivery conduit connector at a proximal end thereof (Figure 9a); and a fluid return conduit extending away from the pad portion (Figure 8a, 806), the fluid return conduit including a return conduit connector at a proximal end thereof (Figure 9a); and wherein: the delivery conduit connector and the return conduit connector are configured to couple with a hub of a fluid delivery line of a TTM module to establish fluid communication of the fluid delivery conduit and the fluid return conduit with the fluid delivery line (Figure 9a; wherein connector 904 contains both the delivery conduit connector and the fluid conduit connector which are connected to fluid delivery line 168 and fluid return line 170 which connect to 174 the TTM fluid connector), at least one of the delivery conduit connector or the return conduit connector are configured to be locked to the hub in accordance with a hub locking mechanism of the hub (Paragraph [0117]; wherein quick-release buttons on opposite ends of the extension cord respectively release prongs within the device-side fitting and the pad-side fitting, which snap into place over corresponding notches on the device interface fitting, such that when the prongs are within the device corresponding notches, the delivery and return conduit is locked into device such that, the release button has to be used to be able to shift the locking mechanism, which in this case is a snap fit coupling), the hub locking mechanism is configured to transition between: an unlocked state (Paragraph [0117]; wherein the unlocked state is when quick release button are held down such that the prongs are disengaged from the notches and the conduits may either be decoupled and removed from the device or can be recoupled to the device), wherein the at least one of the delivery conduit connector or the return conduit connector is allowed to couple to and decouple from the hub (Paragraph [0117]; wherein the connector contains both the delivery and return conduits and when quick release button are held down such that the prongs are disengaged from the notches and the conduits may either be decoupled and removed from the device or can be recoupled to the device), and a locked state (Paragraph [0117]; wherein when the prongs are within the device corresponding notches, the delivery and return conduit is locked into device such that, the release button has to be used to be able to shift the locking mechanism,), wherein the at least one of the delivery conduit connector or the return conduit connector is prevented from coupling to and decoupling from the hub (Paragraph [0117]; wherein when the prongs are within the device corresponding notches, the delivery and return conduit is locked into device such that, the release button has to be used to be able to shift the locking mechanism to be unlocked therefore allows for prevention of the coupling and decoupling); and an RFID tag configured to provide pad identification data to an RFID sensor (Figure 8a, 180; Paragraph [0108]; wherein the RFID tag communicates with a component capable of enabling a tag reader or processor to identify at least one characteristic of a treatment pad, such as a sensor). However, Schaefer does not explicitly disclose fluid delivery conduit and the fluid return conduit are coupled to the pad portion via a joint on the top side, and the joint provides for a rotatable connection between the respective fluid delivery and fluid return conduit and the pad portion; and the hub locking mechanism having a rotatable member configured to transition between an unlocked state when the rotatable member is rotated to a first potion and a locked state when the rotatable member is rotated to a second position different from the first position.
Lennox discloses a thermal therapy device (Figure 18) wherein fluid delivery conduit and the fluid return conduit are coupled to the pad portion via a joint on the top side (Figure 18, 152), and the joint provides for a rotatable connection between the respective fluid delivery and fluid return conduit and the pad portion (Figure 18, 154). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the medical pad taught by Schaefer to include the joint as taught by Lennox. The motivation being allowing for positioning of the pad at various locations or orientations relative while minimizing strain on, or bending and kinking of, the tubes (Lennox, Paragraph [0139]).
Lewis discloses a medical pad (Figure 2a) comprising a hub locking mechanism having a rotatable member (Figure 2C, 2203) configured to transition between an unlocked state when the rotatable member is rotated to a first position (Paragraph [0079]; wherein first position is when the fittings are engaged and twisted is the opposite direct as the locked position) and a locked state when the rotatable member is rotated to a second position different from the first position (Paragraph [0079]; wherein the second position is when the fitting are engaged and rotated in the direct towards the locked position). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the hub locking mechanism taught by Schafer in view of Lennox to be a rotatable locking mechanism. The motivation being a simple substitution of one known locking mechanism, snap fit as taught by Schafer, for another, the rotatable locking mechanism taught by Lewis, to obtain predictable results of locking a conduit to a hub (MPEP 2143 (B)).
Regarding claim 16, Schaefer and Lennox in further view of Lewis discloses the pad according to claim 14, Schaefer also discloses the medical pad further comprising: a fluid containing layer configured to contain circulating TTM fluid therein (Figure 8A, 802); and an insulation layer coupled with the fluid containing layer (Figure 8B, 808), wherein the RFID tag is disposed between the insulation layer and the fluid containing layer (Figure 8A, 180; Figure 8B; wherein RFID tag sits on top of 802 and is in-between 802 and 808).
Regarding claim 17, Schaefer and Lennox in further view of Lewis discloses the pad according to claim 14, Schaefer also discloses wherein the delivery conduit connector and the return conduit connector are attached together (figure 9a, 904).
Regarding claim 20, Schaefer and Lennox in further view of Lewis discloses the pad according to claim 14. Lewis also discloses wherein the pad further comprising a filter in fluid communication with the fluid delivery conduit such that TTM fluid passing through the fluid delivery conduit passes through the filter (Figure 2C, 2107). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to modify the medical pad taught by Schaefer in view of Lennox to include Lewis’s teachings of a filter. The motivation being to filter out bacteria and contaminants in the conduit (Lewis, Paragraph [0071])
Regarding claim 21, Schaefer and Lennox in further view of Lewis discloses the pad according to claim 20. Lewis also discloses wherein the filter comprises a porous wall oriented parallel to a continuous flow path through the filter (Figure 2C, 2107). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to modify the medical pad taught by Schaefer in view of Lennox to include Lewis’s teachings of a filter. The motivation being to filter out bacteria and contaminants in the conduit (Lewis, Paragraph [0071])
Regarding claim 32, Schaefer and Lennox in further view of Lewis discloses the pad according to claim 14. Lewis also discloses wherein the locking mechanism, once transitioned to the unlocked state, is configured to self-retain the locking mechanism in the unlocked state (Paragraph [0079]; wherein in the unlocked state, the teeth are still engaged therefore is self-retaining until the rotatable member is twisted into a locked state or the conduit is removed manually). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to modify the medical pad taught by Schaefer in view of Lennox to include Lewis’s teachings of self-retaining. The motivation being to add additional mating features (Lewis, Paragraph [0079])
Claim 15 is rejected under 35 U.S.C 103 as being unpatentable over Schaefer, Lennox and Lewis in further view of Stefan et al. (US 20170135855) herein referred to as Stefan.
Regarding Claim 15, Schaefer and Lennox in further view of Lewis discloses the pad according to claim 14. However, Schaefer and Lennox in further view of Lewis does not explicitly disclose wherein the RDIF tag is attached to the pad portion.
Stefan discloses a heating pad (Figure 1, 110) wherein the RFID tag is attached to the pad portion (Paragraph [0051]; wherein RFID tag us disposed on the outer surface of the pad). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to modify the medical pad taught by Schaefer and Lennox in further view of Lewis to include the RFID tag on the pad portion as taught by Stefan. The motivation being it would be obvious to try and place the RFID tag in different locations on the pad to see which location produces the best solution as moving an RFID tag would have the same use of having information stored and moving would result in creating just different use patterns. (MPEP § 2143 (E))
Claims 33 are rejected under 35 U.S.C 103 as being unpatentable over Schaefer, Lennox and Lewis in view of Blalock et al. (US 6551348) herein referred to as Blalock.
Regarding Claim 33, Schaefer and Lennox in further view of Lewis discloses the pad according to claim 14 wherein the hub includes a fluid delivery valve (Schaefer, Figure 1, 126 & 130) and a fluid return valve (Schaefer, Figure 1, 140 & 142). However, Schaefer and Lennox in further view of Lewis does not explicitly disclose wherein each valve including a deflectable valve member that when deflected transitions the respective valve from a closed state to an open state, and coupling the delivery conduit connector or the return conduit connector to the hub deflects the corresponding valve member to allow a TTM fluid to flow through the delivery conduit connector or the return conduit connector, respectively.
Blalock discloses a pad (Figure 1, 18) wherein each valve including a deflectable valve member that when deflected transitions the respective valve from a closed state to an open state (Figure 2, 86; Column 4, lines 47-62; wherein throat actuator orifices 90, which is seen as the deflectable valve member, allow for transition of the valve when male connector is connected to the female connector through throat actuator 86, such that it allows for fluid to flow through, when they are not connected, 90 stays occluded and automatically prevents TTM fluid flow), and coupling the delivery conduit connector or the return conduit connector to the hub deflects the corresponding valve member to allow a TTM fluid to flow through the delivery conduit connector or the return conduit connector, respectively (Figure 2, 86; Column 4, lines 47-62; wherein throat actuator orifices 90, which is seen as the deflectable valve member, allow for transition of the valve when male connector is connected to the female connector through throat actuator 86, such that it allows for fluid to flow through, when they are not connected, 90 stays occluded and automatically prevents TTM fluid flow). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the valves taught by Schaefer and Lennox in further view of Lewis to allow for a self-retained locking mechanism in the unlocked state. The motivation being a simple substation of one known type of valve, the one taught by Schaefer, for another, the valve taught by Blalock to obtain predictable results of selectively allowing fluid flow.
Conclusion
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ALYSSA M. PAPE
Examiner
Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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