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 .
Response and Amendment Filed
Applicant’s response and amendment, filed March 2, 2026, has been entered and made of record. Accordingly, the status of the claims is as follows: Claims 1-9, 13-15 and 25-38 are canceled; claims 10, 11 and 18-20 are amended; claims 12, 16, 17, 22 and 23 are unamended; claims 39-50 are newly added.
Previously Set Forth Objections and Rejections
The status of the objections and rejections set forth in the previous Office action (mailed December 2, 2025) is as follows:
The objection to the specification has been overcome by amendments to the specification.
The 35 USC 102(a)(2) rejection of claims 10-14 and 16-18 as being anticipated by Taylor et al. (U.S. Patent Application Publication No. 2018/0140459) is hereby withdrawn.
The 35 USC 103 rejection of claim 15 as being unpatentable over Taylor et al. (U.S. Patent Application Publication No. 2018/0140459) in view of Yang (U.S. Patent Application Publication No. 2020/0352781) is hereby rendered moot by the cancellation of claim 15.
The 35 USC 103 rejection of claims 19-24 as being unpatentable over Yang (U.S. Patent Application Publication No. 2020/0352781) in view of Taylor et al. (U.S. Patent Application Publication No. 2018/0140459) is hereby withdrawn.
The following new grounds of rejection are set forth:
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 41 is 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 41 recites the limitation "the hub" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 10-12, 16-18 and 39-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (U.S. Patent Application Publication No. 2018/0140459) in view of Griffin et al. (U.S. Patent No. 4,901,734).
In regard to claims 10, 11, 16, 17 and 18, Taylor et al. teach a thermal control system 20 adapted to control the temperature of a patient 30 which may involve raising, lowering or maintaining a patient’s temperature including a thermal control unit 22 coupled to one or more thermal therapy devices 24 (thermal pads) configured for placement on one or more portions of the patient 30 (see Fig. 1 and para. 0023). Thermal control unit 22 is coupled to thermal pads 24 via a plurality of hoses 26 where each hose includes one or more lines 28 such as a fluid supply line 28a and a fluid return line 28b (see Fig. 1 and para. 0024). Thermal control unit 22 is adapted to raise or lower the temperature of the fluid supplied to the thermal pads 24 using a pump 32, a heat exchanger 38, an air separator 58, a reservoir 62, an outlet manifold 40 having an outlet temperature sensor 42, a plurality of valves 44 and a plurality of outlet ports 46 (see Fig. 2 and paras. 0026 and 0040). Control unit 22 includes a controller 48 may include one or more microprocessors, volatile or non-volatile memory, software or other electronic components that are programmed to carry out the thermal temperature regulation functions (see para. 0037). Controller 48 also examines the rate at which a patient’s temperature is falling using a conventional patient temperature probe that is coupled to a selected location of the patient’s body and communicates with a cable with control unit 22 (see para. 0063). Taylor et al. are not specific as to the temperature probe. However, Griffin et al. teach a multilumen catheter 1 with a lumen 220 having that has an opening in the catheter wall 205 to expose a thermistor bead 200 that continuously monitors the temperature (see Fig. 6 and col. 3, line 64 to col. 4, line 11). The thermistor bead 200 connects to a thermistor wire 210 (see Fig. 6). Griffin et al. thus demonstrate that thermistors residing on a catheter for monitoring the temperature of a patient are well known in the art for providing a more accurate temperature measurement (see col. 2, lines 7-48 of Griffin et al.). Since Taylor et al. teach the use of a conventional patient temperature probe, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Taylor et al. with the thermistor catheter of Griffin et al. in order to provide a more accurate temperature measurement. As such, the thermistor catheter would communicate with the controller 48 of Taylor et al., in the manner discussed above. Taylor et al. do not specifically state that the device is used for hyperthermic cancer treatment. However, this recitation is considered an intended use recitation that is given little patentable weight. Moreover, the structure recited by Taylor et al. does not include any structural limitations that would preclude its use for hyperthermic cancer treatment and thus, the device taught by Taylor et al. is capable of being used for hyperthermic cancer treatment. It should be noted that it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). Also, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004).
In regard to claim 12, Taylor et al. teach that thermal pads 24 includes a sensor layer 72, a lower chamber layer 74, an upper chamber layer 76 and an insulating layer 78 (see Fig. 3 and para. 0042). Sensor layer 72 is comprised of a gel layer that is adapted to releasably adhere to the skin of the patient such as urethane gel, which is a hydrogel (see para. 0047). Lower chamber layer 74 and upper chamber layer 76 are bonded to each other at a plurality of internal locations 86 and the space between lower chamber layer 74 and upper chamber layer 76 where they are not bonded to each other defines a fluid chamber in which the temperature-controlled fluid supplied by thermal control unit 22 circulates (see Fig. 4 and para. 0049). Thermal pad 24 also includes a fluid inlet line 96 that couples to fluid supply line 28a and a fluid outlet line 98 that coupled to fluid return line 28b (see Fig. 4 and para. 0051). In regard to claims 39-41, Figure 6 of Griffin et al. shows that the wire 210 is disposed in a lumen 221 and extends distally from a hub 4, 14, 104 to the thermistor bead 200 and the thermistor bead 220 is attached to appropriate instrumentation (microammeter) (see col. 4, lines 20-24). Figure 1 also shows that the electrical connector assembly 6 extends proximally from the hub 4, 14, 104 and it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to connect the electrical connector 6, 16, 106 with the controller 48 of Taylor et al. In regard to claims 42 and 43, Griffin et al. teach lumen assemblies 7, 17, 107 and 8, 18, 108 can be provided for the infusion of fluids such as a drug (chemotherapy or immunotherapy) (see col. 3, lines 19-22). It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to utilize an infusion pump to convey a drug through the lumens to the patient as infusion pumps are well known and conventional in the art.
Claim(s) 19-24 and 45-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang (U.S. Patent Application Publication No. 2020/0352781) in view of Taylor et al. (U.S. Patent Application Publication No. 2018/0140459) and further in view of Griffin et al. (U.S. Patent No. 4,901,734).
In regard to claims 19-21 and 23, Yang teaches a multi-use electronically heated patch system that includes a heat patch 100 and an adhesive pad 200 for coupling the patch 100 to a patient (see Figs. 1-3 and para. 0036). The patch 100 includes a lower layer 102 and an upper layer 104 that is bonded or coupled to the lower layer 102 (see para. 0036). The first end portion 108 of patch 100 has an end of a USB connector 116 that receives a connector plug 118 and cable for transmitting electricity to patch 100 (see Fig. 4A). The patch 100 includes a heater 120 disposed between the lower layer 102 and the upper layer 104 that may include a heater wire alloy fixed in a fabric matrix (see para. 0037). The heater 120 and the USB connector 116 are electrically attached to a printed circuit board 122 that has a control circuit such as an integrated circuit 124 (microprocessor) (see Fig. 2 and para. 0037). The adhesive pad 200 includes a flexible layer 202 with a first side 204 that has adhesive coated thereon (see para. 0038 and Fig. 3) and a flexible sheet 210 serves as a release liner to maintain integrity of the adhesive pad 200 prior to use (see Figs. 3 and 4B). Yang is silent as to whether the integrated circuit 124 includes a memory or instructions to operate the device. However, as noted above, Taylor et al. teach a similar device with a control unit 22 includes a controller 48 may include one or more microprocessors, volatile or non-volatile memory, software or other electronic components that are programmed to carry out the thermal temperature regulation functions (see para. 0037). Taylor et al. thus demonstrate that it was well known in the art to provide a controller on a thermal therapy device where the controller is equipped with memory and instructions stored in the memory to operate the device. Accordingly, it would have been obvious for one of ordinary skill in the art at the time the invention was made to provide the device of Yang with a memory and instructions stored in the memory in integrated circuit 124 in order to provide the device with the ability to carry out processes for operating the device. Yang is also silent as to a core-temperature determining means. However, as noted above, Taylor et al. teach that controller 48 also examines the rate at which a patient’s temperature is falling using a conventional patient temperature probe that is coupled to a selected location of the patient’s body and communicates with a cable with control unit 22 (see para. 0063). Taylor et al. thus demonstrate that it was well known and conventional in the art to utilize a patient temperature probe to determine the core temperature of the patient during use of a thermal therapy device so that the thermal therapy device can be properly used and calibrated. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Yang with a conventional patient temperature probe in order to determine the core temperature of the patient during use of a thermal therapy device so that the thermal therapy device can be properly used and calibrated. Taylor et al. are not specific as to the temperature probe. However, Griffin et al. teach a multilumen catheter 1 with a lumen 220 having that has an opening in the catheter wall 205 to expose a thermistor bead 200 that continuously monitors the temperature (see Fig. 6 and col. 3, line 64 to col. 4, line 11). The thermistor bead 200 connects to a thermistor wire 210 (see Fig. 6). Griffin et al. thus demonstrate that thermistors residing on a catheter for monitoring the temperature of a patient are well known in the art for providing a more accurate temperature measurement (see col. 2, lines 7-48 of Griffin et al.). Since Taylor et al. teach the use of a conventional patient temperature probe, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Yang in view of Taylor et al. with the thermistor catheter of Griffin et al. in order to provide a more accurate temperature measurement. As such, the thermistor catheter would communicate with the controller 48 of Taylor et al., in the manner discussed above. Yang does not specifically state that the device is used for hyperthermic cancer treatment. However, this recitation is considered an intended use recitation that is given little patentable weight. Moreover, the structure recited by Yang does not include any structural limitations that would preclude its use for hyperthermic cancer treatment and Yang states that the device is a multi-use heated patch system (see para. 0036). Thus, the device taught by Yang is capable of being used for hyperthermic cancer treatment and one of ordinary skill in the art at the effective filing date of the invention would have been motivated to utilize the patch system for hyperthermic cancer treatment. Finally, it should be noted that it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). Also, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004).
In regard to claim 22, Yang teaches that the adhesive may be a polyurethane adhesive, which is a hydrogel (see para. 0038). In regard to claim 24, the integrated circuit 124 includes a temperature sensor that would serve as a means to adjust a temperature of the device (see para. 0037). In regard to claims 45-47, Figure 6 of Griffin et al. shows that the wire 210 is disposed in a lumen 221 and extends distally from a hub 4, 14, 104 to the thermistor bead 200 and the thermistor bead 220 is attached to appropriate instrumentation (microammeter) (see col. 4, lines 20-24). Figure 1 also shows that the electrical connector assembly 6 extends proximally from the hub 4, 14, 104 and it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to connect the electrical connector 6, 16, 106 with the controller 48 of Taylor et al. In regard to claims 48 and 49, Griffin et al. teach lumen assemblies 7, 17, 107 and 8, 18, 108 can be provided for the infusion of fluids such as a drug (chemotherapy or immunotherapy) (see col. 3, lines 19-22). It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to utilize an infusion pump to convey a drug through the lumens to the patient as infusion pumps are well known and conventional in the art.
Claim(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (U.S. Patent Application Publication No. 2018/0140459) in view of Sullivan et al. (U.S. Patent No. 4,497,324).
In regard to claim 44, Taylor et al. are not specific as to the temperature probe. However, Sullivan et al. teach a temperature monitoring urinary catheter 10 with a temperature transducer 32 that can be a thermistor (see Fig. 1 and col. 3, lines 60-65).
Sullivan et al. thus demonstrate that thermistors residing on a urinary catheter for monitoring the temperature of a patient are well known in the art for providing a more accurate temperature measurement (see col. 2, lines 20-44 of Sullivan et al.). Since Taylor et al. teach the use of a conventional patient temperature probe, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Taylor et al. with the thermistor urinary catheter of Sullivan et al. in order to provide a more accurate temperature measurement. As such, the thermistor urinary catheter would communicate with the controller 48 of Taylor et al., in the manner discussed above.
Claim(s) 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang (U.S. Patent Application Publication No. 2020/0352781) in view of Taylor et al. (U.S. Patent Application Publication No. 2018/0140459) and further in view of Sullivan et al. (U.S. Patent No. 4,497,324).
In regard to claim 50, Taylor et al. are not specific as to the temperature probe. However, Sullivan et al. teach a temperature monitoring urinary catheter 10 with a temperature transducer 32 that can be a thermistor (see Fig. 1 and col. 3, lines 60-65).
Sullivan et al. thus demonstrate that thermistors residing on a urinary catheter for monitoring the temperature of a patient are well known in the art for providing a more accurate temperature measurement (see col. 2, lines 20-44 of Sullivan et al.). Since Taylor et al. teach the use of a conventional patient temperature probe, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Yang in view of Taylor et al. with the thermistor urinary catheter of Sullivan et al. in order to provide a more accurate temperature measurement. As such, the thermistor urinary catheter would communicate with the controller 48 of Taylor et al., in the manner discussed above.
Response to Arguments
Applicant’s arguments with respect to claim(s) 10-12, 16-24 and 39-50 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. Specifically, Griffin et al. and Sullivan et al. both teach thermistor-tipped catheters (see the rejections above).
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 BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794