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 .
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 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.
Status of Claims
Claims 1-17 are pending and under consideration for patentability.
Claim Objections
Claim 15 is objected to because of the following informalities.
Claim 15 contains a minor typographical/grammatical error.
Claim 15, line 2: Applicant is advised to change “thermal pad” to “the thermal pad”
Appropriate correction is required.
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.
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.
Claims 1-7, 11-15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kushnir (US 6,508,831 B1) in view of Kolarovic et al. (US 2002/0173696 A1).
Regarding claim 1, Kushnir describes a thermal control unit for controlling a patient’s temperature (col 1:5-10), the thermal control unit comprising
a fluid outlet 104 adapted to fluidly couple to a fluid supply line 244 of a thermal pad 220 (col 9:1-19), the thermal pad adapted to be wrapped around a portion of the patient’s body (figure 7)
a fluid inlet 101 adapted to fluidly couple to a fluid return line 246 of the thermal pad (col 9:1-19)
a circulation channel (figures 6, 8, fluid loop as shown) coupled to the fluid outlet and the fluid inlet (col 9:1-19)
a pump 105 for circulating fluid through the circulation channel from the fluid inlet to the fluid outlet (col 9:1-19)
a heat exchanger 315 adapted to add or remove heat from the fluid circulating in the circulation channel (col 9:46-67)
a fluid temperature sensor 370, 372 adapted to sense a temperature of the fluid (col 9:46-67)
a patient temperature probe port 364 adapted to receive patient core temperature readings from a patient temperature probe (col 9:46-67)
a second sensor port adapted to receive sensor readings from a second sensor adapted to detect a patient parameter (col 8:56-62)
a controller 94 in communication with the patient temperature probe port, the pump, the fluid temperature sensor, and the second sensor port, the controller adapted to control the heat exchanger based on both the patient core temperature readings and the sensor readings from the second sensor (col 9:1-12, 46-67)
Regarding claim 1, although Kushnir describes that a variety of non-temperature sensors may be used with the described thermal control unit (col 5:54-60), Kushnir does not explicitly disclose the use of a perfusion sensor adapted to detect a patient’s blood perfusion levels at at least one of a palm or a foot of the patient. However, Kolarovic also describes a thermal unit for controlling a patient’s temperature ([0011]) including the use of a perfusion sensor adapted to detect a patient’s blood prefusion levels (Abstract, [0012]: “…a video camera is within the definition of the term ‘sensor’ as used herein”) at at least one of a palm or a foot of the patient (Abstract, the camera is configured for sensing skin perfusion; the Examiner respectfully submits that the camera may be repositioned or placed as desired to detect perfusion at any body part desired, the exact placement of the sensor does not change the fact that it is “adapted to” detect the patient’s blood perfusion levels). As Kolarovic is also directed towards a thermal control unit and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a perfusion sensor similar to that described by Kolarovic into the thermal control unit described by Kushnir, as doing so advantageously allows the resulting device to better monitor and respond to multiple patient parameters.
Regarding claim 2, Kushnir describes wherein the controller is adapted to use a feedback control loop with a first set of coefficients to control the heat exchanger when the sensor readings from the second sensor meet a first criteria and to use the feedback control loop with a second and different set of coefficients to control the heat exchanger when the sensor readings from the second sensor meet a second criteria (col 5:61-6:17).
Regarding claim 3, Kushnir describes wherein the controller is further adapted to control the heat exchanger such that the patient core temperature readings move toward a target patient temperature (col 10:38-52).
Regarding claim 4, Kushnir describes wherein the controller uses the patient parameter to control the heat exchanger in a feedforward manner (col 5:61-6:3), and Kolarovic describes wherein the patient parameter is the patient’s blood perfusion level (Abstract).
Regarding claim 5, Kushnir describes wherein the second sensor is integrated into the thermal pad (col 9:1-12).
Regarding claim 6, Kushnir describes an auxiliary sensor port adapted to receive sensor readings from an auxiliary sensor (col 8:56-62).
Regarding claim 7, Kushnir describes wherein the auxiliary sensor is an intermediate temperature sensor positioned at an exterior location of the patient’s body and adapted to measure a temperature of the patient at an intermediate depth between the patient’s skin and the patient’s core (col 9:46-67, core temperature measuring device, skin temperature measuring device).
Regarding claim 11, Kushnir describes wherein the auxiliary sensor is a bio-impedance sensor adapted to detect electrical impedance of the patient (col 5:54-60).
Regarding claim 12, Kolarovic describes wherein the auxiliary sensor is an ultrasonic sensor adapted to detect attenuation levels of ultrasonic waves traveling through at least a portion of the patient’s body ([0030]).
Regarding claim 13, Kushnir describes wherein the auxiliary sensor is a near infrared sensor adapted to detect attenuation levels of near infrared waves traveling through at least a portion of the patient’s body (col 8:47-53).
Regarding claim 14, Kushnir describes wherein the auxiliary sensor port is adapted to receive sensor readings from a plurality of non-temperature sensors (col 9:1-12, when describing a “plurality of sensing devices” referred to as element 90), and the controller is further adapted to control the heat exchanger based on the sensor readings from the plurality of non-temperature sensors (col 9:1-12,46-67).
Regarding claim 15, Kushnir describes wherein the plurality of non-temperature sensors are integrated into the thermal pad (col 9:1-12).
Regarding claim 17, Kushnir describes wherein the auxiliary sensor is adapted to measure a subcutaneous temperature of the patient (col 9:46-67).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kushnir in view of Kolarovic, further in view of Noda et al. (US 2007/0293921 A1).
Regarding claim 8, Kushnir in view of Kolarovic suggests the thermal control unit of claim 7, but neither Kushnir nor Kolarovic explicitly discloses wherein the controller is adapted to monitor a lag time between external application of a cold temperature to the patient’s skin via the thermal pad and propagation of the cold temperature to the intermediate depth. However, Noda also describes a thermal control unit for controlling a patient’s temperature ([0019]), including monitoring a lag time between external application of a cold temperature to the patient and propagation of the temperature to an intermediate depth ([0023] - [0026]; figure 2, monitoring the lag between starting the pump and reaching a set point temperature within the patient). As Noda is also directed towards a thermal control unit and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to monitor for the lag time between external application of a temperature and reaching a target temperature within the patient, in a manner similar to that described by Noda, when using the system described by Kushnir and Kolarovic, as doing so advantageously allows the resulting system to have finer control over the patient’s temperature.
Regarding claim 9, Noda describes wherein the controller is adapted to use the lag time to determine when to transition from cooling the fluid to heating the fluid ([0024]).
Regarding claim 10, Noda describes wherein the controller is adapted to use the lag time to predict when the patient core temperature readings will reach a target patient temperature ([0008] - [0009] describe the problems associated with undershoot or overshoot; [0023] - [0026] describe measuring the lag time and allowing the patient to reach a target temperature; [0022] describes maintaining the patient at a target temperature; predicting the time at which the patient will reach a target temperature would be straightforward based on the above and inspection of the graph in figure 2).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Kushnir in view of Kolarovic, further in view of Lee et al. (US 2013/0296743 A1).
Regarding claim 16, Kushnir in view of Kolarovic suggests the thermal control unit of claim 6, but neither Kushnir nor Kolarovic explicitly discloses wherein the auxiliary sensor is an acoustic thermometer. However, Lee also describes a thermal control unit ([0019]), including the use of an acoustic thermometer ([0022], [0067]). As Lee is also directed towards monitoring patient temperature and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate an acoustic thermometer similar to that described by Lee when using the system described by Kushnir and Kolarovic, as doing so advantageously allows the resulting system to monitor the patient’s temperature in a non-invasive manner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of copending Application No. 16/957,809 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a thermal control unit comprising a fluid outlet, a fluid inlet, a circulation channel, a pump, a heat exchanger, a patient temperature probe port, a perfusion sensor port, and a controller. A brief, but non-exhaustive matching of the instant claims and the reference claims is provided via the table below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
U.S. Application No. 18/952,201
Pending Claims
U.S. Application No. 16/957,809
Reference Claims
1
1+5
2
10
3
21
4
11
5
8
6
1
7
12
8
15
9
15
10
21
11
2
12
2
13
2
14
1
15
8
16
13
17
14
Statement on Communication via Internet
Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant:
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure.
Voorhees et al. (US 2017/0246374 A1), which describes a thermal control unit including monitoring the temperature of a circulating fluid and the temperature of the subject in order to allow the subject to reach a target temperature ([0017], [0033], [0092])
Leschinsky et al. (US 2014/0236020 A1), which describes measuring tissue temperature while accounting for a lag time between application of a thermal stimulus and the measured tissue response ([0094])
Kreck et al. (US 2013/0030411 A1), which describes a thermal control unit adapted to switch between cooling and heating functions in order to maintain a patient at a set temperature, including accounting for a lag between application of the heating or cooling and the resulting patient temperature ([0012], [0463])
Ellingboe (US 2003/0114903 A1), which describes a thermal control unit including a circulating pump, heat exchanger, and controller similar to those recited in the pending claims
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. 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, Carl Layno, can be reached by telephone at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3796
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