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 .
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.
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.
Claims 25-30, 35 and 42-44 are rejected under 35 U.S.C. 103 as being unpatentable over Dabrowiak (US 2016/0287434) in view of Dabrowiak et al. (US 2014/0094881).
Regarding claim 25 and 42, Dabrowiak discloses a system (fig.1) for warming or cooling a body of a subject comprising: an extracorporeal control system (system 10), the extracorporeal control system (system 10) including: a warming or cooling device (the cold plates 30/32); a controller (a control system 14); and; and a body surface heat exchanger (pad 18 and/or catheter 12), the body surface heat exchanger operatively connectable to the extracorporeal control system (fig.1), the body surface heat exchanger positionable against the body of the subject to effect heat exchange between the body of the subject and a heat exchange fluid circulating through the body surface heat exchanger ([0025]-[0026]), the heat exchange fluid being warmed or cooled by the warming or cooling device ([0025]-[0026]); a catheter body (the catheter body of catheter 12), the catheter body connectable to the extracorporeal control system to establish a fluid path (fig.1, see also [0027]), the catheter body including a delivery lumen and a return lumen, the delivery lumen and the return lumen configured to receive the heat exchange fluid therethrough (fig.1, see also [0022]-[0023]); a heat exchange region (the region of catheter 12 that exchange heat with the body of the patient), the heat exchange region coupled to the catheter body (fig.1, see also [0022]), the heat exchange region in communication with the delivery and return lumens of the catheter body to receive the heat exchange fluid therethrough and effect heat exchange with blood flowing through a vasculature of the subject ([0022]).
Dabrowiak does not disclose a reader for reading machine readable encoded information; the body surface heat exchanger including an electronic storage medium including machine readable encoded information, the machine readable encoded information having identifying information that identifies the body surface heat exchanger and wherein the reader of the extracorporeal control system is configured to read the machine readable encoded information of the body surface heat exchanger to determine the identity of the body surface heat exchanger, and wherein based on the identity of the body surface heat exchanger, the controller is configured to execute a heat exchange control algorithm by adjusting at least one of temperature, flow rate/fluid loop parameter or pressure of the heat exchange fluid circulating through the body surface heat exchanger.
Dabrowiak 881 teaches a system includes a heat exchange catheter line assembly configured to convey working fluid circulating to and from at least one heat exchange element on an intravascular heat exchange catheter. The system also includes a heat exchange system that itself includes a processor and is configured for fluidly communicating with the heat exchange catheter line assembly to exchange heat with the working fluid. The system includes a reader for reading machine readable encoded information (fig.1; NFC 28, see also [0017]); the body surface heat exchanger (catheter 10) including an electronic storage medium including machine readable encoded information, the machine readable encoded information having identifying information that identifies the body surface heat exchanger and wherein the reader of the extracorporeal control system is configured to read the machine readable encoded information of the body surface heat exchanger to determine the identity of the body surface heat exchanger [0016], and wherein based on the identity of the body surface heat exchanger, the controller is configured to execute a heat exchange control algorithm by adjusting at least one of temperature, flow rate or pressure of the heat exchange fluid circulating through the body surface heat exchanger ([0013]: “The system 12 includes a processor executing logic that in some non-limiting examples is in accordance with disclosure in the above-referenced system patents to control the temperature of working fluid circulating (fluid loop parameters) through the catheter 10 in accordance with a treatment paradigm responsive to patient core temperature feedback signals.”). The system clearly teaches that the processor is configured to prevent operation of the heat exchange system if authorization is not valid (i.e., the device is not identified). If the authorization is valid (i.e., the correct device is identified), the heat exchange system is configured to operate properly, which includes controlling the temperature of working fluid circulating through the catheter 10 in accordance with a treatment paradigm responsive to patient core temperature feedback signals. Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was effectively filed to modify the device of Dabrowiak with a controller that includes reader and a catheter comprises an electronic storage medium including machine readable encoded information as taught by Dabrowiak 881 for the purpose more controlled and safe treatment.
Regarding claim 26, Dabrowiak/Dabrowiak 881 teaches the system according to claim 25, wherein the body surface heat exchanger comprises a heat exchange pad, a heat exchange blanket, or a heat exchange mattress (fig.1 of Dabrowiak).
Regarding claim 27, Dabrowiak/Dabrowiak 881 teaches the system according to claim 25, wherein the electronic storage medium of the body surface heat exchanger comprises non-volatile random access memory or non-volatile flash memory ([0024] of Dabrowiak 881).
Regarding claim 28, Dabrowiak/Dabrowiak 881 teaches the system according to claim 25, wherein the electronic storage medium of the body surface heat exchanger comprises electrically erasable programmable read-only memory (EEPROM) or ferroelectric random access memory (FRAM) ([0024] of Dabrowiak 881).
Regarding claim 29 and 43, Dabrowiak/Dabrowiak 881 teaches the system according to claim 25, wherein the controller of the extracorporeal control system is programmed to perform one or more actions in response to the operational parameters selected ([0026] - [0027] of Dabrowiak 881).
Regarding claim 30 and 44, Dabrowiak/Dabrowiak 881 teaches the system according to claim 29, wherein the controller is programmed to determine whether the preprogrammed information meets a prerequisite requirement and to proceed with warming or cooling of the body of the subject if the prerequisite requirement is met ([0058]- [0059] of Dabrowiak 881).
Regarding claim 35, Dabrowiak/Dabrowiak 881 teaches the system according to claim 25, wherein the extracorporeal control system further includes a pump for circulating the heat exchange fluid through the body surface heat exchanger (fig.1, see also [0022] of Dabrowiak).
Claims 36-41 are rejected under 35 U.S.C. 103 as being unpatentable over (US 2016/0287434) in view of Paradis et al. (US 2017/0354534) in view of Dabrowiak 881 et al. (US 2014/0094881).
Regarding claim 36, Dabrowiak discloses a system for warming or cooling a body of a subject comprising: an extracorporeal control system, the extracorporeal control system including: a warming or cooling device configured to warm or cool a heat exchange fluid ; a controller (control system 14); and a heat exchange catheter (catheter 12), the heat exchange catheter operatively connectable to the extracorporeal control system (fig.1), the heat exchange catheter including: a catheter body (the catheter body of catheter 12), the catheter body connectable to the extracorporeal control system to establish a fluid path (fig.1, see also [0027]) , the catheter body including a delivery lumen and a return lumen, the delivery lumen and the return lumen configured to receive the heat exchange fluid therethrough (fig.1, see also [0022]-[0023]); a heat exchange region (the region of catheter 12 that exchange heat with the body of the patient), the heat exchange region coupled to the catheter body (fig.1, see also [0022]), the heat exchange region in communication with the delivery and return lumens of the catheter body to receive the heat exchange fluid therethrough and effect heat exchange with blood flowing through a vasculature of the subject ([0022]). Dabrowiak does not disclose a reader for reading machine readable encoded information; the body surface heat exchanger including an electronic storage medium including machine readable encoded information, the machine readable encoded information having identifying information that identifies the body surface heat exchanger and wherein the reader of the extracorporeal control system is configured to read the machine readable encoded information of the body surface heat exchanger to determine identity of the body surface heat exchanger, and wherein based on the identity of the body surface heat exchanger, the controller is configured to execute a heat exchange control algorithm by adjusting at least one of temperature, flow rate or pressure and fluid loop parameters of the heat exchange fluid circulating through the heat exchanging catheter and the heat exchange fluid circulating through the body surface heat exchanger.
Paradis teaches at least one temperature sensor operatively connectable to the extracorporeal control system and configured to measure a temperature of the subject (fig.1). Paradis further teaches that the controller selects a control algorithm to control warming or co0ling of the body of the subject [0095], wherein the control algorithm includes adjusting a heat exchange rate between the blood and the heat exchange fluid by altering the temperature of the heat exchange fluid circulated through the heat exchange catheter [0095] or by altering a rate of flow of the heat exchange fluid circulated through the heat exchange catheter [0098].
Dabrowiak 881 teaches a system includes a heat exchange catheter line assembly configured to convey working fluid circulating to and from at least one heat exchange element on an intravascular heat exchange catheter. The system also includes a heat exchange system that itself includes a processor and is configured for fluidly communicating with the heat exchange catheter line assembly to exchange heat with the working fluid. The system includes a reader for reading machine readable encoded information (fig.1; NFC 28, see also [0017]); the body surface heat exchanger (catheter 10) including an electronic storage medium including machine readable encoded information, the machine readable encoded information having identifying information that identifies the body surface heat exchanger and wherein the reader of the extracorporeal control system is configured to read the machine readable encoded information of the body surface heat exchanger to determine the identity of the body surface heat exchanger [0016], and wherein based on the identity of the body surface heat exchanger, the controller is configured to execute a heat exchange control algorithm by adjusting at least one of temperature, flow rate or pressure of the heat exchange fluid circulating through the heat exchanging catheter ([0013]: “The system 12 includes a processor executing logic that in some non-limiting examples is in accordance with disclosure in the above-referenced system patents to control the temperature of working fluid circulating (fluid loop parameters) through the catheter 10 in accordance with a treatment paradigm responsive to patient core temperature feedback signals.”). The system clearly teaches that the processor is configured to prevent operation of the heat exchange system if authorization is not valid (i.e., the device is not identified). If the authorization is valid (i.e., the correct device is identified), the heat exchange system is configured to operate properly, which includes controlling the temperature of working fluid circulating through the catheter 10 in accordance with a treatment paradigm responsive to patient core temperature feedback signals. Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was effectively filed to modify the device of Dabrowiak with at least one temperature sensor operatively connectable to the extracorporeal control system and configured to measure a temperature of the subject/ and a controller that is configured to control the flow rate of the fluid as taught by Paradis for the purpose of delivering the desired target temperature to the patient and with a controller that includes reader and a catheter comprises an electronic storage medium including machine readable encoded information as taught by Dabrowiak 881 for the purpose of using different type and/model of catheters with unique instructions for specific treatment.
Regarding claim 37, Dabrowiak/Paradis/Dabrowiak 881 teaches the system according to claim 36, wherein the controller selects a control algorithm to control warming or cooling of the body of the subject, wherein the control algorithm includes adjusting a heat exchange rate between the blood and the heat exchange fluid by altering the temperature of the heat exchange fluid circulated through the heat exchange catheter or by altering a rate of flow of the heat exchange fluid circulated through the heat exchange catheter ([0095]-[0099] of Paradis).
Regarding claim 38, Dabrowiak/Paradis/Dabrowiak 881 teaches the system according to claim 36, wherein the controller is configured to receive temperature signals indicating temperatures of the heat exchange fluid flowing into and out of the heat exchange region, and based on such temperature signals, the controller is programmed to use the temperature signals to calculate warming or cooling power output of the heat exchange region ([0098] of Paradis).
Regarding claim 39, Dabrowiak/Paradis/Dabrowiak 881 teaches the system according to claim 38, wherein the controller is configured to control operational parameters of the extracorporeal control system to adjust the warming or cooling power output of the heat exchange region based on the identity of the heat exchange catheter.
Regarding claim 40, Dabrowiak/Paradis/Dabrowiak 881 teaches the system according to claim 36, wherein the at least one temperature sensor is a blood sensor or tissue sensor ([0095] of Paradis).
Regarding claim 41, Dabrowiak/Paradis/Dabrowiak 881 teaches the system according to claim 36, wherein the heat exchange region includes a balloon configured to receive the heat exchange fluid therethrough (fig.1 of Dabrowiak).
Claims 31-34 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Dabrowiak (US 2016/0287434) in view of Dabrowiak et al. (US 2014/0094881) in further view of Todd et al. (US 2006/0129140).
Regarding claim 31, Dabrowiak/Dabrowiak 881 does not teach wherein the machine-readable encoded information of the body surface heat exchanger includes an expiration date, and the prerequisite requirement comprises a determination that the encoded expiration date has not expired.
Todd teaches a system and method for identifying a component for a medical device. The system includes a console 110 may be enabled if the data 104 is accepted 140, or disabled if the data 104 is denied 142. The console 110 may be conditionally enabled. The controller 115 can configure the console 110 to operate in a different manner in view of safety and other considerations since the probe 100 may not function as intended due to incompatible specifications, excessive use and wear, or expiration of the probe 100 [0043]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was effectively filed to further modify the device of Dabrowiak/Dabrowiak 881 with a system that is configured to check expiration of a device as taught by Todd for the purpose of patient safety.
Regarding claim 32, Dabrowiak/Dabrowiak 881/Todd teaches the system according to claim 31, wherein an indication of prior use becomes added to the encoded information when a first use of the body surface heat exchanger is carried out or attempted and the prerequisite requirement comprises a determination that no indication of prior use is included in the encoded information ([0019] of Dabrowiak 881).
Regarding claim 33 and 45, Dabrowiak/Dabrowiak 881/Todd teaches wherein the controller is connected to or incorporates memory and is programmed to verify and store in memory at least one unique identifier included in the encoded information ([0078] of Dabrowiak 881).
Regarding claim 34, Dabrowiak/Dabrowiak 881/Todd teaches the system according to claim 33, wherein the at least one unique identifier is selected from manufacturer identification, part number, and lot number ([0005] of Dabrowiak 881).
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.
Claim 25-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-14 of U.S. Patent No. US 11,337,851. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US 11,337,851 anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Response to Arguments
Applicant’s arguments with respect to claim 25, 36 and 42 have been considered but are moot because the amendment necessitated a new ground of rejection.
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 TIGIST S DEMIE whose telephone number is (571)270-5345. The examiner can normally be reached Monday-Friday 8am-5Pm.
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794
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