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 (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.
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.
Claims 1-3, 5, 13-24, 26 and 32-33 are 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 1 recites the limitations "the fluid" in line 7 and “the user” in lines 19-20. There is insufficient antecedent basis for these limitations in the claim.
Claim 18 recites the limitations "the fluid" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitations “the user” in line 8. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 2-3, 5, 13-17, 19-21, 23-24, 26 and 32-33 are rejected by virtue of their dependency upon an indefinite base claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 18 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kostic et al. (US 2018/0098878).
Regarding claim 18, Kostic discloses a thermal control unit for controlling a patient's temperature during a thermal therapy session (see thermal control unit 22, Fig. 1-2), the thermal control unit comprising: a fluid outlet adapted to couple to a first hose in fluid communication with a thermal pad in contact with a patient (see outlet 48, Fig. 2); a fluid inlet adapted to couple to a second hose in fluid communication with the thermal pad (see fluid inlet 50, Fig. 2); a circulation channel coupled to the fluid inlet and the fluid outlet (see primary fluid path 32, Fig. 2); a pump for circulating the fluid through the circulation channel from the fluid inlet to the fluid outlet (see pump 32; [0045], Fig. 2); a heat exchanger adapted to add or remove heat from the fluid circulating in the circulation channel (see heat exchanger 44; [0046], Fig. 2); a display (see user interface 54, considered a display since it displays controller outputs, [0056], [0069], [0071] and [0077], Figs. 1 and 2); and a controller adapted to control the heat exchanger in order to control the patient's temperature (see controller 52, [0046], Fig. 2), the controller further adapted to display an indicator on the display, the indicator indicating information about a disinfection status of the thermal control unit (see [0063], [0074] and [0077]).
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.
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 1-3, 5, 13-14, 22-24, 26 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Kostic et al. (US 2018/0098878) in view of Dollar et al. (US 2013/0190717).
Regarding claim 1, Kostic discloses a thermal control unit for controlling a patient's temperature during a thermal therapy session (see thermal control unit 22, Fig. 1-2), the thermal control unit comprising: a fluid outlet adapted to couple to a first hose in fluid communication with a thermal pad in contact with a patient (see outlet 48, Fig. 2); a fluid inlet adapted to couple to a second hose in fluid communication with the thermal pad (see fluid inlet 50, Fig. 2); a circulation channel coupled to the fluid inlet and the fluid outlet (see primary fluid path 32, Fig. 2); a pump for circulating the fluid through the circulation channel from the fluid inlet to the fluid outlet (see pump 32; [0045], Fig. 2); a heat exchanger adapted to add or remove heat from the fluid circulating in the circulation channel (see heat exchanger 44; [0046], Fig. 2); a display (see user interface 54, considered a display since it displays controller outputs, [0056], [0069], [0071] and [0077], Figs. 1 and 2); a disinfection control for initiating a disinfection cycle (see controller programming for initiating a cleaning cycle for biofilm, which is considered a disinfection cycle, [0063] and [0077]); and a controller adapted to control the heat exchanger in order to control the patient's temperature (see controller 52, [0046], Fig. 2), the controller further adapted to display alerts and indications for disinfection corresponding to the disinfection cycle in response to the disinfection control being activated (see [0063], [0074] and [0077]). However, Kostic fails to further disclose the controller further adapted to display a series of disinfection steps corresponding to the disinfection cycle in response to the disinfection control being activated, the series of disinfection steps including a particular step in which the controller automatically performs at least one of the following: (a) selects a target temperature for the circulating fluid and controls the heat exchanger such that a temperature of the fluid in the circulation channel is changed to the target temperature; or (b) measures a set amount of time and provides an indication to the user after the set amount of time has elapsed.
Dollar teaches a cardioplegia apparatus (see Abstract, Fig. 1B) comprising a touchscreen display for displaying a series of steps in a cleaning process in response to a user activating the steps of the cleaning process, wherein each step in the process is used to update the display with highlighting and corresponding instructional message for each step (see [0074], Figs. 9-7 through 9-13). Upon activation of the cleaning process, the controller automatically measures a set amount of time and provides a display of the time remaining to the user, including when the set time has elapsed (see [0074], Fig. 9-13). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller and display as disclosed by Kostic to comprise a touch screen and controller adapted to display a series of disinfection steps corresponding to the disinfection cycle in response to the disinfection control being activated, the series of disinfection steps including a particular step in which the controller automatically performs measures a set amount of time and provides an indication to the user after the set amount of time has elapsed in light of Dollar, the motivation being to provide the additional advantage of informing the user of progress of the disinfection cycle visually, providing additional instructions to the user, and enabling the user to have additional control over the disinfection process.
Regarding claim 2, Kostic in view of Dollar further teaches the limitations of the claim under the same citations and rationale as that applied in the rejection of claim 1 above.
Regarding claim 3, Kostic in view of Dollar further teaches wherein the series of disinfection steps includes a step in which the controller displays a message on the display reminding the user to drain the thermal control unit (see Fig. 9-13); and a step in which the controller displays a timer counting down from a predetermined time (see Dollar Figs. 9-9 and 9-12). It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the disinfection steps as disclosed by Kostic to include the above steps in light of Dollar, the motivation being to provide the additional advantages as set forth in the rejection of claim 1 above as well as ensuring the user drains any residual contaminants from the system after cleaning as shown in Fig. 9-13 of Dollar.
Regarding claim 5, Kostic in view of Dollar further teaches wherein the controller is adapted to display a completion message on the display when the disinfection cycle is completed (see Dollar Fig. 9-13).
Regarding claims 13 and 14, Kostic in view of Dollar further teaches the limitations of the claims under the same obviousness rationale as that applied in the rejection of claim 3 above since having the user confirm draining the device after cleaning falls would have been obvious under the same rationale, see also options to stop as taught by Dollar in Figs. 9-9 and 9-12.
Regarding claims 22-24, 26 and 32, Kostic in view of Dollar teaches the limitations of these claims under the same citations and rationale as that applied in the rejections of claims 1-3, 5 and 13-14 above.
Claims 15-16 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Kostic in view of Dollar and in further view of Taylor (US 2020/0000629).
Regarding claims 15-16 and 33, Kostic in view of Dollar teaches the limitations of claims 1 and 22, however fails to further teach a communication interface adapted to transmit a message to a server when the disinfection cycle has been completed, wherein the message indicates a time when the disinfection cycle was completed.
Taylor teaches a disinfection process for disinfecting a fluid circulation device (see Abstract, Fig. 1) comprising commencing a disinfection cycle and then controller stores the time and date at which that particular thermal control unit is disinfected, the information is displayable on the user interface, and may be transmitted off-board disinfection station to one or more other entities, such as one or more servers on a local area network of the healthcare facility (see [0069]-[0070]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the thermal control unit as taught by Kostic in view of Dollar to further include a communication interface adapted to transmit a message to a server when the disinfection cycle has been completed, wherein the message indicates a time when the disinfection cycle was completed in light of Taylor, the motivation being to provide the additional advantage of tracking when maintenance is required for the device and coordinating disinfection cycles with the user at regular intervals (see Taylor [0071]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kostic in view of Dollar and in further view of Hoffman (US 2016/0008529).
Regarding claim 17, Kostic in view of Dollar teaches the limitations of claim 1, however fails to further teach wherein the controller is adapted to display an indicator on the display, the indicator indicating when a next disinfection cycle should be performed on the thermal control unit.
Hoffman teaches a fluid based peritoneal dialysis device (see Fig. 1), wherein the device continuously tracks and displays the number of days remaining until a next required periodic maintenance activity and includes audio and visual notifications that prompt the patient and instructs them how to perform the activity (see [0015] and [0098]-[0113]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the indicators as disclosed by Kostic to further include when a next disinfection cycle should be performed on the thermal control unit in light of Hoffman, the motivation being to provide the additional advantage of ensure the device is maintained at appropriate maintenance intervals such that the device remains in adequate working order to provide its functions safely and effectively (see Hoffman [0015]).
Claims 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Kostic in view of Hoffman.
Regarding claims 19-21, Kostic discloses the limitations of claim 18, however fails to further disclose wherein the indicator indicates when a next disinfection cycle should be performed on the thermal control unit, wherein the indicator indicates a number of days until the next disinfection cycle should be performed, and wherein the indicator indicates at least one of: up to date, disinfection required soon, disinfection required, or disinfection overdue.
Hoffman teaches a fluid based peritoneal dialysis device (see Fig. 1), wherein the device continuously tracks and displays the number of days remaining until a next required periodic maintenance activity and includes audio and visual notifications that prompt the patient and instructs them how to perform the activity (see [0015] and [0098]-[0113]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the indicator as disclosed by Kostic to further include when a next disinfection cycle should be performed on the thermal control unit, wherein the indicator indicates a number of days until the next disinfection cycle should be performed, and wherein the indicator indicates at least one of: up to date, disinfection required soon, disinfection required, or disinfection overdue in light of Hoffman, the motivation being to provide the additional advantage of ensure the device is maintained at appropriate maintenance intervals such that the device remains in adequate working order to provide its functions safely and effectively (see Hoffman [0015]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN W COLLINS whose telephone number is (408)918-7607. The examiner can normally be reached M-F 9:00 AM-5:00 PM ET.
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/SEAN W COLLINS/Primary Examiner, Art Unit 3794