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 § 102
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 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.
Claims 1, 3, 9-11, 13, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Degen et al (US 2013/0211322 A1).
Regarding claims 1 and 11, Degen (‘322) discloses a system 10 and method (Figs 1A, 4, 9-10) capable for using with a DSR solution [0043] for conducting direct sodium removal therapy in a patient, the system and method comprising:
an implantable device 20 including a pump, a transceiver, a battery and a processor operably coupled to the pump, transceiver and battery [0014, 0041; Fig 1A], and implanting the device (figs 1B-1E),
the pump having an inlet port 22 and an outlet port 24;
a peritoneal catheter 23 having a first end configured to be disposed in a peritoneal cavity of the patient and a second end configured to be in fluid communication to the inlet port of the pump (fig 1B, [0014, 0041]), and implanting the peritoneal catheter;
a bladder catheter 25 having an inlet end configured to be coupled to the outlet port of the pump and an outlet end configured to be disposed in a urinary bladder of the patient [Fig, 1B, [0014, 0041], and implanting the bladder catheter,
infusing a DSR solution (claim 11) having no or low sodium into the peritoneal cavity (fig 1B),
a sensor ([0019, 0038, 0044-0045, 0076]; fig 4, figs 10-11) configured to output a signal indicative of a monitored parameter of an infusate instilled into a peritoneal cavity of the patient ([0090] where additional biosensors may be provided to monitor one or more toxins/waste products in the peritoneal dialysis fluid),
the sensor operably coupled to the processor ([0090, 0077] see figure 4 processor 70 controlling sensors 77-81 and data is saved in the memory]) and further configured to generate data indicative of a rate of change of an analyte concentration within the peritoneal cavity [0125, 0129, 0134, 0136 (the window will display information from sensor data from additional sensors in the implantable device that measure the levels of toxins/waste products in the fluid), 0137, 0146], and monitoring the sensor a constituent of the DSR solution and accumulated in the peritoneal cavity ([0091, 0136, 0146] where states it can be adjusted due to patients need),
wherein the processor is configured and controls the pump operation to execute programmed instructions to [0088]:
-monitor the output of the sensor,
determine a rate of change of analyte concentration has decreased over a time period [0003 decrease of albumin), 0004, 0019, 0091, 0129], and
- cause actuation of the pump to move fluid/DSR solution from the peritoneal cavity to the urinary bladder responsive to the determination that the rate of change of analyte concentration has decreased over the time period ([0014, 0077, 0125, 0127] figure 10),
wherein the processor is programmed to selectively vary the speed of the pump during actuation/operation [0014, 0018-0019, 0044].
Regarding claim 3, the implantable device further comprises one or more sensors for monitoring operational status of the pump [0127, 0128], and wherein the processor further is programmed to generate an alarm condition when the operational status of the pump indicates a fault ([0077 and 0081 (alarm), [0085-0088]).
Regarding claim 9, further comprising an external charging and communications system configured to inductively charge the battery, wherein the external charging and communications system is configured to periodically couple to a monitoring and control system to exchange data generated by the implantable device [0014, 0019,0038, 0046-47].
Regarding claim 10, wherein the pump is a motor-driven gear pump [0018, 0041].
Regarding claim 13, wherein the implantable device further comprises one or more sensors for monitoring operational status of the pump, the method further comprising generating an alarm condition when the operational status of the pump indicates a fault [0077, 0081, 0085-0088].
Regarding claim 19, further comprising inductively charging a battery of the implantable device using an external charging and communications system, and periodically coupling the external charging and communications system to a monitoring and control system to exchange data generated by the implantable device [0014, 0019, 0038, 0046-47].
Regarding claim 20, wherein the pump of the implantable device comprises a motor-driven gear pump, the method further comprising varying a voltage applied to the motor-driven gear pump to vary an output flow rate of the pump [0018, 0041, 0127].
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.
Claims 4-5, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Degen et al (US 2013/0211322 A1) in view of Degen et al (US 2018/0056050 A1).
Degen (‘322) discloses the invention substantially as claimed. Degen (‘’322) discloses a transceiver 76 with an antenna (fig 4) for communication with charging and communication system 30 [0076, 0079] and processor 70. In fig 9, the implantable device has a transceiver 155 with Bluetooth or IEEE 802.11 wireless standard, for bi-directional communications via antenna 160 with transceiver circuit 76 disposed in the implantable device [0109], [0115]. In [0077, 0081], the processor 70 stores event logs and alarms. In [0111-112], alarm information and message from controller 152 is stored.
However, it fails to disclose a patient smartphone having an application configured to communicate with the transceiver of the implantable device to report the alarm condition (claims 4 and 14) and further reporting the alarm condition on a display of the smartphone (claim 14), the application further is programmed to enable the patient to issue commands to the implantable device via the transceiver (claims 5 and 15) and further issuing a command to resolve the fault (claim 15).
Degen (‘050) teaches similar system and method of performing DSR therapy including a patient smart phone 45 including an application configured to communicate with the
transceiver 56,67 in figure 2 of the implantable device [0036] to report an alarm condition [0033] via text or voice message on a display of the smartphone. Furthermore, the application further is programmed to enable the patient to issue commands to the implantable device via the transceiver [0038], and further issuing a command to resolve the fault [0033]. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Degen (‘’322) system and method for performing a DSR therapy, by including a patient smartphone as described above and in Degen (‘050), in order to have the system communicate real time monitoring data and operating parameters to the patient via a smartphone for further action from the patient.
Allowable Subject Matter
Claims 6-8, and 16-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 11/06/2025 have been fully considered but they are not persuasive.
In regards to applicant’s arguments about Degen (‘322), the claimed limitations as amended has been found in Degen (‘322) as stated above in the rejection(s). Degen (‘322) discloses that other sensors (chemical or biosensors) can be added into the implantable device that are controlled by the processor 70 (figure 4). The sensor’s generated data is collected in the memory and then used to indicated a rate in change on the parameters in the analyte (one or more toxins and/or waste products) collected by the biosensor. The rate in change collected (increase or decrease of the parameter) allows for change the fluid rate and the pump activation based on the change. Therefore, Degen (‘322) meets the claimed limitations. Degen (‘050) consequently too as being part in the 103 with Degen (‘322).
Conclusion
THIS ACTION IS MADE FINAL. 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 Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Mon-Thur 8am- 2pm..
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783