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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 22 December 2025 has been entered.
Response to Arguments
Applicant’s argument. filed 22 December 2025, with respect to the rejection(s) of claim(s) 1-9, 11-19 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. Applicant has amended to overcome the previous rejection. Specifically, Applicant has amended the claims to further recite recharge capability of the external charging system. However, upon further consideration, a new ground(s) of rejection is made in view of Forsell as seen below.
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 1-3, 5-9, 11-13, 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Dacey (US 2010/0249692) in view of Forsell (US 2004/0098113) further in view of Mass (US 2009/0062887).
Regarding claim 1, Dacey discloses a fluid management and infection monitoring system comprising:
an inflow catheter (112, Figure 1A, [0093]) comprising an inlet end and an outlet end (inlet and outlet of one of the shunts 112), the inlet end in fluid communication with a first cavity (inlet adjacent 118 in the cavity in the ventricle shown in figure 1A);
an outflow catheter (another 112, figure 1A, [0093]) comprising an inlet end and an outlet end (inlet and outlet of one of the shunts 112), the outlet end in fluid communication with a second cavity (outlet end adjacent 122, figure 1A, [0096]);
an implantable device (102 including system 100, 302, 306, figure 3) coupled to the outlet end of the inflow catheter and the inlet end of the outflow catheter (figure 3), the implantable device comprising a housing ([0088-0089]) containing a battery (700, [0250]), a processor (404, figure 3), at least one sensor (440, figure 3) configured to detect a presence of an infection marker ([0191]),
an external charging and communication system (user interface and energy supply [0254]) configured to wirelessly communicate transcutaneously with the implantable device ([0254]),
receive a signal indicative of the presence of the infection marker from the at least one sensor ([0191], [0120], [0379);
generate an alert upon receipt of the signal ([0177], [0200], [0371]).
Dacey does not disclose a positive displacement gear pump coupled to an electric motor; and the processor configured to periodically activate the electric motor and positive displacement gear pump to move fluid from the first cavity to the second cavity; the external charging and communication system configured to wirelessly and transcutaneously charge the battery of the implantable device and adjust operation of the implantable device and communicate the alert to the external charging and communication system, to cause the external charging and communicating system to automatically transmit the alert to a monitoring and control system via a communications network.
Forsell discloses an implantable device relatively pertinent to problem posed by Applicant of moving material in the body. Forsell teaches a pump assembly (28, [0091]) comprising a positive displacement gear pump ([0022]) coupled to an electric motor ([0022]); and the processor configured to periodically activate the electric motor and positive displacement gear pump to move fluid from the first cavity to the second cavity ([0046-0047], the external control controls the operation of the pump); an external charging and communication system to wirelessly and transcutaneously charge the battery of the implantable device ([0027-0031]).
Forsell provides external control of the pump to accurate control the operation of the pump device to move fluid when desired ([0044]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Dacey to include motor assembly and control of Forsell in order to accurately control operation of the implanted device when moving material in the body.
Dacey and Forsell do not teach the external charging and communication system configured to adjust operation of the implantable device and communicate the alert to the external charging and communication system, to cause the external charging and communicating system to automatically transmit the alert to a monitoring and control system via a communications network.
Mass discloses a portable device with communications network relatively pertinent to problem posed by Applicant of communicating with an implant. Mass teaches the external charging and communication system (14) configured to adjust operation of the implantable device and communicate the alert to the external charging and communication system ([0038-0040]), to cause the external charging and communicating system to automatically transmit the alert to a monitoring and control system via a communications network ([0096]).
Mass provides a network of communication in order to allow readily available information for the stakeholders ([0039]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify the cited prior art with Mass in order to further provide information to stakeholders in a life critical network.
Regarding claims 2, and 5-7, Dacey discloses the detection of infection makers ([0191]) but does not disclose specifically wherein the presence of the infection marker detected by the at least one sensor is indicative of spontaneous bacterial peritonitis (claim 2), wherein the at least one sensor comprises a sensor configured to detect the presence of leukocyte esterase, and wherein the processor is configured to generate the alert if the signal received from the at least one sensor indicates a level of leukocyte esterase that exceeds a predetermined threshold (claim 5), wherein the at least one sensor comprises a sensor configured to detect the presence of a biofilm indicative of bacterial growth, and wherein the processor is configured to generate the alert if the signal received from the at least one sensor indicates a level of the biofilm that exceeds a predetermined threshold (claim 6), wherein the at least one sensor comprises a sensor configured to detect the presence of procalcitonin, and wherein the processor is configured to generate the alert if the signal received from the at least one sensor indicates a level of procalcitonin that exceeds a predetermined threshold (claim 7).
However, the claim recitations to the detection of the specific bacterial infection markers including spontaneous bacterial peritonitis, leukocyte esterase, a biofilm indicative of bacterial growth, and procalcitonin are all recitations of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here the infection sensors of Dacey are capable of performing the function of detecting the recited infection markers ([0191]), and when the markers overcome a threshold ([0168-0169]). Further, it would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Dacey using the knowledge of the sensors disclosed in Dacey to use the sensors to measure different types of infection markers.
Regarding claim 3, Dacey does not teach wherein the second cavity is a patient’s bladder, and wherein processor is configured to activate the electric motor and positive displacement gear pump to move fluid from the first cavity to the bladder, responsive to user input, in an amount sufficient to induce urination by the patient.
Forsell discloses an implantable device relatively pertinent to problem posed by Applicant of moving material in the body. Forsell teaches a pump assembly (28, [0091]) comprising a positive displacement gear pump ([0022]) coupled to an electric motor ([0022]); and the processor configured to periodically activate the electric motor and positive displacement gear pump to move fluid from the first cavity to the second cavity ([0046-0047], the external control controls the operation of the pump); Regarding the recitation of the second cavity being a bladder and removing fluid from the first cavity to the bladder, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here the device of Forsell and Dacey would be capable of moving fluid as intended from one are to another and appear to be capable of performing he intended use of moving and implanted on the bladder. Therefore, the structural limitations are met by the prior art and it appears the intended use can be performed by the cited prior art device.
Forsell provides external control of the pump to accurate control the operation of the pump device to move fluid when desired ([0044]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Dacey to include motor assembly and control of Forsell in order to accurately control operation of the implanted device when moving material in the body.
Regarding claim 8, Dacey discloses wherein the at least one sensor comprises a sensor configured to measure at least one of temperature, respiratory rate, or ascitic fluid viscosity ([0182]) , such that the at least one sensor is configured to detect the presence of a change in temperature, respiratory rate, or fluid viscosity, and wherein the processor is configured to generate the alert if the signal received from the at least one sensor indicates a change in temperature, respiratory rate, or ascitic fluid viscosity that exceeds a predetermined threshold ([0182], [0185-0186]).
Regarding claim 9, Dacey discloses wherein the signal indicative of the presence of the infection marker resolves after a successful treatment causes a level of the detected infection marker to fall below a predetermined threshold ([0168-0169], [0213] the comparison is throughout the operation of the device which would include after treatment).
Regarding claim 11, Dacey discloses a fluid management and infection monitoring system comprising:
an inflow catheter (112, Figure 1A, [0093]) comprising an inlet end and an outlet end (inlet and outlet of one of the shunts 112), the inlet end in fluid communication with a first cavity (inlet adjacent 118 in the cavity in the ventricle shown in figure 1A);
an outflow catheter (another 112, figure 1A, [0093]) comprising an inlet end and an outlet end (inlet and outlet of one of the shunts 112), the outlet end in fluid communication with a second cavity (outlet end adjacent 122, figure 1A, [0096]);
an implantable device (102 including system 100, 302, 306, figure 3) coupled to the outlet end of the inflow catheter and the inlet end of the outflow catheter (figure 3), the implantable device comprising a housing ([0088-0089]) containing a battery (700, [0250]), a processor (404, figure 3), at least one sensor (440, figure 3) configured to detect a presence of an infection marker ([0191]),
an external charging and communication system ([0254]) configured to wirelessly communicate transcutaneously with the implantable device ([0254]),
predict a presence of a bacterial infection on data received from the at least one sensor indicative of the presence of the infection marker ([0191], [0120], [0279], [0379]);
generate an alert upon receipt of the bacterial infection ([0177], [0200], [0279], [0371]); and
Dacey does not disclose a positive displacement gear pump coupled to an electric motor; and the processor configured to periodically activate the electric motor and positive displacement gear pump to move fluid from the first cavity to the second cavity; the external charging and communication system configured to wirelessly and transcutaneously charge the battery of the implantable device and configured to adjust operation of the implantable device and communicate the alert to the external charging and communication system, to cause the external charging and communicating system to automatically transmit the alert to a monitoring and control system via a communications network.
Forsell discloses an implantable device relatively pertinent to problem posed by Applicant of moving material in the body. Forsell teaches a pump assembly (28, [0091]) comprising a positive displacement gear pump ([0022]) coupled to an electric motor ([0022]); and the processor configured to periodically activate the electric motor and positive displacement gear pump to move fluid from the first cavity to the second cavity ([0046-0047], the external control controls the operation of the pump); an external charging and communication system to wirelessly and transcutaneously charge the battery of the implantable device ([0027-0031]).
Forsell provides external control of the pump to accurate control the operation of the pump device to move fluid when desired ([0044]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Dacey to include motor assembly and control of Forsell in order to accurately control operation of the implanted device when moving material in the body.
Dacey and Forsell do not teach the external charging and communication system configured to adjust operation of the implantable device and communicate the alert to the external charging and communication system, to cause the external charging and communicating system to automatically transmit the alert to a monitoring and control system via a communications network.
Mass discloses a portable device with communications network relatively pertinent to problem posed by Applicant of communicating with an implant. Mass teaches the external charging and communication system (14) configured to adjust operation of the implantable device and communicate the alert to the external charging and communication system ([0038-0040]), to cause the external charging and communicating system to automatically transmit the alert to a monitoring and control system via a communications network ([0096]).
Mass provides a network of communication in order to allow readily available information for the stakeholders ([0039]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify the cited prior art with Mass in order to further provide information to stakeholders in a life critical network.
Regarding claims 12, and 15-17, Dacey discloses the detection of infection makers ([0191]) but does not disclose specifically wherein the presence of the infection marker detected by the at least one sensor is indicative of spontaneous bacterial peritonitis (claim 2), wherein the at least one sensor comprises a sensor configured to detect the presence of leukocyte esterase, and wherein the processor is configured to generate the alert if the signal received from the at least one sensor indicates a level of leukocyte esterase that exceeds a predetermined threshold (claim 5), wherein the at least one sensor comprises a sensor configured to detect the presence of a biofilm indicative of bacterial growth, and wherein the processor is configured to generate the alert if the signal received from the at least one sensor indicates a level of the biofilm that exceeds a predetermined threshold (claim 6), wherein the at least one sensor comprises a sensor configured to detect the presence of procalcitonin, and wherein the processor is configured to generate the alert if the signal received from the at least one sensor indicates a level of procalcitonin that exceeds a predetermined threshold (claim 7).
However, the claim recitations to the detection of the specific bacterial infection markers including spontaneous bacterial peritonitis, leukocyte esterase, a biofilm indicative of bacterial growth, and procalcitonin are all recitations of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here the infection sensors of Dacey are capable of performing the function of detecting the recited infection markers ([0191]), and when the markers overcome a threshold ([0168-0169]). Further, it would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Dacey using the knowledge of the sensors disclosed in Dacey to use the sensors to measure different types of infection markers.
Regarding claim 13, Dacey does not teach wherein the second cavity is a patient’s bladder, and wherein processor is configured to activate the electric motor and positive displacement gear pump to move fluid from the first cavity to the bladder, responsive to user input, in an amount sufficient to induce urination by the patient.
Forsell discloses an implantable device relatively pertinent to problem posed by Applicant of moving material in the body. Forsell teaches a pump assembly (28, [0091]) comprising a positive displacement gear pump ([0022]) coupled to an electric motor ([0022]); and the processor configured to periodically activate the electric motor and positive displacement gear pump to move fluid from the first cavity to the second cavity ([0046-0047], the external control controls the operation of the pump); Regarding the recitation of the second cavity being a bladder and removing fluid from the first cavity to the bladder, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here the device of Forsell and Dacey would be capable of moving fluid as intended from one are to another and appear to be capable of performing he intended use of moving and implanted on the bladder. Therefore, the structural limitations are met by the prior art and it appears the intended use can be performed by the cited prior art device.
Forsell provides external control of the pump to accurate control the operation of the pump device to move fluid when desired ([0044]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Dacey to include motor assembly and control of Forsell in order to accurately control operation of the implanted device when moving material in the body.
Regarding claim 18, Dacey discloses wherein the at least one sensor comprises a sensor configured to measure at least one of temperature, respiratory rate, or ascitic fluid viscosity ([0182]) , such that the at least one sensor is configured to detect the presence of a change in temperature, respiratory rate, or fluid viscosity, and wherein the processor is configured to generate the alert if the signal received from the at least one sensor indicates a change in temperature, respiratory rate, or ascitic fluid viscosity that exceeds a predetermined threshold ([0182], [0185-0186]).
Regarding claim 19, Dacey discloses wherein the signal indicative of the presence of the infection marker resolves after a successful treatment causes a level of the detected infection marker to fall below a predetermined threshold ([0168-0169], [0213] the comparison is throughout the operation of the device which would include after treatment).
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Dacey in view of Forsell further in view of Mass further in view of Sorenson (US 2002/0123715).
Regarding claim 4, Dacey and Forsell do not disclose the device comprising a colorimetric strip configured to visually indicate presence of the infection marker upon interaction with urine.
Sorenson discloses a device for moving fluid relatively pertinent to problem posed by Applicant of indicating desired material. Sorenson teaches a color strip indicator (70, [0051-0052]) configured to visually indicate presence of the marker ([0051-0052]). The device can perform the intended function of indicating the presence of markers in urine.
Sorenson provides the indicator in order to detect the presence of undesired material ([0051]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Dacey and Forsell with the indicators of Sorenson in order to further indicate undesired material in the system.
Regarding claim 14, Dacey and Forsell do not disclose the device comprising a colorimetric strip configured to visually indicate presence of the infection marker upon interaction with urine.
Sorenson discloses a device for moving fluid relatively pertinent to problem posed by Applicant of indicating desired material. Sorenson teaches a color strip indicator (70, [0051-0052]) configured to visually indicate presence of the marker ([0051-0052]). The device can perform the intended function of indicating the presence of markers in urine.
Sorenson provides the indicator in order to detect the presence of undesired material ([0051]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Dacey and Forsell with the indicators of Sorenson in order to further indicate undesired material in the system.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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/KAI H WENG/Primary Examiner, Art Unit 3781