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 Objections
Claims 2, 7, and 9 are objected to because of the following informalities:
Regarding claim 2, line 5, “measured by circuit” should be –measured by the circuit--.
Regarding claim 7, last line, “the third electrical” should be –the third electrical contact--.
Regarding claim 9, line 4, “measure and electrical resistance” should be –measure an electrical resistance--.
Appropriate correction is required.
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.
Claim 17 is 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.
Regarding claim 17, line 2, “the first electrical contact” and “the second electrical contact” lack antecedent basis. The first and second electrical contacts were set forth in claim 2.
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.
Claim(s) 1-3,10,13-14 and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Westrum(US20050228220) herein after (Westrum).
Westrum teaches a method and system for detecting an unsatisfactory condition of an inflatable penile prosthesis system comprising a pump, cylinder(s), fluid circuit, a septum and a reservoir. The method comprises the steps of: i) implanting the inflatable penile prosthesis system in a patient; ii) providing a probe assembly with first and second sensors; iii) placing the first sensor through the septum and into the fluid circuit of the inflatable penile prosthesis system; iv) placing a second sensor outside the penile prosthesis system in the patient's tissue, v) sensing conditions with the first and second sensors, and vi) comparing the conditions sensed by the first and second sensors to detect an unsatisfactory condition. The unsatisfactory condition may comprise fluid leakage or infection. The first and second sensors may be capable of sensing pH, electrical resistance or electrical potential.
Regarding claims 1 and 18, Westrum teaches a fluid reservoir defining a cavity;
an inflatable member;
an inflation fluid;
a pump assembly configured to transfer the inflation fluid from the fluid reservoir to the inflatable member; and a circuit for measuring electrical resistance, the circuit being configured to measure an electrical resistance between the inflation fluid within the implantable inflation device and a portion of a body of a patient in which the implantable inflation device is implanted.
Note figs. 4, 7-8 and paragraphs 13,14, 37, 41-43. [0013] Inflatable penile prosthesis system comprising a pump, at least one and preferably two cylinders capable of inflated and deflated states, a septum and a reservoir capable of inflated and deflated states; ii) providing sufficient fluid to inflate the cylinder(s) and the reservoir to the inflated condition; [0014] i) implanting the inflatable penile prosthesis system in a patient; ii) providing a probe assembly with first and second sensors; iii) placing the first sensor through the septum and into the fluid circuit of the inflatable penile prosthesis system; iv) placing a second sensor outside the penile prosthesis system in the patient's tissue, v) sensing conditions with the first and second sensors, and vi) comparing the conditions sensed by the first and second sensors to detect an unsatisfactory condition. The unsatisfactory condition may comprise fluid leakage or infection. The first and second sensors may be capable of sensing pH, electrical resistance or electrical potential.
Regarding claims 2 and 19, Westrum teaches the circuit includes a first electrical contact disposed on an exterior surface of the implantable inflation device and a second electrical contact disposed in a fluid passageway of the implantable inflation device; and the electrical resistance measured by circuit is an electrical resistance between the first electrical contact and the second electrical contact. Note figs. 4, 7-8 and paragraphs 13,14, 37, 41-43. In a preferred embodiment, at least one of the first and second sensors is integrated into the inflatable penile prosthesis system, and the probe system includes means for communicating with the sensor integrated into the inflatable penile prosthesis system.
Regarding claims 3 and 20, Westrum teaches the fluid reservoir is fluidically coupled with the pump assembly via a first tubular member;
the inflatable member is fluidically coupled with the pump assembly via a second tubular member; and
the pump assembly is configured to fluidically isolate the fluid reservoir and the first tubular member from the inflatable member and the second tubular member. Note figs. 4, 7-8 and paragraphs 13,14, 37, 41-43. Specifically figure 4, tubular members connecting the inflatable cylinders(36) and the reservoir(38) to the pump assembly(32). In a preferred embodiment, at least one of the first and second sensors is integrated into the inflatable penile prosthesis system, and the probe system includes means for communicating with the sensor integrated into the inflatable penile prosthesis system.
Regarding claim 10, Westrum teaches a housing, the pump assembly and at least a portion of the circuit being disposed within the housing. Note figs. 4, 7-8 and paragraphs 13,14, 37, 41-43. Specifically figure 4, [0037] The present invention contemplates that the septum may be placed in a variety of different locations. Referring to FIGS. 4 and 5, there is shown another embodiment of system 40 according to the present invention. The system 40 includes cylinder(s) 36, reservoir 38, pump with pump bulb 32 and a septum 50. The septum 50 is located on the side of the pump assembly instead of in the walls of the pump bulb (as shown in FIG. 1). Alternatively, the septum may be located on a cylinder. While one septum is preferred, a plurality of septums, at different locations, may also be employed in accordance with the present invention. Providing a probe assembly with first and second sensors; placing the first sensor through the septum and into the fluid circuit of the inflatable penile prosthesis system; placing a second sensor outside the penile prosthesis system in the patient's tissue, sensing conditions with the first and second sensors, and comparing the conditions sensed by the first and second sensors to detect an unsatisfactory condition. The unsatisfactory condition may comprise fluid leakage or infection. The first and second sensors may be capable of sensing pH, electrical resistance or electrical potential. In a preferred embodiment, at least one of the first and second sensors is integrated into the inflatable penile prosthesis system, and the probe system includes means for communicating with the sensor integrated into the inflatable penile prosthesis system. It is the examiner’s interpretation that integrating the sensors into the penile prosthesis system would include placing the first and second sensors in different locations within the system the same as placing the septum access for the second sensor in different locations within the system to complete the circuit.
Regarding claim 13, Westrum teaches wherein the portion of the body of the patient is proximate an exterior surface of the implantable inflation device. Note figs. 4, 7-8 and paragraphs 13,14, 37, 41-43.
Regarding claim 14, Westrum teaches wherein the inflatable member is one of:
an inflatable penile prosthesis; or an artificial urinary sphincter. Note figs. 4, 7-8 and paragraphs 13,14, 37, 41-43.
Regarding claim 17, Westrum teaches wherein the circuit is configured to measure the resistance between the first electrical contact and the second electrical contact in response to a signal from a device external to the body of the patient. Note figs. 4, 7-8 and paragraphs 13,14, 37, 41-43.
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.
Claim(s) 5 – 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Westrum(US20050228220) herein after (Westrum).
Westrum teaches the claimed invention as set forth above including at least one of the first and second sensors is integrated into the inflatable penile prosthesis system, and the probe system includes means for communicating with the sensor integrated into the inflatable penile prosthesis system. [0045] At least one of the first and second sensors is integrated into the inflatable penile prosthesis system, and the probe system includes means for communicating with the sensor integrated into the inflatable penile prosthesis system. For example, the means for communicating with the sensor may include a probe for establishing electrical contact with the sensor. Alternatively, the means may comprise remote sensors. Westrum also teaches providing a probe assembly with first and second sensors; placing the first sensor through the septum and into the fluid circuit of the inflatable penile prosthesis system; placing a second sensor outside the penile prosthesis system in the patient's tissue, sensing conditions with the first and second sensors, and comparing the conditions sensed by the first and second sensors to detect an unsatisfactory condition. [0037] The present invention contemplates that the septum may be placed in a variety of different locations. This would also provide a teaching of placing the sensors ( or remote sensors) in multiple locations within the fluidic system ( the pump, the reservoir, as well as the inflatable members) to allow for measurements from multiple locations within the system.
Westrum does not specifically teach wherein the second electrical contact is disposed on an interior wall of at least one of: the second tubular member; or the inflatable member or the circuit further including a third electrical contact disposed on an interior wall of at least one of:
the first tubular member; or the fluid reservoir, the circuit being further configured to measure an electrical resistance between the first electrical contact and the third electrical.
It is noted that there would be a limited number of choices available to a person of ordinary skill in the art for locating the sensors of Westrum within the fluidic circuit to take the desired measurements to identify possible leaks within the circuit. The fluidic circuit of Westrum includes a limited number of locations to place a sensors and includes the inflatable members, the reservoir as well as the pump assembly and the tubes interconnecting those elements and all of those elements could be a location where a leak could occur and one of ordinary skill in the art would recognize the need to monitor each of those areas. Westrum teaches in [0037] The present invention contemplates that the septum may be placed in a variety of different locations. This would also provide a teaching of placing or integrating the sensors ( or remote sensors) in multiple locations within the fluidic system ( the pump, the reservoir, the interconnecting tubing as well as the inflatable members) to allow for measurements from multiple locations within the system. It is the examiner’s interpretation that one of ordinary skill in the art would also recognize the need for additional electrodes as a well know duplication of parts to measure for leaks in the multiple locations within the fluidic system.
Therefore, it would have been obvious to one of ordinary skill in the art to duplicate the number of sensors and place or integrate them in multiple locations within the fluidic circuit of Westrum as is recognized in paragraph [0037] and [0045] of Westrum with a reasonable expectation of successfully measuring the resistance between the various placed or integrated sensors to monitor the fluidic circuit for leaks. See KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Westrum(US20050228220) herein after (Westrum) in view of Erbey et al.(20200268947) herein after (Erbey et al.).
Westrum teaches the claimed invention as set forth above including at least one of the first and second sensors is integrated into the inflatable penile prosthesis system, and the probe system includes means for communicating with the sensor integrated into the inflatable penile prosthesis system. [0045] At least one of the first and second sensors is integrated into the inflatable penile prosthesis system, and the probe system includes means for communicating with the sensor integrated into the inflatable penile prosthesis system. For example, the means for communicating with the sensor may include a probe for establishing electrical contact with the sensor. Alternatively, the means may comprise remote sensors. Westrum also teaches providing a probe assembly with first and second sensors; placing the first sensor through the septum and into the fluid circuit of the inflatable penile prosthesis system; placing a second sensor outside the penile prosthesis system in the patient's tissue, sensing conditions with the first and second sensors, and comparing the conditions sensed by the first and second sensors to detect an unsatisfactory condition. Since Westrum teaches that the first and second sensors may be integrated into the inflatable penile prosthesis system the examiner interprets this to include the second sensor that is placed in the patient’s tissue could also be integrated into the penile prosthesis system which would include integrating the sensor into the external housing of the system in contact with the patient’s tissue.
However, Westrum does not specifically teach wherein the first electrical contact is disposed on an exterior of the housing.
Erbey et al. teaches an implantable pump assembly wherein the pump assembly comprises: a housing defining an opening for the at least one fluid port; and a pump chamber at least partially enclosed within the housing fluidly connected to the at least one fluid port, wherein the pump is configured to draw the fluid through the drainage lumen of the at least one ureteral catheter to the pump chamber and at least one pressure sensor on an exterior surface of a housing of the pump configured to measure intra-abdominal pressure of the patient, when the pump is at least partially implanted in an abdominal cavity or peritoneum of the patient.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Westrum to include a sensor on an exterior of the pump housing in contact with the patient tissue as taught by Erbey et al. to enable the second sensor to be integrated into the system while being placed external to the system and in contact with the patient tissue to obtain the needed measurements.
Claim(s) 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Westrum(US20050228220) herein after (Westrum) in view of Forsell(6482145) herein after (Forsell).
Westrum teaches the claimed invention as set forth above. Westrum does not specifically teach a control module, the control module being configured to;
activate the pump assembly to transfer the inflation fluid from the fluid reservoir to the inflatable member, or from the inflatable member to the fluid reservoir; and
deactivate the pump assembly to fluidically isolate the fluid reservoir from the inflatable member or wherein the control module is configured to be controlled by a device located outside of the body of the patient.
Forsell in the same field of endeavor teaches an anal incontinence treatment apparatus and method which includes and uses an adjustable restriction device implanted in a patient, who suffers from anal incontinence. The restriction device engages the rectum of the patient to restrict the fecal passageway. An adjustment device is adapted to adjust the restriction device such that the rectum is temporarily released, in order to open the fecal passageway when the patient wishes to achieve defaecation. The hydraulic operation device comprises a pump for pumping fluid between the reservoir and the cavity of the restriction device. The pump preferably comprises a first activation member for activating the pump to pump fluid from the reservoir to the cavity of the restriction device, and a second activation member for activating the pump to pump fluid from the cavity to the reservoir. (26) FIG. 19 schematically illustrates how any of the above-described embodiments of the anal incontinence treatment apparatus of the invention can be implanted in a patient. Thus, an implanted adjustable hydraulic restriction device 234 extends almost completely around the rectum 242 to be capable of squeezing the rectum 242 as a single unit. An adjustment device in the form of an inflatable cavity in the restriction device 234 is adapted to adjust the restriction device 234 so that the fecal passageway is restricted. An implanted assembly 246 includes a hydraulic fluid reservoir and an operation device (which may include a pump) for distributing hydraulic fluid between the reservoir and the inflatable/contractible cavity of the restriction device 234 via a fluid conduit 240. A wireless remote control of the apparatus comprises an external signal transmitter 248, which may comprise a hand-held unit, and an implanted signal receiver, which is incorporated in the implanted assembly 246, includes a control unit for controlling the restriction device 234 in response to a control signal from the external transmitter. The signal receiver of the assembly 246 further includes an energizer unit which transfers energy from the control signal transmitted by the external transmitter into electric energy for energy consuming implanted components of the apparatus.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the device of Westrum to include external and wireless control of the pump assembly as taught by Forsell to allow the patient to have better control over the implanted system.
Conclusion
Allowable Subject Matter
Claims 4, 9 and 12 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.
The prior art of record does not reasonably teach alone or in combination the subject matter of the independent claim and wherein the second electrical contact is an electrically conductive connector used to fluidically couple the first tubular member or the second tubular member with the pump assembly as set forth in claim 4.
The prior art of record does not reasonably teach alone or in combination the subject matter of the independent claim and wherein the second electrical contact and the third electrical contact are connected in parallel with each other; and the circuit is configured to selectively measure and electrical resistance between the first electrical contact and the parallel connected second electrical contact and third electrical contact as set forth in claim 9.
The prior art of record does not reasonably teach alone or in combination the subject matter of the independent claim and wherein the housing is the first electrical contact, the housing including an electrically conductive material as set forth in claim 12.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Newman(US20170079760) teaches a wirelessly controlled inflatable medical implant system includes an external control module and an implantable module. The external control module may transmit wireless power and control signals, which are received by circuitry on a flexible printed circuit board in the implantable module. In response to the received signals, circuitry in the flexible printed circuit board may cause a motor and pump combination to transfer fluid from a reservoir in the implantable device, through tubing, and into inflatable medical implant located in the penis. The flexible printed circuit board, motor, and pump may be placed within the fluid reservoir, which provides a heat sink that prevents overheating of the implant.
Minaie et al. ( US 20090093756) teaches A programming device for an implantable drug pump includes a display device, a communication device, and a controller. The communication device is adapted to facilitate a communication link between the programming device and an implantable drug pump. The controller adapted to receive bolus data stored on the implantable drug pump when the communications link has been established, to process the bolus data, and to control the display device to generate a visual representation of numbers of bolus attempts for multiple periodic time intervals.
Herbert et al.( US 20070255336) teaches his disclosure describes an implantable medical device that delivers electrical stimulation to a patient in combination with limiting ingestion of food by the patient to treat obesity. The device includes a gastric constriction device, such as a hydraulic or electro-mechanical gastric band, having a plurality of electrodes integrally formed thereon. One or more of the electrodes, i.e., an electrode combination, are selected to deliver electrical stimulation energy, e.g., in the form of stimulation pulses, to the patient.
Smith et al. (US 20220304807) teaches an implantable fluid operated device may include a fluid reservoir configured to hold fluid, an inflatable member, and a pump assembly configured to transfer fluid between the fluid reservoir and the inflatable member. The pump assembly may include one or more fluid pumps and one or more valves. One or more sensing devices may be positioned within fluid passageways of the fluid operated device.
Ortiz et al.( US 20090204131) teaches Devices and methods for forming a restriction in a patient are disclosed. In one exemplary embodiment, a restriction system is provided including an implantable restriction device, an implantable port in fluid communication with the implantable restriction device, and an implantable pump in fluid communication with the restriction device. In general, the implantable restriction device is adjustable and configured to form a restriction in a patient, and the implantable port is configured to receive fluid from a fluid source external to the patient. The implantable pump is a micro-electro-mechanical systems (MEMS) device effective to create pumping action to move fluid through the pump.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN L CASLER whose telephone number is (571)272-4956. The examiner can normally be reached M-Th 6:30 to 4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN L CASLER/Primary Examiner, Art Unit 3791