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 .
Response to Amendment
In view of the newly cited reference by applicant to Cinquin et al.( US 10383714), rejections of the previously allowed claims 1-4,7-8, and 19-21 are set forth below.
Claims 9 and 10-18 remain allowable in view of the prior art of record.
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) 1-3, 7 and 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cinquin et al.( US 10383714) hereinafter Cinquin et al. in view of Smith et al. (US2020/0222188) hereinafter Smith et al.
Cinquin et al. teaches a device to prevent urinary leakage intended to be implanted in a patient, comprising: compression means (1, 3, 4, 5) to compress the patient's urethra, electronic control means (2) to actuate the compression means (1, 3, 4, 5), characterized in that it further comprises measurement means (7) to measure the patient's activity, coupled with the control means (2), the control means (2) functioning according to a predictive model of urinary leakage based on patient activity, so as to anticipate a possible urinary leak in relation to the measured activity of the patient.
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Regarding claim 1, Cinquin et al. teaches a fluid reservoir, an inflatable cuff, an electric pump assembly including a valve and a controller. Cinquin et al. further teaches an accelerometer to measure patient activity and movement and determines the user’s sleep phase based on acceleration measurements and controls the cuff to inflate. Note annotated fig. 1 above and Paragraphs (8), (10) – (13), (15) It is possible for example to use a micropump as circulation means 5. To increase the performance of the micropump if necessary it is possible to place an overpressure chamber at the outlet of the pump and a microvalve with proportional control at the input to the cuff, which will allow the required pressure to be reached in a shorter time. Another solution is to use as circulation means 5 a piston system actuated by a micromotor, the piston enabling the liquid to be injected quicker into the cuff and thereby reach the desired pressures. (17) The device comprises a plurality of sensors 7 allowing the patient's activity to be measured. These sensors 7 may be of any type; an accelerometer may be used for example to measure movements of the patient, MMG (mechanomyograph) or EMG (electromyograph) sensors to measure the activity of some of the patient's muscles, or pressure sensors (abdominal, urethral, even intra-vesical when this is possible). ( 20) The predictive model of urinary leakage is designed to anticipate a urinary leak which may be suffered by the patient, based on information concerning the activity of the patient. Some particular activities effectively lead to a change in the ratio between intra-vesical pressure and urethral pressure, which may cause undesired urinary leaks. This is the case for example if the patient exerts an effort that is greater than normal activity. It is also the case when the patient is in sleep phase when urethral pressure is reduced as compared with intra-vesical pressure. Detection of these particular situations therefore makes it possible to anticipate any possible leak and therefore to modify the pressure exerted on the urethra. (23) As already indicated, another important phase is the sleep phase during which the body relaxes. The corresponding pressure P.sub.lying may be relatively low even close to P.sub.0 in some cases. It is noted that this pressure is patient-dependent and may be determined on a case-by-case basis once the device has been implanted. Claim 23 sets forth wherein the predictive model correlates the data from the accelerometer with the type of activity of the patient so as to break down the patient's activity between at least: a sleep phase, a normal activity phase and a phase of activity involving an effort, and wherein the electronic controller is configured to vary the pressure to at least three predetermined pressures, each predetermined pressure being specific to a type of activity of the patient.
Cinquin et al. does not specifically teach the valve is an active valve.
Smith et al. (US2020/0222188) teaches an implantable device includes a fluid reservoir configured to hold fluid, where the fluid reservoir is configured to be implanted in a body of a patient at a first location, an inflatable member configured to be implanted in the body of the patient at a second location, and a pump assembly configured to be implanted in the body of the patient at a third location. The pump assembly is configured to transfer the fluid from the fluid reservoir to the inflatable member in response to the implantable device being in an inflation mode, and the pump assembly configured to transfer the fluid from the inflatable member to the fluid reservoir in response to the implantable device being in a deflation mode. The pump assembly includes an electronic control module, an electronically powered pump, a first valve, and a second valve. The electronic control module is configured to activate or deactivate the electronically powered pump. The implantable device includes a pressure sensor configured to monitor a pressure of the inflatable member. The pressure sensor is communicatively coupled to the electronic control module. The electronic control module is configured to deactivate the electronically powered pump in response to the pressure of the inflatable member exceeding a threshold level. Smith et al. also teaches an active valve. see Fig 2., [0004] – [0005].
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of Cinquin et al. an active valve as taught by Smith et al. to better control fluid transfer between the reservoir and the inflatable cuff.
Regarding claims 2 and 3, Cinquin et al. does teach monitoring pressures with respect to a threshold and controlling inflation and deflation based on the threshold pressure but does not specifically teach wherein the controller is configured to cause the active valve to be in an open position to transfer a portion of the fluid from the inflatable member to the fluid reservoir in response to the measured pressure being greater than or less than a threshold.
Smith et al. (US2020/0222188) teaches wherein the controller is configured to cause the active valve to be in an open position to transfer a portion of the fluid from the inflatable member to the fluid reservoir in response to the measured pressure being greater than a threshold. See Fig 2., [0004] – [0005].
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of Cinquin et al. wherein the controller is configured to cause the active valve to be in an open position to transfer a portion of the fluid from the inflatable member to the fluid reservoir in response to the measured pressure being greater than a threshold as taught by Smith et al. to better control fluid transfer between the reservoir and the inflatable cuff.
Regarding claim 7, Cinquin et al. teaches heart rate sensor to monitor the heart rate of the user of the implantable prosthesis. Note paragraph (13).
Regarding claim 19, Cinquin et al. teaches receiving, a wireless control signal from an external device; activating, by a controller, a pump of the electronic pump assembly to operate to transfer fluid from a fluid reservoir to an inflatable member in response to the wireless control signal such that a pressure of the inflatable member reaches a threshold; detecting a sleep pattern of a user of the inflatable penile prosthesis; and activating, by a controller, the pump of the electronic pump assembly to operate to transfer fluid from the fluid reservoir to the inflatable member while the user is asleep.
Cinquin et al. does not specifically teach an antenna configured to receive a wireless control signal from an external device to enable the controller to control the pump, or the valve. It is noted that the use of various types of wireless control of implantable devices is well known and there are a limited number of choices available to a person of ordinary skill in the art for wireless communications and the need for an antenna to enable wireless communication between the implanted device and the external device is also well known.
Therefore, it would have been obvious to one of ordinary skill in the art to try using an antenna for wireless communication with a reasonable expectation of successfully communicating and controlling the device. See KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claims 20 and 21, Cinquin et al. teaches measuring, by a pressure sensor, the pressure of the inflatable member; and activating, by the controller, a valve of the electronic pump assembly to
be in an open position to transfer a portion of the fluid from the inflatable member to the fluid
reservoir in response to the measured pressure being greater than the threshold.
Cinquin et al. does not specifically teach the valve is an active valve.
Smith et al. teaches the use of an active valve as set forth above.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of Cinquin et al. an active valve as taught by Smith et al. to better control fluid transfer between the reservoir and the inflatable cuff.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cinquin et al.( US 10383714) hereinafter Cinquin et al. in view of Smith et al. (US2020/0222188) hereinafter Smith et al. and further in view of Evans et al. (US 2017/0273792) hereinafter Evans et al.
Cinquin et al. as modified by Smith et al. teaches the implantable device as set forth above. However, Cinquin et al. as modified by Smith et al. does not specifically set forth wherein the reservoir includes a pressure-regulating flexible member.
Evans et al. teaches in paragraph [0004], an inflatable penile prosthesis includes an inflatable member, a reservoir configured to hold fluid, and a reversible flow pump assembly configured to facilitate a transfer of the fluid from the reservoir to the inflatable member when in an inflation mode, and facilitate the transfer of the fluid from the inflatable member to the reservoir when in a deflation mode. The reversible flow pump assembly includes a pump, an input check valve coupled to the pump, an output check valve coupled to the pump, and a reversing valve. The input check valve is configured to permit transfer of fluid into the pump. The output check valve is configured to permit transfer of fluid out of the pump. The reversing valve is configured to switch between the inflation mode and the deflation mode. [0027] The reservoir 102 may include a biasing member 109 configured to pressurize the fluid in the reservoir 102. For example, upon injection of fluid into the reservoir 102, the biasing member 109 may provide a force on the fluid, thereby pressurizing the reservoir 102. The biasing member 109 may be biased to an original size or position, and the biasing member 109 may expand to a different size or position when the fluid is injected into the reservoir 102 and/or the biasing member 109, thereby creating a pressurized reservoir 102. In some examples, the biasing member 109 may include a spring or a spring-loaded assembly that biases the reservoir 102 to a particular size or position. In some examples, the biasing member 109 may be an expandable balloon inside a more rigid container of the reservoir 102. For instance, the expandable balloon may be biased to a smaller size when it is not filled with fluid. Then, upon injection of the fluid into the expandable balloon, the expandable balloon may expand and pressurize the fluid contained therein. In some examples, the biasing member 109 may be a biased diaphragm, which may be a membrane, flap, or other structure contained within the reservoir 102 that may separate one area of the reservoir 102 from another area of the reservoir 102. The reservoir 102 may pre-charged or pressurized (to at least two or three psi) ahead of the desired moment of transformation of the penis from flaccid to erect.
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 Cinquin et al. as modified by Smith et al. to include a reservoir with a pressure-regulating flexible member that allows the reservoir to be pre-charged or pressurized (to at least two or three psi) ahead of the desired moment of transformation of the penis from flaccid to erect as taught by Evans et al.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cinquin et al.( US 10383714) hereinafter Cinquin et al. in view of Smith et al. (US2020/0222188) hereinafter Smith et al. and further in view of CN 108338855.
Cinquin et al. as modified by Smith et al. teaches the implantable device as set forth above including an electronically powered pump. However, Cinquin et al. as modified by Smith et al. does not specifically set forth wherein the electronic pump assembly includes a temperature sensor configured to measure a temperature of the fluid.
CN 108338855 teaches a penis embedding mechanism, a liquid storage chamber, a tube and a pump, wherein the mechanism for penis implanted subcutaneously and the sponge, the phallus implant mechanism has a hollow cavity, and that can flex axially affixed to the proximal end of the penis; storing the fluid in the liquid storage chamber, the liquid storage chamber embedding mechanism with the penis through at least one catheter of the cavity; the pump is coupled to the fluid reservoir and penile implant mechanism, the pump for the fluid in the fluid reservoir and the penile implant mechanism providing power for the transmission. CN 108338855 teaches further teaches a temperature sensor, a temperature of the fluid temperature sensor coupled with the heating device, used for real-time detecting the heating by the heating device, the control device according to the temperature detected by the temperature sensor for controlling the heating device to stop heating. The temperature sensor is provided with a threshold value, when the temperature detected by the temperature sensor reaches the threshold value, closing the heating device. The penis implant device increases the heating device, which is output to the fluid heating embedding mechanism to eliminate the difference of the fluid in the liquid storage chamber to the penis part temperature and makes the patient more comfortable. Further, the penis implant device also increases the temperature sensor, the heating device includes a power supply for controlling the heating device and the temperature sensor by the control device, the temperature sensor is set to the threshold value, the fluid reaches the threshold value, the signal is sent to the control device, the control device controlling the pump fluid by conveying to the penile implant mechanism, so as to effectively control fluid heating temperature. Also taught by CN 108338855 is remote control of the heating device and the temperature sensor, which makes the operation patient more convenient.
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 Cinquin et al. as modified by Smith et al. to include a temperature sensor configured to measure and remotely control a temperature of the fluid to remain with a threshold value to make the patient more comfortable as taught by CN 108338855.
Allowable Subject Matter
Claims 10-18 are allowed.
Claim 9 is 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 in combination with wherein the controller is configured to iteratively initiate an inflation cycle and a deflation cycle during a testing duration defining a series of sub-durations, wherein at each subsequent sub-duration, the pressure in the inflatable member is adjusted.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Newman et al.( US 20170079760) teaches 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.
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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/BRIAN L CASLER/ Primary Examiner, Art Unit 3791
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