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 Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot in view of the new ground of rejection. A new reference to NEWMAN et al. (US 20170079760) hereinafter NEWMAN et al. was utilized in place of the Smith et al. reference previously used.
Regarding the added language: “the processor is configured to cause the pump to cease pumping fluid from the inflatable member when the plateau is identified.”
It is the examiner’s interpretation that both Hohlrieder et al. and NEWMAN et al. teach controlling pumping operations and pressure levels within the implanted inflated device. Therefore, it would have been obvious to one of ordinary skill in the art to try shutting off the pump once a desired pressure level is reached or maintained to ensure over inflation or over pressurization does not occur as a matter of design choice and as one of a finite number of methods for controlling the pressure within the implanted inflatable system with a reasonable expectation of successfully maintaining safe and effective pressure levels within the implanted device. See KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
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) 1-11 and 13-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hohlrieder et al(2019/0133737) hereinafter Hohlrieder et al. and further in view of NEWMAN et al. (US 20170079760) hereinafter NEWMAN et al. and Snow et al.( US 20110208220) hereinafter Snow et al.
Regarding Claim 1 – Hohlrieder et al. teaches an apparatus, including: a bodily implant, band -1-, hose -9- and pump -10- configured to be implanted into a body of a patient, the implant including an inflatable member, see hollow chamber -3- inside elements -1- and -1a-, a sensor -22-, and an electronic control system -17- and -20-, the inflatable member -1- being configured to be disposed proximate a portion of the body of the patient, urethra see paragraph [0028], the sensor -22- is operatively coupled to the inflatable member and is configured to detect a fluidic pressure within the inflatable member, and the electronic control system is configured to receive pressure data from the sensor and determine when the inflatable member is placing a pressure on the portion of the body of the patient, see paragraph [0055].
Hohlrieder et al. teaches an electronic control system but does not specifically set forth the electronic control system is a processor or ceasing pumping when a plateau or threshold is achieved.
NEWMAN et al. 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. [0038] Patient controls 305 may be provided via push buttons, a touch screen or both. They may include “On, Off, Inflate and Deflate.” Multiple controls may be provided for implants operating more than one Inflatable Medical Device 106. Upon activating any control, an interrupt may be sent to a Microprocessor 307 which contains a nonvolatile memory storing an executable computer program, physician's settings, such as number of urinary cuff motor rotations for day and for night use, and implant usage data. A software interrupt service routine then determines which control was activated and what action to take. Should the action require operation of the Pump in Reservoir Implant 104, control signals and the appropriate data, such as pump rotations, are sent to the Power transmitting Unit 308 over a data bus, such as an I.sup.2C serial interface. [0039] The Microprocessor 307 may be programmed through the Physician's Software Application 101 located on the physician's computational device 102. The Microprocessor 307 may be programmed to stop operation if the signal is lost or preset safety parameters, such as pressure, pump speed range, motor current and voltage and temperature are exceeded. The Microprocessor 307 may turn off power if no activation signals are received after a preset time interval. Upon reception of a control signal and data from the Microprocessor 307, a Power Transmitting Unit, PTU, 308 may generate and transmit power and data transdermally via a Transmitting Resonator 309 to the Pump in Reservoir Implant 104, and may operate at the 6.78 MHz “AirFuel Alliance” resonance specified frequency, a decade below the 63.87 MHz RF transmitter frequency of 1.5-tesla MRI machines.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in Hohlrieder et al. where the electronic control system is embodied in one or more processors and the processor is programmed to stop operation if a threshold is detected as taught by NEWMAN et al. to improve system processing and automation. Furthermore, It is noted that there are a limited number of choices available to a person of ordinary skill in the art for controlling the inflation/deflation and pressure levels within the inflatable device or fluid pathways. Both Hohlrieder et al. and NEWMAN et al. teach controlling pumping operations and pressure levels within the implanted inflated device. Therefore, it would have been obvious to one of ordinary skill in the art to try shutting off the pump once a desired pressure level is reached or maintained to ensure over inflation or over pressurization does not occur as a matter of design choice and as one of a finite number of methods for controlling the pressure within the implanted inflatable system with a reasonable expectation of successfully maintaining safe and effective pressure levels within the implanted device. See KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Hohlrieder et al. as modified by Smith et al. teaches the processor or electronic control system receives pressure data where the sensed pressure data allows for more nuanced control of pressure and volume transfer including determining a pressure differential across the pump assembly based on the sensed pressure of the fluid reservoir and the sensed pressure of the inflatable member and deactivating the electronically powered pump(s) in response to the pressure of the inflatable member exceeding a threshold level.
Hohlrieder et al. as modified by NEWMAN et al. does not specifically teach identifying a plateau or static or stable point in which the pressure has leveled out for a period of time.
Snow et al. teaches in the same field of endeavor implantable device monitors a pressure of fluid within an inflatable portion of a gastric band. The implantable device comprises a tube defining a lumen, and a pressure sensor positioned within at least one of the lumen or the tube. The pressure sensor is configured to sense the pressure of the fluid within the inflatable portion of the gastric band. The pressure sensor is also configured to transmit a pressure signal based on the pressure to a microcontroller, which transmits the pressure signal to a remote control device. Including where the implantable device is configured for monitoring static and fluctuating pressure levels of a fluid moving to and from an inflatable portion of a gastric band. [0083] Using the remote controller unit 110 to communicate with the pressure sensor 108, a clinician can monitor pressure inside the gastric band 106, for example, in "real time" during an adjustment of the constriction within the gastric band 106. This allows the clinician to observe the response of the gastric band 106 to a patient's adjustment. A new modality for gastric band adjustment management is thus enabled, because clinicians can monitor static pressure, as well as pressure and volumes during adjustments. With these pressure sensing capabilities, the clinician can make expanded determinations, for example, whether there is a leak within the system (e.g., an unexpectedly low, declining, or zero pressure reading), or whether there is an obstruction in the system (e.g., an unexpectedly high pressure reading or prolonged pressure rise).
Also note paragraph [0086] sets forth monitoring the pressure over a period of time. Sensing or measuring the pressure within a gastric banding system, for example within the fluid pathway of the gastric banding system 100B, provides diagnostic uses. Clinicians can measure pressure while a patient drinks water, recording and analyzing resulting pressure fluctuations which can help determine if the gastric band 106 is too restrictive. A band that is too restrictive can also be confirmed by the patient's response (generally discomfort) upon drinking the water, and can then be appropriately adjusted. Further, sensing or measuring pressure in the gastric banding system 100B can be useful in diagnosing system leaks or obstructions. For example, if the pressure consistently drops over an extended period of time, the clinician can diagnose a leak within the system and plan for an appropriate treatment to fix the problem. In contrast, if there is an obstruction within the system with a sustained pressure rise over time, the clinician can diagnose an obstruction within the system and plan for an appropriate treatment to fix the problem.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention include in the device of Hohlrieder et al. as modified by NEWMAN et al. sending pressure data including data indicating where the pressure is static or plateaued over a period of time as well as pressure fluctuations as taught by Snow et al. to better identify and control the pressure leaks or obstructions within the system as well as better manage pump control.
Regarding Claim 2 – Hohlrieder et al. teaches the inflatable member is configured to be disposed in an inflated configuration, figure 6 and a deflated configuration, figure 5.
Regarding Claims 3 and 4 – Hohlrieder et al. teaches, wherein the inflatable member is configured to be disposed in an inflated configuration, figure 6 and a deflated configuration, figure 5, the inflatable member being configured to place a first pressure on the portion of the body of the patient when the inflatable member is in its inflated configuration, to close urethra and a second pressure on the portion of the body of the patient when the inflatable member is in its deflated configuration, to allow for urination, the first pressure being greater than the second pressure.
Regarding Claim 5 – Hohlrieder et al. teaches the bodily implant includes a pump -11-, the pump being operatively coupled to the inflatable member -1a- and configured to pump a fluid out of the inflatable member, figure 5.
Regarding Claim 6 – Hohlrieder et al. teaches a pump -11-, the pump being operatively coupled to the inflatable member -1a- and configured to pump a fluid into the inflatable member, figure 6.
Regarding Claim 8 – Hohlrieder et al. teaches the bodily implant includes an electric pump, element -15- electric drive.
Regarding Claim 10 – Hohlrieder et al. teaches the bodily implant includes a reservoir configured to hold fluid, inside pump part -11-.
Regarding Claim 11 – Hohlrieder et al. teaches the electronic control system -17- and -20- includes an evaluation module, the evaluation module being configured to evaluate pressure data, see paragraph [0055]-[0060].
Regarding Claim 13 – Hohlrieder et al. teaches the inflatable member is configured to be disposed proximate a urethra of a patient, see paragraphs [0053] and [0054].
Regarding Claim 14 – Hohlrieder et al. teaches the inflatable member -1- is configured to be disposed in a circular configuration as shown in figure 4.
Regarding Claim 15 – Hohlrieder et al. teaches the inflatable member -1- is configured to be disposed in a circular configuration and is configured to surround a urethra of a patient, see paragraphs [0053] and [0054].
Regarding Claim 19 – Hohlrieder et al. teaches deflating an inflatable member -1- and -1a- that is disposed within a body of a patient, paragraphs [0058] through [0061]; sensing the pressure applied by the inflatable member to a portion of the body of the patient with sensor -22-; and determining when the inflatable member is no longer applying a pressure to the portion of the body of the patient, at the commencement of urination.
Regarding Claim 7 – Hohlrieder et al. teaches an implant as claimed but uses an internal reservoir and a single pump to deliver fluid to and remove fluid from the inflatable member not a two pump system.
NEWMAN et al. teaches an inflatable implant (417,418,419) a reservoir 401, one or more pumps to pump fluid to and from the reservoir(s) to the inflatable member(s).
It would have been obvious to one of ordinary skill in the medical arts at the time the invention was effectively filed to use the reservoir and two pump system as taught by NEWMAN et al. in place of the reservoir and single pump system of Hohlrieder et al. as an ordinary substitution of functionally equivalent systems to provide fluid from a reservoir to the inflatable device and to return fluid from the inflatable member to the reservoir.
Regarding Claim 9 – Hohlrieder et al. as modified by NEWMAN et al. teaches electric pumps.
Regarding Claim 16 – Hohlrieder et al. teaches an apparatus, including: a bodily implant, -1-, -9- and -10- configured to be implanted into a body of a patient, the implant including an inflatable member -1-, -1a-, a reservoir, within -11-, pump -11-, a sensor -22-, and an electronic control system -17- and -20-, the inflatable member -1a- being configured to be disposed proximate a portion of the body of the patient, the sensor -22- is operatively coupled to the inflatable member and is configured to detect a fluidic pressure within the inflatable member, and the electronic control system is configured to receive pressure data from the sensor and determine when the inflatable member is placing a pressure on the portion of the body of the patient, see paragraphs [0054]-[0061]. Hohlrieder et al. does not teach a two pump system as claimed.
NEWMAN et al. teaches an inflatable implant (417,418,419) a reservoir 401, one or more pumps to pump fluid to and from the reservoir(s) to the inflatable member(s).
It would have been obvious to one of ordinary skill in the medical arts at the time the invention was effectively filed to use the reservoir and two pump system as taught by NEWMAN et al. in place of the reservoir and single pump system of Hohlrieder et al. as an ordinary substitution of functionally equivalent systems to provide fluid from a reservoir to the inflatable device and to return fluid from the inflatable member to the reservoir.
Regarding Claim 17 - Hohlrieder et al. teaches the inflatable member is configured to be disposed proximate a urethra of a patient, see paragraphs [0053] and [0054].
Regarding Claim 18 - Hohlrieder et al. teaches the inflatable member -1- is configured to be disposed in a circular configuration and is configured to surround a urethra of a patient, see figure 1 and paragraphs [0053] and [0054].
Claim(s) 12 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hohlrieder et al(2019/0133737) hereinafter Hohlrieder et al. and further in view of NEWMAN et al. (US 20170079760) hereinafter NEWMAN et al. and Snow et al.( US 20110208220) hereinafter Snow et al. as applied to claim 1 above, and further in view of Bratteli(6,733,461) hereinafter Bratteli .
Regarding Claims 12 and 20 – Hohlrieder et al. teaches an apparatus as claimed but does not teach a smoothing module configured to smooth the pressure data.
Bratteli teaches an apparatus for improving pressure calibration including a smoothing module for smoothing the pressure data to enable consistent determining and marking changes in the pressure, column 9 lines 53.
It would have been obvious to one of ordinary skill in the medical arts at the time the invention was effectively filed to include in the device of – Hohlrieder et al. as modified by NEWMAN et al. and Snow et al. a smoothing module(filter) configured to smooth the pressure data measured by the sensor -22- to more effectively determine the changes in the pressure as suggested by Bratteli. Such smoothing is accomplished by using appropriate filtering which produces smoothed pressure data as taught by Bratteli. Such a modification to the apparatus of Hohlrieder et al. as modified by NEWMAN et al. and Snow et al. would produce an apparatus including the appropriate filters configured to smooth the pressure data as suggested by Bratteli.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WEBER et al.( WO 2019222091) teaches an inflatable penile prosthesis (100) includes a fluid reservoir (102) configured to hold fluid, an inflatable member (104), and a pump assembly (106) configured to transfer the fluid from the fluid reservoir to the inflatable member during an inflation cycle. The pump assembly includes a first pump (108) configured to inject the fluid into the inflatable member according to a first flow rate, and a second pump (110) configured to inject fluid into the inflatable member according to a second flow rate, where the second flow rate is less than the first flow rate.
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
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