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
Applicants response filed 3/16/2026 is acknowledged. Applicant amended claims 1, 11, 12, 16, and 19 changing calibration module to processor and adding language from the specification directed to “identifying a plateau in which the fluidic pressure within the inflatable member levels out for a period of time.”.
The rejection of claims 1-20 over 112(a) first paragraph has been withdrawn. Furthermore the objection to the specification has been withdrawn in view of the amendments.
Claims 1-20 remain pending.
Response to Arguments
Applicant's arguments filed 3/16/26 have been fully considered but they are not persuasive. The applicant included limitations to focus the independent claims on subject matter directed to identifying a plateau in which the fluidic pressure within the inflatable member levels out for a period of time. However, Snow et al.( US 20110208220) hereinafter Snow et al teaches monitoring static( plateaus) and fluctuating pressure levels.
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 Smith et al(2020/0222188) hereinafter Smith 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.
Smith et al. teaches an implantable device includes a fluid reservoir 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 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. Smith also teaches [0042] The electronic control module 213 is configured to control the first electronically powered pump 208, the second electronically powered pump 210, the first valve 212, and/or the second valve 214. The electronic control module 213 may include one or more processors (e.g., coupled to a substrate) and a non-transitory computer readable medium that stores instructions executable by processors.
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 as taught by Smith et al. to improve system processing and automation.
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 Smith 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 Smith 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.
Smith teaches an inflatable implant -204- a reservoir -202- a first pump -208- to pump fluid from the reservoir to the inflatable member and a second pump -210- to pump fluid from the inflatable implant back to the reservoir.
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 Smith 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 – the pumps -208 and -210- taught by Smith et al. are 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 a 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.
Smith teaches an inflatable implant -204- a reservoir -202- a first electrical pump -208- to pump fluid from the reservoir to the inflatable member and a second electrical pump -210- to pump fluid from the inflatable implant back to the reservoir.
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 Smith 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 - the inflatable member -1- is configured to be disposed proximate a urethra of a patient, see paragraphs [0053] and [0054].
Regarding Claim 18 - 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 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 Smith et al(2020/0222188) hereinafter Smith 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 Claim 12 – 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 include 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 Smith et al. and Snow et al. would produce an apparatus including the appropriate filters configured to smooth the pressure data as suggested by Bratteli.
Claim(s) 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 Smith et al(2020/0222188) hereinafter Smith et al. and Snow et al.( US 20110208220) hereinafter Snow et al. as applied to claim 19 above, and further in view of Bratteli(6,733,461) hereinafter Bratteli .
Regarding Claim 20 – Hohlrieder et al. teaches a method as claimed but does not teach smoothing the pressure data.
Bratteli teaches a method of improving pressure calibration including 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 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 method of Hohlrieder et al. would produce a method including smoothing the pressure data.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Vaingast et al.( US 20110015738) teaches an inflatable medical implant system configured for implantation in a patient to treat a condition of the patient comprise a first fluid path, an inflatable implant, an electric pump, a controller, and an implantable power supply that provides electrical power to the pump. [0045] In accordance with another embodiment, the controller 216 samples the sensed pressure value indicated by the signal 232 and compares the change in the sensed pressure value over a predetermined period of time to an empirically set threshold change in value, which corresponds to the inflatable implant 202 reaching the desired deflated or inflated state. When the change in the sensed pressure value reaches (e.g., exceeds) the threshold change in value, the controller deactivates the pump 204.
Weber et al.( US 20190350712) teaches an inflatable penile prosthesis includes a fluid reservoir configured to hold fluid, an inflatable member, and a pump assembly configured to transfer the fluid from the fluid reservoir to the inflatable member during an inflation cycle. The pump assembly includes a first pump configured to inject the fluid into the inflatable member according to a first flow rate, and a second pump 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. The controller may activate the second pump during the second phase of the inflation cycle in response to a pressure level in the inflatable member exceeding a threshold level. [0039] The sensor 115 is configured to monitor the pressure level in the inflatable member 104. In some examples, the sensor 115 is calibrated before the inflation and deflation cycle is commenced. The sensor 115 is communicatively coupled to the controller 112 such that the controller 112 can receive signals from the sensor 115.
ZACHAR et al.( 2020165903) teaches an invention providing cuff pressure stabilizers for use with an airway ventilation device having an inflatable cuff. The same cuff pressure stabilizer, without requiring adjustment, calibration, or other configuration, is able to provide pressure stabilization to inflatable cuffs of both tracheal ventilation tubes and laryngeal mask airway devices, even though the cuffs of these devices are inflated to substantially different pressures.
Birk(20070156013) teaches self-regulating gastric band apparatus for adjusting stoma size is disclosed. The apparatus includes an adjustable gastric band that has an expandable portion containing a volume of fluid. The band adjustment assembly includes memory storing an operating range relative to a target fluid pressure, and the pump assembly is operated to maintain the sensed band pressure within the operating range. The target pressure is set to maintain pressure variations below a predefined variation limit generally corresponding with satiated fill volumes for a particular patient and implanted band.
Applicant’s amendment necessitated the new ground(s) of rejection presented in this office action. Accordingly, 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 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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