DETAILED ACTION
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
The Office Action is responsive to the Amendment filed 06 May 2026. Claims 8-14 are now pending. The Examiner acknowledges the amendments to Claims 8-14.
Claim Rejections - 35 USC § 102
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.
Claims 8-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lamraoui (US 20170325926 A1).
Regarding claim 8, Lamraoui teaches a device comprising:
A liquid balloon ("inflatable occlusive sleeve containing a variable volume of a fluid", paragraph [0075]; inflatable occlusive sleeve 3, Fig. 1, also shown in annotated Fig. 1 below);
A pump unit connected to the liquid balloon via a hose for pumping liquid into the liquid balloon and for pumping liquid out of the liquid balloon ("inflatable sleeve is in fluidic connection with a reservoir of fluid for injecting fluid from the reservoir to the sleeve or from the sleeve to the reservoir", paragraph [0007]; fluidic connection 2, Fig. 1, also shown in annotated Fig. 1 below),
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The pump unit (reservoir 5) has a receiving space that is fillable with liquid ("fixed portion", paragraph [0078]) and a volume of which is changeable ("movable portion", paragraph [0078]) by moving an actuating part of the pump unit via an electric motor powered by a battery ("occlusion system comprises an actuator mechanically coupled with the movable portion of the reservoir so as to linearly displace said movable portion relatively to the fixed portion in order to adjust the volume of the reservoir. The actuator may notably comprise an electromagnetic motor", paragraph [0078]; motor 13, Fig. 2);
An electronic control unit configured to control the electric motor ("a connector 9 allows the motor 13 to be powered when the control device transmits an order for operating the motor in one direction or in the other", paragraph [0110]);
At least one pressure sensor configured to detect a pressure of the liquid in the receiving space ("the system further comprises a gas pressure sensor laid out in the casing for measuring the gas pressure in the casing", paragraph [0053]; "gas pressure sensor...laid out in the volume 11 for measuring the pressure in this volume", paragraph [0114]); and
A travel sensor configured to detect a position of the actuating part ("a sensor in mechanical connection with the actuator and/or the movable wall of the reservoir measure a compressive and/or traction force in the direction of displacement of the movable portion of the reservoir", paragraph [0087]).
Wherein the control unit is further configured to execute an actuating process of the actuating part via the electric motor in order to (“the system further comprises a device for controlling the fluid pressure in the fluidic circuit by the volume of the reservoir”, paragraph [0032], “controlling the actuator for displacing the movable portion of the reservoir into a position defining said determined volume”, paragraph [0037]),
starting from a first fill level of the liquid balloon with a first filling pressure (“receiving a fluid pressure set value in the fluidic circuit”, paragraph [0035]),
set a second fill level of the liquid balloon with a second filling pressure (“from the relationship recorded in the memory between the pressure in the reservoir and the volume of the reservoir, determining the volume of the reservoir with which it is possible to attain the pressure set value”, paragraph [0036]),
and the actuating process comprises travel control of the actuating part for approaching a target position of the actuating part (“controlling the actuator for displacing the movable portion of the reservoir into a plurality of determined positions, each position defining a determined volume of the reservoir”, paragraph [0039]),
and after said travel control a check is made as to whether the pressure of the liquid in the receiving space lies within a permissible filling pressure range around the second filling pressure and, if the pressure of the liquid in the receiving space lies outside the permissible filling pressure range around the second filling pressure, adjusts the position of the actuating part (“the device for measuring the pressure is configured for measuring the fluid pressure upon adjusting the volume of the reservoir and for checking the match between said measured value and an expected value”, paragraph [0057], “actuator…coupled with the movable portion of the reservoir…to adjust the volume of the reservoir”, paragraph [0078]).
Regarding claim 9, Lamraoui teaches the pump unit having a bellows within which the receiving space for the liquid is situated ("the reservoir with a variable volume comprises bellows assembled in the casing", paragraph [0094]; bellows 9, Fig. 2, also shown in annotated Fig. 2 below), and an end piece of the bellows is rigidly connected to the actuating part ("the bellows have a flange 6 coupled with a driving screw 17", paragraph [0106]; bellows 9, flange 6, driving screw 17, Fig. 2).
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Regarding claim 10, Lamraoui teaches the pressure sensor having at least one strain gauge attached to an end membrane which delimits an interior of the bellows in an axial direction of the bellows ("the force sensor may be in this case a sensor comprising strain gauges placed so as to measure forces in both directions along the axis of the screw 17 secured to the flange 6 of the bellows 9", paragraph [0132]; Fig. 11).
Regarding claim 11, Lamraoui teaches comprising an air pressure sensor configured to detect atmospheric pressure ("a barometric sensor capable of measuring the current atmospheric pressure exerted on the body of the patient", paragraph [0092]) and a housing air pressure sensor configured to detect an air pressure in a gas-tight-insulated interior of a housing ("integration of a pressure sensor on one of the walls of the reservoir of variable volume", paragraph [0135]) in which the pump unit is arranged, and,
For determining the pressure of the liquid in the receiving space of the pump unit, the electronic control unit ("the system further comprises a device for controlling the fluid pressure in the fluidic circuit by the volume of the reservoir", paragraph [0032]) is configured to subtract the atmospheric pressure which is detected by the air pressure sensor from the measured value which is output by the pressure sensor, and to add the air pressure in the housing which is detected by the housing air pressure sensor ("system further comprises a device placed outside the body of the patient and comprising a barometric sensor suitable for measuring the atmospheric pressure said device being able to communicate said pressure measurement to the treatment unit for calculating said relative fluid pressure in the fluidic circuit", paragraph [0060]). The electronic control unit would be able to add and subtract the atmospheric pressure in order to determine the pressure of the liquid in the receiving space.
Claim Rejections - 35 USC § 103
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.
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being obvious over Lamraoui in view of Hassile (CN 1714754 A).
Regarding claim 12, Lamraoui teaches all the limitations of claim 9, but does not teach the actuating part consisting of an external and internal thread of the actuating ring.
However, Hassile teaches the actuating part having an external thread which interacts with an internal thread of an actuating ring (shown in annotated Fig. 2 below) which is rotatable by the electric motor ("harmonic motors 74,76 are placed within the inner circumference of the drive ring 56 such that harmonic motion of the motor in contact with the ring procedures rotation", paragraph 2, page 7).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the device of Lamraoui with the threading of Hassile and configure the electric motor to rotate the actuating part in order to regulate the fluid pressure within the housing of the device ("the volume of the metal bellows accumulator is strictly controlled by the amount of rotation of the guide rod", paragraph 4, page 2).
Regarding claim 14, Lamraoui teaches all the limitations of claim 9, as well as the device forming an artificial sphincter ("the system is an artificial urinary sphincter", paragraph [0058]), but does not teach the liquid balloon comprising a flexible band.
However, Hassile teaches the liquid balloon comprising a flexible band ("expandable portion of the belt 104 is coupled to the conduit 36 to allow fluid to flow between the belt 104 and the pumping device 22", paragraph 2, page 10) which is closeable to form a ring and has a longitudinally running inner chamber which forms the liquid balloon and is fillable with the liquid ("when the band 104 surrounds the orifice or organ, the expandable portion can be fully or partially filled with fluid by the conduit 36 to reduce the diameter formed by the band and to retract the size of the orifice or organ surrounded by the band", paragraph 2, page 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the device of Lamraoui with the flexible band of Hassile in order to form the liquid balloon and adjust the amount of liquid that fills the balloon, acting as a sphincter.
Claim 13 is rejected under 35 U.S.C. 103 as being obvious over Lamraoui in view of Hassile and further in view of Shatz (Numerical Inductance Calculations Based on First Principles).
Regarding claim 13, Lamraoui teaches all the limitations of claim 9, but does not teach the travel sensor connected to the actuator having a plate with a spiral conductor track.
Futhermore, Hassile teaches the travel sensor having a plate which is rigidly connected to the actuating part and has a conductor track ("plate 78 control circuitry on board 78 is electrically coupled to coil windings 66, 68, for receiving power to drive motors 74, 76, and for receiving and transmitting control signals for pump 22", paragraph 2, page 8) which is situated opposite a static, electrically conductive counter plate. Hassile does not teach a spiral-shaped conductor track.
However, Shatz teaches a spiral conductor track ("a conductor in the shape of a spiral", page 6; Fig. 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the device of Lamraoui with the plate and conductor track of Hassile, as well as the spiral formation of the conductor of Shatz in order to conduct sufficient energy in order to control the actuating part and adjust the level of fluid in the housing.
Response to Arguments
Applicant’s arguments, see page 6, filed 06 May 2026, with respect to claim objections have been fully considered due to the cancellation of claim 15. The language of claim 15 has been incorporated into claim 8 and has been corrected, therefore the claim objections have been withdrawn.
Applicant’s arguments, see page 6, filed 06 May 2026, with respect to 35 U.S.C. 102 have been fully considered by they are not persuasive.
In regards to claim 8, Lamraoui teaches a device comprising a liquid balloon, a pump unit for pumping liquid in and out of the liquid balloon, the pump unit having a receiving space that is fillable with liquid, an actuating part of the pump via an electric motor, an electronic control unit to control the electric motor, at least one pressure sensor to detect a pressure in of the liquid in the receiving space, and a travel sensor to detect a position of the actuating part. The Applicant argues that the gas pressure sensor in Lamraoui is for sensing a gas pressure in a different volume 11 and does not act as a sensor for detecting the pressure of the liquid in the receiving space/reservoir 5, therefore Lamraoui does not teach at least one pressure sensor configured to detect a pressure of the liquid in the receiving space. The Examiner respectfully disagrees, as the volume 11 and reservoir 5 are essentially the same space (“the inner space 11 of the casing surrounding the reservoir 5 is filled with a gas”, paragraph [0112]). The volume 11 is the volume of reservoir 5, where the volume is adjustable and detected by at least one pressure sensor (“adjusting the volume of the reservoir…reservoir with variable volume being laid out in a sealed casing containing a gas…a sensor laid out in the casing”, claim 1).
Claim 8 has been amended to require that the control unit acts in the event that the pressure of the liquid in the receiving space lies outside the permissible filling pressure range around the second filling pressure after movement of the actuating part by further adjusting the position of the actuating part. The Applicant argues that Lamraoui does not suggest a correction of the position of the actuating part in order to address the filling pressure being out of the permissible range. However, the Examiner respectfully disagrees, as the actuator that is coupled with the movable portion of the reservoir to linearly displace said movable portion, in order to adjust the volume of the reservoir (“actuator…coupled with the movable portion of the reservoir…to adjust the volume of the reservoir”, paragraph [0078]), meaning that the device is capable of correcting the position of the actuating part when the pressure within the reservoir is out of a permissible range. Therefore, Lamraoui does teach the limitations of claims 9-11.
In regards to claims 12 and 14, the Applicant argues that Lamraoui in view of Hassile does not teach the deficiencies noted with Lamraoui as applied to claim 8, however the Examiner respectfully disagrees, as Lamraoui does teach all the limitations of claim 8 as explained above.
In regards to claim 13, the Applicant argues that Lamraoui in view of Hassile and further in view of Shatz does not teach the deficiencies noted with Lamraoui as applied to claim 8, however the Examiner respectfully disagrees, as Lamraoui does teach all the limitations of claim 8 as explained above.
Conclusion
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.
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/L.L.T./Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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