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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/23/2026 has been entered.
Status of Claims
Claims 1193 – 1212 are pending and examined below
Response to Arguments
The remarks of 01/23/2026 have been fully considered but they are not persuasive.
Applicant argues that the prior art of record doesn't explicitly teach or disclose all the elements of amended claims 1202 and 1207, in particular applicant argues the following claim language:
“wherein the control device comprises an internal storage configured to store information related to the temperature of the constriction device or the energy source”
“the constriction device comprising at least three clamping elements”
Regarding the first bullet point, Scott discloses a control device (¶0061, control module 30) comprising a temperature sensor (¶0061, power management circuitry 70) configured to measure the temperature of the energy source (¶0061, wherein “70 includes circuits to measure voltages, currents, or temperatures associated with the nonhermetic battery” corresponds to configured to measure the temperature of the energy source) Further, Fig. 4 discloses a memory 62 that is electronically connected to power management circuit 70 via processor 60. Paragraph 0057 clarifies that “processor 60 may also store data collected during treatment and/or monitoring patient 14 within memory 62”. Therefore the memory 62 is configured to store information related to the temperature of the energy source.
Regarding the second bullet point – the argument is moot in light of the new 103 rejection below.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1193 – 1198, and 1201 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2003/0144575 (Forsell) in view of US 7,476,195 B2 (Sayet) in view of US 2005/0194933 (Arnold)
Regarding claim 1193, Forsell discloses an apparatus (device 100, Fig. 4) for controlling the flow of urine in a urethra of a patient (“urinary incontinence treatment apparatus”, ¶0123), comprising:
an implantable adjustable constriction device (circular resilient core 2, Figs. 1-3) for constricting the urethra to influence the flow in the urinary tract;
an operation device (Figs. 1-3, motor 22) for operating the constriction device to change the constriction of the urethra (¶0124, wherein 22 can restrict or release the urethra);
a control device comprising an implantable internal control unit (Fig. 35, 376, ¶0155, “implanted microprocessor 376”) for controlling the operation device (¶0155, wherein 375 controls motor 22), wherein the control device is configured to: control the operation device to constrict the urethra (¶0124, wherein “motor 22 constricts urethra”), and control the operation device to release the urethra (¶0124, wherein “urine passageway is released and opens” corresponds to releasing the urethra); and
an energy source (Fig. 34, energizer source 326) for supplying energy to the operation device (¶0150, wherein 326 powers 22);
wherein the implantable internal control unit (Fig. 35, 376, ¶0155, “implanted microprocessor 376”) is configured to determine the current state of the energy source, (¶0156, wherein “microprocessor monitors the amount of stored energy in the storage capacitor 358” corresponds to determine the current state of the energy source), and wherein the implantable internal control unit (Fig. 35, 376, ¶0155, “implanted microprocessor 376”) is connected to an internal signal transmitter (378, Figure 35) configured to transmit, to an external signal receiver, information related to the current state of the energy source (¶0056, wherein the motor activation signal corresponds to “information related to the current state of the energy source”).
Forsell discloses a control device (376, Fig. 35, ¶0156) configured to determine the current state of the energy source (“microprocessor 376 checks whether the energy stored in the storage capacitor 358 is enough”, ¶0156) and wherein the control device is connected to an internal signal transmitter (334, see also ¶0147 wherein 334 is an antenna which is configured to transmit electromagnetic signals). However, Forsell doesn’t explicitly teach or disclose sending information related to the current state of the energy source to an external signal receiver.
Sayet discloses an external signal receiver (“remote telemetry system”, Col. 9, Lines 56-64) configured to check the charge in batteries via a radio waves or other interactive signals.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the control device of Forsell to transmit the charge level of the battery to a remote telemetry system, as taught by Sayet, in order to allow a physician to interrogate and/or control the device remotely from outside the body without the need for an invasive procedure (Sayet, Col. 9, Lines 56-64).
Forsell discloses a control device configured to determine the current state of the energy source (¶0156, wherein 376 checks energy stored in 358) but doesn’t explicitly teach that the control device is configured to perform this repeatedly at predetermined intervals during discharge of the energy source. Sayet doesn’t explicitly teach or disclose a control device configured to check a battery repeatedly at predetermined intervals during discharge of the energy source.
Arnold discloses a control device (¶0042, microcontroller 300) configured to determine the current state of an energy source (¶0042, wherein 300 checks the charging current value of battery 310) repeatedly at predetermined intervals during discharge of the energy source (¶0042, wherein “cycle is updated at predetermined intervals” corresponds to repeatedly at predetermined intervals and a microcontroller such as 300 is configured to monitor battery level while discharging).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to configure the control device of Forsell in view of Sayet to determine the current state of the energy source, as taught by Arnold, in order to maintain the charge in portal powered devices (Arnold, ¶0002).
Regarding claim 1194, Forsell discloses wherein the energy source comprises a battery (¶0061, where in the energizer unit may comprise a battery)
Regarding claim 1195, Forsell discloses that the battery is at least one of a rechargeable battery and a capacitor (¶0068, where the “rechargeable electric power supply” corresponds to the recited rechargeable battery).
Regarding claim 1196, Forsell discloses wherein the control device (microprocessor 376, ¶0156) is configured to measure a parameter related to a voltage of the energy source to determine the current state of the energy source (¶0156, wherein the stored energy corresponds to the recited parameter related to voltage).
Regarding claim 1197, Forsell discloses wherein the control device (microprocessor 376, ¶0156) is configured to measure a parameter related to the energy consumption to determine the current state of the energy source (¶0156, wherein the energy stored corresponds to the recited parameter related to energy consumption)
Regarding claim 1198, Forsell discloses wherein the control device (microprocessor 376, ¶0156) is configured to measure a parameter related to the temperature of the energy source to determine the current state of the energy source (¶0156, wherein the energy stored corresponds to the recited parameter related to temperature of the energy source).
Regarding claim 1201, Forsell discloses wherein the control device (microprocessor 376, ¶0156) is arranged to measure a current state of the energy source on a repeated at predetermined intervals (“the microprocessor 376 checks whether the energy stored in the storage capacitor 358 is enough”, ¶0156”).
Sayet discloses wherein the control device is arranged to measure a current state of the energy source on a repeated at predetermined intervals (Col. 9, Lines 41-45, wherein monitoring the level of charge in the battery corresponds to measure a current state of the energy source repeated at predetermined intervals.)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the control device of Forsell to monitor the level of charge in the battery, as taught by Sayet, in order to allow a physician to check the charge level of the device remotely from outside the body. (Sayet, Col. 9, Lines 56-64).
Claims 1199 and 1200 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2003/0144575 (Forsell) in view of US 7,476,195 B2 (Sayet) in view of US 2005/0194933 (Arnold), as applied to claims above, and further in view of in view of US 2004/0113790 (Hamel).
Regarding claim 1199, Forsell discloses a control device (control unit, ¶0166) that monitors the state of the energy source (energizer source 326, Figure 34) but doesn’t explicitly teach or discloses that the control device stores measurements related to a current state of the energy source. Sayet doesn’t explicitly teach or disclose a control device arranged to store measurements. Arnold doesn’t explicitly teach or disclose a control device arranged to store measurements.
Hamel discloses a wherein the control device (microprocessor 54, Fig. 2A) is arranged to store measurements (data storage 208, ¶0107)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the control device of Forsell in view of Sayet in view of Arnold to store the measurements, as taught by Hamel, in order to save energy compared to immediate serial transmission (Hamel, ¶0107).
Regarding claim 1200, Forsell discloses a control device (microprocessor 54, Fig. 2A) arranged to transmit a control signal (¶0056 wherein the motor activation signal corresponds to the recited control signal) reflecting measurements of the energy source but does not explicitly teach or disclose storing the measurements. Sayet doesn’t explicitly teach or disclose a control device arranged to store measurements. Arnold doesn’t explicitly teach or disclose a control device arranged to store measurements.
Hamel discloses a wherein the control device (microprocessor 54, Fig. 2A) is arranged to store measurements (data storage 208, ¶0107)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the control device of Forsell in view of Sayet in view of Arnold to store the measurements, as taught by Hamel, in order to save energy compared to immediate serial transmission (Hamel, ¶0107).
Claim 1202-1204, and 1206 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2003/0144575 (Forsell) in view of US 2006/0211913 (Dlugos) in view of WO 2004/103463 (Scott) in view of US 2006/0257445 (Tropsha)
Regarding claim 1202, Forsell discloses an apparatus for controlling the flow of urine in a urethra of a patient (“urinary incontinence treatment apparatus”, ¶0123, Fig. 1) comprising:
an implantable adjustable constriction device (434, Figure 45) for constricting the urethra to influence the flow in the urinary tract;
a control device (microprocessor 376, ¶0156) for controlling the constriction device, wherein the control device is configured to control the constriction device to constrict the urethra or to release a constriction of the urethra; and
an operation device (motor 22, Fig. 34) for operating the constriction device to change the constriction of the urethra; and
an energy source (energizer unit 326, Figure 34) for supplying energy for the operation device; wherein the control device comprises a temperature sensor configured to sense a temperature of the apparatus or a temperature of the patient.
Forsell doesn’t explicitly teach or disclose a temperature sensor configured to sense a temperature of the apparatus of a temperature of the patient.
Dlugos, an implantable restriction device, discloses a temperature sensor (112, Fig. 12) configured to sense a temperature of the apparatus (“A temperature sensor 112 measures the temperature within the implanted port”, ¶0062).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the control device of Forsell with a temperature sensor, as taught by Dlugos, in order to obtain temperature-adjusted pressure measurements useful for adjustment, diagnosis, or monitoring of the apparatus (Dlugos, ¶0003)
Forsell doesn’t explicitly teach or disclose a temperature sensor configured to sense a temperature of the constriction device or energy source or an internal storage configured to store information related to the temperature of the constriction deice or the energy source. Dlugos discloses a temperature sensor (Fig. 12, 112) but doesn't explicitly teach or disclose that it is configured to sense a temperature of the constriction device or energy source or an internal storage configured to store information related to the temperature of the constriction deice or the energy source.
Scott discloses a control device (¶0061, control module 30) comprising a temperature sensor (¶0061, power management circuitry 70) configured to measure the temperature of the energy source (¶0061, wherein 70 measures temperature of nonhermetic battery) and wherein the control device (Fig. 4, 30) comprises an internal storage (Fig. 4, 62) configured to store information related to the temperature of the constriction device or the energy source (¶0057, wherein memory 62 is configured for this intended use because “processor 60 may also store data collected during treatment and/or monitoring of patient 14 within 62”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to configure the control device of Forsell in view of Dlugos to measure and store the temperature of the energy source, as taught by Scott, in order to ensure that the power source is not overcharged, over-discharged, or harmed (Scott, ¶0061).
Forsell doesn't explicitly teach or disclose three clamping elements configured to be arranged in a common plane intersecting the urethra and to be radially movable towards a central axis of the urethra and thereby obtain a constriction of the urethra, and away from the away from the central axis of the urethra to release the constriction on the urethra. Dlugos doesn't explicitly teach or disclose three clamping elements configured to be arranged in a common plane intersecting the urethra and to be radially movable towards a central axis of the urethra and thereby obtain a constriction of the urethra, and away from the away from the central axis of the urethra to release the constriction on the urethra. Scott doesn't explicitly teach or disclose three clamping elements configured to be arranged in a common plane intersecting the urethra and to be radially movable towards a central axis of the urethra and thereby obtain a constriction of the urethra, and away from the away from the central axis of the urethra to release the constriction on the urethra.
Tropsha discloses comprising three clamping elements (Fig. 11, 14A, 14B, and 14C) configured to be arranged in a common plane intersecting the urethra (see annotated Fig. 11, wherein all elements are coplanar, ¶0109, wherein the invention can be applied to the urinary tract) to be radially movable towards a central axis of the urethra and thereby obtain a constriction of the urethra (¶0109, wherein “voluntary control” corresponds to “radially movable towards a central axis of the urethra and thereby obtain a constriction of the urethra”), and away from the away from the central axis of the urethra to release the constriction on the urethra (¶0109, wherein “voluntary control” corresponds to “away from the away from the central axis of the urethra to release the constriction on the urethra”)
PNG
media_image1.png
772
740
media_image1.png
Greyscale
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the implantable adjustable constriction device of Forsell in view of Dlugos in view of Scott with three clamping elements arranged in a common plane to restrict and release the urethra, as taught by Tropsha, in order to control containment and release of urine in a reliable manner (¶0109)
Regarding claim 1203, Forsell doesn’t explicitly teach or disclose an internal signal transmitter arranged to transmit a signal based on temperature measurements.
Dlugos, an implantable restriction device, discloses a control device (microcontroller 106, ¶0062) further comprises an internal signal transmitter (132, figure 12) arranged to transmit a signal based on the temperature measurements (See ¶0065 where the pressure signal is calculated based on the measured temperature)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the control device of Forsell with an internal signal transmitter, as taught by Dlugos, in order to transmit temperature-adjusted pressure measurements useful for adjustment, diagnosis, or monitoring of the apparatus (Dlugos, ¶0003)
Regarding claim 1204, Forsell doesn’t explicitly teach or disclose an internal signal transmitter. Dlugos discloses wherein the internal signal transmitter (156, Fig. 14) is arranged to transmit the signal to an external signal receiver (126, Fig. 12).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify Forsell with an internal signal transmitter, as taught by Dlugos, in order to transmit temperature-adjusted pressure measurements useful for adjustment, diagnosis, or monitoring of the apparatus (Dlugos, ¶0003)
Regarding claim 1206, Forsell discloses a control device (microprocessor 376, ¶0156) but doesn’t explicitly teach or discloses an implantable sensor.
Dlugos discloses wherein the control device (microcontroller 106, ¶0062) further comprises an implantable sensor (temperature sensor 112, Fig. 12) configured to sense a physical parameter (¶0062, where temperature corresponds to a physical parameter), and wherein the control device (microcontroller 106, ¶0062) is adapted to produce an indication in response to the sensor (temperature sensor 112, Fig. 12) sensing the physical parameter (¶0062, wherein the transmitted pressure measurement corresponds to the recited indication).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the control device of Forsell to produce an indication in response to a sensed physical parameter, as taught by Dlugos, in order to transmit temperature-adjusted pressure measurements useful for adjustment, diagnosis, or monitoring of the apparatus (Dlugos, ¶0003)
Claim 1205 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2003/0144575 (Forsell) in view of US 2006/0211913 (Dlugos) in view of WO 2004/103463 (Scott) in view of US 2006/0257445 (Tropsha), as applied to claims above, and further in view of US 2004/0113790 (Hamel)
Regarding claim 1205, Forsell discloses a control device (microprocessor 376, ¶0156) but doesn’t explicitly teach that the control device stores measured values or a temperature sensor.
Dlugos discloses a temperature sensor configured to measure temperature on a regular basis (as outlined in the rejection in claim 1202 above).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify Forsell with a temperature sensor, as taught by Dlugos, in order to monitor the device for overheating.
Forsell doesn’t explicitly teach or disclose a storing measured temperature values in a control device. Dlugos doesn't explicitly teach or disclose storing measured temperature values in a control device. Tropsha doesn't explicitly teach or disclose storing measured temperature values in a control device. Scott doesn’t explicitly teach or disclose storing these values in a control device
Hamel, which qualifies as analogous art because it can be applied to biomedical implants (see Hamel ¶0005), discloses sensors that store data to a control device (data storage 208, ¶0107)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the control device of Forsell in view of Dlugos in view of Scott in view of Tropsha to store the sensor data, as taught by Hamel, in order to save energy as immediate serial transmission would require more power (Hamel, ¶0107).
Claim 1207-1211 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2003/0144575 (Forsell) in view of US 2006/0257445 (Tropsha)
Regarding claim 1207, Forsell discloses an apparatus for controlling a flow of urine in a urethra of a patient (Figs. 1-3) comprising:
an implantable constriction device (circular resilient core 2, Figs. 1-3) for constricting the urethra to influence the flow in the urinary tract, the constriction device comprising a plurality of clamping elements (18,20, Fig. 2) configured to be arranged in a common plane intersecting the urethra (See Fig. 3 wherein 18 and 20 share a plane intersecting the urethra) and to be radially movable towards a central axis of the urethra to abut the urethra and thereby obtain a constriction of the urethra, and away from the central axis of the urethra to release the constriction of the urethra;
an operation device (mechanical adjustment device 12, Fig. 3) configured to operate the movement of the clamping elements;
an implantable motor (motor 22, Fig. 34) configured to operate the operation device;
and a gear box (drive wheel 14, Fig. 3) configured to transfer a force generated by the motor into a force operating the operation device;
wherein the operation device is configured to operate the movement of the clamping elements such that the movement is predominantly inelastic (¶0123 wherein the frictional engagement is inelastic), and such that a clamping force, acting on the urethra, is distributed between the clamping elements (see Fig. 3 wherein the clamping force is distributed between 20 and 18).
Forsell doesn't explicitly teach or disclose at least three clamping elements.
Tropsha discloses three clamping elements (Fig. 11, 14A, 14B, and 14C) configured to be arranged in a common plane intersecting the urethra (see annotated Fig. 11, wherein all elements are coplanar, ¶0109, wherein the invention can be applied to the urinary tract) and to be radially movable towards a central axis of the urethra and thereby obtain a constriction of the urethra (¶0109, wherein “voluntary control” corresponds to “radially movable towards a central axis of the urethra and thereby obtain a constriction of the urethra”), and away from the away from the central axis of the urethra to release the constriction on the urethra (¶0109, wherein “voluntary control” corresponds to “away from the away from the central axis of the urethra to release the constriction on the urethra”)
PNG
media_image1.png
772
740
media_image1.png
Greyscale
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the apparatus of Forsell with at least three clamping elements, as taught by Tropsha, in order to control containment and release of urine in a reliable manner (¶0109)
Regarding claim 1208, Forsell discloses wherein the clamping force (¶0123, where the frictional engagement corresponds to the clamping force), acting on the urethra, is distributed substantially evenly between the clamping elements (see Fig. 3, where the force is distributed evenly between 18 and 20).
Regarding claim 1209, Forsell discloses wherein the plurality of clamping elements (18, 20, Fig. 12) comprises a first and a second clamping element configured to be arranged at least one of 120° and 180° apart along the circumference (see Fig. 2 where counter pressure rollers are 180° apart along the circumference).
Regarding claim 1210, Forsell discloses an operation device (mechanical adjustment device 12, Fig. 3) configured to cause the constriction device to assume a constricted state in which the flow of urine in the urethra is hindered (¶0124. where the urine passageway is restricted corresponds to the recited constricted state), and a released state in which the urine is allowed to flow through the urethra (¶0124, wherein the urine passageway is released corresponds to the released state).
Regarding claim 1211, Forsell discloses an operation device (mechanical adjustment device 12, Fig. 3) which is configured to be coupled to each of the clamping elements (18,20, Fig. 3) so as to transmit the clamping force pushing the clamping elements towards the central axis (¶0124 describes wherein the tissue is squeeze towards the central axis).
Claim 1212 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2003/0144575 (Forsell) in view of US 2006/0257445 (Tropsha), and further in view of US 2007/0249893 (Krumme
Regarding claim 1212, Forsell discloses wherein the operation device (mechanical adjustment device 12, Fig. 3) is configured to distribute the clamping force between the clamping elements (18, 20, Figure 3) such that the flow of urine through the urethra is constricted. Forsell does not explicitly teach or disclose that blood circulation in a wall of the constricted portion of the urethra is substantially unrestricted. Tropsha does not explicitly teach or disclose that blood circulation in a wall of the constricted portion of the urethra is substantially unrestricted.
Krumme, a cuff for a lumen, discloses clamping elements arranged so that blood circulation in a wall of the constricted portion of the urethra is substantially unrestricted. (See Fig. 1 and ¶0008 wherein fluid flow in restricted while still allowing blood flow).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the clamping elements of Forsell in view of Tropsha to restrict the flow of urine while allowing blood flow to the urethra, as taught by Krumme, to prevent tissue necrosis or other damage to the urethral wall (Krumme, ¶0003).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAXIMILIAN TOBIAS SPENCER whose telephone number is (571)272-8382. The examiner can normally be reached M-F 8am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408.918.7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774