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 filed 11/3/2025 have been fully considered but they are not persuasive.
Independent claims 1, 11, and 18 were amended to include “a first pump and a second pump”.
Applicant argues this should be sufficient to define over the prior art and that the prior art does not alone or in combination teach ““a first pump and a second pump”.
The examiner respectfully disagrees.
As noted in the rejection below US 20200222188 A1 (Hereinafter “Smith”) teaches in at least paragraph [0005] and figure 2 a first and second pump as part of the pump assembly and where the first and second pump may be disposed in series or in parallel and may be alternately activated and deactivated in inflation and deflation modes.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 8 and 11-12 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2,3 and 5 of U.S. Patent No. 12648852 in view of US 20200222188 A1 (Hereinafter “Smith”).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2, 3, and 5 of U.S. Patent No. 12648852 teach all of the limitations of claims 1-2, 8, and 11-12 of the instant application as shown in the table below including a pump assembly having a first pump, however U.S. Patent No. 12648852 does not teach where the pump assembly includes a second pump.
Smith 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. In paragraph [0005], Smith further teaches the pump assembly may include a second electronically powered pump, where the first valve is disposed in series with the first electronically powered pump, the second valve is disposed in series with the second electronically powered pump, and the second electronically powered pump is disposed in parallel with the first electronically powered pump. In some examples, the first electronically powered pump is activated and the second electronically powered pump is deactivated in response to the implantable device being in the inflation mode, and the first electronically powered pump is deactivated and the second electronically powered pump is activated in response to the implantable device being in the deflation mode.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the U.S. Patent No. 12648852 a second pump as taught by Smith to improve fluid transfer options between the pressurized reservoir and the inflatable member.
Instant
12648852
Claim 1
An implantable device comprising:
a pressurize fluid reservoir configured to hold fluid;
an inflatable member;
and an electronic pump assembly, including:
a first pump;
a valve;
a pressure sensor configured to monitor a pressure of the inflatable member;
and a controller configured to cause the active valve to be in an open position during at least a portion of an inflation cycle to allow the fluid to be transferred from the pressurized fluid reservoir to the inflatable member,
Claim 1
An implantable device comprising:
a fluid reservoir configured to hold fluid
an inflatable member configured to be implanted in the body of the patient at a second location
a pump assembly; the pump assembly including an electronic control module, a
electronically powered pump,
a single valve disposed within the first fluidic pathway and a single valve disposed within the second fluidic pathway
a first pressure sensor configured to monitor a pressure of the inflatable member
the pump assembly configured to transfer the fluid from the fluid reservoir to the inflatable member via a first fluidic pathway in response to the implantable device being in an inflation mode
the electronic control module configured to activate or deactivate the electronically powered pump disposed within the first fluidic pathway,
Claim 1:
the controller configured to transition the active valve to a closed position in response to the pressure of the inflatable member achieving a target pressure.
Claim 1:
the electronic control module configured to activate or deactivate the electronically powered pump disposed within the first fluidic pathway, the electronic control module configured to active or deactivate the electronically powered pump disposed within the second fluidic pathway
Claim 2: The implantable device of claim 1, wherein, the first pressure sensor is communicatively coupled to the electronic control module, the electronic control module is configured to deactivate the electronically powered pump disposed within the first fluidic pathway in response to the pressure of the inflatable member exceeding a threshold level.
Claim 1:
The valve being an active valve
Claim 3:the valve disposed within the first fluidic pathway is an active valve configured to be electronically controlled.
Claim 2:
The implantable device of claim 1, wherein the controller is configured to cause the first pump to operate during a deflation cycle to transfer the fluid from the inflatable member to the pressurized fluid reservoir.
Claim 1:
the pump assembly configured to transfer the fluid from the inflatable member to the fluid reservoir via a second fluidic pathway different than the first fluidic pathway in response to the implantable device being in a deflation mode
Claim 8:The implantable device of claim 1, wherein the pressure sensor is a first pressure sensor, the electronic pump assembly including a second pressure sensor configured to monitor a pressure of the pressurized fluid reservoir.
Claim 1:
a first pressure sensor configured to monitor a pressure of the inflatable member; and a second pressure sensor configured to monitor a pressure of the fluid reservoir.
Claim 11:
An implantable device comprising:
a pressurize fluid reservoir configured to hold fluid;
an inflatable member; and
an electronic pump assembly, including:
a first pump;
a valve;
Claim 1
An implantable device comprising:
a fluid reservoir configured to hold fluid,
an inflatable member configured to be implanted in the body of the patient at a second location
a pump assembly;
electronically powered pump, a
a single valve disposed within the first fluidic pathway and a single valve disposed within the second fluidic pathway
Claim 11:
and a controller configured to cause the active valve to be in an open position until the pressure of the inflatable member achieves a target pressure during at least a portion of an inflation cycle.
Claim 1:
the electronic control module configured to activate or deactivate the electronically powered pump disposed within the first fluidic pathway, the electronic control module configured to active or deactivate the electronically powered pump disposed within the second fluidic pathway
Claim 2: The implantable device of claim 1, wherein, the first pressure sensor is communicatively coupled to the electronic control module, the electronic control module is configured to deactivate the electronically powered pump disposed within the first fluidic pathway in response to the pressure of the inflatable member exceeding a threshold level.
Claim 11:An active valve
Claim 3:
The implantable device of claim 1, wherein the first valve is an active valve configured to be electronically controlled.
Claim 5:
The implantable device of claim 1, wherein the second valve is an active valve configured to be electronically controlled.
Claim 11:
a pressure sensor configured to monitor a pressure of the inflatable member;
Claim 1:a first pressure sensor configured to monitor a pressure of the inflatable member
Claim 12:
The implantable device of claim 11, wherein the controller is configured to cause the first pump to operate during a deflation cycle to transfer the fluid from the inflatable member to the pressurized fluid reservoir.
Claim 1:
the pump assembly configured to transfer the fluid from the inflatable member to the fluid reservoir via a second fluidic pathway different than the first fluidic pathway in response to the implantable device being in a deflation mode
Claim Rejections - 35 USC § 102
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 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 1-2, 5-6, 8-9, 11-12, 14-15, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20200222188 A1 (Hereinafter “Smith”).
Regarding claim 1, Smith teaches an implantable device (Figure 2, implantable device 200) comprising:
a pressurize fluid reservoir configured to hold fluid (Figure 2, [0045], “In some examples, the fluid reservoir 202 is a pressured reservoir such as a pressure regulating balloon.”)
an inflatable member (Figure 2, inflatable member 204); and
an electronic pump assembly (Figure 2, pump assembly 206; [0038], “The pump assembly 206 includes a first electronically powered pump 208, a second electronically powered pump 210, a first valve 212, a second valve 214, and an electronic control module 213.”), including:
a pump ([0038], Figure 2, electronically powered pump 208);
an active valve ([0040], “In some examples, the first valve 212 is an active valve that is electronically closed and opened, and the second valve 214 is an active valve that is electronically closed and opened.”);
a pressure sensor (Figure 2, pressure sensor 216) configured to monitor a pressure of the inflatable member ([0046], “a first pressure sensor 216 configured to monitor a pressure of the inflatable member 204”);
and a controller (Figure 2, electronic control module 213) configured to cause the active valve to be in an open position during at least a portion of an inflation cycle to allow the fluid to be transferred from the pressurized fluid reservoir to the inflatable member ([0032], “The first valve 112 and the second valve 114 may be passive one-way valves or active valves that are electronically opened and closed.”; [0039], “the first electronically powered pump 208 is a one-way pump configured to transfer fluid from the fluid reservoir 202 to the inflatable member 204 during the inflation mode.”),
the controller configured to transition the active valve to a closed position in response to the pressure of the inflatable member achieving a target pressure ([0044], “To hold a set pressure in the inflatable member 204, the first electronically powered pump 208 and the second electronically powered pump 210 are deactivated (e.g., turned off) and the first valve 212 and the second valve 214 are closed if they are actively controlled valves.”; [0046], “The electronic control module 213 is configured to deactivate the first electronically powered pump 208 in response to the pressure of the inflatable member 204 reaching or exceeding a set pressure target.”)
Regarding claim 2, Smith teaches the implantable device of claim 1, wherein the controller is configured to cause the pump to operate during a deflation cycle to transfer the fluid from the inflatable member to the pressurized fluid reservoir ([0032], “ the secondary electronically powered pump 110 may transfer fluid from the inflatable member 104, through the pump assembly 106 (via the second valve 114—which is open if electronically controlled), and to the fluid reservoir 102 in the deflation mode.”).
Regarding claim 5, Smith teaches the implantable device of claim 1, wherein the active valve is disposed in parallel with the pump (Figure 4 shows the valves and the pumps in parallel. Therefore, the pumps and valves of the embodiment of figure 2 could also have this arrangement.; [0016], “specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the embodiments in virtually any appropriately detailed structure.”)
Regarding claim 6, Smith teaches the implantable device of claim 1, wherein the controller is configured to control the pump to operate to transfer a portion of the fluid from the inflatable member to the pressurized fluid reservoir in response to the pressure of the inflatable member being greater than the target pressure ([0006], “the pump assembly is configured to transfer the fluid from the inflatable member to the fluid reservoir in response to the implantable device being in a deflation mode.”; [0046], “The electronic control module 213 is configured to deactivate the first electronically powered pump 208 in response to the pressure of the inflatable member 204 reaching or exceeding a set pressure target”).
Regarding claim 8, Smith teaches the implantable device of claim 1, wherein the pressure sensor is a first pressure sensor (Figure 2, first pressure sensor 216), the electronic pump assembly including a second pressure sensor configured to monitor a pressure of the pressurized fluid reservoir ([0047], “the implantable device 200 or the pump assembly 206 includes a second pressure sensor 218 configured to monitor a pressure of the fluid reservoir 202”).
Regarding claim 9, implantable device of claim 8, wherein the controller is configured to cause the active valve to be in the open position for a period of time in response to the pressure of the pressurized fluid reservoir exceeding a threshold level ([0005], “the first electronically powered pump and the second electronically powered pump are configured to transfer the fluid from the fluid reservoir to the inflatable member in response to the pressure differential being greater than the threshold amount.”; In order for the fluid to be moved, the valve must be open. This will remain open until the differential is not exceeding a threshold.)
Regarding claim 11, Smith teaches an implantable device (Figure 2, implantable device 200) comprising:
a pressurize fluid reservoir configured to hold fluid (Figure 2, [0045], “In some examples, the fluid reservoir 202 is a pressured reservoir such as a pressure regulating balloon.”);
an inflatable member (Figure 2, inflatable member 204); and
an electronic pump assembly (Figure 2, pump assembly 206), including:
a pump (Figure 2, electronically powered pump 208 and electronically powered pump 210);
an active valve ([0040], “In some examples, the first valve 212 is an active valve that is electronically closed and opened, and the second valve 214 is an active valve that is electronically closed and opened.”);
a pressure sensor (Figure 2, pressure sensor 216) configured to monitor a pressure of the inflatable member ([0046], “a first pressure sensor 216 configured to monitor a pressure of the inflatable member 204”);
and a controller (Figure 2, electronic control module 213) configured to cause the active valve to be in an open position until the pressure of the inflatable member achieves a target pressure during at least a portion of an inflation cycle ([0039], “the first electronically powered pump 208 is a one-way pump configured to transfer fluid from the fluid reservoir 202 to the inflatable member 204 during the inflation mode.”; [0046], “The electronic control module 213 is configured to deactivate the first electronically powered pump 208 in response to the pressure of the inflatable member 204 reaching or exceeding a set pressure target.”).
Regarding claim 12, Smith teaches the implantable device of claim 11, wherein the controller is configured to cause the pump to operate during a deflation cycle to transfer the fluid from the inflatable member to the pressurized fluid reservoir ([0032], “ the secondary electronically powered pump 110 may transfer fluid from the inflatable member 104, through the pump assembly 106 (via the second valve 114—which is open if electronically controlled), and to the fluid reservoir 102 in the deflation mode.”).
Regarding claim 14, Smith teaches the implantable device of claim 11, wherein the active valve is disposed in parallel with the pump Figure 4 shows the valves and the pumps in parallel. Therefore, the pumps and valves of the embodiment of figure 2 could also have this arrangement.; [0016], “specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the embodiments in virtually any appropriately detailed structure.”).
Regarding claim 15, Smith teaches the implantable device of claim 11, wherein the controller is configured to control the pump to operate to transfer a portion of the fluid from the inflatable member to the pressurized fluid reservoir in response to the pressure of the inflatable member being greater than the target pressure ([0006], “the pump assembly is configured to transfer the fluid from the inflatable member to the fluid reservoir in response to the implantable device being in a deflation mode.”; [0046], “The electronic control module 213 is configured to deactivate the first electronically powered pump 208 in response to the pressure of the inflatable member 204 reaching or exceeding a set pressure target”).
Regarding claim 17, Smith teaches the implantable device of claim 11, wherein the pressure sensor is a first pressure sensor (Figure 2, first pressure sensor 216), the electronic pump assembly including a second pressure sensor configured to monitor a pressure of the pressurized fluid reservoir ([0047], “the implantable device 200 or the pump assembly 206 includes a second pressure sensor 218 configured to monitor a pressure of the fluid reservoir 202”)., the controller configured to cause the active valve to be in the open position for a period of time in response to the pressure of the pressurized fluid reservoir exceeding a threshold level ([0005], “the first electronically powered pump and the second electronically powered pump are configured to transfer the fluid from the fluid reservoir to the inflatable member in response to the pressure differential being greater than the threshold amount.”; In order for the fluid to be moved, the valve must be open. This will remain open until the differential is not exceeding a threshold.).
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.
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Smith as applied to claim 2 and 12 above in view of US 20190133737 A1 (Hereinafter “Hohlrieder”).
Regarding claim 3, Smith teaches the implantable device of claim 2, wherein the electronic pump assembly is configured to receive a control signal from a patient interface element, the controller configured to activate the inflation cycle or the deflation cycle based on the control signal ([0043], “For example, the patient may activate the interface element 211 to place the pump assembly 206 in the inflation mode, which causes the electronic control module 213 to activate the first electronically powered pump 208 (e.g., by sending a signal to the first electronically powered pump 208). In some examples, if the first valve 212 is an active valve, the electronic control module 213 is configured to open the first valve 212 (e.g., by sending a signal to the first valve 212).”).
Smith does not explicitly teach the electronic pump assembly including an antenna configured to receive a wireless signal from an external device.
Hohlrieder teaches an implantable medical device with an electronic pump assembly (Figure 1, pump electronics unit 17) includes an antenna configured to receive a wireless control signal from an external device ([0045], “An operating electronics unit 20 of the operating unit 19 in this case communicates with the pump electronics unit 17 via a radio link.”; Claim 3, “an operating unit arranged spatially separate from the pump unit, the pump unit includes a pump electronics unit and the operating unit includes an operating electronics unit, and the electronic control system of the device comprises the pump electronics unit and the operating electronics unit, and the pump electronics unit and the operating electronics unit communicate via a wireless link.”; A radio link would require an antenna in order to receive the signal).
Hohlrieder is analogous art because it is also directed toward an implantable medical device with an electronic pump. It would have been obvious to one of ordinary skill in the art prior to the effective filing date to modify the pumps and interface of Smith to include the electronics of Hohlrieder that allow the device to communicate wirelessly. Doing so would be a combination of known elements in the prior art to yield a predictable result. The predictable result being the patient interface and pumps of the device communicating wirelessly. This would allow the patient interface to be external from the device and would allow the patient to control the device without having to touch the medical device making the control easier.
Regarding claim 13, Smith teaches the implantable device of claim 12, wherein the electronic pump assembly is configured to receive a control signal from a patient interface element, the controller configured to activate the inflation cycle or the deflation cycle based on the control signal ([0043], “For example, the patient may activate the interface element 211 to place the pump assembly 206 in the inflation mode, which causes the electronic control module 213 to activate the first electronically powered pump 208 (e.g., by sending a signal to the first electronically powered pump 208). In some examples, if the first valve 212 is an active valve, the electronic control module 213 is configured to open the first valve 212 (e.g., by sending a signal to the first valve 212).”).
Smith does not explicitly teach the electronic pump assembly including an antenna configured to receive a wireless signal from an external device.
Hohlrieder teaches an implantable medical device with an electronic pump assembly (Figure 1, pump electronics unit 17) includes an antenna configured to receive a wireless control signal from an external device ([0045], “An operating electronics unit 20 of the operating unit 19 in this case communicates with the pump electronics unit 17 via a radio link.”; Claim 3, “an operating unit arranged spatially separate from the pump unit, the pump unit includes a pump electronics unit and the operating unit includes an operating electronics unit, and the electronic control system of the device comprises the pump electronics unit and the operating electronics unit, and the pump electronics unit and the operating electronics unit communicate via a wireless link.”; A radio link would require an antenna in order to receive the signal).
Hohlrieder is analogous art because it is also directed toward an implantable medical device with an electronic pump. It would have been obvious to one of ordinary skill in the art prior to the effective filing date to modify the pumps and interface of Smith to include the electronics of Hohlrieder that allow the device to communicate wirelessly. Doing so would be a combination of known elements in the prior art to yield a predictable result. The predictable result being the patient interface and pumps of the device communicating wirelessly. This would allow the patient interface to be external from the device and would allow the patient to control the device without having to touch the medical device making the control easier.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Smith as applied to claim 1 above in view of US 20070232848 A1 (Hereinafter “Forsell”).
Regarding claim 4, Smith teaches the implantable device of claim 1.
Smith does not explicitly teach wherein the fluid is transferred from the pressurized fluid reservoir to the inflatable member during the inflation cycle without using the pump.
Forsell teaches a fluid reservoir having a variable volume controlled without a pump which distributed the fluid to a cavity of the device (Figures 3-4; Figure 3 has a reservoir having a variable volume controlled by a remote control motor and Figure 4 has a reservoir having a variable volume controlled by manual manipulation as described in paragraphs [0093]-[0094]; [0019]-[0020], “The hydraulic operation device may distribute fluid from the reservoir to the cavity of the restriction member in response to a predetermined first displacement of the first wall portion of the reservoir relative to the second wall portion of the reservoir and may distribute fluid from the cavity to the reservoir in response to a predetermined second displacement of the first wall portion relative to the second wall portion. The first and second wall portions of the reservoir may be displaceable relative to each other by manual manipulation, such as by manually pushing, pulling or rotating any of the wall portions in one direction, or alternatively, may be displaceable relative to each other by a device powered magnetically, hydraulically, or electrically (e.g. by an electric motor). In this embodiment no pump is used, only the volume of the reservoir is varied.).
Forsell is analogous art because it is also directed toward an implantable, inflatable medical device such as an anal incontinence treatment device. It would have been obvious to one of ordinary skill in the art prior to the effective filing date to modify the reservoir of Smith to have wall portions that are displaceable by manual manipulation or rotation of the wall portion as described in paragraphs [0019]-[0020] and Figs 3-4 of Forsell. Doing so would be a combination of known elements in the art without change to their respective functions. The combination would also have a predictable result. The result being a device that allows fluid to be transferred from the reservoir to the inflatable member without the use of the pump which also allows the fluid to be transferred without a non-return valve as described in paragraph [0020] of Forsell.
Claims 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Smith as applied to claim 1 and 11 above in view of US 20200188006 A1 (Hereinafter “Harmouche”).
Regarding claim 7, Smith teaches the implantable device of claim 1.
Smith does not explicitly teach wherein the controller is configured to transition the active valve from the open position to a partially-opened position in response to the pressure exceeding a threshold level, the threshold level being a value that is less than the target pressure.
Harmouche teaches a controller of a medical device adjusting the flow rate of fluid through an inflatable balloon by partially opening or partially closing a control valve in order to keep the balloon pressure within a predetermined range ([0008], “maintaining the balloon pressure within a predetermined pressure range based at least partially upon the sensor output received by the controller by adjusting a flow rate of a cryogenic fluid through the inflatable balloon while moving the inflatable balloon from a first treatment site to a second treatment site. “; [0010], “The step of controlling can include at least partially opening the control valve with the controller based at least partially on the sensor output received by the controller.”; [0066], “In certain embodiments, the control valves 342A, 342B can control and/or adjust the flow rate of the cryogenic fluid 327 moving through the fluid injection line 328 and/or the fluid exhaust line 329. The control valves 342A, 342B can include any suitable type of valve. The pressure maintenance assembly 326 can be configured to partially and/or fully open and/or close the control valves 342A, 342B.”).
Harmouche is analogous art because it is also directed toward an implantable, inflatable device. It would have been obvious to one of ordinary skill in the art prior to the effective filing date to modify the flow rate of the fluid of the device of Smith to partially close or open the active valve in order to keep the pressure within a desired range as taught by Harmouche. It would be obvious for this adjusting of control valves to happen within a range that is less than the target value so that the pressure does not exceed the threshold value and is able to be maintained at that point. Doing so would be a combination of known elements in the prior art that has predictable results. The results being an inflatable medical device that can keep reservoir pressure within a determined range by adjusting the valves to be partially open or close as taught by Harmouche.
Regarding claim 16, Smith teaches the implantable device of claim 11.
Smith does not explicitly teach wherein the controller is configured to transition the active valve from the open position to a partially-opened position in response to the pressure exceeding a threshold level, the threshold level being a value that is less than the target pressure.
Harmouche teaches a controller of a medical device adjusting the flow rate of fluid through an inflatable balloon by partially opening or partially closing a control valve in order to keep the balloon pressure within a predetermined range ([0008], “maintaining the balloon pressure within a predetermined pressure range based at least partially upon the sensor output received by the controller by adjusting a flow rate of a cryogenic fluid through the inflatable balloon while moving the inflatable balloon from a first treatment site to a second treatment site. “; [0010], “The step of controlling can include at least partially opening the control valve with the controller based at least partially on the sensor output received by the controller.”; [0066], “In certain embodiments, the control valves 342A, 342B can control and/or adjust the flow rate of the cryogenic fluid 327 moving through the fluid injection line 328 and/or the fluid exhaust line 329. The control valves 342A, 342B can include any suitable type of valve. The pressure maintenance assembly 326 can be configured to partially and/or fully open and/or close the control valves 342A, 342B.”).
Harmouche is analogous art because it is also directed toward an implantable, inflatable device. It would have been obvious to one of ordinary skill in the art prior to the effective filing date to modify the flow rate of the fluid of the device of Smith to partially close or open the active valve in order to keep the pressure within a desired range as taught by Harmouche. It would be obvious for this adjusting of control valves to happen within a range that is less than the target value so that the pressure does not exceed the threshold value and is able to be maintained at that point. Doing so would be a combination of known elements in the prior art that has predictable results. The results being an inflatable medical device that can keep reservoir pressure within a determined range by adjusting the valves to be partially open or close as taught by Harmouche.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Smith as applied to claim 8 above in view of US 20230320830 A1 (Hereinafter “Lamraoui”).
Regarding claim 10, Smith teaches the implantable device of claim 8.
Smith does not explicitly teach wherein the controller is configured to detect a posture of a patient of the implantable device based on pressure readings from at least one of the first pressure sensor or the second pressure sensor, the controller configured to adjust the pressure of the inflatable member based on the detected posture.
Lamraoui teaches wherein an implantable medical device that has a control unit configured to detect a posture of a patient of the implantable device based on pressure readings from a pressure sensor ([0104]-[0106], “the current pressure value is compared with the previous pressure value and with the values recorded during the calibration step 23 to detect a change in posture and therefore a new posture in step 26. According to the invention, the control unit 10 is arranged to repeat steps 24, 25 and 26 at regular and frequent time intervals to detect the posture changes.”), the control unit configured to adjust the pressure of the inflatable member based on the detected posture ([0113], “ the present invention therefore allows a detection of the posture or of the change in posture that is more robust and more reliable in order to allow best adapting the pressure exerted on the natural conduit by the deformable element and thus avoiding overstressing it and damaging it.”).
Lamraoui is analogous art because it is also directed toward an inflatable, implantable medical device. It would have been obvious to one of ordinary skill in the art prior to the effective filing date to modify the control unit of Smith to store records of pressure values that correspond with postures and using the collected data to determine changes in posture using the pressure of the reservoir. Doing so would be a combination of two known elements in the prior art to yield a predictable result. The predictable result being a device that is able to adapt the pressure exerted on the natural conduit. Adapting the pressure allows the device to be used in all postures and at more times and is able to manage stress incontinence as described in paragraphs [0014]-[0016] of Lamraoui.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 20200222188 A1 (Hereinafter “Smith”) in view of US 20190133737 A1 (Hereinafter “Hohlrieder”).
Regarding claim 18, Smith teaches a method of operating an implantable device (Method of Figure 5 and implantable device 200 of Figure 2), the method comprising:
receiving, a control signal from a device; generating, by a controller, a first control signal to control an active valve of the electronic pump assembly in response to the control signal ([0043], “For example, the patient may activate the interface element 211 to place the pump assembly 206 in the inflation mode, which causes the electronic control module 213 to activate the first electronically powered pump 208 (e.g., by sending a signal to the first electronically powered pump 208). In some examples, if the first valve 212 is an active valve, the electronic control module 213 is configured to open the first valve 212 (e.g., by sending a signal to the first valve 212).”);
and actuating, in response to the first control signal, the active valve to an open position to transfer fluid from a pressurized fluid reservoir to an inflatable member until the pressure in the inflatable member reaches a threshold level ([0039], “the first electronically powered pump 208 is a one-way pump configured to transfer fluid from the fluid reservoir 202 to the inflatable member 204 during the inflation mode.”; [0046], “The electronic control module 213 is configured to deactivate the first electronically powered pump 208 in response to the pressure of the inflatable member 204 reaching or exceeding a set pressure target.”).
Smith does not explicitly teach the electronic pump assembly including an antenna configured to receive a wireless signal from an external device.
Hohlrieder teaches an implantable medical device with an electronic pump assembly (Figure 1, pump electronics unit 17) includes an antenna configured to receive a wireless control signal from an external device ([0045], “An operating electronics unit 20 of the operating unit 19 in this case communicates with the pump electronics unit 17 via a radio link.”; Claim 3, “an operating unit arranged spatially separate from the pump unit, the pump unit includes a pump electronics unit and the operating unit includes an operating electronics unit, and the electronic control system of the device comprises the pump electronics unit and the operating electronics unit, and the pump electronics unit and the operating electronics unit communicate via a wireless link.”; A radio link would require an antenna in order to receive the signal).
Hohlrieder is analogous art because it is also directed toward an implantable medical device with an electronic pump. It would have been obvious to one of ordinary skill in the art prior to the effective filing date to modify the pumps and interface of Smith to include the electronics of Hohlrieder that allow the device to communicate wirelessly. Doing so would be a combination of known elements in the prior art to yield a predictable result. The predictable result being the patient interface and pumps of the device communicating wirelessly. This would allow the patient interface to be external from the device and would allow the patient to control the device without having to touch the medical device making the control easier.
Regarding claim 19, the combination teaches the method of claim 18, further comprising: generating, by the controller, a second control signal to control a pump of the electronic pump assembly; actuating, in response to the second control signal, the pump to transfer the fluid from the inflatable member to the pressurized fluid reservoir (Smith, [0032], “ the secondary electronically powered pump 110 may transfer fluid from the inflatable member 104, through the pump assembly 106 (via the second valve 114—which is open if electronically controlled), and to the fluid reservoir 102 in the deflation mode.”; [0044], “ the interface element 211 to place the pump assembly 206 in the deflation mode, which causes the electronic control module 213 to activate the second electronically powered pump 210 (e.g., by sending a signal to the second electronically powered pump 210”).
Regarding claim 20, the combination teaches the method of claim 19, further comprising: detecting, by the controller, that the pressure of the inflatable member exceeds the threshold level, wherein the second control signal is generated in response to the pressure of the inflatable member being detected as exceeding the threshold level (Smith, [0046], “The electronic control module 213 is configured to deactivate the first electronically powered pump 208 in response to the pressure of the inflatable member 204 reaching or exceeding a set pressure target.” [0044], “ the interface element 211 to place the pump assembly 206 in the deflation mode, which causes the electronic control module 213 to activate the second electronically powered pump 210 (e.g., by sending a signal to the second electronically powered pump 210”).
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.
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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/BRIAN L CASLER/Primary Examiner, Art Unit 3791
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