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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 6, 7, 12-16, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (U.S. Pub. No. 2020/0222188 A1; cited in the IDS filed 03 August 2023; hereinafter known as “Smith”), in view of Newman et al. (U.S. Pub. No. 2017/0079760 A1; hereinafter known as “Newman”).
Regarding claim 1, Smith discloses an inflatable penile prosthesis (Abstract; [0003]; [0080]) comprising: a fluid reservoir 102 configured to hold fluid ([0022]-[0023]); an inflatable member 104 ([0022]); and an electronic pump assembly 106 configured to transfer the fluid between the fluid reservoir and the inflatable member, the electronic pump assembly including: a pump 108; an active valve 112/114; and a controller 113 configured to receive a signal to activate an inflation cycle and control at least one of the pump or the active valve to transfer the fluid to the inflatable member ([0026]; [0028]-[0030]; [0040]; [0042]-[0043]), the controller including a printed circuit board assembly, the printed circuit board assembly including a processor ([0042]). Smith fails to expressly disclose that the signal is an external signal, as well as that the processor is a microprocessor. Newman discloses a similar apparatus (Abstract) comprising an electronic pump assembly that includes a controller configured to receive an external signal to control the pump, wherein the controller includes a microprocessor, in order to remotely and noninvasively control inflation/deflation ([0012]; [0015]-[0016]; [0019]; [0035]; [0050]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Smith with a controller that is configured to receive an external signal and is a microprocessor, as taught by Newman, in order to remotely and noninvasively control inflation/deflation.
Regarding claim 2, the combination of Smith and Newman discloses the invention as claimed, see rejection supra, and Newman further discloses that the electronic pump assembly includes an antenna, the antenna configured to receive the external signal, in order to allow for bidirectional communication ([0046]), the external signal including a Bluetooth signal ([0040]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Smith and Newman with an antenna for receiving a Bluetooth signal, as taught by Newman, in order to allow for bidirectional communication.
Regarding claim 3, the combination of Smith and Newman discloses the invention as claimed, see rejection supra, and Newman further discloses that the electronic pump assembly includes an antenna, the antenna configured to receive the external signal, in order to allow for bidirectional communication ([0046]), the external signal including a near-field communication (NFC) signal ([0040]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Smith and Newman with an antenna for receiving an NFC signal, as taught by Newman, in order to allow for bidirectional communication.
Regarding claim 4, the combination of Smith and Newman discloses the invention as claimed, see rejection supra, and Newman further discloses that the printed circuit board assembly includes a power source, wherein the power source is configured to be charged by the NFC signal in order to provide power to the pump assembly ([0014]; [0017]; [0035]-[0036]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Smith and Newman with a power source that is configured to be charged by the NFC signal, as taught by Newman, in order to provide power to the pump assembly.
Regarding claim 6, the combination of Smith and Newman discloses the invention as claimed, see rejection supra, and Newman further discloses that the electronic pump assembly includes an antenna, the antenna configured to receive the external signal, in order to allow for bidirectional communication ([0046]), the external signal including a radio frequency (RF) signal ([0046]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Smith and Newman with an antenna for receiving a RF signal, as taught by Newman, in order to allow for bidirectional communication.
Regarding claim 7, the combination of Smith and Newman discloses the invention as claimed, see rejection supra, and Newman further discloses that the electronic pump assembly includes an inductive antenna, the antenna configured to receive the external signal, the external signal including an inductive signal, in order to allow for bidirectional communication and receive power ([0046]-[0047]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Smith and Newman with an inductive antenna for receiving an inductive signal, as taught by Newman, in order to allow for bidirectional communication and receive power.
Regarding claim 12, Smith discloses an inflatable penile prosthesis (Abstract; [0003]; [0080]) comprising: a fluid reservoir 102 configured to hold fluid ([0022]-[0023]); an inflatable member 104 ([0022]); and an electronic pump assembly 106 configured to transfer the fluid between the fluid reservoir and the inflatable member, the electronic pump assembly including: a pump 108; an active valve 112/114; a controller 113 configured to determine to activate an inflation cycle based on a received signal and control at least one of the pump or the active valve to transfer the fluid to the inflatable member ([0026]; [0028]-[0030]; [0040]; [0042]-[0043]), and a power source 130 configured to power the controller ([0028]). Smith fails to disclose an antenna configured to receive an external signal for the controller, as well as that the power source is configured to be recharged by wireless transmissions received by the antenna. Newman discloses a similar apparatus (Abstract) comprising an electronic pump assembly that includes an antenna 403 configured to receive an external signal to control the pump, as well as a power source configured to be recharged by wireless transmissions received by the antenna, in order to remotely and noninvasively control inflation/deflation and power the pump assembly ([0012]; [0015]-[0016]; [0035]-[0036]; [0046]-[0050]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Smith with an antenna configured to receive an external signal and a power source configured to be recharged by wireless transmissions received by the antenna, as taught by Newman, in order to remotely and noninvasively control inflation/deflation and power the pump assembly.
Regarding claim 13, the combination of Smith and Newman discloses the invention as claimed, see rejection supra, and Newman further discloses that the wireless transmissions include near-field communication (NFC) transmissions ([0012]; [0031]; [0040]).
Regarding claim 14, the combination of Smith and Newman discloses the invention as claimed, see rejection supra, and Newman further discloses that the wireless transmissions include radio frequency (RF) transmissions ([0012]; [0031]; [0039]-[0040]; [0046]).
Regarding claim 15, the combination of Smith and Newman discloses the invention as claimed, see rejection supra, and Newman further discloses that the wireless transmissions include capacitive or inductive transmissions ([0046]-[0047]).
Regarding claim 16, the combination of Smith and Newman discloses the invention as claimed, see rejection supra, and Newman further discloses that the controller includes a printed circuit board assembly, the printed circuit board assembly including a microprocessor configured to interpret the external signal in order to control the pump assembly based on the external signal ([0017]; [0050]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Smith and Newman with such a microprocessor, as taught by Newman, in order to control the pump assembly based on the external signal.
Regarding claim 19, Smith discloses a method of controlling an inflatable penile prosthesis (Abstract; [0003]; [0080]) comprising: detecting, by a controller 113 of an electronic pump assembly 106, a signal, the controller including a printed circuit board assembly, the printed circuit board assembly including a processor; determining to activate an inflation cycle of the inflatable penile prosthesis based on the signal; and actuating at least one of a pump 108 or an active valve 112/114 to transfer fluid from a fluid reservoir 102 to an inflatable member 104 ([0022]-[0023]; [0026]; [0028]-[0030]; [0040]; [0042]-[0043]). Smith fails to expressly disclose that the signal is an external signal, as well as that the processor is a microprocessor. Newman discloses a similar method (Abstract) that uses an electronic pump assembly that includes a controller that detects an external signal to control the pump, wherein the controller includes a microprocessor, in order to remotely and noninvasively control inflation/deflation ([0012]; [0015]-[0016]; [0019]; [0035]; [0050]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Smith with a controller that is configured to detect and receive an external signal and is a microprocessor, as taught by Newman, in order to remotely and noninvasively control inflation/deflation.
Regarding claim 20, the combination of Smith and Newman discloses the invention as claimed, see rejection supra, and further discloses charging a battery (Smith: [0028]; Newman: [0006]) of the electronic pump assembly based on wireless transmissions received via an antenna 403 of the electronic pump assembly, the wireless transmissions including inductive, ultrasonic, near-field communication (NF), radio frequency (RF), or capacitive transmissions, in order to remotely power the pump assembly (Newman: [0012], [0015]-[0016], [0035]-[0036], [0046]-[0050]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Smith and Newman with such a wireless charging, as taught by Newman, in order to remotely power the pump assembly.
Claims 5, 8, 11, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Smith and Newman as applied to claims 1 and 12 above, and further in view of Forsell (U.S. Pub. No. 2023/0067834 A1).
Regarding claim 5, the combination of Smith and Newman discloses the invention as claimed, see rejection supra, but fails to disclose that the printed circuit board assembly includes a magnetic sensing circuit, the controller configured to detect activation of the inflation cycle in response to the magnetic sensing circuit detecting a presence of a magnetic field. Forsell discloses a similar apparatus (Abstract) comprising a controller for controlling a pump assembly, wherein the controller includes a magnetic sensing circuit and is configured to detect activation of the inflation cycle in response to the magnetic sensing circuit detecting a presence of a magnetic field ([0207]-[0208]; [1470]-[1475]; [1574]-[1577]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Smith and Newman with such a magnetic sensing circuit, as taught by Forsell, as this would have been a simple substitution of one known prior art element for another with predictable results. The wireless external controlling taught by Newman and the wireless external magnetic controlling taught by Forsell both function to provide external control of an internal pump.
Regarding claim 8, the combination of Smith and Newman discloses the invention as claimed, see rejection supra, and Newman further discloses that the electronic pump assembly includes an antenna, the antenna configured to receive the external signal, in order to allow for bidirectional communication ([0046]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Smith and Newman with an antenna for receiving the external signal, as taught by Newman, in order to allow for bidirectional communication. The combination of Smith and Newman fails to disclose that the external signal includes an ultrasonic signal. Forsell discloses a similar apparatus (Abstract) comprising a controller for controlling a pump assembly based upon external signals, wherein the external signal includes an ultrasonic signal ([0223]-[0224]; [0651]; [0826]; [1501]-[1502]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Smith and Newman with such an ultrasonic external signal, as taught by Forsell, as this would have been a simple substitution of one known prior art element for another with predictable results. The wireless external controlling taught by Newman and the wireless external controlling taught by Forsell both function to provide external control of an internal pump.
Regarding claim 11, the combination of Smith and Newman discloses the invention as claimed, see rejection supra, but fails to disclose an acoustic sensor configured to receive an acoustic signal, the controller configured to determine activation of the inflation cycle in response to the acoustic signal. Forsell discloses a similar apparatus (Abstract) comprising a controller for controlling a pump assembly based upon external signals, wherein the pump assembly includes an acoustic sensor configured to receive an acoustic signal, the controller configured to determine activation of the inflation cycle in response to the acoustic signal ([0223]-[0224]; [0651]; [0826]; [0846]; [1501]-[1502]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Smith and Newman with such an acoustic sensor, as taught by Forsell, as this would have been a simple substitution of one known prior art element for another with predictable results. The wireless external controlling taught by Newman and the wireless external controlling taught by Forsell both function to provide external control of an internal pump.
Regarding claim 17, the combination of Smith and Newman discloses the invention as claimed, see rejection supra, but fails to disclose that the controller includes a printed circuit board assembly that includes a state machine configured to interpret the external signal. Forsell discloses a similar apparatus (Abstract) comprising a controller for controlling a pump assembly based upon external signals, wherein the controller includes a printed circuit board assembly that includes a state machine configured to interpret the external signal in order to provide special purpose processing ([0508]; [0546]; [0683]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Smith and Newman with such a state machine, as taught by Forsell, in order to provide special purpose processing.
Regarding claim 18, the combination of Smith, Newman, and Forsell discloses the invention as claimed, see rejection supra, and Forsell further discloses that the state machine includes a field-programmable gate array or an application-specific integrated circuit ([0508]; [0546]; [0683]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Smith and Newman as applied to claim 1, and further in view of Weber et al. (U.S. Pub. No. 2019/0350712 A1; hereinafter known as “Weber”). The combination of Smith and Newman discloses the invention as claimed, see rejection supra, and Smith further discloses that the electronic pump assembly includes a pressure sensor, the controller configured to receive a pressure reading from the pressure sensor that indicates a pressure of the inflatable member ([0031]). The combination of Smith and Newman fails to expressly disclose that the controller is configured to determine that the inflation cycle is activated in response to pressure exceeding a threshold level. Weber discloses a similar apparatus (Abstract) comprising a controller for controlling a pump assembly, wherein the controller is configured to receive a pressure reading from a pressure sensor that indicates a pressure of an inflatable member and to determine that the inflation cycle is activated in response to pressure exceeding a threshold level in order to provide a second phase of the inflation cycle ([0008]; [0039]-[0042]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Smith and Newman with such controller logic, as taught by Weber, in order to provide a second phase of the inflation cycle.
Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: none of the prior art of record teaches or reasonably suggests such an electronic pump assembly that includes a first conductive plate and a controller that determines activation of the inflation cycle in response to a second conductive plate of an external device being placed within a threshold distance of the first conductive plate, in combination with such an inflatable penile prosthesis.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791