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 the Applicant’s arguments
The previous rejection is withdrawn. Applicant’s amendments are entered. Applicant’s remarks are also entered into the record. A new search was made necessitated by the applicant’s amendments.
A new reference was found. A new rejection is made herein.
Applicant’s arguments are now moot in view of the new rejection of the claims.
In regard to claim, 1 and 11, the primary reference is silent but Ganguly teaches “...a programable control module, the programmable control module being configured to
identify when a user is asleep, (see paragraph 169 where an accelerometer can detect if the user is asleep and one or more sleep stages of the patient)
It would have been obvious for one of ordinary skill in the art before the effective filing date to combine the teachings of GENGULY with the disclosure of the primary reference since GANGULY teaches that an accelerometer can be provided on the wrist of the member to detect if the member is sleeping to administer therapy when the user is sleeping and in a deep sleep as evidenced by a sleep stage that indicates a deep sleep. See paragraph 169-179.
The primary reference is silent but Orr teaches “... the programable control module being configured activate the
pump assembly to transfer fluid from the fluid reservoir to the inflatable member while the user is asleep.” (see paragraph 191-194 where the pump can inflate the bladder and where this can occur at night when sleeping and when recharging with a blanket charger in paragraph 135)
It would have been obvious for one of ordinary skill in the art before the effective filing date to combine the disclosure of the primary reference with the teachings of Orr since Orr teaches to provide a pump that can inflate an inflatable member. This also can happen during the day or when the user is sleeping with a rechargeable battery that can be charged with a blanket charger. See paragraph 135.
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.
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.
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.
Claims 1-3, and 5-21 are rejected under 35 U.S.C. sec. 103 as being unpatentable as obvious in view of United States Patent Application Pub. No.: US 2017/079760Al to NEWMAN that was filed in 2016 and assigned to MHN BIOTECH LLC and in view of United States Patent Application Pub. No.: US20220280792A1 to GANGULY et al. filed in 2017 and in view of U.S. Patent No.: US12059543B2 to Orr.
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Newman discloses “ 1. An implantable inflatable device, comprising: (see Fig. 4b where the device is a penile implant or an anal implant)
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a fluid reservoir defining
a cavity; (see elements 401 and 416 where the device has a reservoir with a fill port and a case)
an inflatable member;
a pump assembly configured to transfer fluid from the fluid reservoir to the inflatable member; and (see pump 411 that is reversible and can provide a transfer of the fluid to the penile pump implant and see abstract)
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a programable control module, (see processor 307)
the programable control module being configured activate the pump assembly to transfer fluid from the fluid reservoir to the inflatable member”. (see claims 1-14 where the controller can provide a signal to provide transdermal power transfer to the pump and see paragraph 16-17 and 30-39 where the external controller can provide a pump to inflate the pump implant to treat erectile dysfunction and include a signal for on and off and deflate)
In regard to claim, 1 and 11, the primary reference is silent but Ganguly teaches “...a programable control module, the programmable control module being configured to
identify when a user is asleep, (see paragraph 169 where an accelerometer can detect if the user is asleep and one or more sleep stages of the patient)
It would have been obvious for one of ordinary skill in the art before the effective filing date to combine the teachings of GENGULY with the disclosure of the primary reference since GANGULY teaches that an accelerometer can be provided on the wrist of the member to detect if the member is sleeping to administer therapy when the user is sleeping and in a deep sleep as evidenced by a sleep stage that indicates a deep sleep. See paragraph 169-179.
The primary reference is silent but Orr teaches “... the programable control module being configured activate the
pump assembly to transfer fluid from the fluid reservoir to the inflatable member while the user is asleep.” (see paragraph 191-194 where the pump can inflate the bladder and where this can occur at night when sleeping and when recharging with a blanket charger in paragraph 135)
It would have been obvious for one of ordinary skill in the art before the effective filing date to combine the disclosure of the primary reference with the teachings of Orr since Orr teaches to provide a pump that can inflate an inflatable member. This also can happen during the day or when the user is sleeping with a rechargeable battery that can be charged with a blanket charger. See paragraph 135.
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Newman discloses “...2. The implantable inflation device of claim 1, wherein the programable control module is configured to be controlled by a device located outside of a body of the patient. (see claims 1-14 where the controller can provide a signal to provide transdermal power transfer to the pump and see paragraph 16-17 and 30-39 where the external controller can provide a pump to inflate the pump implant to treat erectile dysfunction and include a signal for on and off and deflate)”.
Newman discloses “...3. The implantable inflation device of claim 1, wherein the programable control module is configured to activate the pump assembly according to a schedule. (see paragraph 36 where the operation can provide a signal based on pressure data, pump speed and motor current and voltage and reservoir temperature or use data and see claims 1-14 where the controller can provide a signal to provide transdermal power transfer to the pump and see paragraph 16-17 and 30-39 where the external controller can provide a pump to inflate the pump implant to treat erectile dysfunction and include a signal for on and off and deflate)
Claim 4 is canceled.
Newman discloses “..4. The implantable inflation device of claim 1, wherein the programable control module is configured to activate the pump assembly while a user is asleep. (see paragraph 33 where the pump can be operated during the speed and time of day and see p. 36 where the operation can provide a signal based on pressure data, pump speed and motor current and voltage and reservoir temperature or use data and see claims 1-14 where the controller can provide a signal to provide transdermal power transfer to the pump and see paragraph 16-17 and 30-39 where the external controller can provide a pump to inflate the pump implant to treat erectile dysfunction and include a signal for on and off and deflate)
Newman discloses “...5. The implantable inflation device of claim 1, wherein the programable control module is configured to activate the pump assembly such that the inflatable member inflates and deflates according to a schedule. (see paragraph 33 where the pump can be operated during the speed and time of day and see p. 36 where the operation can provide a signal based on pressure data, pump speed and motor current and voltage and reservoir temperature or use data and see claims 1-14 where the controller can provide a signal to provide transdermal power transfer to the pump and see paragraph 16-17 and 30-39 where the external controller can provide a pump to inflate the pump implant to treat erectile dysfunction and include a signal for on and off and deflate)
Newman discloses “...6. The implantable inflation device of claim 1, wherein the programable control module is configured to activate the pump assembly such that the inflatable member inflates and deflates while a user is asleep. (see paragraph 33 where the pump can be operated during the speed and time of day and see p. 36 where the operation can provide a signal based on pressure data, pump speed and motor current and voltage and reservoir temperature or use data and see claims 1-14 where the controller can provide a signal to provide transdermal power transfer to the pump and see paragraph 16-17 and 30-39 where the external controller can provide a pump to inflate the pump implant to treat erectile dysfunction and include a signal for on and off and deflate)
Newman discloses “...7. The implantable inflation device of claim 1, wherein the programable control module is configured to activate the pump assembly such that the inflatable member inflates and deflates according to a schedule. (see paragraph 33 where the pump can be operated during the speed and time of day and see p. 36 where the operation can provide a signal based on pressure data, pump speed and motor current and voltage and reservoir temperature or use data and see claims 1-14 where the controller can provide a signal to provide transdermal power transfer to the pump and see paragraph 16-17 and 30-39 where the external controller can provide a pump to inflate the pump implant to treat erectile dysfunction and include a signal for on and off and deflate)
Newman discloses “...8. The implantable inflation device of claim 1, wherein the programable control module is configured to activate the pump assembly such that the inflatable member inflates and deflates a plurality of times over a period of several hours. (see paragraph 33 where the pump can be operated during the speed and time of day and see p. 36 where the operation can provide a signal based on pressure data, pump speed and motor current and voltage and reservoir temperature or use data and see claims 1-14 where the controller can provide a signal to provide transdermal power transfer to the pump and see paragraph 16-17 and 30-39 where the external controller can provide a pump to inflate the pump implant to treat erectile dysfunction and include a signal for on and off and deflate)
Newman discloses “...9. The implantable inflation device of claim 1, wherein the programable control module is configured to activate the pump assembly such that a frequency of the pump actuation pulses over a period of time. (see paragraph 33-38 where the pump can be operated during the speed and time of day and see p. 36 where the operation can provide a signal based on pressure data, pump speed and motor current and voltage and reservoir temperature or use data and see claims 1-14 where the controller can provide a signal to provide transdermal power transfer to the pump and see paragraph 16-17 and 30-39 where the external controller can provide a pump to inflate the pump implant to treat erectile dysfunction and include a signal for on and off and deflate)
Newman discloses “..10. The implantable inflation device of claim 1, wherein the programable control module is configured to activate the pump assembly such that the frequency of the pump actuation pulses a plurality of time over a period of 10 minutes. (see paragraph 51 where the pump pressure can be set for revolution per minute and for 10 minutes 10x revolutions and see paragraph 33 where the pump can be operated during the speed and time of day and see p. 36 where the operation can provide a signal based on pressure data, pump speed and motor current and voltage and reservoir temperature or use data and see claims 1-14 where the controller can provide a signal to provide transdermal power transfer to the pump and see paragraph 16-17 and 30-39 where the external controller can provide a pump to inflate the pump implant to treat erectile dysfunction and include a signal for on and off and deflate)
Newman discloses “...11. A method, comprising:
activating a pump assembly of an inflation device disposed within a body of a user (see Fig. 4b where the device is a penile implant or an anal implant) (see elements 401 and 416 where the device has a reservoir with a fill port and a case) (see pump 411 that is reversible and can provide a transfer of the fluid to the penile pump implant and see abstract) (see processor 307) (see claims 1-14 where the controller can provide a signal to provide transdermal power transfer to the pump and see paragraph 16-17 and 30-39 where the external controller can provide a pump to inflate the pump implant to treat erectile dysfunction and include a signal for on and off and deflate)
such that a pressure within an inflatable member of the inflation device increases and decreases a plurality of times according to a schedule. (see paragraph 51 where the pump pressure can be set for revolution per minute and for 10 minutes 10x revolutions and see paragraph 33 where the pump can be operated during the speed and time of day and see p. 36 where the operation can provide a signal based on pressure data, pump speed and motor current and voltage and reservoir temperature or use data and see claims 1-14 where the controller can provide a signal to provide transdermal power transfer to the pump and see paragraph 16-17 and 30-39 where the external controller can provide a pump to inflate the pump implant to treat erectile dysfunction and include a signal for on and off and deflate)”.
In regard to claim, 1 and 11, the primary reference is silent but Ganguly teaches “...a programable control module, the programmable control module being configured to
identify when a user is asleep, (see paragraph 169 where an accelerometer can detect if the user is asleep and one or more sleep stages of the patient)
It would have been obvious for one of ordinary skill in the art before the effective filing date to combine the teachings of GENGULY with the disclosure of the primary reference since GANGULY teaches that an accelerometer can be provided on the wrist of the member to detect if the member is sleeping to administer therapy when the user is sleeping and in a deep sleep as evidenced by a sleep stage that indicates a deep sleep. See paragraph 169-179.
The primary reference is silent but Orr teaches “... the programable control module being configured activate the
pump assembly to transfer fluid from the fluid reservoir to the inflatable member while the user is asleep.” (see paragraph 191-194 where the pump can inflate the bladder and where this can occur at night when sleeping and when recharging with a blanket charger in paragraph 135)
It would have been obvious for one of ordinary skill in the art before the effective filing date to combine the disclosure of the primary reference with the teachings of Orr since Orr teaches to provide a pump that can inflate an inflatable member. This also can happen during the day or when the user is sleeping with a rechargeable battery that can be charged with a blanket charger. See paragraph 135.
Newman discloses “...12. The method of claim 11, wherein the pressure within the inflatable member of the inflation device increases and decreases a plurality of times while the user is asleep”. . (see paragraph 33 where the pump can be operated during the speed and time of day and see p. 36 where the operation can provide a signal based on pressure data, pump speed and motor current and voltage and reservoir temperature or use data and see claims 1-14 where the controller can provide a signal to provide transdermal power transfer to the pump and see paragraph 16-17 and 30-39 where the external controller can provide a pump to inflate the pump implant to treat erectile dysfunction and include a signal for on and off and deflate)
Newman discloses “...13. The method of claim 11, wherein the pressure within an inflatable member of the inflation device increases and decreases a plurality of times over a period of hours”. (see paragraph 33 where the pump can be operated during the speed and time of day and see p. 36 where the operation can provide a signal based on pressure data, pump speed and motor current and voltage and reservoir temperature or use data and see claims 1-14 where the controller can provide a signal to provide transdermal power transfer to the pump and see paragraph 16-17 and 30-39 where the external controller can provide a pump to inflate the pump implant to treat erectile dysfunction and include a signal for on and off and deflate)
Newman discloses “...14. The method of claim 11, wherein the pressure within an inflatable member of the inflation device increases and decreases a plurality of times over a period of minutes”. . (see paragraph 51 where the pump pressure can be set for revolution per minute and for 10 minutes 10x revolutions and see paragraph 33 where the pump can be operated during the speed and time of day and see p. 36 where the operation can provide a signal based on pressure data, pump speed and motor current and voltage and reservoir temperature or use data and see claims 1-14 where the controller can provide a signal to provide transdermal power transfer to the pump and see paragraph 16-17 and 30-39 where the external controller can provide a pump to inflate the pump implant to treat erectile dysfunction and include a signal for on and off and deflate)
Newman discloses “..15. The method of claim 11, wherein the inflation device is at least partially disposed within a pelvic region of the user (see Fig. 4b where the device is implanted in the anal region or penile or urth. implant region).
Newman discloses “...16. The method of claim 11, wherein the inflation device is at least partially disposed within a penis of a user. (see Fig. 4b where the device is implanted in the anal region or penile or urth. implant region).
Newman discloses “...17. The method of claim 11, wherein the inflatable member of the inflation device is at least partially disposed within a pelvic region of the user. (see Fig. 4b where the device is implanted in the anal region or penile or urth. implant region).
Newman discloses “...18. The method of claim 11, wherein the inflatable member of the inflation device is at least partially disposed within a penis of a user. (see Fig. 4b where the device is implanted in the anal region or penile or urth. implant region).
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Newman discloses “...19. The method of claim 11, wherein the inflation device includes a fluid reservoir”. (see elements 400-416)
Neman discloses “...20. The method of claim 11, wherein the inflation device includes a programable control module, the programable control module being configured activate the pump assembly. (see paragraph 50-57)”.
In regard to claim, 21, the primary reference is silent but Ganguly teaches “..21. (New) The implantable inflation device of claim 1, wherein the programable control
Module device is operatively connected to an accelerometer.
(see paragraph 169 where an accelerometer can detect if the user is asleep and one or more sleep stages of the patient)
It would have been obvious for one of ordinary skill in the art before the effective filing date to combine the teachings of GENGULY with the disclosure of the primary reference since GANGULY teaches that an accelerometer can be provided on the wrist of the member to detect if the member is sleeping to administer therapy when the user is sleeping and in a deep sleep as evidenced by a sleep stage that indicates a deep sleep. See paragraph 169-179.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEAN PAUL CASS whose telephone number is (571)270-1934. The examiner can normally be reached Monday to Friday 7 am to 7 pm; Saturday 10 am to 12 noon.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scott A. Browne can be reached at 571-270-0151. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEAN PAUL CASS/Primary Examiner, Art Unit 3666
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