DETAILED ACTION
The following Office Action is in response to the Amendment filed on May 11, 2026. Claims 185-194, 206, 209-212, and 214-223 are currently pending.
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
Concerning the “Claim Rejections under 35 U.S.C. §§ 102 & 103” section on pages 11-12 of the Applicant’s response filed on May 11, 2026, the applicant’s arguments have been fully considered, but they are moot in view of the new ground(s) of rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 217 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Lines 2-3 of the claim recite the limitation of “a second tube”. However, claim 215, the claim which claim 217 depends on does not recite a tube or a first tube, which is instead claimed in claim 216, therein making it indefinite as to whether claim 217 is intended to depend on claim 215 or claim 216.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 185-189, 210-211, and 220-223 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pool et al. (US 2025/0281295, hereinafter Pool) in view of Leysieffer (US 2002/0051550).
Concerning claim 185, the Pool et al. prior art reference teaches a system (Figures 1A-6B) comprising: an implantable control system (Figure 1A; 406) for controlling a blood flow modulator (Figure 1A; 402), the implantable controller system comprising: a housing (Figure 4B; housing of 214); a microcontroller disposed in the housing ([¶ 0091]), the microcontroller comprising: one or more computer readable storage devices configured to store a plurality of computer-executable instructions ([¶ 0110]); one or more hardware computer processors in communication with the one or more computer readable storage devices ([¶ 0110]); an actuator (Figure 4B; 214) comprising: a control member having a first end configured to be coupled with the blood flow modulator and a second end configured to be disposed adjacent to or in the housing (Figure 4B; 204); a traveler configured to be coupled to the second end of the control member (Figure 4B; 212); and a motor coupled to the traveler, the motor configured to control movement of the traveler relative to the housing ([¶ 0091]), wherein movement of the traveler in a first direction is configured to cause the blood flow modulator to move between a low profile state and a high profile pressure modulating state ([¶ 0090]); and a first power source disposed in the housing configured to generate current for the actuator ([¶ 0091]), but it does not specifically teach the housing comprising a first compartment and a second compartment, the first compartment fluidly isolated from the second compartment, the microcontroller disposed in the first compartment of housing, the control member disposed adjacent to or in the second compartment of the housing, and the motor disposed in the second compartment of the housing.
However, the Leysieffer reference teaches an implantable controller system for a medical device, therein being in the same field of endeavor as the Pool reference, wherein the implantable controller system includes a housing (Figure 1; 10) comprising a first compartment (Figure 1; 26) and a second compartment (Figure 1; 40), the first compartment fluidly isolated from the second compartment ([¶ 0045]), a microcontroller disposed in the first compartment of the housing (Figure 1; 12), and the remainder of the controller system being disposed in the second compartment of the housing.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the housing of the Pool reference comprise a first compartment and a second compartment, the first compartment fluidly isolated from the second compartment, the microcontroller disposed in the first compartment of housing, and the remainder of the controller, being the control member and the motor, disposed in the second compartment of the housing as in the Leysieffer reference to prevent unwanted interactions between the different parts of the controller that may produce unwanted damage to the system or the housing (Leysieffer; [¶ 0017]).
Concerning claim 186, the combination of the Pool and Leysieffer references as discussed above teaches the system of claim 185, wherein the Pool reference further teaches a pressure sensor configured to generate a pressure signal to be transmitted to the microcontroller as an input for changing states of the blood flow modulator ([¶ 0042]).
Concerning claim 187, the combination of the Pool and Leysieffer references as discussed above teaches the system of claim 185, wherein the Pool reference further teaches the computer-executable instructions, when executed, configure the one or more hardware computer processors to: receive, from a pressure sensor, a pressure signal; and activate the actuator such that the traveler translates in the first direction until the pressure signal indicates a target pressure ([¶ 0069]).
Concerning claims 188 and 189, the combination of the Pool and Leysieffer references as discussed above teaches the system of claim 185, wherein the Pool reference further teaches the computer-executable instructions, when executed, configure the one or more hardware computer processors to: receive, from an external device, treatment instructions comprising a treatment duration and a target state for the blood flow modulator or that the treatment duration should expire; and activate the actuator such that the traveler translates a first distance in the first direction or second direction, the first distance corresponding to the target state and the second direction opposite the first direction ([¶ 0076], controller may be preprogramed with a rule set or predefined parameters and may further be in communication with a computer device).
Concerning claim 210, the combination of the Pool and Leysieffer references as discussed above teaches the system of claim 185, wherein the Pool reference further teaches an induction receiver configured to active the actuator or charge the first power source ([¶ 0039, 0060]).
Concerning claim 211, the combination of the Pool and Leysieffer references as discussed above teaches the system of claim 185, wherein the Pool reference further teaches the housing comprising an outer surface and one or more isolated compartments recessed into the outer surface (Figure 4B), wherein the induction receiver is disposed in one of the one or more isolated compartments ([¶ 0091], housing includes power source, which may include induction receiver), and wherein the induction receiver is electrically connected to the actuator (induction receiver is connected to power source, which is ultimately connected to the actuator).
Concerning claim 220, the Pool et al. prior art reference teaches a system (Figures 1A-6B) comprising: an implantable control system (Figure 1A; 406) for controlling a blood flow modulator (Figure 1A; 402), the implantable controller system comprising: a housing (Figure 4B; housing of 214); an actuator (Figure 4B; 214) comprising: a control member having a first end configured to be coupled with the blood flow modulator and a second end configured to be disposed adjacent to or in the housing (Figure 4B; 204); a traveler configured to be coupled to the second end of the control member (Figure 4B; 212); and a motor disposed in the housing and coupled to the traveler, the motor configured to control movement of the traveler relative to the housing ([¶ 0091]), wherein movement of the traveler in a first direction is configured to cause the blood flow modulator to move between a low profile state and a high profile pressure modulating state ([¶ 0090]); a microcontroller disposed in the housing, the microcontroller configured to control the motor ([¶ 0091]), but it does not specifically teach the housing comprising a first compartment and a second compartment, a wall separating the first compartment from the second compartment such that the first compartment is fluidly isolated from the second compartment, the microcontroller disposed in the first compartment of the housing, and one or more components disposed in the second compartment, the one or more components electrically connected to the microcontroller via one or more conductors extending through hermetic passthroughs in the wall separating the first compartment from the second compartment.
However, the Leysieffer reference teaches an implantable controller system for a medical device, therein being in the same field of endeavor as the Pool reference, wherein the implantable controller system includes a housing (Figure 1; 10) comprising a first compartment (Figure 1; 26) and a second compartment (Figure 1; 40), a wall separating the first compartment from the second compartment (Figure 1; 18) such that the first compartment is fluidly isolated from the second compartment ([¶ 0045]), a microcontroller disposed in the first compartment of the housing (Figure 1; 12), and one or more components disposed in the second compartment, the one or more components electrically connected to the microcontroller via one or more conductors extending through hermetic passthroughs in the wall separating the first compartment from the second compartment (Figure 1; 50).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the housing of the Pool reference comprise a first compartment and a second compartment, a wall separating the first compartment from the second compartment such that, the first compartment fluidly isolated from the second compartment, the microcontroller disposed in the first compartment of housing, and the remainder of the components, disposed in the second compartment of the housing the components being electrically connected to the microcontroller via one or more conductors extending through hermetic passthroughs in the wall separating the first compartment from the second compartment as in the Leysieffer reference to prevent unwanted interactions between the different parts of the controller that may produce unwanted damage to the system or the housing (Leysieffer; [¶ 0017]).
Concerning claim 221, the combination of the Pool and Leysieffer references as discussed above teaches the system of claim 220, wherein the Pool reference further teaches the one or more components comprising an antenna configured to transmit and receive electronic communications with an external device ([¶ 0076]).
Concerning claim 222, the combination of the Pool and Leysieffer references as discussed above teaches the system of claim 220, wherein the Pool reference further teaches the one or more components comprising an electrocardiogram sensor configured to detect electrical activity of the patient’s heart ([¶ 0097], sensors may include heart rate monitor or sensors to measure physical characteristics of the heart).
Concerning claim 223, the combination of the Pool and Leysieffer references as discussed above teaches the system of claim 220, wherein the Pool reference further teaches the one or more components comprising an accelerometer configured to generate an accelerometer signal to be transmitted to the microcontroller, the accelerometer signal indicating a patient condition ([¶ 0097]).
Claim(s) 215 and 216 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pool et al. (US 2025/0281295, hereinafter Pool) in view of Gaffney et al. (US 2023/0106663, hereinafter Gaffney).
Concerning claim 215, the Pool et al. prior art reference teaches a system (Figures 1A-6B) comprising: an implantable control system (Figure 1A; 406) for controlling a blood flow modulator (Figure 1A; 402), the implantable controller system comprising: a housing (Figure 4B; housing of 214); a microcontroller disposed in the housing ([¶ 0091]), the microcontroller comprising: one or more computer readable storage devices configured to store a plurality of computer-executable instructions ([¶ 0110]); one or more hardware computer processors in communication with the one or more computer readable storage devices ([¶ 0110]); an actuator (Figure 4B; 214) comprising: a control member having a first end configured to be coupled with the blood flow modulator and a second end configured to be disposed adjacent to or in the housing (Figure 4B; 204); a traveler configured to be coupled to the second end of the control member (Figure 4B; 212); a drive shaft disposed along a first axis, the drive shaft configured to be coupled to the traveler (Figure 4B; 206); and a motor coupled to the traveler, the motor configured to control movement of the traveler relative to the housing ([¶ 0091]), wherein movement of the traveler in a first direction is configured to cause the blood flow modulator to move between a low profile state and a high profile pressure modulating state ([¶ 0090]); and a first power source disposed in the housing configured to generate current for the actuator ([¶ 0091]), but it does not specifically teach the motor comprising an output shaft disposed along a second axis disposed parallel to and spaced apart from the first axis, the output shaft configured to couple to the drive shaft such that when the motor causes the output shaft to rotate about the second axis.
However, the Gaffney reference teaches an implantable medical device including an actuator comprising a traveler (Figure 3; 164) and a drive shaft disposed along a first axis (Figure 3; 150), the drive shaft configured to be coupled to the traveler, and a motor (Figure 7; 168) comprising an output shaft (Figure 7; 184) disposed along a second axis disposed parallel to and spaced apart from the first axis (Figure 76; shaft 178 receives drive shaft 150 therein defining the first axis, parallel to the axis of the motor), the output shaft configured to couple to the drive shaft such that when the motor causes the output shaft to rotate about the second axis, the output shaft causes the drive shaft to rotate about the first axis to control movement of the traveler relative to the housing ([¶ 0091-0092]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace the motor of the Pool reference with the motor of the Gaffney reference as a simple substitution of one known motor and drive shaft configuration (coaxial configuration of motor and drive shaft of Pool) for another known motor and drive shaft configuration (parallel configuration of motor and drive shaft of Gaffney) that would yield the predictable result of operating in effectively the same manner.
Concerning claim 216, the combination of the Pool and Gaffney references as discussed above teaches the system of claim 215, wherein the Pool reference teaches the traveler comprising a tube having an internally threaded surface configured to engage the drive shaft (Figure 4B; 212 defined as nut).
Claim(s) 190 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pool et al. (US 2025/0281295, hereinafter Pool) in view of Gaffney et al. (US 2023/0106663, hereinafter Gaffney) as applied to claim 215 above, and further in view of Kane et al. (US 2019/0223909, hereinafter Kane).
Concerning claim 190, the combination of the Pool and Gaffney references as discussed above teaches the system of claim 215, wherein the Pool reference further teaches the actuator further including a magnet, but does not specifically teach the implantable control system comprising at least one hall effect sensor positioned near the control member, the at least one hall effect sensor configured to detect a magnetic field produced by the magnet and transmit a corresponding voltage to the microcontroller.
However, the Kane reference teaches a controller system for an implantable device, therein being in the same field of endeavor as the Pool reference, wherein the Kane reference teaches the controller system including an actuator including a control member (Figure 4; 72), a traveler (Figure 4; 80), and a motor (Figure 4; 74), wherein the reference teaches that the device may further include a magnetic position sensor comprising a hall effect sensor ([¶ 0057]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the implantable control system of the Pool and Gaffney combination include at least one hall effector sensor configured to detect a magnetic field produced by the magnet and transmit a corresponding output voltage to the microcontroller as in the Kane reference to provide a position sensor within the control system to provide the controller with an indication of the position of the actuator (Kane; [¶ 0004]).
Allowable Subject Matter
Claims 191-194, 206, 209, 212, 214, and 218-219 are allowed.
Conclusion
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.
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/MARTIN T TON/Examiner, Art Unit 3771 5/23/2026
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