DETAILED ACTION
The following Office Action is in response to the Response to Restriction filed on January 2, 2026. Claims 155-194 and 205-214 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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on January 2, 2026 is acknowledged.
Claims 195-204 were cancelled without prejudice or disclaimer. Election was made without traverse in the reply filed on January 2, 2026.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 185-189, 191-192, 210, and 213-214 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fahey et al. (US 2021/0370032, hereinafter Fahey).
Concerning claim 185, the Fahey et al. prior art reference teaches a system (Figures 2-8C) comprising: an implantable control system (Figure 3; 325) for controlling a blood flow modulator (Figure 2; 250 | Figure 3; 302), the implantable controller system comprising: a housing (Figure 3; housing of 325); a microcontroller disposed in the housing (Figure 3; 326a-c), the microcontroller comprising: one or more computer readable storage devices configured to store a plurality of computer-executable instructions ([¶ 0133-0134]); one or more hardware computer processors in communication with the one or more computer readable storage devices ([¶ 0133-0134]); and a first communication module ([¶ 0073]); an actuator (Figure 8A-C; 850 | [¶ 0064]) comprising: a control member having a first end configured to be coupled with the blood flow modulator (Figure 8A-C; first end 851 connects to blood flow modulator via struts) and a second end configured to be disposed adjacent to or in the housing (Figure 8A-C; 852); a traveler configured to be coupled to the second end of the control member (Figure 8A-C; 853); and a motor coupled to the traveler, the motor configured to control movement of the traveler relative to the housing ([¶ 0050]), wherein movement of the traveler in a first direction is configured to cause the blood flow modulator to move between a low profile state (Figure 8B) and a high profile pressure modulating state (Figure 8C); and a first power source disposed in the housing configured to generate current for the actuator (Figure 2; 232 | [¶ 0091]).
Concerning claim 186, the Fahey reference teaches the system of claim 185, further comprising: 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 (Figure 2; 240a).
Concerning claim 187, the Fahey reference teaches the system of claim 185, wherein 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 ([¶ 0046]).
Concerning claim 188, the Fahey reference teaches the system of claim 185, wherein the computer-executable instructions, when executed, further configure the one or more hardware computer processers to: receive, from an external device (Figure 2; 260), treatment instructions comprising a treatment duration and a target state for the blood flow modulator (treatment duration = time it takes to achieve desired flow rate); and activate the actuator such that the traveler translates a first distance in the first direction, the first distance corresponding to the target state ([¶ 0056]).
Concerning claim 189, the Fahey reference teaches the system of claim 188, wherein the computer-executable instructions, when executed, further configure the one or more hardware computer processors to: determine that the treatment duration is expired (treatment duration = time it takes to achieve desired flow rate); and activate the actuator such that the traveler translates the first distance in a second direction, the second direction opposite the first direction ([¶ 0056], controller controls actuator via feedback from sensors).
Concerning claim 191, the Fahey reference teaches the system of claim 185, wherein at least a portion of the actuator is configured to be enclosed within an ingress protection system (Figure 8A; portion of the wall of the housing from which strut extends may be interpreted as ingress protection system) configured to prevent fluid received within the ingress protection system from entering a main portion of the housing (prevents fluid from entering main portion of housing by nature of being a wall that separates fluid from housing).
Concerning claim 192, the Fahey reference teaches the system of claim 185, wherein the housing is an external housing (Figure 4B; housings of each component 432ab, 425 may together be interpreted as an external housing) and the ingress protection system comprises an internal housing (Figure 8A; housing of actuator specifically may be interpreted as an internal housing), the internal housing is positioned within the external housing and hermetically sealed relative to the housing (housing of actuator positioned within the grouping of component housings interpreted as the external housing, and hermetically sealed relative to the external housing in that it is a separated housing structure).
Concerning claim 210, the Fahey reference teaches the system of claim 188, wherein the implantable controller system further comprises an induction receiver configured to activate the actuator or charge the first power source ([¶ 0052]).
Concerning claim 213, the Fahey reference teaches the system of claim 188, wherein the microcontroller is disposed in a first compartment of the housing (Figure 2; 260), and the actuator is disposed in a second compartment of the housing (Figure 2; 250), and wherein the first compartment is isolated from the second compartment.
Concerning claim 214, the Fahey reference teaches the system of claim 214, further comprising: the blood flow modulator coupled to the first end of the control member wherein the blood flow modulator comprises a flow restrictor configured to be positioned in a vessel of a patient (8A; 805).
Claim(s) 185, 193-194, 207-208, and 210-211 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Pool et al. (US 2025/0281295, hereinafter Pool).
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]); and a first communication module ([¶ 0091, 110]); 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]).
Concerning claim 193, the Pool reference teaches the system of claim 185, wherein the implantable controller system further comprises a tube (Figure 4A; 218) having a first end configured to be coupled with the blood flow modulator (Figure 4A; 200) and a second end configured to be disposed adjacent to or in the housing (Figure 4A; 214), the control member extending through the tube such that the control member is not exposed to a patient in use at least along a portion of a length thereof, the control member configured to move relatively to the tube.
Concerning claim 194, the Pool reference teaches the system of claim 185, wherein the housing further comprises an extension portion defining a passage into the housing (Figure 4C; tapered front portion of housing of 214), wherein the second end of the control member is configured to extend through the passage (Figure 4B; 204) and the second end of the tube is configured to extend at least partially through the passage, wherein the tube can be selectively fixed to the housing by applying a compressive force on the second end of the tube.
Concerning claim 207, the Pool reference teaches the system of claim 185, wherein the actuator further comprises an externally threaded shaft engaged with the traveler, the externally threaded shaft configured to be rotated by the motor (Figure 4B; 206 | [¶ 0090]).
Concerning claim 208, the Pool reference teaches the system of claim 185, wherein the motor comprises an output shaft rotatable about a first axis, the output shaft configured to drive rotation of the externally threaded shaft about a second axis, the first axis parallel to the second axis ([¶ 0091]).
Concerning claim 210, the Pool reference teaches the system of claim 185, wherein the implantable controller system further comprises an induction receiver configured to active the actuator or charge the first power source ([¶ 0039, 0060]).
Concerning claim 211, the Pool reference teaches the system of claim 210, wherein the housing comprises 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).
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) 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 Kane et al. (US 2019/0223909, hereinafter Kane).
Concerning claim 190, the Pool reference teaches the system of claim 185, wherein the actuator further includes 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 a 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 reference 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]).
Claim(s) 212 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pool et al. (US 2025/0281295, hereinafter Pool) in view of Zhang (US 2014/0276159).
Concerning claim 212, the Pool reference teaches the system of claim 185, wherein the implantable controller system further comprises a heart rate sensor, which may be an electrocardiogram sensor, connected to the microcontroller and configured to detect electrical activity of a patient’s heart ([¶ 0097]), but it does not specifically teach the electrocardiogram sensors being disposed on an outer surface of the housing.
However, the Zhang reference teaches an implantable device which is for cardiac sensing, therein being in the same field of endeavor as the Pool reference, wherein the Zhang reference teaches that the implantable device may include electrodes on an outer surface of a housing to be used as electrocardiogram sensors ([¶ 0017]).
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 electrocardiogram sensor of the Pool reference be positioned on an outer surface of the housing as in the Zhang reference given the Zhang reference teaches that such is a proper positioning for an electrocardiogram sensor relative to a housing for an implantable controller (Zhang; [¶ 0017]).
Allowable Subject Matter
Claims 205-206 and 209 are 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Kapur et al. reference (US 2021/0177425) and the Yildirim et al. reference (US 2024/0226535) both teach implantable controller systems for controlling a blood flow modulator similar to the invention.
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/MARTIN T TON/Examiner, Art Unit 3771 2/4/2026