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 .
Claim Objections
Claim 4 is objected to because of the following informalities: lines 4- 5- “the restriction member restricts at least 90 percent of the blood flow through the superior vena cava” should be amended to - - the restriction member is configured to restrict at least 90 percent of the blood flow through the superior vena cava - - since claim 4 is an apparatus claim, amending the claim would provide functional language consistent with an apparatus claim rather than a method claim and to provide consistent claim terminology with claim 9. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: lines 4- 5 – “the restriction member restricts approximately 50 percent of the blood flow through the inferior vena cava” should be amended to - - the restriction member is configured to restrict approximately 50 percent of the blood flow through the inferior vena cava - - since claim 5 is an apparatus claim, amending the claim would provide functional language consistent with an apparatus claim rather than a method claim and to provide consistent claim terminology with claim 10. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: lines 1- 2- “wherein the action is performed via manual manipulation of the actuator by a clinician” should be amended to - - wherein the action is configured to be performed via manual manipulation of the actuator by a clinician - - since claim 6 is an apparatus claim, amending the claim would provide functional language consistent with an apparatus claim rather than a method claim. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: lines 3- 4- “and blood-flow regulation mechanism” should be amended to - - and the blood-flow regulation mechanism - - to correct an apparent typographical error. Appropriate correction is required.
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.
Claims 5, 10, 16- 17 and 21 are 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.
Claim 5 recites the limitation "the patient" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the patient" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the second relative position" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the first relative position" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the second relative position" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation "the distal deployed state" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1- 12, 14- 15, 18- 20, 22 and 24- 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barbut et al. (US Pub. No. 2005/0159640 A1).
Regarding claim 1, Barbut discloses a catheter, comprising:
an elongate member (102) (Figs. 14- 15) configured for advancement along a blood vessel, the elongate member (102) extending between a proximal end and a distal end;
an actuator (103) (Fig. 14) disposed at the proximal end (P. [0148] - - A proximal end of the catheter is equipped with adapter 103, from which pull wires 132 can be manipulated for collapsing the occluder), and
a restriction member (104) (Figs. 14- 15, 17- 19) disposed at the distal end, the restriction member (104) operatively coupled with the actuator (103) via an elongate connection member (132) (Fig. 14) extending along the elongate member (102) (P. [0148] - - A proximal end of the catheter is equipped with adapter 103, from which pull wires 132 can be manipulated for collapsing the occluder), wherein:
the restriction member (104):
is configured to transition between a collapsed state and a deployed state in response to an action by the actuator (103) (P. [0148] - - A proximal end of the catheter is equipped with adapter 103, from which pull wires 132 can be manipulated for collapsing the occluder), and defines a cone in the deployed state, the cone having a conical wall (118) (Figs. 16, 20- 22) extending radially outward and distally away from an apex portion of the cone (P. [0149] - - the occlusion device comprises catheter 102 and constrictor 104 … The occluding mechanism consists of outer conical shell 118 and inner conical shell 136, each having a distal open base and a proximal apex),
the conical wall (118) includes a number of apertures (128) (Figs. 15, 16B, 17- 22), extending through the conical wall (118),
the conical wall (118) is configured to extend radially outward to a blood vessel wall so that blood flow within the blood vessel is constrained to pass through the number of apertures (128) (Ps. [0148], [0151] - - The constrictor, when expanded, has maximum periphery 110, which conforms to the inner wall of a vessel to form a secure seal with the vascular wall, such that blood flow through the vessel can be effectively controlled; When the constrictor is deployed, blood flows into opening 124, through interior 106, and exits through ports 128), and
the number of apertures (128) are sized to define a restriction of the blood flow (P. [0153] - - The outer and inner shells include 2, 3, 4, 5, 6, or any other number of ports 128 and 144, respectively, in communication with the conical interior to permit blood flow through the occluder; it is noted since the occluder limits the blood flow to only pass through the ports 128, 144, the number of apertures (128) are sized to define a restriction of the blood flow).
Regarding claim 2, Barbut further discloses wherein at least a portion of the restriction member (104) includes an anti-thrombotic coating (P. [0153] - - The constrictor is preferably composed of a biocompatible material coated with heparin to prevent blood clotting).
Regarding claim 3, Barbut further discloses wherein: in the collapsed state, the restriction member (104) is disposed within a sheath of the catheter (102), and in the deployed state, the restriction member (104) is distally extended away from the distal end of the elongate member (102) (See Fig. 15)(Ps. [0148], [0150] - - FIG. 14 depicts occlusion catheter 100 for use in the methods described herein. The device includes elongate catheter 102, distally mounted expandable constrictor, i.e., occluder, 104 having distal opening 124 and variable flow mechanism 108; The constrictor can be collapsed to facilitate insertion into and removal from a vessel).
Regarding claim 4, Barbut further discloses wherein: the catheter (102) is configured for placement within a superior vena cava of a patient, and when deployed within the superior vena cava, the restriction member (104) restricts at least 90 percent of the blood flow through the superior vena cava (See Figs. 1, 4) (Ps. [0111], [0157] - - The descending aorta gives rise to a multitude of arteries, including lumbar (i.e., spinal) arteries 38, which perfuse the spinal cord, renal arteries 40, which perfuse the kidneys, and femoral arteries 42, which perfuse the lower extremities; In FIG. 20, the inner shell is rotated so that ports 144 and 128 are completely misaligned, thereby achieving no flow through the ports and complete vascular occlusion distally; it is noted since the aorta and the vena cava share tributaries like renal or lumbar vessels, the restriction member 104 is capable of being placed within a superior vena cava of a patient).
Regarding claim 5, Barbut further discloses wherein: the catheter is configured for placement within an inferior vena cava of the patient, and when deployed within the inferior vena cava, the restriction member restricts approximately 50 percent of the blood flow through the inferior vena cava (See Figs. 1, 4) (Ps. [0111], [0157] - - The descending aorta gives rise to a multitude of arteries, including lumbar (i.e., spinal) arteries 38, which perfuse the spinal cord, renal arteries 40, which perfuse the kidneys, and femoral arteries 42, which perfuse the lower extremities; As the inner shell is rotated clockwise relative to the second shell in FIG. 21, ports 144 on the inner shell become partially aligned with ports 128 on the outer shell, thereby achieving partial flow through the ports and partial vascular occlusion; it is noted since the aorta and the vena cava share tributaries like renal or lumbar vessels, the restriction member 104 is capable of being placed within an inferior vena cava of a patient; it is also noted that the partial flow through the ports is considered capable of restricting approximately 50 percent of the blood flow through the inferior vena cava).
Regarding claim 6, Barbut further discloses wherein the action is performed via manual manipulation of the actuator (103) by a clinician (Ps. [0148], [0150], [0152] - - A proximal end of the catheter is equipped with adapter 103, from which pull wires 132 can be manipulated for collapsing the occluder; A plurality of pull wires 132 (FIG. 14) are disposed within torque cable 148, and are distally connected to base 120 of outer shell 118 and proximally passes through adapter 103. The constrictor is collapsed by applying a tensile force on wires 132, using torque cable 148 to provide leverage to the pull wires, thereby drawing the circumference of the open base 120 towards its center and collapsing the occluder; Without the rotary unit, torque cable 148 can also be manually rotated to obtain desired upstream and downstream blood pressures).
Regarding claim 7, Barbut discloses a blood flow regulation device, comprising:
an elongate member (102) (Figs. 14- 15) configured for advancement along a blood vessel, the elongate member (102) extending between a proximal end and a distal end;
a blood-flow regulation mechanism (104) (Figs. 14- 15, 17- 19) disposed at the distal end of the elongate member (102); and
an actuator (103) (Fig. 14) disposed at the proximal end of the elongate member (102), the actuator (103) operatively coupled with the regulation mechanism (104) (Ps. [0148] - - A proximal end of the catheter is equipped with adapter 103, from which pull wires 132 can be manipulated for collapsing the occluder; ), wherein:
the regulation mechanism (104) is configured to transition between a non- restriction state and a blood-flow restriction state in response to an action by the actuator (103) (Ps. [0148], [0172] - - A proximal end of the catheter is equipped with adapter 103, from which pull wires 132 can be manipulated for collapsing the occluder; Constrictor 104 can be introduced in its collapsed geometry through an incision on a peripheral artery, such as the femoral, subclavian, axillary, or radial artery, into the patient's aorta … The constrictor is expanded, such that maximum periphery 110 of the occluder, formed by expandable ring 130, sealingly contacts the inner aortic wall),
the regulation mechanism (104) includes:
a first regulation member (118) (Figs. 16, 20- 22) operatively coupled with the actuator (103) via a first elongate connection member (132) (Fig. 14) extending along the elongate member (102), and
a second regulation member (136) (Figs. 16, 20- 22) operatively coupled with the actuator (103) via a second elongate connection member (132) (Fig. 14 - -showing multiple pull wires with the same reference number) extending along the elongate member (102) (Ps. [0148], [0153] - - A proximal end of the catheter is equipped with adapter 103, from which pull wires 132 can be manipulated for collapsing the occluder; the expanded constrictor comprises outer conical shell 118 having base 120 and apex 122, and inner conical shell 136 having base 138 and apex 140),
in the non-restriction state, each of the first and second regulation members (136, 118) are disposed in a collapsed state (P. [0172] - - Constrictor 104 can be introduced in its collapsed geometry through an incision on a peripheral artery, such as the femoral, subclavian, axillary, or radial artery, into the patient's aorta),
in the blood-flow restriction state, each of the first and second regulation members (136, 118) are disposed in an expanded state, and
the first regulation member (118) is positioned proximal the second regulation member (136) (See Figs. 15, 20- 22) (P. [0149] - - the occlusion device comprises catheter 102 and constrictor 104 … The occluding mechanism consists of outer conical shell 118 and inner conical shell 136, each having a distal open base and a proximal apex).
Regarding claim 8, Barbut further discloses wherein at least a portion of the device includes an anti-thrombotic coating (P. [0153] - - The constrictor is preferably composed of a biocompatible material coated with heparin to prevent blood clotting).
Regarding claim 9, Barbut further discloses wherein: the device is configured for placement within a superior vena cava of a patient, and the blood-flow regulation mechanism is configured to restrict at least 90 percent of the blood flow through the superior vena cava ((See Figs. 1, 4) (Ps. [0111], [0157] - - The descending aorta gives rise to a multitude of arteries, including lumbar (i.e., spinal) arteries 38, which perfuse the spinal cord, renal arteries 40, which perfuse the kidneys, and femoral arteries 42, which perfuse the lower extremities; In FIG. 20, the inner shell is rotated so that ports 144 and 128 are completely misaligned, thereby achieving no flow through the ports and complete vascular occlusion distally; it is noted since the aorta and the vena cava share tributaries like renal or lumbar vessels, the restriction member 104 is capable of being placed within a superior vena cava of a patient).
Regarding claim 10, Barbut further discloses wherein: the device is configured for placement within an inferior vena cava of the patient, and blood-flow regulation mechanism is configured to restrict approximately 50 percent of the blood flow through the inferior vena cava (See Figs. 1, 4) (Ps. [0111], [0157] - - The descending aorta gives rise to a multitude of arteries, including lumbar (i.e., spinal) arteries 38, which perfuse the spinal cord, renal arteries 40, which perfuse the kidneys, and femoral arteries 42, which perfuse the lower extremities; In FIG. 20, the inner shell is rotated so that ports 144 and 128 are completely misaligned, thereby achieving no flow through the ports and complete vascular occlusion distally; it is noted since the aorta and the vena cava share tributaries like renal or lumbar vessels, the restriction member 104 is capable of being placed within an inferior vena cava of a patient).
Regarding claim 11, Barbut further discloses wherein: in the collapsed state each of the first and second regulation members (118, 136) is disposed within a sheath of the elongate member (102), and in the expanded state each of the first and second regulation members (118, 136) is distally extended away from the distal end of the elongate member (See Fig. 15)(Ps. [0148], [0150] - - FIG. 14 depicts occlusion catheter 100 for use in the methods described herein. The device includes elongate catheter 102, distally mounted expandable constrictor, i.e., occluder, 104 having distal opening 124 and variable flow mechanism 108; The constrictor can be collapsed to facilitate insertion into and removal from a vessel).
Regarding claim 12, Barbut further discloses wherein: the blood-flow regulation mechanism (104) is transitionable between a first blood-flow restriction state (Fig. 21) configured to restrict the blood flow a first restriction amount and a second blood-flow restriction state (Fig. 21/22) configured to restrict the blood flow a second restriction amount, and the second restriction amount is different from the first restriction amount (P. [0157] - - As the inner shell is rotated clockwise relative to the second shell in FIG. 21, ports 144 on the inner shell become partially aligned with ports 128 on the outer shell, thereby achieving partial flow through the ports and partial vascular occlusion. In FIG. 22, with continuing clockwise rotation of the inner shell, ports 144 become completely aligned with ports 128, thereby achieving maximum flow through the ports; it is noted since there is an intermediate restriction state between Fig. 21 and Fig. 22 during the clockwise rotation, the intermediate restriction state Fig. 21/22 is considered the second blood-flow restriction state).
Regarding claim 14, Barbut further discloses wherein each of the first and second regulation members (118, 136) defines a hollow cone having a proximal apex portion and a distal open end in the expanded state (See Figs. 15, 20- 22) (P. [0149] - - the occlusion device comprises catheter 102 and constrictor 104 … The occluding mechanism consists of outer conical shell 118 and inner conical shell 136, each having a distal open base and a proximal apex).
Regarding claim 15, Barbut further discloses wherein: the second regulation member (136) includes a number of second apertures (144) (Figs. 16, 20- 22) extending through a second conical wall of the second regulation member (136), and the second conical wall is configured to extend radially outward to a wall of the blood vessel so that the blood flow is constrained to pass through the number of second apertures (Ps. [0148], [0157] - - The constrictor, when expanded, has maximum periphery 110, which conforms to the inner wall of a vessel to form a secure seal with the vascular wall, such that blood flow through the vessel can be effectively controlled; As the inner shell is rotated clockwise relative to the second shell in FIG. 21, ports 144 on the inner shell become partially aligned with ports 128 on the outer shell, thereby achieving partial flow through the ports and partial vascular occlusion. In FIG. 22, with continuing clockwise rotation of the inner shell, ports 144 become completely aligned with ports 128, thereby achieving maximum flow through the ports).
Regarding claim 18, Barbut further discloses wherein: in the first blood-flow restriction state (Fig. 21/22), the second regulation member (136) is in the expanded state such that a second conical wall of the second regulation member (136) is radially expanded to define an annular second passageway between the second regulation member (136) and the wall of the blood vessel, and the annular second passageway is sized to define the first blood-flow restriction amount (P. [0157] - - As the inner shell is rotated clockwise relative to the second shell in FIG. 21, ports 144 on the inner shell become partially aligned with ports 128 on the outer shell, thereby achieving partial flow through the ports and partial vascular occlusion. In FIG. 22, with continuing clockwise rotation of the inner shell, ports 144 become completely aligned with ports 128, thereby achieving maximum flow through the ports; it is noted since there is an intermediate restriction state between Fig. 21 and Fig. 22 during the clockwise rotation, the intermediate restriction state Fig. 21/22 is considered the first blood-flow restriction state).
Regarding claim 19, Barbut further discloses wherein: in the second blood-flow restriction state (Fig. 21), the first regulation member (118) is in the expanded state such that a first conical wall of the first regulation member (118) is radially expanded to define an annular first passageway between the first regulation member (118) and the wall of the blood vessel, and the annular first passageway is sized to define the second blood-flow restriction amount.
Regarding claim 20, wherein the second blood-flow restriction amount is greater than the first blood-flow restriction amount (P. [0157] - - As the inner shell is rotated clockwise relative to the second shell in FIG. 21, ports 144 on the inner shell become partially aligned with ports 128 on the outer shell, thereby achieving partial flow through the ports and partial vascular occlusion. In FIG. 22, with continuing clockwise rotation of the inner shell, ports 144 become completely aligned with ports 128, thereby achieving maximum flow through the ports; it is noted since there is an intermediate restriction state between Fig. 21 and Fig. 22 during the clockwise rotation, the intermediate restriction state Fig. 21/22 is considered the first blood-flow restriction state and it is further noted that the second blood-flow restriction state (Fig. 21) has a greater blood flow restriction amount than the first restriction state (Fig. 21/22)).
Regarding claim 22, Barbut further discloses wherein: the blood-flow regulation mechanism (104) is further transitionable to a third blood-flow restriction state (Fig. 22) configured to restrict the blood flow a third restriction amount, and the third restriction amount is less than the first restriction amount and the second restriction amount (P. [0157] - - As the inner shell is rotated clockwise relative to the second shell in FIG. 21, ports 144 on the inner shell become partially aligned with ports 128 on the outer shell, thereby achieving partial flow through the ports and partial vascular occlusion. In FIG. 22, with continuing clockwise rotation of the inner shell, ports 144 become completely aligned with ports 128, thereby achieving maximum flow through the ports; it is noted the partial flow restriction of Fig. 21/22 and Fig. 21 are greater than the lack of flow restriction of Fig. 22).
Regarding claim 24, Barbut further discloses wherein: the actuator (103) includes a controller (114, 150, 156) (Fig. 14) including controller logic, and an electro-mechanical actuating mechanism coupled between the controller and the first and second elongate connection members (132), the actuator (103) is configured to variably transition the regulation mechanism (104) between the first blood-flow restriction state and the second blood-flow restriction state (Ps. [0152], [0153] - - The upstream and downstream blood pressure measurements are recorded and displayed by the pressure monitor at a proximal end of the catheter. A pressure limiter, programmed with a maximum pressure threshold to limit the upstream blood pressure and a minimum pressure threshold to limit the downstream blood pressure, is connected to the pressure monitor to receive pressure measurements therefrom, and transmits information to a rotary unit. The limiter thereby prevents the rotary unit from rotating the inner shell relative to the outer shell in a manner that would cause the upstream blood pressure to exceed the maximum threshold, or the downstream blood pressure to fall below the minimum threshold. Without the rotary unit, torque cable 148 can also be manually rotated to obtain desired upstream and downstream blood pressures; A rotary unit, preferably including a stepper motor (not shown), may be mechanically coupled to a proximal end of the torque cable to provide precise rotational position of the inner shell relative to the outer shell, thereby providing variable flow through the occluder
Regarding claim 25, Barbut further discloses further comprising: a sensor (112) (Fig. 14) positioned along the elongate member and coupled with the controller (114, 150, 156), the sensor (112) configured to provide a signal to the controller (114, 150, 156) based on one or more of a static pressure, a dynamic pressure, or a velocity of the blood within the blood vessel, wherein the logic is configured to variably transition the regulation mechanism (104) in response to the signal from the sensor (112) (P. [0148] - - Preferably, the device includes manometer 112, which is connected to pressure monitor 156 and pressure limiter 114. Rotary unit 150 receives blood pressure measurements from the manometer. Pressure limiter 114, connected to the rotary unit and the pressure monitor, prevents the upstream and downstream blood pressure from exceeding, respectively, a set maximum and minimum pressure differential. A proximal end of the catheter is equipped with adapter 103, from which pull wires 132 can be manipulated for collapsing the occluder and to which the rotary unit, pressure monitor, and/or pressure limiter can be connected).
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) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barbut et al. (US Pub. No. 2005/0159640 A1).
Regarding claim 21, Barbut discloses the apparatus of claim 18, but the embodiment of Figs. 14- 22 does not explicitly disclose
(claim 21) wherein: the second regulation member defines a bullet shape in the distal deployed state, and the bullet shape includes a cone shaped proximal portion having a proximally oriented apex and a cone shaped distal portion having a distally oriented apex.
However, the embodiment of Fig. 10 teaches a bullet shape (107) (Fig. 10) in the distal deployed state, and the bullet shape (107) includes a cone shaped proximal portion having a proximally oriented apex and a cone shaped distal portion having a distally oriented apex (P. [0114] - - It will be understood that the constrictor, when implemented as a balloon, can be of any shape that is suitable for use in the aorta. An elongate balloon (e.g., balloons 104 and 107 in FIG. 3), elliptical or sausage-shape, is particularly desirable because this shape is more stable within rapidly flowing blood. A spherical balloon (although useful in the disclosed inventions) will tend to rock within the aorta, and rotate and bend the catheter to which it is affixed. The use of an elongate balloon, however, reduces the rocking and rotating within the vessel because this shape effectively eliminates one of the degrees of freedom present with a spherical balloon; it is noted that the shape of reference number 107 is similar to the shape of applicant’s Fig. 5B and is interpreted as a bullet shape).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the second regulation member associated with the embodiment of Figs. 14- 22 such that it defines a bullet shape including a cone shaped proximal portion having a proximally oriented apex and a cone shaped distal portion having a distally oriented apex as shown in the regulation member 107 in the embodiment of Fig. 10 because the shape is more stable within rapidly flowing blood (P. [0114]).
Allowable Subject Matter
Claims 13 and 23 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.
Regarding claim 13, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, wherein: the first blood-flow restriction state is defined by a first relative position between the first and second regulation members in the expanded state, the second blood-flow restriction state is defined by a second relative position between the first and second regulation members in the expanded state, and the second relative position is different from the first relative position.
The closest cited prior art reference Barbut et al. (US Pub. No. 2005/0159640 A1) teaches that the relative positions of the first and second regulation members is fixed during operation of the device (See Figs. 16A, 16B) (P. [0153] - - The collars may include engaging threads, so that collar 142 can be inserted and secured into collar 126). As such, Barbut does not teach or suggest, alone or in combination, wherein: the first blood-flow restriction state is defined by a first relative position between the first and second regulation members in the expanded state, the second blood-flow restriction state is defined by a second relative position between the first and second regulation members in the expanded state, and the second relative position is different from the first relative position.
Regarding claim 23, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, wherein: the regulation mechanism further includes a third regulation member operatively coupled with the actuator via a third elongate connection member extending along the elongate member, the third regulation member is positioned distal the first and second regulation members, in the non-restriction state, the third regulation member is disposed in a collapsed state within the sheath, in the third blood-flow restriction state, the third restriction member is disposed in an expanded state such that a third conical wall of the first regulation member is radially expanded to define an annular third passageway between the third regulation member and the wall of the blood vessel, and the annular third passageway is sized to define the third blood-flow restriction amount.
The closest cited prior art reference Barbut et al. (US Pub. No. 2005/0159640 A1) teaches two regulation members and does not teach or suggest, alone or in combination, a third regulation member.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Ma (US Pub. No. 2017/0119409) teaches a proximal flow restrictor 212 having a generally conical or frusto-conical proximal section 232.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KANKINDI RWEGO whose telephone number is (303)297-4759. The examiner can normally be reached Monday- Friday: 10:00- 5:00 MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, (Jackie) Tan-Uyen Ho can be reached at 571 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KANKINDI RWEGO/Primary Examiner, Art Unit 3771