DETAILED ACTION
Upon reconsideration of the patentability of claim 13 and its dependents, prosecution on the merits of this application is reopened. New rejections follow below.
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 Amendment
The Amendment filed 4/21/26 has been entered. Claims 1, 4- 6, 10, 16- 17 and 21 have been amended. Claim 3 is canceled. Claims 1- 2 and 4- 25 are being addressed by this Action.
Response to Arguments
Applicant’s amendment to the claims have obviated the claim objections recited in the Non-Final Office Action, mailed 1/21/26. As such, the claim objections recited in the Non-Final Office Action, mailed 1/21/26 are withdrawn.
Applicant’s amendment to the claims have obviated the claim rejections under 35 USC 112 recited in the Non-Final Office Action, mailed 1/21/26. As such, the claim rejections under 35 USC 112 recited in the Non-Final Office Action, mailed 1/21/26 are withdrawn.
Even though applicant argues that amended claim 1 incorporates the subject matter of claim 3 (now canceled) (See p. 10 of applicant’s Remarks, filed 4/21/26), the Office respectfully submits that “the elongate member includes a sheath extending along the elongate member, the sheath defining a lumen” is new to Amended claim 1 and its dependent claims (2- 6), requiring a new rejection.
Applicant’s arguments, see applicant’s Remarks, filed 4/21/26, with respect to the rejection(s) of claim(s) 1- 6 under 35 U.S.C. (102)(a) as being anticipated by Barbut have been fully considered and are persuasive because Barbut does not disclose the newly added limitation regarding the elongate member includes a sheath extending along the elongate member, the sheath defining a lumen. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Barbut et al. (US Pub. No. 2005/0159640 A1) in view of Miller et al. (US Pub. No. 2008/0082107 A1). It is noted applicant’s arguments against Barbut are directed to a separate sheath lumen feature upon which the new reference Miller is relied.
Applicant’s arguments, see applicant’s Remarks, filed 4/21/26, with respect to the rejection(s) of claim(s) 7- 12, 14- 15, 18- 20, 22 and 24- 25 under 35 U.S.C. (102)(a) as being anticipated by Barbut have been fully considered and are not persuasive. In response to applicant’s arguments on pp. 12- 13 that Barbut does not disclose “the first regulation member is positioned proximal the second regulation member” required by claim 7, the Office respectfully submits that inner shell 136 is proximally adjacent to outer shell 118. Inner shell 136 and outer shell 118 are not superimposed on each other nor occupy the exact same space, as that is physically impossible. The Office respectfully submits that the nested inner and outer shells (136, 118) are longitudinally separated by a distance of at least the thickness of the shells.
In response to applicant’s arguments on p. 13 that Barbut does not disclose “a second regulation member operatively coupled with the actuator via a second elongate connection member extending along the elongate member” required by claim 7, The Office respectfully submits that the second regulation member 136 is operatively coupled to pull wires 132 due to their nested configuration discussed above. It is noted that the claim does not require that the second regulation member 136 is directly coupled to pull wires 132.
It is noted claim 11 fails to positively recite “a sheath” separate from the elongate member. The broadest reasonable interpretation of “a sheath of the elongate member” is that the elongate member is the sheath and vice versa. It is noted applicant does not traverse this interpretation (See p. 10 of applicant’s Remarks). As such, the rejection of claim 11 reads on the claim limitations, particularly since in both collapsed and expanded configurations, a portion of the first and second regulation members is disposed within the distal end of the elongate member/sheath and a portion of the first and second regulation members is distally extended away from the distal end of the elongate member/sheath as shown in the Annotated Fig. 15 below:
PNG
media_image1.png
636
914
media_image1.png
Greyscale
Claim Objections
Claim 18 is objected to because of the following informalities: line 5- “the wall of the blood vessel” should be amended to - - [[the]] a wall of the blood vessel - - since it is clear that the blood vessel associated with claim 7, line 2 has a wall, amending the claim would provide proper antecedent basis. Appropriate correction is required.
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) 7- 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 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 13, Barbut further discloses wherein:
the first blood-flow restriction state (Fig. 20) is defined by a first relative position between the first (118) and second regulation members (136) in the expanded state,
the second blood-flow restriction state (Fig. 21) is defined by a second relative position between the first (118) and second regulation members (136) in the expanded state, and
the second relative position (Fig. 21) is different from the first relative position (Fig. 20) (P. [0157] - - 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. 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).
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 16, Barbut further discloses herein in a second relative position, the second regulation member (136) is at least partially disposed within the first regulation member (118) so that at least portion of the number of second apertures (144) is occluded by a first conical wall of the first regulation member (118) (See Figs. 20, 21) (P. [0157] - - The flow rate of blood through the constrictor can be easily controlled by rotating inner conical shell 136 (shown with dotted lines) relative to outer conical shell 118 as depicted in FIGS. 20, 21, and 22. 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. 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).
Regarding claim 17, Barbut further discloses wherein:
the first regulation member (118) includes a number of first apertures (128) (Figs. 16, 20, 21, 22) extending through a first conical wall (P. [0151] - - Conical interior 106 communicates with ports 128 of the outer shell),
the second regulation member (136) is disposed within the first regulation member (118) so that the second conical wall overlaps the first conical wall (P. [0151] - - The occluding mechanism comprises inner conical shell 136 (partially shown in phantom in FIG. 15)),
in a first relative position, the second regulation member (136) is rotatably positioned relative to the first regulation member (118) so that the number of first apertures (128) overlaps the number of second apertures (144) a first overlapping amount (Fig. 20),
in the second relative position, the second regulation member (136) is rotatably positioned relative to the first regulation member (118) so that the number of first apertures (128) overlaps the number of second apertures (144) a second overlapping amount (Fig. 21), and
the second overlapping amount (Fig. 21) is different from the first overlapping amount (Fig. 20) (P. [0157] - - 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. 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).
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) 1- 2 and 4- 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barbut et al. (US Pub. No. 2005/0159640 A1) in view of Miller et al. (US Pub. No. 2008/0082107 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 (P. [0148] - - The device includes elongate catheter 102, distally mounted expandable constrictor, i.e., occluder, 104), 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), and
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).
Barbut does not explicitly disclose
(claim 1) the elongate member includes a sheath extending along the elongate member, the sheath defining a lumen as claimed.
However, Miller teaches devices for removing obstruction from a cerebral vessel in the same field of endeavor (Abstract, P. [0001])
(claim 1) the elongate member includes a sheath (6) (Figs. 1- 2, 4) extending along the elongate member (8) (Figs. 1- 2, 4), the sheath (6) defining a lumen, the restriction member (12) (Figs. 1- 2, 4):
is configured to transition between a collapsed state and a deployed state in response to an action by the actuator,
in the collapsed state, the restriction member (12) (Figs. 1- 2, 4) is disposed within the lumen of the sheath (6), and in the deployed state, the restriction member (12) is distally extended away from a distal end of the sheath (6) (Ps. [0012], [0013], [0014] - - Referring to FIG. 1, a system 2 for removing an obstruction from a vascular location is shown. The system 2 is particularly useful for removing obstructions from the cerebral vasculature. The system 2 includes a guide catheter 4, a support catheter 6, a microcatheter 8, a guidewire and an obstruction retriever 12. The guide catheter 4 is advanced within the vasculature and guides the other catheters and devices through the larger vessels leading to the obstruction. The guidewire is then withdrawn and the retriever 12 is advanced through the microcatheter 8. The microcatheter 8 is then withdrawn to expose part of the retriever 12 within or distal to the obstruction and withdrawn, if necessary, to contact the obstruction; The guidewire is advanced into or distal to the obstruction and the microcatheter 8 is then advanced over the guidewire so that the microcatheter 8 is also positioned within or distal to the obstruction. The guidewire is then withdrawn and the retriever 12 is advanced through the microcatheter 8; The support catheter 6 is sized to be advanced through the guide catheter 4 and over the retriever 12 and optionally over the microcatheter 8 as well. The support catheter 6 has a proximal portion which may be somewhat stiff and rigid for optimized advancement and support).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the applicant’s invention to modify the elongate member associated with Barbut in order to include outer sheath(s) taught by Miller such that the restriction member associated with Barbut is disposed at least partially within the outer sheath(s) because the outer sheath(s) would be advanced within the vasculature and would guide the other catheters and devices through the larger vessels leading to the obstruction and subsequently through tortuous vessels without kinking or collapsing (Miller - - Ps. [0012], [0014]). The motivation for the modification would have been to provide optimized support during the advancement of other catheters and devices through larger vessels and subsequently through smaller, tortuous vessels for dislodging and removing an obstruction further into the vasculature (Miller - - Ps. [0014], [0016]).
Regarding claim 2, Barbut in view of Miller discloses the apparatus of claim 1, Barbut further disclosing 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 4, Barbut in view of Miller discloses the apparatus of claim 1, Barbut further disclosing 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 in view of Miller discloses the apparatus of claim 1, Barbut further disclosing 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 in view of Miller discloses the apparatus of claim 1, Barbut further disclosing 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).
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
Claim 23 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
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
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KANKINDI RWEGO/ Primary Examiner, Art Unit 3771
Prosecution Insights