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 Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 44-58 and 61-63 are rejected under 35 U.S.C. 103 as being unpatentable over Rowe et al. (US 2020/0187945 A1) in view of Kapur et al. (US 2021/0177425 A1).
Regarding claim 44, Rowe discloses a system for treating heart failure of a patient (¶0003-0005 and 0012-0014: Rowe discloses systems for treating hypoxemia, which may be associated with right heart failure), the system comprising: a shunt configured to direct blood flow from a pulmonary artery to an azygos vein (Figs. 15-17; ¶0085, 0102-0111, and 0139-0140: Rowe discloses right-to-right shunts, from one vessel on the right side of the heart, such as the pulmonary artery, to a second vessel also on the right side of the heart, such as the azygos vein).
Rowe does not disclose an expandable occluder configured to be positioned within the azygos vein to at least partially occlude blood flow through the azygos vein into a superior vena cava or an implantable control unit configured to regulate expansion of the expandable occluder to cause blood flow from the pulmonary artery through the sunt to the azygos vein in a retrograde direction through the azygos vein.
Kapur teaches systems for treating heart failure by regulating venous return to the heart through the superior vena cava (hereinafter referred to as the SVC) (¶0017-0023) comprising an occlusion system (Fig. 45) comprising an azygos vein occlusion element (142) positioned in the junction of the SVC and the azygos vein (16) and an SVC occlusion element (143) positioned in the SVC upstream of the right atrium (¶0178-0181). Kapur further teaches an implantable control unit (Figs. 4A-B, feat. 33) for regulating the expansion and contraction of the occlusion elements in order to regulate blood flow into the right atrium (¶0102-0106). Kapur teaches that the azygos vein occlusion element (Fig. 45, feat. 142) may be partially or completely expanded in order to control blood flow between the SVC and azygos vein, which allows for more control of blood flow back to the right atrium (¶0179-0181). Kapur teaches that regulating blood flow from the SVC (and from the azygos vein which drains into the SVC) to the right atrium advantageously reduces cardiac preload and pulmonary arterial pressure without increasing renal vein pressure (¶0022-0023). By combining the system including a shunt from the pulmonary artery to the azygos vein of Rowe with the azygos vein and SVC occlusion elements and controller of Kapur, there would be anterograde blood flow from the pulmonary artery, through the shunt, through the azygos vein, and to the SVC when the azygos vein occlusion element is contracted, and retrograde blood flow from the pulmonary artery, through the shunt, through the azygos vein, and to the hemiazygos vein when the azygos vein occlusion element is expanded. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system disclosed by Rowe so that it includes an expandable occluder configured to be positioned within the azygos vein to at least partially occlude blood flow through the azygos vein into a superior vena cava and an implantable control unit configured to regulate expansion of the expandable occluder to cause blood flow from the pulmonary artery through the sunt to the azygos vein in a retrograde direction through the azygos vein in order to treat heart failure by regulating venous return to the right atrium, thereby reducing cardiac preload and pulmonary arterial pressure without increasing renal vein pressure as taught by Kapur.
Regarding claim 45, Rowe in view of Kapur suggests the system of claim 44, and Rowe further discloses that the shunt comprises a check valve (Fig. 16, feats. 394, 396; ¶0140).
Regarding claims 46-48, Rowe in view of Kapur suggests the system of claim 44. Rowe further discloses that the shunt may be any of the shunts disclosed in U.S. Application No. 16/576,704, which corresponds to Schwartz et al. (US 2020/0085600 A1), and is incorporated by reference into the disclosure of Rowe (Rowe: ¶0104 and 0107-0111). Schwartz discloses shunts which may comprise a simple lumen (Schwartz: Figs. 6A-B, feat. 22; ¶0141-0142) with anchoring features (Schwartz: 26, 28) with no flow control features. Such a shunt would passively allow flow from one side to the other based on the pressure differential across the lumen. Schwartz further discloses that the shunt may comprise anchoring features which seal against the tissues on either side of the shunt against leakage (Schwartz: Fig. 6A-B, feats. 26 and 28; ¶0010, 0135, and 0141-0142), and that the anchoring features may be flared (Schwartz: ¶0156). Schwartz further discloses that the shunt may comprise an expandable stent which engages the vessels into which it is implanted (Schwartz: ¶0019-0024 and 0161-0169).Therefore, because Rowe incorporates the disclosure of Schwartz by reference, Rowe further discloses that the shunt is configured to passively allow blood to flow from the pulmonary artery to the azygos vein, with respect to claim 46, that the shunt comprises a first flared end configured to seal against a puncture in the pulmonary artery and a second flared end configured to seal against a puncture in the azygos vein, with respect to claim 47, and that the system further comprises an expandable stent configured to engage inner walls of the azygos vein, with respect to claim 48.
Regarding claim 49, Rowe in view of Kapur suggests the system of claim 44. Kapur further teaches that the implantable control unit (Figs. 4A-B, feat. 33) may comprise a motor as a drive mechanism for actuating the occlusion elements (36; ¶0103). Therefore, Rowe in view of Kapur further suggests that the system further comprises a drive motor connectable to the expandable occluder, the drive motor configured to expand and collapse the expandable occluder.
Regarding claim 50, Rowe in view of Kapur suggests the system of claim 44. Kapur further teaches that the implantable control unit (Figs. 4A-B, feat. 33) may be implanted subcutaneously under the clavicle (¶0105). Therefore, Rowe in view of Kapur further suggests that the control unit is configured to be implanted subcutaneously.
Regarding claim 51, Rowe in view of Kapur suggests the system of claim 44. Kapur further teaches pressure sensors for monitoring pressure upstream and downstream from the occlusion elements and within the occlusion elements (Fig. 45, feats. 129, 139, 145, 149, and 155; ¶0178). Kapur further teaches that the controller (Figs. 4A-B, feat. 33) includes a data transfer circuit (38) for receiving measurements from sensors, such as pressure sensors, and adjusts the occlusion provided by the occlusion elements in response to the pressure sensor measurement (¶0105-0106 and 0121). Therefore, Rowe in view of Kapur further suggests that the system further comprises one or more implantable pressure sensors, the implantable control unit configured to receive pressure measurements from the one or more implantable pressure sensors, the implantable control unit configured to control the expandable occluder based on the pressure measurements.
Regarding claim 52, Rowe in view of Kapur suggests the system of claim 44. Kapur further teaches that the controller (Figs. 4A-B, feat. 33) includes a data transfer circuit (38) may receive data from electrocardiogram electrodes in order to adjust the degree of occlusion provided by the occlusion elements in response to the patient’s heart rate (¶0107 and 0120). Therefore, Rowe in view of Kapur further suggests that the implantable control unit comprises an accelerometer and/or an electrocardiogram.
Regarding claim 53, Rowe in view of Kapur suggests the system of claim 44. Kapur further teaches an expandable occluder (Fig. 6, feat. 50; ¶0115) comprising a distal cap (53) attached to an actuation wire (54). The occluder further comprises a plurality of wires (51) which are attached to the distal cap (53) at their distal end (52), and a sliding ring or cap (55) at their proximal end (56). The sliding ring (55) slides freely on the actuation wire (54) such that when the actuation wire is actuated by a drive mechanism (36), such as a rotary motor, the distal cap (53) and sliding ring (55) are brought closer to a sheath (57) and closer together, and the wires are caused to radially expand outward (¶0115). When the drive mechanism is deactivated, the spring force in the wires (51) collapses the occluder (¶0115). When the drive mechanism (36) is a rotary motor rotating the actuation wire (54), the distal cap (53) affixed to the actuation wire would be rotated by the actuation wire relative to the sliding ring (55), which would slide over the rotating actuation wire. Therefore, Rowe in view of Kapur further suggests that the expandable occluder comprises: a first cap; a second cap; a plurality of members, each member comprising a first end positioned on the first cap and a second end positioned on the second cap; and a drive line attached to the first cap, the drive line configured to: rotate the first cap with respect to the second cap in a first direction to cause the plurality of members to expand radially outward, and rotate the first cap with respect to the second cap in a second direction to cause the plurality of members to expand radially inward.
Regarding claim 54, Rowe discloses a method of treating heart failure of a patient (¶0003-0005, 0012-0014, and 0095-0100), the method comprising: positioning a shunt to direct blood flow from a pulmonary artery to an azygos vein (Figs. 15-17; ¶0085, 0102-0111, and 0139-0140: Rowe discloses right-to-right shunts, from one vessel on the right side of the heart, such as the pulmonary artery, to a second vessel also on the right side of the heart, such as the azygos vein).
Rowe does not disclose positioning an expandable occluder within the azygos vein to at least partially occlude blood flow through the azygos vein into a superior vena cava or expanding the expandable occluder based on feedback received from one or more pressure sensors to at least partially occlude blood flow through the azygos vein such that blood flows from the pulmonary artery through the shunt to the azygos vein in a retrograde direction through the azygos vein.
Kapur teaches systems for treating heart failure by regulating venous return to the heart through the SVC (¶0017-0023) comprising an occlusion system (Fig. 45) comprising an azygos vein occlusion element (142) positioned in the junction of the SVC and the azygos vein (16) and an SVC occlusion element (143) positioned in the SVC upstream of the right atrium (¶0178-0181). Kapur further teaches an implantable control unit (Figs. 4A-B, feat. 33) with a data transfer unit (38) in communication with pressure sensors (Fig. 45, feats. 129, 139, 145, 149, and 155; ¶0178) for regulating the expansion and contraction of the occlusion elements in response to the measurements from the pressure sensors in order to regulate blood flow into the right atrium (¶0102-0106). Kapur teaches that the azygos vein occlusion element (Fig. 45, feat. 142) may be partially or completely expanded in order to control blood flow between the SVC and azygos vein, which allows for more control of blood flow back to the right atrium (¶0179-0181). Kapur teaches that regulating blood flow from the SVC (and from the azygos vein which drains into the SVC) to the right atrium advantageously reduces cardiac preload and pulmonary arterial pressure without increasing renal vein pressure (¶0022-0023). By combining the system and method including a shunt from the pulmonary artery to the azygos vein of Rowe with the azygos vein and SVC occlusion elements and controller of Kapur, there would be anterograde blood flow from the pulmonary artery, through the shunt, through the azygos vein, and to the SVC when the azygos vein occlusion element is contracted, and retrograde blood flow from the pulmonary artery, through the shunt, through the azygos vein, and to the hemiazygos vein when the azygos vein occlusion element is expanded. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method disclosed by Rowe so that it includes positioning an expandable occluder within the azygos vein to at least partially occlude blood flow through the azygos vein into a superior vena cava and expanding the expandable occluder based on feedback received from one or more pressure sensors to at least partially occlude blood flow through the azygos vein such that blood flows from the pulmonary artery through the shunt to the azygos vein in a retrograde direction through the azygos vein in order to treat heart failure by regulating venous return to the right atrium, thereby reducing cardiac preload and pulmonary arterial pressure without increasing renal vein pressure as taught by Kapur.
Regarding claim 55, Rowe in view of Kapur suggests the method of claim 54. Kapur further teaches a pressure sensor (Fig. 45, feat. 155) within the azygos vein occlusion element (142) positioned in the junction of the SVC and azygos vein and pressure sensors (129, 139, 145, and 149) within the SVC (¶0178). Therefore, Rowe in view of Kapur further suggests that receiving the feedback from the one or more pressure sensors comprises measuring a first pressure measurement in the azygos vein using a first implantable sensor positioned in the azygos vein and a second pressure measurement in a superior vena cava.
Regarding claims 56-57, Rowe in view of Kapur suggests the method of claim 54. Kapur further teaches that the controller may expand the occluding element in response to the measurements from the pressure sensors in the SVC (Fig. 45, feat. 149; ¶0175 and 0178-0181) and that the controller may be configured to expand the occluding element in response to a pressure measurement is above a predetermined threshold, such as 15 mmHg (¶0106 and 0121). Therefore, Rowe in view of Kapur further suggests expanding the expandable occluder based on feedback receive from the one or more pressure sensors comprises expanding the expandable occluder when central venous pressure exceeds a threshold pressure value, with respect to claim 56, and that the threshold pressure value is 15 mmHg, with respect to claim 57.
Regarding claim 58, Rowe in view of Kapur suggests the method of claim 54. Kapur further teaches that the controller adjusts the degree of occlusion by expanding or contracting the occluding element in response to measurements from the pressure sensors (¶0104 and 0106) and that the expansion may be controlled in response to a pressure measurement being outside a predetermined range and/or above or below a predetermined threshold (¶0121). Therefore, Rowe in view of Kapur further suggests collapsing the expandable occluder when central venous pressure falls below a threshold pressure value.
Regarding claim 61, Rowe in view of Kapur suggests the method of claim 54. Kapur further teaches that the controller (Figs. 4A-B, feat. 33) includes a data transfer circuit (38) may receive data from electrocardiogram electrodes in order to adjust the degree of occlusion provided by the occlusion elements in response to the patient’s heart rate (¶0107 and 0120). Therefore, Rowe in view of Kapur further suggests receiving, by an electrocardiogram, one or more electrical activity measurements, and expanding the expandable occluder based at least in part on the one or more electrical activity measurements.
Regarding claims 62-63, Rowe in view of Kapur suggests the method of claim 54. As discussed above, Kapur further teaches an expandable occluder (Fig. 6, feat. 50; ¶0115) comprising a distal cap (53) attached to an actuation wire (54). The occluder further comprises a plurality of wires (51) which are attached to the distal cap (53) at their distal end (52), and a sliding ring or cap (55) at their proximal end (56). The sliding ring (55) slides freely on the actuation wire (54) such that when the actuation wire is actuated by a drive mechanism (36), such as a rotary motor, the distal cap (53) and sliding ring (55) are brought closer to a sheath (57) and closer together, and the wires are caused to radially expand outward (¶0115). When the drive mechanism is deactivated, the spring force in the wires (51) collapses the occluder (¶0115), driving the distal end (52) away from the sliding ring (55). When the drive mechanism (36) is a rotary motor rotating the actuation wire (54), the distal cap (53) affixed to the actuation wire would be rotated by the actuation wire relative to the sliding ring (55), which would slide over the rotating actuation wire. Therefore, Rowe in view of Kapur further suggests that expanding the expandable occluder comprises moving, by a drive motor, a first end of the expandable occluder closer to a second end of the expandable occluder and moving, by the drive motor, the first end of the expandable occluder away from the second end of the expandable occluder, with respect to claim 62, or that expanding the expandable occluder comprises: rotating, with a drive line attached to a first cap of the expandable occluder, the first cap with respect to a second cap of the expandable occluder, with respect to claim 63.
Claim 60 is rejected under 35 U.S.C. 103 as being unpatentable over Rowe in view of Kapur and in further view of Kaiser et al. (WO 2015/109028 A1).
Regarding claim 60, Rowe in view of Kapur suggests the method of claim 54. Kapur further teaches that a patient’s activity levels may cause fluctuations in a patient’s hemodynamic state (¶0025), and that the controller may regulate the expansion of the occluding element based on a detected level of the patient’s activity (¶0105-0107). Therefore, Rowe in view of Kapur further suggests collecting one or more activity measurements, and expanding the expandable occluder based at least in part on the one or more activity measurements. Rowe in view of Kapur are silent with respect to the activity measurements being collected by an accelerometer.
Kaiser teaches systems and methods for prevention or treatment of heart disease (Fig. 2, feat. 110; Page 3, lines 5-11; Page 15, line 33 – Page 16, line 5) comprising an implantable controller (Fig. 2, feat. 140) comprising an accelerometer for measuring changes in patient movement and estimating patient activity (Page 16, lines 6-13). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method suggested by Rowe in view of Kapur so that the activity measurements are collected by an accelerometer in order to estimate patient activity levels as taught by Kaiser and account for fluctuations in a patient’s hemodynamic state due to their activity levels as taught by Kapur.
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over Rowe in view of Kapur and in further view of Mehta (US 2022/0240895 A1).
Regarding claim 59, Rowe in view of Kapur suggests the method of claim 58, but does not suggest that the threshold pressure value of central venous pressure at which the expandable occluder is collapsed is 5 mmHg. Kapur teaches that the occluder is expanded in order to reduce cardiac preload in order to improve cardiac performance as measured by, among other things, a reduced cardiac filling pressure (Kapur: ¶0022-0023 and 0030-0031). Kapur further teaches that the controller may monitor the pressure sensors to determine when to stop actuating the occluder, and that treatment with the occluder may cease when the heart has recovered to normal function (Kapur: ¶0024 and 0031). Because the right atrium of the heart is filled from the superior and inferior vena cava, the central venous pressure is related to the cardiac filling pressure. Mehta teaches that the normal, healthy central venous pressure for a human adult is in the range of 3-8 mmHg (Mehta: ¶0032 and Table 1). If a patient’s central venous pressure has fallen to the normal range, then the cardiac filling pressure has been recovered to a normal range, and the heart has recovered to normal function. The claimed value of 5 mmHg lies within the prior art range of 3-8 mmHg, and therefore a prima facie case of obviousness exists for the claimed value. Please see MPEP §2144.05(I). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method suggested by Rowe in view of Kapur so that the threshold pressure value is 5 mmHg because that would indicate that the patient’s heart function has recovered to normal levels as taught by Mehta and that occlusion may cease as taught by Kapur.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Taft et al. (US 2020/0254228 A1) discloses a rivet shunt.
Sutherland (US 2020/0101270 A1) discloses a pulmonary arterial shunt.
Passman et al. (US 2021/0401494 A1) discloses a pulmonary arterial hypertension catheter.
O’Halloran et al. (US 2022/0218352 A1) discloses a shunt for draining blood from the left atrium to the azygos vein.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/JACQUELINE F STEPHENS/Primary Examiner, Art Unit 3781
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