DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This Office Action is responsive to the amendment filed 07/15/2026. As per the amendment: claims 25, 27-33, 35, 37, and 40 have been amended, claims 1-24 were previously cancelled, claims 26, 38-39, and 41 have been cancelled, and no claims have been added. Therefore, claims 25, 27-37, and 40 are presently pending and under consideration.
Response to Arguments
Response to Arguments Regarding 35 USC § 102/103
Applicant’s arguments, see pg. 5-9 of Remarks, filed 07/15/2026, with respect to the rejection(s) of claim(s) 25, 30, and 34-37 under 35 U.S.C. 103(a) in view of Kensey et al. (US Patent 4,753,221 A) in view of Olsen et al. (US Patent 4,688,998 A) in view of Kung (US Patent 7,914,436 A) and the rejection(s) of claim(s) 25-27 under 35 U.S.C. 103(a) in view of Kensey in view of Pasque and further in view of Kung have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Diaz et al. (US 2004/0034272 A1), hereinafter Diaz.
Diaz teaches a cardiac-assist device wherein a one-way inflow valve configured to prevent blood from flowing out of the inner chamber through the inflow opening; and a one-way outflow valve configured to prevent blood from flowing into the inner chamber through the outflow opening (view Figure 3, [0057] “The SAM also includes upper and lower check valves 51, 53 which control the flow of blood into and out of the rigid housing 33. Check valve 51 opens under vacuum and closes under pressure. Similarly, check valve 53 closes under vacuum but opens under pressure. Check valve 51 thus allows blood flow into the housing interior 37 but closes under pressure so that the blood passing through the valve cannot return in the direction of the ventricle…Check valve 53 opens under the presence of pressure, allowing fluid ejection through the housing outlet 36 in the direction of the femoral bifurcation 49 or other desired location”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kensey to incorporate the teachings of Diaz to have a one-way inflow valve configured to prevent blood from flowing out of the inner chamber through the inflow opening; and a one-way outflow valve configured to prevent blood from flowing into the inner chamber through the outflow opening, as these prior art references and the instant application are directed to blood pumps used in the heart/ventricular systems. One would be motivated to do this to prevent blood from flowing back and ejecting the blood into desired location, as recognized by Diaz ([0057]).
Examiner would also like to make note of Leschinsky (US Patent 5,928,132 A) that teaches an inflow and outflow valve (Figure 3 and 4: a leaflet intake valve 114, outlet valve 115) and Dobak et al. (US Patent 5,820,542 A) teaches an inflow and outflow valve (one-way inlet valve 40, one-way outlet valve 42).
Therefore, claims 25, 27, 30, and 34-37 remain rejected as described in detail below under 35 USC 103.
No additional specific arguments were presented with previous 35 U.S.C. rejections of dependent claims 28-29, 31-33, and 40 nor specifically with respect to the previously cited Leschinsky and Jarvik references.
Therefore, claims 28-29, 31-33, and 40 are rejected as described below under 35 U.S.C. 103.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 25, 27, 30, and 34-37 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kensey et al. (US Patent 4,753,221, previously presented), hereinafter Kensey in view of Diaz et al. (US 2004/0034272 A1), hereinafter Diaz, further in view of Kung (US Patent 7, 914,436 B1, previously cited), hereinafter Kung.
Regarding claim 25, Kensey teaches a blood pump (Column 1, line 6-9: “catheter-based instruments for effecting the pumping of blood through the vascular system”, Figure 6) comprising:
a catheter (Figure 6: catheter 200);
a conveying element (Figure 6: blades 42, Column 4, lines 25-27: “the pump 42 is an axial type pump basically comprising a central hub 62 from which four blades or impellers 64 extend”, Column 6, lines 15-16: “the blades 64 of the pump means 42 of device 200”, Column 6, lines 25-27: “device 200 can utilize the flexible arm centrifugal pump 100 in lieu of the bladed or propeller-like pump 42”, Column 3, lines 15-18: “a centrifugal pump which is arranged to be operated, e.g., rotated, by drive means 44. The drive means 44 can take various forms, but preferably comprises the high-speed rotary drive system”);
an expandable housing (Column 4, lines 8-10: “the pump 42 is an expandable/contractable member so that when the free end portion 58 of the catheter is expanded”, Examiner also notes that the “device 200 is constructed similarly to device 20, except for its pump (to be described later)”( Column 5, lines 64-66), Figure 6: boundaries are 50/58 and 52) defining an inner chamber (Figure 6: passageway 80) configured to receive the conveying element (Column 3, lines 11-12 “the distal end portion 36 of the catheter 20 includes pump means 42.”, Examiner also notes that the “device 200 is constructed similarly to device 20, except for its pump (to be described later)”( Column 5, lines 64-66)) , the expandable housing coupled to a distal end of the catheter and being configured to transition between a compressed state (Column 4, line 31: “unexpanded”) and an expanded state (Column 6, lines 4-6: “The balloon 52 is then fully inflated in the manner as described with reference to FIG. 2 to hold the distal end of device 200 in place.”) within a blood vessel (Figure 6: the heart’s coronary arteries 37), the expandable housing comprising:
an outflow opening (Column 6, line 18:“the apertures 74 now form its outlet”);
an inflow opening (Column 6, lines 16-18: “the opening 60 at the free end 58 of the catheter, now forms the inlet for the device”, Figure 6) positioned distal to the outflow opening (view Figure 6, Column 6, lines 4-6:“the balloon 52 is then fully inflated…to hold the distal end of device 200 in place”) ;
an inner wall (Figure 6: 58); and
an outer wall (Figure 6: 52); and
wherein the conveying element (Figure 6B: blades 42) is disposed within the inner chamber (Figure 6: passageway 80, the blades 42 are positioned inside the passageway 80) and configured to be radially compressed by the inner wall when the housing is in the compressed state (Column 4, lines 30-33: “the blades are formed of the flexible material so that when the free end 58 of the distal end of the device Is compacted (unexpanded) the blades are flexed into the closed or compressed position shown in FIG 4B.”), and
wherein the conveying element is further configured to pulsate to convey blood from the inflow opening to the outflow opening when the expandable housing is in the expanded state (Figure 6: direction of blood flow, Column 6, lines 19-24: “upon the rotation of drive cable 46 blood is pulled from the left ventricle 35 into inlet 60 by the rotation of pump 42, the blood flows upward through the passageway 80 and out of the outlet apertures 74 into the aorta 31 and coronary arteries 37. The direction of blood flow is again denoted by the arrows 68.”) .
Kensey does not disclose a one-way inflow valve configured to prevent blood from flowing out of the inner chamber through the inflow opening; and a one-way outflow valve configured to prevent blood from flowing into the inner chamber through the outflow opening.
However, Diaz teaches a cardiac-assist device wherein a one-way inflow valve configured to prevent blood from flowing out of the inner chamber through the inflow opening; and a one-way outflow valve configured to prevent blood from flowing into the inner chamber through the outflow opening (view Figure 3, [0057] “The SAM also includes upper and lower check valves 51, 53 which control the flow of blood into and out of the rigid housing 33. Check valve 51 opens under vacuum and closes under pressure. Similarly, check valve 53 closes under vacuum but opens under pressure. Check valve 51 thus allows blood flow into the housing interior 37 but closes under pressure so that the blood passing through the valve cannot return in the direction of the ventricle…Check valve 53 opens under the presence of pressure, allowing fluid ejection through the housing outlet 36 in the direction of the femoral bifurcation 49 or other desired location”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kensey to incorporate the teachings of Diaz to have a one-way inflow valve configured to prevent blood from flowing out of the inner chamber through the inflow opening; and a one-way outflow valve configured to prevent blood from flowing into the inner chamber through the outflow opening, as these prior art references and the instant application are directed to blood pumps used in the heart/ventricular systems. One would be motivated to do this to prevent blood from flowing back and ejecting the blood into desired location, as recognized by Diaz ([0057]).
Kensey and Diaz, alone or in configuration fail to teach, wherein the conveying element is a balloon.
However, Kung teaches a pump system for pumping blood through a body passageway comprising a balloon (a balloon 126), wherein the balloon is disposed within the inner chamber (expandable section 110, view Figure 1B) and configured to be radially compressed by the inner wall when the expandable housing is in the compressed state (view Figure 5, Column 11, lines 13-19: “In FIG. 5, the expandable section 110 of the cannula 104 is shown in a wrapped or collapsed configuration for insertion into an artery in solid lines and in an expanded configuration for use in dashed lines. In the embodiment shown in FIG. 5, the balloon 126 is within the collapsed section during insertion of the cannula.”), and wherein the balloon is further configured to pulsate to convey blood from the inflow opening through the inner chamber to the outflow opening when the expandable housing is in the expanded state (Column 7, lines 52-64: “The expandable section is located in the descending aorta, and the proximal section extends through an incision in the femoral artery. Expansion of the expandable section sets up a chamber in which the balloon can expand and contract. At this point, the blood pump can begin operating to pump blood from the chamber of the expandable section. Once blood is drawn into the chamber of the expandable section, the control device begins to cyclically inflate and deflate the balloon to cause pressurized blood to flow through the valves when the balloon is inflated and to cause blood to flow into the chamber of the expandable section from the left ventricle when the balloon is deflated.”)
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kensey and Diaz to incorporate the teachings of Kung to have a balloon wherein the balloon is disposed within the inner chamber and configured to be radially compressed by the inner wall when the housing is in the compressed state and wherein the balloon is further configured to pulsate to convey blood from the inflow opening through the inner chamber to the outflow opening when the housing is in the expanded state, as these prior art references are directed to circulatory assisting pumps. One would be motivated to do this as cardiac assist pumping balloons do not require major thoracic or invasive surgery and can still provide cardiac support, as recognized by Kung (Column 1, lines 23-28).
Regarding claim 27, Kensey/Diaz/Kung teaches the blood pump according to claim 25 (as shown above). Kensey further discloses the blood pump configured such that, during operation of the pump, blood is suctioned into the inner chamber (Figure 6: passageway 80) through the inflow opening (Column 6, lines 16-18: “the opening 60”) and expelled out of the inner chamber through the outflow opening (Column 6, line 18:“the apertures 74 now form its outlet”, Column 6, lines 18-24: “Thus, upon the rotation of drive cable 46 blood is pulled from the left ventricle 35 into inlet 60 by the rotation of pump 42, the blood flows upward through the passageway 80 and out of the outlet apertures 74 into the aorta 31 and coronary arteries 37. The direction of blood flow is again denoted by the arrows 68.”).
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Modified Figure 2 (Jarvik)
Regarding claim 30, Kensey/Diaz/Kung teaches the blood pump according to claim 25 (as shown above). Kensey and Kung, alone or in combination, fail to explicitly teach the housing comprising the inflow valve. However, Diaz further teaches wherein the expandable housing (supplemental assist mechanism (SAM) 19: ) comprises the one-way inflow valve ([0057] “The SAM also includes upper and lower check valves 51, 53 which control of blood into and out of the rigid housing 33”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the blood pump of Kensey in view of Kung to incorporate the teachings of Diaz to have the expandable housing comprised of the one-way inflow valve. One would be motivated to do this to control the flow of blood into and out of the housing and to ensure that the blood is not returned in the direction of the ventricle, as recognized by Diaz ([0057]). Further, it is within the general skill level of a worker in the art to properly position an inflow valve in a pump housing.
Regarding claim 34, Kensey/Diaz/Kung teaches the blood pump according to claim 25 (as shown above). Kensey further discloses wherein at least one of the inner wall and the outer wall (Figure 6: 52) is configured to contract elastically from the expanded stated into the compressed state (Column 4, lines 8-13: “the pump 42 is an expandable/contractable member so that when the free end portion 58 of the catheter is expanded, by the inflation of balloon 52, the pump 42 expands from a closed or compact position shown in FIG. 4B to an open and operative position shown in FIG. 2”, Column 4, lines 31-32 “the end of the device is compacted (unexpanded)”).
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Modified Figure 1. (Kensey)
Regarding claim 35, Kensey/Diaz/Kung teaches the blood pump according to claim 25 (as shown above). Kensey further discloses the blood pump further comprising at least one expandable stabilization chamber (interior volume of balloon 52, view modified Figure 1), wherein the housing is configured to transition between the compressed state and the expanded state based on a change in inflation pressure of the at least one expandable stabilization chamber (Column 4, lines 8-13: “the pump 42 is an expandable/contractable member so that when the free end portion 58 of the catheter is expanded, by the inflation of balloon 52, the pump 42 expands from a closed or compact position shown in FIG. 4B to an open and operative position shown in FIG. 2”). Examiner interprets the change in inflation pressure to be the change from no pressure in the deflated state to the pressure of the fully inflated state.
Regarding claim 36, Kensey/Diaz/Kung teaches the blood pump according to claim 35 (as shown above). Kensey further discloses wherein the at least one expandable stabilization chamber (interior volume of balloon 52, view modified Figure 1) is disposed between the inner wall (Figure 6: 50/58); and the outer wall (Figure 6: 52).
Regarding claim 37, Kensey/Diaz/Kung teaches the blood pump according to claim 35 (as shown above). Kensey further discloses wherein the at least one expandable stabilization chamber (interior volume of balloon 52, view modified Figure 1) is configured to be supplied with a blood pressure (Column 5, lines 8-11: “the balloon is then fully inflated by providing air or some other blood through lumen 62 into the interior of the balloon”), wherein the compressed state of the housing, corresponds to a first blood pressure in the expandable stabilization chamber (Column 4, line 4: “balloon is partially inflated or uninflated”), and the expanded state of the expandable housing corresponds to a second blood pressure in the expandable stabilization chamber (Column 4, line 1: “the balloon 52 is fully inflated”), and wherein the second blood pressure is higher than the first blood pressure.
Although, Kensey doesn’t explicitly state that the second blood pressure is higher than the first blood pressure. It would be obvious for one of ordinary skill in the art that in the expanded state with more air or blood there would be a higher blood pressure than when the balloon is partially inflated uninflated.
Claim 28 and 40 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kensey in view of Diaz in view of Kung as applied to claim 25 above, and further in view of Jarvik (US 5,613,935 A, previously cited), hereinafter Jarvik.
Regarding claim 28, Kensey/Diaz/Kung teach the blood pump according to claim 25 (as shown above). Kensey, Diaz, and Kung, alone or in combination, fail to teach wherein the outflow valve comprises one or more valve flaps. However, Jarvik further teaches wherein the outflow valve comprises one or more valve flaps (modified Figure 2: valve 10, valve flaps A and B, Figure 2).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the blood pump of Kensey/Diaz/Kung to incorporate the teachings of Jarvik to have the outflow valve comprise of one or more valve flaps, as these prior art references and the instant application are directed to pumps used in the ventricular system. One would be motivated to do this to effectively prevent backflow and to imitate natural valves present in the heart as known in the art.
Regarding claim 40, Kensey/Diaz/Kung teach the blood pump according to claim 25 (as shown above). Kensey and Kung, alone or in combination, fail to explicitly teach wherein the expandable housing comprises the one-way outflow valve.
However, Diaz further teaches wherein the expandable housing (supplemental assist mechanism (SAM) 19) comprises the one-way outflow valve ([0057] “The SAM also includes upper and lower check valves 51, 53 which control of blood into and out of the rigid housing 33”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the blood pump of Kensey in view of Kung to incorporate the teachings of Diaz to have the expandable housing comprised of the one-way outflow valve. One would be motivated to do this to control the flow of blood into and out of the housing and to ensure that the blood is not returned in the direction of the ventricle, as recognized by Diaz ([0057]). Further, it is within the general skill level of a worker in the art to properly position an outflow valve in a pump housing.
Kensey, Diaz, and Kung, alone or in combination, fail to explicitly teach wherein the expandable housing comprises the one-way outflow valve.
However, Jarvik further teaches wherein the housing (Figure 2. housing 58, outflow graft 8) comprises the outflow valve (valve 10).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the blood pump of Kensey in view of Diaz in view of Kung to incorporate the teachings of Jarvik to have the housing comprise of the outflow valve. One would be motivated to do this to prevent blood from flowing out or to prevent backflow. Further, it is within the general skill level of a worker in the art to properly position an outflow valve in a pump housing.
Claims 29 and 31-33 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kensey in view of Diaz in view of Kung as applied to claim 25 above, and further in view of Leschinsky (US Patent 5,928,132 A, previously presented), hereinafter Leschinsky.
Regarding claim 29, Kensey in view of Diaz in view of Kung teach the blood pump according to claim 25 (as shown above). Kensey, Diaz, and Kung, alone or in combination, fail to teach wherein the one-way inflow valve comprises one or more valve flaps.
However, Leschinsky teaches an intra-aortic catheter based ventricular assist device comprising an intra-aortic balloon catheter and a pumping chamber which has inflow and outflow valves (Figure 4. : valves 115, one is the inflow valve and the other is the outflow valve – see direction of flow arrows) wherein the inflow valve comprises one or more valve flaps (view modified figure 3). Further, one of ordinary skill in the art would know that it is typical to use flap-type one-way valves in pump inlets and outlets. Such valves are widely known and readily available.
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Modified figure 3 (Leschinsky)
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the inflow valve of Kensey/Diaz/Kung as taught by Leschinsky as the prior art references and the instant application are directed to blood pumps used in the ventricular system. One would be motivated to do this to effectively prevent backflow and to imitate natural valves present in the heart as known in the art.
Regarding claim 31, Kensey in view of Diaz in view of Kung teach the blood pump according to claim 25 (as shown above). Kensey and Kung, alone or in combination, fail to explicitly teach the pump further comprising a proximal end and a distal end, the proximal end of the hose connected to the inflow opening of the expandable housing and the distal end of hose configured to extend into a ventricle of a patient.
However, Diaz teaches a hose (flexible catheter 23) comprising a proximal end and a distal end (view Examiner modified Figure 3 (Diaz)), the proximal end of the hose connected to the inflow opening of the expandable housing (view Examiner modified Figure 3 (Diaz)), and the distal end of the hose configured to extend into a ventricle of a patient ((view Examiner modified Figure 3 (Diaz): [0054] “The catheter 23 has at least one opening 31 along the length of the flexible catheter for admitting blood into the open interior 25 after the catheter has been installed within the arterial circulation.”).
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Examiner Modified Figure 3 (Diaz)
Alternatively, Leschinsky teaches a blood pump (Column 4 lines 46-48: "The present invention 11 comprises an Intra-Aortic Balloon (IAB) catheter 100 and a pumping chamber 110") further comprising a hose (the smaller tube cannula portion 112) comprising a proximal end and a distal end, the proximal end of the hose connected to the inflow opening of the expandable housing (tip 103, pumping chamber 110) and the distal end of the hose configured to extend into a ventricle of a patient (left ventricle 80, view modified Figure 4).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kensey/Diaz/Kung to incorporate the teachings of Leschinsky to have a hose comprising a proximal end and a distal end, the proximal end of the hose connected to the inflow opening of the housing and the distal end of the hose configured to extend into a ventricle of a patient, as these prior arts are directed to ventricular assist pumps. One would be motivated to do this in order for the inflow and/or outflow of the pump to be directed to the appropriate organ as needed.
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Modified Figure 4. (Leschinsky)
Regarding claim 32, Kensey/Diaz/Kung/Leschinsky teach the blood pump according to claim 31 (as shown above). Kensey, Diaz, and Kung, alone or in combination, fail to teach wherein the hose comprises the one-way inflow valve.
However, Leschinsky further teaches wherein the hose comprises the inflow valve (view modified figure 4, leaflet intake valve 114, outlet valves 115).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kensey/Diaz/Kung to incorporate the teachings of Leschinsky to have the hose comprise of the one-way inflow valve. One would be motivated to do this to prevent blood from flowing out or to prevent backflow. Further, it is within the general skill level of a worker in the art to properly position an inflow valve in an elongate hose.
Regarding claim 33, Kensey/Diaz/Kung/Leschinsky teach the blood pump according to claim 31 (as shown above). Kensey, Diaz, and Kung, alone or in combination fail to teach wherein the expandable housing is configured to be positioned within an aorta and the elongate hose is configured to extend across an aortic valve.
However, Leschinsky further teaches wherein the housing (pumping chamber 110) is configured to be positioned within an aorta (aorta 70) and the elongate hose is configured to extend across an aortic valve (aortic valve 140, view modified figure 4).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kensey/Diaz/Kung to incorporate the teachings of Leschinsky to have the housing positioned within an aorta and the elongate hose configured to extend across the aortic valve. One would be motivated to do this as placing the hose in the aortic valve could help with the pulsate movement of the blood flowing through the tube, additionally, it is within the general skill level of a worker in the art to properly position the housing and the elongate hose to reach the desired areas.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Schmitz-Rode et al. (US 6,533,716 B1), teaches an elongate hose reaching into the ventricle.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ATTIYA SAYYADA HUSSAINI whose telephone number is (703)756-5921. The examiner can normally be reached Monday-Friday 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at 5712724156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ATTIYA SAYYADA HUSSAINI/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
