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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on April 11, 2024 and October 23, 2024 contain over 1000 references. The IDSs have been considered by the examiner to the extent possible under examination time constraints. If Applicant believes specific references are particularly pertinent to patentability, Applicant is requested to explicitly point out those references.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tuval et al. (hereinafter “Tuval”) (U.S. Pub. No. 2019/0209758).
Regarding claim 1, Tuval teaches an apparatus (Abstract), comprising a left-ventricular assist device (¶[0009]) comprising:
a pump-outlet tube shaped to define one or more blood-outlet openings and comprising:
a narrower section (¶[0462], where “the tube extends to the end of distal conical portion 40 of frame 34. For such applications, the tube typically defines a distal conical portion 46, with the narrow end of the cone being distal with respect to the wide end of the cone, as shown in FIG. 2C”); and
a wider section which is proximal to and wider than the narrower section (¶[0462], where “tube 24 includes … a cylindrical central portion 44 … the tube typically defines a distal conical portion 46, with the narrow end of the cone being distal with respect to the wide end of the cone, as shown in FIG. 2C … the central portion of the tube may widen from its proximal end to is distal end”), and which is shaped to define at least a portion of each of the blood-outlet openings such that a normal vector to the portion has a distally-facing component (Figure 2C, blood outlet openings 109, cylindrical central portion 44);
the pump-outlet being configured for insertion, through an aorta of a subject, into a left ventricle of a heart of the subject such that the blood-outlet tube transverse an aortic valve of the subject with a pump-outlet openings being disposed within the aorta; (¶[0359], where “a tube configured to traverse an aortic valve of a subject, such that a proximal portion of the tube is disposed within an aorta of the subject and a distal portion of the tube is disposed within a left ventricle of the subject, the tube defining one or more blood inlet openings within the distal portion of the tube, and one or more blood outlet openings within the proximal portion of the tube”); and
an impeller disposed within the narrower section of the pump-outlet tube (¶[0009], where “the impeller, the axial shaft and the frame are disposed within a distal portion of the tube inside the subject's left ventricle”) and configured to pump blood of the subject through the blood-outlet openings, from the left ventricle into the aorta proximally through the pump-outlet tube (¶[0009], where “Typically, the impeller is configured to pump blood from the left ventricle into the aorta by rotating … the proximal portion of the tube defines one or more blood outlet openings, via which blood flows from the tube into the ascending aorta, during operation of the impeller”).
Regarding claim 2, Tuval additionally discloses wherein the pumping of the blood produces a distal thrust on the pump-outlet tube, and wherein, by virtue of the distally-facing component, a flow of the blood through the blood-outlet openings produces a proximal thrust on the pump-outlet tube that at least partially cancels the distal thrust (pump as shown in Figure 2A-2C will necessarily provide the required distal and proximal thrust).
Regarding claim 3, Tuval additionally discloses wherein an angle between the normal vector and a longitudinal axis of the pump-outlet tube at the wider section is between 20 and 80 degrees (¶[0462], wherein the conical portion 40 will have the desired degree vector; as shown in Figure 2C).
Regarding claim 4, Tuval additionally discloses wherein the normal vector is parallel to a longitudinal axis of the pump-outlet tube at the wider section (¶[0462], wherein the portion past the conical portion 40 will have the desired degree vector; as shown in Figure 2C).
(¶[0462], wherein the conical portion 40 will have the desired degree vector; as shown in Figure 2C).
Regarding claim 5, Tuval additionally discloses wherein each of the blood-outlet openings spans an interface between the narrower section and the wider section (as shown in Figure 2C).
Regarding claim 6, Tuval additionally discloses wherein the pump-outlet tube is configured to curve proximally to the impeller (Figure 2C, tube 24, impeller 50, where the tube curves proximally to the impeller, ¶[0450], where “Reference is also made to FIGS. 2A, 2B, and 2C, which are schematic illustrations of a blood pump portion 27 of ventricular assist device 20, in accordance with some applications of the present invention. Typically, an impeller 50 is disposed within a distal portion 102 of tube 24 and is configured to pump blood from the left ventricle into the aorta by rotating”).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Tuval in view of and further in view of Tuval et al. (hereinafter “Tuval ‘986”) (U.S. Pub. No. 2020/0237986).
Regarding claim 7, Tuval discloses the claimed invention including that the pump-outlet tube is configured to curve by virtue of being pre-shaped (Figure 2C, tube 24, impeller 50, where the tube curves proximally to the impeller, ¶[0450], where “Reference is also made to FIGS. 2A, 2B, and 2C, which are schematic illustrations of a blood pump portion 27 of ventricular assist device 20, in accordance with some applications of the present invention. Typically, an impeller 50 is disposed within a distal portion 102 of tube 24 and is configured to pump blood from the left ventricle into the aorta by rotating.” Examiner takes the position that Tuval teaches the pump-outlet tube is configured to curve by virtue of being pre-shaped. Pre-shaping is functional language, where the structure of Tuval is configured to be curved by pre-shaping, and since the structure of Tuval is capable of performing the intended use, it meets the claim.).
However, should Applicant contend that the curvature does not refer to the curvature at the end of the pump-outlet tube, but that the pump-outlet tube curves as a whole, Tuval ‘986 teaches that the pump-outlet tube is configured to curve by virtue of being pre-shaped.
Tuval ‘986 teaches a ventricular assist device includes an impeller disposed upon an axial shaft (¶[0010]), and further teaches that the pump-outlet tube is configured to curve by virtue of being pre-shaped (¶[0391], where “tube 24 is pre-shaped such that, during operation of the impeller, when the pressure of the blood flow through the tube maintains the proximal portion of the tube in an open state, the tube is curved. Typically, the curvature is such that when the proximal end of the tube is disposed within the aorta, at least a portion of the tube is disposed within the left ventricle and curving away from the posterior wall of the left ventricle, toward the apex of the left ventricle and/or toward the free wall”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Tuval ‘986, which teaches that the pump-outlet tube is configured to curve by virtue of being pre-shaped, with the invention of Tuval in order to maintain the proximal portion of the tube in an open state (Tuval ‘986 ¶[0391]).
Regarding claim 8, Tuval discloses the claimed invention except the express mention of a blood-outlet openings are arranged in a non-axisymmetric arrangement, and wherein the pump-outlet tube is configured to curve by virtue of the blood flowing through the blood-outlet openings.
Tuval ‘986 teaches that the blood-outlet openings are arranged in a non-axisymmetric arrangement (¶[0395], where “For some applications, inlet openings 108 and/or outlet openings 109 are disposed in a non-axisymmetric configuration around tube 24”), and wherein the pump-outlet tube is configured to curve by virtue of the blood flowing through the blood-outlet openings (¶[0389], where “Reference is now made to FIG. 25A, which is a schematic illustration of ventricular assist device 20, tube 24 of the device being configured to become curved when blood is pumped through the tube,” ¶[0395], where “Typically, tube 24 defines the inlet openings and/or the outlet openings at locations that are such as to cause tube 24 to become curved and/or such as to maintain the curvature of tube 24 as described with reference to FIGS. 25A-C … additionally, the blood outlet openings 109 may be disposed on the side of tube 24 that is at the inside of the curve of the tube (or on the inside of the desired curve of the tube). As blood exits the blood outlet openings the blood impacts the wall of the aorta, which causes the proximal end of tube 24 to be pushed in the opposite direction, in the direction of arrow 312”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Tuval ‘986, which teaches that the blood-outlet openings are arranged in a non-axisymmetric arrangement, wherein the pump-outlet tube is configured to curve by virtue of the blood flowing through the blood-outlet openings, with the modified invention of Tuval in order to cause the tube to become curved and/or such as to maintain the curvature of tube (Tuval ‘986 ¶[0395]) and so that a separation is maintained between the blood inlet openings and posterior wall of the left ventricle, mitral valve leaflets, and/or subvalvular components of the mitral valve, such as chordae tendineae and/or papillary muscles (Tuval ‘986 ¶[0396]).
Regarding claim 9, Tuval discloses the claimed invention but does not expressly disclose a pump-outlet tube that is further shaped to define one or more blood-inlet openings arranged in a non-axisymmetric arrangement, and wherein the pump-outlet tube is configured to curve by virtue of the blood flowing through the blood-inlet openings.
Tuval ‘986 teaches that the pump-outlet tube is further shaped to define one or more blood-inlet openings arranged in a non-axisymmetric arrangement (¶[0395], where “For some applications, inlet openings 108 and/or outlet openings 109 are disposed in a non-axisymmetric configuration around tube 24”), and wherein the pump-outlet tube is configured to curve by virtue of the blood flowing through the blood-inlet openings (¶[0389], where “Reference is now made to FIG. 25A, which is a schematic illustration of ventricular assist device 20, tube 24 of the device being configured to become curved when blood is pumped through the tube,” ¶[0395], where “Typically, tube 24 defines the inlet openings and/or the outlet openings at locations that are such as to cause tube 24 to become curved and/or such as to maintain the curvature of tube 24 as described with reference to FIGS. 25A-C. For example, as shown, the blood inlet holes may be disposed on the side of tube 24 that is at the inside of the curve of the tube (or on the inside of the desired curve of the tube). As blood flows into the blood inlet opening, this lowers the pressure in the region above the blood inlet opening, and the distal end of tube 24 is then pulled toward this region (as indicated by arrow 310)”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Tuval ‘986, which teaches one or more blood-inlet openings arranged in a non-axisymmetric arrangement, wherein the pump-outlet tube is configured to curve by virtue of the blood flowing through the blood-inlet openings, with the modified invention of Tuval in order to cause the tube to become curved and/or such as to maintain the curvature of tube (Tuval ‘986 ¶[0395]) and so that a separation is maintained between the blood inlet openings and posterior wall of the left ventricle, mitral valve leaflets, and/or subvalvular components of the mitral valve, such as chordae tendineae and/or papillary muscles (Tuval ‘986 ¶[0396]) .
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Tuval and Tuval ‘986 in further view of Mitze et al. (hereinafter “Mitze”) (U.S. Pub. No. 2022/0161018).
Regarding claim 10, Tuval disclose the claimed invention except a left-ventricular assist device that further comprises one or more bands bonded to an outer wall of the pump-outlet tube, and wherein the pump-outlet tube is configured to curve by virtue of the bands being bonded to the outer wall.
Tuval ‘986 teaches that the left-ventricular assist device further comprises the pump-outlet tube that is configured to curve (¶[0389], where “Reference is now made to FIG. 25A, which is a schematic illustration of ventricular assist device 20, tube 24 of the device being configured to become curved when blood is pumped through the tube,” ¶[0391], where “tube 24 is pre-shaped such that, during operation of the impeller, when the pressure of the blood flow through the tube maintains the proximal portion of the tube in an open state, the tube is curved. Typically, the curvature is such that when the proximal end of the tube is disposed within the aorta, at least a portion of the tube is disposed within the left ventricle and curving away from the posterior wall of the left ventricle, toward the apex of the left ventricle and/or toward the free wall”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Tuval ‘986, which teaches that the pump-outlet tube is configured to curve, with the modified invention of Tuval in order to maintain the proximal portion of the tube in an open state (Tuval ‘986 ¶[0391]), to maintain the curvature of tube (Tuval ‘986 ¶[0395]), and so that a separation is maintained between the blood inlet openings and posterior wall of the left ventricle, mitral valve leaflets, and/or subvalvular components of the mitral valve, such as chordae tendineae and/or papillary muscles (Tuval ‘986 ¶[0396]).
None of Tuval or Tuval ‘986 teaches that the left-ventricular assist device further comprises one or more bands bonded to an outer wall of the pump-outlet tube, and wherein the pump-outlet tube is configured to curve by virtue of the bands being bonded to the outer wall.
Mitze teaches a mechanical circulatory support system for transcatheter delivery to the heart, where the device may comprise a tubular housing, an impeller and the guidewire aid (Abstract), and further teaches that the left-ventricular assist device further comprises one or more bands bonded to an outer wall of the pump-outlet tube (Figure 7, tubular housing 61, pump inlets 66, pump outlets 68, inlet tube 70, ¶[0056], where “pump 22 include a tubular housing 61, which may include an inlet tube 70, a distal tip 64, and/or a motor housing 74. The tubular housing 61 may include one or more pump inlets 66 and/or outlets 68, which may be part of the inlet tube 70, or part of other structures such as an intermediate structure joining a proximal end of the inlet tube 70 to the motor housing 74,” ¶[0059], where “inlet tube 70 may comprise a highly flexible slotted (e.g., laser cut) metal (e.g., Nitinol) tube having a polymeric (e.g., Polyurethane) tubular layer to isolate the flow path.” Examiner interprets that the inlet tube has bands bonded to the outer wall based on the figure shown.), and wherein the pump-outlet tube is configured to curve by virtue of the bands being bonded to the outer wall (¶[0118], where “FIG. 23 is a perspective view of an alternative embodiment of an inlet tube 105b of an MCS system. The inlet tube 105b may be used with any of the pumps or MCS systems described herein,” ¶[0123], where “the inlet tube 105b may be bent in the direction of the first connection section 210b, the bend being shaped, for example, as an obtuse angle with respect to a longitudinal axis of the inlet tube 105b. The bend can be realized by heat treatment of the nitinol braid section 220b. Due to the shape-memory properties of the nitinol, the inlet tube 105b can be formed with a curve shape of the braid section 220b corresponding to the human anatomy in order to enable the inlet opening of the pump inlet 230b of the first connection section 210b to be positioned in the center of the heart chamber”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Mitze, which teaches that the left-ventricular assist device further comprises one or more bands bonded to an outer wall of the pump-outlet tube, and wherein the pump-outlet tube is configured to curve by virtue of the bands being bonded to the outer wall, with the modified invention of Tuval in order to form a curve shape corresponding to the human anatomy in order to enable the inlet opening of the pump inlet to be positioned in the center of the heart chamber (Mitze ¶[0123]).
Claims 11-16 are are rejected under 35 U.S.C. 103 as being unpatentable over Tuval et al. (hereinafter “Tuval”) (U.S. Pub. No. 2019/0209758) in view of Keren et al. (hereinafter “Keren”) (U.S. Pub. No. 2004/0064090) and Fierens et al. (hereinafter “Fierens”) (U.S. Pub. No. 2015/0018597).
Regarding claim 11, Tuval discloses the claimed invention as included above and additionally discloses:
a delivery tube configured to extend, from outside a body of a subject, through the pump-outlet tube to the distal portion of the pump-outlet tube (Figure 10A, second outer tube 142, ¶[0393],where “an outer tube disposed around the drive cable configured to extend from outside the subject's body to within the blood-pump tube, the outer tube defining first and second openings on a portion of the outer tube disposed within the blood-pump tube”); and
a drive cable (¶[0508], where “Reference is now made to FIGS. 10A, 10B, and 10C, which are schematic illustrations of drive cable 130 of ventricular assist device 20”) passing through the delivery tube (¶[0508], where “drive cable is typically disposed within a first outer tube 140 … the first outer tube is disposed within a second outer tube 142”) and configured to rotate the impeller (¶[0508], where “the rotational motion of the impeller (which is imparted via the axial shaft), as well as the axial back-and-forth motion of the axial shaft described hereinabove, is imparted to the axial shaft via the drive cable”).
The above-described embodiment of Tuval does not teach an expandable element surrounding the delivery tube at least partially proximally to the blood-outlet openings nor a length of the delivery tube between the expandable element and the blood-outlet openings being less than 30 mm.
A second embodiment of Tuval teaches an expandable element (¶[0563], where “the outer surface of the distal tip portion includes an inflatable portion 278 (e.g., a balloon), which is configured to be inflated when the distal tip portion is disposed inside the subject's left ventricle”) surrounding the delivery tube (Figure 21C, where the inflatable portion 278 surrounds a tube within delivery catheter 143, where Examiner interprets that said tube is outer tube 142 since outer tube 142 is disposed within the delivery catheter 143, ¶[0509], where “delivery catheter 143 … outer tube 142 is disposed inside the delivery catheter,” ¶[0563], where “an inflation lumen for inflating the inflatable portion is configured to pass through outer tube 142, and to then pass along the outer surface of tube 24, and to the inflatable portion of the distal tip portion”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of a second embodiment of Tuval, which teaches an expandable element surrounding the delivery tube, with the invention of Tuval in order to prevent backflow of blood, for example, in the event that the impeller of the ventricular assist device malfunctions (Tuval ¶[0582]).
Neither embodiment of Tuval explicitly teaches an expandable element proximal to the blood-outlet openings nor a length of the delivery tube between the expandable element and the blood-outlet openings being less than 30 mm.
Keren teaches an apparatus for treating congestive heart by actively or passively enhancing perfusion to the renal arteries, where an embodiment comprises a specially configured balloon catheter and extracorporeal pump (Abstract), and further teaches an expandable element at least partially proximally to the blood-outlet openings (Figure 12, blood outlet 229, proximal balloon 215, where the balloon is proximal to the blood-outlet opening, ¶[0092], where “FIG. 12 better illustrates the inner workings of catheter 211 at the catheter distal end 214 … An additional blood outlet then may be provided proximal to proximal balloon 215, thereby providing blood to the lower extremities … screw pump 218 is causing high pressure blood to exit the blood outlet 229, the proximal balloon 215 and distal balloon 216 may be inflated”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Keren, which teaches an expandable element at least partially proximally to the blood-outlet openings, with the modified invention of Tuval in order to provide blood to the lower extremities (Keren ¶[0092]).
Neither Tuval nor Keren teaches a length of the delivery tube between the expandable element and the blood-outlet openings being less than 30 mm.
Fierens teaches a medical treatment system (¶[0001]) with an inflatable balloon (¶[0145]), and further teaches a length of the delivery tube between the expandable element and the blood-outlet openings being less than 30 mm (Figure 9, distance J, distance L, ¶[0145], where “the outlets 62 allowing the perfusion and/or drainage are positioned at the distal end X of the balloon 59 of the device and the distance J at the distal end X and over which the outlets 62 are distributed is comprised between 10 and 14 mm … The balloon length L is comprised between 10 and 50 mm, preferably between 15 and 40 mm, more preferably between 20 and 30 mm, most preferably around 24 mm.” Examiner interprets that the length of the tube between the balloon and the outlets is less than 30 mm since the length of the balloon is as little as 10 mm and the outlets are distributed along a length as little as 10 mm, where the total length is 20 mm.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Fierens, which teaches a length of the delivery tube between the expandable element and the blood-outlet openings being less than 30 mm, with the modified invention of Tuval so that the device properly fits within the patient’s heart.
Regarding claim 12, Tuval in combination with Keren and Fierens teaches all limitations of claim 11 as described in the rejection above.
Keren teaches that the expandable element is configured to center the delivery tube within the aorta (¶[0024], where “the balloon material is chosen so that inflation of the balloon to a volume sufficient to occlude the aorta, i.e., to a diameter of between 15 and 35 mm, will create a sufficient pressure within the balloon so as to provide the balloon with some degree of mechanical rigidity and to likewise apply a small amount of outward radial force to the aortic wall so as to provide positional and orientational stability to the balloon.” Examiner interprets that since Tuval teaches a delivery tube within the center of expandable element as described above, and since the inflation of the expandable element occludes the aorta, that the delivery tube will be centered within the aorta, where the structure of Keren is capable of centering the delivery tube.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Keren, which teaches that the expandable element is configured to center the delivery tube within the aorta, with the modified invention of Tuval in order to provide positional and orientational stability to the balloon (Keren ¶[0024]).
Regarding claim 13, Tuval in combination with Keren and Fierens teaches all limitations of claim 11 as described in the rejection above.
Keren teaches that the expandable element is entirely proximal to the pump-outlet tube (Figure 12, proximal balloon 215, housing 219, blood outlet 229, where the proximal balloon is entirely proximal to the pump-outlet tube since the proximal balloon is proximal to the blood outlet, which is a point of output for the housing and consequently a pump-outlet tube.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Keren, which teaches that the expandable element is entirely proximal to the pump-outlet tube, with the modified invention of Tuval in order to provide blood to the lower extremities (Keren ¶[0092]).
Regarding claim 14, Tuval in combination with Keren and Fierens teaches all limitations of claim 11 as described in the rejection above.
A second embodiment of Tuval teaches that the expandable element comprises an inflatable element (¶[0563], where “the outer surface of the distal tip portion includes an inflatable portion 278 (e.g., a balloon), which is configured to be inflated when the distal tip portion is disposed inside the subject's left ventricle”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of a second embodiment of Tuval, which teaches that the expandable element comprises an inflatable element, with the modified invention of Tuval in order to prevent backflow of blood, for example, in the event that the impeller of the ventricular assist device malfunctions (Tuval ¶[0582]).
Regarding claim 15, Tuval in combination with Keren and Fierens teaches all limitations of claim 14 as described in the rejection above.
None of the above-described embodiments of Tuval, Keren, nor Fierens explicitly teaches that the inflatable element, when inflated, is disposed at least partly within the pump-outlet tube.
A third embodiment of Tuval teaches that the inflatable element, when inflated, is disposed at least partly within the pump-outlet tube (Figure 28C, safety balloon 80, tube 312, where the safety balloon is at least partially within the tube, ¶[0582], where “Reference is now made to FIGS. 28A, 28B, and 28C, which are schematic illustrations of ventricular assist device 308, the device including a safety balloon 80 to prevent backflow of blood, for example, in the event that the impeller of the ventricular assist device malfunctions”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of a second embodiment of Tuval, which teaches that the inflatable element, when inflated, is disposed at least partly within the pump-outlet tube, with the modified invention of Tuval in order to prevent backflow of blood, for example, in the event that the impeller of the ventricular assist device malfunctions (Tuval ¶[0582]).
Regarding claim 16, Tuval in combination with Keren and Fierens teaches all limitations of claim 15 as described in the rejection above.
A third embodiment of Tuval teaches that the inflatable element is disposed entirely within the pump-outlet tube (Figure 28C, safety balloon 80, tube 312, where the safety balloon is fully within the tube, ¶[0582], where “Reference is now made to FIGS. 28A, 28B, and 28C, which are schematic illustrations of ventricular assist device 308, the device including a safety balloon 80 to prevent backflow of blood, for example, in the event that the impeller of the ventricular assist device malfunctions”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of a second embodiment of Tuval, which teaches that the inflatable element is disposed entirely within the pump-outlet tube, with the modified invention of Tuval in order to prevent backflow of blood, for example, in the event that the impeller of the ventricular assist device malfunctions (Tuval ¶[0582]).
Regarding claim 17, Tuval in combination with Keren and Fierens teaches all limitations of claim 15 as described in the rejection above.
Keren teaches that the inflatable element is shaped to direct the blood through the blood-outlet openings (¶[0092], where “blood exits from the housing 219 through blood outlet 229 into the renal arteries 220 … An additional blood outlet then may be provided proximal to proximal balloon 215, thereby providing blood to the lower extremities … As screw pump 218 is causing high pressure blood to exit the blood outlet 229, the proximal balloon 215 and distal balloon 216 may be inflated. The balloons 215 and 216 may also be inflated prior to the screw pump 218 activation … The balloons 215 and 216 inflate against the aorta 210 to a final outer diameter indicated in phantom, thereby isolating the area surrounding the renal arteries 220. This allows the increased pressure caused by the pump to be most effective. Higher pressure blood will be more likely to enter the renal arteries 220, thereby effectively perfusing the constricted renal arteries 220.” Examiner interprets that the inflation of the proximal balloon directs blood through the blood outlet since the balloon increases pressure to perfuse blood.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Keren, which teaches that the inflatable element is shaped to direct the blood through the blood-outlet openings, with the modified invention of Tuval in order to provide blood to the lower extremities and to increase pump effectiveness (Keren ¶[0092]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 18/632533 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 11 of the instant application is substantially similar to and contains all of the same limitations as claim 4 of the ‘533 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/Amanda K Hulbert/Primary Examiner, Art Unit 3792
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