VENTRICULAR ASSIST DEVICE

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 This office action is in response to the amendment filed on 7/23/2026. Currently claims 1-24 are pending. Response to Arguments Applicant’s arguments, see pg. 8, filed 7/23/2026, with respect to the double patenting rejection of claims: 1-3, 6, 12-17 and 19-24 in view of US pat. 12127820 4-5 and 8-11 in view of US pat. 12127820 in view of Corbett 7 and 18 in view of US pat. in view of Evans have been fully considered and are persuasive based on the terminal disclaimer filed. The double patenting rejection of these claims has been withdrawn. Applicant’s arguments, see pgs. 8-11, filed 7/23/2026, with respect to the rejection(s) of claim(s) 1-24 under 35 USC 103 as being unpatentable over Evans in view of Corbett 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 Therefore, the rejection has been withdrawn.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 the additional reference of Siess et al (WO 2016207293). Terminal Disclaimer The terminal disclaimer filed on 7/23/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US pat. 12127820 has been reviewed and is accepted. The terminal disclaimer has been recorded. 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. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. Claim(s) 1-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Evans et al (US 20130053623) hereafter known as Evans in view of Corbett et al (US 20180055979) hereafter known as Corbett in view of Siess et al (WO 2016207293) hereafter known as Siess. Independent claims: Claim 1: Evans discloses: An apparatus [see abstract... “A pump for inducing flow within a vascular system"], comprising: a left ventricular assist device [see Fig. 1 element 100 and para 58... “FIG. 1 illustrates one embodiment of an expandable blood pump 100 according to the present disclosure”] comprising: an axial flow impeller [see Figs. 6 and 7D-7F and para 85… “in which the impeller (e.g., impeller 500 as shown in FIG. 6”] configured to be disposed within a left ventricle of a subject and configured to pump blood axially from the subject's left ventricle to an aorta of the subject [see para 121 of Evans… “The pump and impeller mechanisms, and the corresponding cannula and flow passage and channel structures, may also be fixed in anatomical position by a catheter support, by the cannula resting against a vessel wall or valve 1103, by a guidance feature resting against the internal or external anatomical structure of a heart, vein, artery, or blood vessel” This section discloses that the ventricular assist device with the impeller inside it is configured to be placed inside a structure of the heart or an artery or vein (i.e. that which includes a left ventricle and aorta) which makes the impeller at least capable of being placed to recite the functional language as claimed], by rotating [see para 53… “The mechanical generator may be operably connected with the impeller, thereby transferring rotational motion of the generator about the impeller axis to rotational motion of the impeller about the impeller axis.”]; a frame disposed around the impeller [see Fig. 6 and 7D-7F elements 604 and 606 and para 85… “one or more substantially rigid or semi-rigid support members 604 in spiral configuration, creating a plurality of ribs 606.”], the frame being shaped such that, in a non-radially-constrained configuration of the frame, the frame defines a central cylindrical portion, and a distal conical portion that is disposed distally with respect to the central cylindrical portion [see labelled figure directly below rejection to claim 1]; and the frame being at least partially covered with one or more tube portions that extend distally over the distal conical portion of the frame [see Fig. 7D element 602 and see para 85… “flexible film or mesh cover 602” The mesh cover is at least one or more tube portions], the one or more tube portions defining one or more blood-inlet openings [see para 113… “operation of an impeller within the various embodiments of cannulas described herein may cause a flow of fluid, e.g., blood, into an inlet opening at one end of the cannula, through the cannula, and out an outlet opening at an opposite end of the cannula.”] that are configured to allow blood to flow from the subject's left ventricle into the one or more tube portions [see para 121 of Evans… “The pump and impeller mechanisms, and the corresponding cannula and flow passage and channel structures, may also be fixed in anatomical position by a catheter support, by the cannula resting against a vessel wall or valve 1103, by a guidance feature resting against the internal or external anatomical structure of a heart, vein, artery, or blood vessel”. This section discloses that the ventricular assist device with the inlets/outlets on it are configured to be placed inside a structure of the heart or an artery or vein (i.e. that which includes a left ventricle) which makes the tube at least capable of being placed to recite the functional language of the inlets/outlets as claimed] However, Evans fails to fully disclose “wherein at least some of the one or more blood-inlet openings are at least partially disposed over the distal conical portion of the frame” or that the distal conical portion “that continuously narrows from a distal end of the central cylindrical portion towards a distal end of the frame” as recited in claim 1. Corbett discloses in the analogous prior art of heart pumps [see para 3… “Systems, devices, and methods described herein provide heart pump assemblies with improved inflow apertures.”] that a known configuration of a blood pump assembly [see Fig. 4 element 400… “FIG. 4 shows an illustrative view of a heart pump assembly 400”] includes a cannula body (i.e. tube portions) [see Fig. 4 element 409… “a cannula body 409 having a circumference 422”] with a distal portion [see Fig. 4 element 414 and para 60… “a distal end portion 414”] that includes multiple inflow inlets [see Fig. 4 element 416 specifically elements 418a-d which are at least blood-inlet openings and para 62… “the plurality of apertures 416 provide redundant inflow inlets for blood to enter” and para 60… “a first ring 418 having apertures 418a-d”] that are laterally-facing with respect to the longitudinal axis of the tube [see Fig. 4 element 444 and para 60… “a longitudinal axis 444” and Fig. 4 showing the position of elements 418a-d relative to the longitudinal axis] and a proximal portion [see Fig. 4 element 411 and para 60… “The cannula assembly 408 includes a proximal end 411”] that includes a plurality of outlets (i.e. blood outlet openings) [see Fig. 4 elements 424 and para 60… “blood exhaust outlets 424”] that are laterally-facing with respect to the longitudinal axis of the tube [see Fig. 4 elements 424 relative to element 444 (the longitudinal axis)]. Siess discloses, in the analogous art of blood pumps [para 1… “This invention relates to a blood pump”], openings (which form either the inlets or outlets of blood flow) when placed on a tapered surface (i.e. a continuously conical surface) are less likely to be blocked when the blood pump is placed inside the body [see Fig. 1A-1B elements 44 are the openings and element 43 is the tapered surface and para 19… “A tapered or conical shape of the downstream end portion may also be provided, such that the blood flow outlet, through which blood can exit the outflow cannula, opens at least partially in an axial direction, in order to prevent blocking of the blood flow outlet when the outflow cannula is pressed against an inner wall of a vessel.”] Since, Evans is silent as to the exact design and exact placement of the inlets and outlets, and Corbett discloses placing rings of apertures including at least four blood inlet openings that are laterally-facing with respect to the longitudinal axis of the tube at the distal part of the tube and placing a plurality of blood outlet openings that are laterally-facing with respect to the longitudinal axis of the tube near a proximal end as a known configuration for the placement of blood inlets and outlets, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Evans by placing inlets and outlets similar to that of Corbett at the distal and proximal portion of the tube, respectively (i.e. reciting “wherein at least some of the one or more blood-inlet openings are at least partially disposed over the distal conical portion of the frame”) similarly to that disclosed by Corbett as this is a known configuration for the placements of inlets and outlets used in blood pumps. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Evans in view of Corbett by modifying the distal conical portion to taper similarly to that disclosed by Siess (thereby reciting that continuously narrows from a distal end of the central cylindrical portion towards a distal end of the frame) because as taught by Siess this placement would help to prevent the inlets from being blocked when the blood pump is placed inside a user’s body. PNG media_image1.png 439 849 media_image1.png Greyscale Claim 12: An apparatus [see abstract... “A pump for inducing flow within a vascular system"], comprising: a left ventricular assist device [see Fig. 1 element 100 and para 58... “FIG. 1 illustrates one embodiment of an expandable blood pump 100 according to the present disclosure”] comprising: an axial flow impeller [see Figs. 6 and 7D-7F and para 85… “in which the impeller (e.g., impeller 500 as shown in FIG. 6”] configured to be disposed within a left ventricle of a subject and configured to pump blood axially from the subject's left ventricle to an aorta of the subject [see para 121 of Evans… “The pump and impeller mechanisms, and the corresponding cannula and flow passage and channel structures, may also be fixed in anatomical position by a catheter support, by the cannula resting against a vessel wall or valve 1103, by a guidance feature resting against the internal or external anatomical structure of a heart, vein, artery, or blood vessel” This section discloses that the ventricular assist device with the impeller inside it is configured to be placed inside a structure of the heart or an artery or vein (i.e. that which includes a left ventricle and aorta) which makes the impeller at least capable of being placed to recite the functional language as claimed], by rotating [see para 53… “The mechanical generator may be operably connected with the impeller, thereby transferring rotational motion of the generator about the impeller axis to rotational motion of the impeller about the impeller axis.”]; a frame disposed around the impeller [see Fig. 6 and 7D-7F elements 604 and 606 and para 85… “one or more substantially rigid or semi-rigid support members 604 in spiral configuration, creating a plurality of ribs 606.”]; the frame being at least partially covered with one or more tube portions [see Fig. 7D element 602 and see para 85… “flexible film or mesh cover 602” The mesh cover is at least one or more tube portions], the one or more tube portions defining one or more blood-inlet openings that are configured to allow blood to flow from the subject's left ventricle into the one or more tube portions [see para 113… “operation of an impeller within the various embodiments of cannulas described herein may cause a flow of fluid, e.g., blood, into an inlet opening at one end of the cannula, through the cannula, and out an outlet opening at an opposite end of the cannula.”] However, Evans is silent as to all the details of the blood-inlet openings and therefore fails to disclose “the frame being shaped such that, in a non-radially-constrained configuration of the frame, the frame defines a distal conical portion that continuously narrows towards a distal end of the frame” or “the one or more blood-inlet openings being at least partially laterally facing” or “wherein at least some of the one or more blood-inlet openings are at least partially disposed over the distal conical portion of the frame” as recited by claim 12. Corbett discloses in the analogous prior art of heart pumps [see para 3… “Systems, devices, and methods described herein provide heart pump assemblies with improved inflow apertures.”] that a known configuration of a blood pump assembly [see Fig. 4 element 400… “FIG. 4 shows an illustrative view of a heart pump assembly 400”] includes a cannula body (i.e. a tube) [see Fig. 4 element 409… “a cannula body 409 having a circumference 422”] with a distal portion [see Fig. 4 element 414 and para 60… “a distal end portion 414”] that includes multiple inflow inlets [see Fig. 4 element 416 specifically elements 418a-d which are at least blood-inlet openings and para 62… “the plurality of apertures 416 provide redundant inflow inlets for blood to enter” and para 60… “a first ring 418 having apertures 418a-d”] that are laterally-facing (i.e. at least partially laterally facing) with respect to the longitudinal axis of the tube [see Fig. 4 element 444 and para 60… “a longitudinal axis 444” and Fig. 4 showing the position of elements 418a-d relative to the longitudinal axis] and a proximal portion [see Fig. 4 element 411 and para 60… “The cannula assembly 408 includes a proximal end 411”] that includes a plurality of outlets (i.e. blood outlet openings) [see Fig. 4 elements 424 and para 60… “blood exhaust outlets 424”] that are laterally-facing with respect to the longitudinal axis of the tube [see Fig. 4 elements 424 relative to element 444 (the longitudinal axis)]. Siess discloses, in the analogous art of blood pumps [para 1… “This invention relates to a blood pump”], openings (which form either the inlets or outlets of blood flow) when placed on a tapered surface (i.e. a continuously conical surface) are less likely to be blocked when the blood pump is placed inside the body [see Fig. 1A-1B elements 44 are the openings and element 43 is the tapered surface and para 19… “A tapered or conical shape of the downstream end portion may also be provided, such that the blood flow outlet, through which blood can exit the outflow cannula, opens at least partially in an axial direction, in order to prevent blocking of the blood flow outlet when the outflow cannula is pressed against an inner wall of a vessel.”] Since, Evans is silent as to the exact design and exact placement of the inlets and outlets except near the ends the tube, and Corbett discloses placing rings of apertures including at least four blood inlet openings that are laterally-facing with respect to the longitudinal axis of the tube at the distal part of the tube and placing a plurality of blood outlet openings that are laterally-facing with respect to the longitudinal axis of the tube near the proximal end the tube as a known configuration for the placement of blood inlets and outlets, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Evans by placing inlets and outlets similar to that of Corbett at the distal and proximal portion of the tube, respectively (i.e. reciting “the one or more blood-inlet openings being at least partially laterally facing” or “wherein at least some of the one or more blood-inlet openings are at least partially disposed over the distal conical portion of the frame”) similarly to that disclosed by Corbett as this is a known configuration for the placements of inlets and outlets used in blood pumps. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Evans in view of Corbett by modifying the distal conical portion to taper similarly to that disclosed by Siess (thereby reciting that continuously narrows from a distal end of the central cylindrical portion towards a distal end of the frame) because as taught by Siess this placement would help to prevent the inlets from being blocked when the blood pump is placed inside a user’s body. Claim 23: An apparatus [see abstract... “A pump for inducing flow within a vascular system"], comprising: a left ventricular assist device [see Fig. 1 element 100 and para 58... “FIG. 1 illustrates one embodiment of an expandable blood pump 100 according to the present disclosure”] comprising: an axial flow impeller [see Figs. 6 and 7D-7F and para 85… “in which the impeller (e.g., impeller 500 as shown in FIG. 6”] configured to be disposed within a left ventricle of a subject and configured to pump blood axially from the subject's left ventricle to an aorta of the subject [see para 121 of Evans… “The pump and impeller mechanisms, and the corresponding cannula and flow passage and channel structures, may also be fixed in anatomical position by a catheter support, by the cannula resting against a vessel wall or valve 1103, by a guidance feature resting against the internal or external anatomical structure of a heart, vein, artery, or blood vessel” This section discloses that the ventricular assist device with the impeller inside it is configured to be placed inside a structure of the heart or an artery or vein (i.e. that which includes a left ventricle and aorta) which makes the impeller at least capable of being placed to recite the functional language as claimed], by rotating [see para 53… “The mechanical generator may be operably connected with the impeller, thereby transferring rotational motion of the generator about the impeller axis to rotational motion of the impeller about the impeller axis.”]; a frame disposed around the impeller [see Fig. 6 and 7D-7F elements 604 and 606 and para 85… “one or more substantially rigid or semi-rigid support members 604 in spiral configuration, creating a plurality of ribs 606.”]; However, Evans fails to fully disclose “the frame being shaped such that, in a non-radially-constrained configuration of the frame, the frame defines a distal conical portion that continuously narrows towards a distal end of the frame” or “the one or more blood-inlet openings being at least partially non-axially facing” or “wherein at least some of the one or more blood-inlet openings are at least partially disposed over the distal conical portion of the frame” as recited by claim 23. Corbett discloses in the analogous prior art of heart pumps [see para 3… “Systems, devices, and methods described herein provide heart pump assemblies with improved inflow apertures.”] that a known configuration of a blood pump assembly [see Fig. 4 element 400… “FIG. 4 shows an illustrative view of a heart pump assembly 400”] includes a cannula body (i.e. a tube) [see Fig. 4 element 409… “a cannula body 409 having a circumference 422”] with a distal portion [see Fig. 4 element 414 and para 60… “a distal end portion 414”] that includes multiple inflow inlets [see Fig. 4 element 416 specifically elements 418a-d which are at least blood-inlet openings and para 62… “the plurality of apertures 416 provide redundant inflow inlets for blood to enter” and para 60… “a first ring 418 having apertures 418a-d”] that are laterally-facing (i.e. partially non-axially facing) with respect to the longitudinal axis of the tube [see Fig. 4 element 444 and para 60… “a longitudinal axis 444” and Fig. 4 showing the position of elements 418a-d relative to the longitudinal axis] and a proximal portion [see Fig. 4 element 411 and para 60… “The cannula assembly 408 includes a proximal end 411”] that includes a plurality of outlets (i.e. blood outlet openings) [see Fig. 4 elements 424 and para 60… “blood exhaust outlets 424”] that are laterally-facing with respect to the longitudinal axis of the tube [see Fig. 4 elements 424 relative to element 444 (the longitudinal axis)]. Siess discloses, in the analogous art of blood pumps [para 1… “This invention relates to a blood pump”], openings (which form either the inlets or outlets of blood flow) when placed on a tapered surface (i.e. a continuously conical surface) are less likely to be blocked when the blood pump is placed inside the body [see Fig. 1A-1B elements 44 are the openings and element 43 is the tapered surface and para 19… “A tapered or conical shape of the downstream end portion may also be provided, such that the blood flow outlet, through which blood can exit the outflow cannula, opens at least partially in an axial direction, in order to prevent blocking of the blood flow outlet when the outflow cannula is pressed against an inner wall of a vessel.”] Since, Evans is silent as to the exact design and exact placement of the inlets and outlets except near the ends the tube, and Corbett discloses placing rings of apertures including at least four blood inlet openings that are laterally-facing with respect to the longitudinal axis of the tube at the distal part of the tube and placing a plurality of blood outlet openings that are laterally-facing with respect to the longitudinal axis of the tube at the proximal end the tube as a known configuration for the placement of blood inlets and outlets, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Evans by placing inlets and outlets similar to that of Corbett at the distal and proximal portion of the tube, respectively similarly to that disclosed by Corbett (thereby reciting “the one or more blood-inlet openings being at least partially non-axially facing” or “wherein at least some of the one or more blood-inlet openings are at least partially disposed over the distal conical portion of the frame”) as this is a known configuration for the placements of inlets and outlets used in blood pumps. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Evans in view of Corbett by modifying the distal conical portion to taper similarly to that disclosed by Siess (thereby reciting that continuously narrows from a distal end of the central cylindrical portion towards a distal end of the frame) because as taught by Siess this placement would help to prevent the inlets from being blocked when the blood pump is placed inside a user’s body. Dependent claims: Regarding claim 2, see rejection to claim 1 above which recites laterally-facing inlet openings (i.e. at least one or more blood-inlet openings that are partially laterally-facing). Regarding claim 3, see rejection to claim 1 which recites four blood-inlet openings. Regarding claims 4-5, see Fig. 4 elements 418a-418d of Corbett, which discloses the inlet openings of Evans in view of Corbett in view of Siess, elements 418a-418d are shown as having a length (first dimension) that greater than the width (second dimension). Regarding claim 6: Para 121 of Evans [see “The pump and impeller mechanisms, and the corresponding cannula and flow passage and channel structures, may also be fixed in anatomical position by a catheter support, by the cannula resting against a vessel wall or valve 1103, by a guidance feature resting against the internal or external anatomical structure of a heart, vein, artery, or blood vessel”] discloses that the ventricular assist device which includes the tube is configured to be placed inside a structure of the heart or an artery or vein (i.e. that which includes a left ventricle and aorta) which makes the ventricular at least capable of being placed to recite the functional language claimed. Regarding claim 7, para 83 of Evans [see… “In some embodiments, as noted above, the cannula may be activated between a collapsed, deployment configuration and an expanded, operable configuration separately from an activation of the impeller between a collapsed, deployment configuration and an expanded, operable configuration.”] discloses how the cannula (understood to include the tube portions) is collapsable and is structurally configured to have a collapsed deployment configuration (i.e. “in response to pressure outside of the portion of the tube exceeding pressure inside the collapsible portion of the tube, the collapsible portion of the tube collapses inwardly,”) and an expanded, operable configuration (i.e. “during operation of the impeller, pressure of the blood flow through the tube maintains the collapsible portion of the tube in an open state”) as claimed. Regarding claim 8, see rejection to claim 1 above which discloses blood outlet openings in the proximal part as claimed. Regarding claim 9-11, see rejection to rejection to claim 1 above which recites Evans in view of Corbett in view of Siess using the placement of Corbett’s blood outlets and inlets which includes a plurality of blood outlets (i.e. at least two of outlet openings). And see placement of outlets in the labelled figure directly below rejection to these claims. PNG media_image2.png 680 840 media_image2.png Greyscale Regarding claim 13, see rejection to rejection to claim 12 above which recites Evans in view of Corbett in view of Siess using the placement of Corbett’s blood outlets and inlets which includes a plurality of blood inlets). PNG media_image2.png 680 840 media_image2.png Greyscale Regarding claims 14, see rejection to claim 12 above which recites four blood-inlet openings. Regarding claims 15-16, see Fig. 4 elements 418a-418d of Corbett, which discloses the inlet openings of Evans in view of Corbett in view of Siess, elements 418a-418d are shown as having a length (first dimension) that greater than the width (second dimension). Regarding claims 17 and 19: Para 121 of Evans [see “The pump and impeller mechanisms, and the corresponding cannula and flow passage and channel structures, may also be fixed in anatomical position by a catheter support, by the cannula resting against a vessel wall or valve 1103, by a guidance feature resting against the internal or external anatomical structure of a heart, vein, artery, or blood vessel”] discloses that the ventricular assist device which includes the tube is configured to be placed inside a structure of the heart or an artery or vein (i.e. that which includes a left ventricle and aorta) which makes the ventricular at least capable of being placed to recite the functional language claimed. Regarding claim 18, para 83 of Evans [see… “In some embodiments, as noted above, the cannula may be activated between a collapsed, deployment configuration and an expanded, operable configuration separately from an activation of the impeller between a collapsed, deployment configuration and an expanded, operable configuration.”] discloses how the cannula (understood to include the tube portions) is collapsable and is structurally configured to have a collapsed deployment configuration (i.e. “in response to pressure outside of the portion of the tube exceeding pressure inside the collapsible portion of the tube, the collapsible portion of the tube collapses inwardly,”) and an expanded, operable configuration (i.e. “during operation of the impeller, pressure of the blood flow through the tube maintains the collapsible portion of the tube in an open state”) as claimed. Regarding claims 20-22: see rejection to rejection to claim 12 above which recites Evans in view of Corbett in view of Siess having the placement of Corbett’s blood outlets and inlets which includes a plurality of blood outlets (i.e. at least two of outlet openings). And see placement of outlets in the labelled figure directly below rejection to these claims. PNG media_image2.png 680 840 media_image2.png Greyscale Regarding claim 24: see rejection to rejection to claim 23 above which recites Evans in view of Corbett in view of Siess using the placement of Corbett’s blood outlets and inlets. And see placement of inlets in the labelled figure directly below rejection to this claim. PNG media_image2.png 680 840 media_image2.png Greyscale Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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