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 .
Status of Claims
Claims 1-20 are rejected.
Response to Arguments
Claim Rejections - 35 USC § 101
The 101 rejection has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 112
The 112(b) rejections have been withdrawn in view of the amendment.
Claim Rejections - 35 USC §§ 102 and 103
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant specifically argues that Theran does not teach the amended limitation “the elongated body is configured to extend from the left atrium, through the aortic valve, and into the aorta” in claims 1 and 13. However, new reference Siegel teaches this limitation:
¶55-the trajectory is from the left atrium 1, through the mitral valve orifice 2, between the papillary muscles 6, through the LVOT 10, across the aortic valve 8 and into the ascending aorta 9; Figs. 3-4.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Theran to include wherein the elongated body is configured to extend from the left atrium, through the aortic valve, and into the aorta of Siegel in order to eliminate the need for a cut-down of the peripheral artery and/or reduce or minimize the risk of the blood vessel tearing around a percutaneous access sheath (Siegel, ¶125).
Applicant additionally argues that Theran fails to disclose the amended limitation “so that the elongated body extends through the aortic valve” in claim 17. However, secondary reference Siess teaches this limitation:
¶20-advancing the pumping device through the left ventricle and the aortic valve towards the aorta, and placing the blood pump such that the blood flow inlet is disposed in the left ventricle, the blood flow outlet is disposed in the aorta, and the drive section is also disposed in the aorta, whereas the supply catheter extends through the puncture in the apex of the heart and percutaneously exits the patient’s body; and
¶81-connecting catheters are useful in the above described placement methods according to the first placement principle in order to guide the blood pump from the venous vasculature through the atrial septum into the left ventricle and up into the aorta.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/19/26 is being considered by the examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1 and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Theran (US 20230079625 filed on 11/18/22) in view of Siegel (US 20210030534 filed on 8/21/20).
Regarding claim 1, Theran teaches a catheter having a portion that is configured to be positioned within a heart having a left atrium, an aorta, an aortic valve, and a septum (¶30; ¶86; ¶172; Fig. 22), the catheter comprising: an elongate body (¶147-tubes 610, 620, 624 may be formed integrally with device 600; see Fig. 22) having an outer surface and an inner surface defining an interior passage of the elongate body (See Fig. 22-where there is an inner surface inside of outer surface tubs 610, 620, and 624), the elongate body comprising: a first portion (See Fig. 22-third tube 624) that is configured to be positioned within the left atrium (See Fig. 22-624 connects to left atrium 184), the first portion defining at least one opening extending from the outer surface to the inner surface of the elongate body (see Fig. 22-opening located at 607); and a second portion (See Fig. 22-second tube 620) that is distal of the first portion and configured to be positioned in the aorta when the first portion is positioned within the left atrium (¶153-second tube 620 and through anchor 640 into the aorta 182 of the patient. This primary blood flow path assists the heart by pumping blood from the left atrium directly into the aorta; Fig. 22), the second portion defining at least one opening extending from the outer surface to the inner surface of the elongate body (¶153-second tube 620 and through anchor 640 into the aorta 182 of the patient; Fig. 22), an impeller (See Fig. 22-impeller 608) that is positioned between the first portion and the second portion (¶153-impeller 608 creates a primary blood flow path 650 from left atrium 184, through first tube 610 and inlet 612 into device 600. The blood flows past impeller 608 through outlet 622 to second tube 620 and through anchor 640 into the aorta 18; Fig. 22), wherein the impeller is configured to effect blood flow through the elongate body from the first portion to the second portion (¶153-impeller 608 creates a primary blood flow path 650 from left atrium 184, through first tube 610 and inlet 612 into device 600. The blood flows past impeller 608 through outlet 622 to second tube 620 and through anchor 640 into the aorta 18; Fig. 22); a first anchor (See Fig. 22-anchor 640) positioned proximal of the second portion, wherein the first anchor is configured to inhibit movement of the second portion proximally past the aortic valve (¶150-anchor 640 coupled to an outlet of second tube 620 and configured for anchoring second tube 620 to a wall 642 between the SVC 162 and an aorta 182 of the patient; ¶150-anchoring second tube 620 to a wall 642 between the SVC 162 and an aorta 182 of the patient; Fig. 22; through anchoring the second tube 620 is held in place); a second anchor (third anchor 670, mislabeled as 607 in Fig. 22) positioned proximal of the first portion (607 in Fig. 22), wherein the second anchor is configured to inhibit movement of the first portion of the elongate body proximally past the septum (¶168-third anchor 670 is coupled to an inlet of third tube 624 and configured for anchoring tube 624 to septal wall 632 between the right atrium 602 and a left atrium 634 of the patient; through anchoring tube 624 is held in place); and a third anchor (first anchor 630 in Fig. 22) positioned proximally of the second anchor (630 in Fig. 22), wherein the third anchor is configured to inhibit movement of the first portion of the elongate body distally (¶158-a first anchor 630 coupled to an inlet of first tube 610 and configured for anchoring tube 610 to a septal wall 632 between the right atrium 602 and a left atrium 634 of the patient; through anchoring tube 624 is held in place).
While Theran discusses the aortic valve (¶172), Theran does not explicitly teach wherein the elongated body is configured to extend from the left atrium, through the aortic valve, and into the aorta.
Siegel is directed to cardiac valve prostheses and to apparatuses and methods for deploying such devices in a minimally invasive manner (¶2). Siegel further teaches the invention using the following step:
wherein the elongated body is configured to extend from the left atrium, through the aortic valve, and into the aorta (¶55-the trajectory is from the left atrium 1, through the mitral valve orifice 2, between the papillary muscles 6, through the LVOT 10, across the aortic valve 8 and into the ascending aorta 9; Figs. 3-4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Theran to include wherein the elongated body is configured to extend from the left atrium, through the aortic valve, and into the aorta of Siegel in order to eliminate the need for a cut-down of the peripheral artery and/or reduce or minimize the risk of the blood vessel tearing around a percutaneous access sheath (Siegel, ¶125).
Regarding claim 12, the combination of Theran and Siegel teaches the catheter of claim 1, wherein the impeller is configured to effect a maximum flow rate of at least 5 liters per minute (Theran, ¶116-pump 600 provides an efficient design that may pump at least 5 Liters of blood per minute, preferably at least about 6 Liters/minute).
Regarding claim 13, Theran teaches a system comprising: a catheter having a portion that is configured to be positioned within a heart having a left atrium, an aorta, an aortic valve, and a septum (¶30; ¶86; ¶172; Fig. 22), the catheter comprising: an elongate body (¶147-tubes 610, 620, 624 may be formed integrally with device 600; see Fig. 22) having an outer surface and an inner surface defining an interior passage of the elongate body (See Fig. 22-where there is an inner surface inside of outer surface tubs 610, 620, and 624), the elongate body comprising: a first portion (See Fig. 22-third tube 624) that is configured to be positioned within the left atrium (See Fig. 22-624 connects to left atrium 184), the first portion defining at least one opening extending from the outer surface to the inner surface of the elongate body (see Fig. 22-opening located at 607); and a second portion (See Fig. 22-second tube 620) that is distal of the first portion and configured to be positioned in the aorta when the first portion is positioned within the left atrium (¶153-second tube 620 and through anchor 640 into the aorta 182 of the patient. This primary blood flow path assists the heart by pumping blood from the left atrium directly into the aorta; Fig. 22), the second portion defining at least one opening extending from the outer surface to the inner surface of the elongate body (¶153-second tube 620 and through anchor 640 into the aorta 182 of the patient; Fig. 22), an impeller (See Fig. 22-impeller 608) that is positioned between the first portion and the second portion (¶153-impeller 608 creates a primary blood flow path 650 from left atrium 184, through first tube 610 and inlet 612 into device 600. The blood flows past impeller 608 through outlet 622 to second tube 620 and through anchor 640 into the aorta 18; Fig. 22), wherein the impeller is configured to effect blood flow through the elongate body from the first portion to the second portion (¶153-impeller 608 creates a primary blood flow path 650 from left atrium 184, through first tube 610 and inlet 612 into device 600. The blood flows past impeller 608 through outlet 622 to second tube 620 and through anchor 640 into the aorta 18; Fig. 22); a first anchor (See Fig. 22-anchor 640) positioned proximal of the second portion, wherein the first anchor is configured to inhibit movement of the second portion proximally past the aortic valve (¶150-anchor 640 coupled to an outlet of second tube 620 and configured for anchoring second tube 620 to a wall 642 between the SVC 162 and an aorta 182 of the patient; ¶150-anchoring second tube 620 to a wall 642 between the SVC 162 and an aorta 182 of the patient; Fig. 22; through anchoring the second tube 620 is held in place); a second anchor (third anchor 670, mislabeled as 607 in Fig. 22) positioned proximal of the first portion (607 in Fig. 22), wherein the second anchor is configured to inhibit movement of the first portion of the elongate body proximally past the septum (¶168-third anchor 670 is coupled to an inlet of third tube 624 and configured for anchoring tube 624 to septal wall 632 between the right atrium 602 and a left atrium 634 of the patient; through anchoring tube 624 is held in place); and a third anchor (first anchor 630 in Fig. 22) positioned proximally of the second anchor (630 in Fig. 22), wherein the third anchor is configured to inhibit movement of the first portion of the elongate body distally (¶158-a first anchor 630 coupled to an inlet of first tube 610 and configured for anchoring tube 610 to a septal wall 632 between the right atrium 602 and a left atrium 634 of the patient; through anchoring tube 624 is held in place); and a power supply operably coupled to the impeller (¶147-wireless power system; ¶183-internal controller 708 then transfers the power to the motor in pump 702, which drives the impeller and provides work to the blood 704 to propel the blood through pump 702).
While Theran discusses the aortic valve (¶172), Theran does not explicitly teach wherein the elongated body is configured to extend from the left atrium, through the aortic valve, and into the aorta.
Siegel teaches wherein the elongated body is configured to extend from the left atrium, through the aortic valve, and into the aorta (¶55-the trajectory is from the left atrium 1, through the mitral valve orifice 2, between the papillary muscles 6, through the LVOT 10, across the aortic valve 8 and into the ascending aorta 9; Figs. 3-4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Theran to include wherein the elongated body is configured to extend from the left atrium, through the aortic valve, and into the aorta of Siegel in order to eliminate the need for a cut-down of the peripheral artery and/or reduce or minimize the risk of the blood vessel tearing around a percutaneous access sheath (Siegel, ¶125).
Regarding claim 14, the combination of Theran and Siegel teaches the system of claim 13, further comprising a wireless charge receiver that is in electrical communication with the power supply, wherein the wireless charge receiver is configured to deliver power to the power supply (Theran, ¶182-the control signals are based on the power transferred to the receiver 708. These control signals may, for example monitor the dynamic power coupling between the transmitter and the receiver to ensure the efficient transfer of power therebetween).
Regarding claim 15, the combination of Theran and Siegel teaches the system of claim 14, further comprising a wireless charge transmitter that is configured to deliver power to the wireless charge receiver (Theran, ¶18-the internal controller receives this data related to the second level of the power and transmits it to an external controller, which modulates one or more of the parameters of the wireless power transmission; ¶174).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Theran in view of Siegel as applied to claim 1 above, and further in view of Hata (WO 2017159849 filed on 3/17/17).
Regarding claim 2, the combination of Theran and Siegel teaches the catheter of claim 1. However, the combination of Theran and Siegel does not teach wherein the elongate body further comprises an intermediate portion extending between the first portion and the second portion, wherein at least a portion of the impeller is positioned within the intermediate portion.
Hata teaches wherein the elongate body further comprises an intermediate portion extending between the first portion and the second portion, wherein at least a portion of the impeller is positioned within the intermediate portion (page 7, ¶6-the distal portion of the impeller 50 is located in the intermediate tubular portion 33; Fig. 5-left ventricle H; aorta A; distal tubular portion 31; intermediate tubular portion 33; proximal tubular portion 32).
Hata relates to a catheter pump and a treatment method for assisting cardiac output (page 1, ¶1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Theran to include wherein the elongate body further comprises an intermediate portion extending between the first portion and the second portion, wherein at least a portion of the impeller is positioned within the intermediate portion of Hata in order to allow the blood inside the cannula to flow from the left ventricle into the aorta to assist in cardiac rhythm (Hata, page 1, ¶2).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Theran in view of Siegel as applied to claim 1 above, and further in view of Yuval (WO 2021198881 filed on 3/29/21).
Regarding claim 3, the combination of Theran and Siegel teaches the catheter of claim 1. However, the combination of Theran and Siegel does not teach wherein the at least one opening defined by the first portion of the elongate body comprises a plurality of openings.
Yuval teaches wherein the at least one opening defined by the first portion of the elongate body comprises a plurality of openings (page 25, last ¶-the pump-outlet tube defines one or more blood inlet openings 108 via which blood is pumped into a distal end of pump-outlet tube 28 (which is configured to be placed within the ventricle); Abstract-pump blood from a subjects left ventricle to the subjects aorta, by pumping the blood into the pump-outlet tube (28) via one or more blood inlet openings (108) disposed within the left ventricle).
Yuval relates to medical apparatus. Specifically, some applications of the present invention relate to a ventricular assist device and methods of use thereof (page 1, lines 7-9).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Theran to include wherein the at least one opening defined by the first portion of the elongate body comprises a plurality of openings of Yuval in order to pump blood from the left ventricle, through the volutes, into the pump-outlet tube (Yuval, page 2, ¶1).
Regarding claim 4, the combination of Theran and Siegel teaches the catheter of claim 1. However, the combination of Theran and Siegel does not teach wherein the at least one opening defined by the second portion of the elongate body comprises a plurality of openings.
Yuval teaches wherein the at least one opening defined by the second portion of the elongate body comprises a plurality of openings (page 1, last ¶-page 2, ¶1-a pump-outlet tube, which is disposed such that blood-outlet openings defined by a proximal portion of the pump-outlet tube, are disposed in the subject's aorta; Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Theran to include wherein the at least one opening defined by the second portion of the elongate body comprises a plurality of openings of Yuval in order to pump blood into the aorta (Yuval, page 2, ¶1).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Theran in view of Siegel as applied to claim 1 above, and further in view of Kassel (US 20210316133 filed on 5/30/19).
Regarding claim 5, the combination of Theran and Siegel teaches the catheter of claim 1. However, the combination of Theran and Siegel does not teach wherein the catheter comprises an anti-traumatic tip distal of the second portion.
Kassel teaches wherein the catheter comprises an anti-traumatic tip distal of the second portion (¶42-rounded, tapered ends for easy positioning by means of a catheter in a blood vessel, e.g., the aorta).
Kassel relates to a motor housing module for sealing a motor compartment of a motor of a heart support system and to a heart support system and a method for mounting a heart support system (¶1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Theran to include wherein the catheter comprises an anti-traumatic tip distal of the second portion of Kassel in order for easy positioning by means of a catheter in a blood vessel, e.g., the aorta (Kassel, ¶42).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Theran in view of Siegel as applied to claim 1 above, and further in view of Garrigue (US 20140207232 filed on 7/28/11).
Regarding claim 6, the combination of Theran and Siegel teaches the catheter of claim 1. However, the combination of Theran and Siegel does not teach a cable that is configured to deliver power to the impeller.
Garrigue teaches further comprising a cable that is configured to deliver power to the impeller (¶55-the connecting wire 13 connects the impeller 14 to the management unit 12, which comprises a power supply 23 such as a battery and a control unit 24, which can be configured remotely).
Garrigue relates to an artificial heart pump for regulating blood flow (¶1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Theran to include a cable that is configured to deliver power to the impeller of Garrigue in order to enable the control unit to send control instructions to the impeller (Garrigue, ¶55).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Theran in view of Siegel and further in view of Garrigue as applied to claim 6 above, and further in view of Spanier (US 20230063196 filed on 8/30/22).
Regarding claim 7, the combination of Theran, Siegel, and Garrigue teaches the catheter of claim 6. However, the combination of Theran, Siegel, and Garrigue does not teach wherein the cable comprises a braided stainless steel sleeve.
Spanier teaches wherein the cable comprises a braided stainless steel sleeve (¶88-braided metal (e.g., stainless steel, nitinol, etc.) may be pulled over the extruded polyurethane and melted into the tube. The sleeve 22 is then placed over this structure. More polymer (e.g., polyurethane) may then be formed over this structure; ¶60; ¶108).
Spanier relates to a sleeve configured to control a position of a blood pump with a catheter in a patient's heart (¶7).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Theran to include wherein the cable comprises a braided stainless steel sleeve of Spanier in order to be biologically compatible (Spanier, ¶108).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Theran in view of Siegel as applied to claim 1 above, and further in view of Fabiunke (WO 2023003937 filed on 7/20/22).
Regarding claim 8, the combination of Theran and Siegel teaches the catheter of claim 1. However, the combination of Theran and Siegel does not teach a first radiopaque marker proximate to the first portion of the elongate body.
Fabiunke teaches a first radiopaque marker proximate to the first portion of the elongate body (¶73-the first radiopaque marker 151 and/or the second radiopaque marker 152 can be positioned within the left ventricle 93; Fig. 1B).
Fabiunke relates to one or more radiopaque markers to aid in positioning the guidewire 100 within the cardiovascular system of a patient and/or to ensure it, as well as any device such as an MCS device or VAD positioned by the guidewire 100, stays in the desired position (¶72).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Theran to include a first radiopaque marker proximate to the first portion of the elongate body of Fabiunke in order to aid in positioning the guidewire 100 within the cardiovascular system of a patient and/or to ensure it, as well as any device such as an MCS device or VAD positioned by the guidewire 100, stays in the desired position (Fabiunke, ¶72).
Regarding claim 9, the combination of Theran and Siegel teaches the catheter of claim 1. However, the combination of Theran and Siegel does not teach a second radiopaque marker proximate to the second portion of the elongate body.
Fabiunke teaches a second radiopaque marker proximate to the second portion of the elongate body (¶73-the third radiopaque marker can be positioned within the ascending aorta 95; Fig. 1B).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Theran to include a second radiopaque marker proximate to the second portion of the elongate body of Fabiunke in order to aid in positioning the guidewire 100 within the cardiovascular system of a patient and/or to ensure it, as well as any device such as an MCS device or VAD positioned by the guidewire 100, stays in the desired position (Fabiunke, ¶72).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Theran in view of Siegel as applied to claim 1 above, and further in view of Harea (US 20200000999 filed on 6/27/19).
Regarding claim 10, the combination of Theran and Siegel teaches the catheter of claim 1. However, the combination of Theran and Siegel does not teach wherein the catheter has a maximum cross sectional outer dimension from 18 French to 30 French.
Harea teaches wherein the catheter has a maximum cross sectional outer dimension from 18 French to 30 French (¶88-accommodate higher flow rates e.g. 1 Liter (L) per minute using an 18 F catheter; through 2 L per minute using a 23 F catheter).
Harea relates to the field of medical devices (¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Theran to include wherein the catheter has a maximum cross sectional outer dimension from 18 French to 30 French of Harea in order to accommodate a higher flow rate (Harea, ¶88).
Regarding claim 11, the combination of Theran and Siegel teaches the catheter of claim 1. However, the combination of Theran and Siegel does not teach wherein the catheter has a maximum cross sectional outer dimension from 22 French to 30 French.
Harea teaches wherein the catheter has a maximum cross sectional outer dimension from 22 French to 30 French (¶88-accommodate higher flow rates e.g. 1 Liter (L) per minute using an 18 F catheter; through 2 L per minute using a 23 F catheter).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Theran to include wherein the catheter has a maximum cross sectional outer dimension from 22 French to 30 French of Harea in order to accommodate a higher flow rate (Harea, ¶88).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Theran in view of Siegel as applied to claim 13 above, and further in view of Nestler (US 20180369466 filed on 7/6/18).
Regarding claim 16, the combination of Theran and Siegel teaches the system of claim 13. However, the combination of Theran and Siegel does not teach a controller that is configured to control a speed of the impeller.
Nestler teaches a controller that is configured to control a speed of the impeller (¶158-the controller determines a change in rotational speed of the impeller).
Nestler relates to a heart pump and in particular to a method of controlling an axial position of an impeller in a heart pump (¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Theran to include a controller that is configured to control a speed of the impeller of Nestler in order to control the magnetic bearing to cause the impeller to move until a bearing power indicator indicative of the power used by the magnetic bearing reaches the reference power (Nestler, ¶10).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Theran in view of Siess (WO 2021156257 filed on 2/2/21).
Regarding claim 17, Theran teaches a method of positioning a catheter, the catheter having a portion that is configured to be positioned within a heart having a left atrium, an aorta, an aortic valve, and a septum (¶30; ¶86; ¶172; Fig. 22), the catheter comprising: an elongate body (¶147-tubes 610, 620, 624 may be formed integrally with device 600; see Fig. 22) having an outer surface and an inner surface defining an interior passage of the elongate body (See Fig. 22-where there is an inner surface inside of outer surface tubs 610, 620, and 624), the elongate body comprising: a first portion (See Fig. 22-third tube 624) that is configured to be positioned within the left atrium (See Fig. 22-624 connects to left atrium 184), the first portion defining at least one opening extending from the outer surface to the inner surface of the elongate body (see Fig. 22-opening located at 607); and a second portion (See Fig. 22-second tube 620) that is distal of the first portion and configured to be positioned in the aorta when the first portion is positioned within the left atrium (¶153-second tube 620 and through anchor 640 into the aorta 182 of the patient. This primary blood flow path assists the heart by pumping blood from the left atrium directly into the aorta; Fig. 22), the second portion defining at least one opening extending from the outer surface to the inner surface of the elongate body (¶153-second tube 620 and through anchor 640 into the aorta 182 of the patient; Fig. 22); an impeller (See Fig. 22-impeller 608) that is positioned between the first portion and the second portion (¶153-impeller 608 creates a primary blood flow path 650 from left atrium 184, through first tube 610 and inlet 612 into device 600. The blood flows past impeller 608 through outlet 622 to second tube 620 and through anchor 640 into the aorta 18; Fig. 22), wherein the impeller is configured to effect blood flow through the elongate body from the first portion to the second portion (¶153-impeller 608 creates a primary blood flow path 650 from left atrium 184, through first tube 610 and inlet 612 into device 600. The blood flows past impeller 608 through outlet 622 to second tube 620 and through anchor 640 into the aorta 18; Fig. 22); a first anchor (See Fig. 22-anchor 640) positioned proximal of the second portion, wherein the first anchor is configured to inhibit movement of the second portion proximally past the aortic valve (¶150-anchor 640 coupled to an outlet of second tube 620 and configured for anchoring second tube 620 to a wall 642 between the SVC 162 and an aorta 182 of the patient; ¶150-anchoring second tube 620 to a wall 642 between the SVC 162 and an aorta 182 of the patient; Fig. 22; through anchoring the second tube 620 is held in place); a second anchor (third anchor 670, mislabeled as 607 in Fig. 22) positioned proximal of the first portion (607 in Fig. 22), wherein the second anchor is configured to inhibit movement of the first portion of the elongate body proximally past the septum (¶168-third anchor 670 is coupled to an inlet of third tube 624 and configured for anchoring tube 624 to septal wall 632 between the right atrium 602 and a left atrium 634 of the patient; through anchoring tube 624 is held in place); and a third anchor positioned proximally of the second anchor (630 in Fig. 22), wherein the third anchor (first anchor 630 in Fig. 22) is configured to inhibit movement of the first portion of the elongate body distally (¶158-a first anchor 630 coupled to an inlet of first tube 610 and configured for anchoring tube 610 to a septal wall 632 between the right atrium 602 and a left atrium 634 of the patient; through anchoring tube 624 is held in place). However, Theran does not teach the method comprising: advancing the catheter through the septum to position the second portion of the elongate body within the aorta and the first portion of the elongate body within the left ventricle so that the elongated body extends through the aortic valve.
Siess relates to methods of placing an intravascular blood pump in a patient for assisting the left ventricle of the patient’s heart, placement tools for use in such methods and an intravascular blood pump which is particularly suitable for the placement methods (¶1). Siess further teaches the invention using the following steps:
the method comprising: advancing the catheter through the septum to position the second portion of the elongate body within the aorta and the first portion of the elongate body within the left ventricle so that the elongated body extends through the aortic valve (¶81-connecting catheters are useful in the above described placement methods according to the first placement principle in order to guide the blood pump from the venous vasculature through the atrial septum into the left ventricle and up into the aorta; ¶20-advancing the pumping device through the left ventricle and the aortic valve towards the aorta, and placing the blood pump such that the blood flow inlet is disposed in the left ventricle, the blood flow outlet is disposed in the aorta, and the drive section is also disposed in the aorta, whereas the supply catheter extends through the puncture in the apex of the heart and percutaneously exits the patient’s body).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Theran to include the method comprising: advancing the catheter through the septum to position the second portion of the elongate body within the aorta and the first portion of the elongate body within the left ventricle so that the elongated body extends through the aortic valve of Siess because the supply catheter or supply line does not hinder the arterial blood flow at all, so that an accordingly higher blood flow volume can be achieved with an intravascular blood pump placed in this way (Siess, ¶19).
Regarding claim 18, the combination of Theran and Siess teaches the method of claim 17, wherein advancing the catheter comprises advancing the catheter through a sheath (Siess, ¶12- a Swan-Ganz catheter, is advanced through the introducer sheath into the left part of the heart).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Theran to include wherein advancing the catheter comprises advancing the catheter through a sheath of Siess because the supply catheter or supply line does not hinder the arterial blood flow at all, so that an accordingly higher blood flow volume can be achieved with an intravascular blood pump placed in this way (Siess, ¶19).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Theran in view of Siess as applied to claims 17-18 above, and further in view of Fabiunke.
Regarding claim 19, the combination of Theran and Siess teaches the method of claim 18. However, the combination of Theran and Siess does not teach using imaging to determine proper positioning of the catheter.
Fabiunke teaches using imaging to determine proper positioning of the catheter (¶151-a fluoroscopic image can be obtained and saved. If the guidewire 100 is not positioned as desired, the guidewire 100 can be adjusted until it is positioned at the desired position within the heart anatomy).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Theran to include using imaging to determine proper positioning of the catheter of Fabiunke in order to aid in positioning the guidewire 100 within the cardiovascular system of a patient and/or to ensure it, as well as any device such as an MCS device or VAD positioned by the guidewire 100, stays in the desired position (Fabiunke, ¶72).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Theran in view of Siess and further in view of Fabiunke as applied to claim 19 above, and further in view of Conklin (US 20200069426 filed on 3/5/20).
Regarding claim 20, the combination of Theran, Siess, and Fabiunke teaches the method of claim 19. However, the combination of Theran, Siess, and Fabiunke does not teach retracting the sheath to deploy the first anchor to inhibit movement of the second portion proximally past the aortic valve; retracting the sheath to deploy the second anchor inhibit movement of the first portion of the elongate body proximally past the septum; and retracting the sheath to deploy the third anchor to inhibit movement of the first portion of the elongate body distally.
Conklin teaches retracting the sheath (¶379-the sheath 170 may then be withdrawn) to deploy the first anchor to inhibit movement of the second portion proximally past the aortic valve (¶500-both heart anchors 202, 202′ may be deployed endovascularly. The entry to the patient's left ventricle 1200 may be via the aortic valve 7800); retracting the sheath (¶379-the sheath 170 may then be withdrawn) to deploy the second anchor inhibit movement of the first portion of the elongate body proximally past the septum (¶421-anchor 202 being deployed to a position on the septum 1210); and retracting the sheath (¶379-the sheath 170 may then be withdrawn) to deploy the third anchor to inhibit movement of the first portion of the elongate body distally (¶21-the method may include tensioning a first tension member for coupling the first heart anchor to the third heart anchor; ¶302-limit movement).
Conklin relates to medical treatment, including transcatheter medical treatments and/or for treatment of dilated hearts (e.g., dilated left ventricle) or functional mitral valve regurgitation within a human heart (¶8).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Theran to include retracting the sheath to deploy the first anchor to inhibit movement of the second portion proximally past the aortic valve; retracting the sheath to deploy the second anchor inhibit movement of the first portion of the elongate body proximally past the septum; and retracting the sheath to deploy the third anchor to inhibit movement of the first portion of the elongate body distally of Conklin in order to secure the apparatus to a portion of a patient’s body (Conklin, ¶544).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20220339426: These MCS devices are pumps that continuously draw blood from the left ventricle through an inlet port and expel the blood into the ascending aorta, or draw blood from the left atrium or femoral vein and expel in the aorta. The MCS can be inserted via a standard catheterization procedure through the femoral artery, into the ascending aorta, across the aortic valve, and into the left ventricle (FIG. 1) (¶5).
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). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/L.N.H./Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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