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 statement(s) filed 09/04/2024 and 09/24/2024 has/have been considered by the Examiner.
Claim Interpretation
The term(s) “for” and “configured to” in the claim(s) may be interpreted as intended use. Intended use/functional language does not require that references teach or disclose the intended use of an element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP section 2114. II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 14-16 and 20 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being ANTICIPATED by Schwammenthal (US 20180169313 A1 – hereinafter Schwammenthal).
Re. claim 1, Schwammenthal teaches a renal support device (paragraph 0002 – “Some applications of the present invention generally relate to medical apparatus. Specifically, some applications of the present invention relate to apparatus and methods associated with placing a pump in one or more of a subject's renal veins…”; blood pump catheter 20),
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comprising:
an outer catheter shaft having a longitudinal axis (figure 1B, guide catheter 23) and a distal end region coupled to a renal pump assembly (figure 1B shows the distal end of the guide catheter 23 includes the pumps),
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wherein the renal pump assembly includes a frame (figures 1B, 8A-8C, cage 30) and an impeller assembly (figures 1B, 8A-8C, impeller 28),
wherein the impeller assembly is disposed within the frame (figures 1B, 8A-8C),
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and wherein the impeller assembly is configured to rotate relative to the frame about the longitudinal axis of the outer catheter shaft (paragraph 0010 – “…impellers of the downstream and the upstream pumps rotate in the same direction…and there is a shaft disposed between the impellers that imparts rotational motion from a first one of the impellers to a second one of the impellers”).
Re. claim 2, Schwammenthal further teaches wherein the impeller assembly includes a first impeller blade coupled to an impeller shaft (figure 1B shows two different impellers for first and second impellers; figures 8A-8C shows rotating telescopic shaft 120 coupled to impeller 28).
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Re. claim 14, Schwammenthal further teaches wherein the rotation of the impeller assembly is configured to create a high-pressure region within a body vessel of a patient (paragraph 0036 – “…the first and second pumps are configured to generate a region within the blood vessel that is of higher blood pressure than elsewhere within the blood vessel by pumping blood toward a region of the blood vessel between the first and second pumps”).
Re. claim 15, Schwammenthal teaches a renal pump system comprising the renal support device as stated above in claim 1, and further teaches a console including a processor (paragraph 0346 – “It is noted that control unit 52 typically includes a computer processor that comprises circuitry and that is configured to execute the actions described herein”);
a motor assembly coupled to the console (paragraph 0352 – “For applications in which the upstream and downstream blood pumps include impellers, typically, respective motors 70 and 72 are used to control rotation of the impellers”; figure 1A shows the control unit 52 connected to motor 46);
and wherein rotation of the impeller assembly is configured to create a high-pressure region within a body vessel of a patient (paragraph 0036 – “…the first and second pumps are configured to generate a region within the blood vessel that is of higher blood pressure than elsewhere within the blood vessel by pumping blood toward a region of the blood vessel between the first and second pumps”).
Re. claim 16, Schwammenthal further teaches wherein the impeller assembly includes a first impeller blade coupled to an impeller shaft (figure 1B shows two different impellers for first and second impellers; figures 8A-8C shows rotating telescopic shaft 120 coupled to impeller 28).
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Re. claim 20, Schwammenthal teaches the renal support device as stated above in claim 1, and further teaches a method for positioning a renal pump system adjacent the renal arteries of a patient, the method comprising:
advancing a renal pump device adjacent to a renal artery of the patient (paragraph 0426 – “For example, the upstream pump may be placed in the subject's aorta upstream of the subject's renal arteries…the pumps acting to pump blood into the renal arteries…”).
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.
Claim(s) 3-7, 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwammenthal (US 20180169313 A1 – hereinafter Schwammenthal) in view of Tuval (US 20190209758 A1 – hereinafter Tuval).
Re. claim 3, Schwammenthal further teaches wherein the impeller shaft includes a first end region and a second end region (figure 8B shows that the telescopic shaft 120 includes a proximal and distal end),
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But does not explicitly teach wherein both the first end region and the second end region of the impeller shaft are coupled to an electrical drive cable.
Tuval teaches a similar renal support device (paragraph 0544 – “For some applications, components of device 20 are applicable to different types of blood pumps. For example, aspects of the present invention may be applicable to a pump that is used to pump blood from the vena cava and/or the right atrium into the right ventricle, from the vena cava and/or the right atrium into the pulmonary artery, and/or from the renal veins…”), and further teaches an impeller shaft (figures 11C-E, axial shaft 92), and wherein both the first end region and the second end region of the impeller shaft are coupled to an electrical drive cable (paragraph 0517 – “Reference is now made to FIGS. 11C, 11D, and 11E, which are schematic illustrations of an interface 156 between the drive cable and axial shaft 92”).
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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 device of Schwammenthal, specifically the impeller shaft, to incorporate the electrical drive cable coupling to the impeller shaft as taught by Tuval, since such modification would predictably result in actuating/rotating the impeller as desired.
Re. claim 4, the combined invention of Schwammenthal and Tuval (hereinafter the combined invention) further teaches wherein the impeller shaft includes a lumen extending therein, and wherein the electrical drive cable is configured to extend within the lumen of the impeller shaft (Tuval figure 11E shows the drive cable extending within the lumen of impeller shaft 92).
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Re. claim 5, the combined invention further teaches wherein a proximal end of the electrical drive cable is coupled to a motor core (Tuval figure 7 shows motor housing 23 which houses a motor core 74; paragraph 0451 – “…the computer processor may control a motor 74 (shown in FIG. 7), which is disposed within a motor unit 23 and which drives the impeller to rotate via a drive cable 130 (also shown in FIG. 7)”; paragraph 0494 – “Typically, motor unit 23 includes a motor 74 that is configured to impart rotational motion to impeller 50, via drive cable 130”).
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Re. claim 6, the combined invention further teaches wherein the electrical drive cable and the motor core are configured to rotate around the impeller shaft (Tuval paragraph 0494 – “Typically, motor unit 23 includes a motor 74 that is configured to impart rotational motion to impeller 50, via drive cable 130”).
Re. claim 7, the combined invention further teaches wherein the first impeller blade extends from the first end region of the impeller shaft to the second end region of the impeller shaft (Schwammenthal figure 8B shows the impeller 28 extending from a first end to a second end of the telescopic shaft 120).
Re. claim 17, Schwammenthal further teaches wherein the impeller shaft includes a first end region and a second end region (figure 8B shows that the telescopic shaft 120 includes a proximal and distal end),
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But does not explicitly teach wherein both the first end region and the second end region of the impeller shaft are coupled to an electrical drive cable.
Tuval teaches a similar renal support device (paragraph 0544 – “For some applications, components of device 20 are applicable to different types of blood pumps. For example, aspects of the present invention may be applicable to a pump that is used to pump blood from the vena cava and/or the right atrium into the right ventricle, from the vena cava and/or the right atrium into the pulmonary artery, and/or from the renal veins…”), and further teaches an impeller shaft (figures 11C-E, axial shaft 92), and wherein both the first end region and the second end region of the impeller shaft are coupled to an electrical drive cable (paragraph 0517 – “Reference is now made to FIGS. 11C, 11D, and 11E, which are schematic illustrations of an interface 156 between the drive cable and axial shaft 92”).
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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 device of Schwammenthal, specifically the impeller shaft, to incorporate the electrical drive cable coupling to the impeller shaft as taught by Tuval, since such modification would predictably result in actuating/rotating the impeller as desired.
Re. claim 18, the combined invention further teaches wherein the impeller shaft includes a lumen extending therein, and wherein the electrical drive cable is configured to extend within the lumen of the impeller shaft (Tuval figure 11E shows the drive cable extending within the lumen of impeller shaft 92).
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Re. claim 19, the combined invention further teaches wherein the first impeller blade extends from the first end region of the impeller shaft to the second end region of the impeller shaft (Schwammenthal figure 8B shows the impeller 28 extending from a first end to a second end of the telescopic shaft 120).
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Claim(s) 8 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwammenthal (US 20180169313 A1 – hereinafter Schwammenthal) in view of Smith (US 20070156006 A1 – hereinafter Smith).
Re. claim 8, Schwammenthal teaches a motor (motors 46), but does not explicitly teach a motor assembly including a motor core disposed within a motor housing, and wherein the motor housing is coupled to the distal end region of the outer catheter shaft.
Smith teaches a similar blood pump support device (abstract – “A blood pump (26) includes a stator assembly including a fluid inlet (24) and a fluid outlet (26). A rotor assembly (120) includes an impeller (40) rotatable about an axis (44) to move fluid from the inlet (24) to the outlet (26)”; figure 2A),
and further teaches a motor assembly including a motor core disposed within a motor housing (figure 2A, catheter 20 includes a motor 50 with a motor core 64, shown in figure 3A),
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and wherein the motor housing is coupled to the distal end region of the outer catheter shaft (figure 2A shows the motor 50 at the distal end of the catheter 20).
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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 motor of Schwammenthal to incorporate the motor core and motor placement in the catheter as taught by Smith since such modification would predictably result in actuating/rotating the impeller as desired.
Re. claim 13, the combined invention of Schwammenthal and Smith (hereinafter the combined invention) further teaches a console coupled to the motor assembly (Schwammenthal paragraph 0346 – “It is noted that control unit 52 typically includes a computer processor that comprises circuitry and that is configured to execute the actions described herein”; paragraph 0352 – “For applications in which the upstream and downstream blood pumps include impellers, typically, respective motors 70 and 72 are used to control rotation of the impellers”; figure 1A shows the control unit 52 connected to motor 46).
Claim(s) 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwammenthal (US 20180169313 A1 – hereinafter Schwammenthal) in view of Smith (US 20070156006 A1 – hereinafter Smith), and In further view of Kanz (US 20210170081 A1 – hereinafter Kanz).
Re. claim 9, the combined invention of Schwammenthal and Smith (hereinafter the combined invention) teaches an outer catheter shaft as stated above in claim 1, but does not explicitly teach wherein an electrical drive cable extends along an inner surface of the outer catheter shaft.
Kanz teaches a similar blood pump support device (abstract – “A percutaneous trans-valvular blood pump system including a pump subsystem, catheter, and sheath is described”; figures 1-3),
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and further teaches the known element of an electrical drive cable (figure 9, drive cable 32) extending along an inner surface of an outer catheter shaft (figure 8, drive cable 32 extends along the inner surface of the pump housing 66).
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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 combined invention to incorporate extending along an inner surface of an outer catheter shaft as taught by Kanz since such modification would predictably result in allowing transfer of actuation motion to the impellers.
Re. claim 10, the combined invention of Schwammenthal, Smith and Kanz (hereinafter the combined invention) further teaches wherein the electrical drive cable includes a lumen and wherein an inner catheter shaft is configured to extend within the lumen of the electrical drive cable (Kanz figure 9 shows the drive cable includes a lumen 88 to receive the shaft 84; paragraph 0130 – “The proximal shaft 84 is sized and configured to pass through the central aperture 96 of the shaft bearing 70 and engage the drive cable 32 directly as shown through inner lumen 88 or indirectly with a cylindrical coupler (not shown), thereby coupling the drive cable 32 to the impeller 68 so that the drive cable 32 may transfer rotational energy from the drive motor”).
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Re. claim 11, the combined invention further teaches wherein the electrical drive cable extends circumferentially around an outer surface of the inner catheter shaft (Kanz figures 8-9, drive cable 32 has lumen 88 to extend circumferentially around the shaft 84).
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Re. claim 12, the combined invention further teaches wherein the motor core includes an aperture, and wherein the inner catheter shaft is configured to extend through the aperture of the motor core (Smith figure 3A, motor core 64 includes a central aperture to receive the shaft 42; paragraph 0040 – “The pump 20 includes a motor portion 50 that is adapted to impart rotation of the shaft 42 and impeller 40”).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CARL LAYNO can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796