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 01/09/2025 has/have been considered by the Examiner.
Claim Objections
Claim2 is objected to because of the following informalities:
Claim 2 recites, “…wherein the subject include a subject suffering from cardiogenic shock…”, where the word include should be pluralized. Appropriate correction is required.
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) 1-6 and 11-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Campbell (US 20110004046 A1 – hereinafter Campbell) in view of Keenan (GB 2504177 A – hereinafter Keenan) and Throckmorton (US 20160256619 A1 – hereinafter Throckmorton).
Re. claim 1, Campbell teaches an apparatus, comprising:
a left-ventricular assist device (paragraph 0003 – “This application relates to blood pumps such as left or right ventricular assist devices with an expandable impeller for treatment of heart disease”),
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Comprising:
a self-expandable impeller (paragraph 0003 – “This application relates to blood pumps such as left or right ventricular assist devices with an expandable impeller for treatment of heart disease”)
and a pump-outlet tube (figure 4, cannula [tube] 40 includes expandable portion 44 including outlet 54; paragraph 0067 – “The length of the expandable portion 44 can vary over a wide range. In some embodiments the expandable portion 44 can have a length from inlet 52 to outlet 54 that extends from a chamber of a patient's heart, such as a left ventricle 500…”),
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the impeller being configured to be deployed in a left ventricle of a subject and to pump blood from the subject's left ventricle to an aorta of the subject via the pump-outlet tube (paragraph 0121 – “The pump 10 tracks over the guidewire 72 until the inlet 52 is disposed in a source of blood, such as in a chamber of a patient's heart. For example, the inlet 52 can be positioned in the left ventricle 500 and the outlet can be positioned in the aorta proximal of the aortic valve such that blood can be pumped from the ventricle through the conduit and into the systemic circulatory system”).
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Campbell teaches the operating the impeller to pump blood from the subject's left ventricle to an aorta of the subject as stated above, but does not expressly teach for a period of more than two days.
Keenan teaches a catheter pump (abstract) which further teaches a catheter body 104 comprising an impeller 112,
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which can rest on a left ventricle for up to several days (page 10, lines 10-16: “The drive shaft 144 couples with the motor at the proximal end and with the impeller 112 at the distal end thereof. The drive shaft 144 can be formed with any suitable structure, but should be sufficient flexible to traverse at least from a peripheral (e.g., femoral) artery to a heart chamber, such as the left ventricle, as well as sufficiently durable to rotate at a high speed for several hours, for several days, and in some cases, months”).
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 impeller of Campbell, to incorporate the implantation for several days as taught by Keenan, since such modification would predictably result in ensuring continuous blood flow circulation.
Campbell of the combined invention further teaches the impeller which operates at a range of 2-5 L/min under 90 mmHg (Campbell paragraph 0132 – “The blood pump 10 can be operated at any desired rate, such as at a generally cardiac rate or at a generally subcardiac rate. In some embodiments, the blood pump 10 is capable of operating at a rate in the range of from about 2 L/min to about 5 L/min under typical physiological pressure, e.g., 90 mm Hg. In other embodiments, the blood pump 10 can be operated at a rate in the range of from about 1 L/min to about 3 L/min against typical physiological pressure, e.g., 90 mm Hg”) but does not expressly teach the impeller being configured to provide blood flow of more than 4.5 L/min, when pumping against a mean pressure gradient of 50 mmHg.
Throckmorton teaches a total artificial heart 10 (paragraph 0027 – “The TAH 10 can be made at a fraction of the size of conventional TAHs. For this purpose, the TAH 10 utilizes an axial flow blood pump 16 which is arranged to extend directly through an open center 20 of the centrifugal blood flow pump 14 thereby reducing void and unused space in the centrifugal blood flow pump 14”), and further teaches impellers 16 and 18 (figure 2),
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Which drive systemic circulation of flow of more than 4.5 L/min, when pumping against a pressure gradient of 50 mmHg (figure 9 shows pressure of 50 mmHg at a flow rate greater than 4.5 L/min; paragraph 0043 – “The centrifugal flow pump may provide systemic circulation at a flow range of 0.5 to 6 L/min at a pressure of 70 to 140 mmHg with the impeller rotating at between 2,000 to 10,000 RPMs”).
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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 impeller of the combined invention, to incorporate the blood flow rate as taught by Throckmorton, since such modification would predictably result in continuous and pulsatile blood flow circulation.
Re. claim 2, Campbell of the combined invention further teaches wherein the subject include a subject suffering from cardiogenic shock, and wherein the left-ventricular assist device is configured to provide left- ventricular assistance to the subject suffering from cardiogenic shock (Campbell paragraphs 0005-0006).
Re. claim 3, the combined invention further teaches wherein the impeller is configured to provide blood flow of more than 4.5 L/min, when pumping against a mean pressure gradient of 50 mmHg (see claim 1 rejection) and when rotating at a rotation rate of less than 20,000 RPM (Throckmorton figure 9 shows pressure of 50 mmHg at a flow rate greater than 4.5 L/min for rotation rate of 1750 RPM).
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Re. claim 4, Throckmorton of the combined invention further teaches wherein the impeller is configured to provide positive blood flow, when rotating at a rotation rate of less than 20,000 RPM, when pumping against a pressure gradient of 100-120 mmHg (Throckmorton figure 9 shows pressure of 50 mmHg at a flow rate greater than 4.5 L/min for rotation rate of 1750 RPM).
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Re. claim 5, Throckmorton of the combined invention further teaches wherein the impeller is configured to provide blood flow of more than 4.5 L/min, when rotating at a rotation rate of less than 19,000 RPM, when pumping against a mean pressure gradient of 50 mmHg (Throckmorton figure 9 shows pressure of 50 mmHg at a flow rate greater than 4.5 L/min for rotation rate of 1750 RPM).
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Re. claim 6, Throckmorton of the combined invention further teaches wherein the impeller is configured to provide blood flow of more than 4.5 L/min, when rotating at a rotation rate of less than 20,000 RPM, when pumping against a mean pressure gradient of 60 mmHg (Throckmorton figure 9 shows pressure of 60 mmHg at a flow rate greater than 4.5 L/min for rotation rate of 1750 RPM).
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Re. claim 11, Campbell teaches a method, comprising:
identifying a subject a suffering from cardiogenic shock (paragraphs 0005-0006);
and in response thereto,
deploying an impeller of a left-ventricular assist device within a left ventricle of the subject (paragraph 0003 – “This application relates to blood pumps such as left or right ventricular assist devices with an expandable impeller for treatment of heart disease”),
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and operating the impeller to pump blood from the subject's left ventricle to an aorta of the subject (paragraph 0121 – “The pump 10 tracks over the guidewire 72 until the inlet 52 is disposed in a source of blood, such as in a chamber of a patient's heart. For example, the inlet 52 can be positioned in the left ventricle 500 and the outlet can be positioned in the aorta proximal of the aortic valve such that blood can be pumped from the ventricle through the conduit and into the systemic circulatory system”).
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Campbell teaches the operating the impeller to pump blood from the subject's left ventricle to an aorta of the subject as stated above, but does not expressly teach for a period of more than two days.
Keenan teaches a catheter pump (abstract) which further teaches a catheter body 104 comprising an impeller 112,
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which can rest on a left ventricle for up to several days (page 10, lines 10-16: “The drive shaft 144 couples with the motor at the proximal end and with the impeller 112 at the distal end thereof. The drive shaft 144 can be formed with any suitable structure, but should be sufficient flexible to traverse at least from a peripheral (e.g., femoral) artery to a heart chamber, such as the left ventricle, as well as sufficiently durable to rotate at a high speed for several hours, for several days, and in some cases, months”).
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 impeller of Campbell, to incorporate the implantation for several days as taught by Keenan, since such modification would predictably result in ensuring continuous blood flow circulation.
Campbell of the combined invention further teaches the impeller which operates at a range of 2-5 L/min under 90 mmHg (Campbell paragraph 0132 – “The blood pump 10 can be operated at any desired rate, such as at a generally cardiac rate or at a generally subcardiac rate. In some embodiments, the blood pump 10 is capable of operating at a rate in the range of from about 2 L/min to about 5 L/min under typical physiological pressure, e.g., 90 mm Hg. In other embodiments, the blood pump 10 can be operated at a rate in the range of from about 1 L/min to about 3 L/min against typical physiological pressure, e.g., 90 mm Hg”) but does not expressly teach the impeller being configured to provide blood flow of more than 4.5 L/min, when pumping against a mean pressure gradient of 50 mmHg.
Throckmorton teaches a total artificial heart 10 (paragraph 0027 – “The TAH 10 can be made at a fraction of the size of conventional TAHs. For this purpose, the TAH 10 utilizes an axial flow blood pump 16 which is arranged to extend directly through an open center 20 of the centrifugal blood flow pump 14 thereby reducing void and unused space in the centrifugal blood flow pump 14”), and further teaches impellers 16 and 18 (figure 2),
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Which drive systemic circulation of flow of more than 4.5 L/min, when pumping against a pressure gradient of 50 mmHg (figure 9 shows pressure of 50 mmHg at a flow rate greater than 4.5 L/min; paragraph 0043 – “The centrifugal flow pump may provide systemic circulation at a flow range of 0.5 to 6 L/min at a pressure of 70 to 140 mmHg with the impeller rotating at between 2,000 to 10,000 RPMs”).
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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 impeller of the combined invention, to incorporate the blood flow rate as taught by Throckmorton, since such modification would predictably result in continuous and pulsatile blood flow circulation.
Re. claim 12, Keenan of the combined invention further teaches wherein operating the impeller to pump blood from the subject's left ventricle to an aorta of the subject for a period of more than two days comprises operating the impeller to pump blood from the subject's left ventricle to the subject's aorta for a period of more than four days (Keenan (page 10, lines 10-16: “The drive shaft 144 couples with the motor at the proximal end and with the impeller 112 at the distal end thereof. The drive shaft 144 can be formed with any suitable structure, but should be sufficient flexible to traverse at least from a peripheral (e.g., femoral) artery to a heart chamber, such as the left ventricle, as well as sufficiently durable to rotate at a high speed for several hours, for several days, and in some cases, months”).
Re. claim 13, the combined invention further teaches wherein the impeller is configured to provide blood flow of more than 4.5 L/min, when pumping against a mean pressure gradient of 50 mmHg (see claim 11 rejection above) and when rotating at a rotation rate of less than 20,000 RPM (Throckmorton figure 9 shows pressure of 50 mmHg at a flow rate greater than 4.5 L/min for rotation rate of 1750 RPM).
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Re. claim 14, Throckmorton of the combined invention further teaches wherein the impeller is configured to provide positive blood flow, when rotating at a rotation rate of less than 20,000 RPM, when pumping against a pressure gradient of 100-120 mmHg (Throckmorton figure 9 shows positive flow rate at pressure between 100-120 mmHg and at rotation rate of 2250 RPM).
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Re. claim 15, Throckmorton of the combined invention further teaches wherein the impeller is configured to provide blood flow of more than 4.5 L/min, when rotating at a rotation rate of less than 19,000 RPM, when pumping against a pressure gradient of 50 mmHg (Throckmorton figure 9 shows pressure of 50 mmHg at a flow rate greater than 4.5 L/min for rotation rate of 1750 RPM).
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Re. claim 16, Throckmorton of the combined invention further teaches wherein the impeller is configured to provide blood flow of more than 4.5 L/min, when rotating at a rotation rate of less than 20,000 RPM, when pumping against a mean pressure gradient of 60 mmHg (Throckmorton figure 9 shows pressure of 60 mmHg at a flow rate greater than 4.5 L/min for rotation rate of 1750 RPM).
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Claim(s) 7-8 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Campbell (US 20110004046 A1 – hereinafter Campbell) in view of Keenan (GB 2504177 A – hereinafter Keenan) and Throckmorton (US 20160256619 A1 – hereinafter Throckmorton) and Hastings (US 20110152999 A1 – hereinafter Hastings).
Re. claim 7, Campbell of the combined invention teaches the expandable impeller as stated above (Campbell paragraph 0003 – “This application relates to blood pumps such as left or right ventricular assist devices with an expandable impeller for treatment of heart disease”), but does not expressly teach wherein the impeller is configured to self-expand to a maximum diameter of more than 7 mm.
Hastings teaches a blood pump (abstract – “A percutaneous pumping system for providing hemodynamic support to a patient includes a pumping sleeve that defines a lumen extending along the length of the pumping sleeve”) comprising an impeller (figure 1, impeller 110),
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And further teaches the impeller configured to self-expand to a maximum diameter of more than 7 mm (paragraph 0030 – “In at least some embodiments, the one or more impellers have expanded diameters of at least 10 mm. In at least some embodiments, the one or more impellers have expanded diameters of at least 11 mm. In at least some embodiments, the one or more impellers have expanded diameters of at least 12 mm. In at least some embodiments, the one or more impellers have expanded diameters of at least 13 mm. In at least some embodiments, the one or more impellers have expanded diameters of at least 14 mm”).
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 expandable impeller of the combined invention, to incorporate the expandable impeller of more than 7 mm as taught by Hastings, since such modification would predictably result in ensuring efficient blood pumping flow.
Re. claim 8, Hastings of the combined invention further teaches wherein the impeller is configured to self-expand to a maximum diameter of more than 8 mm (Hastings paragraph 0030 – “In at least some embodiments, the one or more impellers have expanded diameters of at least 10 mm. In at least some embodiments, the one or more impellers have expanded diameters of at least 11 mm. In at least some embodiments, the one or more impellers have expanded diameters of at least 12 mm. In at least some embodiments, the one or more impellers have expanded diameters of at least 13 mm. In at least some embodiments, the one or more impellers have expanded diameters of at least 14 mm”).
Re. claim 17, Campbell of the combined invention teaches the expandable impeller as stated above (Campbell paragraph 0003 – “This application relates to blood pumps such as left or right ventricular assist devices with an expandable impeller for treatment of heart disease”), but does not expressly teach wherein the impeller is configured to self-expand to a maximum diameter of more than 7 mm.
Hastings teaches a blood pump (abstract – “A percutaneous pumping system for providing hemodynamic support to a patient includes a pumping sleeve that defines a lumen extending along the length of the pumping sleeve”) comprising an impeller (figure 1, impeller 110),
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And further teaches the impeller configured to self-expand to a maximum diameter of more than 7 mm (paragraph 0030 – “In at least some embodiments, the one or more impellers have expanded diameters of at least 10 mm. In at least some embodiments, the one or more impellers have expanded diameters of at least 11 mm. In at least some embodiments, the one or more impellers have expanded diameters of at least 12 mm. In at least some embodiments, the one or more impellers have expanded diameters of at least 13 mm. In at least some embodiments, the one or more impellers have expanded diameters of at least 14 mm”).
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 expandable impeller of the combined invention, to incorporate the expandable impeller of more than 7 mm as taught by Hastings, since such modification would predictably result in ensuring efficient blood pumping flow.
Re. claim 18, Hastings of the combined invention further teaches wherein the impeller is configured to self-expand to a maximum diameter of more than 8 mm (Hastings paragraph 0030 – “In at least some embodiments, the one or more impellers have expanded diameters of at least 10 mm. In at least some embodiments, the one or more impellers have expanded diameters of at least 11 mm. In at least some embodiments, the one or more impellers have expanded diameters of at least 12 mm. In at least some embodiments, the one or more impellers have expanded diameters of at least 13 mm. In at least some embodiments, the one or more impellers have expanded diameters of at least 14 mm”).
Claim(s) 9-10 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Campbell (US 20110004046 A1 – hereinafter Campbell) in view of Keenan (GB 2504177 A – hereinafter Keenan) and Throckmorton (US 20160256619 A1 – hereinafter Throckmorton) and McBride (US 20080114339 A1 – hereinafter McBride).
Re. claim 9, Campbell of the combined invention teaches the impeller is disposed in a radially-constrained configuration (Campbell 7A shows the impeller 20 radially constrained within the blood pump 10).
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But does not expressly teach wherein the impeller is configured to have an outer diameter of less than 2 mm.
McBride teaches a blood pump (abstract – “A blood pump may include a cannula having a proximal portion with a fixed diameter, and a distal portion with an expandable diameter. The impeller may reside in the expandable portion of the cannula”) comprising an impeller 200 in a radially constrained configuration (figure 2A),
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And further teaches the impeller can have a diameter of 3 mm (paragraph 0180 – “An improved process for blood pumping within a living subject includes providing an expandable impeller, inserting the impeller into a patient in a stored configuration (for example, with a diameter of between about 3 mm and about 4 mm)…”). Although McBride does not expressly teach an outer diameter of less than 2 mm, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close, see MPEP 2144.05.
Therefore, since the range of about 3-4 mm is close to less than 2 mm, 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 impeller of the combined invention, to incorporate the diameter impeller as taught by McBride, since such modification would predictably result in ensuring efficient blood pumping flow.
Re. claim 10, McBride of the combined invention further teaches wherein the impeller is configured to become radially constrained by axially elongating (McBride paragraph 0065 – “Impeller 200 can be deployed by urging the impeller axially out of storage housing 260, for example using drive shaft 230 attached to the impeller. The impeller then unfolds into the deployed configuration using the stored potential energy of blades 212 in the stored configuration”).
Re. claim 19, Campbell of the combined invention teaches the impeller is disposed in a radially-constrained configuration (Campbell 7A shows the impeller 20 radially constrained within the blood pump 10).
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But does not expressly teach wherein the impeller is configured to have an outer diameter of less than 2 mm.
McBride teaches a blood pump (abstract – “A blood pump may include a cannula having a proximal portion with a fixed diameter, and a distal portion with an expandable diameter. The impeller may reside in the expandable portion of the cannula”) comprising an impeller 200 in a radially constrained configuration (figure 2A),
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And further teaches the impeller can have a diameter of 3 mm (paragraph 0180 – “An improved process for blood pumping within a living subject includes providing an expandable impeller, inserting the impeller into a patient in a stored configuration (for example, with a diameter of between about 3 mm and about 4 mm)…”). Although McBride does not expressly teach an outer diameter of less than 2 mm, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close, see MPEP 2144.05.
Therefore, since the range of about 3-4 mm is close to less than 2 mm, 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 impeller of the combined invention, to incorporate the diameter impeller as taught by McBride, since such modification would predictably result in ensuring efficient blood pumping flow.
Re. claim 20, McBride of the combined invention further teaches wherein the impeller is configured to become radially constrained by axially elongating (McBride paragraph 0065 – “Impeller 200 can be deployed by urging the impeller axially out of storage housing 260, for example using drive shaft 230 attached to the impeller. The impeller then unfolds into the deployed configuration using the stored potential energy of blades 212 in the stored configuration”).
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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/ANH-KHOA N DINH/Examiner, Art Unit 3796
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