DETAILED ACTION
This Office Action supercedes the previous Non-Final of 1/16/26 since the previous action only addressed claims 1-56. This action addresses all 88 of the originally filed claims.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends. Claim 16 states a value for the valve thickness within the range prescribed by claim 15 so it fails to further limit claim 15. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1-4,7-12, 33-38, 45, 55, 56, 61, 64,66-68,76,77, 84, and 88 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alexander et al (WO2020264417A1); hereinafter Alexander.
Regarding claim 1, Alexander teaches a percutaneous heart pump (part 500) comprising:
an impeller ([0248] impellers 200) having a proximal end and a distal end ([0294] the blades may extend radially inward in a proximal to distal direction), and extendable blades rotatable outwardly creating centrifugal force ([0325] the centrifugal action of rotation may keep the blades in an open configuration);
a rotatable shaft attached proximate the proximal end of said impeller ([0021] the gearbox is configured with two output contra rotating shafts);
a non-rotatable stator supporting said shaft ([0100] The support comprises at least one propeller; a shaft aligned along the axis of rotation of the at least one propeller; an anchoring mechanism; and at least one ring-shaped stator);
a valve conduit attached to said stator and having valves; a non-rotatable expandable frame attachable to said valve conduit and circumscribing said impeller (tubular hose is adapted to fit within the heart valve as non-return valve (3.1));
and a removeable sheath ([0337] The sheath can be retracted, [0325] removeable sleeves) circumscribing said frame prior to said frame being expanded ([0337] The MCS device 500 can be uncovered at least partially from the sheath or larger catheter).
Regarding claim 2, Alexander teaches the percutaneous heart pump of claim 1, wherein said impeller comprises at least one level of at least two extendable vanes positioned equidistant along the circumference of said impeller (fig. 1G shows the extendable vanes).
Regarding claim 3, Alexander teaches the percutaneous heart pump of claim 1, wherein said impeller comprises at least one level of at least two extendable vanes positioned equidistant along the circumference of said impeller (fig. 1G shows the extendable vanes).
Regarding claim 4, Alexander teaches the percutaneous heart pump of claim 1 further comprising a motor rotatably connected to said rotatable shaft for rotating said impeller ([0013] the gearbox has two concentric output shafts driving the impellers in opposite directions, and one input shaft connected via a flexible shaft to an electric motor or gearmotor).
Regarding claim 7 and 66, Alexander teaches the percutaneous heart pump of claim 1 and claim 55, wherein prior to removal of said sheath said percutaneous heart pump comprises an outer diameter between about 1.5 mm and about 5 mm ([0462] the outer diameter of the sheath 1220 may be about 4 mm).
Regarding claim 8 and 67, Alexander teaches the percutaneous heart pump of claim 7 and 55, wherein the outer diameter of said percutaneous heart pump being preferably 3 mm ([0134] the impeller tip diameter is about 5 mm-about 33 mm diameter – it would be an obvious variation of the cited range to make the outer diameter 3mm).
Regarding claim 9, Alexander teaches the percutaneous heart pump of claim 1, wherein said frame being composed of a shapeable material ([0122] the blades are flexible) comprises at least one anchor region adapted to contact the native leaflet of the heart ([0096] The anchoring mechanism may comprise a plurality of leaflet springs coupled to the propeller. The leaflet springs may be configured to extend in a radially outward direction from the propeller to contact the blood vessel wall and anchor the propeller within the blood vessel - doesn't mention leaflet of the heart specifically but it would be obvious to anchor there if it can be anchored anywhere else in vasculature).
Regarding claim 10, Alexander teaches the percutaneous heart pump of claim 9, wherein said frame comprises at least two anchor regions ([0257] the anchoring mechanisms 600, [0273] the anchoring mechanism 600 may also include one or more struts).
Regarding claim 11, Alexander teaches the percutaneous heart pump of claim 10, wherein said frame expands to a diameter between about 9 mm and about 20 mm ([0340] In some embodiments, the minimum internal diameter of the patient’s aorta is 19-20 mm, and the maximum is 32 mm - the device must fit inside the aorta).
Regarding claim 12, Alexander teaches the percutaneous heart pump of claim 11, wherein said frame expands to a diameter of about 15 mm ([0340] In some embodiments, the minimum internal diameter of the patient’s aorta is 19-20 mm, and the maximum is 32 mm - the device must fit inside the aorta).
Regarding claim 13 and 64, Alexander teaches the percutaneous pump of claim 1 and claim 55. It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the valve conduit to comprise 3 regions of varying diameter because it is a matter of design choice.
Regarding claim 33, Alexander teaches a percutaneous heart pump (part 500) comprising:
an impeller ([0248] impellers 200) having a proximal end and a distal end ([0294] the blades may extend radially inward in a proximal to distal direction), and extendable blades rotatable outwardly creating centrifugal force ([0325] the centrifugal action of rotation may keep the blades in an open configuration); a rotatable shaft attached proximate the proximal end of said impeller ([0021] the gearbox is configured with two output contra rotating shafts), wherein said impeller comprises at least one level of at least two extendable vanes positioned equidistant along the circumference of said impeller (fig. 1G shows the extendable vanes); a non-rotatable stator supporting said shaft ([0100] The support comprises at least one propeller; a shaft aligned along the axis of rotation of the at least one propeller; an anchoring mechanism; and at least one ring-shaped stator); a valve conduit attached to said stator and having valves radially displaceable as a function of pressure differential created by the rotation of said impeller (tubular hose is adapted to fit within the heart valve as non-return valve (3.1)). a non-rotatable expandable frame being composed of a shapeable material comprising at least one anchor region adapted to contact the native leaflet of the heart ([0096] The anchoring mechanism may comprise a plurality of leaflet springs coupled to the propeller. The leaflet springs may be configured to extend in a radially outward direction from the propeller to contact the blood vessel wall and anchor the propeller within the blood vessel - doesn't mention leaflet of the heart specifically but it would be obvious to anchor there if it can be anchored anywhere else in vasculature); and a sheath circumscribing said frame prior to said frame being expanded ([0337] The sheath can be retracted, [0325] removeable sleeves).
Regarding claim 34, Alexander teaches the percutaneous heart pump of claim 33 further comprising a motor rotatably connected to said rotatable shaft for rotating said impeller ([0013] the gearbox has two concentric output shafts driving the impellers in opposite directions, and one input shaft connected via a flexible shaft to an electric motor or gearmotor).
Regarding claim 35 and 77, Alexander teaches the percutaneous heart pump of claim 33 and 76, wherein said impeller rotates between about 4000 revolutions per minute and about 25,000 revolutions per minute ([0133] In some embodiments, the rotors operate between 1,000 and 60,000 rpm).
Regarding claims 37 and 61, Alexander teaches the percutaneous heart pump of claim 33 and 55, wherein said frame being composed of a shapeable material ([0122] the blades are flexible) comprises at least one anchor region adapted to contact the native leaflet of the heart ([0096] The anchoring mechanism may comprise a plurality of leaflet springs coupled to the propeller. The leaflet springs may be configured to extend in a radially outward direction from the propeller to contact the blood vessel wall and anchor the propeller within the blood vessel - doesn't mention leaflet of the heart specifically but it would be obvious to anchor there if it can be anchored anywhere else in vasculature).
Regarding claim 38, Alexander teaches the percutaneous heart pump of claim 33, wherein said frame comprises at least two anchor regions ([0257] the anchoring mechanisms 600, [0273] the anchoring mechanism 600 may also include one or more struts).
The percutaneous heart pump of claim 33, wherein said frame comprises at least two anchor regions ([0257] the anchoring mechanisms 600, [0273] the anchoring mechanism 600 may also include one or more struts).
Regarding claim 45 and 68, Alexander teaches the percutaneous heart pump of claim 33 and claim 55 further comprising a shaft stabilizer attached to the distal end of the impeller ([0257] the anchoring mechanisms 600, [0273] the anchoring mechanism 600 may also include one or more struts).
Regarding claim 55, Alexander teaches a method for installing a percutaneous heart pump (part 500) in the human body comprising:
providing a heart pump having: an impeller ([0248] impellers 200) having a proximal end and a distal end ([0294] the blades may extend radially inward in a proximal to distal direction), and extendable blades rotatable outwardly by centrifugal force ([0325] the centrifugal action of rotation may keep the blades in an open configuration), a rotatable shaft attached proximate the proximal end of said impeller ([0021] the gearbox is configured with two output contra rotating shafts), a non-rotatable stator supporting said shaft ([0100] The support comprises at least one propeller; a shaft aligned along the axis of rotation of the at least one propeller; an anchoring mechanism; and at least one ring-shaped stator), a valve conduit attached to said stator and having valves, a non-rotatable expandable frame being manufactured of a shapable material attachable to said valve conduit and circumscribing said impeller (tubular hose is adapted to fit within the heart valve as non-return valve (3.1)), and a removeable sheath ([0337] The sheath can be retracted, [0325] removeable sleeves) circumscribing said frame prior to said frame being expanded ([0337] The MCS device 500 can be uncovered at least partially from the sheath or larger catheter); routing the heart pump through a predetermined artery or vein into the human heart; placing the valve conduit proximate a predetermined native valve of the human heart; removing the sheath allowing the frame to expand to a predetermined shape ([0337] The sheath can be retracted, [0325] removeable sleeves) ; anchoring the frame to contact a native leaflet of the predetermined valve ([0096] The anchoring mechanism may comprise a plurality of leaflet springs coupled to the propeller. The leaflet springs may be configured to extend in a radially outward direction from the propeller to contact the blood vessel wall and anchor the propeller within the blood vessel - doesn't mention leaflet of the heart specifically but it would be obvious to anchor there if it can be anchored anywhere else in vasculature); and rotating the impeller causing an axial fluid flow transferred into a radial outwardly fluid flow through the valves ([0101],[0181], figures 24-25).
Regarding claim 56, 76, and 88, Alexander teaches a method for installing a percutaneous heart pump (part 500) in the human body comprising:
providing a heart pump having: an impeller([0248] impellers 200) having a proximal end and a distal end ([0294] the blades may extend radially inward in a proximal to distal direction), and extendable blades rotatable outwardly by centrifugal force ([0325] the centrifugal action of rotation may keep the blades in an open configuration), a rotatable shaft attached proximate the proximal end of said impeller ([0021] the gearbox is configured with two output contra rotating shafts), a non-rotatable stator supporting said shaft ([0100] The support comprises at least one propeller; a shaft aligned along the axis of rotation of the at least one propeller; an anchoring mechanism; and at least one ring-shaped stator), a valve conduit attached to said stator and having valves, a non-rotatable expandable frame being manufactured of a shapable material attachable to said valve conduit and circumscribing said impeller (tubular hose is adapted to fit within the heart valve as non-return valve (3.1)), and a removeable sheath circumscribing said frame prior to said frame being expanded; routing the heart pump through a predetermined artery or vein into the human heart; placing the valve conduit proximate a predetermined native valve of the human heart; removing the sheath allowing the frame to expand to a predetermined shape; anchoring the frame to contact a native leaflet of the predetermined native valve; re-positioning the heart pump to a preferred position; re-anchoring the frame to contact a native leaflet of the predetermined native valve; rotating the impeller causing an axial fluid flow transferred into a radial outwardly fluid flow through the valves. re-sheathing the sheath; and remove the heart pump.
Regarding claim 84, Alexander teaches the method of claim 76. Alexander further teaches the step of ceasing rotation of the impeller and re-sheathing the frame prior to removal of the heart pump from the patient ([0012] the blades of the impellers rotating in opposite directions have flexible connections to the impeller hubs to accommodate insertion and removal with folded blades, and operation with unfolded blades - if the blades are folded, they are not rotating and it would be obvious to re-sheathe after folding the blades).
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.
Claim(s) 85 and 86 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alexander.
Regarding claim 85, Alexander teaches the method of claim 76. It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the method of claim 76 to place the valve conduit elsewhere so it would constitute simple substitution to place the valve in the pulmonary valve rather than the generic location of claim 76.
Regarding claim 86, Alexander teaches the method of claim 76. It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the method of claim 76 to place the valve conduit elsewhere so it would constitute simple substitution to place the valve in the tricuspid valve rather than the generic location of claim 76.
Claim(s) 5, 6,14-23, 36, 39-44, 57-59,60, 62,63, and 65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alexander in view of Pfeffer et al (US20200129683A1); hereinafter Pfeffer.
Regarding claim 5, Alexander teaches the percutaneous heart pump of claim 1. Pfeffer teaches the rotation of said impeller converts an axial flow along the longitudinal axis of said valve conduit into a transverse radially outwardly centrifugal flow through said valves (the inlet openings are in the pump housing, and the cannula having the tubular hose is an outflow cannula, wherein the outlet cannula distal end is sealingly positioned with respect to the pump housing so the outlet cannula can receive an outflow of blood from the pump housing and release that blood from the outlet cannula proximal end, wherein the pump housing inlet openings further configured to be positioned in a left ventricle and the tubular hose outlet openings configured to be positioned in the aorta, and the pump maybe provided from use in the right ventricle ([0101],[0181], figures 24-25)). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Alexander with Pfeffer because this it constitutes known work in the field of impellers that change the direction of the blood flow.
Regarding claim 6, the combination of Alexander and Pfeffer teaches the pump of claim 5. Alexander teaches the percutaneous heart pump of claim 5, wherein said impeller rotates between about 4000 revolutions per minute and about 25,000 revolutions per minute ([0133]. In some embodiments, the rotors operate between 1,000 and 60,000 rpm).
Regarding claim 14, Alexander teaches the percutaneous heart pump of claim 1. Pfeffer teaches said valves open and close as a function of pressure differential ([0101], claim 16 - the tubular hose is configured to that the tubular hose opens and closes within the heart valve in response to a pressure difference between inside the tubular hose and outside the tubular hose). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Alexander with Pfeffer because it is obvious to try. There are a limited number of predictable options for controlling the valves in a device implanted in a high blood flow area of the vasculature so it would have been obvious to have it be controlled by a pressure differential.
Regarding claim 15, Alexander teaches the percutaneous heart pump of claim 1. Pfeffer teaches said valves have a thickness between about 0.01mm and about 0.30 mm ([0098] outlet hose has a wall thickness of roughly 0.01-0.1mm - 0.03mm). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the valves to have this thickness as the blood vessel has limited space so there is a finite number of possible options for ranges and there is no specific benefit to using this value.
Regarding claim 16, Alexander teaches the percutaneous heart pump of claim 16. Pfeffer teaches said valves have a thickness between about 0.05 mm ([0098] outlet hose has a wall thickness of roughly 0.01-0.1mm - 0.03mm).
Regarding claim 17, Alexander teaches the percutaneous heart pump of claim 1. Pfeffer teaches the percutaneous heart pump being for arterial application provides for commencement of axial flow proximate the distal end of the impeller along the longitudinal axis of said valve conduit and expulsion through the valves radially outwardly, and wherein the proximate end of said valve conduit being substantially sealed assists in the expulsion of flow through the valves radially outwardly (inlet openings are in the pump housing, and the cannula having the tubular hose is an outflow cannula, wherein the outlet cannula distal end is sealingly positioned with respect to the pump housing so the outlet cannula can receive an outflow of blood from the pump housing and release that blood from the outlet cannula proximal end, wherein the pump housing inlet openings further configured to be positioned in a left ventricle and the tubular hose outlet openings configured to be positioned in the aorta, and the pump maybe provided from use in the right ventricle ([0101],[0181], figures 24-25)). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Alexander with Pfeffer because this it constitutes known work in the field of impellers that change the direction of the blood flow.
Regarding claim 18, the combination of Alexander and Pfeffer teaches the pump of claim 17. The combination further teaches sealed end includes at least one aperture. It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention that it is an obvious design choice that there must be an aperture.
Regarding claim 19, the combination of Alexander and Pfeffer teaches the pump of claim 18. The combination further teaches said aperture being between about 0.1 mm and about 3 mm, preferably about 0.5 mm. It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to make the aperture this particular size since the size of the instruments are limited to the size of the target blood vessel and there is no obvious benefit to using this size compared to any other within the range of the size of the blood vessel.
Regarding claim 20, Alexander teaches the percutaneous heart pump of claim 1. Pfeffer teaches the percutaneous heart pump being for venous application provides for commencement of axial flow proximate the proximal end of the impeller along the longitudinal axis of said valve conduit and expulsion through the valves radially outwardly, and wherein the distal end of said valve conduit being substantially sealed assists in the expulsion of flow through the valves radially outwardly (the inlet openings are in the pump housing, and the cannula having the tubular hose is an outflow cannula, wherein the outlet cannula distal end is sealingly positioned with respect to the pump housing so the outlet cannula can receive an outflow of blood from the pump housing and release that blood from the outlet cannula proximal end, wherein the pump housing inlet openings further configured to be positioned in a left ventricle and the tubular hose outlet openings configured to be positioned in the aorta, and the pump maybe provided from use in the right ventricle ([0101,[0181], figures 24-25)). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Alexander with Pfeffer because this it constitutes known work in the field of impellers that change the direction of the blood flow.
Regarding claim 21, the combination of Alexander and Pfeffer teaches the heart pump of claim 20. It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention that it is an obvious design choice that there must be an aperture.
Regarding claim 22, the combination of Alexander and Pfeffer teaches the heart pump of claim 21. The combination further teaches said aperture being between about 0.1 mm and about 3 mm, preferably about 0.5 mm. It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to make the aperture this particular size since the size of the instruments are limited to the size of the target blood vessel and there is no obvious benefit to using this size compared to any other within the range of the size of the blood vessel.
Regarding claim 23, Alexander teaches the percutaneous heart pump of claim 1. Pfeffer teaches a shaft stabilizer attached to the distal end of the impeller (Distal shaft protector (13.1) is arranged axially within the distal catheter body element, the distal shaft protector extends in the flow direction from shortly before the distal connection bush (12.1) to the distal end of the pump section (3.1.3) wherein the connection bush ensures the axial centricity of the drive shaft in particular in the pump housing ([0073] - [0076]; figure 6)). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Alexander with Pfeffer because it is obvious to try and constitutes an obvious choice from a list of finite options.
Regarding claim 29, the combination of Alexander and Pfeffer teaches the heart pump of claim 23. It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination to include a pH sensor because it is well known in the art of heart pumps to include various sensors for monitoring the condition of the patient.
Regarding claim 30, the combination of Alexander and Pfeffer teaches the heart pump of claim 23. It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination to include a lactate sensor because it is well known in the art of heart pumps to include various sensors for monitoring the condition of the patient.
Regarding claim 36 and 60, Alexander teaches the pump of claim 33 and 55. Pfeffer teaches the rotation of said impeller converts an axial flow along the longitudinal axis of said valve conduit into a transverse radially outwardly centrifugal flow through said valves (the inlet openings are in the pump housing, and the cannula having the tubular hose is an outflow cannula, wherein the outlet cannula distal end is sealingly positioned with respect to the pump housing so the outlet cannula can receive an outflow of blood from the pump housing and release that blood from the outlet cannula proximal end, wherein the pump housing inlet openings further configured to be positioned in a left ventricle and the tubular hose outlet openings configured to be positioned in the aorta, and the pump maybe provided from use in the right ventricle ([0101],[0181], figures 24-25)). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Alexander with Pfeffer because this it constitutes known work in the field of impellers that change the direction of the blood flow.
Regarding claim 39, Alexander teaches the percutaneous heart pump of claim 33. Pfeffer teaches the percutaneous heart pump being for arterial application provides for commencement of axial flow proximate the distal end of the impeller along the longitudinal axis of said valve conduit and expulsion through the valves radially outwardly, and wherein the proximate end of said valve conduit being substantially sealed assists in the expulsion of flow through the valves radially outwardly (Disclosure of D1 that the inlet openings are in the pump housing, and the cannula having the tubular hose is an outflow cannula, wherein the outlet cannula distal end is sealingly positioned with respect to the pump housing so the outlet cannula can receive an outflow of blood from the pump housing and release that blood from the outlet cannula proximal end, wherein the pump housing inlet openings further configured to be positioned in a left ventricle and the tubular hose outlet openings configured to be positioned in the aorta, and the pump maybe provided from use in the right ventricle ([0101,[0181], figures 24-25)). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Alexander with Pfeffer because this it constitutes known work in the field of impellers that change the direction of the blood flow.
Regarding claims 40, 43, and 57, the combination of Alexander and Pfeffer teaches the percutaneous heart pump of claim 39 and 56. The combination further teaches sealed end includes at least one aperture. It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention that it is an obvious design choice that there must be an aperture.
Regarding claims 41, 44, and 58, the combination of Alexander and Pfeffer teaches the percutaneous heart pump of claims 40, 43, and 57. The combination further teaches said aperture being between about 0.1 mm and about 3 mm, preferably about 0.5 mm. It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to make the aperture this particular size since the size of the instruments are limited to the size of the target blood vessel and there is no obvious benefit to using this size compared to any other within the range of the size of the blood vessel.
Regarding claim 42 and 59, Alexander teaches the heart pump of claim 33 and 55. Pfeffer teaches the percutaneous heart pump being for venous application provides for commencement of axial flow proximate the proximal end of the impeller along the longitudinal axis of said valve conduit and expulsion through the valves radially outwardly, and wherein the distal end of said valve conduit being substantially sealed assists in the expulsion of flow through the valves radially outwardly (the inlet openings are in the pump housing, and the cannula having the tubular hose is an outflow cannula, wherein the outlet cannula distal end is sealingly positioned with respect to the pump housing so the outlet cannula can receive an outflow of blood from the pump housing and release that blood from the outlet cannula proximal end, wherein the pump housing inlet openings further configured to be positioned in a left ventricle and the tubular hose outlet openings configured to be positioned in the aorta, and the pump maybe provided from use in the right ventricle ([0101,[0181], figures 24-25)). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Alexander with Pfeffer because this constitutes known work in the field of impellers that change the direction of the blood flow.
Regarding claim 62, the combination of Alexander and Pfeffer teaches the pump of claim 60. Alexander further teaches said frame expands to a diameter between about 9 mm and about 20 mm ([0340] In some embodiments, the minimum internal diameter of the patient’s aorta is 19-20 mm, and the maximum is 32 mm - the device must fit inside the aorta).
Regarding claim 63, the combination of Alexander and Pfeffer teaches the pump of claim 62. Alexander further teaches said frame expands to a diameter of about 15 mm ([0340] In some embodiments, the minimum internal diameter of the patient’s aorta is 19-20 mm, and the maximum is 32 mm - the device must fit inside the aorta).
Regarding claim 65, the combination of Alexander and Pfeffer teaches the pump of claim 63. Alexander further teaches said impeller rotates between about 4000 revolutions per minute and about 25,000 revolutions per minute ([0133] In some embodiments, the rotors operate between 1,000 and 60,000 rpm.).
Claim(s) 24-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alexander in view of Alexander, Pfeffer, and Smith et al (US20210113826A1); hereinafter Smith .
Regarding claim 24, the combination of Alexander and Pfeffer teaches the heart pump of claim 23. Smith teaches at least one sensor affixed to said stator proximal said impeller ([0090]-[0091] during operation of the pump, a processor may store and/or process data from the pump and/or patient, and may execute instructions from memory to automatically adjust pump parameters based on data received from one or more sensors provided with the pump, wherein the sensors include pressure sensor, flow sensors, temperature sensors, heart rate sensors, and heart rhythm sensors). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Alexander and Pfeffer with Smith because using a sensor to collect patient data on an implanted device is well-known in the art.
Regarding claim 25, the combination of Alexander and Pfeffer teaches the heart pump of claim 23. Smith teaches at least two sensors, said second sensor affixed to said shaft stabilizer ([0090]-[0091] during operation of the pump, a processor may store and/or process data from the pump and/or patient, and may execute instructions from memory to automatically adjust pump parameters based on data received from one or more sensors provided with the pump, wherein the sensors include pressure sensor, flow sensors, temperature sensors, heart rate sensors, and heart rhythm sensors). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Alexander and Pfeffer with Smith because using a sensor to collect patient data on an implanted device is well-known in the art.
Regarding claim 26, the combination of Alexander and Pfeffer teaches the heart pump of claim 23. Smith teaches sensors measure pressure differential ([0053] locations for pressure sensor attachment to the pump). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Alexander and Pfeffer with Smith because using a sensor to collect patient data on an implanted device is well-known in the art.
Regarding claim 27, the combination of Alexander and Pfeffer teaches the heart pump of claim 23. Smith teaches at least one of said sensors measures temperature ([0091] temperature sensors). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Alexander and Pfeffer with Smith because using a sensor to collect patient data on an implanted device is well-known in the art.
Regarding claim 28, the combination of Alexander and Pfeffer teaches the heart pump of claim 23. Smith teaches at least one of said sensors measures direction and rate of fluid flow ([0091] flow sensors). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Alexander and Pfeffer with Smith because using a sensor to collect patient data on an implanted device is well-known in the art.
Claim(s) 31, 32, 53, and 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alexander in view of Chen et al (US20030108588A1); hereinafter Chen.
Regarding claim 31, Alexander teaches the percutaneous heart pump of claim 1. Chen teaches said impeller includes a drug capable of being eluted ([abstract, claims 1, 49-51] coating comprises a sustained release formulation of a combination of pharmaceutical compounds dispersed within a biologically tolerated polymer composition, wherein the device is an expendable stent, and wherein the device is selected from the group consisting of a pacemaker, ventricular assist pumps, extracorporeal devices). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Alexander with Chen because it is well-known in the art of heart pumps to include a drug to be eluted.
Regarding claim 32, Alexander teaches the percutaneous heart pump of claim 1. Chen teaches frame includes a drug capable of being eluted ([abstract, claims 1, 49-51] coating comprises a sustained release formulation of a combination of pharmaceutical compounds dispersed within a biologically tolerated polymer composition, wherein the device is an expendable stent, and wherein the device is selected from the group consisting of a pacemaker, ventricular assist pumps, extracorporeal devices). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Alexander with Chen because it is well-known in the art of heart pumps to include a drug to be eluted.
Regarding claim 53, Alexander teaches the percutaneous heart pump of claim 33. Chen teaches said impeller includes a drug capable of being eluted ([abstract, claims 1, 49-51] coating comprises a sustained release formulation of a combination of pharmaceutical compounds dispersed within a biologically tolerated polymer composition, wherein the device is an expendable stent, and wherein the device is selected from the group consisting of a pacemaker, ventricular assist pumps, extracorporeal devices). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Alexander with Chen because it is well-known in the art of heart pumps to include a drug to be eluted.
Regarding claim 54, Alexander teaches the percutaneous heart pump of claim 33. Chen teaches frame includes a drug capable of being eluted ([abstract, claims 1, 49-51] coating comprises a sustained release formulation of a combination of pharmaceutical compounds dispersed within a biologically tolerated polymer composition, wherein the device is an expendable stent, and wherein the device is selected from the group consisting of a pacemaker, ventricular assist pumps, extracorporeal devices). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Alexander with Chen because it is well-known in the art of heart pumps to include a drug to be eluted.
Claim(s) 46-52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alexander in view of Smith.
Regarding claim 46, Alexander teaches the pump of claim 33. Smith teaches at least one sensor affixed to said stator proximal said impeller ([0090]-[0091] during operation of the pump, a processor may store and/or process data from the pump and/or patient, and may execute instructions from memory to automatically adjust pump parameters based on data received from one or more sensors provided with the pump, wherein the sensors include pressure sensor, flow sensors, temperature sensors, heart rate sensors, and heart rhythm sensors). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination to include a sensor because it is well known in the art of heart pumps to include various sensors for monitoring the condition of the patient.
Regarding claim 47 and 78, the combination of Alexander and Smith teaches the pump of claim 46 and Alexander teaches the pump of 76. Smith teaches at least two sensors, said second sensor affixed to said shaft stabilizer ([0090]-[0091] during operation of the pump, a processor may store and/or process data from the pump and/or patient, and may execute instructions from memory to automatically adjust pump parameters based on data received from one or more sensors provided with the pump, wherein the sensors include pressure sensor, flow sensors, temperature sensors, heart rate sensors, and heart rhythm sensors). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination to include a sensor because it is well known in the art of heart pumps to include various sensors for monitoring the condition of the patient.
Regarding claim 48, the combination of Alexander and Smith teaches the pump of claim 47. Smith teaches said sensors measure pressure differential ([0053] locations for pressure sensor attachment to the pump).
Regarding claim 49, the combination of Alexander and Smith teaches pump of claim 46. Smith teaches at least one of said sensors measures temperature ([0091] temperature sensors).
Regarding claim 50, the combination of Alexander and Smith teaches pump of claim 46. Smith teaches at least one of said sensors measures direction and rate of fluid flow ([0091] flow sensors).
Regarding claim 51, 74, and 82, the combination of Alexander and Smith teaches the pump of claim 46 and claim 70 and claim 78. It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination to measure pH since it commonly known in the art of heart pumps and catheters to measure pH.
Regarding claim 52, 75, and 83, the combination of Alexander and Smith teaches the pump of claim 46, 70, and 78. It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination to measure lactate since it commonly known in the art of heart pumps and catheters to measure lactate.
Claim(s) 69-73 and 78-81 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alexander and Smith.
Regarding claim 69, Alexander teaches the pump of claim 55. Smith teaches at least one sensor affixed to said stator proximal said impeller ([0090]-[0091] during operation of the pump, a processor may store and/or process data from the pump and/or patient, and may execute instructions from memory to automatically adjust pump parameters based on data received from one or more sensors provided with the pump, wherein the sensors include pressure sensor, flow sensors, temperature sensors, heart rate sensors, and heart rhythm sensors). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the Alexander with Smith because using a sensor to collect patient data on an implanted device is well-known in the art.
Regarding claim 70, the combination of Alexander and Smith teaches the pump of claim 69. Smith further teaches at least two sensors, said second sensor affixed to said shaft stabilizer ([0090]-[0091] during operation of the pump, a processor may store and/or process data from the pump and/or patient, and may execute instructions from memory to automatically adjust pump parameters based on data received from one or more sensors provided with the pump, wherein the sensors include pressure sensor, flow sensors, temperature sensors, heart rate sensors, and heart rhythm sensors).
Regarding claims 71 and 79, the combination of Alexander and Smith teaches the pump of claim 70 and claim 78. Smith further teaches said sensors measure pressure differential ([0053] locations for pressure sensor attachment to the pump).
Regarding claims 72 and 80, the combination of Alexander and Smith teaches the pump of claim 70 and claim 78. Smith further teaches at least one of said sensors measures temperature ([0091] temperature sensors).
Regarding claims 73 and 81, the combination of Alexander and Smith teaches the pump of claim 70 and claim 78. Smith further teaches at least one of said sensors measures direction and rate of fluid flow ([0091] flow sensors).
Claim(s) 87 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alexander in view of Tuval et al (US 20220072297 A1); hereinafter Tuval. Alexander teaches the method of claim 76. Tuval teaches the valve conduit is placed proximate the mitral valve ([0310] mitral valve leaflets 402). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Alexander to place the valve conduit elsewhere so it would constitute simple substitution to place the valve in the pulmonary valve rather than the generic location of claim 76.
Conclusion
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/D.S.D./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796