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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3, 5-6, 10-11, and 21-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over McBride et al. (hereinafter ‘McBride’, U.S. PGBpub No. 2016/0354525) in view of Groß-Hardt et al. (hereinafter ‘Groß-Hardt’, U.S. PGPub No. 2017/0087288).
In regards to claim 1, McBride discloses a blood pump, comprising one or more struts configured to be coupled to a catheter, the one or more struts defining a housing having a blood inlet and a blood outlet, the one or more struts having an inner surface and an outer surface opposite the inner surface ([0065]: "On the left of the figure, conduit 250 is shown into which impeller 200 is deployed for operation in its larger deployed configuration. Conduit 250 may represent any structure through which a fluid may flow relative to impeller 200, such as a tube, catheter, cannula, or body vessel such as a blood vessel.", [0151]: "Inlet 642 may be provided with a plurality of inlet struts 652 which prevent obstructions from entering the cannula. Similarly, outlet 644 may be provided with a plurality of discharge struts 654 which act as stationary stator blades and remove swirl velocity from the discharge flow of impeller 605. Inlet struts 652 and discharge struts 654 may occupy a short section of the cannula assembly (such as 1 cm) and may be flat linear elements arranged in a uniform circular disposition about the central axis of the device or may be part of mesh 631."), an inner coating disposed on the inner surface at the blood inlet and extending partially towards the blood outlet in an axial direction, the inner coating defining a smooth inner surface ([0147]: "Once mesh 631 has been formed, a coating, such as elastomer coating 633, may be applied to the mesh inner surface, outer surface and/or interstitially. The coating (which may be, for example, biocompatible, corrosion resistant and/or flow improving) may be formed by a solution casting method or by other techniques known in the art, including forming the coating as a separate tube, fitting it over the mesh and heat shrinking it to produce a tight fit."), an outflow tube coupled to the outer surface, the outflow tube surrounding the blood outlet and surrounding at least a first portion of the inner coating, and extending axially beyond the blood outlet ([0151]: 'The expanded portion 626 of cannula 625 includes a distal end 646 having an inlet 642 through which blood enters the cannula, and a proximal end 648 having an outlet 644 through which blood leaves the cannula.", outflow tube analogous to outlet 644), and an impeller disposed within the housing, the impeller including at least one blade, with a wrap angle ([0048]: "Impellers according to embodiments of the present invention may include a plurality of blades which may be arranged in one or more blade rows positioned along the impeller hub.", [0059]: "The wrap angle (from the leading edge to the trailing edge) can be limited to a maximum of about 30 degrees.").
However, McBride does not disclose a wrap angle of the at least one blade relative to a central axis is at least 100 degrees.
Groß-Hardt teaches a blood pump with a wrap angle of the at least one blade relative to a central axis is at least 100 degrees (see Fig. 3, [0042]: "In some embodiments, the wrap angle may be 100+/−10 degrees."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the blood pump to have a blade wrap angle of at least 100 degrees, as taught by Groß-Hardt, as adjusting the wrap angle affects the speed of the pump and the flow of the blade passage ([0043]: "The proper inlet blade angle may depend on the length and shape of the bare hub and the speed of the pump.", [0067]: "The main changes conducted in phase II were the iterative adaptation of inlet and outlet blade angle to achieve an overall better flow guidance of the impeller, as well as an increase in wrap angle which allowed a better flow guidance within the blade passage.").
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In regards to claim 3, McBride/Groß-Hardt combination discloses the invention substantially as described above in claim 1.
However, McBride/Groß-Hardt combination does not disclose that the wrap angle is at least 180 degrees.
Despite this, the claim recites a limitation which is not inventive and, according to prior art, can be obtained as a result of optimization by routine experimentation (see MPEP 2144.05) (see McBride [0041]: "Additionally, various parameters of the shroud 10 may also influence performance, including the shroud inlet length, inlet to blade angle matching, wrap angle, or combinations of these various parameters."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the blood pump to adjust the wrap angle, as taught by Groß-Hardt, as doing so shows adjustment of parameters, including the wrap angle, can be made to achieve optimum result of the device ([0043]: "The proper inlet blade angle may depend on the length and shape of the bare hub and the speed of the pump.", [0067]: "The main changes conducted in phase II were the iterative adaptation of inlet and outlet blade angle to achieve an overall better flow guidance of the impeller, as well as an increase in wrap angle which allowed a better flow guidance within the blade passage.").
In regards to claims 5-6, McBride/Groß-Hardt combination discloses the invention substantially as described above in claim 1.
However, McBride/Groß-Hardt combination does not disclose a leading edge angle of the at least one blade relative to a central axis is equal to a trailing edge angle of the at least one blade relative to the central axis or that the leading edge angle and the trailing edge angle are 55-60 degrees.
Despite this, the claim recites a limitation which is not inventive and, according to prior art, can be obtained as a result of optimization by routine experimentation (see MPEP 2144.05) (see McBride [0057]: "Where the impeller blades join the hub, parameters of interest include leading edge angle and shape (or roundness). Along the bladed portion of the impeller, the parameter of interest was the wrap angle (or blade extent). At the downstream edge of the impeller blades, the parameter of interest was the trailing edge angle or outlet blade angle."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the blood pump to adjust the leading edge and trailing edge angle, as taught by Groß-Hardt, as doing so shows adjustment of parameters, including the leading and trailing edge angle, can be made to achieve optimum result of the device ([0057]: "Testing showed certain design features may result in improvement...").
In regards to claims 10, McBride/Groß-Hardt combination discloses the invention substantially as described above in claim 1.
McBride further discloses an outer coating disposed on the outer surface of the one or more struts and coupled to the outflow tube, the outer coating disposed at the blood inlet and extending no further than a trailing end of the inner coating ([0147]: "Once mesh 631 has been formed, a coating, such as elastomer coating 633, may be applied to the mesh inner surface, outer surface and/or interstitially. The coating (which may be, for example, biocompatible, corrosion resistant and/or flow improving) may be formed by a solution casting method or by other techniques known in the art, including forming the coating as a separate tube, fitting it over the mesh and heat shrinking it to produce a tight fit.").
In regards to claims 11, McBride/Groß-Hardt combination discloses the invention substantially as described above in claim 1.
McBride further discloses that the blood pump is free of an outer coating disposed on the outer surface of the one or more struts ([0147]: "Once mesh 631 has been formed, a coating, such as elastomer coating 633, may be applied to the mesh inner surface, outer surface and/or interstitially. The coating (which may be, for example, biocompatible, corrosion resistant and/or flow improving) may be formed by a solution casting method or by other techniques known in the art, including forming the coating as a separate tube, fitting it over the mesh and heat shrinking it to produce a tight fit.").
In regards to claims 21, McBride/Groß-Hardt combination discloses the invention substantially as described above in claim 1.
McBride further discloses that the one or more struts comprises nitinol ([0152]: "Hence, the cannula can and also be various attached components can be manufactured from a single piece of tube, for example from a nitinol tube using laser cutting, with a mandrel used for shaping the mesh portion.").
In regards to claims 22, McBride/Groß-Hardt combination discloses the invention substantially as described above in claim 1.
McBride further discloses that the inner coating is polyurethane ([0147]: "An elastic polymer such as Elastane™ or Biospan™ may be used for coating 633, as may other polyurethanes, or other polymers.").
In regards to claims 23, McBride/Groß-Hardt combination discloses the invention substantially as described above in claim 1.
McBride further discloses that the at least one blade comprises at least two blades ([0052]: "An impeller according to the present invention may include at least two blades arranged about the circumference of the hub in a first blade row.").
In regards to claims 24, McBride/Groß-Hardt combination discloses the invention substantially as described above in claim 1.
McBride further discloses that the at least one blade consists of two blades ([0052]: "An impeller according to the present invention may include at least two blades arranged about the circumference of the hub in a first blade row.").
In regards to claim 25, McBride discloses a blood pump, comprising one or more struts configured to be coupled to a catheter, the one or more struts defining a housing having a blood inlet and a blood outlet, the one or more struts having an inner surface and an outer surface opposite the inner surface ([0065]: "On the left of the figure, conduit 250 is shown into which impeller 200 is deployed for operation in its larger deployed configuration. Conduit 250 may represent any structure through which a fluid may flow relative to impeller 200, such as a tube, catheter, cannula, or body vessel such as a blood vessel.", [0151]: "Inlet 642 may be provided with a plurality of inlet struts 652 which prevent obstructions from entering the cannula. Similarly, outlet 644 may be provided with a plurality of discharge struts 654 which act as stationary stator blades and remove swirl velocity from the discharge flow of impeller 605. Inlet struts 652 and discharge struts 654 may occupy a short section of the cannula assembly (such as 1 cm) and may be flat linear elements arranged in a uniform circular disposition about the central axis of the device or may be part of mesh 631."), an inner coating disposed on the inner surface at the blood inlet and extending partially towards the blood outlet in an axial direction, the inner coating defining a smooth inner surface ([0147]: "Once mesh 631 has been formed, a coating, such as elastomer coating 633, may be applied to the mesh inner surface, outer surface and/or interstitially. The coating (which may be, for example, biocompatible, corrosion resistant and/or flow improving) may be formed by a solution casting method or by other techniques known in the art, including forming the coating as a separate tube, fitting it over the mesh and heat shrinking it to produce a tight fit."), an outflow tube coupled to the outer surface, the outflow tube surrounding the blood outlet and surrounding at least a first portion of the inner coating, and extending axially beyond the blood outlet ([0151]: 'The expanded portion 626 of cannula 625 includes a distal end 646 having an inlet 642 through which blood enters the cannula, and a proximal end 648 having an outlet 644 through which blood leaves the cannula.", outflow tube analogous to outlet 644), and an impeller disposed within the housing, the impeller including at least one blade ([0048]: "Impellers according to embodiments of the present invention may include a plurality of blades which may be arranged in one or more blade rows positioned along the impeller hub.", Claim recites a limitation which is not inventive and, according to prior art, can be obtained as a result of optimization by routine experimentation (see MPEP 2144.05) [0057]: "Where the impeller blades join the hub, parameters of interest include leading edge angle and shape (or roundness). Along the bladed portion of the impeller, the parameter of interest was the wrap angle (or blade extent). At the downstream edge of the impeller blades, the parameter of interest was the trailing edge angle or outlet blade angle.").
However, McBride/Groß-Hardt combination does not disclose a leading edge angle of the at least one blade relative to a central axis is equal to a trailing edge angle of the at least one blade relative to the central axis.
Despite this, the claim recites a limitation which is not inventive and, according to prior art, can be obtained as a result of optimization by routine experimentation (see MPEP 2144.05) (see McBride [0057]: "Where the impeller blades join the hub, parameters of interest include leading edge angle and shape (or roundness). Along the bladed portion of the impeller, the parameter of interest was the wrap angle (or blade extent). At the downstream edge of the impeller blades, the parameter of interest was the trailing edge angle or outlet blade angle."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the blood pump to adjust the leading edge and trailing edge angle, as taught by Groß-Hardt, as doing so shows adjustment of parameters, including the leading and trailing edge angle, can be made to achieve optimum result of the device ([0057]: "Testing showed certain design features may result in improvement...").
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over McBride in view of Groß-Hardt and in further view of Tuval et al. (hereinafter ‘Tuval’, U.S. PGPub No. 2021/0178147).
In regards to claims 7-8, McBride/Groß-Hardt combination discloses the invention substantially as described above in claim 1.
However, McBride/Groß-Hardt combination does not disclose that the at least one blade has an axial length that is 7mm or 7.5 mm or less.
Tuval teaches a blood pump with at least one blade has an axial length that is 7mm or 7.5 mm or less ([0574]: "Typically, ceteris paribus, the greater the pitch of the helical elongate element (and therefore the impeller blade), the greater the blood flow that is generated by the impeller. Therefore, as described, the pitch of the helical elongate elements 52, when impeller 50 is in the non-radially-constrained configuration, is typically greater than 1 mm (e.g., greater than 6 mm). Therefore, as described, the pitch of the helical elongate elements 52, when impeller 50 is in the non-radially-constrained configuration, is typically less than 20 mm (e.g., less than 10 mm)."), which thus includes the blade length to be within .5 mm and 10 mm). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the blood pump to use blades with an axial length that is 7 mm or less, as taught by Tuval, as doing so would affect occlusion of the backflow of the device ([0574]: "On the other hand, it is typically desirable that the impeller occludes backflow of blood into the subject's left ventricle. Ceteris paribus, it is typically the case that the smaller the pitch of the helical elongate element (and therefore the impeller blade), the greater the occlusion that is provided by the impeller.").
Claim(s) 12-13, 15, 18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over McBride in view of Groß-Hardt and in further view of VanCamp et al. (hereinafter ‘VanCamp’, U.S. PGPub No. 2020/0306434).
In regards to claims 12-13, 15, 18, and 20, McBride/Groß-Hardt combination discloses the invention substantially as described above in claim 1.
However, McBride/Groß-Hardt combination does not disclose that the inner coating has an axial length configured to surround a length of the at least one blade or impeller, the axial length being 50%, 30%, 15% or less, or not at all, of a total length of the at least one blade or impeller.
VanCamp teaches a blood pump which uses a coating that is partially covering at least one blade or impeller ([0061]: "For example, in embodiments, the protective coating may be configured to cover the entire outer surface of the rotor 218, while in other embodiments, the protective coating may be configured to cover a portion of the outer surface of the rotor 218. In embodiments, the rotor 218 is integrated with the impeller 216 and the protective coating is at least partially disposed over an outside surface of the impeller (and, thus, the rotor 218).").
Despite this, the claim recites a limitation which is not inventive and can be obtained as a result of optimization by routine experimentation (see MPEP 2144.05). The amount of coating covering a blade or impeller of the blood pump device may be obtained as a result of routine experimentation to optimize the device. It would be obvious to one of ordinary skill in the art to experiment with different coating amounts for a blade or impeller as some coatings are protective, and it would be obvious to improve efficiency of the device by optimizing the amount of protective coating that a blade or impeller requires ([0050]: "For example, the coating may include a corrosion-resistant coating such as an amorphous silicone, a diamond-like coating, a polymeric compound, and/or the like. In embodiments, the protective coating may be configured to cover at least a portion of the rotor 118. For example, in embodiments, the protective coating may be configured to cover the entire outer surface of the rotor 118, while in other embodiments, the protective coating may be configured to cover a portion of the outer surface of the rotor 118.").
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Groß-Hardt in view of McBride.
In regards to claim 26, Groß-Hardt discloses a blood pump, comprising a pump housing coupled to a catheter configured for insertion into a blood vessel, the pump housing comprising an inner layer disposed on an inner surface of an expandable mesh layer defining a blood inlet and a blood outlet, the inner layer having a first end at the blood inlet and a second end offset axially from the first end by a first predetermined distance (D1) ([0037]: "The shroud 10 may provide an inlet 20 for incoming blood flow and outlet for outgoing blood flow.", [0077]: "The results for the shroud show how both maximum and mean shear stress could be lowered from the reference to the proposed design P31. FIGS. 16a-16b show the maximum and mean shear stress for the reference and P31 design. A significant offset could be achieved.").
However, Groß-Hardt does not disclose an impeller disposed within the pump housing, the impeller including at least one blade, the impeller having a first end and a second end, where the first end of the impeller being offset axially from the first end of the inner layer by a second predetermined distance (D2), the second end of the impeller being offset axially from the first end of the inner layer by a third predetermined distance (D3).
McBride teaches a blood pump with an impeller with at least one blade having one a first end and a second end, where the first end of the impeller being offset axially from the first end of the inner layer by a second predetermined distance, the second end of the impeller being offset axially from the first end of the inner layer by a third predetermined distance (see Fig. 1-2B, [0052], [0055]: "The blades of the first blade row may be angularly offset (clocked) relative to the corresponding blades of the second blade row.").
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Despite this, Groß-Hardt/McBride combination does not teach that D3>D2 and wherein either D2>D1 or D1-D2 < 50% of an axial length of the impeller. However, this is a claim limitation which is not inventive and can be obtained as a result of optimization by routine experimentation (see MPEP 2144.05). It would be obvious to one of ordinary skill in the art to adjust the offset to specific predetermined distances as doing so would optimize the reduction of hemolysis ([0055]: "In blood pumping applications, the angular offset can be adjusted to reduce hemolysis.").
Conclusion
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/B.M.L./Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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