DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
The amendments and remarks filed on 27AUG2025 have been entered and considered.
Claims 1-2, 4-13, & 21-28 are currently pending.
Claims 1-2, 4-5, & 12 have been amended.
No claims are withdrawn.
Claims 3 & 14-16 have been canceled by applicant.
Claims 21-28 have been added.
No new matter has been added.
Claims 1-2, 4-13, & 21-28 are under examination.
Response to Arguments
Applicant's amendments filed 27AUG2025 regarding the Drawing Objections have been fully considered and obviates the objection. Therefore, the objection has been withdrawn.
Applicant's amendments filed 27AUG2025 regarding the Claim Objections have been fully considered and obviates the objection. Therefore, the objection has been withdrawn.
Applicant's amendments filed 27AUG2025 regarding the Duplicate Claim Warning have been fully considered but do not obviate the duplicate claim warnings. Therefore, the objections are being maintained.
Applicant's amendments filed 27AUG2025 regarding the rejections under 35 USC 102(a)(1) have been fully considered and have been found obviate the rejection. New grounds for rejection can be seen below. Arguments regarding Alexander et al. (US Patent No. 11116959) deemed not persuasive are discussed below:
Applicant states (see Page 8 of the Remarks):
“Alexander doesn’t suggest or teach at least the limitations, “rotatable relative to the impeller housing to create a turbulent barrier and thereby cause blood to flow away from the proximal end portion of the housing.” Instead Alexander states that the “casing 300 may include an inlet 102 for receiving blood flow into the MCS 100, and an outlet 104 for directing exiting blood flow from the MCS 100, both extending from a main body for housing the impeller 200." (Column 24 Lines 18-21). Thus, any second impellers in Alexander are not analogous to the counter impellers disclosed by Applicant as Alexander’s plurality of propellers do not create a “turbulent barrier” to prevent blood pooling, rather they simply “reduce the torque reaction.” (Office action page 7, quoting Merriam-Webster contra-rotating propeller, definition and meaning). Therefore, the claimed counter impeller is not anticipated by Alexander because it is an entirely different type of impeller, creating a “turbulent barrier.””
The examiner is not persuaded. Alexander as cited in Column 24 Lines 18-21 teaches that blood is flowing away from the proximal portion. Alexander also discloses not only contra-rotating impellers but many configurations of impeller or propeller systems, which as stated in Alexander Column 81 Lines 6-13 “The propellers 511 may comprise one or more radially extending blades 520 configured to transfer force to the blood flowing through the vasculature. The blades 520 can have any configuration of blades described herein. In some embodiments, the MCS 500 may comprise one or more impellers 200 described herein. The impellers 200 can have any configuration of impellers described herein.”. Alexander Column Lines 12-14 states “In some embodiments, the at least two propellers or impellers comprises a plurality of propellers configured to rotate together.”. Since applicant is arguing a stated effect of the blood flow caused by the impellers, and alexander shows the impellers creating this blood flow and in a similar configuration with the blood flow disclosed to flow away from the inlet, this tangential barrier should be an obvious result of Alexander similarly to the instant application. Therefore, the examiner maintains that Alexander teaches the claimed limitations.
“claim 1, as currently amended, states “the motor is configured to rotate the primary impeller and the counter impeller together in the same direction relative to the impeller housing.” Dissimilarly, Alexander appears to disclose “contra-rotating” impellers. See col. 8, lines 60-62. If the impellers are contra-rotating they cannot be rotating together in the same direction as they are rotating in opposite directions and thus must be attached to separate shafts.”
The examiner is not persuaded. Alexander also discloses not only contra-rotating impellers but many configurations of impeller or propeller systems, which as stated in Alexander Column 81 Lines 6-13 “The propellers 511 may comprise one or more radially extending blades 520 configured to transfer force to the blood flowing through the vasculature. The blades 520 can have any configuration of blades described herein. In some embodiments, the MCS 500 may comprise one or more impellers 200 described herein. The impellers 200 can have any configuration of impellers described herein.”. Additionally, Alexander Column Lines 12-14 states “In some embodiments, the at least two propellers or impellers comprises a plurality of propellers configured to rotate together.”. Therefore, the examiner maintains that Alexander teaches the claimed limitations, particularly the dual impellers being rotatable about the same rotational direction.
“Claim 12 is not anticipated by Alexander, at least because the claimed impellers are rotating together in the same rotational direction and thus cannot be contra-rotating. For at least these reasons, claim 12 is patentable over Alexander.”
The examiner is not persuaded. Alexander also discloses not only contra-rotating impellers but many configurations of impeller or propeller systems, which as stated in Alexander Column 81 Lines 6-13 “The propellers 511 may comprise one or more radially extending blades 520 configured to transfer force to the blood flowing through the vasculature. The blades 520 can have any configuration of blades described herein. In some embodiments, the MCS 500 may comprise one or more impellers 200 described herein. The impellers 200 can have any configuration of impellers described herein.”. Additionally, Alexander Column Lines 12-14 states “In some embodiments, the at least two propellers or impellers comprises a plurality of propellers configured to rotate together.”. Therefore, the examiner maintains that Alexander teaches the claimed limitations, particularly the dual impellers being rotatable about the same rotational direction.
Applicant's arguments filed 27AUG2025 regarding the rejections under 35 USC 103(a) have been fully considered and have been found to be not persuasive. Parts deemed not persuasive discussed below:
Applicant states (see Page 9 of the Remarks):
“It would not be obvious to use a pair of impellers “rotating together in_ the same direction” over Alexander’s disclosure of contra-rotating impellers, which turn “in_ opposite directions.” Especially, since the function of contra-rotating impellers is to “reduce the torque reaction.” there is no motivation to have the impellers rotate in the same direction. “
The examiner is not persuaded. Alexander also discloses not only contra-rotating impellers but many configurations of impeller or propeller systems, which as stated in Alexander Column 81 Lines 6-13 “The propellers 511 may comprise one or more radially extending blades 520 configured to transfer force to the blood flowing through the vasculature. The blades 520 can have any configuration of blades described herein. In some embodiments, the MCS 500 may comprise one or more impellers 200 described herein. The impellers 200 can have any configuration of impellers described herein.”. Additionally, Alexander Column Lines 12-14 states “In some embodiments, the at least two propellers or impellers comprises a plurality of propellers configured to rotate together.”. Therefore, the examiner maintains that Alexander teaches the claimed limitations, particularly the dual impellers being rotatable about the same rotational direction.
Duplicate claim warning
Applicant is advised that should claim 2 be found allowable, claim 13 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The claims stand as substantial duplicates because these claims are related to separate devices but are found to recite identical wording in claims 2 & 13. After review, only the term “primary impeller” from claim 2 differs from claim 13, which instead uses the term “first impeller”; and claim 13 recites a motor. All other parts of the limitations of claims 2 & 13 are identical. The terms do not differ in scope as they are used to recite the same parts of the invention, nor do the terms have meanings that affect the limitations differently.
Applicant is advised that should claim 8 be found allowable, claim 26 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The claims stand as substantial duplicates because these claims are related to separate devices but are found to recite identical wording in claims 8 & 26. After review, all parts of the limitations of claims 8 & 26 are identical. The terms do not differ in scope as they are used to recite the same parts of the invention, nor do the terms have meanings that affect the limitations differently.
Applicant is advised that should claim 10 be found allowable, claim 23 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The claims stand as substantial duplicates because these claims are related to separate devices but are found to recite identical wording in claims 10 & 23. After review, only the term “counter impeller” from claim 10 differs from claim 23, which instead uses the term “second impeller”. All other parts of the limitations of claims 10 & 23 are identical. The terms do not differ in scope as they are used to recite the same parts of the invention, nor do the terms have meanings that affect the limitations differently.
Applicant is advised that should claim 23 be found allowable, claim 28 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The claims stand as substantial duplicates because these claims are related to separate devices but are found to recite identical wording in claims 5 & 15. After review, only the term “second impeller” from claim 23 differs from claim 28, which instead uses the term “counter impeller”. All other parts of the limitations of claims 23 & 28 are identical. The terms do not differ in scope as they are used to recite the same parts of the invention, nor do the terms have meanings that affect the limitations differently.
Applicant is advised that should claim 10 be found allowable, claim 28 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The claims stand as substantial duplicates because these claims are related to separate devices but are found to recite identical wording in claims 10 & 28. After review, all parts of the limitations of claims 10 & 28 are identical. The terms do not differ in scope as they are used to recite the same parts of the invention, nor do the terms have meanings that affect the limitations differently.
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claim 27 which recites “The percutaneous circulatory support device of claim 25, wherein the primary impeller comprises a first number of impeller blades and the counter impeller comprises a second number of impeller blades, the second number of impeller blades being greater than the first number of impeller blades.” been renumbered 26.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4-8, 10-13, 22-26, & 28 are rejected under 35 U.S.C. 103(a) as being unpatentable over Alexander et al. (US Patent No. 11116959; Previously Cited).
Regarding claim 1, Alexander discloses a percutaneous circulatory support device (Alexander Abstract “Mechanical circulatory supports…percutaneously deliverable to the aorta.”), comprising: an impeller housing comprising a proximal end portion (Alexander Column 24 Lines 25-40 “The impeller 200 may be contained entirely within the casing 300.”)”); a primary impeller disposed within the impeller housing, the primary impeller being rotatable relative to the impeller housing to cause blood to flow through the percutaneous circulatory support device; and a counter impeller disposed within the impeller housing, the counter impeller being rotatable relative to the impeller housing (Alexander Column Lines 12-14 “In some embodiments, the at least two propellers or impellers comprises a plurality of propellers configured to rotate together.”) to create a turbulent barrier and thereby cause blood to flow away from the proximal end portion of the housing (Alexander Column 24 Lines 18-21 “The casing 300 may include an inlet 102 for receiving blood flow into the MCS 100, and an outlet 104 for directing exiting blood flow from the MCS 100, both extending from a main body for housing the impeller 200.”.); and a motor operatively coupled to both the primary impeller and the counter impeller such that the motor is configured to rotate the primary impeller and the counter impeller together in the same direction relative to the impeller housing (Alexander Column 9 Lines 32-37 “The at least one stator comprises one or more electromagnets positioned around the circumference of the stator. The at least one stator is configured to be positioned concentrically around the blades of the at least one propeller to electromagnetically drive rotation of the at least one magnetic blade.”; Column 10 Lines 17-18 “The at least one propeller may comprise a plurality of propellers configured to rotate together.”).
Before the effective filing date, one of ordinary skill in the art would think to combine the embodiments of Alexander to create a circulatory support device that will reduce hemolysis and having higher fluid dynamic efficiency (Alexander column 2 lines 10-14) for the purposes of reducing disruptions to heart function (Alexander Column 20 Lines 62-67) since using multiple impellers will increase device efficiency.
Regarding claim 2, claim 1 is obvious over Alexander. Alexander further discloses wherein rotating the primary impeller relative to the impeller housing causes blood to flow through the percutaneous circulatory support device (Alexander Column 6 Lines 34-42 “The impeller is configured to rotate around the longitudinal axis to pump the blood in a centrifugal manner toward the outer circumference. The support further comprises a diffuser integral with or joined to the casing, the diffuser configured to receive blood outflow from the impeller and direct the blood flow to the outlet. The diffuser is at least partially open to the internal volume of the main body of the casing along at least a portion of the outer circumference of the impeller.”).
Regarding claim 4, Alexander further discloses an impeller shaft being fixed relative to the primary impeller and the counter impeller (Alexander Column 9 Lines 32-37 “The at least one stator comprises one or more electromagnets positioned around the circumference of the stator. The at least one stator is configured to be positioned concentrically around the blades of the at least one propeller to electromagnetically drive rotation of the at least one magnetic blade.”; Column 10 Lines 17-18 “The at least one propeller may comprise a plurality of propellers configured to rotate together.”). Before the effective filing date, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine the embodiments of Alexander to configure an impeller shaft being fixed relative to the primary impeller and the counter impeller to create a circulatory support device that will reduce hemolysis and having higher fluid dynamic efficiency (Alexander column 2 lines 10-14) for the purposes of reducing disruptions to heart function (Alexander Column 20 Lines 62-67) since using multiple impellers will increase device efficiency
Regarding claim 5, Alexander further discloses a driving magnet operatively coupled to the motor and a driven magnet operatively coupled to the driving magnet, (Alexander Column 86 Lines 8-23 “ FIG. 62C illustrates a magnetic coupling 552. The magnetic coupling is illustrated between the rotor 510 and the motor 700. The rotor is the hub of the propeller and provides a location for coupling to the motor. The coupling can be any mechanical couple to transmit rotational movement from the motor to the rotor. In some embodiments, the rotor and/or propeller may be coupled to the motor by any magnetic means. In the illustrated embodiment, magnets are provided on the rotor and the motor. In some embodiments, the rotor and/or propeller may be directly rotated by the motor stator and may be referred to as part of the motor 700. For instance, magnets driven by the electromagnetic stator of the motor may be coupled to or installed within the rotor or rotors 510.”; Column 7 Lines 35-41 “The support may further comprise a motor for electromagnetically rotating the impeller around the axial direction. The motor may comprise a stator within the casing comprising a plurality of electromagnets and a rotor within the impeller comprising a plurality of permanent drive magnets, the rotor configured to be positioned concentrically within the stator.”) and the motor rotates the primary impeller and the counter impeller together, via the driving magnet and the driven magnet, relative to the impeller housing (Alexander Column 9 Lines 32-37 “The at least one stator comprises one or more electromagnets positioned around the circumference of the stator. The at least one stator is configured to be positioned concentrically around the blades of the at least one propeller to electromagnetically drive rotation of the at least one magnetic blade.”). Before the effective filing date, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine the embodiments of Alexander to configure a driving magnet operatively coupled to the motor and a driven magnet operatively coupled to the driving magnet and the motor rotates the primary impeller and the counter impeller together, via the driving magnet and the driven magnet, relative to the impeller housing, for the purpose of maximizing hydraulic efficiency, minimizing rotor RPM, and minimizing hemolysis (Alexander Column 92 Lines 16-24).
Regarding claim 6, Claims 1-2 & 5 are obvious over Alexander. Alexander further discloses wherein the counter impeller is disposed between the primary impeller and the driven magnet (Alexander Figure 60A-60G showing the multiple impeller configurations; Column 81 Lines 10-13 “In some embodiments, the MCS 500 may comprise one or more impellers 200 described herein. The impellers 200 can have any configuration of impellers described herein.”). Before the effective filing date, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine the embodiments of Alexander to configure wherein the counter impeller is disposed between the primary impeller and the driven magnet, for the purpose of replicating the velocity components of natural helical blood flow in healthy individuals (Alexander Column 48 Lines 57-60).
Regarding claim 7, Claims 1-2 & 5 are obvious over Alexander. Alexander further discloses wherein the driven magnet is disposed in the proximal end portion of the impeller housing (Alexander Column 86 Lines 8-23 “ FIG. 62C illustrates a magnetic coupling 552. The magnetic coupling is illustrated between the rotor 510 and the motor 700. The rotor is the hub of the propeller and provides a location for coupling to the motor. The coupling can be any mechanical couple to transmit rotational movement from the motor to the rotor. In some embodiments, the rotor and/or propeller may be coupled to the motor by any magnetic means. In the illustrated embodiment, magnets are provided on the rotor and the motor. In some embodiments, the rotor and/or propeller may be directly rotated by the motor stator and may be referred to as part of the motor 700. For instance, magnets driven by the electromagnetic stator of the motor may be coupled to or installed within the rotor or rotors 510.”).
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Before the effective filing date, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine the embodiments of Alexander to configure a driven magnet that is disposed in the proximal end portion of the impeller housing, for the purpose of maximizing hydraulic efficiency, minimizing rotor RPM (Alexander Column 92 Lines 16-24).
Regarding claim 8, claim 1 is obvious over Alexander. Alexander further discloses wherein the primary impeller comprises a first number of impeller blades and the counter impeller comprises a second number of impeller blades, the second number of impeller blades being greater than the first number of impeller blades (Alexander Column 83 Lines 21-23 “In some embodiments, the two or more propellers 511 have a different number of blades.” Wherein the propellers and impellers are used interchangeably by the reference, and having a different number of blades can mean that the counter impeller will have a greater amount of blades in certain configurations). Before the effective filing date, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine the embodiments of Alexander to configure wherein the primary impeller comprises a first number of impeller blades and the counter impeller comprises a second number of impeller blades, the second number of impeller blades being greater than the first number of impeller blades, for the purpose of maximizing hydraulic efficiency and minimizing hemolysis (Alexander Column 92 Lines 16-24).
Regarding claim 10, claim 1 is obvious over Alexander. Alexander further discloses wherein the impeller housing further comprises an outlet, and the outlet extends both proximally and distally beyond the counter impeller (Alexander Column 24 Lines 18-21 “The casing 300 may include an inlet 102 for receiving blood flow into the MCS 100, and an outlet 104 for directing exiting blood flow from the MCS 100, both extending from a main body for housing the impeller 200.”.).
Regarding claim 11, Claim 1 is obvious over Alexander. Alexander discloses wherein the primary impeller has a first axial length, the counter impeller has a second axial length, and the second axial length is less than the first axial length (Alexander Column 50 Lines 14-24 “In some embodiments, all of the propellers 511 may be axially spaced uniform distances from each other. In some embodiments, propellers 511 within a pair of contra-rotating propellers 512, 514 may be spaced a first distance from each other and pairs of contra-rotating propellers 512, 514 may be spaced a second distance from each. The first distance may be less than, the same, or greater than the second distance. In some embodiments, all of the propellers 511 may be spaced variable distances from each other or the spacing may comprise a configuration of the various patterns disclosed herein.”). Before the effective filing date, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine the embodiments of Alexander to configure wherein the primary impeller has a first axial length, the counter impeller has a second axial length, and the second axial length is less than the first axial length, for the purpose of decreasing weight and size of the device and increasing efficiency (Alexander Column 37 Lines 45-67 - Column 38 Lines 1-3).
Regarding claim 12, Alexander discloses a percutaneous circulatory support device (Alexander Abstract “Mechanical circulatory supports…percutaneously deliverable to the aorta.”), comprising: an impeller housing comprising a proximal end portion (Alexander Column 24 Lines 25-40 “The impeller 200 may be contained entirely within the casing 300.”)”); a primary impeller disposed within the impeller housing, the primary impeller being rotatable relative to the impeller housing to cause blood to flow through the percutaneous circulatory support device; and a counter impeller disposed within the impeller housing, the counter impeller being rotatable relative to the impeller housing(Alexander Column Lines 12-14 “In some embodiments, the at least two propellers or impellers comprises a plurality of propellers configured to rotate together.”) to create a turbulent barrier and thereby cause blood to flow away from the proximal end portion of the housing (Alexander Column 24 Lines 18-21 “The casing 300 may include an inlet 102 for receiving blood flow into the MCS 100, and an outlet 104 for directing exiting blood flow from the MCS 100, both extending from a main body for housing the impeller 200.”.). wherein the first impeller and the second impeller are configured to rotate together in the same rotational direction relative to the impeller housing (Alexander Column 9 Lines 32-37 “The at least one stator comprises one or more electromagnets positioned around the circumference of the stator. The at least one stator is configured to be positioned concentrically around the blades of the at least one propeller to electromagnetically drive rotation of the at least one magnetic blade.”; Column 10 Lines 17-18 “The at least one propeller may comprise a plurality of propellers configured to rotate together.”).
Before the effective filing date, one of ordinary skill in the art would think to combine the embodiments of Alexander to create a circulatory support device that will reduce hemolysis and having higher fluid dynamic efficiency (Alexander column 2 lines 10-14) for the purposes of reducing disruptions to heart function (Alexander Column 20 Lines 62-67) since using multiple impellers will increase device efficiency.
Regarding claims 13, claim 12 is obvious over Alexander. Alexander further discloses a motor operatively coupled to the primary impeller and rotating the primary impeller relative to the impeller housing to cause blood to flow through the percutaneous circulatory support device (Alexander Column 9 Lines 32-37 “The at least one stator comprises one or more electromagnets positioned around the circumference of the stator. The at least one stator is configured to be positioned concentrically around the blades of the at least one propeller to electromagnetically drive rotation of the at least one magnetic blade.”; Column 10 Lines 17-18 “The at least one propeller may comprise a plurality of propellers configured to rotate together.”).
Regarding claim 22, Claim 12 is obvious over Alexander. Alexander further discloses wherein the first impeller comprises a first number of impeller blades and the second impeller comprises a second number of impeller blades, the second number of impeller blades being greater than the first number of impeller blades. the primary impeller comprises a first number of impeller blades and the counter impeller comprises a second number of impeller blades, the second number of impeller blades being greater than the first number of impeller blades (Alexander Column 83 Lines 21-23 “In some embodiments, the two or more propellers 511 have a different number of blades.” Wherein the propellers and impellers are used interchangeably by the reference, and having a different number of blades can mean that the counter impeller will have a greater amount of blades in certain configurations). Before the effective filing date, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine the embodiments of Alexander to configure wherein the primary impeller comprises a first number of impeller blades and the counter impeller comprises a second number of impeller blades, the second number of impeller blades being greater than the first number of impeller blades, for the purpose of maximizing hydraulic efficiency and minimizing hemolysis (Alexander Column 92 Lines 16-24).
Regarding claim 23, claim 12 is obvious over Alexander. Alexander further discloses wherein the impeller housing further comprises an outlet, and the outlet extends both proximally and distally beyond the second impeller (Alexander Column 24 Lines 18-21 “The casing 300 may include an inlet 102 for receiving blood flow into the MCS 100, and an outlet 104 for directing exiting blood flow from the MCS 100, both extending from a main body for housing the impeller 200.”.).
Regarding claim 24, Claim 12 is obvious over Alexander. Alexander further discloses wherein the primary impeller has a first axial length, the counter impeller has a second axial length, and the second axial length is less than the first axial length (Alexander Column 50 Lines 14-24 “In some embodiments, all of the propellers 511 may be axially spaced uniform distances from each other. In some embodiments, propellers 511 within a pair of contra-rotating propellers 512, 514 may be spaced a first distance from each other and pairs of contra-rotating propellers 512, 514 may be spaced a second distance from each. The first distance may be less than, the same, or greater than the second distance. In some embodiments, all of the propellers 511 may be spaced variable distances from each other or the spacing may comprise a configuration of the various patterns disclosed herein.”). Before the effective filing date, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine the embodiments of Alexander to configure wherein the primary impeller has a first axial length, the counter impeller has a second axial length, and the second axial length is less than the first axial length, for the purpose of decreasing weight and size of the of the device and increasing efficiency (Alexander Column 37 Lines 45-67 - Column 38 Lines 1-3).
Regarding claim 25, Alexander further discloses A percutaneous circulatory support device (Alexander Abstract “Mechanical circulatory supports…percutaneously deliverable to the aorta.”), comprising: an impeller housing comprising a proximal end portion (Alexander Column 24 Lines 25-40 “The impeller 200 may be contained entirely within the casing 300.”)”); a primary impeller disposed within the impeller housing, the primary impeller being rotatable relative to the impeller housing to cause blood to flow through the percutaneous circulatory support device; a counter impeller disposed within the impeller housing, the counter impeller being rotatable relative to the impeller housing (Alexander Column Lines 12-14 “In some embodiments, the at least two propellers or impellers comprises a plurality of propellers configured to rotate together.”) to create a turbulent barrier and thereby cause blood to flow away from the proximal end portion of the housing (Alexander Column 24 Lines 18-21 “The casing 300 may include an inlet 102 for receiving blood flow into the MCS 100, and an outlet 104 for directing exiting blood flow from the MCS 100, both extending from a main body for housing the impeller 200.”.); and an impeller shaft being fixed relative to both the primary impeller and the counter impeller such that rotation of the impeller shaft in a first rotational direction rotates both the primary impeller and the counter impeller in the first rotational direction. (Alexander Column 9 Lines 32-37 “The at least one stator comprises one or more electromagnets positioned around the circumference of the stator. The at least one stator is configured to be positioned concentrically around the blades of the at least one propeller to electromagnetically drive rotation of the at least one magnetic blade.”; Column 10 Lines 17-18 “The at least one propeller may comprise a plurality of propellers configured to rotate together.”).
Before the effective filing date, one of ordinary skill in the art would think to combine the embodiments of Alexander to create a circulatory support device that will reduce hemolysis and having higher fluid dynamic efficiency (Alexander column 2 lines 10-14) for the purposes of reducing disruptions to heart function (Alexander Column 20 Lines 62-67) since using multiple impellers will increase device efficiency.
Regarding claim 26, Claim 25 is obvious over Alexander. Alexander further discloses wherein the primary impeller comprises a first number of impeller blades and the counter impeller comprises a second number of impeller blades, the second number of impeller blades being greater than the first number of impeller blades (Alexander Column 83 Lines 21-23 “In some embodiments, the two or more propellers 511 have a different number of blades.” Wherein the propellers and impellers are used interchangeably by the reference, and having a different number of blades can mean that the counter impeller will have a greater amount of blades in certain configurations). Before the effective filing date, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine the embodiments of Alexander to configure wherein the primary impeller comprises a first number of impeller blades and the counter impeller comprises a second number of impeller blades, the second number of impeller blades being greater than the first number of impeller blades, for the purpose of maximizing hydraulic efficiency and minimizing hemolysis (Alexander Column 92 Lines 16-24).
Regarding claim 28, claim 25 is obvious over Alexander. Alexander further discloses wherein the impeller housing further comprises an outlet, and the outlet extends both proximally and distally beyond the counter impeller. (Alexander Column 24 Lines 18-21 “The casing 300 may include an inlet 102 for receiving blood flow into the MCS 100, and an outlet 104 for directing exiting blood flow from the MCS 100, both extending from a main body for housing the impeller 200.”.).
Claims 9, 21, & 27 are rejected under 35 U.S.C. 103(a) as being unpatentable over Alexander et al. (US Patent No. 11116959; Previously Cited) in view of Peters et al (US Publication No. 20120310036).
Regarding claim 9, claim 1 is obvious over Alexander. Alexander does not further disclose wherein the primary impeller comprises a plurality of first impeller blades and the counter impeller comprises a plurality of second impeller blades, the second impeller blades having the opposite pitch than the first impeller blades. Peters in a similar field of endeavor of blood pumps teaches wherein the primary impeller comprises a plurality of first impeller blades and the counter impeller comprises a plurality of second impeller blades, the second impeller blades having the opposite pitch than the first impeller blades (Peters Figure 6 (seen below) described in ¶0078 that two halves of a total blood pump will have an opposite or disproportional pitch (4) on impellers (3) of the left and right side.).
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Before the effective filing date, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine the pump of Alexander with Peter’s impeller blade configuration to configure wherein the primary impeller comprises a plurality of first impeller blades and the counter impeller comprises a plurality of second impeller blades, the second impeller blades having the opposite pitch than the first impeller blades, for the purpose of minimizing flow turbulence which reduces hemolysis (Alexander Column 4 Lines 23-25).
Regarding claim 21, claim 12 is obvious over Alexander. Alexander does not further disclose wherein the primary impeller comprises a plurality of first impeller blades and the counter impeller comprises a plurality of second impeller blades, the second impeller blades having the opposite pitch than the first impeller blades. Peters in a similar field of endeavor of blood pumps teaches wherein the primary impeller comprises a plurality of first impeller blades and the counter impeller comprises a plurality of second impeller blades, the second impeller blades having the opposite pitch than the first impeller blades (Peters Figure 6 (seen below) described in ¶0078 that two halves of a total blood pump will have an opposite or disproportional pitch (4) on impellers (3) of the left and right side.).
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Before the effective filing date, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine the pump of Alexander with Peter’s impeller blade configuration to configure wherein the primary impeller comprises a plurality of first impeller blades and the counter impeller comprises a plurality of second impeller blades, the second impeller blades having the opposite pitch than the first impeller blades, for the purpose of minimizing flow turbulence which reduces hemolysis (Alexander Column 4 Lines 23-25).
Regarding claim 27, claim 25 is obvious over Alexander. Alexander does not further disclose wherein the primary impeller comprises a plurality of first impeller blades and the counter impeller comprises a plurality of second impeller blades, the second impeller blades having the opposite pitch than the first impeller blades. Peters in a similar field of endeavor of blood pumps teaches wherein the primary impeller comprises a plurality of first impeller blades and the counter impeller comprises a plurality of second impeller blades, the second impeller blades having the opposite pitch than the first impeller blades (Peters Figure 6 (seen below) described in ¶0078 that two halves of a total blood pump will have an opposite or disproportional pitch (4) on impellers (3) of the left and right side.).
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Before the effective filing date, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine the pump of Alexander with Peter’s impeller blade configuration to configure wherein the primary impeller comprises a plurality of first impeller blades and the counter impeller comprises a plurality of second impeller blades, the second impeller blades having the opposite pitch than the first impeller blades, for the purpose of minimizing flow turbulence which reduces hemolysis (Alexander Column 4 Lines 23-25).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/MEGAN T FEDORKY/
Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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