DETAILED ACTION
This Office Action supersedes the Office Action filed 05/05/2026. The Non-Final Office Action filed 05/05/2026 is hereby withdrawn, and a replacement Non-Final Rejection is provided herein.
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 .
Election/Restrictions
Newly submitted claim 24 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claim 24 is directed to a heart-pump apparatus and to distinct subject matter. Claim 24 introduces new subject matter that didn’t previously exist in the claims, such as (1) the impeller housing defining a volute and (2) a self-expandable frame being radially compressible for receipt within a delivery sheath and self-expandable upon release from the delivery sheath.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 24 withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
Applicant’s arguments, see claims 7-8, filed 08/05/2026, with respect to 35 U.S.C. 112(a) and 112(b) rejections have been fully considered and are persuasive. The 35 U.S.C. 112(a) and 112(b) rejections have been obviated by amendments to the claims. The 35 U.S.C. 112(a) and 112(b) rejections have been withdrawn.
Applicant’s arguments, see pages 8-17, filed 08/05/2026, with respect to the rejections of claims 1-20 under 35 U.S.C. 102 have been fully considered and are persuasive. In particular, the Applicant’s argument that Tuval does not teach “the motor housing is configured to generate the magnetic field that rotates the impeller” is found persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Mitze, et al. (US 2022/0161019 – cited on IDS) and Muller, et al. (US 2018/0021495 – cited on IDS). Please see 35 U.S.C. 102 and 103 rejections hereinbelow.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-8, 10, 12, 15-18, and 21-22 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Mitze, et al. (US 2022/0161019 – cited on IDS).
Regarding claim 1, Mitze teaches a heart pump system (Title; Abstract), comprising:
(Fig. 4, # 402 – elongate tubular body, i.e. cannula) a cannula (Par. [0075]) comprising a (Fig. 11, # 1100 + 1110 of 710 – sensor head unit and first connecting element of inlet tube 710, i.e. ventricle interface; Fig. 9, # 904 – impeller housing) ventricle interface coupled to an impeller housing (Par. [0103]; Par. [0133]), (Figs. 7, 8a, 9e) the impeller housing coupled to a conduit (e.g., Par. [0079]), (Fig. 7 and 8a, # 712 – impeller) the impeller housing comprising an impeller (e.g., Par. [0083]), (Fig. 9, # 944 – second magnet array, i.e. impeller driver magnets) the ventricle interface comprising impeller driver magnets (e.g., Par. [0097]), the impeller driver magnets configured to rotate the impeller in a presence of a magnetic field (Par. [0097] – The impeller 712 may include the second magnet array 944 (or driven magnet array) in the form of, for example, a hollow cylinder mounted to rotate about the first axis 912; Pars. [0100-0101]; Par. [0110] – The second magnet array 944 may be mounted such that it can rotate about the axis 912.); and
(Fig. 7, # 714) a motor housing comprising a motor (Par. [0083] – the impeller 712 is rotationally driven by a motor contained within motor housing 714) and (Fig. 9, # 942 – first/drive magnet array) motor magnets (e.g., Par. [0094]), the motor coupled to the motor magnets and configured to rotate the motor magnets (Par. [0094] – a first magnet array 942 (or drive magnet array) may be seated on a shaft 958 that can be driven by a motor; Par. [0110] – The first magnet array 942 may be seated on the shaft 958 driven by the motor (not shown), where the shaft 958 may rotate about the axis 912 ... The second magnet array 944 may be mounted such that it can rotate about the axis 912.), wherein (Figs. 9B-C) the motor housing is configured to generate the magnetic field that rotates the impeller (Par. [0094]; Par. [0110]; Par. [0111] – The second magnet array 944 may include four tangentially magnetized magnet ring segments 981 between the four radial segments 982, which can guide the magnetic field generated around the second magnet array 944. … and may increase the efficiency of the magnetic coupling between the first magnet array 942 and the second magnet array 944).
Therefore, claim 1 is unpatentable over Mitze, et al.
Regarding claim 2, Mitze teaches the heart pump system of claim 1, wherein (Figs. 7 and 9, # 712) the impeller comprises a centrifugal impeller (Par. [0103] - when the impeller 712 spins, liquid (for example, blood) is centrifugally expelled from the bores 956) or an axial impeller.
Therefore, claim 2 is unpatentable over Mitze, et al.
Regarding claim 3, Mitze teaches the heart pump system of claim 1, wherein (Fig. 9, # 958) the motor housing is configured to rotate the impeller with the motor without contacting the ventricle interface (e.g., Par. [0110]; The impeller is driven by the motor within the motor housing that is spaced remotely from the ventricle interface by shaft 958).
Therefore, claim 3 is unpatentable over Mitze, et al.
Regarding claim 5, Mitze teaches the heart pump system of claim 1, further comprising:
(Fig. 9, # 940 – housing, i.e. bottom part considered a plate) a plate comprising a first side (i.e., side facing the impeller, Fig. 9) and a second side (i.e., side facing shaft 958) with an impeller driver connector on the second side (i.e., cylindrical wall of 940), (Fig. 9, # 940, 942, 944) the impeller driver connector configured to align the impeller driver magnets of the ventricle interface with the motor magnets of the motor housing when the motor housing is placed alongside the first side (e.g., Par. [0110]).
Therefore, claim 5 is unpatentable over Mitze, et al.
Regarding claim 6, Mitze teaches the heart pump system of claim 1, wherein (Figs. 4, 7, 11; 710 is integral to 100/402) the conduit comprises a spiral conduit (Par. [0136] – The inlet tube 710 may include a guide cannula 1150, which at least partially has a structure or a surface structured at least partially along an extension direction. In some embodiments, the guide cannula 1150 can have a spiral-shaped surface structure.).
Therefore, claim 6 is unpatentable over Mitze, et al.
Regarding claim 7, Mitze teaches the heart pump system of claim 1, wherein (Fig. 7, # 710) the ventricle interface is coupled to the cannula through a flexible shaft (Par. [0082] – The inlet tube 710 may comprise a highly flexible slotted (e.g., laser cut) metal (e.g., Nitinol) tube having a polymeric (e.g., Polyurethane) tubular layer to isolate the flow path.).
Therefore, claim 7 is unpatentable over Mitze, et al.
Regarding claim 8, Mitze teaches the heart pump system of claim 6, wherein the cannula comprises: (Figs. 7 and 9, # 712) a centrifugal impeller (Par. [0103] - when the impeller 712 spins, liquid (for example, blood) is centrifugally expelled from the bores 956); and (Fig. 9, # 922 – second housing, i.e. stabilizer) a stabilizer (Par. [0123] – The combined axial and radial bearing 930 may be arranged on the end (for example, a distal end) of the tapered portion 902 of the impeller 712 facing away from housing 940. The combined bearing 930 may be arranged between the impeller 712 and the insert 926, which may be fastened to (or clamped into) a ring-shaped end of the second housing 922, which is in turn fastened to the housing 940. The ball 916 may be arranged on the end (for example, a distal end) of the tapered portion 902 of the impeller 712 and pressed onto a cone 918 arranged on or attached to the insert 926) coupled to the centrifugal impeller (Figs. 9 and 14; Par. [0123]; Par. [0145]).
Therefore, claim 8 is unpatentable over Mitze, et al.
Regarding claim 10, Mitze teaches the heart pump system of claim 1, wherein (Fig. 3, # 324) the conduit comprises a valve at an end of the conduit opposite the impeller (Par. [0076] – The hub 324 may additionally be provided with a hemostasis valve).
Therefore, claim 10 is unpatentable over Mitze, et al.
Regarding claim 12, Mitze teaches the heart pump system of claim 1, wherein (Fig. 11, #1100 – sensor head unit) the cannula comprises one or more of a plurality of physiological sensors (Pars. [0133-0134]).
Therefore, claim 12 is unpatentable over Mitze, et al.
Regarding claim 15, Mitze teaches (Fig. 4) an apparatus (Title; Abstract), comprising:
(Fig. 4, # 402 – elongate tubular body, i.e. cannula) a cannula (Par. [0075]) comprising (Fig. 11, # 1100 + 1110 of 710 – sensor head unit and first connecting element of inlet tube 710, i.e. ventricle interface; Fig. 9, # 904 – impeller housing) a ventricle interface coupled to an impeller housing (Par. [0103]; Par. [0133]), (Figs. 7, 8a, 9e) the impeller housing coupled to a conduit (e.g., Par. [0079]), (Fig. 7 and 8a, # 712 – impeller) the impeller housing comprising an impeller (e.g., Par. [0083]) coupled (Fig. 9, # 944 – second magnet array, i.e. impeller driver magnets) to impeller driver magnets (e.g., Par. [0097]),
(Fig. 9, # 944 – second magnet array, i.e. impeller driver magnets) the ventricle interface comprising the impeller driver magnets (e.g., Par. [0097]), (Figs. 9B-C) the impeller driver magnets configured to rotate the impeller in a presence of a magnetic field (Par. [0097] – The impeller 712 may include the second magnet array 944 (or driven magnet array) in the form of, for example, a hollow cylinder mounted to rotate about the first axis 912; Pars. [0100-0101]; Par. [0110] – The second magnet array 944 may be mounted such that it can rotate about the axis 912.; Par. [0111] – The second magnet array 944 may include four tangentially magnetized magnet ring segments 981 between the four radial segments 982, which can guide the magnetic field generated around the second magnet array 944. … and may increase the efficiency of the magnetic coupling between the first magnet array 942 and the second magnet array 944).
Therefore, claim 15 is unpatentable over Mitze, et al.
Regarding claim 16, Mitze teaches the apparatus of claim 15, further comprising (Fig. 7, # 710) a flexible shaft coupled to the ventricle interface (Par. [0082] – The inlet tube 710 may comprise a highly flexible slotted (e.g., laser cut) metal (e.g., Nitinol) tube having a polymeric (e.g., Polyurethane) tubular layer to isolate the flow path.).
Therefore, claim 16 is unpatentable over Mitze, et al.
Regarding claim 17, Mitze teaches the apparatus of claim 15, wherein the cannula comprises (Fig. 9, # 922 – second housing, i.e. stabilizer) a stabilizer (Par. [0123] – The combined axial and radial bearing 930 may be arranged on the end (for example, a distal end) of the tapered portion 902 of the impeller 712 facing away from housing 940. The combined bearing 930 may be arranged between the impeller 712 and the insert 926, which may be fastened to (or clamped into) a ring-shaped end of the second housing 922, which is in turn fastened to the housing 940. The ball 916 may be arranged on the end (for example, a distal end) of the tapered portion 902 of the impeller 712 and pressed onto a cone 918 arranged on or attached to the insert 926) coupled to the impeller (Figs. 9 and 14; Par. [0123]; Par. [0145]).
Therefore, claim 17 is unpatentable over Mitze, et al.
Regarding claim 18, Mitze teaches the apparatus of claim 15, wherein (Fig. 7, # 710) the ventricle interface is coupled to the cannula through a flexible shaft (Par. [0082] – The inlet tube 710 may comprise a highly flexible slotted (e.g., laser cut) metal (e.g., Nitinol) tube having a polymeric (e.g., Polyurethane) tubular layer to isolate the flow path.), and the cannula comprises: (Figs. 7 and 9, # 712) a centrifugal impeller (Par. [0103] - when the impeller 712 spins, liquid (for example, blood) is centrifugally expelled from the bores 956); and (Fig. 9, # 922 – second housing, i.e. stabilizer) a stabilizer (Par. [0123] – The combined axial and radial bearing 930 may be arranged on the end (for example, a distal end) of the tapered portion 902 of the impeller 712 facing away from housing 940. The combined bearing 930 may be arranged between the impeller 712 and the insert 926, which may be fastened to (or clamped into) a ring-shaped end of the second housing 922, which is in turn fastened to the housing 940. The ball 916 may be arranged on the end (for example, a distal end) of the tapered portion 902 of the impeller 712 and pressed onto a cone 918 arranged on or attached to the insert 926) coupled to the centrifugal impeller (Figs. 9 and 14; Par. [0123]; Par. [0145]).
Therefore, claim 18 is unpatentable over Mitze, et al.
Regarding claim 21, Mitze teaches the heart pump system of claim 1, wherein (Fig. 7, # 706, 708, 712, 714, 750) the conduit comprises an inflow conduit and an outflow conduit, the inflow conduit coupled to the impeller housing (e.g., Par. [0079]; inlets 706 and outlets 708 indicative of inflow and outflow conduits).
Therefore, claim 21 is unpatentable over Mitze, et al.
Regarding claim 22, Mitze teaches the apparatus of claim 15, wherein (Fig. 7, # 706, 708, 712, 714, 750) the conduit comprises an inflow conduit and an outflow conduit, the inflow conduit coupled to the impeller housing (e.g., Par. [0079]; inlets 706 and outlets 708 indicative of inflow and outflow conduits).
Therefore, claim 22 is unpatentable over Mitze, et al.
Claims 1 and 11 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Muller, et al. (US 2018/0021495 – cited on IDS).
Regarding claim 1, Muller teaches a heart pump system (Title; Abstract), comprising:
(Fig. 1, # 101 – catheter assembly, i.e. cannula) a cannula (Par. [0040]) comprising (Fig. 1B, # 116A – impeller assembly, i.e. ventricle interface, 1401 – primer housing, i.e. impeller housing, 1404) a ventricle interface coupled to an impeller housing (Par. [0048]), (Fig. 1B) the impeller housing coupled to a conduit (Pars. [0039-0040]), (Fig. 1B, # 116A) the impeller housing comprising an impeller (Par. [0040] – an impeller in an impeller assembly 116A), (Figs. 1-4) the ventricle interface comprising impeller driver magnets (Par. [0060] – For example, the stator assembly 2 can comprise a stator and a plurality of conductive windings producing a controlled magnetic field), the impeller driver magnets configured to rotate the impeller in a presence of a magnetic field (Par. [0060] – Providing changing electrical currents through the windings of the stator assembly 2 can create magnetic fields that interact with the rotor 15 to cause the rotor 15 to rotate; Par. [0061] – drive shaft 16 extends distally through an internal lumen of the catheter body 120A. A distal end portion of the drive shaft 16 is mechanically connected with the impeller. Thus, rotation of the rotor 15 causes the output shaft 13 to rotate, which, in turn, causes the drive shaft 16 and the impeller to rotate.); and
(Fig. 1B, # 1) a motor housing comprising a motor (Par. [0041] – the housing in which the motor 1 … is disposed) and motor magnets (Par. [0060] – The rotor 15 can comprise a magnetic material, e.g., can include one or more permanent magnets), the motor coupled to the motor magnets and configured to rotate the motor magnets, wherein the motor housing is configured to generate the magnetic field that rotates the impeller (Par. [0060] – Providing changing electrical currents through the windings of the stator assembly 2 can create magnetic fields that interact with the rotor 15 to cause the rotor 15 to rotate; Par. [0061] – drive shaft 16 extends distally through an internal lumen of the catheter body 120A. A distal end portion of the drive shaft 16 is mechanically connected with the impeller. Thus, rotation of the rotor 15 causes the output shaft 13 to rotate, which, in turn, causes the drive shaft 16 and the impeller to rotate.).
Therefore, claim 1 is unpatentable over Muller, et al.
Regarding claim 11, Muller teaches the heart pump system of claim 1, wherein the motor housing is positioned extracorporeally and replaced or removed (Par. [0038] – the disclosed motor assembly is disposed outside the patient in some embodiments).
Therefore, claim 11 is unpatentable over Muller, et al.
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Mitze, et al. (US 2022/0161019 – cited on IDS) in view of Wampler (U.S. PGPub No. 2016/0144087).
Regarding claim 4, Mitze teaches the heart pump system of claim 1, as indicated hereinabove. Mitze does not teach the limitation of instant claim 4, that is wherein the motor housing comprises a battery coupled to the motor, and wherein energy stored in the battery is used to rotate the impeller.
Wampler teaches a heart assist device having a rotary pump housing having a motor and an impeller (Title, Abstract). Wampler teaches the limitation of instant claim 4, that is wherein (Figs. 1A, # 20, 30 – motor and rechargeable battery) the motor housing comprises a battery coupled to the motor, and wherein energy stored in the battery is used to rotate the impeller (Par. [0094] – As shown schematically in FIG. 1B, power is supplied to the pump 20 via a percutaneous wire 32 from an externally worn motor controller and rechargeable battery system 30.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented Wampler’s motor and rechargeable battery into Mitze’s heart pump system because doing so would be an example of applying a known technique to a known device ready for improvement to yield predictable results. One of ordinary skill in the art would have desired using a battery to avoid needing additional wires to connect to a power source, and to make the whole device more compact with less components.
Therefore, claim 4 is unpatentable over Mitze, et al. and Wampler.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Mitze, et al. (US 2022/0161019 – cited on IDS) in view of Muller, et al. (US 2018/0021495 – cited on IDS).
Regarding claim 9, Mitze teaches the heart pump system of claim 1, as indicated hereinabove. Mitze does teach (Fig. 5, # 506) an expandable tubular body for an introducer tool 400 (Par. [0078]), but does not explicitly teach the limitation of instant claim 9, that is wherein the cannula comprises a self- expandable cannula.
Muller, directed to analogous art, teaches catheter pumps for mechanical circulatory support of a heart (Par. [0002]). Muller also teaches the limitation of instant claim 9, that is wherein (Fig. 1A, # 116A) the cannula comprises a self- expandable cannula (Par. [0015] – The catheter pump system can include a cannula in which the working element is disposed, the cannula and impeller expandable from a stored configuration to a deployed configuration; Par. [0043] – impeller assembly 116A (e.g., the impeller and cannula) can be expandable and collapsible).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented the self-expandable feature of Muller’s cannula into Mitze’s cannula because doing so would be an example of using a known technique to improve similar devices in the same way. One of ordinary skill in the art would desire a self-expandable cannula in order for the cannula to be in a collapsed state when it is advanced through the heart and in an expanded state when it is in place in the heart in order to pump blood at relatively high rate (Par. [0043]).
Therefore, claim 9 is unpatentable over Mitze, et al. and Muller, et al.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Mitze, et al. (US 2022/0161019 – cited on IDS) in view of Kracker (US 2021/0178037).
Regarding claim 13, Mitze teaches the heart pump system of claim 12 as indicated hereinabove. Mitze does teach (Fig. 11, # 1100) a sensor head unit including a number of sensors for measuring pressure and/or temperature (Pars. [0133-0134]). Mitze further teaches (Fig. 2, # 200; Fig. 11, # 100, 1100, 1140) that the MCS device can be connected to an external evaluation or control device (for example, the MCS controller 200 shown in Fig. 2) (Par. [0135]). However, Mitze does not explicitly teach the limitation of instant claim 13, that is wherein the motor housing comprises a processor configured to perform steps comprising:
receiving, from the physiological sensor, a physiological measurement value;
determining, by the processor, whether the physiological measurement value is below a threshold; and
adjusting, by the processor, a speed of the motor based on determining that the physiological measurement value is below the threshold.
Kracker, directed to analogous art, teaches an intra-ventricular pulsatile assist system (Title; Abstract). Kracker also teaches the limitation of instant claim 13, that is wherein (Figs. 1 and 8, # 60, 62, 66, 68) the motor housing comprises a processor (Par. [0060]) configured to perform steps comprising:
(Fig. 2, # 31; Fig. 8, # 68) receiving, from the physiological sensor, a physiological measurement value (Par. [0065] – The processing circuitry 68 is configured to determine the amount of fluid in the chamber 20, for example using the sensor 31 (FIG. 2));
(Fig. 11; Fig. 14, # 76) determining, by the processor, whether the physiological measurement value is below a threshold (Par. [0067] – At step 76…); and
(Fig. 11; Fig. 14, # 78) adjusting, by the processor, a speed of the motor based on determining that the physiological measurement value is below the threshold (Pars. [0065-0066]; Par. [0067] – At step 78…).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented Kracker’s processor and method steps into Mitze’s heart pump system, because doing so would be an example of applying a known technique to a known device ready for improvement to yield predictable results. As mentioned, Mitze does teach using sensed data for external evaluation and control, and so one of ordinary skill in the art would be motivated to implement Kracker’s processor for evaluation and control into Mitze’s device. One of ordinary skill in the art would have desired such adjustment of speed of the motor in order to adjust the power of the blood pump relative to a patient’s remaining heart activity, which could result in less weaning time (i.e., off of the heart pump) for patients (see Par. [0004] of Kracker).
Therefore, claim 13 is unpatentable over Mitze, et al. and Kracker.
Regarding claim 14, Mitze, in view of Kracker, renders obvious the heart pump system of claim 13, as indicated hereinabove. Kracker also teaches the limitations of instant claim 14, that is wherein the processor is configured to perform steps comprising:
(Fig. 11) receiving, from the physiological sensor, a first physiological measurement value;
receiving, from the physiological sensor, a second physiological measurement value;
determining, by the processor, a historical value based on the first physiological measurement value and the second physiological measurement value; and
determining, by the processor, the threshold based on the historical value (Par. [0066] – The target pressure value in the chamber may be determined using one or more pressure values associated with the patient and/or the system 10; Par. [0068] – the predetermined threshold value is a target pressure value for the chamber 20. … the system 10 may determine the target pressure value in the chamber 20 using, as shown in FIG. 13, the sensor 31 in communication with the chamber 20.).
Therefore, claim 14 is unpatentable over Mitze, et al. and Kracker.
Claims 19-20 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Muller, et al. (US 2018/0021495 – cited on IDS) in view of Garrigue (US 2014/0207232 – cited on IDS).
Regarding claim 19, Muller teaches a method (Par. [0016]), comprising:
accessing a chest cavity of an individual by surgical incision […](Par. [0008] – a blood pump that can be placed minimally-invasively, for example, through an 18 FR, 14 FR, or 8 FR incision.);
(Fig. 1B, # 101) implanting a cannula within a heart through the chest cavity (Par. [0040]), (Fig. 1B, # 116A – impeller assembly, i.e. ventricle interface, 1401 – primer housing, i.e. impeller housing) the cannula comprising a ventricle interface coupled to an impeller housing (Par. [0048]), (Fig. 1B, # 116A) the impeller housing comprising an impeller (Par. [0040] – an impeller in an impeller assembly 116A) coupled (Figs. 1-4) to impeller driver magnets (Pars. [0060-0061]; An impeller is coupled to drive shaft 16, which is coupled to the rotor comprising magnetic material; drive shaft extends distally through an internal lumen of the catheter body 120a. A distal end portion of the drive shaft 16 extends distally through an internal lumen of the catheter body 120A. A distal end portion of the drive shaft 16 is mechanically connected with the impeller … rotation of the rotor 15 causes the output shaft 13 to rotate, which, in turn, causes the drive shaft 16 and the impeller to rotate; Par. [0079] – rotor can comprise a magnetic material); and
(Figs. 1B-C, # 1) coupling a motor housing (Par. [0041] – the housing in which the motor 1… is disposed) outside of the individual (Par. [0038] – the disclosed motor assembly is disposed outside the patient in some embodiments) to the ventricle interface of the cannula for rotating the impeller by application of a magnetic field that rotates the impeller driver magnets (Par. [0060] – the stator assembly 2 can create magnetic fields that interact with the rotor 15 to cause the rotor 15 to rotate; Par. [0061]; drive shaft 16 extends distally through an internal lumen of the catheter body 120A. A distal end portion of the drive shaft 16 is mechanically connected with the impeller … rotation of the rotor 15 causes the output shaft 13 to rotate, which, in turn, causes the drive shaft 16 and the impeller to rotate).
Muller does not explicitly teach the limitation of instant claim 19, that is wherein the surgical incision is of the chest wall.
Garrigue, directed to analogous art, teaches a removable heart pump (Title; Abstract). Garrigue also teaches the limitation of instant claim 19, that is wherein the surgical incision is of the chest wall (Par. [0051] – a mini-thoracotomy (surgical incision)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented Garrigue’s teaching of a chest incision into Muller’s method because doing so would yield the predictable result of minimally-invasively accessing a chest cavity to place a heart pump.
Therefore, claim 19 is unpatentable over Muller, et al. and Garrigue.
Regarding claim 20, Muller, in view of Garrigue, renders obvious the method of claim 19, as indicated hereinabove. Muller also teaches the limitation of instant claim 20, that is wherein (Fig. 1A) the cannula is advanced within the heart through a target cardiac valve (Par. [0039] and [0042]).
Therefore, claim 20 is unpatentable over Muller, et al. and Garrigue.
Regarding claim 23, Muller, in view of Garrigue, renders obvious the method of claim 19, as indicated hereinabove. Muller also teaches the limitation of instant claim 23, that is wherein the method is further comprising:
(Fig. 1A, # 100A) drawing blood from the ventricle through an inflow passage defined by an inflow conduit of the cannula; and
discharging blood through an outflow passage defined by an outflow conduit of the cannula, the outflow passage being distinct from the inflow passage (Par. [0042] – A distal portion of the pump 100A including a catheter assembly including the impeller assembly 116A is placed in the left ventricle (LV) of the heart to pump blood from the LV into the aorta).
Therefore, claim 23 is unpatentable over Muller, et al. and Garrigue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL TAYLOR HOLTZCLAW whose telephone number is (571)272-6626. The examiner can normally be reached Monday-Friday (7:30 a.m.-5:00 p.m. EST).
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/MICHAEL T. HOLTZCLAW/Primary Examiner, Art Unit 3796
