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 .
Response to Amendment
The amendment filed July 27, 2026 has been entered. Claims 1-29 remain pending in the application. Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection, and 112 rejections previously set forth in the Non-Final Office Action mailed Feb. 26, 2026.
Response to Arguments
Drawings:
Applicant amended drawings and addressed all previous objections, and the drawing objections have been withdrawn.
Specification:
Applicant amended specification and addressed all previous objections, and the specification objections have been withdrawn.
Claim Objections:
Applicant amended claims and addressed all previous objections, and the claim objections have been withdrawn.
35 U.S.C. § 112:
Applicant amended claims and addressed all previous 112 rejections, and the 112 rejections have been withdrawn.
35 U.S.C. § 102/103:
Applicant’s amendments and arguments, see pg. 12, filed July 27, 2026, with respect to Muller and Beekman have overcome the previous 35 USC 102 rejections from the Feb. 26, 2026 Office Action. Examiner agrees that Muller and Beekman alone do not teach the claimed configuration. A new 35 USC 103 rejection below is being applied using Beekman in light of the amendments to the claim.
Claim Objections
Claim 29 is objected to because of the following informalities: the word “the” should be added before “motor” in the last line. Appropriate correction is required.
Applicant is advised that should claim 3 be found allowable, claim 29 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).
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.
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.
Claims 1-3, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Richardson (US 20230075608 A1, published Mar. 9, 2023, hereinafter referred to as “Richardson”), as evidenced by MedDeviceOnline.com and Maxon Group 2013, in view of Beekman (US 20230149699 A1, published May 18, 2023, hereinafter referred to as “Beekman”).
Regarding claims 1 and 29, Richardson teaches an intravascular blood pump (“circulatory assist pump, generally 10, shown in FIGS. 1, 3, and 4 in its operational position” ¶[0028] and “FIG. 5, a wireless circulatory assist pump 100 may be configured to be deployed into and removed from a vein or artery (e.g., the aorta) via one or more catheters (FIGS. 8-9)” ¶[0036]), comprising: a catheter (“deployment catheter 130 (FIG. 8) and a retrieval catheter 140 (FIG. 9)” ¶[0053]); and a pump section coupled to a distal end of the catheter (“FIG. 5, a wireless circulatory assist pump 100 may be configured to be deployed into and removed from a vein or artery (e.g., the aorta) via one or more catheters (FIGS. 8-9). In certain embodiments, a spring or retainer clip on the catheter is used to secure the deployment and removal process with the catheter” ¶[0036]), the pump section comprising: an electric motor (Fig. 5 “motor 114” ¶[0036]; “motor 114 may be a miniature brushless direct current (“DC” or “BLDC”) motor. For example, the motor 114 may be a miniature brushless DC motor such as available under the tradename “EC6” from Maxon Precision Motors, Inc. of Foster City, California US” ¶[0038]; according to MedDeviceOnline.com, Maxon brushless motors have stators and rotors) comprising a stator and a rotor operably coupled to the stator; a drive shaft disposed within the pump section (Fig.’s 10-11 “A drive shaft 113 connects the motor to the impeller 106” ¶[0070]), the drive shaft operably coupled to the rotor; a motor housing disposed around the electric motor and a portion of the drive shaft (the disclosed Maxon Precision Motors has a housing disposed around the drive shaft as shown in the product specification); and an impeller housing (Fig.’s 1-4 “tubular elongated casing 12” ¶[0028] and Fig. 5 “impeller 106 enclosed within a stent cage 108” ¶[0036]) in which an expandable impeller is housed (Fig.’s 1-4 “The impeller blades (14,16) are outwardly foldable and retractable, and can move, e.g., into a position perpendicular to the tubular elongated casing 12” ¶[0028]), the expandable impeller being coupled to the drive shaft (Fig.’s 10-11 “A drive shaft 113 connects the motor to the impeller 106” ¶[0070]); and a housing connector (FIGS. 12-14 “set of clips 115 (or capture clasps) that interact with an indented feature on the proximal docking end 104 of the wireless pump attach the catheter 140 to the wireless pump.” ¶[0072]) having a proximal portion disposed within a distal end of the catheter (Fig. 12-17 show element 115 expanding from the distal end of the catheter 140), and a distal portion disposed around a proximal end of a housing.
Richardson does not disclose the distal portion disposed around the proximal end of a motor housing.
Beekman’s invention relates to percutaneous circulatory support systems (blood pumps) (¶[0002]). Referring to Fig. 1, the motor housing 104 couples to a catheter 126 opposite the impeller housing 102. The catheter 126 may couple to the motor housing 104 in various manners, such as laser welding, soldering, or the like (¶[0053]). The instant specification defines the housing connector may include any appropriate means for doing so, including, e.g., axially welding two components, or bonding two components together (¶[0042]). With continued reference to FIG. 1, the motor housing 104 carries a motor 105, and the motor 105 is configured to rotatably drive the impeller 112 relative to the impeller housing 102. In the illustrated embodiment, the motor 105 rotates a drive shaft 120 (¶[0051]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have a housing connector at the distal end of the catheter and the proximal end of the motor housing as taught by Beekman in the device of Richardson as it is a way to secure the motor housing to the catheter. Further, MPEP 2144.04(VI)(C) states “In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).” Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to rearrange the connection point to connect the catheter to the motor housing as it would not change the functionality of the blood pump.
Regarding claim 2, Richardson teaches wherein the expandable impeller is coupled to the drive shaft at a location distal to the rotor (Fig. 10 and 11, impeller element 106 is located distally from the rotor element 114).
Regarding claim 3, Richardson teaches wherein the pump section further comprises a motor housing disposed around the electric motor, and a portion of the drive shaft (the disclosed Maxon Precision Motors has a housing disposed around the drive shaft as shown in the product specification).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Richardson, as evidenced by MedDeviceOnline.com and Maxon Group, in view of Beekman (hereinafter referred to as “modified Richardson”), as applied to claim 3 above, and in further view of Isaacson (US 5205721 A, published Apr. 27, 1993, hereinafter referred to as “Isaacson”).
Regarding claim 4, modified Richardson teaches the blood pump of claim 3. Modified Richardson does not disclose wherein an outer surface of the motor housing is partially disposed within the catheter.
Isaacson’s invention relates to a split stator for a motor that drives an axial flow blood pump in a heart/lung machine (Col. 1 ln. 6-8). The pump includes a housing connected in line with the blood flow path. To connect the pump to the blood flow path, tubes are connected to the ends of the housing (Col. 1 ln. 42-46). As shown in Fig.’s 1 and 4, housing assembly 21, includes an interior sleeve 22 with exterior sections 23 and 24 inserted into outer ends of the sleeve 22 (Col. 4 ln. 62-65). Sections 23 and 24 have fluted outer ends onto which tubes (shown in FIG. 4) are connected (Col. 5 ln. 9-10).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to dispose part of the motor housing within the catheter as taught by Isaacson in the device of modified Richardson since it is a successful and art-recognized method of connecting tubing to pumps.
Claims 9-10, 13-15, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over modified Richardson, as applied to claim 1 above, and in even further view of Muller et al. (US 20180021494 A1, published Jan. 25, 2018, hereinafter referred to as “Muller”).
Regarding claim 9, modified Richardson teaches the blood pump of claim 1. Modified Richardson does not teach wherein the rotor and stator of the electric motor are coaxially aligned.
Muller’s invention relates to catheter pumps for mechanical circulatory support of a heart (¶[0002]). The journal bearings 18A (FIGS. 3 and 5) and 18B (FIG. 3) can be provided on opposite axial sides of the rotor 15 to help maintain the rotor 15 … in axial alignment with the stator assembly 2 (¶[0085]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have the rotor and stator coaxially aligned as taught by Muller in the blood pump of modified Richardson in order to help maintain the rotor.
Regarding claim 10, Muller teaches the device further comprising at least one bearing within a motor housing (“the external motor housing (e.g., the outer shell or housing surrounding the motor assembly)” ¶[0076]) disposed around the electric motor (“The journal bearings 18A (FIGS. 3 and 5) and 18B (FIG. 3) can be provided on opposite axial sides of the rotor 15” ¶[0085]).
Regarding claim 13, Muller teaches the device further comprising one or more wires extending proximally from the pump section (“one or more electrical lines may extend from the motor to the console outside the patient” ¶[0050]).
Regarding claim 14, Muller teaches wherein the one or more wires are coupled to a circuit disposed within the pump section, the circuit configured to control electricity provided to the stator (“the electrical lines can send signals for controlling the operation of the motor.” ¶[0050], and Fig. 1B “The console 122 can provide electrical power (e.g., 24V) to the stator assembly 2 to drive the motor assembly 1. One or more leads 9 can electrically communicate with the stator assembly 2” ¶[0069]).
Regarding claim 15, Muller teaches further comprising a purge fluid lumen extending through the catheter, the purge fluid lumen being operably coupled to the pump section (“FIG. 1B, a fluid supply line 6 can fluidly couple with the console 122 to supply saline or other fluid to the catheter pump 100A. The saline or other fluid can pass through an internal lumen of the internal catheter body 120A and can provide lubrication to the impeller assembly 116A and/or chemicals to the patient.” ¶[0061]).
Regarding claim 27, Muller teaches where there is an axial gap between a proximal end of blades of the expandable impeller and a distal end of a motor section (see annotated Fig. 1B below).
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Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over modified Richardson, as applied to claim 3 above, and in further view of Neumann (US 20170119945 A1, published May 4, 2017, hereinafter referred to as “Neumann”).
Regarding claim 5, Modified Richardson teaches the intravascular blood pump of claim 3.
Although Beekman teaches that in other embodiments, the impeller housing and motor housing can be integrally formed, modified Richardson does not teach a reason wherein the motor housing and the impeller housing form a single combined housing.
Neumann’s invention relates to a pump for implantation into a vessel or a heart (¶[0012]). The stator S with rotor R (motor) as well as delivery part FE (impeller) are arranged within the support structure SG (cannula) in Fig.’s 1A-1B. The pump 1 is embodied according to the invention such that it can produce the required pump output and yet be small enough that it can be transported through an appropriate vessel (lumen) to the application site without damaging this vessel (¶[0028]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to house the motor and the impeller in one single housing as taught by Neumann in the device of modified Richardson in order to transport the device without damaging the vessel as well as produce the required pump output. Further, by making the drive shaft and rotor one material, production costs and sources of error can be minimized (¶[0061]) and therefore, the same idea can be applied to combining the motor housing and impeller housing within one housing component.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over modified Richardson, as applied to claim 3 above, and in further view of Earles et al. (US 20220080183 A1, published Mar. 17, 2022, hereinafter referred to as “Earles”).
Regarding claim 6, modified Richardson teaches the intravascular blood pump of claim 3.
Modified Richardson does not disclose wherein an outer surface of the motor housing is partially disposed within the impeller housing.
Earles’s invention relates to improved blood pumps (¶[0002]). In Fig.’s 1A-1C, a motor is disposed in the motor housing 29 capped by a distal drive unit cover 11 (¶[0071]). The impeller assembly 4 can be disposed in a shroud 16 and the sleeve bearing 15, and the shroud 16 can cooperate to at least partially define the pump housing 35 (¶[0072]). The shroud 16 can comprise a tube with an inlet end and an outlet end. The shroud 16 can be placed over the various internal components that make up the pump rotor (e.g., the impeller assembly 4 and the rotor assembly 46). The outlet end of the shroud 16 can be secured to the drive unit cover 11 of the drive unit 9 (¶[0119]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to partially dispose the outer surface of the motor housing in the impeller housing as taught by Earles in the device of modified Richardson since having a motor partially disposed within impeller housing is known in the art to would have yielded predictable results to connect the two components for an effective operation of a blood pump.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over modified Richardson, as applied to claim 3 above, and in further view of Siess (US 7011620 B1, published Mar. 14, 2006, hereinafter referred to as “Siess ‘620”).
Regarding claim 8, modified Richardson discloses the intravascular blood pump of claim 3.
The specification discloses the appropriate ranges that apply to the claimed invention on page(s) ¶[0039], [0040], [0048]-[0050]. However, the specification does not disclose that the specifically claimed range(s) of no larger than 12 is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
Modified Richardson does not disclose wherein an average outer diameter of the motor housing is no larger than 12 french.
Siess ‘620’s invention relates to an intravascular blood pump comprising a housing accommodating an electric motor, with the proximal end of the housing being connected to a catheter and the distal end thereof carrying a pump (Col. 1 ln. 1-6). In the blood pump of the invention, the housing containing the electric motor can be reduced to an outer diameter of about 4 mm, which corresponds to a catheter of 12 F (F=French). Thus, the intravascular blood pump can be advanced through the blood vessel system of the patient and be placed at the desired site. The dimensions also make it possible to maneuver the blood pump in an unobstructed and controlled manner through the arcus aortae (Col. 2 ln. 21-30).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have an average outer diameter of the motor housing 12 French as taught by Siess ‘620 in the device of modified Richardson in order to maneuver the blood pump in an unobstructed and controlled manner through the patient.
Since Siess teach that the dimension of intravascular blood pump housing can be adjusted to allow maneuver of the blood pump in an unobstructed and controlled manner through the arcus aortae as set forth above, the prior art therefore provides teaching that the size of the blood pump motor housing is a variable that achieves a recognized result.
Because Applicants fail to disclose that the claimed range(s) of no larger than 12 provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art discloses that size of the motor housing can be adjusted absent unexpected results, it would therefore have been obvious for one of ordinary skill to discover the optimum workable range(s) of no larger than 12 by normal optimization procedures known in the catheter pump arts.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over modified Richardson and Muller, as applied to claim 10 above, and in further view of Spanier et al. (US 20150051436 A1, published Feb. 19, 2015, hereinafter referred to as “Spanier”).
Regarding claim 11, modified Richardson and Muller discloses the intravascular blood pump of claim 10. Muller teaches wherein the at least one bearing includes a plurality of bearings (“journal bearings 18A (FIGS. 3 and 5) and 18B (FIG. 3)” ¶[0085])
Modified Richardson and Muller does not disclose where one or more bearings of the plurality of bearings is a ceramic bearing.
Spanier’s invention relates to an intravascular blood pump for supporting blood circulation in human. It is preferred to make the radial sliding bearing of the device located at the proximal end of the motor housing of ceramic, with the ceramic bearing lying directly against the circumferential surface of the motor shaft ¶[0021]. Surfaces made of ceramic have high strength and low wear ¶[0016].
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have constructed one or more bearings out of a ceramic material as taught by Spanier in the device of modified Richardson and Muller because ceramics have high strength and low wear.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over modified Richardson, as applied to claim 1 above, and in even further view of Yamazaki et al. (EP 0768091A1, published Apr. 16, 1997, hereinafter referred to as “Yamazaki”).
Regarding claim 12, modified Richardson teaches the intravascular blood pump of claim 1.
Modified Richardson does not disclose wherein the drive shaft is ceramic.
Yamazaki’s invention relates to an artificial organ, for example an artificial heart (Col. 1 ln. 1-4). The driving shaft is made from ceramic material which is stable both chemically and dimensionally and highly resistant against abrasion making the artificial heart more reliable and prolonging its service life (Col. 6 ln. 19-25).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to construct the drive shaft out of a ceramic material as taught by Yamazaki in the device of modified Richardson in order to create a more reliable device and prolong its service life.
Claims 16 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over modified Richardson, as applied to claim 1 above, in further view of Campbell et al. (US 20120172655 A1, published Jul. 5, 2012, hereinafter referred to as “Campbell”).
Regarding claim 16, modified Richardson teaches the pump of claim 1. Modified Richardson does not disclose the pump wherein the catheter comprises a defined bend.
Campbell’s invention is directed to heart pumps that can be applied percutaneously (¶[0003]). Campbell teaches the atraumatic tip 182 in the catheter in Fig.’s 1A and 2 can have an arcuate configuration such that interactions with a patient's internal tissues are controlled and do not cause trauma thereto ¶[0082].
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have a defined bend in the catheter as taught by Campbell in the blood pump of modified Richardson in order to control interactions with the patients internal tissues and avoid trauma.
Regarding claim 21, modified Richardson teaches the pump of claim 1. Modified Richardson does not disclose teach the pump further comprising a flexible atraumatic tip coupled to a distal end of the impeller housing.
Campbell teaches in Fig.’s 1A and 2 that the distal end 108 of the catheter assembly 100 includes an atraumatic tip 182 disposed distal of the impeller assembly 116. The tip is designed to be atraumatic so that after retraction of the guidewire, when the tip is left inside, for example, a ventricle, it cannot cause injury or trauma to the inner wall or endocardial surface of the ventricle resulting from motion of the ventricle (¶[0082]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have an atraumatic tip at the distal end of the catheter as taught by Campbell in the blood pump of modified Richardson in order to avoid causing trauma to the ventricle.
Claims 17 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over modified Richardson, as applied to claim 1 above, and in even further view of D'Ambrosio et al. (US 20210236797 A1, published Aug. 5, 2021, hereinafter referred to as “D'Ambrosio ‘797”).
Regarding claim 17, modified Richardson does not explicitly disclose further comprising downstream tubing coupled to the impeller housing and to a portion of the catheter, wherein the downstream tubing has one or more blood flow outlets.
D’Ambrosio ‘797’s invention relates to intravascular blood pumps and, more particularly, to intravascular blood pumps that include intake filters (¶[0002]). Fig. 2 depicts a limp collapsible outflow hose (downstream tubing) 204 in fluid communication between the output of the impeller 200 and the output port 128 (blood flow outlet) (¶[0066]). The downstream tubing enables the impeller to be positioned much closer to the input port (¶[0068]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to incorporate this downstream tubing with one of more blood flow outlets as taught by D’Ambrosio ‘797 in the device of modified Richardson in order to enable to impeller positioning to be closer to the input port.
Regarding claim 22, modified Richardson does not disclose wherein the impeller housing comprises a mesh filter at a blood flow inlet.
D’Ambrosio ‘797 teaches an intake filter reduces the risk of heart tissue being sucked into an intake port of the intravascular blood pump (¶[0052]). The filter 130 is disposed on the input port (¶[0068]) and Fig.’s 3-5 depict mesh filter element 130 (¶[0074]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to add a mesh filter at the blood flow inlet as taught by D’Ambrosio ‘797 in the device of modified Richardson in order to reduce the risk of heart tissue being sucked into the pump.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over modified Richardson and D’Ambrosio ‘797 as applied to claim 17, and in further view of Campbell.
Regarding claim 18, modified Richardson and D’Ambrosio ‘797 teaches the device of claim 17.
Modified Richardson and D’Ambrosio ‘797 do not teach wherein the catheter comprises a defined bend, the defined bend occurring inside the downstream tubing.
Campbell teaches the atraumatic tip 182 in the catheter in Fig.’s 1A and 2 can have an arcuate configuration such that interactions with a patient's internal tissues are controlled and do not cause trauma thereto ¶[0082].
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have a defined bend in the downstream tubing of the catheter as taught by Campbell in the device of modified Richardson and D’Ambrosio ‘797 in order to control interactions with the patient’s internal tissues and avoid causing trauma to them.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over modified Richardson and D’Ambrosio ‘797 as applied to claim 17, and in further view of Neumann.
Regarding claim 19, modified Richardson and D’Ambrosio ‘797 teaches the intravascular blood pump of claim 17.
Modified Richardson and D’Ambrosio ‘797 does not disclose wherein the downstream tubing is disposed around a motor housing.
Neumann teaches the stator S (motor) are arranged within the support structure SG (cannula) in Fig.’s 1A-1B. The pump 1 is embodied according to the invention such that it can produce the required pump output and yet be small enough that it can be transported through an appropriate vessel (lumen) to the application site without damaging this vessel (¶[0028]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to dispose the motor within the downstream tubing as taught by Neumann in the device of modified Richardson and D’Ambrosio ‘797 in order to transport it without damaging the vessel as well as produce the required pump output. Further, by making the drive shaft and rotor one material, production costs and sources of error can be minimized (¶[0061]) and therefore, the same idea can be applied to combining the motor housing within one housing component.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over modified Richardson and D’Ambrosio ‘797, as applied to claim 17 above, and in further view of Carmel et al. (US 20150359998 A1, published Dec. 17, 2015, hereinafter referred to as “Carmel”).
Regarding claim 20, modified Richardson and D’Ambrosio ‘797 teaches the intravascular blood pump of claim 17.
Modified Richardson and D’Ambrosio ‘797 does not disclose wherein the downstream tubing includes a slit extending from a proximal end of a blood flow outlet to a proximal end of the downstream tubing.
Carmel’s invention relates to medical devices, and in particular to balloon catheters applicable for treating blood vessels (¶[0002]). The device includes fluid outlet 117 (Fig. 6A) which may include any number of openings of any form and size, and of any arrangement with any pattern. As such, fluid outlet may include at least one hole (i.e. a through opening), at least one slit and/or at least one pressure sensitive opening. Optionally the at least one slit is configured to open above a predetermined infusion pressure (¶[0075]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to include a slit extending from the blood flow outlet as taught by Carmel in the device of modified Richardson and D’Ambrosio ‘797 in order to open when there is a certain amount of pressure in from the flow.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over modified Richardson, as applied to claim 1, in view of Campbell, and further in view of Siess (US 20080103591 A1, published May 1, 2008, hereinafter referred to as “Siess ‘591”).
Regarding claim 23, modified Richardson teaches the intravascular blood pump of claim 1. Richardson also teaches wherein the impeller housing has a compressed state and an expanded state (“the stent cage 108 may be compressed and stowed for placement and removal of the wireless circulatory assist device 100.” ¶[0037]).
Campbell teaches the impeller housing having a maximum outer diameter of about 21 French (21F) in the expanded state. In Fig. 1A, the distal end 108 of the catheter assembly 100 can be configured to have about an 11 French (approximately 3.5 mm) size in a first configuration for insertion and an expanded configuration, such as up to about 21 French (approximately 7 mm) once in place in the body. The larger size facilitates greater flow rates (¶[0072]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to expand up to 21 French as taught by Campbell in order to facilitate greater flow rates by the pump.
Modified Richardson and Campbell do not teach the impeller housing having a maximum outer diameter of about 10 French (10F) in the compressed state.
Siess ‘591’s invention relates to a foldable intravascularly insertable blood pump comprising a rotor provided with vanes, a flexible shaft extending through a catheter and adapted to drive the impeller, and an envelope enclosing the impeller (¶[0002]). Insertion is performed intra-vascularly, namely through the blood vessel system of the patient. It is thus required that, upon insertion, the maximum diameter of the blood pump does not exceed 3 mm (9 French in a compressed state), if the insertion is to be carried out through an insertable tube and with as little complication as possible (¶[0004]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to compress the pump no larger than 9 French as taught by Siess ‘591 in the device of modified Richardson and Campbell in order to insert the device through the blood vessel system of a patient with minimal complication.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over modified Richardson, as applied to claim 1 above, and in further view of Aboul-Hosn et al. (US 7022100 B1, published Apr. 4, 2006, hereinafter referred to as “Aboul-Hosn”).
Regarding claim 24, modified Richardson teaches the pump of claim 1. Modified Richardson does not disclose wherein the pump section forms an extended cannula extending distally from a motor housing.
Aboul-Hosn’s invention relates generally to blood pumps and, more particularly, to an improved intra-vascular blood pump having a guide mechanism which provides the ability to selectively guide the intravascular pump to a desired location within a patient's circulatory system. Aboul-Hosn teaches the cannula 14 of Fig. 2 (downstream tubing) is fixedly attached to the rotor shroud 36 (impeller housing) and may extend any suitable length therefrom depending upon the particular intravascular application. The cannula 14 preferably includes a plurality of ports or fenestrations 40 about its distal region, as well as an end port 42, which allow for the ingress or egress of blood into or from the cannula 14 depending upon the operation of the blood pump 12 (Col. 8 ln. 21-28). The pump is distal from motor assembly 20.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have an extended cannula distal from the motor housing as taught by Aboul-Hosn in the blood pump of Richardson in order to allow ingress or egress of blood.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over modified Richardson in view of Aboul-Hosn, as applied to claim 24 above, and in further view of D'Ambrosio et al. (US 20210236797 A1, published Aug. 5, 2021, hereinafter referred to as “D'Ambrosio ‘797”).
Regarding claim 25, modified Richardson and Aboul-Hosn teaches the intravascular blood pump of claim 24.
Modified Richardson and Aboul-Hosn do not disclose wherein the expandable impeller is disposed within the extended cannula.
D’Ambrosio ‘797 teaches the impeller 200 is shown located inside the housing 122 (extended cannula) (¶[0065]). Conventionally, intravascular blood pumps have not included such downstream tubing. Such a conventional intravascular blood pump therefore has a relatively long intake cannula, upstream of its impeller, to make the intravascular blood pumps sufficiently long to span the heart valve into which it is to be inserted. This length allows for some longitudinal displacement, such as due to heart action and patient movement, without risking displacing the intake and output ports to the same side of the heart valve. Although not consciously designed to do so, such a long intake cannula also makes it almost impossible to damage heart tissue by the impeller (¶[0067]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have the expandable impeller within the extended cannula as taught by D’Ambrosio ‘797 in the device of modified Richardson and Aboul-Hosn so that the impeller is placed where it will be effective without causing damage to the heart tissue.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over modified Richardson in view of Aboul-Hosn, as applied to claim 24 above, in further view of D’Ambrosio et al. (US 20170348470 A1, published Dec. 7, 2017, hereinafter referred to as “D’Ambrosio ’470”).
Regarding claim 26, modified Richardson in view of Aboul-Hosn teach the blood pump of claim 24. Modified Richardson in view of Aboul-Hosn do not disclose wherein the extended cannula includes a defined bend distal to the expandable impeller.
D’Ambrosio ‘470’s invention relates to blood pump assembly, such as an intracardiac blood pump assembly (¶[0002]). D’Ambrosio ‘470 teaches the cannula assembly 102 in Fig. 1 includes a bend 112. In some embodiments, the bend 112 is 45°. In certain implementations being designed for use in the right heart, the cannula assembly 102 can have one or more bends and may have different and/or multiple bend radii to adapt to the needs of passage and final position of the cannula assembly 102 (¶[0048]). This bend is distal to the impeller hub 113.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to include a defined bend in the cannula as taught by D’Ambrosio ‘470 in the device of modified Richardson and Aboul-Hosn in order to adapt the blood pump for suitable conditions of use such as for use in the right heart.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over modified Richardson, as applied to claim 1 above, in further view of Muller, and in further view of Nix et al. (US 6176822 B1, published Jan. 23, 2001, hereinafter referred to as “Nix”).
Regarding claim 28, modified Richardson teaches the intravascular blood pump of claim 1. Muller teaches a controller operably coupled to the intravascular blood pump (“A controller within the console 122 can control the operation of the motor assembly 1 during use.” Fig. 1B and ¶[0061]).
Modified Richardson and Muller do not disclose the controller configured to control a rotational speed of the electric motor.
Nix’s invention relates to an intracardiac blood pump, and in particular to a blood pump that may be inserted entirely into the heart to assist the natural cardiac pump function or to replace the same by a continuous pumping operation (Col. 1 ln. 3-6). The pumps are driven by synchronous motors, with the control unit 66 (fig. 3) (controller) supplying the required drive frequency or rotational speed (Col. 5 ln. 40-41). The rotational speed of the respective pump will then be reduced for a certain time so that the cardiac tissue may disengage itself, and, subsequently, the rotational speed will be increased again to the desired number. When the measured absolute pressure becomes too high, the control unit 66 will affect a limitation--and, if need be, a reduction--of the volume flow to avoid damage to downstream organs (lungs) (Col. 6 ln. 1-9).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to control the rotational speed of the electric motor as taught by Nix in the device of modified Richardson and Muller in order to moderate the flow rate to avoid damage to organs.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Muller et al. (US 20150290371 A1) – Fig. 11
Muller et al. (US 20230043099 A1) – Fig. 15D
Keenan et al. (US 20230071248 A1) – Fig. 12
Pfeffer et al. (EP 2234658 B1) – a housing connector connecting the motor and the catheter
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/E.N.C./Patent Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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