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 on 08/10/2026 has been entered. Claims 1-2, 4-13, and 15-20 remain pending in the application. Applicant’s amendment to the claim in view of previously set Non-final Office Action mailed on 05/19/2026 has been acknowledged.
Response to Arguments
Claim Rejection – 35 USC § 112:
The previous rejection of Claim 1, 4-5, and 13 under 112(b) is withdrawn in view of the
amendment to the claims.
Claim Rejection – 35 USC § 103:
Applicant’s arguments/remarks, see page 7-12, filed on 08/10/2026, with respect to the
rejection(s) of claim(s) under 35 U.S.C § 103 have been fully considered but are not persuasive. Examiner acknowledges the claim remarks but respectfully disagrees; upon further consideration of the newly amended limitations, a new ground(s) of rejection is made. As explained in the rejection set forth below, the newly cited reference teaches the amended claim limitation(s), and, therefore, renders applicant’s prior arguments directed to previous combination of references moot. Accordingly, the new combination of references renders the amended claim subject matter obvious.
Applicant’s argument/remark regarding Claim 1 is that “Struthers does not disclose that the laser-cut hypo tube rotates within the polymer covering” and “Charafeddine’s discloser of pump-housing diameter is not disclosed, so the claimed diameter relationship is unsupported by the references”. However, Struthers does disclose (see Fig. 3A-3B (embodiment 300), and Para 61-62) “a flexible drive line 320 coupled to the motor 302, extending through an interior chamber 322 of the pivotable housing connector 310, and coupled to the driving magnet 318. The flexible drive line 320 is configured to be caused to rotate by the motor and, in turn, rotate the driving magnet 318”. Charafeddine also disclose that “at least one flexible sheath extending between the motor housing and the pump housing and at least one flexible cable extending through the flexible sheath so as to transfer a rotational movement from the electric motor to the impeller” (see Para 9) and “at least one magnet to form a magnetic coupling between the impeller and the at least one flexible cable” (see Para 15). Regarding the claimed diameter relationship unsupported by the reference, Charafeddine’s discloser of necessarily appropriate diameter to connect and form a single housing to provide better flexibility and navigation is a design choice/common engineering practice for catheter-based device.
Applicant’s arguments/remarks regarding Claim 11 and 20 is that the amended claim requires the elongate core member to extend through a bearing assembly that is coupled to a proximal end of the impeller housing and neither reference disclose “the elongate core member of the flexible elongate shaft extends through those pump-housing bearings while rotating within the elongate casing”. This amended limitation has been addressed in the rejection set forth below, the newly cited reference in combination with previous references teaches the amended claim limitation(s), and, therefore, renders applicant’s prior arguments moot. Accordingly, the new combination of references renders the amended claim subject matter obvious.
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 1-2, 4-13 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 20210275796 A1 to Struthers et al. (hereinafter “Struthers”) in view of US 20210260361 A1 to Charafeddine et al. (hereinafter “Charafeddine”) and further in view of US 20190365973 A1 to Flores (hereinafter “Flores”).
Regarding Claim 1, Struthers teaches a blood pump (see Abstract: “a blood pump”) comprising: an impeller housing (see Para 4: “an impeller assembly housing”);
an impeller (see Para 4: “an impeller”) disposed in the impeller housing (see Para 4: “an impeller assembly disposed within the impeller assembly housing and having an impeller”);
a magnetic assembly operatively coupled with the impeller (see Para 15: “the impeller assembly includes a driven magnet assembly coupled to the impeller and configured to rotate with the impeller”);
a motor housing (see Para 4: “a motor housing”);
a motor disposed in the motor housing (see Para 4: “a motor disposed within the motor housing and configured to drive the impeller”), wherein the motor is configured to drive the magnetic assembly to thereby drive the impeller (see Para 15: “the motor includes a driving magnet assembly and the impeller assembly includes a driven magnet assembly coupled to the impeller and configured to rotate with the impeller, the driving magnet assembly is configured to cause the driven magnet assembly to rotate”); and
a flexible elongate shaft (see Para 21: “the pivotable housing connector includes a flexible membrane”) coupled with the magnetic assembly (see Para 60: “magnetic coupling may be used to transfer torque from the motor to the impeller across the pivotable housing connector ... the motor may be a direct drive motor configured to drive a flexible drive shaft (e.g., a drive line) that passes through the pivotable housing connector”) and the motor housing (see Para 13: “a pivotable housing connector coupled to the motor housing and the impeller assembly housing”), and
wherein the flexible elongate shaft comprises an elongate core member (see Para 49: “the pivotable housing connector 118 may be a flexible membrane … an accordion-like semirigid membrane material that allows deflection radially but retains push of the device axially over a wire, a polymer-covered laser cut hypo tube, and/or the like”; examiner interpret that “the hypo tube” inherently comprises an elongate core member and “the polymer-covered” inherent as casing) and an elongate casing extending along the elongate core member, wherein the elongate core member is configured to rotate within the elongate casing to transfer rotational movement generated by the motor to the magnetic assembly (see Fig. 3A-3B (embodiment 300), and Para 61-62: “a flexible drive line 320 coupled to the motor 302, extending through an interior chamber 322 of the pivotable housing connector 310, and coupled to the driving magnet 318. The flexible drive line 320 is configured to be caused to rotate by the motor and, in turn, rotate the driving magnet 318”), and
wherein the elongate casing has a first outer diameter that is less than a second outer diameter of the impeller housing (see Para 48: “the drive shaft 110 is at least partially disposed within the impeller 112”; Para 49: “a pivotable housing connector 118 disposed between the motor housing 104 and the impeller assembly housing 108. … the pivotable housing connector 118 is coupled, at a first end 120, to a distal end 122 of the motor housing 104 and, at a second end 124, to a proximal end 126 of the impeller assembly housing 108 … the pivotable housing connector 118 may be a flexible membrane, in which case, the pivotable housing connector 118 may be able to bend in any number of different directions … the flexible membrane may be made of any number of a variety of materials such as, for example, an accordion-like semirigid membrane material that allows deflection radially but retains push of the device axially over a wire, a polymer-covered laser cut hypo tube, and/or the like”; also Para 53: “the pivotable housing connector divides the rigid length of the circulatory support device roughly in half, separating the halves of the housing which contain the motor and the impeller via a flexible connection” and Fig. 1A, 1B, 2A, 3A AND 3B).
However, Struthers doesn’t specify teach the flexible elongate shaft has an elongate casing extending along the elongate core member and a first outer diameter that is less than a second outer diameter of the impeller housing.
Charafeddine, teach a percutaneous blood pump (see Abstract) wherein the flexible elongate shaft comprises an elongate core member and an elongate casing extending along the elongate core member (see Para 9-10: “at least one flexible sheath extending between the motor housing and the pump housing and at least one flexible cable extending through the flexible sheath so as to transfer a rotational movement” and Para 15: “at least one magnet to form a magnetic coupling between the impeller and the at least one flexible cable”), wherein the elongate casing has a first outer diameter that is less than a second outer diameter of the impeller housing (see Para 60: “an impeller 12 that is housed inside a pump housing 11” and Para 62: “The impeller 12 is attached at its proximal end to a distal flexible cable 27 … The distal flexible cable 27 is housed inside a distal catheter sheath 15” also Para Fig. 1-2 and 4-6).
Charafeddine discloses the pump housing diameter but fails to specifically teach the outer diameter for the casing.
Another reference, Flores teach a blood pump (see Abstract), wherein the elongate casing has a first outer diameter that is less than a second outer diameter of the impeller housing (see Para 97-100: “Sheath 102 has the largest diameter of any of the fixed-diameter tubes of catheter blood pump 100 … The diameter of fixed-diameter impeller 120 is at least as great as the outer diameter of sheath 102 … drive cable 116 extends essentially the full length of catheter blood pump 100, from motor assembly 670 (see FIG. 6) to fixed-diameter impeller 120. Drive cable 116 transmits torque from the drive motor to fixed-diameter impeller 120, causing the impeller to rotate at high speeds” and Para 105-106, Fig.1 (outer tube/sheath (casing surrounding the drive cable) has an outer diameter that does not exceed (i.e. is less) the diameter of impeller)).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date to combine the disclosure of Struthers with the teaching of Charafeddine and Flores to have the flexible elongate casing have a diameter less than impeller housing for connecting the distinct housings and have a flexible-shaft structure, thereby incorporating routine engineering necessities for insertability and by way of flexible cables extending through flexible sheaths (see Para 10) to protect surrounding tissue during device operation (see Para 62).
Regarding Claim 2, the modified blood pump of claim 1, Struthers further teach the blood pump wherein the motor housing has a third outer diameter and the first outer diameter is less than the third outer diameter (see Para 49: “the pivotable housing connector 118 is coupled, at a first end 120, to a distal end 122 of the motor housing 104 and, at a second end 124, to a proximal end 126 of the impeller assembly housing 108” also Fig 1A, 1B, 2A, 3A and 3B).
However, Struthers doesn’t specify teach the motor housing has a third outer diameter and the first outer diameter is less than the third outer diameter.
Charafeddine, teach a percutaneous blood pump wherein the motor housing (see “motor housing 30”) has a third outer diameter and the first outer diameter is less than the third outer diameter (see Para 59: “the motor housing 30 is connected proximally to a proximal catheter sheath 35”; also Fig. 1-2 and 4-6).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date to combine the modified disclosure of Struthers with the teaching of Charafeddine to have the flexible elongate shaft have a diameter less than impeller housing for connecting the distinct housings by way of flexible cables extending through flexible sheaths (see Para 10).
Regarding Claim 4 , Struthers further teaches the modified blood pump of above, further comprising: a motor drive shaft (see Para 62: “the motor 302 includes a flexible drive line 320”), and wherein the elongate core member has a proximal portion coupled with the motor drive shaft to receive rotational movement from the motor drive shaft and a distal portion coupled with the magnetic assembly to transfer rotational movement to the magnetic assembly (see Para 61-62: “… the motor 302 includes a flexible drive line 320 coupled to the motor 302, extending through an interior chamber 322 of the pivotable housing connector 310, and coupled to the driving magnet 318 …”).
Regarding Claim 5, Struthers further teaches the modified blood pump of above, wherein the magnetic assembly comprises a driven shaft and the elongate core member has a distal portion coupled with the driven shaft such that rotation of the elongate core member rotates the driven shaft (see Para 62: “the impeller assembly 306 includes a drive shaft 312 and an impeller 314 coupled thereto, where the drive shaft 312 is configured to rotate with the impeller 314. The impeller assembly 306 may further include a driven magnet 316 coupled to at least one of the drive shaft 312 and the impeller 314”).
Regarding Claim 6, Struthers further teaches the modified blood pump of above, wherein the magnetic assembly is located in the impeller housing (see Para 62: “the driving magnet 318 which, in the illustrated embodiment, is disposed in the impeller assembly housing 308”).
Regarding Claim 7, Struthers further teaches the modified blood pump of above, wherein the magnetic assembly comprises: a driven magnet coupled with the impeller B (see Para 15: “the impeller assembly includes a driven magnet assembly coupled to the impeller”); and a drive magnet fluidly isolated from the driven magnet and configured to drive the driven magnet (see Para 60: “magnetic coupling may be used to transfer torque from the motor to the impeller across the pivotable housing connector ... For example, in embodiments, the motor may be a direct drive motor configured to drive a flexible drive shaft (e.g., a drive line) that passes through the pivotable housing connector. In embodiments, to preserve the benefits of using a magnetic drive (e.g., sealing the driving magnet from the blood flow, etc.), a flexible drive line may be used”; examiner interpret that “sealing the driving magnet from the blood flow” corresponds to a driving magnet being fluidly isolated).
Regarding Claim 8, Struthers further teaches the modified blood pump of above, wherein the driven magnet is located in the impeller housing (see Para 61-62: “The impeller assembly 306 is disposed within an impeller assembly housing 308, which includes a number of outlet apertures … the impeller assembly 306 includes a drive shaft 312 and an impeller 314 coupled thereto, … The impeller assembly 306 may further include a driven magnet 316 coupled to at least one of the drive shaft 312 and the impeller 314”).
Regarding Claim 9, Struthers further teaches the modified blood pump of above, further comprising: a driven shaft having a proximal portion coupled with the flexible elongate shaft and a distal portion coupled with the drive magnet (see Para 62: “the motor 302 includes a flexible drive line 320 coupled to the motor 302, extending through an interior chamber 322 of the pivotable housing connector 310, and coupled to the driving magnet 318”).
Regarding Claim 10, the modified blood pump of above, Struthers further teach the blood pump further comprising: a bearing assembly coupled with the impeller housing and the flexible elongate shaft (see Para 48: “the impeller assembly 106 may be maintained in its orientation by the drive shaft 110, which may be retained by one or more bearing assemblies”).
Struthers fails to specifically teach a bearing assembly coupled with the impeller housing and the flexible elongate shaft.
Charafeddine, teach a bearing assembly coupled with the impeller housing and the flexible elongate shaft (see Para 12: “The blood pump may further comprise a bearing housing distinct from and arranged between the pump housing and the motor housing, … A proximal flexible sheath may extend proximally from the bearing housing and a distal flexible sheath may extend distally from the bearing housing, wherein a proximal flexible cable extends through the proximal flexible sheath so as to receive a rotational movement caused by the electric motor and a distal flexible cable extends through the distal flexible sheath so as to transfer the rotational movement to the impeller”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date to combine the modified disclosure of Struthers with the teaching of Charafeddine to have the bearing to take the axial and radial loads introduced by the electric motor and to reduce the heat generated at the pump to helps reduce clotting (see Para 13).
Regarding Claim 11, Struthers teaches a blood pump (see Abstract: “a blood pump”) comprising: an impeller housing (see Para 4: “an impeller assembly housing”, Para 45, 47-49);
an impeller (see Para 4: “an impeller”) disposed in the impeller housing (see Para 4: “an impeller assembly disposed within the impeller assembly housing and having an impeller”);
a bearing assembly coupled with a proximal end of the impeller housing (see Para 48: “the impeller assembly 106 may be maintained in its orientation by the drive shaft 110, which may be retained by one or more bearing assemblies”);
a motor housing (see Para 4: “a motor housing”); a motor disposed in the motor housing (see Para 4: “a motor disposed within the motor housing and configured to drive the impeller”); and
a flexible elongate shaft (see Para 21: “the pivotable housing connector includes a flexible membrane”) having a proximal portion coupled with the motor housing (see Para 13: “a pivotable housing connector coupled to the motor housing and the impeller assembly housing”).
However, Struthers doesn’t specifically teach a bearing assembly coupled with the proximal end of the impeller housing, the flexible elongate shaft having a distal portion coupled with the bearing assembly and the elongate core member extends through the bearing assembly.
Charafeddine, teach a bearing assembly coupled with the proximal end of the impeller housing (see Para 59-60: “pump head 10 connected proximally to a bearing housing 21 by means of a distal catheter sheath 15 … an impeller 12 that is housed inside a pump housing 11” and Fig. 1-2 (bearing housing 21 and impeller 12 housed inside pump housing 11)); and a flexible elongate shaft having a proximal portion coupled with the motor housing and a distal portion coupled with the bearing assembly (see Para 12: “The blood pump may further comprise a bearing housing distinct from and arranged between the pump housing (a pump housing with an impeller housed in the pump housing (Para 9)) and the motor housing, … A proximal flexible sheath may extend proximally from the bearing housing and a distal flexible sheath may extend distally from the bearing housing, wherein a proximal flexible cable extends through the proximal flexible sheath so as to receive a rotational movement caused by the electric motor and a distal flexible cable extends through the distal flexible sheath so as to transfer the rotational movement to the impeller”; also Fig. 1-2 and 4-5), wherein the flexible elongate shaft comprises an elongate core member and an elongate casing extending along the elongate core member (see Para 09: “at least one flexible sheath extending between the motor housing and the pump housing and at least one flexible cable extending through the flexible sheath so as to transfer a rotational movement”), wherein the elongate core member is configured to rotate within the elongate casing (see Para 06: “a rotating flexible cable housed inside a protective flexible catheter …”).
Charafeddine fails to explicitly disclose the elongate core member extends through the bearing assembly.
Another reference, Flores teach a blood pump (see Abstract), wherein elongate core member extends through the bearing assembly (see Para 105: “Bearing (i.e., sleeve bearing) 108 accepts drive cable 116 … its inner surface abuts drive cable 116, which, during operation, may be rotating at speeds in excess of 5,000 rpm”, and Fig. 1A-1C).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date to combine the disclosure of Struthers with the teaching of Charafeddine and Flores to have the bearing to take the axial and radial loads introduced by the electric motor also to reduce the heat generated at the pump; and to receive rotational movement caused by the electric motor and to transfer the rotational movement to the impeller. (see Para 12-13).
Regarding Claim 12, Struthers further teach the modified blood pump above, but fails to teach the elongate casing is coupled with the bearing assembly.
Charafeddine, teach wherein the elongate casing is coupled with the bearing assembly (see Para 12: “A proximal flexible sheath may extend proximally from the bearing housing and a distal flexible sheath may extend distally from the bearing housing”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date to combine the modified disclosure of Struthers with the teaching of Charafeddine to have transfer and receive a rotational movement (see Para 12).
Regarding Claim 13 , Struthers further teaches the modified blood pump of above, further comprising: a motor drive shaft (see Para 62: “the motor 302 includes a flexible drive line 320”), and wherein the elongate core member has a proximal portion coupled with the motor drive shaft to receive rotational movement from the motor drive shaft (see Para 62: “the motor 302 includes a flexible drive line 320 coupled to the motor 302, extending through an interior chamber 322 of the pivotable housing connector 310, and coupled to the driving magnet 318”).
Regarding Claim 15, Struthers further teaches the modified blood pump of above, further comprising: a magnetic assembly coupled with the distal portion of the flexible elongate shaft, and wherein the magnetic assembly is configured to drive the impeller in response to actuation of the motor (see Para 62: “the motor 302 includes a flexible drive line 320 coupled to the motor 302, extending through an interior chamber 322 of the pivotable housing connector 310, and coupled to the driving magnet 318. The flexible drive line 320 is configured to be caused to rotate by the motor and, in turn, rotate the driving magnet 318 which, in the illustrated embodiment, is disposed in the impeller assembly housing 308”).
Regarding Claim 16, Struthers further teaches the modified blood pump of above, wherein the magnetic assembly comprises: a driven magnet coupled with the impeller (see Para 15: “the impeller assembly includes a driven magnet assembly coupled to the impeller”); and a drive magnet fluidly isolated from the driven magnet and coupled with the distal portion of the flexible elongate shaft to drive the driven magnet in response to actuation of the motor (also see Para 56: “The impeller assembly 206 further includes a driven magnet 216 coupled to, and at least partially surrounding, the drive shaft 212 and/or the impeller 214. The driven magnet 216 may be any type of magnetic rotor capable of being driven by a driving magnet assembly 218. In this manner, as a magnetic field is applied to the driven magnet 216 by the driving magnet assembly 218, the driven magnet 216 rotates, causing the drive shaft 212 and impeller 214 to rotate”; also, Para 60: “magnetic coupling may be used to transfer torque from the motor to the impeller across the pivotable housing connector ... For example, in embodiments, the motor may be a direct drive motor configured to drive a flexible drive shaft (e.g., a drive line) that passes through the pivotable housing connector. In embodiments, to preserve the benefits of using a magnetic drive (e.g., sealing the driving magnet from the blood flow, etc.), a flexible drive line may be used”; examiner interpret that “sealing the driving magnet from the blood flow” corresponds to a driving magnet being fluidly isolated, also Para 53: “By isolating the motor from the impeller in an enclosed housing, the motor is protected from corrosive biological factors that may shorten the lifespan of the motor”).
Regarding Claim 17, Struthers further teaches the modified blood pump of above, further comprising: a driven shaft having a proximal portion extending through the bearing assembly and a distal portion coupled with the drive magnet (see Para 47: “the impeller assembly 106 includes a drive shaft 110 and an impeller 112 coupled thereto, where the drive shaft 110 is configured to rotate with the impeller 112. As shown, the drive shaft 110 is at least partially disposed within the impeller 112” and Para 48: “the impeller assembly 106 may be maintained in its orientation by the drive shaft 110, which may be retained by one or more bearing assemblies” and Para 62: “The impeller assembly 306 may further include a driven magnet 316 coupled to at least one of the drive shaft 312 and the impeller 314”).
Regarding Claim 18, Struthers further teaches the modified blood pump of above, wherein the flexible elongate shaft has an elongate core member having a distal portion extending through the bearing assembly and coupled with the drive magnet (see Para 62: “the motor 302 includes a flexible drive line 320 coupled to the motor 302, extending through an interior chamber 322 of the pivotable housing connector 310, and coupled to the driving magnet 318”).
Regarding Claim 19, Struthers further teaches the modified blood pump of above, wherein the elongate core member comprises a flexible portion and a rigid portion (see Para 49: “the flexible membrane may be made of any number of a variety of materials such as, for example, an accordion-like semirigid membrane material that allows deflection radially but retains push of the device axially over a wire, a polymer-covered laser cut hypo tube, and/or the like”), wherein the rigid portion extends through the bearing assembly and is coupled to the drive magnet (see Para 62: “the motor 302 includes a flexible drive line 320 coupled to the motor 302, extending through an interior chamber 322 of the pivotable housing connector 310, and coupled to the driving magnet 318”).
Regarding Claim 20, Struthers teaches a blood pump (see Abstract: “a blood pump”) comprising: an impeller housing (see Para 4: “an impeller assembly housing”);
an impeller (see Para 4: “an impeller”) disposed in the impeller housing (see Para 4: “an impeller assembly disposed within the impeller assembly housing and having an impeller”);
a bearing assembly coupled with the impeller housing at a proximal end thereof and disposed at least partially within the impeller housing (see Para 48: “the impeller assembly 106 may be maintained in its orientation by the drive shaft 110, which may be retained by one or more bearing assemblies”);
a motor housing (see Para 4: “a motor housing); a motor disposed in the motor housing (see Para 4: “a motor disposed within the motor housing and configured to drive the impeller”); and
a flexible elongate shaft (see Para 21: “the pivotable housing connector includes a flexible membrane”) having a proximal portion coupled with the motor housing (see Para 13: “a pivotable housing connector coupled to the motor housing and the impeller assembly housing,)” and a distal portion coupled with the bearing assembly (see Para 49: “the pivotable housing connector 118 is coupled, at a first end 120, to a distal end 122 of the motor housing 104 and, at a second end 124, to a proximal end 126 of the impeller assembly housing 108”).
wherein the flexible elongate shaft has a first outer diameter between the motor housing and the bearing assembly and the impeller housing has a second outer diameter that is greater than the first outer diameter (see Para 48: “the drive shaft 110 is at least partially disposed within the impeller 112”; and Para 49: “a pivotable housing connector 118 disposed between the motor housing 104 and the impeller assembly housing 108. … the pivotable housing connector 118 is coupled, at a first end 120, to a distal end 122 of the motor housing 104 and, at a second end 124, to a proximal end 126 of the impeller assembly housing 108 … the pivotable housing connector 118 may be a flexible membrane, in which case, the pivotable housing connector 118 may be able to bend in any number of different directions … the flexible membrane may be made of any number of a variety of materials such as, for example, an accordion-like semirigid membrane material that allows deflection radially but retains push of the device axially over a wire, a polymer-covered laser cut hypo tube, and/or the like”; also Para 53: “the pivotable housing connector divides the rigid length of the circulatory support device roughly in half, separating the halves of the housing which contain the motor and the impeller via a flexible connection”, and Fig. 1A, 1B, 2A, 3A and 3B).
However, Struthers doesn’t specifically teach a bearing assembly coupled with the proximal end of the impeller housing and a proximal end thereof and disposed at least partially within the impeller housing, the flexible elongate shaft having a distal portion coupled with the bearing assembly and the flexible elongate shaft has a first outer diameter between the motor housing and the bearing assembly and the impeller housing has a second outer diameter that is greater than the first outer diameter.
Charafeddine, teach a percutaneous blood pump (see Abstract) wherein a bearing assembly coupled with the impeller housing at a proximal end thereof and disposed at least partially within the impeller housing (see Para 59-60: “pump head 10 connected proximally to a bearing housing 21 by means of a distal catheter sheath 15 … an impeller 12 that is housed inside a pump housing 11” and Fig. 1-2 (bearing housing 21 and impeller 12 housed inside pump housing 11) and Para 70: “the pump housing 11, houses the impeller 12 and possibly a set of radial and axial bearings intended to center the impeller 12 inside the pump housing 11 during operation”),
a flexible elongate shaft having a proximal portion coupled with the motor housing and a distal portion coupled with the bearing assembly (see Para 12: “a bearing housing distinct from and arranged between … distal flexible sheath may extend distally from the bearing housing, wherein a proximal flexible cable extends through the proximal flexible sheath so as to receive a rotational movement caused by the electric motor and a distal flexible cable extends through the distal flexible sheath so as to transfer the rotational movement to the impeller”, also Fig. 1-2 and 4-5),
wherein the flexible elongate shaft has a first outer diameter between the motor housing and the bearing assembly and the impeller housing has a second outer diameter that is greater than the first outer diameter (see Para 6: “a housing inside which a radially pumping impeller is arranged for rotation by means of a rotating flexible cable housed inside a protective flexible catheter and attached to a bearing housing”; Para 9: “The blood pump further comprises at least one flexible sheath extending between the motor housing and the pump housing and at least one flexible cable extending through the flexible sheath” Para 60: “The pump housing 11 outer diameter may range from 3 mm to 8 mm”).
Charafeddine disclosed bearing structure located within the impeller/pump housing and coupled to the distal portion (see Para 12, 70), however fails to disclose the diameter difference for bearing assembly and impeller housing.
Another reference, Flores teach a blood pump (see Abstract), wherein the flexible elongate shaft has a first outer diameter between the motor housing and the bearing assembly and the impeller housing has a second outer diameter that is greater than the first outer diameter (see Para 97-100: “Sheath 102 has the largest diameter of any of the fixed-diameter tubes of catheter blood pump 100 … The diameter of fixed-diameter impeller 120 is at least as great as the outer diameter of sheath 102 … drive cable 116 extends essentially the full length of catheter blood pump 100, from motor assembly 670 (see FIG. 6) to fixed-diameter impeller 120. Drive cable 116 transmits torque from the drive motor to fixed-diameter impeller 120, causing the impeller to rotate at high speeds” and Para 105-106, Fig.1 (outer tube/sheath (casing surrounding the drive cable) has an outer diameter that does not exceed (i.e. is less) the diameter of impeller)).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date to combine the disclosure of Struthers with the teaching of Charafeddine and Flores to have the flexible sheath/cable to have necessarily appropriate diameters compare to each housing and assembly to connect and formed a single housing also to provide better flexibility and navigation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
EP2661303B1 – Art relevant as a whole.
WO 2015160942 A1 – Art relevant as a whole.
US 20230149691 A1 - Art relevant as a whole.
US 20210220637 A1 - Art relevant as a whole.
US 20230149692 A1 - Art relevant as a whole.
US 20200121835 A1 - Art relevant as a whole.
US 20170072120 A1 - Art relevant as a whole.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Patel Niketa can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/I.J./Examiner, Art Unit 3792
/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
Prosecution Insights