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 .
Priority
This application is a continuation of PCT/US2022/031627 filed 31 May 2022, which claims the benefit of domestic priority from US Provisional Application no. 63/196,078 filed 2 June 2021.
Claim Objections
Claim 6 is objected to because of the following informalities: line 2 recites “elongate lead” which is inconsistent with earlier terminology reciting “elongate power lead”. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: line 18 recites “…the at least a distal portion…” is considered to better read as “…at least the distal end portion” which would be consistent with earlier recited terminology. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: line 9 recites “…to releasable connect…” is considered to better read as “…to releasably connect…”. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: line 19 recites “…on exposed on…” is considered to better read as “…exposed on…”. Appropriate correction is required.
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.
Claim(s) 1, 7, and 14-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Petersen (US Publication no. 2019/0290816 – disclosed by Applicant).
In regard to claim 1, Petersen discloses a blood flow assist system (i.e., a ventricular assist device “VAD”, para 2) comprising:
a blood pump 12 (para 45, medical device 12 which is described as a VAD type blood pump in para 42, see figure 17);
an elongate power lead (driveline 26) having a distal end portion connected to the blood pump and a proximal end portion opposite the distal end portion (e.g., figure 1 showing driveline 26 connecting an implantable device 12 to a connector assembly 40 at the proximal end of the drive line), the power lead 26 comprising:
a lumen extending distally from the proximal end portion of the power lead along a longitudinal axis of the blood flow assist system (not explicitly shown, however see figure 6 in which a plurality of conductor leads 68, 70, 72, 74, 76, and 78 for transmission of electrical power extend through the drive line and extend through the driveline as shown in figure 17, wherein a lumen is necessary part of the drive line to conceal and carry leads 68, 70, 72, 74, 76, and 78 carried therethrough);
one or more electrical contacts 54 disposed on an outer surface of the lead at the proximal end portion (i.e., the contact assembly 40) of the elongate power lead 26 (para 51); and
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a recess extending into the proximal portion 40 of the power lead 26 in a direction transverse to the longitudinal axis, the recess configured to receive a locking pin 56/60 to releasably connect the power lead to an external device (para 51-52, 57, figure 7 shown below, a recess houses pins 56/60, wherein protruding pin 56/60 connects contact assembly 40 to the contact assembly 32 of driveline 22)
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Also see paragraph 10 of Peterson which teaches that the electrical contacts of the first driveline contact assembly are aligned with first electrical contacts of the distal driveline contact assembly when the first protruding pin is disposed in the recess of the first driveline contact assembly. In regard to claim 7, Petersen shows the one or more electrical contacts 54 are disposed distal the recess (fig. 6, para 51).
In regard to claim 14, Petersen discloses a percutaneous medical system (i.e., a ventricular assist device “VAD”, para 2) comprising: a medical device 12 (para 45, medical device 12 which is described as a VAD type blood pump in para 42, see figure 17); an elongate lead (driveline 26) having a distal end portion connected to the medical device 12 and a proximal end portion opposite the distal end portion (e.g., figure 1 showing driveline 26 connecting an implantable device 12 to a connector assembly 40 at the proximal end of the drive line), the lead 26 comprising: a lumen extending distally from the proximal end portion of the lead along a longitudinal axis of the system (not explicitly shown, however see figure 6 in which a plurality of conductor leads 68, 70, 72, 74, 76, and 78 for transmission of electrical power extend through the drive line and extend through the driveline as shown in figure 17, wherein a lumen is necessary part of the drive line to conceal and carry leads 68, 70, 72, 74, 76, and 78 carried therethrough); and a recess extending into the proximal end portion 40 of the lead 26 in a direction transverse to the longitudinal axis, the recess configured to receive a locking pin 56/60 to releasably connect the lead to an external device (para 51-52, 57, figure 7 shown below, a recess houses pins 56/60, wherein protruding pin 56/60 connects contact assembly 40 to the contact assembly 32 of driveline 22)
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Also see paragraph 10 of Peterson which teaches that the electrical contacts of the first driveline contact assembly are aligned with first electrical contacts of the distal driveline contact assembly when the first protruding pin is disposed in the recess of the first driveline contact assembly.
In regard to claim 15, Petersen teaches the elongate lead 26 comprises an elongate power lead 68/74 configured to convey current to the medical device 12 (para 51, first and second positive leads 68, 74 and the first and second ground leads 70, 76 provide for redundant power transmission through the distal driveline 26).
In regard to claim 16, Petersen teaches one or more electrical contacts 54 disposed on an outer surface of the lead 26 at the proximal end portion (i.e., the contact assembly 40) of the elongate power lead 26 (para 51, figures 6 and 7).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2-4, 6, 17-19, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Petersen (US Publication no. 2019/0290816 – disclosed by Applicant) in view of Arnold et al. (US Publication no. 2018/0236150 – disclosed by Applicant).
In regard to claim 2, Petersen describes the invention as claimed, however does not describe wherein the lumen is an inner lumen and further comprising a plurality of outer lumens disposed around the inner lumen, the plurality of outer lumens extending along the longitudinal axis. The driveline 26 of Petersen comprises multiple lead conductors 68, 70, 72, 74, 76, and 78, but does not teach anything pertaining to the construction of the cable in which lead conductors extend. Arnold et al. describe a percutaneous connector cable for use with heart assist devices (FIG. 1, Abstract, para 15) and discloses construction details of the body, specifically wherein the lumen is an inner lumen (13, FIG. 2) and further comprising a plurality of outer lumens disposed around the inner lumen (14', 15', FIG. 2, para 55), the plurality of outer lumens extending along the longitudinal axis (para 55, implantable cable element 1 is represented in FIG. 2 in detail and in cross section). It would have been obvious to one skilled in the art to provide a central lumen (for a strain relief element) and concentrically disposed lumens (for the conductors) as disclosed by Arnold et al. to impart flexibility to the implantable cable.
In regard to claim 3, Petersen describes the invention as claimed, however does not describe a plurality of elongate conductors, each elongate conductor of the plurality of elongate conductors extending through a corresponding outer lumen of the plurality of outer lumens. The driveline 26 of Petersen comprises multiple lead conductors 68, 70, 72, 74, 76, and 78, but does not teach anything about the conductors in separate lumens. Arnold et al. describe a plurality of elongate conductors, each elongate conductor of the plurality of elongate conductors extending through a corresponding outer lumen of the plurality of outer lumens (14/15, FIG. 2, para 55, conductors 14, 15, of which eight are present around the tension relief element 12 in the represented example, are in each case individually surrounded by an insulation 14', 15', wherein the insulations apart from effecting the electrical insulation of the conductors to one another also effect a slight sliding to one another).
In regard to claim 4, Peterson describes the one or more electrical contacts 54 comprises a plurality of electrical contacts spaced apart along the longitudinal axis on the outer surface of the lead, wherein each elongate conductor of the plurality of elongate conductors is electrically connected to a corresponding electrical contact of the plurality of electrical contacts (FIGS. 6-7, para 51, each of the distal driveline conductive leads 68, 70, 74, 74 is electrically connected with a respective one of the first set of distal driveline electrical contacts 54 and with a respective one of the second set of distal driveline electrical contacts 58).
In regard to claim 6, Petersen describes the invention as claimed, however does not describe the elongate lead comprises an insulating material along an outer surface thereof, the insulating material comprising polyurethane. Arnold et al. describe wherein the elongate lead comprises an insulating material along an outer surface thereof, the insulating material comprising polyurethane (para 58-59, The stranded group of conductors 14, 15 for its part is covered radially to the outside by a combination of a metal-coated plastic non-woven and a braiding of copper stands, and these form an electrical shielding 41. The strand braiding can thereby be integrated and moulded into the cable sheath as a reinforcement of this Materials such as polyurethane and silicones are considered, in order to meet the demands placed on the cable sheath).
In regard to claim 17, Petersen describes the invention as claimed, however does not describe a plurality of outer lumens disposed around the lumen, the plurality of outer lumens extending along the longitudinal axis. The driveline 26 of Petersen comprises multiple lead conductors 68, 70, 72, 74, 76, and 78, but does not teach anything pertaining to the construction of the cable in which lead conductors extend. Arnold et al. describe a percutaneous connector cable for use with heart assist devices (FIG. 1, Abstract, para 15) and discloses construction details of the body, specifically wherein the lumen is an inner lumen (13, FIG. 2) and further comprising a plurality of outer lumens disposed around the inner lumen (14', 15', FIG. 2, para 55), the plurality of outer lumens extending along the longitudinal axis (para 55, implantable cable element 1 is represented in FIG. 2 in detail and in cross section). It would have been obvious to one skilled in the art to provide a central lumen (for a strain relief element) and concentrically disposed lumens (for the conductors) as disclosed by Arnold et al. to impart flexibility to the implantable cable.
In regard to claim 18, Petersen describes the invention as claimed, however does not describe a plurality of elongate conductors, each elongate conductor of the plurality of elongate conductors extending through a corresponding outer lumen of the plurality of outer lumens. The driveline 26 of Petersen comprises multiple lead conductors 68, 70, 72, 74, 76, and 78, but does not teach anything about the conductors in separate lumens. Arnold et al. describe a plurality of elongate conductors, each elongate conductor of the plurality of elongate conductors extending through a corresponding outer lumen of the plurality of outer lumens (14/15, FIG. 2, para 55, conductors 14, 15, of which eight are present around the tension relief element 12 in the represented example, are in each case individually surrounded by an insulation 14', 15', wherein the insulations apart from effecting the electrical insulation of the conductors to one another also effect a slight sliding to one another).
In regard to claim 19, Peterson describes the one or more electrical contacts 54 comprises a plurality of electrical contacts spaced apart along the longitudinal axis on the outer surface of the lead, wherein each elongate conductor of the plurality of elongate conductors is electrically connected to a corresponding electrical contact of the plurality of electrical contacts (FIGS. 6-7, para 51, each of the distal driveline conductive leads 68, 70, 74, 74 is electrically connected with a respective one of the first set of distal driveline electrical contacts 54 and with a respective one of the second set of distal driveline electrical contacts 58).
In regard to claim 21, Petersen describes the invention as claimed, however does not describe the elongate lead comprises an insulating material along an outer surface thereof, the insulating material comprising polyurethane. Arnold et al. describe wherein the elongate lead comprises an insulating material along an outer surface thereof, the insulating material comprising polyurethane (para 58-59, The stranded group of conductors 14, 15 for its part is covered radially to the outside by a combination of a metal-coated plastic non-woven and a braiding of copper stands, and these form an electrical shielding 41. The strand braiding can thereby be integrated and moulded into the cable sheath as a reinforcement of this Materials such as polyurethane and silicones are considered, in order to meet the demands placed on the cable sheath).
Claim(s) 5 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Petersen (US Publication no. 2019/0290816 – disclosed by Applicant) in view of Bernstein (US Publication no. 2017/0188903 – disclosed by Applicant).
In regard to claim 5, Petersen describes the invention as claimed, however does not teach wherein each electrical contact of the plurality of electrical contacts comprises a ring, wherein adjacent electrical contacts are spaced apart by an insulating material. Petersen does describe the contacts 54 as multiple segments which collectively may form a ring as well as multiple concentric sets of such arcs (FIGS. 6-7, para 51) so as to maintain connection during rotation (para 16). Berstein describes an internal medical device with an percutaneous electrical connector for interfacing with an external medical device (FIG. 2, para 46-47) wherein the external connector comprises rings 220 (FIG. 2, para 45). It would have been obvious to one skilled in the art to provide the segments of Petersen as full rings, as disclosed by Bernstein, so as to allow connection of the parts in any rotational orientation that physically mates between the two parts.
In regard to claim 20, Petersen describes the invention as claimed, however does not teach wherein each electrical contact comprises a ring, wherein adjacent electrical contacts are spaced apart by an insulating material. Petersen does describe the contacts 54 as multiple segments which collectively may form a ring as well as multiple concentric sets of such arcs (FIGS. 6-7, para 51) so as to maintain connection during rotation (para 16). Bernstein describes an internal medical device with an percutaneous electrical connector for interfacing with an external medical device (FIG. 2, para 46-47) wherein the external connector comprises rings 220 (FIG. 2, para 45). It would have been obvious to one skilled in the art to provide the segments of Petersen as full rings, as disclosed by Bernstein to allow connection of the parts in any rotational orientation that physically mates between the two parts.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Petersen (US Publication no. 2019/0290816 – disclosed by Applicant).
In regard to claim 8, Petersen may be interpreted to disclose that the recess is disposed distal to a proximal end of the elongate power lead 26 such that the recess, as described with respect to FIG. 7 above is not at the tip of the contact assembly 40. However, the present specification fails to provide adequate criticality to this location. Therefore, locating the recess distal the proximal end is considered to be an obvious modification based on choice in design.
Claim(s) 9 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Petersen (US Publication no. 2019/0290816 – disclosed by Applicant) in view of Delaney et al. (US Publication no. 2015/0025608).
In regard to claim 9, Petersen substantially describes the invention as claimed, however does not teach that a thickness of the elongate lead is not uniform along a length of the elongate lead. Delaney et al. teach a medical electrical lead that may vary in insulative material composition may vary in any direction, including along the length and/or thickness. Therefore, it is considered to have been obvious to one of ordinary skill in the art to vary the thickness of the lead to support steering through and provide conformity with the curvature of the vascular anatomy.
Claim(s) 10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Petersen (US Publication no. 2019/0290816 – disclosed by Applicant) in view of Muller (US Publication no. 2019/0015570).
In regard to claim 10, Petersen describes the invention substantially as claimed, however does not teach a delivery system to deliver the blood pump to a target location in a patient. Muller teaches a catheter based delivery system for percutaneously advancing a blood pump through the patient’s vascular system and deployed at a target location (Figs. 8-13). The delivery system includes a catheter assembly 450 and introducer to deliver the blood pump (para 49-55). It would have been obvious to one of ordinary skill in the art to provide a delivery system for the blood pump of Petersen since Muller explicitly demonstrates use of a delivery system to permit controlled, minimally invasive delivery of the pump to the desired intravascular location.
In regard to claim 12, Petersen describes the invention substantially as claimed, however does not teach a retrieval system configured to remove the blood pump from a patient. Muller also uses the catheter assembly 450 to remove and retract the blood pump from the patient when the pump is no longer required (para 55). It would have been obvious to one of ordinary skill in the art to provide a retrieval system for the blood pump of Petersen since Muller explicitly demonstrates use of a retrieval system to permit removal of the pump from a percutaneous access path in minimally invasive manner when the pump is no longer required for assist.
Allowable Subject Matter
Claims 11 and 13 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In regard to claim 11, Muller teaches the delivery system for the blood pump but does not describe the claimed proximal handle having a power lead retention and release assembly, the selectively lockable transfer stop, or the selectively lockable distal handle having a cavity that houses the blood pump. The prior art fails to teach this combination of features.
In regard to claim 13, Muller teaches the retrieval system for the blood pump but does not describe use of a retrieval dilator selectively clamped to the pump power lead or the claimed dual-connected retrieval handle. The prior art fails to teach this combination of features.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Baqar et al. (US Publication no. 2022/0193423), Laurent et al. (US Publication no. 2014/0370736), and Siebens (US Publication no. 2010/0015834) all teach use of a locking pin and recess configuration for making electrical connections. None are directed to blood pump applications.
Roelle et al. (US Publication no. 2021/0361932) is directed to a system similar to Petersen for making electrical connections in blood pumps. The connectors described in figure 2 utilize a receptable type connector.
Fantuzzi et al. (US Publication no. 2020/0330667), Fiser (US Publication no. 2014/0081289), and Chebator et al. (US Publication no. 2012/0083740) all describe introducer systems for percutaneous devices, however none teach the combination of elements as required by the claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E. Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 22 August 2026
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