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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claim 98 – 114) in the reply filed on 06/25/2026 is acknowledged.
Claim 98 – 122 remain pending in the application;
Claim 115 – 122 are withdrawn from consideration.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 98 – 114 are rejected under 35 U.S.C. 103 as being unpatentable over Georges et al. (WO 2020/198765 A2; published on 10/01/2020) (hereinafter "Georges") in view of Thompson et al. (US 2008/0154328 A1; published on 06/26/2008) (hereinafter "Thompson").
Regarding claim 98, Georges teaches a modular implantable medical device ("Referring to Fig. 88, there is shown a modular mammalian body implantable fluid flow influencing device being a ventricle assist device (VAD) 10 …" [272]), comprising:
an implantable medical device ("… and three pumping units 14." [273]) including a device electrical connector ("There is an electrical connector tip 1045a, 1045b, 1045c on each control wire 1038a, 1038b, 1038c (respectively)." [321]);
a control element configured to be attached to and to extend from the implantable medical device ("Each pumping unit 14 has an elongate body 80 and a control wire 38." [281]; see Fig.92); and
an implantable dock ("… has a docking unit 16 …" [273]; see Fig.88 – 91),
wherein at least one of the control element and the implantable dock is moveable relative to the other one of the control element and the implantable dock ("Specifically, each pumping unit 14 is moveable at the implantation site into its docked configuration from its undocked configuration by pulling the control wire 38 of that pumping unit 14." [293]), when the control element is attached to the implantable medical device (see Fig.64 and Fig.88).
Georges fails to explicitly teach the implantable dock including a dock electrical connector configured to electrically connect to the device electrical connector, wherein at least one of the control element and the implantable dock is moveable relative to the other one of the control element and the implantable dock for establishing an electrical connection between the device electrical connector and the dock electrical connector inside a subject's body.
However, in the same field of endeavor, Thompson teaches an implantable medical device ("Referring to FIG. 1, an exemplary electrode lead 10 is shown." [0024]; "Carriers of interest include, but are not limited to, vascular lead structures, where such structures are generally dimensioned to be implantable and are fabricated from a physiologically compatible material." [0037]) including a device electrical connector ("An input structure, such as a male plug 18 may be located at a proximal end for interconnecting lead 10 ... input plug 18 includes a tip contact 20 and ring contact 22." [0025]); and
an implantable dock ("What is meant by connector is an implantable structure that physically and electrically interconnects two implantable devices or objects." [0021]; "Referring to FIG. 2, a connector 24 according to an embodiment of the invention is shown." [0026]) including a dock electrical connector configured to electrically connect to the device electrical connector ("The input plug 18 of each lead 10 is received within its own output port 26 of connector 24. Each of the two output ports 26 of connector 24 replicate the output port of the pacemaker." [0026]),
wherein at least one of the control element and the implantable dock is moveable relative to the other one of the control element and the implantable dock for establishing an electrical connection between the device electrical connector and the dock electrical connector inside a subject's body ("The input plug 18 of each lead 10 is received within its own output port 26 of connector 24." [0026]; see Fig.2; "What is meant by connector is an implantable structure that physically and electrically interconnects two implantable devices or objects." [0021]; "... each of the at least three input/output structures are electrically connected to each other." [0023[; because the connector is implanted, the electrical connection is established within patient body), when the control element is attached to the implantable medical device (considering the teaching of Georges for pulling control wire 38 to insert pumping unit 14 into docking unit 16, those are equivalent parts of the device body and connector as taught by Thompson).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the implantable device and docking unit as taught by Georges with the implantable connector and corresponding device contacts as taught by Thompson. By providing implantable electrical connector, it is possible to provide "the ability to place additional electrode leads into a subject during surgery without increasing the size of the pacemaker or other implantable device" (see Thompson; [0007]).
Regarding claim 99, Georges in view of Thompson teaches all claim limitations, as applied in claim 98, and Georges further teaches wherein the control element and the implantable dock are slidably moveable relative to each other ("Figure 7 is similar to figure 6, except that docking unit 1016 is shown. The first pumping unit 1014a has been pulled forward by its control wire 1038a having been pulled so that its docking surface (not shown) will slide along the first receiving surface 1024a of the docking unit 1016." [312]), when the control element is attached to the implantable medical device (see Fig.64 and Fig.88).
In addition, in the same field of endeavor, Thompson further teaches wherein the control element and the implantable dock are slidably moveable relative to each other for establishing the electrical connection, when the control element is attached to the implantable medical device (considering the teaching of Georges for pulling control wire 38 to insert pumping unit 14 into docking unit 16, those are equivalent parts of the device body and connector as taught by Thompson).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the implantable device and docking unit as taught by Georges with the implantable connector and corresponding device contacts as taught by Thompson. By providing implantable electrical connector, it is possible to provide "the ability to place additional electrode leads into a subject during surgery without increasing the size of the pacemaker or other implantable device" (see Thompson; [0007]).
Regarding claim 100, Georges in view of Thompson teaches all claim limitations, as applied in claim 99, and Georges further teaches wherein the control element is configured to be manipulated from outside the subject's body for moving the implantable medical device relative to the implantable dock inside the subject's body ("Once the control cable 42 is outside of the patient’s body, the control wires 38 will exit the cavity of the control cable 42 through a seal 46 and will then be individually manipulatable by the surgeon." [292]).
Regarding claim 101, Georges in view of Thompson teaches all claim limitations, as applied in claim 100, and Georges further teaches wherein the control element is configured to be pulled from outside the subject's body for moving the implantable medical device toward the implantable dock ("Figure 7 is similar to figure 6, except that docking unit 1016 is shown. The first pumping unit 1014a has been pulled forward by its control wire 1038a having been pulled so that its docking surface (not shown) will slide along the first receiving surface 1024a of the docking unit 1016." [312]).
In addition, in the same field of endeavor, Thompson further teaches wherein the control element is configured for moving the implantable medical device toward the implantable dock and for establishing the electrical connection inside the subject's body ("The input plug 18 of each lead 10 is received within its own output port 26 of connector 24." [0026]; see Fig.2; "What is meant by connector is an implantable structure that physically and electrically interconnects two implantable devices or objects." [0021]; because the connector is implanted, the electrical connection is established within patient body).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the implantable device and docking unit as taught by Georges with the implantable connector and corresponding device contacts as taught by Thompson. By providing implantable electrical connector, it is possible to provide "the ability to place additional electrode leads into a subject during surgery without increasing the size of the pacemaker or other implantable device" (see Thompson; [0007]).
Regarding claim 102, Georges in view of Thompson teaches all claim limitations, as applied in claim 101, and Georges further teaches wherein the control element is further moveable relative to the implantable dock for disconnecting the electrical connection between the device electrical connector and the dock electrical connector inside the subject's body, when the control element is attached to the implantable medical device ("Also, each pumping unit 14 is moveable at the implantation site from the docked configuration into the undocked configuration by pushing the control wire 38 of that pumping unit 14." [293]; disconnecting the electrical connection is the predictable result of undocking operation, considering the teaching of Thompson).
Regarding claim 103, Georges in view of Thompson teaches all claim limitations, as applied in claim 102, and Georges further teaches wherein the control element is configured to be pushed from outside the subject's body for moving the implantable medical device away from the implantable dock and for disconnecting the electrical connection between the device electrical connector and the dock electrical connector inside the subject's body, when the control element is attached to the implantable medical device ("Also, each pumping unit 14 is moveable at the implantation site from the docked configuration into the undocked configuration by pushing the control wire 38 of that pumping unit 14." [293]; disconnecting the electrical connection is the predictable result of undocking operation, considering the teaching of Thompson).
Regarding claim 104, Georges in view of Thompson teaches all claim limitations, as applied in claim 103, and Georges further teaches wherein the control element is configured to be attached to and extend from the end of the implantable medical device ("Each pumping unit 14 has an elongate body 80 and a control wire 38." [281]; see Fig.92).
In addition, in the same field of endeavor, Thompson teaches the device electrical connector is located on the end of the implantable medical device ("An input structure, such as a male plug 18 may be located at a proximal end for interconnecting lead 10 ... input plug 18 includes a tip contact 20 and ring contact 22." [0025]), therefore, the control element is configured to be attached to and extend from the device electrical connector.
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the implantable device and docking unit as taught by Georges with the implantable connector and corresponding device contacts as taught by Thompson. By providing implantable electrical connector, it is possible to provide "the ability to place additional electrode leads into a subject during surgery without increasing the size of the pacemaker or other implantable device" (see Thompson; [0007]).
Regarding claim 105, Georges in view of Thompson teaches all claim limitations, as applied in claim 103, and Thompson further teaches wherein the control element is configured to be removed from the implantable medical device, when the device electrical connector and the dock electrical connector are electrically connected together ("The electrode lead 107 is placed in the heart using standard cardiac lead placement devices which include introducers, guide catheters, guidewires, and/or stylets." [0046]; removing introducers or wires are typical operation after the device placement).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the implantable device and docking unit as taught by Georges with the implantable connector and corresponding device contacts as taught by Thompson. By providing implantable electrical connector, it is possible to provide "the ability to place additional electrode leads into a subject during surgery without increasing the size of the pacemaker or other implantable device" (see Thompson; [0007]).
Regarding claim 106, Georges in view of Thompson teaches all claim limitations, as applied in claim 103, and Thompson further teaches wherein the implantable dock is configured for the implantable medical device to be to electrically operated therethrough, when the device electrical connector and the dock electrical connector are electrically connected together ("The input plug 18 of each lead 10 is received within its own output port 26 of connector 24." [0026]; see Fig.2; "What is meant by connector is an implantable structure that physically and electrically interconnects two implantable devices or objects." [0021]; "... a device such as a pacemaker, allowing individual electrodes and/or electrode segments on multiple leads to be individually addressed and operated." [0022]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the implantable device and docking unit as taught by Georges with the implantable connector and corresponding device contacts as taught by Thompson. By providing implantable electrical connector, it is possible to provide "the ability to place additional electrode leads into a subject during surgery without increasing the size of the pacemaker or other implantable device" (see Thompson; [0007]).
Regarding claim 107, Georges in view of Thompson teaches all claim limitations, as applied in claim 106, and Georges further teaches wherein the implantable dock comprises an extension ("… the device further comprises a control cable attached to the docking unit.").
In addition, Thompson further teaches wherein the implantable dock comprises an extension configured for the implantable medical device to be electrically operated therethrough, when the device electrical connector and the dock electrical connector are electrically connected together ("... each contact of each output port 26 is electrically connected in parallel to the corresponding contact on input plug 18 of connector 24, such that each output structure includes at least one contact that is electrically connected to a corresponding contact on the input structure." [0026]; see Fig.2).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the implantable device and docking unit as taught by Georges with the implantable connector and corresponding device contacts as taught by Thompson. By providing implantable electrical connector, it is possible to provide "the ability to place additional electrode leads into a subject during surgery without increasing the size of the pacemaker or other implantable device" (see Thompson; [0007]).
Regarding claim 108, Georges in view of Thompson teaches all claim limitations, as applied in claim 107, and Georges further teaches wherein the control element and the extension are slidably moveable relative to each other, when the control element is attached to the implantable medical device ("... once the control cable has exited the body of the patient, the control wires exit the control cable cavity such that each of the control wires and the control cable itself are individually actionable by the surgeon (without actioning the others)." [96]; "Figure 7 is similar to figure 6, except that docking unit 1016 is shown. The first pumping unit 1014a has been pulled forward by its control wire 1038a having been pulled so that its docking surface (not shown) will slide along the first receiving surface 1024a of the docking unit 1016." [312]).
In addition, Thompson further teaches wherein the control element and the extension are moveable relative to each other for establishing the electrical connection, when the control element is attached to the implantable medical device ("What is meant by connector is an implantable structure that physically and electrically interconnects two implantable devices or objects." [0021]; considering the teaching of Georges for pulling control wire 38 to insert pumping unit 14 into docking unit 16, those are equivalent parts of the device body and connector as taught by Thompson).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the implantable device and docking unit as taught by Georges with the implantable connector and corresponding device contacts as taught by Thompson. By providing implantable electrical connector, it is possible to provide "the ability to place additional electrode leads into a subject during surgery without increasing the size of the pacemaker or other implantable device" (see Thompson; [0007]).
Regarding claim 109, Georges in view of Thompson teaches all claim limitations, as applied in claim 108, and Georges further teaches wherein the extension is configured to be manipulated from outside the subject's body for moving the implantable dock relative to the implantable medical device inside the subject's body ("... once the control cable has exited the body of the patient, the control wires exit the control cable cavity such that each of the control wires and the control cable itself are individually actionable by the surgeon (without actioning the others)." [96]).
Regarding claim 110, Georges in view of Thompson teaches all claim limitations, as applied in claim 109, and Georges further teaches wherein the extension is configured to be pushed from outside the subject's body for moving the implantable dock toward the implantable medical device and for establishing the electrical connection inside the subject's body ("… wherein guiding the first functional unit and the docking unit within the delivery sheath to the implantation site includes pushing the docking unit." X-206).
Regarding claim 111, Georges in view of Thompson teaches all claim limitations, as applied in claim 110, and Georges further teaches wherein the extension is moveable relative to the control element for disconnecting the electrical connection between the device electrical connector and the dock electrical connector inside the subject's body, when the control element is attached to the implantable medical device ("In such an implementation, direct retrieval of the device by placing the functional units into the undocked configuration and then pulling the components out via their cables …" [213]).
Regarding claim 112, Georges in view of Thompson teaches all claim limitations, as applied in claim 111, and Georges further teaches wherein the extension is configured to be pulled from outside the subject's body for moving the implantable dock away from the implantable medical device and for disconnecting the electrical connection between the device electrical connector and the dock electrical connector inside the subject's body, when the control element is attached to the implantable medical device ("In such an implementation, direct retrieval of the device by placing the functional units into the undocked configuration and then pulling the components out via their cables …" [213]).
Regarding claim 113, Georges in view of Thompson teaches all claim limitations, as applied in claim 112, and Thompson further teaches wherein the electrical connection between the device electrical connector and the dock electrical connector is for electrically operating the implantable medical device inside the subject's body ("The input plug 18 of each lead 10 is received within its own output port 26 of connector 24." [0026]; see Fig.2; "What is meant by connector is an implantable structure that physically and electrically interconnects two implantable devices or objects." [0021]; "... a device such as a pacemaker, allowing individual electrodes and/or electrode segments on multiple leads to be individually addressed and operated." [0022]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the implantable device and docking unit as taught by Georges with the implantable connector and corresponding device contacts as taught by Thompson. By providing implantable electrical connector, it is possible to provide "the ability to place additional electrode leads into a subject during surgery without increasing the size of the pacemaker or other implantable device" (see Thompson; [0007]).
Regarding claim 114, Georges in view of Thompson teaches all claim limitations, as applied in claim 98 – 113, and Georges further teaches wherein the implantable medical device is a transcatheterly implantable blood pump (“A transcatheterly-implantable modular pump assembly can (once assembled in vivo ) employ multiple pumping units in parallel” [42]; "… the first functional unit, the second functional unit (where present) and the third functional unit (where present) are each a pumping unit." [211]; "… the conduit system of the body is the vasculature and heart chambers of the body, and the fluid is blood." [212]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
North (US 2010/0331924 A1; published on 12/30/2010) teaches an implantable medical device connector. Multiple leads with electrical contacts are inserted into the connector to establish electrical connection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHAO SHENG whose telephone number is (571)272-8059. The examiner can normally be reached Monday to Friday, 8:30 am to 5:00 pm.
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/CHAO SHENG/ Primary Examiner, Art Unit 3797
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