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 US Application no. 17/071,463, now US Patent no. 11,883,673, filed 15 October 2020, which claims the benefit of domestic priority from US Provisional Application no. 62/927,329 filed 29 October 2019.
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, 2, 7-12, and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wasson et al. (US Publication no. 2018/0333586 – disclosed by Applicant).
In regard to claim 1, Wasson et al. discloses an implantable medical device (IMD 15, or in exploded/cutaway views of figures 2 or 4A,B), comprising:
a battery 48;
an electronics module 58 (comprising electronic circuitry 56) electrically connected to the battery 48 (para 50, power connector 49 extends from power source 48 through passageway 52 to electrically connect to electronic circuitry 56);
an elongated housing 30, the battery at least partially contained within the elongated housing (para 49, the IMD includes case 30);
a tissue fixation element 42, 44 disposed at a first end of the elongated housing 30 (para 56);
an external electrode 40 disposed at the first end of the elongated housing 30, the electrode 40 in electrical communication with the electronics module 58 (Para 56, tip electrode 40 is connected to electronic circuitry 56 to provide electrical stimulation therapy);
wherein the electronics module 58 comprises one or more circuit layers oriented perpendicular to a longitudinal axis of the elongated housing (figures 2, and 4A,B depict the electronics package 58 are being oriented perpendicular to the longitudinal axis 59 of case 30; figure 4D shows a detailed view of the electronics package 58 comprising layers 123, 134, and 136 (layers described in para 89), wherein said layers are also perpendicular to axis 59).
In regard to claim 2, Wasson et al. in figure 4D depict the electronics module 58 comprising a plurality of circuit layers 132, 134, 135 located adjacent to each other and oriented perpendicular to the longitudinal axis of the elongated housing (para 89, discrete module layer 132, die module layer 134, passive component network layer 136, wherein said layers resides within package 58, wherein said package comprising said layers is perpendicular to longitudinal axis 59).
In regard to claim 7, Wasson et al. explicitly teach that the fixation element 42, 44 may comprise a helix configured to penetrate heart tissue (para 60, fixation mechanism may be a screw, wherein a screw is recognized as being helical).
In regard to claim 8, Wasson et al. explicitly teach that the fixation element 42, 44 comprises tines configured to penetrate heart tissue (para 60, fixation mechanisms 42 and 44 may be flexed forward to pierce tissue).
In regard to claim 9, Wasson et al. explicitly teach the electronics module 58 is located longitudinally between the battery 48 and the first end 38 of the elongated housing 30 (para 55, longitudinal axis 59 orients the battery 48 longitudinally with electronics package 58, that package 58 resides between battery 48 and end cap 38).
In regard to claim 10, Wasson et al. explicitly teach the external electrode 40 is electrically isolated from the elongated housing 30 (para 58, case 30 and cap 38 may be an electrically insulating material, or otherwise electrically insulated relative to electrode 40).
In regard to claim 11, Wasson et al. disclose an implantable medical device (IMD 15 of figure 2 or exploded/cutaway views of fig. 4A,B) comprising:
an elongated housing 30 (para 48, case 30);
a distal end portion comprising a distal-facing external electrode 40 and a tissue fixation element 42,44 that extends at least in part in the distal direction from a position near the external electrode 40 (para 56, the tip electrode 40 is considered located at a distal tip of housing 30);
an electronics module 58 electrically connected to the external electrode 40 via a feedthrough pin 116 (para 86, conductor 116 serves as a feedthrough to connect electronics package 58 to electrode 40; another feedthrough pin 49 connected battery 48 to electronics module 58);
wherein the electronics module 58 comprises one or more circuit layers oriented perpendicular to a longitudinal axis of the elongated housing (figures 2, and 4A,B depict the electronics package 58 are being oriented perpendicular to the longitudinal axis 59 of case 30; figure 4D shows a detailed view of the electronics package 58 comprising layers 123, 134, and 136 (layers described in para 89), wherein said layers are also perpendicular to axis 59).
In regard to claim 12, Wasson et al. in figure 4D depict the electronics module 58 comprising a plurality of circuit layers 132, 134, 135 located adjacent to each other and oriented perpendicular to the longitudinal axis of the elongated housing (para 89, discrete module layer 132, die module layer 134, passive component network layer 136, wherein said layers resides within package 58, wherein said package comprising said layers is perpendicular to longitudinal axis 59).
In regard to claim 17, Wasson et al. explicitly teach that the fixation element 42, 44 may comprise a helix configured to penetrate heart tissue (para 60, fixation mechanism may be a screw, wherein a screw is recognized as being helical).
In regard to claim 18, Wasson et al. explicitly teach that the fixation element 42, 44 comprises tines configured to penetrate heart tissue (para 60, fixation mechanisms 42 and 44 may be flexed forward to pierce tissue).
In regard to claim 19, Wasson et al. explicitly include a battery 48; wherein the electronics module 58 is located longitudinally between the battery 48 and the distal end portion 40 (para longitudinal axis 59 aligns the battery 48, electronics module 48 with the tip electrode 40).
In regard to claim 20, Wasson et al. explicitly teach the external electrode 40 is electrically isolated from the elongated housing 30 (para 58, case 30 and cap 38 may be an electrically insulating material, or otherwise electrically insulated relative to electrode 40).
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) 3-6 and 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wasson et al. (US Publication no. 2018/0333586 – disclosed by Applicant) in view of Sahabi et al. (US Publication no. 2016/0296760 – disclosed by Applicant).
In regard to claims 3, 4, 13, and 14, Wesson et al. substantially describes the invention as claimed, however does not teach the IMD comprising a first spring contact positioned between the battery and the electronics module, or between the electronics module and the end cap. Sahibi et al. describes an IMD similar to the present invention comprising an elongate housing 102, electronic module 110, fixation mechanism 105, distal electrode 106 (figure 1, para 30-31), and battery subassembly 206 connected to electronics module subassembly 202 (figure 2, para 34). Referring to the features of figure 2, Sahibi et al. show the arrangement of the battery subassembly 206 connected to electronics module subassembly 202 comprising electronics package 208, wherein figure 4 shows the electronics package 202/208 is connected to the battery subassembly 206 by a spring contacts 262 (para 41). Another spring connector 261 connects electronics package 202/208 to feedthrough assembly 204 at the distal end cap (para 41-42). The spring connector 262 is considered to comprise the claimed embodiment of the spring contact positioned between the battery and the electronics module. The spring connector 261 considered to comprise the claimed embodiment of the spring contact positioned between the electronics module and the end cap.
In view of this, it is considered to have been obvious to one of ordinary skill in the art to modify Wesson et al. to include spring contact between the end cap 38 and electronics package 58 and spring contact between electronics package 58 and battery 48 as a substitute to a rigid electrical connection as a predictable solution for maintaining electrical continuity across components under variable mechanical movements or variations in dimensional tolerance conditions.
In regard to claims 5 and 15, Wesson et al. substantially describes the invention as claimed, however does not teach when assembled, at least one of the first spring contact or the second spring contact applies pressure in a direction parallel to a longitudinal axis of the housing and toward the electronics module. As modified in view of the teachings of Sahibi et al. with respect to the location of the spring contacts 261 and 262 between the battery subassembly and electronics subassembly and between electronics subassembly and feedthrough subassembly, pressure is considered necessarily exerted in this direction in order to maintain alignment and ensure electrical contact between elements. Therefore, it is considered to have been obvious to one of ordinary skill in the art that, when a spring contact is positioned between components arranged along the longitudinal axis, the spring contact would apply a compressive force or pressure in a direction parallel to the longitudinal axis and toward the electronics module, since the spring contacts 261 and 262 of Sahibi et al. would necessarily apply a force along their axis of compression thereby stabilizing elements in alignment with and electrical contact with another.
In regard to claims 6 and 16, Wesson et al. shows that the elongated housing 30 comprises a side wall 47, and the side wall is positioned between the battery 48 and the electronics module 58 (para 52, top surface 47 is the top surface of power source 48 that is situated between the battery 48 and electronics package 58).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Rettedal et al. (US Publication no. 2013/0197323) is directed to an electronic device for use in animal monitoring. This reference is cited since the configuration of the device shown in figure 4 includes an elongated housing with a battery 120, electronics module 104 electrically connected to battery 120, wherein the electronics module 104 includes a printed circuit board layer oriented perpendicular to the longitudinal axis 108 of the device.
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 14 April 2026
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