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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/23/26 has been entered.
Election/Restrictions
Claims 12-17 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/27/26.
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.
Claims 1-4, 10, 11, 20, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Verzal et al (2020/0086117) in view of Zhang et al (7706866). Verzal discloses the claimed elements as follows:
--a device housing configured to be implanted having a first external surface (e.g. para. 93, figure 15b, element 52, figures 1-13, element 52, etc.) that is configured to be in contact with a biocompatible electrical insulator (Note that the insulator is not being positively recited, any biocompatible electrical insulator such as parylene may be placed in contact with the external surface. In addition, the battery housing has an insulator on it, paras. 57-58, and therefore is in contact with the insulator, etc.)
--a first electrode on the device housing (e.g. figures 8-10, para. 93 stating fig 15b can use any of the features of the previous disclosed embodiments, etc.)
--a header unit (e.g. figure 15b, element 498, etc.) that is configured to be in contact with a biocompatible insulator (Note that the insulator is not being positively recited, any biocompatible electrical insulator such as parylene may be placed in contact with the external surface. In addition, the battery housing has an insulator on it, paras. 57-58, etc.)
--an electrical component housed within the device housing (e.g. circuitry 59, etc.)
--a battery external to the device housing and hermetically sealed to provide power to the electrical component (e.g. figures 1-13, 15b, element 62/69, paras. 57-58, 51, etc.)
--an internal surface in contact with a voltaic cell of the battery (e.g. para. 51, etc., necessarily requiring internal contact as the internal surface is connected to the battery, whether directly or through other elements)
--a third external surface configured to be in contact with the biocompatible electrical insulator (Note that the insulator is not being positively recited, any biocompatible electrical insulator such as parylene may be placed in contact with the external surface. In addition, the battery housing has an insulator on it, paras. 57-58, etc.)
Verzal discloses the electrodes can be sources or sinks (positive or negative) but does not disclose the header has an electrode (a second electrode) on the header external surface where the second electrode can sink stimulation. Zhang teaches that it is known to have an implantable medical device having multiple electrodes on the device housing and header (e.g. col. 4, lines 15-40, col. 5, lines 4-11, figures 1, 6, etc.) to allow the device to choose the best electrode(s) for sensing or stimulation, such as the second electrode being a sink (e.g. col. 6, lines 29-62, col. 9, line 42 to col. 12, line 62, etc.). It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Verzal, with a second electrode on the header external surface for sensing or being a stimulation sink, as taught by Zhang, since it would provide the predictable results of allowing the device to choose the best electrode(s) for sensing or being a stimulating sink from multiple electrodes on the device to provide the best way to sense the cardiac signal or deliver therapy.
For claims: 2, internal surface and external surface are opposing surfaces (e.g. see figures 1-13, 15b, etc.); 3, a negative terminal of the battery (e.g. para. 51, etc.); 4, electrode in contact with tissue, stimulation circuitry, to make electrode a current source or sink (e.g. figures 8-10, paras. 13, 60, 108-113, etc.); 10, first electrode isolated from battery housing by the insulator (e.g. paras. 45, 58, 126, etc.); 11, parylene (e.g. para. 58, etc.).
Claims 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Verzal et al in view of Zhang et al (i.e. “modified Verzal”) and further in view of Starke et al (2018/0028821). Modified Verzal discloses the claimed invention but does not discuss a second insulator that electrically insulates the battery housing from the device housing, such as the insulator attaching the device housing to the battery housing, and the device housing and battery housing being a ceramic material. Starke discloses a second insulator that electrically insulates the battery housing from the device housing, such as the insulator attaching the device housing to the battery housing, and the device housing and battery housing being a ceramic material, so as to provide proper electrical isolation between components/housings of the device and provide a conventional device housing that is biocompatible and provides high wear resistance and is RF transparent. Starke has the second/other insulators in the feedthrough (e.g. figure 6, multiple elements 61, which necessarily are biocompatible due to their material and since it is contacting internal tissue). As the feedthrough has multiple layers of insulation and hermetically seals each housing, the housings are in direct contact with the insulator and voltaic cell, and also in indirect contact with the other insulators and cell through the other components in the system (note that the claims do not state that the components are in “direct” contact with other specific elements/components). Starke discloses that the housing and insulators may be ceramic (e.g. paras. 16, 31, 39, etc.) or parylene (e.g. paras. 29, 48, etc.). It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by modified Verzal, with a second insulator that electrically insulates the battery housing from the device housing, such as the insulator attaching the device housing to the battery housing, and the device housing and battery housing being a ceramic material, as taught by Starke, so as to provide the predictable results of proper electrical isolation between components/housings of the device and provide conventional device housings that are biocompatible and provide high wear resistance and are RF transparent.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot in view of the new ground of rejection necessitated by amendment.
Conclusion
The prior art made of record is considered pertinent to applicant's disclosure and show several other pieces of prior art that are capable of meeting the limitations of the claims and the use of external electrodes on the outside of a housing.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/George R Evanisko/Primary Examiner, Art Unit 3792 9/5/26
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