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 Arguments
Applicant’s arguments filed 6/29/2026, with respect to the art of Nikolski (2021/0268297) have been fully considered and are persuasive. Nikolski is disqualified as prior art under the 102(b)(1) exception. The rejections with respect to Nikolski have been withdrawn.
Applicants amendment has overcome the previously applied 35 USC 112b rejection of claims 4 and 18. The 35 USC 11b rejection of the claims has been withdrawn.
Applicant’s amendment and arguments filed 6/29/2026, with respect to the rejection of the claims under 35 USC 103 as being obvious over Morgan in view of various references have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Morgan et al. (2007/0239244) in view of Christie et al. (2019/0111268), further in view of Foster et al. (2018/0133458). Particularly Christie discloses that placing a pacing electrode between two defibrillation electrodes on an implanted lead is a know configuration in implantable cardioverter-defibrillators.
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 1-5 and 8-19 are rejected under 35 U.S.C. 103 as being unpatentable over Morgan et al. (2007/0239244) in view of Christie et al. (2019/0111268), further in view of Foster et al. (2018/0133458).
Regarding Claims 1 and 13-15, Morgan discloses a system having a housing 70 with therapy delivery circuitry therein (Fig. 5; par. [0037]) and a lead comprising a plurality of electrodes. Morgan discloses embodiments having four electrodes (FIG. 17, 18) and discloses that the electrodes can be for pacing (Par. [0050] and also discloses that defibrillation electrodes can be included with the pacing electrodes (par. [0003]). Morgan further discloses shielding 112 over each electrode (specifically labeled in the embodiments of Fig. 5-8) but also shown unlabeled in Fig. 17, 18. Morgan fails to disclose that the pacing electrode is located between the first and second defibrillation electrode and Morgan fails to disclose a conductive surface disposed on the shield and electrically coupled to the pacing electrode.
In the same field of endeavor of implantable cardioverter-defibrillators(ICDs), Christie discloses a lead 102 with pacing and defibrillation electrodes thereon that is implantable in proximity to the heart (see Fig. 1A, B) having defibrillation electrodes 106A, B and a pacing electrode 108B located between them (see Fig. 1B; par. [0062], “Additionally or alternatively, ICD 110 may deliver pacing therapy, such as via electrodes 106, 108 and or the housing electrode of ICD 110. In an example, the pacing therapy includes anti-tachycardia pacing (ATP)”) for the purpose of effectively applying either defibrillation and/.or anti-tachyarrhythmia pacing therapy to a user. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Morgan reference to include a pacing electrode located between two defibrillation electrodes on a lead, as taught and suggested by Christie, for the purpose of effectively applying either defibrillation and/.or anti-tachyarrhythmia pacing therapy to a user.
Additionally, Foster, in the same field of endeavor of pacing and defibrillation devices, discloses a shield 320 disposable over an electrode of a lead, wherein the shield has a conductive surface for the purpose of effectively increasing the surface area of the lead but in a preferential direction (par. [0030]; Fig. 8A). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Morgan reference to include a conductive surface on the shield, as taught and suggested by Foster, for the purpose of effectively increasing the surface area of the lead but in a preferential direction.
In regard to Claims 2 and 16, Morgan discloses the shield can be silicone rubber (par [0045]).
In regard to Claims 3 and 17, Morgan discloses the shield folds or curves over the lead and Foster also discloses a foldable shield having the conductive surface thereon (Foster; Fig. 8A).
In regard to Claims 4, 5, 18 and 19, Morgan, Christie and Foster discloses shielding the electrodes with a shield that covers some but not all of the surface area of the electrode and also discloses having a conductive surface on a portion of the shield that contacts the electrode. Morgan and Foster are silent regarding the exact coverage area of the conductive surface and while the drawings disclose some but not all of the electrode is covered, these drawings are not necessarily to scale and do not provide any indication of the exact coverage area. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the conductive portion of the shield cover at least 25% of the electrode or cover a range of 10%-75% of the surface area of the, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding Claim 8, Morgan, Christie and Foster disclose a conductive surface but do not disclose the surface being a mesh shape. It would have been an obvious matter of design choice to make the different portions of the conductive surface of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
In regards to Claim 9-11, Morgan, Christie and Foster disclose a polymer shield having a conductive surface thereon but fail to disclose relative thicknesses of different portions of the polymer surface or relative conductivities/material choices for various sections of the conductive surface. It would have been an obvious matter of design choice to make the different portions of the polymer of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use different conductive materials for the conductive surface, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding Claim 12, Morgan discloses the shield and overall device can be compressed/folded to pass through an introducer for delivery and can then be expanded when taken out of the introducer (par. [0065, 0069]).
Claims 6, 7 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Morgan et al. (2007/0239244) in view of Christie et al. (2019/0111268), further in view of Foster et al. (2018/0133458) and Zeijlemaker (2003/0144719). Morgan, Christie and Foster disclose all of the claimed invention except for a foldable wire arranged in a spiral or petal shaped configuration. However, Zeijlemaker, in the same field of endeavor of electrical stimulation devices, discloses including a wire that is capable of being folded (due to its small diameter) and that can be wrapped around the lead (a spiral configuration) in the shielding that connects to a ring electrode for the purpose of dissipating RF energy from the system, such as during an MRI (Abstract; par. [0038, 0040]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Morgan, Christie and Foster combination to include a foldable wire wrapped round the lead and connected to an electrode, as taught and suggested by Zeijlemaker, for the purpose of dissipating RF energy from the system, such as during an MRI.
Conclusion
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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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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