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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 4/7/26; 5/28/26 has/have been acknowledged and is/are being considered by the Examiner.
Response to Arguments
Applicant’s amendments to the claims cure the 112 issues and the 112 rejections have been withdrawn.
Applicant's arguments filed 5/26/26 regarding the 102 rejections have been fully considered but they are not persuasive. The Applicant argues that the Examiner impermissibly inflates conflates 2 incompatible embodiments of Zhang. The Examiner respectfully disagrees. Figure 10 and the corresponding written description describe a system that utilizes intra-cardiac electrodes that use the stimulation system of figure 5 (Paragraph 135). The stimulation system of figure 5 is described in paragraphs 60-90 and therefore explicitly teaches the claimed invention. Even if the cited sections did not have explicit teaching, paragraph 161 clearly states that each embodiment can be used together or separately. Thereby providing explicit teaching of combining references.
The Applicant further argues that Zhang fails to teach 5-10 milliseconds. The examiner argues that paragraph 70 fails to teach it. However, paragraph 71 clearly discloses a duration between 5-10ms. Further it is noted that the limitation states at least one of a duration of 5-10ms or an amplitude of 5-10V. Zhang clearly discloses an amplitude of 5-10V in paragraphs 67, 70 and 71. Therefore, the Applicant’s arguments are moot.
The Applicant further argues in the duration, amplitude and delivery sections of the remarks that the rejections are invalid as the cited sections are for extra-cardiovascular ATP delivery and not intra-cardiovascular ATP delivery. As pointed out above, a careful reading the cited sections clearly points out that the stimulation circuitry of figure 5 which is described in paragraphs 70-71 is utilized by the intra-cardiac electrodes as clearly and explicitly stated in paragraph 135. Therefore, the Applicants arguments regarding the intra-cardiac vs. extra-cardiac are erroneous and moot as the cited sections are clearly taught to be used by the intra-cardiac embodiment. Further paragraph 161 clearly states that each embodiment can be used together or separately. Thereby providing explicit teaching of combining references. Therefore the 102 rejections stand.
Regarding the 103 rejections the Applicant argues that the 103 rejections should be withdrawn and the claims are dependent from allowable independent claims. The Examiner respectfully disagrees for the reasons above. Therefore the 103 rejections stand.
Claim Rejections - 35 USC § 102
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, 12 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. (U.S. Pub. 2019/0054297 hereinafter “Zhang”).
Regarding claim 1, Zhang discloses an implantable cardiac device (e.g. Fig. 10; ¶¶ 17, 128-129) comprising: at least two lead electrodes configured to contact intra-cardiac tissue (e.g. Fig. 10; 406, 411, 416; ¶129); a housing including circuitry for controlling and activating said at least one lead electrode (e.g. Fig. 10; 415; ¶135); and a pulse generator (e.g. Fig. 5; 84) configured to generate anti-tachycardia pacing pulses to be delivered by at least one lead electrodes from said at least two lead electrode (e.g. Fig. 10; 410, 415; ¶135); wherein an anti-tachycardia pacing pulse comprises at least one of: a duration of between 5-10 msec and an amplitude of between 5-10V (e.g. ¶¶ 67, 70, 71); and wherein said pulse generator is configured to generate synchronized anti- tachycardia pacing pulses to be delivered via said at least two lead electrodes configured to be positioned in at least two different intra-cardiac locations (e.g. ¶¶ 81, 92).
Regarding claim 2, Zhang further discloses wherein each of aid at least two lead electrodes are configured to contact said intra-cardiac tissue located in one of the following is one of: the ventricular septum, the left ventricle wall, the right ventricle wall (e.g. Fig. 10; 417, 429; ¶¶130, 133).
Regarding claim 12, Zhang further discloses wherein said pulse generator is configured to generate said anti-tachycardia pacing pulses simultaneously (e.g. ¶83; [simultaneous]).
Regarding claim 17, Zhang further discloses wherein said pulse generator is configured to generate anti-tachycardia pacing pulses having different durations selected from between 5- 10msec (e.g. ¶¶67, 70-71 [duration between]).
Claim Rejections - 35 USC § 103
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang as applied to claims 1-2, 12 and 17 above, and further in view of Ghanem et al. (U.S. Pat. 7,761,150 hereinafter “Ghanem”).
Regarding claim 4, Zhang discloses the claimed invention including determining the heart rate but fails to explicitly state that the system detecting a tachycardia episode when a heart rate is between 180-250 BPM. However, Ghanem teaches that it is known to use heart rate between 180-250 BPM as set forth in Column 14, lines 41-47 to provide a known means for determining tachycardia. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Zhang, with the tachycardia determination using heart rate as taught by Ghanem, since such a modification would provide the predictable results of using known methods for providing a well-known means for determining tachycardia.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang as applied to claims 1-2, 12 and 17 above, and further in view of Burnes (U.S. Pub. 2004/0088014).
Regarding claims 13-14, Zhang discloses the claimed invention including providing synchronized pulses but fails to explicitly state that the system includes a time delay selected from the R-wave occurrences. However, Burnes teaches that it is known to use a delay determined from the R-wave difference as set forth in Abstract and Paragraphs 47-48 and 65 to provide a way to increase the effectiveness of the ATP therapy. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Zhang, with pacing delays determined from the R wave differences as taught by Burnes, since such a modification would provide the predictable results of increasing the effectiveness of the ATP therapy.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. CN 109952127 to Ternes et al. (cited by Applicant) – teaches a similar ATP pacing method and intracardiac electrodes.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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/REX R HOLMES/Primary Examiner, Art Unit 3796
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