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 8/24/2026, with respect to the 35 USC 112(a) rejection of the claims have been fully considered and are persuasive. The 35 USC 112(a) rejection of the claims has been withdrawn.
Applicant's arguments filed 8/24/2026 regarding the 35 USC 102 and 103 rejections with respect to Sambelashvili have been fully considered but they are not persuasive. Applicant argues with respect to Sambelashvili that a coronary sinus lead of Sambelashvili cannot be at a left bundle branch pacing site. The Examiner notes the claim, as currently written, is broad and does not require locating a lead at any particular site and instead only requires a display to provide some sort of indication of a left bundle branch pacing site. Sambelashvili is concerned with identifying pacing sites in a heart chamber, particularly using RBBB morphologies as a guide for where to pace, which is the same criteria claimed by Applicant. Sambelashvili discloses providing a display of scores that show different correlations of pacing sites to an RBBB template (see par. [0071-0072]), which again is the same functionality provided by Applicant. Applicant defines the indicated LBBB pacing site as one where the circuitry detects “at least the right bundle block waveform”. Sambelashvili likewise identifies a pacing site that correspond to an RBBB waveform thus meeting the claimed criteria.
The Examiner notes new claims 23 and 24 further define what is considered to be the LBBB pacing site, namely an interventricular septum. The Examiner notes Sambelashvili does not disclose this feature. However, Shuros et al. (2014/0172035) discloses an adaptation of a system like Sambelashvili that can also provide pacing to the interventricular septum. A new rejection is made with respect to Shuros to address the amended claim limitations.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 8-14 and 18-22 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Sambelashvili et al. (2013/0053916).
Regarding Claims 1, 11 and 22, Sambelashvili discloses a medical device system having sensing circuitry 86 for sensing cardiac electrical signals; pulse generating circuitry 84 for delivering pacing signals; and a processor 80, 90 for evaluating the response to the pacing signal using the sensing circuitry to identify candidate pacing sites (Fig. 1, 2). Sambelashvili discloses the processor receives electrical signals form the sensing circuitry; compares it to a bundle branch block (BBB) morphology and identifies a pacing site in response to the signal being highly correlated to a right bundle branch (RBBB) morphology, wherein the results are displayed (par. [0067-0068]; Fig. 5).
In regard to Claims 2 and 12, Sambelashvili teaches that if the BBB morphology represents a LBBB waveform, a new pacing site is tested since the site needs to have a low correlation with a LBBB waveform (par. [0069]).
Regarding Claims 3, 8-10, 13 and 18-20, Sambelashvili discloses iteratively testing various pacing sites involving pacing a site; detecting a response; comparing the response to BBB morphology criteria; noting high correlations to RBBB metrics and low correlations to LBBB metrics; and selecting the site that meets the recommended correlation criteria. In operation, this would involve pacing a site; sensing electrical data; comparing it to a threshold; noting a high correlation to an RBBB metric (par. [0068]); moving the electrode; pacing again; sensing again; comparing again and determining a high correlation to an LBBB metric; and so on until all sites are tested (par. [0065-0072]; Fig. 5).
In regard to Claims 4 and 14, Sambelashvili discloses determining high correlations to RBBB waveforms and low correlations to LBBB waveforms for each site and assign numerical values for weighting to create a score. The score is tracked for each site; store din memory and displayed to a user. The display will show changes related to LBBB and RBBB waveforms based on the comparative results (par. [0071-0072]).
In regard to Claim 21, Sambelashvili discloses iterative testing at multiple sites by applying pacing pulses and detecting responses (any of which can occur after detecting an RBBB-like waveform). Sambelashvili also dislcoses, after testing all sites, selecting a pacing site and delivering pacing from that site, which again would occur after the testing process in which an RBBB-like waveform is detected (par. [0067-0073]; Fig. 5).
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 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Sambelashvili et al. (2013/0053916) in view of Obel (2008/0249375).
In regard to Claims 5 and 15, Applicant is claiming detecting a typical RBBB waveform of a notched waveform; and a post-pace waveform having a single peak and determining a change/difference between them to classify the morphology. Sambelashvili discloses that LBBB and RBBB-like morphologies can be detected from a waveform and that a single deflection after a pacing pulse is delivered can be monitored in a waveform; compared to BBB metrics and displayed to a user (par. [0060]). Sambelashvili does not explicitly disclose that a notched waveform is indicative of a bundle branch block metric. However, in the same field of endeavor of identifying bundle branch blocks, Obel discloses that notched waveforms and single peak waveforms are known indicators of bundle branch block (Fig. 5). 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 Sambelashvili reference to include monitoring for notched waveforms and single peak waveforms, as taught and suggested by Obel, for the purpose of accurately identifying left bundle branch and right bundle branch morphologies.
Claims 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Sambelashvili et al. (2013/0053916) in view of Medical Exam Prep (“Bundle Branch Blcoks (Part 1 -Left and Right Bundle Branch Blocks”).
In regard to Claims 6 and 16, Applicant is claiming detecting a typical RBBB waveform of a ‘M’ wavforms (positive and negative peaks); and a post-pace waveform and determining a change/difference between them to classify the morphology. Sambelashvili discloses that LBBB and RBBB-like morphologies can be detected from a waveform; compared to BBB metrics and displayed to a user (par. [0060]). Sambelashvili does not explicitly disclose that two peaks of opposite polarity are indicative of a bundle branch block metric. However, in the same field of endeavor of identifying bundle branch blocks, Medical Exam Prep discloses that waveforms having peaks of opposite polarity (such as an ‘M’ shaped wavefortm) are knonw inictaors of RBBB (see Fig. 3). 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 Sambelashvili reference to include monitoring for peaks of opposite polarity, as taught and suggested by Medical Exam Prep, for the purpose of accurately identifying left bundle branch and right bundle branch morphologies.
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Sambelashvili et al. (2013/0053916) in view of Thakur et al. (2016/0030747).
Regarding Claims 7 and 17, Sambelashvili discloses utilizing capture detection in addition to comparison to BBB metrics to identify a recommended pacing site (par. [0035-0036]). Sambelashvili is silent regarding the use of activation times for capture detection assessment. However, Thakur, in the same field of endeavor of pacing optimization, discloses utilizing activation times to identify the optimal pacing site that delivers the best capture detection metrics (par. [0078]). 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 Sambelashvili reference to include monitoring of activation times during capture assessment, as taught and suggested by Thakur, for the purpose of optimizing pacing site selection.
Claims 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Sambelashvili et al. (2013/0053916) in view of Shuros et al. (2014/0172035). Sambelashvili discloses all of the claimed invention except for the selection of an interventricular septum for the LBB pacing site. However, in the same field of endeavor of pacing devices for promoting ventiruclar synchronization, Shuros discloses that a bi-ventricular pacing system can be adapted to provide interventricular septum pacing sites (par. [0038]) for the purpose of correcting RBBB while maintaining normal LV conduction paths (par. [0017]) in situations where the LV conduction path is intact (par. [0023]). 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 Sambelashvili reference to include selecting an interventricular septum pacing site, as taught and suggested by Shuros, for the purpose of correcting RBBB while maintaining normal LV conduction paths (par. [0017]) in situations where the LV conduction path is intact.
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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