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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 states “detect a right bundle branch block waveform from the first cardiac electrical signal” and “…indicating a left bundle branch pacing site of the pacing electrode in response to the processing circuitry detecting at least the right bundle branch block waveform”. The claiming of “a right bundle branch block waveform” indicates a signal detected from the right bundle branch. However, Applicant’s specification does not disclose detecting a right bundle branch waveform. Instead, the specification discloses detecting a left bundle branch waveform and determining if the LBB waveform resembles a shape that is ypically found in a right bundle rbanch block waveform. Par. [0093] of Applciant’s published application states: “This morphology of a narrow negative peak followed by a narrow positive peak is similar to the ECG morphology expected in a patient having RBB block and is therefore a “RBB block-like signal” that occurs when LBB pacing capture occurs and is therefore an LBB signal pattern. Processor 52 may be configured to perform morphology waveform analysis of the ECG evoked response waveforms following a delivered pacing pulse 232 for detecting this transition from a “W” shaped negative polarity evoked response waveform 222 to a single-peaked negative polarity evoked response waveform 223 to the narrow negative polarity followed by narrow positive polarity waveform 224 during advancement of the pacing electrode 32/132 through the ventricular septum 12 while delivering pacing pulses 232 via the pacing electrode (cathode) 32/132 and a selected return anode electrode, which may be a catheter or delivery tool electrode or a surface (cutaneous) electrode.” Paragraph [0094] of the published application further states : “The evoked response morphology in the V1 ECG signal following an LBB pacing pulse that captures the LBB may resemble an RBB block ECG signal morphology because the RBB is not captured by the pacing pulse. An RBB block pattern may exhibit an rSR morphology or QR or S wave morphology. As such, an overall evoked response waveform morphology analysis may be performed by processor 52 to determine an LBB signal when an RBB block-like signal morphology in the V1 (or V2) ECG signal following a pacing pulse delivered by the pacing electrode 32/132. “
Applicant never discloses in the originally filed specification that a RBB signal is detected and this would not appear to be possible given the nature of the invention is to determine a LBB pacing site which is on one side of the interventricular septum and not an RBB site which is on the other side of the interventricular septum. It appears that, when read in light of the specification, Applicant is detecting an LBB signal and determining if it resembles a shape of a signal typically found in right bundle branch block. This is the interpretation that will be taken in this action.
If Applicant instead intends for the claim to measure a signal from the right bundle branch, the Examiner notes the specification would be objected to for not providing antecedent support for the claimed limitation and the drawings would be objected to for not providing an illustration if detected an RBB signal.
The claims and specification contain conflicting interpretations thus making the metes and bounds of the claim unclear.
Claims 11 and 22 contain the same issue.
Claims 2-10 and 12-21 are rejected for being dependent on indefinite claims 1 and 11.
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.
Conclusion
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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