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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “1206” has been used to designate both the dominant frequency timepoint and grayed-out portion (Fig. 12).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 1308.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 1-2, 5-6, 11-12, and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Relan (US Pre-Grant Publication 2019/0320927), hereinafter ‘Relan’.
Regarding claims 1 and 11, Relan teaches a method/device for assessing lesion formation based on monitored electrogram signals ([0032], electrodes used to gather electrophysiological data from the cardiac surface, Fig. 6), the method comprising/an electronic control unit (ECU) (processors 28, Fig. 1) configured to:
receiving intracardiac electrogram signals (step 402, receive electrogram signals S(t), Fig. 4) from one or more electrodes (electrodes 17, 52, 54, 56, Fig. 2, [0028], [0031], at least one electrode/additional measurement electrodes) located at a distal end of a catheter (catheter 13, Fig. 2) positioned within a patient;
detecting an activation timepoint and selecting a roving activation interval (RAI) based on the detected activation timepoint ([0048], defining RAI based on reference time point Tref corresponding to trigger event);
applying a continuous wavelet transform (CWT) ([0010], continuous wavelet transform) to one or more of the received intracardiac electrogram signals within each RAI (step 404, transform S(t) into wavelet domain, Fig. 4) to generate a power spectrum response (step 406, compute energy function L(t), Fig. 4), a phase spectrum response, or both a power spectrum and a phase spectrum response (energy functions 504a, 504b, 504c, Figs. 5A-5C);
calculating one or more per-RAI metrics based on the power spectrum response, phase spectrum response, or both the power spectrum response and the phase spectrum response (step 408, compute QRS duration from L(t), Fig. 4);
calculating a per-lesion metric based on the one or more per-RAI metrics ([0054], repeating steps 402, 404, 406, 408, step 410, output QRS duration map, Fig. 4, [0055], map can identify areas of diseased substrate); and
displaying a lesion assessment marker on a display based on the calculated per-lesion metric (Fig. 6, 3-D cardiac model 600), wherein the lesion assessment marker provides an indication of lesion formation ([0045], [0055], identify potential therapy/ablation targets, classify areas of heart as diseased).
Regarding claims 2 and 12, Relan teaches the method/device of claims 1 and 11, further comprising:
wherein the intracardiac electrogram signal includes a first unipolar electrogram signal and a second unipolar electrogram signal ([0033], [0037], roving electrodes measured with respect to ground, surface reference electrode/belly patch 21, Fig. 1, [0028], multiple roving electrodes used).
Regarding claims 5 and 15, Relan teaches the method/device of claims 1 and 11, further comprising:
wherein the intracardiac electrogram signal includes a bipolar electrogram signal ([0047], electrogram signal S(t) is bipolar).
Regarding claims 6 and 16, Relan teaches the method/device of claims 5 and 15, further comprising:
wherein calculating one or more per-RAI metrics includes:
determining a per-RAI peak-to-peak voltage associated with the bipolar electrogram signal ([0049], peak-to-peak voltage of electrogram signal).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3-4 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Relan (US Pre-Grant Publication 2019/0320927) in view of Bar-Tal et al. (US Pre-Grant Publication 2015/0208942), hereinafter ‘Bar-Tal’.
Regarding claims 3 and 13, Relan teaches the method/device of claims 2 and 11, further comprising:
wherein calculating one or more per-RAI metrics includes:
wherein the CWT is applied to the bipole electrogram ([0047], electrogram signal S(t) is bipolar) and at least one of the first and second unipolar electrogram signals ([0048], S(t) is transformed into wavelet domain to G(f, t));
locating a dominant frequency timepoint based on a power spectrum response generated by applying the CWT to the bipole electrogram (Tmax points 502a, 502b, 502c, Figs. 5A-5C, [0052], detecting time when G(f, t) reaches a maximum);
calculating a maximum power value associated with one of the first unipolar electrogram signal or second unipolar electrogram signal based on a power spectrum response generated by applying the CWT to either the first or second unipolar electrogram signal and the dominant frequency timepoint ([0052], L(t) equation, max(G(f, t))); and
calculating a per-RAI unipolar energy metric for at least one of the first unipolar electrogram signal or second unipolar electrogram signal based on the calculated maximum power ([0053-0054], calculating QRS duration for a plurality of electrogram signals).
Relan teaches unipolar electrogram signals (surface reference electrode/belly patch 21, Fig. 1) and bipolar electrogram signals ([0047], electrogram signal S(t) is bipolar), but does not explicitly teach creating a bipole electrogram based on two unipolar electrogram signals.
Bar-Tal teaches a method for generating a 3-D map of the heart with quality values (abstract), further comprising:
creating a bipole electrogram based on the first and second unipolar electrogram signals ([0015], two pairs of unipolar electrodes to create bipolar signal).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Relan to incorporate the teachings of Bar-Tal to include creating a bipole electrogram with two unipolar electrograms. Doing so would improve the analysis, as recognized by Bar-Tal [0011].
Regarding claims 4 and 14, Relan teaches the method/device of claims 2 and 11, further comprising:
wherein calculating one or more per-RAI metrics includes:
wherein the CWT is applied to the bipole electrogram ([0047], electrogram signal S(t) is bipolar) and at least one of the first and second unipolar electrogram signals ([0048], S(t) is transformed into wavelet domain to G(f, t));
locating a dominant frequency timepoint based on a power spectrum response generated by applying the CWT to the bipole electrogram (Tmax points 502a, 502b, 502c, Figs. 5A-5C, [0052], detecting time when G(f, t) reaches a maximum); and
calculating one or more per-RAI “QRS” metrics based on the located ‘Q’, ‘R’, and ‘S’ timepoints associated with at least one of the first unipolar electrogram signal or the second unipolar electrogram signal, including at least one of a Q-R voltage, a R-S voltage, and a Q-S voltage ([0049], peak-to-peak voltage of electrogram signal).
Relan teaches unipolar electrogram signals (surface reference electrode/belly patch 21, Fig. 1) and bipolar electrogram signals ([0047], electrogram signal S(t) is bipolar), but does not explicitly teach creating a bipole electrogram based on two unipolar electrogram signals. Relan also teaches a QRS detection module (58, Fig. 1, [0045], measures QRS duration), but does not specifically teach that the QRS timepoints are located based on a phase spectrum response.
Bar-Tal teaches a method for generating a 3-D map of the heart with quality values (abstract), further comprising:
creating a bipole electrogram based on the first and second unipolar electrogram signals ([0015], two pairs of unipolar electrodes to create bipolar signal); and
locating ‘Q’, ‘R’, and ‘S’ timepoints on at least one of the first and second unipolar electrogram signals based on a phase spectrum response generated by applying the CWT to at least one of the first and second unipolar electrogram signals and the dominant frequency timepoint calculated with respect to the bipole electrogram (Fig. 13, [0070-0071], generation of QRS signal).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Relan to incorporate the teachings of Bar-Tal to include creating a bipole electrogram with two unipolar electrograms and detecting QRS timepoints based on a phase spectrum response. Doing so would improve the analysis, as recognized by Bar-Tal [0011].
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Relan (US Pre-Grant Publication 2019/0320927) in view of Tenbrink et al. (US Pre-Grant Publication 2023/0050834), hereinafter ‘Tenbrink’.
Regarding claims 7 and 17, Relan teaches the method/device of claims 6 and 16, further comprising:
wherein determining a per-RAI peak-to-peak voltage associated with the bipolar electrogram signal includes:
locating a dominant frequency timepoint based on a power spectrum response generated by applying the CWT to the bipolar electrogram signal (Tmax points 502a, 502b, 502c, Figs. 5A-5C, [0052], detecting time when G(f, t) reaches a maximum); and
determining a per-RAI peak-to-peak voltage based on the dominant frequency timepoint ([0049], peak-to-peak voltage of electrogram signal).
Relan does not specifically teach determining a per-RAI peak-to-peak voltage within a subset of the RAI selected.
Tenbrink teaches a device/method for extracting atrial signals from a patient (abstract), further comprising:
determining a per-RAI peak-to-peak voltage within a subset of the RAI selected based on the dominant frequency timepoint (Fig. 9C, [0147-0148], find window around local maxima).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Relan to incorporate the teachings of Tenbrink to include determining a per-RAI peak-to-peak voltage within a subset of the RAI selected. Doing so would mitigate the possible effects of other QRS-T instances, as recognized by Tenbrink [0148].
Claims 8-10 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Relan (US Pre-Grant Publication 2019/0320927) in view of Schmidt et al. (US Pre-Grant Publication US 2023/0255684), hereinafter ‘Schmidt’.
Regarding claims 8 and 18, Relan teaches the method/device of claims 1 and 11, further comprising identifying areas of diseased substrate [0055] and ablation targets [0045], but does not specifically teach comparing pre-ablation and intra-ablation per-lesion metrics to generate the lesion assessment marker.
Schmidt teaches a method for evaluating a cardiac lesion based on a bioelectrical signal (abstract), further comprising:
wherein calculating a per-lesion metric based on the one or more per-RAI metrics includes:
collecting a plurality of pre-ablation per-RAI metrics (Fig. 5, pre-ablation 534) of the same type and averaging the plurality of pre-ablation per-RAI metrics to generate a pre-ablation per-lesion metric ([0099], average amplitude);
collecting a plurality of intra-ablation per-RAI metrics ([0044], bioelectrical signal measured during or shortly after delivery of ablation) of the same type and averaging the plurality of intra-ablation per-RAI metrics to generate an intra-ablation per-lesion metric ([0099], average amplitude); and
comparing the pre-ablation per-lesion metric with the intra-ablation per-lesion metric ([0054-0055], [0072], comparisons of signals) and generating the lesion assessment marker based on this comparison ([0048], lesion durability index is displayed based on EGM analysis).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Relan to incorporate the teachings of Schmidt to include comparing pre-ablation and intra-ablation per-lesion metrics to generate the lesion assessment marker. Doing so would provide an estimate of lesion efficacy, as recognized by Schmidt [0072].
Regarding claims 9 and 19, Relan teaches the method/device of claims 1 and 11, further comprising identifying areas of diseased substrate [0055] and ablation targets [0045], but does not specifically teach comparing pre-ablation and post-ablation per-lesion metrics to generate the lesion assessment marker.
Schmidt teaches a method for evaluating a cardiac lesion based on a bioelectrical signal (abstract), further comprising:
wherein calculating a per-lesion metric based on the one or more per-RAI metrics includes:
collecting a plurality of pre-ablation per-RAI metrics (Fig. 5, pre-ablation 534) of the same type and averaging the plurality of pre-ablation per-RAI metrics to generate a pre-ablation per-lesion metric ([0099], average amplitude);
collecting a plurality of post-ablation per-RAI metrics (Fig. 5, post-ablation 536, 538) of the same type and averaging the plurality of post-ablation per-RAI metrics to generate a post-ablation per-lesion metric ([0099], average amplitude); and
comparing the pre-ablation per-lesion metric with the post-ablation per-lesion metric ([0054-0055], [0072], comparisons of baseline and post-ablation signals) and generating the lesion assessment marker based on this comparison ([0048], lesion durability index is displayed based on EGM analysis).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Relan to incorporate the teachings of Schmidt to include comparing pre-ablation and post-ablation per-lesion metrics to generate the lesion assessment marker. Doing so would provide an estimate of lesion efficacy, as recognized by Schmidt [0072].
Regarding claims 10 and 20, Relan teaches the method/device of claims 1 and 11, further comprising identifying areas of diseased substrate [0055] and ablation targets [0045], but does not specifically teach collecting/averaging per-RAI metrics to generate a per-lesion metric.
Schmidt teaches a method for evaluating a cardiac lesion based on a bioelectrical signal (abstract), further comprising:
wherein calculating a per-lesion metric based on one or more per-RAI metrics includes:
collecting a plurality of per-RAI metrics of the same type during therapy application ([0044], bioelectrical signal measured during or shortly after delivery of ablation) and averaging the plurality of per-RAI metrics ([0099], average amplitude) to generate a per-lesion metric.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Relan to incorporate the teachings of Schmidt to include collecting/averaging per-RAI metrics to generate a per-lesion metric. Doing so would provide an estimate of lesion efficacy, as recognized by Schmidt [0072].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Koblish et al. (US Pre-Grant Publication 2019/0038349) teaches generating an electrogram for detecting the impact of energy delivery before/during/after a procedure [0397], sufficient to reject claims 8-10 and 18-20 under 35 USC 103.
Nair (US Pre-Grant Publication 2014/0180273) teaches a system/method for characterizing ablated tissue (see Figs. 7, 29b).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH L OKONAK whose telephone number is (571)272-1594. The examiner can normally be reached Monday-Friday 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/E.L.O./Examiner, Art Unit 3792
/SHIRLEY X JIAN/Primary Examiner, Art Unit 3792
Prosecution Insights