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 1-36 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 is unclear with the scope of the claim, in particular with the recitation “wherein the at least a portion of the cardiovascular lesion is created by pulsed electric field ablation”. That limitation appears to be drawn to a method step making the scope of the claim unclear as the preamble is directed to an apparatus. Moreover, there is no structure to support the creation of a lesion by a pulsed electric field. Claims 2-36 are rejected based on their dependency from claim 1.
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.
Claims 1-3, 11, 18-34, 37-39, 49, 50, 55 and 60-64 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chou et al (2021/0169394).
Regarding claim 1, Chou et al provide a lesion analysis system (Abstract, for example) comprising an instrument configured to measure at least one voltage value of at least a portion of a cardiovascular lesion (para. [0036] and [0184], for example) and an algorithm that evaluates the at least one voltage value so as to determine the durability of the lesion (para. [0088] and [0184], for example). The lesion may be created by a pulsed field ablation (para. [0072], for example). There is also a feedback system that conveys the durability (i.e. toughness) of the lesion. See, for example, paragraphs [0085] and [0088] and the user interface and display of Figure 1.
Regarding claim 2, Chou et al teaches the use of pre-ablation voltages and post-ablation voltages with the algorithm evaluating the voltages to determine a voltage reduction between the voltages to assess the durability of the lesion. See, for example, paragraphs [0067] and [0088]. Regarding claim 3, the algorithm compares the reduction of voltage values to a threshold to determine the durability of the lesion (para. [0089] and [0104], for example). Regarding claim 11, there is inherently a reference point, or baseline, upon which the measured voltage is compared to determine the amount of change and therefore the condition of the tissue/lesion. Regarding claim 18, the algorithm is integrated with an electroanatomic mapping system for displaying the results on an image of the tissue (para. [0079], for example). Regarding claim 19, the feedback system is integrated with a pre-existing visual map (para. [0079] again). Regarding claims 20-24, see paragraph [0085] which discloses various different alerts including visual, color and symbols (e.g. values), and paragraph [0169] which discloses the use of audible alerts. Regarding claim 25 and 26, the alert is binary (i.e. digitally displayed) and may be gradated (i.e. the display of values). Regarding claim 27, Chou et al provide a feedback system illustrating a map of tissue with the lesions overlayed on the image (para. [0070], [0079] and [0102], for example). Regarding claim 28, the feedback system includes an indicator of the durability of the lesion on the anatomical map (para. [0028], for example). Regarding claim 29, the values of the data are provided in real time (para. [0162] and [0182], for example). Regarding claim 30, the system may include a device configured to deliver the pulsed electric field (para., [0072], for example). Regarding claim 31, the device comprises one or more electrodes (Figure 2) for creating lesions. Regarding claims 32 and 33, the algorithm may plan the next treatment site (para. [0086], for example), which site may be ‘near’ or overlapping the first site. Regarding claim 34, the location may create a continuous pattern of lesions (para. [0184], for example).
Regarding claim 37, Chou et al provide a system for determining lesion placement comprising a catheter (16) having an electrode (Figure 2) to delivery pulsed electric field energy (para. [0072]) to cardiovascular tissue to create a lesion. There is an algorithm that determines a second location (para. [0086]) and a feedback system to convey the second location (e.g. via imaging and display).
Regarding claims 38 and 39, the durability of a lesion is determined by comparing a reduction of a voltage threshold during pre and post-ablation values as addressed with respect to claims 1 and 2 above.
Regarding claim 49, Chou et al provide a cardiac lesion analysis system comprising a catheter having an electrode (Figure 2) and a pulsed electric field generator (para. [0072]) comprising an algorithm to control the delivery of energy to create a lesion an to measure a voltage value to determine the durability of a lesion (see discussion of claim 1 above).
Regarding claim 50, the algorithm compares a measured voltage value to a threshold to determine lesion durability (para. [0089] and [0104], for example). Regarding claims 60-64, see above discussion with regards to claims 18-24 above which discussion addresses these claimed limitations.
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.
Claims 4-9, 12-17, 35, 36, 40-45, 47, 48, 51-56, 58 and 59 are rejected under 35 U.S.C. 103 as being unpatentable over Chou et al (‘394) in view of the teaching of Garcia et al (2016/0143698).
Regarding claims 4-6, Chou et al disclose providing pre- and post-ablation voltages that are monitored to determine the durability of a lesion created by pulsed electric field ablation, but fail to disclose the specific voltage levels as required by these claims.
Garcia et al disclose another pulsed field ablation system that monitors parameters (e.g. current and impedance) to determine the effectiveness (i.e. durability) of a lesion, as well as a system that provides an image of the target tissue as well as images of predicted lesions and actual lesions. In particular, Garcia et al disclose pre- and post-ablation of the lesion to determine its effectiveness, and specifically teach of using a voltage within the range claimed by applicant. See, for example, paragraph [0032] which discloses the use of pre- and post-ablation pulses for measuring the lesion and paragraph [0039] which discloses a voltage level of 1mV to 125V for the test signal.
To have provided the Chou et al system with any well-known voltage level for the determination of the durability of the lesion would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Garcia et al fairly teach the use of voltages within the applicant’s claimed range to perform a similar procedure on tissue.
Regarding claim 5, the averaging of levels is deemed to be an obvious consideration for one of ordinary skill in the art to normalize the values used to perform the claimed tasks. Regarding claims 7-9, providing the voltage reduction as a flat (measured) value of the difference or a percentage is deemed to be an obvious alternative means of displaying the data, and the specific acceptable ranges that would be deemed acceptable are also considered to be within the purview of the skilled artisan as would befit the given procedure. Regarding claims 12-17, the examiner maintains that the use of digital (i.e. discrete) or analog (continuous) signals is generally within the purview of the skilled artisan and would be obvious variants in such a system. Also, displaying such values as a percentage, as opposed to a changing value, would be an obvious display option for one of ordinary skill in the art. Regarding claims 35 and 36, Garcia et al more clearly disclose the pulsed field ablation generator which delivers the energy is a series of packets (i.e. pulses) as is generally known in the art, as well as disclose the intended results of a pulsed field ablation generator (i.e. to leave extracellular matrices intact due to the nature of the irreversible electroporation as in para. [0234], for example). Regarding claims 40-45, see above discussion of claims 4-9 above. Regarding claim 47, Garcia et al disclose providing irreversible electroporation to avoid thermal damage (para. [0096]) as well as the monitoring of impedance. Regarding claim 48, Garcia et al disclose a pulsed field ablation device that delivers packets of bi-phasic pulses as is generally well-known in the art. Regarding claims 51-56, see again discussion of claims 6-9 and 41 above. Regarding claim 58, see discussion of claim 35 above. Regarding claim 59, see again discussion of claim 36 above.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Chou et al (‘394) in view of the teaching of He et al (9,326,814).
Regarding claim 10, Chou et al is silent with respect to employing confidence levels with the functions being performed. The examiner maintains that it is generally known to consider confidence levels in the prior art, particularly with complicated systems employing various levels of diagnostic and therapeutic control of the system. In particular, He et al disclose an ablation device that measures various parameters to assess lesions created in tissue, and employs the use of confidence levels in determining the results (Figure 5 and Brief Description of Figure 5).
To have employed confidence levels to verify the results of the Chou et al system would have been an obvious consideration for one of ordinary skill in the art as this is a routine safety measure employed to verify results as fairly taught by He et al.
Claims 46 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Chou et al (‘394) in view of the teaching of Garcia et al (2016/0143698) and further in view of the teaching of He et al (9,326,814).
The combination of the Garcia et al teachings with the Chou et al system has been addressed previously. Chou et al is silent with respect to employing confidence levels with the functions being performed. The examiner maintains that it is generally known to consider confidence levels in the prior art, particularly with complicated systems employing various levels of diagnostic and therapeutic control of the system. In particular, He et al disclose an ablation device that measures various parameters to assess lesions created in tissue, and employs the use of confidence levels in determining the results (Figure 5 and Brief Description of Figure 5).
To have employed confidence levels to verify the results of the Chou et al system, as modified by the teachings of Garcia et al, would have been an obvious consideration for one of ordinary skill in the art as this is a routine safety measure employed to verify results as fairly taught by He et al.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ben-Haim et al (11,622,713), Viswanathan et al (11,389,234) and Sherman et al (9,265,557) disclose various other systems that deliver pulsed field ablation to create tissue lesions and systems to assess the lesions.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL PEFFLEY whose telephone number is (571)272-4770. The examiner can normally be reached Mon-Fri 8 am-5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached at (571) 272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/January 29, 2026