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 should recite “calculating one or more ablation zones”. Claim 2 lacks antecedent basis for “the application number”, “the max value of V” and “the initial value”. Claims 3 and 4 lack proper antecedent basis for “the determining”. Claim 5 lacks proper antecedent basis for “the electroporation”. Claim 7 lacks proper antecedent basis for “the ablation lesions”. Claim 8 lacks proper antecedent basis for “the ablation application parameter”. Claim 10 lacks proper antecedent basis for “the map”, which should read “the electro-anatomical map” to maintain consistency with previous claims. Claim 10 also lacks proper antecedent basis for “the zone of electroporation”. Claims 14 and 15 lack antecedent basis for “the performed regression”, and further lack antecedent basis for “the ablation parameters”. Claim 16 lacks antecedent basis for “the controller” (line 6). It is noted “a controller” is recited later in the claim. Similarly, claim 16 also lacks antecedent basis for “the number of times (line 9). Claim 16 also lacks proper antecedent basis for “the determined one or more ablation zones” and is unclear with the recitation of “one or more zones of electroporation” as there is no antecedent basis for electroporation energy. Claims 17 and 18 lack antecedent basis for “the processor”. Claim 19 lacks proper antecedent basis for “the map”, which should read “the electro-anatomical map” to maintain consistency with previous claims. Claim 19 also lacks antecedent basis for “the zone of electroporation”. Claim 20 lacks antecedent basis for “the ablation lesion”. Claim 21 lacks antecedent basis for “the size of the visual” and “the ablation lesion” and “the size of the lesion”. Claim 22 lacks antecedent basis for “the performed regression” and “the ablation parameters”.
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 1, 5-13, 16 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Leo et al (8,641,705) in view of the teaching of Goldberg et al (2022/0005198).
Regarding claim 1, Leo et al disclose a method for determining an ablation lesion zone (Abstract, for example) that is projected onto an electro-anatomical map (Figures 15 and 16 and associated description) comprising the steps of delivering energy between at least two electrodes (col. 12, lines 22-25) in contact with tissue (Figure 1, for example). Leo et al disclose measuring a magnitude of contact force and using the contact force to calculate an ablation zone which is then projected onto an electro-anatomical map (Figures 15 and 16). There is inherently a memory/storage component to manipulate the data via the processor. Leo et al disclose the use of various energy forms, but fail to expressly disclose the use of pulsed energy.
Goldberg et al disclose another system that measures force on an electrode for treating tissue (para. [0061], for example), and also disclose various different energy modalities, including RF and microwave (as taught by Leo et al) as well as irreversible electroporation energy (para. [0085]) which requires the use of high voltage pulses as is commonly known in the art.
To have provided the Leo et al device with an energy source to provide pulses of energy to generate irreversible electroporation in tissue to create the lesion would have been an obvious modification for one of ordinary skill in the art at the time of the invention since Goldberg et al fairly teach it is known to use such an energy modality in an analogous treatment method.
Regarding claim 5, as addressed above, Goldberg et al disclose the use of irreversible electroporation energy. Regarding claim 6, Leo et al disclose the use of a 3-D representation of a heart on a display screen (Figures 14-19 and associated description). Regarding claim 7, the Figures are deemed to present information about the lesion (i.e. lesion location) and Leo et al further disclose displaying various parameters associated with the procedure (col. 17, lines 35-50). Regarding claim 9, Figures 14-19 show the types of tissue nearby (e.g. nearby structures on the anatomical map). Regarding claim 10, see again Figures 14-19 of Leo et al and associated description. Regarding claims 11 and 12, Leo et al disclose the use of color coding for marking the lesions (col. 18, lines 1-37, for example) and Goldberg et al provide the teaching of using irreversible electroporation as addressed above. Regarding claim 13, the size of the lesion on the image correlates with the size of the lesion as seen in the Figures.
Regarding claim 16, Leo et al provide a system for determining an ablation zone projected onto an electro-anatomical map comprising an ablation catheter (32) having one or more electrodes an at least one sensor (38) for measuring force. A monitor (i.e. displays 176 – Figure 10) is coupled to a controller (170) that controls operation of the ablation catheter and the sensor. The controller includes a memory (i.e. storage 168) that stores the algorithm to operate the catheter based on the contact force and the time of application of energy. The controller (i.e. processor) calculates the zones of ablation based on the contact force and time of energy delivery, and the monitor projects the determined ablation zones onto an electro-anatomical map (Figures 14-19, for example). As addressed above, Leo et al fail to expressly disclose the use of electroporation energy, which is vaguely recited in the claim.
Goldberg et al disclose another system that measures force on an electrode for treating tissue (para. [0061], for example), and also disclose various different energy modalities, including RF and microwave (as taught by Leo et al) as well as irreversible electroporation energy (para. [0085]) which requires the use of high voltage pulses as is commonly known in the art.
To have provided the Leo et al device with an energy source to provide pulses of energy to generate irreversible electroporation in tissue to create the lesion would have been an obvious modification for one of ordinary skill in the art at the time of the invention since Goldberg et al fairly teach it is known to use such an energy modality in an analogous treatment method.
Regarding claims 19-21, see discussion of claims 10, 11 and 13 above.
Claims 1, 3-5, 7-9, 14-18 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Fish et al (2017/0319279) in view of the teaching of Goldberg et al (2022/0005198).
Fish et al disclose a method for determining an ablation lesion zone (Abstract) projected onto an electro-anatomical map (para. [0014], for example) comprising the steps of delivering energy between at least two electrodes (para. [0037], for example) in contact with tissue and measuring a contact force at the electrodes (Abstract). An ablation zone (i.e. lesion size) is calculated based on the contact force and is projected onto an electro-anatomical map (para. [0014]). The examiner maintains the processor inherently includes a storage (i.e. memory) for the contact force for performing the necessary algorithm to predict the lesion size. See, for example, paragraph [0081]. The only feature not expressly taught by Fish et al is the use of pulsed energy. Fish et al generally disclose the use of RF energy, but fail to expressly disclose the use of pulsed energy.
Goldberg et al disclose another system that measures force on an electrode for treating tissue (para. [0061], for example), and also disclose various different energy modalities, including RF and microwave (as taught by Fish et al) as well as irreversible electroporation energy (para. [0085]) which requires the use of high voltage pulses as is commonly known in the art.
To have provided the Fish et al device with an energy source to provide pulses of energy to generate irreversible electroporation in tissue to create the lesion would have been an obvious modification for one of ordinary skill in the art at the time of the invention since Goldberg et al fairly teach it is known to use such an energy modality in an analogous treatment method.
Regarding claims 3 and 4, Fish et al disclose the use of regression analysis for determining lesion size (para. [0105-0109], for example) as well as the use of one or more variables. Regarding claim 5, Goldberg et al disclose the use of irreversible electroporation energy. Regarding claim 7, the Fish et al display shows information about the lesions (including the lesions themselves). Regarding claims 8 and 9, Fish et al take into consideration the type of tissue (i.e. smooth vs. trabeculated- para. [0109]) and is used to treat myocardial tissue (para. [0086]). Regarding claims 14 and 15, see again paragraphs [0105-0109] of Fish et al.
Regarding claim 16, Fish et al disclose a system for determining an ablation zone as addressed with respect to claim 1 above. The device includes an ablation catheter (14- Figure 2) with at least one sensor (i.e. force sensor 15). There is a monitor (i.e. display 34) coupled to a controller (i.e. processor) operating the ablation catheter, the processor programmed to calculate the one or more zones of ablation based on the magnitude of force. The processors all include a memory (Figure 2) to store the contact force data for manipulation to calculate the lesion size, and the monitor may project an image of the one or more ablation zones onto an electro-anatomical map as addressed with respect to claim 1 above. Fish et al fail to provide a teaching of using electroporation energy (as vaguely recited in claim 16). As addressed above with respect to claim 1, Goldberg et al teach that it is known to use an electroporation energy source in a similar device, and the use of such an electroporation energy source in Fish et al is deemed an obvious consideration for one of ordinary skill in the art for the same reasons as addressed with respect to claim 1 above.
Regarding claims 17 and 18, see discussion of claims 3 and 4 above. Regarding claim 22, see discussion of claim 14 above.
Claims 6, 10-13 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Fish et al (2017/0319279) in view of the teaching of Goldberg et al (2022/0005198) and further in view of the teaching of Leo et al (8,641,705).
Fish et al disclose the use of an electro-anatomical map to display the lesions, but fails to expressly disclose a 3-D representation of the heart and the use of color-coding as required by these claims. As addressed previously, Leo et al disclose an analogous system that provides energy to an electrode catheter and measures contact force of the electrode to predict lesion size. In particular, Leo et al provides the specific display that includes a 3-D representation of the heart as well as color coding of the lesions to display different lesion sizes and characteristics.
To have provided the Fish et al device, as modified by the teaching of Goldberg et al, with the display of Leo et al to provide a more comprehensive depiction of the predicted lesions would have been an obvious modification for one of ordinary skill in the art at the time of the invention since Leo et al provide the display for an analogous treatment system.
Allowable Subject Matter
Claim 2 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bar-Tal et al (10,517,670), Govari et al (9,962,217) and Fish et al (9,492,226) disclose other catheter devices that use a force sensor to provide a prediction of lesion size in an ablation catheter. Eyster et al (2021/0393327) provides another ablation catheter utilizing a force sensor and delivers pulses of electroporation energy to treat tissue.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/January 15, 2026