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 .
Information Disclosure Statement
The information disclosure statement filed May 14, 2024 has been entered and the references cited therein have been considered by the examiner.
Claim Objections
Claims 2, 6, 7, 11 and 15-17 are objected to because of the following informalities:
Claim 2 recites “ablition” in line 2 (it should be “ablation”);
Claim 6 recites “fully ablation” in line 3 (it should be “fully ablated”);
Claim 7 recites “fully ablation” in line 3 (it should be “fully ablated”) and “abalted” in line 4 (it should be “ablated”);
Claim 11 recites “forther” in line 2 (it should be “further”) and “abltion” in line 3 (it should be “ablation”);
Claim 15 recites “fully ablation” in line 3 (it should be “fully ablated”) and “abalted” in line 4 (it should be “ablated”);
Claim 16 recites “graphical re-encode by graphical re encoding” which is grammatically incorrect;
Claim 17 recites “graphical re-encode” in line 2 (it should be “graphically re-encode”).
Appropriate correction is required.
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)(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.
Claim(s) 1-5, 8-14, 17 and 18 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Garrott et al. (PCT Publication No. 2024/118327).
In regard to claims 1-5, 8-14, 17 and 18, Garrott et al. teach an electrophysiology system 50 and method of use (see Fig. 3) where the system 50 includes an electroporation catheter system 60 and an electro-anatomical mapping (EAM) system 70 (see Fig. 1). The electroporation catheter system 60 is configured to deliver electric field energy to targeted tissue in the patient’s heart 30 and includes a catheter 105 having an electrode assembly thereon (see paras. 0057 and 0059). The EAM system 70 includes a localization field generator 80, a mapping and navigation controller 90 and a display 92 (see para. 0056 and Fig. 1). The catheter system 60 is configured to generate, based on models of electrical fields, graphical representations of the electric fields that can be produced using the catheter 105 and to overlay, on the display 92, the graphical representations of the electric fields or expected or predicted lesions on an anatomical map of the patient’s heart to aid a user in planning ablation (see para. 0057). Prior to delivery of the pulsed electrical signals to the selected ones of the plurality of electrodes at each of the plurality of locations, a predicted lesion zone (ablation tags) corresponding to an intersection of the model of electric fields and a surface of the anatomical map is generated on the anatomical map of the heart on the graphical display at 306 (see Fig. 3 and para. 0077). After or concurrently with deliver of the pulsed electrical signals to the selected ones of the plurality of electrodes at each of the plurality of locations, the anatomical map is automatically annotated on the graphical display by applying an ablation marker based on the predicted lesion zone (see para. 0077). Garrott et al. also teach a first graphical representation 400 that includes a first graphical representation of the catheter 402, a first graphical representation of the electrode assembly 404 and a graphical representation of the target tissue 406 (see Fig. 4A and para. 0080). In addition, the first graphical representation 400 includes a graphical representation of a first model electric field 408 generated with the electrode assembly proximate the target tissue where the extent or size of the first model electric field 408 can be based on a threshold value of electric field strength (see para. 0080). The visual appearance of the model electric field 408 can indicate an alert such as if the field strength is not sufficient to provide irreversible electroporation or if the field strength is extreme or past a threshold upper limit (see para. 0080). The first graphical representation 400 also includes a lesion zone 410 that is a graphical representation of the size and location of the target tissue subjected to irreversible electroporation (see paras. 0083-0084). After or concurrently with the delivery of pulsed electrical signals to the electrodes the graphical representation of the target tissue 406 is annotated by applying an ablation marker 422 based on the first predicted lesion zone 414 (thus, the lesion zone 414 or ablation tag is re-encoded) (see para. 0086). The ablation marker 422 is made a fixture of the anatomical map and the first predicted lesion zone 414 can include a visual appearance distinguishable from the visual appearance of the ablation marker 422 (see para. 0086). Garrott et al. also teach creating additional ablation markers 482 (see para. 0091-0093). Each ablation marker 422, 482 can be indicated on a graphical representation as a selected shade of a selected color (see para. 0093) and the graphical representation 480 can show unablated tissue 412 (see para. 0091).
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.
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.
Claim(s) 6, 7, 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garrott et al. (PCT Publication No. 2024/118327) in view of Fishel (U.S. Patent Application Publication No. 2022/0079500).
In regard to claims 6, 7, 15 and 16, as noted above, Garrott et al. teach that each ablation marker 422, 482 can be indicated on a graphical representation as a selected shade of a selected color (see para. 0093) but are silent as to the specific colors used or to the shape being different. However, Fishel teaches the creation of an electro-anatomical timing map using annotation 240 with color codes, such as green, yellow and red, to differentiate between circuits (see para. 0051) as well as differences in diameter to indicate different circuits (see para. 0052). Fishel thus demonstrates that the use of different colors and sizes/shapes to differentiate electrical annotations on an anatomical map are well known in the art and Garrott et al. recognize the use of different colors. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to utilize the green, yellow and red color designations or the different diameter designations in the device of Garrott et al. as al alternative means to differentiate between the different ablation markers 422, 482.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794