DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Claim Objections
3. Claim 15 is objected to because of the following informalities: claim 15 is recited to be dependent upon Claim 1. However, based on the language of the preamble of claim 15, it is assumed this is meant to recite “The system according to claim 10”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
4. 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.
5. Claims 1-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reinders U.S. 2023/0346468 (herein referred to as “Reinders”).
6. Regarding Claim 10, Reinders teaches a system (Figs. 2, 3, 8A-8D), comprising:
a. a display device (Figs. 2 and 3, ref num 332);
b. a processor (Fig. 1, ref num 100/110/130), which is configured to:
b.i. receive or generate an anatomical map of wall tissue (Fig. 3, ref num 332; para 0130, “output from a mapping process may be displayed by a display device system 332”) of at least a portion of a cardiac chamber (para 0136, “various degrees of proximity with a tissue wall”; para 0120 describes cardiac tissue ablation), the map superimposed with ablation tags at locations of ablated wall tissue (Figs. 9A-9H; Fig. 9B, ref character “1st lesion quality/2nd lesion quality”; Fig. 9D, ref num 912);
b.ii upon placing an ablation catheter having one or more electrodes in a vicinity of the wall tissue, identifying at least one electrode among the one or more electrodes that violates a location proximity criterion to one or more of the ablation tags (Fig. 8A, ref nums 806, 806-1, 806-2; para 0157-0158, “if the first degree of separation referred to in block 806-1 is a lower degree of separation than the second degree of separation referred to in block 806-2, then, all else being equal, the data processing device system may be configured to determine that the first quality of lesion in the first state of block 806-1 is better (e.g., resulting in greater tissue damage) than the second quality of lesion in the second state of block 806-2, due to the lesser separation between the second transducer set and the tissue surface in the first state. Other factors besides mere degree of separation may be considered, however, in determining a quality of a lesion…” );
b.iii graphically encoding the identified at least one electrode (Fig. 9A, ref num 905x; para 0164, “transducer graphical elements indicated as 905x… corresponds to a respective transducer in the selected transducer set, which is separated from (not in contact with) the tissue surface”); and
b.iv displaying the anatomical map, showing the graphically encoded at least one electrode, to a user (see Fig. 9A-9H).
7. Regarding Claim 1, Reinders teaches a method (Figs. 8A-8D), comprising:
a. receiving or generating an anatomical map of wall tissue (Fig. 3, ref num 332; para 0130, “output from a mapping process may be displayed by a display device system 332”) of at least a portion of a cardiac chamber (para 0136, “various degrees of proximity with a tissue wall”; para 0120 describes cardiac tissue ablation), the map superimposed with ablation tags at locations of ablated wall tissue (Figs. 9A-9H; Fig. 9B, ref character “1st lesion quality/2nd lesion quality”; Fig. 9D, ref num 912);
b. upon placing an ablation catheter having one or more electrodes in a vicinity of the wall tissue, identifying at least one electrode among the one or more electrodes that violates a location proximity criterion to one or more of the ablation tags (Fig. 8A, ref nums 806, 806-1, 806-2; para 0157-0158, “if the first degree of separation referred to in block 806-1 is a lower degree of separation than the second degree of separation referred to in block 806-2, then, all else being equal, the data processing device system may be configured to determine that the first quality of lesion in the first state of block 806-1 is better (e.g., resulting in greater tissue damage) than the second quality of lesion in the second state of block 806-2, due to the lesser separation between the second transducer set and the tissue surface in the first state. Other factors besides mere degree of separation may be considered, however, in determining a quality of a lesion…” );
c. graphically encoding the identified at least one electrode (Fig. 9A, ref num 905x; para 0164, “transducer graphical elements indicated as 905x… corresponds to a respective transducer in the selected transducer set, which is separated from (not in contact with) the tissue surface”); and
d. displaying the anatomical map, showing the graphically encoded at least one electrode, to a user (see Fig. 9A-9H).
Regarding method claim 1, the claim is rejected by the same or substantially the same rationale as applied to the rejection of system claim 10, since operation of the prior art relied on to reject system claim 10 would naturally result in the step of method claim 1 being satisfied.
8. Regarding Claims 2 and 11, Reinders teaches the ablation tags are graphically encoded according to a level of ablation (see Fig. 9B, ref character ““1st lesion quality/2nd lesion quality”; Fig. 8B, ref num 808A, 814A) , and wherein graphically encoding the electrode comprise graphically encoding the electrode according to the graphic encoding of the ablation tags for which the location proximity criterion is violated (see Figs. 8A-8B, ref num 808A/814A are determined and displayed based on the location and proximity of the electrodes to the tissue).
9. Regarding Claims 3 and 12, Reinders teaches graphically encoding the electrode comprises encoding the electrode differently when the location proximity criterion is violated with respect to an ablation tag indicative of a fully ablated location (Fig. 9D, ref num 912), and when the location proximity criterion is violated with respect to an ablation tag indicative of a partially ablated location (para 0258, “the determined second quality of the lesion may be an indication of a predicted cumulative effect, e.g., at least in a case in which the first ablation energy has been delivered, but the second ablation energy has not yet been delivered or has not yet been completely delivered”).
10. Regarding Claims 4 and 13, Reinders teaches encoding the electrode differently comprises highlighting the electrode with different colors depending on whether the location proximity criterion is violated with respect to an ablation tag indicative of a fully ablated location, or with respect to an ablation tag indicative of the partially ablated location (Figs. 9G-1, 9G-2; para 0242, “a first quality represented by the region with no color fill in the respective lesion marker (such as region 913b in the case of lesion marker 912-2 and region 913c in the case of lesion marker 912-1), and a second quality represented by the darker-shaded region in the respective lesion marker (such as region 913a, which is in each of lesion markers 912-1 and 912-2)”).
11. Regarding Claims 5 and 14, Reinders teaches the location proximity criterion is violated when an electrode is in a defined location proximity to the ablation tags but does not overlap any of the ablation tags (see Figs. 9D and 9E, ref nums 905x are not overlapped with ref num 912).
12. Regarding Claims 6 and 15, Reinders teaches encoding the at least one electrode is performed in real-time, as the ablation catheter is navigated in the cardiac chamber (para 0007, “model may be combined with real-time sensing of a location of the medical device or probe”).
13. Regarding Claims 7 and 16, Reinders teaches comprising providing a graphical user interface (GUI) configured to allow the user to modify the location proximity criterion (Figs. 2 and 3, ref num 332; para 0130, “Input-output device system 320 may include a user-activatable control that is responsive to a user action. Input-output device system 320 may include one or more user interfaces or input/output (I/O) devices, for example, one or more display device systems 332, speaker device systems 334, one or more keyboards, one or more mice (e.g., mouse 335), one or more joysticks, one or more track pads, one or more touch screens or other transducers to transfer information to, from, or both to and from a user, for example, a care provider such as a physician or technician”).
14. Regarding Claims 8 and 17, Reinders graphically encoding the at least one electrode comprises graphically encoding only electrodes belonging to a group of electrodes selected by the user (para 0130, “other transducers employed by a user to indicate a particular selection or series of selections of various graphical information”).
15. Regarding Claims 9 and 18, Reinders teaches the anatomical map is an electroanatomical (EA) map (para 0107, “the described systems employ a navigation system or electro-anatomical mapping system (e.g., as described below with respect to at least FIG. 2 or 3, according to some embodiments)…”).
16. Regarding method claims 2-9, the claims are rejected by the same or substantially the same rationale as applied to the rejections of system claims 11-18, respectively, since operation of the prior art relied on to reject system claims 11-18 would naturally result in the step of method claims 2-9 being satisfied.
Conclusion
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794