DETAILED ACTION
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4-6, and 15-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea without significantly more.
Step 1
The claimed invention in claims 1-20 are directed to statutory subject matter as the claims recite a display system, user interface, and method of display.
Step 2A, Prong One
Regarding claims 1 and 15, the recited steps are directed to a mental process of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsection (III)).
Regarding claim 1, the limitations of “output a circular graphical representation, the circular graphical representation comprising: a plurality of color areas forming a first circular shape, each of the plurality of color areas communicating a categorized value for a respective electrode indicative of tissue proximity for the respective electrode; and a plurality of graph areas forming a second circular shape, each of the plurality of graph areas communicating a relative value for the respective electrode indicative of the tissue proximity for the respective electrode” are a process, as drafted, covers performance of the limitation that can be performed by a human using a pen and paper under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional drawing an image of the tissue proximity data for each of the electrodes.
Regarding claim 15, the limitations of “ receiving tissue proximity data from a plurality of electrodes; transforming received data into a circular arrangement, the circular arrangement including a plurality of circle sectors, each of the circle sectors corresponding to one or more electrodes; and displaying the circular arrangement on a user interface, wherein each of the circle sectors includes a categorized value display and a relative value display” are a process, as drafted, covers performance of the limitation that can be performed by a human mind or by a human using a pen and paper under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional observing ECG data and drawing an image of the tissue proximity data associated with electrodes of ECG system.
Step 2A, Prong Two
For claims 1 and 15, the judicial exception is not integrated into a practical application. In particular, the claims recite “a plurality of electrodes”. The electrodes are recited a high-level of generality and amount to nothing more than genereric sensing/stimulation electrodes. However, “electrodes” are not performing any of the steps recited in the claims and therefore does not integrate judicial exception into a practical application. The “display” is also recited at a high-level of generality and amount to nothing more than a generic display. Additionally, Merely including displaying the results amount to nothing more than insignificant post-solution activity of outputting resultsinstructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Step 2B
Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The plurality of electrodes on a catheter and display disclosed by the applicant are well-understood, routine, and conventional as evidenced by figures 4 and 5 of Rosenberg et al. (Pub. No.: US 2021/0082157 11), figures 3B and 5B of Brewster et al. (Pub. No.: US 2021/0346105 A1), and figures 1-3 of Ozeri et al. (Pub. No.: US 2022/0192742 A1). Display is recited at a high level of generality, i.e., as a part of generic computer display, since the specification does not provide any exemplary or specific display structures. Therefore, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)). Court decisions cited in MPEP 2106.05(d)(II) indicate that computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim, as a whole, amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). Accordingly, a conclusion that the generic computer functions merely being used to implement an abstract idea is well-understood, routine, conventional activity is supported under Berkheimer Option 2.
Dependent claims 4-6 and 16-20 further limit the abstract idea already indicated in independent claims 1 and 15 and they are ineligible for the same reasons provided for claims 1 and 15 above.
For these reasons, there is no inventive concept in the claims and thus they are ineligible.
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.
Claim(s) 1, 5-6, and 15-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rosenberg et al. (Pub. No.: US 2021/0082157 A1); hereinafter referred to as “Rosenberg”.
Regarding claim 1, Rosenberg discloses a display system configured to communicate tissue proximity data from a plurality of electrodes, the display system comprising: a display (e.g. see figure 5 element 100) configured to output a circular graphical representation (e.g. see figure 6B element 1010B), the circular graphical representation comprising: a plurality of color areas (e.g. see figure 6B, element 602, [0050], [0058]) forming a first circular shape, each of the plurality of color areas communicating a categorized value for a respective electrode indicative of tissue proximity for the respective electrode (e.g. see [0050], [0058]); and a plurality of graph areas (e.g. see figure 6B labels 606, 608, 610, [0058]) forming a second circular shape (e.g. see figure 6B labels 606, 608, 610, [0058]. Note: 606, 608, 610 will have a different pattern and thus shape than 602), each of the plurality of graph areas communicating a relative value for the respective electrode indicative of the tissue proximity for the respective electrode (e.g. see figure 6B labels 606, 608, 610, [0058]. Note: 606, 608, 610 will communicate “a relative value for the respective electrode indicative of the tissue proximity for the respective electrode”).
Regarding claim 5, Rosenberg discloses the categorized value is indicative of whether a threshold level of electrode contact is met (e.g. see [0050], [0058]), and wherein the relative value is indicative of an electrode contact value (e.g. see figure 6B labels 606, 608, 610, [0058]. Note: 606, 608, 610 will be “indicative of an electrode contact value”).
Regarding claim 6, Rosenberg discloses the circular graphical representation represents a circular electrode distribution on a medical device (e.g. see figure 6B element 1010B).
Regarding claim 15, Rosenberg discloses a method of display, comprising: receiving tissue proximity data from a plurality of electrodes (e.g. see [0050], [0058]); transforming received data into a circular arrangement (e.g. see figure 6B element 1010B), the circular arrangement including a plurality of circle sectors (e.g. see figure 6B electrodes 1-10), each of the circle sectors corresponding to one or more electrodes (e.g. see figure 6B electrodes 1-10); and displaying the circular arrangement on a user interface (e.g. see figure 6B element 1010B), wherein each of the circle sectors includes a categorized value display (e.g. see figure 6B, elements 602, 610 [0050], [0058]) and a relative value display (e.g. see figure 6B labels 606, 608, [0058]).
Regarding claim 16, Rosenberg discloses the categorized value display includes output values, the output values including an optimal proximity (e.g. see [0056], “white contour”), a sub-optimal proximity (e.g. see [0056], “black contour”), and an error state (e.g. see element 610, [0058]), each of the output values corresponding to a respective color output.
Regarding claim 17, Rosenberg discloses the relative value display includes a threshold line and a current proximity line (e.g. see [0056], “white contour”, “black contour”, [0058], element 610).
Regarding claim 18, Rosenberg discloses the plurality of electrodes are arranged on a plurality of splines circumferentially spanning around a central axis of a medical device (e.g. see figure 3 element 30, [0035]).
Regarding claim 19, Rosenberg discloses a number of splines included on the medical devices corresponds to a number of circle sectors of the circular arrangement (e.g. see [0045], [0051]).
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.
Claim(s) 2-3, 7-12, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg as applied to claim 1 above, and further in view of Ozeri et al. (Pub. No.: US 2022/0192742 A1); hereinafter referred to as “Ozeri”.
Regarding claims 2 and 3, Rosenberg discloses the invention but is silent as to the display outputs a graphical user interface, wherein the graphical user interface enables direct manipulation of the plurality of electrodes and the graphical user interface enables direct manipulation of a treatment device. Ozeri teaches it is known to use such a modification as set forth in figure 3, [0052]-[0060] to provide a more intuitive electrode selection directly through the graphical user interface (“touchscreen” in [0058]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the GUI to enable direct manipulation of the plurality of electrodes and direct manipulation of a treatment device as taught by Ozeri in the system of Rosenberg, since said modification would provide the predictable results of a more intuitive electrode selection directly through the graphical user interface.
Regarding claim 7, Rosenberg discloses a user interface system for a catheter device, the user interface system comprising: a display (e.g. see figure 5 element 100), including a circular proximity display area (e.g. see figure 5 element 1010), the circular proximity display area including a plurality of circle sectors (e.g. see figure 6A elements 1-10), each of the plurality of circle sectors corresponding to one or more electrodes disposed on the catheter device (e.g. see figure 6A elements 1-10).
Rosenberg discloses the invention but is silent as to one or more control features configured to manipulate the catheter device and/or the one or more electrodes disposed on the catheter device, wherein the one or more control features are configured to select one or more system states. Ozeri teaches it is known to use such a modification as set forth in figure 3, [0052]-[0060] to provide a more intuitive electrode selection directly through the graphical user interface. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the GUI to enable direct manipulation of the plurality of electrodes and direct manipulation of a treatment device as taught by Ozeri in the system of Rosenberg, since said modification would provide the predictable results of a more intuitive electrode selection directly through the graphical user interface.
Regarding claim 8, Rosenberg discloses the one or more system states include a tissue proximity state, wherein the tissue proximity state displays a categorized value of an electrode measurement in each of the plurality of circle sectors (e.g. see figure 6B, element 602, [0050], [0058]).
Regarding claim 9, Rosenberg discloses the tissue proximity state displays a relative value of an electrode measurement in each of the plurality of circle sectors (e.g. see figure 6B labels 606, 608, 610, [0058]).
Regarding claim 10, Rosenberg discloses a color segment communicates the categorized value of the electrode measurement (e.g. see figure 6B, element 602, [0050], [0058]), and a graph segment displays the relative value of the electrode measurement (e.g. see figure 6B labels 606, 608, 610, [0058]).
Regarding claim 11, Rosenberg discloses the one or more system states include a baseline collection state, wherein the baseline collection state displays a plurality of radial sections within each of the circular sectors, each of the radial sections communicating a categorized value of a baseline measurement (e.g. see figure 6B elements 602, 606, 608, 610).
Regarding claim 12, Rosenberg discloses the one or more system states includes a therapy delivery state, wherein the therapy delivery state initiates an ablation treatment though the catheter device (e.g. see [0005], [0035]).
Regarding claim 14, Rosenberg discloses the invention but is silent as to the one or more control features are configured to select the one or more electrodes, wherein selection of an electrode selectively enables the electrode for therapy delivery. Ozeri teaches it is known to use such a modification as set forth in figure 3, [0052]-[0060] to provide a more intuitive electrode selection directly through the graphical user interface. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the GUI to enable direct manipulation of the plurality of electrodes and direct manipulation of a treatment device as taught by Ozeri in the system of Rosenberg, since said modification would provide the predictable results of a more intuitive electrode selection directly through the graphical user interface.
Claim(s) 4 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg and Ozeri as applied to claims 1-3 and 7 above, and further in view of Gross et al. (Pub. No.: US 2017/0202614 A1); hereinafter referred to as “Gross”.
Regarding claims 4 and 13, Rosenberg and Ozeri disclose the invention but are silent as the graphical user interface performs one or more gatekeeper functions. Gross teaches it is known to use such a modification as set forth in [0162], [0193], figures 7A and 12 to provide safer electrical stimulation. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a gatekeeper safeguards as taught by Gross in the system of Rosenberg and Ozeri, since said modification would provide the predictable results of safer electrical stimulation.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg as applied to claim 15 above, and further in view of Paul et al. (Pub. No.: US 2011/0264000 A1); hereinafter referred to as “Paul”.
Regarding claim 20, Rosenberg discloses the claimed invention except for transforming received data into the circular arrangement includes comparing a measured bipolar electrode complex impedance (BECI) measurement to a baseline BECI measurement. Paul teaches that it is known to use such a modification as set forth in [0034], [0052] (Note: “criteria to be used in evaluating electrical parameters, such as, for example, the magnitude of evaluation time intervals, the magnitude of various threshold values, and the like” in [0052] will read on “comparing a measured bipolar electrode complex impedance (BECI) measurement to a baseline BECI measurement”) to provide superior means to identify a tissue type from a plurality of candidate tissue types including regular tissue (e.g., endocardial, myocardial, or epicardial tissue), lesioned (i.e., ablated) tissue, ischemic scar tissue, and fat tissue (e.g. see [0054]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to compare the bipolar electrode complex impedance to a baseline measure as taught by Paul in the method of Rosenberg, since said modification would provide the predictable results of superior means to identify a tissue type from a plurality of candidate tissue types including regular tissue (e.g., endocardial, myocardial, or epicardial tissue), lesioned (i.e., ablated) tissue, ischemic scar tissue, and fat tissue.
Conclusion
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/P.C.E/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792