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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/29/2026 has been entered.
Response to Amendment
Claims 1-20 are pending, with claims 1 and 11 being independent. Claims 1, 4, 5, 11, 14, 15, and 20 have been amended.
Response to Arguments
Applicant’s arguments, see Remarks, filed 06/29/2026, with respect to the rejection of claims 1, 3-6, 10-11, 13-16, and 20 under 35 U.S.C. 103 as unpatentable over Govari (US 2020/0367829) in view of Bar-Tal (US 2015/0208942) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Koblish (US 2019/0038349).
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.
Claim 10 is 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.
Regarding claim 10, the claim recites the limitation "over the period of time" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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 and 11 (and therefore, their dependent claims 2-10 and 12-20, respectively) are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea and mental process without significantly more. The claims recite sensing/acquiring signals from electrodes and computing a plurality of metrics of each of the electrodes. This judicial exception is not integrated into a practical application because the only output or application of this process is to display a graphical icon representing the calculated data, which is a form of insignificant extra-solution activity. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the acquiring and computing step is recited at a high level of generality, and amounts to mere data gathering, which is a form of insignificant extra-solution activity. See below for a two-prong analysis of the claims.
Regarding claims 1 and 11, Prong 1: Are the claims directed to a statutory category?
Yes. The claims recite a series of steps within a system and is a product.
Step 2A, Prong 1: Is a Judicial Exception Recited?
Yes. The claims recite the limitation of acquiring signals from electrodes, and computing in response to the signals received a plurality of metrics. These limitations, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting a “processor configured”, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “a processor” language, the claim encompasses a user being able to calculate a metric and determining a value/influence of a value. The mere nominal recitation of a generic processor does not take the claim limitation out of the mental processes grouping. Thus, the claim recites a mental process.
Step 2A, Prong 2: Is it Integrated into a Practical Application?
No. The claim recites an additional element: output, to a display, a graphical icon representing the distal end of the probe and an indication of each metric associated with each respective electrode of the array of electrodes at the respective electrode’s respective location. The output to display step is recited at a high level of generality and further is considered is a form of insignificant extra-solution activity. The combination of these additional elements is no more than mere instructions to apply the exception using a generic computer component. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The output is not actually used for other activity. The claim is therefore directed to the abstract idea.
Step 2B, Prong 2: Does the claim provide an inventive concept?
No. As discussed with respect to Step 2A Prong 2, the additional elements in the claim amount to no more than mere extra solution activity to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Since there needs to be a re-evaluation of the output step in Step 2B, further re-evaluation as to whether the recitations are more than what is well-understood, routine, conventional activity in the field is needed. There is no indication that the processor/output is anything other than a generic, off-the-shelf computer component, and the Symantec, TLI, and OIP Techs. court decisions cited in MPEP 2106.05(d)(II) indicate that mere collection or receipt of data over a network is a well-understood, routine, and conventional function when it is claimed in a merely generic manner (as it is here). Accordingly, a conclusion that the acquiring and output step is well-understood, routine, conventional activity is supported under Berkheimer Option 2.
Furthermore, the ability to compute a value is seen as well-understood, routine and conventional as different control structures using off-the-shelf computers integrate feedback into their systems. For these reasons, there is no inventive concept in the claim, and thus it is ineligible.
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.
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.
Claims 1, 3, 4, 5, 6, 10, 11, 13, 14, 15, 16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Govari (US Patent Publication 2020/0367829), herein after “Govari” in view of Koblish (US 2019/0038349), herein after “Koblish”.
Regarding claims 1 and 11, Govari teaches
“A system for electrophysiological measurement (Figures 1-3, p.[0061-0063])”, “a probe having a distal end configured for insertion into a body cavity of a living subject (Fig. 1, the heart) and comprising an array of electrodes (Fig. 2, 55) that are disposed along the distal end and are configured to contact tissue at multiple locations within the body cavity, each electrode being disposed at a respective location on the distal end (Fig. 1, 2, electrodes 55, i.e., electrodes on the distal end of the cardiac catheter, see also p.[0063])”,
“a processor (Fig. 1, 24, console comprising processing circuitry 41, typically a general-purpose computer, p.[0067]) configured to acquire a plurality of signals from the electrodes over a period of time during which the probe moves within the body cavity (p.[0079], the processing circuitry receives signals from the electrodes)”,
“compute, in response to the plurality of signals, a plurality of metrics, each metric being (i) associated with a respective electrode of the array of electrodes and (ii) indicative of a quality of contact between the respective electrode and the tissue (p.[0079], signals from the catheter electrodes 55 for use in assessing quality of contact of the catheter electrodes 55 with the tissue)”,
“output an indication of each metric (see Fig. 1, 27, i.e. a display driven by the console, see also p.[0070, 0096], i.e., modify the visual feature of the traces sensed by the electrodes having a quality of contact with the tissue greater than a threshold quality of contact)”.
However, Govari does not explicitly teach “… acquire a plurality of signals from each electrode of the array of electrodes over a period of time, compute, in response to the plurality of signals acquired from each electrode over the period of time, … indicative of a quality of contact between the respective electrode and the tissue over the period of time…”, as the amended claims now state, but Koblish does.
Koblish teaches “a processor configured to: acquire a plurality of signals from respective electrodes of the array of electrodes (p.[0039]), compute, in response to the plurality of signals acquired from the respective electrodes, a plurality of metrics, each metric being (i) associated with a respective electrode of the array of electrodes and (ii) indicative of a quality of contact between the respective electrode (p.[0042]) and the tissue, and output, to a display, a graphical icon representing the distal end of the probe and an indication of each metric associated with each respective electrode of the array of electrodes at the respective electrodes location (p.[0233, 0650] and Fig. 37A)”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Koblish in Govari. As stated in Koblish, p.[0002], “In ablation procedures involving radiofrequency energy delivery using one or more electrodes, the clinician strives to establish stable and uniform contact between the electrode(s) and the tissue to be ablated” and the combination of Koblsih/Govari produces predictable results of improving contact between tissue and the electrodes.
Regarding claim 11 specifically, the limitations of claim 11 are taught by the rejection of claim 1 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 11 is nearly identical to the apparatus of claim 11 and therefore, claim 11 would perform the method of claim 1 and is considered to be anticipated by the rejection of claim 1, as outlined above.
Regarding claims 3 and 13, the limitations of claims 1 and 11 are taught as described above. Govari teaches “wherein the distal end of the probe comprises a plurality of flexible spines on which the electrodes are disposed along, the flexible spines being arranged in a multi-arm assembly” in p.[0062-63], i.e., deflectable arms 54 including electrodes 55, and further teaches that the metrics are indicative of contact between the sections of the expandable device and the tissues in p.[0079-0084] and illustrated in Figures 2 and 4.
Regarding claim 13 specifically, the limitations of claim 13 are taught by the rejection of claim 3 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 13 is nearly identical to the apparatus of claim 3 and therefore, claim 3 would perform the method of claim 13 and is considered to be anticipated by the rejection of claim 3, as outlined above.
Regarding claims 4 and 14, the limitations of claims 1 and 11 are taught as described above. Govari does not teach “the processor is configured to render the graphical icon to a display and each indication comprises a color-coded marking, the color-coded marking comprising a color that is based on the computed metric”, but Koblish does in an analogous catheter device. Koblish teaches “the processor is configured to render the graphical icon to a display (Fig. 37A)”, “each indication comprises a color-coded marking, the color-coded marking comprising a color that is based on the computed metric (p.[0009,0022,0207,0229,0232,0233]”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Koblish in Govari. The use of color-coded display icons is known in the art for indicating the degree of contact and produces predicable results of assisting the physician in increasing, decreasing, or maintaining the degree of contact between the electrodes and the treated tissue.
Regarding claim 14 specifically, the limitations of claim 14 are taught by the rejection of claim 4 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 14 is nearly identical to the apparatus of claim 4 and therefore, claim 4 would perform the method of claim 14 and is considered to be anticipated by the rejection of claim 4, as outlined above.
Regarding claim 5 and 15, the limitations of claim 1 and 11 are taught as described above. Govari teaches “wherein each metric is indicative of a number of valid signals acquired by the associated respective electrode from the tissue over a period of time” in p.[0093-0094], which describes that the process of collecting metric signals via the electrodes over a period of time (at least one to three seconds), and that the valid signals from the electrodes are considered to be effective or sufficient contact with tissue overtime. The number of valid signals or sufficient contact with tissue signals is shown though the intensity, or brightness, of the color.
Regarding claim 15 specifically, the limitations of claim 15 are taught by the rejection of claim 5 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 15 is nearly identical to the apparatus of claim 5 and therefore, claim 5 would perform the method of claim 15 and is considered to be anticipated by the rejection of claim 5, as outlined above.
Regarding claim 6 and 16, the limitations of claim 5 and 15 are taught as described above. Govari teaches “wherein the processor is configured to apply one or more filtering criteria to the signals in order to classify as valid a respective first set of the signals acquired from each of the electrodes while classifying as invalid a respective second set of the signals acquired by each of the electrodes” in p.[0085], which describes that the processor is able to determine valid signals (in contact state) versus invalid signals (out-of-contact state) and therefore teaches the limitation as described.
Regarding claim 16 specifically, the limitations of claim 16 are taught by the rejection of claim 6 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 16 is nearly identical to the apparatus of claim 6 and therefore, claim 6 would perform the method of claim 16 and is considered to be anticipated by the rejection of claim 6, as outlined above.
Regarding claim 10 and 20, the limitations of claim 1 and 11 are taught as described above. Govari teaches “wherein each metric is indicative of a respective duration during which the respective electrode was in contact with the tissue in the body cavity over the period of time” in p.[0099], which describes how the processor is able to use a fading effect on the displayed electrode to demonstrate the duration of time the electrode was in sufficient contact with the desired tissue, therefore teaching the limitation as described.
Regarding claim 20 specifically, the limitations of claim 20 are taught by the rejection of claim 10 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 20 is nearly identical to the apparatus of claim 10 and therefore, claim 10 would perform the method of claim 20 and is considered to be anticipated by the rejection of claim 10, as outlined above.
Claims 2, 7, 8, 9, 12, 17, 18 and 19 are rejected under 35 U.S.C. 103 as being obvious over Govari and Koblish in further view of Mosesov (US Patent Publication 2019/0183378), herein after “Mosesov”.
Regarding claims 2 and 12, the limitations of claim 1 and 11 are taught as described above. Govari teaches that a series of metrics indicative of contact between an expandable electrode assembly and tissue (abstract, p.[0078-0079,0081]), but Govari does not teach the use of a basket assembly, and instead teaches the use of a system of splines. However, Mosesov teaches the use of a basket catheter in an analogous ablative catheter device. Mosesov teaches the use of a basket catheter to determine the contact between electrodes and tissue in Fig. 4, basket 18a-h, and p.[0058,0094]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the basket catheter of Mosesov in Govari/Koblish's system. The use of a basket catheter allows for the selective expansion and retraction of the electrodes (p.[0111]) as needed for navigating the circulatory system before arriving at the desired hollow organ, and is known in the art as a predictable design choice for ablative catheters (as suggested in Govari, p.[0075], which states "Any suitable catheter may be used instead of catheter 40... or a different probe shape, such as a balloon catheter or a lasso catheter...") and produces predictable results of navigating a hollow organ.
Regarding claim 12 specifically, the limitations of claim 12 are taught by the rejection of claim 2 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 12 is nearly identical to the apparatus of claim 2 and therefore, claim 2 would perform the method of claim 12 and is considered to be anticipated by the rejection of claim 2, as outlined above.
Regarding claims 7 and 17, the limitations of claim 6 and 16 are taught as described above. Govari/Koblish does not teach that the processor is configured to determine a proximity of each electrode to the tissue, nor classify the set of signals as valid based on the proximity of the tissue to the electrode based on a threshold distance, but Mosesov does in an analogous electrosurgical catheter device. Mosesov teaches the establishment of baseline impedance values (threshold) to determine the tissue proximity or contact (p.[0110, 0113, 0117]), via a processor, and further identify valid or "desired" signals based on the proximity or contact conditions stored in the memory 94 of the processor. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the processor of Mosesov in view of Govari/Koblish. As stated in Mosesov, p.[0004] "In many procedures, it may be beneficial to know the contact status of an electrode (e.g., in contact with tissue, in a blood pool) on a catheter. For example, in an electrophysiology mapping procedure, the electrical signal present on an electrode may vary depending on whether the electrode is in contact with tissue, or adjacent to the tissue in a blood pool, and that difference may be accounted for in software” and produces predictable results of determining the contact state between the electrode and the tissue.
Regarding claim 17 specifically, the limitations of claim 17 are taught by the rejection of claim 7 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 17 is nearly identical to the apparatus of claim 7 and therefore, claim 7 would perform the method of claim 17 and is considered to be anticipated by the rejection of claim 7, as outlined above.
Regarding claims 8 and 18, the limitations of claims 6 and 16 are taught as described above. Govari/Koblish does not teach that the processor is configured to determine a second set of signals as invalid based on the probe moving more than a maximal distance during acquisition of the plurality of signals, but Mosesov does in an analogous electrosurgical device. Mosesov teaches the establishment of baseline impedance values (threshold) to determine the tissue proximity or contact (p.[0110, 0113, 0117]), via a processor, and further identify invalid or "undesired" signals based on the proximity or contact conditions stored in the memory 94 of the processor. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the processor of Mosesov in view of Govari/Koblish. As stated in Mosesov, p.[0004] "In many procedures, it may be beneficial to know the contact status of an electrode (e.g., in contact with tissue, in a blood pool) on a catheter. For example, in an electrophysiology mapping procedure, the electrical signal present on an electrode may vary depending on whether the electrode is in contact with tissue, or adjacent to the tissue in a blood pool, and that difference may be accounted for in software” and produces predictable results of determining the contact state between the electrode and the tissue.
Regarding claim 18 specifically, the limitations of claim 18 are taught by the rejection of claim 8 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 18 is nearly identical to the apparatus of claim 8 and therefore, claim 8 would perform the method of claim 18 and is considered to be anticipated by the rejection of claim 8, as outlined above.
Regarding claim 9 and 19, the limitations of claim 6 and 16 are taught as described above. Govari/Koblish does not teach "wherein the processor is configured to filter the plurality of signals by voltage level and classify the respective first set of the signals as valid based on the voltage levels being above a predetermined minimum voltage levels", but Mosesov teaches this limitation in an analogous electrosurgical device. Mosesov teaches the establishment of baseline impedance values (threshold) to determine the tissue proximity or contact (p.[0110, 0113, 0117]), via a processor, and further identify valid or "desired" signals based on the proximity or contact conditions stored in the memory 94 of the processor. The Examiner notes for the sake of the record and clarity that impedance (Z) is calculated as a function of resistance voltage (V) and current (I), as given in the equation Z = V/I. Therefore, the processor is determining the voltage level and classifying the signals as valid or invalid based on voltage levels being above a certain predetermined voltage (impedance) level. Impedance will vary as voltage will vary, therefore, while Mosesov does not explicitly teach measuring voltage levels for classifying signals, Mosesov does so indirectly by calculating impedance values as a threshold. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the processor of Mosesov in view of Govari/Koblish. As stated in Mosesov, p.[0004] "In many procedures, it may be beneficial to know the contact status of an electrode (e.g., in contact with tissue, in a blood pool) on a catheter. For example, in an electrophysiology mapping procedure, the electrical signal present on an electrode may vary depending on whether the electrode is in contact with tissue, or adjacent to the tissue in a blood pool, and that difference may be accounted for in software” and produces predictable results of determining the contact state between the electrode and the tissue.
Regarding claim 19 specifically, the limitations of claim 19 are taught by the rejection of claim 9 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 19 is nearly identical to the apparatus of claim 9 and therefore, claim 9 would perform the method of claim 19 and is considered to be anticipated by the rejection of claim 9, as outlined above.
Conclusion
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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