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 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 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.
Claim(s) 1-3 and 5-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mosesov et al., (US 20190183378; hereinafter Mosesov) in view of Shelton, IV et al., (US 20190201087; hereinafter Shelton) and Aiken et al., (US 20090275827; hereinafter Aiken).
Regarding claim 1, Mosesov discloses (Figures 1, 7, and 17A-17C) a method for determining a tissue contact profile, the method comprising: receiving, at a location agnostic system (116), a first plurality of electronic signals (corresponding to impedance values obtained in the time to measure baseline plus the time of measuring changes in impedance) that includes signals from a plurality of electrodes (20) of a catheter (24), ([0045]-[0050], [0106]-[0010]); obtaining, by the location agnostic system (116), a first impedance value from the first plurality of electronic signals ([0109]: system 116 may monitor electrode impedance changes, e.g. for each electrode, relative to established baseline impedance values in the time to measure baseline plus the time of measuring changes in impedance); receiving, at a location aware (baseline) system ([0106]: the baselining procedure algorithm of processor system 94+96), a subset of electronic signals of the first plurality of electronic signals (corresponding to a subset of impedance values used for determining the baseline in the time to measure baseline plus the time of measuring changes in impedance), ([0106]); determining, by the location aware (baseline) system (baselining procedure algorithm of processor system 94+96), a location of the catheter when the first plurality of signals were generated within an intra-body organ (stored as a known location for baseline value), ([0106]-[0107]); obtaining, by the location aware (baseline) system, a second impedance value from the subset of the plurality of the electronic signals ([0109]: system 116 may monitor electrode impedance changes, e.g. for each electrode, relative to established baseline impedance values); and generating, by the location agnostic system (116), a location agnostic system contact profile (contact assessment profile) for the catheter based on the location of the catheter determined, wherein the location agnostic system contact profile includes the first impedance value obtained by the location agnostic system ([0109]: electrode impedance changes for each electrode are monitored relative to the baseline impedance values, and the respective electrode impedance changes are used to categorize electrode contact based on a contact assessment profile ranging from insufficient, sufficient, and elevated/excessive coupling); disconnecting from the location aware (baseline) system (baselining procedure algorithm of processor system 94+96) prior to a second time during the surgical procedure ([0106]-[0110]: the baselining procedure algorithm of processor system 94+96 is connected/run first during a surgical procedure to establish the baseline, then the baselining procedure algorithm of processor system 94+96 is completed/disconnected prior to the second time, for contact assessment, in which test impedance values are compared to the baseline values established by the disconnected baselining procedure algorithm of processor system 94+96); and determining, by the location agnostic system (116) at the second time for contact assessment, tissue contact independently of catheter location by applying the location agnostic system contact profile (contact assessment profile) to subsequent signals from the plurality of electrodes (20). The location aware/baseline system (94+96) is used to establish the baseline impedance values for the system, so the determination that the catheter is in contact with the tissue at the location is made by first determining these baseline values using the location aware system (94+96), then monitoring the impedance changes of each electrode using the location agnostic system (116) and generating the contact profile by categorizing electrode contact based on a contact assessment profile ranging from insufficient, sufficient, and elevated/excessive coupling ([0106]-[0110]).
Although Mosesov discloses that the method involves the use of both the location agnostic system (116) and the location aware/baseline system (94+96) utilizing a processor and memory, Mosesov fails to disclose that the location agnostic system and the location aware system are separate systems. However, Shelton teaches an electrosurgical treatment method using a system which include two distinct processors (main processor and safety processor), with respective internal memories, to perform two distinct functional algorithms ([0326]-[0330]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to separate the systems used for the location agnostic system and the location aware/baseline system, disclosed by Mosesov into two processors, with respective memories, as taught by Shelton, with each processor/memory combination associated with one of the location agnostic system and the location aware/baseline system, respectively, since it has been held that deconstructing a formerly integral structure into its various elements or parts involves only routine skill in the art. MPEP 2144.04 (V)(C).
Mosesov/Shelton fails to teach determining, by the location aware system, a proximity of the catheter when the first plurality of signals were generated with respect to tissue at the location based on the second impedance value and the location, wherein the location agnostic system contact profile is generated based on the determined proximity of the catheter. However, Aiken (Figure 1) teaches a method for determining a tissue contact profile, wherein a proximity of the catheter is determined when a first plurality of signals is generated with respect to tissue based on a location and the corresponding impedance value ([0065]: proximity is determined as close proximity or not). Specifically, first and second components of a complex impedance between electrodes and tissue are used to calculate an electrical coupling index (ECI). Using this ECI, the method of Aiken includes comparing the calculated ECI, derived from the impedance measurements, to a threshold to determine/categorize the proximity of the device to the tissue. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mosesov/Shelton to include determining, by the location aware system, a proximity of the catheter when the first plurality of signals were generated with respect to tissue at the location based on the second impedance value and the location, as taught by Aiken, because the modification would provide a means to determine the proximity of the catheter to target tissue, which determines the safety and effectiveness of treatment (Aiken; [0006]). Furthermore, in the modified method, the location agnostic system contact profile would also be generated based on the determined proximity of the catheter since this would be an additional input to the controller. Namely, the modified method would comprise using the impedance measurements to derive an electrical coupling index (ECI) and use that ECI compared to a threshold to determine the proximity of the device to tissue, as taught by Aiken.
Regarding claim 2, Mosesov further discloses (Figures 1, 7, and 17A-17C) receiving, at a second time, a second plurality of electronic signals (corresponding to impedance values) from the electrodes (20) and providing the second plurality of electronic signals (corresponding to impedance values) to the location agnostic system (116); determining that the second plurality of electronic signals (corresponding to impedance values) meet the location agnostic system contact profile (contact assessment profile); and determining that the catheter is in contact with the location based on determining that the second plurality of electronic signals (corresponding to impedance values) meet the location agnostic system contact profile (contact assessment profile), ([0106]-[0110]).
Regarding claim 3, Mosesov further discloses (Figures 1, 7, and 17A-17C) determining that the second plurality of electronic signals (corresponding to impedance values) meet the location agnostic system contact profile (contact assessment profile) comprises determining that an impedance value corresponding to the second plurality of electronic signals is greater than the first impedance value (contact assessment profile), ([0106]-[0110]).
Regarding claim 5, Mosesov further discloses (Figures 1, 7, and 17A-17C) wherein the proximity of the catheter is further determined by determining that the second impedance value is greater than an impedance value threshold of the location ([0106]-[0110]).
Regarding claim 6, Mosesov further discloses (Figures 1, 7, and 17A-17C) that the proximity of the catheter is further based on the second impedance value exceeding an impedance threshold for a particular location ([0106]-[0110]).
Regarding claim 7, Mosesov further discloses (Figures 1, 7, and 17A-17C) that the impedance threshold for the location is based on a change in impedance ([0106]-[0110]).
Regarding claim 8, Mosesov further discloses (Figures 1, 7, and 17A-17C) that the impedance threshold for the location is based on a percentage of change in impedance ([0106]-[0110]).
Regarding claim 9, Mosesov further discloses (Figures 1, 7, and 17A-17C) that the location agnostic system contact profile (contact assessment profile) comprises one or more impedance thresholds for the plurality of electrodes (20) ([0106]-[0110]).
Regarding claim 10, Mosesov further discloses (Figures 1, 7, and 17A-17C) that the one or more impedance thresholds are determined based on determining, by the location aware (baseline) system (94+96), that the catheter is in contact with tissue at the location ([0106]-[0110]).
Regarding claim 11, Mosesov discloses (Figures 1, 7, and 17A-17C) a system for determining a tissue contact profile, the system comprising: a catheter (24) comprising a plurality of electrodes (20), ([0045]-[0050]); a location aware (baseline) system including at least a processor (96) and memory (94), ([0106]: the baselining procedure algorithm of processor system 94+96), configured to: receive a subset of electronic signals (corresponding to a subset of impedance values for determining the baseline) from a first plurality of electronic signals (corresponding to impedance values) that are generated by the plurality of electrodes at a first time during a surgical procedure (the “first time during a surgical procedure” is interpreted as the time to measure baseline plus the time of measuring changes in impedance); determine a location of the catheter (24) when the plurality of signals were generated within an intra-body organ; obtain a second impedance value from the subset of the electronic signals; a location agnostic system (116) configured to: receive, the first plurality of electronic signals (corresponding to impedance values obtained in the time to measure baseline plus the time of measuring changes in impedance) corresponding to a respective plurality of electrodes (20) of the catheter (24); determine a first impedance value based on the first plurality of electronic signals ([0109]: system 116 may monitor electrode impedance changes, e.g. for each electrode, relative to established baseline impedance values the time to measure baseline plus the time of measuring changes in impedance); and generate a location agnostic system contact profile (contact assessment profile) for the catheter (24) based on the location of the catheter determined, wherein the location agnostic system contact profile includes the first impedance value ([0109]: electrode impedance changes for each electrode are monitored relative to the baseline impedance values, and the respective electrode impedance changes are used to categorize electrode contact based on a contact assessment profile ranging from insufficient, sufficient, and elevated/excessive coupling), and determine tissue contact independently of catheter location by applying the location agnostic system contact profile (contact assessment profile) to subsequent signals from the plurality of electrodes (20) at a second time (for the contact assessment) during the surgical procedure, wherein, at the second time (for the contact assessment), the location aware (baseline) system (the baselining procedure algorithm of processor system 94+96) is disconnected such that the subsequent signals are provided only to the location agnostic system (116), ([0106]-[0110]: the baselining procedure algorithm of processor system 94+96 is connected/run first during a surgical procedure to establish the baseline, then the baselining procedure algorithm of processor system 94+96 is completed/disconnected prior to the second time, for contact assessment, in which test impedance values are compared to the baseline values established by the disconnected baselining procedure algorithm of processor system 94+96). The location aware/baseline system 94+96 is used to establish the baseline impedance values for the system, so the determination that the catheter is in contact with the tissue at the location is made by first determining these baseline values using the location aware/baseline system 94+96, then monitoring the impedance changes of each electrode using the location agnostic system 116 and generating the contact profile by categorizing electrode contact based on a contact assessment profile ranging from insufficient, sufficient, and elevated/excessive coupling ([0106]-[0110]).
Although Mosesov discloses that the method involves the use of both the location agnostic system (116) and the location aware/baseline system (94+96) utilizing a processor and memory, Mosesov fails to disclose that the location agnostic system and the location aware system are separate systems. However, Shelton teaches an electrosurgical treatment method using a system which include two distinct processors (main processor and safety processor), with respective internal memories, to perform two distinct functional algorithms ([0326]-[0330]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to separate the systems used for the location agnostic system and the location aware/baseline system, disclosed by Mosesov into two processors, with respective memories, as taught by Shelton, with each processor/memory combination associated with one of the location agnostic system and the location aware/baseline system, respectively, since it has been held that deconstructing a formerly integral structure into its various elements or parts involves only routine skill in the art. MPEP 2144.04 (V)(C).
Regarding claim 12, Mosesov further discloses (Figures 1, 7, and 17A-17C) that the location agnostic system (116) is further configured to: receive, at a second time, a second plurality of electronic signals (corresponding to impedance values) from the plurality of electrodes (20); determine that the second plurality of electronic signals (corresponding to impedance values) meet the location agnostic system contact profile (contact assessment profile); and determine that the catheter is in contact with the location based on determining that the second plurality of electronic signals (corresponding to impedance values) meet the location agnostic system contact profile ([0106]-[0110]).
Mosesov/Shelton fails to teach determining, by the location aware system, a proximity of the catheter when the first plurality of signals were generated with respect to tissue at the location based on the second impedance value and the location, wherein the location agnostic system contact profile is generated based on the determined proximity of the catheter. However, Aiken (Figure 1) teaches a method for determining a tissue contact profile, wherein a proximity of the catheter is determined when a first plurality of signals is generated with respect to tissue based on a location and the corresponding impedance value ([0065]: proximity is determined as close proximity or not). Specifically, first and second components of a complex impedance between electrodes and tissue are used to calculate an electrical coupling index (ECI). Using this ECI, the method of Aiken includes comparing the calculated ECI, derived from the impedance measurements, to a threshold to determine/categorize the proximity of the device to the tissue. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mosesov/Shelton to include determining, by the location aware system, a proximity of the catheter when the first plurality of signals were generated with respect to tissue at the location based on the second impedance value and the location, as taught by Aiken, because the modification would provide a means to determine the proximity of the catheter to target tissue, which determines the safety and effectiveness of treatment (Aiken; [0006]). Furthermore, in the modified method, the location agnostic system contact profile would also be generated based on the determined proximity of the catheter since this would be an additional input to the controller. Namely, the modified method would comprise using the impedance measurements to derive an electrical coupling index (ECI) and use that ECI compared to a threshold to determine the proximity of the device to tissue, as taught by Aiken.
Regarding claim 13, Mosesov further discloses (Figures 1, 7, and 17A-17C) determining that the second plurality of electronic signals (corresponding to impedance values) meet the location agnostic system contact profile (contact assessment profile) comprises determining that an impedance value corresponding to the second plurality of electronic signals (corresponding to impedance values) is greater than the first impedance value (contact assessment profile), ([0106]-[0110]).
Regarding claim 14, Mosesov further discloses (Figures 1, 7, and 17A-17C) that the proximity determination comprises determining that the second impedance value is greater than an impedance value threshold of the location ([0106]-[0110]).
Regarding claim 15, Mosesov further discloses (Figures 1, 7, and 17A-17C) that the proximity determination is further based on the second impedance threshold for a particular location ([0106]-[0110]).
Regarding claim 16, Mosesov further discloses (Figures 1, 7, and 17A-17C) that the impedance threshold for the location is based on a change in impedance ([0106]-[0110]).
Regarding claim 17, Mosesov further discloses (Figures 1, 7, and 17A-17C) that the impedance threshold for the location is based on a percentage of change in impedance ([0106]-[0110]).
Regarding claim 18, Mosesov further discloses (Figures 1, 7, and 17A-17C) that the location agnostic system contact profile (contact assessment profile) comprises one or more impedance thresholds for electrodes of the location agnostic system ([0106]-[0110]).
Regarding claim 19, Mosesov further discloses (Figures 1, 7, and 17A-17C) that the one or more impedance thresholds are determined based on determining, by the location aware (baseline) system (94+96), that the catheter is in contact with tissue at the location ([0106]-[0110]).
Regarding claim 20, Mosesov/Shelton teaches that the first impedance value and the second impedance value are different even on a condition that identical signals are provided to both the location agnostic system and the location aware system. Specifically, the modified method includes the two distinct processor/memory combinations for the location agnostic system and the location aware system. Therefore, the impedance values and the second impedance values sent to the processor/memory combinations for the location agnostic system and the location aware system, respectively, would be different even on a condition that identical signals are provided to both the location agnostic system and the location aware system.
Regarding claim 21, Mosesov/Shelton teaches wherein the first impedance value and the second impedance value are different due to at least one of circuitry, electricity propagation, internal components, and conversion mechanisms of the location agnostic system and the location aware system. Specifically, the modified method includes the two distinct processor/memory combinations for the location agnostic system and the location aware system. Therefore, the impedance values and the second impedance values sent to the processor/memory combinations for the location agnostic system and the location aware system, respectively, would be different due to at least one of circuitry, electricity propagation, internal components, and conversion mechanisms of the distinct processor/memory combinations for the location agnostic system and the location aware system.
Response to Arguments
Applicant's arguments filed 04/20/2026 have been fully considered but they are not persuasive. In response to Applicant’s argument that the cited references fail to teach the newly amended limitation “disconnecting from the location aware system prior to a second time during the surgical procedure; and determining, by the location agnostic system at the second time, tissue contact independently of catheter location” in claim 1, as well as the similar amendments in claim 11, Examiner respectfully disagrees. As disclosed in paragraphs [0106]-[0110] of Mosesov, the location aware system (the baselining procedure algorithm of processor system 94+96) is connected/run first during a surgical procedure to establish the baseline, then the location aware system (the baselining procedure algorithm of processor system 94+96) is completed/disconnected prior to the second time, for contact assessment, in which test impedance values are compared to the baseline values established by the disconnected location aware system (the baselining procedure algorithm of processor system 94+96). Therefore, Examiner maintains that the Mosesov/Shelton combination teaches the invention as presently claimed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
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