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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/18/2023, 11/16/2023, 1/15/2025 was filed after the mailing date of the application on 08/02/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
Claim 16 recites an “isolation line”, wherein the Specification of the instant application uses the phrase “isolation line” three times throughout the disclosure, particularly as an example in p.[117] which states “The therapeutic strategy can further include… connecting the first pattern to either an anatomical structure such as a valve ring and/or to another lesion set (e.g., an isolation line for one or more pulmonary veins)… whereby each end of the line of energy delivery is anchored either in an anatomical structure or previous energy delivery line (e.g., isolation line) for the pulmonary veins.”
Cleveland Clinic refers to an isolation line as carefully placed series of scars created in the heart to block abnormal electrical signals, most commonly used to treat atrial fibrillation. In light of both the common definition and Applicant’s use of the phase, the Examiner is interpreting the limitation to be describing a line of scars, lesions, or otherwise treated tissue that is the result of ablation.
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.
Claims 3, 4, 7, 9, and 15 are 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 claims 3 and 4, the claim recites a mathematical formula with variables W, K, α, B, P, у, T, t, and t0, but does not define any variable except for t0, which is defined as the time at the start of the ablation. The Examiner cannot determine what these variables refer to in the context of this application from the claims alone. The Examiner suggests including the definitions of each variable as done in claim 12. Appropriate correction is required.
Regarding claim 7, the claim recites a mathematical formula with variables Fs, F^, C1, C2, Ѳ, but only defines Ѳ, C1, and C2. The Examiner cannot determine what these variables refer to in the context of this application from the claims alone. The Examiner suggests including the definitions of each variable as done in claim 12. Appropriate correction is required.
Regarding claim 9, the limitation recites “… wherein the amplitude and/or frequency of the vibration of the vibrational transducer”. The phrase “and/or” renders the claim indefinite, as the Examiner cannot determine what is and is not being claimed in the limitation. In other words, the haptic feedback cannot be either amplitude driven, frequency driven, or both, simultaneously. Appropriate correction is required.
Regarding claim 15, the limitation states “… that connects the first set of lesions to an anatomical structure and/or a second set of lesions”. The phrase “and/or” renders the claim indefinite, as the Examiner cannot determine what is and is not being claimed in the limitation. In other words, the first set of lesions cannot be connected to an anatomical structure, a second set of lesions, or both, simultaneously. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 2, 5, 13, and 15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Govari (US Patent Publication 2014/0100563).
Regarding claim 2, Govari teaches
“an ablation catheter (catheter 14) comprising:”,
“a shaft (implicit for catheter 14, see also Fig. 1 and 2);”,
“at least one therapeutic element (ablation electrodes 32) positioned on the shaft (Fig. 1 and 2)”,
“and one or more tissue-contact sensing components (sensing electrodes 33, p.[0039] "… plurality of location sensing electrodes (not shown) located distally in the catheter 14") configured to provide a contact signal related to the level of contact between the at least one therapeutic element and tissue (p.[0047] "... contact force between the ablation electrode 32 and the wall 37 may be measured using a position sensor")”,
“an energy delivery unit (ablation power generator 25) configured to deliver ablative energy to the at least one therapeutic element to create a lesion in target tissue (p.[0036] "catheter 14 may be adapted to conduct ablative energy to the heart"), and to provide an energy delivery data related to one or more parameters of the delivered energy (p.[0048] "In operation, two of the variables, F, P, T, are held constant, and the third is varied, either randomly or systematically, so as to produce a desired lesion size S by the ablation");”,
“a force module (positioning processor 22) configured to receive the contact signal and provide contact data related to the level of contact between the at least one therapeutic element and tissue (p.[0039] "signal processing circuits typically receive, amplify, filter and digitize signals from the catheter 14, including signals generated by the above-noted sensors and a plurality of location sensing electrodes")”,
“a processing unit configured to receive the energy delivery data and the contact data and to determine an ablation index based on both the energy delivery data and the contact data (Fig. 3)”,
“wherein the ablation index represents the status of the lesion being created (Lesion Size (S) in Fig. 3)”,
“the processing unit is configured to determine that an ablation is considered effective if a contact force of the at least one therapeutic element to the tissue is greater than a minimum value (Fsat and Ssat in Fig. 2)”.
Regarding claim 5, the limitations of claim 2 are taught as described above. Govari teaches “wherein the atleast one therapeutic element comprises an electrode positioned on a distal tip of the shaft” with the position of electrode 32 in Figure 2.
Regarding claim 13, the limitations of claim 2 are taught as described above. Govari teaches “wherein the system is configured to provide a therapeutic strategy to a user comprising a set of one or more energy delivery patterns collectively configured to address one or more conduction patterns identified by the system” in Figure 3 and p.[0053] which describes that different lesion sizes are created based on the quantity of energy delivered and the force used where the energy is applied. Different lesions are created by different curves 45, 47, 49, 51. Further, the applicant is advised that it has been held by the courts that the recitation that an element is adapted to perform a function or serve in a given application is not a positive limitation, but only requires the ability to so perform. In re Hutchinson, 69 USPQ 138. In this case, the system of Govari could provide a therapeutic strategy to a user comprising one or more energy delivery patterns collectively configured to address one or more conduction patterns identified by the system. The system is able to determine how varying energy patterns results in different conduction patterns (and therefore, different lesions sizes) as shown in Figure 3. Further, it is known in the art to use different energy delivery patterns to garner different conduction patterns as required for different ablation procedures and produces predictable results.
Regarding claim 15, the limitations of claim 13 are taught as described above. Govari teaches “wherein a first set of energy delivery patterns creates a first set of lesions, and a second set of energy delivery patterns comprises a lesion segment that connects the first set of lesions to an anatomical structure and/or a second set of lesions” in Figure 3 and p.[0053] which describes that different lesion sizes are created based on the quantity of energy delivered and the force used where the energy is applied. Different lesions are created by different curves 45, 47, 49, 51. Further, the applicant is advised that it has been held by the courts that the recitation that an element is adapted to perform a function or serve in a given application is not a positive limitation, but only requires the ability to so perform. In re Hutchinson, 69 USPQ 138. In this case, the system of Govari could create a second set of energy delivery patterns that comprises a lesion segment that connects the first set of lesions to a second set of lesions, or other desired structure. Connecting the lesion sites together with more lesions does not provide any nonobvious or novel results.
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Govari (US Patent Publication 2014/0100563) in view of Asconeguy (US Patent Publication 2022/0401146).
Regarding claim 6, the limitations of claim 2 are taught as described above. Govari does not teach that the contact data includes a bias to the angle of contact between the at least one therapeutic element and the tissue, but Asconeguy does in an analogous ablation catheter. Asconegy teaches this limitation in p.[0153] which states "One or more sensors of EDD... can be configured to produce a signal correlating to a level of contact between one or more energy delivery elements 130 and tissue (e.g. cardiac tissue)... EDC can provide qualitative and/or quantitative contact information to a user... comprising: ... orientation or angle-of-attack to a boundary or other tissue location;". This is further described in p.[0211]. 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 Asconeguy in Govari. As suggested in Asconeguy (p.[0153]), knowing the angle of contact between the therapeutic element and tissue can help the user determine if adequate contact is made for the treatment of the tissue and produces predictable results.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Govari (US Patent Publication 2014/0100563) in view of Chou (US Patent Publication 2020/0015876).
Regarding claim 8, the limitations of claim 2 are taught as described above. Govari does not teach that the system is configured to provide haptic information related to the ablation index to a user, but Chou teaches the use of haptic feedback to communicate the condition of tissue to the user in an analogous ablation catheter system. Chou teaches in p.[0583] that "the clinician can be warned, or otherwise made aware of the alert mode, such as via haptic feedback, audible queues, visual indicators, and combinations thereof." While Chou's system discusses haptic feedback for an alert of contact force instead of ablation index directly, it is the Examiner's position 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 haptic feedback of Chou in Govari because they both solve the same problem of receiving real-time feedback of the tissue undergoing treatment. Further, it is known in the art to incorporate haptic feedback in handheld electrosurgical devices and such incorporation produces predictable results.
Regarding claim 9, the limitations of claim 8 are taught as described above. Govari does not teach that the ablation catheter further comprises a vibrational transducer to provide haptic feedback to the user, but Chou does in an analogous ablation catheter system in p.[0476] which states " In some embodiments, functional elements 119, 129, 219, 229, and/or 309 comprise a transducer selected from the group consisting of: heating element; cooling element; vibrational transducer.... In some embodiments, functional elements 129 and/or 229 comprise functional elements configured to provide feedback, and/or otherwise alert the user to the status of one or more components of system 10 (e.g. when an undesired condition is present)."
Govari nor Chou explicitly teach that the amplitude or frequency of the vibrations produced from the vibrational transducer changes as the ablation index changes, but it is the Examiner's position that this is an obvious design choice that does not provide any novelty or nonobvious results. It is known in the art to use haptic feedback mechanisms on handheld surgical devices, and moreover, it is known to change the vibrational characteristics to convey additional information and produces predictable results.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Govari (US Patent Publication 2014/0100563) in view of Fish (US Patent Publication 2017/0319279).
Regarding claim 11, the limitations of claim 2 are taught as described above. Govari does not teach three or more electrodes wherein the force module is configured to determine a contact state between ablation catheter and a cardiac wall based on a resistor network model, nor does Govari teach wherein the force module is further configured to build a series of non-linear equations based on the model and to solve the equations for the resistance values between two or three of the more electrodes in the ablation catheter, but Fish does in an analogous ablative catheter. Fish teaches electrodes 17, 50, and 52, and further a force sensor 15 that "may be provided for a measurement of contact force between the catheter 14 and tissue 16" (p.[0039]). Further, Fish teaches "Various embodiments herein provide a system for lesion assessment based on, for example, impedance and force. In at least one embodiment, a system can include an ECU configured to receive a measurement of impedance between an electrode and tissue, and a measurement of a contact force between the electrode and the tissue. The system presents a lesion size (e.g., the lesion depth, width, depth at maximum diameter, volume, or cross-sectional area). The ECU may calculate or estimate the size of the lesion based upon, for example, a lesion size index (LSI) value (which itself may be based upon RF power, force, and time) and the ratio of at least one of at least one of the following to contact force: RF generator impedance, an electrical coupling index (ECI) value, resistance between the catheter tip and tissue, or reactance between the catheter tip and tissue. The system may also present the lesion size by including, for example, the lesion depth in a map or model of the tissue and displaying the map or the model for a clinician or the user." (p.[016]), showing that Fish can determine the resistance values between electrodes (between catheter tip and tissue, electrical coupling index, p.[0073], See further in p.[0074-0080], including equations 6-8) and teaches the limitations as described. It would have been obvious to one of ordinary skill in the art to use the system of Fish in Govari. As stated in Fish, the use of these modules and electrodes allows for the user to "estimate a lesion size" (p.[0085]) and produces predictable results.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Govari (US Patent Publication 2014/0100563) in view of Salahieh (US Patent Publication 2016/0051321).
Regarding claim 14, the limitations of claim 13 are taught as described above. Govari does not teach that the first set of energy delivery patterns comprises an energy delivery pattern that creates a set of lesions in a rosette pattern, but Salahieh does. Salahieh teaches in Figures 31-32 and further in p.[0185] that different shape lesions can be created as required in the desired ablation procedure. Further, the lesions formed in Fig. 31A-C could reasonably form a rosette shape under broadest reasonable interpretation, and therefore teach the claimed invention as described. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a first set of energy delivery patterns that creates a set of lesions in a rosette pattern, as suggested in Salahieh, in Govari. As stated in Salahieh, "The number and arrangement of the electrodes disposed on the expandable member, each of which is individually addressable and can be used to deliver energy in either monopolar or bipolar mode, provides for a wide variety of lesion formations without having to remove and insert a separate RF catheter" and produces predictable results.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Govari (US Patent Publication 2014/0100563) in view of Koblish (US Patent No. 11,147,617 B1).
Regarding claim 16, the limitations of claim 15 are taught as described above. Govari does not teach that the second set of lesions comprises an isolation line for one or more pulmonary veins, but Koblish does in an analogous ablation catheter. Koblish teaches in col. 2, lines 4-14 that "a catheter having a loop structure carrying electrodes can be employed to create circumferential electro-isolation lines along the atrial wall around the ostia of pulmonary veins." 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, it is known in the art to create electrical isolation lines along the pulmonary veins and produces predictable results.
Allowable Subject Matter
Claims 10 and 12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 10, the prior art does not teach or provide any motivation to a force module that is configured to determine a contact state by implementing k-mean clustering of measurements made in 4D space.
Regarding claim 12, the prior art does not teach the mathematical formula described wherein the quantity K is used to detect a contact state of the ablation catheter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Bock whose telephone number is (571)272-8856. The examiner can normally be reached M-F 7:30am - 5:00pm.
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794