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 09/05/2025 was filed after the mailing date of the application on 02/20/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Allowable Subject Matter
Claims 14-20 are rejected 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.
Claim Interpretation
The Examiner notes the phrase in claim 1 “… cause, via the input-output device system and in response to identifying that the fault condition has occurred, the first group of electrodes to non-concurrently deliver, in separate subsets of electrodes, respective second energies to cause pulsed field ablation of bodily tissue, the separate subsets of electrodes comprising electrodes that collectively make up the first group of electrodes”. The Examiner is unsure what the applicant is claiming by stating “the first group of electrodes… the separate subsets of electrodes comprising electrodes that collectively make up the first group of electrodes”. Is the Applicant claiming that the subset of electrodes are the same as the first electrodes, or that the subset of electrodes is a separate group of electrodes that when combined constitutes the first group of electrodes, or some other third interpretation?
For clarification on the record, the Examiner is interpreting the first set of electrodes to be a plurality of electrodes, wherein the subset of electrodes are the electrodes of the first set of electrodes that are not impeded by the fault state. In other words, the claim is being read that the first group of electrodes receives energy, and the subset of electrodes are the electrodes of the first group that are not in a fault condition. The Examiner requests appropriate clarification on the record upon receipt of this Office Action.
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “data processing device system” and “input-output device system” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
The Examiner interprets the data processing device system as any suitable structure that can process data, such as a controller, computer, processor, or any analogous system/device. The Examiner interprets the input-output device system to be any suitable structure that can collect and export data, such as a controller, computer, processor, or any analogous system/device.
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 1-13 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Moisa (US 2018/0078218), herein after “Moisa” in view of Fraasch (US 2024/0252225), herein after “Fraasch”, further in view of Stewart (US 2019/0030328), herein after “Stewart”.
Regarding claim 1, Moisa teaches “A medical system (Fig. 3A) comprising: a data processing device system (p.[0229]); an input-output device system (input-output device system 120, p.[0125,0129]) communicatively connected to the data processing device system (p.[0129]), the input-output device system communicatively connectable to a plurality of electrodes supported by a structure of a catheter (p.[0120, 0130, 0136]); a memory device system (memory device system 330, p.[0148])communicatively connected to the data processing device system and storing a program executable by the data processing device system (p.[0124, 0128, 0148]); the data processing device system configured by the program at least to cause, via the input-output device system, a first group of electrodes from the plurality of electrodes to concurrently and collectively deliver as a group first energy configured to cause pulsed field ablation of bodily tissue (p.[0227-0228])”.
Moisa does not teach "identify, at least in response to the first group of electrodes concurrently and collectively attempting to deliver as a group the first energy to cause pulsed field ablation of bodily tissue, that a fault condition has occurred" but Fraasch does in an analogous ablation device. Fraasch teaches "identify, at least in response to the first group of electrodes concurrently and collectively attempting to deliver as a group the first energy to cause pulsed field ablation of bodily tissue, that a fault condition has occurred (p.[0068, 0071], Figs. 7, 13, wherein the first energy is the sample voltage of the integrity tests, with the first electrodes being the electrodes of the system)". 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 Fraasch in Moisa/Stewart. As stated in Fraasch, the use of detecting a fault system can prevent "inadvertent energy delivery to the patient" and produces predictable results of creating electromechanical safeguards.
Moisa/Fraasch does not teach "cause, via the input-output device system and in response to identifying that the fault condition has occurred, the first group of electrodes to non-concurrently deliver, in separate subsets of electrodes, respective second energies to cause pulsed field ablation of bodily tissue, the separate subsets of electrodes comprising electrodes that collectively make up the first group of electrodes" but Stewart does in an analogous ablation device. Stewart teaches "cause, via the input-output device system and in response to identifying that the fault condition has occurred, the first group of electrodes to non-concurrently deliver, in separate subsets of electrodes, respective second energies to cause pulsed field ablation of bodily tissue, the separate subsets of electrodes comprising electrodes that collectively make up the first group of electrodes (p.[0071-0075], where the processing circuitry is analogous to the input-output device, and the fault condition is a warning, and the subset of electrodes are the electrodes 18 that are not deactivated, and electroporation energy is a type of pulsed field ablation)". 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 Stewart in Moisa/Fraasch. As stated in Stewart, deactivating electrodes with a warning while continuing to deliver energy to other electrodes without a warning prevents unintended damage to tissue from electrodes in a fault/warning state without requiring the medical device to be repositioned, producing predictable results of saving procedure time and minimizing damage to tissue (p.[0071]).
Regarding claim 2, the limitations of claim 1 are taught as described above. Neither Moisa nor Fraasch explicitly teaches the limitation "wherein each of the subsets of electrodes is a subset of two or more electrodes" but Stewart does in an analogous ablation electrode catheter. Stewart teaches "wherein each of the subsets of electrodes is a subset of two or more electrodes (Figs. 5-21, p.[0071-0075], where the subset is the electrodes that are not deactivated)". 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 Stewart in Moisa/Fraasch. As stated in Stewart, by selectively activating or deactivating electrodes based on a warning, undesired damage can be prevented while saving procedure time (p.[0071]).
Regarding claim 3, the limitations of claim 1 are taught as described above. Neither Moisa nor Fraasch explicitly teaches the limitation "wherein each of the separate subsets of electrodes is a subset of even number of electrodes" but Stewart does in an analogous ablation electrode catheter. Stewart teaches "wherein each of the subsets of electrodes is a subset of electrodes is a subset of even number of electrodes (Figs. 5-21, p.[0071-0075], where the subset is the electrodes that are not deactivated and could be an even number if desired/selected)". 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 Stewart in Moisa/Fraasch. As stated in Stewart, by selectively activating or deactivating electrodes based on a warning, undesired damage can be prevented while saving procedure time (p.[0071]).
Regarding claim 4, the limitations of claim 1 are taught as described above. Neither Moisa nor Fraasch teaches the limitation "wherein each of the separate subsets of electrodes comprises at least one electrode that is other than another electrode in another of the separate subsets of electrodes" but Stewart does in an analogous ablation electrode catheter. Stewart teaches "wherein each of the separate subsets of electrodes comprises at least one electrode that is other than another electrode in another of the separate subsets of electrodes(Figs. 5-21, p.[0071-0075], where the subset is the electrodes that are not deactivated and could be at least one other electrode)". 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 Stewart in Moisa/Fraasch. As stated in Stewart, by selectively activating or deactivating electrodes based on a warning, undesired damage can be prevented while saving procedure time (p.[0071]).
Regarding claim 5, the limitations of claim 1 are taught as described above. Neither Moisa nor Fraasch teaches the limitation "wherein each of the separate subsets of electrodes does not comprise any electrode that is also included in any of the other separate subsets of electrodes" but Stewart does in an analogous ablation electrode catheter. Stewart teaches "wherein each of the separate subsets of electrodes does not comprise any electrode that is also included in any of the other separate subsets of electrodes (Figs. 5-21, p.[0071-0075], where the subset is the electrodes that are not deactivated and could be selectively isolated/activated from other electrodes 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 the system of Stewart in Moisa/Fraasch. As stated in Stewart, by selectively activating or deactivating electrodes based on a warning, undesired damage can be prevented while saving procedure time (p.[0071]).
Regarding claim 6, the limitations of claim 1 are taught as described above. Moisa teaches “wherein the first group of electrodes comprises four or more electrodes (Fig. 3B, electrodes 315, wherein the first group of electrodes are the group of electrodes shown)”. Fraasch and Stewart also teach the use of at least four electrodes in Figs. 7, 13, and electrodes 18, respectively.
Regarding claim 7, the limitations of claim 1 are taught as described above. Moisa does not teach "wherein the data processing device system is configured by the program at least to: receive, via the input-output device system, a signal set and execute the identifying that the fault condition has occurred based at least on an analysis of the received signal set", but Fraasch does in an analogous ablation device. Fraasch teaches "wherein the data processing device system is configured by the program at least to: receive, via the input-output device system, a signal set and execute the identifying that the fault condition has occurred based at least on an analysis of the received signal set (abstract, p.[0022, 0061, 0088, 0100-109], Fig. 16, wherein the received signal set is the current that is sampled and the fault detector 86 is the data processing device and the input-output device is the catheter energy distribution system (CEDS) 16)". It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a data processing device system to receive a signal set and identify that a fault has occurred based on the signal set, as taught in Fraasch, in Moisa/Stewart. As stated in Fraasch, detecting the fault condition prevents unintentional energy to the patient and produces predictable results of preventing damage to the patient (p.[0009]).
Regarding claim 8, the limitations of claim 1 are taught as described above. Moisa does not teach "wherein the data processing device system is configured by the program at least to receive, via the input-output device system, the signal set from an electrode set, wherein the data processing device system is communicatively connected to the plurality of electrodes via the input-output device system", but Fraasch does in an analogous ablation device. Fraasch teaches "wherein the data processing device system is configured by the program at least to receive, via the input-output device system, the signal set from an electrode set, wherein the data processing device system is communicatively connected to the plurality of electrodes via the input-output device system (abstract, p.[0022, 0061, 0088, 0100-109], Fig. 16, wherein the received signal set is the current that is sampled and the fault detector 86 is the data processing device and the input-output device is the catheter energy distribution system (CEDS) 16)". It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a data processing device system to receive a signal set and identify that a fault has occurred based on the signal set, as taught in Fraasch, in Moisa/Stewart. As stated in Fraasch, detecting the fault condition prevents unintentional energy to the patient and produces predictable results of preventing damage to the patient (p.[0009]).
Neither Moisa nor Fraasch teaches the limitation "wherein the electrode set is from the plurality of electrodes wherein the electrode set is from the first group of electrodes." but Stewart does in an analogous ablation electrode catheter. Stewart teaches "wherein the electrode set is from the plurality of electrodes wherein the electrode set is from the first group of electrodes (Figs. 5-21, p.[0071-0075], where the subset is the electrodes that are not deactivated)". 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 Stewart in Moisa/Fraasch. As stated in Stewart, by selectively activating or deactivating electrodes based on a warning, undesired damage can be prevented while saving procedure time (p.[0071]).
Regarding claim 9, the limitations of claim 1 are taught as described above. Moisa does not teach "wherein the fault condition is an overcurrent condition or a low impedance condition", but Fraasch does in an analogous ablation device. Fraasch teaches "wherein the fault condition is an overcurrent condition or a low impedance condition (p.[0026], wherein the overcurrent condition is where the current is greater than the in-treatment threshold current amount)". 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 Fraasch in Moisa/Stewart. Identifying a fault condition from an overcurrent condition produces predictable results of limiting run-away energy delivery to the system (p.[0005]).
Regarding claim 10, the limitations of claim 1 are taught as described above. Moisa/Stewart does not teach "wherein the fault condition is a low current condition or a high impedance condition", but Fraash does in an analogous ablation device. Fraasch teaches "wherein the fault condition is a low current condition or a high impedance condition (p.[0026], where the low current condition is when the instantaneous and peak current is less than the in-treatment threshold current amount). 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 Fraash in Moisa/Stewart. Identifying a fault condition as a result of low-current produces predictable results of reducing patient risks during procedures (p.[0007]).
Regarding claim 11, the limitations of claim 1 are taught as described above. Moisa teaches “wherein the input-output device system is communicatively connected to an energy source device system (p.[0150,0152]); the energy source device system comprising a single power delivery driver configured to transmit energy to the first group of electrodes (p.[0251], wherein the first group of electrodes is analogous to the group of transducers queued for tissue ablation)”.
Moisa/Fraasch does not teach "wherein the causing the first group of electrodes from the plurality of electrodes to concurrently and collectively deliver as a group the first energy configured to cause pulsed field ablation of bodily tissue includes causing the single power delivery driver to transmit the first energy to the first group of electrodes wherein the causing the first group of electrodes to non-concurrently deliver, in the separate subsets of electrodes, the respective second energies to cause pulsed field ablation of bodily tissue includes causing the single power delivery driver to transmit the respective second energies to the separate subsets of electrodes." but Stewart does in an analogous ablation device. Stewart teaches "wherein the causing the first group of electrodes from the plurality of electrodes to concurrently and collectively deliver as a group the first energy configured to cause pulsed field ablation of bodily tissue includes causing the single power delivery driver to transmit the first energy to the first group of electrodes wherein the causing the first group of electrodes to non-concurrently deliver, in the separate subsets of electrodes, the respective second energies to cause pulsed field ablation of bodily tissue includes causing the single power delivery driver to transmit the respective second energies to the separate subsets of electrodes. (p.[0071-0075], where the processing circuitry is analogous to the input-output device, and the fault condition is a warning, and the subset of electrodes are the electrodes 18 that are not deactivated, and electroporation energy is a type of pulsed field ablation, the first set of energy is the test, the second set of energy is the ablation energy delivered after deactivation of the undesired/fault electrodes to the desired electrodes, the subset of electrodes)". 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 Stewart in Moisa/Fraasch. As stated in Stewart, deactivating electrodes with a warning while continuing to deliver energy to other electrodes that are without a warning prevents unintended damage to tissue from electrodes in a fault/warning state without requiring the medical device to be repositioned, producing predictable results of saving procedure time and minimizing damage to tissue (p.[0071]).
Regarding claim 12, the limitations of claim 1 are taught as described above. Moisa teaches “wherein the separate subsets of electrodes comprise at least a first subset of electrodes and a second subset of electrodes (p.[0251], where the transducers being read as electrodes as described in p.[0115], and the first subset of electrodes is 8 of 20 transducers as described, and the second subset of electrodes is 8 of 20 transducers as described); wherein the causing the first group of electrodes to non-concurrently deliver, in the separate subsets of electrodes, the respective second energies to cause pulsed field ablation of bodily tissue (p.[0251[) includes causing: (a) a delivery of a first portion of the respective second energy delivered by the second subset of electrodes to be delivered after a delivery of a first portion of the respective second energy delivered by the first subset of electrodes (p.[0251-0252]), (b) a delivery of a second portion of the respective second energy delivered by the first subset of electrodes to be delivered after the delivery of the first portion of the respective second energy delivered by the second subset of electrodes (p.[0251-0252]).”
Regarding claim 13, the limitations of claim 12 are taught as described above. Moisa teaches “wherein the first portion of the respective second energy delivered by the first subset of electrodes is a first voltage pulse set, the first portion of the respective second energy delivered by the second subset of electrodes is a second voltage pulse set (p.[0252-0253], wherein the first voltage pulse set is the portion of energy delivered to a first transducer of the set of two or more transducers, the second voltage pulse set is a portion of the energy delivered to the second transducer, wherein the transducers are read as analogous to the electrodes of the instant claim as described in p.[0115]) and the second portion of the respective second energy delivered by the first subset of electrodes is a third voltage pulse set (p.[0252-0253], wherein third voltage pulse set is the portion of energy delivered to the first transducer from the second transducer)”.
Regarding claim 21, the limitations of claim 1 are taught as described above. Neither Moisa nor Fraasch teaches the limitation "wherein the data processing device system is configured by the program at least to identify that the fault condition has occurred in a particular subset of the separate subsets of electrodes at least in response to at least the particular subset of the separate subsets of electrodes attempting to deliver the respective second energy" but Stewart does in an analogous ablation device. Stewart teaches "wherein the data processing device system is configured by the program at least to identify that the fault condition has occurred in a particular subset of the separate subsets of electrodes at least in response to at least the particular subset of the separate subsets of electrodes attempting to deliver the respective second energy (p.[0071-0075], wherein the fault condition is determined via the continual checks and the certain electrodes that are identified as being in a fault state can be deactivated at any point for any iteration of energy)". 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 Stewart in Moisa/Fraasch. As discussed in Stewart, doing so allows for the deactivation of the electrodes that are in a faulty or erroneous operation state and produces predictable results of the operation continuing without the device having to be repositioned (p.[0072]).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at (617) 320-2637. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ABIGAIL BOCK/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights