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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/24/2025 and 12/11/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, requires the specification to be written in “full, clear, concise, and exact terms.” The specification is replete with terms which are not clear, concise and exact. The specification should be revised carefully in order to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112. Examples of some unclear, inexact or verbose terms used in the specification are: Table 1 on page 21.
Claim Objections
Claims 2-20 are objected to because of the following informalities:
“A system” should read “The system.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification, while indicating that a processor “generates the algorithm,” fails to disclose the specific steps, logic, structure, or mathematical formulas utilized by the processor to actually generate or execute said algorithm. Claim 1 recites “wherein the generator includes a processor that generates at least one algorithm,” and “wherein the processor generates the algorithm based on at least one of one or more inputs by a user” claim 2 recites “the processor generates the algorithm by dynamically generating the algorithm based on the one or more inputs in real time” and claim 3 recites “wherein the processor generates the algorithm by selecting the algorithm from a group of algorithms based on the one or more inputs.” The specification does not give support for any specifics of an algorithm. It appears that the algorithm is essential to the invention, however, the specification fails to provide a written description of the claimed invention in a manner sufficient to reasonably convey to one of ordinary skill in the art that the inventor had possession of the claimed subject matter. The specification merely states “the processor is configured to execute one or more algorithms for running a feedback control loop based on one or more measured system parameters” (Applicant specification [00106]).
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, 6 and 9-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Howard et al (US20180221078A1) herein referred to as “Howard ‘078”.
Regarding claim 1, Howard ‘078 discloses: A system (See FIG 1 where 10 is the system) for generating a lesion in tissue ([Abstract] creating a desired lesion in tissue) comprising: a generator electrically couplable to a treatment catheter, (See FIG 1 where the generator (14) is coupled to the medical device (12) which is seen as the catheter) wherein the generator includes a processor ([0035] the generator includes a processor) that generates at least one algorithm ([0037] a waveform parameter selection algorithm is generated which is at least one algorithm) configured to provide an electric signal of pulsed electric field energy deliverable through a delivery electrode of the treatment catheter, ([0037] the algorithm can correlate a desired treatment outcome which relates to a pulsed electric field [0005] to the energy setting in the generator which is then sent to the electrodes in the medical device portion which is seen as the catheter [0036]) wherein the processor generates the algorithm based on at least one of one or more inputs by a user ([0037] the algorithm which is produced by the processor incorporates user input)
Regarding claim 4, Howard '078 in view of Howard ‘353 discloses: A system as in claim 1, wherein the one or more inputs comprises a desired dimension of the lesion ([0037] the user input desired lesion characteristics such as surface area, length, and width which are all seen as dimensions).
Regarding claim 6 Howard '078 in view of Howard ‘353 discloses: A system as in claim 1, wherein the one or more inputs comprises a threshold for muscle contraction ([0039] threshold is seen as a value; an input for constant waveform parameter, which is seen as the algorithm, can include the amount of energy delivered to reduce unintended muscle stimulation; muscle stimulation is seen as muscle contraction).
Regarding claim 9, Howard '078 in view of Howard ‘353 discloses: A system as in claim 1, wherein the processor utilizes the one or more inputs and at least one default value to generate the algorithm ([0039] some of the inputs for the waveform parameters, which is seen as the algorithm, are constant and cannot be changed, these are seen as the default values).
Regarding claim 10, Howard '078 in view of Howard ‘353 discloses: A system as in claim 1, wherein the processor correlates the one or more inputs to electric field strength thresholds ([0018] the threshold is seen as a value; the processor correlates the inputs to determine the pulsed field ablation waveform which is seen as the applied electric field [0023]).
Regarding claim 11, Howard '078 in view of Howard ‘353 discloses: A system as in claim 10, wherein the processor determines the electric field strengths of the at least one delivery electrode ([0026] the processor is coupled to the electrodes through the generator and can determine the applied voltage amplitude which is seen as the electric field strength).
Regarding claim 12, Howard '078 in view of Howard ‘353 discloses: A system as in claim 11, wherein the processor correlates the electric field strengths to the electric field strength thresholds ([0026] the threshold is seen as a value; the processor correlates the inputs to determine whether the voltage amplitude, which is seen as the applied electric field strength, is within the threshold).
Regarding claim 13, Howard '078 in view of Howard ‘353 discloses: A system as in claim 1, wherein the processor selects at least one parameter of the at least one algorithm to generate the electric signal ([0018] the processor correlates the inputs to determine the pulsed field ablation waveform which is seen as the applied electric field [0023] which is seen as an electric signal).
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.
Claims 2, 3, 5, 8, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Howard et al (US20180221078A1) herein referred to as “Howard ‘078” in view of Howard et al (US20220273353) herein referred to as “Howard ‘353”
Regarding claim 2, Howard ‘078 discloses: A system as in claim 1, wherein the processor generates the algorithm by dynamically generating the algorithm based on the one or more inputs (Howard ‘078 [0037] a waveform parameter selection algorithm is generated using different parameters which is seen as being generated through one or more inputs) however, Howard ‘078 does not explicitly disclose: in real time.
Howard ‘353 discloses: in real time ([0053] the index of completeness which is generated by the processer which is seen as the algorithm, is produced in real time).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the algorithm as disclosed in Howard ‘078 to include generation in real time as disclosed in Howard ‘353. The motivation being that generating this allows for real-time feedback regarding the lesion formation which the clinician can then use to determine subsequent ablation therapy (Howard ‘353 [0053]).
Regarding claim 3, Howard ‘078 discloses: A system as in claim 1, however, Howard ‘078 does not explicitly disclose: wherein the processor generates the algorithm by selecting the algorithm from a group of algorithms based on the one or more inputs.
Howard ‘353 discloses: wherein the processor generates the algorithm by selecting the algorithm from a group of algorithms based on the one or more inputs ([0072] there are set programs, which are seen as the algorithm, and these can be selected based on the user input of desired depth).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor as disclosed in Howard ‘078 to include the selection of an algorithm from a group of algorithms as disclosed in Howard ‘353. The motivation being that there are only a finite number of ways that an algorithm can run, either by selecting from a group of preset instructions or running while information is being input in real time.
Regarding claim 5, Howard ‘078 discloses: A system as in claim 1, However, Howard ‘078 does not explicitly disclose: wherein the one or more inputs comprises a threshold for a temperature rise.
Howard ‘353 discloses: wherein the one or more inputs comprises a threshold for a temperature rise (a threshold is seen as a value; [0057] the measured parameters are seen as the input for the ratio or index of completeness which is seen as the algorithm; temperature rise is measured as an input)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inputs as disclosed in Howard ‘078 to include temperature rise as disclosed in Howard ‘353. The motivation being that incorporating this input can help determine whether the electrodes were in contact with the tissue thus determining whether the ablation is complete (Howard ‘353 [0057]).
Regarding claim 8, Howard ‘078 discloses: A system as in claim 1, wherein the one or more inputs comprises a plurality of the one or more inputs ([0037] the user input can consist of a plurality of inputs) and wherein the processor utilizes the plurality of the one or more inputs ([0039] the model optimizes and uses parameters such as the voltage and the number of pulse trains). However, Howard ‘078 does not explicitly disclose: based on a ranking or weighting of the plurality of the one or more inputs
Howard ‘353 discloses: based on a ranking or weighting of the plurality of the one or more inputs ([0042] the index of completeness which is seen as the algorithm is based on one or more ratios of completeness such as the weighted sum of ratios of completeness).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the input as disclosed in Howard ‘078 to incorporate weighting the plurality of the inputs as disclosed in Howard ‘353. The motivation being by incorporating more inputs gives the clinician more information to make better informed decisions about the ablation therapy (Howard ‘353 [0069]).
Regarding claim 14, Howard ‘078 discloses: A system as in claim 1, however, Howard ‘078 does not explicitly disclose: wherein the processor modifies the algorithm based on tissue thickness
Howard ‘353 discloses: wherein the processor modifies the algorithm based on tissue thickness ([0054] tissue thickness is used as a factor to calculate the ratio of completeness, which is seen as an input into the algorithm)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the algorithm as disclosed in Howard ‘078 to include the factor of tissue thickness as disclosed in Howard ‘353. The motivation being to determine an expected transmurality based on lesion depth [0054] for increased safety.
Regarding claim 15, Howard ‘078 discloses: A system as in claim 14, however, Howard ‘078 does not explicitly disclose: wherein tissue thickness is determined by ultrasound, magnetic resonance or fluoroscopy.
Howard ‘353 discloses: wherein tissue thickness is determined by ultrasound, magnetic resonance or fluoroscopy ([0054] magnetic resonance is used to measure tissue thickness)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system as disclosed in Howard ‘078 to include a means for measuring tissue thickness as disclosed in Howard ‘353. The motivation being there are only a finite number of ways that transmurality can be measured.
Claims 7, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over “Howard ‘078” in view of Panescu (US20030158477A1) herein referred to as “Panescu”
Regarding claim 7, Howard ‘078: A system as in claim 1, however, Howard ‘078 does not explicitly disclose: wherein the one or more inputs comprises a threshold dose time
Panescu discloses: wherein the one or more inputs comprises a threshold dose time ([0061] a threshold is seen as a value; dose time is seen as the length of energy delivery; the user may input the desired time of delivery of energy which is seen as the user inputting a value and thus a threshold, since the clock tracks time elapsed, this user input time is seen as the length of the energy delivery).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the input as disclosed in Howard ‘078 to incorporate a threshold dose time as disclosed in Panescu. The motivation being that this allows for the treatment delivery source to controllably deliver ablation energy to target sites (Panescu [0094]).
Regarding claim 16, Howard ‘078 discloses: A system as in claim 1, however, Howard ‘078 does not explicitly disclose: wherein the processor generates a prediction of an outcome of the treatment based on at least one of one or more inputs by a user
Panescu discloses: wherein the processor generates a prediction of an outcome of the treatment based on at least one of one or more inputs by a user ([0061] Fully incorporates US5383874 Jackson et al herein referred to as “Jackson”; Jackson [col 5: lines 39 to col 6: line 8] the user inputs an operating value, the processor then analyses this to compare the derived apparent power with the actual phase power and quantifies it, a warning is then generated if the value is exceeds the limit, this is seen as the generator making a prediction of the outcome of the treatment).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor as disclosed in Howard ‘078 to incorporate a prediction of an outcome of the treatment based on the user input as disclosed in Panescu. The motivation being that this acts as a power control means which ensures safety (Jackson [col 6: lines 9-19]).
Regarding claim 17, Howard ‘078 in view of Panescu discloses: A system as in claim 16, wherein the prediction comprises at least one lesion dimension (Howard ‘078 [0037] the user input desired lesion characteristics such as surface area, length, and width which are all seen as dimensions).
Regarding claim 18, Howard ‘078 in view of Panescu discloses: A system as in claim 17, wherein the at least one lesion dimension comprises lesion depth (Howard ‘078 [0037] the user input desired lesion characteristics such as lesion depth).
Regarding claim 19 Howard ‘078 in view of Panescu discloses: A system as in claim 17, wherein the at least one lesion dimension comprises lesion width (Howard ‘078 [0037] the user input desired lesion characteristics such as lesion width).
Regarding claim 20, Howard ‘078 discloses: A system as in claim 16, wherein the one or more inputs comprises a single input, ([0022] single input is seen as at least one input; the desired lesion characteristic can be a single characteristic selected from a group) however Howard ‘078 does not explicitly disclose: wherein the single input comprises dose time
Panescu discloses: wherein the single input comprises dose time ([0061])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the input as disclosed in Howard to incorporate a threshold dose time as disclosed in Panescu. The motivation being that this allows for the treatment delivery source to controllably deliver ablation energy to target sites (Panescu [0094]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M GANAN-SINGH whose telephone number is (571)272-3194. The examiner can normally be reached Monday to Friday 7:30am to 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne M Rodden can be reached at 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.G.S/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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