DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 13, 2026 has been entered.
Currently, claims 1, 2, 4-22 and 24 are pending with claims 3 and 23 cancelled, claim 24 newly added, and claims 1, 14, 21, and 22 amended. The following is a complete response to the August 13, 2026 communication.
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 .
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 13-17 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.
Regarding claim 13, the claim presently sets forth the method step of “calculating a lesion durability index based on the determined amplitude of the bioelectrical signal in the frequency band, wherein the lesion durability index comprises a prediction of the efficacy of the cardiac lesion” therein.
The Examiner has reviewed the instant disclosure but is of the position that neither the instant Specification nor Drawing in this application or in the provisional US Pat. App. No. 63/267,868 would 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 at-issue claim limitations set forth above.
As a preliminary matter, the Examiner notes that claim 13 is an original claim. MPEP 2163(I)(A) discusses the need for originally filed claims to comply with the written description requirement in 35 U.S.C. 112(a). This section of the MPEP establishes that “issues of adequate written description may arise even for original claims, for example, when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the inventor had possession of the claimed invention at the time of filing. The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional or known in the art.”
The Examiner has reviewed the instant Specification and Drawings to determine if adequate written description exists for the feature of a lesion durability index, or for the step of calculating a lesion durability index based on the determined amplitude of the bioelectrical signal in the frequency band, wherein the lesion durability index comprises a prediction of the efficacy of the cardiac lesion”, but has failed to find sufficient disclosure that would describe the claimed features noted above with sufficient particularity such that one skilled in the art would recognize that the inventor had possession of the claimed invention at the time of filing.
Turning to the instant Specification, the Examiner recognizes that the terminology of “lesion durability index” appears a number of times throughout. For example, the following recitations of the terminology exist:
Paragraph [0006]: This disclosure may provide analysis techniques to develop an index, e.g., a lesion durability index, to assess lesion formation based on iEGM characteristics, for example, by selecting and analyzing iEGM components from one or more frequency bands. In some examples the index may also include other biological measurements such as temperature, impedance, and similar measurements. The specific analysis details, e.g., number of frequency bands, bandwidth of each frequency band, total frequency range of recorded signals, the timing of when to measure the iEGM and so on may differ for different types of ablation.
Paragraph [0030]: This disclosure may provide analysis techniques to develop an index to assess lesion formation based on iEGM characteristics, for example, by analyzing specific frequency spectra of measured iEGMs. In some examples the index, e.g., a lesion durability index, may also include other measurements such as temperature, monophasic action potential (MAP) waveform properties, impedance, and so on. The specific analysis details of the lesion characterization process, e.g., number of frequency bands, bandwidth of each frequency band, frequency range, the timing of when to measure the iEGM and so on may differ for different types of ablation.
Paragraph [0047] provides processing circuitry 38 is used to estimate an efficacy of the cardiac lesion and that this estimate “may be in the form of a lesion durability index, which, for example, processing circuitry 38 may cause to be displayed on user interface 52”.
Paragraph [0048]: In some examples, the estimate of the cardiac lesion may include an estimate of long-term, e.g., chronic efficacy of the lesion. The generator may display a lesion durability index based on the frequency analysis of the iEGMs and possible other physiological measurements (e.g. temperature, impedance, total iEGM signals) to the operator. In some examples, the lesion durability index may be less than a lesion durability index threshold. Then subsequent ablation energy may be delivered responsive to the estimated efficacy being less than an efficacy threshold, for example, the lesion durability index may be less than a lesion durability index threshold.
Paragraph [0052]: In some examples, ablation system 11 may collect and store bioelectrical signals, such as an iEGM, over a wide frequency range, divide the collected and stored signal into frequency bands and analyze the signals in two or more frequency bands to estimate the lesion efficacy. In other words, processing circuitry 38 of ablation system 11 may estimate the lesion efficacy, such as by calculating a lesion durability index, based on the measured bioelectrical signal in the first frequency band and in a second frequency band. In some examples, processing circuitry 38 may estimate lesion efficacy based on measurements, such as peak-to-peak voltage, in three or more frequency bands. In some examples, estimates of lesion efficacy, e.g., a lesion durability index, may also be based on signals from other sensors, such as a temperature, an impedance, a pressure, thoracic impedance, cardiac rhythm, a blood chemistry measurement, an echocardiogram and so on. In some examples, the estimated efficacy of the lesion may be based on signals in the two or more frequency bands collected at the same time or approximately the same time. In other examples, the estimated efficacy may be based on signals received at different times, such as at a second time that is a predetermined duration subsequent to receiving the first bioelectrical signals.
Paragraph [0072]: in some examples, processing circuitry of an ablation device of this disclosure may determine a threshold characteristic, e.g., a threshold amplitude based on the baseline measurement. The processing circuitry may provide an estimate of lesion efficacy based on comparing post-ablation bioelectrical signals to the threshold. For example, in the A6 frequency band, comparing signal 532 to a threshold of approximately 2 – 5 mV may provide an indication of the efficacy of the cardiac lesion. In other examples, the amplitude of the signal may increase by a different value, e.g., depending on the ablation equipment, patient, electrode location and other factors and the processing circuitry may determine a different threshold value. Similarly, comparing the decrease in amplitude found in signals 536 and 538, or other bioelectrical signals in the d3, d2 and d1 frequency bands may provide some indication of lesion efficacy. In other examples, the processing circuitry may compare the post-ablation signals to the baseline signals to estimate lesion efficacy. The processing circuity may use such comparisons to pre-ablation, post-ablation, and recovery signals or to a threshold, or any such combination of comparisons to calculate the lesion durability index.
Paragraph [0089]: “In this manner the ablation system, e.g., system 11 of FIG. 1, may estimate an efficacy of the cardiac lesion based on the measured peak-to-peak voltage of the post-ablation bioelectrical signal in the A6 frequency band. In some examples, the ablation system of this disclosure may further include analysis of other frequency bands, as well as other measurements from sensors, such as sensors 20 and sensors 46 described above in relation to FIG.1, as part of a lesion durability index to predict the chronic efficacy of a cardiac lesion formed by an ablation procedure, such as PFA.”
Paragraph [0094]: In other examples other sensors, e.g., sensor 20, including temperature, pressure or force and other types of sensors may provide a second bioelectrical signal to the processing circuitry to help evaluate the efficacy of the cardiac lesion. In some examples, the processing circuitry may use any one or more such bioelectrical to calculate a lesion durability index, as described above, which may provide a prediction of the clinical efficacy of the cardiac lesion. For example, if temperature or force increases are observed in a certain electrode, this indicates tissue contact, and can be used in conjunction with the iEGM frequency analysis to predict lesion efficacy.
Paragraph [0095]: In other example, a third and fourth bioelectrical signal may provide additional information to the processing circuity to evaluate lesion efficacy. For example, in addition an algorithm involving the change of frequency spectrum of iEGM signals, temperature, local impedance, and contact force following ablation can be integrated into an algorithm that provides predication of lesion formation. For example, a slight increase in electrode temperature, an increase in local contact force (measured via a contact force sensor), a decrease in local impedance, in conjunction with characteristic changes of frequency spectra of iEGM can provide an integrated algorithm to more accurately predict lesion efficacy. Additional bioelectrical signals may be added to such examples to make such algorithms more robust and reliable.
The Examiner has reviewed the entirety of the filed Specification including these above highlighted paragraphs that make mention to the lesion durability index and its calculation. The Examiner finds that the Specification does not sufficiently identify how the lesion durability index is calculated by the system/processor. The Examiner further finds that the Specification fails to provide for any such steps/procedures/algorithms to utilize any or all of the various parameters mentioned to have a role in the lesion durability index or for the calculation of such a lesion durability index.
To this end, much of the disclosure related to the determination, development or calculation of the lesion durability index seemingly amounts to high-level disclosure regarding possible factors and parameters that may be utilized as a portion of the lesion durability index. For example, paragraph [0006] sets forth that iEGM components from one or more frequency may be used to develop the index, and then continues in that “the index may also include other biological measurements such as temperature, impedance, and similar measurements. The specific analysis details, e.g., number of frequency bands, bandwidth of each frequency band, total frequency range of recorded signals, the timing of when to measure the iEGM and so on may differ for different types of ablation”. Paragraphs [0030], [0048], [0052] and [0089] similarly recite these high-level concepts/parameters that may be utilized as a portion of the lesion durability index. Paragraph [0072] provides additional concepts with respect to the estimation of lesion efficacy including values taken prior-to and post-ablation, but only generally notes that such estimation comparisons may be used “to calculate the lesion durability index”. Paragraph [0094] sets forth that “the processing circuitry may use any one or more such bioelectrical to calculate a lesion durability index … which may provide a predication of the clinical efficacy of the cardiac lesion”.
Paragraph [0095], while not specifically reciting a lesion durability index, provides the only disclosure of an algorithm directed to the evaluation of lesion efficacy including the use of various parameters such as a) a change of frequency spectrum of iEGM signals, b) temperature, c) local impedance, d) contact force following ablation, and e) additional bioelectrical signals. This portion of the disclosure, however, fails to convey any manner of algorithm that has specifically been developed by Applicant that integrates any one or more of the disclosure parameters so as to determine lesion efficacy, let alone an algorithm that specifically results in the calculating of a lesion durability index as contemplated in claim 13.
Said differently, while the instant Specification provides a number of recitations that make mention of a lesion durability index as well as various parameters and concepts that may be included in the calculation of the lesion durability index, the Examiner has failed to find sufficient disclosure as to how Applicant envisioned the actual calculation of the lesion durability index to be achieved at the time of filing utilizing any one or more of the parameters noted in the disclosure. The disclosure, rather, provides a broad range of parameters that may be utilized to provide for the claimed lesion durability index with no specific contemplation as to how each relate to one another or how each would factor into an overall calculation of the index. The Examiner has further reviewed the prior art during the examination of the pending claims but has failed to find that the claimed feature of a lesion durability index is a conventional, well-known feature in the prior art that would readily cure any/all of the deficiencies noted with respect to the instant disclosure. Additionally, the Examiner has reviewed the filed Drawings but such fail to provide any additional insight as to the lesion durability index.
For the sake of completeness, the Examiner notes that dependent claims 14-17 set forth additional features with respect to various processing completed by the processing circuitry. Claims 14 and 17 set forth the most relevant claim limitations to the at-issue calculation of the lesion durability index. Claim 14 sets forth the additional step of “calculating the lesion durability index based on the amplitude of the bioelectrical signal in the first frequency band and in second frequency band, wherein the lesion durability index comprises a prediction of the efficacy of the cardiac lesion” therein. While the limitations of this claim set forth that the calculation of the lesion durability index is specifically “based on the amplitude of the bioelectrical signal in the first frequency band and the second frequency band”, The Examiner is again of the position that the disclosure in this claim does nothing to remedy the above noted deficiencies in the balance of the disclosure.
Paragraph [0072] of the Specification sets forth similar disclosure with respect to the use of the amplitude of the bioelectrical signal being used to calculate the lesion durability index. In particular, [0072] provides for “comparing the decrease in amplitude found in signals 536 and 538, or other bioelectrical signals in the d3, d2 and d1 frequency bands may provide some indication of lesion efficacy. In other examples, the processing circuitry may compare the post-ablation signals to the baseline signals to estimate lesion efficacy. The processing circuity may use such comparisons to pre-ablation, post-ablation, and recovery signals or to a threshold, or any such combination of comparisons to calculate the lesion durability index.”
This additional claim language, however, further fails to provide sufficient disclosure as to how Applicant envisioned the actual calculation of the lesion durability index to be achieved at the time of filing utilizing the specific parameters set forth in claim 14, or any one or more of the parameters noted in the disclosure.
As such, it is for at least the reasoning set forth above that the above-noted limitations in claim 13 related to the calculating of the lesion durability index are considered 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. Claims 14-17 are rejected due to their respective dependency on claim 13. Appropriate correction is required.
Allowable Subject Matter
Claims 1, 2, 4-12, 18-22 and 24 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
During the search of the prior art, the Examiner has previously-identified Altmann et al. (US Pat. Pub. 2021/0401491 A1) and Koblish (US Pat. Pub. 2020/0107877 A1) as particularly relevant to each of pending independent claims 1, 21 and 22. Applicant’s amendments to each respective independent claim have defined over the prior rejections under 35 U.S.C. 103 based on the combination of Altmann and Koblish. In particular, while the Examiner has previously-relied upon the subject matter in Altmann in [0053] and [0054] to provide disclosure of a comparison between a determined amplitude of a bioelectrical signal and a threshold amplitude, the Examiner notes that such a comparison was dependent upon the determined amplitude to fall below the threshold amplitude. Such a disclosure is in opposition to the current requirement in each of claims 1, 21 and 22 that requires “to determining that the determined amplitude is greater than the threshold amplitude”. The Examiner has failed to find any reference or combination of references that would cure or otherwise render obvious this deficiency in the teaching of Altmann. Further, the Examiner has failed to find any reference or combination of references that would disclose, fairly suggest or make obvious each and every limitation set forth in any of independent claims 1, 21 and 22.
Response to Arguments
Applicant's arguments filed August 13, 2026 with respect to the rejection of claims 13-17 under 35 U.S.C. 112(a) have been fully considered but they are not persuasive.
Applicant contends in the Remarks that "the Examiner is imposing a requirement that does not exist in the claims" and that the claim 13 "strictly and narrowly recites 'calculating a lesion durability index based on the determined amplitude of the bioelectrical signal in the frequency band'". Applicant continues that "the Examiner is inappropriately evaluating Claim 13 against the optional, multi-parameter embodiments described elsewhere in the specification ... rather than evaluating the support for the specific, narrower limitation actually claimed." Applicant then points to the disclosure in paragraph [0072] of the Specification to support the language of claim 13. Applicant contends that this disclosure "definitively links this algorithmic step to the calculation itself, stating exactly how the calculation is performed using these threshold comparisons" and concludes that a "comparison against a numerical threshold is a complete, defined mathematical algorithm that directly results in the claimed calculation."
To this end, Applicant disagrees with the Examiner's characterization of the disclosure in [0072] that such "only generally notes that such estimation comparisons may be used 'to calculate the lesion durability index'" and specifically contends that the disclosure provides for an enabling disclosure with specifically defined inputs, mathematical operation(s), numerical values, and an output. Applicant additionally argues on page 10 of the Remarks, that paragraph [0052] "directly equates the estimation of efficacy with the calculation of the index" with such providing that "the processing circuitry 'may estimate the lesion efficacy, such as by calculating a lesion durability index, based on the measured bioelectrical signal'". Applicant concludes on page 10 that "[b]ecause the specification explicitly describes using 'comparisons to pre-ablation, post-ablation, and recovery signals or to a threshold, or any such combination of comparisons to calculate the lesion durability index', the claims are adequately supported" in the disclosure.
This is not persuasive.
As a preliminary matter, the Examiner notes that claim 13 specifically requires the method step of "calculating a lesion durability index based on the determined amplitude of the bioelectrical signal in the frequency band, wherein the lesion durability index comprises a prediction of the efficacy of the cardiac lesion". While Applicant alleges that the Examiner is too narrowly construing the requirements of claim 13 to require some multi-parameter calculation rather than the "specific, narrower limitation actually claimed", the Examiner maintains the position set forth in the rejection of claim 13 above that the disclosure fails to provide sufficient disclosure as to how Applicant envisioned an actual calculation of the lesion durability index to be achieved utilizing "one or more of the parameters noted in the disclosure". The Examiner further reiterates that the Examiner's position in the rejection is not solely focused on complex mathematical calculations with multi-parameter embodiments, but rather is focused on the disclosure failing to establish any manner of calculation of the lesion durability index so 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.
Turning to Applicant's arguments with respect to the alleged support for the at-issue subject matter in claim 1 in paragraph [0072] of the filed Specification, the Examiner finds Applicant's arguments in the third paragraph on page 9 of the instant Remarks to overstate what is being described therein. Applicant contends that this disclosure "explicitly describe[s] the steps and comparisons to calculate the index" with such describing "a specific, step-by-step threshold comparison algorithm" that is then used in the calculation of the lesion durability index; and that such a "comparison against a numerical threshold is a complete, defined mathematical algorithm that directly results in the claimed calculation". But this is simply not what paragraph [0072] contemplates when describing any of the disclosed comparisons (individually, or in any combination) taken pre-ablation, post-ablation, recovery or threshold with respect to the lesion durability index. Rather, paragraph [0072] specifically sets forth that one or more of these comparisons are used "to calculate the lesion durability index". Said differently, the Examiner cannot reasonably find that paragraph [0072] supports Applicant's alleged step-by-step algorithm that is a "defined mathematical algorithm that directly results in the claimed calculation" is the sole factor in the generation of the disclosed lesion durability index when paragraph [0072] itself states that the comparison(s) are then used "to calculate the lesion durability index".
Turning to the alleged support of the at-issue subject matter in paragraph [0052] of the filed Specification, the Examiner fails to find that such disclosure provides for any specific manner of calculation. This disclosure, rather, correlates the analysis of signals in two or more frequency bands to estimate lesion efficacy such as "by calculating a lesion durability index". These estimations are disclosed therein to include comparisons of bioelectrical signals in more than one frequency and specifically including peal-to-peak voltage in three or more frequency bands. Nothing in paragraph [0052] provides, however, any insight as to how such a comparison is used along to calculate a lesion durability index as set forth in claim 13. Further, this disclosure in paragraph [0052] fails to provide context to any other portion of the disclosure, including paragraph [0072], so 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 in the form any manner of calculation of the lesion durability index based on the determined amplitude of the bioelectrical signal in the frequency band, wherein the lesion durability index comprises a prediction of the efficacy of the cardiac lesion as set forth in claim 13.
As such, the Examiner finds that the rejection of claims 13-15 under 35 U.S.C. 112(a) for failing to comply with the written description requirement remains tenable for at least the reasoning set forth in rejection of claims 13-15 under 35 U.S.C. 112(a) in the May 13, 2026 Final Action as well as in view of the above remarks in response to Applicant's arguments in the July 13, 2026 after-final response.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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/Ronald Hupczey, Jr./ Primary Examiner, Art Unit 3794
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