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.
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 and 63-65 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The independent claims all recite a system with two components: a standard cardiac ablation catheter with an electrode array and a processor configured to perform specific steps. The ablation is performed using electroporation, which is a common ablation modality. The processor performs various steps including detecting an artifact and using the time of that detecting, inter alia, to determine a treatment time. However, a review of the specification shows that the artifact is a product of freezing tissue not electroporation. For example: “the processor 344 is configured to receive measurement of pacing capture output from non-targeted tissue and to receive second an electrical measurement derived from presence of high impedance ice artifact on the recording electrodes” ([0115], citations to the printed publication US 2025/0049490), “During the course of treatment, the signal indicating the onset of the high impedance ice artifact is sent to the algorithm, which will be used in conjunction with pace capture output to risk-adjust the therapeutic dosage” ([0232]), “The high impedance artifact does not appear if the underlying tissue is not frozen” ([0413]), “the artifact 2902 may be identified based on an impedance value calculated from the electrical signal… [t]he calculated impedance value may be proportional to the thickness of ice that has built up on a measuring electrode” ([0557]). The dependent claims deepen the issue, as claim 7, for example, recites a formula that is explicitly used in the cryosurgical context (“When the processing system detects the artifact in an electrical signal, the processing system may start a ‘freeze timer’ that automatically terminates treatment once the optimal freeze time has elapsed since the artifact was detected. In turn, the optimal treatment time for a treatment site may be defined by the formulae below:” [0520] followed by the formula given in claim 7). As another example, claim 20 recites an impedance value for the artifact that is significantly higher (1000-2000 ohms) than the impedance of merely ablated tissue (that could be expected to result from electroporation, see for example [0037] of US 2014/0243780 to Leschinsky which notes that 20 ohms indicates sufficient ablation). The specification only mentions electroporation a total of six times ([0113], [0114], [0202], [0276], [0580] and [0582]). Two of those times are related to drug delivery and not ablation ([0580] and [0582]). The rest of those times electroporation is just one of a laundry list of hypothetical energy ablation modalities that can be used. The specification does discuss some details for the use of pulsed field ablation, another name for electroporation, in paragraphs [0560]-[0579], but there is not a single mention of an artifact or even the determination of a treatment time in this embodiment. Generally, a claim reciting that ablation can be performed using one or more of several commonly known ablation modalities would not present a problem because the level of ordinary skill in the art is high enough for that. But in this case specifically, since electroporation does not freeze tissue, it is not clear (a) whether an artifact is even generated, (b) what an electroporation artifact might actually be, and (c) how a hypothetical electroporation artifact distinct from the disclosed frozen tissue artifact can be used to determine treatment time. Having explained the context, the Wands factors (MPEP 2164.01(a)) will now be addressed with respect to the amount of experimentation necessary to make and use the full scope of the claimed invention. The claim language in particular of “artifact” is extremely broad and Applicant has not provided a specific definition. To the extent that the artifact is related to ice formation, the word is used to mean “abnormal condition” (i.e. ice does not naturally occur in the heart, see discussion associated with fig. 29). But this has no clear correlation to what would happen in tissue during electroporation. That is, there is no evidence such an artifact would be generated during electroporation. The state of the prior art includes a concern for protecting the phrenic nerve (unclaimed until claim 11, [0399]), or collateral tissue in general, but because there is no evidence that electroporation creates an artifact in the way that cryogenic temperatures do, the state of the art does not include any information which would indicate any understanding of using an “artifact” generated by electroporation for any purpose. While the level of ordinary skill in the art of cardiac ablation is quite high, and electroporation and cryogenic ablation are commonly used, they do have different effects on tissue (creating pores in cell walls leading to apoptosis versus freezing the water within cells so that they burst, respectively) and so there is no basis for translating the exact procedure used to determine treatment time in a cryosurgical ablation system to protect a phrenic nerve based in part on when an artifact is detected to an electroporation ablation system. The amount of direction provided by the inventor is, as discussed above, non-existent. The artifact is discussed extensively with respect to the cryosurgical embodiment and absent from the very brief discussion of the electroporation embodiment. There are no working examples. Therefore, the examiner takes the position that it would take an undue amount of experimentation for a person of ordinary skill in the art to make and use the full scope of the claimed invention, such that the specification does not enable the claimed invention.
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 1-20 and 63-65 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 1-20 and 63-65, the independent claims, as discussed above, recite that an electroporation system that includes a processor that detects an artifact and uses the time of detection as one of the values in a formula to calculate treatment time. But because it is not clear what kind of artifact is generated by electroporation, or what electroporation parameters would generate an artifact, or how such an artifact would be measured, or how a formula might account for such an artifact, the structural elements required by the claim are indefinite. The other claims depend from one of the dependent claims and are therefore also indefinite.
Note about Relevant Prior Art
The claims are not enabled and indefinite to the degree that a comprehensive prior art search is impossible, which also makes a reasonable rejection using prior art impossible. However, in the interest of compact prosecution, the following references are cited as being relevant to cardiac ablation using cryogenic temperatures or electroporation while protecting the phrenic nerve.
Regarding the control of cryogenic fluid to prevent the freeze zone from passing through cardiac tissue in a manner that could damage non-target tissues such as the phrenic nerve, see paragraph [0036] of US 2015/0119868 to Lalonde.
Regarding a system with very similar figures and a shared inventor which includes an array of sensing electrodes and a cryosurgical element and is concerned with protecting the phrenic nerve including a pacing step with the sensing electrodes, see figure 6, and paragraph [0034] of US 2017/0189106 to Schuler. It is noted this reference makes similarly vague claims about the use of various ablation modalities including electroporation ([0046], [0047]).
Regarding the use of impedance to determine ice formation by using an electrode array, see paragraph [0034] of US 2012/0191081 to Markowitz.
Regarding delivering cryosurgical energy, measuring the time it takes to reach a first sensed value, and then determining the treatment end point based on the time, see paragraph [0036] (and the discussion of time-to-isolation based on time-to-effect) of US 2019/0175244 to Lalonde. This reference also includes a discussion of accounting for critical non-target structures such as the phrenic nerve ([0033]).
Regarding the general teaching that treatment times can be determined in advance, or based on feedback of various kinds, see paragraph [0037] of US 2010/0179827 to Watson.
It is noted that US 2021/0177509 to Schuler, published less than 1 year before the effective filing date of the pending application, is available as prior art under 35 U.S.C. 102(a)(1). This document shares an inventor and an assignee (see the updated information in U.S. Application 17/119,783) with the pending application. Further, the specifications of the two documents overlap substantially, most notably including the exact same formula and example for determining treatment time (paragraphs [0326]-[0333] of ‘509 to Schuler, [0400]-[0408] of the printed publication of the pending application). There are also numerous identical figures. It seems likely, therefore, that the ‘509 document to Schuler constitutes an inventor-originated disclosure (MPEP 2153.01(a)) and as such is not available as prior art due to the 35 U.S.C. 102(b)(1) exception. However, as noted in MPEP 2153.01(a), second paragraph, where the number of inventors in the publication (in this case four) is greater than the number of inventors in the application (in this case two), it cannot be determined from the documents alone whether the exception applies. It seems very likely this document will end up being relevant to the pending claims unless Applicant makes a statement asserting that the ‘509 document is in fact an inventor-originated disclosure (see MPEP 2153.01(a) for details).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794