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.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03 March 2026 has been entered.
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 1, 3, 5, 7, 17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan (US 2018/0085160) in view of Boll (US 2018/0000533).
Regarding claims 1, 3, 5, 7, 17 and 19-20, Viswanathan discloses an electroporation system (abstract) including a catheter with an assembly that can be considered both a gird (figs. 6, 29A) or a basket (figs. 9B, 29B) with splines each having a plurality of electrodes (616, fig. 6; 916, 918 fig. 9B; etc.) independently connected to a pulse generator ([0004], [0066], [0074], etc.). The system further includes a “computing device” (i.e. whatever circuitry that is used) to allow the electrodes to be energized in an energization pattern that can different polarities (thus constituting bipolar therapy, [0074]). Viswanathan specifically notes that that the electrodes can be independently addressable ([0066]) but does not disclose any particular structure or examples, thus illustrating that the level of ordinary skill in the art includes selecting less than all electrodes. Viswanathan does not disclose that the computing device defines at least two pixels each comprising a subset of the electrodes (two to potentially hundreds in claim 1, four in claim 3), and further a half-pixel comprising a subset of the electrodes (two in claim 1), and combines the two pixels and the half-pixel to form the energization pattern. It is first noted that the language of “pixel” and “half-pixel” is so broad it is meaningless. Applicant could have used any words to describe one grouping of electrodes and another grouping of electrodes, where the number of electrodes could be 2 in both groups (as in claim 1), without changing the limitations of the claims at all. Applicant has therefore claimed (in claim 1 at least) that the computing devices combines at least three sets of electrodes, one of which has two electrodes while the other two have two to infinity electrodes. Using the terms “pixel” and “half-pixel” neither adds nor subtracts anything from those requirements. The breadth of interpretation is a function of the claim language itself, but it is also noted that this interpretation allows the claims to avoid indefiniteness issues since it would be unclear given a plain reading of the terms how a pixel could be anything other than four electrodes if the half-pixel is exactly two electrodes. It is also noted that any selection of electrodes of an array of electrodes is configured for use in the heart can be considered “fixed” at least for the duration of the selection and is of “adjacent” electrodes given the broadest reasonable interpretation of “adjacent” to mean “near.” Boll discloses a medical device with an array of independently controllable electrodes that can be supplied with RF energy to create specific lesion patterns (fig. 1A, [0090], note also monopolar/bipolar operation, [0068]). Boll further discloses that a computing device can define groups of electrodes into any number of pixels/half-pixels (“electrode clusters”) that can then be used to create specific energization patterns ([0031], [0106], see also [0117]). A cluster of two, three or more electrodes which would at least be four electrodes can be considered a “pixel,” while a cluster of two electrodes can be considered a “half-pixel” and a cluster of any number of any number of other electrodes can be considered an “n-pixel” ([0106]). Boll discloses no upper limit to the number of pixels, half-pixels, or n-pixels that can be used (“to another electrode cluster in the electrode array, and so on” implying at least three, [0106]), but given there is an embodiment with 16 electrodes (fig. 4) that results in at least eight pixels/half-pixels with respect to claim 1 (since both can be two electrodes), or, alternatively, three pixels and two half-pixels with respect to claim 3 (since pixels are four electrodes and half-pixels are two electrodes). Those numbers assume that electrodes can only be part of one pixel/half-pixel, which the claims do not require (see also figs. 5E-F which suggest significantly more electrodes than 16 total). In fact, Applicant’s drawings clearly show that electrodes can be part of different pixels (fig. 5A described as showing five pixels but only having twelve electrodes rather than twenty), which also contributes to a broad definition of “fixed” noted above since there are several electrodes that could be part of 4 pixels as discussed in the specification without reference to the broader claim language. Therefore, before the application was filed, it would have been obvious to one to of ordinary skill in the art in the art to modify the system of Viswanathan to have a mode of operation which involves the computing device placing any commonly known number of electrodes into any commonly known number of clusters (i.e. “pixel”/”half-pixels”) including one or more sets of two electrodes and two or more sets of four electrodes such as taught by Boll, or any of the other electrode/cluster number disclosed by Boll, and using those clusters in order to produce a specific treatment pattern (monopolar or bipolar) as also disclosed by Boll, that would produce the predictable result of allowing a user to apply energy to a specific region or regions of tissue in a desired manner.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan and Boll, further in view of Dahlen (US 2019/0110750)
Regarding claim 4, Viswanathan does not disclose the use of a planar grid. However, planar grids of electrodes are common in the art (including as taught by Boll, f4) where there is no evidence that the use of a planar grid produces an unexpected result (within the meaning of MPEP 716.02(a)). The fact that Applicant has claimed two mutually exclusive species for the array (planar grid and basket in claim 5) suggests the opposite, that flat and round electrode arrays only do what a person of ordinary skill in the art would expect. Dahlen discloses a cardiac treatment device and teaches that the electrode array can be planar (fig. 1) or a basket (fig. 4) which is understood to be a teaching of functional equivalence (MPEP 2144.04). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of Viswanathan to include any commonly known shape of electrode array, including planar as taught by Dahlen, that would produce the predictable result of a medical device usable to interact with cardiac tissue in a desired manner.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan and Boll, further in view of Olson (US 2019/0282116).
Regarding claim 6, Viswanathan does not disclose that the computing device can cause the electrodes to deliver diagnostic pulses. However, using electrodes for various sensing and energy delivery steps is common in the art. Olson, for example, discloses an ablation device (with grid, fig. 2A, and basket, fig. 1A, embodiments) and teaches that the electrodes can have a wide range of ablation, diagnostic and sensing functions ([0076]). Therefore, before the application was filed, it would have been obvious to modify the system of Viswanathan to include a computing device that is capable of allowing electrodes in an array to do all the things electrodes in an array are known to be useful for, including the functions disclosed by Olson, at least some of which can be considered “diagnostic pulses,” that would produce the predictable result of allowing a user to make use of those functions.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan and Boll, further in view of Keidar (US 2004/0147920).
Regarding claim 8, Viswanathan does not disclose that the computing device can compute a lesion pattern based on the energization pattern and display the projection on “geometry.” However, overlaying both estimated and actual lesion size on a tissue map based on electrode location and ablation energy is common in the art. Keidar, for example, discloses a tissue site (80, fig. 4) is provided with both estimated (86) and actual (88) lesion size, where the estimation is provided based on energy delivery ([0078]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the computing device of Viswanathan to include estimating how the energy delivery will influence tissue, and displaying that estimation on a map of the tissue site, both taught by Keidar, that would produce the predictable result of allowing a user to know the predicted extent of ablation for a given set of parameters.
Response to Arguments
Applicant's arguments filed 03 March 2026 have been fully considered but they are not persuasive. While the examiner agrees that there are meaningful differences between Boll and the disclosed invention, those differences are not reflected in the claims. Applicant argues that part of the specification regarding what a “half-pixel” is should be read into the claims. First, it is well established that while the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Second, there is at least a potential indefiniteness issue since a half-pixel being “a region between two electrodes” (as in the specification) is apparently a contradictory definition to a half-pixel being “two electrodes” (as in the claims). In fact, the paragraph quoted by Applicant for support for this definition ([0050]) also notes that the half-pixel is “defined by two electrodes” and it is not immediately clear what the difference is between saying that the half-pixel is defined by two electrodes and the half-pixel is defined by the region between two electrodes. Third and perhaps most substantially it is not clear how a half-pixel including “a region between two electrodes” limits the prior art in any meaningful way even if it was in the claims. Any two electrodes will always define a region between them, by definition, which may explain why Applicant’s specification uses those definitions interchangeably. Therefore, any computing device which is programmed to choose a subset of electrodes is also programmed to choose a region between those electrodes, and that without accounting for the fact that in bipolar ablation it is the region between the electrodes that is being treated in the first place and thus driving at least part of the process by which a subset of electrodes is chosen. That is, if a plurality of subsets of bipolar electrodes are used to treat tissue, those subsets are chosen at least in part because of the tissue between them. Therefore, even if Boll does not explicitly disclose considering the region between the two electrodes when demining an energization pattern of electrodes, that is irrelevant to the question of whether Boll discloses creating subsets of electrodes (including four-electrode clusters and two-electrode clusters) which at the very least can then be understood to include an arbitrary word (“half-pixel”) that includes the region between the selected electrodes. Applicant also appears to place weight on the creation of the pixels and half-pixels. But since Boll discloses that numerous clusters of electrodes exist as a subset of a larger group of electrodes, it is unclear how Applicant can argue that Boll does not disclose creation of those clusters. Without defining the clusters, they would not exist, where anything a computing device does it is “programmed” to do. It is also unclear what Applicant means by pixel/half-pixel if they are intended to be more than what the claims say pixels and half-pixels are, 2+ or 4 electrodes and 2 electrodes (respectively). And if pixels and half-pixels are just 4 and 2 electrodes, then Boll clearly teaches that electrodes can be grouped into multiple sets of 4 and 2 electrodes and the specific language of “pixel” and “half-pixel” is irrelevant. Frankly, in terms of electrode selection, the only difference between the claimed invention and Boll appears to be that the claimed invention specifically uses electrode groupings of two and four while Boll teaches the electrode groupings can include any number of electrodes (2 minimum) and it seems difficult to argue that using specific numbers should be patentably distinct where the prior art discloses an encompassing range of numbers.
Without commenting on the disclosed invention and therefore whether there is support in the specifications for the following language, the claims do not recite, for example, that all the electrodes in the array are placed into groups of two or four, or that the pixels/half-pixels are defined by sets of electrodes that do not include any intervening electrodes, or that the pixels/half-pixels themselves are adjacent to each other such that the energization pattern is contiguous, or that subsequent to defining the pixels/half-pixels some number of pixels/half-pixels less than the total number is used to create the energization pattern, or on what basis the computing device is programed to define the pixels/half-pixels (sensed information? User input? System startup? Type of attached array?). The examiner’s contact information can be found below if Applicant would care to discuss the issues before filing a response.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding another medical system with an array of bipolar electrodes where two or more electrodes are grouped into sets, see paragraph [0064], [0316] and the discussion associated with figures 7A-B of US 2013/0310828 to Reinders.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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).
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, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794
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