DETAILED ACTION
This action is pursuant to the claims filed on December 6, 2024. Claims 1-20 are pending. Claims 1-10 is/are withdrawn. A first action on the merits of claims 11-20 is as follows.
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 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.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-10, drawn to a method, classified in A61B5/276.
II. Claims 11-20, drawn to a system, classified in A61B5/287.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the method of receiving a diagnostic electrical signals can be performed by an interface module or by directly connecting to a microcontroller/processor and determining, identifying and initiating can be performed by a processor or by hand.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
(c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(d) the prior art applicable to one invention would not likely be applicable to another invention
(e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or U.S.C. 112, first paragraph.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Gabriel Azar on July 10, 2026 a provisional election was made without traverse to prosecute the invention II, claims 11-20. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-10 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 11-14, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Whayne et al. (hereinafter ‘Whayne’, U.S. PGPub. No. 2002/0115941), and further in view of Tarakci et al. (hereinafter ‘Tarakci’, U.S. PGPub. No. 2023/0310770).
In regards to independent claim 11 and claims 12, 14, 17, Whayne discloses a system (system 10 in Fig. 1) comprising:
an interface (instrument interface 26 in Fig. 2) configured to receive diagnostic electrical signals acquired over a given time window from multiple electrodes disposed over a distal end assembly of a catheter (instrument 12 comprising an array of multiple electrodes 18) located inside a cardiac chamber ([0051]: interface 26 links the instrument 12 to a controller 22 to process diagnostic data and signals; [0071]: In the illustrated embodiment (see FIG. 2), the instrument 12 comprises a composite, three-dimensional basket structure 58 that is carried at the distal end of a catheter tube 56 for introduction into the targeted heart chamber); and
a processor (microprocessor MPU 28 in Fig. 2) configured to indicate a short circuit ([0096]: application A5 constitutes a prescribed testing utility. When the testing application A5 is executed on the MPU 28, the switch manager 90 responds to high level commands generated by the application A4 to stop recording, pacing, and navigation switching tasks, and configure the cross point switch matrix 82 to perform various prescribed system tests, e.g., open or short-circuit detection and confirmation of system connections), and
wherein the processor is configured to initiate the responsive action by notifying a user of the short circuit ([0253]: The test application generates a Shorted Electrode message in the associated RESULTS data field 476), thus meeting claim 17.
However, Whayne does not specifically disclose that the processor is configured to determine a level of similarity between couples of the received diagnostic electrical signals; identify electrical signals having a level of similarity that is indicative of a short circuit between the respective electrodes; and initiate a response action to the identification, wherein the processor is configured to identify the level of similarity that is indicative of the short circuit by identifying that the level of similarity exceeds a similarity threshold, wherein the processor is configured to identify the level of similarity by performing cross-correlation between the electrical signals.
Tarakci teaches a method that is implemented to compare similarity of two signals to produce a score of similarity using a statistical correlation such as a cross-correlation function. Based upon the output of the cross-correlation function, it is then compared to a predefined value such that if the output is high (significantly similar), it indicates a potentially faulty condition and if the comparison output is low, it indicates that the device is not faulty ([0165]). Although Tarakci discloses that this method is used particularly for determining the fault of a respiratory therapy (RT) device by comparing real-time acoustic signal from a motor to a previously gathered acoustic signal from a motor of another RT device, the aspect of comparing two or more signals and determining similarity between the signals via a statistical correlation such as cross-correlation for the purpose of fault detection in the system is pertinent to the Applicant’s problem. Given that Whayne is silent as to a specific fault determination process (e.g. short-circuit, open-circuit) performed by the processor, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to identify the level of similarity of the signals using cross-correlation function as taught by Tarakci as doing so is one of the known ways to determine if there is a specific fault, such as short-circuit based upon high similarity between the signals ([0165]).
In regards to claim 13, Whayne further discloses wherein the interface is configured to receive the electrical signals comprises acquiring unipolar signals during the given time window ([0251]: “Upon selection of the SHORT/OPEN TEST button 470 and the START button 484, the test application A5 configures the switch manager 90 to detect open or shorted electrodes. In the illustrated embodiment, the ASIC 80 includes a constant current source 490 (see FIG. 3), which can be selectively switched to each of the electrodes 18 and 68 coupled to the interface 26”).
In regards to claim 19, Tarakci further teaches that the similarity threshold can be set depending upon the required fault detection and risk tolerance, for instance, threshold can be a respective percentage of the 100% correlation ([0165]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the similarity threshold to be 100% which would inherently imply that there is a direct connection or short between the electrodes.
Claims 15 & 16 are rejected under 35 U.S.C. 103 as being unpatentable over Whayne and Tarakci as applied to claim 11 above, and further in view of Chen et al. (hereinafter ‘Chen’, U.S. PGPub. No. 2013/0338519).
In regards to claim 15, Whayne/Tarakci combination discloses wherein the processor is configured to identify the level of similarity by calculating a difference between the electrical signals (Tarakci, [0165]: compare similarity of two signals to produce a score of similarity using a statistical correlation such as a cross-correlation function).
However, Whayne/Tarakci combination does not disclose finding an average of the difference.
Chen teaches a processor configured to determine if there is an unacceptable signal within a plurality of electrodes by determining an average of each of the signals from the plurality of electrodes over a predetermined period and comparing to a threshold ([0027]). The concept of taking an average of signals to increase signal to noise ratio compared to a single raw signal is a well-known signal processing method. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the process of calculating a difference between the electrical signals of Whayne/Tarakci combination with calculating the average difference between the electrical signals over a period of time as taught by Chen, as doing so increases signal to noise ratio compared to a single signal for more accurate signal analysis such as, for identifying fault conditions or noise within the signals.
In regards to claim 16, Whayne/Tarakci combination discloses the invention substantially as claimed in claim 11 and discussed above.
However, Whayne/Tarakci combination does not disclose wherein the processor is configured to initiate the responsive action by omitting data points derived from the indetified electrical signals from a subsequent computation.
Chen teaches a processor configured to determine if there is an unacceptable signal within a plurality of electrodes by determining an average of each of the signals from the plurality of electrodes over a predetermined period and comparing to a threshold ([0027]). Based upon the comparison, the unacceptable signal is further rejected from subsequent computation or can be weighed at a low level ([0027]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the processor configured to initiate the responsive action of Whayne/Tarakci combination by omitting data points or signals that are unacceptable as taught by Chen, so as to ensure that further signal processing is based upon signals that do not have any faults.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Whayne and Tarakci as applied to claim 11 above, and further in view of Fraasch (U.S. PGPub. No. 2018/0214195).
In regards to claim 18, Whayne/Trakci combination discloses the invention substantially as claimed in claim 11 and discussed above.
However, Whayne/Trakci combination does not disclose wherein the processor is further configured to, based on identities of the electrodes having the short circuit, detect that the distal end assembly is in a folded configuration during the time window.
Fraasch teaches various types of faults associated with a distal end assembly of a catheter ([0103]-[0105]). Specifically, Fraasch teaches that electrodes along the catheter may be shorted via an external force (e.g. when the distal assembly is compressed or distorted, such that the two electrodes comes into very close proximity or direct contact with one another) or excessive current may damage the catheter ([0103]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the processor configured to identify short circuit of Whayne/Tarakci combination such that it is also capable of detecting that the distal end assembly is folded, compressed, and/or distorted configurations as taught by Fraasch, since folding of the distal end assembly may cause shorting of the electrodes and repositioning the distal end assembly may be further required to properly use the catheter ([0103]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Whayne and Tarakci as applied to claim 11 above, and further in view of Marecki et al. (hereinafter ‘Marecki’, U.S. PGPub. No. 2017/0143227).
In regards to claim 20, Whayne/Tarakci combination discloses the invention substantially as claimed in claim 11 and discussed above.
However, Whayne/Tarakci combination does not disclose that the distal end assembly is a planar assembly.
Marecki teaches an expandable electrode assembly (expandable electrode assembly 30 in Fig. 2B) that is formed from a planar substrate (a flexible sheet 80 in Fig. 9A comprising a plurality of slits) and bonding two edges to define a generally cylindrical structure (see Figs. 9B-9D). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide the distal end assembly from a planar sheet assembly as doing so allows manufacturing of the expandable assembly from a single printed circuit ([0101]-[0102]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EUNHWA KIM whose telephone number is (571)270-1265. The examiner can normally be reached 9AM-5:30PM.
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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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/EUN HWA KIM/Primary Examiner, Art Unit 3794 7/17/2026
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