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 .
Claim Objections
Claims 1 and 11 are objected to because of the following informalities: in claim 1, line 6, “locations on from each electrode” appears to contain a typographical error; and in claim 11, line 2, “locations on from each electrode” appears to contain a typographical error. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1, 4-9, 11 and 14-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 7, 9-12, 17, 18, 20 and 21 of U.S. Patent No. 11,712,172 in view of Kalinin et al. (US 2016/0338611, hereinafter “Kalinin”).
In regards to claims 1 and 11, claims 1 and 12 of the issued patent are narrower than (i.e., “anticipate”) claims 1 and 11 of the instant application except for the plurality of electrodes comprising a second portion of electrodes distinct from the first portion and not in contact with myocardial tissue.
However, Kalinin in the same field of endeavor of electrophysiological mapping teaches providing a plurality of electrodes comprising a second portion of electrodes distinct from the first portion and not in contact with myocardial tissue (e.g., par. 0049, “In still another embodiment, data obtained using both MES 100 and EP catheter system 500 are combined and processed using MMU 200, scanner 300 and/or PVM 400”; note that the “MES” utilizes body surface electrodes; par. 0038) to provide the predictable results of more accurate reconstruction of the patient’s heart and thorax (par. 0049).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the ‘172 issued claims by providing a plurality of electrodes comprising a second portion of electrodes distinct from the first portion and not in contact with myocardial tissue to provide the predictable results of more accurate reconstruction of the patient’s heart and thorax.
In regards to claims 4-6 and 14-16, the catheter of the issued patent comprises a basket (necessarily having a plurality of splines) or balloon catheter (claims 9, 10, 20 and 21 of ‘172).
In regards to claims 7 and 17, the instructions are further configured to cause the medical system to: generate an electroanatomical map; and superimpose the indication of the spatial relationship between the geometric center and the focus on the electroanatomical map (claims 6, 7, 17 and 18 of ‘172).
In regards to claims 8 and 18, the indication of a spatial relationship between the geometric center and the focus comprises a geometric shape centered at the geometric center and a visual indicator of the focus positioned within the geometric shape (claims 6, 7, 17 and 18 of ‘172).
In regards to claims 9 and 19, the visual indicator of the focus has an oval shape (claims 1 and 12 of ‘172; “a circle” is narrower than (i.e., “anticipates”) “an oval shape” because a circle is a specific type of oval).
Claims 1, 4, 5, 11, 14 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 12 and 13 of U.S. Patent No. 12,295,720 in view of Kalinin.
In regards to claims 1 and 11, claims 1 and 12 of the issued patent are narrower than (i.e., “anticipate”) claims 1 and 11 of the instant application except for the plurality of electrodes comprising a second portion of electrodes distinct from the first portion and not in contact with myocardial tissue.
However, Kalinin in the same field of endeavor of electrophysiological mapping teaches providing a plurality of electrodes comprising a second portion of electrodes distinct from the first portion and not in contact with myocardial tissue (e.g., par. 0049, “In still another embodiment, data obtained using both MES 100 and EP catheter system 500 are combined and processed using MMU 200, scanner 300 and/or PVM 400”; note that the “MES” utilizes body surface electrodes; par. 0038) to provide the predictable results of more accurate reconstruction of the patient’s heart and thorax (par. 0049).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the ‘720 issued claims by providing a plurality of electrodes comprising a second portion of electrodes distinct from the first portion and not in contact with myocardial tissue to provide the predictable results of more accurate reconstruction of the patient’s heart and thorax.
In regards to claims 4, 5, 14 and 15, the catheter of the issued patent comprises a basket having a plurality of splines (claims 1 and 12 of ‘720).
Allowable Subject Matter
In regards to section 101, claims 1 and 11 recite the ostensibly mental processes of “determin[ing] a geometric center of the first portion of the plurality of electrodes,” and “determin[ing], based at least in part on the electrical signals, a focus of an arrhythmia” (step 2A, prong one). However, under step 2A, prong two, the claim as a whole integrates the “mental processes” into a practical application of the exception. For instance, analyzing how the claim limitations reciting the judicial exception interact with the remaining claim limitations indicates that the functionality/method steps are not merely carried out with generic computing components, but as part of a system and method that control a particular medical system having a catheter with a plurality of electrodes at a distal end configured for contact with myocardial tissue and a second plurality of electrodes not in contact with myocardial tissue. With this in mind, the “determin[ing] a geometric center of the first portion of the plurality of electrodes” is not “directed to” a judicial exception (i.e., is patent eligible) because, as used in concert with the claim as a whole, cannot be performed mentally because the plurality of electrodes, when being used as claimed, are within the heart of a patient at the distal end of a catheter with some visually unknowable first portion of electrodes in contact with myocardium (for which the geometric center is determined) and second portion not in contact with myocardium. The clinician/user has no visual access to the electrodes to make such a determination, and so requires more than mere mental activity, such as by measuring impedance (claim 2), and requires a particular apparatus. Regardless of whether claims 1 and 11 require impedance measurement (they do not), the step/functionality of determining a geometric center of the portion of electrodes during use cannot be performed mentally. Further, “determin[ing], based at least in part on the electrical signals, a focus of an arrhythmia” likewise cannot be performed mentally for similar reasons (including that the human mind cannot detect/receive electrical signals, as claimed), and so the claim as a whole is not “directed to” a judicial exception.
Further, claims 1 and 11 as a whole reflect an improvement to a particular technology or technical field. Again, the claims require not just a generic computing platform, but a system and method controlling the particular technology of an intracardiac sensing and targeting device that uses a catheter with distal electrodes in contact with myocardial tissue and second electrodes not in contact with myocardial tissue. The improvement provided by the system and method is more accurate placement of the electrodes of the catheter device that are actually in contact with myocardial tissue (par. 0035) and is reflected in the claim limitations drawn to “output[ting] the spatial relationship between the geometric center and the focus” that thusly allows the user to place the catheter more accurately (par. 0035). Although claims 1 and 11 appear to contain language reciting a judicial exception, the preponderance of the evidence indicates that the claims as a whole are not drawn to a judicial exception for the reasons above.
Claims 1-20 avoid the prior art, but remain rejected under double-patenting grounds above. The closest prior art is to Desai (US 5,657,755). Desai generally discloses a system and method including outputting an indication of the spatial relationship between a center of a set of electrodes and a focus of an arrhythmia (e.g., Fig. 6B). However, Desai is drawn to a two-dimensional electrode array (Figs. 2A-2C) used to contact the myocardium. Desai does not disclose or fairly render obvious, alone or in combination with the remaining prior art, the combination of limitations including receiving electrical signals using a second portion of electrodes distinct from the first portion and not in contact with myocardial tissue because Desai is not drawn to a basket or balloon-type mapping system with 3-dimensionality that would result in a portion of electrodes not being in contact with myocardium. Further, Desai does not appear to perform a step of determining a geometric center of the first portion of the plurality of electrodes, but instead merely determines a spatial relationship between the center electrode (which may or may not be the geometric center of all electrodes) and the arrhythmia location. No “determining” of a geometric center step is carried out by Desai, but instead the center electrode is presumed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/ Primary Examiner, Art Unit 3792