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 .
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 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,311,029 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because each the instant application more broadly claims the use of body surface electrodes, probe in heart chamber and respective measurement circuity to estimate a position of an esophagus and heart chamber and associated mapping.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 9, 14, 15, 17 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20040254437 A1 to Hauck et al. (hereinafter, Hauck) in view of EnSite Velocity cardiac mapping system: a new platform for 3D mapping of cardiac arrhthmias to Eitel et al. (hereinafter, Eitel) and further in view of Lemola et al. (hereinafter, Lemola).
Regarding Claims 1, 2 and 19, Hauck discloses a device for estimating esophagus position, comprising inter alia:
at least one body surface electrode connectible to a field generator and configured to apply an electric field from said field generator to a heart chamber (paragraph [0037] “Each patch electrode is coupled to the switch 24 and pairs of electrodes are selected by software running on computer 20, which couples the patches to the signal generator 25. A pair of electrodes, for example 18 and 19, are excited by the signal generator 25 and they generate a field in the body of the patient 11 and the heart 10.”);
measuring circuitry configured to receive signal measurements of an electric parameter of the electric field applied by the at least one body surface electrode from an electrode probe navigating within the heart chamber (paragraph [0038] “… fixed electrode in the heart can be used as a reference for measuring voltages and displacements. All of the raw patch voltage data is measured by the AtoD converter 26 and stored in the computer under the direction of software. This electrode excitation process occurs rapidly and sequentially as alternate sets of patch electrodes are selected and the remaining members of the set are used to measure voltages. This collection of voltage measurements is referred to herein as the "patch data set". The software has access to each individual voltage measurement made at each patch during each excitation of each pair of electrodes.”); and
control circuitry, configured to map the heart chamber (paragraph [0020] “The electrical potentials on these electrodes are measured and there location in space noted. The electrical data is then projected on the geometry as an activation map. The activation mapping methodology permits the display of peak to peak voltages at various locations on the geometry. The activation mapping methodology permits the display of timing relationships between the measured voltages and a fiducial timing reference at various locations on the geometry.”)
Hauck does not expressly disclose estimating a position of at least part of an esophagus adjacent to the heart chamber and estimating that said esophagus is not within a certain range from a wall of said heart chamber, based on said signal measurements. However, Eitel teaches a system for monitoring impedance changes between body surface electrodes and electrode probe navigating within the heart chamber (Page 185, Col. 2 “The noncontact mapping system utilizes a multielectrode array catheter to simultaneously record multiple areas of endocardial activation. This facilitates performed of high-density maps … using externally applied surface patches that generate transthoracic electric fields in three orthogonal directions.”). Harley teaches field distortions may arise from respiratory motion of the thorax and can influence planning and placement of ablation lines when integrated with the 3D cardiac mapping technology (Page 187, Col. 2 “… identification of transthoracic impedance … respiratory compensation is prerequisites for successful image integration and subsequent 3D model-guided therapy, where planning and placement of ablation lines is being performed …”). Thus, Eitel teaches where the identification of distortion of impedance measurements are caused by the thorax, which includes the esophagus and is at least part of an esophagus. Especially as broadly claimed, a skilled artisan would have recognized that field distortion of impedance measurements would have been an estimation of at least some distance between a heart chamber and an esophagus. The recognition that there is a least some distortion due to esophagus presence reads on estimating a distance between the heart chamber and esophagus. One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify Hauck to include the recognition that field distortion of impedance measurements, thereby indicating at least some sort of distance between a heart chamber and an esophagus, or, if there is no distortion, recognizing that the esophagus is not within change of the heart, because Eitel teaches at Page 187, Col. 2 that identification of breathing-dependent changes and respiratory compensation can be identified and teaches at Page 187, Col. 1 that there is an unmet need for the recognition of field distortions in cardiac mapping due to the thorax. Such combination of references is further bolstered by Lemola, who teaches in the abstract that during arterial ablation, injury during the esophagus can occur, and the relationship between the heart and the esophagus is imperative to prevent injury (Abstract). Based on the combination of references of Hauck and Eitel, and further motivation provided by Lemola, understanding that a field distortion in cardiac impedance measurement would have estimated at least some distance proximity (or the absence of proximity) between the heart and esophagus would have been obvious to one having ordinary skill in the art at the time the invention was filed.
Regarding Claim 14, Hauck in view of Eitel and Lemola teach the device of claim 1, wherein said measuring circuitry is connected to a catheter system configured to be at least partly placed within a heart chamber to measure said electric parameter (Hauck paragraph [0020] “One or more catheters having one or more electrodes are moved around in the heart chamber. Throughout this process the electrodes are in contact with the heart wall. The electrical potentials on these electrodes are measured and there location in space noted.”).
Regarding Claim 15, Hauck in view of Eitel and Lemola teach device of claim 1, further comprising: at least one electrode connectable to said measuring circuitry; wherein said electrode is shaped and sized to be placed within a heart chamber to measure said electric parameter (Hauck paragraph [0020] “One or more catheters having one or more electrodes are moved around in the heart chamber. Throughout this process the electrodes are in contact with the heart wall. The electrical potentials on these electrodes are measured and there location in space noted.”).
Regarding Claim 17, Hauck in view of Eitel and Lemola teach the device of claim 1, wherein the control circuitry is further configured to model the heart chamber based on the signal measurements (Hauck paragraph [0048] “The raw location data is corrected for respiration and other artifacts and then a geometry process is started. In this process the exterior most location points in the data are used to create a shape. The preferred surface is a convex hull using standard algorithms such as Qhull. This surface is then resampled over a more uniform grid and interpolated to give a reasonably smooth surface stored as a "geometry" for presentation to the physician.”.
Regarding Claim 18, Hauck in view of Eitel and Lemola teach the device of claim 1, wherein the electric parameter of the electric field is electric potential (paragraph [0049] “During each measurement the real time location of the catheter electrode is noted along with the value of the EP voltage or signal.”).
Allowable Subject Matter
Claims 3-8, 10-13 and 16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791