DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 19 December 2025 has been entered. Claims 23-25 are new. Claims 3-25 are pending in the application.
Claim Objections
Claim 23 is objected to because of the following informalities: in line 1, “is comprised of” should read --comprises-- or --is composed of--. Appropriate correction is required.
Response to Arguments
Applicant's arguments filed 19 December 2025 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Although the de la Rama reference does not teach stacked electrode pairs, de la Rama is not relied upon to teach this limitation. Instead, de la Rama teaches a system incorporating a two-dimensional array of measurement sites, as well as the advantages of such an array, namely, the ability to simultaneously map larger areas relative to a one-dimensional array. It therefore would have been obvious to one of ordinary skill in the art to modify the combined reference of Nayaran ‘614 and Goldreyer, which does teach stacked electrode pairs, by arranging the stacked electrode pairs of the combined reference in a two-dimensional array in order to achieve a larger mapping area, as taught by de la Rama.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 3, 5-6, 10-13, 17, 20, and 25 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nayaran et al. (US PGPub No. 2014/0371614), hereinafter Nayaran ‘614, in view of Goldreyer (US Patent No. 5,385,146), and further in view of de la Rama et al. (US Patent No. 6,029,091), hereinafter de la Rama.
Regarding claim 3, Nayaran ‘614 teaches a method of detecting atrial fibrillation (par. 0043: “A system and method for reconstructing cardiac activation information associated with heart rhythm disorders are disclosed herein;” par. 0054: “the heart rhythm disorder can be a complex rhythm disorder AF, VF and polymorphic VT, or another heart rhythm disorder”), the method comprising:
navigating a catheter into a heart of a patient (Fig. 1: catheter 102, heart 120; par. 0046: “The catheter includes a plurality of probes/sensors 104-112, which can be inserted into the heart through the patient's blood vessels”);
wherein the catheter comprises an array of electrodes (Fig. 4: array of sensors 400), wherein a first electrode is in contact with the cardiac tissue to record a first signal, and a second electrode is separated from the first electrode by a distance that enables the second electrode to record a second signal (Fig. 4: analysis signal 1 and reference signal 2 at sensors separated by a distance);
recording, through the array of electrodes, signals from a respective plurality of locations in the cardiac tissue (Figs. 4-5 and par. 0062: “Pairs of sensors (signals of sensors) in the array 400 are iteratively selected for processing as will be described in greater detail herein in order to reconstruct cardiac activation information (activation onsets) of the heart 120 in the right atrium 122, or another chamber in which the array 400 may be disposed”);
processing the signals to reconstruct electrical events from the locations in the tissue corresponding to atrial fibrillation (par. 0107: “At the conclusion of the method 900, signals collected from the heart 120 have been reconstructed with cardiac activation information (activation onsets) such that a cause of the heart rhythm disorder can be determined”);
constructing a map comprising regions of the atrial fibrillation, said map being registered onto a representation of the heart (par. 0107: “unipolar electrograms or monophasic action potentials (MAPs) can be mapped to the reconstructed activation onsets of the signals to show unipolar or MAP sequences or representations for the signals. An activation map or pattern can be constructed from these unipolar voltage or MAP voltage representations of the signals to locate the cause of the heart rhythm disorder”);
and defining from the map an optimal placement of at least one ablation lesion in the cardiac tissue (par. 0110: “As shown by the arrows in the example mappings 1106 (e.g., activation onsets 1108-1114), the electrical activity indicates a rotational activation pattern of activation onsets (rotor) in the heart rhythm disorder. At least a portion of the area of the heart 120 indicated by the rotational activation pattern indicated by the arrows in FIG. 11 can be treated to eliminate the cause of the heart rhythm disorder, and therefore the heart rhythm disorder itself. Such treatment may be delivered by ablation using various energy sources”).
Nayaran ‘614 does not explicitly teach wherein the electrodes are stacked electrode pairs arranged in an orthogonal, close, unipolar configuration and orthogonal to cardiac tissue. However, in an analogous art, Goldreyer teaches stacked electrodes in an orthogonal, close, unipolar configuration and orthogonal to cardiac tissue (Fig. 2: sets of orthogonal electrodes 34-46 behind stimulating tip 58; col 5, lines 12-14: “Each set of electrodes 34-46 is separated from the adjacent set of electrodes 34-46 by a distance 48 of approximately 3 to 5 millimeters;” col 5, lines 16-17: “Catheter 32 is laid against the atrial or ventricle walls;” examiner notes that when the catheter is laid against cardiac tissue, the sets of orthogonal electrodes would be stacked orthogonally to the cardiac tissue) and further teaches that providing orthogonal electrodes behind a tissue-contacting electrode improves discrimination between slow excitation areas and normal activation areas (col 6, lines 12-17: “reliable identification of such abnormal cites is based on upon being able to identify those areas of slow excitation responsible for reentry. Using orthogonal electrodes immediately behind a stimulating tip, the identified areas of slow excitation can be easily discriminated from areas of normal activation”).
It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of Nayaran ‘614 by providing orthogonal electrodes behind the tissue-contacting electrodes, as suggested by Goldreyer, in order to improve discrimination between slow excitation areas and normal activation areas, as taught by Goldreyer.
The combination of Nayaran ‘614 in view of Goldreyer further does not teach wherein the catheter comprises a two-dimensional array of the stacked electrode pairs. However, in an analogous art, de la Rama teaches a cardiac mapping catheter with a two-dimensional array of electrodes (Fig. 2: two-dimensional array of lattices 21 with electrodes 32 thereon; col 5, lines 2-6: “The inner catheter 12 comprises a first plurality of lattices 21 positioned essentially perpendicular to a second plurality of support lattices 22, wherein all lattices are connected in a manner so that it forms a trellis-like structure 23”), which de la Rama teaches has the advantage of mapping an entire area simultaneously (col 4, lines 14-17: “As a result of the trellis-type electrode arrangement, a whole area can be mapped simultaneously, particularly effective for atrial fibrillation and atrial flutter indications”). It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to further modify the method of the combined reference by using a two-dimensional array, as taught by de la Rama, in order to map a whole area simultaneously for detection of atrial fibrillation, as taught by de la Rama.
Regarding claim 5, the combination teaches the method of claim 3 as described previously. Nayaran ‘614 further teaches wherein the electrical events comprise repetitive or asynchronous activation of separate groups of cells within recording regions of the stacked electrode pairs (Fig. 11: activation onsets 1108-1114 at separate groups of cells; par. 0109: “The electrical activity of all MAPs is mapped in a sequence of example activation mappings 1106 to show activation onsets 1108, 1110, 1112 and 1114 at each time interval, respectively;” examiner interprets sequentially ordered activation onset times at different locations as asynchronous activation of separate groups of cells).
Regarding claim 6, the combination teaches the method of claim 3 as described previously. Nayaran ‘614 further teaches wherein the electrical events comprise local activation times at the locations in the cardiac tissue (Fig. 11: signal 1100 with activation onset times; par. 0109: “Raw signal 1100 represents a signal that is processed to assign activation onsets (vertical lines)”).
Regarding claim 10, the combination teaches the method of claim 3 as described previously. Nayaran ‘614 further teaches wherein the electrical events reveal localized defects in conduction of activation signals by the heart (Fig. 11: activation onsets 1108-1114 in a rotational activation pattern).
Regarding claim 11, the combination teaches the method of claim 3 as described previously. Nayaran ‘614 further teaches further comprising ablating the cardiac tissue at the optimal placement defined by the map (par. 0110: “At least a portion of the area of the heart 120 indicated by the rotational activation pattern indicated by the arrows in FIG. 11 can be treated to eliminate the cause of the heart rhythm disorder, and therefore the heart rhythm disorder itself. Such treatment may be delivered by ablation using various energy sources”).
Regarding claim 12, Nayaran ‘614 teaches a method for treating fibrillation (par. 0110: “At least a portion of the area of the heart 120 indicated by the rotational activation pattern indicated by the arrows in FIG. 11 can be treated to eliminate the cause of the heart rhythm disorder, and therefore the heart rhythm disorder itself”), the method comprising:
obtaining measurements of tissue activation at locations across cardiac tissue in a patient using a catheter (Fig. 1: catheter 120; Fig. 4: array of sensors 400; par. 0059: “FIG. 4 illustrates an example array of sensors 400 of catheter 102 and an example selection of signals from the sensors to reconstruct cardiac activation information (e.g., activation onsets). The array 400 includes fifteen (15) example sensors for simplicity and clarity of the description. It is to be understood that the array 400 can include fewer or more sensors to as may be determined to cover different portions of the heart 120”);
wherein the catheter comprises an array of electrodes (Fig. 4: array of sensors 400), wherein a first electrode is in contact with the cardiac tissue to record a first signal, and a second electrode is separated from the first electrode by a distance that enables the second electrode to record a second signal (Fig. 4: analysis signal 1 and reference signal 2 at sensors separated by a distance);
processing, with a processing system, the measurements to detect in the cardiac tissue localized defects in conduction by the cardiac tissue of activation signals (par. 0094: “signals can be received from sensors of the sensor array 400 disposed in the right atrium 122 of the heart 120, as shown in FIGS. 1 and 4. In some embodiments or aspects, at least a portion of the signals from the sensors can be recorded by signal processing device 114 and then provided to computing device 116” and par. 0107: “signals collected from the heart 120 have been reconstructed with cardiac activation information (activation onsets) such that a cause of the heart rhythm disorder can be determined”);
and creating, by the processing system, a map comprising the localized defects registered onto a representation of the patient's heart (par. 0107: “unipolar electrograms or monophasic action potentials (MAPs) can be mapped to the reconstructed activation onsets of the signals to show unipolar or MAP sequences or representations for the signals. An activation map or pattern can be constructed from these unipolar voltage or MAP voltage representations of the signals to locate the cause of the heart rhythm disorder”).
Nayaran ‘614 does not explicitly teach wherein the electrodes are stacked electrode pairs arranged in an orthogonal, close, unipolar configuration and orthogonal to cardiac tissue, and wherein the catheter comprises a two-dimensional array of the stacked electrode pairs. However, as described in the rejection for claim 3, Goldreyer teaches stacked electrodes in an orthogonal, close, unipolar configuration and orthogonal to cardiac tissue, and de la Rama teaches a two-dimensional array of electrodes, and it would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of Nayaran ‘614 in view of Goldreyer and de la Rama and thereby arrive at the method of the claimed invention.
Regarding claims 13 and 17, the combination teaches the method of claim 12 as described previously. Nayaran ‘614 further teaches further comprising defining from the map an optimal placement of at least one ablation lesion in the cardiac tissue and applying ablation therapy at the optimal placement of the ablation lesion (Fig. 11 and par. 0110: “As shown by the arrows in the example mappings 1106 (e.g., activation onsets 1108-1114), the electrical activity indicates a rotational activation pattern of activation onsets (rotor) in the heart rhythm disorder. At least a portion of the area of the heart 120 indicated by the rotational activation pattern indicated by the arrows in FIG. 11 can be treated to eliminate the cause of the heart rhythm disorder, and therefore the heart rhythm disorder itself. Such treatment may be delivered by ablation using various energy sources”).
Regarding claim 20, Nayaran teaches a method of detecting fibrillation (par. 0043: “A system and method for reconstructing cardiac activation information associated with heart rhythm disorders are disclosed herein;” par. 0054: “the heart rhythm disorder can be a complex rhythm disorder AF, VF and polymorphic VT, or another heart rhythm disorder”), the method comprising:
navigating a catheter into a heart of a patient (Fig. 1: catheter 102, heart 120; par. 0046: “The catheter includes a plurality of probes/sensors 104-112, which can be inserted into the heart through the patient's blood vessels”);
wherein the catheter comprises an array of electrodes (Fig. 4: array of sensors 400), wherein a first electrode is in contact with the cardiac tissue to record a first signal, and a second electrode is separated from the first electrode by a distance that enables the second electrode to record a second signal (Fig. 4: analysis signal 1 and reference signal 2 at sensors separated by a distance);
recording, through the array of electrodes, signals from a respective plurality of locations in the cardiac tissue (Figs. 4-5 and par. 0062: “Pairs of sensors (signals of sensors) in the array 400 are iteratively selected for processing as will be described in greater detail herein in order to reconstruct cardiac activation information (activation onsets) of the heart 120 in the right atrium 122, or another chamber in which the array 400 may be disposed”);
processing the signals to detect in the cardiac tissue localized defects in conduction tissue of activation signals (par. 0094: “signals can be received from sensors of the sensor array 400 disposed in the right atrium 122 of the heart 120, as shown in FIGS. 1 and 4. In some embodiments or aspects, at least a portion of the signals from the sensors can be recorded by signal processing device 114 and then provided to computing device 116” and par. 0107: “signals collected from the heart 120 have been reconstructed with cardiac activation information (activation onsets) such that a cause of the heart rhythm disorder can be determined”);
and creating in a processing system a map comprising the localized defects registered onto a representation of the patient's heart (par. 0107: “unipolar electrograms or monophasic action potentials (MAPs) can be mapped to the reconstructed activation onsets of the signals to show unipolar or MAP sequences or representations for the signals. An activation map or pattern can be constructed from these unipolar voltage or MAP voltage representations of the signals to locate the cause of the heart rhythm disorder”).
Nayaran ‘614 does not explicitly teach wherein the electrodes are stacked electrode pairs arranged in an orthogonal, close, unipolar configuration and orthogonal to cardiac tissue, and wherein the catheter comprises a two-dimensional array of the stacked electrode pairs. However, as described in the rejection for claim 3, Goldreyer teaches stacked electrodes in an orthogonal, close, unipolar configuration and orthogonal to cardiac tissue, and de la Rama teaches a two-dimensional array of electrodes, and it would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of Nayaran ‘614 in view of Goldreyer and de la Rama and thereby arrive at the method of the claimed invention.
Regarding claim 25, the combination teaches the method of claim 20 as described previously. Goldreyer further teaches wherein the first electrode and the second electrode are placed opposite each other on either side of the two-dimensional array (Fig. 2: sets of orthogonal electrodes 34-46; examiner interprets the stacked electrode pairs as first and second electrodes placed opposite each other on either side of the array).
Claims 4, 9, 15, and 19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nayaran ‘614 in view of Goldreyer and de la Rama and further in view of Nayaran et al. (US PGPub No. 2013/0006131), hereinafter Nayaran ‘131.
Regarding claims 4 and 19, Nayaran ‘614 in view of Goldreyer and de la Rama teaches the methods of claims 3 and 13 as described previously. Nayaran ‘614 further teaches wherein the optimal placement of an ablation lesion is determined from identified locations of circuit cores or reentrant circuits in the cardiac tissue (Fig. 11: rotational activation pattern; par. 0110: “As shown by the arrows in the example mappings 1106 (e.g., activation onsets 1108-1114), the electrical activity indicates a rotational activation pattern of activation onsets (rotor) in the heart rhythm disorder. At least a portion of the area of the heart 120 indicated by the rotational activation pattern indicated by the arrows in FIG. 11 can be treated to eliminate the cause of the heart rhythm disorder, and therefore the heart rhythm disorder itself”), but does not explicitly teach wherein the locations are identified from local tissue activation frequency.
However, in an analogous art, Nayaran ‘131 teaches a method of detecting atrial fibrillation comprising identifying reentrant circuit locations from local tissue activation frequency (Fig. 12: rotors 1030 and 1040; par. 0171: “An example of the present methods in the human atria is shown in FIG. 12, elements 1030 and 1040, which show rotors in the right atrium computed using frequency-domain methods”) as an alternative to time-domain or spatial-phase methods for identifying and locating causes for a rhythm disorder (par. 0162: “analysis may identify and locate causes for a rhythm disorder using frequency domain methods, time-domain methods or spatial-phase methods”). It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of the combined reference by using frequency-domain analysis to identify reentrant circuit locations, as taught by Nayaran ‘131, because Nayaran ‘131 teaches that frequency-domain methods can be effectively used as an alternative to time-domain or spatial-phase methods for this type of computation.
Regarding claim 9, Nayaran ‘614 in view of Goldreyer and de la Rama teaches the method of claim 3 as described previously. The combined reference does not explicitly teach wherein the electrical events include one or more of multiple activation fronts, abnormal concentrations of activation vectors, and changes in a conduction velocity vector.
However, Nayaran ‘131 teaches reconstructing electrical events including one or more of multiple activation fronts, abnormal concentrations of activation vectors, and changes in a conduction velocity vector (Figs. 30-32: activation wavefronts and vectors reconstructed for fibrillation; par. 0179: “Vectorial analyses of the ECG for regions of regularity and high rate, particularly if surrounded by regions of lower regularity and rate, indicate locations within the heart where sources lie”).
To modify the method of the combined reference by reconstructing wavefronts and activation vectors and analyzing for regions of regularity and high rate, as suggested by Nayaran ‘131, would have been obvious to one of ordinary skill in the art at the time the invention was made for the following reasons:
Nayaran ‘614 in view of Goldreyer and de la Rama teaches a prior art atrial fibrillation detection method upon which the claimed invention, with activation front and vectorial analysis, can be seen as an “improvement” (the combined reference does not explicitly teach analysis of activation fronts and vectors). Nayaran ‘131 teaches a comparable prior art method comprising activation front and vectorial analysis for atrial fibrillation detection. Thus, the manner of improving a particular atrial fibrillation detection method was made part of the ordinary capabilities of one skilled in the art based upon the teaching of such improvement in Nayaran ‘131. Accordingly, one of ordinary skill in the art would have been capable of applying this known “improvement” technique in the same manner to the prior art atrial fibrillation detection method of the combined reference, and the results would have been predictable to one of ordinary skill in the art, namely, one skilled in the art would have readily recognized that performing analysis on activation fronts and vectors would provide indications of where fibrillation sources are located in the heart.
Regarding claim 15, Nayaran ‘614 in view of Goldreyer and de la Rama teaches the method of claim 3 as described previously. The combined reference does not explicitly teach wherein the optimal placement corresponds to reentrant circuit core density or distribution across the cardiac tissue.
However, Nayaran ‘131 teaches placing an ablation lesion corresponding to reentrant circuit core distribution (Fig. 42 and par. 0330: “As shown in FIG. 42, human AF may be terminated by shaped ablation tailored to the locus of migration of a left atrial rotor;” examiner interprets the locus of migration of a rotor as reentrant circuit core distribution) in order to treat migrating fibrillation sources (par. 0335: “Shaped ablation can be used to target at least a portion of a migrating locus of a source of a complex rhythm disorder of an organ (e.g., cardiac rhythm disorder of the heart) to eliminate or alter the complex rhythm disorder. In accordance with an example method of treating a heart rhythm disorder, a shape (e.g., indicated by circumference or perimeter) of a region of tissue defined by a migrating source for the rhythm disorder can be determined”). It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of the combined reference by defining the optimal placement of the ablation lesion corresponding to reentrant circuit core density or distribution, as suggested by Nayaran ‘131, in order to treat migrating fibrillation sources, as taught by Nayaran ‘131.
Claim 7 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nayaran ‘614 in view of Goldreyer and further in view of Marchlinski et al. (US Patent No. 5,447,529), hereinafter Marchlinski.
Nayaran ‘614 in view of Goldreyer and de la Rama teaches the method of claim 3 as described previously but does not teach further comprising deploying the catheter via thoracotomy.
However, in the same field of endeavor, Marchlinski teaches thoracotomy as one of various well-known methods for guiding electrode catheters into the heart for mapping and ablation, and specifically for mapping of the epicardium (col 5, lines 8-25: “The catheter may be guided to any chamber or area of the heart. In practicing the method of the present invention, the measuring electrode may be mounted in any way that allows direct contact with the endocardium. For example, left ventricular endocardial mapping may be performed by percutaneous insertion of the catheter into the femoral artery using the Seldinger technique, then retrograde passage of the catheter via the aorta and into the ventricle after crossing the aortic valve. Of course, access to any endocardial site in either atria or either ventricle may be achieved. In addition, mapping of the epicardium may be performed by thoracotomy and direct application of the electrode to the heart. The guidance of catheters into the heart, often using fluoroscopy, is known as cardiac catheterization, and is well known to those skilled in the art and need not be described here in detail”). It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to have modified the method of the combined reference by deploying the catheter via thoracotomy, as suggested by Marchlinski, since Marchlinski teaches that thoracotomy is appropriate for mapping the epicardium and that guidance of catheters into the heart by multiple pathways is well known to those skilled in the art.
Claims 8, 14, 16, and 21-22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nayaran ‘614 in view of Goldreyer and de la Rama and further in view of Ciaccio (WO 2012/149128).
Regarding claims 8, 14, 16, and 21, Nayaran ‘614 in view of Goldreyer and de la Rama teaches the methods of 3, 12-13, and 20 as described previously. The combined reference is silent with respect to fractionated electrograms and does not teach wherein the processing includes detecting fractionated electrograms corresponding to reentrant circuits or circuit cores in the cardiac tissue, or further comprising analyzing the signals to detect electrogram fractionation indicative of circuit core density or distribution.
However, in an analogous art, Ciaccio teaches that complex fractionated atrial electrograms are known in the art to be indicators of reentrant circuits or circuit cores in cardiac tissue (par. 0004: “the analysis of complex fractionated atrial electrograms (CFAE) […], which are likely formed by multiple independent generators (e.g., focal areas of high frequency and/or reentrant circuits)”) and further teaches obtaining and processing fractionated electrograms corresponding to reentrant circuits or circuit cores (Fig. 25: receiving signal at step 2501 and analysis at step 2505; par. 0055: “in procedure 2501, a signal can be received. The signal may be (i) a CFAE signal;” par. 00105: “By devising a data-driven frequency transform, independent drivers can be successfully extracted and characterized by both frequency and morphologic measurements. The transform can be further developed for clinical use by activation mapping of the substrate during AF in patients, identifying independent sources in the maps (focal or reentrant), and determining the correspondence of these to the most important ensemble basis vectors and frequency components. It is believed that ablation lesions at these sources can best prevent reinduction of AF”).
To modify the method of the combined reference by obtaining and processing fractionated electrograms corresponding to reentrant circuits or circuit cores, as suggested by Ciaccio, would have been obvious to one of ordinary skill in the art at the time the invention was made for the following reasons:
Nayaran ‘614 in view of Goldreyer and de la Rama discloses a prior art atrial fibrillation detection method upon which the claimed invention, with detection and analysis of fractionated electrograms, can be seen as an “improvement” (the combined reference does not explicitly teach detection and analysis of fractionated electrograms). Ciaccio teaches a prior art atrial fibrillation detection method using a known technique that is applicable to the method of the combined reference, namely, the technique of detecting and processing fractionated electrograms in order to identify focal or reentrant circuits in the cardiac substrate. Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Ciaccio to the method of the combined reference would have yielded predictable results and resulted in an improved method, namely, a method that identifies focal or reentrant circuits in the cardiac substrate by detecting and processing fractionated electrograms.
Regarding claim 22, the combination teaches the method of claim 22 as described previously. Nayaran ‘614 further teaches further comprising determining by the processing system an optimal location for an ablation lesion in the cardiac tissue; and ablating the cardiac tissue at the optimal location (Fig. 11 and par. 0110: “As shown by the arrows in the example mappings 1106 (e.g., activation onsets 1108-1114), the electrical activity indicates a rotational activation pattern of activation onsets (rotor) in the heart rhythm disorder. At least a portion of the area of the heart 120 indicated by the rotational activation pattern indicated by the arrows in FIG. 11 can be treated to eliminate the cause of the heart rhythm disorder, and therefore the heart rhythm disorder itself. Such treatment may be delivered by ablation using various energy sources”).
Claim 18 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nayaran ‘614 in view of Goldreyer and de la Rama and further in view of Ryu (US Patent No. 8,010,186).
Nayaran ‘614 in view of Goldreyer and de la Rama teaches the method of claim 17 as described previously. The combined reference does not explicitly teach further comprising repeating the steps of obtaining, processing, creating, and applying until the ablation therapy minimizes or treats the fibrillation. However, Ryu teaches repeating the steps of detecting fibrillation and applying ablation until fibrillation is minimized or treated (Fig. 11 and col 12, lines 14-17: “Typically, this process of mapping, performing the cardiac cycle length variability analysis, and ablating will be repeated until the medical practitioner 32 is satisfied that the driver has been eliminated”). It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of the combined reference by repeating the steps of detection and treatment, as suggested by Ryu, in order to eliminate the fibrillation driver, as taught by Ryu.
Claims 23-24 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nayaran ‘614 in view of Goldreyer and de la Rama and further in view of Ghaffari et al. (US PGPub No. 2013/0274562), hereinafter Ghaffari.
Nayaran ‘614 in view of Goldreyer and de la Rama teaches the method of claim 20 as described previously. The combination does not explicitly teach wherein the two-dimensional array comprises a soft flexible planar material, or wherein the material can deform to a shape of the cardiac tissue. However, in the same field of endeavor, Ghaffari teaches placing sensing elements on a soft flexible planar material (par. 0235: “the sensing elements, can be disposed on a flexible substrate that is part of a patch, a bandage, or other substantially flat substrate”) that can deform to a shape of the cardiac tissue (par. 0222: “The low bending stiffness of the electronics described herein facilitate strong conformal contact to soft tissues (such as of the heart), without requiring pins or separate adhesives”), which allows for high density mapping and reduced electrical mapping times (par. 0222: “Accordingly, high density mapping within the atria is afforded and insights into the mechanisms underlying CFAEs are allowed, including analysis of rotors and wave fronts in persistent AF cases. The example implementations described herein may be used to detect the presence of AF mechanisms at significantly reduce electrical mapping times while decreasing safety risks and improving clinical outcomes during ablation procedures”). It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of the combined reference by using a soft flexible planar material that can deform to a shape of the cardiac tissue, as taught by Ghaffari, in order to allow for high density mapping and reduced electrical mapping times, as taught by Ghaffari.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794