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
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 1 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of prior U.S. Patent No. U.S. 11,974,854. This is a statutory double patenting rejection.
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) 1-11 & 17-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dubois et al. (US 2018/0325400).
Dubois et al. discloses;
1.
A method for cardiac mapping of a patient comprising: positioning a two-dimensional electrode array at a location in a patient's heart, wherein the two-dimensional electrode array comprises a plurality of electrodes arranged in a nonlinear configuration distributed across the array at known locations and each electrode is separated by a known distance;
E.G. via the disclosed method 10 utilizing measured electrical activity across a surface of a patient’s body via a sensor array 164, i.e. a plurality of electrodes, at step 12, in order to measure said electrical activity across the entire thorax of the patient, providing a two-dimensional surface of interest {[0006], [0024], [0080]-[0082] & (Figs. 1 & 4)}.
simultaneously detecting at least one local activation signal and activation time at each electrode of the array; and calculating a conduction velocity (CV) vector for a first electrode of the array using the activation time of the first electrode, the activation time of a second electrode, and the activation time of at least a third electrode; thereby to construct a map of cardiac electrical activity
E.G. via the disclosed measured electrical activity being reconstructed, at step 14, in order to represent said activity into electrical data representing the time-varying electrical potential estimated at each node, i.e. location of the plurality of electrodes, which is further used to calculate and generate a conduction velocity map, as defined by steps 16 and 18 {[0033]-[0036] & (Fig 1)}.
*Note that the examiner is interpreting the disclosed electrical potential at each node, wherein each node is represented by the plurality of electrodes used to measure electrical activity across the thorax of a patient, as being the activation times of the first, second and third electrodes.
2.
The method of claim 1, wherein calculating further comprises: determining the activation time of the local activation signal for the first electrode, the second electrode, and the third electrode;
E.G. via step 16 for each node which is utilized by method 50 {[0035], [0044] & (Fig 1)}.
obtaining the difference between the activation time of the first electrode and the second electrode, between the activation time of the second electrode and the third electrode, and the first electrode and the third electrode; obtaining the respective distances between each of the first, second, and third electrodes;
calculating a velocity vector between each of the first, second, and third electrode; and combining the velocity vectors.
E.G. {[0060]-[0065] & (Fig. 3)}.
3.
The method of claim 1, wherein a CV vector is determined with respect to a group of electrodes of the array using the activation time of a first electrode and the activation times of at least two adjacent electrodes.
E.G. via the disclosed calculation of the CV based on the spatial regions of interest (ROI) and the further computation orthogonal projection of ROIs, i.e. step 54-56, {[0051]-[0052] & (Fig 2)}.
4.
The method of claim 3, further comprising compiling an isochronal activation map comprising the two-dimensional electrode array and the CV vector for each group of electrodes.
E.G. via the disclosed step of determining the 2D local velocity vector for the ROI [0053].
5.
The method of claim 4, further comprising mapping the trajectory of a cardiac activation wave based on the CV vectors for adjacent electrodes of the two-dimensional electrode array.
E.G. ([0053]-[0054]).
6.
The method of claim 5, further comprising detecting a conduction block and calculating the CV vector for each electrode of the array to exclude the vector associated with conduction block.
E.G. {[0060]-[0065] & (Fig. 3)}.
7.
The method of claim 6, wherein the step of detecting a conduction block comprises determining that the activation times between two or more adjacent electrodes are below a threshold indicative of direct propagation of the cardiac activation wave between the two or more adjacent electrodes.
E.G. {[0060]-[0065] & (Fig. 3)}.
8.
The method of claim 7, wherein said threshold is adjusted based on a direction of a propagation vector with respect to a putative site of conduction block.
E.G. {[0060]-[0065] & (Fig. 3)}.
9.
The method of claim 4, further comprising calculating the spatial context for each local activation signal of each electrode of the two-dimensional array.
E.G. [0053].
10.
The method of claim 9, wherein calculating the spatial context comprises constructing a directed graph connecting adjacent electrodes having closely related activation times to identify clusters of spatio-temporally related activations.
E.G. via the disclosed GUI that output the graphical maps associated with the visual EP information of the activation time maps 250 (Figs. 5-11).
11.
The method of claim 10, further comprising determining a single contiguous cardiac activation wave for each cluster of spatio-temporally related activations.
E.G. via the disclosed GUI displaying a direction map 209 showing the propagation pattern direction across the heart surface {[0099]-[0105] & (Figs. 5-11)}.
17.
The method of claim 4, further comprising calculating the temporal context for each local activation signal of each electrode of the two-dimensional array.
E.G. [0053].
18.
The method of claim 17, wherein calculating the temporal context comprises detecting a plurality of local activation signals at one or more electrodes of the two-dimensional array and determining whether the activation times for each of the plurality of local activation signals for each of the one or more electrodes fall within a single refractory period.
E.G. ([0051]-[0053]).
19.
The method of claim 1, further comprising calculating the spatial context and temporal context for each local activation signal of each electrode of the two-dimensional array.
E.G. ([0051]-[0053]).
20.
The method of claim 19, wherein data is collected over multiple waves and aggregated.
E.G. ([0051]-[0053]).
21.
The method of claim 20, wherein the aggregated data reveals substrate-mediated patterns of conduction.
E.G. see (Figs. 5-11)
22.
A method for cardiac mapping comprising the steps of simultaneously obtaining electrode data from an array of at least three electrodes; calculating a conduction velocity vector for a first electrode of the array using the activation time of the first electrode, the activation time of a second electrode, and the activation time of at least a third electrode;
E.G. via the disclosed method 10 that utilizes measured electrical activity being reconstructed, at step 14, in order to represent said activity into electrical data representing the time-varying electrical potential estimated at each node, i.e. location of the plurality of electrodes, which is further used to calculate and generate a conduction velocity map, as defined by steps 16 and 18 {[0033]-[0036] & (Fig 1)}.
*Note that the examiner is interpreting the disclosed electrical potential at each node, wherein each node is represented by the plurality of electrodes used to measure electrical activity across the thorax of a patient, as being the activation times of the first, second and third electrodes.
thereby to construct a map of cardiac electrical activity; wherein characteristics of said map are unaffected by cardiac or respiratory motion.
E.G. via the disclosed measured electrical activity being reconstructed, at step 14, in order to represent said activity into electrical data representing the time-varying electrical potential estimated at each node, i.e. location of the plurality of electrodes, which is further used to calculate and generate a conduction velocity map, as defined by steps 16 and 18 {[0033]-[0036] & (Fig 1)}.
*The examiner notes that it is inherently understood that the disclosed method, provides electrical data representing the time-varying electrical potential estimated at each node, i.e. location of the plurality of electrodes, provides the claimed ‘unaffected’ characteristics of the generated map. The examiner also notes that the claim does not provide an explicit step to provide the claimed characteristics, i.e. nothing within the claim provides how one would prevent and/or guarantee that said characteristics would be “unaffected” by cardiac/respiratory motion.
Allowable Subject Matter
Claims 12-16 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 NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
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