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 1-15 are objected to because of the following informalities:
In regards to claim 1, the claim language “Method for characterization activation of…” should be changed to “A method for characterization activation of…”. Appropriate correction is required.
In regards to claims 2-15, the claim language “Method according to claim…” should be changed to “The method according to claim…”
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15, specifically independent claim 1 is directed to an abstract idea without significantly more. Please see the below analysis providing the details as to why the invention is directed towards non-statutory subject matter.
Step 1:
Claim 1 is directed to a method, a statutory category of invention.
Step 2A, Prong 1:
Claim 1 recites the method steps of:
“…acquiring an activation signal representative of an electrical activity…”
“…acquiring consecutive images of the anatomical tissue…”
“…determining an activity signal representative of a mechanical activity…”
“…dividing the activation time period in a plurality of elementary time windows…”
“…determining a dominant frequency in each elementary time window
“…and identifying a peak of dominant frequency…”
The limitations, under the broadest reasonable interpretation, falls within the mental processes (i.e. acquiring, determining, and identifying) and mathematical concepts (i.e. dividing). It would be practical to perform the method steps in a human’s mind, or with a pen and paper, to utilize the claimed signals.
Step 2A, Prong 2:
Claim 1 does not recite any additional elements that would integrate the abstract idea into a practical application.
Step 2B:
The claims as a whole fails to recite an inventive concept. The additional elements, when considered individually and in combination, do not recite significantly more than the abstract idea for the reasons as set forth above in Step 2A, Prong 2. Upon re-evaluating the limitation that was previously identified as insignificant extra-solution activity in Step 2A, Prong 2, the following evidence to show that the limitation is well-understood, routine and conventional:
The examiner further notes that the dependent claims 2-15 define steps determining a contraction timing corresponding to a pixel, identifying the peak of dominant frequency, determining elementary time window, acquiring images, refining the activation time period, which further limits the claim limitations already indicated above as directed to an abstract idea. Therefore, the above claims are directed to patient-ineligible subject matter.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6 & 8-13 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Konofagou et al. (US 2020/0163646).
Konofagou et al. discloses,
1.
Method for characterizing activation of an anatomical tissue subjected to contraction, the method comprising: acquiring an activation signal representative of an electrical activity of the anatomical tissue with respect to time,
E.G. ([0073] & [0102]).
and determining an activation time period including a single electrical pulse corresponding to the contraction.
E.G. [0053].
in synchronization with acquisition of the activation signal, acquiring consecutive images of the anatomical tissue at a high cadence over the activation time period, and segmenting each image of the anatomical tissue in a plurality of pixels
E.G. via the disclosed illustration(s) as defined by a high frame rate acquisition ([0073] & [0101]-[0102]).
for each pixel, determining an activity signal representative of a mechanical activity of the pixel with respect to time between consecutive images over the activation time period,
E.G. via the disclosed estimated axial electromechanical strains which can be used to determine two or more images of the heart acquired at one or more pixel locations ([0088] & [0094]).
for each pixel, dividing the activation time period in a plurality of elementary time windows, calculating a spectral content of the activity signal in each elementary time window,
E.G. ([0088], [0095] & [0106]).
determining a dominant frequency in each elementary time window and identifying a peak of dominant frequency in the activation time period, the peak of dominant frequency characterizing the contraction.
E.G. via the disclosed application of a FFT to the estimated incremental strain curves ([0088] & [0106]).
2.
Method according to claim 1, further comprising: for each pixel, determining a contraction timing corresponding to a pixel peak time at which the peak of dominant frequency occurs from an initial time of the activation time period,
E.G. via the disclosed estimation of the period of activation based on the electromechanical signal that display correlated mechanical and electrical cycle lengths and propagation patterns ([0094]-[0095] & [0106]).
displaying a pattern of contraction by attributing a display parameter to the contraction timing of each pixel.
E.G. via the disclosed electromechanical activation propagation patterns that reveal characteristics of certain arrhythmias which are shown as illustrations via an image processor ([0061] & [0095]).
3.
Method according claim 1, wherein identifying the peak of dominant frequency in the activation time period comprises: determining a tissue peak time at which peaks of dominant frequency are reached in a largest number of pixels comprised in the tissue,
refining the activation time period with respect to the tissue peak time,
and defining the peak of dominant frequency for each pixel as a first local maximum of dominant frequency within the refined activation time period.
E.G. via the disclosed image processor being able to measure a peak frequency of the image data for each of the pixel locations and determine a peak cycle length from each peak frequency via the further use of FFT ([0013] & [0106]-[0107]).
4.
Method according to claim 3, wherein refining the activation time period comprises beginning the activation time period at a time interval before the tissue peak time.
E.G. ([0013] & [0106]-[0107]).
5.
Method according to claim 1, wherein determining the activity signal comprises measuring a mechanical parameter representative of the mechanical activity of each pixel on the each consecutive images.
E.G. via the disclosed use of a cycle length parameter that can measure the electromechanical activation rate during treatment [0106].
6.
Method according to claim 5, wherein the mechanical parameter is chosen among a displacement of the pixel and a strain of the pixel.
E.G. [0106].
8.
Method according to claim 1, wherein calculating the spectral content of the activity signal in each elementary time window is performed by implementing Short Time Fourier transform.
E.G. [0106].
9.
Method according to claim 1, wherein acquiring images is performed by ultrasound modality, images of a plane in tissue thickness being acquired.
E.G. via the disclosed ultrasound-based, electromechanical activation mapping ([0050] & [0061]).
10.
Method according to claim 9, wherein the ultrasound modality is implemented in electromechanical wave imaging.
E.G. ([0050] & [0061]).
11.
Method according to claim 9, wherein acquiring images is performed by an intracorporeal ultrasound configured to emit an ultrasound signal and to receive echoes of a reflected signal.
E.G. via ([0050] & [0061]).
12.
The method according to claim 1, wherein the anatomical tissue is cardiac tissue.
E.G. via the disclosed systems/methods for mapping behavior of electromechanical systems of a heart ([0006]-[0007]).
13.
Method according to claim 12, wherein refining the activation time period comprises beginning the activation time period at a time interval corresponding to a duration of isovolumetric contraction of the cardiac tissue.
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, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 7 & 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Konofagou et al. (US 2020/0163646) in view of one having ordinary skill in the art.
Konofagou et al. discloses the claimed invention having acquiring consecutive images of anatomical tissue at a high cadence over the activation time period via the disclosed illustration(s) as defined by a high frame rate acquisition ([0073] & [0101]-[0102]) except wherein high cadence is a specific N images per second a the activation time period Ta divided in successive elementary time windows defined by specific parameters. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the high cadency and successive elementary time windows shifted at specific parameters, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
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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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796