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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9, 13, and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 9, the phrase “determining a maximum value of the local maximum from the number of times the node of the plurality of nodes is labeled as the local maximum” renders the claim indefinite. It is unclear what it means to determine a maximum value of “the local maximum from the number of times the node of the plurality of nodes is labeled as the local maximum”. As best understood by the specification, a maximum amplitude projection of a node is identified by determining a maximum local maximum value of labeled local maximum values of a node within an analysis time window. This is the interpretation that will be used for the examination of the claim.
Regarding claim 13, it is unclear what further limitation the claim provides to the claimed invention as the claim merely defines what a difference value represents (inward polarity vs outward polarity).
Regarding claim 14, the phrase “the neurological data” lacks proper antecedent basis. It is suggested that the phrase be amended to read “the neurological activity data” in order to properly refer back to the neurological activity data recited in claim 7.
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 1-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 7 follows.
Regarding claim 7, the claim recites a series of steps or acts, including receiving neurological activity data, and calculating at least one metric from the neurological activity data. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of calculating at least one metric comprising a maximum amplitude projection, a node visit frequency, a node transition frequency, a node transition polarity, or a combination thereof, from received neurological activity data sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. The calculation of the at least one metric does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the calculated at least one metric, nor does the method use a particular machine to perform the Abstract Idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites the additional step of receiving neurological activity data. Receiving data is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the receiving step is recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of an additional element such as the receiving step does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 1, the system recited in the claim is a generic system comprising generic components configured to perform the Abstract Idea. The claimed at least one processor and memory accessible to the at least one processor make up a computer system, wherein the computer system is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering, mental observations/evaluations of received data, and/or the display of data. The receiving and calculating steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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.
Claims 1-4, 7, 8, and 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Staljanssens et al. (Seizure Onset Zone Localization… – cited by Applicant).
It is noted that for the rejections of these claims, the copy of Staljanssens et al. provided by the Office will be referenced.
Regarding claim 7, Staljanssens et al. discloses a method, the method comprising: receiving neurological activity data (page 260 – Collection of Patient Data); and calculating a maximum amplitude projection from the neurological activity data (the description of Figure 4, beginning on page 261 and ending on page 265, discloses determining a source (i.e., a node) with the “highest power”; a “highest power” is analogous to a “maximum amplitude”).
Regarding claim 8, the neurological activity data comprises a three dimensional source localization (page 260 – Collection of Patient Data: “…each of these eight sources is represented by three time series, for the x, y and z direction.”; page 263 – EEG Source Imaging and Source Selection and Time Series).
Regarding claim 14, the method further comprises preprocessing the neurological activity data by: comparing values of the neurological activity data to a threshold value; based on the comparing, discarding or ignoring one or more of the values of the neurological activity data; and from remaining values of the neurological activity data, calculating at least one local maximum (page 263, EEG Preprocessing – values of the neurological activity data are compared to a threshold value (the limits of the bandpass filter); values below the lower limit of the bandpass filter and values above the upper limit of the bandpass filter are discarded; the remaining values of the neurological activity data are used to calculate the at least one local maximum).
Regarding claim 15, Figures 4g and 4h show that a graphical representation of the calculated maximum amplitude projection is provided on a display.
Regarding claim 16, Figure 4h shows that the graphical representation of the maximum amplitude projection comprises a node of a three dimensional source localization overlaid on an image of a brain.
Regarding claims 1, 3, and 4, the sections of Staljanssens et al. cited above inherently require a system, the system comprising: at least one processor; and a memory accessible to the at least one processor, the memory encoded with computer-readable instructions that when executed, cause the system to calculate the maximum amplitude projection from neurological activity data.
Regarding claim 2, the neurological activity data comprises electroencephalography (EEG) data (see ABSTRACT, and page 260 – Collection of Patient Data).
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.
Claims 5, 6, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Staljanssens et al., as applied to claims 1 and 7, in view of Krishna et al.’702 (US Pub No. 2015/0227702).
Regarding claims 5 and 21, Staljanssens et al. discloses all of the elements of the current invention, as discussed in paragraph 7 above, except for the system and method being configured to provide a report on a display, the report comprising a plurality of contents comprising one or more graphical representations of the maximum amplitude projection and further comprising a timeline of the neurological activity data, one or more statistics, one or more additional parameters, or a combination thereof.
Figure 2A of Krishna et al.’702 illustrates a display of an EEG analysis system, wherein a report is provided on the display, the report comprising one or more graphical representations of at least one metric and further comprising a timeline of acquired neurological activity data (sections [0019], [0021], [0076], [0084-0085], [0095-0096]). Krishna et al.’702 teaches that providing a report on a display with two or more graphical analysis results at the same time facilitates the making of a medical decision (section [0021]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system and method of Staljanssens et al. to include providing a timeline of the neurological activity data on the display along with the graphical representation of the maximum amplitude projection, as Krishna et al.’702 teaches that providing both graphical analysis results at the same time would help facilitate the making of a medical decision.
Regarding claim 6, Staljanssens et al. in view of Krishna et al.’702 discloses all of the elements of the current invention, as discussed above, except for the system further comprising an input device configured to receive a user input, wherein the user input indicates which ones of the plurality of contents are included in the report.
Krishna et al.’702 discloses a system comprising an input device configured to receive a user input, wherein the user input indicates which ones of a plurality of contents are included in a report (sections [0077-0078]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Staljanssens et al. in view of Krishna et al.’702 to include an input device configured to receive a user input, as taught by Krishna et al.’702, as it would allow a user of the system to choose which ones of the plurality of contents are included in the displayed report. The modification to Staljanssens et al. in view of Krishna et al.’702 would merely be combining prior art elements according to known methods to yield predictable results.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Staljanssens et al., as applied to claim 16, in view of Richard et al.’103 (US Pub No. 2020/0114103).
Regarding claim 17, Staljanssens et al. discloses all of the elements of the current invention, as discussed in paragraph 7 above, except for a size of the node being proportional to a value of the maximum amplitude projection.
Richard et al.’103 teaches providing a displayed element that is proportional in size to a value that the displayed element represents. Richard et al.’103 teaches providing such a displayed element in order to facilitate its interpretation or understanding by a user (sections [0143-0144]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Staljanssens et al. such that the size of the displayed node is proportional to a value of the maximum amplitude projection, as Richard et al.’103 teaches that this would help facilitate its interpretation or understanding.
Regarding claim 18, Staljanssens et al. discloses all of the elements of the current invention, as discussed in paragraph 7 above, except for a shade, a color, or a combination thereof of the node being indicative of a value of the maximum amplitude projection.
Richard et al.’103 teaches providing a displayed element in a color that is indicative of a value that the displayed element represents. Richard et al.’103 teaches providing such a displayed element in order to facilitate its interpretation or understanding by a user (sections [0143-0144]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Staljanssens et al. such that a color of the displayed node is indicative of a value of the maximum amplitude projection, as Richard et al.’103 teaches that this would help facilitate its interpretation or understanding.
Examiner’s Note
The following is a statement of reasons for the lack of prior art rejections against claims 9-13:
Regarding claim 9, none of the prior art discloses or suggests, either alone or in combination, a method wherein calculating a maximum amplitude projection of a node of a plurality of nodes comprises finding a number of times the node of the plurality of nodes is labeled as a local maximum within an analysis time window and determining a maximum value of the local maximum from the number of times the node of the plurality of nodes is labeled as the local maximum, in combination with the other claimed steps.
Regarding claim 10, none of the prior art discloses or suggests, either alone or in combination, a method wherein calculating a node visit frequency for a node of a plurality of nodes comprises counting a number of times the node of the plurality of nodes is labeled as a local maximum within an analysis time window and dividing the number of times by a duration of the analysis time window, in combination with the other claimed steps.
Regarding claim 11, none of the prior art discloses or suggests, either alone or in combination, a method wherein calculating a node transition frequency comprises counting a number of times a local maximum transitions between a first node and a second node of a plurality of nodes within an analysis time window and dividing the number of times by a duration of the analysis time window, in combination with the other claimed steps.
Regarding claims 12 and 13, none of the prior art discloses or suggests, either alone or in combination, a method wherein calculating a node transition polarity for a node of a plurality of nodes comprises counting a first number of times a local maximum transitioned to the node of the plurality of nodes from one or more nodes of the plurality of nodes, counting a second number of times the local maximum transitioned from the node of the plurality of nodes to one or more nodes of the plurality of nodes, and taking a difference of the first number of times and the second number of times, in combination with the other claimed steps.
Regarding claims 19 and 20, none of the prior art discloses or suggests, either alone or in combination, a method wherein a graphical representation further comprises a second node of a 3D source localization and an arrow between the node and the second node, wherein a direction of the arrow indicates a transition of a local maximum between the node and the second node, in combination with the other claimed steps.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Official notice is being taken that it is well known in the EEG signal analysis art to provide a graphical representation of a node of a three dimensional source localization overlaid on an image of a brain in order to provide information relating to the location within the brain from which EEG activity is being received (see, for example, section [0089] of Brown et al.’085 – US Pub No. 2019/0117085; sections [0037], [0072], [0131] of He et al.’482 – US Pub No. 2010/0049482; sections [0081], [0091-0092] of He et al.’408 – US Pub No. 2013/0096408; Figures 2 and 3 of Sohrabpour et al.’394 – US Pub No. 2018/0055394; [0045] of Nierenberg et al.’181 – US Pub No. 2021/0369181; and the INTRODUCTION of Ding et al. Spatio-temporal EEG Source Localization Using a Three-dimensional Subspace…). Shahaf et al.’569 (US Pub No. 2012/0296569) teaches a system and method for analyzing neurological activity data, wherein a graphical representation of a metric comprises a node of a three dimensional source localization overlaid on an image of a brain.
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791