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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07 November 2025 has been entered.
This is a response to Applicant’s amendment filed on 07 November 2025, wherein:
Claims 1-3 and 18 are amended.
Claims 4-7 and 9-15 are original.
Claims 16 and 19 are previously presented.
Claims 8, 17, and 20 are canceled.
Claims 1-7, 9-16, 18, and 19 are pending.
Claim Objections
Claims 1-7, 9-16, 18, and 19 are objected to because of the following informalities:
Amended claims 1-3 and 18 include multiple amendments that are improperly marked. 37 CFR 1.121 which requires all amendments to be appropriately marked. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived (e.g., deletion of the number "4" must be shown as [[4]]). As an alternative to using double brackets, however, extra portions of text may be included before and after text being deleted, all in strike-through, followed by including and underlining the extra text with the desired change (e.g., number 14 as). See MPEP 714. It is particularly noted that it appears that Applicant is attempting to add or remove singular elements in some of these amendments without following these examples causing these amendments to be particularly difficult to perceive.
It is unclear what meaning is imparted in claim 1 with the addition of the term “and” to the end of limitation (g). Conventional practice is to only place the term “and” in this manner at the end of the second-to-last limitation to indicate that the subsequent limitation is the last.
Similar to claim 1, claim 16 includes the term “and” at the end of the first limitation. However, this term should be at the end of the second-to-last limitation, not the end of the first limitation.
Dependent claims 2-7, 9-16, 18, and 19 inherit the deficiencies of their respective parent claims, and are thus objected to under the same rationale.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code 112(b) not included in this action can be found in a prior Office action.
Claims 1-7, 9-16, 18, and 19 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.
Claim 1 has been amended to include four “wherein” limitations at the end of the claim. Given how these limitations are formatted with the rest of the claim (including the unconventional use of the term “and” as identified in the objection above), it is unclear how these limitations further limitation the claim. For instance, they all follow step (h), yet it is unclear if these “wherein” limitations only apply to (1) step (h), (2) all of the steps, (3) each preceding “wherein” limitation, or (4) certain other steps. Thus, one of ordinary skill in the art would not be apprised of the metes and bounds of the patent protection sought. Dependent claims 2-7, 9-16, 18, and 19 inherit the deficiencies of their respective parent claims, and are thus rejected under the same rationale.
Further regarding claim 1, it is unclear what constitutes “wherein the digital measures comprise all of: time when a patient interacts with each character; latency between each interaction; accuracy of interactions; orientation of the user’s stylus; and pressure applied to the electronic screen by the user.” In particular, it is unclear whether time when a patient interacts with each character, latency between each interaction, accuracy of interactions, orientation of the user’s stylus, and pressure applied to the electronic screen by the user are each, separately, a digital measure or whether each digital measure includes all of these metrics. The disclosure does not aid understanding because the only metrics that are explicitly identified as digital measures are “the time to circle each character and the latency between characters circled.” See para. 20 of the specification. Thus, one of ordinary skill in the art would not be apprised of the metes and bounds of the patent protection sought. For the purposes of compact prosecution, each of these metrics is considered as a separate digital measure. Dependent claims 2-7, 9-16, 18, and 19 inherit the deficiencies of their respective parent claims, and are thus rejected under the same rationale.
Regarding claim 18, it is unclear what constitutes “wherein the digital measures comprise all of: correct response; commissions; percent drawing time; percent not drawing time; total distance; mean inter-response latency; mean touch; and epoch measures.” In particular, it is unclear whether correct response, commissions, percent drawing time, percent not drawing time, total distance, mean inter-response latency, mean touch, and epoch measures are each, separately, a digital measure or whether each digital measure includes all of these metrics. The disclosure does not aid understanding because the only metrics that are explicitly identified as digital measures are “the time to circle each character and the latency between characters circled.” See para. 20 of the specification. In other words, none of the claimed metrics are identified in the disclosure as digital measures. Thus, one of ordinary skill in the art would not be apprised of the metes and bounds of the patent protection sought. For the purposes of compact prosecution, each of these metrics is considered as a separate digital measure.
The text of those sections of Title 35, U.S. Code 112(a) not included in this action can be found in a prior Office action.
Claims 1-7, 9-16, 18, and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1-3, 17, and 18, the originally filed disclosure is silent regarding the newly added limitation “(h) analyzing the digital measures to generate the neurocognitive score” in claim 1, “wherein the digital measures in step (g) includes time to circle each character for each of the first input, the second input, and the third input” in claim 2, “wherein the digital measures in step (g) further includes latency between characters circled for each of the first input, the second input, and the third input” in claim 3, and “wherein the digital measures comprises all of: correct response; commissions; percent drawing time; percent not drawing time; total distance; mean inter-response latency; mean touch; and epoch measures” in claim 18 to show one of ordinary skill in the art that Applicant had possession of the claimed invention. Claims lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See MPEP 2161.01(I). The disclosure is particularly silent regarding “generating a neurocognitive score” as well as silent regarding any meaningful description for analyzing the claimed digital measures. See, for example, at least para. 29 of the specification which merely recites examples of “information, measurements, and/or data collected from each test/display”. The only metrics that are explicitly identified in the disclosure as digital measures are “the time to circle each character and the latency between characters circled.” See para. 20 of the specification. Thus, this is new matter. Dependent claims 2-7, 9-16, 18, and 19 inherit the deficiencies of their respective parent claims, and are thus rejected under the same rationale.
Claim Rejections - 35 USC § 101
The text of those sections of Title 35, U.S. Code 101 not included in this action can be found in a prior Office action.
Claims 1-7, 9-16, 18, and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without including additional elements that are sufficient to amount to significantly more than the judicial exception itself.
Step 1
The instant claims are directed to a method and a product which falls under the four statutory categories (STEP 1: YES).
Step 2A, Prong 1
Independent claim 1 recites:
A computer-implemented method of generating a neurocognitive score, comprising:
(a) providing a first display on an electronic screen, the first display including:
a first plurality of characters, the first plurality of characters including a designated first target character; and
a first test instruction to a user to select the first target character;
(b) receiving a first input from the user on the electronic screen;
(c) providing a second display on the electronic screen, the second display including:
a second plurality of characters, the second plurality of characters including a designated second target character; and
a second test instruction to the user to select the second target character;
(d) receiving a second input from the user on the electronic screen;
(e) providing a third display on the electronic screen, the third display including:
a third plurality of characters, the third plurality of characters including a designated third target character and a designated fourth target character; and
a third test instruction to the user to select the third target character and the fourth target character in alternation;
(f) receiving a third input from the user on the electronic screen;
(g) extracting digital measures from the first input, the second input, and the third input; and;
(h) analyzing the digital measures to generate the neurocognitive score;
wherein each of the digital measures is calculated for at least one 30 second time epoch;
wherein a complexity of the second test is greater than a complexity of the first test;
wherein a complexity of the third test is greater than a complexity of the second test; and
wherein the digital measures comprises all of:
time when a patient interacts with each character;
latency between each interaction;
accuracy of interactions;
orientation of the user’s stylus; and
pressure applied to the electronic screen by the user.
All of the foregoing underlined elements, identified above, amount to the abstract idea grouping of a certain method of organizing human activity because they amount to managing personal behavior or interactions between people (including social activities, teaching, and following rules or instructions) as they merely describe providing a test to an individual, assessing the individual’s performance on the test, and generating a report which is merely collecting information, analyzing the information, and outputting the results of the collection and analysis. This collection, analysis, and outputting the results of the collection and analysis amounts to the abstract idea grouping of mental processes as the claims, under their broadest reasonable interpretation, cover performance of the limitations in the mind (including observation, evaluation, judgment, opinion) with the aid of pen and paper but for the recitation of generic computer components. See MPEP 2106.04(a)(2)(III)(C) - A Claim That Requires a Computer May Still Recite a Mental Process.
The dependent claims amount to merely further defining the judicial exception.
Therefore, the claims recite a judicial exception. (STEP 2A, PRONG 1: YES).
Step 2A, Prong 2
This judicial exception is not integrated into a practical application because the independent and dependent claims do not include additional elements that are sufficient to integrate the exception into a practical application under the considerations set forth in MPEP 2106.04(d). The elements of the claims above that are not underlined constitute additional elements.
The following additional elements, both individually and as a whole, merely generally link the judicial exception to a particular technological environment or field of use: reciting the method as “computer-implemented” (claim 1), an electronic screen (claim 1), reciting a measure as “digital” (claim 1), a device (claim 16), a tablet computer (claim 16), a screen (claim 16), a processing unit (claim 16). Although the claims recite computer components for performing at least some of the recited functions, these elements are recited at a high level of generality for performing their basic computer functions. This is evidenced by at least Fig. 2 which illustrates the components as non-descript black boxes or stock images and Fig. 1A-1C and 3 which illustrate the claimed invention as a process implemented as a software application. Further evidence is provided by the specification. See, for example, at least para. 20, 21, 26-30, and 43-45 of the published specification which identify that the structural elements are ancillary to the claimed invention. Thus, the judicial exception is not implemented with, or used in, a particular machine or manufacture. Additionally, the method claims are silent regarding any additional elements actively performing the claimed functions indicating that the entire method is performed by a human, including a human operating the recited additional elements. The claims, both individually and as a whole, do not recite any limitations that improve the functionality of the computer system because the claimed receiving and analyzing steps are merely performing the steps of processing data. Furthermore, the computer components are merely an attempt to link the abstract idea to a particular technological environment, but do not result in an improvement to the technology or computer functions employed. Again, this is evidenced by the manner in which these components are disclosed. It should be noted that because the courts have made it clear that the mere physicality or tangibility of an additional element or elements is not a relevant consideration in the eligibility analysis, the physical nature of the computing device and associated hardware does not affect this analysis. See MPEP 2106.05(I) for more information on this point, including explanations from judicial decisions including Alice Corp. Pty Ltd. v. CLS Bank Int’l, 573 US 208, 224-26 (2014). The claims do not recite any specific rules with specific characteristics that improve the functionality of the computer system. For example, the claimed performance of steps is wholly encompassed by the judicial exception as identified in Step 2A, Prong 1 above, as they merely amount to collecting information, analyzing the information, and outputting the results of the collection and analysis. This further identifies that none of the hardware offer a meaningful limitation beyond generally linking the performance of the steps to a particular technological environment, that is, implementation via computers. The claims do not apply or use a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. For example, the disclosure identifies that the claimed invention is for detecting cognitive conditions, while the claims and disclosure are silent regarding any treatment for a disease or medical condition, let alone a particular treatment for a particular disease or medical condition. Accordingly, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, the claim is directed to a judicial exception. (STEP 2A, PRONG 2: NO).
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception under the considerations set forth in MPEP 2106.05. As identified in Step 2A, Prong 2, the claims do not provide a particular machine or improvement thereof, nor effect a particular treatment. Also, as addressed in Step 2A, Prong 2, above, the process does not require the use of a particular machine, nor does it result in the transformation of an article. In particular, the method as claimed can be construed as performed entirely by a human. The claims do not involve an improvement in a computer or other technology. This is at least evidenced by the manner in which this is disclosed that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 USC 112(a) as identified in Step 2A, Prong 2, above. Thus, the judicial exception is not implemented with, or used in, a particular machine or manufacture. Furthermore, this also evidences that the components are an attempt to link the abstract idea to a particular technological environment, but do not result in an improvement to the technology or computer functions employed. The lack of improvement to the computer or other technology is also evidenced by the lack of incorporation of specific rules which enable the automation of a computer-implemented task that previously could only be performed subjectively by humans. In particular, the claimed invention is a series of cancellation tests, which is, in and of itself, not an additional element nor new to cancellation test assessment, contrary to assertions made in the specification (see, for example, at least para. 5). For example, the cited prior art identify that measuring latency was known and measured well before the effective filing date of the claimed invention. In particular, this also evidences that using a computer to measure latency while implementing a cancellation test, as claimed and organized, merely adds insignificant extrasolution data gathering activity to the judicial exception. Thus, the focus of the claimed invention is on the analysis of the collected data, which is itself at best merely an improvement within the abstract idea. See pg. 2-3 in SAP America Inc. v. lnvestpic, LLC (890 F.3d 1016, 126 USPQ2d 1638 (Fed. Cir. 2018) which proffered “[w]e may assume that the techniques claimed are groundbreaking, innovative, or even brilliant, but that is not enough for eligibility. Nor is it enough for subject-matter eligibility that claimed techniques be novel and nonobvious in light of prior art, passing muster under 35 U.S.C. §§ 102 and 103. The claims here are ineligible because their innovation is an innovation in ineligible subject matter. Their subject is nothing but a series of mathematical calculations based on selected information and the presentation of the results of those calculations. Furthermore, the steps are merely recited to be performed by, or using, the elements while the specification makes clear that the computerized system itself is ancillary to the claimed invention as identified above. This further identifies that none of the hardware offer a meaningful limitation beyond, at best, generally linking the performance of the steps to a particular technological environment, that is, implementation via computers. Viewed as a whole, the additional claim elements do not provide a meaningful limitation to transform the abstract idea into a patent eligible application of the abstract idea such that the claim amounts to significantly more than the abstract idea of itself (STEP 2B: NO).
Therefore, the claims are ineligible under 35 USC 101 because they are directed to judicial exceptions (abstract ideas), and the claims as a whole do not integrate the exceptions into a practical application or amount to significantly more than the exceptions.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code 103 not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-7, 9-16, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Alberts et al. (US 2012/0330182, hereinafter referred to as Alberts) in view of Graham et al. (US 2016/0120437, hereinafter referred to as Graham).
Regarding claim 1, Alberts teaches a computer-implemented method for generating a neurocognitive score, comprising:
(a) providing a first display on an electronic screen (Alberts, para. 99, “a user takes one or more tests”), the first display including:
a first plurality of characters, the first plurality of characters including a designated first target character (Alberts, para. 134, “The GUI 182 presents a plurality of targets positioned in a display area according to application data determined by a corresponding test application. In the examples of FIGS. 18 and 19, the targets are circles, each of which defines a bounded region having a corresponding set of coordinates. In the display GUI 182, a portion of the targets indicated at 184, have letters ranging consecutively from A through H and another corresponding portion of the targets, indicated at 186, have numbers ranging consecutively from 1 through 13.”); and
a first test instruction to a user to select the first target character (Alberts, para. 86, “The test application 26, 28 can provide instructions requesting the user to position the cursor/object or draw lines between two or more particular targets. The movement of the cursor on the screen relative to the known position of each of the targets (corresponding to the test data 30 to 32) can be analyzed by the analysis engine 16.”);
(b) receiving a first input from the user on the electronic screen (Alberts, para. 88, “For example, the motor calculator 34 can be programmed to determine a position of the cursor or pointer device, a velocity, an acceleration, a speed and/or a tangential acceleration for each sample of test data acquired during a test interval. For example, the tangential acceleration may be used by the analysis engine 16 as an indication of degree of curvature in user movements.” Para. 135, “FIG.19 shows an example outcome of a test in which a user has used a cursor having a position that can be tracked via the corresponding API. The system is configured to dynamically render a graphical depiction of a line onto the display GUI 182 in response to movements of the cursor, for example, via a corresponding pointing element, such as a mouse, stylus or touch screen. Information associated with the position and times associated with the positions, representing times for each of the movements, can be recorded for subsequent analysis and evaluation as described herein.”);
(c) providing a second display on the electronic screen (Alberts, para. 99, “a user takes one or more tests”), the second display including:
a second plurality of characters, the second plurality of characters including a designated second target character (Alberts, para. 134, “In the display GUI 182, a portion of the targets, indicated at 184, have letters ranging consecutively from A through H and another corresponding portion of the targets, indicated at 186, have numbers ranging consecutively from 1 through 13. Those skilled in the art will understand that the test engine can be programmed to automatically generate any arrangement of targets consistent with the format of the trail making test (Part B), which arrangement may be part of the test data provided to the analysis engine 16."); and
a second test instruction to the user to select the second target character (Alberts, para. 133, “FIG. 17 depicts an example of an instruction GUI 180 that can be provided for instructing a user for a trail making test (Part B) test such as shown in FIGS. 18 and 19, for testing cognitive and/or motor skill.");
(d) receiving a second input from the user on the electronic screen (Alberts, para. 88, “For example, the motor calculator 34 can be programmed to determine a position of the cursor or pointer device, a velocity, an acceleration, a speed and/or a tangential acceleration for each sample of test data acquired during a test interval. For example, the tangential acceleration may be used by the analysis engine 16 as an indication of degree of curvature in user movements.” Para. 135, “FIG.19 shows an example outcome of a test in which a user has used a cursor having a position that can be tracked via the corresponding API. The system is configured to dynamically render a graphical depiction of a line onto the display GUI 182 in response to movements of the cursor, for example, via a corresponding pointing element, such as a mouse, stylus or touch screen. Information associated with the position and times associated with the positions, representing times for each of the movements, can be recorded for subsequent analysis and evaluation as described herein.”);
(e) providing a third display on the electronic screen (Alberts, para. 99, “a user takes one or more tests”), the third display including:
a third plurality of characters, the third plurality of characters including a designated third target character and a designated fourth target character (Alberts, para. 129, “In the example of FIGS. 15 and 16, the targets are numbered from 1 to 24 and the user (as instructed by the instruction GUI 168 of FIG. 14) is to connect the targets in a sequential order. The test engine can populate the display area for the GUI 170 in a pseudo random fashion such that each of the sequential targets can be interconnected by an ideal straight line without crossing a line interconnecting any other sequential targets."); and
a third test instruction to the user to select the third target character and the fourth target character in alternation (Alberts, para. 135, “For instance, the instructions (e.g., via the instruction GUI 180 of FIG. 17) specify that a user-patient is to alternate between consecutive sequential letters and numbers by connecting respective targets with straight lines, similar to what is shown in FIG. 19 up to letter E, beginning with the lowest number to the lowest letter, to the second lowest number, to the second highest letter, etc. Thus, FIG. 19 shows an example outcome of a test in which a user has used a cursor having a position that can be tracked via the corresponding API.");
(f) receiving a third input from the user on the electronic screen (Alberts, para. 86, “A user can position on the display a cursor or other graphical object having its own object position in two-dimensional space (e.g., having X and Y coordinates), for example, using a pointing device, such as a mouse or stylus for touch screen, or without a pointing device, such as via a finger on a touch screen. The test application 26, 28 can provide instructions requesting the user to position the cursor/object or draw lines between two or more particular targets. The movement of the cursor on the screen relative to the known position of each of the targets (corresponding to the test data 30 to 32) can be analyzed by the analysis engine 16.");
(g) extracting digital measures from the first input, the second input, and the third input (Alberts, at least para. 87-95 describe various digital measures that are extracted from the inputs.); and
(h) analyzing the digital measures to generate the neurocognitive score (Alberts, para. 96, “the analysis engine 16 can output results of calculations to provide corresponding analysis data 36. Thus, the analysis data 36 can include results data based upon the methods and calculations performed by the motor calculator 34 and/or the cognitive calculator 38 based on test data 30 to 32 acquired for each of the respective test applications.” Para. 97, “the index calculator 40 can compute an index (or score) having a value indicative of cognitive function for a patient based upon the set of test data.”);
wherein a complexity of the second test is greater than a complexity of the first test (Alberts, para. 100, “In an example embodiment, the change in test difficulty may be implemented by re-administering the same type of test as a previously administered test, with changes to the target accuracy and distances and thus chances in the difficulty level of the re-administered test.” Para. 101, “In an alternative example embodiment, the change in test difficulty may be implemented by selecting a different type of test, which test type is ranked at a different difficulty level than that of a previously administered test.”);
wherein a complexity of the third test is greater than a complexity of the second test (Alberts, para. 100, “In an example embodiment, the change in test difficulty may be implemented by re-administering the same type of test as a previously administered test, with changes to the target accuracy and distances and thus chances in the difficulty level of the re-administered test.” Para. 101, “In an alternative example embodiment, the change in test difficulty may be implemented by selecting a different type of test, which test type is ranked at a different difficulty level than that of a previously administered test.”); and
wherein the digital measures comprise all of:
time when a patient interacts with each character (Alberts, para. 10, “recording time information for each of a plurality of positions between start and end positions”);
latency between each interaction (Alberts, para. 135, “times for each of the movements”);
accuracy of interactions (Alberts, para. 89, “accuracy of lines drawn”);
While Alberts teaches measuring “position information responsive to movement of a pointer device (e.g., a mouse or stylus or a touch screen that responds to a user’s touch) performed by a user” (see Alberts at para. 12), Alberts does not explicitly teach orientation of the user’s stylus; and pressure applied to the electronic screen by the user.
However, in a related art, Graham teaches orientation of the user’s stylus (Graham, para. 103, “the orientation of the stylus relative to the touch panel may be determined (e.g. via one or more sensors such as gyroscopic sensors, accelerometers, and/or fiducial markers that are detectable by a navigation system)”; and pressure applied to the electronic screen by the user (Graham, para. 87, “the touch panel itself may include force sensors, such that it is configured to record the applied force (such as via a pressure sensitive array), such that the input can be provided by an instrument (e.g. a stylus) or directly by finger.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention for Alberts to incorporate the stylus orientation and pressure measurements of Graham because it allows for the thickness of a rendered line during contact to be dependent on the angle of the stylus “thus mimicking the real-world behaviour of a pencil or pen having a tip with a finite extension.” See Graham at para. 103.
Alberts does not explicitly teach wherein each of the digital measures is calculated for at least one 30 second epoch.
However these differences are only found in the nonfunctional descriptive material and are not functionally involved in the steps recited. The method would be performed the same regardless of how long the epoch is since the cancellation test would be performed the same regardless of epoch length. Thus, this descriptive material will not distinguish the claimed invention from the prior art in terms of patentability, see In re Gulack, 703 F.2d 1381, 1385, 217 USPQ 401, 404 (Fed. Cir. 1983); In re Lowry, 32 F.3d 1579, 32 USPQ2d 1031 (Fed. Cir. 1994).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention for Alberts to include wherein each of the digital measures is calculated for at least one 30 second epoch because setting the epoch for 30 seconds is merely a design choice that does not functionally relate to the steps claimed and has not been disclosed to solve any stated problem or is for any particular purpose which does not patentably distinguish the claimed invention.
Regarding claim 2, Alberts in view of Graham teaches the computer-implemented method of claim 1, wherein the digital measures in step (g) includes time to circle each character for each of the first input, the second input, and the third input (Alberts, para. 85, “For example, the test application 26 to 28 can employ a get_cursor_pos( ) or other Application Programming Interface (API) to monitor and obtain cursor position information that is stored along with temporal information, such as the times corresponding to the obtained cursor positions, as the test data 30 to 32. The sampling of such data may be at a rate of, for example, 30 Hz." Para. 93, "The above is not intended as an exhaustive list of calculations which the motor calculator 34 may perform, and other example embodiments provide for calculation of additional or alternative variables and parameters based on-the acquired test data 30 to 32 that is sampled over time. The results of the calculations determined by the motor calculator 34 can be stored as part of analysis data 36." Para. 128, "FIG. 14 depicts an example of another instruction GUI 168 that can be presented to a user fen providing instructions for performing a third test, including such as shown and described with respect to FIGS. 15 and 16." Para. 134, "In the examples of FIGS. 18 and 19, the targets are circles, each of which defines a bounded region having a corresponding set of coordinates.").
Regarding claim 3, Alberts teaches the computer-implemented method of claim 2, wherein the digital measures in step (g) further includes measuring latency between characters circled for each of the first input, the second input, and the third input (Alberts, para. 94, “The computed dwell lime may be used to assess a patient's set switching ability, to refocus attention from one task to another, for example, where dwell time reflects a dwell period in a first target (abet initial movement to the first target) before moving to the next target. Dwell time may be an indicator of ‘cognitive freezing’ in neurocognitive or other patient groups. The cognitive calculator 38 can also calculate the reaction time, such as corresponding to a time interval between a presentation of a stimulus and the initiation of movement of a pointing device by a user during a reaction test application 26, 28, which can be further utilized by the cognitive calculator 38 to generate a score of the patient's information processing capacity. In an example embodiment of the present invention, the cognitive calculator 38 may further use data output by the. motor calculator 34, e.g., representative of motor function quality, to calculate data representative of cognitive ability.”).
Regarding claim 4, Alberts in view of Graham teaches the computer-implemented method of claim 1, wherein the first plurality of characters are letters (Alberts, para. 134, “In the display GUI 182, a portion of the targets, indicated at 184, have letters ranging consecutively from A through Hand another corresponding portion of the targets, indicated at 186, have numbers ranging consecutively from 1 through 13. Those skilled in the art will understand that the test engine can be programmed to automatically generate any arrangement of targets consistent with the format of the trail making test (Part B), which arrangement may be part of the test data provided to the analysis engine 16.").
Regarding claim 5, Alberts in view of Graham teaches the computer-implemented method of claim 1, wherein the second plurality of characters are symbols (Alberts, para. 86, “As an example, a test application 26, 28 can display on the display a GUI having one or more targets, each as a graphical object having a shape (e.g., circle, oval, triangle or rectangle) that encompasses or bounds a set of coordinates on the user's display device." Para. 134, "In the display GUI 182, a portion of the targets, indicated at 184, have letters ranging consecutively from A through H and another corresponding portion of the targets, indicated at 186, have numbers ranging consecutively from 1 through 13. Those skilled in the art will understand that the test engine can be programmed to automatically generate any arrangement of targets consistent with the format of the trail making test (Part B), which arrangement may be part of the test data provided to the analysis engine 16.").
Regarding claim 6, Alberts in view of Graham teaches the computer-implemented method of claim 1, wherein the third plurality of characters are a combination of letters and symbols (Alberts, para. 80, “The test engine 12 also includes a plurality of test applications (e.g., functions or methods) 26 and 28, indicated as TEST I application through TEST N application, where N is a positive integer denoting any number of tests. Each test application can be programmed in a manner to test motor and/or cognitive functions, and/or a combination of motor and cognitive functions, of a user." Para. 135, "For instance, the instructions (e.g., via the instruction GUI 180 of FIG. 17) specify that a user-patient is to alternate between consecutive sequential letters and numbers by connecting respective targets with straight lines, similar to what is shown in FIG. 19 up to letter E, beginning with the lowest number to the lowest letter, to the second lowest number, to the second highest letter; etc. Thus, FIG. 19 shows an example outcome of a test in which a user has used a cursor having a position that can be tracked via the corresponding API.").
Regarding claim 7, Alberts in view of Graham teaches the computer-implemented method of claim 6, wherein the third target character is a letter, and the fourth target character is a symbol (Alberts, para. 86, “As an example, a test application 26, 28 can display on the display a GUI having one or more targets, each as a graphical object having a shape (e.g., circle, oval, triangle or rectangle) that encompasses or bounds a set of coordinates on the user's display device." Para. 135, "For instance, the instructions (e.g., via the instruction GUI 180 of FIG. 17) specify that a user-patient is to alternate between consecutive sequential letters and numbers by connecting respective targets with straight lines, similar to what is shown in FIG. 19 up to letter E, beginning with the lowest number to the lowest letter, to the second lowest number, to the second highest letter, etc. Thus, FIG. 19 shows an example outcome of a test in which a user has used a cursor having a position that can be tracked via the corresponding API.").
Regarding claim 9, Alberts in view of Graham teaches the computer-implemented method of claim 1, wherein the first instruction to the user includes to select the first target character in a first quadrant of the first display (Alberts, para. 94, “dwell time can correspond to a time period during which a cursor or other graphical object is within a given predefined bounded area, such as can be defined as an X and Y position or range that encompasses a displayed graphical object or target." Para. 145, "For example, dwell time can correspond to an amount of time that a cursor or other user-controlled graphical interface element resides within a bounded region, such as a defined border of a target. Such bounded regions can be identified in the testing data according to position data (e.g., X and Y coordinates) for each of the targets populating a test GUI. The identified regions for which dwell time is .calculated can be identified by identifying the X and Y positions corresponding to each time during which no change occurs in the X and Y position or a period in which there is no velocity (e.g., from plot 198).").
Regarding claim 10, Alberts in view of Graham teaches the computer-implemented method of claim 9, wherein the first instruction to the user includes to select the first target character in a plurality of quadrants of the first display (Alberts, para. 129, “For instance, a plurality of targets 172 are distributed across the display area provided by the GUI 170. In the example of FIGS. 15 and 16, the targets are numbered from 1 to 24 and the user (as instructed by the instruction GUI 168 of FIG. 14) is to connect the targets in a sequential order. The test engine can populate the display area for the GUI 170 in a pseudo random fashion such that each of the sequential targets can be interconnected by an ideal straight line without crossing a line interconnecting any other sequential targets.”).
Regarding claim 11, Alberts in view of Graham teaches the computer-implemented method of claim 1, wherein the first instruction to the user includes to select the first target character in a first quadrant of the first display (Alberts, para. 79, “In an alternative example embodiment, differences in the display screens may be ignored, and the test data presented to the user-and the test result may be uniform across the various test platforms." Para. 134, "FIGS. 18 and 19 depict an example of a GUI 182 that can be presented to a user in connection with performing and recording information associated with a trail making test (Part B). The GUI 182 presents a plurality of targets positioned in a display area according to application data determined by a corresponding test application. In the examples of FIGS. 18 and 19, the targets are circles, each of which defines a bounded region having a corresponding set of coordinates.").
Regarding claim 12, Alberts in view of Graham teaches the computer-implemented method of claim 11, wherein the first instruction to the user includes to select the first target character in a plurality of quadrants of the first display (Alberts, para. 138, “By way of example, the plot 192 ·depicts X position versus Y position, thereby showing the graphical object as a pair of interconnected line segments in a relative coordinate system based upon user input with a corresponding pointing device, representing the path the user took between the targets of the "seven's test." A representative plot 194 shows the X data of plot 192 plotted as a function of time, and plot 196 shows the Y data of plot 192 plotted as a function of time.").
Regarding claim 13, Alberts in view of Graham teaches the computer-implemented method of claim 1, wherein the first instruction to the user includes to select the first target character in a first quadrant of the first display (Alberts, para. 80, “The test engine 12 also includes a plurality of test applications (e.g., functions or methods) 26 and 28, indicated as TEST I application through TEST N application, where N is a positive integer denoting any number of tests. Each test application can be programmed in a manner to test motor and/or cognitive functions, and/or a combination of motor and cognitive functions, of a user." Para. 146, "As described above, the dwell time corresponds to a time during which a cursor/pointing object is within a given pre-defined X-Y position range that encompasses a displayed target. Thus, the dwell time can be determined. by correlation of position information (e.g., indicating that the cursor is within a bounded target) and velocity information (e.g., indicating that the cursor is either not moving or is moving within the bounded target at a rate that is below a predetermined threshold)." Para. 150, "Those skilled in the art will understand various other protocols and combinations of protocols that can be utilized for specifying patient control parameters associated with a given set of tests.”).
Regarding claim 14, Alberts in view of Graham teaches the computer-implemented method of claim 13, wherein the first instruction to the user includes to select the first target character in a plurality of quadrants of the first display (Alberts, para. 134, “The GUI 182 presents a plurality of targets positioned in a display area according to application data determined by a corresponding test application. In the examples of FIGS. 18 and 19, the targets are circles, each of which defines a bounded region having a corresponding set of coordinates. In the display GUI 182, a portion of the targets; indicated at 184,have letters ranging consecutively from A through H and another corresponding portion of the targets, indicated at 186, have numbers ranging consecutively from 1 through 13. Those skilled in the art will understand that the test engine can be programmed to automatically generate any arrangement of targets consistent with the format of the trail making test (Part B), which arrangement may be part of the test data provided to the analysis engine 16.").
Regarding claim 15, Alberts in view of Graham teaches the computer-implemented method of claim 1, wherein user selects any of the target characters by circling the target characters (Alberts, para. 143, “For example, the shape of a plotted velocity or acceleration may be compared to a stored smooth bell-shaped curve, which may be considered to represent ideal motion by a healthy person when raking a test. The analysis engine 16 may score the graphs of the test taker's motion, such that the closer the shapes of the graphs to the stored graph shapes, the higher the score. Similarly, the analysis engine 16 may determine the extent (with respect to number and/or degree) to which the graph(s) include spikes, where such spikes may be used as indications of low quality movement including significant and/or many corrective and/or tremor-like motions." Para. 145, "By way of further example, FIG. 22 is a reproduction of the GUI 190 shown in FIG. 21 in which selected portions of position and kinematic data have been identified by circles 220 corresponding to relevant data that can be utilized by the cognitive calculator 38 for computing dwell time.”) .
Regarding claim 16, Alberts in view of Graham teaches a device configured and adapted to implement the method of claim 1 comprising:
a tablet computer configured and adapted to provide a plurality of displays on a screen of the tablet computer (Alberts, para. 82, “Each test application 26 to 28 can be provided to a user computer in an interactive manner that provides interactive graphical objects in the GUI 22, within a hardware display device, such as a computer or tablet screen.”); and
a processing unit configured to analyze the inputs of the user (Alberts, Fig. 1, Analysis Engine 16);
wherein the screen is configured and adapted to receive a plurality of inputs from a user (Alberts, para. 12, “the system provides a testing system that tracks patient-controlled movement, such as by storing time and position information responsive to movement of a pointer device (e.g., a mouse or stylus or a touch screen that responds to a user's touch) performed by a user.”).
Regarding claim 18, Alberts in view of Graham teaches the computer-impleme