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.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The abstract of the disclosure is objected to because it is of improper form and undue length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
A substitute specification excluding the claims is required pursuant to 37 CFR 1.125(a) because the specification is improperly formatted including at least missing section identification and paragraph numbers.
A substitute specification must not contain new matter. The substitute specification must be submitted with markings showing all the changes relative to the immediate prior version of the specification of record. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. An accompanying clean version (without markings) and a statement that the substitute specification contains no new matter must also be supplied. Numbering the paragraphs of the specification of record is not considered a change that must be shown.
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1-14 are objected to because of the following informalities:
The claims that have multiple limitations are not formatted consistent with conventional practice. In particular, many limitations end with a comma (some with nothing at all) when each limitation should end with semi-colon while the second to last limitation should end with a semi-colon followed by the term “and”. See, in particular, at least claims 1, 7, 8, and 10. This inconsistency reduces clarity.
Dependent claims 2-9 and 11-14 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 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.
Claims 1-14 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 1, the preamble recites “[a] method, particularly a computer-implemented method for determining a fatigue value of a person, the method comprising the steps of:”. It is unclear how the language “particularly a computer-implemented method for determining a fatigue value of a person” provides a limitation on the claim as the body of the claim is silent regarding computer implementation of any of the method steps. In particular, as written, the claimed method includes computer implementation but does not require it. Thus, one of ordinary skill in the art would not be apprised of the metes and bounds of the patent protection sought. If applicant seeks this method to be more clearly directed to a computer-implemented method, it is recommended to at least clean up this preamble to follow conventional practice such that it only recites “a computer-implemented method for determining a fatigue value of a person, the method comprising:”. Dependent claims 2-9 inherit the deficiencies of their respective parent claims, and thus are rejected under the same rationale.
Regarding claim 8, the claim recites
“wherein the person has selected a predetermined minimum number of symbols of the second group (2) of symbols and if a predetermined minimum ratio between
a number of true values determined based on the selected symbols (12) and
the minimum number of symbols
has been determined.”
It is unclear what the “if” statement further limits because this conditional limitation is disconnected from any language. In other words, the conditional limitation is not applied to anything. Thus, one of ordinary skill in the art would not be apprised of the metes and bounds of the patent protection sought.
Regarding claim 10, it is unclear how the limitation “wherein one symbol (11) of the first group of symbols is highlighted” further limits the claim. In particular, this limitation is not indented while all of the other limitations in the claim are indented at some level to illustrate how relate to the limitations before and after them. Thus, it is unclear if the limitations following it are sub-limitations of this limitation or if this limitation is a sub-limitation of a limitation preceding it. Therefore, 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, this limitation is construed as a sub-limitation of “a display (5) configured to display”. Dependent claims 11-14 inherit the deficiencies of their respective parent claims, and are thus rejected under the same rationale.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Although claim 9 refers to independent claim 1, claim 9 is written such that infringement of this claim may occur without infringement of independent claim 1. For instance, claim 9 recites “A computer program comprising instructions which, when the program is executed by a processing unit, cause the processing unit to carry out the steps i) to ix) of the method according to claim 1.” Thus, claim 9 does not specify a further limitation of the subject matter claimed in independent claim 1 nor does it include all of the limitations of independent claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 10-14 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Although claim 10 refers to claim 9, claim 10 is written such that infringement of this claim may occur without infringement of claim 10. For instance, claim 10 is directed a system while the reference to claim 9 is found within the body of the claim in a single limitation which recites “a processing unit, particularly configured to execute the computer program of claim 9, wherein the processing unit is configured to” followed by a series of functions. Similarly, claims 11-14 are drawn to the system claimed in claim 10. Thus, claims 10-14 do not specify a further limitation of the subject matter claimed in claim 9 nor do they include all of the limitations of claim 9. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Dependent claims 11-14 inherit the deficiencies of their respective parent claims, and are thus rejected under the same rationale.
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.
Claim 9 is rejected under 35 U.S.C. 101 because it covers both non-statutory subject matter and statutory subject matter. More specifically, the claim is directed to functions that amount to software per se, which is non-statutory subject matter. For instance the claimed subject matter is directed towards a computer program. Therefore the claim as drafted is found to lack structure and appear to be directed to software. As the claim is found to be software per se the claim is found to be directed towards ineligible subject matter as set forth in MPEP 2106(I) (see computer program per se, Gottschalk v. Benson, 409 US at 72, 175 USPQ at 676-77).
Claims 1-14 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 products and a method which fall under at least one of the four statutory categories (STEP 1: YES).
Step 2A, Prong 1
Independent claim 1 recites:
A method, particularly a computer-implemented method for determining a fatigue value of a person, the method comprising the steps of:
i) displaying of:
a) a first group (1) of symbols and a second group (2) of symbols,
b) a selection rule (3) associating each of the symbols of the first group (1) of symbols to one symbol of the second group (2) of symbols,
ii) highlighting one symbol (11) of the first group (1) of symbols,
iii) receiving a user input from the person selecting on symbol (12) of the second group (2) of symbols,
iv) determining a truth value based on the selected symbol (12) of the second group (2) of symbols, wherein the truth value assumes a true value if the selected symbol (12) is selected in accordance with the selection rule (3) and wherein the truth value takes on a false value if not, wherein the highlighted symbol (11) of the first group (1) of symbols is highlighted for a predetermined time based on a statistical response time of the person, and wherein if the user input is not received within the predetermined time in step iv), the method is set forth with step v) having the truth value set to the false value, or the method is set forth with step vi),
v) storing the truth value on a non-transitory memory device,
vi) changing the selection rule (3), such that each of the symbols of the first group (1) of symbols is associated anew to one symbol of the second group (2) of symbols,
vii) changing the highlighted symbol (11) of the first group (1) of symbols,
viii) repeating steps iii) to vii) at least once and
ix) based on at some of the stored truth values, determining a fatigue value of the person.
Claim 10 recites:
A system for determining a fatigue value of a person, wherein the system comprises:
a display (5) configured to display:
a) a first group (1) of symbols and a second group (2) of symbols,
b) a selection rule (3) logically associating each of the symbols of the first group (1) of symbols to a respective associated symbol of the second group (2) of symbols,
wherein one symbol (11) of the first group of symbols is highlighted,
a user interface (6) for receiving a user input from the person, wherein the user input is indicative of selections of symbols of the second group (2) of symbols by the person and
a processing unit, particularly configured to execute the computer program of claim 9, wherein the processing unit is configured to
i) determine truth values based on the selected symbols (12) of the second group (2) of symbols, wherein the truth value assumes a true value if the selected symbol (12) of the second group (2) of symbols was selected in accordance with the selection rule (3) and wherein the truth value assumes a false value if not, wherein the processing unit is further configured to cause the display (5) to highlight the highlighted symbol ( 11) of the first group ( 1) of symbols for a predetermined time based on a statistical response time of the person, and if the user input is not received within the predetermined time in step i), to execute item ii) below, having the truth value set to the false value, or to execute item iii) below,
ii) store the truth values on a non-transitory memory device
iii) change the selection rule (3) upon every selection of a symbol of the second group (2) of symbols by the person such that each of the symbols of the first group ( 1) of symbols is associated anew to one symbol of the second group (2) of symbols,
iv) change the highlighted symbol (11) of the first group (1) of symbols upon every selection of a symbol of the second group (2) of symbols by the person and
v) determine a fatigue value of the person based on at least some of the stored truth values.
All of the foregoing underlined elements identified above, both individually and as a whole, amount to the abstract idea grouping of a certain method of organizing human activity because it is managing personal behavior or interactions between people (including social activities, teaching, and following rules or instructions) by collecting information, analyzing the information, and outputting the results of the collection and analysis in the implementation of a modified Symbol Digit Modalities Test (mSDMT). This also 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 with the aid of pen and paper (including observation, evaluation, judgment, opinion) 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, except for claim 9, 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 a method as “computer-implemented” (claim 1); a non-transitory memory device (claims 1 and 10), a computer program (claim 9); a processing unit (claim 9); a system comprising a display, a user interface, and a processing unit (claim 10). This is evidenced by the absence of structure in the drawings and the nature in which any additional element is described in the claims and the specification. See, for example, Fig. 1-5 which illustrate the display of a smartphone and at least para. 1, 7, 24, 28, 60-76, 87, 88, 105, and 127 of the published specification which identify that the disclosed elements are merely schematically illustrated based on their function and do not represent specific hardware or software or combinations thereof. This also evidences that 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 as well as that the claims do not recite any specific rules with specific characteristics that improve the functionality of the computer system. Additionally, the method claim is 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 (this includes a human operating a computer). Therefore, the claims merely define the abstract idea identified above, and are focused on the abstract idea rather than an improvement to the computer functionality or another technology. The claims do not apply or use a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. In particular, the claims are silent regarding any specific treatment or prophylaxis for any specific disease or medical condition. Accordingly, based on all of the considered factors, these additional elements do not integrate the abstract idea into a practical application. Therefore, the claims are directed to the judicial exception. (STEP 2A, PRONG 2: NO).
Step 2B
The independent and dependent 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, above, the claimed system and the process it performs does not require the use of a particular machine, nor does it result in the transformation of an article. The claims do not involve an improvement in a computer or other technology. Although claims recite computer components associated with performing at least some of the recited functions, these elements are recited at a high level of generality in a conventional arrangement for performing their basic computer functions (i.e., collecting, processing, and outputting data). This is at least evidenced by the manner in which this is disclosed that indicates that Applicant believes 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. This also evidences that 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. In particular, the claims are wholly focused on mathematically estimating cognitive performance of an individual. Thus, the focus of the claimed invention is on the analysis of the collected data (i.e., determining cognitive performance), 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. See, for example, para. 1, 7, 24, 28, 60-76, 87, 88, 105, and 127 which, at best, merely recite in results-based language that they are used. This further evidences that the claims do not recite any specific rules with specific characteristics that improve the functionality of the computer system. Thus, none of the additional elements offer a meaningful limitation beyond generally linking the performance of the steps to a particular technological environment, that is, implementation via computers. Therefore, viewed as a whole, these additional claim elements do not provide any meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea of itself (STEP 2B: NO).
Thus, the claims are rejected under 35 USC 101 as being directed to non-statutory 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)(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.
(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.
Claims 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baker et al. (US 2020/0258631, hereinafter referred to as Baker).
Regarding claim 1, Baker teaches a method, particularly a computer-implemented method for determining a fatigue value of a person, the method comprising the steps of:
displaying of:
a first group (1) of symbols and a second group (2) of symbols (Baker, Fig. 14A, upper section illustrates a first group of symbols and a second group of symbols),
a selection rule (3) associating each of the symbols of the first group (1) of symbols to one symbol of the second group (2) of symbols (Baker, Fig. 14A, upper section illustrates the selection rule as each symbol from the first group is associated with the symbol of the second group directly below as is conventionally known as a “key” in a symbol digit modalities test (SDMT).),
highlighting one symbol (11) of the first group (1) of symbols (Baker, Fig. 14A, center section illustrates a symbol of the first group of symbols is “highlighted” in the same manner as in the instant application. See, for example, at least Fig. 2A of the instant drawings.),
receiving a user input from the person selecting on symbol (12) of the second group (2) of symbols (Baker, para. 100, “The study participant is asked to provide as many correct responses as possible by typing for each iterative symbol the matching key as fast as possible on a numeric keypad on the smartphone's screen during 90 seconds.”),
determining a truth value based on the selected symbol (12) of the second group (2) of symbols, wherein the truth value assumes a true value if the selected symbol (12) is selected in accordance with the selection rule (3) and wherein the truth value takes on a false value if not, wherein the highlighted symbol (11) of the first group (1) of symbols is highlighted for a predetermined time based on a statistical response time of the person, and wherein if the user input is not received within the predetermined time in step iv), the method is set forth with step v) having the truth value set to the false value, or the method is set forth with step vi) (Baker, para. 100, “The study participant is asked to provide as many correct responses as possible by typing for each iterative symbol the matching key as fast as possible on a numeric keypad on the smartphone's screen during 90 seconds.” Para. 101, “The number of correct responses to the symbol matching and baseline test will be displayed to the patient.”),
storing the truth value on a non-transitory memory device (Baker, para. 384, “the one or more parameters may also be stored on the mobile device or indicated to the subject, typically, in real time. The stored parameters may be assembled into a time course or similar evaluation measures.”),
changing the selection rule (3), such that each of the symbols of the first group (1) of symbols is associated anew to one symbol of the second group (2) of symbols (Baker, para. 511, “legend key (round Robin alternation of 3 or more versions)”),
changing the highlighted symbol (11) of the first group (1) of symbols (Baker, para. 511, “120 abstract symbols will be displayed in sequence in a maximum of 90 seconds total”),
repeating steps iii) to vii) at least once (Baker, 120 abstract symbols will be displayed in sequence in a maximum of 90 seconds total… The study participant is asked to provide as many correct responses as possible by typing, for each iterative symbol, the matching key as fast as possible on a numeric keypad on the smartphone's screen during 90 seconds.”). and
based on at some of the stored truth values, determining a fatigue value of the person (Baker, 515, ” As an example of cognitive qualimetric activity parameter measuring fluctuations of processing speed and correctness in substitution task performance during the IPS test, the elapsed time between correct responses, as depicted in FIG. 1 (interim analysis of clinical trial NCT02952911), illustrates at the population level a certain degree of intratest 'fatigability' as a worsening is observed over time during the 90-second IPS test when the performance is monitored and analyzed, in this instance, by 15-second epochs (see FIG. 1).”).
Regarding claim 2, Baker teaches the method according to claim 1, wherein during an examination phase, the selection of symbols of the second group (2) of symbols by the person is restricted to a predetermined examination period having a first and a second section, wherein the first section is spaced apart in time from the second section (Baker, at least para. 117-118 and 125-126 illustrate the examination period can be separated into two sections – a first section (0-45sec) and a second section (45-90sec).).
Regarding claim 3, Baker teaches the method according to claim 2, wherein during the examination phase, the fatigue value is computed by means of a relative change between a first number of stored true and/or false values determined within the first section of the predetermined examination period and a second number of stored true and/or false values determined within the second section of the predetermined examination period (Baker, para. 515, “The elapsed time between correct responses as depicted in the graph (interim analysis of clinical trial NCT02952911) illustrates, at the population level, a certain degree of intra-test 'fatigability' as a worsening is observed over time during the 90-second IPS test when the performance is monitored and analyzed, in this instance, by 15-second epochs.”).
Regarding claim 4, Baker teaches the method according to claim 2, wherein during the examination phase, the fatigue value is computed by means of a relative change between a first statistical response time determined within the first section of the predetermined examination period and a second statistical response time determined within the second section of the predetermined examination period (Baker, at least para. 516-517 describes this. It is noted that multiple references throughout Baker identify this.).
Regarding claim 5, Baker teaches the method according to claim 3, characterized in that prior to the examination phase, a preparation phase is conducted, wherein during the preparation phase, steps i) to viii) are executed, wherein upon every selection of a symbol of the second group (2) of symbols by the person, a signal (4) indicative of the truth value of the selected symbol (12) is displayed to the person (Baker, para. 558, “The IPS test, in a further step, determines a baseline information processing speed by measuring a baseline response time.”).
Regarding claim 6, Baker teaches the method according to claim 5, wherein the selection of symbols of the second group (2) of symbols by the person is restricted to a predetermined preparation period of the preparation phase (Baker, baseline testing).
Regarding claim 7, Baker teaches the method according to claim 6, characterized in that between the preparation phase and the examination phase, a calibration phase is conducted, wherein during the calibration phase:
steps i) to viii) are executed (Baker, baseline testing),
the selection of symbols of the second group (2) of symbols by the person is restricted to a predetermined calibration period (Baker, baseline testing) and
the statistical response time is determined, wherein the statistical response time is determined from time intervals between the displaying of a highlighted symbol (11) of the first group (1) of symbols and the selection of a symbol of the second group (2) of symbols by the person (Baker, para. 558, “Said baseline response time is determined by measuring the time for matching a naive number or symbol to the matching naive number or symbol on a keypad of the smartphone device”).
Regarding claim 8, Baker teaches the method according to claim 7, wherein the person has selected a predetermined minimum number of symbols of the second group (2) of symbols (Baker, para. 44 defines the term “assessing” and identifies this using the context of requiring statistical significance which one of ordinary skill in the art would understand to include requiring a minimum number of symbol selections by the participant in order to be considered “statistically significant”.) and if a predetermined minimum ratio between
a number of true values determined based on the selected symbols (12) and
the minimum number of symbols
has been determined (This condition limitation does not need to be taught by the prior art since it is neither tied to anything nor affects any step whether the condition is met or not.).
Regarding claim 9, Baker teaches a computer program comprising instructions which, when the program is executed by a processing unit, cause the processing unit to carry out the steps i) to ix) of the method according to claim 1 (Baker, para. 431, “a computer program, computer program product or computer readable storage medium having tangibly embedded said computer program, wherein the computer program comprises instructions that, when run on a data processing device or computer, carry out the method of the present disclosure as specified above.”).
Regarding claim 10, Baker teaches a system for determining a fatigue value of a person, wherein the system comprises:
a display (5) configured to display (Baker, para. 195, “a display”):
a) a first group (1) of symbols and a second group (2) of symbols (Baker, Fig. 14A, upper section illustrates a first group of symbols and a second group of symbols),
b) a selection rule (3) logically associating each of the symbols of the first group (1) of symbols to a respective associated symbol of the second group (2) of symbols (Baker, Fig. 14A, upper section illustrates the selection rule as each symbol from the first group is associated with the symbol of the second group directly below as is conventionally known as a “key” in a symbol digit modalities test (SDMT).),
wherein one symbol (11) of the first group of symbols is highlighted (Baker, Fig. 14A, center section illustrates a symbol of the first group of symbols is “highlighted” in the same manner as in the instant application. See, for example, at least Fig. 2A of the instant drawings.),
a user interface (6) for receiving a user input from the person, wherein the user input is indicative of selections of symbols of the second group (2) of symbols by the person (Baker, para. 452, “For data acquisition, the mobile device may comprise a user interface such as a screen or other equipment for data acquisition.”) and
a processing unit, particularly configured to execute the computer program of claim 9 (Baker, para. 431, “a computer program, computer program product or computer readable storage medium having tangibly embedded said computer program, wherein the computer program comprises instructions that, when run on a data processing device or computer, carry out the method of the present disclosure as specified above.”), wherein the processing unit is configured to
determine truth values based on the selected symbols (12) of the second group (2) of symbols, wherein the truth value assumes a true value if the selected symbol (12) of the second group (2) of symbols was selected in accordance with the selection rule (3) and wherein the truth value assumes a false value if not, wherein the processing unit is further configured to cause the display (5) to highlight the highlighted symbol ( 11) of the first group ( 1) of symbols for a predetermined time based on a statistical response time of the person, and if the user input is not received within the predetermined time in step i), to execute item ii) below, having the truth value set to the false value, or to execute item iii) below (Baker, para. 100, “The study participant is asked to provide as many correct responses as possible by typing for each iterative symbol the matching key as fast as possible on a numeric keypad on the smartphone's screen during 90 seconds.” Para. 101, “The number of correct responses to the symbol matching and baseline test will be displayed to the patient.”),
store the truth values on a non-transitory memory device (Baker, para. 384, “the one or more parameters may also be stored on the mobile device or indicated to the subject, typically, in real time. The stored parameters may be assembled into a time course or similar evaluation measures.”)
change the selection rule (3) upon every selection of a symbol of the second group (2) of symbols by the person such that each of the symbols of the first group ( 1) of symbols is associated anew to one symbol of the second group (2) of symbols (Baker, para. 511, “legend key (round Robin alternation of 3 or more versions)”),
change the highlighted symbol (11) of the first group (1) of symbols upon every selection of a symbol of the second group (2) of symbols by the person (Baker, para. 511, “120 abstract symbols will be displayed in sequence in a maximum of 90 seconds total”) and
determine a fatigue value of the person based on at least some of the stored truth values (Baker, 515, ” As an example of cognitive qualimetric activity parameter measuring fluctuations of processing speed and correctness in substitution task performance during the IPS test, the elapsed time between correct responses, as depicted in FIG. 1 (interim analysis of clinical trial NCT02952911), illustrates at the population level a certain degree of intratest 'fatigability' as a worsening is observed over time during the 90-second IPS test when the performance is monitored and analyzed, in this instance, by 15-second epochs (see FIG. 1).”).
Regarding claim 11, Baker teaches the system according to claim 10, wherein the system is configured to set a time limit for the person to select a symbol of the second group (2) of symbols and to cause said display (5) to display a time indicator (9) indicative of a time left until said time limit is reached and wherein the system is further configured to change said highlighted symbol (11) of the first group (1) of symbols and said selection rule (3) if the person does not select a symbol of the second group (2) of symbols within said time limit (Baker, para. 511, “120 abstract symbols will be displayed in sequence in a maximum of 90 seconds total”).
Regarding claim 12, Baker teaches the system according to claim 11, wherein the system is further configured to set the truth value to the false value if the person does not select a symbol of the second group (2) of symbols within the time limit (Baker, at least the qualimetrics recited in para. 103-191 include this).
Regarding claim 13, Baker teaches the system according to claim 10, wherein the processing unit is configured to set a predetermined examination period for selection of symbols of the second group (2) of symbols by the person and wherein the processing unit is further configured to determine and particularly to output the fatigue value based on a relative change of a first number of true or false values determined within a first section of the predetermined examination period and a second number of true or false values determined within a second section of the predetermined examination period, wherein the second section is spaced apart in time from the first section; and/or based on a relative change of a first statistical response time determined within the first section of the predetermined examination period and a second statistical response time determined within the second section of the predetermined examination period (Baker, 515, ” As an example of cognitive qualimetric activity parameter measuring fluctuations of processing speed and correctness in substitution task performance during the IPS test, the elapsed time between correct responses, as depicted in FIG. 1 (interim analysis of clinical trial NCT02952911), illustrates at the population level a certain degree of intratest 'fatigability' as a worsening is observed over time during the 90-second IPS test when the performance is monitored and analyzed, in this instance, by 15-second epochs (see FIG. 1).” See also at least para. 142-146.).
Regarding claim 14, Baker teaches the system according to claim 11, wherein the system is further configured to determine a statistical response time of the person determined from time intervals between the displaying of a highlighted symbol (11) of the first group (1) of symbols and the selection of a symbol of the second group (2) of symbols by the person, wherein the time limit is based on the statistical response time of the person (Baker, para. 104, “1) the elapsed time before (from n-1) a response”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gevins (US 2008/0167571) discloses using SDMT to test effects of a dosage of carbamazepine on cognitive performance including assessing task reaction time.
Lam et al. (Reliability, Construct and Concurrent Validity of a Smartphone-based Cognition Test in Multiple Sclerosis) discloses a smartphone-adapted Symbol Digit Modalities Test (sSDMT) which is provided in the MS sherpa® smartphone app that substantively illustrates the same display format of the claimed SDMT.
Bigi et al. (The computer-based Symbol Digit Modalities Test: establishing age-expected performance in healthy controls and evaluation of pediatric MS patients) discloses a computerized version of the SDMT.
Linnhoff and Zaehle (Fatigue prediction needs time: comparing the diagnosing value of short vs. prolonged cognitive load) questions the validity of the claimed invention to reliably assess fatigue.
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/DANIEL LANE/Examiner, Art Unit 3715