DETAILED ACTION
Claims 1-4, 7-10, 14, and 16-26 are hereby under examination.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/25/2024 is being considered by the examiner.
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.
Claim Objections
Claims 1, 3, 7, 8, and 22 are objected to because of the following informalities:
Regarding claim 1, line 19 recites “the idle state”, however it appears it should read --an idle state-- (emphasis added).
Regarding claim 3, lines 3-4 recite “an individual”, however it appears it should read --the individual-- (emphasis added).
Regarding claim 3, line 19 recites “the idle state”, however it appears it should read --an idle state-- (emphasis added).
Regarding claim 7, line 2 recites “a magnitude”, however it appears it should read --the magnitude-- (emphasis added).
Regarding claim 7, line 2 recites “a speed”, however it appears it should read --the speed-- (emphasis added).
Regarding claim 8, line 3 recites “the composite score”, however it appears it should read --a composite score-- (emphasis added).
Regarding claim 8, line 4 recites “user device”, however it appears it should read --a user device-- (emphasis added).
Regarding claim 22, line 2 recites “the screen”, however it appears it should read --a screen-- (emphasis added).
Claim Interpretation - 35 USC § 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 3: The claim limitation “an input interface configured to receive measurements from a remote source …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “interface” coupled with functional language “configured to receive measurements from a remote source …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “interface”.
Claim 4: The claim limitation “an input interface configured to receive a first measurement or set of measurements … and a second measurement or set of measurements …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “interface” coupled with functional language “configured to receive a first measurement or set of measurements … and a second measurement or set of measurements …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “interface”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Regarding a and b, the specification does not provide adequate structure, material or acts to support the claimed function. The specification recites in para. [0016] “the measurements is preferably received via an input interface of a mobile device” and in para. [0157], “the mobile device typically also includes … a user input unit …”. However, the specification does not recite what structure “an input interface” is. Further, it is unclear if “an input interface … from a remote source” is the same as “an input interface” recited in the paragraphs above. For the purposes of examination, “an input interface configured to receive measurements” and “an input interface configured to receive a first measurement …” is being interpreted as any element configured to perform the claimed function.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3, 4, and 7 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because the claim purports to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, but fails to provide the structure, material or acts to support the claimed function. As such, the claim recites a function that has no limits and covers every conceivable means for achieving the stated function, while the specification discloses at most only those means known to the inventor. Accordingly, the disclosure is not commensurate with the scope of the claim.
As discussed above, the claim limitations below are interpreted under 35 U.S.C. 112(f):
Claim 3: “an input interface configured to receive measurements from a remote source …”.
Claim 4: “an input interface configured to receive a first measurement or set of measurements … and a second measurement or set of measurements …”.
The specification merely discloses the functions performed by these limitations. However, one of ordinary skill in the art would not understand the specification, the drawings, and the original claims to disclose any particular structure that achieves the disclosed functionality.
The limitations fail to comply with the written description requirement as the limitations are unbound functional limitations which cover all ways of performing the respective functions and the inventor has not provided sufficient disclosure to show possession of such invention. The limitations therefore fail to comply with the written description requirement. See MPEP 2181.II.A.
The dependent claims of the above rejected claims are rejected due to their dependency.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-4, 7-10, 14, and 19-26 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 2, the claim recites the limitation “the measurements” in line 1. There is insufficient antecedent basis for this limitation in the claim. In light of the specification, it is currently unclear if “the measurements” is the same as, related to, or different from “obtaining a measure”/”receiving the measures”. Additionally, it is currently unclear if “the measurements” is the same as, related to, or different from “baseline measurements”. For the purposes of examination, “the measurements” is being interpreted as being related to “obtaining a measure”/”receiving the measures”. It is recommended to the Applicant to amend the claims to clearly differentiate between the claimed elements.
The dependent claims of the above rejected claim are rejected due to their dependency.
Regarding claims 3 and 4, the claim limitation “an input interface” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Regarding “an input interface”, as recited above, the specification does not provide adequate structure, material or acts to support the claimed function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
The dependent claims of the above rejected claim are rejected due to their dependency.
Regarding claim 3, the claim recites the limitation "the measures" in 20. There is insufficient antecedent basis for this limitation in the claim. In light of the specification, it is currently unclear if “the measures” is the same as, related to, or different from, “receive measurements …”. For the purposes of examination, “the measures” is being interpreted as “the measurements”.
The dependent claims of the above rejected claim are rejected due to their dependency.
Regarding claim 4, line 3 recites “an input interface” and line 6 recites “a processor”. However, claim 3 already introduced “an input interface” and “a processor”. In light of the specification, it is currently unclear if claim 4 is introduced a second input interface and a second processor, or if the input interface and the processor are the same. For the purposes of examination, “an input interface” and “a processor” recited in claim 4 are being interpreted as the same elements recited in claim 3.
Regarding claim 8, line 2 recites “said measurements”. However, in light of the specification, it is currently unclear if “said measurements” is the same as, related to, or different from, “obtaining a measure”/”receiving the measures”. Additionally, it is currently unclear if “said measurements” is the same as, related to, or different from “baseline measurements”. For the purposes of examination, “said measurements” is being interpreted as being related to “obtaining a measure”/”receiving the measures”. It is recommended to the Applicant to amend the claims to clearly differentiate between the claimed elements.
Regarding claim 23, line 3 recites “the measurements”. However, in light of the specification, it is currently unclear if “the measurements” is the same as, related to, or different from, “obtaining a measure”/”receiving the measures”. Additionally, it is currently unclear if “the measurements” is the same as, related to, or different from “baseline measurements”. For the purposes of examination, “the measurements” is being interpreted as being related to “obtaining a measure”/”receiving the measures”. It is recommended to the Applicant to amend the claims to clearly differentiate between the claimed elements.
Regarding claim 25, line 3 recites “the measurements”. However, in light of the specification, it is currently unclear if “the measurements” is the same as, related to, or different from, “obtaining a measure”/”receiving the measures”. Additionally, it is currently unclear if “the measurements” is the same as, related to, or different from “baseline measurements”. For the purposes of examination, “the measurements” is being interpreted as being related to “obtaining a measure”/”receiving the measures”. It is recommended to the Applicant to amend the claims to clearly differentiate between the claimed elements.
Regarding claim 26, lines 2-3 recite “wherein assessing the individuals ability to execute tasks includes assessing their ability to carry out subtasks in an exact order”. However, it is currently unclear what “assessing the individuals ability to execute tasks” is referring to. Is “ability to execute tasks”, the same as, related to, or different from the activity parameters? Dual-task interactions? Is claim 26 intended to depend from claim 25? For the purposes of examination, “ability to execute tasks” is being interpreted as any task.
Claim Rejections - 35 USC § 112(d)
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claims 9 and 10 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.
Regarding claim 9, the claim recites “a plurality of activity parameters is measured”, which fails to further limit the subject matter of claim 1, which already requires obtaining a plurality of measures.
Regarding claim 10, the claim recites “at least the upper extremity neuro-motor parameters is measured”, which fails to further limit the subject matter of claim 1, which already requires obtaining a measure of upper extremity neuro-motor parameters.
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 Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4, 7-10, 14, and 16-26 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 significantly more.
Analysis of independent claims 1 and 3:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to a method, which describes one of the four statutory categories of patentable subject matter, i.e., a process. Claim 3 is directed to a system, which describes one of the four statutory categories of patentable subject matter, i.e., a machine. Therefore, further consideration is necessary.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 1 and 3 recite an abstract idea. In particular, the claims recite the following:
Calculating a plurality of metrics belonging to the activity parameters; the metrics being mapped to a plurality of cognitive domains; and calculating a percentile rank score for each cognitive domain on the basis of baseline measurements obtained from a population of healthy individuals; and
Computing a functional impairment score for the individual on the basis of the individual’s percentile rank scores for the cognitive domains.
These elements recited in claims 1 and 3 are drawn to an abstract idea since (1) they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations; and/or (2) they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Calculating a plurality of metrics, mapping the plurality of metrics to a plurality of cognitive domains, and calculating a percentile rank score on the basis of baseline measurements obtained from a population of healthy individuals is drawn to a mental process that can be practically be performed in the human mind with the aid of pen and paper. For example, a person with ordinary skill in the art could reasonably view measurement results on a piece of paper, calculate metrics from the results, map the metrics, and calculate percentile rank scores on the basis of baseline measurements. There is nothing to suggest an undue level of complexity in the calculating and mapping steps. Additionally, calculating metrics and calculating a percentile rank score are drawn to mathematical calculations using basic mathematical operations.
Computing a functional impairment score on the basis of the individuals percentile rank scores is drawn to a mental process that can practically be performed in the human mind with the aid of pen and paper. For example, a person with ordinary skill in the art could reasonably add all of the percentile rank scores to obtained a total functional impairment score. There is nothing to suggest an undue level of complexity in the calculating step. Additionally, calculating a functional impairment score is drawn to a mathematical calculation using basic mathematical operations.
Prong Two: Claims 1 and 3 not recite additional elements that integrate the exception into a practical application. Therefore, the claims are “directed to” the abstract idea. The additional elements merely:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., “receiving the measures obtained into an algorithm …” (claim 1), “an algorithm …” (claim 3), “a processor …” (claim 3)), and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data-gathering components (e.g. “an input interface …” (claim 3)).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Further, “an algorithm”, “an input interface”, “a processor”, and “computer program code”, does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1 and 3 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. E.g., all elements are directed to pre-solution steps of necessary data gathering, using generic computer structures to gather the data, which merely facilitate the abstract idea. For example, obtaining a measure of activity parameters 1-8 is directed to pre-solution steps of necessary data gathering to be implemented by the abstract idea.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Analysis of the dependent claims:
Claims 2, 4, 7-10, 14, and 16-26 depend from the independent claims. The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
Further describe the abstract idea (“a processor configured to receive said first measurement or set of measurements and configured to execute computer program code to compute, using said first measurement or set of measurements, a first functional impairment score indicative of cognitive performance in the individual, and configured to receive said second measurement or set of measurements and configured to execute computer program code to compute, using said second measurement or set of measurements, a second functional impairment score; the processor configured to compare said second functional impairment score with said first functional impairment score and determine a magnitude and/or a speed of change in said functional impairment scores” (claim 4), “the processor or the system is configured to determine both a magnitude and a speed of change in the functional impairment scores for that individual to calculate a composite score” (claim 7), “wherein the cognitive domains include at least one of perceptual motor coordination, complex attention, cognitive processing speed, inhibition, flexibility, visual perception, planning, prospective memory, and spatial memory” (claim 18)),
Further describe the pre-solution activity (or the structure used for such activity) (“the measurements are obtained using an app on an electronic portable device” (claim 2), “an input interface configured to receive a first measurement or set of measurements obtained at a first time and a second measurement or set of measurements obtained at a second different time in respect of the activity parameter or parameters” (claim 4), “a plurality of activity parameters is measured” (claim 9), “wherein at least the upper extremity neuro-motor parameters are measured” (claim 10), “wherein all eight of the activity parameters are measured” (claim 14), “wherein hand movements of the individual are assessed to obtain at least one of the measurements” (claim 19), “assessing the individual's hand movements includes testing speed and/or accuracy of the individual's hand movements” (claim 20), “wherein the individual's hand movements are assessed by displaying an image to the individual and assessing the individual's ability to trace or tap on the image” (claim 21), “wherein the image is displayed on the screen of a portable electronic device or other user device” (claim 22), “wherein the individual's ability to navigate is assessed to obtain at least one of the measurements” (claim 23), “wherein assessing the individual's ability to navigate includes the individual placing and retrieving a plurality of objects (claim 24), “wherein the individual's ability to execute tasks is assessed to obtain at least one of the measurements” (claim 25), “assessing the individual's ability to execute tasks includes assessing their ability to carry out subtasks in an exact order” (claim 26)),
Further describe the computer implementation (“a system configured to receive said measurements and compute the functional impairment score and/or the composite score is remote from the electronic portable device or user device” (claim 8), “wherein the metrics are calculated on the basis of an algorithm” (claim 16), “wherein the algorithm is or includes one or more of signal analysis, sensor-fusion, algebraic integration, Fourier analysis or wavelet analysis” (claim 17)), and
Further describe the post-solution activity (N/A) (recited at a high level of generality).
Further, “an algorithm”, “an input interface”, “a processor”, and “computer program code” does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subjection matter. Claims 1-4, 7-10, 14, and 16-26 are rejected.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 1-2, 8-10, 14, and 16-26 are rejected under 35 U.S.C. 103 as being unpatentable over Sano et al. (US 20160100788 A1), hereinafter referred to as Sano, in view of Charles Duffy (US 20110066082 A1), hereinafter referred to as Duffy, in view of Jung et al. (US 20080243005 A1), hereinafter referred to as Jung, in view of Alberts et al. (US 20160302710 A1), hereinafter referred to as Alberts.
The claims are generally directed towards a method of obtaining a measurement of cognitive performance in an individual, the method including: obtaining a measure of the following activity parameters for the individual: 1) spatial memory accuracy; 2) ability to carry out dual-task interactions while navigating to a goal, wherein omission of the dual-task interactions is measured; 3) perseverations of incorrect dual-task interactions while navigating to a goal; 4) upper extremity neuro-motor parameters derived from signal processing of 3D acceleration data provided on a portable electronic device; 5) reaction time of dual-task interactions; and one or more of: 6) planning accuracy; 7) total time required by the individual to complete a navigation route; and 8) reaction time of the idle state of the individual; receiving the measures obtained into an algorithm; calculating a plurality of metrics belonging to the activity parameters; the metrics being mapped to a plurality of cognitive domains; and calculating a percentile rank score for each cognitive domain on the basis of baseline measurements obtained from a population of healthy individuals; and computing a functional impairment score for the individual on the basis of the individual's percentile rank scores for the cognitive domains.
Regarding claim 1, Sano discloses a method of obtaining a measurement of cognitive performance in an individual (Abstract, para. [0013]), the method including:
obtaining a measure of the following activity parameters for the individual (Fig. 1, element 20, para. [0053-0054]):
2) ability to carry out dual-task interactions while navigating to a goal, wherein omission of the dual-task interactions is measured (Fig. 8c, para. [0058], “positional accuracy …”, para. [0126], Fig. 11, para. [0148-0149], Fig. 18, Fig. 19, para. [0179], Fig. 23, para. [0207]);
4) upper extremity neuro-motor parameters derived from signal processing of 3D acceleration data provided on a portable electronic device (Fig. 1, element 3, para. [0054], “body movement executed by the subject … acceleration”, para. [0057], para. [0065], “body movement detection sensor … sensor for detecting a body movement of a portion other than hands and fingers may be used … acceleration sensor …”);
5) reaction time of dual-task interactions (Fig. 8c, para. [0059], “time-series accuracy of the body movement of the subject …”, para. [0126], Fig. 11, para. [0148-0149], Fig. 18, Fig. 19, para. [0179], Fig. 23, para. [0207]);
and one or more of:
6) planning accuracy (Fig. 4, para. [0058], para. [0074-0079], “initial position … touches the cross-shaped graphic …”);
7) total time required by the individual to complete a navigation route (para. [0059], “time-series accuracy …”, para. [0207]); and
8) reaction time of the idle state of the individual (para. [0059], “time-series accuracy … difference between an instruction timing of the instruction data and a detection timing of the detection data …”);
receiving the measures obtained into an algorithm (Fig. 1, element 30, para. [0047]);
calculating a plurality of metrics belonging to the activity parameters (Fig. 1, element 31, element 32, element 33, para. [0056-0059]); the metrics being mapped to a plurality of cognitive domains (Fig. 3, para. [0071], “body movement task selection …”).
However, Sano does not explicitly disclose obtaining a measure of 1) spatial memory accuracy.
Duffy teaches of an analogous method of obtaining a measurement of cognitive performance in an individual (Abstract, para. [0033]). Duffy further teaches obtaining a measurement of a following activity parameters for the individual including spatial memory accuracy (para. [0328]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the activity parameters disclosed by Sano to additionally include spatial memory accuracy, as taught by Duffy. This is because Duffy teaches spatial memory testing is suitable test for testing cognitive performance (para. [0003], para. [0263]).
However, modified Sano does not explicitly disclose obtaining a measure of 3) perseverations of incorrect dual-task interactions while navigating to a goal.
Jung teaches of an analogous method of obtaining a measurement of cognitive performance in an individual (Abstract, para. [0010]). Jung further teaches obtaining a measure of activity parameters including perseverations of incorrect dual-task interactions while navigating to a goal (para. [0121-0122]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the activity parameters taught by modified Sano to additionally include perseverations of incorrect dual-task interactions while navigating to a goal, as taught by Jung. This is because Jung teaches perseveration tests are suitable tests for monitoring cognitive performance (para. [0121-0123]).
However, modified Sano does not explicitly disclose calculating a percentile rank score for each cognitive domain on the basis of baseline measurements obtained from a population of healthy individuals; and computing a functional impairment score for the individual on the basis of the individual’s percentile rank scores for the cognitive domains.
Alberts teaches of an analogous method of obtaining a measurement of cognitive performance in an individual (Abstract, para. [0002]), including obtaining a measure of multiple activity parameters (Fig. 2, para. [0055]). Alberts further teaches calculating a percentile rank score for each cognitive domain on the basis of baseline measurements obtained from a population of healthy individuals (Fig. 2, element 60, para. [0059-0060]); and computing a functional impairment score for the individual on the basis of the individual’s percentile rank scores for the cognitive domains (para. [0059-0060]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Sano to additionally include calculating a percentile rank score for each cognitive domain on the basis of baseline measurements obtained from a population of healthy individuals; and computing a functional impairment score for the individual on the basis of the individual’s percentile rank scores for the cognitive domains, as taught by Alberts. This is because Alberts teaches characterizing the cognitive performance based on percentile scores of normal function is a suitable evaluation method for cognitive abilities of the patient, and allows for a combined score to be calculated (para. [0059-0060]).
Regarding claim 2, modified Sano discloses method as claimed in claim 1, wherein the measurements are obtained using an app on an electronic portable device (Fig. 1, Fig. 4, para. [0066], “tablet computer or a table terminal that is equipped with a touch panel sensor … application program”).
Regarding claim 8, modified Sano discloses a method as claimed in claim 2, wherein a system configured to receive said measurements and compute the functional impairment score and/or the composite score is remote from the electronic portable device or user device (Fig. 25, element 102, para. [0223-0227], “server device … function of receiving … data of the body movement … evaluating the cognitive impairment degree of the subject …”).
Regarding claim 9, modified Sano discloses a method as claimed in claim 2, wherein a plurality of activity parameters is measured (see the rejection of claim 1 above regarding the activity parameters).
Regarding claim 10, modified Sano discloses a method as claimed in claim 2, wherein at least the upper extremity neuro-motor parameters are measured (see the rejection of claim 1 above regarding upper extremity neuro-moto parameters).
Regarding claim 14, modified Sano discloses a method as claimed in claim 2, wherein all eight of the activity parameters are measured (see the rejection of claim 1 above).
Regarding claim 16, modified Sano discloses a method as claimed in claim 1, wherein the metrics are calculated on the basis of an algorithm (Fig. 1, element 30, para. [0047]).
Regarding claim 17, modified Sano discloses a method as claimed in claim 16, wherein the algorithm is or includes one or more of signal analysis, sensor-fusion, algebraic integration, Fourier analysis or wavelet analysis (para. [0057-0059], “compares the data of the body movement that is to be executed … calculates positional accuracy … calculates a time-series accuracy …” - signal analysis of the data is performed).
Regarding claim 18, modified Sano discloses a method as claimed in claim 17, wherein the cognitive domains include at least one of perceptual motor coordination, complex attention, cognitive processing speed, inhibition, flexibility, visual perception, planning, prospective memory, and spatial memory (Fig. 3, “reaching”, “rhythm touch”, “finger opening and closing tap”, para. [0071], “body movement task selection …”).
Regarding claim 19, modified Sano discloses a method as claimed in claim 2, wherein hand movements of the individual are assessed to obtain at least one of the measurements (at least Fig. 4, para. [0073-0074], “releases the finger … touches the cross-shaped graphic …”).
Regarding claim 20, modified Sano discloses a method as claimed in claim 19, wherein assessing the individual's hand movements includes testing speed and/or accuracy of the individual's hand movements (para. [0058-0059], “positional accuracy … time-series accuracy …”).
Regarding claim 21, modified Sano discloses a method as claimed in claim 19, wherein the individual's hand movements are assessed by displaying an image to the individual and assessing the individual's ability to trace or tap on the image (Fig. 23, para. [0206-0207], “subject tracks these two tracking target graphics …”).
Regarding claim 22, modified Sano discloses a method as claimed in claim 21, wherein the image is displayed on the screen of a portable electronic device or other user device (Fig. 23, para. [0064], “tablet computer equipped with a touch panel sensor …”).
Regarding claim 23, modified Sano discloses a method as claimed in claim 2, wherein the individual's ability to navigate is assessed to obtain at least one of the measurements (Fig. 23, para. [0206-0207], “subject tracks these two tracking target graphics …”).
Regarding claim 24, modified Sano discloses a method as claimed in claim 23, wherein assessing the individual's ability to navigate includes the individual placing and retrieving a plurality of objects (Fig. 23, para. [0206-0207], “subject tracks these two tracking target graphics with the respective fingers in accordance with the movements of the tracking target graphics …”).
Regarding claim 25, modified Sano discloses a method as claimed in claim 2, wherein the individual's ability to execute tasks is assessed to obtain at least one of the measurements (Fig. 21, para. [0191-0195], “displays a touch instruction graphic … subject touches the displayed touch instruction graphic …”).
Regarding claim 26, modified Sano discloses a method as claimed in claim 2, wherein assessing the individual's ability to execute tasks includes assessing their ability to carry out subtasks in an exact order (Fig. 21, para. [0191-0195], “displays a touch instruction graphic … subject touches the displayed touch instruction graphic … selects another touch instruction region and displays a touch instruction graphic …”).
Claims 3-4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Sano et al. (US 20160100788 A1), hereinafter referred to as Sano, in view of Alberts et al. (US 20160302710 A1), hereinafter referred to as Alberts.
Regarding claim 3, Sano discloses a computer implemented system for obtaining a measurement of cognitive performance in an individual (Abstract, para. [0013]), said system including:
an input interface configured to receive measurements from a remote source on an individual in respect of at least one of the following activity parameters (Fig. 1, element 20, element 100, para. [0041-0054], para. [0064], para. [0066]):
1) spatial memory accuracy;
2) ability to carry out dual-task interactions while navigating to a goal, wherein omission of the dual-task interactions is measured (Fig. 8c, para. [0058], “positional accuracy …”, para. [0126], Fig. 11, para. [0148-0149], Fig. 18, Fig. 19, para. [0179], Fig. 23, para. [0207]);
3) perseverations of incorrect dual-task interactions while navigating to a goal;
4) upper extremity neuro-motor parameters derived from signal processing of 3D acceleration data provided on a portable electronic device (Fig. 1, element 3, para. [0054], “body movement executed by the subject … acceleration”, para. [0057], para. [0065], “body movement detection sensor … sensor for detecting a body movement of a portion other than hands and fingers may be used … acceleration sensor …”);
5) reaction time of dual-task interactions (Fig. 8c, para. [0059], “time-series accuracy of the body movement of the subject …”, para. [0126], Fig. 11, para. [0148-0149], Fig. 18, Fig. 19, para. [0179], Fig. 23, para. [0207]);
6) planning accuracy (Fig. 4, para. [0058], para. [0074-0079], “initial position … touches the cross-shaped graphic …”);
7) total time required by the individual to complete a navigation route (para. [0059], “time-series accuracy …”, para. [0207]); and
8) reaction time of the idle state of the individual (para. [0059], “time-series accuracy … difference between an instruction timing of the instruction data and a detection timing of the detection data …”);
receiving the measures obtained into an algorithm (Fig. 1, element 30, para. [0047]);
a processor configured to receive said measurements and configured to execute
computer program code to compute, using said measurements, a plurality of metrics
belonging to the activity parameters (Fig. 1, element 31, element 32, element 33, para. [0047], para. [0056-0059], para. [0066-0067]); the metrics being mapped to a plurality of cognitive
domains (Fig. 3, para. [0071], “body movement task selection …”).
However, Sano does not explicitly disclose the processor is configured to calculate a percentile rank score for each cognitive domain on the basis of baseline measurements obtained from a population of healthy individuals; and to compute therefrom a functional impairment score indicative of cognitive performance in the individual based on the individual's percentile rank scores for the cognitive domains.
Alberts teaches of an analogous system of obtaining a measurement of cognitive performance in an individual (Abstract, para. [0002]), including obtaining a measure of activity parameters (Fig. 2, para. [0055]). Alberts further teaches a processor is configured to calculate a percentile rank score for each cognitive domain on the basis of baseline measurements obtained from a population of healthy individuals (Fig. 2, element 60, para. [0059-0060]); and to compute therefrom a functional impairment score indicative of cognitive performance in the individual based on the individual's percentile rank scores for the cognitive domains (para. [0059-0060]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed by Sano to additionally include a processor configured to calculate a percentile rank score for each cognitive domain on the basis of baseline measurements obtained from a population of healthy individuals; and to compute therefrom a functional impairment score indicative of cognitive performance in the individual based on the individual's percentile rank scores for the cognitive domains, as taught by Alberts. This is because Alberts teaches characterizing the cognitive performance based on percentile scores of normal function is a suitable evaluation method for cognitive abilities of the patient, and allows for a combined score to be calculated (para. [0059-0060]).
Regarding claim 4, modified Sano discloses a computer implemented system as claimed in claim 3, said system including: an input interface configured to receive a first measurement or set of measurements obtained at a first time (Fig. 1, Fig. 9, element 20, element 100, para. [0041-0054], para. [0064], para. [0066], para. [0131]) and a second measurement or set of measurements obtained at a second different time in respect of the activity parameter or parameters (Fig. 1, Fig. 9, element 20, element 100, para. [0041-0054], para. [0064], para. [0066], para. [0131]); a processor configured to receive said first measurement or set of measurements and configured to execute computer program code to compute, using said first measurement or set of measurements, a first functional impairment score indicative of cognitive performance in the individual, and configured to receive said second measurement or set of measurements and configured to execute computer program code to compute, using said second measurement or set of measurements, a second functional impairment score; the processor configured to compare said second functional impairment score with said first functional impairment score and determine a magnitude and/or a speed of change in said functional impairment scores (Fig. 9, para. [0131-0137]).
Regarding claim 7, modified Sano discloses a system as claimed in claim 4, wherein the processor or the system is configured to determine both a magnitude and a speed of change in the functional impairment scores for that individual to calculate a composite score (Fig. 9, para. [0131-0137]).
Conclusion
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791