DETAILED ACTION
This is the first Office Action on the merits and is responsive to the papers filed on 08/23/2022. Claims 1-15 are currently pending and are examined below.
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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
FIG. 1B includes the element “10” that is not in the Specification.
FIG. 1C includes the element “20” that is not in the Specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
The Specification recites “The time period between the DSST and the this recall portion of the test…” in paragraph [0022]. Examiner suggests amending the underlined portion to use clear and concise language.
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.
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 6-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites “for one or both of mild cognitive impairment” in line 2-3 of the claim. Examiner suggests amending to recite “a mild cognitive impairment” for proper antecedent basis. Claims 7-11 depend from claim 6 and are therefore rejected to on the same grounds.
Claim 7 recites “wherein the assessing steps accounts for no other cognitive test administered to the patient.” In lines 1-2 of the claim. Claim 6 recites “based on results of administering the DSST, the TMT, and the recall test” in lines 4 of the claim. It is unclear if there are other cognitive tests being administered or if there could be other results that would influence the assessing step.
Claim 10 recites “the assessing step” in line 1 of the claim. It is unclear how the assessing step from claim 6 which is “assessing the patient for one or both of mild cognitive impairment and the presence of β-amyloid burden, based on the results of based on results of administering the DSST, the TMT, and the recall test” is also assessing the demographic of the patient when the tests do not ask that question.
Claim 11 recites “the assessing step” in line 1 of the claim. It is unclear how the assessing step from claim 6 which is “assessing the patient for one or both of mild cognitive impairment and the presence of β-amyloid burden, based on the results of based on results of administering the DSST, the TMT, and the recall test” it is unclear how the results could change if they are only being assessed from these three tests and if there is another portion to the claimed cognitive screening tests that could impact the results.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 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.
Claim 1 is directed to “A medical process” (i.e. a process). The claims are directed to one of the four statutory categories (i.e. process, machine, manufacture, or composition of matter).
Step 1 of the subject-matter eligibility analysis: Yes.
However, the claims are drawn to an abstract idea of “assessing the patient for one or both of mild cognitive impairment” either in the form of “certain methods of organizing human activity,” in terms of managing personal behavior or relationships or interactions between people (including social activities, teaching and following rules or instructions), or reasonably in the form of “mental processes,” in terms of processes that can be performed in the human mind (including an observation, evaluation, judgement or opinion) which are “performed on a computer” (per MPEP 2106(III)(C) “A Claim That Requires a Computer May Still Recite a Mental Process”).
Regardless, the claims are reasonably understood as either “certain methods of organizing human activity” or “mental processes,” which require the following limitations:
Claim 1: “administering a digital symbol substitution test (DSST) to a patient; administering a trails marking test (TMT) to the patient after the administration of the DSST; and administering a recall test, wherein the recall test includes requesting the patient to recall digits and/or symbols from the DSST”
The Specification recites that these tests that are administrated are known cognitive screening tests that are given to patients (see at least: ¶24).
Claim 3: “wherein administering the DSST, the TMT, and/or the recall test is performed digitally”
Claim 6: “further comprising assessing the patient for one or both of mild cognitive impairment and a presence of p-amyloid burden, based on results of administering the DSST, the TMT, and the recall test.”
Claim 8: “determining one or more demographic characteristics of the patient.”
These limitations simply describe a process of data gathering and manipulation, which is partially analogous to “collecting information, analyzing it, and displaying certain results of the collection analysis” (i.e. Electric Power Group, LLC, v. Alstom, 830 F.3d 1350, 119 U.S.P.Q.2d 1739 (Fed. Cir. 2016)). Hence, these limitations are akin to an abstract idea which has been identified among non-limiting examples to be an abstract idea.
Step 2A, Prong 1 of the subject-matter eligibility analysis: Yes.
Furthermore, the claims do not include additional elements that either alone or in combination are sufficient to claim a practical application because to the extent that, e.g., “performed digitally” are claimed, as these are merely claimed to add insignificant extra-solution activity to the judicial exception (e.g., data gathering) and/or do no more than generally link the use of a judicial exception to a particular technological environment or field of use. In other words, the claimed “assessing the patient for one or both of mild cognitive impairment” is not providing a practical application.
Step 2A, Prong 2 of the subject-matter eligibility analysis: No.
Likewise, the claims do not include additional elements that either alone or in combination are sufficient to amount to significantly more than the judicial exception because to the extent that, e.g. “performed digitally” is claimed and the use of a digital test means that these are all generic, well-known, and conventional computing elements. As evidence that these are generic, well-known, and conventional computing elements, Applicant’s specification discloses them in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a), per MPEP § 2106.07(a) III (a), which satisfies the Examiner’s evidentiary burden requirement per the Berkheimer memo.
Specifically, the Applicant’s claimed cognitive screening test that can be completed “digitally,” is described in ¶24, as follows:
“[024] They may be hand drawn tests-pen to paper, or can be done digitally on a tablet, for example.”
This element is reasonably interpreted as a generic computer which provides no details of anything beyond ubiquitous standard equipment. As such, the claimed limitation of “digitally,” is reasonably understood as not providing anything significantly more
Step 2B, of the subject-matter eligibility analysis: No.
In addition, dependent claims 2-15 do not provide a practical application and are insufficient to amount to significantly more than the judicial exception. As such, dependent claims 2-15 are also rejected under 35 U.S.C. § 101, based on their respective dependencies to independent claim 1.
Therefore, claims 1-15 are rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3, 4-8, and 11-15 are rejected under 35 U.S.C. § 103 as being unpatentable over Judith Jaeger (“Digit Symbol Substitution Test” (2018); hereinafter Jaeger) view of Trail Making Test Wiki (“Trail Making Test” (2012); hereinafter TMT Wiki) in further view of Kuhman, Daniel & Joyner, Keanan & Bloomer, Richard. (2015) (“Cognitive Performance and Mood Following Ingestion of a Theacrine-Containing Dietary Supplement, Caffeine, or Placebo by Young Men and Women.” Nutrients. 7. 9618 – 9632; hereinafter Kuhman) and Michelle LaPlaca and David Wright (US 20070027406 A1; hereinafter LaPlaca).
Regarding claim 1, Jaeger discloses a medical process, comprising: administering a digital symbol substitution test (DSST) to a patient (utility of the DSST as a clinical tool in neuropsychology first became evident when it was shown to reliably distinguish patients with brain damage from healthy patients during the screening of soldiers in World War II. The use of the DSST widened after becoming incorporated in the Wechsler-Bellevue Intelligence Scale (WBIS), developed in 19392; the WBIS relied heavily on early versions of the DSST dating to at least 1900 (see at least: Jaeger NPL pg. 3; and FIG. 1 below);
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(FIG. 1: Screengrab from Jaeger pg. 3 of attached NPL)
However, Jaeger does not explicitly disclose administering a trails marking test (TMT) to the patient after the administration of the DSST and administering a recall test, wherein the recall test includes requesting the patient to recall digits and/or symbols from the DSST;
TMT Wiki teaches administering a trails marking test (TMT) to the patient (The Train Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as fast as possible while still maintaining accuracy (see at least: TMT Wiki NPL pg. 1; and FIG 2 below).
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(FIG. 2: Screengrab from TMT Wiki pg. 1 of attached NPL)
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included a TMT test as the one taught in TMT Wiki after the administration of the DSST test as taught by Jaeger for the added benefit of using well known cognitive screening tests (see at least: paragraph [0024] of the instant application that states these tests are known tests used for cognitive screening) to assess a patient.
Jaeger and TMT Wiki do not explicitly teach administering the TMT after the administration of the DSST and administering a recall test, wherein the recall test includes requesting the patient to recall digits and/or symbols from the DSST.
Kuhman teaches administering the TMT after the administration of the DSST (The TMT [16] and DSST [17] are commonly used as assessments of cognitive performance and provide numeric scores, which can then be used as objective indicators of condition effectiveness. Two practice trials were administered to subjects for both the DSST and the TMT (see at least: Kuhman pg. 9622 (16) of the attached NPL).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have used two different commonly used assessments of cognitive performances on patients/subjects in order as taught by Kuhman for the added benefit of properly assessing a patient’s scores.
Jaeger in view of TMT WIKI in further view of Kuhman do not explicitly teach administering a recall test, wherein the recall test includes requesting the patient to recall digits and/or symbols from the DSST.
LaPlaca teaches administering a recall test, wherein the recall test includes requesting the patient to recall digits and/or symbols from the DSST (memory tests were given to patients using a recall test (see at least: Table 6; and FIG. 15).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have used a recall test when conducting a cognitive screening test to see how much a patient is able to remember within a period of time.
Regarding claim 3, Jaeger in view of TMT Wiki in further view of Kuhman and LaPlaca teach the claimed matter as stated above and LaPlaca further suggests wherein administering the recall test is performed digitally (includes a display screen (see at least: LaPlaca paragraph [0054])). Also, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have implemented the tests using a digital platform/format as a predictable design choice for the use of computer technology to streamline existing commonly used cognitive screen testing.
Regarding claim 4, Jaeger in view of TMT Wiki in further view of Kuhman and LaPlaca teach the claimed matter as stated above and Kuhman further suggests wherein administering the DSST lasts approximately two minutes (For the DSST, subjects were provided with two minutes to record as many correct matching digits and symbols as they could (see at least: Kuhman pg. 9622 of NPL)).
Regarding claim 5, Jaeger in view of TMT Wiki in further view of Kuhman and LaPlaca teach the claimed matter as stated above and Kuhman further suggests wherein administering the recall test is within six minutes of completion of administering the DSST (During the immediate 5 min before beginning testing at each of the testing times, subjects were seated quietly in a chair (see at least: Kuhman pg. 9662 (16).
Regarding claim 6, Jaeger in view of TMT Wiki in further view of Kuhman and LaPlaca teach the claimed matter as stated above and Jaeger further suggests assessing the patient for one of mild cognitive impairment (The DSST is a valid and sensitive measure of cognitive dysfunction impacted by many domains. Performance on the DSST correlates with real-world functional outcomes (e.g., the ability to accomplish everyday tasks) and recovery from functional disability in a range of psychiatric conditions including schizophrenia and major depressive disorder (see at least: Jaeger pg. 2).
Regarding claim 7, Jaeger in view of TMT Wiki in further view of Kuhman and LaPlaca teach the claimed matter as stated above and Kuhman further suggests wherein the assessing step accounts for no other cognitive test administered to the patient (see at least: Section 2.5 of Kuhman attached NPL pgs 2621-2622 where the only tests being offered are the cognitive screening tests).
Regarding claim 8, Jaeger in view of TMT Wiki in further view of Kuhman and LaPlaca teach the claimed matter as stated above and Kuhman suggests further comprising determining one or more demographic characteristics of the patient (see at least: All 20 subjects successfully completed the study; however, data were not obtained for one male subject during the placebo condition at 2 h collection time (due to an oversight on the part of the investigators). Subject characteristics are presented in Table 1. As expected, some differences were noted between men and women for the various characteristics assessed (e.g., height, weight, and waist circumference) (see at least: Kuhman pg. 9623 of NPL)).
Regarding claim 11, Jaeger in view of TMT Wiki in further view of Kuhman and LaPlaca teach the claimed matter as stated above and Kuhman suggests The medical process of claim 6, wherein the assessing step is based on only the results of administering the DSST, the TMT, and the recall test (The TMT [16] and DSST [17] are commonly used as assessments of cognitive performance and provide numeric scores, which can then be used as objective indicators of condition effectiveness. Two practice trials were administered to subjects for both the DSST and the TMT, and some learning effects are expected [18,19]. Different versions of each test were provided to subjects at all assessment times and attempts were made to provide equal difficulty for all tests (see at least: Kuhman pg. 9622))..
Regarding claim 12, Jaeger in view of TMT Wiki in further view of Kuhman and LaPlaca teach the claimed matter as stated above and TMT Wiki further suggests wherein administering the TMT includes administering a first portion and a second portion (The Train Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as fast as possible while still maintaining accuracy (see at least: TMT Wiki pg. 1), and administering the recall test is immediately after completion of administering the TMT.
It would have been obvious for a person having ordinary skill in the art before the effective filing date to modify the TMT assessment as taught by TMT Wiki to assess a recall test because it's a predictable design choice and an expected feature of cognitive assessments since the patient will have to recall the assessment they just took.
Regarding claim 13, Jaeger in view of TMT Wiki in further view of Kuhman and LaPlaca teach the claimed matter as stated above and Jaeger further suggests wherein administering the recall test further includes requesting the patient to recall as many digits or symbols as possible from the DSST (The DSST is sensitive to the presence of cognitive dysfunction as well as to change in cognitive function across a wide range of clinical populations but has low specificity to determine exactly which cognitive domain has been affected. However, the DSST offers a practical and effective method to monitor cognitive functions over time in clinical practice (see at least: Jaeger pg. 2).
Regarding claim 14, Jaeger in view of TMT Wiki in further view of Kuhman and LaPlaca teach the claimed matter as stated above and Kuhman further suggests where no cognitive test is administered to the patient between administering the DSST and administering the TMT, and between administering the TMT and administering the recall test (see at least: Section 2.5 of Kuhman attached NPL pgs 2621-2622 where the only tests being offered are the cognitive screening tests). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have administered cognitive screening tests to patients without distractions in between to properly determine and assess how a person who may have a cognitive dysfunction responds to the assessments.
Regarding claim 15, Jaeger in view of TMT Wiki in further view of Kuhman and LaPlaca teach the claimed matter as stated above and TMT Wiki further suggests wherein administering the TMT includes administering a first portion and a second portion (see at least: Section 2.5 of Kuhman attached NPL pgs 2621-2622 where the only tests being offered are the cognitive screening tests).
Claim 2 is rejected under Jaeger in view of TMT Wiki, Kuhman, and LaPlaca in further view of in further view of Protopapas (US 5868683 A).
Regarding claim 2, Jaeger in view of TMT Wiki in further view of Kuhman and LaPlaca teach the claimed matter as stated above; however, they do not explicitly disclose wherein the medical process is completed within approximately 10 minutes.
Protopapas teaches wherein the medical process is completed within approximately 10 minutes (Another test, termed "rapid naming," consists in the verbal report of the identity of a number of drawings of familiar objects and animals. The number of drawings that can be named in a predefined time interval (e.g., one minute) is believed to relate to the facility with which reading will likely be initiated (see at least: Protopapas [column 1, lines 57-64])).
It would have been obvious for a person having ordinary skill in the art before the effective filing date to modify the DSST cognitive screening test as taught by Jaeger with Protopapas's teaching of a time interval during test taking to have an administration time limit as a predictable design choice since a time limit is an expected feature of cognitive assessments.
Claims 9-10 are rejected under Jaeger in view of TMT Wiki, Kuhman, and LaPlaca in further view of in further in view of Amarashingham (US 20150025329 A1) in further view of Hettrick (US 20180236235 A1).
Regarding claim 9, Jaeger in view of TMT Wiki in further view of Kuhman and LaPlaca teach the claimed matter as stated above; however, they do not explicitly disclose wherein the demographic characteristics include age, education, gender, and genetic disposition.
Amarashingham teaches wherein the demographic characteristics include age, education, gender, and genetic disposition (wherein the clinical and non-clinical data are selected from the group consisting of: past medical history, age, weight, height, race, gender, marital status, education, address, housing status, allergy and adverse medical reactions, family medical information, prior surgical information, emergency room records, medication administration records, culture results, clinical notes and records, gynecological and obstetric information, mental status examination, vaccination records, radiological imaging exams, invasive visualization procedures, psychiatric treatment information, prior histological specimens, laboratory results, genetic information (see at least: Amarashingham claim 9).
It would have been obvious for a person having ordinary skill in the art before the effective filing date to include teachings of Amarashingham to assess demographic characteristics in the evaluation of patient information to see if there are correlations for future studies.
However, Jaeger in view of TMT Wiki, Kuhman, and LaPlaca in further view of Amarashingham do not explicitly teach wherein the genetic disposition includes the presence of a ApoE genotype.
Hettrick teaches wherein the genetic disposition includes the presence of a ApoE genotype (genetic variances can constitute dementia predictors or risk factors in certain patients. For example, a patient presenting a high or increased risk of developing dementia can have a genetic disorder or determined genetic pre-disposition to developing dementia. In a particular example, a specific form of the apolipoprotein E gene, APOE-ε4, is linked to Alzheimer's disease. A genetic predisposition may also cause the early onset of cognitive decline, and in some cases present a high risk of developing early onset dementia (e.g., EOFAD) (see at least: Hettrick paragraph [0043])).
It would have been obvious for one in ordinary skill in the art before the effective filing date in the claimed invention to have included the teachings of Hettrick because patient presenting a high or increased risk of developing dementia can have a genetic disorder or determined genetic pre-disposition to developing dementia. In a particular example, a specific form of the apolipoprotein E gene (see at least: Hettrick paragraph [0043]).
Regarding claim 10, Jaeger in view of TMT Wiki, Kuhman, and LaPlaca in further view of Amarashingham and Hettrick teach the claimed matter as stated above, and Amarashingham further teaches wherein the assessing step accounts for one or more of the demographic characteristics (wherein the clinical and non-clinical data are selected from the group consisting of: past medical history, age, weight, height, race, gender, marital status, education, address, housing status, allergy and adverse medical reactions, family medical information, prior surgical information, emergency room records, medication administration records, culture results, clinical notes and records, gynecological and obstetric information, mental status examination, vaccination records, radiological imaging exams, invasive visualization procedures, psychiatric treatment information, prior histological specimens, laboratory results, genetic information (see at least: Amarashingham claim 9).
Conclusion
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/SELWA A ALSOMAIRY/Examiner, Art Unit 3715
/PETER S VASAT/Supervisory Patent Examiner, Art Unit 3715