DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
The Claims are objected to because of the following informalities:
In Claim 7, the term ‘wherein the parameters of hepatic encephalopathy comprise a high, low or medium risk:
- "low" meaning "low probability of developing a HE event";
- "medium" meaning a "high probability of developing a HE event";
- "High" meaning "detection of a HE event at the time of patient taking the test".’ should be replaced with -- wherein the parameters of hepatic encephalopathy comprise a [[high, low]] Low, Medium, or [[medium]]High risk:
- “Low” [["low"]] meaning "low probability of developing a HE event";
-“Medium” [["medium"]] meaning a "high probability of developing a HE event";
- "High" meaning "detection of a HE event at the time of patient taking the test". -- for claim consistency. Mirrored changes should be made to Claim 15.
In Claim 12, the term “a step for interpreting to interpret the test results, in order to determine parameters of hepatic encephalopathy,
a step for providing to provide a diagnosis aid based on the parameters of hepatic encephalopathy,” should be replaced with -- a step for interpreting the test results, in order to determine parameters of hepatic encephalopathy,
a step for providing a diagnosis aid based on the parameters of hepatic encephalopathy,-- to correct a grammatical error.
In Claim 17, the term “a step for reminding to signal or remind the patient that a new animal recognition test is to be performed.” Should be replaced with -- a step for reminding the patient that a new animal recognition test is to be performed.-- for grammatical clarity.
In Claim 19, the term “A computer program product comprising instructions which, when the program is executed by one or more computerised unit, causes the said computerised unit to carry out steps of a computer-implemented method for assessing hepatic encephalopathy of at least one patient” should be replaced with -- A computer program product comprising instructions which, when the program is executed by one or more computerised units, causes the said computerised units to carry out steps of a computer-implemented method for assessing hepatic encephalopathy of at least one patient -- to correct a grammatical error.
In Claim 19, the term “a step for interpreting to interpret the test results, in order to determine parameters of hepatic encephalopathy,
a step for providing to provide a diagnosis aid based on the parameters of hepatic encephalopathy,” should be replaced with -- a step for interpreting the test results, in order to determine parameters of hepatic encephalopathy,
a step for providing a diagnosis aid based on the parameters of hepatic encephalopathy,-- to correct a grammatical error.
Appropriate correction is required and applicant should carefully review the Claims for any other informalities.
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.
Claim(s) 1, 3, 6, 10, 12, 13, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forbes et al (US 2011/0035232) (“Forbes”) in view of Macallister et al (US 2023/0321114) (“Macallister”) and further in view of Amodio (“Hepatic encephalopathy: Diagnosis and management”) and further in view of Lee et al (US 2017/0181685) (Lee”).
Regarding Claim 1, while Forbes teaches a system for assessing hepatic encephalopathy of at least one patient (Abstract), the system comprising:
A patient device, the patient device being configured to be used to take at least one test for assessing hepatic encephalopathy, and to determine test results ([0055] flicker box” and measurement device, the measurement device measuring critical flicker frequency of a subject);
at least one interpretation device receiving the test results and configured to interpret the test results in order to determine parameters of hepatic encephalopathy ([0053]-[0055] tests results of CFF used to determine parameters of hepatic encephalopathy, [0095], [0104]-[0106], [0213]-[0215] how tests results should be interpreted),
the system being configured to receive at least the parameters of hepatic encephalopathy to provide a diagnosis aid (Abstract, [0053]-[0055], [0095], [0104]-[0106], [0213]-[0215] how tests results of CFF should be interpreted, thus acting as a diagnostic aid),
and further teaches that hepatic encephalopathy manifests in impaired memory, poor concentration, can be recognized in cognitive tasks/mental status examinations, and is diagnosed by a variety of patient parameters ([0105]-[0106]);
and further teaches that the method of the invention can be accomplished by software with various modules distributed across a network ([0222] e.g. server, sending remote clients, receiving remote clients);
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the testing, interpreting, receiving, and providing functions of described by Forbes can be accomplished by software modules as taught by Forbes to provide efficient hepatic encephalopathy monitoring and treating, at a variety of locations convenient to the user. Furthermore, the implementation of interpretation and receipt of parameters of hepatic encephalopathy in a software module as described fulfills the limitation of “at least one practitioner application module for at least one practitioner device” as the practitioner device is not positively claimed as part of the system.
Yet Forbes fails to teach
the patient application modules being configured to be used to take at least one animal recognition test for assessing hepatic encephalopathy, and to determine test results;
wherein the animal recognition test is based on animal images and corresponding text descriptions from a junior school repertoire, the text descriptions being names of animals to be selected; and
wherein the animal recognition test is made without colour shades parameters.
However Macallister teaches an evaluation of cognitive decline (Abstract) may include an animal recognition test that tests working memory, wherein the animal recognition test is based on animal images and corresponding text descriptions, the text descriptions being names of animals to be selected ([0106], Table 2, list sorting test provides pictures, written names, and audio names of food and animals, has subject recite the animals in order from smallest to largest as a single task, and then has subject recite the foods, then animals in order from smallest to largest as a single task. This test requires recognition of animals to identify relative sizes between different animals, where the written names of the animals are corresponding text descriptions of animals selected in the sorting).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that a cognitive task based on impaired memory as taught by Macallister would be useful for Forbes as this tests for the memory deficit sought by Forbes. Further, a testing of working memory specifically is desirable in the context of hepatic encephalopathy as this appears in the mild brain dysfunction of covert hepatic encephalopathy (Amodio: p967-968, 2 | Diagnosis and Classification of Hepatic Encephalopathy and Table 1). And Amodio further confirms the applicability of an animal-related cognitive task as it notes the success of an animal naming test for screening for hepatic encephalopathy (p967-968, 2 | Diagnosis and Classification of Hepatic Encephalopathy). Finally, Applicant defines a test made without colour shades parameters as “a test in which a clear distinction and understanding of different colours and/or different colour shades is not a parameter which intervene in the understanding and/or the completion of the test.” As the test described by Macallister is accompanied by written names and audio names of the animals, a colour of the visualized animal will not intervene in the understanding and/or completion of the test and the limitation is met.
Yet their combined efforts fail to teach wherein the animal recognition test is based on animal images and corresponding text descriptions from a junior school repertoire.
However Lee teaches a cognitive impairment analysis (Abstract) comprising an animal-based cognitive task ([0011]) and further teaches that animal-based cognitive tasks can be applied in a manner that is minimally influenced by level of education ([0016]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the testing of Forbes and Macallister be applied in a form independent of level of education as taught by Lee as this makes the tests easier to administer. And one of ordinary skill in the art would understand that animal-related cognitive testing that is independent of education reflects animals recognized at a very early age, indicating animals recognized from a junior school repertoire. Further, Lee states testing judgement is also reflective of working memory ([0005]), confirming an applicability of the details of a judgement-based animal recognition tests of Lee to the judgement-based animal recognition tests of Macallister.
Regarding Claim 3, Forbes, Macallister, Amodio, and Lee teaches the system according to claim 1, and Lee teaches that cognitive testing includes modules and a device for presenting a test to a patient ([0034]-[0036]), where the animal recognition test is provided to the user by a user interface device ([0034] cognitive testing program facilitated by user interface devices and software, [0035] “User interface devices can include display screen(s), keyboard(s), a mouse, stylus, modems or other networking hardware/firmware, etc., or any combination thereof.” Where a visual presentation of Macallister requires a display screen and a user can provide their answer in Macallister by keyboard), thus teaching an animal recognition test is made by typing the right animal image or the right text description on a tactile screen.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the animal recognition test of Forbes and Macallister be performed with the user answering by keyboard as taught by Lee as a standardized way to provide the test to all users, ensuring consistency across trials of the test.
Regarding Claim 6, Forbes, Macallister, Amodio, and Lee teach the system according to claim 1, and Forbes teaches wherein the parameters of hepatic encephalopathy comprise a positive/negative diagnosis, or a positive/negative probability ([0214], [0220]).
Regarding Claim 10, Forbes, Macallister, Amodio, and Lee teach the system according to claim 1, and Lee teaches a system further comprising at least one patient device comprising a corresponding patient module; at least one practitioner device comprising a corresponding practitioner module; and at least one server comprising the interpretation module. ([0034]-[0036] programs may be distributed across a network, with corresponding devices for the user and for the clinician, components of the assessment can be provided at a server).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to utilize devices distributed across a network as taught by Lee for the delivery and processing of the cognitive testing of Forbes and Macallister as this provides greater convenience to all parties by enabling the user to take a test at home, a clinician to review the results at the clinic at a convenient time, and a remote server to house necessary computation components outside of the user’s home and clinician’s clinic.
Regarding Claim 12, while Forbes teaches a computer-implemented method for assessing hepatic encephalopathy of at least one patient (Abstract, [0051], [0055]), the method comprising:
a step for taking at least one test to assess hepatic encephalopathy, and to determine test results ([0055] measuring critical flicker frequency of a subject);
a step for interpreting to interpret the test results, in order to determine parameters of hepatic encephalopathy ([0053]-[0055] tests results of CFF used to determine parameters of hepatic encephalopathy, [0095], [0104]-[0106], [0213]-[0215] how tests results should be interpreted),
a step for providing a diagnosis aid based on the parameters of hepatic encephalopathy (Abstract, [0053]-[0055], [0095], [0104]-[0106], [0213]-[0215] how tests results of CFF should be interpreted, thus acting as a diagnostic aid),
and further teaches that hepatic encephalopathy manifests in impaired memory, poor concentration, can be recognized in cognitive tasks/mental status examinations, and is diagnosed by a variety of patient parameters ([0105]-[0106]);
and further teaches that the method of the invention can be accomplished as a distributed computer-implement method ([0222] e.g. server, sending remote clients, receiving remote clients);
Forbes fails to teach
taking at least one animal recognition test to assess hepatic encephalopathy, and to determine test results;
wherein the animal recognition test is based on animal images and corresponding text descriptions from a junior school repertoire, the text descriptions being names of animals to be selected; and
wherein the animal recognition test is made without colour shades parameters.
However Macallister teaches an evaluation of cognitive decline (Abstract) may include an animal recognition test that tests working memory, wherein the animal recognition test is based on animal images and corresponding text descriptions, the text descriptions being names of animals to be selected ([0106], Table 2, list sorting test provides pictures, written names, and audio names of food and animals, has subject recite the animals in order from smallest to largest as a single task, and then has subject recite the foods, then animals in order from smallest to largest as a single task. This test requires recognition of animals to identify relative sizes between different animals, where the written names of the animals are corresponding text descriptions of animals selected in the sorting).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that a cognitive task based on impaired memory as taught by Macallister would be useful for Forbes as this tests for the memory deficit sought by Forbes. Further, a testing of working memory specifically is desirable in the context of hepatic encephalopathy as this appears in the mild brain dysfunction of covert hepatic encephalopathy (Amodio: p967-968, 2 | Diagnosis and Classification of Hepatic Encephalopathy and Table 1). And Amodio further confirms the applicability of an animal-related cognitive task as it notes the success of an animal naming test for screening for hepatic encephalopathy (p967-968, 2 | Diagnosis and Classification of Hepatic Encephalopathy). Finally, Applicant defines a test made without colour shades parameters as “a test in which a clear distinction and understanding of different colours and/or different colour shades is not a parameter which intervene in the understanding and/or the completion of the test.” As the test described by Macallister is accompanied by written names and audio names of the animals, a colour of the visualized animal will not intervene in the understanding and/or completion of the test and the limitation is met.
Yet their combined efforts fail to teach wherein the animal recognition test is based on animal images and corresponding text descriptions from a junior school repertoire.
However Lee teaches a cognitive impairment analysis (Abstract) comprising an animal-based cognitive task ([0011]) and further teaches that animal-based cognitive tasks can be applied in a manner that is minimally influenced by level of education ([0016]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the testing of Forbes and Macallister be applied in a form independent of level of education as taught by Lee as this makes the tests easier to administer. And one of ordinary skill in the art would understand that animal-related cognitive testing that is independent of education reflects animals recognized at a very early age, indicating animals recognized from a junior school repertoire. Further, Lee states testing judgement is also reflective of working memory ([0005]), confirming an applicability of the details of a judgement-based animal recognition tests of Lee to the judgement-based animal recognition tests of Macallister.
Regarding Claim 13, Forbes, Macallister, Amodio, and Lee teaches the method according to claim 12, and Lee teaches that cognitive testing includes presenting a test to a patient ([0034]-[0036]), where the animal recognition test is provided to the user by a user interface device ([0034] cognitive testing program facilitated by user interface devices and software, [0035] “User interface devices can include display screen(s), keyboard(s), a mouse, stylus, modems or other networking hardware/firmware, etc., or any combination thereof.” Where a visual presentation of Macallister requires a display screen and a user can provide their answer in Macallister by keyboard), thus teaching an animal recognition test is made by typing the right animal image or the right text description on a tactile screen.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the animal recognition test of Forbes and Macallister be performed with the user answering by keyboard as taught by Lee as a standardized way to provide the test to all users, ensuring consistency across trials of the test.
Regarding Claim 18, Forbes, Macallister, Amodio, and Lee teach the method according to claim 12, and Lee teaches a step for taking a test is made through at least one patient device;
A step for providing is made through at least one practitioner device; and
a step for interpreting is made through at least one server ([0034]-[0036] steps may be distributed across a network, with corresponding devices for the user and for the clinician, components of the assessment can be provided at a server).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to perform steps of the method distributed across a network as taught by Lee for the delivery and processing of the cognitive testing of Forbes and Macallister as this provides greater convenience to all parties by enabling the user to take a test at home, a clinician to review the results at the clinic at a convenient time, and a remote server to house necessary computation components outside of the user’s home and clinician’s clinic.
Regarding Claim 19, while Forbes teaches a computer program product comprising instructions which, when the program is executed by one or more computerised unit, causes the said computerised unit to carry out steps of a computer-implemented method for assessing hepatic encephalopathy of at least one patient (Abstract, [0051], [0055], [0222] the method of the invention can be accomplished by software with various modules distributed across a network, e.g. server, sending remote clients, receiving remote clients), the method comprising:
a step for taking at least one test to assess hepatic encephalopathy, and to determine test results ([0055] measuring critical flicker frequency of a subject);
a step for interpreting the test results, in order to determine parameters of hepatic encephalopathy ([0053]-[0055] tests results of CFF used to determine parameters of hepatic encephalopathy, [0095], [0104]-[0106], [0213]-[0215] how tests results should be interpreted),
a step for providing a diagnosis aid based on the parameters of hepatic encephalopathy (Abstract, [0053]-[0055], [0095], [0104]-[0106], [0213]-[0215] how tests results of CFF should be interpreted, thus acting as a diagnostic aid),
and further teaches that hepatic encephalopathy manifests in impaired memory, poor concentration, can be recognized in cognitive tasks/mental status examinations, and is diagnosed by a variety of patient parameters ([0105]-[0106]);
and further teaches that the method of the invention can be accomplished as a distributed computer-implement method ([0222] e.g. server, sending remote clients, receiving remote clients);
Forbes fails to teach
taking at least one animal recognition test to assess hepatic encephalopathy, and to determine test results;
wherein the animal recognition test is based on animal images and corresponding text descriptions from a junior school repertoire, the text descriptions being names of animals to be selected; and
wherein the animal recognition test is made without colour shades parameters.
However Macallister teaches an evaluation of cognitive decline (Abstract) may include an animal recognition test that tests working memory, wherein the animal recognition test is based on animal images and corresponding text descriptions, the text descriptions being names of animals to be selected ([0106], Table 2, list sorting test provides pictures, written names, and audio names of food and animals, has subject recite the animals in order from smallest to largest as a single task, and then has subject recite the foods, then animals in order from smallest to largest as a single task. This test requires recognition of animals to identify relative sizes between different animals, where the written names of the animals are corresponding text descriptions of animals selected in the sorting).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that a cognitive task based on impaired memory as taught by Macallister would be useful for Forbes as this tests for the memory deficit sought by Forbes. Further, a testing of working memory specifically is desirable in the context of hepatic encephalopathy as this appears in the mild brain dysfunction of covert hepatic encephalopathy (Amodio: p967-968, 2 | Diagnosis and Classification of Hepatic Encephalopathy and Table 1). And Amodio further confirms the applicability of an animal-related cognitive task as it notes the success of an animal naming test for screening for hepatic encephalopathy (p967-968, 2 | Diagnosis and Classification of Hepatic Encephalopathy). Finally, Applicant defines a test made without colour shades parameters as “a test in which a clear distinction and understanding of different colours and/or different colour shades is not a parameter which intervene in the understanding and/or the completion of the test.” As the test described by Macallister is accompanied by written names and audio names of the animals, a colour of the visualized animal will not intervene in the understanding and/or completion of the test and the limitation is met.
Yet their combined efforts fail to teach wherein the animal recognition test is based on animal images and corresponding text descriptions from a junior school repertoire.
However Lee teaches a cognitive impairment analysis (Abstract) comprising an animal-based cognitive task ([0011]) and further teaches that animal-based cognitive tasks can be applied in a manner that is minimally influenced by level of education ([0016]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the testing of Forbes and Macallister be applied in a form independent of level of education as taught by Lee as this makes the tests easier to administer. And one of ordinary skill in the art would understand that animal-related cognitive testing that is independent of education reflects animals recognized at a very early age, indicating animals recognized from a junior school repertoire. Further, Lee states testing judgement is also reflective of working memory ([0005]), confirming an applicability of the details of a judgement-based animal recognition tests of Lee to the judgement-based animal recognition tests of Macallister.
Claim(s) 4-5 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forbes in view of Macallister and further in view of Amodio and further in view of Lee and further in view of Singer et al (US 2017/0188932) (“Singer”) and further in view of Smith et al (US 2009/0313047) (“Smith”) as noted in Applicant IDS dated 6/06/2024.
Regarding Claim 4, while Forbes, Macallister, Amodio, and Lee teach the system according to claim 1, and Forbes teaches patient parameters may be judged against baselines ([0047]), and Lee teaches wherein the test results include a time to respond to each question ([0043]), how a number of intrusions (i.e. animals not included in the task but included in the answer of the user) represents a failure of proper recall ([0051]-[0052]), and how successful pairings and recall failures can be utilized diagnostically ([0078]), their combined efforts fail to teach the test results comprise at least:
- a time to perform the test compared to a time baseline or median or mean;
- a number of failed or successfully completed tests, and
- a number of test attempts.
However Singer teaches a system for cognitive testing of brain state (Abstract) comprising one or more cognitive tests involving generating a score based on time to complete tests and number of errors, where these values are judged against normative or patient baselines, and where these cognitive tests are based on working memory ([0061], [0063] where a test performed with no errors would be recognized as a successfully completed test).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to judge the animal recognition test of Forbes, Macallister, and Lee by parameters such as a time to perform the test compared to a time baseline and a successfully completed test as taught by Singer as a way to evaluate the working memory test of Macallister and generate the diagnosis of Forbes with standardized parameters -- ensuring consistent results across applications of the invention.
Yet their combined efforts fail to teach the test results comprise at least a number of test attempts.
However Smith teaches a brain condition assessment system (Abstract) that comprises recall tests with a varying number of trials for training and testing a patient ([0039]) and further teaches that recall of answers will be specific to the number of trials and should be analyzed accordingly ([0039]-[0045] scoring element specific t number of trials, posterior probabilities of responses are specific to number of trials).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to judge the one or more timed tests of Singer by number of attempts as taught by Smith as this influences the probabilities of certain scores in the brain condition assessment (e.g. accounting for expected improvement across multiple trials of the test).
Regarding Claim 5, while Forbes, Macallister, Amodio, Lee, Singer, and Smith teach the system according to claim 4, wherein the test results comprise the time to perform, the number of failed or successfully completed tests, and the number of attempts (See Claim 5 Rejection), wherein the test results comprise a score scaling a combination of parameters ([0069]-[0070] various measured features may be scaled and combined to create a summary index score).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the measured parameters of Singer and Smith as a scaled combination score taught by Singer to provide a standardized method to judge the disparate parameters, ensuring consistency across applications of the invention.
Regarding Claim 14, while Forbes, Macallister, Amodio, and Lee teach the method according to claim 12, and Forbes teaches patient parameters may be judged against baselines ([0047]), and Lee teaches wherein the test results include a time to respond to each question ([0043]), how a number of intrusions (i.e. animals not included in the task but included in the answer of the user) represents a failure of proper recall ([0051]-[0052]), and how successful pairings and recall failures can be utilized diagnostically ([0078]), their combined efforts fail to teach the test results comprise at least:
- a time to perform the test compared to a time baseline or median or mean;
- a number of failed or successfully completed tests, and
- a number of test attempts.
However Singer teaches a system for cognitive testing of brain state (Abstract) comprising one or more cognitive tests involving generating a score based on time to complete tests and number of errors, where these values are judged against normative or patient baselines, and where these cognitive tests are based on working memory ([0061], [0063] where a test performed with no errors would be recognized as a successfully completed test).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to judge the animal recognition test of Forbes, Macallister, and Lee by parameters such as a time to perform the test compared to a time baseline and a successfully completed test as taught by Singer as a way to evaluate the working memory test of Macallister and generate the diagnosis of Forbes with standardized parameters -- ensuring consistent results across applications of the invention.
Yet their combined efforts fail to teach the test results comprise at least a number of test attempts.
However Smith teaches a brain condition assessment system (Abstract) that comprises recall tests with a varying number of trials for training and testing a patient ([0039]) and further teaches that recall of answers will be specific to the number of trials and should be analyzed accordingly ([0039]-[0045] scoring element specific t number of trials, posterior probabilities of responses are specific to number of trials).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to judge the one or more timed tests of Singer by number of attempts as taught by Smith as this influences the probabilities of certain scores in the brain condition assessment (e.g. accounting for expected improvement across multiple trials of the test).
Regarding Claim 15, while Forbes, Macallister, Amodio, and Lee teach the method according to claim 14, their combined efforts fail to teach wherein the parameters of hepatic encephalopathy comprise a high, low or medium risk:
- "Low" meaning "low probability of developing a HE event";
- "Medium" meaning a "high probability of developing a HE event";
- "High" meaning "detection of a HE event at the time of patient taking the test".
However Smith teaches a brain condition assessment system (Abstract) that comprises recall tests with a varying number of trials for training and testing a patient ([0039]) and further teaches that an identification of a brain condition from response parameters can be optimized for a high probability of the brain condition being present ([0048]-[0051] evaluation of a condition can be optimized for a high specificity, ensuring there is a high risk / high probability the identification of hepatic encephalopathy of the patient is accurate).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to optimize the analysis and diagnosing of hepatic encephalopathy of Forbes, Macallister, Amodio, and Lee for a high specificity and thus a high risk the patient is experiencing hepatic encephalopathy as taught by Smith as a way to achieve a desired accuracy.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forbes in view of Macallister and further in view of Amodio and further in view of Lee and further in view of Smith.
Regarding Claim 7, while Forbes, Macallister, Amodio, and Lee teach the system according to claim 6, their combined efforts fail to teach wherein the parameters of hepatic encephalopathy comprise a high, low or medium risk:
- "Low" meaning "low probability of developing a HE event";
- "Medium" meaning a "high probability of developing a HE event";
- "High" meaning "detection of a HE event at the time of patient taking the test".
However Smith teaches a brain condition assessment system (Abstract) that comprises recall tests with a varying number of trials for training and testing a patient ([0039]) and further teaches that an identification of a brain condition from response parameters can be optimized for a high probability of the brain condition being present ([0048]-[0051] evaluation of a condition can be optimized for a high specificity, ensuring there is a high risk / high probability the identification of hepatic encephalopathy of the patient is accurate).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to optimize the analysis and diagnosing of hepatic encephalopathy of Forbes, Macallister, Amodio, and Lee for a high specificity and thus a high risk the patient is experiencing hepatic encephalopathy as taught by Smith as a way to achieve a desired accuracy.
Claim(s) 8-9 and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forbes in view of Macallister and further in view of Amodio and further in view of Lee and further in view of Ramachandran et al (US 2015/0359477) (“Ramachandran”) as noted in Applicant IDS dated 6/06/2024.
Regarding Claim 8, while Forbes, Macallister, Amodio, and Lee teach the system according to claim 1, their combined efforts fail to teach the system further comprising a prescription module to prescribe at least one new animal recognition test to be performed through the patient module of a patient.
However Ramachandran teaches a system for assessing cognitive impairment (Abstract) where the system comprises an assessment request function ([0055], [0057] communication processor requests an assessment task from a user device, [0016] where the assessments are done to identify cognitive impairment in relation to previous baseline tasks).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that a request/prescription of an assessment for the purpose of identifying cognitive impairment as taught by Ramachandran applied to the hepatic encephalopathy testing of Forbes, Macallister, Amodio, and Lee enables a practitioner to quickly and conveniently test the subject, regardless of whether the subject is in a clinical setting, if hepatic encephalopathy becomes a concern.
Regarding Claim 9, while Forbes, Macallister, Amodio, and Lee teach the system according to claim 1, their combined efforts fail to teach the system further comprising a reminder module configured to signal or remind the patient that a new animal recognition test is to be performed.
However Ramachandran teaches a system for assessing cognitive impairment (Abstract) where the system comprises a test reminder process that requests a subject take an assessment to maintain a current baseline of the subject ([0066], [0076], [0079]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide a reminder module configured to signal or remind the patient that a new animal recognition test is to be performed as taught by Ramachandran for the hepatic encephalopathy testing of Forbes, Macallister, Amodio, and Lee as this provides a rolling baseline of the subject as a comparison point with which to judge a decline in memory.
Regarding Claim 16, while Forbes, Macallister, Amodio, and Lee teach the method according to claim 12, their combined efforts fail to teach the method further comprising a step for prescribing at least one new animal recognition test to be performed by a patient.
However Ramachandran teaches a system for assessing cognitive impairment (Abstract) where the system comprises an assessment request function ([0055], [0057] communication processor requests an assessment task from a user device, [0016] where the assessments are done to identify cognitive impairment in relation to previous baseline tasks).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that a request/prescription of an assessment for the purpose of identifying cognitive impairment as taught by Ramachandran applied to the hepatic encephalopathy testing of Forbes, Macallister, Amodio, and Lee enables a practitioner to quickly and conveniently test the subject, regardless of whether the subject is in a clinical setting, if hepatic encephalopathy becomes a concern.
Regarding Claim 17, while Forbes, Macallister, Amodio, and Lee teach the method according to claim 12, their combined efforts fail to teach the system further comprising a step for reminding the patient that a new animal recognition test is to be performed.
However Ramachandran teaches a system for assessing cognitive impairment (Abstract) where the system comprises a test reminder process that requests a subject take an assessment to maintain a current baseline of the subject ([0066], [0076], [0079]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide a reminder module configured to signal or remind the patient that a new animal recognition test is to be performed as taught by Ramachandran for the hepatic encephalopathy testing of Forbes, Macallister, Amodio, and Lee as this provides a rolling baseline of the subject as a comparison point with which to judge a decline in memory.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached on M-F 9:00 am - 5:15 pm.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791