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
Claim 8 and 16 objected to because of the following informalities:
Claim 8, line 2, “one or more mental health conditions” should read “the one or more mental health conditions”.
Claim 16, line 2, “the presence of one or more DSM-5 disorders” should read “a presence of one or more DSM-5 disorders”.
Appropriate correction is required.
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 1-20 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. The claims are directed to at least one of abstract idea groupings, according to the 2019 Revised Patent Subject Matter Guidelines (Mathematical Concepts, Mental Processes and/or Certain Methods of Organizing Human Activity). Further, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception as discussed below.
Step 1 of the 2019 Revised Patent Subject Matter Eligibility Guidance
More specifically, regarding Step 1 of the 2019 Revised Patent Subject Matter Eligibility Guidance, the claims are directed to a system and/or process, which is are statutory categories of invention.
Step 2A-1 of the 2019 Revised Patent Subject Matter Eligibility Guidance
Next, the claims are analyzed to determine whether it is directed to a judicial exception.
Independent claim 5 recites the following, with the abstract ideas highlighted in bold, including an indication as to the abstract idea grouping(s) to which the indicated limitations belong to, according to the 2019 Revised Patent Subject Matter Guidelines. Independent claims 1 and 11, having substantially similar features, were also analyzed and to which the following conclusion is also applicable:
A system comprising: a host computing device that includes a web server and an application server; and a user device in communication with the host computing device by way of a communication framework to provide a user access to an assessment platform via the web server and the application server; wherein the assessment platform comprises: a screening engine that provides screening tests, confirmatory tests, or questionnaires to a user and receives input from the user via a display device; a testing engine that assesses information gained from the screening tests, confirmatory tests, or questionnaires against a set of condition-specific rating scales to determine diagnostic specifiers that are indicative of existence, non-existence, or likelihood of one or more mental health conditions; and a report generator that generates a report based on the diagnostic specifiers.
The limitations in claim 5 (as well as claim(s) 1 and 11) recites an abstract idea included in the groupings of mental processes, connected to technology only through application thereof using generic computing elements (e.g., computing device, etc.) and/or insignificant extra-solution activity. According to the 2019 Revised Patent Subject Matter Guidelines:
Mental Processes include concepts performed in the human mind (including an observation, evaluation, judgement, opinion);
Specifically, the instant claims include functions/limitations, as highlighted in the independent claim above, that constitute at least:
D. Concepts performed in the human mind (e.g., “providing tests or questionnaires, receiving user input, assessing information from tests of questionnaires, determine diagnostic specifiers, and generating a report”), which is an abstract idea included in the grouping of Mental Processes. These limitations are interpreted as at least Mental Processes insomuch as the claim limitations are directed to steps/concepts which are capable of being performed in the human mind, while only generically connected to interaction with a computer utilizing non-special purpose generic computing elements and/or insignificant extra-solution activity as set forth in the claims.
Regarding dependent claims 2-4, 6-10, 12-20:
Each claim is dependent either directly or indirectly from the independent claim identified above and includes all the limitations of said independent claim. Therefore, each dependent claim recites the same abstract idea as identified above. Each of the dependent claim further describes additional aspects of the abstract idea, i.e., additional aspects to the Mathematical Concepts and/or Mental Processes. For example, some dependent claims merely provide additional Mathematical Concepts and/or Mental Processes to be performed and/or additional insignificant extra-solution activity, without anything more significant to establish eligibility under 35 U.S.C. 101.
Dependent claim 19 recites the following, with Mathematical concepts highlighted in bold:
The method of claim 11 wherein based on sensitivity and specificity data of the sets of condition-specific rating scales, a probability level of a true positive finding or level of evidence is calculated by a formula: 1 [maximum possible probability] - (Error%test1x Error%test2x ... Error%test(n)), wherein a conservative estimate of probability is used by assigning an assumed error rate to a measure through setting an error value equal to: (1 - Sensitivity) + (1 - Specificity), and wherein the conservative estimate of probability may be presented as a % for each condition or as a level of evidence such as strong, moderate, or mild.
Step 2A-2 of the 2019 Revised Patent Subject Matter Eligibility Guidance
The second prong of step 2a is the consideration if the claim limitations are directed to a practical application.
Limitations that are indicative of integration into a practical application:
-Improvements to the functioning of a computer, or to any other technology or technical field - see MPEP 2106.05(a)
-Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition – see Vanda Memo
-Applying the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b)
-Effecting a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c)
-Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception - see MPEP 2106.05(e) and Vanda Memo
Limitations that are not indicative of integration into a practical application:
-Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f)
-Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g)
-Generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.05(h)
Claims 1-20 clearly do not improve the functioning of a computer, as they only incorporate generic computing elements, do not effect a particular treatment, and do not transform or reduce a particular article to a different state or thing. Similarly, there is no improvement to a technical field. In addition the claims do not apply the judicial exception with, or by use of a particular machine. The claims do not apply or use the judicial exception in a meaningful way. The claimed invention does not suggest improvements to the functioning of a computer or to any other technology or technical field (see MPEP 2106.05 (a)).
This judicial exception is not integrated into a practical application because the claimed invention merely applies the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform the abstract idea (MPEP 2106.05 (f)) and/or generally links the use of the judicial exception to a particular technology or field of use (MPEP 2106.05 (h)). The claimed computer components are recited at a level of generality and are merely invoked as tool to perform the abstract idea. Simply implementing the abstract idea on a generic computer is not a practical application of the abstract idea.
For the reasons as discussed above, the claim limitations are not integrated to a practical application.
Step 2b of the 2019 Revised Patent Subject Matter Eligibility Guidance
Next, the claims as a whole are analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no element or combination of elements is sufficient to ensure any claim of the present application as a whole amounts to significantly more than one or more judicial exceptions, as described above. For example, the recitations of utilization of “computing device”, etc. used to apply the abstract idea merely implements the abstract idea at a low level of generality and fail to impose meaningful limitations to impart patent-eligibility. These elements and the mere processing of data using these elements do not set forth significantly more than the abstract idea itself applied on general purpose computing devices. The recited generic elements are a mere means to implement the abstract idea. Thus, they cannot provide the “inventive concept” necessary for patent-eligibility. “[I]f a patent’s recitation of a computer amounts to a mere instruction to ‘implement]’ an abstract idea ‘on ... a computer,’... that addition cannot impart patent eligibility.” Alice, 134 S. Ct. at 2358 (quoting Mayo, 132 S. Ct. at 1301). As such, the significantly more required to overcome the 35 U.S.C. 101 hurdle and transform the claimed subject matter into a patent-eligible abstract idea is lacking. Accordingly, the claims are not patent-eligible.
Further, the claims would require structure that is beyond generic, such as structure that can be interpreted analogous to a general-purpose structure and general-purpose computing elements in that they represent well-understood, routine, conventional elements that do not add significantly more to the claims. See Alice Corp. v. CLS Bank International, 134 S. Ct. at 2358-59. The elements of a computing device are well known conventional devices used to electronically implement provide information, receive user input, assess information, determine information, and generate information by Kubota et al. (US 20100115587 A1; hereinafter Kubota). Kubota discloses that a computer are well-known information processing devices (¶72). See Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018).
The dependent claims do not add “significantly more” for at least the same reasons as directed to their respective independent claims, at least based on the position, as discussed above, that each of the dependent claims merely provide additional limitations to further expand the abstract idea of the independent claims, without adding anything which would establish eligibility under 35 U.S.C. 101.
Consequently, consideration of each and every element of each and every claim, both individually and as an ordered combination, leads to the conclusion that the claims are not patent-eligible under 35 USC §101.
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, 3-5, 7-8, 11, 15, 18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shriberg et al. (US 20190385711 A1; hereinafter Shriberg) in view of Regier et al. (The DSM-5: classification and criteria changes; hereinafter Regier).
Regarding claims 1, 5, and 11, Shriberg discloses a platform to provide digital assessments of mental health (computer can be used for questions or assessments; ¶30) comprising: a screening engine that provides screening tests, confirmatory tests, or questionnaires to a user (providing questions to a user; ¶19) and receives input from the user via a display device (input/output module; ¶299); a testing engine that assesses information gained from the screening tests, confirmatory tests, or questionnaires (assessing scores from the test or questionnaires; ¶23); and a report generator that generates a report (¶69) based on the diagnostic specifiers (electronic report identifying if the subject is at risk of a mental health condition; ¶71). Regarding additional limitations of claim 5, Shriberg discloses a system comprising: a host computing device (computer can be used for questions or assessments; ¶30) that includes a web server (web server 240; ¶159) and an application server (application server included; ¶583); and a user device in communication with the host computing device (computer platform in communication with host computing device; ¶583) by way of a communication framework to provide a user access to an assessment platform via the web server and the application server (communication through the internet; ¶583). Shriberg does not explicitly disclose assessing information gained from the screening tests, confirmatory tests, or questionnaires against a set of condition-specific rating scales to determine diagnostic specifiers that are indicative of existence, non-existence, or likelihood of one or more mental health conditions.
However, Regier teaches a set of condition-specific rating scales (DSM-5 uses cross cutting symptom assessments and severity ratings; Page 95 - ¶1-2) to determine diagnostic specifiers that are indicative of existence, non-existence, or likelihood of one or more mental health conditions (specifiers for the presence or absence of mental health conditions; Page 95 - ¶3).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shriberg to implement the teachings of Regier because the DSM-5 is the standardized authoritative manual used globally by clinicians to define mental disorders. It is necessary for psychologists or psychiatrists to compare results from tests or questionnaires to the rating scales and criteria defined in the DSM-5.
Regarding claims 3 and 7, Shriberg discloses wherein the screening engine screens the user for symptoms associated with psychiatric conditions through a series of questions based on a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (implements assessments that uses queries associated with the DSM-5; ¶180).
Regarding claim 4, Shriberg discloses wherein the report includes a user's response (report based on user screening, monitoring, and diagnosing; ¶173) to life factor questions that are further provided by the screening engine (includes life factor questions that tell how the user is feeling; ¶251 and Fig. 17).
Regarding claim 8, Shriberg discloses wherein the assessment platform, via the testing engine, determines that one or more mental health conditions have been supported or not when a user's pattern of responses on individual tests resulted in a majority of positive versus scores for a specific condition (binary score from the system that indicates whether a condition is present or not; ¶427).
Regarding claim 15, Shriberg discloses further comprising administering a set of one or more daily impact questions about how symptoms impact a user's daily life (questions about daily impact on user's daily life; Fig. 17).
Regarding claim 18, Shriberg discloses administering a set of one or more life factor questionnaires that comprises questions about a user's life that may help a healthcare provider tailor treatments for the user (includes life factor questions that tell how the user is feeling; ¶251 and Fig. 17).
Regarding claim 20, Shriberg discloses further comprising displaying the report on a user device (¶70).
Claims 2 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Shriberg in view of Regier in view of Robert Whent (US 20110282682 A1; hereinafter Whent).
Regarding claims 2 and 6, Shriberg discloses a profile generator that generates a profile for the user (¶524) and providing characteristics such as, but not limited to, name, email, and age (related to age; ¶524). Shriberg does not explicitly disclose generating a profile for the user based on a user's input upon registering on a website.
However, Whent teaches generating a profile for the user based on a user's input upon registering on a website (registering for a website; ¶23).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shriberg to implement the teachings of Whent for the benefit of registering on a website to keep your profile information saved and available anytime you visit the website. Furthermore, having a profile when registering on a website is a very common practice to save your information, save you user history, personalize your account, etc.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Shriberg in view of Regier in view of Stefan C. Dombrowski (Psychoeducational Assessment and Report Writing; hereinafter Dombrowski).
Regarding claim 9, Shriberg discloses a second part that includes information a healthcare provider would need in order to make sound decisions about a user's mental health (electronic report identifying whether the subject is at risk of a possible mental or physiological condition; ¶71). Shriberg does not explicitly disclose wherein the report comprises a first part that includes a comprehensive psychoeducation.
However, Dombrowski teaches wherein the report comprises a first part that includes a comprehensive psychoeducation (comprehensive psychoeducation to be part of an assessment report; Page 80 - 6.4 Conclusion).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shriberg to implement the teachings of Dombrowski for the benefit of helping the user understand their specific diagnosis. Instead of just providing a diagnosis, it helps to provide a structured and detailed education about their specific mental health condition.
Regarding claim 10, Shriberg discloses wherein the second part comprises: (a) demographic information, (b) reason for testing, (c) relevant medical history, (d) evaluation of suicide risk, (e) data on possible conditions detected, (f) raw or underlying data supporting possible conditions detected, or (g) drug tables for relevant conditions (data on possible conditions detected by electronic report identifying whether the subject is at risk of a possible mental or physiological condition; ¶71).
Claims 12-14 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Shriberg in view of Regier in view of PCL-5 (PTSD Checklist for DSM-5; hereinafter PCL-5).
Regarding claim 12, Shriberg does not disclose wherein the screening tests prompt the user to answer a checklist of common signs and symptoms of more than 50 psychiatric conditions to provide a list of hypothesized conditions for further testing.
However, PCL-5 teaches wherein the screening tests prompt the user to answer a checklist of common signs and symptoms (checklist to assess the presence of PTSD symptoms; Page 1 - What is the PCL-5?) of more than 50 psychiatric conditions (PCL-5 is based on DSM-5 and DSM-5 has nearly 300 psychiatric conditions. Common symptoms and signs here can overlap with other conditions of the DSM-5) to provide a list of hypothesized conditions for further testing (the conditions diagnosed need further testing; Page 2 - How is the PCL-5 scored and interpreted?).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shriberg to implement the teachings of PCL-5 because a screening test can have multiple common signs and symptoms found in the PCL-5. The PCL-5 assesses symptoms of intrusion, avoidance, negative alterations in cognition and mood, and these symptoms can be applied to multiple other psychiatric conditions found in the DSM-5. Furthermore, it is common for common symptoms and signs to overlap a wide range of mental health conditions.
Regarding claim 13, Shriberg does not disclose wherein the checklist of common sign and symptoms has a one-to-one alignment with symptoms enumerated in a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and the checklist of common sign and symptoms prompts the user to endorse whether the symptoms for a given condition is presence or absence.
However, PCL-5 teaches wherein the checklist of common sign and symptoms has a one-to-one alignment with symptoms enumerated in a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (corresponds to DSM-5 criteria for PTSD; Page 1 - What is the PCL-5?), and the checklist of common sign and symptoms prompts the user to endorse whether the symptoms for a given condition is presence or absence (with the scoring, you can endorse if a given condition is present or absent; Page 2 - How is the PCL-5 scored and interpreted).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shriberg to implement the teachings of PCL-5 because a screening test with common signs and symptoms found in the PCL-5 are based on the DSM-5 criteria. DSM-5 is the standardized authoritative manual used globally by clinicians to define mental disorders, and it is necessary for to compare results from tests or questionnaires to the rating scales and criteria defined in the DSM-5.
Regarding claim 14, Shriberg discloses wherein the screening tests comprises three tiers, and wherein: Tier 1 comprises questions regarding broadly described symptoms that are required per the DSM-5 for certain categories of DSM-5 disorders (A question like 1702 in Fig 17); Tier 2 comprises questions regarding symptoms whose presence is required for certain DSM-5 disorders to be present (question 1720 mentions the presence of insomnia which is a disorder present in the DSM-5; Fig 17); and Tier 3 comprises questions regarding the symptoms of which the presence of a certain amount or timeframe is required for the certain DSM-5 disorders to be present (questions can cover same assessments tests such as PHQ-9 and GAD-7 in ¶245 with questions like "Feeling tired or having little energy?" from PHQ-9 which is on par with the examples given in the specification of the present invention for Tier 3).
Regarding claim 16, Shriberg does not disclose wherein if, based on a user's characteristics and symptom endorsements the presence of one or more DSM-5 disorders is possible, the method further comprises: administering a set of one to four established and well -known self-report survey-type rating scales validated and peer-reviewed for use in screening for possible disorders.
However, PCL-5 teaches wherein if, based on a user's characteristics and symptom endorsements the presence of one or more DSM-5 disorders is possible (from user characteristics and score you can endorse the presence of PTSD; Page 2 - How the PCL-5 is score and interpreted?), the method further comprises: administering a set of one to four established and well -known self-report survey-type rating scales validated and peer-reviewed for use in screening for possible disorders (The PCL-5 has a 5-point likert scale and is highly validated and peer-reviewed by multiple entities, including the U.S. Department of Veteran Affairs; see first page - Bottom left).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shriberg to implement the teachings of PLC-5 because the PCL-5 is based on the DSM-5 criteria, and thus, the PCL-5 is highly validated and peer-reviewed in scientific literature and multiple entities. A test, such as the PCL-5 is beneficial to patients because it is universally recognized as the gold standard for self-report screening tool.
Regarding claim 17, Shriberg does not disclose wherein whether the presence of one or more DSM-5 disorders is possible means that disorder-specific Tier 3 symptoms were endorsed and at least one less than a DSM5-required volume of the disorder-specific Tier 3 symptoms were endorsed.
However, PCL-5 teaches wherein whether the presence of one or more DSM-5 disorders is possible means that disorder-specific Tier 3 symptoms were endorsed and at least one less than a DSM5-required volume of the disorder-specific Tier 3 symptoms were endorsed (essentially, when you have at least one less than the required volume to endorse a disorder, it means it's still possible to have it. With PCL-5, if scores are lower than 31-33, it may indicate that the patient has subthreshold symptoms of PTSD, which means it's possible to have it; Page 2 - How might the PCL-5 help my patients?).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shriberg to implement the teachings of PLC-5 because the PCL-5 is only a screening tool and in almost all cases, further testing is required. This is beneficial for user because it can tell them if there is an area of concern, or if there is a risk of having PTSD. However, final confirmation is required form other sources, such as the CAPS-5 structured interview.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSE ANGELES whose telephone number is (703)756-5338. The examiner can normally be reached Mon-Fri 8am-5pm.
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/JOSE ANGELES/Examiner, Art Unit 3715
/DMITRY SUHOL/Supervisory Patent Examiner, Art Unit 3715