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 . This non-final office action on merits is in response to the Patent Application filed on 11/14/2024.
Status of claims
Claims 1-11 are pending and considered below. This application claims the benefit of KR Application Number KR10-2023-0182878 filed on 12/15/2023.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 11/14/2024 have been acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an evaluation module” in claim 10, “a treatment module” in claim 10, and “a reporting module” in claim 11.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 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 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Under step 1, the analysis is based on MPEP 2106.03, and claims 1-9 are drawn to a method, and claims 10-11 are drawn to a system. Thus, each claim, on its face, is directed to one of the statutory categories (i.e., useful process, machine, manufacture, or composition of matter) of 35 U.S.C. §101.
Step 2A Prong One
Claim 1 recites the limitation of an evaluation step of evaluating, a degree of the child's attachment and a degree of a caregiver's parenting sensitivity from answers submitted by a user deriving the user's attachment category from a result of the evaluation, and selecting a promotion therapy program. This limitation, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind or by using a pen and paper. But for the “by a server computer” language, the claim encompasses a user simply observing responses, making judgements about attachment and sensitivity levels, categorizing the relationship, and selecting an appropriate therapy program in their mind or by using a pen and paper. The mere nominal recitation a server computer does not take the claim limitation out of the mental processes grouping. Thus, the claim recites a mental process which is an abstract idea.
Independent claim 10 recites identical or nearly identical steps with respect to claim 1 (and therefore also recite limitations that fall within this subject matter grouping of abstract ideas), and this claim is therefore determined to recite an abstract idea under the same analysis.
Under Step 2A Prong Two
The claimed limitations, as per method claim 1, include the steps of:
an evaluation step of evaluating, by a server computer, a degree of the child's attachment and a degree of a caregiver's parenting sensitivity from answers submitted by a user using a terminal device, deriving the user's attachment category from a result of the evaluation, and selecting a promotion therapy program; and
a promotion therapy program providing step of transmitting, by the server computer, a promotion therapy program to the user's terminal device, and allowing the user to execute the promotion therapy program on the terminal device.
Examiner Note: underlined elements indicate additional elements of the claimed invention identified as performing the steps of the claimed invention.
The judicial exception expressed in claim 1 is not integrated into a practical application. The claim as a whole merely describes how to generally “apply” the concept of evaluating and categorizing attachment relationships between a child and a caregiver, and recommending corresponding therapy activities in a computer environment. The claimed computer components (i.e., a server computer, a terminal device, and allowing the user to execute the promotion therapy program on the terminal device) are recited at a high level of generality and are merely invoked as tools to perform an existing process of collecting responses, evaluating attachment levels, selecting therapy content, and presenting the results for user interaction. Simply implementing the abstract idea on a generic computer is not a practical application of the abstract idea. Accordingly, alone and in combination, these additional elements do not integrate the abstract idea into a practical application.
The judicial exception expressed in claim 1 is not integrated into a practical application. The claim recites the additional element a promotion therapy program providing step of transmitting a promotion therapy program to the user's terminal device. This limitation is recited at a high level of generality (i.e., as a general means of displaying information), and amounts to merely presenting results which is a form of insignificant extra-solution activity. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
Therefore, under step 2A, the claims are directed to the abstract idea, and require further analysis under Step 2B.
Under step 2B
Claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed with respect to Step 2A, the claim as a whole merely describes how to generally “apply” the concept of evaluating and categorizing attachment relationships between a child and a caregiver, and recommending corresponding therapy activities in a computer environment. Thus, even when viewed as a whole, nothing in the claim adds significantly more (i.e., an inventive concept) to the abstract idea.
Claim 1 does not include an additional element that are sufficient to amount to significantly more than the judicial exception. For the providing limitation that was considered extra-solution activity in Step 2A, this has been re-evaluated in Step 2B and determined to be well-understood, routine, conventional activity in the field. The specification does not provide any indication that the limitation of providing a medication based on an efficacy score is anything other than a conventional action that simply comes after evaluating and categorizing attachment relationships (see Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016)). For these reasons, there is no inventive concept. The claim is not patent eligible.
Claim 9 recites no further additional elements, and only further narrow the abstract idea. The previously identified additional elements, individually and as a combination, do not integrate the narrowed abstract idea into a practical application for reasons similar to those explained above, and do not amount to significantly more than the narrowed abstract idea for reasons similar to those explained above.
Claims 2-8, and 11 recite the additional element of the server computer (claims 2-8, and 11), a reporting step of processing, a result of evaluating a degree of the child's attachment and a degree of the caregiver's parenting sensitivity and a result of performing the user's promotion therapy program (claim 8 and 11) and transmitting the processed results to the user's terminal device (claim 8 and 11). However, this additional element amounts to implementing an abstract idea on a generic computing device or mere data gathering (i.e., an insignificant extra-solution activity)). As such, this additional element, when considered individually or in combination with the prior devices, does not integrate the abstract idea into a practical application or amount to significantly more than the abstract idea.
Thus, as the dependent claims remain directed to a judicial exception, and as the additional elements of the claims do not amount to significantly more, the dependent claims are not patent eligible.
Therefore, the claims here fail to contain any additional element(s) or combination of additional elements that can be considered as significantly more and the claim is rejected under 35 U.S.C. 101 for lacking eligible subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Wall (U.S. Patent Publication 2021/0335489 A1), referred to hereinafter as Wall, in view of Children's Home Society of Minnesota (Children's Home Society of Minnesota, 15 Games that encourage attachment, 2014, online article, pages 1-6 (Year: 2014)), referred to hereinafter as CHSM.
Regarding claim 1, Wall teaches a method of evaluating an attachment of a developmentally disabled child and providing a therapy (Wall [0002] “The present invention relates generally to a method, system, non-transitory computer-readable medium and apparatus for diagnosis of an illness or disorder. Specifically, in one embodiment, a mobile (e.g., web, smart device or the like) tool that enables rapid video-based screening of children for risk of having an autism spectrum disorder is disclosed. The tool is designed to speed the process of diagnosis and increase coverage of the population.”, Wall [0034] “Yet another aspect of the present invention includes a repository of quantitative scores valuable for the diagnosis of subjects with autism spectrum disorder, for assessment of confidence in diagnosis of subjects with autism spectrum disorder, and for the stratification of subjects for subsequent analysis including further phenotypic evaluation/categorization as well as genotypic evaluation/categorization”, Wall [0669] “For example, the invention can be applied in the manner described herein to any mental disorder such as acute stress disorder, adjustment disorder, amnesia, anxiety disorder, anorexia nervosa, antisocial personality disorder, asperger syndrome, attention deficit/hyperactivity disorder, autism, autophagia, avoidant personality disorder, bereavement, bestiality, bibliomania, binge eating disorder, bipolar disorder, body dysmorphic disorder, borderline personality disorder, brief psychotic disorder, bulimia nervosa, childhood disintegrative disorder, circadian rhythm sleep disorder, conduct disorder, conversion disorder, cyclothymia, delirium, delusional disorder, dementia, dependent personality disorder, depersonalization disorder, depression, disorder of written expression, dissociative fugue, dissociative identity disorder, down syndrome, dyslexia, dyspareunia, dyspraxia, dysthymic disorder, erotomania, encopresis, enuresis, exhibitionism, expressive language disorder, factitious disorder, folie a deux, ganser syndrome, gender identity disorder, generalized anxiety disorder, general adaptation syndrome, histrionic personality disorder, hyperactivity disorder, primary hypersomnia, hypochondriasis, hyperkinetic syndrome, hysteria, intermittent explosive disorder, joubert syndrome, kleptomania, mania, munchausen syndrome, mathematics disorder, narcissistic personality disorder, narcolepsy, nightmares, obsessive-compulsive disorder, obsessive-compulsive personality disorder, oneirophrenia, oppositional defiant disorder, pain disorder, panic attacks, panic disorder, paranoid personality disorder, parasomnia, pathological gambling, perfectionism, pervasive developmental disorder, pica, postpartum depression, post-traumatic embitterment disorder, post-traumatic stress disorder, primary insomnia, psychotic disorder, pyromania, reading disorder, reactive attachment disorder”, and Wall [0013] “According to the present invention, caregivers are empowered to detect a disorder as early as possible and plan an intervention with therapy as early as possible, which is highly desirable in the treatment of disorders such as autism”.), the method comprising:
an evaluation step of evaluating, by a server computer, a degree of the child's attachment and a degree of a caregiver's parenting sensitivity from answers submitted by a user using a terminal device (Wall [0046] “In one aspect, provided herein is a computer implemented method of generating a diagnostic tool by applying artificial intelligence to an instrument for diagnosis of a disorder, wherein the instrument comprises a full set of diagnostic items, the computer implemented method comprising: on a computer system having one or more processors and a memory storing one or more computer programs for execution by the one or more processors, the one or more computer programs including instructions for: testing diagnostic items from the instrument using a technique using artificial intelligence; determining from the testing the most statistically accurate set of diagnostic items from the instrument; selecting a set of the most statistically accurate diagnostic items from the instrument; determining the accuracy of the set of the most statistically accurate diagnostic items from the instrument by testing the set of the most statistically accurate diagnostic items from the instrument against an independent source; and generating the diagnostic tool for diagnosis of the disorder.”, Wall [0178] “In another embodiment of this aspect, the subject's shared enjoyment in interaction is scored on a scale from 0 to 8, wherein the score of 0 corresponds with a subject who shows clear and appropriate happiness with the caregiver or other individuals during two or more activities, wherein the score of 1 corresponds with a subject who shows somewhat inconsistent signs of happiness with the caregiver or other individuals during more than one activity, or only shows signs of happiness with the caregiver or others involved during one interaction, wherein the score of 2 corresponds with a subject who shows little or no signs of happiness in interaction with the caregiver or others in the observation of the subject in a video, video conference or in person although may exhibit signs of happiness when playing alone, wherein the score of 8 corresponds with a subject whose shared enjoyment in interaction is not applicable or cannot be scored.”, Wall [0179] “In another embodiment of this aspect, the subject's tendency to show objects to another person is scored on a scale from 0 to 8, wherein the score of 0 corresponds with a subject who spontaneously shows toys or objects at various times during the observation of the subject in a video, video conference or in person by holding them up or putting them in front of others and using eye contact with or without vocalization, wherein the score of 1 corresponds with a subject who shows toys or objects partially or inconsistently, wherein the score of 2 corresponds with a subject who does not show objects to another person, and wherein the score of 8 corresponds with a subject whose tendency to show objects to another person is not applicable or cannot be evaluated.”, Wall [0180] “In another embodiment of this aspect, the subject's tendency to initiate joint attention is scored on a scale from 0 to 2, wherein the score of 0 corresponds with a subject who uses normal eye contact to reference an object that is out of reach by looking back-and-forth between the caregiver or other person and the object, wherein eye contact may be used with pointing and/or vocalization, wherein the score of 1 corresponds with a subject who partially references an object that is out of reach, wherein the subject may spontaneously look and point to the object and/or vocalize, but does not use eye contact to get the attention of another person and then look at or point to the examiner or the parent/caregiver, but not look back at the object, and wherein the score of 2 corresponds with a subject that does not attempt to try to get another person's attention to reference an object that is out of reach.” Wall [0514] “Example 1: The 7 questions and answer choices. The answers to these 7 questions become the input to the classifier described in FIG. 27. According to the invention, these questions and the answers are preferably understood and answerable by the parent or caregiver without input or assistance by a clinician and within the framework of a web-based or smart device-based user interface.”), deriving the user's attachment category from a result of the evaluation, and selecting a therapy (Wall [0033] “Another aspect of the present invention includes a quantitative score for diagnosis of subjects and for placement of subjects on a continuous scale from least extreme or severe, to most extreme or severe. For example, in the case of autism spectrum disorders this scale would range from the most severe form of autism to the most extreme phenotype in a neurotypical population.” and Wall [0027] “The present invention can include the following: (1) Novel algorithms for screening and risk assessment using 2-5 minute video clips of the subject. (2) Web portal for secure access to risk assessment report. (3) A carefully designed risk report for clinicians that includes a preliminary diagnosis, the video of the subject, recommendations for therapy (e.g., ABA, speech therapy) and detailed summary of scoring.”); and
a therapy providing step of transmitting, by the server computer, a therapy to the user's terminal device, and allowing the user to execute the therapy on the terminal device (Wall [0035] “Still another aspect of the present invention includes user interface technology developed for use on personal computers and smart devices such as iPhones, iPads, iPods, and tablets.”, Wall [0046] “In one aspect, provided herein is a computer implemented method of generating a diagnostic tool by applying artificial intelligence to an instrument for diagnosis of a disorder, wherein the instrument comprises a full set of diagnostic items, the computer implemented method comprising: on a computer system having one or more processors and a memory storing one or more computer programs for execution by the one or more processors, the one or more computer programs including instructions for: testing diagnostic items from the instrument using a technique using artificial intelligence; determining from the testing the most statistically accurate set of diagnostic items from the instrument; selecting a set of the most statistically accurate diagnostic items from the instrument; determining the accuracy of the set of the most statistically accurate diagnostic items from the instrument by testing the set of the most statistically accurate diagnostic items from the instrument against an independent source; and generating the diagnostic tool for diagnosis of the disorder.”).
Wall fails to explicitly teach a promotion therapy program service.
CHSM teaches a promotion therapy program service ((Children's Home Society of Minnesota, page 2, “The following list of games that encourage attachment for a variety of age levels has been recommended by one of our social workers. These activities have proven to be great suggestions for parents of children with RAD (reactive attachment disorder.”).
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to modify the computer implemented diagnostic and therapy selection system of Wall to incorporate the type of promotion therapy program service involving caregiver child cooperative activities as taught by CHSM, because the references provides a clear motivation to combine such teachings in order to encourage attachment and therapeutic bonding between the child and caregiver following diagnostic evaluation. This combination represents a predictable use of known elements according to their established functions, Wall’s automated evaluation and therapy delivery framework with CHSM’s attachment enhancing game activities, which yield the expected result of providing a computerized attachment based therapy service.
Regarding claim 2, Wall and CHSM teach the invention in claim 1, as discussed above, and further teach wherein, in the evaluation step, the server computer assigns a score to each answer submitted by the user in response to the evaluation items of the child's attachment test, and adds up the assigned scores to calculate the child's attachment evaluation score (Wall [0183] In another aspect, provided herein is a computer implemented method of generating a diagnostic tool by applying artificial intelligence to an instrument for diagnosis of a disorder, wherein the instrument comprises a full set of diagnostic items, the computer implemented method comprising: on a computer system having one or more processors and a memory storing one or more computer programs for execution by the one or more processors, the one or more computer programs including instructions for: scoring the subject's behavior; analyzing results of the scoring with a diagnostic tool to generate a final score, wherein the diagnostic tool is generated by applying artificial intelligence to an instrument for diagnosis of the autism spectrum disorder; and providing an indicator as to whether the subject has the autism spectrum disorder based on the final score generated by the analyzing step.” Wall [0178] “In another embodiment of this aspect, the subject's shared enjoyment in interaction is scored on a scale from 0 to 8, wherein the score of 0 corresponds with a subject who shows clear and appropriate happiness with the caregiver or other individuals during two or more activities, wherein the score of 1 corresponds with a subject who shows somewhat inconsistent signs of happiness with the caregiver or other individuals during more than one activity, or only shows signs of happiness with the caregiver or others involved during one interaction, wherein the score of 2 corresponds with a subject who shows little or no signs of happiness in interaction with the caregiver or others in the observation of the subject in a video, video conference or in person although may exhibit signs of happiness when playing alone, wherein the score of 8 corresponds with a subject whose shared enjoyment in interaction is not applicable or cannot be scored.”, Wall [0144] “In another embodiment of this aspect, the measurement questions selected from the ADI-R exam consist of: Comprehension of simple language: answer most abnormal between 4 and 5 (comps15); Reciprocal conversation (within subject's level of language): answer if ever (when verbal) (conver5); Imaginative play: answer most abnormal between 4 and 5 (play5); Imaginative play with peers: answer most abnormal between 4 and 5 (peerp15); Direct gaze: answer most abnormal between 4 and 5 (gazes); Group play with peers: answer most abnormal between 4 and 5 (grplay5); and Age when abnormality first evident (ageabn).)”).
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to implement Wall’s scoring of diagnostic responses in the attachment therapy context of CHSM by assigning numerical values to caregiver submitted answers and totaling those scores to generate an attachment evaluation score, because Wall teaches automated scoring and quantitative analysis of behavioral responses, and applying the same scoring technique to assess attachment would have been a predictable use of known methods to yield expected results.
Regarding claim 3, Wall and CHSM teach the invention in claim 1, as discussed above, and further teach wherein, in the evaluation step, the server computer assigns a score to each answer submitted by the user in response to the evaluation items of the caregiver's parenting sensitivity test, and adds up the assigned scores to calculate the caregiver's parenting sensitivity evaluation score Wall [0183] In another aspect, provided herein is a computer implemented method of generating a diagnostic tool by applying artificial intelligence to an instrument for diagnosis of a disorder, wherein the instrument comprises a full set of diagnostic items, the computer implemented method comprising: on a computer system having one or more processors and a memory storing one or more computer programs for execution by the one or more processors, the one or more computer programs including instructions for: scoring the subject's behavior; analyzing results of the scoring with a diagnostic tool to generate a final score, wherein the diagnostic tool is generated by applying artificial intelligence to an instrument for diagnosis of the autism spectrum disorder; and providing an indicator as to whether the subject has the autism spectrum disorder based on the final score generated by the analyzing step.” Wall [0153] In another embodiment of this aspect, the subject's use of eye contact is scored on a scale from 0 to 8, wherein the score of 0 corresponds with a subject for whom normal eye contact is used to communicate across a range of situations and people, wherein the score of 1 corresponds with a subject who makes normal eye contact, but briefly or inconsistently during social interactions, wherein the score of 2 corresponds with a subject who makes uncertain/occasional direct eye contact, or eye contact rarely used during social interactions, wherein the score of 3 corresponds with a subject who exhibits unusual or odd use of eye contact, and wherein the score of 8 correspond with a subject whose use of eye contact is not applicable or scorable.”, Wall [0144] “In another embodiment of this aspect, the measurement questions selected from the ADI-R exam consist of: Comprehension of simple language: answer most abnormal between 4 and 5 (comps15); Reciprocal conversation (within subject's level of language): answer if ever (when verbal) (conver5); Imaginative play: answer most abnormal between 4 and 5 (play5); Imaginative play with peers: answer most abnormal between 4 and 5 (peerp15); Direct gaze: answer most abnormal between 4 and 5 (gazes); Group play with peers: answer most abnormal between 4 and 5 (grplay5); and Age when abnormality first evident (ageabn).)”).
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to extend Wall’s computerized scoring methodology to evaluate the caregiver’s parenting sensitivity responses in the same manner as the child’s attachment test, because Wall teaches scoring of behavioral indicators on quantitative scales, and using such scoring for caregiver sensitivity would represent use of a known technique to evaluate similar behavioral characteristics in the same way.
Regarding claim 4, Wall and CHSM teach the invention in claim 1, as discussed above, and further teach wherein, in the evaluation step, the server computer combines the child's attachment level and the caregiver's parenting sensitivity level to classify the user's attachment category (Wall [0178] “In another embodiment of this aspect, the subject's shared enjoyment in interaction is scored on a scale from 0 to 8, wherein the score of 0 corresponds with a subject who shows clear and appropriate happiness with the caregiver or other individuals during two or more activities, wherein the score of 1 corresponds with a subject who shows somewhat inconsistent signs of happiness with the caregiver or other individuals during more than one activity, or only shows signs of happiness with the caregiver or others involved during one interaction, wherein the score of 2 corresponds with a subject who shows little or no signs of happiness in interaction with the caregiver or others in the observation of the subject in a video, video conference or in person although may exhibit signs of happiness when playing alone, wherein the score of 8 corresponds with a subject whose shared enjoyment in interaction is not applicable or cannot be scored.”, Wall [0153] In another embodiment of this aspect, the subject's use of eye contact is scored on a scale from 0 to 8, wherein the score of 0 corresponds with a subject for whom normal eye contact is used to communicate across a range of situations and people, wherein the score of 1 corresponds with a subject who makes normal eye contact, but briefly or inconsistently during social interactions, wherein the score of 2 corresponds with a subject who makes uncertain/occasional direct eye contact, or eye contact rarely used during social interactions, wherein the score of 3 corresponds with a subject who exhibits unusual or odd use of eye contact, and wherein the score of 8 correspond with a subject whose use of eye contact is not applicable or scorable.” Wall [0269] The analysis used machine learning techniques to analyze previous collections of data from autistic individuals, a practice that to date has not been commonplace in the field, but one that promotes novel and objective interpretation of autism data and promotes the development of an improved understanding of the autism phenotype. In the present case, several alternative machine learning strategies of the present invention yielded classifiers with very high accuracy and low rates of false positives. The top performing ADTree algorithm proved most valuable for classification as well as for measuring classification confidence, with a nearly 100% accuracy in the diagnosis of autistic cases. The ADTree algorithm resulted in a simple decision tree (FIG. 2) that can, according to the present invention, be readily converted into a behavioral algorithm for deployment in screening and/or diagnostic settings. In addition, the ADTree score provided an empirical measure of confidence in the classification that can be used to flag borderline cases likely warranting closer inspection and further behavioral assessment. In the present case, a small number of controls were misclassified, but with a low confidence score that suggested further screening and additional diagnostic tests might provide evidence that the original diagnosis was incorrect.”).
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to combine the separately calculated attachment and parenting sensitivity scores to classify users into defined relationship categories, because Wall teaches combining multiple diagnostic metrics to classify subjects using decision tree or machine learning algorithms, and applying that combination to caregiver child interaction data would have been a predictable adaptation of known classification techniques for behavioral assessment.
Regarding claim 5, Wall and CHSM teach the invention in claim 4, as discussed above, and further teach wherein the server computer classifies the user's attachment category as category A when both the child's attachment level and the caregiver's parenting sensitivity level are "high", classifies the user's attachment category as category B when one of the child's attachment level and the caregiver's parenting sensitivity level is "high" and the other one is "low", and classifies the user's attachment category as category C when both the child's attachment level and the caregiver's parenting sensitivity level are "low" (Wall [0297] “ADOS-G Module 1 data from the Autism Genetic Resource Exchange (AGRE) (Geschwind, et al., “The autism genetic resource exchange: a resource for the study of autism and related neuropsychiatric conditions,” American journal of human genetics, 2001, 69(2):463-466) repository of families with at least one child diagnosed with autism can be used as the input for machine learning classification. The ADOS-G examination classifies individuals into categories of “autism” or “autism spectrum” based on the ADOS-G diagnostic algorithm. The diagnostic algorithm adds up the scores from 12 (original) to 14 (revised) items and classifies individuals as having autism or autism spectrum according to thresholds scores. Those individuals who did not meet the required threshold were classified as “non-spectrum” and were used as controls in the study. For the purposes of the analysis, the analysis can be restricted to only those with the classification of “autism.” Any individuals who were untestable or where the majority of their scores were unavailable were excluded from the analysis. The final data matrix contained 612 individuals with a classification of “autism” and 11 individuals with a classification of “non-spectrum” (Table 4)”, and Wall [0033] “Another aspect of the present invention includes a quantitative score for diagnosis of subjects and for placement of subjects on a continuous scale from least extreme or severe, to most extreme or severe. For example, in the case of autism spectrum disorders this scale would range from the most severe form of autism to the most extreme phenotype in a neurotypical population.”).
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to implement category thresholds based on high or low score combinations, following Wall’s teaching of threshold based diagnostic classification for autism severity, since defining categorical levels from numerical scores is a routine and predictable design choice used in behavioral and diagnostic systems to facilitate interpretation of quantitative data.
Regarding claim 6, Wall and CHSM teach the invention in claim 4, as discussed above, and further teach wherein the server computer selects the type of a promotion therapy program to be provided to the user or selects the level of the promotion therapy program in response to the classified user's attachment category (Wall [0027] “The present invention can include the following: (1) Novel algorithms for screening and risk assessment using 2-5 minute video clips of the subject. (2) Web portal for secure access to risk assessment report. (3) A carefully designed risk report for clinicians that includes a preliminary diagnosis, the video of the subject, recommendations for therapy (e.g., ABA, speech therapy) and detailed summary of scoring.”, Wall [0464] “ii. Applied Behavioral Analysis (ABA) [0465] 1. High “eye contact” and “showing” scores indicate patient could benefit from behavioral analysis for support and further evaluation before clinical appointment.”, Wall [0466] “iii. Speech Therapy”, Wall [0467] “1. High “vocalization” score indicates patient could benefit from speech therapy for support and further evaluation before clinical appointment.” Wall [0297] “ADOS-G Module 1 data from the Autism Genetic Resource Exchange (AGRE) (Geschwind, et al., “The autism genetic resource exchange: a resource for the study of autism and related neuropsychiatric conditions,” American journal of human genetics, 2001, 69(2):463-466) repository of families with at least one child diagnosed with autism can be used as the input for machine learning classification. The ADOS-G examination classifies individuals into categories of “autism” or “autism spectrum” based on the ADOS-G diagnostic algorithm. The diagnostic algorithm adds up the scores from 12 (original) to 14 (revised) items and classifies individuals as having autism or autism spectrum according to thresholds scores. Those individuals who did not meet the required threshold were classified as “non-spectrum” and were used as controls in the study. For the purposes of the analysis, the analysis can be restricted to only those with the classification of “autism.” Any individuals who were untestable or where the majority of their scores were unavailable were excluded from the analysis. The final data matrix contained 612 individuals with a classification of “autism” and 11 individuals with a classification of “non-spectrum” (Table 4)”, and Wall [0033] “Another aspect of the present invention includes a quantitative score for diagnosis of subjects and for placement of subjects on a continuous scale from least extreme or severe, to most extreme or severe. For example, in the case of autism spectrum disorders this scale would range from the most severe form of autism to the most extreme phenotype in a neurotypical population.” And Children's Home Society of Minnesota, page 2, “The following list of games that encourage attachment for a variety of age levels has been recommended by one of our social workers. These activities have proven to be great suggestions for parents of children with RAD (reactive attachment disorder.”).
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to configure the server computer of Wall to select the type or level of therapy program based on the user’s classified category, incorporating CHSM’s teaching of selecting attachment promoting activities appropriate for a child’s condition, because Wall teaches tailoring therapeutic recommendations according to diagnostic classifications. Adapting this selection logic to choose among multiple levels or types of attachment promoting games would have been a predictable application of known therapeutic customization techniques to achieve the expected benefit of providing individualized, developmentally appropriate therapy content.
Regarding claim 7, Wall and CHSM teach the invention in claim 1, as discussed above, and further teach wherein, in the promotion therapy program providing step, the server computer transmits at least one of a game in which the child and the caregiver cooperate to make one dish from among a pancake, a cookie, and an ice cream, content displaying a cooking recipe step by step, content capturing and decorating a photo with an image of a dish created from the game in which the user makes the dish, and content viewing a photo captured and decorated by the user to the user's terminal device (Wall [0035] “Still another aspect of the present invention includes user interface technology developed for use on personal computers and smart devices such as iPhones, iPads, iPods, and tablets.”, Wall [0065] “In another embodiment of this aspect, the one or more computer programs further comprise instructions for: testing a test subject with the diagnostic tool; and testing the test subject with the full set of diagnostic items if the test subject demonstrates a need for the full set of diagnostic items based on the results of the diagnostic tool.”, Wall [0160] “In another embodiment of this aspect, the subject's shared enjoyment in interaction is scored on a scale from 0 to 8, wherein the score of 0 corresponds with a subject who shows clear and appropriate happiness with the caregiver or other individuals during two or more activities, wherein the score of 1 corresponds with a subject who shows somewhat inconsistent signs of happiness with the caregiver or other individuals during more than one activity, or only shows signs of happiness with the caregiver or others involved during one interaction, wherein the score of 2 corresponds with a subject who shows little or no signs of happiness in interaction with the caregiver or others in the observation of the subject in a video, video conference or in person although may exhibit signs of happiness when playing alone, wherein the score of 8 corresponds with a subject whose shared enjoyment in interaction is not applicable or cannot be scored.” and Children's Home Society of Minnesota, page 2, “The following list of games that encourage attachment for a variety of age levels has been recommended by one of our social workers. These activities have proven to be great suggestions for parents of children with RAD (reactive attachment disorder.”) and Children's Home Society of Minnesota, page 2, “2. Paint each other's faces with paint, powder, make up, or just pretend. 3. Donut Dare. Hold a donut on your finger through the hole and have your child see how many bites they can take before it falls off. If you want to make this a bit healthier you could change the donut to a pineapple ring.”).
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to implement CHSM’s interactive caregiver child games, such as cooperative food making and role play activities, within Wall’s computerized therapy delivery platform, because Wall teaches transmitting diagnostic content and materials to smart devices, and CHSM discloses the therapeutic value of shared playful and nurturing games to build attachment. Combining these teachings would have been motivated by the desire to increase engagement and attachment through digital therapy experiences, which represents a predictable combination of prior art elements performing their known functions.
Regarding claim 8, Wall and CHSM teach the invention in claim 1, as discussed above, and further teach further comprising: a reporting step of processing, by the server computer, a result of evaluating a degree of the child's attachment and a degree of the caregiver's parenting sensitivity and a result of performing the user's promotion therapy program, and transmitting the processed results to the user's terminal device (Wall [0063] “In another embodiment of this aspect, the one or more computer programs further comprise instructions for: generating a report based on the diagnostic tool, the report comprises a suggested clinical action.”, Wall [0064] “In another embodiment of this aspect, the report further comprises at least one of the following: a link to a video of a test subject; at least one chart depicting results of the diagnostic tool; a list of facilities or clinicians, the facilities or clinicians are capable of performing the suggested clinical action; and a map depicting locations of facilities or clinicians, the facilities or clinicians are capable of performing the suggested clinical action.”, [0165] “In another aspect, provided herein is a system of diagnosing an autism spectrum disorder in a subject, the system comprising: a scoring system for scoring the subject's behavior; an analysis system for analyzing results of the scoring with a diagnostic tool to generate a final score, wherein the diagnostic tool is generated by applying artificial intelligence to an instrument for diagnosis of the autism spectrum disorder; and an indicator system for indicating whether the subject has the autism spectrum disorder based on the final score generated by the analyzing step.”, Wall [0651] “FIG. 29 shows an example of a pipeline for generating a classification score using the video-based classifier (VBC). A caregiver interacts with a system according to the invention (including but not limited to a website and smart device application) to upload a home video from their computer, digital camera, smartphone or other device. The video is then evaluated by video analysts (usually 2 or more for inter-rater reliability and classification accuracy) to answer the questions (Example 3) needed by the classifier (FIG. 5). The answers to these questions are transformed into a discrete numerical vector and delivered as input to the VBC (FIG. 5) to generate a score that is then plotted within a distribution of scores to create a preliminary impact report that can be used in the process of diagnosis a person with (or without) Autism Spectrum Disorder.” And Children's Home Society of Minnesota, page 2, “The following list of games that encourage attachment for a variety of age levels has been recommended by one of our social workers. These activities have proven to be great suggestions for parents of children with RAD (reactive attachment disorder.” and Children's Home Society of Minnesota, page 2, “5. Play a memory game but with a more personal touch. First, have your child look you over very carefully. Then leave the room and return after