CTNF 19/144,950 CTNF 90661 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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 1-3, 5, 6, 8-10, 13-23, and 25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 1 recites (additional limitations crossed out): A method for determining if a child has autism, the method comprising: obtaining eye tracking metrics from at least two eye tracking tests; applying a trained machine learning model using the eye tracking metrics; and obtaining an autism risk score. The above limitations, as drafted, is a process that, under its broadest reasonable interpretation covers managing personal behavior, and mental processes. That is, other than reciting the application of a “trained machine learning model”, nothing in the claim precludes the steps as being described as managing personal behavior, or mental processes. For example, but for the “trained machine learning model” language, the limitations describe the obtaining of eye tracking metrics, and using the eye tracking metrics to obtain an autism risk score, which describes both managing personal behavior, and actions that may be performed mentally and/or with pen and paper. If a claim limitation, under its broadest reasonable interpretation, describes managing personal behavior, then it falls within the “Certain Methods of Organizing Human Activities” grouping of abstract ideas. Further, if a claim limitation, under its broadest reasonable interpretation, describes steps that may be performed mentally or with pen and paper, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. The judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of a “trained machine learning model” to perform the steps. The functionality intended to be performed by the “trained machine learning model” appears to be based on very rudimentary constraints (e.g., eye tracking metrics). Without some prohibition in the claims regarding scalability, computation load, etc., this “trained machine learning model” could reasonably be considered as merely being applied to the abstract idea (i.e., “apply it”). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a “trained machine learning model” to perform the steps amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component, or generally linking the judicial exception to a particular environment cannot provide an inventive concept. Therefore, the claim is not found to be patent eligible. Claims 2, 3, 5, 6, 8-10, and 13-23 are dependent on claim 1, and include all the limitations of claim 1. Therefore, they are also directed to the same abstract idea. The dependent claims do not feature any additional elements, and have not been found to integrate the judicial exception into a practical application, or provide significantly more than the abstract idea since they merely further narrow the abstract idea. Claim Rejections - 35 USC § 112 07-30-01 AIA The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. 07-31-01 Claims 6, 8, and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Regarding claim 6, the limitation “… wherein the metrics that measure autonomic nervous system arousal comprise pupillometry, level of parent concern, and a combination thereof ” lacks a proper written description. The Examiner points to at least paragraph [0006] which states, in part, “ Additional information such as autonomic arousal and a parent's level of concern can be integrated into the model. ” This appears to indicate that autonomic nervous system arousal and level of parent concern are two separate sets of information. The Examiner further points to paragraph [0031] of the specification which states, in part, “ Parental questions, and the answers thereto, are used to establish a level of parent concern. For example, the answers to parental questions can elicit information about whether or not a parent has concerns about their child's development (yes/no) and/or information relating to visual and auditory attention (e.g., such as whether or not a child responds when his/her name is called). ” Based on this, there is insufficient support for a metric that measures autonomic nervous system arousal being comprised of level of parent concern. Regarding claim 8, the limitation “ wherein the validation step provides a sensitivity of at least about 50%; a specificity of at least about 85%; a positive predictive value of at least about 80%; and/or a negative predictive value of at least about 60% ” lacks a proper written description. There does not appear to be any language in the specification detailing how the validation step provides such values. Regarding claim 21, the limitation “ wherein the method can be/is completed in less than 30 minutes ” lacks a proper written description. The specification is devoid of any details regarding how this timing is achieved. 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claims 6, 8, and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 6, the limitation “… wherein the metrics that measure autonomic nervous system arousal comprise pupillometry, level of parent concern, and a combination thereof ” is indefinite. It is unclear how the level of parent concern may be used to measure autonomic nervous system arousal. The Examiner points to at least paragraph [0006] which states, in part, “ Additional information such as autonomic arousal and a parent's level of concern can be integrated into the model. ” This appears to indicate that autonomic nervous system arousal and level of parent concern are two separate sets of information. The Examiner further points to paragraph [0031] of the specification which states, in part, “ Parental questions, and the answers thereto, are used to establish a level of parent concern. For example, the answers to parental questions can elicit information about whether or not a parent has concerns about their child's development (yes/no) and/or information relating to visual and auditory attention (e.g., such as whether or not a child responds when his/her name is called). ” It is unclear as to how answers to parental questions may be used to measure biometric data such as autonomic nervous system arousal. 07-34-03 The terms “about 50%”, “about 85%”, “about 80%”, and about 60%” in claim 8 are relative terms which render the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The terms “insistence on sameness ”, “ highly restricted”, “abnormal in intensity”, and “ unusual interest” in claim 18 are relative terms which render the claim indefinite. The terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim (s) 1, 3, 5, 6, 8, 10, 14, 22, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lian (WO 2021/109855) 1 in view of “Social Attention and Mirroring Faces: Utilizing Eye Tracking and EEG Mu Suppression toward Biomarkers for Autism Spectrum Disorder” by Adrienne Moore, available 2018, hereinafter referred to as Moore 2 . Regarding claim 1, Lian discloses A method for determining if a child has autism, the method comprising: obtaining eye tracking metrics; (See at least page 3 – “the data collection and feature extraction unit is used to collect eye movement data of the subject watching the video to obtain the corresponding heat map and focus map And a scan path map, the heat map is used to characterize the time and position of the fixation point dynamic changes, the focus map is used to characterize the fixation position, the dynamic change of time, the path scan chart continuously displays the fixation point position and Each gaze time information;” applying a trained machine learning model using the eye tracking metrics; (See at least page 3 – “the first neural network is used to input the heat map to obtain a first classification result; the second neural network is used to input the focus map to obtain a second classification result; the third neural network The network is used to input the scanning path graph to obtain a third classification result;” obtaining an autism risk score . (See at least page 3 – “the result output unit gathers the first classification result, the second classification result, and the third classification result to obtain the subject’s autism detection result.” Lian does not explicitly disclose eye tracking metrics from at least two eye tracking tests (See Moore, page 75 – “AUC, sensitivity, specificity, and PPV and NPV values were then examined when using a two-test screening model on data from the 126 subjects who participated in both the Complex Social and original GeoPref tests in order to determine if use of two tests enhanced classification performance. Results are shown in Table 4 (see data in the left two columns). Sensitivity increased substantially from 18% for the Complex Social test alone (Table 3) to 35% with two tests, while specificity remained high. AUC calculated for this two-test model was 0.75. Pilot results in the Additional file 1 suggest this enhancement does not occur if the two tests are given immediately back-to-back but only if separated in time.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Lian to utilize the teachings of Moore since it would provide additional information to be utilized in determining a result which may improve accuracy. Regarding claim 3, Lian does not explicitly disclose The method of claim 1, wherein the at least two eye tracking tests are selected from the GeoPref test, the complex social test, the outside play test, the joint attention test, and a motherese tests . (See Moore, page 75 – ““AUC, sensitivity, specificity, and PPV and NPV values were then examined when using a two-test screening model on data from the 126 subjects who participated in both the Complex Social and original GeoPref tests in order to determine if use of two tests enhanced classification performance.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Lian to utilize the teachings of Moore since they are in the same field of endeavor (i.e., diagnosis and treatment of autism), and all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Regarding claim 5, Lian discloses The method of claim 1, further comprising adding metrics that measure autonomic nervous system arousal and/or further comprising a validation step . (See at least page 4 – “When testing the effects of the present invention, a cross-validation method is used, and the confusion matrix of the classification result is used according to the receiver operating characteristic curve (Receiver Operating Characteristic Curve). Characteristic, ROC) and AUC (Area Under ROC Curve) to judge the effectiveness of the neural network classifier.” Regarding claim 6, Lian does not explicitly disclose The method of claim 5, wherein the metrics that measure autonomic nervous system arousal comprise pupillometry, level of parent concern, and a combination thereof . (See Moore, at least page 14 – “It would be interesting to see the additional results of autonomic measures of emotional contagion (e.g. heart rate changes, pupillary response, skin conductance) in a large developmental study of ASD and non-ASD toddlers, similar to these feasibility studies (Billeci et al., 2018; Di Palma et al., 2017), but this apparently has not been done thus far.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Lian to utilize the teachings of Moore since they are in the same field of endeavor (i.e., diagnosis and treatment of autism), and all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The Examiner notes that the language of the claim is optional at least due in part to the language of claim 5 (see “and/or”). Regarding claim 8, Lian does not explicitly disclose The method of claim 5, wherein the validation step provides a sensitivity of at least about 50%; a specificity of at least about 85%; a positive predictive value of at least about 80%; and/or a negative predictive value of at least about 60% (See Moore, at least page 84 – “Table S1 shows classification validation statistics based on the cutoff for maximizing specificity with the Complex Social GeoPref test, 75% Geo looking time. At this cutoff, where specificity is 99% (more accurately, it is 99.78%), the PPV of the Complex Social GeoPref test slightly exceeds that of the original GeoPref test, at 92%. That is, on the original GeoPreftest, at the 69% cutoff for %Geo the specificity is 99%, however the PPV is 90%. PPV is the likelihood that a given positive test is a true positive, and is therefore of particularly strong interest to clinicians.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Lian to utilize the teachings of Moore since they are in the same field of endeavor (i.e., diagnosis and treatment of autism), and all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The Examiner notes that the claim limitation merely features language that conveys an intended result, and therefore lacks patentable weight.) Regarding claim 10, Lian discloses The method of claim 1, further comprising indexing a child's visual social attention; further comprising indexing a child's gaze-shifting; and/or further comprising indexing a child's auditory social attention . (See at least page 11 – “The AOI (area of interest) method is widely used in eye movement analysis. AOI aims to measure the areas of interest that the eyes are looking at, usually including the eyes, nose, and mouth, and then count the frequency and time of the eyes looking at these areas. In the preexperiment of the present invention, children with ASD have relatively less fixation time and number of fixations in AOI compared to normal children.”) Regarding claim 14, Lian does not explicitly disclose The method of claim 1, wherein autism risk score of 50 or higher indicates that the child would meet the diagnostic criteria for autism spectrum disorder (ASD) when a child is formally evaluated . (See Moore, at least page 85 – Table 3.S1 – “%Geo threshold for positive test = 75%”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Lian to utilize the teachings of Moore since it would provide a standard threshold in making a determination regarding diagnosis of ASD. Regarding claim 22, Lian discloses The method of claim 1, wherein the method can be/is performed on a child that is less than 12 months old. (See page 4 – “The subject does not need to wear any device, and the stimulating material can be appropriately adjusted according to the age of the subject, which can be suitable for autistic patients of different ages and different developmental levels, especially for children from 6 to 18 months of age.”) Claim 25 features limitations similar to those of claim 1, and is therefore rejected using the same rationale . 07-21-aia AIA Claim (s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lian and Moore, and in further view of Arora (US 2022/0206774) Regarding claim 2, Lian and Moore do not explicitly disclose The method of claim 1, wherein the trained machine learning model is matched to the number and combination of eye tracking tests that the child took . (See Arora, at least Para. [0006] – “The one or more processors receive user input defining at least a portion of a first machine learning application, the portion of the first machine learning application comprising a first component, the first component defining a first data type as input to the first component and identifying input data having the first data type; automatically select a machine learning model for the first machine learning application by: (1) identifying one or more machine learning models each associated with the first data type; (2) for each of the one or more machine learning models associated with the first data type, generating a respective metric value indicating a performance of the machine learning model over at least a first portion of the input data having the first data type; and (3) selecting a machine learning model from among the one or more machine learning models by comparing metric values generated for each of the one or more machine learning models.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Lian and Moore to utilize the teachings of Arora since it would ensure use of the model best suited for the type of input . 07-21-aia AIA Claim (s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lian and Moore, and in further view of Harrison (US 2015/0279226) Regarding claim 9, Lian and Moore do not explicitly disclose The method of claim 1, further comprising weighting each of the at least two eye tracking tests so that tests that are more accurate will make a greater contribution to the autism risk score than those that are less accurate . (See Harrison, at least Para. [0035] - In one or more embodiments of the invention, weights ( 218 ) include test weights and activity weights. Based on the test weights, the data from psychological tests administered to the user can be analyzed and modified in order to appropriately assess the user's strengths in the various cognitive domains. A given test may be assigned a weight that indicates the test's accuracy in determining a user's cognitive strength in a number of cognitive domains relative to other tests in the test battery.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Lian and Moore to utilize the teachings of Harrison since it may improve accuracy of the final result . 07-21-aia AIA Claim (s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lian and Moore, and in further view of Park (US 2021/0236032) Regarding claim 13, Lian and Moore do not explicitly disclose The method of claim 10, further comprising weighting the indexing of the child's visual social attention, the child's gaze-shifting, and/or the child's auditory social attention . (See Park at least Para. [0075] – “As shown in FIG. 7, the graph includes an engagement index 740 and a general engagement trend 760. Video data was coded for the target behaviors above (smile, eye gaze focus, vocalizations/verbalizations, triadic interaction, self-initiated interaction, and imitation) and the engagement index 740 was derived as the indicator of every child's varying social engagement throughout the interaction with the emotionally expressive robots 160. The engagement index 740 was computed as a sum of these factors, each with the same weight, such that the maximum value of the engagement index 740 was 1.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Lian and Moore to utilize the teachings of Park since they are in the same field of endeavor (i.e., diagnosis and treatment of autism), and all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention . 07-21-aia AIA Claim (s) 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lian and Moore, and in further view of “Diagnostic Criteria for Autism Spectrum Disorder in the DSM-5”, available June 9, 2020, hereinafter referred to as CAR 3 Regarding claim 15, Lian and Moore do not explicitly disclose The method of claim 14, wherein the diagnostic criteria for ASD comprise persistent deficits in social communication and social interaction across multiple contexts . (See CAR – “To be diagnosed with ASD, an individual must meet all three of the following criteria: 1. Difficulties in social emotional reciprocity, including trouble with social approach, back and forth conversation, sharing interests with others, and expressing/understanding emotions. 2. Difficulties in nonverbal communication used for social interaction including abnormal eye-contact and body language and difficulty with understanding the use of nonverbal communication like facial expressions or gestures for communication. 3. Deficits in developing and maintaining relationships with other people (other than with caregivers), including lack of interest in others, difficulties responding to different social contexts, and difficulties in sharing imaginative play with others.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Lian and Moore to utilize the teachings of CAR since they are in the same field of endeavor (i.e., diagnosis and treatment of autism), and all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Regarding claim 16, Lian and Moore do not explicitly disclose The method of claim 15, wherein the persistent deficits in social communication and social interaction across multiple contexts comprise deficits in social-emotional reciprocity; deficits in nonverbal communicative behaviors used for social interaction, and deficits in developing, maintaining, and understanding relationships . (See CAR excerpt cited above, and stated motivation for combining) Regarding claim 17, Lian and Moore do not explicitly disclose The method of claim 14, wherein the diagnostic criteria for ASD further comprises restricted, repetitive behaviors . (See CAR – “The criteria in the DSM-5 also include demonstrating at least 2 of the following 4 restricted and repetitive behavior, interests, or activities: 1. Stereotyped speech, repetitive motor movements, echolalia (repeating words or phrases, sometimes from television shows or from other people), and repetitive use of objects or abnormal phrases. 2. Rigid adherence to routines, ritualized patterns of verbal or nonverbal behaviors, and extreme resistance to change (such as insistence on taking the same route to school, eating the same food because of color or texture, repeating the same questions); the individual may become greatly distressed at small changes in these routines. 3. Highly restricted interests with abnormal intensity or focus, such as a strong attachment to unusual objects or obsessions with certain interests, such as train schedules. 4. Increased or decreased reactivity to sensory input or unusual interest in sensory aspects of the environment, such as not reacting to pain, strong dislike to specific sounds, excessive touching or smelling objects, or fascination with spinning objects.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Lian and Moore to utilize the teachings of CAR since they are in the same field of endeavor (i.e., diagnosis and treatment of autism), and all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Regarding claim 18, Lian and Moore do not explicitly disclose The method of claim 17, wherein the restricted, repetitive behaviors comprise stereotyped or repetitive motor movements, use of objects, or speech; insistence on sameness, inflexible adherence to routines, or ritualized patterns of verbal or nonverbal behavior; highly restricted, fixated interests that are abnormal in intensity or focus;and/or hyper- or hyporeactivity to sensory input or unusual interest in sensory aspects of the environment . (See CAR excerpt cited above, and stated motivation for combining.) 07-21-aia AIA Claim (s) 19 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lian and Moore, and in further view of Official Notice . Regarding claim 19, Lian and Moore do not explicitly disclose The method of claim 1, wherein the obtaining eye tracking metrics is from at least five eye tracking tests . (Moore teaches utilizing multiple tests but only features the use of data from two tests. However, the Examiner takes Official Notice that obtaining multiple sets of test data is old and well known in the art and that a person having ordinary skill in the art would recognize that the analysis of more data would result in more accurate results. It would have been obvious to a person having ordinary skill in the art at the time of the invention to modify the system of Lian and Moore to obtain metrics from at least five eye tracking tests because all the claimed elements/steps were known in the prior art and one skilled in the art could have combined the elements/steps as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.) Regarding claim 21, Lian and Moore do not explicitly disclose The method of claim 1, wherein the method can be/is completed in less than 30 minutes. (The Examiner takes Official Notice that the claimed functions can be performed in less than 30 minutes. This is evidenced by the processing capabilities of available generic computers at the time of invention. Therefore, it would have been obvious to one of ordinary skill in the art that the system of Lian and Moore would be capable of completing the claimed method within 30 minutes. The Examiner further notes that the language of the claim merely expresses the intended result of the method and lacks patentable weight (See MPEP 2111.04).) 07-21-aia AIA Claim (s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lian and Moore, and in further view of Abbas (US 2022/0369976) Regarding claim 20, Lian and Moore do not explicitly disclose The method of claim 1, wherein trained machine learning model is selected from XGBoost, linear regression, linear discriminant analysis, and gradient boosting . (See Abbas, at least Para. [0014] – “ In some embodiments, said behavioral disorder, developmental delay, or neurologic impairment is autism spectrum disorder or autism. In some embodiments, identifying said plurality of behavioral units within said input data and/or identifying said higher order behavior is done using a machine learning software module. In some embodiments, said machine learning algorithm is a supervised learning algorithm. In some embodiments, said machine learning software module is selected from nearest neighbor, naive Bayes, decision tree, linear regression, support vector machine, or neural network.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Lian and Moore to utilize the teachings of Abbas since they are in the same field of endeavor (i.e., use of models to diagnose autism), and all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention . 07-21-aia AIA Claim( s) 23 i s/are rejected under 35 U.S.C. 103 as being unpatentable over L ian and Moore, and in further view of “Naturalistic Developmental Behavioral Interventions: Empirically Validated Treatments for Autism Spectrum Disorder” by Laura Schreibman, available March 4, 2015, hereinafter referred to as Schreibman. 4 R egarding claim 23, Lian and Moore do not explicitly disclose The method of claim 1, further comprising treating the child using naturalistic developmental behavioral interventions (NDBI) . (See Schreibman, at least page 4 (2414) – (“Efforts to improve the effectiveness of DTT procedures quickly led to incorporation of new techniques for increasing children’s motivation and performance—techniques that would ultimately prove quite compatible with the models of early learning processes being developed in the developmental sciences. Such techniques included varying teaching stimuli (Dunlap and Koegel 1980), alternative prompting strategies (Schreibman et al. 1982), use of child-preferred activities Koegel et al. (1987a), use of incidental teaching strategies (McGee 2005) and consideration of developmental prerequisites (Dawson and Galpert 1986, 1990; Lewy and Dawson 1992; Kasari et al. 2006, Rogers and Lewis 1989). These newer approaches used natural rather than artificial (arbitrary response-reward contingencies) rewards (Koegel and Williams 1980), child-preferred materials (McGee et al. 1991), reinforcement of approximations and communicative attempts, and treatment delivery in more naturalistic and developmentally sensitive contexts (McGee et al. 2000).”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Lian and Moore to utilize the teachings of Schreibman since they are in the same field of endeavor (i.e., diagnosis and treatment of autism), and all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE G ROBINSON whose telephone number is (571)272-9261. The examiner can normally be reached Monday - Thursday, 7:00 - 4:30 EST; Friday 7:00-11:00 EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi can be reached at 571-272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KYLE G ROBINSON/Examiner, Art Unit 3685 /KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685 Application/Control Number: 19/144,950 Page 2 Art Unit: 3685 Application/Control Number: 19/144,950 Page 3 Art Unit: 3685 Application/Control Number: 19/144,950 Page 4 Art Unit: 3685 Application/Control Number: 19/144,950 Page 5 Art Unit: 3685 Application/Control Number: 19/144,950 Page 6 Art Unit: 3685 Application/Control Number: 19/144,950 Page 7 Art Unit: 3685 Application/Control Number: 19/144,950 Page 8 Art Unit: 3685 Application/Control Number: 19/144,950 Page 9 Art Unit: 3685 Application/Control Number: 19/144,950 Page 10 Art Unit: 3685 Application/Control Number: 19/144,950 Page 11 Art Unit: 3685 Application/Control Number: 19/144,950 Page 12 Art Unit: 3685 Application/Control Number: 19/144,950 Page 13 Art Unit: 3685 Application/Control Number: 19/144,950 Page 14 Art Unit: 3685 Application/Control Number: 19/144,950 Page 15 Art Unit: 3685 Application/Control Number: 19/144,950 Page 16 Art Unit: 3685 Application/Control Number: 19/144,950 Page 17 Art Unit: 3685 Application/Control Number: 19/144,950 Page 18 Art Unit: 3685 Application/Control Number: 19/144,950 Page 19 Art Unit: 3685 Application/Control Number: 19/144,950 Page 20 Art Unit: 3685 1 Interpretation provided by ip.com 2 Available at https://escholarship.org/uc/item/2xc6z418 3 Available at https://www.research.chop.edu/car-autism-roadmap/diagnostic-criteria-for-autism-spectrum-disorder-in-the-dsm-5 4 Available at https://pmc.ncbi.nlm.nih.gov/articles/PMC4513196/pdf/10803_2015_Article_2407.pdf
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