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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, and 8 of copending Application No. 18/330683. Although the claims at issue are not identical, they are not patentably distinct from each other because of at least the below reasons. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Pending US Application 18/330,690
Co-pending US Application 18/330683
Claim 1: A method for assessing one or more feeding behaviors in a subject, comprising the steps of:
determining an appropriate assessment type for a subject based on subject data;
receiving assessment data based on an observation, wherein the observation is based on the appropriate assessment type;
determining if additional assessment is appropriate, wherein the additional assessment is appropriate if the assessment data does not meet one or more predefined rules;
upon determining that the additional assessment is not appropriate, determining an intervention program; and
assigning the subject to the intervention program.
Claim 1: A method for treating one or more feeding behaviors in a subject, comprising the steps of:
screening a subject for one or more feeding behaviors…
assessing the subject to determine a particular intervention by comparing the one or more feeding behaviors observed during screening with one or more predefined rules;
conducting the particular intervention, wherein the particular intervention comprises at least one meal session during which a feeder presents food to the subject and records intervention data; and…
Claim 3: The method of claim 1, wherein assessing the subject comprises the steps of:
determining an appropriate assessment type based on the screening; and
conducting an observation based on the appropriate assessment type.
Claim 4: The method of claim 3, further comprising the steps of:
determining if an additional assessment is appropriate based on the observation; and
upon determining that the additional assessment is appropriate, conducting the additional assessment.
Claim 2: The method of claim 1, further comprising the steps of:
transmitting an evaluation to a caregiver of the subject;
receiving evaluation data from the caregiver, wherein the evaluation data comprises subject data and is based on the evaluation; and
determining that the subject is eligible for the intervention program based on one or more eligibility rules.
Claim 8: The method of claim 1, wherein the screening comprises the steps of:
transmitting an evaluation to a caregiver electronic computing device;
receiving evaluation data from the caregiver electronic computing device, wherein the evaluation data is based on the evaluation; and
determining that the one or more feeding behaviors are present in the subject
Claim 1: …assessing the subject to determine a particular intervention by comparing the one or more feeding behaviors observed during screening with one or more predefined rules…
The Examiner notes that transmitting an evaluation to “a caregiver electronic computing device” as recited by claim 8 of the copending application is being interpreted as a form of transmitting an evaluation to the caregiver as recited by claim 2 of the present application since the caregiver’s electronic computing device is merely a way to access the transmitted evaluation.
Pending US Application 18/330,690
Co-pending US Application 18/330683
Claim 3: The method of claim 2, wherein the evaluation is transmitted to a caregiver electronic computing device.
Claim 8: The method of claim 1, wherein the screening comprises the steps of:
transmitting an evaluation to a caregiver electronic computing device;
receiving evaluation data from the caregiver electronic computing device, wherein the evaluation data is based on the evaluation; and
determining that the one or more feeding behaviors are present in the subject.
Claims 4-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-4 of copending Application No. 18/330683 as applied to claim 1 of the present application above, and further in view of a 1994 publication entitled “Behavioral Assessment and Treatment of Pediatric Feeding Disorders” (hereinafter “Babbitt”).
Regarding Claim 4, US Application 18/330683 is silent on the evaluation comprising questions. However, Babbitt discloses the evaluation comprises a plurality of questions related to the subject (p. 281: “The assessment of the caregiver begins with an interview in which caregivers detail the child's behavioral and medical histories… When discussing environment-behavior relations, the therapist asks the caregivers first to identify specific behavior problems from a checklist”).
US Application 18/330683 and Babbitt are analogous arts because they both teach methods of assessing and treating feeding disorders. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the type of evaluation described by Babbitt as the evaluation used in US Application 18/330683 in order to most clearly gather relevant information about the patient from the caregiver (Babbitt, p. 281).
Pending US Application 18/330,690
Co-pending US Application 18/330683
Claim 5: The method of claim 2, wherein the one or more eligibility rules comprises criteria for avoidant/restrictive food intake disorder.
Claim 1: A method for treating one or more feeding behaviors in a subject, comprising the steps of:
screening a subject for one or more feeding behaviors…
assessing the subject to determine a particular intervention by comparing the one or more feeding behaviors observed during screening with one or more predefined rules;
conducting the particular intervention, wherein the particular intervention comprises at least one meal session during which a feeder presents food to the subject and records intervention data; and…
Regarding Claim 5, US Application 18/330683 is silent on any criteria for avoidant/restrictive food intake disorder. However, Babbitt discloses the one or more eligibility rules comprises criteria for avoidant/restrictive food intake disorder (p. 280: “Referring problems included primary food refusal [and] food selectivity by type or texture;" p. 281: “Information is gathered on the natural course of the child's feeding problems, the current status of the problems, previous and ongoing strategies that have or have not helped manage the child's eating, foods and textures that are now and were previously regularly consumed or rejected, meal duration and amounts consumed, the child's daily routine and family home structure, and caregivers' reports of environment-behavior relations surrounding feeding”).
It would have been obvious to include the criteria for ARFID as disclosed by Babbitt in the screening process of US Application 18/330683 because ARFID is a key feeding disorder with many symptoms that can be observed (Babbitt, abstract; pp. 280-281).
Pending US Application 18/330,690
Co-pending US Application 18/330683
Claim 6: The method of claim 2, wherein the one or more eligibility rules comprises criteria for oral motor skills.
Claim 1: A method for treating one or more feeding behaviors in a subject, comprising the steps of:
screening a subject for one or more feeding behaviors…
assessing the subject to determine a particular intervention by comparing the one or more feeding behaviors observed during screening with one or more predefined rules;
conducting the particular intervention, wherein the particular intervention comprises at least one meal session during which a feeder presents food to the subject and records intervention data; and…
Regarding Claim 6, US Application 18/330683 is silent on any criteria for oral motor skills. However, Babbitt discloses the one or more eligibility rules comprises criteria for oral motor skills (p. 280: “Referring problems included … self-feeding skill deficit [and] swallowing skill deficit;” p. 281: “Furthermore, investigations of the upper gastrointestinal tract are undertaken. A radiographic assessment of the swallowing mechanism is performed to ensure that structure and function of the hypopharynx in these patients is safe and they are capable of protecting their airway during the swallowing process”).
It would have been obvious to include the criteria for oral motor skills as disclosed by Babbitt in the screening process of US Application 18/330683 because deficient oral motor skills are a major factor in feeding disorders and the consequent treatment process would have to reflect that deficiency (Babbitt, p. 281).
Pending US Application 18/330,690
Co-pending US Application 18/330683
Claim 7: The method of claim 2, further comprising the steps of: determining a referral to a provider is not appropriate for the subject
Claim 1: A method for treating one or more feeding behaviors in a subject, comprising the steps of:
screening a subject for one or more feeding behaviors…
assessing the subject to determine a particular intervention by comparing the one or more feeding behaviors observed during screening with one or more predefined rules;
conducting the particular intervention, wherein the particular intervention comprises at least one meal session during which a feeder presents food to the subject and records intervention data; and…
Regarding Claim 7, US Application 18/330683 is silent on any criteria for avoidant/restrictive food intake disorder. However, Babbitt discloses determining a referral to a provider is not appropriate for the subject (p. 281: “The initial intention of a medical assessment is to determine if any underlying condition can be identified that might be amenable to therapeutic intervention;” the Examiner notes that because the assessment is used to determine when intervention would be beneficial or necessary, it logically must also be able to determine when it is not appropriate or necessary).
It would have been obvious to include this option of not referring a subject to a provider/intervention as disclosed by Babbitt in the screening and assessment process of US Application 18/330683 because it is possible the assessment will show no indication of a feeding disorder that would be amenable to or otherwise require intervention (Babbitt, p. 281).
Claims 8, 10, and 12-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-5 of copending Application No. 18/330683, and further in view of US 2015/0112694 (hereinafter “Blake”).
Pending US Application 18/330,690
Co-pending US Application 18/330683
Claim 8: A system for assessing one or more feeding behaviors in a subject, comprising:
an electronic computing device; and
a feeding management system configured to:
determine an appropriate assessment type for a subject based on subject data;
receive assessment data based on an observation, wherein the observation is based on the appropriate assessment type;
determining if additional assessment is appropriate, wherein the additional assessment is appropriate if the assessment data does not meet one or more predefined rules;
determine if additional assessment is appropriate, wherein the additional assessment is appropriate if the assessment data does not meet one or more predefined rules;
upon determining that the additional assessment is not appropriate, determine an intervention program; and
assign the subject to the intervention program.
Claim 1: A method for treating one or more feeding behaviors in a subject, comprising the steps of:
screening a subject for one or more feeding behaviors…
assessing the subject to determine a particular intervention by comparing the one or more feeding behaviors observed during screening with one or more predefined rules;
conducting the particular intervention, wherein the particular intervention comprises at least one meal session during which a feeder presents food to the subject and records intervention data; and…
Claim 3: The method of claim 1, wherein assessing the subject comprises the steps of:
determining an appropriate assessment type based on the screening; and
conducting an observation based on the appropriate assessment type.
Claim 4: The method of claim 3, further comprising the steps of:
determining if an additional assessment is appropriate based on the observation; and
upon determining that the additional assessment is appropriate, conducting the additional assessment.
Regarding Claim 8, US Application 18/330683 is silent on an electronic computing device which performs the described actions. However, Blake discloses an electronic computing device (par. 0019: “The present invention is directed to the field of behavioral health assessment systems, specifically, a user friendly computer assisted behavioral health assessment systems using proprietary algorithms to interpret and score user generated input to produce a substantially real-time preliminary evaluation of a subject's behavioral health vital signs including recommendations for treatment;” par. 0083: “an instruction execution system such as, for example, a processor 703 in a computer system or other system”).
Application No. 18/330683 and Blake are analogous arts because they both teach methods and systems for assessing a patient’s health status in relation to potential feeding disorders (Blake, pars. 0053-0054), at least in part, and recommending intervention programs as needed. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the automation and digitization taught by Blake with the specific system steps of copending Application No. 18/330683. Like the copending application, Blake teaches a system which, driven by a computer, is able to similarly receive patient data and observations related to feeding/eating concerns (Blake, pars. 0053-0054) and issue an intervention recommendation (Blake, par. 0058). The act of automating and digitizing such a system is a common practice within the art and can simplify the process for the medical practitioners and caregivers alike (Blake, abstract; pars. 0010-0016).
Pending US Application 18/330,690
Co-pending US Application 18/330683
Claim 10: The system of claim 8, wherein the observation is completed by one or more practitioners.
Claim 5: The method of claim 3, wherein the observation is completed by one or more practitioners.
Claim 12: The system of claim 8, wherein the observation comprises a feeding session completed by a caregiver of the subject.
Claim 6: The method of claim 3, wherein the observation comprises a feeding session completed by a caregiver of the subject
Claim 13: The system of claim 8, wherein the appropriate assessment type is based at least in part on a severity associated with the one or more feeding behaviors.
Claim 7: The method of claim 3, wherein the appropriate assessment type is based at least in part on a severity associated with the one or more feeding behaviors.
Claim 14: A non-transitory computer-readable medium that, when executed by at least one computing device, cause the at least one computing device to:
determine an appropriate assessment type for a subject based on subject data;
receive assessment data based on an observation, wherein the observation is based on the appropriate assessment type;
determine if additional assessment is appropriate, wherein the additional assessment is appropriate if the assessment data does not meet one or more predefined rules;
upon determining that the additional assessment is not appropriate, determine an intervention program; and
assign the subject to the intervention program.
Claim 1: A method for treating one or more feeding behaviors in a subject, comprising the steps of:
screening a subject for one or more feeding behaviors…
assessing the subject to determine a particular intervention by comparing the one or more feeding behaviors observed during screening with one or more predefined rules;
conducting the particular intervention, wherein the particular intervention comprises at least one meal session during which a feeder presents food to the subject and records intervention data; and…
Claim 3: The method of claim 1, wherein assessing the subject comprises the steps of:
determining an appropriate assessment type based on the screening; and
conducting an observation based on the appropriate assessment type.
Claim 4: The method of claim 3, further comprising the steps of:
determining if an additional assessment is appropriate based on the observation; and
upon determining that the additional assessment is appropriate, conducting the additional assessment.
Regarding Claim 14, US Application 18/330683 is silent on a non-transitory computer-readable medium which performs the described actions. However, Blake discloses a non-transitory computer-readable medium that [is] executed by at least one computing device (par. 0083: “Also, any logic or application described herein, including the behavioral health assessment application 228, that comprises software or code can be embodied in any non-transitory computer-readable medium for use by or in connection with an instruction execution system such as, for example, a processor 703 in a computer system or other system”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the executable non-transitory computer-readable medium taught by Blake with the specific system steps of copending US Application 18/330683. Like the copending application, Blake teaches a system which, driven by a computer, is able to similarly receive patient data and observations related to feeding/eating concerns (Blake, pars. 0053-0054) and issue an intervention recommendation (Blake, par. 0058). The act of automating and digitizing such a system is a common practice within the art and can simplify the process for the medical practitioners and caregivers alike (Blake, abstract; pars. 0010-0016).
Claims 9 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-5 of copending Application No. 18/330683 in view of Blake as applied to claim 8 of the present application above, and further in view of Babbitt.
Regarding Claim 9, US Application 18/330683 is silent on a patient file. However, Babbitt discloses the feeding management system is further configured to: receive the subject data, wherein the subject data comprises a patient file for the subject (p. 280: “During this interval, 43% of inpatient referrals came from the Johns Hopkins Hospital Gastroenterology Department, and 25% from other Johns Hopkins Hospital departments, with the balance (32%) coming from other hospitals, health maintenance organizations, psychologists, or self-referral… Referring problems included primary food refusal, food selectivity by type or texture, expulsion, vomiting, rumination, self-feeding skill deficit, swallowing skill deficit, and inappropriate mealtime behaviors such as disruption, self-injury, and aggression. At time of admission, the average child had experienced significant feeding problems for slightly more than 2 years. Many of our children have major medical complications requiring close collaboration with medical staff. In the last 2 years, 38% were gastrostomy tube dependent and 25% were nasogastric tube dependent. Ten percent of the children had cerebral palsy and at least 18% presented with gastroesophageal reflux, esophagitis, or duodenitis. Additional medical problems included bronchopulmonary dysplasia with oxygen dependence, celiac disease, end stage renal disease, and Dubowitz, Opitz-Frias, and Pfeiffer's syndromes;” p. 280: “our assessment process involves consideration of the child's feeding history.” The Examiner notes that when patients were referred, subject data comprising a patient file and history were received).
It would have been obvious to combine the patient file of Babbitt with the system of modified US Application 18/330683 in order to ensure all relevant background information of a patient is being considered in determination of an intervention program (Babbitt, abstract; pp. 280-281).
Regarding Claim 11, US Application 18/330683 is silent on the location of the observation being familiar to the subject. However, Babbitt discloses the observation is completed at a location familiar to the subject (p. 281: “Initial direct observations are made under a series of pretreatment baseline conditions. These conditions include a home condition”).
It would have been obvious to incorporate the familiar location of Babbitt with the screening and observation of US Application 18/330683 in order to reduce potential external factors, such as a new or uncomfortable environment, that could impact the observation of the feeding session (Babbitt, pp. 280-281).
Claims 15-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-5 of copending Application No. 18/330683 in view of Blake as applied to claim 14 of the present application above, and further in view of Babbitt.
Regarding Claim 15, US Application 18/330683 is silent on any meal structure data. However, Babbitt discloses the assessment data comprises meal structure data (p. 281: “Information is gathered on the natural course of the child's feeding problems, the current status of the problems, … foods and textures that are now and were previously regularly consumed or rejected, meal duration and amounts consumed”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the specific observation and assessment of meal structure data of Babbitt with the observations and assessments of US Application 18/330683 in order to maximize the amount of observed data to make the best possible assessment (Babbitt, pp. 280-281).
Regarding Claim 16, US Application 18/330683 is silent on collecting caregiver data. However, Babbitt discloses the assessment data comprises caregiver data (p. 282: “the assessment delineates caregiver behaviors that serve as antecedents and consequences for the child's feeding behaviors, and thus contribute to the maintenance of the feeding problems. Data are collected on the caregiver's correct use of antecedent stimuli (e.g., providing verbal instructions to eat accompanied by the presentation of a bite), prompts (e.g., in a spoken-gestural-physical prompt sequence unless instructed otherwise, representing expelled food), and consequences (providing positive reinforcement, such as contingent praise or play, for accepting and/or consuming the food and providing neutral consequences after other behaviors”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the specific observation and assessment of meal structure data of Babbitt with the observations and assessments of US Application 18/330683 in order to maximize the amount of relevant data to make the best possible assessment (Babbitt, pp. 280, 282).
Regarding Claim 17, US Application 18/330683 is silent on collecting subject response data. However, Babbitt further discloses the assessment data comprises subject response data (p. 281: “In order to develop and implement an effective treatment, objective measures of the target behaviors must be made;” p. 282: “direct observation of children's food preferences;” the Examiner notes that the subject’s food preferences and engagement in particular target behaviors after being given food are being interpreted as subject response data).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the specific observation and assessment of subject response data of Babbitt with the observations and assessments of US Application 18/330683 in order to maximize the amount of relevant data to make the best possible assessment (Babbitt, pp. 280-282).
Regarding Claim 18, US Application 18/330683 is silent on observing potential reinforcers. However, Babbitt discloses the observation comprises identifying one or more potential reinforcers (p. 282: “Data are collected on the caregiver's correct use of antecedent stimuli (e.g., providing verbal instructions to eat accompanied by the presentation of a bite), prompts (e.g., in a spoken-gestural-physical prompt sequence unless instructed otherwise representing expelled food), and consequences (providing positive reinforcement, such as contingent praise or play, for accepting and/or consuming the food and providing neutral consequences after other behaviors, unless instructed to do otherwise)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the specific observation and assessment of potential reinforcers of Babbitt with the observations of US Application 18/330683 in order to maximize the amount of relevant data to make the best possible assessment (Babbitt, pp. 280-282).
Regarding Claim 19, US Application 18/330683 is silent on observing foods for the intervention program. However, Babbitt discloses the observation comprises identifying one more foods for the intervention program (p. 282: “During the sampling component, the child is first verbally and then physically prompted as necessary to sample a pair of foods. Once both foods have been sampled, the choice component is implemented in which the child is given the opportunity to choose which of two foods she or he would like to eat more. This procedure is conducted for a number of pairs of foods within a food group. Foods not initially chosen are re-paired and the procedure is repeated. In the end, the therapist compiles a list of highly preferred foods (chosen on the first round), moderately preferred foods (chosen after being re-paired), and nonpreferred foods (not chosen). This procedure is then repeated for other food groups”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the specific observation and assessment of foods for the intervention program of Babbitt with the observations and assessments of US Application 18/330683 in order to maximize the amount of relevant data to make the best possible assessment and determine the most effective possible intervention (Babbitt, pp. 280, 282).
Claim 20 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-5 of copending Application No. 18/330683 in view of Blake as applied to claim 14 of the present application above, and further in view of a 2016 publication entitled “Adult picky eaters with symptoms of avoidant/restrictive food intake disorder” (hereinafter “Zickgraf”).
Regarding Claim 20, US Application 18/330683 is silent on therapeutic support devices. However, Zickgraf discloses the observation comprises identifying one or more therapeutic support devices (p. 5: Inflexible eating behavior, p. 10: Appendix; one observation includes identifying therapeutic support devices, such as particular utensils or dishes).
US Application 18/330683 and Zickgraf are analogous arts because they both teach methods and systems assessing a patient’s health in regards to feeding/eating disorders, such as ARFID. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the specific observation of therapeutic support devices of Zickgraf with the comprehensive observations and assessments of US Application 18/330683 in order to maximize the amount of observed data to make the best possible assessment (Zickgraf, abstract; p. 11).
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 an abstract idea(s) without significantly more.
Regarding Claim 8, analyzed as the representative claim:
[Step 1] Claim 8 recites “A system…” which falls within the “machine” statutory category of invention under 35 U.S.C. § 101.
[Step 2A – Prong 1] Claim 8 recites “A system for assessing one or more feeding behaviors in a subject, comprising: an electronic computing device; and a feeding management system configured to: determine an appropriate assessment type for a subject based on subject data; receive assessment data based on an observation, wherein the observation is based on the appropriate assessment type; determine if additional assessment is appropriate, wherein the additional assessment is appropriate if the assessment data does not meet one or more predefined rules; upon determining that the additional assessment is not appropriate, determine an intervention program; and assign the subject to the intervention program.” The bolded limitations, under their broadest reasonable interpretation, encompass mental processes (including observation, evaluation, judgment, and opinion) or methods of organizing human activity (managing personal behavior or relationships or interactions between people – including social activities, teaching, and following rules or instructions). Specifically, the claim encompasses a system which completes the steps of assessing a patient, making relevant determinations based on the data observed, and consequently assigning the patient to a treatment/intervention program. Accordingly, the claim recites an abstract idea(s).
[Step 2A – Prong 2] The judicial exception is not integrated into a practical application. Specifically, the claim recites the additional elements of an electronic computing device and a feeding management system, which are both recited at a high level of generality and merely automate the determining, receiving, and assigning steps. Therefore, these additional elements amount to no more than mere instructions to apply the exception using a generic computing device, which does not impose any meaningful limits on practicing the abstract idea(s). Thus, the claim is directed to an abstract idea(s).
[Step 2B] The claim does 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(s) into a practical application, the additional elements of an electronic computing device and a feeding management system performing the above steps of determining, receiving, and assigning amounts to no more than mere instructions to apply the exception using a generic computing device, which cannot provide an inventive concept. Accordingly, representative claim 8 is not patent eligible.
Claims 1 and 14 are rejected under the same reasoning as claim 1. Dependent claims 2-7, 9-13, and 15-20 recite the same abstract idea(s) as independent claims. While the dependent claims may have a narrower scope than the representative claim, no claim contains an additional element to integrate the abstract idea(s) into a practical application or to render an inventive concept that transforms the corresponding claim into a patent eligible application of the otherwise ineligible abstract idea(s). Thereby, claims 9-13 are also patent ineligible.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2 and 4-7 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Babbitt.
Regarding Claim 1, Babbitt discloses determining an appropriate assessment type for a subject based on subject data (p. 281: “The standard baseline assessment is individually tailored for each child;” pp. 280-281: “our assessment process involves consideration of the child's feeding history as well as direct observations of the child and caregiver under multiple baseline conditions. The KKI assessment protocol includes an initial medical assessment followed by behavioral assessment including a semistructured caregiver interview, standardized observations of behavior under baseline conditions, as well as functional consequence and food preference assessments;” the Examiner notes that the assessment types include medical assessment (such as lab testing and/or scans), caregiver interview, direct observation, functional analysis (such as assessment of interaction between caregiver and child), and food preference analysis;” p. 289: “in the program described here these adaptations and extensions of behavior analysis to feeding problems are incorporated into a highly integrated and orchestrated interdisciplinary program with both inpatient and outpatient capabilities;” the Examiner further notes that the appropriate assessment type(s) are selected from an interdisciplinary set of assessments for each individual patient based on their specific data and circumstance);
receiving assessment data based on an observation, wherein the observation is based on the appropriate assessment type (p. 283: “After a child's initial assessment is completed, treatment decisions are made taking into account a variety of considerations, including the nature of the problem, functional analysis results, the child's intellectual functioning level, and medical status”);
determining if additional assessment is appropriate (p. 281: “assessment protocol includes an initial medical assessment followed by behavioral assessment including a semistructured caregiver interview, standardized observations of behavior under baseline conditions, as well as functional consequence and food preference assessments;” p. 280: “Other disciplines such as Physical Therapy, Psychiatry, or Special Education participate as needed;” p. 282: “the child is first verbally and then physically prompted as necessary to sample a pair of foods. Once both foods have been sampled, the choice component is implemented in which the child is given the opportunity to choose which of two foods she or he would like to eat more. This procedure is conducted for a number of pairs of foods within a food group…This procedure is then repeated for other food groups;” the Examiner notes that various forms of assessments are mentioned and are completed as needed depending on outcome of previous tests), wherein the additional assessment is appropriate if the assessment data does not meet one or more predefined rules (p. 281: “Laboratory testing is performed to search for any underlying abnormalities such as renal, hepatic, or metabolic diseases;” p. 281: “Target behaviors are operationally defined in terms of their quantifiable physical characteristics. For example, accepting a bite of food (accept) may be operationally defined as ‘child's mouth open such that food enters within 5 seconds of presentation’… When conceptualized in these terms, individual responses may be recorded objectively, and considered reliable if interobserver agreement figures are high;” p. 281: “The standard baseline assessment is individually tailored for each child, depending primarily on whether the child is a self- or nonself-feeder. A detailed list of operational definitions for behaviors often targeted during baseline”);
upon determining that the additional assessment is not appropriate, determining an intervention program (p. 283: “After a child's initial assessment is completed, treatment decisions are made taking into account a variety of considerations, including the nature of the problem, functional analysis results, the child's intellectual functioning level, and medical status. Treatment usually begins with the least intrusive intervention available with additional treatment components introduced as necessary”); and
assigning the subject to the intervention program (p. 283: “Treatment usually begins with the least intrusive intervention available with additional treatment components introduced as necessary;” pp. 288-289: “Average length of admission was 61 days. Upon admission, children consumed on average 70 g for parent-fed meals (SD = 58 g), and 74 g for therapist-fed meals (SD = 99 g). By discharge, children registered an increase in intake of 214 g for parent-fed meals (SD = 120 g) and 206 g for therapist-fed meals (SD = 12 l g). In addition, 10% of eligible children became self-feeders during their stay, and 29% moved up to a higher food texture. Eighty-six percent of those children who were tube dependent at admission took all nutrition and hydration orally by time of discharge”).
Regarding Claim 2, Babbitt further discloses transmitting an evaluation to a caregiver of the subject (p. 281: “The assessment of the caregiver begins with an interview in which caregivers detail the child's behavioral and medical histories”);
receiving evaluation data from the caregiver, wherein the evaluation data comprises subject data and is based on the evaluation (p. 281: “Information is gathered on the natural course of the child's feeding problems, the current status of the problems, previous and ongoing strategies that have or have not helped manage the child's eating, foods and textures that are now and were previously regularly consumed or rejected, meal duration and amounts consumed, the child's daily routine and family home structure, and caregivers' reports of environment-behavior relations surrounding feeding”); and
determining that the subject is eligible for the intervention program based on one or more eligibility rules (p. 281: “the therapist asks the caregivers first to identify specific behavior problems from a checklist;” p. 281: “Target behaviors are operationally defined in terms of their quantifiable physical characteristics. For example, accepting a bite of food (accept) may be operationally defined as ‘child's mouth open such that food enters within 5 seconds of presentation’… When conceptualized in these terms, individual responses may be recorded objectively, and considered reliable if interobserver agreement figures are high;” p. 283: “After a child's initial assessment is completed, treatment decisions are made taking into account a variety of considerations”).
Regarding Claim 4, Babbitt further discloses the evaluation comprises a plurality of questions related to the subject (p. 281: “The assessment of the caregiver begins with an interview in which caregivers detail the child's behavioral and medical histories… When discussing environment-behavior relations, the therapist asks the caregivers first to identify specific behavior problems from a checklist”).
Regarding Claim 5, Babbitt further discloses the one or more eligibility rules comprises criteria for avoidant/restrictive food intake disorder (p. 280: “Referring problems included primary food refusal [and] food selectivity by type or texture;" p. 281: “Information is gathered on the natural course of the child's feeding problems, the current status of the problems, previous and ongoing strategies that have or have not helped manage the child's eating, foods and textures that are now and were previously regularly consumed or rejected, meal duration and amounts consumed, the child's daily routine and family home structure, and caregivers' reports of environment-behavior relations surrounding feeding”).
Regarding Claim 6, Babbitt further discloses the one or more eligibility rules comprises criteria for oral motor skills (p. 280: “Referring problems included … self-feeding skill deficit [and] swallowing skill deficit;” p. 281: “Furthermore, investigations of the upper gastrointestinal tract are undertaken. A radiographic assessment of the swallowing mechanism is performed to ensure that structure and function of the hypopharynx in these patients is safe and they are capable of protecting their airway during the swallowing process”).
Regarding Claim 7, Babbitt further discloses determining a referral to a provider is not appropriate for the subject (p. 281: “The initial intention of a medical assessment is to determine if any underlying condition can be identified that might be amenable to therapeutic intervention;” the Examiner notes that because the assessment is used to determine when intervention would be beneficial or necessary, it logically must also be able to determine when it is not appropriate or necessary).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Babbitt as applied to claim 1 above, and further in view of Blake.
Regarding Claim 3, Babbitt does not explicitly disclose any electronic computing device. However, Blake discloses the evaluation is transmitted to a caregiver electronic computing device (par. 0040: “The behavioral health assessment application may be accessed over the Internet at home or on tablet computers in the pediatrician's office. Prior to seeing the healthcare provider, parents are asked to complete an initial assessment that compiles a particular child's behavioral health issues and establishes a baseline measuring point for the particular child's behaviors”).
Babbitt and Blake are analogous arts because they both teach methods and systems for assessing a patient’s health status in relation to potential feeding disorders (Blake, pars. 0053-0054), at least in part, and recommending intervention programs as needed. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to transmit the evaluation of Babbitt to a caregiver electronic computing device as disclosed by Blake in order to provide a user-friendly evaluation which can be done anywhere, thereby affording convenience to the caregiver (Blake, pars. 0039-0040).
Claims 8-19 are rejected under 35 U.S.C. 103 as being unpatentable over Babbitt, and further in view of Blake.
Regarding Claim 8, Babbitt discloses a feeding management system (abstract) configured to:
determine an appropriate assessment type for a subject based on subject data (p. 281: “The standard baseline assessment is individually tailored for each child;” pp. 280-281: “our assessment process involves consideration of the child's feeding history as well as direct observations of the child and caregiver under multiple baseline conditions. The KKI assessment protocol includes an initial medical assessment followed by behavioral assessment including a semistructured caregiver interview, standardized observations of behavior under baseline conditions, as well as functional consequence and food preference assessments;” the Examiner notes that the assessment types include medical assessment (such as lab testing and/or scans), caregiver interview, direct observation, functional analysis (such as assessment of interaction between caregiver and child), and food preference analysis;” p. 289: “in the program described here these adaptations and extensions of behavior analysis to feeding problems are incorporated into a highly integrated and orchestrated interdisciplinary program with both inpatient and outpatient capabilities;” the Examiner further notes that the appropriate assessment type(s) are selected from an interdisciplinary set of assessments for each individual patient based on their specific data and circumstance);
receive assessment data based on an observation, wherein the observation is based on the appropriate assessment type (p. 283: “After a child's initial assessment is completed, treatment decisions are made taking into account a variety of considerations, including the nature of the problem, functional analysis results, the child's intellectual functioning level, and medical status”);
determine if additional assessment is appropriate (p. 281: “assessment protocol includes an initial medical assessment followed by behavioral assessment including a semistructured caregiver interview, standardized observations of behavior under baseline conditions, as well as functional consequence and food preference assessments;” p. 280: “Other disciplines such as Physical Therapy, Psychiatry, or Special Education participate as needed;” p. 282: “the child is first verbally and then physically prompted as necessary to sample a pair of foods. Once both foods have been sampled, the choice component is implemented in which the child is given the opportunity to choose which of two foods she or he would like to eat more. This procedure is conducted for a number of pairs of foods within a food group…This procedure is then repeated for other food groups;” the Examiner