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 .
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed provisional applications, Application No. 62/479,855 and Application No. 62/491,538, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. That is, the recited provisional applications fail to provide support for electronic computing device(s) and/or a feeding management system configured to perform the claimed functions. Accordingly, claims 1-20 are not entitled to the benefit of the provisional applications.
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 1-7, 10, 14, 17, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 and 18 of U.S. Patent No. 11,158,416. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-7, 10, 14, 17, and 19 are anticipated by patent claims 14 and 18.
Specification
The Specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
The Specification does not appear to disclose a feeding management system configured for performing an assessment of one or more feeding behaviors of a subject or recording intervention data in response to intervention with the subject as required by claim 7 (see Specification, p. 6, ln. 9-p. 7, ln. 2, disclosing wherein the practitioner electronic computing device generates the assessment and transmits the assessment to the feeding management system, and further disclosing wherein the practitioner electronic computing device records the response of the human (intervention data)); and
The Specification does not appear to disclose performing a comparison of the intervention data and the one or more predefined rules, and modifying the one or more predefined rules in response to the comparison, as required by claim 8 (see Specification, p. 27, ln. 1-20, only disclosing wherein the patient’s response (intervention data) is analyzed to determine if appropriate progress is being made and wherein assessment criteria may be modified accordingly, wherein the Specification makes no mention that analyzing the response comprises performing a comparison of the intervention data and the one or more predefined rules, nor that the assessment criteria and one or more predefined rules are synonymous).
Claim Objections
Claims 5, 7, 11, and 14 are objected to because of the following informalities:
“a predetermine threshold” recited in claim 5, ln. 2 should likely read “a predetermined threshold”;
“record” recited in claim 7, ln. 9 should likely read “recording”;
“in response to intervention” recited in claim 7, ln. 9 should likely read “in response to the intervention”;
“determine” recited in claim 7, ln. 11 should likely read “determin[[e]]ing”;
“wherein the intervention comprises” recited in claim 11, ln. 1 should likely read “wherein the intervention further comprises”; and
“the subject” recited in claim 14, ln. 3 should likely read “[[the]]a subject”.
Appropriate correction is required.
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 limitations use 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 limitations are: “electronic computing device” recited in claim 1, “feeding management system” recited in claims 1 and 6, and “caregiver electronic computing device” recited in claims 3-4.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structures described in the Specification as performing the claimed functions, and equivalents thereof.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 structures to perform the claimed functions); or (2) present a sufficient showing that the claim limitations recite sufficient structures to perform the claimed functions so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
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.
Claims 1-13 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.
Claim 1 recites in part “an electronic computing device configured to perform an assessment of one or more feeding behaviors of a subject”. It is indefinite as to how the electronic computing device performs the assessment of one or more feeding behaviors of the subject, and the Specification does not offer further guidance (see Fig. 5, #506; p. p. 24, ln. 3-5, “At step 506, the assessment of the patient is conducted by the appropriate medical practitioners. In one embodiment, the assessment comprises an observation of the patient being fed by the caregiver in the home setting.”).
Claim 7 is rejected for similar reasoning, wherein it is indefinite as to how the feeding management system performs the assessment of one or more feeding behaviors of the subject (see claim 7, ln. 2-3).
Claims 2-6 and 8-13 are rejected by virtue of their dependencies on claims 1 and 7, respectively.
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 without significantly more.
[Step 1] Independent claims 1, 7, and 14 recite a system, method, and non-transitory computer-readable medium, respectively, which fall within the machine, process, and manufacture statutory categories of invention, respectively.
[Step 2A – Prong 1] The claims recite limitations which can be practically performed by one or more humans through mental process (i.e., observation, evaluation, judgment, and/or opinion) (see MPEP 2106.04(a)(2)(III)) and/or certain methods of organizing human activity (i.e., managing personal behavior or relationships or interactions between people – including social activities, teaching, and following rules or instructions) (see MPEP 2106.04(a)(2)(II)).
The claims recite, using claim 7 as representative claim: A method for treating one or more behaviors in a subject, comprising the steps of:
performing, via a feeding management system, an assessment of one or more feeding behaviors of a subject;
receiving, via the feeding management system, the assessment;
determining, via the feeding management system, based on a comparison of the assessment with one or more predefined rules, an intervention that will treat the one or more feeding behaviors of the subject, wherein the intervention comprises at least one meal session during which food is presented to the subject according to predetermined guidelines;
record, via the feeding management system, intervention data in response to intervention with the subject; and
determine, via the feeding management system, whether to conduct an additional intervention based on the intervention data.
The recited limitations, under their broadest reasonable interpretation, encompass limitations that can practically be performed in the human mind (i.e., mental processes, including observation, evaluation, judgment, and/or opinion) but for the recitation of a generic computer component (feeding management system). That is, a human (e.g., medical practitioner, therapist, etc.) can perform and receive an assessment of one or more feeding behaviors of a subject through visual observation/evaluation, mentally determine a treatment (e.g., by mentally comparing the visual assessment (i.e., food refusal behavior) with a feeding disorder and using their judgment and evaluation to come up with an intervention), record (e.g., visually observe and mentally, and/or using pen and paper, note response(s) of the subject to the determined treatment), and mentally determine whether additional intervention/treatment is needed based on the observed/documented response(s) (intervention data).
Additionally, and/or alternatively, the limitations can be practically performed between people but for the recitation of a generic computer component. That is, other than reciting a feeding management system, nothing in the claim element precludes the steps from practically being performed between people (i.e., managing personal behavior or relationships or interactions between people – including social activities, teaching, and following rules or instructions). For example, the recited limitations encompass a medical practitioner assessing a patient (e.g., via visual observation and/or verbal questioning) and intervening (e.g., determining and providing a treatment and documenting/observing the patient’s response to the treatment).
Accordingly, the claims encompass an abstract idea(s).
[Step 2A – Prong 2] The claims fail to recite additional limitations to integrate the abstract idea(s) into a practical application. In particular, the independent claims only recite the additional elements of a “feeding management system”, “electronic computing device”, and/or “non-transitory computer-readable medium” executed by “at least one computing device” for performing the above-discussed limitations. These limitations are recited at a high-level of generality such that they amount to no more than mere instructions to apply the exception using a generic computer component(s) (see Specification, p. 16, ln. 30-p. 17, ln. 3, wherein the practitioner device 204 is any device that is capable of performing the functionality disclosed herein (e.g., desktop computer, laptop computer, smartphone, etc.; see also Fig. 1 & p. 18, ln. 21-24, wherein the feeding management system 102 may be any computing device (e.g., desktop computer, laptop, servers, tablets, etc.); see further p. 29, ln. 8-25, wherein the computer-readable media can be any available media which can be accessed by a computer, or downloadable through communication networks). Moreover, the additional limitations of transmitting and receiving data (e.g., the assessment and the intervention data) are directed to insignificant extra-solution activity (data gathering and data transmission), which do not integrate the abstract idea(s) into a practical application. See MPEP 2106.05(g). Similarly, recording the intervention data may alternatively be directed to data gathering, which also does not integrate the abstract idea into a practical application. Therefore, the additional elements do not integrate the abstract idea(s) into a practical application, as the additional element(s) do not impose any meaningful limits on practicing the abstract idea(s). There is no indication that the combination of elements improves the functionality of a computer or other technology (See MPEP 2106.05(a)), recites (ii) a “particular machine” to apply or use the abstract idea(s) (See MPEP 2106.05(b)), recites (iii) a particular transformation of an article to a different thing or state (See MPEP 2106.05(c)), or recites (iv) any other meaningful limitation (See MPEP 2106.05(e)). Thus, the claims are directed to the abstract idea(s).
[Step 2B] As discussed above with respect to integration of the abstract idea(s) into a practical application, the claims fail to include additional limitations that are sufficient to amount to significantly more than the abstract idea(s). That is, while the independent claims recite that the limitations are performed by a “feeding management system”, “electronic computing device”, and/or “non-transitory computer-readable medium” executed by “at least one computing device”, these limitations are recited at a high-level of generality such that they amount to no more than mere automation of a manual process, or application of the abstract idea(s) using a generic computer component(s), which cannot provide an inventive concept. Moreover, the recited transmitting and receiving limitations amount to no more than insignificant extra-solution activity, which cannot provide an inventive concept. Similarly, recording the intervention data recited in claims 1 and 7 may alternatively be directed to insignificant extra-solution activity, which cannot provide an inventive concept. There is no indication that the combination of elements improves the functionality of a computer or other technology (See MPEP 2106.05(a)), recites (ii) a “particular machine” to apply or use the abstract idea(s) (See MPEP 2106.05(b)), recites (iii) a particular transformation of an article to a different thing or state (See MPEP 2106.05(c)), or recites (iv) any other meaningful limitation (See MPEP 2106.05(e)).
Additionally, under Step 2B, the conclusion that an element amounts to mere instructions to apply an exception or is directed to insignificant extra-solution activity should be reevaluated to determine if it is more than what is well-understood, routine, conventional activity in the field (See MPEP 2106.05(d)). As noted above, the Specification does not provide any indication that the additional elements are anything other than generic, off-the-shelf computer components, and further, the courts have indicated that receiving or transmitting data over a network is a well-understood, routine, and conventional function when claimed in a merely generic manner, as is claimed herein (See MPEP 2106.05(d)(II), citing Intellectual Ventures v. Symantec, 838 F.3d 1307, 1321, 120 USPQ2d 1353, 1362 (Fed. Cir. 2016), TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016), and OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015)).
As noted above, each independent claim, as a whole, merely describes how to generally “apply” the abstract idea(s) in a computer environment and recites insignificant extra-solution activity. Thus, even when viewed as a whole, nothing in the claims adds significantly more (i.e., an inventive concept) to the abstract idea(s). Therefore, claims 1, 7, and 14 are not patent eligible.
Dependent claims 2-6, 8-13, and 15-20 are dependent on claims 1, 7, and 14, respectively, and therefore recite the same abstract idea(s) noted above. While dependent claims 2-6, 8-13, and 15-20 may have a narrower scope than the independent claims, the claims fail to recite additional limitations that would integrate the abstract idea(s) into a practical application or provide significantly more (i.e., an inventive concept). For example, while claims 2-4 recite the additional limitation of a caregiver electronic computing device for receiving and transmitting data (evaluation/evaluation data), the additional limitations amount to no more than mere instructions to apply the abstract idea(s) using a generic computing component, generally linking the abstract idea(s) to a particular technological environment (computing environment), and/or insignificant extra-solution activity (see Specification, p. 17, ln. 11-15, noting that the caregiver device 106 is any device capable of performing the functionality disclosed herein, such as a desktop computer, laptop computer, tablet computer, smartphone, etc.). Further, as noted above, the steps of transmitting/receiving data were considered to be insignificant extra-solution activity that is well-understood, routine, and conventional when claimed in a merely generic manner, as is claimed herein, while additionally, the Specification fails to provide any indication that the caregiver electronic computing device is anything other than a generic, off-the-shelf computer component.
Therefore, claims 2-6, 8-13, and 15-20 are also not patent eligible.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-11 and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Babbitt et al., Behavioral assessment and treatment of pediatric feeding disorders, Developmental and Behavioral Pediatrics, Vol. 15, pp. 278-291 (1994) (hereinafter “Babbitt”) in view of Mahapatra et al. (U.S. Pub. 2018/0060495 A1) (hereinafter “Mahapatra”).
Regarding claim 1, Babbitt discloses a system for treating one or more feeding behaviors in a subject (pp. 278-279; pp. 283-285, assessment and treatment procedures for feeding disorders), comprising:
perform an assessment of one or more feeding behaviors of a subject (pp. 280-281, wherein the assessment involves direct observations of the child and caregiver under multiple baseline conditions);
determine, based on a comparison of the assessment with one or more predefined rules, an intervention that will treat the one or more feeding behaviors of the subject (pp. 282-283, where the assessment is used to collect baseline data in order to plan and carry out a treatment while maintaining systematic measurement, such that functional relationships between treatment procedures and the child’s behavior are demonstrated, wherein 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), wherein the intervention comprises at least one meal session during which food is presented to the subject according to predetermined guidelines (pp. 282-285, wherein treatment includes presenting foods to the child, which may start with foods the child is already likely to consume, and further includes guidelines to increase appropriate behavior or decrease maladaptive behavior), and, in response to the intervention with the subject, intervention data is recorded (Figs. 2-3, pp. 283-284, wherein consumption data, or expel and/or interruption data, during the intervention(s) is recorded); and
determine, based on the intervention data, whether to conduct an additional intervention (pp. 283-286, wherein additional intervention is conducted based on intervention data (child behavior/response) until a target/stable rate of behavior is achieved).
Babbitt may not disclose an electronic computing device and a feeding management system, the electronic computing device configured to perform the assessment, transmit the assessment to the feeding management system, record the intervention data, and transmit the intervention data to the feeding management system, and the feeding management system configured to receive the assessment, determine an intervention, receive the intervention data, and determine whether to conduct an additional intervention. However, Mahapatra, directed to a system for processing data for healthcare and recommending medical intervention activities for caregivers and/or human subjects ([0001]), teaches wherein an application server (e.g., computing device) (feeding management system) may receive medical data (e.g., assessment data) from a subject computing device (electronic computing device), generate a recommendation of one or more medical intervention activities, and receive feedback (intervention data) from the subject computing device corresponding to an action taken by the subject based on the recommendation (intervention), wherein the application server may then update a customized ontology used to generate the recommendations of intervention activities ([0004]; [0040-0043]; [0049]). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a subject computing device in communication with another computing device (application server) to receive and transmit medical and intervention data between the devices, as taught by Mahapatra, in order to perform the limitations of Babbitt remotely (e.g., transmittal/receipt of the assessment data and intervention data).
Regarding claim 2, Babbitt may not further explicitly disclose a caregiver electronic computing device. However, Mahapatra teaches this limitation ([0038]; [0041]; [0053-0055], caregiver computing device, which may also or alternatively provide medical (assessment data) to the application server). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to further incorporate a caregiver computing device, as taught by Mahapatra, in Babbitt to transmit data which may be collected by a caregiver remote from a practitioner, therapist, or the like.
Regarding claim 3, Babbitt further discloses receive an evaluation (p. 281, wherein an interview with a caregiver of the child is performed for data collection aside from direct observation of the child).
Babbitt may not further disclose the caregiver electronic computing device receiving the evaluation from the feeding management system. However, Mahapatra teaches wherein the caregiver computing device may also or alternatively provide medical data (evaluation data) to the application server ([0038]; [0041]; [0053-0055]). Accordingly, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to receive from the caregiver computing device the medical (evaluation) data, in response to a request from the application server (feeding management system) for said data (the evaluation), in order to transmit the medical data which may be collected by a caregiver remote from a practitioner, therapist, or the like for use in the generation of the recommendation for one or more intervention activities.
Regarding claim 4, Babbitt further discloses transmit evaluation data (p. 281, wherein caregivers detail the child’s behavioral and medical histories (evaluation data)).
Babbitt may not further disclose the caregiver electronic computing device configured to transmit the evaluation data to the feeding management system. However, Mahapatra teaches wherein the caregiver computing device may also or alternatively provide medical data (evaluation data) to the application server ([0038]; [0041]; [0053-0055]). Accordingly, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to transmit from the caregiver computing device to the application server (feeding management system) the medical (evaluation) data which may be collected by a caregiver remote from a practitioner, therapist, or the like for use in the generation of the recommendation for one or more intervention activities.
Regarding claim 5, Babbitt further discloses wherein the additional intervention is appropriate if the intervention data does not meet a predetermine threshold (pp. 283-286, wherein the additional intervention is conducted based on the intervention data (child behavior/response) until a target/stable rate of behavior (threshold) is achieved).
Regarding claim 6, Babbitt further discloses provide discharge instructions for the subject (pp. 287-288, wherein caregivers are trained in the feeding process to reduce any detrimental effect on the child’s progress and include instructions for feeding the child (e.g., verbal prompts, consequences, etc.); pp. 288-289, wherein the children of the program were instructed to be discharged).
Babbitt may not disclose the discharge instructions being provided by the feeding management system. However, Mahapatra teaches wherein the application server transmits recommendations to the subject and/or caregiver ([0042]). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide for the discharge instructions (e.g., recommendation) to be provided from a feeding management system (e.g., application server/computing device) as taught in Mahapatra in order to provide for remote communications between users of the system.
Regarding claim 7, claim 7 is rejected for similar reasoning as claim 1 presented above.
Regarding claim 8, Babbitt further discloses performing a comparison of the intervention data and the one or more predefined rules (pp. 282-283, wherein functional relationships between treatment procedures and the child’s behavior are demonstrated, and wherein data collected during treatment (intervention data) is compared to the baseline condition to assess treatment efficacy); and
modifying the one or more predefined rules in response to the comparison (pp. 283-285, wherein treatment decisions may be modified accordingly (e.g., wherein the frequency of reinforcement may be systematically decreased once a high, stable rate of behavior is achieved such that high rates of behavior are maintained with little effort on the part of the person feeding the child)).
Regarding claim 9, Babbitt further discloses determining to discharge the subject based on a determination not to conduct the additional intervention (pp. 288-289, wherein of 40 children treated in the last two years, 15% were discharged home on a basic positive reinforcement protocol, 86% of those children who were tube dependent at admission took all nutrition and hydration orally by time of discharge, and one child had to be discharged prematurely due to medical complications; pp. 283-285, presenting case studies indicating discharge following successful food acceptance and swallowing or reduced interrupts); and
providing training information to a caregiver for the subject (pp. 287-288, wherein caregivers are trained in the feeding process to reduce any detrimental effect on the child’s progress and include instructions for feeding the child (e.g., verbal prompts, consequences, etc.)).
Regarding claim 10, Babbitt further discloses determining a second assessment based on a determination to conduct the additional intervention (pp. 283-286, wherein additional intervention and assessment is conducted based on intervention data (child behavior/response) until a target/stable rate of behavior is achieved).
Regarding claim 11, Babbitt further discloses wherein the intervention comprises an inpatient intervention or an outpatient intervention (p. 279, “the basic assessment and treatment procedures used by a specialized pediatric inpatient program”; pp. 288-289, alternatively noting that some treatment procedures could be implemented through a home health care model (outpatient intervention)).
Regarding claim 13, Babbitt further discloses the outpatient intervention comprises conducting the at least one meal session at least once a week (pp. 288-289, wherein some treatment procedures could be implemented through a home health care model (outpatient intervention) and include at least one meal session at least once a week).
Regarding claim 14, claim 14 is rejected for similar reasoning as claim 1 presented above.
Regarding claim 15, Babbitt further discloses wherein the at least one meal session includes a plurality of food items (p. 285, e.g., wherein all four food groups may be introduced into the at least one meal session).
Regarding claim 16, Babbitt further discloses wherein at least one food item is randomly selected from the plurality of food items to present to the subject (p. 285, wherein there is no indication that the order of foods presented the child is preset, and where, for example, peaches (at least one food item) is selected for presentation to the child).
Regarding claim 17, Babbitt further discloses wherein the predetermined guidelines comprise a form of presentation for the at least one food item (p. 285, e.g., wherein the at least one food item (peaches) is to be presented in pureed form).
Regarding claim 18, Babbitt further discloses wherein the intervention data comprises an amount of the at least one food item consumed by the subject (Figs. 2-3, p. 285, intervention data comprising an amount consumed and/or expelled, wherein the percentage not expelled by the child was consumed).
Regarding claim 19, Babbitt further discloses wherein the intervention data comprises a response by the subject (Figs. 2-3, pp. 283-285, wherein consumption amount, expelled percentage, and/or interruption percentage (response by the child to the intervention) is/are received).
Regarding claim 20, Babbitt further discloses wherein the predetermined guidelines comprise a consequence for a behavior by the subject (pp. 283-285, wherein consequences for accepting a bite of food may include praise or access to a preferred toy or activity, or wherein consequences for inappropriate behavior may include time out, taking something away, or hands down prompting (e.g., physically guiding child’s hands to a folded down position or to their side for a specified period of time)).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Babbitt in view of Mahapatra, as applied to claim 11, and in further view of “Feeding and Swallowing Center – Introduction – The Children’s Hospital of Philadelphia (1 of 6)”, 3 pages, uploaded on June 8, 2010 by user “The Children’s Hospital of Philadelphia” (hereinafter “CHOP”).
Regarding claim 12, Babbitt may not further explicitly disclose wherein the inpatient intervention comprises more than one meal session per day. However, CHOP, directed to an intensive day hospital feeding program (inpatient intervention) (0:08-0:10), teaches three feeding sessions provided per day (0:36-054). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to perform multiple meal sessions per day in order to collect more data (intervention data) to aid with determining how the child is progressing over each meal session and thus with the treatment of the one or more feeding behaviors.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA N BRANDLEY whose telephone number is (571)272-4280. The examiner can normally be reached M-F: 8:30am-5:00pm.
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, Dmitry Suhol, can be reached at (571)272-4430. 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.
/ALYSSA N BRANDLEY/Examiner, Art Unit 3715