CTNF 18/262,052 CTNF 94137 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. 12-151 AIA 26-51 12-51 Status of Claims Claims 1-20 were originally filed for examination and pending on July 19, 2023. On January 6, 2026, claims 1-20 were subject to a restriction/election requirement (the “January 6, 2026 Restriction/Election Requirement”). On March 4, 2026, Applicant elected claims 1-19 ( Invention I ) without traverse, in a response to the January 6, 2026 Restriction/Election Requirement (the “March 4, 2026 Response to Restriction Requirement”). As such, pursuant to the March 4, 2026 Response to Restriction Requirement, claims 1-20 as originally filed on July 19, 2023 are currently pending: of which (i) claims 1-19 are elected and examined; and (ii) claim 20 is non-elected and withdrawn from consideration. Claims 1-19 , as originally filed on July 19, 2023, are subject to the non-final office action below. Priority 02-26 AIA Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. 23-19 AIA Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application. Information Disclosure Statement The information disclosure statement (IDS) submitted on July 19, 2023 is in compliance with the provisions of 37 CFR 1.97, and has been considered by the examiner. 07-30-03-h AIA Claim Interpretation 07-30-03 AIA 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. 07-30-05 The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: - first data generation unit in claims 1, 2, 5, and 6 ; - second data generation unit in claims 1 and 2 ; and - image generation unit in claims 1, 7-9, 17, and 18 . Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Applicant discloses sufficient structure for the above generation units in the specification, where Applicant describes: (1) an analysis unit, processing unit, and generation unit as capable of of being implemented by both hardware or software configurations; (2) (i) the analysis unit 41 as being an example of the first data generation unit; (ii) the processing unit 42 as being an example of the second data generation unit; and (iii) the generation unit 44 as being an example of the image generation unit; and (3) a CPU of the computer executes an information processing program loaded on the RAM, thereby implementing all or some of the functions of the analysis unit, processing unit, and generation unit. See Applicant’s specification as filed on July 19, 2023, paragraphs [0030], and [0089], [0119]. Therefore, for examination purposes, the first data generation unit, second data generation unit, and image data generation unit are interpreted as software programs that are implemented by a generic computer hardware device, like a CPU. 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 limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Claim Rejections - 35 USC § 101 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 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. See MPEP § 2106 (hereinafter referred to as the “2019 Revised PEG”). Step 1 of the Alice/Mayo Test Following Step 1 of the 2019 Revised PEG, claims 1-18 are directed to an information processing device, which is within one of the four statutory categories ( i.e. , a machine or apparatus). See MPEP § 2106.03. Claim 19 is directed to an information processing method, which is also within one of the four statutory categories ( i.e. , a process). See id. Step 2A of the 2019 Revised PEG - Prong One Following Prong One of Step 2A of the 2019 PEG, the claim limitations are to be analyzed to determine whether they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. See MPEP §2106.04. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: (1) Mathematical Concepts; (2) Certain Methods of Organizing Human Activity, and (3) Mental Processes. See MPEP § 2106.04(a). Claims 1-19 are rejected under 35 U.S.C. § 101, because the claimed invention is directed to an abstract idea without significantly more. Representative independent claims 1 and 19 include limitations that recite an abstract idea. Note that independent claim 1 is directed to an information processing device, while claim 19 covers the matching information processing method. Specifically, independent claim 1 recites the following limitations: A information processing device comprising: a first data generation unit that generates objective score data, which indicates objective scores in time series, based on a plurality of pieces of objective data regarding a patient ; and a second data generation unit that generates subjective score data, which indicates subjective scores in time series, based on a plurality of pieces of subjective data obtained from the patient ; and an image generation unit that generates a score image indicating the objective score data and the subjective score data . However, the Examiner submits that the foregoing underlined limitations constitute a process that, under its broadest reasonable interpretation, falls within the “Mental Processes” grouping of abstract ideas. See 2019 Revised PEG. The Mental Processes category covers concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper (including an observation, evaluation, judgment, or opinion) ( i.e. , an information processing method, comprising: generating objective score data, which indicates objective scores in time series, based on a plurality of pieces of objective data regarding a patient; generating subjective score data, which indicates subjective scores in time series, based on a plurality of pieces of subjective data obtained from the patient; and generating a score image indicating the objective score data and the subjective score data ). See MPEP § 2106.04(a)(2)(III). That is, other than reciting some computer components and functions (the foregoing limitations in claim 1 which are not underlined), the context of claims 1 and 19 encompass concepts that are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper (including an observation, evaluation, judgment, and/or opinion) ( i.e. , an information processing method, comprising: generating objective score data, which indicates objective scores in time series, based on a plurality of pieces of objective data regarding a patient; generating subjective score data, which indicates subjective scores in time series, based on a plurality of pieces of subjective data obtained from the patient; and generating a score image indicating the objective score data and the subjective score data ). The aforementioned claim limitations described in claims 1 and 19 are analogous to claim limitations directed toward concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper, because they merely recite limitations which encompass a person mentally and/or manually: (1) generating objective score data, which indicates objective scores in time series ( i.e. , a type of observation, evaluation, judgment, and/or opinion where a person could mentally and/or manually generate scores for objective data regarding a patient ); (2) generating subjective score data, which indicates subjective scores in time series ( i.e. , a type of observation, evaluation, judgment, and/or opinion where a person could mentally and/or manually generate scores for subjective data regarding a patient ); and (3) generating a score image indicating the objective score data and the subjective score data ( i.e. , a type of observation, evaluation, judgment, and/or opinion where a person could manually write down the objective scores and the subjective scores on a piece of paper ). Therefore, the aforementioned underlined claim limitations may reasonably be interpreted as mental/manual observations, evaluations, judgments, and/or opinions made by a person, such as a healthcare professional. If a claim limitation, under its broadest reasonable interpretation, covers concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper, then it falls within the “Mental Processes” grouping of abstract ideas. See 2019 Revised PEG. Accordingly, claims 1 and 19 recite an abstract idea that falls within the Mental Processes category. Furthermore, Examiner notes that dependent claims 2-6 and 10-18 further define the at least one abstract idea (and thus fail to make the abstract idea any less abstract) as set forth below. Examiner notes that: (1) dependent claims 2, 5-9, 17, and 18 include limitations that are deemed to be additional elements, and require further analysis under Prong Two of Step 2A; and (2) dependent claims 3, 4, and 10-16 do not provide any limitations that are deemed to be additional elements which require further analysis under Prong Two of Step 2A. - For example, claim 2 describes further mental concepts directed to generating the scores by multiplying the objective and subjective data by a weighting factor depending on the degrees of importance of each piece of data and summing up the results. This is deemed to be part of the abstract mental process, because multiplying data and summing up the results is a form of basic math that can be performed mentally and/or manually and represents a form of a mental observation, evaluation, judgment, and/or opinion. However, Examiner notes that claim 2 includes a limitation that is deemed to be an additional element and requires further analysis under Prong Two of Step 2A. - Next, claims 3 and 4 describe further limits on the type of weighting factor being either set depending on a disease of the patient or being variable. This is deemed to be part of the abstract mental process, because this limitation merely modifies the weighting factor that is used to multiply with the objective data and subjective data. - Claims 5 and 6 describe further mental concepts directed to: (i) determining a symptom of the patient based on sound information occurring from the patient or determines a sleep state of the patient and generates sleep information of the patient (as described in claim 5 ); and (ii) determining intake/non-intake of medication by the patient based on sound information, motion information, or image information (as described in claim 6 ). This is deemed to be part of the abstract mental process, because this making such determinations are forms of mental observations, evaluations, judgments, and/or opinions. - Lastly, claims 10-18 include a further mental/manual steps for different types of information that is included in the image score. These steps are deemed to be part of the abstract mental process, because these limitations merely modify the type of information that is included in the image which is a form of a mental and/or manual observation, evaluation, judgment, and/or opinion. However, Examiner notes that claims 17 and 18 includes a limitation that are deemed to be additional elements and require further analysis under Prong Two of Step 2A. Step 2A of the 2019 Revised PEG – Prong Two Regarding Prong Two of Step 2A of the 2019 Revised PEG, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted in the 2019 Revised PEG, it must be determined whether any additional elements in the claims are indicative of integrating the abstract idea into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” See MPEP §§ 2106.05 (f)-(h). In the present case, for independent claim 1 , the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”): A information processing device ( the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f) ) comprising : a first data generation unit ( the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f) ) that generates objective score data, which indicates objective scores in time series, based on a plurality of pieces of objective data regarding a patient ; and a second data generation unit ( the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f) ) that generates subjective score data, which indicates subjective scores in time series, based on a plurality of pieces of subjective data obtained from the patient ; an image generation unit ( the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f) ) that generates a score image indicating the objective score data and the subjective score data ; and a computer ( the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f) ) (as recited in claim 19 ). However, the recitation of these generic computer components and functions in , such that it amounts to no more than: (1) adding the words “apply it” (or is the equivalent of) with the judicial exception; mere instructions to implement an abstract idea on a computer; or merely uses a computer as a tool to perform an abstract idea; (2) adding insignificant extra-solution activity to the judicial exception; and (3) generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP § 2106.05(f)-(h). For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application. - The following are examples of court decisions that demonstrate merely applying instructions by reciting the computer structure as a tool to implement the claimed limitations ( e.g. , see MPEP § 2106.05(f)): - Invoking computers or other machinery merely as a tool to perform an existing process, e.g. see, Affinity Labs v. DirecTV – similarly, the current invention invokes computers ( i.e. , the information processing device and the computer ) and other machinery to perform the existing process of generating the scores and the image with the scores. - Requiring the use of software to tailor information and provide it to the user on a generic computer, e.g. see, Intellectual Ventures I LLC v. Capital One Bank – similarly, the current invention merely requires the first generation unit; second generation unit; and image generation unit, to ultimately perform the abstract mental process of generating the scores and the image with the scores, as described in claim 1 and 19 . Thus, the additional elements in independent claims 1 and 19 are not indicative of integrating the judicial exception into a practical application. Similarly, dependent claims 3, 4, and 10-16 do not recite any additional elements outside of those identified as being directed to the abstract idea (or those additional elements which were already identified and analyzed in claim 1 ), described above. Examiner notes that dependent claims 2, 5-9, 17, and 18 recite the following additional elements identified in bold font below (with limitations deemed to be part of the above identified abstract idea identified in underlined font): wherein the first data generation unit ( the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f) ) obtains each of the objective scores by multiplying each of the plurality of pieces of objective data by a weighting factor depending on a degrees of importance of the each of the plurality of pieces of objective data and summing up results of the multiplication, and the second data generation unit ( the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f) ) obtains each of the subjective scores by multiplying each of the plurality of pieces of subjective data by a weighting factor depending on a degrees of importance of the each of the plurality of pieces of subjective data and summing up results of the multiplication (as described in claim 2 ); wherein the first data generation unit ( the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f) ) determines a symptom of the patient based on sound information occurring from the patient and generates symptom information of the patient as the objective data, or determines a sleep state of the patient and generates sleep information of the patient as the objective data (as described in claim 5 ); wherein the first data generation unit determines intake/non-intake of medication by the patient based on sound information, motion information, or image information at a time of intake of the medication by the patient, and generates information regarding intake/non-intake of medication by the patient as the objective data ( the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f) ) (as described in claim 6 ); wherein the image generation unit generates an image that enables the patient to select an answer to a medical inquiry ( the Examiner submits that this additional element amounts adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); and the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d) ) (as described in claim 7 ); wherein the image generation unit generates an image that prompts the patient to answer a medical inquiry ( the Examiner submits that this additional element amounts adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); and the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d) ) (as described in claim 8 ); wherein the image generation unit generates an image indicating behavior information or calendar information of the patient ( the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f) ) (as described in claim 9 ); wherein the image generation unit generates a graph as the score image ( the Examiner submits that this additional element amounts adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); and the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d) ), and the score image includes an image indicating a warning corresponding to an inclination of the graph at a certain time point (as described in claim 17 ); and wherein the image generation unit generates a graph as the score image ( the Examiner submits that this additional element amounts adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); and the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d) ), and the score image includes an image indicating a warning corresponding to an area of the graph within a range between certain time points (as described in claim 18 ). As such, the additional elements in claims 1, 2, 5-9, and 17-19 are not indicative of integrating the judicial exception into a practical application. Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, unlike the claims that have been held as a whole to be directed to an improvement or otherwise directed to something more than the abstract idea, claims 1-19 : (1) are not directed to improvements to the functioning of a computer, or to any other technology or technical field similar to the Enfish, LLC v. Microsoft Corp. case (see MPEP § 2106.05(a)); (2) do not apply or use a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition (see MPEP § 2106.04(d)(2)); (3) do not apply the judicial exception with, or by use of, a particular machine (see MPEP § 2106.05(b)); (4) do not effect a transformation or reduction of a particular article to a different state or thing (see MPEP § 2106.05(c)); nor do they (5) apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as whole is more than a drafting effort designed to monopolize the exception (see MPEP § 2106.05(e) and MPEP § 2106.04(d)(2)). For these reasons, claims 1-19 do not recite additional elements that integrate the judicial exception into a practical application. Step 2B of the 2019 Revised PEG Regarding Step 2B of the 2019 Revised PEG, claims 1-19 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 abstract idea into a practical application, the additional elements of claims 1-19 amount to no more than: (1) adding the words “apply it” (or is the equivalent of) with the judicial exception; mere instructions to implement an abstract idea on a computer; or merely uses a computer as a tool to perform an abstract idea; (2) adding insignificant extra-solution activity to the judicial exception; and (3) generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP §§ 2106.05(f)-(h). Further the additional elements, other than the abstract idea per se, when considered both individually and as an ordered combination, amount to no more than limitations consistent with what the courts recognize, or those having ordinary skill in the art would recognize, to be well-understood, routine, and conventional computer components. See MPEP § 2106.05 (d). Specifically, the Examiner submits that the additional elements of claims 1-19 , as recited, the information processing device; first data generation unit; second data generation unit; image generation unit; computer; and the steps directed to: “wherein the image generation unit generates an image that enables the patient to select an answer to a medical inquiry”; “wherein the image generation unit generates an image that prompts the patient to answer a medical inquiry”; “wherein the image generation unit generates an image indicating behavior information or calendar information of the patient”; “wherein the image generation unit generates a graph as the score image”; and “wherein the image generation unit generates a graph as the score image”, are well-understood, routine, and conventional functions. See MPEP § 2106.05(d)(II). - In regard to the information processing device; first data generation unit; second data generation unit; image generation unit; and computer, these additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than well-understood, routine, and conventional activities previously known to the industry, because: - Applicant’s disclosure supports this assertion. For example, Applicant discloses that: (1) the information processing device may be implemented by a computer, including a CPU, RAM, ROM, hard disk drive, communication interface, and an input/output interface (see Applicant’s specification as filed on July 19, 2023, paragraphs [0111] and [0112]); (2) a CPU of the computer executes an information processing program loaded on the RAM, thereby implementing all or some of the functions of the analysis unit, processing unit, and generation unit; and (i) the analysis unit is an example of the first data generation unit; (ii) the processing unit is an example of the second data generation unit; and (iii) the generation unit is an example of the image generation unit; and a CPU of the computer executes an information processing program loaded on the RAM, thereby implementing all or some of the functions of the analysis unit, processing unit, and generation unit (see Applicant’s specification as filed on July 19, 2023, paragraphs [0030], and [0089], [0119]); and (3) the computer includes a CPU, RAM, ROM, hard disk drive, communication interface, and an input/output interface (see Applicant’s specification as filed on July 19, 2023, paragraph [0112]). These descriptions in the specification describe these additional elements as basic computer components and functions, such as well-understood, routine, and conventional computer components. Therefore, the Examiner submits that these computer components and functions represent well-understood, routine, and conventional computer components and functions which are known in the medical industry. - The Examiner submits that these limitations amount to merely using a computer or other machinery as tools for performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f) and analysis of these limitations under Step 2A, Prong Two above). - Regarding the steps directed to: “wherein the image generation unit generates an image that enables the patient to select an answer to a medical inquiry”; “wherein the image generation unit generates an image that prompts the patient to answer a medical inquiry”; “wherein the image generation unit generates an image indicating behavior information or calendar information of the patient”; “wherein the image generation unit generates a graph as the score image”; and “wherein the image generation unit generates a graph as the score image” - The following represents an example that courts have identified to be well-understood, routine, and conventional activities ( e.g. , see MPEP § 2106.05(d)): - Receiving or transmitting data over a network, e.g. , see Intellectual Ventures v. Symantec – similarly the limitations directed to: “wherein the image generation unit generates an image that enables the patient to select an answer to a medical inquiry”; “wherein the image generation unit generates an image that prompts the patient to answer a medical inquiry”; “wherein the image generation unit generates an image indicating behavior information or calendar information of the patient”; “wherein the image generation unit generates a graph as the score image”; and “wherein the image generation unit generates a graph as the score image”, are similarly deemed to be well-understood, routine, and conventional activity in the medical field, because they also represent mere transmission of various data over a network ( i.e. , generating images and graphs is the equivalent of transmitting data ( i.e. , the images and graphs) over a network) . Therefore, the additional elements described in claims 1-19 are deemed to be additional elements which do not amount to significantly more than the abstract idea identified above. Thus, taken alone, the additional elements of claims 1-19 do not amount to significantly more than the above-identified judicial exception (the abstract idea). Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functionality of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation. Therefore, whether taken individually or as an ordered combination, claims 1-19 are nonetheless rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15 AIA Claim s 1, 5, and 7-19 are rejected under 35 U.S.C. 102( a)(1) and (a)(2 ) as being anticipated by : - Douglas et al. (Pub. No. US 2019/0282436). Regarding claims 1 and 19 , - Douglas et al. (Pub. No. US 2019/0282436) discloses: - an information processing device ( Douglas , paragraph [0024]; Paragraph [0024] discloses a dynamic treatment system in network communication with interested parties, that includes a therapy device.) comprising (as described in claim 1 ): - an information processing method performed by a computer ( Douglas , paragraph [0023]; Paragraph [0023] discloses methods of using treatment related parameters, including a method of operating a compression therapy hub.) , the method comprising (as described in claim 19 ): - a first data generation unit that generates objective score data, which indicates objective scores in time series, based on a plurality of pieces of objective data regarding a patient (as described in claim 1 ); and generating objective score data, which indicates objective scores in time series, based on a plurality of pieces of objective data regarding a patient (as described in claim 19 ) ( Douglas , paragraphs [0042], [0043],and [0050]; Paragraph [0042] discloses that the microprocessor receives signals associated with the user’s use of a compression therapy device, including signals associated with a user’s blood pressure, blood flow, flow of other bodily fluids (e.g., Lymph), heart rate, tissue health, tissue density, lymph measurement, and/or blood oxygenation; and paragraph [0043] discloses that the microprocessor may calculate a metric associated with a user’s physical health ( i.e. , the metric associated with the user’s physical health is interpreted as the equivalent of “generating objective score data” ). Paragraph [0050] discloses that the patient’s objective health metric is plotted on a graph versus time ( i.e. , the objective scores are in time series, based on a plurality of pieces of objective data obtained from the patient ).); - a second data generation unit that generates subjective score data, which indicates subjective scores in time series, based on a plurality of pieces of subjective data obtained from the patient (as described in claim 1 ); and generating subjective score data, which indicates subjective scores in time series, based on a plurality of pieces of subjective data obtained from the patient (as described in claim 19 ) ( Douglas , paragraph [0042]; Paragraph [0042] discloses that the user may input data associated with the user’s emotional state (e.g., happy, frustrated, afraid) and paragraph [0043] discloses that the microprocessor may calculate a metric associated with a user’s emotional state ( i.e. , the metric associated with the user’s emotional state is interpreted as the equivalent of “generating subjective score data” ). Paragraph [0050] discloses that the patient’s subjective health metric is plotted on a graph versus time ( i.e. , the subjective scores are in time series, based on a plurality of pieces of subjective data obtained from the patient ).); and - an image generation unit that generates a score image indicating the objective score data and the subjective score data (as described in claim 1 ) ( Douglas , paragraph [0050]; Paragraph [0050] discloses that the patient’s objective health metric and subjective health metric are plotted on a graph versus time ( i.e. , generating a score image indicating the objective score data and the subjective score data ).). Regarding claim 5 , - Douglas discloses the limitations of claim 1 (which claim 5 depends on), as described above. - Douglas further discloses a device, wherein: - the first data generation unit determines a symptom of the patient based on sound information occurring from the patient and generates symptom information of the patient as the objective data, or determines a sleep state of the patient and generates sleep information of the patient as the objective data ( Douglas , paragraph [0045]; Paragraph [0045] discloses performing voice monitoring (detecting fluctuations or spectral signature that may suggest deteriorations in physical wellbeing or mental states) ( i.e. , determining a symptom of the patient based on sound information occurring from the patient and generating the symptom information of the patient as the objective data ) and sleep monitoring in order to determine a patient personal profile, where paragraph [0067] discloses that the hub may assess the quality and amount of the patient’s sleep ( i.e. , determining a sleep state of the patient and generating sleep information of the patient as the objective data ).). Regarding claim 7 , - Douglas discloses the limitations of claim 1 (which claim 7 depends on), as described above. - Douglas further discloses a device, wherein: - the image generation unit generates an image that enables the patient to select an answer to a medical inquiry ( Douglas , paragraph [0051; Paragraph [0051] describes a user being able to accept recommended therapy times based on suggestions from the dynamic therapy calculator ( i.e. , an image enables the patient to select an answer to a medical inquiry ).). Regarding claim 8 , - Douglas discloses the limitations of claim 1 (which claim 8 depends on), as described above. - Douglas further discloses a device, wherein: - the image generation unit generates an image that prompts the patient to answer a medical inquiry ( Douglas , paragraph [0045]; Paragraph [0045] discloses that devices may query a patient about the patient’s well-being on a regular schedule, for example, a schedule or content of questions asked of a patient may be adapted by an AI (artificial intelligence) algorithm, to detect the severity of a patient’s mental or emotional condition, whether the mental or emotional condition has changed significantly, and whether the change in mental or emotional condition is a result of, or cause of, changes in disease state ( i.e. , prompting the patient to answer a medical inquiry ).). Regarding claim 9 , - Douglas discloses the limitations of claim 8 (which claim 9 depends on), as described above. - Douglas further discloses a device, wherein: - the image generation unit generates an image indicating behavior information or calendar information of the patient ( Douglas , paragraph [0045]; Paragraph [0045] discloses that devices may query a patient about the patient’s well-being on a regular schedule, for example, a user may provide input representative of how often they use the system, the general nutrition level of the user, and tracked user activities ( i.e. , generating an image indicative of behavior information of the patient ). Further, paragraph [0052] discloses that the a graph may be presented displaying measured health and/or perceived health versus days ( i.e. , generating an image indicative of calendar information of the patient ).). Regarding claim 10 , - Douglas discloses the limitations of claim 1 (which claim 10 depends on), as described above. - Douglas further discloses a device, wherein: - one of the plurality of pieces of objective data is biometric information of the patient ( Douglas , paragraph [0042]; Paragraph [0042] discloses that the microprocessor receives signals associated with the user’s use of a compression therapy device, including signals associated with a user’s blood pressure, blood flow, flow of other bodily fluids (e.g., Lymph), heart rate, tissue health, tissue density, lymph measurement, and/or blood oxygenation.); and - another piece of the plurality of pieces of objective data is environmental information around the patient ( Douglas , paragraph [0041]; Paragraph [0041] discloses that the microprocessor 305 may receive signals associated with environmental conditions (e.g., ambient temperature, barometric pressure, etc.).). Regarding claim 11 , - Douglas discloses the limitations of claim 1 (which claim 11 depends on), as described above. - Douglas further discloses a device, wherein: - one of the plurality of pieces of subjective data is information concerning answer to the medical inquiry to the patient ( Douglas , paragraph [0045]; Paragraph [0045] discloses that devices may query a patient about the patient’s well-being on a regular schedule, for example, a schedule or content of questions asked of a patient may be adapted by an AI (artificial intelligence) algorithm, and the interrogative schedule may be determined as a function of the patient’s past answers ( i.e. , the subjective data includes information concerning answers to the medical inquiry to the patient ).). Regarding claim 12 , - Douglas discloses the limitations of claim 1 (which claim 12 depends on), as described above. - Douglas further discloses a device, wherein: - the score image includes an image indicating both or one of a change point of the objective score data and a change point of the subjective score data ( Douglas , paragraph [0045]; Paragraph [0045] discloses that the personalized profile includes data related to whether the patient’s mental or emotional condition has changed significantly ( i.e. , the image includes an image indicative of a change point of the subjective score data ); and paragraph [0067] discloses that observed inputs may indicate trends, changes, or levels of user’s emotional wellness ( i.e. , the image includes an image indicative of a change point of the subjective score data ), as well as assessing the patient’s emotional state based on metrics related to an electronic signature (e.g., computer usage, unread email rates, number of messages sent), work activities, content, frequency, location and intensity of recreational or other physical movement, diet, and quality and amount of sleep ( i.e. , the image includes an image indicative of a change point of the objective score data ).). Regarding claim 13 , - Douglas discloses the limitations of claim 1 (which claim 13 depends on), as described above. - Douglas further discloses a device, wherein: - the score image includes an image indicating detailed information related to the objective score included in the objective score data or to the subjective score included in the subjective score data ( Douglas , paragraphs [0067] and [0098]; Paragraph [0067] discloses that the hub outputs may include content delivered to promote, encourage, and guide the patient to health-directed lifestyle choices including but not limited to use of the treatment device in the prescribed manner. The observed inputs may indicate trends, changes, or levels of emotional wellness ( i.e. , the score image indicates detailed information related to the subjective score included in the subjective score data ), especially for home-based therapies that are not under constant supervision by medical professionals (e.g., in a hospital, direct care facility). Also, paragraph [0098] discloses the system may provide historical data tracking the patient's response to treatment over time ( i.e. , the score image indicates detailed information related to the objective score included in the subjective score data ).). Regarding claim 14 , - Douglas discloses the limitations of claim 1 (which claim 14 depends on), as described above. - Douglas further discloses a device, wherein: - the score image includes an image indicating a message directed to the patient ( Douglas , paragraphs [0033] and [0046]; Paragraph [0033] discloses that if the patient skips a daily therapy session, from time to time, the patient monitoring engine 292 may send a reminder signal either to the device or directly to the patient via text message or email ( i.e. , the score image includes an image indicating a message directed to the patient ), and paragraph [0046] discloses that the system outputs may alert a user to abrupt changes in treatment ( i.e. , the score image includes an image indicating a message directed to the patient ).). Regarding claim 15 , - Douglas discloses the limitations of claim 1 (which claim 15 depends on), as described above. - Douglas further discloses a device, wherein: - the score image includes an image indicating information for encouraging the patient to continue treatment ( Douglas , paragraph [0067]; Paragraph [0067] discloses that the hub may monitor compliance with a therapeutic course of treatment, and take corrective action steps when the patient is not complying (e.g., deliver encoura ging messages to the patient, contacting third parties such as relative or care provider), and the hub can also provide positive encouragement to sustain compliance and reward the patient with praise ( i.e. , the score image includes an image indicating information for encouraging the patient to continue treatment ).). Regarding claim 16 , - Douglas discloses the limitations of claim 1 (which claim 16 depends on), as described above. - Douglas further discloses a device, wherein: - the score image includes an image indicating a message directed to a clinician ( Douglas , paragraphs [0046], [0063], and [0066]; Paragraph [0046] discloses that the system outputs may alert physicians to changes in patient health status or patient emotional well-being ( i.e. , the score image includes an image indicating a message directed to a clinician ), and paragraphs [0063] and [0066] disclose that a caregiver may be alerted for potential intervention if a patient is not complying with therapy and suggested behavior changes ( i.e. , the score image includes an image indicating a message directed to a clinician ).). Regarding claim 17 , - Douglas discloses the limitations of claim 1 (which claim 17 depends on), as described above. - Douglas further discloses a device, wherein: - the image generation unit generates a graph as the score image ( Douglas , paragraph [0050]; Paragraph [0050] discloses that Figure 6 depicts an exemplary graph of a health metric plotted versus time, where the patient’s objective health metric and subjective health metric are plotted on this graph ( i.e. , the image generation unit generates a graph as the score image ).); and - the score image includes an image indicating a warning corresponding to an inclination of the graph at a certain time point ( Douglas , paragraph [0043]; Paragraph [0043] discloses that if one or more of the calculated metrics exceeds the predetermined maximum threshold or is less than the predetermined minimum threshold, then the microprocessor may send a signal at 525 to a physician associated with the patient ( i.e. , the score image includes an image indicating a warning corresponding to an inclination of the graph at a certain time point ).). Regarding claim 18 , - Douglas discloses the limitations of claim 1 (which claim 18 depends on), as described above. - Douglas further discloses a device, wherein: - the image generation unit generates a graph as the score image ( Douglas , paragraph [0050]; Paragraph [0050] discloses that Figure 6 depicts an exemplary graph of a health metric plotted versus time, where the patient’s objective health metric and subjective health metric are plotted on this graph ( i.e. , the image generation unit generates a graph as the score image ).); and - the score image includes an image indicating a warning corresponding to an area of the graph within a range between certain time points ( Douglas , paragraph [0050]; Paragraph [0050] discloses that graph 600 has a vertical axis 610 that indicates a particular health metric, with higher values associated with better health, and lower values associated with poorer health. Further, paragraph [0050] discloses that below the minimum threshold 620, the patient’s objective health metric may be considered pathological ( i.e. , the score image includes an image indicating a warning corresponding to an area of the graph within a range between certain time points ), and above the minimum threshold 620, the patient’s objective health metric may be considered normal.) . Claim Rejections - 35 USC § 103 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 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. 07-23-aia AIA 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. 07-21-aia AIA Claim s 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over : - Douglas et al. (Pub. No. US 2019/0282436), in view of: - Ohnemus et al. (Pub. No. US 2017/0147775). Regarding claim 2 , - Douglas et al. (Pub. No. US 2019/0282436) discloses the limitations of claim 1 (which claim 2 depends on), as described in the Claim Rejections - 35 USC § 102 Section above. - Douglas does not explicitly teach, however, in analogous art of health data acquisition, processing, and communication systems and methods, Ohnemus et al. (Pub. No. US 2017/0147775) teaches a device, wherein: - the first data generation unit obtains each of the objective scores by multiplying each of the plurality of pieces of objective data by a weighting factor depending on a degrees of importance of the each of the plurality of pieces of objective data and summing up results of the multiplication ( Ohnemus , paragraphs [0054], [0152], and [0161]; Paragraph [0054] teaches that each lifestyle component generates a score, where the scores can be combined using a dynamic weighing scheme based on the relevance of each for a fiver user at a given time ( i.e. , a weighting factor depending on a degree of importance of each of the plurality of pieces of data ). Paragraph [0161] teaches that the weighting factors can be multiplication coefficients that are used to increase or decrease the relative value of each health parameters ( i.e. , multiplying each of the plurality of pieces of objective data ) and are used to control the relative values of the health parameters based on importance ( i.e. , multiplying each of the plurality of pieces of objective data depending on a degree of importance of each of the plurality of pieces of data ). Paragraph [0152] teaches that health score is calculated by adding the results of multiplying a weighting factor to each health parameter, where more importing health parameters have a weighting factor that is greater than weighting factors associated with lesser important health parameters (e.g., Healthscore=Glucose*a+(Weight/100)*b) ( i.e. , multiplying each of the plurality of pieces of objective data depending on a degree of importance of each of the plurality of pieces of data and summing up results of the multiplication ).); and - the second data generation unit obtains each of the subjective scores by multiplying each of the plurality of pieces of subjective data by a weighting factor depending on a degrees of importance of the each of the plurality of pieces of subjective data and summing up results of the multiplication ( Ohnemus , paragraphs [0054], [0152], and [0161]; Paragraph [0054] teaches that each lifestyle component generates a score, where the scores can be combined using a dynamic weighing scheme based on the relevance of each for a fiver user at a given time ( i.e. , similarly, this disclosure is interpreted as teaching “a weighting factor depending on a degree of importance of each of the plurality of pieces of data” ). Paragraph [0161] teaches that the weighting factors can be multiplication coefficients that are used to increase or decrease the relative value of each health parameters ( i.e. , similarly, this disclosure is interpreted as teaching “multiplying each of the plurality of pieces of subjective data”, because the health parameters described in Ohnemus cover both objective data and subjective data ) and are used to control the relative values of the health parameters based on importance ( i.e. , multiplying each of the plurality of pieces of subjective data depending on a degree of importance of each of the plurality of pieces of data ). Paragraph [0152] teaches that health score is calculated by adding the results of multiplying a weighting factor to each health parameter, where more importing health parameters have a weighting factor that is greater than weighting factors associated with lesser important health parameters (e.g., Healthscore=Glucose*a+(Weight/100)*b) ( i.e. , multiplying each of the plurality of pieces of subjective data depending on a degree of importance of each of the plurality of pieces of data and summing up results of the multiplication ). Paragraph [0161] teaches that these features are beneficial for increasing or decreasing the relative affect each factor has in the calculation of the user’s Health Score depending on how important each health parameter is to user at a given time.). Therefore, it would have been obvious to one of ordinary skill in the art of health data acquisition, processing, and communication systems and methods at the time of the effective filing date of the claimed invention to modify the therapy device taught by Douglas , to incorporate steps and features directed to (i) multiplying the plurality of pieces of objective data by a weighting factor and adding up the results of the multiplication, and (ii) multiplying the plurality of pieces of subjective data by a weighting factor and adding up the results of the multiplication, as taught by Ohnemus , in order to increase or decrease the relative affect each factor has in the calculation of the user’s Health Score depending on how important each health parameter is to user at a given time. See Ohnemus , paragraph [0161]; see also MPEP § 2143 G. Regarding claim 3 , - The combination of: Douglas , as modified in view Ohnemus , teaches the limitations of claim 2 (which claim 3 depend on), as described above. - Ohnemus further teaches a device, wherein: - the two types of weighting factors are set depending on a disease of the patient ( Ohnemus , paragraph [0047]; Paragraph [0047] teaches that the weighting factors can be percentages that are static values ( i.e. , the weighting factors are set ) and are based on the patient’s pre-existing conditions ( i.e. , the weighting factors are set depending on a disease of the patient ).). The motivation and rationale for modifying the therapy device taught by Douglas , in view of Ohnemus , described in the analysis of the obviousness rejection of claim 2 similarly apply to this obviousness rejection, and are incorporated herein by reference. Regarding claim 4 , - The combination of: Douglas , as modified in view Ohnemus , teaches the limitations of claim 2 (which claim 4 depend on), as described above. - Ohnemus further teaches a device, wherein: - the two types of weighting factors are variable ( Ohnemus , paragraph [0047]; Paragraph [0047] teaches that the weighting factors can be percentages that are dynamic ( i.e. , the weighting factors are variable ).). The motivation and rationale for modifying the therapy device taught by Douglas , in view of Ohnemus , described in the analysis of the obviousness rejection of claim 2 similarly apply to this obviousness rejection, and are incorporated herein by reference . 07-21-aia AIA Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over : - Douglas et al. (Pub. No. US 2019/0282436), in view of: - Hanina et al. (Pub. No. US 2019/0058848). Regarding claim 6 , - Douglas et al. (Pub. No. US 2019/0282436) discloses the limitations of claim 1 (which claim 6 depends on), as described in the Claim Rejections - 35 USC § 102 Section above. - Douglas does not explicitly teach, however, in analogous art of compliance and medication adherence systems and methods, Hanina et al. (Pub. No. US 2019/0058848) teaches a device, wherein: - the first data generation unit determines intake/non-intake of medication by the patient based on sound information, motion information, or image information at a time of intake of the medication by the patient, and generates information regarding intake/non-intake of medication by the patient as the objective data ( Hanina , paragraphs [0032]-[0034]; Paragraph [0032] teaches that once identified and notified of a type of medication to be administered, the patient may display a medication, such as a pill, dissolvable film or the like, administration apparatus, such as an inhaler, injectable apparatus, or other medication form (including a pill bottle or the like) to confirm that the medication is correct and is the currently prescribed medication to be taken through the use of text recognition, medication recognition, barcode or other code reading of one or more unique identifiers from the administration apparatus, pill bottle or the like, or other appropriate medication recognition scheme ( i.e. , determining medication based on image information at a time of intake of the medication by the patient ). Paragraph [0033] teaches in addition to recognizing the pill or other medication, the system may preferably track how patient holds the pill or other medication, and further may track continuous motion from hand to mouth to confirm that no suspicious action has taken place ( i.e. , determining intake/non-intake of a medication by the patient based on motion information and image information at a time of intake of the medication by the patient ). Thus, the system may also check consistent hand usage between identification of the pill and placing the pill in the mouth of the user. In addition to tracking the motion of the hand, if the user is to take the pill out of a blister pack, the user may track a motion sequence for tracking complete gestures on screen from taking out of the pill bottle or blister pack all the way to placing in mouth/ingesting, drinking water, showing and tracking water go down, swallowing, and even showing empty mouth so that any deviation from the desired sequence may be identified as a potentially suspicious activity. Furthermore, the system may view the blister pack to determine if the correct number of pills have been removed, that the correct number of pills are remaining, and whether other pills or the like have been removed that should not have been removed. Such suspicious activity may be used to automatically flag potentially suspicious activity ( i.e. , generating information regarding intake/non-intake of medication by the patient as the objective data ).). Paragraph [0034] also teaches that the patient may be instructed to administer the medication in the prescribed manner. One or more of these administration sequences may comprise confirmation that a user has placed a pill in their mouth (ingested the pill) through visual confirmation of location ( i.e. , determining intake/non-intake of a medication by the patient based on image information at a time of intake of the medication by the patient ), confirmation that the user has properly used an inhaler device through visual confirmation of position and/or audio confirmation of actuation, confirmation that the user has properly used an injectable device through visual confirmation of position and/or audio confirmation of actuation ( i.e. , determining intake/non-intake of a medication by the patient based on sound information and image information at a time of intake of the medication by the patient ). Thus, for an oral administration, the user may be asked to place the pill in their mouth, show the pill in their mouth to the camera to confirm its presence, drink a glass of water, and show an empty mouth to the camera to confirm the pill is gone. Paragraph [0034] also teaches that swallowing motions may also be confirmed and different sounds, for example different frequencies emitted from an inhaler may confirm or suggest evidence of potentially suspicious or malicious behavior ( i.e. , determining intake/non-intake of a medication by the patient based on sound information and motion information at a time of intake of the medication by the patient ). Paragraph [0035] teaches that these features are beneficial for providing a more complete picture of attempts to trick the medication compliance system, thus allowing for intervention to identify the patient, and addressing the suspicious behavior.). Therefore, it would have been obvious to one of ordinary skill in the art of compliance and medication adherence systems and methods at the time of the effective filing date of the claimed invention to modify the therapy device taught by Douglas , to incorporate steps and features directed to (i) determining the intake/non-intake of a medication by a patient through sound information, motion information, and image information; and (ii) generating information regarding intake/non-intake of medication by the patient as objective data, as taught by Hanina , in order to provide a more complete picture of attempts to trick the medication compliance system, thus allow for intervention to identify the patient, and address the suspicious behavior. See Hanina , paragraph [0035]; see also MPEP § 2143 G. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas Akogyeram II whose telephone number is (571) 272-0464. 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Mailed replies should be addressed to: United States Patent and Trademark Office: Commissioner of Patents and Trademarks P.O. Box 1450 Alexandria, VA 22313-1450 Hand delivered responses should be brought to the United States Patent and Trademark Office Customer Service Window: Randolph Building 401 Dulany Street Alexandria, VA 22314-1450 /N.A.A./Examiner, Art Unit 3686 /JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686 Application/Control Number: 18/262,052 Page 2 Art Unit: 3686 Application/Control Number: 18/262,052 Page 3 Art Unit: 3686
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