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 .
DETAILED ACTION
Response to Amendment
In the preliminary amendment dated 10 June 2025, the following has occurred: Claims 1-6 have been amended; Claim 7 is new.
The present office action represents the first action on the merits.
Claims 1-7 are pending.
Priority
This application claims ‘371 priority to PCT/KR2023/021521 dated 26 December 2023 which claims priority to Korean Application No. KR10-2023-0011636 dated 30 January 2023.
Claim Objections
Claim 1 is objected to because it is missing an article. The Examiner believes that claim should recite “B) inputting a patient's questionnaire....” Appropriate correction/clarification is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show descriptions of the labeled boxes in Figs 1 and 3 as described in the specification, (For example reference character 110 should be labeled with the description “database of probe questions”). The extensive and exclusive use of reference characters within nondescript boxes devoid of any description fails to show detail that is essential for a proper understanding of the disclosed invention. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d).
The drawings are further objected to as failing to comply with 37 CFR 1.84(I) because the following figure(s) is/are unreadable and/or are unsatisfactory for reproduction:
Fig. 4-9, 11, 14, 16, 20 (drawings/text unreadable, some text appears to be below 1/8”, text within shading)
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The Examiner has made an effort to uncover as many drawing issues as possible in the amount of time afforded for examination; however, it is possible that certain issues remain. It is incumbent upon the Applicant to review to Specification and Drawings to ensure that no addition objectionable issues remain.
Information Disclosure Statement
The Information Disclosure Statement(s) (lDS) submitted on 10 June 2025 is/are in compliance with the provisions of 37 CFR 1.97 and has/have been fully considered by the Examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 1
a network information providing unit
a clustering unit
a drug prescription information deriving unit
Claim 4
a network information providing unit
a clustering unit
a cluster-based drug prescription information deriving unit
a network-based drug prescription information deriving unit
an output unit
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The recited units are described at Spec. Para. 0066 to be tied to one or more computers, thus providing sufficient structure.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 6 and 7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claims 6 and 7 are rejected because it does not sufficiently recite a non-transitory computer readable storage medium. The United States Patent and Trademark Office (USPTO) is obliged to give claims their broadest reasonable interpretation consistent with the specification during proceedings before the USPTO. See In re Zletz, 893 F.2d 319(Fed. Cir. 1989) (during patent examination the pending claims must be interpreted as broadly as their terms reasonably allow). The broadest reasonable interpretation of a claim drawn to a computer readable medium (also called machine readable medium and other such variations) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent. See MPEP 2111.01. When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. §101 as covering non-statutory subject matter. See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to statutory subject matter) and Interim Examination Instructions for Evaluating Subject Matter Eligibility Under 35 U.S.C. §101, Aug. 24, 2009; p. 2.
The USPTO recognizes that applicants may have claims directed to computer readable media that cover signals per se, which the USPTO must reject under 35 U.S.C. §101 as covering both non-statutory subject matter and statutory subject matter. In an effort to assist the patent community in overcoming a rejection or potential rejection under 35 U.S.C. §101 in this situation, the USPTO suggests the following approach. A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. §101 by adding the limitation "non-transitory" to the claim. Cf. Animals – Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (suggesting that applicants add the limitation "non-human" to a claim covering a multi-cellular organism to avoid a rejection under 35 U.S.C. §101). Such an amendment would typically not raise the issue of new matter, even when the specification is silent because the broadest reasonable interpretation relies on the ordinary and customary meaning that includes signals per se. The limited situations in which such an amendment could raise issues of new matter occur, for example, when the specification does not support a non-transitory embodiment because a signal per se is the only viable embodiment such that the amended claim is impermissibly broadened beyond the supporting disclosure. See, e.g., Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998).
Claims 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1, 4, 6, and 7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more (or are presumed to be within a statutory category for subject matter eligibility analysis purposes, see “non-transitory” rejection of Claim 6 and 7, supra).
Step 1
The claims recite a method, system, and computer-readable recording medium (“CRM”) for providing mental illness-related information and drug prescription-related information, which are within a statutory category. The Examiner notes that Claim 6 and 7 are quasi-independent claim and have been analyzed as independent claims for subject matter eligibility purposes.
Step 2A1
The limitations of (Claim 4 being representative) construct a network derivable from mental illness-related questionnaire information; classify mental illness groups based on mental illness-related questionnaire-based information and algorithm information based on the derived network information; derive cluster-based drug prescription information based on mental illness group information that was classified; derive network-based drug prescription information based on the derived network information; and provide mental illness group information that was derived and drug prescription information that was outputted, as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to providing mental illness-related information and drug prescription-related information in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “construct[ed] …classify …derive …derive …and provide” as indicated supra.
Other than reciting a CRM (Claims 6 and 7) or various “units” (Claim 1 and 4), which are interpreted to be generic computer components for subject matter eligibility purposes, the claimed invention amounts to managing personal behavior or interaction between people. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of a computer (Claims 1 & 4; see 112(f) interpretation) or a CRM (Claims 6 and 7) that implements the identified abstract idea. The computer/CRM is not described by the applicant and is recited at a high-level of generality (i.e., a generic computer or a component thereof) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a computer or a CRM to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
Claims 2, 3, and 5 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claim(s) 2, 5 merely describe(s) how the classification occurs, which further defines the abstract idea.
Assuming arguendo that k-means and Louvain algorithms are not part of the Certain Methods of Organizing Human Activity, these features alternately represent mathematical concepts. The types of identified abstract ideas are considered together as a single abstract idea for analysis purposes.
Claim(s) 3 merely describe(s) the number of groups, which further defines the abstract idea.
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 1-7 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 pre-AIA the applicant regards as the invention.
Claims 1 and 4 recite (Claim 1 being representative) “b) a clustering unit configured to classify mental illness groups based on… and algorithm information based on the network information derived in a)….” The claim is indefinite because it is unclear what “algorithm information” the claim is referring to. No “algorithm information based on the network information derived in a)” exists and thus it is unclear how the function of classifying can occur based on it. A review of the specification does not provide any clarity and merely reiterates the claim language. The Examiner suggests reciting a limitation that determines algorithm information based on the network information derived in a).
Claim 1 further recites “c) a drug prescription information deriving unit configured to derive…and cluster-based drug prescription information based on mental illness group information classified in b)….” Similar to step b), above, the claim is indefinite because it is unclear how the cluster-based drug prescription information can be derived from data that does not exist. Step b) does not recite prescription information being present and thus it is unclear how clusters can be derived.
By virtue of their dependence from Claim 1 of 4, this basis of rejection also applies to dependent Claims 2, 3, 5, 6 , and 7.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. §§ 102 and 103 (or as subject to pre-AIA 35 U.S.C. §§ 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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.
Claim(s) 1, 4, 6, and 7 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Bergmann-Good et al. (hereinafter “BG;” U.S. Pre-Grant Patent Publication No. 2025/0135287) in view of Ryan et al. (U.S. Pre-Grant Patent Publication No. 2017/0177801).
REGARDING CLAIM 1
BG teaches the claimed method for providing mental illness-related information and drug prescription-related information, comprising steps of:
A) constructing a system for providing mental illness-related information and […intervention-related…] information, [Para. 0276-0279 teaches that a system is generated relating to mental illness and related interventions.] wherein the system comprises:
a) a network information providing unit [Para. 0006, 0157, 0352 teaches that the system is implemented on a computer meaning that it necessarily teaches the claimed units whenever the function is taught.] in which a network derivable from mental illness-related questionnaire information is constructed; [Para. 0276, 0277 teaches generating cohorts (a network) based on users’ questionnaires and communities defined by the questionnaires. The cohorts have features associated with them (shared well-being measurements, etc.).]
b) a clustering unit configured to classify mental illness groups based on
mental illness-related questionnaire-based information and [Para. 0277, 279 teaches that the users are grouped/mapped (classified) into cohorts based on the questionnaire.]
algorithm information based on the network information derived in a); and [Para. 0237, 0235, 0276 teaches that users are mapped to the cohorts by evaluating each user’s data (including community information). Because the system of BG is computerized, the mapping of users to a cohort is interpreted to occur via an algorithm. The mapping is thus algorithm results (algorithm information).]
c) a […intervention…] information deriving unit configured to derive
network-based […intervention…] information based on the network information derived in a) and [Para. 0276 teaches that cohort feature information is used when refining a proposed intervention.]
cluster-based […intervention…] information based on mental illness group information classified in b); and [Para. 0276 teaches that cohort feature information is used when refining a proposed intervention. The Examiner notes that there is no claimed indication as to what the “network-based drug prescription information” and the “cluster-based drug prescription information” entail and/or if there are any differences in between the type(s) of information.]
B) inputting patient's questionnaire response information into the system and
providing both mental illness-related information based on the mental illness groups classified in the clustering unit b) and […intervention-related…] information derived in the deriving unit c). [Para. 0276-0279 teaches that a particular user’s information (including content of a questionnaire) is analyzed in association with the cohort information and an intervention is determined.]
BG may not explicitly teach that the intervention is
drug prescription information
Ryan at Para. 0022, 0025, 0029, 0055 teaches that it was known in the art of computerized healthcare, at the time of filing, to define sub-cohorts related to mental illness using medication information
drug prescription information [Ryan at Para. 0025, 0029 teaches defining sub-cohorts (the communities of BG; a network) by taking into account surveys (questionnaires) that describe prior health interventions. Para. 0022 teaches that health interventions include medications (drug prescription information). Para. 0055 teaches that stratification of the coarse cohort is related to mental illness.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, at the time of filing, to modify the system for individualizing interventions using cohorts of BG to define sub-cohorts related to mental illness using medication information as taught by Ryan, with the motivation of eliminating waste, improving consistency in the deployment of resources, and advancing compliance with wellness or treatment regimens (see Ryan at Para. 0007).
REGARDING CLAIM(S) 4
Claim(s) 4 is/are analogous to Claim(s) 1, thus Claim(s) 4 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 1.
BG/Ryan further teaches
an output unit configured to provide
mental illness group information derived in the clustering unit and
drug prescription information output from the network-based drug prescription information deriving unit and the cluster-based drug prescription information deriving unit. [BG at Para. 0097, 0158, 0318 teaches an interface provides (i.e., displays) the intervention. Ryan at Para. 0022 teaches that the intervention is medication (prescription information).]
BG/Ryan may not explicitly teach
configured to provide mental illness group information derived in the clustering unit
However, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to combine the display of information of BG with the cohort information of BG since the combination is merely combining prior art elements according to known methods to yield predictable results (KSR A). It can be seen that each element claimed is present in BG. Displaying cohort information of BG does not change or affect the normal display of intervention information of BGs. Displaying intervention information would be performed the same way even with the addition of cohort information. Since the functionalities of the elements in BG do not interfere with each other, the results of the combination would be predictable.
REGARDING CLAIM(S) 6
Claim(s) 6 is/are analogous to Claim(s) 1, thus Claim(s) 6 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 1.
REGARDING CLAIM(S) 7
Claim(s) 7 is/are analogous to Claim(s) 4, thus Claim(s) 7 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 4.
Claim(s) 2, 3, and 5 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Bergmann-Good et al. (hereinafter “BG;” U.S. Pre-Grant Patent Publication No. 2025/0135287) in view of Ryan et al. (U.S. Pre-Grant Patent Publication No. 2017/0177801) in view of Gurpur et al. (U.S. Pre-Grant Patent Publication No. 2022/0293252) in view of Applicant Admitted Prior Art (“AAPA”).
REGARDING CLAIM 2
BG/Ryan teaches the claimed method for providing mental illness-related information and drug prescription-related information of Claim 1. BG/Ryan may not explicitly teach
wherein the clustering unit b) classifies the mental illness groups based on k-means and Louvain algorithms.
Gurpur at Para. 0025 teaches that it was known in the art of computerized healthcare, at the time of filing, to cluster patients into cohorts using k-means clustering and another clustering technique defining algorithms
wherein the clustering unit b) classifies the mental illness groups based on k-means and […additional…] algorithms. [Gurpur at Para. 0025 teaches cluster patients into cohorts using k-means clustering and another clustering technique defining algorithms.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, at the time of filing, to modify the system for individualizing interventions using cohorts of BG having the defining of sub-cohorts related to mental illness using medication information of Ryan to cluster patients into cohorts using k-means clustering and another clustering technique defining algorithms as taught by Gurpur, with the motivation of providing more patient-data specific cohorts.
BG/Ryan/Gurpur may not explicitly teach that the additional algorithms comprise
Louvain algorithms.
However, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to combine the Louvain algorithms of AAPA with teaching of BG/Ryan/Gurpur since the combination of the references is merely simple substitution of one known element for another producing a predictable result (KSR rationale B). Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself—that is, in the substitution of the Louvain algorithms of AAPA (see Spec. Para. 0046 as describing Louvain algorithms as known in the art) for the additional clustering algorithms of BG/Ryan/Gurpur (see Gurpur at Para. 0025 described supra). Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
REGARDING CLAIM 3
BG/Ryan/Gurpur/AAPA teaches the claimed method for providing mental illness-related information and drug prescription-related information of Claims 1 and 2. BG/Ryan/Gurpur/AAPA may not explicitly teach
wherein clustering based on the k-means algorithm is classification into 9 groups, and clustering based on the Louvain algorithm is classification into 10 groups.
However, the selection of 9 and 10 groups, respectively, would have been prima facie obvious to one of ordinary skill in the art at the time of filing based on the routine optimization rationale. The combination of BG, Ryan, and Gurpur teaches creating multiple cohorts and/or sub-cohorts/communities (see BG at Para. 0275, 0276; Ryan at Para. 0025, 0029) using multiple clustering techniques (see Gurpur at Para. 0025). It would have been obvious to person having ordinary skill in the art at the time of filing to optimize the number of cohorts and/or sub-cohorts/communities to the claimed values in order meet the design need of greater granularity with respect to patient/user/individual groupings and there are a finite number of possible groups that can be produced. And, a person having skill in the art would have a reasonable expectation of success. MPEP 2144.05.
REGARDING CLAIM(S) 5
Claim(s) 5 is/are analogous to Claim(s) 2, thus Claim(s) 5 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 2.
Conclusion
Prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Iyer et al. (U.S. Pre-Grant Patent Publication No. 2023/0134811) which discloses calculation of several patient scores and using the scores to create clusters.
Newmann (U.S. Pre-Grant Patent Publication No. 2024/0221901) which discloses creating a user profile cluster and assigning a one or more cohort labels as a function of the data in the profile.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON S TIEDEMAN whose telephone number is (571)272-4594. The examiner can normally be reached 7:00am-4:00pm, off alternate Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached at 571-272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683
