DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-11 are pending and under examination.
Claims 1-11 are rejected.
Claims 2, 7, and 11 are objected to.
Claims 1 and 10 are independent.
No claims are allowed, canceled, new, or withdrawn.
Office Action Overview
Rejections applied
Abbreviations
X
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
X
112 Other
IDS
Information Disclosure Statement
X
102, 103
JE
Judicial Exception
X
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
X
101 Other
N:N
page:line
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed in the 03/07/2022 filing receipt, this application claims priority to as early as 09/25/2019, which is the filing date of parent application JP 2019-173968. This application is also a CON of PCT/JP2020/030307, filed 08/07/2020. At this point in examination, all claims have been interpreted as being accorded the priority date of 09/25/2019.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. See paper entered 04/07/2022.
Overview of Withdrawal/Revision of Objections/Rejections
In view of the amendment and remarks received 01/30/2026:
• The objection to claim 11 is withdrawn.
• The 112(a) rejection of claims 1-11 is withdrawn.
• The 112(b) rejection of claim 5 is withdrawn. The 112(b) rejections below are either revised or newly applied.
• The 101 rejection is maintained with revision.
• The 103 rejection is maintained with revision.
• Additionally, regarding 112(f), the 112(f) interpretation is maintained with revision.
Rejections and/or objections not maintained from previous office actions are withdrawn. The following rejections and/or objections are either maintained or newly applied. They constitute the complete set applied to the instant application.
Objection to the Specification: Title
The title should be amended to more specifically reflect the claims, particularly the independent claims and referencing steps/elements, setting the context of the invention, particular to all claims, and distinguishing the instant application from any related applications, for example a title including terms such as: medical value prediction device and medical value prediction system. The title should be "descriptive" and "as... specific as possible" (MPEP 606, 1st para. and 37 CFR 1.72; also MPEP 606.01 pertains).
Claim Interpretation
Claim 1 recites the limitation of "to receive a target value and to perform an inverse prediction..." (similarly recited in claim 11), in which it is not apparent that the inverse prediction is performed on the target value. (Note, claim 10 recites "to receive a target value to perform an inverse prediction of predicting of input medical inspection value...," which does not have the term "and" between "target value" and "to perform;" this minimally connects the target value with the inverse prediction, however it is still not wholly apparent that the inverse prediction is done on the target value in claim 10.) If it is Applicant's intention that the inverse prediction is done using the target value, please amend claim 1, 10, and 11 to reflect this. At present, independent claims 1, 10, and 11 are interpreted to include an embodiment that the inverse prediction is not required to be performed on the target value.
Additionally, it is not apparent in claim 1, 10, and 11 (and the dependent claims) that the value of the target value and the values of the medical inspection values are measurements of different biomarkers altogether (e.g., Fig. 9 shows blood pressure as current inspection values and as a target values, and HbA1c as future inspection values). If it is Applicant's intention that the medical inspection value(s) and the target value are different measured biomarkers, please amend claim 1, 10, and 11 to reflect this. At present, independent claims 1, 10, and 11 are interpreted to include the embodiment that the target value and the medical inspection values are measurements of the same biomarker.
The terms "learned" and/or "learning," recited in claims 1, 4, 5, 10, and 11, are being interpreted respectively as "trained" and "training." Consideration was given to Specification 9:6-8 as well as Specification 9:12-14, and although the ordinary terms "trained" and "training" are not recited in the disclosure, the terms "learned" and "learning" are being interpreted respectively as "trained" and "training."
Claims 1, 5, 10, and 11 are interpreted to recite the product-by-process limitation of a "model, which has been learned." It is brought to Applicant's attention that a product by process claim is examined for novelty and obviousness of the claimed product only, and that no consideration is given to the novelty or obviousness of the method of making the claimed product. See MPEP 2113, which includes as an example, Biogen MA, Inc. v. EMD Serano, Inc. (Fed. Cir. 9-28-2020, precedential).
Claims 4, 6, and 9 are interpreted to recite contingent clauses as follows:
• Claim 4 recites "when the predicted future medical inspection value output from the first learned model coincides with the target value."
• Claim 6 recites "when a plurality of prediction results of the inverse prediction are obtained."
• Claim 9 recites "when processing by the inverse prediction unit is performed as compared with a case where a processing by the prediction unit is performed."
Applicant is reminded that there are embodiments of claims 4, 6, and 9 in which the contingent limitations are not performed, therefore, those steps are not required by the claims (see MPEP 2111.04(II)). However, with compact prosecution in mind, the claims have been examined with the understanding that Applicant will amend to correct the contingent claim language.
Claim Objections
Claims 2, 7, and 11 are objected to because of the following informalities:
Claim 2 recites "the future medical inspection value of other users having attributes common to or similar to the user..." in which "value" should be plural as follows: "the future medical inspection values of other users having attributes common to or similar to the user..."
Claim 7 recites "who is a source of the prediction result..." in which "result" should be plural as follows: "who is a source of the prediction results..."
Claim 11 recites the element "receiving a target value and performing an inverse prediction of predicting what input medical inspection value should be input to the first learned model to output the predicted future medical inspection value corresponding to the target value." Because instant claim 11 depends from claim 1, the element should be corrected to "receiving the[[a]] target value and performing the[[an]] inverse prediction..."
Appropriate correction is required.
Claim Interpretation - 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term "means" or "step" or a term used as a substitute for "means" that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term "means" or "step" or the generic placeholder is modified by functional language, typically, but not always linked by the transition word "for" (e.g., "means for") or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term "means" or "step" or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word "means" (or "step") in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word "means" (or "step") in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word "means" (or "step") are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word "means" (or "step") are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word "means," but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim 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:
Instant claim limitations interpreted as PROPERLY invoking 112(f)
The following claim limitation are interpreted as properly invoking 112(f):
• A "prediction unit," in claims 1 and 10, recites means and function (an equivalent, nonce term, here a "unit," and function, here "to input a newly measured medical inspection value...to output a predicted future medical inspection value...") without reciting steps or structure to prevent invoking. The Specification does disclose sufficient structure, material, or acts and not just desired results, as exemplified at 6:23 through 7:6, and as such, is definite under 112(b) as properly invoking 112(f). MPEP 2181.III-IV pertain.
• An "inverse prediction unit," in claims 1, 2, and 10, recites means and function (an equivalent, nonce term, here a "unit," and function, here "to receive a target value...and to perform an inverse prediction...") without reciting steps or structure to prevent invoking. The Specification does disclose sufficient structure, material, or acts and not just desired results, as exemplified at 6:23 through 7:6, and as such, is definite under 112(b) as properly invoking 112(f). MPEP 2181.III-IV pertain.
• A "charge management unit," in claim 9, recites means and function (an equivalent, nonce term, here a "unit," and function, here "to determine a charge content...") without reciting steps or structure to prevent invoking. The Specification does disclose sufficient structure, material, or acts and not just desired results, as exemplified at 8:7-9, when considering 6:23 through 7:6, and as such, is definite under 112(b) as properly invoking 112(f). MPEP 2181.III-IV pertain.
• An "inspection value prediction device," in claim 10, recites means and function (an equivalent, nonce term, here a "device," and function, here "to operate as: a prediction unit...and an inverse prediction unit...") without reciting steps or structure to prevent invoking. The Specification does disclose sufficient structure, material, or acts and not just desired results, as exemplified at 2:23-24 and 3:9-20, and as such, is definite under 112(b) as properly invoking 112(f). MPEP 2181.III-IV pertain.
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.
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 § 112(b)
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 1-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate.
Claim 1 and 11 recite the phrase "perform an inverse prediction of predicting what input ...," which is unclear as to the relationship of "prediction" and "predicting," and what exactly is being predicted. Possibly amending to recite "perform an inverse prediction that predicts what input ..." might help overcome the rejection.
There is a similar issue in claim 10; however, claim 10 is rejected immediately below to include a further issue in the same phrase.
Claim 10 recites the phrase "perform an inverse prediction of predicting of input..." which is unclear grammatically in that it appears to be missing the term "what" (especially when compared to similar limitations in claims 1 and 11, which recite the term "what"). Additionally, claim 10 also presents the issue of being unclear as to the relationship of "prediction" and "predicting," and what exactly is being predicted. Possibly amending to recite "perform an inverse prediction that predicts what input ..." might help overcome the rejection.
Claims 1, 10, and 11 recite the term "newly" in "newly measured medical inspection value." The recited "newly" is a term of relative or vague degree or form of association, neither defined, let alone disclosed, in the specification, nor having a well-known and sufficiently particular definition in the art and in the instant context. (MPEP 2173.05(b) pertains.)
Claim 2 recites "extracting the input medical inspection value corresponding to the designated target value." It is not clear if the input medical inspection value being extracted is from "other users" or not.
Claim 4 recites the term "comprehensively" in "the inverse prediction unit comprehensively changes the input medical inspection value." The recited "comprehensively " is a term of relative or vague degree or form of association, neither defined in the specification at [13:20-14:7; 17:10; 20:20] nor having a well-known and sufficiently particular definition in the art and in the instant context. (MPEP 2173.05(b) pertains.)
Regarding claim 4, while the amending of claim 4 by Applicant is acknowledged, the relationship is unclear between the following: the input medical inspection value which is comprehensively changed and is to be inputted to the first learned model, the input medical inspection value which the inverse prediction is based on, and the inspection value output from the first learned model. The claim is unclear because there are several recitations of "inspection value" in which it is not clear if they are referring to the same or different "inspection value," and further unclear when considering the "inspection value" recited in independent claim 1, from which claim 4 depends.
Additionally, specifically in claim 4, the recited "the inspection value output from the first learned model" requires but lacks clear antecedent. If this recitation refers to a previously instantiated instance, then it is not clear which instance that is. If this recitation instantiates this claim element, this is not clear. This rejection might be overcome by for example amending to recite the article "a" instead of "the."
Further, in claim 4, it is not clear if "the input medical inspection value" refers to "a newly measured medical inspection value of a user" of claim 1 or to "what medical inspection value" of claim 1, or to another "medical inspection value."
Because the examiner cannot infer Applicant's intended scope of the limitations of claim 4 without considerable speculation, claim 4, will not be examined with respect to the prior art.
Regarding claim 7, the amending of claim 7 by Applicant is acknowledged, but claim 7 still appears to be grammatically flawed and therefore is not clearly interpretable, rendering the claim indefinite. This occurs at least at "orders the plurality of prediction results as a degree of similarity between a user information of the user who is a source of the prediction result and the user information of the user becomes higher refers to the predicted future medical inspection value of another user and uses the input medical inspection value of the other user corresponding to the target value of the user." Because the examiner cannot infer Applicant's intended scope of the limitations of claim 7 without considerable speculation, claim 7, will not be examined with respect to the prior art.
Additionally, the term "higher" in claim 7 is a relative term which renders the claim indefinite. The term "higher" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Further, in a related issue of claim 7, the difference is unclear between the limitations: "a user information of the user who is a source of the prediction result" and "the user information of the user," such that there is a lack of clarity as to what elements are being compared in order to determine a similarity is higher.
In claim 11, the recited "the predicted future medical inspection value corresponding to the target value" requires but lacks clear antecedent. If this recitation refers to a previously instantiated instance, then it is not clear which instance that is. If this recitation instantiates this claim element, this is not clear. This rejection might be overcome by for example amending to recite the article "a" instead of "the."
Applicant is encouraged to request an interview to discuss this and other issues.
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.
Claim 10 is rejected under 35 USC 101 because the claimed invention is directed to non-statutory subject matter at Step 1 of the 101 analysis. Briefly, amending claim 10 to recite "a computer server device" would likely overcome the rejection at Step 1 of claim 10 (see full discussion below). For compact examination, claim 10 is included in the further 101 analysis (and rejection) with claims 1-9 and 11.
Claims 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more.
Framework used to evaluate subject matter eligibility:
MPEP 2106 details the following framework to analyze Subject Matter Eligibility:
• Step 1: Are the claims directed to a category of statutory subject matter (a process, machine, manufacture, or composition of matter)? (see MPEP § 2106.03)
• Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e. an abstract idea, a law of nature, or a natural phenomenon? (see MPEP § 2106.04).
• Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application? (see MPEP § 2106.04(d))
• Step 2B: If the claims do not integrate the judicial exception, do the claims provide an inventive concept? (see MPEP § 2106.05)
Framework analysis as pertains to the instant claims:
Step 1:
Matter belonging to no statutory category at Step 1 – Claim 10
Claim 10 is not directed to any 101 process, machine, or manufacture, as claim 10 does not recite any element(s) which falls under a category of statutory subject matter. Discussion immediately follows. (See MPEP § 2106.03). (Step 1: Claim 10, NO.)
Claim 10 is to a system comprising the elements of a "computer server, " "inspection value prediction device," "prediction unit," and "inverse prediction unit," which are not, in all embodiments within a BRI, interpreted as belonging to any category listed in 101 because the listed elements read on software comprising no structure other than software. This is in contrast to the "computer server device" of claim 1 which recites physical structure; consequently, claim 1 is now considered to recite a category of statutory subject matter at Step 1 of the 101 analysis. Claim 10 is not recited as a process, and is not limited to any particular structure as a 101 machine or manufacture. Claim 10 recites no other clearly structural element comprised by the system, and therefore the claim reads on transitory propagating signals which are not proper patentable subject matter because they do not fit within any of the four statutory categories of invention (In re Nuijten, Federal. Circuit, 2006).
As appropriate, this rejection can be overcome by, for example, amending to recite structure such as non-transitory computer-readable storage medium comprising computer instructions stored and structurally configured to store the recited data and to accomplish the recited steps. Amending claim 10 to recite "a computer server device" would likely overcome the rejection at Step 1.
For compact examination, claim 10 is included in the further 101 analysis (i.e., Step 2A Prongs One and Two, Step 2B) and rejection with claims 1-9 and 11, with the expectation Applicant will amend claim 10 appropriately.
Matter belonging to a statutory category at Step 1 – Claims 1-9 and 11
Claims 1-9 and 11 are directed to a 101 machine or manufacture, here a device, which falls under a category of statutory subject matter. (See MPEP § 2106.03). (Step 1: Claims 1-9 and 11, YES.)
Final Step 1 Note:
Reiterating, for compact examination, claim 10 is included in the further 101 analysis and rejection with claims 1-9 and 11 below, with the expectation Applicant will amend claim 10 appropriately, possibly to recite "a computer server device."
Step 2A, Prong One:
The claims recite abstract ideas in the form of mental processes.
Mental processes are recited in the claims as follows:
• input a newly measured medical inspection value to a model (claims 1, 5, 10, 11)
• input a target value to a model (claim 5)
• output a predicted future medical inspection value of the user (claims 1, 10, 11) (Note, it is considered this output can be performed with pencil and paper. Claims 1 and 10 recite an additional output element of "output...to a client device" which are characterized as additional elements listed below at Step 2A Prong Two (emphasis added).
• perform inverse prediction (claims 1, 2, 4, 5, 10, 11)
• refer to reference data; extract the input medical inspection value (claim 2)
• changes the input medical inspection value (claim 4)
• obtain prediction results (claim 6)
• orders the prediction results (claim 7)
• determine a charge content; increasing the charge (claim 9)
Step 2A Prong One Summary: The claims recite abstract ideas, characterized as mental processes. Considering the broadest reasonable interpretation (BRI) of the claims, the mental processes recited in claims 1-11 (e.g., input inspection values and target values to a model; perform inverse prediction; output values; refer to reference data; extract inspection value; order results, etc.) are directed to processes that may be performed in the human mind, or with pen and paper, as there are no details or steps recited in the claims which would prevent mental performance, because these data analysis steps are recited at such a high level of generality that they could practically be performed in the human mind [see MPEP 2106.04(a)(2)(III)]. Such analysis performed mentally, or with paper and pencil, may take considerable time and effort, and although a general-purpose computer can perform these calculations at a rate and accuracy that can far exceed the mental performance of a skilled artisan, the nature of the activity is essentially the same, and therefore constitutes an abstract idea.
Therefore, the claims recite elements that constitute a judicial exception in the form of an abstract idea. (Step 2A, Prong One: Yes.)
Step 2A, Prong Two:
In Step 2A, Prong One above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs). Here at Step 2A, Prong Two, any remaining steps and/or elements not identified as JEs are therefore in addition to the identified JE(s), and are considered additional elements. Because the claims have been interpreted as being directed to judicial exceptions (abstract ideas in this instance) then Step 2A, Prong Two provides that the claims be examined further to determine whether the judicial exception is integrated into a practical application [see MPEP § 2106.04(d)]. A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
MPEP § 2106.04(d)(I) lists the following five example considerations for evaluating whether a judicial exception is integrated into a practical application:
(1) An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a).
(2) Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2).
(3) Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b).
(4) Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c).
(5) Applying or using 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 a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
The claims recite additional elements as follows:
Additional elements of data gathering steps are recited as follows: Receive a target value (claims 1, 5, 10, and 11); register a value (claim 1 and 10); output a value on a device (claims 1 and 10); obtain results and present results to a user (claim 6); and display a value (claim 10). These data gathering steps are additional elements which perform functions of inputting, collecting, and outputting the data needed to carry out the abstract idea. These steps are considered insignificant extra-solution activity, and are not sufficient to integrate an abstract idea into a practical application as they do not impose any meaningful limitation on the abstract idea or how it is performed, nor do they provide an improvement to technology [see MPEP § 2106.04(d)(I)].
Additional elements of computer components: Claims 1-11 recite additional elements of devices, units, systems, and/or programs. The claims require only generic computer components, which do not improve computer technology, and do not integrate the recited judicial exception into a practical application (see MPEP § 2106.04(d)(1) and MPEP § 2106.05(f)).
Step 2A Prong Two summary: The claims have been further analyzed with respect to Step 2A, Prong Two, and no additional elements have been found, alone or in combination, that would integrate the judicial exception into a practical application. At this point in examination, it is not yet the case that any of the Step 2A Prong Two considerations enumerated above clearly demonstrates integration of the identified JE(s) into a practical application. Referring to the considerations above, none of: (1) an improvement, (2) a treatment, (3) a particular machine, or (4) a transformation is clear in the record. For example, regarding the first consideration for improvement at MPEP 2106.04(d)(1), the record, including the Specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field, and the claims do not yet clearly result in such an improvement. (Step 2A, Prong Two: No).
Step 2B:
Because the additional claim elements do not integrate the abstract idea into a practical application, the claims are further examined under Step 2B, which evaluates whether the additional elements, individually and in combination, amount to significantly more than the judicial exception itself by providing an inventive concept. An inventive concept is furnished by an element or combination of elements that is recited in the claim in addition to the judicial exception, and is sufficient to ensure that the claim, as a whole, amounts to significantly more than the judicial exception itself (see MPEP § 2106.05).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that are well-understood, routine, and conventional. Those additional elements are as follows:
Additional elements of inputting, and outputting steps: The additional elements of: receive a target value (claims 1, 5, 10, and 11); register a value (claim 1 and 10); output a value on a device (claims 1 and 10); obtain results and present results to a user (claim 6); and display a value (claim 10), do not cause the claims to rise to the level of significantly more than the judicial exception. The courts have recognized receiving or transmitting data over a network; and storing and retrieving information in memory; [see MPEP§2106.05(d)(II)], as well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity.
Therefore the additional elements of data gathering are shown to be routine, well-understood, and conventional in the art, and do not provide an inventive concept needed to amount to significantly more than the judicial exception.
Additional elements of computer components: The additional elements of devices, units, systems, and/or programs of claims 1-11 do not cause the claims to rise to the level of significantly more than the judicial exception; these are generically claimed, conventional computer components (see MPEP § 2106.05(b) and 2106.05(f)). Additionally, examples of these conventional devices, units, systems, and/or programs are given in Specification at 3:9 (inspection value prediction device); 4:9-11 (terminal device); 5:1-8 (hardware, program); 6:23 through 7:6 (prediction unit, inverse prediction unit, hardware); 8:9 (charge management unit).
Therefore, the additional elements of devices, units, systems, and/or programs do not cause the claims to rise to the level of significantly more than the judicial exception as they do not provide an inventive concept.
Further regarding the conventionality of additional elements, the MPEP at 2106.05(b) and 2106.05(d) presents several points relevant to conventional computers and data gathering steps in regard to Step 2A Prong 2 and Step 2B, including:
• A general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions, does not qualify as a particular machine (see 2106.05(b)(I)), as in the case of claims 1-11, which are interpreted to recite conventional computer components.
• Integral use of a machine to achieve performance of a method may integrate the recited judicial exception into a practical application or provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not integrate the exception into a practical application or provide significantly more (see 2106.05(b)(II). In claims 1-11, the recited devices, units, systems, and/or programs act only as a tool to perform the steps of data analysis, and do not integrate the exception into a practical application or provide significantly more.
• Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more (see 2106.05(b)(III). The recited devices, units, systems, and/or programs of claim 1-11 used in performing data analysis do not impose meaningful limitations on the claims.
• The courts have recognized "receiving or transmitting data over a network," "performing repetitive calculations," and "storing and retrieving information in memory," as well-understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (see MPEP 2106.05(d)(II)). The inputting and outputting of values in claims 1, 4, 5, 10, 11 is recited in a generic manner.
All limitations of claims 1-11 have been analyzed with respect to Step 2B, and none provides a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception, and thus do not transform the judicial exception into a patent eligible application of the exceptions. Step2B: NO. Therefore, the claims, when the limitations are considered individually and as a whole, are rejected under 35 U.S.C. § 101 as being directed to non patent-eligible subject matter.
Response to Applicant Arguments - 35 USC § 101
Applicant's arguments filed 01/30/2026 have been fully considered but they are not persuasive.
Arguments considered to address Step 1 (MPEP § 2106.03):
Applicant asserts (p.9):
• "Claim 1 is amended to clarify that language, and particularly claim 1 now recites a structure of a "computer server device" (p.9, ¶ 3)
The argument is considered to refer to Step 1 of the 101 analysis for claim 1-9 and 11, and is considered persuasive because claim 1 now recites statutory subject matter of a "computer server device." However, Applicant is reminded claim 10 is still directed to non-statutory subject matter at Step 1 of the 101 analysis (see above discussion at Step 1 of the 101 rejection). Briefly, amending claim 10 to recite "a computer server device" would likely overcome the rejection at Step 1 of claim 10.
Arguments considered to address Step 2A Prong One (MPEP § 2106.04(a)):
Applicant asserts (p.9-10):
• "...claim features as currently written are not directed merely to mental processes. "computer server device" (p.9, ¶ 5)
• "...the features directed to a "computer server" and ...to "register..." and "to output...to a client device" are not directed to mental processes." (p.10, ¶ 2)
The argument is considered to refer to Step 2A Prong One of the 101 analysis. The elements of "a computer server," "register...," and " to output...to a client device" have not been characterized as mental processes in the 101 rejection above, but are listed as additional elements at Step 2A prong Two of the 101 rejection.
Note, there are two different outputting steps in the claims ("output a ...value of the user;" and "output...to a client device"). It is considered the step for "output a...value of the user" (claims 1, 10, 11) can be performed with pencil and paper, and has been listed at Step 2A Prong One above as a mental process. The step for "output...to a client device" (claims 1 and 10) (which Applicant asserts is not a mental process), is not considered a mental process in the 101 rejection, but has been characterized as an additional element at Step 2A Prong Two.
Arguments considered to address Step 2A Prong Two (MPEP § 2106.04(d)):
Applicant asserts (p.10):
• "... the claims as currently written are clearly directed to a practical
application. (p.10, ¶ 3)
• "Claim features provide an inspection value prediction device for medical values that can predict future risks based on current conditions but can also provide users with opportunities to review their health and lifestyle habits to achieve better well-being." (p.10, ¶ 3)
• "an improvement prediction reverse-prediction function... and thereby fees for functions can be lower..." (p.10, ¶ 4)
The arguments are considered to refer to Step 2A Prong Two of the 101 analysis. The arguments are not yet persuasive because it is not clear if Applicant is asserting an improvement to technology or a technical field at Step 2A Prong Two, or asserting another consideration at Step 2A Prong Two (see MPEP § 2106.04(d)). Further, regarding the first consideration for improvement to technology or a technical field at MPEP 2106.04(d)(1), the record, including the Specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field, and the claims do not yet clearly result in such an improvement.
Regarding showing an improvement to technology, a detailed explanation of a technical improvement may help to overcome a 101 rejection, (see MPEP 2106.04(d) and (d)(1), as well as MPEP 2106.05(a)). The explanation might include a concise statement of the improvement, including improvement over the previous state of the technology field; identification of the technology field; explanation of how the claims deliver the improvement and that reasonably all embodiments within the claim scope also will result in the asserted improvement, and extension of the explanation to persuasively demonstrate the nexus of integration of the judicial exceptions into a practical application. As further examples, argument may clearly and adequately explain cause and effect leading to improvement or, for example when such cause and effect explanation is not possible, then may include evidence (e.g. experimental data) comparing a claimed result to conventional results. Also, arguments and evidence may be extrinsic to the original disclosure, including references available after the priority date, as long as it is clear that an argument applies to all embodiments of a properly supported claim. In the present invention, there does not appear to be a nexus between the JEs (abstract ideas) and the additional elements, and Applicant's 01/30/2026 arguments do not persuasively explain the improvement.
Further, in addition to the details for presenting an improvement to technology listed in the previous paragraph, it may also help to elaborate on Applicant's assertions regarding the "an improvement prediction reverse-prediction function... and thereby fees for functions can be lower..." (remarks, p.10, ¶ 4) in the pursuit to show an improvement to technology.
Claim Rejections - 35 USC § 103
Note: The scope of claims 4 and 7 cannot be inferred by the Examiner without considerable speculation, therefore, claims 4, 7, and 8 will not be examined with respect to the prior art.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
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.
Claims 1-3, 5, 6, and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Meyer (US 2019/0378619 A1, published 12/12/2019, filed 05/30/2019; cited on the 10/01/2025 Form PTO-892), in view of Wells (Journal of Forensic Sciences, vol. 40(4), pages 585-590 (1995); cited on the 10/01/2025 Form PTO-892).
Independent claims 1, 10, and 11 respectively recite a device, system, and a method for inputting a newly measured medical inspection value into a first trained model (which could have been trained on a first training data set containing series data of past inspection values of the user) to output a predicted future medical inspection value; an inverse prediction unit to receive a target value, perform an inverse prediction of predicting what input medical inspection value should be input to the first trained model; register, and output to a client device, the predicted future medical inspection value coinciding with the target value.
Dependent claim 2 further recites the inverse prediction unit performs the inverse prediction by referring to reference data of the future medical inspection value of other users having attributes common to or similar to the user, and extracting the inspection value corresponding to the designated target value.
Dependent claim 3 further recites the reference data is an accumulation of results predicted by the prediction unit.
Dependent claim 5 further recites when the target value is designated, the inverse prediction unit receives the target value performs the inverse prediction by inputting the target value to a second learned model, which has been learned using a second learning data set in which input and output of the series data of the plurality of past medical inspection values are replaced with the first learning data set.
Dependent claim 6 further recites when a plurality of prediction results of the inverse prediction are obtained, the inverse prediction unit presents the plurality of prediction results to the user.
Dependent claim 9 further recites a charge management unit configured to determine a charge content requested to the user, the charge management unit increasing a charge required of the user when processing is performed by the inverse prediction unit compared prediction unit is performed.
Regarding claims 1, 10, and 11, Meyer teaches the following limitations:
• Inputting an inspection value into a trained model (trained on a dataset of series inspection values of the user), to predict future inspection value: Meyer teaches predicting health conditions of patients using artificial intelligence methods with a focus on machine learning models [0001]. Meyer teaches a first data set is obtained, comprising one or more features of health data associated with one or more patients to train a machine learning model to predict health conditions of patients [0038]. Meyer teaches the time series data set may be provided as input to a trained machine learning model to predict health conditions of the patient; likelihood may be predicted of one or more conditions to occur corresponding to one or more future time values for the patient [0058].
• Outputting a target value pertaining to the inspection value inputted: Meyer teaches the neural network is to be trained with data set that clearly identifies training input (e.g. , features and values) and target output (the outcome to be predicted) [0028].
Regarding claim 2 and 3, Meyer teaches the following limitations:
• Reference data of users having attributes in common; & extracting target value (claim 2); and reference data is accumulation of predicted results (claim 3): Meyer teaches to obtain a first data set comprising one or more features (i.e., attributes) of health data associated with one or more patients to train a machine learning model to predict health conditions of patients [Fig.2, 202]. Meyer teaches extracting a certain feature from the input (i.e., inspection values) [0032].
Regarding claim 5, Meyer teaches the following limitations:
• Second trained model trained with second training dataset; and replacing values: Meyer teaches the training data generator may also use additional machine learning models [0028]. Meyer teaches the values of the first feature of the first data set may be replaced using one or more random values from the set of clinically plausible values [0040]. Meyer teaches training the machine learning model using each data point of the second data set;…and that multiple epochs of training may be performed using the second data set to refine and improve the learning prediction capabilities of model (i.e., a second model) [0041]. Meyer teaches the neural network is to be trained with data set that clearly identifies training input (e.g. , features and values) and target output (the outcome to be predicted) [0028].
Regarding claim 6, Meyer teaches the following limitations:
• Presents results to user: Meyer teaches at a screen near a particular patient, only the likelihood values of the particular patient may be displayed .
Regarding claim 9, Meyer teaches the following limitations:
• Charge management: Meyer teaches data recording in electronic health record systems is usually designed and optimized for reporting, liabilities, and billing purposes [0017].
Regarding claim 10, Meyer teaches the following limitations:
• System and display: Meyer teaches a computer system with video display unit [0064].
Meyer does not teach the inverse prediction method of claims 1, 10, and 11.
Wells teaches inverse prediction of maggot age from maggot weight, by constructing confidence intervals (p.587, col.1) and prediction intervals (p.587, col.2) on weights of 2.75 day old larvae, and calculating the range of ages that corresponds to weight (p.588, col.1). From this model, Wells teaches an approximate confidence interval can be derived on the age of any larva for which the weight is given (p.588, col.1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of using machine learning models to predict health condition values of Meyer, with the inverse prediction method of Wells, to come to a method using inverse prediction in machine learning models to predict health condition values. This is because while Meyer demonstrates a method which may improve accuracy and efficiency of health condition predictions using machine learning techniques [Meyer, 0022], Wells adds motivation to modify by stating calibration or inverse prediction…has been applied in a great variety of settings (p.589, middle of col.1), and further shows that the use of confidence intervals on the target quantity…provides both an estimate… and an assessment of the precision of the estimate (p.589, end of col.1). One of ordinary skill would have had a reasonable expectation of success in modifying Meyer with Wells, as Meyer and Wells are generally drawn to related teaching of biological models used in predicting values, and one of ordinary skill in the art would have understood how to and would have been motivated to modify the teachings of Meyer with Wells, and as such, the modification would have been obvious.
Response to Applicant Arguments - 35 USC § 103
Applicant's arguments filed 01/30/2026 have been fully considered but they are not persuasive.
Applicant asserts (p.11-12):
• " Meyer specializes in "predicting future health conditions from patient data", but applicant submits Meyer does not disclose or suggest clarified claim features of "when a target value is specified, reverse-calculating the input conditions necessary to achieve that target value." (p.11, ¶ 5)
• "...claim feature goes beyond the simple prediction system of Meyer and can
provide specific actual guidelines, in contrast to Meyer." (p.12, ¶ 1)
• "... Wells also does not disclose clarified claim features of "when a target value is specified, reverse-calculate the input conditions necessary to achieve
that target value", as now clarified in the claims. (p.12, ¶ 5)
The arguments are not persuasive in that the claims do not explicitly recite "when a target value is specified, reverse-calculating the input conditions necessary to achieve that target value." There is no "calculating", nor "reverse calculating" in the claims. However, it is understood these concepts are likely similar to what is intended in the claims. Regarding the intentions and what is claimed:
Claim 1 recites the limitation of "to receive a target value and to perform an inverse prediction..." (similarly recited in claim 11), in which it is not apparent that the inverse prediction is performed on the target value.
Claim 10 recites "to receive a target value to perform an inverse prediction of predicting of input medical inspection value...," which does not have the term "and" between "target value" and "to perform;" this minimally connects the target value with the inverse prediction, however it is still not wholly apparent that the inverse prediction is done on the target value in claim 10.
If it is Applicant's intention that the inverse prediction is done using the target value, please amend claim 1, 10, and 11 to reflect this.
At present, independent claims 1, 10, and 11 are interpreted to include an embodiment that the inverse prediction is not required to be performed on the target value.
Additionally, it is not apparent in claim 1, 10, and 11 (and the dependent claims) that the value of the target value and the values of the medical inspection values are measurements of different biomarkers altogether (e.g., Fig. 9 shows blood pressure as current inspection values and as a target values, and HbA1c as future inspection values).
If it is Applicant's intention that the medical inspection value(s) and the target value are different measured biomarkers, please amend claim 1, 10, and 11 to reflect this.
At present, independent claims 1, 10, and 11 are interpreted to include the embodiment that the target value and the medical inspection values are measurements of the same biomarker.
Applicant is encouraged to request an interview to discuss this and other issues; the interview may be conveniently requested using the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith A Vassell whose telephone number is (571)272-1771. The examiner can normally be reached 8:30 - 4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KARLHEINZ SKOWRONEK can be reached at (571)272-9047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.V./Examiner, Art Unit 1687
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686
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