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 .
Response to Amendment
The Amendments filed 5th December 2025 have been entered. Claims 1-2, 5-17 & 19 are pending. Claims 3, 4 & 18 are canceled. Claim 17 has been amended as a dependent claim.
Response to Arguments
Applicant’s arguments regarding the rejection under 35 U.S.C. § 101 have been fully considered but they are not persuasive.
Applicant argues: ‘claim 1 has been amended to be directed to a system that includes the information processing apparatus, a measurement device and a monitoring device. These newly added structural components are also recited in independent claim 19. Of particular note is the fact that the measurement device and monitoring device are now described with a level of detail that sets them apart from generically recited structural elements.’. Examiner respectfully disagrees with Applicant regarding the assertion that the measurement device and monitoring device are now described with a level of detail that sets them apart from generically recited structural elements. Merely stating that the present invention provides significantly more than an abstract idea via a generically recited additional element is not enough to convince the Examiner. There is nothing in the claims to suggest that the information processing system, information processing apparatus, measurement device and monitoring device provide significantly more than the judicial exception. Claim 1 recites the structural elements of ‘a measurement device that sends a measured value… a monitoring device that measures over time a monitoring value… an information processing apparatus comprising at least one processor…’, Claim 19 recites the structural elements of ‘A non-transitory computer-readable storage medium storing an information processing program for causing a computer to execute processing, the computer being communicatively coupled to a measurement device that sends a measured value… and a monitoring device that measures…’.
It is important to note that according to MPEP 2106.05(a), the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field.
The evaluation of whether the claim as a whole integrates the recited judicial exception into a practical application of the exception or whether the claim is ‘directed to’ the judicial exception is performed by identifying additional elements recited in the claim beyond the judicial exception and evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. See MPEP 2106.04(d). The claims recite the additional elements of an information processing system comprising an information processing apparatus, a measurement device and a monitoring device. The limitations as underlined in the rejection below are mere data gathering, manipulating data, and outputting data by the additional elements recited at a high level of generality and thus involve insignificant extra-solutionary activity. See MPEP 2106.05(g) (“whether the limitation is significant”). In addition, all uses of the recited judicial exceptions require such data gathering and output, and as such, these limitations do not impose any meaningful limits on the claim. These limitations amount to necessary data gathering and outputting. See MPEP 2106.05.
Further, the limitations are executed on the additional elements recited at a high level of generality, used to perform an abstract idea, such that it amounts to no more than mere instructions to apply the exception using a generic computer. See MPEP 2106.05(f). There is no indications that the claims as a whole includes an improvement to a computer or to a technological field. See MPEP 2106.04(d)(1).
Applicant’s arguments regarding the rejections under 35 U.S.C. 102 & 103 have been considered, but are not persuasive. In response to Applicant’s arguments with respect to the rejection of claim 4 under 35 U.S.C. 102 to Maruo, Applicant asserts that Maruo fails to disclose ‘deriving the tendency of fluctuation in plural monitoring values nor estimating the tendency of fluctuation in the measured value based on the tendency of fluctuation in the monitoring values’. Examiner respectfully disagrees with Applicant. Examiner asserts that Maruo does disclose deriving the tendency of fluctuation in monitoring values and estimating the tendency of fluctuation in the measured value based on the tendency of fluctuation in the monitoring values, as previously recited in the prior office action, Para. [0032] ‘The estimated blood glucose level after the calibration is displayed every 5 minutes as a relative fluctuation value from the calibration blood glucose level. This display may display the blood glucose level numerically, or it may be displayed as a graph over time to make it easier to grasp the blood glucose level change.’; Note: ‘deriving’ and ‘estimating’ do not imply any specific algorithm or calculation. The limitation of ‘correlation between the measured value and the monitoring value is based on a predetermined correlation data’ is further mapped to Maruo, Para. [0032]. Paragraphs [0011], [0015]-[0016], [0019] & [0029] of Maruo discuss using an invasively measured value as a reference for non-invasive monitoring values of glucose level estimation, therefore the monitoring values are considered to be based on the measured value, and the tendency of fluctuation is derived and estimated through the estimations and display of a graphical representation. The correlation data between the measured and monitoring value is predetermined and the monitoring values are calibrated based on how the measured value changes, since the correlation data is predetermined, so long as there is a correlation, that would meet the claim limitations, currently the claims do not require calculating that correlation. It should be noted that the Applicant’s use of ‘the basis’/’based on’ does not imply any specific relation in the limitations. Therefore, Maruo is held to disclose the aforementioned limitations, and the rejection is maintained below, updated with respect to amended changes.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim 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: ‘a measurement device that sends a measured value’ & ‘a monitoring device that measures over time a monitoring value’ in claims 1 & 19. ‘a measuring device that sends a measured value’ is interpreted to be a device including a non-volatile storage unit implemented by a CPU, HDD, SDD, and flash memory, I/O units, and a network interface configured to perform wired/wireless communication between the information processing apparatus and an external network, per the specification (Para. [0030]). ‘a monitoring device that measures over time a monitoring value’ is interpreted to be a device including a processor, memory, sensor, network I/F for wired/wireless communication between the information processing apparatus and an external network, consisting of an ASIC to monitor biological information, per the specification (Para. [0032])
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
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 1-2, 5-17 & 19 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 1 & 19 ‘a plurality of the monitoring values’, it is unclear specifically what the intended scope is, rendering Claims 1 & 19 indefinite. Examiner suggests amending to ‘the monitoring value at each of the plurality of time points’.
Claims 1 & 19 ‘among the monitoring values at the plurality of time points’, this limitation implies there are multiple values at each time point where initially there was only one value at each time point, rendering Claim 1 indefinite. Examiner suggests amending to ‘the monitoring value at each of the plurality of time points’.
Claims 1 & 19 ‘the basis of the plurality of monitoring values’, there is insufficient antecedent basis for this limitation in this claim.
Claims 1 & 19 ‘the basis of the plurality of monitoring values’, it is unclear specifically what the intended scope is, rendering Claim 1 indefinite. Examiner suggests amending to ‘the monitoring value at each of the plurality of time points’.
Claims 1 & 19 ‘…a tendency of fluctuation in the measured value in the period from the tendency of fluctuation in the monitoring value’, this limitation reads as ‘estimate a tendency of fluctuation from the tendency of fluctuation’, as both tendency of fluctuation recitations refer currently to the same element/value, making it unclear why one would need to estimate a value from itself and further how that is possible, rendering Claim 1 indefinite. Examiner suggests amending to clarify the different tendency of fluctuations for each type of value.
Claims 1 & 19 ‘…a tendency of fluctuation in the measured value in the period from the tendency of fluctuation in the monitoring value on the basis of correlation data…’, there is insufficient antecedent basis for this limitation in this claim.
Claims 2 & 5-17 are rejected for their dependence on a rejected base claim.
Claim Rejections - 35 USC § 101
Claims 1-2, 5-17 & 19 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.
Each of Claims 1-2, 5-17 & 19 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1-2, 5-17 & 19 recites at least one step or instruction for acquiring data, comparing data with reference data, making determinations based on data acquired, outputting data results based on the comparisons and determinations made on the data, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG.
Accordingly, each of Claims 1-2, 5-17 & 19 recites an abstract idea.
Claim 1:
An information processing system, comprising: a measurement device that sends a measured value, which is a level of blood glucose measured by blood test, together with time information indicating a measurement time point of the measured value (Observation);
a monitoring device that measures over time a monitoring value, which is a glucose level contained in interstitial fluid, sweat, or saliva, and which has a correlation with the level of blood glucose (Observation)
an information processing apparatus comprising at least one processor, wherein the at least one processor is configured to:
acquire the measured value, together with the time information (Observation);
acquire the monitoring value at each of a plurality of time points (Observation);
associate the measured value with a plurality of the monitoring values in a predetermined period (Judgement), which includes at least one of a time point before or a time point after the measurement time point indicated by the time information, among the monitoring values at the plurality of time points
derive a tendency of fluctuation in the monitoring value in the period on the basis of the plurality of monitoring values associated with the measured value (Judgement); and
estimate a tendency of fluctuation in the measured value in the period from the tendency of fluctuation in the monitoring value on the basis of correlation data in which a correlation between the measured value and the monitoring value is predetermined (Evaluation/Opinion).
Claim 19:
A non-transitory computer-readable storage medium storing an information processing program for causing a computer to execute processing, the computer being communicatively connected to a measurement device that sends a measured value, which is a level of blood glucose measured by blood test, together with time information indicating a measurement time point of the measured value (Observation/Judgement), and
a monitoring device that measures over time a monitoring value, which is a glucose level contained in interstitial fluid, sweat, or saliva, and which has a correlation with the level of blood glucose (Judgement), the processing including:
acquiring the measured value together with time information (Observation);
acquiring the monitoring value at each of a plurality of time points (Observation)
associating the measured value with a plurality of the monitoring values in a predetermined period, which includes at least one of a time point before or a time point after the measurement time point indicated by the time information, among the monitoring values at the plurality of time points (Judgement);
deriving a tendency of fluctuation in the monitoring value in the period on the basis of the plurality of monitoring values associated with the measured value (Judgement); and
estimating a tendency of fluctuation in the measured value in the period from the tendency of fluctuation in the monitoring value on the basis of correlation data in which a correlation between the measured value and the monitoring value is predetermined (Evaluation/Opinion).
Regarding the dependent claims, the following dependent claims are directed to steps that are also abstract.
Claims 2, 5-17 include steps that are also abstract as a mental process through additional data gathering or analysis
Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claims 1 and 19 (and their respective dependent Claims 2, 5-17) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claims 1 and 19), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: An information processing apparatus ([0040]); at least one processor ([0126-0128]); A non-transitory computer-readable storage medium storing an information processing program ([0030], [0041], [0122], [0130]); a computer ([0041], [0122], [0128]); a monitoring device ([0032]); a measuring device ([0030]).are generically recited computer elements in independent Claims 1 and 19 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claims 1 and 19 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., at least one processor; computer as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1 and 19 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 1 and 19 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1-2, 5-17 & 19 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: an information processing apparatus; at least one processor; a non-transitory computer-readable storage medium storing an information processing program; a computer; a monitoring device; and a measurement device as claims in independent Claims 1 and 19, and their respective dependent Claims.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, An information processing apparatus ([0040]); at least one processor ([0126-0128]); A non-transitory computer-readable storage medium storing an information processing program ([0030], [0041], [0122], [0130]); a computer ([0041], [0122], [0128]); a monitoring device ([0032]); a measuring device ([0034]).
Accordingly, in light of Applicant’s specification, the claimed term information processing apparatus; at least one processor is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the at least one processor; computer. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
Regarding the dependent claims, the dependent claims are directed to further recite additional elements at a high level of generality which are conventional in the art or steps that generally link the use of a judicial exception to a particular technological environment or field of use.
Claims 2, 5-16 recite additional elements at a high level of generality which are conventional in the art
Claims 5 & 17 include steps that generally link the use of a judicial exception to a particular technological environment or field of use
The recitation of the above-identified additional limitations in Claims 1, 5-17 & 19 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the apparatus’ and non-transitory computer readable storage medium of Claims 1, 5-17 & 19 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1, 5-17 & 19 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1-19 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1, 5-17 & 19 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1, 5-17 & 19 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1, 5-17 & 19 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 7-17 & 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP 2011062335 to Maruo.
Regarding Claim 1, Maruo discloses an information processing system (Maruo: Para. [0001]), comprising: a measurement device that sends a measured value, which is a level of blood glucose measured by blood test (Maruo: Para. [0016] ‘a reference blood glucose level measurement means 2 that invasively measures a reference blood glucose level’), together with time information indicating a measurement time point of the measured value (Maruo: Para. [0054] ‘not only the reference blood glucose level but also the subject identification signal (recognition information), measurement time, etc.…’);
a monitoring device that measures over time a monitoring value, which is a glucose level contained in interstitial fluid, sweat, or saliva, and which has a correlation with the level of blood glucose (Maruo: Para. [0019] ‘The blood glucose level estimation means 3 for non-invasively estimating the blood glucose level may be any means that estimates the blood glucose level using a signal measured noninvasively from a physiological state change that correlates with the blood glucose level.’); (Maruo: Para. [0026] ‘in the dermal tissue, capillaries are well developed and highly watersoluble biological components, particularly glucose, have high permeability within the tissue, so it is thought that the biological component concentrations, particularly glucose concentrations, change in accordance with blood glucose levels, just like interstitial fluid (ISF). Therefore, spectral measurements targeting the dermal tissue can provide spectral signals that correlate with blood glucose fluctuations.’)
an information processing apparatus comprising at least one processor (Maruo: Para. [0020] ‘central processing unit (CPU).’), wherein the at least one processor is configured to:
acquire the measured value (Maruo: Para. [0016] ‘a reference blood glucose level measurement means 2 that invasively measures a reference blood glucose level’) together with the time information (Maruo: Para. [0054] ‘not only the reference blood glucose level but also the subject identification signal (recognition information), measurement time, etc.…’);
acquire the monitoring value (Maruo: Para. [0019] ‘The blood glucose level estimation means 3 for non-invasively estimating the blood glucose level may be any means that estimates the blood glucose level using a signal measured noninvasively from a physiological state change that correlates with the blood glucose level.’) at each of a plurality of time points (Maruo: Para. [0032] ‘The estimated blood glucose level after the calibration is displayed every 5 minutes as a relative fluctuation value from the calibration blood glucose level.’; [0034] and [0038]);
associate the measured value with a plurality of the monitoring values in a predetermined period, which includes at least one of a time point before or a time point after the measurement time point indicated by the time information, among the monitoring values at the plurality of time points (Maruo: Para. [0031] ‘the time delay of the estimated blood glucose level by the noninvasive technique with respect to the reference blood glucose level is set to about 5 minutes. Thereafter, the calibration means 4 automatically calibrates the estimated blood glucose level so that the reference blood glucose level matches the estimated blood glucose level, and displays it as the measured blood glucose level.’; Para. [0033] ‘Fig. 3 shows the results of continuous blood glucose level measurement using the blood glucose level monitoring device of this example’; [0034] and [0038])
derive a tendency of fluctuation in the monitoring value in the period on the basis of the plurality of monitoring values associated with the measured value (Maruo: Para. [0032] ‘The estimated blood glucose level after the calibration is displayed every 5 minutes as a relative fluctuation value from the calibration blood glucose level. This display may display the blood glucose level numerically, or it may be displayed as a graph over time to make it easier to grasp the blood glucose level change.’); and
estimate a tendency of fluctuation in the measured value in the period from the tendency of fluctuation in the monitoring value on the basis of correlation data in which a correlation between the measured value and the monitoring value is predetermined (Maruo: Para. [0032] ‘The estimated blood glucose level after the calibration is displayed every 5 minutes as a relative fluctuation value from the calibration blood glucose level. This display may display the blood glucose level numerically, or it may be displayed as a graph over time to make it easier to grasp the blood glucose level change.’).
Regarding Claim 2, Maruo discloses the information processing apparatus system according to claim 1, wherein the at least one processor is configured to associate the acquired measured value with the monitoring value Maruo: Para. [0016] ‘a calibration means 4 that automatically calibrates the estimated blood glucose level estimated by the blood glucose estimation means using the reference blood glucose level.’) at the measurement time point indicated by the time information, after the measured value and the time information are acquired (Maruo: Para. [0054] ‘When transmitting information between the reference blood glucose level measuring means 2 and the blood glucose monitoring device…transmit not only the reference blood glucose level but also the subject identification signal (recognition information), measurement time, etc.…’; [0034] and [0038]).
Regarding Claim 7, Maruo discloses the information processing system according to claim 1, wherein the at least one processor is configured to derive a range of fluctuation in the monitoring value in the period as the tendency of fluctuation in the monitoring value (Maruo: Para. [0032] ‘The estimated blood glucose level after the calibration is displayed every 5 minutes as a relative fluctuation value from the calibration blood glucose level. This display may display the blood glucose level numerically, or it may be displayed as a graph over time to make it easier to grasp the blood glucose level change.’)..
Regarding Claim 8, Maruo discloses the information processing system according to claim 1, wherein the at least one processor is configured to output a comment corresponding to the estimated tendency of fluctuation in the measured value (Maruo: Para. [0065] ‘when the estimated blood glucose value displayed is highly reliable and when it is low, and also when it exceeds a preset threshold value (for example, 140 mg/dl or more and 70 mg/dl or less), prompting the user to measure the reference blood glucose value’).
Regarding Claim 9, Maruo discloses the information processing system according to claim 1, wherein the at least one processor is configured to perform first evaluation (Maruo: Para. [0041]) on the measured value on the basis of the estimated tendency of fluctuation in the measured value (Maruo: Para. [0032] ‘The estimated blood glucose level after the calibration is displayed every 5 minutes as a relative fluctuation value from the calibration blood glucose level. This display may display the blood glucose level numerically, or it may be displayed as a graph over time to make it easier to grasp the blood glucose level change.’).
Regarding Claim 10, Maruo discloses the information processing apparatus system according to claim 9, wherein the at least one processor is configured to output a comment (Maruo: Para. [0065] ‘when the estimated blood glucose value displayed is highly reliable and when it is low, and also when it exceeds a preset threshold value (for example, 140 mg/dl or more and 70 mg/dl or less), prompting the user to measure the reference blood glucose value’) corresponding to the first evaluation (Maruo: Para. [0041]).
Regarding Claim 11, Maruo discloses the information processing system according to claim 1,wherein the at least one processor is configured to: derive a tendency of fluctuation in the monitoring value in the period on the basis of the plurality of the monitoring values associated with the measured value (Maruo: Para. [0032] ‘The estimated blood glucose level after the calibration is displayed every 5 minutes as a relative fluctuation value from the calibration blood glucose level. This display may display the blood glucose level numerically, or it may be displayed as a graph over time to make it easier to grasp the blood glucose level change.’); and
perform first evaluation on the measured value on the basis of the tendency of fluctuation in the monitoring value (Maruo: Para. [0041]).
Regarding Claim 12, Maruo discloses the information processing system according to claim 1, wherein the at least one processor is configured to perform second evaluation (Maruo: Para. [0041]; Note: second evaluation is interpreted as an evaluation triggered after the first evaluation has been triggered.) on the measured value on the basis of a deviation between a reference value of the monitoring value at the measurement time point indicated by the time information and the monitoring value at the measurement time point indicated by the time information (Maruo: Para. [0032] ‘The estimated blood glucose level after the calibration is displayed every 5 minutes as a relative fluctuation value from the calibration blood glucose level. This display may display the blood glucose level numerically, or it may be displayed as a graph over time to make it easier to grasp the blood glucose level change.’).
Regarding Claim 13, Maruo discloses the information processing system according to claim 12, wherein the at least one processor is configured to output a comment (Maruo: Para. [0065] ‘when the estimated blood glucose value displayed is highly reliable and when it is low, and also when it exceeds a preset threshold value (for example, 140 mg/dl or more and 70 mg/dl or less), prompting the user to measure the reference blood glucose value’)
corresponding to the second evaluation (Maruo: Para. [0041]; Note: second evaluation is interpreted as an evaluation triggered after the first evaluation has been triggered.).
Regarding Claim 14, Maruo discloses the information processing system according to claim 1, wherein the at least one processor is configured to perform third evaluation (Maruo Para. [0041]; Note: third evaluation is interpreted as an evaluation triggered after the second evaluation has been triggered.) on the measurement time point indicated by the time information on the basis of the monitoring value associated with the measured value (Maruo: Para. [0032] ‘The estimated blood glucose level after the calibration is displayed every 5 minutes as a relative fluctuation value from the calibration blood glucose level. This display may display the blood glucose level numerically, or it may be displayed as a graph over time to make it easier to grasp the blood glucose level change.’; [0034] and [0038]).
Regarding Claim 15, Maruo discloses the information processing system according to claim 14, wherein the at least one processor is configured to output a comment (Maruo: Para. [0065] ‘when the estimated blood glucose value displayed is highly reliable and when it is low, and also when it exceeds a preset threshold value (for example, 140 mg/dl or more and 70 mg/dl or less), prompting the user to measure the reference blood glucose value’) corresponding to the third evaluation (Maruo Para. [0041]; Note: third evaluation is interpreted as an evaluation triggered after the second evaluation has been triggered.).
Regarding Claim 16, Maruo discloses the information processing apparatus system according to claim 1, wherein the at least one processor is configured to output the monitoring value associated with the measured value (Maruo: Para. [0032] ‘The estimated blood glucose level after the calibration is displayed every 5 minutes as a relative fluctuation value from the calibration blood glucose level.’).
Regarding Claim 17, Maruo discloses the information processing system according to claim 1, wherein the at least one processor is configured to: recommend measurement of the measured value in a case where a deviation between the monitoring value and a reference value of the monitoring value is smaller than a predetermined threshold value (Maruo: Para. [0041] ‘a threshold value for the estimated blood glucose level, for example, a threshold value for determining whether the patient is in a hyperglycemic state or a hypoglycemic state (for example, 140 mg/dl or more and 70 mg/dl or less, respectively), and by having an alarm means for informing the user… when an estimated blood glucose level exceeds the threshold value and encouraging the measurement of the blood glucose level using a reference blood glucose level measuring means… to reconfirm the blood glucose level using a more accurate and reliable invasive method and make a decision on medical treatment.’).
Regarding Claim 19, Maruo discloses a non-transitory computer-readable storage medium storing an information processing program for causing a computer to execute processing, the computer being communicatively connected to a measurement device (Maruo: Para. [0001]; Para. [0020] ‘a central processing unit (CPU).’; Note: A non-transitory computer-readable storage medium would be required for a CPU to function) that sends a measured value, which is a level of blood glucose measured by blood test (Maruo: Para. [0016] ‘a reference blood glucose level measurement means 2 that invasively measures a reference blood glucose level’), together with time information indicating a measurement time point of the measured value (Maruo: Para. [0054] ‘not only the reference blood glucose level but also the subject identification signal (recognition information), measurement time, etc.…’), and a monitoring device that measures over time a monitoring value, which is a glucose level contained in interstitial fluid, sweat, or saliva, and which has a correlation with the level of blood glucose (Maruo: Para. [0019] ‘The blood glucose level estimation means 3 for non-invasively estimating the blood glucose level may be any means that estimates the blood glucose level using a signal measured noninvasively from a physiological state change that correlates with the blood glucose level.’); (Maruo: Para. [0026] ‘in the dermal tissue, capillaries are well developed and highly watersoluble biological components, particularly glucose, have high permeability within the tissue, so it is thought that the biological component concentrations, particularly glucose concentrations, change in accordance with blood glucose levels, just like interstitial fluid (ISF). Therefore, spectral measurements targeting the dermal tissue can provide spectral signals that correlate with blood glucose fluctuations.’), the processing including:
acquiring the measured value (Maruo: Para. [0016] ‘a reference blood glucose level measurement means 2 that invasively measures a reference blood glucose level’), together with time information (Maruo: Para. [0054] ‘not only the reference blood glucose level but also the subject identification signal (recognition information), measurement time, etc.…’);
acquiring the monitoring value (Maruo: Para. [0019] ‘The blood glucose level estimation means 3 for non-invasively estimating the blood glucose level may be any means that estimates the blood glucose level using a signal measured noninvasively from a physiological state change that correlates with the blood glucose level.’) at each of a plurality of time points (Maruo: Para. [0032] ‘The estimated blood glucose level after the calibration is displayed every 5 minutes as a relative fluctuation value from the calibration blood glucose level.’; [0034] and [0038]);
associating the measured value with a plurality of the monitoring values in a predetermined period, which includes at least one of a time point before or a time point after the measurement time point indicated by the time information, among the monitoring values at the plurality of time points (Maruo: Para. [0031] ‘the time delay of the estimated blood glucose level by the noninvasive technique with respect to the reference blood glucose level is set to about 5 minutes. Thereafter, the calibration means 4 automatically calibrates the estimated blood glucose level so that the reference blood glucose level matches the estimated blood glucose level, and displays it as the measured blood glucose level.’; Para. [0033] ‘Fig. 3 shows the results of continuous blood glucose level measurement using the blood glucose level monitoring device of this example’; [0034] and [0038]);
deriving a tendency of fluctuation in the monitoring value in the period on the basis of the plurality of monitoring values associated with the measured value (Maruo: Para. [0032] ‘The estimated blood glucose level after the calibration is displayed every 5 minutes as a relative fluctuation value from the calibration blood glucose level. This display may display the blood glucose level numerically, or it may be displayed as a graph over time to make it easier to grasp the blood glucose level change.’); and
estimating a tendency of fluctuation in the measured value in the period from the tendency of fluctuation in the monitoring value on the basis of correlation data in which a correlation between the measured value and the monitoring value is predetermined (Maruo: Para. [0032] ‘The estimated blood glucose level after the calibration is displayed every 5 minutes as a relative fluctuation value from the calibration blood glucose level. This display may display the blood glucose level numerically, or it may be displayed as a graph over time to make it easier to grasp the blood glucose level change.’).
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 (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.
Claim(s) 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Maruo in view of US 20120286953 A1 to Bousamra et al. (hereinafter, Bousamra).
Regarding Claim 5, Maruo discloses the information processing system according to claim 1, wherein the at least one processor is configured to: acquire timing information (Maruo: Para. [0054] ‘When transmitting information between the reference blood glucose level measuring means 2 and the blood glucose monitoring device…transmit not only the reference blood glucose level but also the subject identification signal (recognition information), measurement time, etc.…’) indicating whether the measurement time point is measured during a fasting period or a postprandial period; and
estimate the tendency of fluctuation in the measured value in the period from the tendency of fluctuation in the monitoring value, on the basis of the correlation data corresponding to the timing indicated by timing information (Maruo: Para. [0032] ‘The estimated blood glucose level after the calibration is displayed every 5 minutes as a relative fluctuation value from the calibration blood glucose level. This display may display the blood glucose level numerically, or it may be displayed as a graph over time to make it easier to grasp the blood glucose level change.’), in the correlation data corresponding to fasting and postprandial, respectively.
Indicating whether the measurement time point is fasting or postprandial and the correlation data corresponding to fasting and postprandial is absent from Maruo.
However, Bousamra teaches indicating whether the measurement time point is fasting or postprandial (Bousamra: Para. [0042] ‘the prescribed conditions are time related conditions and/or exemplarily can include eating of meals, taking a fasting sample, eating a type of meal with a requested window of time, taking a fasting sample at a requested time, sleeping a minimum amount of time, and the like.’; Para. [0086] ‘structured collection procedures 70 which can be used to help address medical questions regarding fasting blood glucose, pre-prandial glucose values, postprandial glucose values, and the like’); and
the correlation data corresponding to fasting and postprandial, respectively (Bousamra: Para. [0098] ‘showing trends in blood glucose levels ("bG Level Trending"). Therefore, an entry criterion 226 for the first structured collection procedure 70d may be for the patient to have a bG level mean which has elevated over a defined period (e.g., a past number of days, weeks, and months from the current date)’).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the processor of Maruo to be configured to indicate whether a measurement time point was during fasting or postprandial as taught by Bousamra, and to utilize that information in the calibration of glucose estimation to factor in interpretive context for the blood glucose measurements (Bousamra: Para. [0004]).
Regarding Claim 6, Maruo discloses the information processing system according to claim 1.
The processor being configured to: acquire meal information indicating a content of a meal that a person from whom the measured value is obtained eats before the measurement of the measured value and the tendency of fluctuation in the measured value in the period from the tendency of fluctuation in the monitoring value, on the basis of the correlation data corresponding to the content of the meal indicated by the meal information in a plurality of pieces of the correlation data different for each content of the meal is absent from Maruo.
However, Bousamra teaches the at least one processor is configured to: acquire meal information indicating a content of a meal that a person from whom the measured value is obtained eats before the measurement of the measured value (Bousamra: Para. [0092] ‘the patient 12 can also be requested by the processor 102 to document his meals, activity, stress, and other relevant details to ensure that the conditions that led to hypoglycemia are recorded.’); and
estimate the tendency of fluctuation in the measured value in the period from the tendency of fluctuation in the monitoring value, on the basis of the correlation data corresponding to the content of the meal indicated by the meal information, in a plurality of pieces of the correlation data different for each content of the meal (Bousamra: Para. [0098] ‘showing trends in blood glucose levels ("bG Level Trending"). Therefore, an entry criterion 226 for the first structured collection procedure 70d may be for the patient to have a bG level mean which has elevated over a defined period (e.g., a past number of days, weeks, and months from the current date)’); (Bousamra: Para. [0042] ‘the prescribed conditions are time related conditions and/or exemplarily can include eating of meals, taking a fasting sample, eating a type of meal with a requested window of time, taking a fasting sample at a requested time, sleeping a minimum amount of time, and the like.’; Para. [0086] ‘structured collection procedures 70 which can be used to help address medical questions regarding fasting blood glucose, pre-prandial glucose values, postprandial glucose values, and the like’); Fig. 10B.
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the processor of Maruo to be configured to indicate whether a measurement time point was during fasting or postprandial as taught by Bousamra, and to utilize that information in the calibration of glucose estimation to factor in interpretive context for the blood glucose measurements (Bousamra: Para. [0004]).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/SHAWN CURTIS BROUGHTON/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791