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 .
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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 13 May 2026 was filed after the mailing date of the Non-final Office Action on19 March 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment/Arguments
35 U.S.C. 101:
Applicant's arguments filed 16 June 2026 have been fully considered but they are not persuasive. Applicant argues that the newly amended claims amount to a practical application of any alleged abstract idea because the newly amended claim limitations impose a meaningful limit upon the judicial exception (see pg. 6-7 of Remarks) thus failing Step 2A Prong 2 analysis. However, the amendment to claim 1 “the management information including a usage count of the accuracy information management substance and a maximum usage count of the accuracy management substance” is merely stating what specific information is being read and is in itself part of the abstract idea. The newly amended limitation “determining whether the usage count is less than the maximum user count” is in itself an abstract idea as under its broadest reasonable interpretation can be performed in the mind exception (see MPEP 2106.04(a) III. Mental Processes). Executing the treatment in response to the result of the determining step fails to integrate the judicial step into a practical application because executing the treatment is still extremely generalized and thus amounts to mere instructions to apply the exceptions in a general way (see MPEP 2106.05(f) Mere Instructions to Apply An Exception). Lastly, the updating step is still an insignificant post solution activity that amounts to mere data gathering (see MPEP 2105.05(g)). Therefore, claim 1 is still not patent eligible. Applicant points out in their arguments the noted technical solution of automation of previously manually performed pre-adjustment and dispensing steps, however this appears to be a conventional technique in the art and it is not clear how the amended claims as written amount to a sufficient technological improvement (see MPEP 2106.05(a) Improvements to the Functioning of a Computer or To any other Technology or Technical Field). In other words, it is not clear how utilizing a usage count and maximum usage count to execute a treatment on a accuracy measurement substance improves the functioning of a computer or improves a particular technology or technological field. The claims as a whole still appear to be directed toward the abstract ideas themselves and not a particular improvement. Claim 9 remains rejected under 35 U.S.C. 101 for the same reasons given above in regards to claim 1.
35 U.S.C. 102(a)(1):
Applicant’s arguments, see pgs. 7-8 of Remarks, filed 16 June 2026, with respect to the rejection(s) of claim(s) 1-9 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 U.S.C. 103.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5 and 9-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1-5 and 10:
Step 1: Claims 1-5 are directed toward a process and thus fall within one of the four statutory categories of invention (see MPEP 2106.03 I. The Four Categories).
Step 2A Prong 1: Independent, instant claim 1 recites the limitation “reading management information regarding the accuracy management substance from an information recording medium, the management information including a usage count of the accuracy management substance and a maximum usage account of the accuracy management substance”; “selecting a treatment adapted to the read management information”; and “determining whether the usage count is less than the maximum usage count”; wherein reading, selecting, and determining, under their broadest reasonable interpretation, can be performed in the mind, falling under the mental processes grouping of abstract ideas, and thus the claim recites a judicial exception (see MPEP 2106.04(a) III. Mental Processes).
Step 2A Prong 2: The judicial exceptions of claim 1 are not integrated into a practical application because, while following the reading, selecting and determining steps, there is a step of “executing the treatment” in response to the determining step and “updating the usage count in the information recording medium according to the treatment”, these are mere instructions to apply the exceptions in a general way without any meaningful limitations that result in providing a technical solution to a technical problem as these limitations are extremely broad (see MPEP 2106.05(f) Mere Instructions to Apply An Exception). The MPEP holds that the abstract idea must be applied in a meaningful way so as to be more than a drafting effort to monopolize the exception (see MPEP 2106.05(e)) and merely using a computer to perform it is not deemed to be enough (see MPEP 2106.05(f))). Additionally, the updating of the information is seen as an insignificant post solution activity as it amounts to mere data gathering (see MPEP 2105.05(g)). Dependent claims 2-3 merely further limit the judicial exceptions themselves and claims 4-5 and 10 merely introduce additional abstract ideas and thus fail to integrate the judicial exceptions of claim 1 into a practical application. These amount to considerations that don’t seem to rise above the level of a particular practical application. These seem to be just the generic use of a computer-based system to apply the abstract ideas.
Step 2B: An accuracy management method for executing accuracy management by using an accuracy management substance in a measurement device that measures a biological specimen, the accuracy management method comprising: reading management information, including usage information, regarding the accuracy management substance from an information recording medium; selecting a treatment adapted to the read management information; executing the selected treatment; and updating the management information in the information recording medium according to the executed treatment is considered well-understood routine and conventional (WURC) in the art as evidence by primary reference JP 2015-135282. While the usage information includes a usage count and maximum usage count, determining whether the usage count is less than the maximum usage count, and updating the usage count is not taught by the primary reference, these limitations are considered conventional in the field as evidenced by JP 2010-121936. As these limitations are not unconventional steps that confine the claims to a particular useful application, they do not amount to significantly more (see MPEP 2106.05 I. A. Relevant Considerations for Evaluating Whether Additional Elements Amount to An Inventive Concept). Dependent claims 2-5 and 10 fail to provide additional steps/structure that would amount to significantly more than the judicial exception.
Thus, claims 1-5 and 10 are not considered patent eligible.
Claim 9:
Step 1: Claim 9 is directed toward a device and thus falls within one of the four statutory categories of invention (see MPEP 2106.03 I. The Four Categories).
Step 2A Prong 1: Independent, instant claim 9 recites the device performs “reading management information regarding the accuracy management substance from an information recording medium, the management information including a usage count of the accuracy management substance and a maximum usage account of the accuracy management substance”; “selecting a treatment adapted to the read management information”; and “determining whether the usage count is less than the maximum usage count”; wherein reading, selecting, and determining, under their broadest reasonable interpretation, can be performed in the mind, falling under the mental processes grouping of abstract ideas, and thus the claim recites a judicial exception (see MPEP 2106.04(a) III. Mental Processes).
Step 2A Prong 2: The judicial exceptions of claim 9 are not integrated into a practical application because, while following the reading, selecting and determining steps, there is a step of “executing the treatment” and “updating the usage count in the information recording medium according to the treatment”, these are mere instructions to apply the exceptions in a general way without any meaningful limitations that result in providing a technical solution to a technical problem as these limitations are extremely broad (see MPEP 2106.05(f) Mere Instructions to Apply An Exception). The MPEP holds that the abstract idea must be applied in a meaningful way so as to be more than a drafting effort to monopolize the exception (see MPEP 2106.05(e)) and merely using a computer to perform it is not deemed to be enough (see MPEP 2106.05(f))). Additionally, the updating of the information is seen as an insignificant post solution activity as it amounts to mere data gathering (see MPEP 2105.05(g)). While Claim 9 indicates that these method steps are carried out using a holding tool of the device, its involvement is an extra-solution activity, because the holder contributes only nominally or insignificantly to the execution of the claimed method (i.e., in a data gathering step) and therefore does not integrate a judicial exception into a practical application or provide significantly more (see MPEP 2106.05(b) Particular Machine).
Step 2B: A measurement device that measures a biological specimen and executes an accuracy management method for executing accuracy management by using an accuracy management substance in the measurement device, the accuracy management method comprising: reading management information, including usage status, regarding the accuracy management substance from an information recording medium; selecting a treatment adapted to the read management information; executing the selected treatment; and updating the management information in the information recording medium according to the executed treatment, by using a holding tool comprising: a container that accommodates the accuracy management substance used for the accuracy management; a holder that accommodates the container; and the information recording medium in which the management information regarding the accuracy management substance is recorded, wherein: the information recording medium is provided at one of the holder or the container, the management information includes variable information of the accuracy management substance, and the variable information is updated according to the treatment executed on the accuracy management substance. is considered well-understood routine and conventional (WURC) in the art as evidence by primary reference JP 2015-135282. While the usage information includes a usage count and maximum usage count, determining whether the usage count is less than the maximum usage count, and updating the usage count is not taught by the primary reference, these limitations are considered conventional in the field as evidenced by JP 2010-121936. As these limitations are not unconventional steps that confine the claims to a particular useful application, they do not amount to significantly more (see MPEP 2106.05 I. A. Relevant Considerations for Evaluating Whether Additional Elements Amount to An Inventive Concept).
Therefore, claim 9 is not patent eligible.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2015-135282 to Hoshi et al. (herein Hoshi) as cited on the 2/23/2024 IDS (see machine translation provided) in view of JP 2010-121936 to Kawamura (see machine translation provided).
Regarding claim 1, Hoshi discloses an automated analyzer for performing accuracy control on analysis of samples, such as blood or urine, using quality control samples (see [0001, 0011-0012]) (i.e., “an accuracy management method for executing accuracy management by using an accuracy management substance in a measurement device that measures a biological specimen”), the method comprising: reading identification information (i.e., management information) regarding the quality control samples (i.e., accuracy management substance) from RF tags based on RFID (i.e., information recording medium) (see [0017-0019]); performing preparation processing, transferring, reacting with a reagent, and measurement of the accuracy measurement substance to be analyzed (see [0025-0028]) (i.e., “selecting a treatment adapted to the read management information”); adding a pretreatment solution to the accuracy management substance (see [0025]) (i.e., “executing the selected treatment”); and updating the management information recording medium according to the executed treatment (see [0019]). Hoshi discloses wherein the management information includes a usage status of the accuracy measurement substance (see [0058]) and determining whether reagents have been used up (i.e., reached a maximum number of usages).
Hoshi fails to disclose “the management information including a usage count of the accuracy measurement substance and a maximum usage count of the accuracy measurement substance … determining whether the usage count is less than the maximum usage count; and updating the usage count” as recited in the instant claim.
Kawamura discloses a CPU that reduces the remaining number of measurements possible for a quality control sample taken into a measurement unit and stores it on a hard disk (i.e., updating the usage count), wherein a pre-stored number of measurements for the quality control sample is on the hard disk (i.e., a maximum usage count); and repeating this step until all measurements have been performed (see (see [0071-0073]), wherein the measurement unit comprises a sample preparation unit (see [0038-0040]).
Kawamura and Hoshi are analogous in the art of automated sample processing systems utilizing quality control samples. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Hoshi to comprise “the management information including a usage count of the accuracy measurement substance and a maximum usage count of the accuracy measurement substance … determining whether the usage count is less than the maximum usage count; and updating the usage count” in view of Kawamura for the benefit of knowing the number of measurements left to be performed on a quality control sample (see [0071-0073]; Fig. 9 of Kawamura).
Regarding claim 2, the combination of references above renders obvious the invention of claim 1, and Hoshi discloses the pretreatment solution is a dissolving solution added to the accuracy measurement substance (see [0025]) based on the preparation protocol (see [0023-0025]), which reads on “the management information includes a dissolving state of the accuracy management substance, and the treatment is selected based on the dissolving state” as recited in the instant claim.
Regarding claim 3, the combination above renders obvious the invention of claim 1, and Hoshi discloses a dissolving solution is added to the accuracy measurement substance that has been stored in a lyophilized state using a storage unit (i.e., container) to create a dissolved sample (see [0025]); transferring the accuracy measurement substance in the dissolved state to an analysis unit (see [0025]); diluting the dissolved accuracy measurement substance with a reagent (i.e., dilutant) to create a third state of the accuracy measurement substance in the measurement device (see [0028]); and performing analysis (i.e., measurement treatment) on the accuracy measurement substance in the third state (see [0028]).
Regarding claim 10, the combination of references above render obvious the invention of claim 3, and Hoshi discloses the sample preparation unit performs preparation processing to prepare a sample for analysis based on a predetermined protocol, wherein the preparation process includes adding a pretreatment solution that may be a dissolving agent or something else (i.e., “wherein the management information includes a dissolving state of the accuracy management substance, the dissolving state indicating whether the accuracy management substance is dissolved or undissolved, and selecting treatment includes selecting the dissolving treatment based on the dissolving state indicating the accuracy measurement management substance is un dissolved”) (see [0025]). In other words, the automated system would have to know the dissolving state of the sample to accurately provide the appropriate pretreatment solution and would provide the dissolving agent only for an undissolved accuracy measurement substance. Hoshi discloses once the sample has undergone the preparation processing (i.e., an undissolved sample has been dissolved) transporting said sample to an analysis unit for use (see [0025]).
Regarding claim 4, the combination of references above render obvious the invention of claim 3, and Hoshi discloses determining an expiration date included in the management information, wherein the selecting is stopped in a case in which it is determined the expiration date has passed (i.e., usage count) has been reached (see [0023-0025, 0047, 0052-0053, 0058]).
Regarding claim 5, the combination of references above render obvious the invention of claim 4, and Hoshi discloses an expiration date (i.e., second expiration date) of the accuracy management substance that has been submitted for processing, which includes the second state, and a separate expiration notification (i.e., first expiration date) when a stored sample is two weeks from their second expiration date.
Regarding claim 6, Hoshi discloses a sample rack loading section 1 (i.e., a holding tool) comprising: sample containers 17 that accommodates quality control substances (i.e., accuracy measurement substances) used for quality control (i.e., accuracy management) of an automatic analyzer (i.e., measurement device) that measures a biological specimen; sample racks 18 (i.e., a holder) that accommodates the containers; and barcodes and/or RF tags (i.e., information recording medium) in which management information regarding the accuracy management substances is recorded, wherein the information recording medium is provided by the holders and/or the containers, the management information includes variable information of the accuracy management substances; and the variable information is updated according information regarding preparation processing (i.e., treatment) executed on the accuracy measurement substances by the measurement device (see [0015-0019]; Fig. 1). Hoshi discloses wherein the management information includes a usage status of the accuracy measurement substance (see [0058]) and determining whether reagents have been used up (i.e., reached a maximum number of usages).
Hoshi fails to disclose “the management information includes a usage count of the accuracy measurement substance and a maximum usage count of the accuracy measurement substance for the measurement device to determine whether the usage count is less than the maximum usage count and update the usage count” as recited in the instant claim.
Kawamura discloses a CPU that reduces the remaining number of measurements possible for a quality control sample taken into a measurement unit and stores it on a hard disk (i.e., updating the usage count), wherein a pre-stored number of measurements for the quality control sample is on the hard disk (i.e., a maximum usage count); and repeating this step until all measurements have been performed (see (see [0071-0073]), wherein the measurement unit comprises a sample preparation unit (see [0038-0040]).
Kawamura and Hoshi are analogous in the art of automated sample processing systems utilizing quality control samples. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Hoshi to comprise the management information includes a usage count of the accuracy measurement substance and a maximum usage count of the accuracy measurement substance for the measurement device to determine whether the usage count is less than the maximum usage count and update the usage count in view of Kawamura for the benefit of knowing the number of measurements left to be performed on a quality control sample (see [0071-0073]; Fig. 9 of Kawamura).
Regarding claim 7, the combination of references above render obvious the invention of claim 6, and Hoshi discloses the information recording medium includes barcodes (i.e., fixed recording section) and RF tags 17a, 8a (i.e., variable recording section), and the variable information includes generated information and information changed during a processing step (i.e., treatment) executed on the accuracy measurement substances by the measurement device (see [0018-0019]; Fig. 1). Hoshi in view of Kawamura renders obvious the fixed recording section recording maximum usage count.
Regarding claim 8, the combination of references above render obvious the invention of claim 7, and Hoshi discloses the variable information includes a dissolving state (see [0025]).
Regarding claim 9, Hoshi discloses an automatic analyzer (i.e., measurement device) that measures a biological sample and executes a quality control method (i.e., accuracy management method) for executing quality control (i.e., accuracy management) by using quality control samples (i.e., accuracy measurement substances) in the measurement device, the accuracy management method comprising: reading management information regarding the accuracy measurement samples from barcodes and/or RF tags 17a, 18a; ]); performing preparation processing, transferring, reacting with a reagent, and measurement of the accuracy measurement substances to be analyzed (i.e., “selecting a treatment adapted to the read management information”); adding a pretreatment solution to the accuracy management substance (i.e., “executing the selected treatment”); and updating the management information recording medium according to the executed treatment, by using a sample rack loading section 1 (i.e., a holding tool) comprising: sample containers 17 that accommodates quality control substances (i.e., accuracy measurement substances) used for quality control (i.e., accuracy management) of an automatic analyzer (i.e., measurement device) that measures a biological specimen; sample racks 18 (i.e., a holder) that accommodates the containers; and barcodes and/or RF tags (i.e., information recording medium) in which management information regarding the accuracy management substances is recorded, wherein the information recording medium is provided by the holders and/or the containers, the management information includes variable information of the accuracy management substances; and the variable information is updated according information regarding preparation processing (i.e., treatment) executed on the accuracy measurement substances by the measurement device (see [0015-0028]; Fig. 1). Hoshi discloses wherein the management information includes a usage status of the accuracy measurement substance (see [0058]) and determining whether reagents have been used up (i.e., reached a maximum number of usages).
Hoshi fails to disclose “the management information including a usage count of the accuracy measurement substance and a maximum usage count of the accuracy measurement substance … determining whether the usage count is less than the maximum usage count; and updating the usage count” as recited in the instant claim.
Kawamura discloses a CPU that reduces the remaining number of measurements possible for a quality control sample taken into a measurement unit and stores it on a hard disk (i.e., updating the usage count), wherein a pre-stored number of measurements for the quality control sample is on the hard disk (i.e., a maximum usage count); and repeating this step until all measurements have been performed (see (see [0071-0073]), wherein the measurement unit comprises a sample preparation unit (see [0038-0040]).
Kawamura and Hoshi are analogous in the art of automated sample processing systems utilizing quality control samples. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Hoshi to comprise “the management information including a usage count of the accuracy measurement substance and a maximum usage count of the accuracy measurement substance … determining whether the usage count is less than the maximum usage count; and updating the usage count” in view of Kawamura for the benefit of knowing the number of measurements left to be performed on a quality control sample (see [0071-0073]; Fig. 9 of Kawamura).
Conclusion
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 KATHRYN E LIMBAUGH whose telephone number is (571)272-0787. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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/KATHRYN ELIZABETH LIMBAUGH/Primary Examiner, Art Unit 1797
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