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 and 9 are pending.
Claims 1 and 9 are rejected.
Claims 2-8 and 10-18 are canceled.
Claims 1 and 9 are independent.
No claims are new or withdrawn.
Office Action Outline
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
112 Other
IDS
Information Disclosure Statement
102, 103
JE
Judicial Exception
X
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed in the 02/25/2025 filing receipt, the instant application is a 371 of PCT application PCT/JP2020/010253 filed 03/10/2020. The instant application claims the benefit of priority to foreign application JP2019-058958 filed 03/26/2019.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. (See paper entered 09/07/2021.) The pending claims are being examined with an effective filing date of 03/26/2019.
Overview of Withdrawal/Revision of Objections/Rejections
In view of the amendment and remarks received 10/14/2025:
• The 112(b) rejection is withdrawn. A new 112(b) rejection is asserted below.
• The 101 rejection is maintained with revision.
• The 103 rejection is withdrawn for the following reasons: The claims are free of the analogous art at least because close art, e.g., Yamaguchi (US 2008/0114559 A1, published 15 May 2008; cited on the 07/15/2025 form PTO-892) and Ashida (US2019/0303361 A1, published 03 October 2019; priority to JP2018-066070, filed 29 March 2018; cited on the 07/15/2025 form PTO-892), either individually or in obvious combination, do not teach the recited combination of "... single deviation determination line information specific to the automatic analyzer, and displaying the integrated regression line information, the integrated deviation determination line information, the single regression line information and the single deviation determination line information of the automatic analyzer on display screens of the first computers in an overlapping manner..." and "wherein the second computer executes a process of determining whether to transmit the integrated regression line information and the generated deviation determination line information to the automatic analyzers connected to the first computers, based on whether an automatic analyzer associated with the information on the automatic analyzers is present among the automatic analyzers connected to the first computers and whether a reagent lot associated with the information on the reagent is used in the automatic analyzers connected to the first computers, and a process of transmitting the integrated regression line information and the integrated deviation determination line information to the first computers when the second computer determines that the integrated regression line information and the integrated deviation determination line information is to be transmitted..." Additionally, Applicant's 10/14/2025 remarks at pp.14-19 supported the withdrawal of the 103 rejection.
Claim Interpretation
The first line of the last element of both claim 1 and claim 9 recites the term "reinspection", which is interpreted as reading on at least re-analyzing the sample. See "inspection" at Specification [0002], [0004], [0007], etc., and see "reinspection" at Specification [0007], [0044], [0072].
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 and 9 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.
In the last element of claim 1 (and claim 9), the connection is unclear between:
• "when the reaction process data deviate…" (from both deviation determination lines),
• "a determination index …is added," and
• "when the reaction process data deviate" (from the integrated deviation determination line only).
The last element of claim 1 (and claim 9) recites: "wherein a reinspection is performed for a reaction process in any one of the automatic analyzers, when the reaction process data deviate from the integrated deviation determination line information and from the single deviation determination line information of the automatic analyzer, and a determination index for checking the reaction process in detail is added to the reaction process data, when the reaction process data deviate from the integrated deviation determination line information but not from the single deviation determination line information of the automatic analyzer" (emphasis added by Examiner).
Specifically, it is unclear if "a determination index for checking the reaction process in detail is added" occurs when the reaction process data deviate from both the determine line information, or if a determination index is added when the reaction process data deviate from the integrated deviation determination line information but not from the single deviation determination line information of the automatic analyzer.
Overall, it is unclear if a reinspection is performed both when the reaction process data deviate from both determination line information, and is also performed when the reaction process data deviate from the integrated deviation determination line information but not from the single deviation determination line information.
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 and 9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more.
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(a)). Note, the MPEP at 2106.04(a)(2) & 2106.04(b) further explains that abstract ideas and laws of nature are defined as:
• mathematical concepts, (mathematical formulas or equations, mathematical
relationships and mathematical calculations);
• certain methods of organizing human activity (fundamental economic practices
or principles, managing personal behavior or relationships or interactions between
people); and/or
• mental processes (procedures for observing, evaluating, analyzing/ judging and
organizing information).
• laws of nature and natural phenomena are naturally occurring principles/ relations that
are naturally occurring or that do not have markedly different characteristics compared to
what occurs in nature.
• 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)
Step 1 Analysis:
Claim 1 is directed to a 101 process, here a method; claim 9 is directed to a 101 machine, here a system; as such, claims 1 and 9 are directed to a related method and system, which fall under categories of statutory subject matter. (See MPEP § 2106.03). (Step 1: Yes.)
Step 2A, Prong One Analysis:
The claims recite judicial exceptions (JEs) of mathematical concepts and mental processes as follows:
Claim 1 recites a method for performing the abstract ideas of mental processes and mathematical concepts for: analyzing measurement data and generating results of the analysis; generating integrated regression line information and integrated deviation determination line information; determining whether to transmit the integrated regression line information and the generated deviation determination line information; and adding a determination index.
Claim 9 recites a system for performing the abstract ideas as recited in claim 1.
Step 2A Prong One Summary: Claims 1 and 9 recite judicial exceptions of abstract ideas (characterized as mental processes and mathematical concepts). Considering the broadest reasonable interpretation (BRI) of the claims, the mental processes recited in independent claim 1 and 9 (e.g., analyzing measurement data, generating results of the analysis, etc.) are directed to processes that may be performed in the human mind, or with pen and paper, because there are no limitations recited which would prevent the analysis and generating of results mentally. Additionally, at least the limitations for generating integrated regression line information and generating integrated deviation determination line information inherently recite mathematical concepts such as those disclosed in Specification [0056-0063], and figs.10-11. 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 analysis:
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 example considerations for evaluating whether 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); and
(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, inputting, and outputting steps: Claims 1 and 9 recite the additional elements of acquiring data; obtaining data (and re-obtaining data) by sample reaction with a reagent in an automatic analyzer; transmitting data; and displaying data. 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 and automatic analyzers: Claims 1 and 9 recite additional elements of computers and automatic analyzers. The claims require only generic computers and analyzers, 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. (Step 2A, Prong Two: No).
Step 2B analysis:
Because the additional claim elements do not integrate the judicial exceptions (i.e., the abstract ideas) 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 data gathering, inputting, and outputting steps: The additional elements of acquiring data, obtaining data (and re-obtaining data) by sample reaction with a reagent in an automatic analyzer, transmitting data, and displaying data (outputting data) of claims 1 and 9 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; storing and retrieving information in memory; performing repetitive calculations; determining the level of a biomarker in blood by any means; detecting enzymes in a sample; etc.[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 extra-solution activity. Therefore the additional elements of data gathering and outputting do not provide an inventive concept needed to amount to significantly more than the judicial exception.
Additional elements of computers and automatic analyzers: The additional elements of computers and automatic analyzers of claims 1 and 9 do not cause the claims to rise to the level of significantly more than the judicial exception; these are conventional computer and automatic analyzers, and therefore, the additional elements of computers and automatic analyzers 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 claim 1 and 9, which recite conventional computers.
• 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 the instant claims, the recited computers and automatic analyzers are used in obtaining and analyzing data; as such, the computers and automatic analyzers act only as tools to perform the steps of data analysis and data obtaining, 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 computers and automatic analyzers of claims 1 and 9 used in data analysis and obtaining data 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 acquiring, obtaining, and transmitting of data in claims 1 and 9 is recited in a generic manner.
Step 2B Summary: All limitations of claims 1 and 9 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, claims 1 and 9, 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's Arguments – 35 U.S.C. 101
Applicant's arguments filed 10/14/2025 regarding the 101 rejection (p.8-14) have been fully considered but they are not yet persuasive.
Regarding Step 2A Prong Two arguments:
Applicant asserts (p.8-12):
• " …claim 1…sets forth a technique for maintaining the accuracy and reliability of automatic analyzers by improving the accuracy of determining a deviation of measurement data from a regression line in an automatic analysis system" (p.8, para. 3).
• "The improvement is a technical solution to a technical problem, as explained
in the specification" (p.9, para. 2).
• "The present disclosure…provides a technique for improving the accuracy of determining a deviation of measurement data from a regression line in an automatic analysis system" (p.10, para. 3).
• " The improvement is also recited in the claims" (p.10, para. 4).
• "The improvement set forth in claim 1 is not to the alleged abstract idea itself (p.11, para. 3).
• "…claim 1 is not directed to an abstract idea…claim 1 includes additional elements that integrate the alleged abstract idea into a practical application…demonstrated by a particular technique for maintaining the accuracy and reliability of automatic analyzers by improving the accuracy of determining a deviation of measurement data from a regression line in an automatic analysis system" (bridging p.11-12).
The above arguments regarding an improvement at Step 2A Prong Two are not yet persuasive because it is not clear that the claims must deliver an improvement to technology.
Regarding the improvement by an improvement to accuracy: A mere assertion of improvement without the detail necessary to be apparent to a person of ordinary skill in the art is not sufficient to show an improvement to technology at Step 2A Prong Two.
To possibly show 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), regarding the first consideration, showing an improvement to technology, at Step 2A Prong Two of the 101 analysis, 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.
Applicant may find it helpful to request an interview for clarification and discussion of this issue and others in this action. The examiner's contact information and instructions on how to submit an Automated Interview Request (AIR) appear below in the conclusion of this action.
Regarding Step 2B arguments:
Applicant asserts (p.12-14):
• "Even assuming, arguendo, that claim 1 is directed to the alleged abstract idea, claim 1 recites meaningful unconventional elements that amount to significantly more than the alleged abstract idea" (p.12, para. 2).
• "…an inventive concept can be found in the non-conventional and non-generic arrangement of the features of the claims…Similar to…BASCOM, Applicant's claim 1 includes additional elements that are sufficient to ensure that the claims amount to significantly more than an abstract idea" (bridging p.12-13).
• "…elements are significant, at least because the claim includes a specific technique for maintaining the accuracy and reliability of automatic analyzers by improving the accuracy of determining a deviation of measurement data from a regression line…" (bridging p.13-14).
• "…claim 1...includes a non-conventional and non-generic arrangement… not directed to routine, conventional, or well-known activities…the claim includes additional elements that singly and as an ordered combination amount to significantly more than the mere abstract idea..." (p.14, para. 1).
The arguments regarding Step 2B are not persuasive because there is not significantly more shown at Step 2B, in that the additional elements of data gathering, data displaying, and generic computer components and analyzers are well-understood, routine, conventional, even when the claim is considered as a whole. At least the steps for analyzing measurement data, generating integrated regression line information, and generating integrated deviation determination line information represent abstract ideas, identified at Step 2A Prong One. The additional elements, individually and in combination, do not amount to significantly more than the judicial exception itself, even when considering the claim as a while, and do not provide an inventive concept.
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.
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/M.A.V./Examiner, Art Unit 1687
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686