DETAILED ACTION
The following is a Final Office action. In response to Examiner’s communication of 1/6/26, Applicant, on 4/28/26, amended claims 1 and 9. Claims 1, 2, 4-10, 12-15 are now pending and have been rejected as indicated below.
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 Amendments
Applicant’s amendments are acknowledged.
The 35 USC 101 rejection of claims 1, 2, 4-10, 12-15 in regard to abstract ideas has been maintained in light of Applicant’s amendments and explanations.
The 35 USC 103 rejection of claims 1, 2, 4-10, 12-15 has been withdrawn in light of Applicant’s amendments and explanations.
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, 2, 4-10, and 12-15 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. Here, under considerations of the broadest reasonable interpretation of the claimed invention, Examiner finds that the Applicant invented a method and system for presenting alarms to laboratory technicians and tracking the technicians’ response to the alarm. Examiner formulates an abstract idea analysis, following the framework described in the MPEP as follows:
Step 1: The claims are directed to a statutory category, namely a "method" (claims 9, 10, and 12-15) and "system" (claims 1, 2, and 4-8).
Step 2A - Prong 1: The claims are found to recite limitations that set forth the abstract idea(s), namely, regarding claim 1:
a person-in-charge schedule management table that registers, for each of the laboratory technicians working in the clinical laboratory, a task currently being performed and a task difficulty, and an alarm handling stop position management table that registers information on a stop position where the laboratory technician who handles the alarm stops prior to a device that generates the alarm in order to handle the alarm generated from the plurality of analyzers or the management device;
…
determine a numerical schedule score, for each of the laboratory technicians, based on the a task currently being performed and a task difficulty of the laboratory technicians from the person-in-charge schedule management table,
determine a numerical position information score, for each of the laboratory technicians, based on a distance from the current position of the laboratory technicians, which is acquired via the communication interface, from the position information device, and the alarm handling stop position indicating a position where the laboratory technician who handles the generated alarm stops prior to the device that generated the generated alarm, which is identified from the alarm information management table,
determine a numerical priority score, for each of the laboratory technicians, based on the schedule score and the position information score and sort the determined priority scores for each of the laboratory technicians, and
notify the terminal of a laboratory technician, among the laboratory technicians having the highest priority score
Independent claim 9 recites substantially similar claim language.
Dependent claims 2, 4-8, 10, and 12-15 recite the same or similar abstract idea(s) as independent claims 1, and 18 with merely a further narrowing of the abstract idea(s) to particular data characterization and/or additional data analyses performed as part of the abstract idea.
The limitations in claims 1, 2, 4-10, and 12-15 above falling well-within the groupings of subject matter identified by the courts as being abstract concepts, specifically the claims are found to correspond to the category of:
"Certain methods of organizing human activity- fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions)" as the limitations identified above are directed to presenting alarms to laboratory technicians and tracking the technicians’ response to the alarm and thus is a method of organizing human activity including at least commercial or business interactions or relations and/or a management of user personal behavior; and/or
"Mental processes - concepts performed in the human mind (including an observation, evaluation, judgement, opinion)" as the limitations identified above include mere data observations, evaluations, judgements, and/or opinions, e.g. including presenting alarms to laboratory technicians and tracking the technicians’ response to the alarm, which is capable of being performed mentally and/or using pen and paper.
Step 2A - Prong 2: Claims 1, 2, 4-10, and 12-15 are found to clearly be directed to the abstract idea identified above because the claims, as a whole, fail to integrate the claimed judicial exception into a practical application, specifically the claims recite the additional elements of:
“a communication interface that is communicatively coupled to the plurality of analysis devices, the plurality of terminals, and the position information acquisition device (claims 1 and 9); " the terminal of the laboratory technician as a person-in-charge who handles the generated alarm receive an input of a comment on handling the generated alarm" (claims 5) however the aforementioned elements directed to the receiving of user input/selection of data to view via a terminal and displaying corresponding data via the terminal merely amount to generic GUI elements of a general purpose computer used to "apply" the abstract idea (MPEP 2106.05(f)) and/or is merely an attempt at limiting the abstract idea of presenting alarms to laboratory technicians and tracking the technicians’ response to the alarm to a particular field of use/technological environment of a GUI dashboard (MPEP 2106.05(h)) and therefore the GUI dashboard input and display of data fails to integrate the abstract idea into a practical application;
" An automatic analysis system comprising: a plurality of analyzers disposed in a clinical laboratory to analyze or pre-process a sample; a plurality of terminals, each of which is held by a respective laboratory technician among a plurality of laboratory technicians working in the clinical laboratory, a position information acquisition device configured to acquire position information of the laboratory technicians, and a management device configured to manage the plurality of analyzers, wherein the management device includes: a storage device configured to… an information processing device coupled to the communication interface and the storage device, configured to," (claims 1 and 9) however the aforementioned elements merely amount to generic components of a general purpose computer used to "apply" the abstract idea (MPEP 2106.0S(f)) and thus fails to integrate the recited abstract idea into a practical application, furthermore the high-level recitation of receiving data from a generic "analysis system" is at most an attempt to limit the abstract to a particular field of use (MPEP 2106.0S(h), e.g.: "For instance, a data gathering step that is limited to a particular data source (such as the Internet) or a particular type of data (such as power grid data or XML tags) could be considered to be both insignificant extra-solution activity and a field of use limitation. See, e.g., Ultramercial, 772 F.3d at 716, 112 USPQ2d at 1755 (limiting use of abstract idea to the Internet); Electric Power, 830 F.3d at 1354, 119 USPQ2d at 1742 (limiting application of abstract idea to power grid data); Intellectual Ventures I LLC v. Erie lndem. Co., 850 F.3d 1315, 1328-29, 121 USPQ2d 1928, 1939 (Fed. Cir. 2017) (limiting use of abstract idea to use with XML tags).") and/or merely insignificant extra-solution activity (MPE 2106.05(g)) and thus further fails to integrate the abstract idea into a practical application;
Step 2B: Claims 1, 2, 4-10, and 12-15 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements as described above with respect to Step 2A Prong 2 merely amount to a general purpose computer that attempts to apply the abstract idea in a technological environment (MPEP 2106.0S(f)), including merely limiting the abstract idea to a particular field of use of presenting alarms to laboratory technicians and tracking the technicians’ response to the alarm using a "analysis system" via a GUI "terminal", as explained above, and/or performs insignificant extra-solution activity, e.g. data gathering or output, (MPEP 2106.0S(g)), as identified above, which is further found under step 2B to be merely well-understood, routine, and conventional activities as evidenced by MPEP 2106.0S(d)(II) (describing conventional activities that include transmitting and receiving data over a network, electronic recordkeeping, storing and retrieving information from memory, electronically scanning or extracting data from a physical document, and a web browser's back and forward button functionality). Therefore, similarly the combination and arrangement of the above identified additional elements when analyzed under Step 2B also fails to necessitate a conclusion that the claims amount to significantly more than the abstract idea directed to presenting alarms to laboratory technicians and tracking the technicians’ response to the alarm.
Claims 1, 2, 4-10, and 12-15 are accordingly rejected under 35 USC§ 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea(s)) without significantly more.
Note: The analysis above applies to all statutory categories of invention. As such, the presentment of any claim otherwise styled as a machine or manufacture, for example, would be subject to the same analysis
For further authority and guidance, see:
MPEP § 2106
https://www.uspto.gov/patents/laws/examination-policy/subject-matter-eligibility
Subject Matter Overcoming Prior Art
Claims 1, 2, 4-10, and 12-15 are found to be provisionally allowable. The claims would be found to be allowable if they overcame the 35 USC 101 rejection.
Reasons for Overcoming the Prior Art
It appears that the instant invention is beyond the skill of one of ordinary skill in the art. Accordingly the invention would NOT have been obvious because one of ordinary skill could not have been expected to achieve it, NOR would they have been able to predict the results, and as such, they would have had no capability of expecting success.
The following is an examiner's statement of features not found in the prior art of record:
Claims 1, 2, 4-10, and 12-15 overcome the prior art of record and are found to be provisionally allowable. The following limitations of claim 1,
…
a storage device configured to store an alarm information management table, a person-in-charge schedule management table that registers, for each of the laboratory technicianstask difficulty, and an alarm handling stop position management table that registers information on a stop position where the laboratory technician who handles the alarm stops prior to a device that generates the alarm in order to handle the alarm generated from the plurality of analyzers or the management device;
a communication interface that is communicatively coupled to the plurality of analysis devices, the plurality of terminals, and the position information acquisition device, and
an information processing device, coupled to the communication interface and the storage device, configured to:
detect a generation of an alarm from any of the plurality of analyzers via the communication interface,
store, in the alarm information management table, the generated alarm,
determine a numerical schedule score, for each of the laboratory technicians, based on the a task currently being performed and a task difficulty of the laboratory technicians from the person-in-charge schedule management table,
determine a numerical position information score, for each of the laboratory technicians, based on a distance from the current position of the laboratory technicians, which is acquired via the communication interface, from the position information device, and the alarm handling stop position indicating a position where the laboratory technician who handles the generated alarm stops prior to the device that generated the generated alarm, which is identified from the alarm information management table,
determine a numerical priority score, for each of the laboratory technicians, based on the schedule score and the position information score and sort the determined priority scores for each of the laboratory technicians, and
notify the terminal of a laboratory technician, among the laboratory technicians having the highest priority score
in combination with the remainder of the claim limitations are neither taught nor suggested, singularly or in combination, by the prior art of record. Furthermore, neither the prior art, the nature of the problem, nor knowledge of a person having ordinary skill in the art provides for any predictable or reasonable rationale to combine prior art teachings. Independent claim 9, and dependent claims 2, 4-8, 10, and 12-15 are likewise provisionally allowable.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
The closest prior art of record is described as follows:
Sasaki et al. (U.S. Patent Application Publication Number 2013/0061693) - The abstract provides for the following: A sample test automation system which is capable of reducing the workload of an operator and precisely carrying out necessary processes of each of samples without stagnation. In the sample test automation system, a sample tray 120 on which a plurality of samples 150 can be installed is prepared, an identifier for distinguishing the sample tray 120 is attached to the sample tray 120, a sample introducing unit 10 is provided with an identifier reading apparatus 111 which reads the identifier of the sample tray 120, and information about the samples 150 is switched based on the read identifier of the sample tray 120.
Bassham et al. (U.S. Patent Application Publication Number 2017/0161443) - The abstract provides for the following: A hospital operations system is provided which centralizes, processes, prioritizes, and presents vast data generated by hospital systems and software applications and partially controls devices, alerts, and overall patient care within hospital systems for greater efficiency and provision of improved patient care, patient safety, and hospital efficiency beyond what currently exists. The hospital operations system capabilities are enabled via dedicated workstation computing devices located in a single location with a video wall for displaying important information from all workstation computing devices. The hospital operations system includes a software product for centralizing decentralized hospital systems by providing instructions allowing software applications on the hospital systems to communicate with a user interface and with each other. The hospital operations capabilities include, without limitation, management and/or monitoring of: patient flow from admission to discharge; hospital network, equipment and software performance; patient physiological data; hospital resources; provision of an infrastructure for telemedicine; near misses and adverse events; situational awareness of hospital-wide data; coordination of emergency crisis responses; and an interface between operations and a hospital simulation center.
Eryurek et al. (U.S. Patent Application Publication Number 2005/0007249) - The abstract provides for the following: Operational status information associated with a process entity in a process plant is received. The operational status information is mapped into one of a plurality of status conditions. Then, an alert message associated with the process entity is generated, where the alert message is indicative of the one status condition of the plurality of status conditions.
Mihai et al. (U.S. Patent Application Publication Number 2004/0167465) - The abstract provides for the following: A method and system for medical device authentication is disclosed. The system may include a plurality of digital assistants and a plurality of medical devices (e.g., infusion pumps) communicating over a wired or wireless network. Because some of the data being transmitted is confidential medical data, the data is preferably encrypted and only communicated in the clear to authorized users and devices. In order to setup a new digital assistant or medical device, a commissioning phase of the authentication process may be performed. Each time a commissioned device is powered up, an authentication process is preferably performed in order to verify communication is occurring with an authorized device and/or user. Once a device and/or user is authenticated, secure one-way and/or two-way communication may occur in order to pass parameters, instructions, data, alarms, status information, and any other type of information between digital assistants, medical devices, and/or servers.
N. Shklovskiy-Kordi et al. “Multimedia case history as a tool for management of patients and clinical trials.” The abstract provides for the following: Monitoring diagnostic procedures, treatment protocols and clinical outcome are key issues in maintaining quality medical care and in evaluating clinical trials. For these purposes, a user-friendly computerized method for monitoring medical events is required. We describe a computerized data collection system for verification, analysis and storage of clinical information on an individual patient. Data was integrated on a single time axis with normalized graphics. Laboratory data was set according to standard protocols selected by the user and diagnostic images were integrated as needed The system automatically detects variables that fall outside established limits and violations of protocols, and generates 'alarm signals' or 'blocking inquiries' (demanding an obligatory user's reaction). Simultaneously, the alarm and an advice on the incident are directed to a defined set of e-mail addresses. The system provided an effective tool for detection of medical errors, administration of inappropriate medications and non-observance of their compatibility, identification of discrepancies between therapeutic and diagnostic procedures, and protocol requirements. This system reduced the incidence of medical errors and provided an accurate method for monitoring the standard-of-care.
ITAMI TAKASHI (JP Patent Application Publication Number JP 2014-194401 A) - The abstract provides for the following: A sample analyzer management system, a sample analyzer management device, and a computer program that enable efficient and appropriate maintenance of a sample analyzer according to the work and skill of a person in charge of the sample analyzer provide. When an abnormality occurs in the sample analyzer 11, abnormality related information is transmitted from the sample analyzer 11 to the management server 31. The management server 31 transmits contact necessity inquiry information to the person in charge of the person in charge of the sample analyzer 11 when it is necessary to inquire about the necessity of contact. The person in charge inputs an answer to the portable information terminal 41 regarding whether or not to contact, and the answer information is transmitted to the management server 31. The management server 31 causes the management client 32 to display a screen corresponding to the answer information.
Response to Arguments
Applicant’s arguments filed 4/28/2026 have been fully considered but they are not fully persuasive.
Applicant argues that the claims are eligible under 35 USC 101. (See Applicant’s Remarks, 4/28/2026, pgs. 12-16). Examiner respectfully disagrees. As noted in the 35 USC 101 analysis presented above, the claims recite an abstract concept that is encapsulated by decision making analogous to a method of organizing human activity. Examiner notes that each of the limitations that encapsulate the abstract concepts are recited in the above 35 USC 101. Additionally, the claims do not recite a practical application of the abstract concepts in that there is no specific use or application of the method steps other than to make conclusory determinations and provide for direction for either a person or machine to follow at some future time. The claims do not recite any particular use for these determinations and directions that improve upon the underlying computer technology (in this instance the computer software, processor, and memory). Instead, Examiner asserts that the additional elements in the claim language are only used as implementation of the abstract concepts utilizing technology. The concepts described in the limitations when taken both as a whole and individually are not meaningfully different than those found by the courts to be abstract ideas and are similarly considered to be certain methods of organizing human activity such as managing personal behavior or relationships or interactions between people, including social activities, teaching, and following rules or instructions. The steps are then encapsulated into a particular technological environment by executing these steps upon a computer processor and utilizing features such as a computer interface or sending and receiving data over a network or displaying information via a computerized graphical user interface. However, sending and receiving of information over a network and execution of algorithms on a computer are utilized only to facilitate the abstract concepts (i.e. selecting data on an interface, publishing/displaying information, etc.). As such, Examiner asserts that the implementation of the abstract concepts recited by the claims utilize computer technology in a way that is considered to be generally linking the use of the judicial exception to a particular technological environment or field of use (See MPEP 2106.05(h)). Accordingly, Examiner does not find that the claims recite a practical application of the abstract concepts recited by the claims.
Conclusion
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW H. DIVELBISS whose telephone number is (571) 270-0166. The fax phone number is 571-483-7110. The examiner can normally be reached on M-Th, 7:00 - 5:00. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerry O'Connor can be reached on (571) 272-6787.
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/M. H. D./
Examiner, Art Unit 3624
/Jerry O'Connor/Supervisory Patent Examiner,Group Art Unit 3624
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