Prosecution Insights
Last updated: April 19, 2026
Application No. 17/904,860

HYGIENE MANAGEMENT SYSTEM, HYGIENE MANAGEMENT METHOD, AND HYGIENE MANAGEMENT PROGRAM

Final Rejection §101
Filed
Aug 23, 2022
Examiner
MISIASZEK, AMBER ALTSCHUL
Art Unit
3682
Tech Center
3600 — Transportation & Electronic Commerce
Assignee
Neogen Food Safety US Holdco Corporation
OA Round
4 (Final)
47%
Grant Probability
Moderate
5-6
OA Rounds
4y 0m
To Grant
71%
With Interview

Examiner Intelligence

Grants 47% of resolved cases
47%
Career Allow Rate
289 granted / 616 resolved
-5.1% vs TC avg
Strong +24% interview lift
Without
With
+24.5%
Interview Lift
resolved cases with interview
Typical timeline
4y 0m
Avg Prosecution
35 currently pending
Career history
651
Total Applications
across all art units

Statute-Specific Performance

§101
43.1%
+3.1% vs TC avg
§103
26.4%
-13.6% vs TC avg
§102
20.9%
-19.1% vs TC avg
§112
3.6%
-36.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 616 resolved cases

Office Action

§101
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 . Notice to Applicant Claims 1, 5, and 9-11 have been amended. Claims 12-18 are new. Now, claims 1-11 are pending. 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 facility skill information reception unit “, “a facility skill information determining unit”, “an authorization unit”, “a hygiene management information extraction unit”, “a hygiene management information transmission unit” in claim 1; “a facility skill information update unit” in claim 4; “a storage unit”, “ a keyword reception unit”, “a hygiene management information extraction unit”, “a hygiene management information transmission unit” in claim 5; “the hygiene management information extraction unit” in claim 6; “the hygiene management information extraction unit” in claim 7; and “the hygiene management information extraction unit” in claim 8. 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 § 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 1-18 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. Claims 1-18 are directed to obtaining and transmitting facility hygiene information, which is considered functions performable in the mind or with pen and paper and are only concepts relating to organizing or analyzing information in a way that can be performed mentally or is analogous to human mental work. Functions performable in the mind or with pen and paper fall within a subject matter grouping of abstract ideas which the Courts have considered ineligible (Mental Processes). The claims do not integrate the abstract idea into a practical application, and do not include additional elements that provide an inventive concept (are sufficient to amount to significantly more than the abstract idea). Under step 1 of the Alice/Mayo framework, it must be considered whether the claims are directed to one of the four statutory classes of invention. In the instant case, claim 1-8 and 12-18 recite a system comprising a server and a storage unit. Claims 9 and 10 recite a method and at least one step. Claim 11 recites a hygiene management program. Therefore, the claims are each directed to one of the four statutory categories of invention (apparatus, process, manufacture). Under step 2A of the Alice/Mayo framework, it must be considered whether the claims are “directed to” an abstract idea. That is, whether the claims recite an abstract idea and fail to integrate the abstract idea into a practical application. Regarding independent claim 1, the claim sets forth a system for obtaining and transmitting facility hygiene information, in the following limitations: receive facility information and skill information of the facilities; determine a pass/fail for the facility information and the skill information, authorize said facilities determined to have passed to view hygiene management information of other facilities and be viewable by other facilities, wherein the hygiene management information is information relating to testing of the test target substance, and store hygiene management information of the test target substance of the plurality of facilities; extracting hygiene management information for an authorized facility; and transmitting hygiene management information extracted to one or more authorized facilities; and a report, generated by analysis of measurement data, and performing an input on a formatted test report; wherein transmitting hygiene management information comprises disseminating said hygiene management information among one or more authorized facilities, which enables cross- facility data sharing. The above-recited limitations obtain and transmit facility hygiene information. This arrangement amounts to observations, evaluations, judgments, and opinions. Such concepts have been considered ineligible Mental Processes by the Courts (See MPEP 2106.04(a)). Claim 1 does recite additional elements: a server; a terminal; a storage unit; a database; a facility skill information reception unit; a facility skill determining unit; an authorization unit; a hygiene management information extraction unit; a hygiene management information transmission unit; automatically displayed. These additional elements merely amount to the general application of the abstract idea to a technological environment (“a server”; “a terminal”; “a storage unit”; “a database”; “a facility skill information reception unit”; “a facility skill determining unit”; “ an authorization unit”; “a hygiene management information extraction unit”; “a hygiene management information transmission unit”; “automatically displayed”) and insignificant pre-and-post solution activity (store, receive, determine, authorize, extracting, transmitting, generated, performing). The specification makes clear the general-purpose nature of the technological environment. Paragraphs 63-64, 70, 76, and 140 indicate that while exemplary general purpose systems may be specific for descriptive purposes, any elements or combinations of elements capable of implementing the claimed invention are acceptable. That is, the technology used to implement the invention is not specific or integral to the claim. Therefore, considered both individually and as an ordered combination, the additional elements do no more than generally link the use of the abstract idea to a particular technological environment or field of use. That is, given the generality with which the additional limitations are recited, the limitations do not implement the abstract idea with, or use the abstract idea in conjunction with, a particular machine or manufacture that is integral to the claim. Additionally, the claims do not reflect an improvement in the functioning of a computer, or an improvement to other technology or technical field, do not apply or use the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition, do not effect a transformation or reduction of a particular article to a different state or thing; and do not apply or use the abstract idea in some other meaningful way beyond generally linking the use of the abstract idea to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the abstract idea. Accordingly, the Examiner concludes that the claim fails to integrate the abstract idea into a practical application, and is therefore “directed to” the abstract idea. Under step 2B of the Alice/Mayo framework, it must finally be considered whether the claim includes any additional element or combination of elements that provide an inventive concept (i.e., whether the additional element or elements are sufficient to amount to significantly more than the abstract idea). As indicated above, considered both individually and as an ordered combination, the additional elements do not implement the abstract idea with, or use the abstract idea in conjunction with, a particular machine or manufacture that is integral to the claim, do not reflect an improvement in the functioning of a computer, or an improvement to other technology or technical field, do not apply or use the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition, do not effect a transformation or reduction of a particular article to a different state or thing, and do not apply or use the abstract idea in some other meaningful way beyond generally linking the use of the abstract idea to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the abstract idea Further, the additional elements (recited above) simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. Communicating information (i.e., receiving or transmitting data over a network) has been repeatedly considered well-understood, routine, and conventional activity by the Courts (See MPEP 2106.05(d)). Accordingly, the Examiner asserts that the additional elements, considered both individually, and as an ordered combination, do not provide an inventive concept, and the claim is ineligible for patent. Independent Claims 5 and 9-11 are parallel in scope to claim 1 and ineligible for similar reasons. Dependent claims Each of these steps of the dependent claims 2-4, 6-8 and 12-18 only serve to further limit or specify the features of independent claims 1, 5, and 9-11 accordingly, and hence are nonetheless directed towards fundamentally the same abstract idea as the independent claim and utilize the additional elements already analyzed in the expected manner. For example, claim 6 sets forth: extracts information of the number of the test target substances obtained by the testing. Claim 7 sets forth: extracts image data of the test target substance obtained by the testing. Claim 8 sets forth: extracts test contents of the test target substance. Such a recitation merely embellishes the abstract idea of obtaining and transmitting facility hygiene information, including observations, evaluations, judgments, and opinions. While the claims do set forth the additional limitation of “the hygiene management information extraction unit”, this recitation is similar to the additional limitations in claim 1, as it does no more than generally link the use of the abstract idea to a particular technological environment. As such, it does not integrate the abstract idea into a practical application, and does not provide an inventive concept. Accordingly, the claims do not confer eligibility on the claimed invention and is ineligible for similar reasons to claim 1. Response to Arguments Applicant's arguments filed December 17, 2025 have been fully considered but they are not persuasive. Applicant argues that the claimed invention provides at least a practical application, e.g., in the form of the dissemination of hygiene management information among authorized facilities, enabling cross- facility data sharing and the generation of a report, generated by analysis of measurement data, which is stored in the storage unit, and/or performing an input on a formatted test report automatically displayed. In response, Examiner respectfully disagrees. The independent claims recite, in part, receive facility information and skill information of the facilities; determine a pass/fail for the facility information and the skill information, authorize said facilities determined to have passed to view hygiene management information of other facilities and be viewable by other facilities, wherein the hygiene management information is information relating to testing of the test target substance, and store hygiene management information of the test target substance of the plurality of facilities; extracting hygiene management information for an authorized facility; and transmitting hygiene management information extracted to one or more authorized facilities; and a report, generated by analysis of measurement data, and performing an input on a formatted test report; wherein transmitting hygiene management information comprises disseminating said hygiene management information among one or more authorized facilities, which enables cross- facility data sharing. . The claims as written constitute a mental process. The claim elements are directed to receiving information, determining a pass or fail, authorizing documents to be viewable, generating a report, and transmitting said information. Appellant’s specification at para. [0060] states “The hygiene management system 1 may be, for example, a portable terminal such as a tablet terminal, a high-performance mobile phone (smartphone), and a laptop personal computer, or may be a desktop personal computer. Alternatively, the hygiene management system 1 may be a distributed processing system including a plurality of computers, or may be a client-server system or a cloud system.”, and at para. [0064] states “The storage unit 21 stores information received by the server 20 from the terminal 10 and information generated within the server”. Receiving information, determining a pass or fail, authorizing documents to be viewable, generating a report, and transmitting said information, include observations, evaluations, judgments, and opinions, can all be done in the human mind and is therefore a mental process. The claims do not integrate the abstract idea into a practical application, and do not include additional elements that provide an inventive concept (are sufficient to amount to significantly more than the abstract idea). (Digitech Image Tech., LLC v. Electronics for Imaging, Inc. (Fed. Cir. 2014)). This judicial exception is not integrated into a practical application. In particular, the claim only recites additional elements of “a server”; “a terminal”; “a storage unit”; “a database”; “a facility skill information reception unit”; “a facility skill determining unit”; “an authorization unit”; “a hygiene management information extraction unit”; “a hygiene management information transmission unit”; and “automatically displayed”. The elements in each of these independent claims are recited at a high-level of generality (i.e., “a server”; “a terminal”; “a storage unit”; “a database”; “a facility skill information reception unit”; “a facility skill determining unit”; “ an authorization unit”; “a hygiene management information extraction unit”; “a hygiene management information transmission unit”; “automatically displayed”), such that the claims are directed to utilizing general purpose computer components (Application Specification [0061], [0063-0066], and [0070-0074])). As such, the limitations amount to no more than adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea. See MPEP 2106.05(f). As a result, there are no meaningful limitations in the claim that transform the exception into a patent eligible application such that the claim amounts to significantly more than the exception itself, and the claims are properly rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter. Thus, the claims do not recite additional limitations that integrate the exception into a Practical Application. Applicant argues that the claims are analogous to Claim 1 of Example 42 of the Subject Matter Eligibility Examples Published by the PTO. In response, Examiner respectfully disagrees. With regard to Claim 1 of Example 42, this example is not analogous to the claims in the present application. The present claims do not follow the same fact pattern as Example 42. In the claimed invention of Example 42, the claim recites a combination of additional elements including storing information, providing remote access over a network, converting updated information that was input by a user in a non-standardized form to a standardized format, automatically generating a message whenever updated information is stored, and transmitting the message in real time to all of the users. The claim as a whole integrates the method of organizing human activity into a practical application. Specifically, the additional elements recite a specific improvement over prior art systems by allowing remote users to share information in real time in a standardized format regardless of the format in which the information was input by the user. The present application does not convert the data and transmit an update message to all of the users. The present application receives information, determining a pass or fail, authorizing documents to be viewable, generating a report and transmitting said report to one or more authorized facilities, it does not transmit a message to all of the users automatically in real time when the information is updated, nor does it convert information from a non-standardized form to a standardized form. In the present application the input is performed on a formatted test report, this test report is already formatted, no conversion of data is taking place and therefore, this is not analogous to converting non-standardized information to a standardized format as found eligible in claim 1 of Example 42. The claims in the instant application are receiving information, making a determination, providing authorization for viewing and displaying the reports, and transmitting the reports Therefore, the present claims are not analogous to those in example 42. 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. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. SYSTEM FOR ON-SITE ENVIRONMENT MONITORING (US 20140046722 A1) teaches monitoring pathogens in various environments and on various items, wherein data from monitoring is trackable, analyzable and comparable versus various standards or thresholds. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amber A. Misiaszek whose telephone number is (571) 270-1362. The examiner can normally be reached on M-Th 7:30-5, F 7:30-4, every other Friday Off. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached on 571-270-5096. The fax phone numbers for the organization where this application or proceeding is assigned are (571) 273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) computer-accessible medium. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR computer-accessible medium, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR computer-accessible medium, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information computer-accessible medium, call 800-786-9199 (IN USA OR CANADA) or (571) 272-1000. /AMBER A MISIASZEK/Primary Examiner, Art Unit 3682
Read full office action

Prosecution Timeline

Aug 23, 2022
Application Filed
Sep 03, 2024
Non-Final Rejection — §101
Dec 16, 2024
Examiner Interview Summary
Dec 16, 2024
Applicant Interview (Telephonic)
Jan 03, 2025
Response Filed
Apr 04, 2025
Final Rejection — §101
Jul 14, 2025
Examiner Interview Summary
Aug 02, 2025
Request for Continued Examination
Aug 04, 2025
Response after Non-Final Action
Sep 15, 2025
Non-Final Rejection — §101
Dec 09, 2025
Applicant Interview (Telephonic)
Dec 09, 2025
Examiner Interview Summary
Dec 17, 2025
Response Filed
Mar 12, 2026
Final Rejection — §101 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

5-6
Expected OA Rounds
47%
Grant Probability
71%
With Interview (+24.5%)
4y 0m
Median Time to Grant
High
PTA Risk
Based on 616 resolved cases by this examiner. Grant probability derived from career allow rate.

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