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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/06/2025 has been entered.
Response to Arguments
Claim Interpretation
Applicant's arguments filed 06/06/2025 have been fully considered.
Applicant argues that the terms analyzer in claim 20 would not be interpreted under 112(f) due to the amendment of “blood cell counter”.
In response to Applicant’s arguments, due to the amendment of the term “diagnostic analyzer” to “blood cell counter” the claim interpretation is withdrawn for this term.
Applicant argues that the terms cloud system in claim 20 is a term that one of ordinary skill in the art would understand as storage.
In response to Applicant’s arguments, Examiner agrees with the argument regarding the term “cloud system” and the claim reciting it comprising storage for the storing limitation. However, the cloud system also sends and receives rules. Interpretating the claim under 112(f), the specification shows us that the cloud system uses the network to send and receive the rules. See Spec. [0057]-[0058], [0063]. Therefore, due to the interpretation the cloud system includes storage and a network. Therefore, the claim interpretation is required. See the claim interpretation below.
Rejection Under 112(b)
Applicant's arguments filed 06/06/2025 have been fully considered. Applicant argues that the amendments overcome the rejection, which is now moot. In response to the arguments, due to the amendments, the rejection is withdrawn.
Rejection Under 101
Applicant's arguments filed 06/06/2025 have been fully considered.
Applicant argues that the claims do not recite an abstract idea. The amended claims do not recite concepts related to organizing human activity, mathematical algorithms, or a mental process. The amended claims are directed to a computing system for managing a test of a patient sample and includes a blood cell counter deployed in a lab, a local system, a cloud system, and a network. There is no interactions between people, the rule verification carried out in the invention is done by the local and cloud system.
In response to Applicant’s argument, the claims are directed towards organizing human activity since we are managing test samples of the patient’s. It is noted that the number of people involved in the activity is not dispositive as to whether a claim limitation falls within this grouping. Instead, the determination should be based on whether the activity itself falls within one of the sub-groupings. See MPEP 2106.04(a)(2)(II). The claims are determined to fall within this grouping because they are executing rules in order to verify test results for a person’s test results. This is understood to be certain activity (i.e., following rules) that falls under this sub grouping of abstract ideas regardless of the person’s direct involvement. Additionally, the computer components, such as the local system, cloud system, etc., are additional elements and not part of the abstract idea, but rather additional elements that amount to carrying out the abstract idea in the computer environment.
The amended claims recite a practical application by reciting additional elements that provide an improvement to test result verification computer technology. The claims as a whole result in a clear improvement to computing technology by ensuring the continuous verification for test results. Similar to Example 42, the combination of claim features in the amended claim, read as a whole, integrate the alleged judicial exception into a practical application of continuous automatic verification irrespective of network disconnection between systems. The verification rules are automatically replicated between systems and provides a clear improvement over prior art systems by allowing the user to receive continuous consistent verification results regardless of the network disconnection.
In response to Applicant’s argument, the additional elements amount to no more than mere instructions to apply an exception using computer components. The recitations of the computing system, local system, blood cell counter, network, interface, and cloud system are recited at such a high level of generality and for their intended purpose that the recited limitations are construed to amount to applying the abstract idea in a computer environment. Due to the recited generality of the features, there is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Any recited improvement would be to the abstract idea rather than the computer components. Additionally, the limitation regarding verification replication in considered part of the abstract idea and therefore not an additional element. See the updated rejection in light of the amended claims.
The additional elements recited in the claims contribute an inventive concept. The recited limitations (see pg. 16 or Remarks filed 6/6/25) are not generic or conventional functions of a computer.
In response to Applicant’s argument, the limitations at issue are part of the abstract idea and not an additional element. See the updated rejection for further clarification.
Claims 20-40 qualify as significantly more than the abstract idea because the add specific limitations other than what is well understood, routine, and conventional in the field. The claimed invention is rooted in technology and does not merely implement conventional functions, but requires specially programmed computing device with particular data and user interfaces.
In response to Applicant’s argument, the additional limitations recited in the independent claim do not amount to significantly more than the abstract idea since the additional elements amount to no more than mere instructions to apply an exception and insignificant extrasolution activity. For example, the claims recites displaying test results using a user interface. This additional element of the user interface amounts to an element that has been recognized as well-understood, routine, and conventional. This is evidenced by Applicant’s own specification as well as by caselaw. Additionally, the dependent claims also do not recite significantly more than the abstract idea since they too recite additional elements that are found beyond the abstract idea to merely amount to invoke the use of computers and are generally linking the abstract idea to a particular field of environment. See the rejection below for further clarification.
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.
Regarding Claim 20 – The claim recites “the cloud system is further configured to: receive…store…send…” See MPEP 2181. The claim limitation uses the term cloud system. The “cloud system” is modified by functional language “configured to: receive…store…send….” The cloud system is not modified by sufficient structure, material or act for performing the claim. Therefore 112(f) is invoked. See Spec. [0057]-[0058], [0063] describes the cloud system as sending and receiving information using a network and using a database to store information. For examination purposes the cloud system is construed to include hardware, such as a network and database, to carry out the limitations.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is 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 limitation 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 20-40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Step 1 of the Alice/Mayo Test
Claims 20-40 are drawn to a system, which is within the four statutory categories (i.e. apparatus).
Step 2A of the Alice/Mayo Test - Prong One
The independent claim recite an abstract idea. For example, independent claim 20 recites:
A system for managing a test of a patient sample, the system comprising:
a blood cell counter deployed in a laboratory, the blood cell counter configured to run a test on the patient sample and generate a test result from the patient sample;
a local system deployed in the laboratory, the local system being in communication with the blood cell counter and comprising a first storage storing a first rule to verify the test result and a first processor configured to read out the first rule from the first storage and execute the first rule on the test result; and
a cloud system in communication with the local system over a network, the cloud system being configured to receive the test result from the local system and comprising a second storage storing a second rule to verify the test result and a second processor configured to read out the second rule from the second storage and execute the second rule on the test result,
wherein the local system is configured to:
monitor a network connection between the local system and the cloud system by sending monitoring data toward the cloud system;
determine the network connection is active in response to receiving a response to the monitoring data from the cloud system within a predetermined time period,
send the test result to the cloud system via the network in response to determining the network connection as being active,
determine whether the first rule is executable in the local system in response to determining the network connection as being not active,
execute the first rule on the test result in response to determining the first rule is executable in the local system,
upon execution of the first rule, send an order to the blood cell counter to run a first additional test on the patient sample in response to the first additional test being triggered by executing the first rule on the test result; and
upon execution of the first rule, validate the test result which satisfies validation criteria defined in the first rule; and wherein the cloud system is configured to:
execute the second rule on the test result upon receiving the test result from the local system,
upon execution of the second rule, send an order to the blood cell counter, via the network and the local system, to run a second additional test on the patient sample in response to the second additional test being triggered by executing the second rule on the test result,
upon execution of the second rule, validate the test result which satisfies validation criteria defined in the second rule; and
display the validated test result via a user interface;
wherein the cloud system is further configured to:
receive configuration of a plurality of verification rules,
store the configured verification rules in the second storage, and
send the configured verification rules to the local system to replicate the verification rules between the cloud system and local system;
wherein the local system is further configured to:
send a replication request comprising a network address of the local system to the cloud system; and
in response to the replication request being allowed, replicate a plurality of verification rules defining at the cloud system and store the plurality of verification rules in the first storage, the first rule is selected from the plurality of verification rules;
wherein the cloud system is further configured to:
receive the replication request from the local system; and
determine whether to allow the replication request based on the network address of the local system.
These underlined elements recite an abstract idea that can be categorized, under its broadest reasonable interpretation, to cover the management of personal behavior or interactions (i.e., following rules or instructions), but for the recitation of generic computer components. For example, but for the computing system, blood cell counter, local system, memory, processor, network, database, cloud system, user interface, the limitations in the context of this claim encompass following rules or instructions to validate a patient’s test results using verification rules. If a claim limitation, under its broadest reasonable interpretation, covers management of personal behavior or interactions but for the recitation of generic computer components, then the limitations fall within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. See MPEP § 2106.04(a).
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 21-40 reciting particular aspects of the abstract idea).
Step 2A of the Alice/Mayo Test - Prong Two
For example, independent claim 20 recites:
A system for managing a test of a patient sample, the system comprising: (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
a blood cell counter deployed in a laboratory, the blood cell counter configured to run a test on the patient sample and generate a test result from the patient sample; (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
a local system deployed in the laboratory, the local system being in communication with the blood cell counter and comprising a first storage storing a first rule to verify the test result and a first processor configured to read out the first rule from the first storage and execute the first rule on the test result; and(merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
a cloud system in communication with the local system over a network, the cloud system being configured to receive the test result from the local system and comprising a second storage storing a second rule to verify the test result and a second processor configured to read out the second rule from the second storage and execute the second rule on the test result, (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
wherein the local system is configured to: (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
monitor a network connection between the local system and the cloud system by sending monitoring data toward the cloud system;
determine the network connection is active in response to receiving a response to the monitoring data from the cloud system within a predetermined time period,
send the test result to the cloud system via the network (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) in response to determining the network connection as being active,
determine whether the first rule is executable in the local system in response to determining the network connection as being not active,
execute the first rule on the test result in response to determining the first rule is executable in the local system,
upon execution of the first rule, send an order to the blood cell counter to run a first additional test on the patient sample in response to the first additional test being triggered by executing the first rule on the test result; and
upon execution of the first rule, validate the test result which satisfies validation criteria defined in the first rule; and wherein the cloud system is configured to:
execute the second rule on the test result upon receiving the test result from the local system,
upon execution of the second rule, send an order to the blood cell counter, via the network and the local system, (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) to run a second additional test on the patient sample in response to the second additional test being triggered by executing the second rule on the test result,
upon execution of the second rule, validate the test result which satisfies validation criteria defined in the second rule; and
display the validated test result via a user interface; (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) and (merely insignificant extrasolution activity steps as noted below, see MPEP 2106.05(g))
wherein the cloud system is further configured to: (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
receive configuration of a plurality of verification rules,
store the configured verification rules in the second storage, and (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
send the configured verification rules to the local system to replicate the verification rules between the cloud system and local system;
wherein the local system is further configured to: (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
send a replication request comprising a network address of the local system to the cloud system; and
in response to the replication request being allowed, replicate a plurality of verification rules defining at the cloud system and store the plurality of verification rules in the first storage, the first rule is selected from the plurality of verification rules;
wherein the cloud system is further configured to: (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
receive the replication request from the local system; and
determine whether to allow the replication request based on the network address of the local system.
The judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations, which:
amount to mere instructions to apply an exception (such as recitations of the computing system, blood cell counter, local system, memory, processor, network, database, cloud system, user interface, thereby invoking computers as a tool to perform the abstract idea, see applicant’s specification [0037], [0041]-[0042], [0048]-[0049], [0089], see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of displaying the validated test result via a user interface amounts to insignificant extrasolution activity, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claim 21 which recites the local system sending test results validated by the first rule to a laboratory system, therefore amounting to furthering the abstract idea by validating the results and amounting to invoking computers as a tool to perform the abstract idea by using the local system; claim 22 recites the cloud system sending the validated test results to the local system and the local system receiving the results to send to the laboratory, which amounts to furthering the abstract idea by validating the results and amounting to invoking computers as a tool to perform the abstract idea; claim 23 recites a second storages to store review lists and a terminal to access the review list, which amounts to invoking computers as a tool to perform the abstract idea; claim 24 recites the terminal displaying the review list, which amounts to invoking computers as a tool to perform the abstract idea; claim 25 recites the terminal allows the user to manually validate results, which amounts to invoking computers as a tool to perform the abstract idea; claim 26 recites a database to store verification rules, which amounts to invoking computers as a tool to perform the abstract idea; claim 27 recites the terminal allows for users to register a verification rule in the database, which amounts to invoking computers as a tool to perform the abstract idea; claim 28 recites the cloud system automatically synchronizes with the local system, which amounts to invoking computers as a tool to perform the abstract idea; claim 29 recites the local system is configured to send the test results, to the cloud system, and receives results from the blood cell counter in response to determining connection is restored after network disruption, which amounts to further the abstract idea and invoking computers as a tool to perform the abstract idea; claim 30 recites the local system sends results when executing the first rule in response to determining restored network connection, which amounts to furthering the abstract idea and invoking computers as a tool to perform the abstract idea; claim 31 recites the local system sending information of the first additional test in response to determining restored network connection, which amounts to furthering the abstract idea and invoking computers as a tool to perform the abstract idea; claim 32 recites the test results includes a number of red blood cells, which furthers the abstract idea; claim 33 recites the additional test is Reflex test; claim 34 recites additional test includes a test of measurement not included in an initial test, which furthers the abstract idea; claim 35 recites the additional test includes creation of a smear of the patient sample, which furthers the abstract idea; claim 36 recites the first storage stores a first set of rules and the second storage stores a second set of rules, which amounts to invoking computers as a tool to perform the abstract idea; claim 37 recites the local system withholds executing the first rule in response to requiring test result verification with certain data, which amounts to furthering the abstract idea; claim 38 recites certain data is a previous test result, which furthers the abstract idea; claim 39 recites the local system send the withheld test result in response to restored connection and the cloud system executes the second rule on the withheld test result referring to the certain data stored in the cloud system, which amounts to furthering the abstract idea and invoking computers as a tool to perform the abstract idea; claim 40 recites receiving user inputs on the user interface and validate test results based on the inputs, which amounts to furthering the abstract idea and invoking computers as a tool to perform the abstract idea; and claims 21-40 additional limitations which generally link the abstract idea to a particular technological environment or field of use). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B of the Alice/Mayo Test for Claims
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception and insignificant extrasolution activity. Additionally, the additional elements, other than the abstract idea per se, amount to no more than elements which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as using the computing system, blood cell counter, local system, memory, processor, network, database, cloud system, user interface, e.g., Applicant’s spec describes the computer system with it being well-understood, routine, and conventional because it describes in a manner that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such elements to satisfy 112a. (See Applicant’s Spec. [0037], [0041]-[0042], [0048]-[0049], [0089], see also Puig (US 2018/0373622)); using computer systems, network, database, cloud systems, processor, memory, interface, local system, e.g., merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions, Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2358-59, 110 USPQ2d 1976, 1983-84 (2014).
adding insignificant extrasolution activity to the abstract idea, for example mere data gathering, selecting a particular data source or type of data to be manipulated, and/or insignificant application. The following represent examples that courts have identified as insignificant extrasolution activities (e.g. see MPEP 2106.05(g)): displaying the validated test result via a user interface, e.g., outputting or providing access to the information, Symantec, 838 F.3d at 1321 and MPEP 2106.05(g)(3)).
Dependent claims recite additional subject matter beyond the abstract idea which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea, and are generally linking the abstract idea to a particular field of environment. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. Therefore, the claims are not patent eligible, and are rejected under 35 U.S.C. § 101.
Subject Matter Free of Prior Art
Claims 20-40 are free of prior art over Puig (US 2018/0373622) in view of Riddle et al. (US 2019/0303609).The prior art references, or reasonable combination thereof, could not be found to disclose, or suggest all of the limitations found in the independent claims. The closest prior art is Puig (US 2018/0373622), which teaches a laboratory system for analytical instruments performing tests and result validations. Riddle et al. (US 2019/0303609) teaches validating device and using cloud systems. The references do not teach or suggest sending the test results to the cloud system in response to an active network connection, executing a first rule on the test results in response to determining the connection is not active, sending an order to run additional tests in response to the triggering of the first rule, execute the second rule upon receiving the results from the local system, send an order to the local system to run additional tests in response to the triggering of the second rule.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA R COVINGTON whose telephone number is (303)297-4604. The examiner can normally be reached Monday - Friday, 10 - 5 MT.
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/AMANDA R. COVINGTON/Examiner, Art Unit 3686
/JASON B DUNHAM/Supervisory Patent Examiner, Art Unit 3686