DETAILED ACTION
Status of Claims
This is a non-final office action on the merits in response to the arguments and/or amendments filed on 11 September 2025 and the request for continued examination filed on 11 September 2025.
Claim(s) 3, 5, 6, 8, 10, 12, 15, 17, and 19 is/are canceled. Claim(s) 2, 4, 9, 11, 16, and 18 is/are amended. Claim(s) 22 is/are new.
Claim(s) 2, 4, 7, 9, 11, 13, 14, 16, 18, and 20-22 is/are currently pending and have been examined.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11 September 2025 has been entered.
Claim Objections
Claim(s) 2, 9, and 16 is/are objected to because of the following informalities:
Claim 2 recites “wherein the laboratory equipment includes at one or more of” which should recite “wherein the laboratory equipment includes at least one or more of.” Claims 9 and 16 are similarly objected to.
Claim 2 recites “selecting a first rule set of the plurality of rule sets for the dependent user, first rule set corresponding to” which should recite “selecting a first rule set of the plurality of rule sets for the dependent user, the first rule set corresponding to”. Claims 9 and 16 are similarly objected to.
Claim 2 recites “determining that the second measured laboratory results is within” which should recite “determining that the second measured laboratory result is within”. Claims 9 and 16 are similarly objected to.
Claim 2 recites “where the determining the plurality of candidate diagnosis of the condition” which should recite “where the determining the plurality of candidate diagnoses of the condition”.
Claim 2 recites “the at least one determined treatment for the at least one diagnoses on a display” which should recite “the at least one determined treatment for the at least one
Claim 2 recites “a plurality of data source” which should recite “a plurality of data .
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 13 and 20 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.
Claim 13 recites “The method as recited in claim 12…”. However, claim 12 is now canceled. The claim’s dependency on a now canceled claim renders the scope of the claim unclear and indefinite. Claim 20 is similarly rejected.
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 2, 4, 7, 9, 11, 13, 14, 16, 18, and 20-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 2, which is representative of claims 9 and 16, recites: a system
tuning a plurality of rule sets for a respective plurality of dependent user populations based at least in part data from the one or more medical machines, wherein each dependent user population corresponds to dependent users in a different respective geographic location;
determining that the dependent user corresponds to a particular dependent user population of the plurality of dependent user populations based on the geographic location of the dependent user;
based at least in part on the determining, selecting a first rule set of the plurality of rule sets for the dependent user, first rule set corresponding to the geographic location of the dependent user, wherein the first rule set comprises ranges of values for a plurality of defined laboratory results from the first set of laboratory equipment and ranges of values for each of a plurality of defined vital signs from the first set of monitoring devices;
for a subset of the data that is collected within a temporal window:
comparing a first measured laboratory result of the plurality of measured laboratory results to a first determined laboratory result of the plurality of the defined laboratory results to determine whether the first measured laboratory result is within a range of values for the first defined laboratory result;
comparing a first measured vital sign of the plurality of measured vital signs to a first defined vital sign of the plurality of the defined vital signs to determine whether the first measured vital sign is within a range of values for the first defined value sign;
determining that the first measured laboratory result is within the range of values for the first defined laboratory result and that the first measured vital sign is within the range of values for the first defined vital sign;
generating a first flag representing a combination of the first measured laboratory result being determined to be within the range of values for the first defined laboratory result and the first measure vital sign being determined to be within the range of values for the first defined vital sign;
comparing a second measured laboratory result of the plurality of measured laboratory results to a second defined laboratory result of the plurality of the defined laboratory results to determine whether the second measured laboratory result is within a range of values for the second defined laboratory result;
comparing a second measured vital sign of the plurality of measured vital signs to a second defined vital sign of the plurality of the defined vital signs to determine whether the second measured vital sign is within a range of values for the second defined vital sign;
determining that the second measured laboratory results is within the range of values for the second defined laboratory result and that the second measured vital sign is within the range of values for the second defined vital sign; and
generating a second flag representing the combination of the second measured laboratory result being determined to be within the range of values for the second defined laboratory result and the second measured vital sign being determined to be within the range of values for the second defined vital sign;
determining a plurality of candidate diagnoses of a condition of the dependent user as a function of the first flag and the second flag, wherein the determining the plurality of candidate diagnosis of the condition of the dependent user as a function of the first flag and the second flag is based at least in part on
ranking
determining
flag, the second flag, the at least one diagnosis, and the at least one determined treatment; and
The preceding recitation of the claim has had strikethroughs applied to the additional elements beyond the abstract idea to more clearly demonstrate the limitations setting forth the abstract idea. The remaining limitations describe a concept of analyzing patient data based on tuned rules to diagnose and treat the patient. This concept describes a mental process that a diagnostician should follow to diagnose and treat a patient similar to the “mental process that a neurologist should follow when testing a patient for nervous system malfunctions” given in MPEP 2106.04(a)(2)(II)(C) as an example of managing personal behavior in the methods of organizing human activity sub-grouping. As such, these limitation set forth a method of organizing human activity. Therefore the claims are determined to recite an abstract idea.
MPEP 2106, reflecting the 2019 PEG, directs examiners at Step 2A Prong Two to consider whether the additional elements of the claims integrate a recited abstract idea into a practical application.
Claim 2 recites the additional element of a system comprising: one or more processing devices; and memory. Claim 16 recites one or more non-transitory, machine-readable media. These additional elements are recited at a very high level of generality, and are interpreted as generic computing devices used to implement part of the abstract idea. Per MPEP 2106.05(f), implementing an abstract idea on a generic computing device does not integrate an abstract idea into a practical application in Step 2A Prong Two, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, these additional elements do not integrate the abstract idea into a practical application.
The independent claims further recite the additional element of laboratory equipment configured to analyze biological samples, wherein the laboratory equipment includes at least one or more of an electric microscope or an ultracentrifuge. Examiner notes that the claim structure does not actually require the use of this additional element. This additional element is claimed as part of “one or more medical machines including: laboratory equipment configured to analyze biological samples, wherein the laboratory equipment includes at least one or more of an electric microscope or an ultracentrifuge; and monitoring devices configured to monitor patient vital signs”. The only time the “medical machines”, or “laboratory equipment” and “monitoring devices” (separate from the “a first set of laboratory equipment” and “a first set of monitoring devices”) is further referenced in the claim is in the limitation “data from the one or more medical machines.” Such data need not necessarily be from the “laboratory equipment … wherein the laboratory equipment includes at least one or more of an electric microscope of an ultracentrifuge” as it may instead be from the “monitoring devices.” Therefore the claims do not actually use this additional element. Therefore it cannot reasonable be considered an example of implementing the abstract idea with a particular machine that is integral to the claim. MPEP 2106.05(b). Thus this additional element is considered to only generally link the abstract idea to a field of use of biological sample analysis. Per MPEP 2106.05(h), such additional elements do not integrate an abstract idea into a practical application. As such, this additional element does not integrate the abstract idea into a practical application.
The independent claims further recite the additional element of monitoring devices configured to monitor patient vital signs selected from the group consisting of temperature, blood oxygenation, blood pressure, and respiratory rate. This additional element is recited at a high level of generality, and may be interpreted as a generic computing device used to implement part of the abstract idea. As previously noted, such additional elements do not integrate an abstract idea into a practical application. As such, this additional element does not integrate the abstract idea into a practical application.
The independent claims further recite the additional element of an artificial intelligence engine. This additional element is recited at a high level of generality, and may be interpreted as a generic computing device used to implement part of the abstract idea. As previously noted, such additional elements do not integrate an abstract idea into a practical application. As such, this additional element does not integrate the abstract idea into a practical application.
The independent claims further recite the additional elements of a first set of laboratory equipment and a first set of monitoring devices. Examiner notes that these features are distinct from the previously recited “laboratory equipment … wherein the laboratory equipment includes at least one or more of an electric microscope or an ultracentrifuge”, and as such the “first set of laboratory equipment” should not be read as necessarily including at least one or more of an electric microscope or an ultracentrifuge. Thus these additional elements are recited at a high level of generality, and may be interpreted as generic computing devices used to implement part of the abstract idea. As previously noted, such additional elements do not integrate an abstract idea into a practical application. As such, these additional elements do not integrate the abstract idea into a practical application.
The independent claims further recite the additional elements of one or more data stores and a database. This additional element is recited at a high level of generality, and may be interpreted as a generic computing device used to implement part of the abstract idea. As previously noted, such additional elements do not integrate an abstract idea into a practical application. As such, this additional element does not integrate the abstract idea into a practical application.
The independent claims further recite the additional element of receiving data, wherein the data is received according to machine learned rules that cause to be execute done or more data query scripts to query the one or more data stores, where the data is received consequent to execution of the one or more data query scripts in accordance with the machine learned rules, and at least one of the data is converted according to conversion rules to a second format from a first format in which the at least some of the data is provided by at least one data source of a plurality of data sources. The independent disclosure provides no technical explanation of how to implement the receiving of data according to machine learned rules that cause scripts to be executed and data be converted. One of ordinary skill in the art would not recognize this additional element as causing the claimed invention to provide a technical improvement. As such, this additional element does not qualify as an improvement in the functioning of a computer or an improvement to other technology. This additional element clearly does not qualify as applying the abstract idea to effect a particular treatment. This additional element clearly does not qualify as using the abstract idea in conjunction with a particular machine that is integral to the claim. If the format conversion is considered for whether it constitutes a particular transformation under the factors of MPEP 2106.05(c), the particularly of the transformation (not particular, highly general), the particularity of the transformed article (not particular, highly general), the nature of the transformation in terms of the extent of change (limited, merely from one data format to another data format), and the nature of article transformed (intangible data) all suggest any transformation does not constitute a transformation of a particular article to a different state or thing. And these additional elements do not appear to apply or use the judicial exception in some other meaningful way. Instead, considering the factors of MPEP 2106.05(g), as the additional element does not impose a meaningful limit on the claim and as the additional element amounts to necessary data gathering, this additional element is considered to be insignificant extra-solution activity. As such, this additional element does not integrate the abstract idea into a practical application.
The independent claims further recite the additional elements of displaying data on a display device; outputting one or more messages comprising data; and updating a dashboard documenting data. These additional elements clearly do not qualify as an improvement in the functioning of a computer or an improvement to other technology. These additional elements clearly do not qualify as applying the abstract idea to effect a particular treatment. These additional elements clearly do not qualify as using the abstract idea in conjunction with a particular machine that is integral to the claim. These additional elements clearly do not qualify as effecting a transformation or reduction of an article to a different state or thing. And these additional elements do not appear to apply or use the judicial exception in some other meaningful way. Instead, considering the factors of MPEP 2106.05(g), as the additional element does not impose a meaningful limit on the claim and as the additional element amounts to data output, this additional element is considered to be insignificant extra-solution activity. As such, this additional element does not integrate the abstract idea into a practical application. As such, these additional elements do not integrate the abstract idea into a practical application.
There are no further additional elements in the independent claims. When considered as a combination, the additional elements identified above merely use generic computing devices to apply the abstract idea and insignificant extra-solution activity to the technological environment of biological sample analysis. As such, the combination of additional elements does not integrate the abstract idea into a practical application. Because the additional elements, individually and as a combination, do not integrate the abstract idea into a practical application, the independent claims are determined to be directed to an abstract idea.
At Step 2B of the Mayo/Alice analysis, examiners are to consider whether the additional elements amount to significantly more than the abstract idea.
As previously noted, the independent claims recite several additional elements which may be interpreted as generic computing devices used to implement the abstract idea. However, per MPEP 2106.05(f), implementing an abstract idea on a generic computing does not add significantly more in Step 2B, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, these additional elements do not amount to significantly more.
The independent claims further recite the additional element of laboratory equipment configured to analyze biological samples, wherein the laboratory equipment includes at least one or more of an electric microscope or an ultracentrifuge. As previously noted, the independent claims do not actually require the use of this additional element. At Step 2B, this additional element continues to only generally link the abstract idea to a field of use of biological sample analysis. As such, this additional element does not amount to significantly more than the abstract idea.
The independent claims further recite the additional element of receiving data, wherein the data is received according to machine learned rules that cause to be execute done or more data query scripts to query the one or more data stores, where the data is received consequent to execution of the one or more data query scripts in accordance with the machine learned rules, and at least one of the data is converted according to conversion rules to a second format from a first format in which the at least some of the data is provided by at least one data source of a plurality of data sources. At Step 2B, this additional element continues to be considered insignificant extra-solution activity. As such, this additional element does not amount to significantly more.
The independent claims further recite the additional elements of displaying data on a display device; outputting one or more messages comprising data; and updating a dashboard documenting data. At Step 2B, this additional element continues to be considered insignificant extra-solution activity. As such, this additional element does not amount to significantly more.
There are no further additional elements in the independent claims. When considered as a combination, the additional elements identified above merely use generic computing devices to apply the abstract idea and insignificant extra-solution activity to the technological environment of biological sample analysis. As such, the combination of additional elements does not amount to significantly more than the abstract idea. Therefore, when considered individually and as a combination, the additional elements of the independent claims do not amount to significantly more than the abstract idea. Thus the independent claims are not patent eligible.
Claims 4, 7, 11, 13, 14, 18, 20, and 21 further narrow the abstract idea, but the claims continue to recite an abstract idea, albeit a narrower one. Claims 4, 7, 11, 13, 14, 18, 20, and 21 recite no further additional elements. The previously identified additional elements, individually and as a combination, do not integrate the narrowed abstract ideas into a practical application for the same reasons as indicated above. As such, claims 4, 7, 11, 13, 14, 18, 20, and 21 are determined to be directed to an abstract idea. Further, the previously identified additional elements, individually and as a combination, do not amount to significantly more than the narrowed abstract ideas for the same reasons as indicated above. Claim 22 recites the additional element of a short message service (SMS) message. This additional element clearly does not qualify as an improvement in the functioning of a computer or an improvement to other technology. This additional elements clearly does not qualify as applying the abstract idea to effect a particular treatment. This additional element clearly does not qualify as using the abstract idea in conjunction with a particular machine that is integral to the claim. This additional elements clearly does not qualify as effecting a transformation or reduction of an article to a different state or thing. And this additional element does not appear to apply or use the judicial exception in some other meaningful way. Instead, considering the factors of MPEP 2106.05(g), as the additional element does not impose a meaningful limit on the claim and as the additional element amounts to data output, this additional element is considered to be insignificant extra-solution activity. As such, this additional element does not integrate the abstract idea into a practical application. Further, when considered in combination with the previously identified additional element, the combination of additional elements merely use generic computing devices to apply the abstract idea and insignificant extra-solution activity to the technological environment of biological sample analysis. As such, the combination of additional elements does not integrate the abstract idea into a practical application. As such, claim 22 is determined to be directed to an abstract idea. Fostick (US 2002/0173319 A1) demonstrates (“a conventional SMS message” [0016]) that SMS messages were conventional long before the priority date of the claimed invention. As such, this additional element does not amount to significantly more. When considered as a combination, the SMS message in combination with the additional elements identified above merely use generic computing devices to apply the abstract idea and insignificant extra-solution activity to the technological environment of biological sample analysis. Therefore, when considered individually and as a combination, the additional elements of claim 22 does not amount to significantly more than the abstract idea. Because the claims 4, 7, 11, 13, 14, 18, and 20-22 remain directed to an abstract idea without reciting significantly more, these claims are not patent eligible.
Response to Arguments
Applicant’s Argument Regarding 101 Rejections of claims 2-21:
Applicant submits that the claimed subject matter does not fall into any of these enumerated sub-groupings and therefore is not a method of organizing human activity. Indeed, the claims recite a system and a method for analyzing laboratory results from laboratory equipment and vital sign data… .
Applicant submits that the amended claims include elements that are not merely “extra solution activity” involving computers. For example, the amended claims integrate data from specific laboratory equipment (electric microscopes and/or ultracentrifuges) and monitoring equipment for monitoring specific patient parameters (e.g., temperature, blood oxygenation, blood pressure, and respiratory rate).
The claimed system further uses machine-learned rules that cause to be executed one or more data query scripts to query one or more data stores to obtain the forementioned information and further converts the information according to conversion rules to a second format from a first format, thus allowing interoperability with a wide variety of equipment and different manufacturers and communication protocols.
Additionally, the system of claims 1: 1. Determines a plurality of candidate diagnoses … 2. ranks, by the artificial intelligence engine, the plurality of candidate diagnoses ... 3. Determines, by the artificial intelligence engine, at least one treatment of the dependent user as a function of the at least one diagnosis of the plurality of candidate diagnoses … 4. Displays the ranked plurality of candidate diagnoses … 5. outputs … one or more messages …. and 6. Updating a dashboard documenting actions … Applicant submits that the aforementioned functions provide measurable improvements in the medical field, reducing medical care, and facilitating accurate and real-time documentation of actions taken with respect to the patient.
With respect Example 42, the USPTO indicates that the method recited above satisfies prong 2A of the Alice test because the claims are not “directed to” an abstract idea … Applicant notes that the above conclusion by the USPTO is applicable to the claims currently at issue.
To the extent the claims involve any sort of judicial exception, the judicial exception is integrated into a practical application that produces and provides information about the physiological condition of the dependent user and a determines a treatment for the condition.
Examiner’s Response: Applicant's arguments filed 11 September 2025 have been fully considered but they are not persuasive.
Examiner respectfully disagrees. Examiner notes that MPEP 2106.04(a)(2)(C) very clearly indicates that processes that a care provider should follow when evaluating a patient fall within the managing personal behavior sub-grouping of methods of organizing human activity grouping. The limitations identified the in the rejection above reasonably describe constitute such a process. As such, this argument is unpersuasive.
As noted in the rejection above, the claim language does not actually appear to require any data from the asserted “specific laboratory equipment.” The claim utilizes on data from “medical machines” which include that equipment, but that data may be acquired from mere monitoring devices. Further, the claimed “first set of laboratory equipment” need not include the asserted “specific laboratory equipment.” Further, monitoring parameters such as temperature, blood oxygenation, blood pressure, and respiratory rate may be achieved by generic computing devices. Note that the claims do not describe the acquisition of these parameters. As such, this argument is unpersuasive.
Per MPEP 2106.05(a), “If it is asserted that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes, a technical explanation as to how to implement the invention should be present in the specification. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement.” Here, the disclosure does not appear to provide a technical explanation of how to implement the machine-learned rules to execute query scripts and convert data. Instead, this additional element appears to amount to insignificant extra-solution activity and it is unclear why applicant understands the limitation differently. As such, this argument is unpersuasive.
Much of the identified features as considered part of the abstract idea, and thus are not “additional elements” for the purposes of Prong Two or Step 2B. Further, per MPEP 2106.05(a), “If it is asserted that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes, a technical explanation as to how to implement the invention should be present in the specification. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement.” Here, the disclosure does not appear to provide a technical explanation of how to implement the identified functions. As such, this argument is unpersuasive.
Examiner notes that Example 42 does not stand for data conversion being per se eligible subject matter. The example notes that “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.” This improvement is based on Example 42’s background which notes “Currently, medical providers must continually monitor a patient’s medical records for updated information, which is often-times incomplete since records in separate locations are not timely or readily-shared or cannot be consolidated due to format inconsistencies as well as physicians who are unaware that other physicians are also seeing the patient for varying reasons.” There does not appear to be any analogous solution in the present claims.
Examiner notes that “produces and provides information about the physiological condition of the dependent user and a determines a treatment for the condition” is not, in of itself, a basis for a claim integrating an abstract idea into a practical application.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bion A Shelden whose telephone number is (571)270-0515. The examiner can normally be reached M-F, 12pm-10pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi can be reached at (571) 272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Bion A Shelden/Primary Examiner, Art Unit 3685 2025-12-06