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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
In the amendment dated 05/21/2026, the following has occurred: Claims 1, 8, 9, 14, and 19 have been amended; Claims 7, 17, and 22 have been canceled.
Claims 2, 5, 15, 20, and 23 – 25 have been previously canceled.
Claims 1, 3, 4, 6, 8 – 14, 16, 18, 19, 21, and 26 – 31 are pending.
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, 3, 4, 6, 8 – 14, 16, 18, 19, 21, and 26 – 31 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.
The claim(s) recite(s) subject matter within a statutory category as a process (claims 1, 3, 4, 6, 8 – 13, and 26 – 31), machine (claims 14, 16, and 18), and manufacture (claims 19 and 21) which recite steps of
Claim 1:
receiving a diagnostic test result for an animal patient as a result of a series of diagnostic tests performed on the animal patient based on a plurality of samples taken from the animal patient at predetermined time intervals following administration of a dose of medication, wherein the diagnostic test result comprises a level of a hormone in the animal patient;
search through lab test results to identify associated patterns of outputs and successful follow-on testing performed by a plurality of remote veterinary laboratories;
providing the diagnostic test result for the series of diagnostic tests performed on the animal patient;
identify correlations across a plurality of disparate analytes within the diagnostic test result, wherein the plurality of disparate analytes include at least two chemistry analytes and at least one hematology parameter;
based at least in part on identifying the correlations as being indicative of a steroid analyte, initiating a clinical decision support interface for the diagnostic test result for the animal patient;
generating a recommendation for follow-on testing based at least in part on the cross-database query identifying patterns of successful follow-on testing;
determine, based at least in part on the diagnostic test result, at least one possible condition of the animal patient;
prompting a user to provide input regarding (i) the dose of medication provided to the animal patient for the diagnostic test, and (ii) information relating to at least one observed clinical sign in the animal patient;
based at least in part on (i) the dose of medication provided to the animal patient and (ii) the information relating to the at least one observed clinical sign in the animal patient, using predetermined rules from a plurality of sets of predetermined rules for the selection so as to process the diagnostic test result for the animal patient to generate a clinical interpretation of the diagnostic test by:
accessing a set of clinical interpretations of the diagnostic test associated with an amount of the dose of medication provided to the animal patient; and
mapping the diagnostic test result with one of the clinical interpretations in the set of clinical interpretations based at least in part on the level of the hormone in the animal patient being in a range of the level of hormone associated with the one of the clinical interpretations; and
providing the clinical interpretation of the diagnostic test.
These steps of 1, 3, 4, 6, 8 – 14, 16, 18, 19, 21, and 26 – 31, as drafted, under the broadest reasonable interpretation, includes methods of organizing human activity. The invention, as claimed, relates to the interaction of a user with a computer. As explained by the Specification:
FIELD
[0002] The present disclosure relates generally to methods and systems for interpreting a diagnostic test result, and more particularly, to providing programmatic clinical decision support based on a predetermined rule set for ease of understanding test results per patient.
The invention is not disclosed as anything more than a system to improve the user experience. The invention automates a human process as explained in paragraphs 4 and 5.
[0004] In many instances, interpretations of the test results can lead to questions. Sometimes, such questions lead to delay in diagnosis due to additional support required to interpret the test results. For example, veterinarians may be required to call Help Lines to speak with medical consultants for further information on the test results.
[0005] Accordingly, a more effective system is needed for providing veterinarians and laboratory technicians with automated interpretation of test results.
The invention is not disclosed or claimed as a technological improvement. The result of the invention is data that has a potential usage. There is no disclosed or claimed practical application.
From MPEP 2106.04(a)(2)II
II. CERTAIN METHODS OF ORGANIZING HUMAN ACTIVITY
The phrase “methods of organizing human activity” is used to describe concepts relating to:
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, and business relations); and
managing personal behavior or relationships or interactions between people, (including social activities, teaching, and following rules or instructions).
Here, the invention is directed towards managing personal behavior or relationships or interactions between people. As the MPEP section continues
The term “certain” qualifies the “certain methods of organizing human activity” grouping as a reminder of several important points. First, not all methods of organizing human activity are abstract ideas (e.g., “a defined set of steps for combining particular ingredients to create a drug formulation” is not a certain "method of organizing human activity”), In re Marco Guldenaar Holding B.V., 911 F.3d 1157, 1160-61, 129 USPQ2d 1008, 1011 (Fed. Cir. 2018). Second, this grouping is limited to activity that falls within the enumerated sub-groupings of fundamental economic principles or practices, commercial or legal interactions, and managing personal behavior and relationships or interactions between people, and is not to be expanded beyond these enumerated sub-groupings except in rare circumstances as explained in MPEP § 2106.04(a)(3). Finally, the sub-groupings encompass both activity of a single person (for example, a person following a set of instructions or a person signing a contract online) and activity that involves multiple people (such as a commercial interaction), and thus, certain activity between a person and a computer (for example a method of anonymous loan shopping that a person conducts using a mobile phone) may fall within the “certain methods of organizing human activity” grouping. 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.
Therefore, the relationship between a user and a computer is included.
It should be emphasized here that the Specification disclosed machine learning in paragraphs 72 and 73. However, the Specification does not disclose the required machine learning algorithm. The invention does not disclose the type of required training. The Specification does not disclose the required training data or how the data iteratively learns over time. Machine learning is disclosed at a high level.
The invention, as disclosed, represents an application of technology to the abstract idea. The result of the invention are the improvements achieved by applying the abstract idea to technology.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 3, 4, 6, 8 – 13, 16, 18, 21, and 26 – 31, reciting particular aspects of how treatment decisions may be performed in the mind but for recitation of generic computer components).
This 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 recitation of computing device or processors amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of receiving … a diagnostic test result, provide input amounts to mere data gathering, recitation of provide via the graphical user interface amounts to insignificant application, 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 claims 3, 4, 6, 8 – 13, 16, 18, 21, and 26 – 31, additional limitations which amount to invoking computers as a tool to perform the abstract idea, 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.
The claim(s) does/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, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as 1, 3, 4, 6, 8 – 14, 16, 18, 19, 21, and 26 – 31; receiving, providing, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i))
Additional elements:
Computing device – figure 2 and paragraph 57
Including a display – paragraph 58
Including a medium – paragraph 60
Decision support interface – paragraph 70 a component of the graphical user interface 134 and can be displayed as a window or an overlay in the graphical user interface 134 to provide information in an organized manner. Paragraph 105 Figures 15A-15D illustrate different additional components of the clinical decision support interface 136 including header, summary, hyperlink text, prompts, and/or clinical interpretation, each of which is triggered for display following receipt of input(s) into the clinical decision support interface 136 and/or via the computing device 102 executing the set of predetermined rules 132 for processing the diagnostic test result for the animal patient.
Dependent claims recite additional subject matter 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. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 3, 4, 6, 8 – 13, 16, 18, 21, and 26 – 31, additional limitations which amount to elements that have been recognized as receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i)). 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.
To be clear, it is the Examiner’s point that the invention represents an abstract idea applied to technology. The technology does not change the abstract idea but rather provides the benefits of applying the abstract idea to technology.
Response to Arguments
Applicant's arguments filed 05/21/2026 have been fully considered but they are not persuasive.
3. Response to the § 101 Rejections
The Applicant states, “The claimed invention is not directed to a "mental process" or "method of organizing human activity," but rather to a specific technical solution for complex veterinary diagnostics through multi-instrument data correlation and distributed database synthesis.” The Examiner’s point has been that this invention is a technical solution applied to an abstract idea. The invention’s goal is to obtain all the benefits of applying that technology to the abstract idea.
The Applicant states, “Unlike the "Help Line" example, which involves human-to-human communication, the claimed invention performs a machine-to-machine synthesis of data to refine local interpretations. This architecture utilizes algorithms to rely on patterns and inferences that are not available to a veterinarian in a standard clinical setting. The claims are therefore directed to an improvement in the functioning of a diagnostic network, not a mere social or commercial interaction.” The Examiner agrees that the invention is directed towards organizing human activity of diagnostic support. This is the interaction of a user with a computer in providing veterinary care.
III. The claims do not fall within the concepts for "methods of organizing human activity" as outlined by the MPEP
The Applicant states, “The claims do not recite features for automating a business method, social interaction, or standard clinical workflow.” However, in the next paragraph the Applicant states, “While a doctor can look at a lab report, the claim recites a specific correlation of disparate data types to "identify a specific dysfunction. " This is a technical tool to generate new information, rather than a managerial tool used to schedule or track human behavior.” It is the Examiner’s point that a tool that improves a clinical workflow via an improved diagnosis is a tool for clinical workflow.
The Applicant states, “Note that if the claim does not simply output instructions to perform a test. Rather, the claim specifies "programmatically initiating... an automated clinical decision support interface ... as a side panel," which is an improvement to the operation of the computer itself.” The invention does not improve the computer but is an application implemented on the computer as explained in paragraphs 57 – 59.
IV. Integration into a Practical Application (Step 2A, Prong 2)
The Applicant states, “The specification identifies a specific problem: diagnostic delays and "delay in diagnosis" caused by the need for manual interpretation and "Help Lines".” The Applicant does not explain how delaying a diagnosis is a technological problem vs a problem solved by technology.
The Applicant states, “This is a specific
graphical user interface improvement that assists the user in navigating complex datasets, which is recognized as a technological improvement under Federal Circuit precedent (e.g., Core Wireless). Core Wireless was a technological improvement in the display. The Specification never states that the invention is a technological improvement.
V. The Claim Recites "Significantly More" (Step 2B)
The Applicant states, “The ordered combination of elements in Claim I provides "significantly more" than well-understood, routine, or conventional activity:” The invention is better described as applying the abstract idea to technology. Therefore the “ordered combination” argument is moot.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Micallef et al Pub. No.: US 2013/0252245 The invention relates to a method for detecting the presence of a gynecological growth, in particular for the diagnosis of endometriosis.
Schentag et al Pub. No.: US 2018/0099001 The present invention is directed to diagnostics and model based methods of treatment, and computer-implementable systems that relate to the treatment of an array of the manifestations of Metabolic Syndromes (MetS).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Neal R Sereboff whose telephone number is (571)270-1373. The examiner can normally be reached M - T, M - F 8AM - 6PM.
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, Robert Morgan can be reached on (571)272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEAL SEREBOFF/
Primary Examiner
Art Unit 3626
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