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 12/15/2025, the following has occurred: Claims 1, 14, and 19 have been amended.
Claims 2, 5, 15, 20, and 23 – 25 have been previously canceled.
Claims 1, 3, 4, 6 – 14, 16 – 19, 21, 22, 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 – 14, 16 – 19, 21, 22, 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 – 13, and 26 – 31), machine (claims 14 and 16– 18), and manufacture (claims 19, 21, and 22) 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;
providing the diagnostic test result for the series of diagnostic tests performed on the animal patient;
based at least in part on the diagnostic test result being indicative of a steroid analyte, initiating a clinical decision support interface for the diagnostic test result for the animal patient;
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 claims 1, 3, 4, 6 – 14, 16 – 19, 21, 22, and 26 – 31, as drafted, under the broadest reasonable interpretation, includes performance of the limitation in the mind but for recitation of generic computer components. That is, other than reciting steps as performed by the generic computer components, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the processor language, prompting in the context of this claim encompasses a mental process of the user. Similarly, the limitation of generate, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, but for the computer language, providing the clinical interpretation in the context of this claim encompasses a mental process of the user. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
These steps of 1, 3, 4, 6 – 14, 16 – 19, 21, 22, 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 – 13, 16 – 18, 21, 22, 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 – 13, 16 – 18, 21, 22, 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 – 14, 16 – 19, 21, 22, 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 – 13, 16 – 18, 21, 22, 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 12/15/2025 have been fully considered but they are not persuasive.
3. Response to Advisory Action
The Applicant states, “The Examiner has not shown how the claimed interface is not a technical improvement, and has not responded to the Applicant's arguments below.” The Examiner does not need to provide that the invention is “not a technical improvement.” The Examiner reviews the lack of evidence in the Specification that the invention is a technical improvement.
The Applicant states, “A person of ordinary skill in the art would understand the pending claims as reciting specific structural elements, such as an innovative user interface that is a more effective system for providing veterinarians and laboratory technicians with automated interpretation of test results. (Specification [0005]).” The Examiner agrees that the specification shows that the invention is an improved method of organizing human activity. It does so by applying technology to the abstract idea to obtain all the benefits of applying technology to the abstract idea.
The Applicant states, “In this regard, the claims recite several technical improvements over the field, including …” The Applicant’s opinion is noted. However, the Specification provides no proof. Further arguments that the invention is a technical improvement without proof are considered moot.
The Applicant states, “These assertions of innovative features in the pending claims must be accepted as true absent a showing by the Examiner for how they are well understood, routine, and conventional to a skilled artisan at the time of the patent application. (see Berkheimer v. HP Inc., 881 F.3d 1360, 1369 (Fed. Cir. 2018)).” However, the Specification makes not assertions. The only assertions arise from the Applicant after the effective filing date.
The Applicant states, “For example, the claims disclose details for how to accomplish the new tasks of generating the clinical interpretation, rather than simply outputting the interpretation. Notably, the claims are directed to a specific way of structuring and executing clinical decision support interfaces on a computer, not merely the abstract idea of correlating a hormone level with a condition.” The portion of the claim regarding “clinical interpretation”
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, the computing device in real-time executing a set of 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, within a database, 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
responsively providing via the graphical user interface the clinical interpretation of the diagnostic test in the side panel.
As shown here, the claim does not describe a “specific way of structure and executing clinical support decision interfaces.” Rather the claim limitations are at a high level using functional terms. Unless the Applicant explicitly shows a specific claim limitation, further arguments to the interpretation or the interface are considered moot.
4. Response to the § 101 Rejections
A. Independent Claims 1, 14, and 19 are not directed to any judicial exception
i. Step 2A Prong One: Organizing Human Activity
The Applicant states, “As noted in MPEP 2106.04(a)(2)(II)(C), this subgrouping includes "social activities, teaching, and following rules or instructions.” The Applicant chose not to include the complete section so the Examiner is doing so here
.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).
The Applicant further states, “The mere fact that a claimed invention replaces a need for a human interaction does not mean that the claim is directed to the abstract idea of managing personal behavior or relationships or interactions between people. The claims are not directed to simply using technology to perform a diagnosis, but rather, claim a specific layout and functionality of a graphical user interface.” The Examiner agrees that the invention applies technology to the abstract idea. However, as mentioned above, the claims are not specific regardless of Applicant assertions without proof.
The Applicant states, “The Example 37 specifically states that "the claim does not recite any method of organizing human activity." As mentioned above, the instant invention is not a technical or technological improvement regarding a problem of technology. The comparison to Example 37 is misplaced.
The Applicant states, “The features recited in the pending claims of triggering the … are examples of improvements to layout and functionality of the user interface that are akin to Example 37 which were found to not recite any judicial exception.” The Examiner agrees that the improvements are related to the user experiences of “layout and functionality” unlike the cited cases.
The Applicant states, “The pending claims further provide specific requirements for the claimed user interface, such as a particular manner of displaying a limited set of information to the user, rather than using conventional user interface methods to display a generic index on a computer, and the limited set of information is generated dynamically per patient based on diagnostic tests on the patient.” As noted by the Specification and as claimed, the invention is disclosed as a high level using functional terms. The invention does not show a “particular manor or displaying” but rather generically displays data.
ii. Step 2A Prong Two: Independent Claims 1, 14, and 19 integrate any abstract idea into a practical application.
The Applicant states, “Rather, the relevant determination is whether the invention is described such that the improvement would be apparent to one of ordinary skill in the art. (MPEP § 2106.0S(a)(II)).” It is understood that a primary examiner such as myself is one of ordinary skill. This examiner sees no improvement within the Specification. The only argument that one exists is from the Applicant after the effective filing data.
The Applicant states, “The claimed invention provides an improvement in the technology of veterinary diagnostics.” This assertion is not found within the originally filed invention.
The Applicant further states, “Thus, the steps of the claim provide an improvement in the technological field by enabling a real-time diagnostic interpretation of clinical results in a graphical user interface alongside the results themselves.” Please see above regarding applying technology to the instant invention.
The Applicant states, “Further, as noted in the discussion above, both the courts and the Office have indicated that improved graphical interfaces can provide an improvement in a technological field that integrates an alleged abstract idea into a practical application.” The Specification does not describe an improved graphical interface.
As for all of the cited cases and the related Example 37, the Court used the Specification as a guide to show that the invention was a technological improvement. It is important to note that throughout all of the Applicant’s arguments, no specific Specification citations are made.
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).
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.
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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