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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 05, 2025 has been entered.
Election/Restrictions
Newly submitted claims 47 and 48 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Originally submitted claims 1-30 were directed to a system and method for interpreting one or more test results for one or more patients. Claims 47 and 48 are directed to a method for presenting patient-specific interpretations of infection test results. These two inventions are related as subcombinations useable together. Inventions are distinct as subcombinations useable together if they do not overlap in scope and are not obvious variants, and if it is shown that at least one subcombination is separately usable. These inventions are not obvious variants as the former interprets test results and the former presents the interpreted test results. Claims 47 and 48 have separate utility from the originally filed claims in that these claims annotate patient records. Accordingly these inventions are distinct.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 47 and 48 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Status of Claims
This office action for the 17/947899 application is in response to the communications filed December 25, 2025.
Claims 1 and 16 were December 25, 2025.
Claims 2-15 and 17-30 were cancelled December 25, 2025.
Claims 31-48 were added as new December 25, 2025.
Claims 47 and 48 hereby withdrawn from consideration for being directed to a non-elected invention.
Claims 1, 16 and 31-46 are currently pending and considered below.
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, 16 and 31-46 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.
As per claim 1,
Step 1: The claim recites subject matter within a statutory category as a process.
Step 2A is a two-prong inquiry, in which Prong 1 determines whether a claim recites a judicial exception. Prong 2 determines if the additional limitations of the claim integrates the recited judicial exception into a practical application. If the additional elements of the claim fail to integrate the judicial exception into a practical application, claim is directed to the recited judicial exception, see MPEP 2106.04(II)(A).
Step 2A Prong 1: The claim contains subject matter that recites an abstract idea, with the steps of a method for interpreting one or more test results for one or more patients comprising: providing a first database and a second database, wherein the first database contains the one or more test results for the one or more patients comprising active infection test results and past infection test results, and the second database comprises a database structure having a first data table comprising received interpretation orders, a second data table comprising received test result(s) corresponding to a plurality of combinations of the active infection test results and the past infection test results, and a third data table comprising sent interpretation results; accessing the active infection test results of a selected patient; accessing the past infection test results of the selected patient; identifying a patient-specific test pattern of the selected patient defined by the active infection results and the past infection test results of the selected patient; and matching the patient-specific test pattern of the selected patient to one of the patient-specific interpretations within the set of patient-specific interpretations of the active infection test results and the past infection test results. These steps, as drafted, under the broadest reasonable interpretation recite:
certain methods of organizing human activity (e.g., fundamental economic principles or practices including: hedging; insurance; mitigating risk; etc., commercial or legal interactions including: agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations; etc., managing personal behavior or relationships or interactions between people including: social activities; teaching; following rules or instructions; etc.) 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 being directed to certain methods of organizing human activity. For example, but for the additional element(s), the identified abstract idea, law of nature, or natural phenomenon identified above, in the context of this claim, encompasses a certain method of organizing human activity, namely managing personal behavior or relationships or interactions between people. This is because each of the limitations of the abstract idea recites a list of rules or instructions that a human person is capable of following in the course of their personal behavior. If a claim limitation, under its broadest reasonable interpretation, covers at least the recited methods of organizing human activity above, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. See MPEP 2106.04(a).
Step 2A Prong 2: The claim does not recite additional elements that integrate the judicial exception 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, see MPEP 2106.05(f), such as:
“computerized”, “automatically”, “providing an input/output interface, a memory, and one or more processors communicably coupled to the input/output interface and the memory”, “communicably coupled to the one or more processors” and “by the one or more processors” which corresponds to merely using a computer as a tool to perform an abstract idea. Paragraph [0016] of the as-filed specification describes that the technology that implements the abstract idea are at a level of a generic computer. Implementing an abstract idea on a generic computer, does not integrate the abstract idea into a practical application in Step 2A Prong Two or 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 of intermediated settlement on a generic computer.
add insignificant extra-solution activity to the abstract idea, see MPEP 2106.05(g), such as:
“storing, by the one or more processors, a set of patient-specific interpretations of the active infection test results and the past infection test results”, “from the first database”, “from the second database” and “presenting the matched patient-specific interpretation of the active infection test results and the past infection test results to one or more devices communicably coupled to the input/output interface” which corresponds to mere data gathering and/or output.
Accordingly, this claim is directed to an abstract idea.
Step 2B: The claim does not recite additional elements that 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/or generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, identified as insignificant extra-solution activity to the abstract idea, 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:
computer functions that have been identified by the courts as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity, see MPEP 2106.05(d)(II), such as:
“storing, by the one or more processors, a set of patient-specific interpretations of the active infection test results and the past infection test results”, “from the first database”, and “from the second database” which corresponds to receiving or transmitting data over a network.
“presenting the matched patient-specific interpretation of the active infection test results and the past infection test results to one or more devices communicably coupled to the input/output interface” which corresponds to storing and retrieving information in memory.
Looking at the limitations of the claim 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 recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 16,
Claim 16 is substantially similar to claim 1. Accordingly, claim 16 is rejected for the same reasons as claim 1.
As per claim 31,
Claim 31 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 31 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein presenting the matched patient-specific interpretation of the active infection test results and the past infection test results to one or more devices communicably coupled to the input/output interface comprises presenting the matched patient-specific interpretation together with the active infection test results and past infection test results of the selected patient to the one or more devices communicably coupled to the input/output interface.” further defines an additional element that was insufficient to provide a practical application and/or significantly more. The claim with this further defining limitation still corresponds to mere data gathering and/or output.
Looking at the limitations of the claim 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 recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 32,
Claim 32 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 32 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the matched patient-specific interpretation is based on a clinical history of the specified patient.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim 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 recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 33,
Claim 33 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 33 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the matched patient-specific interpretation comprises a first interpretation for a majority percentage of patients and a second interpretation for a minority percentage of patients.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim 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 recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 34,
Claim 34 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 34 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the matched patient-specific interpretation comprises a first percentage of patients for which active infection test results are truly positive and a second percentage of patients for which the active infection test results are a false positive.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim 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 recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 35,
Claim 35 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 35 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the matched patient-specific interpretation comprises a first percentage of patients for which past infection test results are truly negative and a second percentage of patients for which the past infection test results are a false negative.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim 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 recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 36,
Claim 36 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 36 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the set of patient-specific interpretations was drafted by a pathologist.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim 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 recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 37,
Claim 37 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 37 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the active infection test results comprise PCR test results.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim 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 recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 38,
Claim 38 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 38 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the past infection results comprise antibody test results.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim 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 recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 39,
Claim 39 is substantially similar to claim 31. Accordingly, claim 39 is rejected for the same reasons as claim 31.
As per claim 40,
Claim 40 is substantially similar to claim 32. Accordingly, claim 40 is rejected for the same reasons as claim 32.
As per claim 41,
Claim 41 is substantially similar to claim 33. Accordingly, claim 41 is rejected for the same reasons as claim 33.
As per claim 42,
Claim 42 is substantially similar to claim 34. Accordingly, claim 42 is rejected for the same reasons as claim 34.
As per claim 43,
Claim 43 is substantially similar to claim 35. Accordingly, claim 43 is rejected for the same reasons as claim 35.
As per claim 44,
Claim 44 is substantially similar to claim 36. Accordingly, claim 44 is rejected for the same reasons as claim 36.
As per claim 45,
Claim 45 is substantially similar to claim 37. Accordingly, claim 45 is rejected for the same reasons as claim 37.
As per claim 46,
Claim 46 is substantially similar to claim 38. Accordingly, claim 46 is rejected for the same reasons as claim 38.
Subject Matter Free of Prior Art
Claims 1-30 contain subject matter free pf prior art. The Examiner has conducted a thorough search of the prior art and could not find a single reference, or combination of references with adequate rationale to combine, to teach the limitation of “providing a first database and a second database communicably coupled to the one or more processors, wherein the first database contains the one or more test results for the one or more patients comprising active infection results and past infection results, and the second database comprises a database structure having a first data table comprising received interpretation orders, a second data table comprising received test result(s) corresponding to a plurality of combinations of the active infection test results and the past infection test results, and a third data table comprising sent interpretation results” in claim 1. Claim 16 recites similar limitations. Not only do these data sources need to come from the same database, the tables themselves (or any comparable data structure) are arranged in a way that the Examiner cannot find a similar disclosure. The closest prior art to this limitation is Adib et al. (US 2023/0030064; herein referred to as Adib). Adib discloses a COVID testing system which has two devices coupled together where one system receives an order for interpretation, receives results, interprets the results and provides order results. See Figure 1. These functions are very similar to what information is stored in the claimed plurality of tables. Further, FIGs 6G and 6H describe data fields arranged in tables to document the medical information exchanges. For example, element 661 has a table with fields of “ordered at” and “order ID”, element 662 has a field of “resulted at”, and element 651 has a field of “created at”. All of these elements could be fairly characterized as separate tables. However, these fields do not explicitly teach that they relate to received interpretation orders, received test results and sent interpretation results. The Examiner would have to rely on impermissible hindsight reasoning to read these meanings into Adib or modify it with other prior art. Furthermore, simply because these data fields are populated into these displayed elements, it does not necessitate that the data is being sourced from three separate tables in the database 140. Adib is silent with this regard. Other close prior arts to this limitation would be Gui et al. (US 2021/0349875), Jain et al. (US 11,824,756) and Moore (US 2006/0173985) which each teach a database with a plurality of data tables that have interdependent sets of information within them. However, these references fall short of having the specific interpretation orders, received test results, and interpretation results all in separate tables. Accordingly, claims 1-30 contain subject matter free of prior art.
Response to Arguments
Applicant's arguments filed December 27, 2024 have been fully considered.
Applicant’s arguments pertaining to rejections made under 35 U.S.C. 101 are not persuasive:
The Applicant argues that the claimed invention recite a technical improvement in the analysis of medical test results. The evidence provided by the Affiant and the lower death rates at UTMB, compared to other hospitals provide basis to conclude that the claimed steps of the invention provide an improvement to technology.
The Examiner disagrees. The Examiner does not disagree with the Declarations made by Dr. Laposata or with the evidence presented, however, it would appear that the pending claims do not provide a sufficient nexus between the evidence and the claim as written. While it may be true that the way that UTMB has being identifying and matching patients with a greater degree of accuracy for medical screening, the claims do not define how these identification or matching steps are accomplished. As written, the identification and matching steps merely define what information is being analyzed, but not how. Any person can identify a patient-specific test pattern. The difference between any kind of identification, as claimed, and argued identification is that the argued identification has evidence of improved patient outcome resultant from more accurate data analysis. If these steps are truly the basis from which improved technology rely, the technical detail for how this technology is being improved must be articulated.
Applicant’s remaining arguments are rendered moot in light of the foregoing response.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHAD A NEWTON whose telephone number is (313)446-6604. The examiner can normally be reached M-F 8:00AM-4:00PM (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, PETER H CHOI can be reached on (469) 295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHAD A NEWTON/Primary Examiner, Art Unit 3686
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