DETAILED ACTION
This is responsive to amendments filed on 03/03/2026 in which claims 1-3, and 5-18 are presented for examination; Claims 17-18 have been newly added.
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 .
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 and 5-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding claim 1:
Step 1: Is the claim to a process, machine, manufacture or composition of matter?” Yes, it’s a process (method).
Step 2a Prong 1 (judicial exception)
Step 2A (1): “Does the claim recite an abstract idea, law of nature, or natural phenomenon? Yes , the claim comes under mathematical concepts.
Claim 1 recites:
“A computer-implemented method comprising: transmitting, to a remote database storing support-system authentication request data, a communication requesting support- system authentication request data associated with a set of subjects, wherein the communication comprises a query represented with a structured syntax; receiving, from the remote database, a response that includes the support- system authentication request data associated with each subject of a set of subjects; for each subject of the set of subjects, extracting, using a key processor, a set of keys from the support-system authentication request data, with the subject , each key of the set of keys having a particular syntax corresponding to the structured syntax of the query and characterizing a system fault or a root cause determination of a set of a system faults; allocating using the key processor, each key of the set of keys to a class corresponding to fault severity based on the particular syntax using a first codebook, wherein the first codebook associates each of multiple system fault keys with a fault severity class, and the multiple system fault keys comprise the set of keys; determining, using the key processor based on data associated with the subject, one or more patches executed by the subject to address the system fault or the root cause determination of the set of system faults; determining, using a state decryption system a compromised system score and/or a system fault identifier based at least in part on the class corresponding to the fault severity of each key of the set of keys code and the one or more patches executed by the subject using a second codebook, wherein: (i) the compromised system score indicates one or more processes of the subject that are disabled or that have modified functionality; (ii) the system fault identifier identifies a particular system fault, a particular corruption, or a sub-type of the particular system fault, and (iii) the second codebook comprises one or more higher level encodings of the multiple system fault keys in the first codebook, wherein the second codebook comprises a multi-dimensional mapping that combines a plurality of heterogenous features to generate the compromised system score and/or the system fault identifier for each subject, wherein the plurality of heterogenous features comprises at least inpatient and outpatient diagnoses, outpatient patch authorizations, inpatient and outpatient operations and procedures, medical aids, special therapies, and dates or periods of diagnosis; and determining, using the state decryption system, a segmented group to which the subject is to be assigned based on the compromised system score and/or the system fault identifier, wherein each subject assigned to the segmented group, a same eligibility or ineligibility for a particular patch testing, or a same response to the particular patch testing; and administering a particular patch testing on a subset of subjects, wherein each subject of the subset of subjects is assigned to a same segmented group having the same eligibility for the particular patch testing or the same response to the particular patch testing.”
All the limitations above are abstract idea related to the mental process (concepts performed in the human mind (including an observation, evaluation, judgment, opinion)) with the exception of bold and underlined limitations. Claim language pertains to extracting information from medical records, such as keys(derived from first or second codebook, e.g. ICD-9, or KFSS )and based on extracted information determining the severity of disease (in instant case of multiple sclerosis). One can perform such task using pen and paper, for example from the patient records on paper, one could extract ICD-9 code, EDSS value, etc.…; and determine the disability level of the patients. Also, searching can be performed on pen and paper using certain attribute (structured syntax); however, to perform databased search using structured syntax, the limitation could also be identified as additional limitation and it is addressed below. Disease symptoms can be matched to second codebook , to determine the severity , and can be done using paper. Patients can be assigned to specific groups based on severity, considering , the group represents people having same severity level of disease, eligibility for patch testing (medicine), and response to patch testing(medication). Any features /characteristics of a particular disease can be analyzed and scored for diagnosis for any patient. A particular patch testing can be administered in a clinical setting for multiple patients(subset of subjects) showing the same response for a particular patch, and can be grouped together. Also, MPEP § 2106.04(a). All of this can be done using paper.
Step 2A(2): Prong Two: evaluate whether the claim recites additional elements that integrate the exception into a practical application of the exception. NO
The claim does recite additional elements; however they don’t integrate the exception into a practical application of the exception.
Transmitting, to a remote database …..(Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g))
receiving from the remote database (Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g))
computer(Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
a query represented with a structured syntax (Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
Step 2B: evaluate whether the claim recites additional elements that amount to an inventive concept (aka “significantly more”) than the recited judicial exception? NO
As discussed previously with respect to Step 2A Prong Two, the additional
element of computer in the claim amounts to no more than mere instructions to apply
the exception using a generic computer component.
Regarding claim limitations :
Transmitting to a remote database (“i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); -See, MPEP 2106.05 (d)(II))
receiving from the remote database (i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); -See, MPEP 2106.05 (d)(II))
a query represented with a structured syntax (Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
computer-implemented( Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
processor( Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
decryption system( Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
remote device( Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
computer( Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
Dependent claims 2-9 further narrows the abstract idea defined in claim 1. In addition , the additional elements are “encryption system”.
Under step 2A, prong two, the additional elements don’t integrate the exception into a practical application of the exception as merely adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f).
As discussed previously with respect to Step 2A Prong Two, the additional elements in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
(Claim 10) is rejected based on same rational as claim 1; it further includes additional element of processor and memory (Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
Dependent claims 11-18 further narrows the abstract idea defined in the claim 10. In addition , the additional elements are “ encryption protocols”, “encoded”, “encryption system”, “encryption keys”.
Under step 2A, prong two, the additional elements don’t integrate the exception into a practical application of the exception as merely adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f).
As discussed previously with respect to Step 2A Prong Two, the additional elements in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Response to Arguments
Applicant's arguments filed on 036 have been fully considered but they are not persuasive.
Remarks - 35 USC § 101
In remarks, Pg. 10, applicant contends:
“The Office alleges the above limitations recite mental processes. Applicant respectfully disagrees. The determining step requires specialized computer systems, specifically, a state decryption system and a second codebook implementing multi-dimensional mapping, to process heterogeneous clinical data. The Office has acknowledged that the state decryption system is considered as an additional element. The determining step expressly requires the use of the state decryption system to combine inpatient and outpatient diagnoses, patch authorizations, procedures, therapies, and temporal information in a structured, automated manner to generate objective scores and identifiers. Such determining step is inseparable to the additional element and cannot be achieved without the claimed elements of the state decryption system and the second codebook. Accordingly, the determining step does not recite a mental process, as it involves integration of high-volume, multi-modal data using technical tools that cannot be reliably performed by human observation or manual calculation. Accordingly, the determining step is an additional elements.”
The above stated steps can be performed using paper and pen, and don’t require the decryption system; however, the examiner agrees that applicant is applying decrypting system to perform these steps, thus the conclusion, the applicant is using decryption system as a tool. For example, looking at the above steps, one can combine inpatient and outpatient diagnosis reports using paper and pen; similarity patch authorization, therapies, evaluation score all can be done via the paper and pen. In fact, even now, the physician can perform all these steps, and provide medical reports/notes.
In remarks, Pg. 11, applicant contends: “The administering step also constitutes an additional element beyond a mental process. By its plain meaning, the administering step refers to the process of conducting a clinical trial or therapeutic evaluation in which a medical patch is applied, tested, or evaluated on a subset of subjects. This administration step is executed based on prior technical steps that objectively assign subjects to specific segmented groups, using automated analysis of encoded clinical data. The administration step encompasses the actual implementation of patch testing protocols on selected subjects, ensuring that all subjects in the subset share defined eligibility criteria or predicted response profiles, providing reproducible and objective testing conditions, which improves the quality and reliability of clinical trial results. Accordingly, the administering step should also be considered as an additional element.”
The claim language recites “administering a particular patch testing on a subset of subjects,wherein each subject of the subset of subjects is assigned to a same segmented group having the same eligibility for the particular patch testing or the same response to the particular patch testing.”
Clearly, one can divide the group of patients into subsets, and administer patch testing on selected subgroup. In fact, if one reads any medical trial, the methodologies, will outline the control group, and the group to administer the patch. This is nothing more than separating the patient group into subgroups. For argument sake, even if one states that physical action of administration is not a mental process, administrating patches is well known and conventional. The applicant is not providing any specific technical detail, as how the claimed administration of patch improves a patch administrating technology. Also, note that organizing patients into groups, and administrating the patch can also fall under organizing human activity grouping of abstract idea (managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions)).
In remarks, Pg. 12, applicant contends: “in response to Applicant's arguments in the last response regarding improvement to the technical field of patch testing, the Office merely alleges "selecting the subset of subjects ... can be done using paper and pen" and further alleges "Under 35 U.S.C. 101 analysis, we analyze the additional limitations to see, if the additional limitations integrate the abstract idea into practical application." This is not an accurate standard. The proper analysis, as set forth in MPEP § 2106.04(d), requires the Office to evaluate the claim as a whole. Additionally, under MPEP § 2106.07(b), when evaluating a response, "examiners must carefully consider all of applicant's arguments and evidence rebutting the subject matter eligibility rejection." The Office fails to consider Applicant's arguments regarding improvement to the technical field of patch testing when considering Claim 1 as a whole.”
The guidelines require “evaluating those additional elements individually and in combination.” The examiner have done so, in the analysis above; as individual claim includes abstract limitations, and additional elements, the examiner have analyzed each of those elements, and reached to conclusion that the claim as whole is merely applying the tools to implement the abstract idea. The claim as a whole is not regarding to any technical improvement or any technical field; in fact, the claim is silent with regard to any technical detail at all.
In remarks, Pg. 12-13, applicant contends: “Under MPEP 2106.04(d)(2), when determining whether a claim applies or uses a recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, the following factors are relevant: (a) the particularity or generality of the treatment or prophylaxis; (b) whether the limitation(s) have more than a nominal or insignificant relationship to the exception(s); and (c) whether the limitation(s) are merely extra-solution activity or a field of use. Applying these factors, representative Claim 1 clearly recites the administration of a specific patch testing to a subset of subjects, with eligibility determined through a detailed, multi-step technical process. This demonstrates particularity, as treatment is tailored to individualized, system-generated criteria, not applied generically. As previously argued, the administering step is integral to the claimed method; it is not merely incidental or nominal, but directly determines which subjects receive treatment based on the technical outputs of the system. Finally, the administration of patch testing is not extra-solution activity or a field of use. The claimed technical process enables improved efficacy and reproducibility in patch testing, and the administering step realizes these technical benefits by operationalizing the group assignments generated through automated, encoded analysis.”
The applicant is completely misconstruing the claimed invention; first of all, what is the technical process being recited in the claimed language? As stated above, the majority of the steps can be performed using paper and pen. Secondly, “the claimed technical process enables improved efficacy and reproducibility in patch testing”; improved efficacy and reproducibility are improvements to the health; however they are not technical improvements.
The remaining arguments are substantially same as previously recited, and also discussed in the interviews and have been previously addressed in multiple office actions. In addition, please note, the examiner, and additional primary examiner have held multiple interviews, to address applicant’s concerns with regard to 35 U.S.C 101. In addition, the examiner again have consulted multiple subject matter experts to ensure that claims as presented are ineligible under 35 U.S.C 101.
Conclusion
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HUMA WASEEM whose telephone number is (571)272-1316. The examiner can normally be reached Monday-Friday(9:00am - 5:00 pm) EST.
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, Jason B. Dunham can be reached on (571) 272-8109. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HUMA WASEEM/Examiner, Art Unit 3686
/JASON B DUNHAM/Supervisory Patent Examiner, Art Unit 3686
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