DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/23/2026 has been entered.
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 .
Response to Amendment
The IDS of 01/23/2026 has been considered.
In light of the amendments, the previous claim objection has been withdrawn.
In light of the amendments, the previous claim 112(b) rejections have been withdrawn.
In light of the amendments, the claims remain rejected under 35 U.S.C. 101.
Notice to Applicant
In the amendment dated 01/23/2026, the following has occurred: claim 21 has been amended; claims 1-20 have been canceled; claims 22-36 remain unchanged; and no new claims have been added.
Claims 21-36 are pending.
Effective Filing Date: 11/16/2017
Response to Arguments
Claim Objection:
Examiner withdraws the previous claim objection.
35 U.S.C. 112(b) Rejections:
Examiner withdraws the previous 112(b) claim rejections.
35 U.S.C. 101 Rejections:
Applicant recites that the claims reflect a technological solution to a technological problem of deciding when to transfer a patient based on their data values. Applicant points to the Oliveira et al. reference and states that making multiple measurements were able to detect early pressure damage. Examiner views this as an improvement, though, the improvement is to the abstract idea involving assessing a patient in order to treat them. Applicant further states that the claims would therefore overcome 101 at Step 2A, Prong Two. Examiner however respectfully disagrees as the Vanda criteria are not strictly being followed. The present claims do not meet this criteria as there is no particular intervention administered in a specific way for a particular condition. Furthermore, the intervention here is not limited to treatments as the breadth of interventions could be met with assessments, etc.
Applicant further states the claims would overcome the 101 at Step 2B. Examiner respectfully disagrees as the claims do not provide additional elements which would integrate with the abstract idea to provide significantly more.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/23/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 21-36 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. Claims 21-36 are drawn to a method, each of which is within the four statutory categories. Claims 21-36 are further directed to an abstract idea on the grounds set out in detail below. As discussed below, the claims do not include additional elements that are sufficient to amount to significantly more than the abstract idea because the additional computer elements, which are recited at a high level of generality, provide conventional computer functions that do not add meaningful limits to practicing the abstract idea (Step 1: YES).
Step 2A:
Prong One:
Claim 21 recites a method of providing a continuity of care for a patient at risk of developing pressure ulcers (PU) during a transfer between care settings, the method comprising the steps of:
1) performing a first assessment of the patient in a first care setting using a sub-epidermal moisture (SEM) scanning apparatus, comprising performing three or more SEM scans of at least one body location of the patient, wherein each of the three or more SEM scans are performed at different times while in the first care setting, wherein each SEM scan comprises a plurality of SEM measurements, wherein the SEM scanning apparatus comprises a sensor configured to measure biocapacitance indicative of SEM,
2) calculating a delta value for each of the three or more SEM scans, wherein each one of the delta values is determined by the difference between the maximum SEM measurement and the minimum SEM measurement from the respective plurality of SEM measurements, wherein each one of the delta values is a positive value, recording the delta values from each of the respective SEM scans,
3) analyzing the delta values to determine one or more of a slope, an acceleration, a curve shape and associated characteristics, and a time-to-intercept of a selected threshold value,
4) administering a PU intervention of level-N for the patient during the transfer, wherein the PU intervention is selected and implemented based partially on the body location of the patient and partially on the delta value for that body location, where N is an integer and N has a value of 0 or greater, wherein the PU intervention further comprises performing a second assessment of the patient at a first pre-determined frequency corresponding to the PU intervention level,
5) performing at least one additional assessment selected from the group consisting of a risk assessment of the patient, a visual skin assessment of at least one body location of the patient, and an image of the at least one body location,
6) deciding to transfer the patient from the first care setting to a second care setting based partially on one or more of the slope, the acceleration, the curve shape and associated characteristics, the time-to-intercept of a selected threshold value, and the PU intervention,
7) preparing a transfer record for transferring to the second care setting comprising the first assessment, the PU intervention, and the at least one additional assessment,
8) transferring the patient, and
9) transmitting the transfer record with the patient to the second care setting.
Claim 21 recites, in part, performing the steps of 1) performing a first assessment of the patient in a first care setting using a sub-epidermal moisture (SEM) scanning apparatus, comprising performing three or more SEM scans of at least one body location of the patient, wherein each of the three or more SEM scans are performed at different times while in the first care setting, wherein each SEM scan comprises a plurality of SEM measurements, wherein the SEM scanning apparatus comprises a sensor configured to measure biocapacitance indicative of SEM (the apparatus here is being used to perform a scan and humans are capable of using this apparatus, so the performance of data capture using the apparatus can be categorized as part of the abstract idea here), 4) administering a PU intervention of level-N for the patient during the transfer, wherein the PU intervention is selected and implemented based partially on the body location of the patient and partially on the delta value for that body location, where N is an integer and N has a value of 0 or greater, wherein the PU intervention further comprises performing a second assessment of the patient at a first pre-determined frequency corresponding to the PU intervention level, 5) performing at least one additional assessment selected from the group consisting of a risk assessment of the patient, a visual skin assessment of at least one body location of the patient, and an image of the at least one body location, 6) deciding to transfer the patient from the first care setting to a second care setting based partially on one or more of the slope, the acceleration, the curve shape and associated characteristics, the time-to-intercept of a selected threshold value, and the PU intervention, 7) preparing a transfer record for transferring to the second care setting comprising the first assessment, the PU intervention, and the at least one additional assessment, 8) transferring the patient, and 9) transmitting the transfer record with the patient to the second care setting. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, these limitations describe a process of determining care and transferring care to another entity.
Additionally, claim 21 recites, in part, performing the steps of 2) calculating a delta value for each of the three or more SEM scans, wherein each one of the delta values is determined by the difference between the maximum SEM measurement and the minimum SEM measurement from the respective plurality of SEM measurements, wherein each one of the delta values is a positive value, recording the delta values from each of the respective SEM scans, 3) analyzing the delta values to determine one or more of a slope, an acceleration, a curve shape and associated characteristics, and a time-to-intercept of a selected threshold value, and 6) deciding to transfer the patient from the first care setting to a second care setting based partially on one or more of the slope, the acceleration, the curve shape and associated characteristics, the time-to-intercept of a selected threshold value, and the PU intervention. These steps correspond to Mathematical Concepts. For example, these limitations describe mathematical calculations.
Here, steps 1), 4), 5), 6), 7), 8), and 9) fall within the certain methods of organizing human activity grouping of abstract ideas, and steps 2), 3), and 6) fall within the mathematical concepts grouping of abstract ideas. Limitations 1) - 9) are considered together as a single abstract idea for further analysis.
Depending claims 22-36 include all of the limitations of claim 1, and therefore likewise incorporate the above described abstract idea. Depending claim 26 adds the additional steps of “performing a first SEM scan of the at least one body location of the patient while in the first care setting, wherein the first SEM scan comprises a plurality of SEM measurements at the body location and calculation of a first delta value from the plurality of SEM values”, “creating a first data record that comprises the first delta value”, “reporting the first data record to a database”, and “reporting the transfer record to the database”; claim 28 adds the additional steps of “performing the second assessment comprising a SEM scan of the at least one body location of the patient and calculating a second delta value while in the second care setting”, “creating a second data record that comprises the patient identifier, the second delta value, and a third date/time when the second assessment was performed”, and “reporting the second data record to a database”; claim 29 adds the additional step of “querying the database to retrieve a portion of data records that comprise the delta values of the at least one body location of the patient”; claim 30 adds the additional steps of “formatting the retrieved delta values in date/time order” and “displaying the formatted delta values”; claim 31 adds the additional steps of “creating an additional data record that comprises the patient identifier, a data element from the group of nutritional information, an implemented intervention, a risk assessment, a visual skin assessment, a care plan, a doctor's note, an event, a vital sign, a body weight, and a lab result, and a date/time associated with the data element” and “reporting the additional data record to the database”; claim 33 adds the additional step of “analyzing the retrieved delta values to determine one or more of a slope, an acceleration, a curve shape and associated characteristics, and a time-to-intercept of a selected threshold value”; claim 35 adds the additional steps of “performing a third assessment comprising a SEM scan of the at least one body location of the patient and calculating a third delta value while in a third care setting”, “creating a third data record that comprises the patient identifier, the third delta value, and a fourth date/time when the third assessment was performed”, and “reporting the third data record to a database”; and claim 36 adds the additional step of “querying the database to retrieve the delta values observed over time for a particular patient across multiple care settings and various episodes of care”. Additionally, the limitations of depending claims 22-25, 27, 32, and 34 further specify elements from the claims from which they depend on without adding any additional steps. These additional limitations only further serve to limit the abstract idea. Thus, depending claims 22-36 are nonetheless directed towards fundamentally the same abstract idea as independent claim 1 (Step 2A (Prong One): YES).
Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims do not recite any additional elements and therefore the claims do not impose a meaningful limit to integrate the abstract idea into a practical application.
Accordingly, the abstract idea is not integrated into a practical application because they lack additional elements which impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea (Step 2A (Prong Two): NO).
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, there are no additional elements. The claims are not patent eligible (Step 2B: NO).
Claims 21-36 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Steven G.S. Sanghera whose telephone number is (571)272-6873. The examiner can normally be reached M-F 7:30-5:00 (alternating Fri).
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/STEVEN G.S. SANGHERA/Primary Examiner, Art Unit 3684