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 .
Response to Amendment
The IDS of 08/21/2026 has been considered.
In light of the amendments, the claims are rejected under 35 U.S.C. 112(b).
In light of the amendments, the claims remain rejected under 35 U.S.C. 101.
Notice to Applicant
In the amendment dated 08/21/2026, the following has occurred: claims 21 and 28 have been amended; claims 1-20 and 24 have been canceled; claims 22-23, 25-27, and 29-36 remain unchanged; and no new claims have been added.
Claims 21-23 and 25-36 are pending.
Effective Filing Date: 11/16/2017
Response to Arguments
35 U.S.C. 101 Rejections:
Applicant argues with respect to the amended claims and states that the administration step is particular enough. Examiner however respectfully disagrees and directs Applicant to Example 43, claim 1 of the 2019 PEG. For the same reason as in this example, the present claims do not recite the treatment in a specific manner. Both the example and the present claims recite the treatment in a generic manner.
Applicant further argues that Examiner needs to examine the claims as a whole, and cites to the claims being directed towards providing a continuity of care during a transfer of a patient. Examiner however has examined the claims as a whole. Initially, do the claims reflect a continuity of care, or does it show that care is being given and then a patient is being transferred?
Lastly, the additional elements do not amount to significantly more. As stated above, the administration is done so in a non-particular manner and is similar to claim 1 of Example 43. Furthermore, the measurement apparatus is only provided in order to provide data is a pre-solution activity manner.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/21/2026 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 § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21-23 and 25-36 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 recites the limitation “the at least one additional assessment” in the “preparing a transfer record…” limitation. There is insufficient antecedent basis for this limitation in the claim.
Claims 22-23 and 25-36 are rejected based on their dependency on claim 21.
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 21-23 and 25-36 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 21-23 and 25-36 are drawn to a method, each of which is within the four statutory categories. Claims 21-23 and 25-36 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) 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, a) 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) administering a PU intervention of level-0 for the patient during the transfer if any of the delta values does not exceed a threshold,
4) administering a PU intervention of level-N for the patient during the transfer if any of the delta values exceeds the threshold, 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 1 or greater,
5) 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,
6) transferring the patient, and
7) 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, 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, 5) 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, 6) transferring the patient, and 7) 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 step 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. This step corresponds to Mathematical Concepts. For example, these limitations describe mathematical calculations.
Here, steps 1), 5), 6), and 7) fall within the certain methods of organizing human activity grouping of abstract ideas, and step 2) falls within the mathematical concepts grouping of abstract ideas. Limitations 1), 2), 5), 6), and 7) are considered together as a single abstract idea for further analysis.
Depending claims 22-23 and 25-36 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 a 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 22-23, 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 22-23 and 25-36 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 recite the additional elements of – using a) a sub-epidermal moisture (SEM) scanning apparatus, wherein the SEM scanning apparatus comprises a sensor configured to measure biocapacitance indicative of SEM to perform the claimed steps.
The claims also include the additional element steps of 3) “administering a PU intervention of level-0 for the patient during the transfer if any of the delta values does not exceed a threshold” and 4) “administering a PU intervention of level-N for the patient during the transfer if any of the delta values exceeds the threshold, 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 1 or greater”.
The a) sub-epidermal moisture (SEM) scanning apparatus in these steps adds insignificant extra-solution activity to the abstract idea which amounts to mere data gathering, see MPEP 2106.05(g).
Additionally, the steps of 3) “administering a PU intervention of level-0 for the patient during the transfer if any of the delta values does not exceed a threshold” and 4) “administering a PU intervention of level-N for the patient during the transfer if any of the delta values exceeds the threshold, 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 1 or greater” are recited at a high-level of generality (i.e., as generic components performing generic computer functions) such that they amount to no more than mere instructions to apply the exception (see: Example 43, claim 1 of the 2019 PEG examples).
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. 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.
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, the additional elements of using a) a sub-epidermal moisture (SEM) scanning apparatus, wherein the SEM scanning apparatus comprises a sensor configured to measure biocapacitance indicative of SEM to perform the claimed steps and using the additional element steps of 3) “administering a PU intervention of level-0 for the patient during the transfer if any of the delta values does not exceed a threshold” and 4) “administering a PU intervention of level-N for the patient during the transfer if any of the delta values exceeds the threshold, 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 1 or greater” amounts to no more than insignificant extra-solution activity in the form of WURC activity (well-understood, routine, and conventional activity) and mere instructions to apply the exception using a generic computer component that does not offer “significantly more” than the abstract idea itself because the claims do not recite an improvement to another technology or technical field, an improvement to the functioning of any computer itself, or provide meaningful limitations beyond generally linking an abstract idea to a particular technological environment. It should be noted that the claims do not include additional elements that amount to significantly more than the judicial exception because the Specification recites mere generic computer components, as discussed above that are being used to apply certain method steps of organizing human activity and certain mathematical steps. Specifically, MPEP 2106.05(d) and MPEP 2106.05(f) recite that the following limitations are not significantly more:
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)); and
Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 134 S. Ct. at 2360, 110 USPQ2d at 1984 (see MPEP § 2106.05(f)).
The a) sub-epidermal moisture (SEM) scanning apparatus, wherein the SEM scanning apparatus comprises a sensor configured to measure biocapacitance indicative of SEM in these steps add insignificant extra-solution activity/pre-solution activity in the form of WURC activity to the abstract idea. The following is an example of a court decision demonstrating computer functions as well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II): Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention receives SEM measurement data.
Furthermore, the current invention treats a patient utilizing the steps of 3) “administering a PU intervention of level-0 for the patient during the transfer if any of the delta values does not exceed a threshold” and 4) “administering a PU intervention of level-N for the patient during the transfer if any of the delta values exceeds the threshold, 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 1 or greater”, thus these steps are adding the words “apply it” with mere instructions to implement the abstract idea using a high level of generality.
Mere instructions to apply an exception using generic computer components or insignificant extra-solution activity in the form of WURC activity cannot provide an inventive concept. The claims are not patent eligible (Step 2B: NO).
Claims 21-23 and 25-36 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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 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 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
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