Office Action 6: Final Rejection (2023-05-24)
Rejection types: 103 - Obviousness

CLAIMS:
IN THE CLAIMS:

Please AMEND the claims as follows:

1-20. (Cancelled) 219

21\. (Currently Amended) A method of providing a continuity of care for a patient at risk of developing pressure ulcers (PU) during transfer from a first care setting to a second care setting, the method comprising the steps of:
identifying a current PU intervention of level-K received by the patient at the first care setting, wherein the current PU intervention of level-K is provided in a transfer record, wherein the transfer record further comprises results obtained from performing a first SEM scan of at least one body location of the patient while in the first care setting, wherein the first SEM scan comprises a plurality of measurements of an SEM value at the body location and calculation of a first delta value from the plurality of SEM values, wherein if the current PU intervention of level-K is a level-0 PU intervention, the level-0 PU intervention comprises performing a daily SEM scan of at least one body location of the patient;
making a plurality of Sub-Epidermal Moisture (SEM) measurements at a body location on the patient at the second care setting, each SEM measurement comprising a measurement of biocapacitance, calculating a delta value by a difference between two of the plurality of SEM measurements, determining whether the delta value exceeds a threshold, continuing to administer the current PU intervention if the delta value does not exceed the threshold, and
administering a new PU intervention of level-N if the delta value exceeds the threshold, where N has a value greater than K.

22\. (Cancelled)

23\. (Previously Presented) The method of claim 21, wherein the transfer record further comprises delta values calculated from a portion of the plurality of SEM scans of the patient taken at different times while in the first care setting.

24\. (Previously Presented) The method of claim 21, wherein the transfer record further comprises results obtained from at least one of assessments 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.

25\. (Previously Presented) The method of claim 21, wherein the transfer record is stored on a database.

26\. (Previously Presented) The method of claim 25, wherein:
the transfer record further comprises a patient identifier and a date and a time when said first SEM scan was performed.

27\. (Previously Presented) The method of claim 21, further comprising continuing to make a plurality of SEM measurements at a pre-determined frequency corresponding to level-K if the delta value does not exceed the threshold, and making a plurality of SEM measurements at a pre-determined frequency corresponding to level-N if the delta value exceeds the threshold.

28\. (Cancelled)

29\. (Previously Presented) The method of claim 26, further comprising the steps of:
performing a second SEM scan of the body location of the patient in the second care setting to obtain a second plurality of SEM measurements, calculating a second delta value, creating a second data record that comprises the patient identifier, the second delta value, and a second date and time when the second SEM scan was performed, and
reporting the second data record to the database.

30\. (Cancelled)

31\. (Previously Presented) The method of claim 29, further comprising the step of:
querying the database for the delta value and the second delta value of the at least one body location of the patient in the transfer record and the second data record respectively to form retrieved delta values.

32\. (Previously Presented) The method of claim 31, further comprising the steps of:
formatting the retrieved delta values in date and time order, and
displaying the formatted delta values.

33\. (Previously Presented) The method of claim 29, further comprising the steps of:
creating an additional data record that comprises the patient identifier, a data element, and a date/time associated with the data element, wherein the data element comprises one or more of a 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
reporting the additional data record to the database.

34\. (Previously Presented) The method of claim 32, wherein the formatted delta values are displayed in the form of a curve.

35\. (Previously Presented) The method of claim 32, further comprising the 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.

36\. (Previously Presented) The method of claim 35, wherein the acceleration is determined by the rate of change of the slope of the curve.

37\. (Previously Presented) The method of claim 29, further comprising the steps of. performing a third SEM scan of the at least one body location of the patient in the second care setting to obtain a third plurality of SEM measurements, calculating a third delta value, creating a third data record that comprises the patient identifier, the third delta value, and
a third date and time when the third SEM scan was performed, and
reporting the third data record to a database.

38\. (Cancelled)

39\. (Previously Presented) The method of claim 37, further comprising the 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.

40\. (Currently Amended) The method of claim 21, wherein \[\[a \]\]the level-0 PU intervention further comprises an intervention \[\[is \]\]selected from the group consisting of providing good nutrition, standard mattress, turning every 24 hours, and a combination thereof.

41\. (Previously Presented) The method of claim 21, wherein a level-1 PU intervention is providing a heel boot to the patient.

42\. (Previously Presented) The method of claim 21, wherein a level-2 PU intervention is changing the patient's support surface.

43\. (Previously Presented) The method of claim 21, wherein a level-3 PU intervention is applying dressing to the back or sides of patient's heel.

44\. (Previously Presented) The method of claim 21, wherein a level-4 PU intervention is changing the patient's sheet cover to a low-friction sheet cover.

45\. (Previously Presented) The method of claim 21, wherein a level-5 PU intervention is providing a low-friction padded mattress surface for the patient's lower leg.

46\. (Previously Presented) The method of claim 21, wherein a level-6 PU intervention is turning the patient at a shorter interval than currently provided for.

47\. (Previously Presented) The method of claim 21, wherein a level-7 PU intervention is applying a barrier cream to the patient's heel.

48\. (Previously Presented) The method of claim 21, wherein a level-8 PU intervention is applying a neuro-muscular stimulation to the patient's heel.

49\. (Previously Presented) The method of claim 21, wherein a level-9 PU intervention is applying a topical cream to the patient's heel to enhance perfusion.

50\. (Previously Presented) The method of claim 21, wherein a level-10 PU intervention is providing a silicon pad for the patient's lower leg.
3 4 5 6 7

OFFICE ACTION:
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 received on 02/27/2023 has been considered.
In light of the amended claims, the claims are rejected under 35 U.S.C. 103.
Notice to Applicant
In the amendment dated 02/27/2023, the following has occurred: claims 21 and 40 have been amended; claims 23-27, 29, 31-37, 39, and 41-50 have remained unchanged; claims 1-20, 22, 28, 30, and 38 remain canceled; and no new claims have been added.
Claims 21, 23-27, 29, 31-37, and 39-50 are pending.
Effective Filing Date: 11/16/2017
Response to Arguments
35 U.S.C. 103 Rejections:
Applicant amended the claims and then argued with respect to these amendments. These arguments have been deemed moot in view of the updated 35 U.S.C. 103 rejections.
Point (a):
With respect to point (a), Lachenbruch does teach the newly added limitation of claim 21 as Lachenbruch teaches of an intervention of daily SEM scans for the patient in order to determine tissue levels. The complete citation and explanation can be seen below in the 103 rejection section.
Point (b):
With respect to point (b), Applicant argues with respect to the Brem reference. However Examiner used the Lachenbruch to further teach the amended portion of the claims. Thus, the arguments directed to Brem with respect to newly amended claim 21 are deemed moot.
Point (c):
With respect to point (c), Examiner disagrees that the claimed method yields unexpected results. Previously, Examiner disagreed with using the Musa reference as support for an explanation that there are unexpected results for three reasons. First, the claims are broader in scope than the scenario that is being argued with respect to the unexpected results. Second, the evidence provided cannot be evidence as the Musa reference is not completely commensurate with the claimed invention. Third, the results of improvement in care based on patient data is not unexpected. Examiner stands by his previous statements.
With regards to the first two points made by Examiner, Applicant argues that Musa unambiguously uses a “medical device, the sub-epidermal moisture (SEM) scanner (Bruin Biometrics, LLC, US) to identify the presence of SEM in the tissue” and that “training was supported by Bruin Biometrics LLC…all nursing staff were fully trained in the correct procedure for using the SEM Scanner, the relevance of recognizing a raised delta and the need to adjust clinical interventions accordingly.” Applicant now believes that the amended claims are commensurate in scope with the Musa reference. Examiner however respectfully disagrees. The evidence which is being provided does not meet the criteria from the MPEP to be given substantial weight. MPEP 2145 states:
“Consideration of rebuttal evidence and arguments requires Office personnel to weigh the proffered evidence and arguments. Id.; see also In re Alton, 76 F.3d 1168, 1174-75, 37 USPQ2d 1578, 1582-83 (Fed. Cir. 1996). Office personnel should avoid giving no weight to evidence submitted by applicant, except in rare circumstances. However, to be entitled to substantial weight, the applicant should establish a nexus between the rebuttal evidence and the claimed invention, i.e., objective evidence of nonobviousness must be attributable to the claimed invention. The Federal Circuit has acknowledged that applicant bears the burden of establishing nexus,”
According to section 2145 in the MPEP there is a lack of nexus between the evidence provided and the invention such that the evidence is attributable to the claimed invention. Musa is not related to the claimed invention even if it offers similar subject matter. The evidence is not attributable to the claimed invention but rather attributable to an outside source. Factual evidence of unexpected results of the claimed process. MPEP 716.02(d) further supports this as the objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.  The Musa reference is not commensurate in scope with the present claims as the present claims are broader in scope.
With regards to the third point made above, Applicant argues that the claimed method provides an unexpectedly high level of patient benefits, which establishes the non-obviousness of the claimed method. Examiner however respectfully disagrees with Applicant. The degree to which something is successful is not an indicator of unexpected results. For example, Musa did not describe these results as unexpectedly high. Musa described these results as improvements to what was previously used, not as something unexpected.
Lastly, Applicant argues with respect to claims 27, 31-36, 39-50 and refers to the independent claim as being a reason why these claims should be allowable. Examiner respectfully disagrees for similar reasons explained above for independent claim 21.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/27/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary.  Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21, 23-26, 29, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren.
As per claim 21, Lachenbruch et al. teaches a method of providing a continuity of care for a patient at risk of developing pressure ulcers (PU) during transfer from a first care setting to a second care setting, the method comprising the steps of:
--results as results obtained from performing a first SEM scan of at least one body location of the patient while in the first care setting, (see: paragraph [0037] where there are SEM scan measurements as well as a determined tissue status of the body location at a setting) wherein the first SEM scan comprises a plurality of measurements of an SEM value at the body location (see: paragraph [0037] where there is multiple measurements for a SEM scans a body location) and calculation of a first delta value from the plurality of SEM values, (see: paragraph [0037] where one or more sensors 102 are positioned to collect information regarding the tissue status of the individual. The sensor collects other values, where the other values is defined in the Berggren reference in claim 21 to be calculated delta values between electrodes)
--wherein if the current PU intervention of level-K is a level-0 PU intervention, the level-0 PU intervention comprises performing a daily SEM scan of at least one body location of the patient; (see: paragraph [0037] where there are SEM scans which are performed at least daily on the patient to track the patient’s tissue status levels. There is an intervention here in the form of daily scans in order to monitor patients, thus this is being considered a level-0 intervention)
--making a plurality of Sub-Epidermal Moisture (SEM) measurements at a body location on the patient at the second care setting, (see: paragraph [0037] where one or more sensors 102 are positioned to collect information regarding the tissue status of the individual. The sensors here collect SEM data at a body location in any setting) each SEM measurement comprising a measurement of biocapacitance, (see: paragraph [0015] where the sensor 102 may be implemented as a thin-film circuit sensor operable to measure capacitance)
--determining whether the delta value exceeds a threshold (see: paragraph [0037] where the SEM information is transmitted to a server which receives and compares the received information with a threshold tissue status that is based on at least some demographic information for the individual. There is a determination here of if the delta value (SEM information including the other values) exceeds a threshold)
--do nothing if the delta value does not exceed the threshold, (see: 206 and 208 of FIG. 2 where the received information (delta value) is checked against a threshold to determine if it has been exceeded. When it is not exceeded the method proceeds to update the threshold with received information) and
--do something if the delta value exceeds the threshold (see: 206 and 210 of FIG. 2 where the received information (delta value) is checked against a threshold to determine if it has been exceeded. When it is exceeded the method proceeds to provide a notification to the computing device).
Lachenbruch et al. teaches the above-mentioned claim limitations. The difference between Lachenbruch et al. and the claimed invention is that while Lachenbruch et al. does disclose SEM measurements and calculating if a threshold is exceeded form measured patient values, it does not explicitly teach a current intervention as well as the optionality to change the intervention based on the measurements. More specifically, Lachenbruch et al. may not further, specifically teach:
1) --identifying a current PU intervention of level-K received by the patient at the first care setting, wherein the current PU intervention of level-K is provided in a transfer record, wherein the transfer record further comprises results;
2) --do nothing by continuing to administer the current PU intervention, and
3) --do something by administering a new PU intervention of level-N, where N has a value greater than K; and
4) --calculating a delta value by a difference between two of the plurality of SEM measurements (within the context of biocapacitance measurements).
Geleijnse et al. teaches:
1) --identifying a current PU intervention of level-K received by the patient at the first care setting, (see: paragraph [0048] where the patient’s current care level is determined. The intervention here are related to a patient’s status, where a patient’s status to be that of pressure ulcers is taught in the primary reference in paragraph [0013] of Lachenbruch et al.) wherein the current PU intervention of level-K is provided in a transfer record, (see: paragraphs [0042] and [0067] where there is an EHR that is used to provide current and historic patient data. The EHR is the transfer record) wherein the transfer record further comprises results; (see: paragraphs [0042] and [0067] where there is an EHR that is used to provide current and historic patient data)
2) --do nothing by continuing to administer the current PU intervention, (see: paragraph [0031] where there is a level of recommendation of staying in the current level of care or to move to a different level of care) and
3) --do something by administering a new PU intervention of level-N, where N has a value greater than K (see: paragraph [0031] where there is a level of recommendation of staying in the current level of care or to move to a different level of care. Further see: paragraph [0043] where this may be a higher level of care).
One of ordinary skill at the time of the invention was filed would have found it obvious to 1) identify a current PU intervention of level-K received by the patient at the first care setting, wherein the current PU intervention of level-K is provided in a transfer record, wherein the transfer record further comprises results, 2) continue to administer the current PU intervention, and 3) administer a new PU intervention of level-N, where N has a value greater than K as taught by Geleijnse et al. in the method as taught by Lachenbruch et al. with the motivation(s) of monitoring a patient’s condition and adjusting the level of care accordingly (see: paragraph [0002] of Geleijnse et al.).
Berggren teaches:
4) --calculating a delta value by a difference between two of the plurality of SEM measurements (see: 3rd paragraph of “1. Introduction” where there is a determination of measured changes (delta value) between two electrodes for capacitive affinity biosensors).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute 4) calculating a delta value by a difference between two of the plurality of SEM measurements as taught by Berggren for the collection of other values as disclosed by Lachenbruch et al. and Geleijnse et al. in combination (more particularly, paragraph [0037] of Lachenbruch et al.) since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al. and Geleijnse et al. teaches of obtaining “other values” that are not SEM levels as a measure of impedance thus it would have been obvious to replace the “other values” with collected delta values for biocapacitance measurements to obtain predictable results of making a determination using captured patient data from sensors. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
As per claim 23, Lachenbruch et al., Geleijnse et al., and Berggren in combination teach the method of claim 21, see discussion of claim 21. Lachenbruch et al. teaches values as delta values calculated from a portion of the plurality of SEM scans of the patient taken at different times while in the first care setting (see: paragraph [0037] where one or more sensors 102 are positioned to collect information regarding the tissue status of the individual. There are delta values (other values) here that include values derived from various scans taken a different times such as on different days).
Lachenbruch et al. may not further specifically teach wherein the transfer record further comprises values.
Geleijnse et al. teaches wherein the transfer record further comprises values (see: paragraphs [0042] and [0067] where there is an EHR that is used to provide current and historic patient data).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
As per claim 24, Lachenbruch et al., Geleijnse et al., and Berggren in combination teach the method of claim 21, see discussion of claim 21. Lachenbruch et al. further teaches results as results obtained from at least one of assessments 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 (see: paragraph [0003] where conventionally, visual detection is used be a caregiver to identify pressure ulcers which is a visual skin assessment of at least one body location of the patient).
Lachenbruch et al. may not further, specifically teach wherein the transfer record further comprises results.
Geleijnse et al. teaches wherein the transfer record further comprises results (see: paragraphs [0042] and [0067] where there is an EHR that is used to provide current and historic patient data).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
As per claim 25, Lachenbruch et al., Geleijnse et al., and Berggren in combination teach the method of claim 21, see discussion of claim 21. Lachenbruch et al. may not further, specifically teach wherein said transfer record is stored on a database.
Geleijnse et al. teaches wherein said transfer record is stored on a database (see: paragraph [0053] where there is a data base 26 storing EHR of the patient).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
As per claim 26, Lachenbruch et al., Geleijnse et al., and Berggren in combination teach the method of claim 25, see discussion of claim 25. Lachenbruch et al. further teaches patient information as the record further comprises a patient identifier and a date and a time when said first scan was performed (see: paragraphs [0024] and [0037] where there is day and time information for different SEM scans as well as the tissue measurements for the individual which are indicative of a patient (also identifies a patient)).
Lachenbruch et al. may not further, specifically teach wherein: the transfer record further comprises a patient information.
Geleijnse et al. teaches wherein: the transfer record further comprises a patient information (see: paragraphs [0042] and [0067] where there is an EHR that is used to provide current and historic patient data).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
As per claim 29, Lachenbruch et al., Geleijnse et al., and Berggren in combination teaches the method of claim 26, see discussion of claim 26. Lachenbruch et al. further teaches further comprising the steps of:
--performing a second SEM scan of the body location of the patient in the second care setting to obtain a second plurality of SEM measurements, (see: paragraph [0037] where there are scans taken on consecutive days, thus there is a second scan performed on the second day at a body location on the individual)
--calculating a second delta value, (see: paragraph [0037] where values are calculated for each day (including a second) and these values are “other values” which are defined in the Berggren reference in claim 21 to be calculated delta values between electrodes)
--creating a second data record that comprises the patient identifier, the second delta value, and a second date and time when the second SEM scan was performed, (see: claim 5 where the database is being updated with a subsequent tissue status for an individual. Also see: paragraphs [0024] and [0037] where there is day and time information for different SEM scans (including a second scan) as well as the tissue measurements for the individual which are indicative of a patient (also identifies a patient)) and
--reporting the second data record to the database (see: claim 5 where the database is being updated with a subsequent tissue status for an individual).
As per claim 37, Lachenbruch et al., Geleijnse et al., and Berggren in combination teaches the method of claim 29, see discussion of claim 29. Lachenbruch et al. further teaches further comprising the steps of:
--performing a third SEM scan of the at least one body location of the patient in the second care setting to obtain a third plurality of SEM measurements (see: paragraph [0037] where there are scans taken on consecutive days, thus there is a third scan performed on the third day at a body location on the individual) and
--calculating a third delta value, (see: paragraph [0037] where values are calculated for each day (including a third) and these values are “other values” which are defined in the Berggren reference in claim 21 to be calculated delta values between electrodes)
--creating a third data record that comprises the patient identifier, the third delta value, and a third date and time when the third SEM scan was performed, (see: claim 5 where the database is being updated with a subsequent tissue status for an individual. Also see: paragraphs [0024] and [0037] where there is day and time information for different SEM scans (including a third scan) as well as the tissue measurements for the individual which are indicative of a patient (also identifies a patient)) and
--reporting the third data record to the database (see: claim 5 where the database is being updated with a subsequent tissue status for an individual).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren as applied to claim 21, further in view of U.S. Patent No. 9,028,407 to Bennet-Guerrero.
As per claim 27, Lachenbruch et al., Geleijnse et al., and Berggren in combination teach the method of claim 21, see discussion of claim 21. Lachenbruch et al. further teaches SEM measurements (see: paragraph [0037] where there are SEM measurements).
The combination may not further, specifically teach continuing to make a plurality of measurements at a pre-determined frequency corresponding to level-K if the delta value does not exceed the threshold, and making a plurality of measurements at a pre-determined frequency corresponding to level-N if the delta value exceeds the threshold.
Bennett-Guerrero teaches:
--continuing to make a plurality of measurements at a pre-determined frequency corresponding to level-K if the delta value does not exceed the threshold, and making a plurality of measurements at a pre-determined frequency corresponding to level-N if the delta value exceeds the threshold (see: column 6, lines 9-21 where a change in the patient’s condition changes the frequency of measurements. If there is no change in the patient’s condition then these measurements would happen a lesser frequency such as once every 10 minutes in one embodiment. A plurality of measurements at a pre-determined frequency corresponding to level-K (once every 10 minutes) is occurring and it is changed to a different predetermined frequency corresponding to level-N (once every minute in one embodiment) if the patient’s condition changes (delta value exceeds a threshold)).
One of ordinary skill at the time of the invention was filed would have found it obvious to continue to make a plurality of measurements at a pre-determined frequency corresponding to level-K if the delta value does not exceed the threshold, and making a plurality of measurements at a pre-determined frequency corresponding to level-N if the delta value exceeds the threshold as taught by Bennett-Guerrero in the method as taught by Lachenbruch et al., Geleijnse et al., and Berggren in combination with the motivation(s) of being beneficial for various reasons such as to enhance, improve, or even optimize battery life (see: column 6, lines 16-21 of Bennett-Guerrero).
Claims 31-32, 34, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren as applied to claim 29, further in view of U.S. Patent No. 9,675,289 to Heaton.
As per claim 31, Lachenbruch et al., Geleijnse et al., and Berggren in combination teaches the method of claim 29, see discussion of claim 29. Lachenbruch et al. further teaches data as the delta value and the second delta value of the at least one body location of the patient in the transfer record and the second data record respectively (see: claim 5 where the tissue status stored in the database. Also see: paragraphs [0024] and [0037] where SEM delta value data (“other values” which are defined in the Berggren reference in claim 21 to be calculated delta values between electrodes) is being retrieved and respectively displayed. The stored information here is the equivalent of a first and second record).
The combination may not further, specifically teach querying the database for data to form retrieved delta values.
Heaton teaches:
--querying the database for data to form retrieved delta values (see: FIG. 9 where there is a directory for storing and retrieving archived responses into and from the database. In order for the system here to access the database here, it would query the database in order to retrieve the necessary data).
One of ordinary skill at the time of the invention was filed would have found it obvious to query the database for data to form retrieved delta values as taught by Heaton in the method as taught by Lachenbruch et al., Geleijnse et al., and Berggren in combination with the motivation(s) of being a way to store and retrieve information from a database (see: column 19, lines 44-45 of Heaton).
As per claim 32, Lachenbruch et al., Geleijnse et al., Berggren, and Heaton in combination teaches the method of claim 31, see discussion of claim 31. Lachenbruch et al. further teaches:
--formatting the retrieved delta values in date and time order, (see: paragraph [0037] where delta values are “other values” which are defined in the Berggren reference in claim 21 to be calculated delta values between electrodes. Also see: paragraph [0024] where the values are retrieved and viewed as a graphical history) and
--displaying the formatted delta values (see: paragraph [0024] where the “other values” are displayed).
As per claim 34, Lachenbruch et al., Geleijnse et al., Berggren, and Heaton in combination teaches the method of claim 32, see discussion of claim 32. Lachenbruch et al. further teaches delta values (see: paragraph [0037] where there are “other values” which are defined in the Berggren reference in claim 21 to be calculated delta values between electrodes).
Lachenbruch et al., Geleijnse et al., and Berggren in combination may not further, specifically teach wherein the formatted values are displayed in the form of a curve.
Heaton further teaches wherein the formatted values are displayed in the form of a curve (see: FIG. 8).
One of ordinary skill at the time of the invention was filed would have found it obvious to have wherein the formatted values are displayed in the form of a curve as taught by Heaton in the method as taught by Lachenbruch et al., Geleijnse et al., and Berggren in combination with the motivation(s) of being a way to display data in a graphical manner (see: FIG. 8 of Heaton).
As per claim 39, Lachenbruch et al., Geleijnse et al., and Berggren in combination teaches the method of claim 37, see discussion of claim 37. Lachenbruch et al. further teaches delta values (see: paragraph [0037] where there are “other values” which are defined in the Berggren reference in claim 21 to be calculated delta values between electrodes).
Lachenbruch et al., Geleijnse et al., and Berggren in combination may not further, specifically teach the step of
--querying the database to retrieve the values observed over time for a particular patient across multiple care settings and various episodes of care.
Heaton further teaches the step of querying the database to retrieve the values observed over time for a particular patient across multiple care settings and various episodes of care (see: FIG. 9 where there is a directory for storing and retrieving archived responses into and from the database. In order for the system here to access the database here, it would query the database in order to retrieve the necessary data. Additionally, the data here are past data values including values across multiple care settings and care episodes. These data values are retrieved regardless of setting and care episode).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 31, and incorporated herein.
Claims 33 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren as applied to claim 29, and further in view of U.S. 2008/0015894 to Miller et al.
As per claim 33, Lachenbruch et al., Geleijnse et al., and Berggren in combination teaches the method of claim 29, see discussion of claim 29. Lachenbruch et al. further teaches a record as a record that comprises the patient identifier, a data element, and a date/time associated with the data element (see: paragraph [0024] where there is a display of data according to date and time. The information shown identifies the individual and is also considered to be a data element).
The combination may not further, specifically the steps of:
1) --creating an additional data record, wherein the data element comprises one or more of a 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
2) --reporting the additional data record to the database.
Miller et al. teaches:
1) --creating an additional data record, wherein the data element comprises one or more of a 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, (see: paragraph [0121] where there are results being recorded in a database and these results are being considered to be the additional data record. The results can include the name of the patient (patient identifier), recommendations or changes to the therapy regimen (a care plan), as well as a date and time associated with the recommendation or change) and
2) --reporting the additional data record to the database (see: paragraph [0121] where the results of the contact with the medical provider are recorded with the database).
One of ordinary skill at the time of the invention was filed would have found it obvious to 1) create an additional data record, wherein the data element comprises one or more of a 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 2) report the additional data record to the database as taught by Miller et al. in the method as taught by Lachenbruch et al., Geleijnse et al., and Berggren in combination with the motivation(s) of updating a patient’s files (see: paragraph [0021] of Miller et al.).
Claims 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren further in view of U.S. Patent No. 9,675,289 to Heaton as applied to claim 32, and further in view of U.S. Patent No. 8,355,925 to Rothman et al.
As per claim 35, Lachenbruch et al., Geleijnse et al., Berggren, and Heaton in combination teaches the method of claim 32, see discussion of claim 32. Lachenbruch et al. further teaches delta values (see: paragraph [0037] where there are “other values” which are defined in the Berggren reference in claim 21 to be calculated delta values between electrodes).
The combination may not further, specifically teach the step of analyzing the retrieved 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.
Rothman et al. teaches:
--the step of analyzing the retrieved 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 (see: column 15, lines 29-43 where a derivative in the slope is calculated and a determination is made based on this acceleration to see if the patient is declining at a faster rate. The change in the acceleration of the slope may trigger an alarm. Also see: column 23, lines 18-29 and 51-59).
One of ordinary skill at the time of the invention was filed would have found it obvious to have the step of analyzing the retrieved 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 as taught by Rothman et al. in the method as taught by Lachenbruch et al., Geleijnse et al., Berggren, and Heaton in combination with the motivation(s) of alerting a user if a patient is getting better or worse at an accelerating rate (see: column 23, lines 51-59 of Rothman et al.).
As per claim 36, Lachenbruch et al., Geleijnse et al., Berggren, Heaton, and Rothman et al. in combination teach the method of claim 35, see discussion of claim 35. Lachenbruch et al., Geleijnse et al., Berggren, and Heaton in combination may not further, specifically teach wherein the acceleration is determined by the rate of change of the slope of the curve.
Rothman et al. further teaches wherein the acceleration is determined by the rate of change of the slope of the curve (see: column 15, lines 29-43 where a derivative in the slope is calculated and a determination is made based on this acceleration to see if the patient is declining at a faster rate. The change in the acceleration of the slope may trigger an alarm. Also see: column 23, lines 18-29 and 51-59).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 35, and incorporated herein.
Claims 40 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren as applied to claim 21, and further in view of “Protocol for the successful treatment of pressure ulcers” to Brem et al.
As per claim 40, Lachenbruch et al., Geleijnse et al., and Berggren in combination teaches the method of claim 21, see discussion of claim 21. The combination may not specifically, further teach wherein the level-0 PU intervention further comprises an intervention selected from the group consisting of providing good nutrition, standard mattress, turning every 24 hours, and a combination thereof.
Brem et al. teaches:
--wherein the level-0 PU intervention further comprises an intervention selected from the group consisting of providing good nutrition, standard mattress, turning every 24 hours, and a combination thereof (see: page 12S, point #7 under “Protocol for the comprehensive treatment of pressure ulcers” where providing good nutrition is an option to address pressure ulcers. Also see: page 13S under “Aggressive nutritional supplementation for all malnourished/undernourished patients”).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute an intervention selected from the group consisting of providing good nutrition, standard mattress, turning every 24 hours, and a combination thereof as taught by Brem et al. for the intervention group as disclosed by Lachenbruch et al., Geleijnse et al., and Berggren in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al., Geleijnse et al., and Berggren teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleijnse et al. because they are types of treatment options, making results predictable. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
As per claim 43, Lachenbruch et al., Geleijnse et al., and Berggren in combination teaches the method of claim 21, see discussion of claim 21. The combination may not teach wherein a level-3 PU intervention is applying dressing to the back or sides of patient’s heel.
Brem et al. teaches:
--a level-3 PU intervention of applying dressing to the back or sides of patient's heel (see: Table 1 of page 10S and “Effective wound-bed preparation of a moist wound healing environment” of page 13S where a wound dressing is being used as a treatment for pressure ulcers).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 40, and incorporated herein.
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren as applied to claim 21, and further in view of U.S. Patent No. 5,367,789 to Lamont.
As per claim 41, Lachenbruch et al., Geleijnse et al., and Berggren in combination teaches the method of claim 21, see discussion of claim 21. The combination may not teach wherein a level-1 PU intervention is providing a heel boot to the patient.
Lamont teaches:
--a level-1 PU intervention of providing a heel boot to the patient (see: column 1, lines 14-17 where there is a heel boot that is used to treat foot ulcers).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-1 PU intervention of providing a heel boot to the patient as taught by Lamont for a treatment level as disclosed by Lachenbruch et al., Geleijnse et al., and Berggren in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al., Geleijnse et al., and Berggren teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleijnse et al. because they are types of treatment options, making results predictable. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren as applied to claim 21, and further in view of U.S. Patent No. 6,634,045 to DuDonis et al.
As per claim 42, Lachenbruch et al., Geleijnse et al., and Berggren in combination teach the method of claim 21, see discussion of claim 21. The combination may not further specifically teach a level-2 PU intervention of changing the patient's support surface.
DuDonis et al. teaches:
--a level-2 PU intervention of changing the patient's support surface (see: column 3, lines 27-46. Also see: column 5, lines 18-21. The support surface is being changed here from the bed using the heel elevator support).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-2 PU intervention of changing the patient's support surface as taught by DuDonis et al. for a treatment level as disclosed by Lachenbruch et al., Geleijnse et al., and Berggren in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al., Geleijnse et al., and Berggren teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleijnse et al. because they are types of treatment options, making results predictable. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren as applied to claim 21, and further in view of “Friction between human skin and medical textiles for decubitus prevention” to Rotaru et al.
As per claim 44, Lachenbruch et al., Geleijnse et al., and Berggren in combination teach the method of claim 21, see discussion of claim 21. The combination may not further specifically teach a level-4 PU intervention of changing the patient's sheet cover to a low-friction sheet cover.
Rotaru et al. teaches:
--a level-4 PU intervention of changing the patient's sheet cover to a low-friction sheet cover (see: Abstract on page 91 and “Conclusions” on page 96 where old hospital bedsheets are being swapped out with lower friction ones to treat pressure ulcers).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-4 PU intervention of changing the patient's sheet cover to a low-friction sheet cover as taught by Rotaru et al. for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al., Geleijnse et al., and Berggren in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al., Geleijnse et al., and Berggren teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleijnse et al. because they are types of treatment options, making results predictable. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren as applied to claim 21, and further in view of U.S. Patent No. 8,011,041 to Hann.
As per claim 45, Lachenbruch et al., Geleijnse et al., and Berggren in combination teach the method of claim 21, see discussion of claim 21. The combination may not further specifically teach a level-5 PU intervention of providing a low-friction padded mattress surface for the patient's lower leg.
Hann teaches:
--a level-5 PU intervention of providing a low-friction padded mattress surface for the patient's lower leg (see: column 5, lines 51-63 where there is a low-friction pad being used. Also see: column 3, lines 30-35).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-5 PU intervention of providing a low-friction padded mattress surface for the patient's lower leg as taught by Hann for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al., Geleijnse et al., and Berggren in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al., Geleijnse et al., and Berggren teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleijnse et al. because they are types of treatment options, making results predictable. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Claims 46 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren as applied to claim 21, and further in view of “Prevention and Treatment of Pressure Ulcers” to Thomas.
As per claim 46, Lachenbruch et al., Geleijnse et al., and Berggren in combination teach the method of claim 21, see discussion of claim 21. The combination may not further specifically teach a level-6 PU intervention of turning the patient at a shorter interval than currently provided for.
Thomas teaches:
--a level-6 PU intervention of turning the patient at a shorter interval than currently provided for (see: “Decrease Pressure, Friction, and Shear” of page 47 where the most common method for reducing pressure is frequent turning and positioning).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-6 PU intervention of turning the patient at a shorter interval than currently provided for as taught by Thomas for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al., Geleijnse et al., and Berggren in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al., Geleijnse et al., and Berggren teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleijnse et al. because they are types of treatment options, making results predictable. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
As per claim 47, Lachenbruch et al., Geleijnse et al., and Berggren in combination teach the method of claim 21, see discussion of claim 21.The combination may not further specifically teach a level-7 PU intervention of applying a barrier cream to the patient's heel.
Thomas teaches:
--a level-7 PU intervention of applying a barrier cream to the patient's heel (see: page 55, paragraph 3 where there is a cream containing 1% silver sulfadiazine being applied to improve clinical appearance of the wound and improve healing. The cream containing the silver sulfadiazine is the barrier cream. Also see: page 2, paragraph 2 of “Pressure Ulcer Prevention in the Hospital Setting Using Silicon Foam Dressings” to Truong et al. where silver sulfadiazine is an ingredient in barrier creams).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 46, and incorporated herein.
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren as applied to claim 21, and further in view of “A systematic review of electrical stimulation for pressure ulcer prevention and treatment in people with spinal cord injuries” to Liu.
As per claim 48, Lachenbruch et al., Geleijnse et al., and Berggren in combination teach the method of claim 21, see discussion of claim 21. The combination may not further specifically teach a level-8 PU intervention of applying a neuro-muscular stimulation to the patient's heel.
Liu teaches:
--a level-8 PU intervention of applying a neuro-muscular stimulation to the patient's heel (see: “Results” on page 703 where ES enhanced PU healing).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-8 PU intervention of applying a neuro-muscular stimulation to the patient's heel as taught by Liu for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al., Geleijnse et al., and Berggren in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al., Geleijnse et al., and Berggren teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleijnse et al. because they are types of treatment options, making results predictable. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren as applied to claim 21, and further in view of “Topical hydrogen peroxide treatment of ischemic ulcers in the guinea pig: Blood recruitment in multiple skin sites” to Tur et al.
As per claim 49, Lachenbruch et al., Geleijnse et al., and Berggren in combination teach the method of claim 21, see discussion of claim 21. The combination may not further specifically teach a level-9 PU intervention of applying a topical cream to the patient's heel to enhance perfusion.
Tur et al. teaches:
--a level-9 PU intervention of applying a topical cream to the patient's heel to enhance perfusion (see: “Results” of page 217 where topical hydrogen peroxide cream was used to enhance vascular perfusion).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-9 PU intervention of applying a topical cream to the patient's heel to enhance perfusion as taught by Tur et al. for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al., Geleijnse et al., and Berggren in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al., Geleijnse et al., and Berggren teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleijnse et al. because they are types of treatment options, making results predictable. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren as applied to claim 21, and further in view of “Pressure Ulcer Prevention in the Hospital Setting Using Silicon Foam Dressings” to Truong et al.
As per claim 50, Lachenbruch et al., Geleijnse et al., and Berggren in combination teach the method of claim 21, see discussion of claim 21. The combination may not further specifically teach a level-10 PU intervention of providing a silicon pad for the patient's lower leg.
Truong et al. teaches:
--a level-10 PU intervention of providing a silicon pad for the patient's lower leg (see: page 5, paragraphs 2, 3, and 5 where silicon foam dressings can be used as treatment to prevent pressure ulcers).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-10 PU intervention of providing a silicon pad for the patient's lower leg as taught by Truong et al. for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al., Geleijnse et al., and Berggren in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al., Geleijnse et al., and Berggren teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleijnse et al. because they are types of treatment options, making results predictable. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
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.

APPLICANT REBUTTAL: REMARKS
Claims 21, 23-27, 29, 31-37, and 39-50 are pending. Claims 1-20, 22, 28, 30, and 38 were previously cancelled. Claims 21 and 40 have been amended without prejudice to, or disclaimer of, the underlying subject matter. Support for the amendments may be found in the original claims and specification, e.g., at [0115], Table 2. No new matter enters by way of the present amendments. Reconsideration of the application based on the above amendments and following remarks is respectfully requested.
Rei
ections under 35 U.S.C. 103
A. Claims 21, 23-26, 29, and 37
Claims 21, 23-26, 29, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. ("Lachenbruch") in view of U.S. 2015/0186607 to Geleijnse et al. ("Geleijnse"), further in view of "Capacitive Biosensors" to Berggren et al. ("Berggren"). See Office Action at 6.
Specifically, the Examiner alleges that "Lachenbruch et al. teaches a method of providing a continuity of for a patient at risk of developing pressure ulcers (PU) during transfer from a first care setting to a second care setting, the method comprising the steps of: results as results obtained from performing a first SEM scan of at least one body location of the patient while in the first care setting, ... wherein the first SEM scan comprises a plurality of measurements of an SEM value at the body location ... and calculation of a first delta value from the plurality of SEM values." Id. The Examiner concedes that Lachenbruch "does not explicitly teach a current intervention as well as the optionality to change the intervention based on the measurements."
Id. at 8. However, the Examiner cites Geleijnse for providing "identifying a current PU intervention of level-K received by the patient at the first care setting... wherein the current PU intervention of level-K is provided in a transfer record... do nothing by continuing to administer the current PU intervention. . . do something by administering a new PU intervention of level-N, where N has a value greater than K." Id. at 8-9. Thus, the Examiner concludes that "[o]ne of ordinary skill at the time of the invention was filed would have found it obvious to 1) identify a current PU intervention of level-K received by the patient at the first care setting, wherein the
current PU intervention of level-K is provided in a transfer record, 2) continue to administer the current PU intervention, and 3) administer a new PU intervention of level-N, where N has a value greater than K as taught by Geleijnse et al. in the method as taught by Lachenbruch et al. with the motivation(s) of monitoring a patient's condition and adjusting the level of care accordingly." Office Action at 9. Furthermore, the Examiner cites Berggren for providing "calculating a delta value by a difference between two of the plurality of SEM measurements," and concludes that "it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute 4) calculating a delta value by a difference between two of the plurality of SEM measurements as taught by Berggren for the collection of other values as disclosed by Lachenbruch et al. and Geleijnse et al. in combination (more particularly, paragraph [0037] of Lachenbruch et al.) since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements."
Id. at 9-10.
In response to Applicant's previous arguments filed on August 22, 2022, that there are unexpected results in the presently claimed method, the Examiner apparently disagrees for three reasons. See id. at 3. The Examiner alleges that "[f]irst, the claims are broader in scope than the scenario that is being argued with respect to the unexpected results. Second, the evidence provided cannot be evidence as the Musa reference is not completely commensurate with the claimed invention. Third, the results of improvement in care based on patient data is not unexpected." Id. Regarding the first and second reasons, the Examiner alleges that the previously cited Musa reference ("Musa") "is not related to the claimed invention even if it offers similar subject matter[,]" and that "[t]he evidence is not attributable to the claimed invention but rather attributable to an outside source." Id. at 4. Regarding the third reason, the Examiner "questions how changing care based on patient measurements can be considered unexpected[,]" and cites to Geleijnse alleging that it teaches "that a patient's condition is monitored and care is adjusted to be better tailored to a patient in paragraphs [0002] and [0004]."
Id. The Examiner acknowledges that "Applicant is trying to highlight that the present invention improves these numbers when there is a transition of care across two settings where the settings may provide that variability of uncertainty[,]" however, the Examiner further alleges that "one
can argue that the goals for both the claimed invention and the Geleijnse reference (where the goal is improvements in treatment results based on monitoring a patient's status) are the same meaning that the results should be expected." Id. Applicant respectfully disagrees.
At the outset, without acquiescing to the rejection, and solely to advance prosecution, claim 21 has been amended to recite "wherein if the current PU intervention of level-K is a level-0 PU intervention, the level-0 PU intervention comprises performing a daily SEM scan of at least one body location of the patient." Applicant has amended claim 21 to recite features of claim 40.
Applicant respectfully disagrees that aprimafacie case of obviousness has been established for claim 21 for at least the following three reasons: (a) Lachenbruch, Geleijnse, Berggren, and Brem, alone or in combination, do not provide or suggest each and every element of amended claim 21; (b) a person of ordinary skill in the art combining the cited references would not have arrived at the claimed subject matter with a reasonable expectation of success; and (c) the claimed method yields unexpected results.
(a) Lachenbruch, Geleijnse, Berggren, and Brem, alone or in combination, do not provide or suggest each and every element of amended claim 21 Applicant respectfully submits that Lachenbruch, Geleijnse, Berggren, and Brem, alone or in combination, do not provide or suggest each and every element of amended claim 21.
It is well-established law for an obviousness rejection under 35 U.S.C. § 103 that the references, either alone or combined, must provide all of the elements of the claim. The Office is required to make "a searching comparison of the claimed invention - including all its limitations - with the teaching of the prior art." In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995), and CFMT v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003). When "[t]he prior art reference (or references when combined) [do] not teach or suggest all the claim limitations, ... [o]ffice personnel must explain why the difference(s) between the prior art and the claimed invention would have been obvious to one of ordinary skill in the art." M.P.E.P. at § 2141 (III).
The Examiner has not at least shown that the cited references, alone or in combination, provide or suggest that wherein if the current PU intervention of level-K is a level-0 PU intervention, the level-0 PU intervention comprises performing a daily SEM scan of at least one body location of the patient.
The Examiner acknowledges that Lachenbruch, Geleijnse, and Berggren "in combination may not specifically, further teach ... a level-0 PU intervention ... ." Office Action at p. 23. Indeed, Lachenbruch, Geleijnse, and Berggren, alone or in combination, are silent regarding a level-0 PU intervention, much less that the level-0 PU intervention comprises performing a daily SEM scan of at least one body location of the patient. The Examiner goes on to cite Brem et al. "Protocol for the successful treatment of pressure ulcers" ("Brem"), to provide "wherein a level-0 PU intervention is selected from the group consisting of providing good nutrition, standard mattress, turning every 24 hours, and a combination thereof" Id. at p. 24. Applicant respectfully submits that Brem, at best, provides a protocol for treating pressure ulcers in the context of "[d]aily visual assessment of the skin," and involves "[o]bjective measurement of every wound by photography ... and thorough documentation of wound's progress with a graph." Brem at 12S, points 2 and 3 under Protocol for the comprehensive treatment of pressure ulcers. A person of ordinary skill in the art reading Brem as a whole would understand that Brem's disclosure is focused on preventing stage IV ulcers, which is the most advanced stage of ulcers, using visual assessment. See id. at 9S. This is different than Applicant's disclosure which addresses "a clear need to identify tissue damage earlier so that interventions can prevent progression of the subepidermal damage to stage-1 and beyond." Specification at [0154]. Applicant's disclosure clearly indicates that the disclosed methods are useful for preventing pressure ulcers prior to stage-1 as shown in Figure 6D "[i]n some instances, the tissue may be considered to be 'stage 1' pressure ulcer after time t4." Id. at [0135] and [0138]. Additionally, Applicant's specification provides that level-0 PU intervention comprises a frequency of subsequent SEM measurement at every 24 hours (daily). See Specification at Table 2. In contrast, Brem is silent regarding using SEM measurements for assessing early stage ulcers, much less that a level-0 PU intervention comprises performing a daily SEM scan of at least one body location of the patient.
For at least the above reasons, Lachenbruch, Geleijnse, Berggren, and Brem, alone or in combination, do not provide or suggest each and every element of amended claim 21.
Accordingly, Applicant respectfully submits that the amended claim 21 is nonobvious over Lachenbruch, in view of Geleijnse, further in view of Berggren and Brem.
(b) A person of ordinary skill in the art combining the cited references would not have arrived at the claimed subject matter with a reasonable expectation of success
Notwithstanding that Lachenbruch, Geleijnse, Berggren, and Brem, alone or in combination, do not provide or suggest all the elements of amended claim 21, the Examiner "questions how changing care based on patient measurements can be considered unexpected[,]" and further alleges that "one can argue that the goals for both the claimed invention and the Geleijnse reference ... are the same meaning that the results should be expected." Office Action at 4. Applicant respectfully disagrees.
To establish aprimafacie case of obviousness, there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of skill in the art, to modify the reference or to combine reference teachings. There must also be a reasonable expectation of success. The teaching or suggestion to make the claimed combination and the reasonable expectation of success must both be found in the prior art, and not based on the applicant's disclosure. In re Vaeck, 947 F.2d 488, 20 USPQ2d 1438 (Fed. Cir. 1991) (emphasis added).
One of ordinary skill in the art combining Lachenbruch, Geleijnse, Berggren, and Brem would not have arrived at the claimed subject matter of amended claim 21 with a reasonable expectation of success. When read as a whole, Brem at best provides visual assessment to prevent advanced stage of ulcer formation (stage IV). Brem at 9S and 12S. As previously discussed in Section A(a), Brem provides an ulcer assessment method based on visual inspection that is different from Applicant's claimed method based on SEM measurements. Accordingly, one of ordinary skill in the art would understand that there would not be a reasonable expectation of success to apply a known element of Brem's assessment protocol to Applicant's assessment
protocol to achieve an alleged comparable result. For example, there is no reasonable expectation of success found in the prior art, or generally in the art, in applying the frequency of daily (every 24 hours) visual assessments disclosed in Brem to Applicant's SEM measurements for effectively preventing early stage ulcers. In view of this lack of reasonable expectation of success, a person of ordinary skill in the art would not have combined Brem with Lachenbruch, Geleijnse, and Berggren as alleged by the Examiner.
For at least the above reasons, Applicant respectfully submits that amended claim 21 is nonobvious over Lachenbruch, in view of Geleijnse, further in view of Berggren and Brem.
(c) The claimed method yields unexpected results
Furthermore, even if assuming arguendo that there is motivation to combine Lachenbruch, Geleijnse, Berggren, and Brem to arrive at the instant claims (Applicant does not concede), Applicant maintains that the claimed subject matter yields unexpected results. The Examiner alleges that "Musa is not related to the claimed invention even if it offers similar subject matter[,]" and that "[t]he evidence is not attributable to the claimed invention but rather attributable to an outside source." Office Action at 4. Applicant respectfully submits that Musa unambiguously uses "a medical device, the sub-epidermal moisture (SEM) scanner (Bruin Biometrics, LLC, US) to identify the presence of SEM in the tissue[,]" and that "[t]raining was supported by Bruin Biometrics LLC ... all nursing staff were fully trained in the correct procedure for using the SEM Scanner, the relevance of recognizing a raised delta and the need to adjust clinical interventions accordingly." Musa at 4 and 6. In view of the amendments to claim 21, together with the reasons provided above, Applicant respectfully submits that the instant claims are commensurate with the evidence as provided in Musa.
Finally, even assuming arguendo that it would be expected to achieve some degree of improvement in patient care using the claimed method (Applicant does not concede), the claimed method provides an unexpectedly high level of patient benefits, which establishes the non-obviousness of the claimed method. Specifically, as described in Musa, the claimed method for continuity of care reduced incidence of PU by 87.2% in acute care settings, and as much as 100% at 10 of the 15 test sites. Musa at 2. In other words, the incidence of PUs was surprisingly
completely eliminated in a majority of test sites. The Examiner has not provided any objective evidence that a person of ordinary skill in the art combining the cited references to arrive at the claim method, would have had the expectation that the claimed method would achieve a 100% incidence reduction of PU in a majority of test sites. The unexpected degree of improvement in patient care resulting from the claimed method is sufficient to overcome any prima facie case of obviousness the Examiner could have raised.
For at least the above reasons, Applicant respectfully requests that the Examiner withdraw the rejection of claims 21, 23-26, 29, and 37 under 35 U.S.C. §103 over Lachenbruch in view of Geleijnse, further in view of Berggren and Brem.
B. Claim 27
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Lachenbruch in view of Geleijnse, further in view of Berggren as applied to claim 21, and further in view of U.S. Patent No. 9,028,407 to Bennet-Guerrero ("Bennet-Guerrero"). See Office Action at 15.
Specifically, the Examiner alleges that Bennet-Guerrero provides "continuing to make a plurality of measurements at a pre-determined frequency corresponding to level-K if the delta value does not exceed the threshold, and making a plurality of measurements at a pre-determined frequency corresponding to level-N if the delta value exceeds the threshold." Id. at 15. As such, the Examiner concludes that "[o]ne of ordinary skill at the time [] the invention was filed would have found it obvious to continue to make a plurality of measurements at a pre-determined frequency corresponding to level-K if the delta value does not exceed the threshold, and making a plurality of measurements at a pre-determined frequency corresponding to level-N if the delta value exceeds the threshold as taught by Bennett-Guerrero in the method as taught by Lachenbruch et al., Geleijnse et al., and Berggren in combination with the motivation(s) of being a way to store and retrieve information from a database." Id. at 15-16. Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Claim 27 is dependent from claim 21, and incorporates the features of claim 21. Since the Examiner has not shown that
claim 21 is obvious in view of Lachenbruch, Geleijnse, Berggren, and Brem, and Bennet-Guerrero does not remedy the deficiencies of these references, claim 27 is also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner withdraw the rejection of claim 27 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Berggren and Brem as previously applied to claim 21, and further in view of Bennet-Guerrero.
C. Claims 31, 32, 34, and 39
Claims 31, 32, 34, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Lachenbruch in view of Geleijnse, further in view of Berggren as applied to claim 29, and further in view of U.S. Patent No. 9,675,289 to Heaton ("Heaton"). See Office Action at 16.
Specifically for claim 31, the Examiner alleges that Heaton provides "querying the database for data to form retrieved data values (see FIG. 9 where there is a directory for storing and retrieving archived responses into and from the database. In order for the system here to access the database here, it would query the database in order to retrieve the necessary data)." Id. at 16. As such, the Examiner concludes that "[o]ne of ordinary skill at the time the invention was filed would have found it obvious to query the database for data to form retrieved delta values as taught by Heaton in the method as taught by Lachenbruch et al., Geleijnse et al., and Berggren in combination with the motivation(s) of being a way to store and retrieve information from a database." Id at 17. Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Claims 31, 32, 34, and 39 are dependent directly or indirectly from claim 21, and incorporates the features of claim 21. Since the Examiner has not shown that claim 21 is obvious in view of Lachenbruch, Geleijnse, Berggren, and Brem, and Heaton does not remedy the deficiencies of these references, claims 31, 32, 34, and 39 are also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner withdraw the rejection of claims 31-32, 34, and 39 under 35 U.S.C. § 103 over Lachenbruch in
view of Geleijnse, further in view of Berggren and Brem as previously applied to claim 29, and further in view of Heaton.
D. Claim 33
Claims 33 is rejected under 35 U.S.C. 103 as being unpatentable over Lachenbruch in view of Geleijnse, further in view of Berggren as applied to claim 29, and further in view of U.S. 2008/0015894 to Miller et al. ("Miller"). See Office Action at 19-20. Specifically, the Examiner alleges that Miller provides "creating an additional data record, wherein the data element comprises one or more of a 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 "reporting the additional data record to the database." Id. at 20.
Thus, the Examiner concludes that "[o]ne of ordinary skill at the time of the invention was filed would have found it obvious to 1) create an additional data record, wherein the data element comprises... and 2) report the additional data record to the database as taught by Miller et al. in the method as taught by Lachenbruch et al. and Geleijnse et al., and Berggren in combination with the motivation(s) of updating a patient files." Id. at 20-21. Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Claim 33 is dependent from claim 21, and incorporates the features of claim 21. Since the Examiner has not shown that claim 21 is obvious in view of Lachenbruch, Geleijnse, Berggren, and Brem, and Miller does not remedy the deficiencies of these references, claim 33 is also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner withdraw the rejection of claim 33 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Berggren and Brem as previously applied to claim 29, and further in view of Miller.
E. Claims 35-36
Claims 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Lachenbruch in view of Geleijnse, further in view of Berggren and further in view of Heaton as applied to claim 32, and further in view of U.S. Patent No. 8,355,925 to Rothman et al. ("Rothman"). See Office Action at 21. Specifically, the Examiner alleges that Rothman provides "the step of analyzing the retrieved 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." Id. at 21. Thus, the Examiner concludes that "[o]ne of ordinary skill at the time [] the invention was filed would have found it obvious to have the step of analyzing the retrieved 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 as taught by Rothman et al. in the method as taught by Lachenbruch et al., Geleijnse et al., Berggren, and Heaton in combination with the motivation(s) of alerting a user if a patient is getting better or worse at an accelerating rate." Id. at 22.
Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Claims 35 and 36 are dependent directly or indirectly from claim 21, and incorporates the features of claim 21. Since the Examiner has not shown that claim 21 is obvious in view of Lachenbruch, Geleijnse, Berggren, and Brem, and Rothman does not remedy the deficiencies of these references, claims 35 and 36 are also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner withdraw the rejection of claims 35 and 36 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Berggren and Brem, further in view of Heaton as previously applied to claim 32, and further in view of Rothman.
F. Claims 40 and 43
Claims 40 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Lachenbruch in view of Geleijnse, further in view of Berggren as applied to claim 21, and further in view of "Protocol for the successful treatment of pressure ulcers" to Brem et al. ("Brem"). See
Office Action at 23. Specifically, the Examiner alleges that Brem provides "wherein a level-0 PU intervention is selected from the group consisting of providing good nutrition, standard mattress, turning ever 24 hours, and a combination thereof," and "a level-3 PU intervention of applying dressing to the back or sides of patient's heel." Id. at 23-24. Thus, the Examiner concludes that "it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a group consisting of providing good nutrition, standard mattress, turning every 24 hours, and a combination thereof as taught by Brem et al. for the group as disclosed by Lachenbruch et al., Geleijnse et al., and Berggren in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements." Id. Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Claims 40 and 43 are dependent directly or indirectly from claim 21, and incorporates the features of claim 21. Since the Examiner has not shown that claim 21 is obvious in view of Lachenbruch, Geleijnse, Berggren, and Brem, claims 40 and 43 are also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner withdraw the rejection of claims 40 and 43 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Berggren and Brem as previously applied to claim 21.
G. Claim 41
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Lachenbruch in view of Geleijnse, further in view of Berggren as applied to claim 21, and further in view of U.S. Patent No. 5,367,789 to Lamont ("Lamont"). See Office Action at 25. Specifically, the Examiner alleges that Lamont provides a level-1 PU intervention of providing a heel boot to the patient. Id. Thus, the Examiner concludes that "it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-1 PU intervention of providing a heel boot to the patient as taught by Lamont for a treatment level as disclosed by Lachenbruch et al., Geleijnse et al., and Berggren in combination since each
individual element and its function are shown in the prior art, with the difference being the substitution of the elements." Id. Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Claim 41 is dependent from claim 21, and incorporates the features of claim 21. Since the Examiner has not shown that claim 21 is obvious in view of Lachenbruch, Geleijnse, Berggren, and Brem, and Lamont does not remedy the deficiencies of these references, claim 41 is also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner withdraw the rejection of claim 41 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Berggren and Brem as previously applied to claim 21, and further in view of Lamont.
H. Claim 42
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Lachenbruch in view of Geleijnse, further in view of Berggren as applied to claim 21, and further in view of U.S. Patent No. 6,634,045 to DuDonis et a. ("DuDonis"). See Office Action at 26. Specifically, the Examiner alleges that DuDonis provides "a level-2 PU intervention of changing the patient's support surface." I. Thus, the Examiner concludes that "it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-2 PU intervention of changing the patient's support surface as taught by DuDonis for a treatment level as disclosed by Lachenbruch et al., Geleijnse et al., and Berggren in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements." Id. Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re fine, 837 F.2d 1071 (Fed. Cir. 1988). Claim 42 is dependent from claim 21, and incorporates the features of claim 21. Since the Examiner has not shown that claim 21 is obvious in view of Lachenbruch, Geleijnse, Berggren, and Brem, and DuDonis does not remedy the deficiencies of these references, claim 42 is also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner withdraw the rejection of claim 42 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Berggren and Brem as previously applied to claim 21, and further in view of DuDonis.
I. Claim 44
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Lachenbruch in view of Geleijnse, further in view of Berggren as applied to claim 21, and further in view of "Friction between human skin and medical textiles for decubitus prevention" to Rotaru et al.
("Rotaru"). See Office Action at 28. Specifically, the Examiner alleges that Rotaru provides a level-4 PU intervention of changing the patient's sheet cover to a low-friction sheet cover. Id.
Thus, the Examiner concludes that "it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-4 PU intervention of changing the patient's sheet cover to a low-friction sheet cover as taught by Rotaru, for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al., Geleijnse et al., and Berggren in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements." Id. at 27-28. Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Claim 44 is dependent from claim 21, and incorporates the features of claim 21. Since the Examiner has not shown that claim 21 is obvious in view of Lachenbruch, Geleijnse, Berggren, and Brem, and Rotaru does not remedy the deficiencies of these references, claim 44 is also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner withdraw the rejection of claim 44 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Berggren and Brem as previously applied to claim 21, and further in view of Rotaru.
J. Claim 45
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Lachenbruch in view of Geleijnse, further in view of Berggren as applied to claim 21, and further in view of U.S. Patent No. 8,011,041 to Hann ("Hann"). See Office Action at 29-30. Specifically, the Examiner alleges that Hann provides "a level-5 PU intervention of providing a low-friction padded mattress surface for the patient's lower leg." Id Thus, the Examiner concludes that "it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-5 PU intervention of providing a low-friction padded mattress surface for the patient's lower leg as taught by Hann for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al., Geleijnse et al., and Berggren in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements." Id. at 28-29. Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. I re Pine, 837 F.2d 1071 (Fed. Cir. 1988). Claim 45 is dependent from claim 21, and incorporates the features of claim 21. Since the Examiner has not shown that claim 21 is obvious in view of Lachenbruch, Geleijnse, Berggren, and Brem, and Hann does not remedy the deficiencies of these references, claim 45 is also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner withdraw the rejection of claim 45 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Berggren and Brem as previously applied to claim 21, and further in view of Hann.
K. Claims 46 and 47
Claims 46 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Lachenbruch in view of Geleijnse, further in view of Berggren as applied to claim 21, and further in view of "Prevention and Treatment of Pressure Ulcers" to Thomas ("Thomas"). See Office Action at 30. Specifically, the Examiner alleges that Thomas provides "a level-6 PU intervention of turning the patient at a shorter interval than currently provided for," and "a level- 7 PU intervention of applying a barrier cream to the patient's heel." Id. at 29-30. Thus, the
Examiner concludes that "it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute [the interventions]. . . as taught by Thomas for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al., Geleijnse et al., and Berggren in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. Id. at 29-30. Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Claims 46 and 47 are dependent directly or indirectly from claim 21, and incorporates the features of claim 21. Since the Examiner has not shown that claim 21 is obvious in view of Lachenbruch, Geleijnse, Berggren, and Brem, and Thomas does not remedy the deficiencies of these references, claims 46 and 47 are also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner withdraw the rejection of claims 46 and 47 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Berggren and Brem as previously applied to claim 21, and further in view of Thomas.
L. Claim 48
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Lachenbruch in view of Geleijnse, further in view of Berggren as applied to claim 21, and further in view of "A systematic review of electrical stimulation for pressure ulcer prevention and treatment in people with spinal cord injuries" to Liu ("Liu"). See Office Action at 31-32. Specifically, the Examiner alleges that Liu provides "a level-8 PU intervention of applying a neuro-muscular stimulation to the patient's heel." Id. Thus, the Examiner concludes that "it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-8 PU intervention of applying a neuro-muscular stimulation to the patient's heel as taught by Liu for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al., Geleijnse et al., and Berggren in combination since each individual element and its function are
shown in the prior art, with the difference being the substitution of the elements." Id. at 31-32. Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Claim 48 is dependent from claim 21, and incorporates the features of claim 21. Since the Examiner has not shown that claim 21 is obvious in view of Lachenbruch, Geleijnse, Berggren, and Brem, and Liu does not remedy the deficiencies of these references, claim 48 is also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner withdraw the rejection of claim 48 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Berggren and Brem as previously applied to claim 21, and further in view of Liu.
M. Claim 49
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Lachenbruch in view of Geleijnse, further in view of Berggren as applied to claim 21, and further in view of "Topical hydrogen peroxide treatment of ischemic ulcers in the guinea pig: Blood recruitment in multiple skin sites" to Tur et al. ("Tur"). See Office Action at 33. Specifically, the Examiner alleges that Tur provides "a level-9 PU intervention of applying a topical cream to the patient's heel to enhance perfusion." Id. at 33. Thus, the Examiner concludes that "it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-9 PU intervention of applying a topical cream to the patient's heel to enhance perfusion as taught by Tur et al. for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al., Geleijnse et al., and Berggren in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements." Id. Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Claim 49 is dependent from claim 21, and incorporates the features of claim 21. Since the Examiner has not shown that
claim 21 is obvious in view of Lachenbruch, Geleijnse, Berggren, and Brem, and Tur does not remedy the deficiencies of these references, claim 49 is also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner withdraw the rejection of claim 49 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Berggren and Brem as previously applied to claim 21, and further in view of Tur.
N. Claim 50
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Lachenbruch in view of Geleijnse, further in view of Berggren as applied to claim 21, and further in view of" Pressure Ulcer Prevention in the Hospital Setting Using Silicon Foam Dressings" to Truong et al.
("Truong"). See Office Action at 34. Specifically, the Examiner alleges that Truong provides "a level-10 PU intervention of providing a silicon pad for the patient's lower leg." Id. at 34. Thus, the Examiner concludes that "it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-10 PU intervention of providing a silicon pad for the patient's lower leg as taught by Truong for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al., Geleijnse et al., and Berggren in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements." Id. at 34. Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Claim 50 is dependent from claim 21, and incorporates the features of claim 21. Since the Examiner has not shown that claim 21 is obvious in view of Lachenbruch, Geleijnse, Berggren, and Brem, and Truong does not remedy the deficiencies of these references, claim 50 is also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner withdraw the rejection of claim 50 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Berggren and Brem as previously applied to claim 21, and further in view of Truong.
CONCLUSION

NEXT OFFICE ACTION: 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 09/21/2023 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 received on 09/21/2023 has been considered.
In light of the amended claims, the claims are rejected under 35 U.S.C. 103.
Notice to Applicant
In the amendment dated 09/21/2023, the following has occurred: claim 21 has been amended; claims 23-26, 29, 31-37, and 39-50 have remained unchanged; claims 1-20, 22, 27-28, 30, and 38 remain canceled; and no new claims have been added.
Claims 21, 23-26, 29, 31-37, and 39-50 are pending.
Effective Filing Date: 11/16/2017
Response to Arguments
35 U.S.C. 103 Rejections:
Point (a):
Applicant states that Examiner has not shown that the cited references teach the “calculating” limitation and the limitations that follow it in independent claim 21. Applicant states that the Lachenbruch, Geleijnse, and Breggen references do not teach the pre-determined frequency aspect of the above limitations. Applicant further states that the Bennet-Guerrero reference was used to teach previous claim 27, and therefore, the newly amended limitations of claim 21 as they are similar limitations to those of previous claim 27. Examiner however respectfully disagrees. Applicant argues that the Bennett-Guerrero reference deals with measuring an incline position of a subject which is different from the present disclosure. The measurements being related to SEM was taught in the reference which preceded it (Lachenbruch). Further, Applicant states that the present disclosure reveals different risk levels and frequencies of monitoring in Table 1 and that in contrast, the Bennett-Guerrero reference is silent to “continuing to…make a plurality of SEM measurements at a pre-determined frequency corresponding to level-K if the delta value does not exceed the threshold.” First, this limitation was taught in three parts. The Lachenbruch reference teaches of doing nothing if the delta value does not exceed a threshold. Next, the Geleijnse reference teaches that the action of “doing nothing” can be the action of continuing to administer the current PU intervention. Lastly, the Bennett-Guerrero reference teaches that there are different frequencies for monitoring based on levels of care determined by patient data. The Bennett-Guerrero reference was thus not used to teach the entire limitation as claimed by Applicant.
Point (b):
Applicant argues that a person of ordinary skill in the art would not have combined the references used with a reasonable expectation of success. Applicant further elaborates that the Bennett-Guerrero provides a frequency of measurement of an incline angle and reducing the frequency to conserve battery life. Applicant states that the present claims however recite the “continuing…to make a plurality of SEM measurements…” and the “making a plurality of SEM measurements…” limitations and that one of ordinary skill in the art would understand that Bennett-Guerrero’s disclosure of reducing measurement frequency is not a basis for predicting success of the claims steps of claim 21. Examiner however respectfully disagrees. Examiner provided the Bennett-Guerrero to teach the above-recited elements of newly-amended claim 21. Further, there would be a reasonable expectation of success when combining these references as the Bennett-Guerrero reference states in column 6, lines 16-21 (which was cited for the motivational statement) that there are various beneficial reasons such as enhancing, improving, or even optimizing battery life. Thus one could combine the measurement frequency aspects taught by Bennett-Guerrero for the purposes of energy conservation when the patient is at a status where frequent measurements would be unnecessary.
Dependent Claims:
Dependent claims are rejected for the same reasoning as independent claim 21 above.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/21/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary.  Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21, 23-26, 29, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren and further in view of U.S. Patent No. 9,028,407 to Bennett-Guerrero.
As per claim 21, Lachenbruch et al. teaches a method of providing a continuity of care for a patient at risk of developing pressure ulcers (PU) during transfer from a first care setting to a second care setting, the method comprising the steps of:
--results as results obtained from performing a first SEM scan of at least one body location of the patient while in the first care setting, (see: paragraph [0037] where there are SEM scan measurements as well as a determined tissue status of the body location at a setting) wherein the first SEM scan comprises a plurality of measurements of an SEM value at the body location (see: paragraph [0037] where there is multiple measurements for a SEM scans a body location) and calculation of a first delta value from the plurality of SEM values, (see: paragraph [0037] where one or more sensors 102 are positioned to collect information regarding the tissue status of the individual. The sensor collects other values, where the other values is defined in the Berggren reference in claim 21 to be calculated delta values between electrodes)
--wherein if the current PU intervention of level-K is a level-0 PU intervention, the level-0 PU intervention comprises performing a daily SEM scan of at least one body location of the patient; (see: paragraph [0037] where there are SEM scans which are performed at least daily on the patient to track the patient’s tissue status levels. There is an intervention here in the form of daily scans in order to monitor patients, thus this is being considered a level-0 intervention)
--making a plurality of Sub-Epidermal Moisture (SEM) measurements at a body location on the patient at the second care setting, (see: paragraph [0037] where one or more sensors 102 are positioned to collect information regarding the tissue status of the individual. The sensors here collect SEM data at a body location in any setting) each SEM measurement comprising a measurement of biocapacitance, (see: paragraph [0015] where the sensor 102 may be implemented as a thin-film circuit sensor operable to measure capacitance)
--determining whether the delta value exceeds a threshold (see: paragraph [0037] where the SEM information is transmitted to a server which receives and compares the received information with a threshold tissue status that is based on at least some demographic information for the individual. There is a determination here of if the delta value (SEM information including the other values) exceeds a threshold)
--do nothing if the delta value does not exceed the threshold, (see: 206 and 208 of FIG. 2 where the received information (delta value) is checked against a threshold to determine if it has been exceeded. When it is not exceeded the method proceeds to update the threshold with received information) and
--do something if the delta value exceeds the threshold (see: 206 and 210 of FIG. 2 where the received information (delta value) is checked against a threshold to determine if it has been exceeded. When it is exceeded the method proceeds to provide a notification to the computing device).
Additionally, Lachenbruch et al. teaches SEM measurements as measurements (see: paragraph [0037] where there are SEM measurements).
Lachenbruch et al. teaches the above-mentioned claim limitations. The difference between Lachenbruch et al. and the claimed invention is that while Lachenbruch et al. does disclose SEM measurements and calculating if a threshold is exceeded form measured patient values, it does not explicitly teach a current intervention as well as the optionality to change the intervention based on the measurements. More specifically, Lachenbruch et al. may not further, specifically teach:
1) --identifying a current PU intervention of level-K received by the patient at the first care setting, wherein the current PU intervention of level-K is provided in a transfer record, wherein the transfer record further comprises results;
2) --do nothing by continuing to administer the current PU intervention and making a plurality of measurements at a pre-determined frequency corresponding to level-K, and
3) --do something by administering a new PU intervention of level-N and making a plurality of measurements at a pre-determined frequency corresponding to level-N, where N has a value greater than K; and
4) --calculating a delta value by a difference between two of the plurality of SEM measurements (within the context of biocapacitance measurements).
Geleijnse et al. teaches:
1) --identifying a current PU intervention of level-K received by the patient at the first care setting, (see: paragraph [0048] where the patient’s current care level is determined. The intervention here are related to a patient’s status, where a patient’s status to be that of pressure ulcers is taught in the primary reference in paragraph [0013] of Lachenbruch et al.) wherein the current PU intervention of level-K is provided in a transfer record, (see: paragraphs [0042] and [0067] where there is an EHR that is used to provide current and historic patient data. The EHR is the transfer record) wherein the transfer record further comprises results; (see: paragraphs [0042] and [0067] where there is an EHR that is used to provide current and historic patient data)
2) --do nothing by continuing to administer the current PU intervention, (see: paragraph [0031] where there is a level of recommendation of staying in the current level of care or to move to a different level of care) and
3) --do something by administering a new PU intervention of level-N, where N has a value greater than K (see: paragraph [0031] where there is a level of recommendation of staying in the current level of care or to move to a different level of care. Further see: paragraph [0043] where this may be a higher level of care).
One of ordinary skill at the time of the invention was filed would have found it obvious to 1) identify a current PU intervention of level-K received by the patient at the first care setting, wherein the current PU intervention of level-K is provided in a transfer record, wherein the transfer record further comprises results, 2) continue to administer the current PU intervention, and 3) administer a new PU intervention of level-N, where N has a value greater than K as taught by Geleijnse et al. in the method as taught by Lachenbruch et al. with the motivation(s) of monitoring a patient’s condition and adjusting the level of care accordingly (see: paragraph [0002] of Geleijnse et al.).
Berggren teaches:
4) --calculating a delta value by a difference between two of the plurality of SEM measurements (see: 3rd paragraph of “1. Introduction” where there is a determination of measured changes (delta value) between two electrodes for capacitive affinity biosensors).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute 4) calculating a delta value by a difference between two of the plurality of SEM measurements as taught by Berggren for the collection of other values as disclosed by Lachenbruch et al. and Geleijnse et al. in combination (more particularly, paragraph [0037] of Lachenbruch et al.) since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al. and Geleijnse et al. teaches of obtaining “other values” that are not SEM levels as a measure of impedance thus it would have been obvious to replace the “other values” with collected delta values for biocapacitance measurements to obtain predictable results of making a determination using captured patient data from sensors. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Bennett-Guerrero teaches:
2) --making a plurality of measurements at a pre-determined frequency corresponding to level-K, (see: column 6, lines 9-21 where a change in the patient’s condition changes the frequency of measurements. If there is no change in the patient’s condition then these measurements would happen a lesser frequency such as once every 10 minutes in one embodiment. A plurality of measurements at a pre-determined frequency corresponding to level-K (once every 10 minutes) is occurring) and
3) --making a plurality of measurements at a pre-determined frequency corresponding to level-N, where N has a value greater than K (see: column 6, lines 9-21 where a change in the patient’s condition changes the frequency of measurements. If there is no change in the patient’s condition then these measurements would happen a lesser frequency such as once every 10 minutes in one embodiment. A plurality of measurements at a pre-determined frequency corresponding to level-K (once every 10 minutes) is occurring and it is changed to a different predetermined frequency corresponding to level-N (once every minute in one embodiment) if the patient’s condition changes (delta value exceeds a threshold)).
One of ordinary skill at the time of the invention was filed would have found it obvious to 2) make a plurality of measurements at a pre-determined frequency corresponding to level-K and 3) make a plurality of measurements at a pre-determined frequency corresponding to level-N, where N has a value greater than K as taught by Bennett-Guerrero in the method as taught by Lachenbruch et al., Geleijnse et al., and Berggren in combination with the motivation(s) of being beneficial for various reasons such as to enhance, improve, or even optimize battery life (see: column 6, lines 16-21 of Bennett-Guerrero).
As per claim 23, Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination teach the method of claim 21, see discussion of claim 21. Lachenbruch et al. teaches values as delta values calculated from a portion of the plurality of SEM scans of the patient taken at different times while in the first care setting (see: paragraph [0037] where one or more sensors 102 are positioned to collect information regarding the tissue status of the individual. There are delta values (other values) here that include values derived from various scans taken a different times such as on different days).
Lachenbruch et al. may not further specifically teach wherein the transfer record further comprises values.
Geleijnse et al. teaches wherein the transfer record further comprises values (see: paragraphs [0042] and [0067] where there is an EHR that is used to provide current and historic patient data).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
As per claim 24, Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination teach the method of claim 21, see discussion of claim 21. Lachenbruch et al. further teaches results as results obtained from at least one of assessments 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 (see: paragraph [0003] where conventionally, visual detection is used be a caregiver to identify pressure ulcers which is a visual skin assessment of at least one body location of the patient).
Lachenbruch et al. may not further, specifically teach wherein the transfer record further comprises results.
Geleijnse et al. teaches wherein the transfer record further comprises results (see: paragraphs [0042] and [0067] where there is an EHR that is used to provide current and historic patient data).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
As per claim 25, Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination teach the method of claim 21, see discussion of claim 21. Lachenbruch et al. may not further, specifically teach wherein said transfer record is stored on a database.
Geleijnse et al. teaches wherein said transfer record is stored on a database (see: paragraph [0053] where there is a data base 26 storing EHR of the patient).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
As per claim 26, Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination teach the method of claim 25, see discussion of claim 25. Lachenbruch et al. further teaches patient information as the record further comprises a patient identifier and a date and a time when said first scan was performed (see: paragraphs [0024] and [0037] where there is day and time information for different SEM scans as well as the tissue measurements for the individual which are indicative of a patient (also identifies a patient)).
Lachenbruch et al. may not further, specifically teach wherein: the transfer record further comprises a patient information.
Geleijnse et al. teaches wherein: the transfer record further comprises a patient information (see: paragraphs [0042] and [0067] where there is an EHR that is used to provide current and historic patient data).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
As per claim 29, Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination teaches the method of claim 26, see discussion of claim 26. Lachenbruch et al. further teaches further comprising the steps of:
--performing a second SEM scan of the body location of the patient in the second care setting to obtain a second plurality of SEM measurements, (see: paragraph [0037] where there are scans taken on consecutive days, thus there is a second scan performed on the second day at a body location on the individual)
--calculating a second delta value, (see: paragraph [0037] where values are calculated for each day (including a second) and these values are “other values” which are defined in the Berggren reference in claim 21 to be calculated delta values between electrodes)
--creating a second data record that comprises the patient identifier, the second delta value, and a second date and time when the second SEM scan was performed, (see: claim 5 where the database is being updated with a subsequent tissue status for an individual. Also see: paragraphs [0024] and [0037] where there is day and time information for different SEM scans (including a second scan) as well as the tissue measurements for the individual which are indicative of a patient (also identifies a patient)) and
--reporting the second data record to the database (see: claim 5 where the database is being updated with a subsequent tissue status for an individual).
As per claim 37, Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination teaches the method of claim 29, see discussion of claim 29. Lachenbruch et al. further teaches further comprising the steps of:
--performing a third SEM scan of the at least one body location of the patient in the second care setting to obtain a third plurality of SEM measurements (see: paragraph [0037] where there are scans taken on consecutive days, thus there is a third scan performed on the third day at a body location on the individual) and
--calculating a third delta value, (see: paragraph [0037] where values are calculated for each day (including a third) and these values are “other values” which are defined in the Berggren reference in claim 21 to be calculated delta values between electrodes)
--creating a third data record that comprises the patient identifier, the third delta value, and a third date and time when the third SEM scan was performed, (see: claim 5 where the database is being updated with a subsequent tissue status for an individual. Also see: paragraphs [0024] and [0037] where there is day and time information for different SEM scans (including a third scan) as well as the tissue measurements for the individual which are indicative of a patient (also identifies a patient)) and
--reporting the third data record to the database (see: claim 5 where the database is being updated with a subsequent tissue status for an individual).
Claims 31-32, 34, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren and further in view of U.S. Patent No. 9,028,407 to Bennett-Guerrero as applied to claim 29, further in view of U.S. Patent No. 9,675,289 to Heaton.
As per claim 31, Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination teaches the method of claim 29, see discussion of claim 29. Lachenbruch et al. further teaches data as the delta value and the second delta value of the at least one body location of the patient in the transfer record and the second data record respectively (see: claim 5 where the tissue status stored in the database. Also see: paragraphs [0024] and [0037] where SEM delta value data (“other values” which are defined in the Berggren reference in claim 21 to be calculated delta values between electrodes) is being retrieved and respectively displayed. The stored information here is the equivalent of a first and second record).
The combination may not further, specifically teach querying the database for data to form retrieved delta values.
Heaton teaches:
--querying the database for data to form retrieved delta values (see: FIG. 9 where there is a directory for storing and retrieving archived responses into and from the database. In order for the system here to access the database here, it would query the database in order to retrieve the necessary data).
One of ordinary skill at the time of the invention was filed would have found it obvious to query the database for data to form retrieved delta values as taught by Heaton in the method as taught by Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination with the motivation(s) of being a way to store and retrieve information from a database (see: column 19, lines 44-45 of Heaton).
As per claim 32, Lachenbruch et al., Geleijnse et al., Berggren, Bennett-Guerrero, and Heaton in combination teaches the method of claim 31, see discussion of claim 31. Lachenbruch et al. further teaches:
--formatting the retrieved delta values in date and time order, (see: paragraph [0037] where delta values are “other values” which are defined in the Berggren reference in claim 21 to be calculated delta values between electrodes. Also see: paragraph [0024] where the values are retrieved and viewed as a graphical history) and
--displaying the formatted delta values (see: paragraph [0024] where the “other values” are displayed).
As per claim 34, Lachenbruch et al., Geleijnse et al., Berggren, Bennett-Guerrero, and Heaton in combination teaches the method of claim 32, see discussion of claim 32. Lachenbruch et al. further teaches delta values (see: paragraph [0037] where there are “other values” which are defined in the Berggren reference in claim 21 to be calculated delta values between electrodes).
Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination may not further, specifically teach wherein the formatted values are displayed in the form of a curve.
Heaton further teaches wherein the formatted values are displayed in the form of a curve (see: FIG. 8).
One of ordinary skill at the time of the invention was filed would have found it obvious to have wherein the formatted values are displayed in the form of a curve as taught by Heaton in the method as taught by Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination with the motivation(s) of being a way to display data in a graphical manner (see: FIG. 8 of Heaton).
As per claim 39, Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination teaches the method of claim 37, see discussion of claim 37. Lachenbruch et al. further teaches delta values (see: paragraph [0037] where there are “other values” which are defined in the Berggren reference in claim 21 to be calculated delta values between electrodes).
Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination may not further, specifically teach the step of
--querying the database to retrieve the values observed over time for a particular patient across multiple care settings and various episodes of care.
Heaton further teaches the step of querying the database to retrieve the values observed over time for a particular patient across multiple care settings and various episodes of care (see: FIG. 9 where there is a directory for storing and retrieving archived responses into and from the database. In order for the system here to access the database here, it would query the database in order to retrieve the necessary data. Additionally, the data here are past data values including values across multiple care settings and care episodes. These data values are retrieved regardless of setting and care episode).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 31, and incorporated herein.
Claims 33 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren and further in view of U.S. Patent No. 9,028,407 to Bennett-Guerrero as applied to claim 29, and further in view of U.S. 2008/0015894 to Miller et al.
As per claim 33, Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination teaches the method of claim 29, see discussion of claim 29. Lachenbruch et al. further teaches a record as a record that comprises the patient identifier, a data element, and a date/time associated with the data element (see: paragraph [0024] where there is a display of data according to date and time. The information shown identifies the individual and is also considered to be a data element).
The combination may not further, specifically the steps of:
1) --creating an additional data record, wherein the data element comprises one or more of a 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
2) --reporting the additional data record to the database.
Miller et al. teaches:
1) --creating an additional data record, wherein the data element comprises one or more of a 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, (see: paragraph [0121] where there are results being recorded in a database and these results are being considered to be the additional data record. The results can include the name of the patient (patient identifier), recommendations or changes to the therapy regimen (a care plan), as well as a date and time associated with the recommendation or change) and
2) --reporting the additional data record to the database (see: paragraph [0121] where the results of the contact with the medical provider are recorded with the database).
One of ordinary skill at the time of the invention was filed would have found it obvious to 1) create an additional data record, wherein the data element comprises one or more of a 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 2) report the additional data record to the database as taught by Miller et al. in the method as taught by Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination with the motivation(s) of updating a patient’s files (see: paragraph [0021] of Miller et al.).
Claims 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren further in view of U.S. Patent No. 9,028,407 to Bennett-Guerrero further in view of U.S. Patent No. 9,675,289 to Heaton as applied to claim 32, and further in view of U.S. Patent No. 8,355,925 to Rothman et al.
As per claim 35, Lachenbruch et al., Geleijnse et al., Berggren, Bennett-Guerrero, and Heaton in combination teaches the method of claim 32, see discussion of claim 32. Lachenbruch et al. further teaches delta values (see: paragraph [0037] where there are “other values” which are defined in the Berggren reference in claim 21 to be calculated delta values between electrodes).
The combination may not further, specifically teach the step of analyzing the retrieved 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.
Rothman et al. teaches:
--the step of analyzing the retrieved 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 (see: column 15, lines 29-43 where a derivative in the slope is calculated and a determination is made based on this acceleration to see if the patient is declining at a faster rate. The change in the acceleration of the slope may trigger an alarm. Also see: column 23, lines 18-29 and 51-59).
One of ordinary skill at the time of the invention was filed would have found it obvious to have the step of analyzing the retrieved 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 as taught by Rothman et al. in the method as taught by Lachenbruch et al., Geleijnse et al., Berggren, and Heaton in combination with the motivation(s) of alerting a user if a patient is getting better or worse at an accelerating rate (see: column 23, lines 51-59 of Rothman et al.).
As per claim 36, Lachenbruch et al., Geleijnse et al., Berggren, Heaton, and Rothman et al. in combination teach the method of claim 35, see discussion of claim 35. Lachenbruch et al., Geleijnse et al., Berggren, and Heaton in combination may not further, specifically teach wherein the acceleration is determined by the rate of change of the slope of the curve.
Rothman et al. further teaches wherein the acceleration is determined by the rate of change of the slope of the curve (see: column 15, lines 29-43 where a derivative in the slope is calculated and a determination is made based on this acceleration to see if the patient is declining at a faster rate. The change in the acceleration of the slope may trigger an alarm. Also see: column 23, lines 18-29 and 51-59).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 35, and incorporated herein.
Claims 40 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren and further in view of U.S. Patent No. 9,028,407 to Bennett-Guerrero as applied to claim 21, and further in view of “Protocol for the successful treatment of pressure ulcers” to Brem et al.
As per claim 40, Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination teaches the method of claim 21, see discussion of claim 21. The combination may not specifically, further teach wherein the level-0 PU intervention further comprises an intervention selected from the group consisting of providing good nutrition, standard mattress, turning every 24 hours, and a combination thereof.
Brem et al. teaches:
--wherein the level-0 PU intervention further comprises an intervention selected from the group consisting of providing good nutrition, standard mattress, turning every 24 hours, and a combination thereof (see: page 12S, point #7 under “Protocol for the comprehensive treatment of pressure ulcers” where providing good nutrition is an option to address pressure ulcers. Also see: page 13S under “Aggressive nutritional supplementation for all malnourished/undernourished patients”).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute an intervention selected from the group consisting of providing good nutrition, standard mattress, turning every 24 hours, and a combination thereof as taught by Brem et al. for the intervention group as disclosed by Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleijnse et al. because they are types of treatment options, making results predictable. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
As per claim 43, Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination teaches the method of claim 21, see discussion of claim 21. The combination may not teach wherein a level-3 PU intervention is applying dressing to the back or sides of patient’s heel.
Brem et al. teaches:
--a level-3 PU intervention of applying dressing to the back or sides of patient's heel (see: Table 1 of page 10S and “Effective wound-bed preparation of a moist wound healing environment” of page 13S where a wound dressing is being used as a treatment for pressure ulcers).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 40, and incorporated herein.
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren and further in view of U.S. Patent No. 9,028,407 to Bennett-Guerrero as applied to claim 21, and further in view of U.S. Patent No. 5,367,789 to Lamont.
As per claim 41, Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination teaches the method of claim 21, see discussion of claim 21. The combination may not teach wherein a level-1 PU intervention is providing a heel boot to the patient.
Lamont teaches:
--a level-1 PU intervention of providing a heel boot to the patient (see: column 1, lines 14-17 where there is a heel boot that is used to treat foot ulcers).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-1 PU intervention of providing a heel boot to the patient as taught by Lamont for a treatment level as disclosed by Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleijnse et al. because they are types of treatment options, making results predictable. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren and further in view of U.S. Patent No. 9,028,407 to Bennett-Guerrero as applied to claim 21, and further in view of U.S. Patent No. 6,634,045 to DuDonis et al.
As per claim 42, Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination teach the method of claim 21, see discussion of claim 21. The combination may not further specifically teach a level-2 PU intervention of changing the patient's support surface.
DuDonis et al. teaches:
--a level-2 PU intervention of changing the patient's support surface (see: column 3, lines 27-46. Also see: column 5, lines 18-21. The support surface is being changed here from the bed using the heel elevator support).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-2 PU intervention of changing the patient's support surface as taught by DuDonis et al. for a treatment level as disclosed by Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleijnse et al. because they are types of treatment options, making results predictable. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren and further in view of U.S. Patent No. 9,028,407 to Bennett-Guerrero as applied to claim 21, and further in view of “Friction between human skin and medical textiles for decubitus prevention” to Rotaru et al.
As per claim 44, Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination teach the method of claim 21, see discussion of claim 21. The combination may not further specifically teach a level-4 PU intervention of changing the patient's sheet cover to a low-friction sheet cover.
Rotaru et al. teaches:
--a level-4 PU intervention of changing the patient's sheet cover to a low-friction sheet cover (see: Abstract on page 91 and “Conclusions” on page 96 where old hospital bedsheets are being swapped out with lower friction ones to treat pressure ulcers).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-4 PU intervention of changing the patient's sheet cover to a low-friction sheet cover as taught by Rotaru et al. for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleijnse et al. because they are types of treatment options, making results predictable. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren and further in view of U.S. Patent No. 9,028,407 to Bennett-Guerrero as applied to claim 21, and further in view of U.S. Patent No. 8,011,041 to Hann.
As per claim 45, Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination teach the method of claim 21, see discussion of claim 21. The combination may not further specifically teach a level-5 PU intervention of providing a low-friction padded mattress surface for the patient's lower leg.
Hann teaches:
--a level-5 PU intervention of providing a low-friction padded mattress surface for the patient's lower leg (see: column 5, lines 51-63 where there is a low-friction pad being used. Also see: column 3, lines 30-35).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-5 PU intervention of providing a low-friction padded mattress surface for the patient's lower leg as taught by Hann for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleijnse et al. because they are types of treatment options, making results predictable. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Claims 46 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren and further in view of U.S. Patent No. 9,028,407 to Bennett-Guerrero as applied to claim 21, and further in view of “Prevention and Treatment of Pressure Ulcers” to Thomas.
As per claim 46, Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination teach the method of claim 21, see discussion of claim 21. The combination may not further specifically teach a level-6 PU intervention of turning the patient at a shorter interval than currently provided for.
Thomas teaches:
--a level-6 PU intervention of turning the patient at a shorter interval than currently provided for (see: “Decrease Pressure, Friction, and Shear” of page 47 where the most common method for reducing pressure is frequent turning and positioning).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-6 PU intervention of turning the patient at a shorter interval than currently provided for as taught by Thomas for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleijnse et al. because they are types of treatment options, making results predictable. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
As per claim 47, Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination teach the method of claim 21, see discussion of claim 21.The combination may not further specifically teach a level-7 PU intervention of applying a barrier cream to the patient's heel.
Thomas teaches:
--a level-7 PU intervention of applying a barrier cream to the patient's heel (see: page 55, paragraph 3 where there is a cream containing 1% silver sulfadiazine being applied to improve clinical appearance of the wound and improve healing. The cream containing the silver sulfadiazine is the barrier cream. Also see: page 2, paragraph 2 of “Pressure Ulcer Prevention in the Hospital Setting Using Silicon Foam Dressings” to Truong et al. where silver sulfadiazine is an ingredient in barrier creams).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 46, and incorporated herein.
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren and further in view of U.S. Patent No. 9,028,407 to Bennett-Guerrero as applied to claim 21, and further in view of “A systematic review of electrical stimulation for pressure ulcer prevention and treatment in people with spinal cord injuries” to Liu.
As per claim 48, Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination teach the method of claim 21, see discussion of claim 21. The combination may not further specifically teach a level-8 PU intervention of applying a neuro-muscular stimulation to the patient's heel.
Liu teaches:
--a level-8 PU intervention of applying a neuro-muscular stimulation to the patient's heel (see: “Results” on page 703 where ES enhanced PU healing).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-8 PU intervention of applying a neuro-muscular stimulation to the patient's heel as taught by Liu for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleijnse et al. because they are types of treatment options, making results predictable. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren and further in view of U.S. Patent No. 9,028,407 to Bennett-Guerrero as applied to claim 21, and further in view of “Topical hydrogen peroxide treatment of ischemic ulcers in the guinea pig: Blood recruitment in multiple skin sites” to Tur et al.
As per claim 49, Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination teach the method of claim 21, see discussion of claim 21. The combination may not further specifically teach a level-9 PU intervention of applying a topical cream to the patient's heel to enhance perfusion.
Tur et al. teaches:
--a level-9 PU intervention of applying a topical cream to the patient's heel to enhance perfusion (see: “Results” of page 217 where topical hydrogen peroxide cream was used to enhance vascular perfusion).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-9 PU intervention of applying a topical cream to the patient's heel to enhance perfusion as taught by Tur et al. for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleijnse et al. because they are types of treatment options, making results predictable. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of “Capacitive Biosensors” to Berggren and further in view of U.S. Patent No. 9,028,407 to Bennett-Guerrero as applied to claim 21, and further in view of “Pressure Ulcer Prevention in the Hospital Setting Using Silicon Foam Dressings” to Truong et al.
As per claim 50, Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination teach the method of claim 21, see discussion of claim 21. The combination may not further specifically teach a level-10 PU intervention of providing a silicon pad for the patient's lower leg.
Truong et al. teaches:
--a level-10 PU intervention of providing a silicon pad for the patient's lower leg (see: page 5, paragraphs 2, 3, and 5 where silicon foam dressings can be used as treatment to prevent pressure ulcers).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-10 PU intervention of providing a silicon pad for the patient's lower leg as taught by Truong et al. for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al., Geleijnse et al., Berggren, and Bennett-Guerrero teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleijnse et al. because they are types of treatment options, making results predictable. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Conclusion

CITED REFERENCE SUMMARIES: Ref US20160338591: Claims:
1. A method for tracking a change in tissue status comprising:
receiving at least some demographic information regarding an individual being monitored; receiving, from a sensor, information regarding a first tissue status for the individual; comparing the received information with a threshold tissue status selected at least in part based on the at least some demographic information regarding the individual; providing an alert indicative of a change in tissue status in response to determining that the received information exceeds the threshold tissue status.
2. The method of claim 1, wherein the at least some demographic information regarding the individual being monitored comprises at least one of an age of the individual, a medical condition of the individual, a sex of the individual, a weight of the individual, a medication provided to the individual, a smoking status of the individual, a mobility level of the individual, a medical device utilized by the individual, and an indication that the individual has previously had a tissue condition.
3. The method of claim 1, wherein the information regarding the first tissue status for the individual comprises a temperature of the tissue, a moisture level of the tissue, mechanical energy dissipation through the tissue, ultrasound or other high frequency information, light frequency information, or a biomarker in the tissue.
4. The method of claim 1, wherein providing the alert indicative of the change in tissue status comprises providing an alert to a caregiver via a computing device.
5. The method of claim 1, further comprising:
storing the received information regarding the first tissue status and the at least some information regarding an individual being monitored in a database; receiving, from the sensor, information regarding at least one subsequent tissue status for the individual; and updating the database with the at least one subsequent tissue status for the individual.
6. The method of claim 5, further comprising:
adjusting the threshold based on at least some of the information in the database.
7. The method of claim 5, further comprising providing a graphical history of tissue status over time based on the first tissue status and the at least one subsequent tissue status for the individual.
8. The method of claim 5, further comprising updating the database with an outcome for the individual.
9. The method of claim 1, further comprising making an adjustment to a person support apparatus upon which the individual is disposed.
10. A system comprising:
at least one sensor for sensing information regarding a tissue status for an individual; a server communicatively coupled to the at least one sensor for receiving the information regarding the tissue status for the individual from the at least one sensor, the server comprising a processor and a memory storing computer readable and executable instructions that, when executed by the processor, cause the server to compare the information regarding the tissue status to a threshold tissue status and provide at least one output based on the comparison; and at least one computing device communicatively coupled to the server for receiving the at least one output from the server.
11. The system of claim 10, wherein the sensor comprises a light source and an optical detector.
12. The system of claim 10, wherein the information regarding the tissue status for the individual comprises information regarding a change in light intensity at a predetermined wavelength.
13. The system of claim 12, wherein the at least one output comprises an instruction to make an adjustment to a person support apparatus upon which the individual is disposed, a notification to a caregiver, or an instruction to provide medication.
14. The system of claim 13, wherein the instruction to make the adjustment to the person support apparatus comprises an instruction to alter an angle of the person support apparatus, an instruction to reduce a pressure associated with the person support apparatus, or an instruction to alter a temperature of the person support apparatus.
15. The system of claim 12, wherein the at least one computing device is associated with a person support apparatus upon which the individual is disposed.
16. The system of claim 10, wherein the server receives at least some information regarding the individual, and the threshold tissue status depends at least in part on the at least some information regarding the individual.
17. The system of claim 16, wherein the server updates the threshold tissue status based on the information regarding the tissue status for the individual.
18. The system of claim 16, wherein the server updates the threshold tissue status based on an outcome for the individual.
19. The system of claim 16, wherein the at least some information regarding the individual comprises at least one of an age of the individual, a medical condition of the individual, a sex of the individual, a weight of the individual, a medication provided to the individual, a smoking status of the individual, a mobility level of the individual, a medical device utilized by the individual, and an indication that the individual has previously had a tissue condition.
20. The system of claim 10, wherein the information regarding the tissue status comprises information regarding a moisture level of the tissue, mechanical energy dissipation through the tissue, ultrasound or other high frequency information, light frequency information, or a biomarker in the tissue.
Ref US20150186607: Claims:
1. A clinical support system comprising a processor and a computer-readable storage medium, wherein the computer-readable storage medium contains instructions for execution by the processor, wherein the instructions cause the processor to perform the steps of:
obtaining current patient data descriptive of a patient, for whom a recommendation for a transition from a current care levels to one or more other care levels shall be provided, in the current care level, obtaining historic patient data of the patient obtained earlier in the current and/or other care levels, and computing two or more patient specific transition scores from said obtained current and historic patient data, wherein a patient specific transition score indicates a level of recommendation of a transition of the patient from the current care level to a different care level or to stay in the current care level.
2. The clinical support system as claimed in claim 1, wherein the instructions further cause the processor to compute said two or more patient specific transition scores by use of a prediction model predicting the patient's future health progress based on said obtained current and historic patient data.
3. The clinical support system as claimed in claim 1, wherein said historic patient data comprises historic transitions between different care levels including information on improvements and/or deteriorations of the patient's health status in response to said historic transitions.
4. (canceled)
5. The clinical support system as claimed in claim 1, wherein the instructions further cause the processor to identify the location of the current care level and to use the location of the current care level as an additional input in the computation of the two or more patient specific transition scores.
6. The clinical support system as claimed in claim 5, wherein the instructions further cause the processor to identify the location of the current care level by reading a location information from the current patient data or by deriving the location from features of the current patient data including the type, amount and/or content of the current patient data.
7. The clinical support system as claimed in claim 1, wherein the instructions further cause the processor to use the risk of readmission of the patient to the current care level as an additional input in the computation of the two or more patient specific transition scores.
8. (canceled)
9. The clinical support system as claimed in claim 1, wherein the instructions further cause the processor to use patient population data providing statistical information on historic transitions of other patients between different care levels including information on improvements and/or deteriorations of their health status in response to said historic transitions.
10. The clinical support system as claimed in claim 1, wherein the instructions further cause the processor to compute one or more disease specific health scores for the patient from said current and historic patient data and to use said one or more disease specific health scores in the computation of said two or more patient specific transition scores.
11. The clinical support system as claimed in claim 1, wherein the instructions further cause the processor to obtain patient data, health progression information and/or transmission scores of patients that had the same or a similar health status and/or health history as the current patient and to use the obtained patient data health progression information and/or transmission scores in the computation of the two or more patient specific transition scores.
12. The clinical support system as claimed in claim 1, wherein the instructions further cause the processor
to compute a general health score for the current care level from historic patient data of patients that have been in the current care level, to compute two or more general transition scores each indicating a level of recommendation of a transition of a patient from the current care level to a different care level or to stay in the current care level, and to combine said two or more general transition scores with said two or more patient specific transition scores to obtain two or more final transition scores.
13. The clinical support system as claimed in claim 12, wherein the instructions further cause the processor to apply a weighted combination of said general transition scores and said patient specific transition scores to obtain said final transition scores, the weights being determined manually or from the accuracy of past transition scores of the current patient, other patients and/or all patients.
14. A clinical support method comprising the steps of
obtaining current patient data descriptive of a patient, for whom a recommendation for a transition from a current care levels to one or more other care levels shall be provided, in the current care level, obtaining historic patient data of the patient obtained earlier in the current and/or other care levels, and computing two or more patient specific transition scores from said obtained current and historic patient data, wherein a patient specific transition score indicates a level of recommendation of a transition of the patient from the current care level to a different care level or to stay in the current care level.
15. A computer-readable non-transitory storage medium containing instructions for execution by a processor, wherein the instructions cause the processor to perform the steps of:
obtaining current patient data descriptive of a patient, for whom a recommendation for a transition from a current care levels to one or more other care levels shall be provided, in the current care level, obtaining historic patient data of the patient obtained earlier in the current and/or other care levels, and computing two or more patient specific transition scores from said obtained current and historic patient data, a patient specific transition score indicating a level of recommendation of a transition of the patient from the current care level to a different care level or to stay in the current care level.
16. Computer program comprising program code means for causing a computer to carry out the steps of the method as claimed in claim 14 when said computer program is carried out on the computer.
17. A clinical support system comprising:
means for obtaining current patient data descriptive of a patient, for whom a recommendation for a transition from a current care levels to one or more other care levels shall be provided, in the current care level, means for obtaining historic patient data of the patient obtained earlier in the current and/or other care levels, and means for computing two or more patient specific transition scores from said obtained current and historic patient data, wherein a patient specific transition score indicates a level of recommendation of a transition of the patient from the current care level to a different care level or to stay in the current care level.
Ref US9028407: Claims:
1. An apparatus for monitoring patient orientation, comprising:
a reusable sensor configured to detect inclination angles of an anterior region of the patient; and
an elongated disposable attachment device having a first end and a second end, a distance between the first end and the second end defining a length of the elongated disposable attachment device, the length of the elongated disposable attachment device being greater than a maximum width of the elongated disposable attachment device that is perpendicular to a first direction between the first end and the second end of the elongated disposable attachment device, the elongated disposable attachment device configured for removable attachment to both the sensor and the patient's anterior region such that the first direction of the attachment device extends along a longitudinal axis of a sternum of the patient, the attachment device including:
a sensor attachment portion configured for removable attachment to the sensor such that the sensor is prevented from direct contact with the patient,
a patient attachment portion configured for removable attachment to the patient's anterior region, and
a first connector attached to the sensor attachment portion and a second connector attached to the patient attachment portion, the first connector and the second connector being configured to detachably mate to each other.
2. The apparatus for monitoring patient orientation according to claim 1, wherein the sensor attachment portion is elongated and opposite ends of the elongated sensor attachment portion comprise the first and second ends of the elongated disposable attachment device, respectively, and the patient attachment portion includes two separate, physically distinct and non-integral attachment portions that are each individually removably attachable to locations adjacent the opposite ends of the elongated sensor attachment portion.
3. The apparatus for monitoring patient orientation according to claim 2, wherein at least a part of the sensor attachment portion is hollow and configured for disposing the sensor therein.
4. The apparatus for monitoring patient orientation according to claim 2, wherein the sensor attachment portion defines a sealable pouch that is configured for disposing the sensor therein.
5. The apparatus for monitoring patient orientation according to claim 4, wherein the pouch is defined at an upper surface of the sensor attachment portion.
6. The apparatus for monitoring patient orientation according to claim 1, wherein the sensor is an accelerometer.
7. The apparatus for monitoring patient orientation according to claim 1, further including a sensor sheath that houses the sensor and that is insertable into the sensor attachment portion.
8. The apparatus for monitoring patient orientation according to claim 7, further comprising a controller that is spaced apart from and physically unconnected with the sensor, and a transmitter that wirelessly transmits signals between the sensor and the controller, the sensor sheath housing the transmitter.
9. The apparatus for monitoring patient orientation according to claim 8, wherein the controller includes an indicator that enables viewing of the incline angles detected by the sensor.
10. The apparatus for monitoring patient orientation according to claim 8, wherein the controller controls the sensor to vary the frequency of incline measurements.
11. The apparatus for monitoring patient orientation according to claim 8, wherein the controller provides an alarm indication if the sensor detects certain incline angles.
12. The apparatus for monitoring patient orientation according to claim 11, wherein the controller provides an alarm indication if the sensor detects that the patient's incline angle falls below a certain angle.
13. The apparatus for monitoring patient orientation according to claim 12, wherein the controller provides an alarm indication if the sensor detects that the patient's incline angle falls below 30 degrees.
14. The apparatus for monitoring patient orientation according to claim 11, wherein the controller provides an alarm indication if the sensor detects that the patient's incline angle indicates that the patient is attempting to stand.
15. The apparatus for monitoring patient orientation according to claim 11, wherein the controller provides an alarm indication if the sensor detects that the patient's incline angle exceeds a certain angle.
16. The apparatus for monitoring patient orientation according to claim 8, wherein the controller is configured to monitor the patient conditions, including at least one of heart rate, respiratory rate, respiratory depth, GI motility, sleep analysis, and seizure detection.
17. The apparatus for monitoring patient orientation according to claim 16, wherein the controller is configured to control an aspect of sensing of at least one of the monitored conditions based on at least one of another of the monitored conditions.
18. The apparatus for monitoring patient orientation according to claim 17, wherein the controller is configured to affect the frequency of monitoring of patient incline based on data of at least one of the other monitored conditions.
19. The apparatus for monitoring patient orientation according to claim 18, wherein the controller is configured to reduce the frequency of monitoring of patient incline if data of at least one heart rate, respiratory rate, and respiratory depth indicates that the patient is asleep.
20. The apparatus for monitoring patient orientation according to claim 1, wherein the sensor attachment portion comprises a pouch configured to fully encapsulate the sensor.
21. An apparatus for monitoring patient orientation, comprising:
a reusable sensor configured to detect inclination angles of an anterior region of the patient; and
an elongated disposable attachment device having a first end and a second end, a distance between the first end and the second end defining a length of the elongated disposable attachment device, the length of the elongated disposable attachment device being greater than a maximum width of the elongated disposable attachment device that is perpendicular to a first direction between the first end and the second end of the elongated disposable attachment device, the elongated disposable attachment device configured for removable attachment to both the sensor and the patient's anterior region such that the first direction of the attachment device extends along a longitudinal axis of a sternum of the patient, the attachment device including:
a sensor attachment portion configured for removable attachment to the sensor such that the sensor is prevented from direct contact with the patient, and
a patient attachment portion configured for removable attachment to the patient's anterior region,

wherein the sensor at attachment portion is configured to connect to the reusable sensor such that the reusable sensor has an alignment having a fixed relationship to the first direction, and,
wherein the patient attachment portion is configured for removable attachment to skin of the patient at the sternum of the patient.
22. The apparatus for monitoring patient orientation according to claim 21, wherein the maximum width of the elongated disposable attachment device is less than a width of the sternum 
[Truncated to input limit]