Office Action 3: Non-Final Rejection (2021-07-09)
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;
making a plurality of Sub-Epidermal Moisture (SEM) measurements at a body location on the patient at the second care setting, 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\. (Currently Amended) The method of claim \[\[22\]\] 2\_L 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\. (Currently Amended) The method of claim \[\[22\]\] 2 \_, 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\. (Currently Amended) The method of claim \[\[22\]\] 21, 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, and wherein said 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\. (Previously Presented) The method of claim 21, wherein said delta value is calculated by a difference between a maximum SEM measurement and a minimum SEM measurement selected from the plurality of SEM measurements.

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\. (Previously Presented) The method of claim 29, wherein said second delta value is calculated by a difference between a maximum SEM measurement and a minimum SEM measurement selected from the second plurality of SEM measurements.

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\. (Previously Presented) The method of claim 37, wherein said third delta value is calculated by a difference between a maximum SEM measurement and a minimum SEM measurement selected from the third plurality of SEM measurements.

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\. (Previously Presented) The method of claim 21, 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.

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.

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 12/22/2020 has been entered.
Response to Amendment
In light of the amended claims, the claims are rejected under 35 U.S.C. 103.
Notice to Applicant
In the amendment dated 12/18/2020, the following has occurred: claims 21 and 23-25 have been amended; claims 26-50 have remained unchanged; claim 22 was canceled; and no new claims have been added.
Claims 21 and 23-50 are pending.
Effective Filing Date: 11/16/2017
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 Arguments
35 U.S.C. 103 Rejections:
Applicant made arguments directed towards the previously used art. These arguments are deemed moot in view of the newly cited art.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/22/2020 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.
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:
--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)
--calculating a delta value by a difference between two of the plurality of SEM measurements, (see: paragraph [0037] where one or more sensors 102 are positioned to collect information regarding the tissue status of the individual. The sensor collects information regarding SEM levels as a measure of impedance in dermal phase units. Impedance is also a measure of flow, thus it is measured using two points in order to determine the flow. An individual sensor itself would therefore include two measurements points in order to calculate the impedance. Accordingly, the measurement of an impedance itself is a delta value)
--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 impedance in DPU) 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;
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.
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) 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)
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, 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 Geleseijnse 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.).
As per claim 23, Lachenbruch et al. and Geleseijnse et al. 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 (DMU 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.
Geleseijnse 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. and Geleseijnse et al. 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.
Geleseijnse 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. and Geleseijnse et al. in combination teach the method of claim 21, see discussion of claim 21. Lachenbruch et al. further teaches 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 information regarding SEM levels as a measure of impedance in dermal phase units. Impedance is also a measure of flow, thus it is measured using two points in order to determine the flow. An individual sensor itself would therefore include two measurements points in order to calculate the impedance. Accordingly, the measurement of an impedance itself is a delta value).
Lachenbruch et al. may not further, specifically teach wherein the transfer record further comprises results and wherein said transfer record is stored on a database.
Geleseijnse 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) and 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. and Geleseijnse et al. 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.
Geleseijnse 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. and Geleseijnse et al. 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 delta values are calculated for each day in DPU)
--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. and Geleseijnse et al. 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 delta values are calculated for each day in DPU)
--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. 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. and Geleseijnse et al. 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. and Geleseijnse et al. 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 28, 30, and 38 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. as applied to claim 21, further in view of U.S. 2017/0007153 to Tonar et al.
As per claim 28, Lachenbruch et al. and Geleseijnse et al. in combination teach the method of claim 21, see discussion of claim 21. The combination may not further, specifically teach wherein said delta value is calculated by a difference between a maximum SEM measurement and a minimum SEM measurement selected from the plurality of SEM measurements.
Tonar et al. teaches:
--wherein said delta value is calculated by a difference between a maximum SEM measurement and a minimum SEM measurement selected from the plurality of SEM measurements (see: paragraph [0008] where a difference between a max SEM value and min SEM value is determined).
One of ordinary skill at the time of the invention was filed would have found it obvious to have wherein said delta value is calculated by a difference between a maximum SEM measurement and a minimum SEM measurement selected from the plurality of SEM measurements as taught by Lachenbruch et al. and Geleseijnse et al. in combination in the method as taught by Tonar et al. with the motivation(s) of helping determine damaged tissue (see: paragraph [0002] of Tonar et al.).
As per claim 30, Lachenbruch et al. and Geleseijnse et al. in combination teach the method of claim 29, see discussion of claim 29. Lachenbruch et al. teaches second set of values and measurements (see: paragraphs [0024] and [0037] where there are multiple SEM scan measurements including a second set).
The combination may not further, specifically teach wherein said delta value is calculated by a difference between a maximum SEM measurement and a minimum SEM measurement selected from the plurality of SEM measurements.
Tonar et al. teaches:
--wherein said delta value is calculated by a difference between a maximum SEM measurement and a minimum SEM measurement selected from the plurality of SEM measurements (see: paragraph [0008] where a difference between a max SEM value and min SEM value is determined).
One of ordinary skill at the time of the invention was filed would have found it obvious to have wherein said delta value is calculated by a difference between a maximum SEM measurement and a minimum SEM measurement selected from the plurality of SEM measurements as taught by Lachenbruch et al. and Geleseijnse et al. in combination in the method as taught by Tonar et al. with the motivation(s) of helping determine damaged tissue (see: paragraph [0002] of Tonar et al.).
As per claim 38, Lachenbruch et al. and Geleseijnse et al. in combination teach the method of claim 37, see discussion of claim 37. Lachenbruch et al. teaches third set of values and measurements (see: paragraphs [0024] and [0037] where there are multiple SEM scan measurements including a second set).
The combination may not further, specifically teach wherein said delta value is calculated by a difference between a maximum SEM measurement and a minimum SEM measurement selected from the plurality of SEM measurements.
Tonar et al. teaches:
--wherein said delta value is calculated by a difference between a maximum SEM measurement and a minimum SEM measurement selected from the plurality of SEM measurements (see: paragraph [0008] where a difference between a max SEM value and min SEM value is determined).
One of ordinary skill at the time of the invention was filed would have found it obvious to have wherein said delta value is calculated by a difference between a maximum SEM measurement and a minimum SEM measurement selected from the plurality of SEM measurements as taught by Lachenbruch et al. and Geleseijnse et al. in combination in the method as taught by Tonar et al. with the motivation(s) of helping determine damaged tissue (see: paragraph [0002] of Tonar et al.).
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. 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. and Geleseijnse et al. 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 (DPU data) 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. and Geleseijnse et al. 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., Geleseijnse et al., 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 in DPU. Also see: paragraph [0024] where the delta values are retrieved and viewed as a graphical history) and
--displaying the formatted delta values (see: paragraph [0024] where the delta values are displayed).
As per claim 34, Lachenbruch et al., Geleseijnse et al., 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 delta values in DPU).
Lachenbruch et al. and Geleseijnse et al. 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. and Geleseijnse et al. 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., Geleseijnse et al., and Heaton 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 delta values in DPU).
Lachenbruch et al. and Geleseijnse et al. 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. 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. and Geleseijnse et al. 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. and Geleseijnse et al. 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 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., Geleseijnse et al., 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 delta values in DPU).
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., Geleseijnse et al., 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., Geleseijnse et al., Heaton, and Rothman et al. in combination teach the method of claim 35, see discussion of claim 35. Lachenbruch et al., Geleseijnse et al., 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. 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. and Geleseijnse et al. in combination teaches the method of claim 21, see discussion of claim 21. The combination may not specifically, further teach 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.
Brem et al. teaches:
--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 (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 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. and Geleseijnse et al. 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. and Geleseijnse et al. 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 Geleseijnse et al. because they are types of treatment options. 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. and Geleseijnse et al. 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. 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. and Geleseijnse et al. 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. and Geleseijnse et al. 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. and Geleseijnse et al. 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 Geleseijnse et al. because they are types of treatment options. 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. 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. and Geleseijnse et al. 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. and Geleseijnse et al. 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. and Geleseijnse et al. 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 Geleseijnse et al. because they are types of treatment options. 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. 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. and Geleseijnse et al. 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. and Geleseijnse et al. 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. and Geleseijnse et al. 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 Geleseijnse et al. because they are types of treatment options. 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. 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. and Geleseijnse et al. 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. and Geleseijnse et al. 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. and Geleseijnse et al. 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 Geleseijnse et al. because they are types of treatment options. 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. 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. and Geleseijnse et al. 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. and Geleseijnse et al. 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. and Geleseijnse et al. 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 Geleseijnse et al. because they are types of treatment options. 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. and Geleseijnse et al. 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. 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. and Geleseijnse et al. 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. and Geleseijnse et al. 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. and Geleseijnse et al. 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 Geleseijnse et al. because they are types of treatment options. 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. 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. and Geleseijnse et al. 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. and Geleseijnse et al. 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. and Geleseijnse et al. 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 Geleseijnse et al. because they are types of treatment options. 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. 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. and Geleseijnse et al. 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. and Geleseijnse et al. 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. and Geleseijnse et al. 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 Geleseijnse et al. because they are types of treatment options. 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 REBUTTAL: REMARKS
Claims 21, 23-27, 29, 31-37, and 39-50 are pending. Claim 21 is amended. Support for the claim amendments may be found in the as-filed claims and specification; e.g., at [0039]- [0041]. Claims 1-20 and 22 were previously cancelled. Claims 28, 30, and 38 are cancelled without prejudice to, or disclaimer of, the underlying subject matter. Applicant expressly reserves the right to file the subject matter of any cancelled claims in a later continuation application. No new matter enters by way of the present amendment. Entry of the amendment and reconsideration of the application based on the following remarks is respectfully requested.
I.    Rejections under 35 U.S.C. § 103
A.    Claims 21, 23-26, 29, and 37
The Examiner rejects claims 21, 23-26, 29, and 37 under 35 U.S.C. § 103 for allegedly being unpatentable over US Publication 2016/0338591 to Lachenbruch et al. ("Lachenbruch") in view of US Publication 2015/0186607 to Geleijnse et al. ("Geleijnse"). See Office Action at 4. Specifically, the Examiner alleges that "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: making a plurality of Sub-Epidermal Moisture (SEM) measurements at a body location on the patient at the second care setting. . . calculating a delta value by a difference between two of the plurality of SEM measurements... determining whether the delta value exceeds a threshold... do nothing if the delta value does not exceed the threshold. . . do something if the delta value exceeds the threshold. " Id. at 4-5. 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 5. 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 6. 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 Geleseijnse [sic] 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." Id. at 6-7.
At the outset, without acquiescing to the rejection, and solely to advance prosecution, Applicant amends claim 21 to recite "each SEM measurement comprising a measurement of biocapacitance."
"The key to supporting any rejection under 35 U.S.C. § 103(a) is the clear articulation of the reason(s) why the claimed invention would have been obvious.... [R]ejections on obviousness cannot be sustained with mere conclusory statements." MPEP § 2142. "[T]he framework for the objective analysis for determining obviousness under 35 U.S.C. § 103(a) is stated in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966).... The factual inquiries ... [include determining the scope and content of the prior art and] ... [a]scertaining the differences between the claimed invention and the prior art." MPEP § 2141(11). In rejecting a claim, "Office 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." MPEP § 2141(11). Here, no primafacie case of obviousness has been established, for at least the reason that the Office has not (1) properly determined the scope and content of the prior art, (2) properly ascertained the differences between the prior art and the claimed subject matter, or (3) demonstrated a motivation to combine the cited references.
1.    Scope and content of Lachenbruch
Applicant submits that the Office has not properly determined the scope and content of Lachenbruch.
The Examiner cites Lachenbruch and alleges that it provides "calculating a delta value by a difference between two of the plurality of SEM measurements." Office Action at 4. For support, the Examiner alleges Lachenbruch for providing "one or more sensors 102 are positioned to collect or sense information regarding a tissue status for the individual. . . the sensor collects information regarding subepidermal moisture (SEM) levels as a measure of impedance in dermal phase units (DPU). . . ." Lachenbruch at [0037]. However, the Examiner then deviates from Lachenbruch, by further alleging that:
"Impedance is also a measure of flow, thus it is measured using two points in order to determine the flow. An individual sensor itself would therefore include two measurements points in order to calculate the impedance. Accordingly the measurement of an impedance itself is a delta value."
Office Action at 4-5.
Applicant respectfully disagrees with the Examiner's characterization of impedance. "[W]hile 'common sense' can be invoked, even potentially to supply a limitation missing from the prior art, it must still be supported by evidence and a reasoned explanation.... [T]his is particularly true where the missing limitation goes to the heart of an invention." Arendi v. Apple, 832 F.3d 1355, 1363 (Fed. Cir. 2016). Beyond mere conclusory statements, the Examiner has not provided evidence or a reasoned explanation for his assertion that the measurement of an impedance is itself a delta value. Applicant respectfully submits that the measurement of impedance is a complex quantity and is not merely a difference between measurements made at two measurement points, whatever the variable of measurement may be. See e.g., Electrical Impedance, Wikipedia,
https
://
en.wikipedia.org/wiki/Electrical impedance
(last visited November 6, 2021). Accordingly, the Examiner has not made aprimafacie showing that the measurement of impedance itself is a delta value.
2.    Differences between Lachenbruch, Geleijnse, and the instant claims Applicant submits that the Examiner also has not properly ascertained the differences between the prior art and the claimed subject matter. In particular, Applicant submits that
contrary to the Examiner's allegations, neither Lachenbruch nor Geleijnse provide "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," and "calculating a delta value by a difference between two of the plurality of SEM measurements," as recited in amended claim 21.
As amended, claim 21 recites that each SEM measurement comprises a measurement of biocapacitance. The as-filed disclosure also provides that "'delta' refers to a calculated
difference between two SEM values
." Specification at [0050] (emphasis added). As explained in Section 1 above, the Examiner has not shown that Lachenbruch provides measurement of impedance it itself a delta value. Whatever Lachenbruch allegedly provides, it does not provide "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," and "calculating a delta value by a difference between two of the plurality of SEM measurements," as recited in amended claim 21.
Geleijnse was allegedly cited for providing "identifying a current PU intervention of level-K received by the patient at the first care setting," "do nothing by continuing to administer the current PU intervention," and "do something by administering a new PU intervention of level-N, where N has a value greater than K." However, Geleijnse does not remedy the deficiencies of Lachenbruch. That is, it also does not provide "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," and "calculating a delta value by a difference between two of the plurality of SEM measurements," as recited in amended claim 21.
Applicant respectfully submits that since neither Lachenbruch nor Geleijnse, whether alone or in combination, provide each and every element of amended claim 21, the Examiner has not made aprimafacie showing of obviousness.
3.    No motivation to combine Lachenbruch and Gelijnse; Improper hindsight used
Applicant respectfully submits that the Examiner has not made a primafacie showing that a skilled artisan would have been motivated to combine the teachings of Lachenbruch and Geleijnse. The Examiner indicates 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 Gelesenijnse 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.)." Office Action at 7-8.
Applicant respectfully disagrees with this characterization of Geleijnse. Geleijnse, at best, provides a clinical support system and a corresponding clinical support method. Geleijnse at Abstract. Geleijnse also provides a computer-readable storage medium that 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." Id. However, Geleijnse does not provide this in the context of skin indications, much less pressure ulcer. Amended claim 1 recites "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. . . 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." Applicant respectfully submits that one of ordinary skill in the art would not have been motivated to combine Geleijnse with Lachenbruch, at least because Geleijnse is silent on administering any interventions for pressure ulcers or skin conditions. The Examiner
otherwise has not established that elsewhere in the art provides motivation to modify Geleijnse with Lachenbruch. As such, any motivation to combine the references must have been reconstructed from the Examiner's understanding of the Applicant's disclosure. Since any motivation to combine the Geleijnse with the rest of the cited references can only be in view of the Applicant's disclosure, Applicant submits that the Examiner appears to be using impermissible hindsight to improperly interpret the claimed subject matter as obvious over Lachenbruch in view of Geleijnse.
Applicant submits that amended claim 21 is not obvious over Lachenbruch and Geleijnse, and Applicant respectfully requests that the Examiner withdraw his rejection of amended claim 21. Claims 23-26, 29, and 37 depend from claim 21. Dependent claims are nonobvious under 35 U.S.C. § 103 if the independent claims from which they depend are nonobvious. See e.g., In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Thus, claims 23-26, 29, and 37 are also nonobvious.
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.
B.    Claim 27
The Examiner rejects claim 27 under 35 U.S.C. § 103 for allegedly being unpatentable over Lachenbruch in view of Geleijnse, further in view of U.S. Patent 9,028,407 to Bennet- Guerrero ("Bennet-Guerrero"). See Office Action at 12. 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. Applicant respectfully disagrees.
Bennet-Guerrero provides an apparatus for monitoring patient orientation.
Bennett-Guerrero at Abstract. However, whatever Bennet-Guerrero provides, it does not remedy the deficiencies of Lachenbruch and Geleijnse, as discussed in Subsection A above. Bennet-
Guerrrero does not provide or suggest at least 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, and calculating a delta value by a difference between two of the plurality of SEM measurements, as recited in amended claim 21. Accordingly, Lachenbruch, Geleijnse, and Bennet-Guerrero, whether alone or in combination do not provide or suggest each and every element of amended claim 21. Claim 27 depends from claim 21, and as such, is also non-obvious over these references by virtue of its dependence from amended claim 21.
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, and further in view of Bennet-Guerrero.
C.    Claims 28, 30, and 38
The Examiner rejects claims 28, 30, and 38 under 35 U.S.C. § 103 for allegedly being unpatentable over Lachenbruch in view of Geleijnse, further in view of US Publication 2017/0007153 to Tonar et al. ("Tonar"). Office Action at 13. Without acquiescing to the rejection, and solely to advance prosecution, Applicant cancels claims 28, 30, and 38, without prejudice to, or disclaimer of, the underlying subject matter. Applicant respectfully submits that the rejection claims 28, 30, and 38 is moot by virtue of their cancellation.
D.    Claims 31, 32, 34, and 39
The Examiner rejects claims 31, 32, 34, and 39 under 35 U.S.C. § 103 for allegedly being unpatentable over Lachenbruch in view of Geleijnse, further in view of US Patent 9,675,289 to Heaton ("Heaton"). 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)." Office Action at 17. 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. and Gele[]ijnse et al. in combination with the motivation(s) of being a way to store and retrieve information from a database." Id. Applicant respectfully disagrees.
Heaton at best provides "[a] system and method for monitoring individual metabolic response and for generating nutritional feedback involve monitoring of a glucose level in a qualified subject." Heaton at Abstract. Whatever Heaton does provide, it does not remedy the deficiencies of Lachenbruch and Geleijnse, as discussed in Subsection A above. Heaton does not provide or suggest at least 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, and calculating a delta value by a difference between two of the plurality of SEM measurements, as recited in amended claim 21. Accordingly, Lachenbruch, Geleijnse, and Heaton, whether alone or in combination do not provide or suggest each and every element of amended claim 21. Claim 31, 32, 34, and 39 depend from claim 21, and as such, are also non-obvious over these references by virtue of its dependence from amended claim 21.
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 Heaton.
E.    Claim 33
The Examiner rejects claim 33 under 35 U.S.C. § 103 for allegedly being unpatentable over Lachenbruch in view of Geleijnse, further in view of US Publication 2008/0015894 to Miller et al. ("Miller"). Office Action at 19. 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 Gele[]ijnse et al. in combination with the motivation(s) of updating a patient files." Id. Applicant respectfully disagrees.
Miller, at best, provides "[a] method of assessing a health risk associated with a medication therapy regimen identifies potentially adverse health outcomes resulting from the medication therapy regimen." Miller at Abstract. Whatever Miller does provide, it does not remedy the deficiencies of Lachenbruch and Geleijnse, as discussed in Subsection A above. Heaton does not provide or suggest at least 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, and calculating a delta value by a difference between two of the plurality of SEM measurements, as recited in amended claim 21. Accordingly, Lachenbruch, Geleijnse, and Miller, whether alone or in combination do not provide or suggest each and every element of amended claim 21. Claim 33 depends from claim 21, and as such, are also non-obvious over these references by virtue of its dependence from amended claim 21.
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 Miller.
F.    Claims 35 and 36
The Examiner rejects claims 35 and 36 under 35 U.S.C. § 103 for allegedly being unpatentable over Lachenbruch in view of Geleijnse, further in view of Heaton, and further in view of US Patent 8,355,925 to Rothman et al. ("Rothman"). Office Action at 20-21.
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." Id. at 21. Thus, the Examiner
concludes that "[o]ne 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 as taught by Rothman et al. in the method as taught by Lachenbruch et al., Gele[]ijnse et al., 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 21-22. Applicant respectfully disagrees.
Rothman at best provides "methods of assessing risk based on medical data and uses thereof, and more particularly, to deriving functions for assessing risk associated with medical data." Rothman at col. 1 lines 14-17. Whatever Rothman does provide, it does not remedy the deficiencies of Lachenbruch, Geleijnse, and Heaton, as discussed in Subsection D above. Rothman does not provide or suggest at least 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, and calculating a delta value by a difference between two of the plurality of SEM measurements, as recited in amended claim 21. Accordingly, Lachenbruch, Geleijnse, Heaton, and Rothman, whether alone or in combination do not provide or suggest each and every element of amended claim 21. Claim 35 and 36 depend from claim 21, and as such, are also non-obvious over these references by virtue of its dependence from amended claim 21.
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 Heaton, and further in view of Rothman.
G.    Claims 40 and 43
The Examiner rejects claims 40 and 43 under 35 U.S.C. § 103 for allegedly being unpatentable over Lachenbruch in view of Geleijnse, further in view of "Protocol for the successful treatment of pressure ulcers" to Brem et al. ("Brem"). Office Action at 22.
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 and Gele[]ijnse et al. 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 23. Applicant respectfully disagrees.
Brem provides, at best, a 12-step protocol for treatment of pressure ulcers. Brem at Abstract. Brem is silent on providing good nutrition, standard mattress, turning every 24 hours, and any combination thereof as a level-0 PU intervention, or applying dressing to the back or sides of patient's heel as a level-3 PU intervention. At a minimum, the Examiner has not provided any rationale to modify and designate Brem's intervention methods as a level-0 or a level-3 PU intervention, as opposed to other intervention levels. Further, whatever Brem provides, it does not remedy the deficiencies of Lachenbruch and Geleijnse, as discussed in Subsection A above. Brem does not provide or suggest at least 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, and calculating a delta value by a difference between two of the plurality of SEM measurements, as recited in amended claim 21. Accordingly, Lachenbruch, Geleijnse, and Brem, whether alone or in combination do not provide or suggest each and every element of amended claim 21. Claim 40 and 43 depend from claim 21, and as such, are also non-obvious over these references by virtue of its dependence from amended claim 21.
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 Brem.
H.    Claim 41
The Examiner rejects claim 41 under 35 U.S.C. § 103 for allegedly being unpatentable over Lachenbruch in view of Geleijnse, further in view of US Patent 5,367,789 to Lamont ("Lamont"). Office Action at 24. Specifically, the Examiner alleges that Lamont provides a level-1 PU intervention of providing a heel boot to the patient. Id. at 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 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 and Gele[]ijnse et al. 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 25. Applicant respectfully disagrees.
Lamont provides, at best, a soft medical boot having an articulated splint bar for adjusting the angle of the foot of a patient dispose in a supine position. Lamont at Abstract. Lamont is silent on applying its soft medical boot as a level-1 PU intervention. At a minimum, the Examiner has not provided any rationale to modify and designate Lamont's soft medical boot as a level-1 PU intervention, as opposed to other intervention levels. Furthermore, whatever Lamont provides, it does not remedy the deficiencies of Lachenbruch and Geleijnse, as discussed in Subsection A above. Lamont does not provide or suggest at least 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, and calculating a delta value by a difference between two of the plurality of SEM measurements, as recited in amended claim 21. Accordingly, Lachenbruch, Geleijnse, and Lamont, whether alone or in combination do not provide or suggest each and every element of amended claim 21. Claim 41 depends from claim 21, and as such, is also non-obvious over these references by virtue of its dependence from amended claim 21.
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 Lamont.
.    Claim 42
The Examiner rejects claim 42 under 35 U.S.C. § 103 for allegedly being unpatentable over Lachenbruch in view of Geleijnse, further in view of US Patent 6,634,045 to DuDonis et al.
("DuDonis"). Office Action at 25. Specifically, the Examiner alleges that DuDonis provides "a level-2 PU intervention of changing the patient's support surface." 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-2 PU intervention of changing the patient's support surface as taught by DuDonis for a treatment level as disclosed by Lachenbruch et al and Gele[]ijnse et al. 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 26. Applicant respectfully disagrees.
DuDonis provides, at best, a heel elevating foam cushion is used to relieve heel pressure ulcers in patients confined to bed. DuDonis at Abstract. DuDonis is silent on changing the patient's support surface as a level-2 PU intervention. At a minimum, the Examiner has not provided any rationale to modify and designate DuDonis's intervention methods as a level-2 PU intervention, as opposed to other intervention levels. Further, whatever DuDonis provides, it does not remedy the deficiencies of Lachenbruch and Geleijnse, as discussed in Subsection A above. DuDonis does not provide or suggest making at least 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, and calculating a delta value by a difference between two of the plurality of SEM measurements, as recited in amended claim 21. Accordingly, Lachenbruch, Geleijnse, and DuDonis, whether alone or in combination do not provide or suggest each and every element of amended claim 21. Claim 42 depends from claim
21, and as such, is also non-obvious over these references by virtue of its dependence from amended claim 21.
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 DuDonis.
J.    Claim 44
The Examiner rejects claim 44 under 35 U.S.C. § 103 for allegedly being unpatentable over Lachenbruch in view of Geleijnse, further in view of "Friction between human skin and medical textiles for decubitus prevention" to Rotaru et al. ("Rotaru"). Office Action at p. 26.
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. at 27. 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 and Gele[]ijnse et al. 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. Applicant respectfully disagrees.
Rotaru provides, at best, that risk of pressure ulcers could be reduced by improved hospital bedsheets. Rotaru at Abstract. Rotaru is silent on providing changing the patient's sheet cover to a low-friction sheet cover as a level-4 PU intervention. At a minimum, the Examiner has not provided any rationale to modify and designate Rotaru's intervention methods as a level- 4 PU intervention, as opposed to other intervention levels. Further, whatever Rotaru provides, it does not remedy the deficiencies of Lachenbruch and Geleijnse, as discussed in Subsection A above. Rotaru does not provide or suggest making at least 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, and calculating a delta value by a difference between two of the plurality of SEM measurements, as recited in amended claim 21.
Accordingly, Lachenbruch, Geleijnse, and Rotaru, whether alone or in combination do not provide or suggest each and every element of amended claim 21. Claim 44 depends from claim 21, and as such, is also non-obvious over these references by virtue of its dependence from amended claim 21.
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 Rotaru.
K.    Claim 45
The Examiner rejects claim 45 under 35 U.S.C. § 103 for allegedly being unpatentable over Lachenbruch in view of Geleijnse, further in view of US Patent 8,011,041 to Hann ("Hann"). Office Action at 27. 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. at 28. 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 and Gele[]ijnse et al. 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. Applicant respectfully disagrees.
Hann provides, at best, a multi-layered textile assembly that possesses qualities that are important for reducing the risk of pressure sore formation through improved comfort, moisture wicking, breathability, shear reducing, rapid drying and anti-microbial, while being durable, launderable and lightweight. Hann at col. 3 lines 23-29. Hann is silent on providing a low- friction padded mattress surface for the patient's lower leg as a level-5 PU intervention. At a minimum, the Examiner has not provided any rationale to modify and designate Hann's intervention methods as a level-5 PU intervention, as opposed to other intervention levels.
Further, whatever Hann provides, it does not remedy the deficiencies of Lachenbruch and
Geleijnse, as discussed in Subsection A above. Hann does not provide or suggest at least 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, and calculating a delta value by a difference between two of the plurality of SEM measurements, as recited in amended claim 21. Accordingly, Lachenbruch, Geleijnse, and Hann, whether alone or in combination do not provide or suggest each and every element of amended claim 21. Claim 45 depends from claim 21, and as such, is also non-obvious over these references by virtue of its dependence from amended claim 21.
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 Hann.
L.    Claims 46 and 47
The Examiner rejects claims 46 and 47 under 35 U.S.C. § 103 for allegedly being unpatentable over Lachenbruch in view of Geleijnse, further in view of "Prevention and Treatment of Pressure Ulcers" to Thomas ("Thomas"). Office Action at 28-29. 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 and Gele[]ijnse et al. 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.
Thomas provides, at best, the principles of treatment of pressure ulcers includ[ing] assessing severity, reducing pressure, friction and shear forces, optimizing local wound care, removing necrotic debris, managing bacterial contamination, and correcting nutritional deficits.
Thomas at Abstract. Thomas is silent on turning the patient at a shorter interval than currently
provided for as a level-6 PU intervention, or applying a barrier cream to the patient's heel as a level-7 PU intervention. At a minimum, the Examiner has not provided any rationale to modify and designate Thomas's intervention methods as a level-6 or a level-7 PU intervention, as opposed to other intervention levels. Further, whatever Thomas provides, it does not remedy the deficiencies of Lachenbruch and Geleijnse, as discussed in Subsection A above. Thomas does not provide or suggest at least 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, and calculating a delta value by a difference between two of the plurality of SEM measurements, as recited in amended claim 21.
Accordingly, Lachenbruch, Geleijnse, and Thomas, whether alone or in combination do not provide or suggest each and every element of amended claim 21. Claims 46 and 47 depend from claim 21, and as such, are also non-obvious over these references by virtue of its dependence from amended claim 21.
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 Thomas.
M.    Claim 48
The Examiner rejects claim 48 under 35 U.S.C. § 103 for allegedly being unpatentable over Lachenbruch in view of Geleijnse, 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"). Office Action at 30. Specifically, the Examiner alleges that Liu provides "a level-8 PU intervention of applying a neuro-muscular stimulation to the patient's heel." Id. at 31. 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 and Gele[]ijnse et al. 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 26. Applicant respectfully disagrees.
Liu provides, at best, electrical stimulation for pressure ulcer prevention and treatment in people with spinal cord injuries. Liu at Abstract. Liu is silent on applying a neuro-muscular stimulation to the patient's heel as a level-8 PU intervention. At a minimum, the Examiner has not provided any rationale to modify and designate Liu's intervention methods as a level-8 PU intervention, as opposed to other intervention levels. Further, whatever Liu provides, it does not remedy the deficiencies of Lachenbruch and Geleijnse, as discussed in Subsection A above. Liu does not provide or suggest at least 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, and calculating a delta value by a difference between two of the plurality of SEM measurements, as recited in amended claim 21.
Accordingly, Lachenbruch, Geleijnse, and Liu, whether alone or in combination do not provide or suggest each and every element of amended claim 21. Claim 48 depends from claim 21, and as such, is also non-obvious over these references by virtue of its dependence from amended
claim 21.
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 Liu.
N.    Claim 49
The Examiner rejects claim 49 under 35 U.S.C. § 103 for allegedly being unpatentable over Lachenbruch in view of Geleijnse, 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"). Office Action at 31-32. 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 32.
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 evel-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 and Gele[]ijnse et al. 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 26. Applicant respectfully disagrees.
Tur provides, at best, that treatment of ischemia-induced ulcers with hydrogen peroxide cream enhanced cutaneous blood recruitment not only to ulcers and adjacent sites, but also to distant sites. Tur at Abstract. Tur is silent on applying a topical cream to the patient's heel to enhance perfusion as a level-9 PU intervention. At a minimum, the Examiner has not provided any rationale to modify and designate Tur's intervention methods as a level-9 PU intervention, as opposed to other intervention levels. Further, whatever Tur provides, it does not remedy the deficiencies of Lachenbruch and Geleijnse, as discussed in Subsection A above. Tur does not provide or suggest at least 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, and calculating a delta value by a difference between two of the plurality of SEM measurements, as recited in amended claim 21. Accordingly, Lachenbruch, Geleijnse, and Tur, whether alone or in combination do not provide or suggest each and every element of amended claim 21. Claim 49 depends from claim 21, and as such, is also non-obvious over these references by virtue of its dependence from amended claim 21.
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 Tur.
0.    Claim 50
The Examiner rejects claim 50 under 35 U.S.C. § 103 for allegedly being unpatentable over Lachenbruch in view of Geleijnse, further in view of "Pressure Ulcer Prevention in the Hospital Setting Using Silicon Foam Dressings" to Truong et al. ("Truong"). Office Action at 33. Specifically, the Examiner alleges that Truong provides "a level-10 PU intervention of
providing a silicon pad 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-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 and Gele[]ijnse et al. 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 26. Applicant respectfully disagrees.
Truong provides, at best, that silicone foam dressings, when used as prophylactic treatment. Truong at Abstract. Truong is silent on providing a silicon pad for the patient's lower leg as a level-10 PU intervention. At a minimum, the Examiner has not provided any rationale to modify and designate Truong's intervention methods as a level-10 PU intervention, as opposed to other intervention levels. Further, whatever Truong provides, it does not remedy the deficiencies of Lachenbruch and Geleijnse, as discussed in Subsection A above. Truong does not provide or suggest at least 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, and calculating a delta value by a difference between two of the plurality of SEM measurements, as recited in amended claim 21. Accordingly, Lachenbruch, Geleijnse, and Truong, whether alone or in combination do not provide or suggest each and every element of amended claim 21. Claim 50 depends from claim 21, and as such, is also non- obvious over these references by virtue of its dependence from amended claim 21.
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 Truong.
CONCLUSION

NEXT OFFICE ACTION: DETAILED ACTION
Response to Amendment
In light of the amended claims, the claims are rejected under 35 U.S.C. 103.
Notice to Applicant
In the amendment dated 12/08/2021, the following has occurred: claim 21 has been amended; claims 23-27, 29, 31-37, and 39-50 have remained unchanged; claims 1-20, 22, 28, 30, and 38 have been or 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
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 Arguments
35 U.S.C. 103 Rejections:
Applicant made arguments with respect to the impedance calculation by stating that the impedance calculation is not specifically describing a calculation of a delta value and that Examiner’s characterization of impedance is not correct. Further, Applicant states that the measurement of impedance is a complex quantity and is not merely a difference between measurements made at two measurement points. In response, Examiner would like to state that the claimed invention states “calculating a delta value by a difference between two of the plurality of measurements”. This limitation is broad enough it include a calculation of change between two measurement points. The calculation is not limited to a 1-to-1 difference between the two points. Regardless, the claim was amended to now recite that the SEM measurements comprise of measurements of biocapacitance. Thus, the basis from which the calculation is made has changed. The previous basis was for measurements related to impedance, while the presently claimed invention now specifically requires biocapacitance. Accordingly, Examiner has cited new art to help address this.
Applicant also argues that while Geleijnse et al. does teach transitioning care levels, the reference does not teach it within the context of skin indications, thus PU interventions are not taught. Care level adjustment is not a novel concept as taught in Geleijnse. While Geleijnse et al. may not specifically teach pressure ulcer interventions, it does teach care level interventions based on a patient’s status. Within the context of claim 21 and the Lachenbruch et al. reference, the patient’s status is taught to be directed at pressure ulcers in the primary reference (see: paragraph [0013] of Lachenbruch et al.).
Additionally, Applicant argues that there is no motivation to combine the Geleijnse et al. reference with the Lachenbruch et al. reference as Examiner is using impermissible hindsight. Applicant also states that interventions being PU interventions is not taught, thus one would not combine these references. Examiner respectfully disagrees. As explained above, a patient’s status directed towards PU is taught in the Lachenbruch et al. reference where an intervention based on a patient status is taught in the Geleijnse et al. reference. Further, the motivation to combine the Geleijnse et al. reference with the Lachenbruch et al. reference is as follows:
“with motivation(s) of monitoring a patient’s condition and adjusting the level of care accordingly (see: paragraph [0002] of Geleijnse et al.)”
As seen above, there is motivation to combine. Lachenbruch et al. is a system and method for mitigating tissue breakdown thus integrating another system in Geleijnse et al. that helps manage a condition would not be unusual, nor considered impermissible hindsight.
Furthermore, Applicant argues that dependent claims 39-50 do not teach interventions at certain levels of PU and Examiner has not provided any rationales to modify and designate the cited references as certain-level interventions. Examiner however respectfully disagrees. First, Geleijnse et al. teaches administration of care on a care level where there are different levels of care, while the additional references for claims 39-50 teach each claimed intervention as shown below in the 35 U.S.C. rejections section. Examiner then used these references in addition to a substitution rationale statement which outlines that the combination of Lachenbruch et al., Geleijnse et al., and Berggren teaches treatment used at certain threshold levels and the treatment is being substituted with each of the treatments from each of the additional references for claims 39-50 to produce predictable results of using a treatment to treat a patient. One can substitute any treatment into a care level to obtain predictable results of treating a patient.
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:
--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;
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)
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, 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. further teaches 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).
Lachenbruch et al. may not further, specifically teach wherein the transfer record further comprises results and wherein said transfer record is stored on a database.
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) and 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 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.
Brem et al. teaches:
--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 (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 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. 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).
Additional Relevant Art
Examiner would also like to cite U.S. 2014/0298928 to Duesterhoft et al. and U.S. Patent No. 6,756,793 to Hirono et al. as relevant art.
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.

CITED REFERENCE SUMMARIES: Ref US20160338591A1: Claims:
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.
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.
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.
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.
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.
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.
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.
The method of claim 5 , further comprising: adjusting the threshold based on at least some of the information in the database.
adjusting the threshold based on at least some of the information in the database.
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.
The method of claim 5 , further comprising updating the database with an outcome for the individual.
The method of claim 1 , further comprising making an adjustment to a person support apparatus upon which the individual is disposed.
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.
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.
The system of claim 10 , wherein the sensor comprises a light source and an optical detector.
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.
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.
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.
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.
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.
The system of claim 16 , wherein the server updates the threshold tissue status based on the information regarding the tissue status for the individual.
The system of claim 16 , wherein the server updates the threshold tissue status based on an outcome for the individual.
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.
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 US20150186607A1: [content unavailable]
Ref US9028407B1: [content unavailable]
Ref US6634045B1: [content unavailable]
Ref US8011041B2: Claims:
A support surface for preventing pressure ulcers in a patient, the support surface comprising a multi-layer composite fabric comprising: a skin contact layer comprising a woven fabric of synthetic filament yarns woven to provide air permeability and moisture vapor permeability and having a thickness of less than 1 mm, the skin contact layer having an upper, skin contact surface and a bottom surface; an absorbent middle layer abutting the bottom surface of the skin contact layer, the middle layer comprising a breathable microfiber fabric woven from synthetic fibers having a cross-sectional shape that includes a plurality of voids for generating a capillary effect for moisture transition from an upper surface of the middle layer to a bottom surface of the middle layer, wherein the skin contact layer and the middle layer are stitched together using a stitching pattern that is optimized to produce an open pattern with minimal puckering; a bottom layer attached to the skin contact layer and the middle layer at a peripheral edge of each layer, the bottom layer comprising a breathable, waterproof fabric having a thickness of less that 1 mm that is woven from synthetic yarn to produce a moisture vapor transfer rate within the range of 5,000 to 20,000 grams per meter squared per 24 hours.
a skin contact layer comprising a woven fabric of synthetic filament yarns woven to provide air permeability and moisture vapor permeability and having a thickness of less than 1 mm, the skin contact layer having an upper, skin contact surface and a bottom surface;
an absorbent middle layer abutting the bottom surface of the skin contact layer, the middle layer comprising a breathable microfiber fabric woven from synthetic fibers having a cross-sectional shape that includes a plurality of voids for generating a capillary effect for moisture transition from an upper surface of the middle layer to a bottom surface of the middle layer, wherein the skin contact layer and the middle layer are stitched together using a stitching pattern that is optimized to produce an open pattern with minimal puckering;
a bottom layer attached to the skin contact layer and the middle layer at a peripheral edge of each layer, the bottom layer comprising a breathable, waterproof fabric having a thickness of less that 1 mm that is woven from synthetic yarn to produce a moisture vapor transfer rate within the range of 5,000 to 20,000 grams per meter squared per 24 hours.
The support surface of claim 1 , wherein the stitching pattern comprises a plurality of straight and curved lines, wherein no lines cross over other lines.
The support surface of claim 1 , wherein the stitching pattern comprises a plurality of detached circles and a plurality of parallel lines, wherein the circles and parallel lines intersect within the pattern but do not cross.
The support surface of claim 3 , wherein each circle has a diameter in the range of 25-50 mm.
The support surface of claim 3 , wherein the parallel lines are separated by a distance in the range of 25-50 mm.
The support surface of claim 1 , wherein the stitching pattern comprises a plurality of parallel wavy lines.
The support surface of claim 1 , wherein a combined thickness of the skin contact layer, the middle layer and the bottom layer is within the range of 2 to 5 mm.
The support surface of claim 1 , wherein the support surface is a bed pad and further comprising at least one hand grip disposed along at least one edge of the bed pad.
The support surface of claim 1 , wherein the bottom layer is coated with a polyurethane.
The support surface of claim 1 , further comprising an array of pressure sensors disposed beneath the bottom layer.
The support surface of claim 10 , wherein the array of pressure sensors generate electronic signals for input into a computer monitoring system.
The support surface of claim 10 , wherein the computer monitoring system includes software for determining a risk of pressure sore development in the patient based upon an algorithm that identifies a patient-specific pattern using a plurality of risk factors selected from the group consisting of medical diagnosis, clinical assessment, Braden scale, laboratory data, mattress type and the electronic signals generated by the array of pressure sensors.
The support surface of claim 12 , wherein the computer monitoring systems generates an alarm when a pre-determined combination of risk factors according to the patient-specific pattern is present.
The support surface of claim 1 , wherein the skin contact layer is treated with an anti-microbial finish.
A support surface for preventing pressure ulcers in a patient, the support surface comprising a multi-layer composite fabric comprising: a skin contact layer comprising a woven fabric of nylon-polyester filament yarns woven to provide a pore size of 4 to 10 microns and having a thickness of less than 1 mm, the skin contact layer having an upper, skin contact surface and a bottom surface; an absorbent middle layer abutting the bottom surface of the skin contact layer, the middle layer comprising a breathable microfiber fabric woven from polyester fibers having a cross-sectional shape that includes a plurality of channels for generating a capillary effect for moisture transition from an upper surface of the middle layer to a bottom surface of the middle layer, wherein the skin contact layer and the middle layer are stitched together with a tension and a stitch length that is optimized to produce minimal puckering; a bottom layer attached to the skin contact layer and the middle layer at a peripheral edge of each layer, the bottom layer comprising a breathable, waterproof fabric coated with polyurethane and having a thickness of less that 1 mm that is woven from synthetic yarn to produce a moisture vapor transfer rate within the range of 5,000 to 20,000 grams per meter squared per 24 hours.
a skin contact layer comprising a woven fabric of nylon-polyester filament yarns woven to provide a pore size of 4 to 10 microns and having a thickness of less than 1 mm, the skin contact layer having an upper, skin contact surface and a bottom surface;
an absorbent middle layer abutting the bottom surface of the skin contact layer, the middle layer comprising a breathable microfiber fabric woven from polyester fibers having a cross-sectional shape that includes a plurality of channels for generating a capillary effect for moisture transition from an upper surface of the middle layer to a bottom surface of the middle layer, wherein the skin contact layer and the middle layer are stitched together with a tension and a stitch length that is optimized to produce minimal puckering;
a bottom layer attached to the skin contact layer and the middle layer at a peripheral edge of each layer, the bottom layer comprising a breathable, waterproof fabric coated with polyurethane and having a thickness of less that 1 mm that is woven from synthetic yarn to produce a moisture vapor transfer rate within the range of 5,000 to 20,000 grams per meter squared per 24 hours.
The support surface of claim 15 , wherein the stitching pattern comprises a plurality of parallel lines, wherein no lines cross over other lines.
The support surface of claim 16 , wherein each of the parallel lines is wavy.
The support surface of claim 15 , wherein a combined thickness of the skin contact layer, the middle layer and the bottom layer is within the range of 2 to 5 mm.
The support surface of claim 15 , wherein the support surface is a bed pad and further comprising at least one hand grip disposed along at least one edge of the bed pad.
The support surface of claim 15 , further comprising an array of pressure sensors disposed beneath the bottom layer.
The support surface of claim 20 , wherein the array of pressure sensors generate electronic signals for input into a computer monitoring system.
The support surface of claim 21 , wherein the computer monitoring system includes software for determining a risk of pressure sore development in the patient based upon an algorithm that identifies a patient-specific pattern using a plurality of risk factors selected from the group consisting of medical diagnosis, clinical assessment, Braden scale, laboratory data, mattress type and the electronic signals generated by the array of pressure sensors.
The support surface of claim 22 , wherein the computer monitoring systems generates an alarm when a pre-determined combination of risk factors according to the patient-specific pattern is present.
The support surface of claim 21 , wherein the skin contact layer is treated with an anti-microbial finish.
Ref US9675289B2: [content unavailable]
Ref US5367789A: Claims:
A medical boot, comprising: a substantially boot-shaped main body portion formed primarily of a substantially soft, flexible, compressible, shape-retaining material having a foot portion, an ankle portion; and a heel opening; splint means for supporting the limb of a user with his foot disposed in the boot-shaped main body portion comprising: a substantially rigid insole connected to the foot portion of the main body portion of the boot so as to moveable therewith; the insole being disposed in the foot portion of the boot; a substantially rigid splint bar, and means for connecting the splint bar to the ankle portion of the boot; hinge means for connecting the insole to the splint bar such that the insole is moveable to a selected angular position with respect to the splint bar; the hinge means comprising an elongated hinge member having one end received in the heel opening and connected to the insole; pin means connecting the opposite end of the hinge member to the splint bar; and means for locking the hinge means in said selected angular position, comprising the splint bar having a pair of spaced lugs, said hinge member being received between the lugs, the lugs having pairs of aligned openings, the hinge member having a toe swingeable between the pairs of aligned openings, and locking pin means being received in a selected aligned pair of said openings in the lugs to engage the toe of the hinge in a selected angular position.
a substantially boot-shaped main body portion formed primarily of a substantially soft, flexible, compressible, shape-retaining material having a foot portion, an ankle portion; and a heel opening;
splint means for supporting the limb of a user with his foot disposed in the boot-shaped main body portion comprising:
a substantially rigid insole connected to the foot portion of the main body portion of the boot so as to moveable therewith;
the insole being disposed in the foot portion of the boot;
a substantially rigid splint bar, and means for connecting the splint bar to the ankle portion of the boot;
hinge means for connecting the insole to the splint bar such that the insole is moveable to a selected angular position with respect to the splint bar;
the hinge means comprising an elongated hinge member having one end received in the heel opening and connected to the insole;
pin means connecting the opposite end of the hinge member to the splint bar; and
means for locking the hinge means in said selected angular position, comprising the splint bar having a pair of spaced lugs, said hinge member being received between the lugs, the lugs having pairs of aligned openings, the hinge member having a toe swingeable between the pairs of aligned openings, and locking pin means being received in a selected aligned pair of said openings in the lugs to engage the toe of the hinge in a selected angular position.
A medical boot comprising: a substantially boot-shaped main body portion formed primarily of a substantially soft, flexible, compressible, shape-retaining material having a foot portion and an ankle portion; splint means for supporting the limb of a user with his foot disposed in the boot-shaped main body portion, comprising: an elongated substantially rigid insole connected to the foot portion of the main body portion so as to be moveable therewith; an elongated substantially rigid splint bar, and means for connecting the splint bar to the ankle portion of said main body portion; articulated hinge means for connecting one end of the insole to one end of the splint bar, the articulated hinge means including a hinge pin disposed such that the insole is pivotal about the hinge pin to a first selected angular position with respect to the splint bar; and means for locking the hinge means in said selected angular position including a locking pin mounted on the hinge means adjacent the hinge pin, in a position depending upon the selected angle of the insole to the splint bar, the locking pin being removable from the hi
[Truncated to input limit]