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 21-50 were previously pending. Claims 21 and 23-25 have been amended. Claim 22 has been cancelled without prejudice to, or disclaimer of, the underlying subject matter. Claims 1-20 were previously cancelled without prejudice to, or disclaimer of, the underlying subject matter. Support for the claim amendments may be found in the original claims and specification; e.g., at [0009] of the as-filed specification. 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.    After Final Consideration Pilot
Applicant respectfully requests that the Examiner consider this Response After Final based on the After Final Consideration Pilot (AFCP) 2.0. A Certification and Request for Consideration under the After Final Consideration Pilot Program 2.0 (Form PTO/SB/434) is being filed concurrently herewith.
II.   Advisory Action
Applicant filed an Amendment and Response to Final Office Action ("Response") on September 23, 2020. In an Advisory Action issued on October 23, 2020, the Examiner did not enter the proposed amendments as they allegedly "raise new issues that would require further consideration and/or search," and they allegedly "are not deemed to place the application in better form for appeal." Advisory Action at 2. The arguments previously presented in the Response are reproduced in the following Sections III-V for the convenience of the Examiner.
Applicant thanks the Examiner for his consideration of the Response, and his detailed explanation in the Advisory Action. Applicant previously argued that there is no motivation to combine the cited references U.S. Publication 2002/0143262 ("Bardy"), U.S. Publication 2016/0278692 ("Larson"), U.S. Publication 2017/0007153 ("Tonar"), and U.S. Publication 2011/0191122 ("Kharraz Tavakol").
A.    Motivation to Combine
In the Advisory Action, the Examiner alleges that he "used two motivations." Advisory Action at 3. In particular, the Examiner alleges that he "satisfies the finding of the invention of Bardy contain a method which differs from the claimed invention (the citation of paragraph [0008] meets this)." Id. The Examiner further alleges that the treatment of pressure ulcers is taught in [0012] of Larson and that "one can replace the limitation taught by Larson into the limitation of Bardy to obtain predictable results." Id. The Examiner points out that [0008] of Bardy states that "the invention can be capable of diagnosing symptoms of other diseases, not just myocardial ischemia," and he directly relates the teaching of "symptoms of other disease" to pressure ulcers. Finally, the Examiner brings in Tonar for teaching SEM values, stating that it "falls in line with the combination of Bardy and Larson references because they, in combination, teach a method related to pressure ulcers. The Tonar reference is related to pressure ulcers." Id. Applicant respectfully disagrees.
Although obviousness can be established by combining or modifying the teachings of the prior art, "[t]he mere fact that references
can
be combined or modified does not render the resultant combination obvious unless the results would have been predictable to one of ordinary skill in the art." M.P.E.P at § 2143.01(III) (emphasis in original). That is, just because any two references can be combined does not mean it
will
be combined by one of ordinary skill in the art. Here, the claimed subject matter involves (i) a method of using (ii) a measurement modality to care for (iii) a condition. The Examiner has cited (i) Bardy and Kharraz Tavakol for the method, (ii) Tonar for the measurement modality, and (iii) Larson for the condition. The primary reference, Bardy, is directed to an automated system and method for diagnosing and monitoring myocardial ischemia and outcomes thereof. Bardy provides that its systems and methods may be used for "other diseases and health disorders with
similar or related etiological indicators and for those other disorders that may have an impact on myocardial ischemia
." Bardy at [0095] (emphasis added). Accordingly, Bardy as a whole, taken alone or in combination with the other references, at best provides systems and methods where the use is limited to diseases with similar etiologies or related to myocardial ischemia. The Examiner has not shown how pressure ulcers are similar etiologies or related to myocardial ischemia. Instead, the Examiner has limited his
reading of Bardy to [0008], focusing only on the words "other diseases," to justify his substitution of "other diseases" for pressure ulcers as taught in Larson. Applicant asserts that one of ordinary skill in the art would not have combined Bardy, Larson, Tonar, and Kharraz Tavakol.
B.    Cited references do not teach each and every element of claims "The key to supporting any rejection under 35 U.S.C. § 103 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." M.P.E.P. § 2142, 9th Ed. (March 2014) (internal citation and inner quotation omitted). It is well-established law for an obviousness rejection under 35 U.S.C. § 103 that the references, either alone or combined, must provide all of the elements of the claim. The Office is required to make "a searching comparison of the claimed invention - including all its limitations - with the teaching of the prior art." In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995), and CFMT v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003). When "[t]he prior art reference (or references when combined) [do] not teach or suggest all the claim limitations, . . . 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." M.P.E.P. at § 2141 (III). Here, no prima facie case of obviousness can be established at least because the cited references, either alone or in combination, do not provide all of the elements of the claims, nor do they teach or suggest the modifications that would be required to achieve the claimed subject matter.
Regarding Claim 1, the Examiner alleges that Kharraz Tavakol provides "identifying a current intervention of level-K received by the patient at the first care setting." Office Action at 14. Applicant respectfully disagrees. Without acquiescing to the rejection, and solely to advance prosecution, Applicant has amended Claim 1 to recite "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.
" Kharraz Tavakol at best provides methods and apparatus for managing physician referral processes, whereby a referring physician refers a patient to another physician for a particular medical procedure, analysis, or care. Kharraz
Tavakol at [0001]. Kharraz Tavakol does not provide or suggest identifying a current 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, as required by amended Claim 1. Thus,
Bardy, Larson, Tonar, and Kharraz Tavakol, taken in combination, do not teach each and every element of amended Claim 1.
For at least these reasons, Applicant submits that noprimafacie case of obviousness can be established. Applicant respectfully requests that the Examiner reconsider and withdraw the rejection of claim 1 under 35 U.S.C. § 103 based on Bardy, Larson, Tonar, and Kharraz Tavakol. "[I]f an independent claim is nonobvious under 35 U.S.C. § 103, then any claim depending therefrom is nonobvious." In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Thus, dependent claims 23-50, should also be allowable due to their dependence from Claim 21.
C.    Improper Use of Hindsight
The Examiner alleges that he "used both KSR rationales and TSM rationales to address the combination of references. These rationales are supported within the MPEP and do not result in impermissible hindsight (see MPEP 2143)." Advisory Action at 3. Applicant respectfully disagrees.
As discussed above, a person of ordinary skill in the art would have lacked the motivation to combine at least Bardy with Larson and Tonar. Furthermore, the Examiner has not shown how one of ordinary skill in the art would have been motivated to combine Bardy, Larson, Tonar, and Kharraz Tavakol. The Examiner purportedly cites Kharraz Tavakol for providing "identifying a current intervention of level-K received by the patient at the first care setting," a characterization to which Applicant respectfully disagrees with for the reasons discussed above in section B. Office Action at 14. Rather, Kharraz Tavakol at best provides methods and apparatus for managing physician referral processes, whereby a referring physician refers a patient to another physician for a particular medical procedure, analysis, or care, and is silent on any interventions, much less a current intervention. Kharraz Tavakol at [0001]. As Kharraz Tavakol does not provide or suggest identifying a current intervention of level-K, any understanding that it does, must have been reconstructed from the Examiner's understanding of
the Applicant's disclosure. Since any motivation to combine the Kharraz Tavakol 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 Bardy in view of Larson in view of Tonar and in further view of Kharraz Tavakol.
III.   Claim Objections'
The Applicant thanks the Examiner for the indication that the claim objections have been overcome by Applicant's amendments to the claims in the Amendment filed April 21, 2020.
IV.    Rejections under 35 U.S.C. § 112
The Applicant thanks the Examiner for their careful consideration and indication that the rejections under 35 U.S.C. § 112 have been overcome by Applicant's amendments to the claims in the Amendment filed April 21, 2020.
V.
Rejections under 35 U.S.C. § 103
A.
Claims 21-25 and 28
The Examiner rejects claims 21-25 and 28 under 35 U.S.C. § 103 for allegedly being unpatentable over U.S. Publication 2002/0143262 to Bardy ("Bardy"), in view of U.S.
2016/0278692 to Larson et al. ("Larson"), in view of U.S. Publication 2017/0007153 to Tonar et al. ("Tonar"), and further in view of U.S. Publication 2011/0191122 to Tavakol et al. ("Kharraz Tavakol"). See id. at p. 11. The Examiner acknowledged that "the substitution rational[e]" is used to combine the references. Id. at p. 3; see also p. 14.
Specifically, regarding claim 21, the Examiner alleges that Bardy provides 1 Applicant filed an Amendment and Response to Final Office Action ("Response") on September 23, 2020. In an Advisory Action issued on October 23, 2020, the Examiner did not enter the proposed amendments as they allegedly "raise new issues that would require further consideration and/or search," and they allegedly "are not deemed to place the application in better form for appeal." Advisory Action at 2. The arguments previously presented in the Response are reproduced in the following Sections III-V for the convenience of the Examiner.
a method of providing a continuity of care for a patient having or 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 measurements at a body location on the patient at the second care setting, . . . determining whether the value exceeds a threshold, . . . continuing to administer the current intervention if the value does not exceed the threshold, .
. . administering a new intervention of level-N if the value exceeds the threshold, where N has a value greater than K (emphasis omitted).
Id. at pp. 11-12. The Examiner also acknowledges that Bardy "does not explicitly teach SEM measurements, calculating a delta value, and determining if that delta value exceeds a threshold." Id. at p. 13.
The Examiner then cites to Larson alleging that Larson provides for "PU intervention as an intervention" and further alleges that "[o]ne of ordinary skill in the art could have substituted the detecting of pressure ulcer disease for the diagnosing of diseases in Brady." Id.
The Examiner further cites Tonar for allegedly providing SEM measurements, calculating a delta value by a difference between two of the plurality of SEM measurements. See id. at pp. 13 to 14. The Examiner continues to alleges that it would have been obvious to one of ordinary skill in the art to substitute the SEM values provided by Tonar "for myocardial ischemia measurements and myocardial ischemia threshold values as disclosed by Bardy and Larson 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 p. 14.
The Examiner also acknowledges that Bardy fails to specifically provide "identifying a current intervention of level-K received by the patient at the first care setting (emphasis omitted)." Id. at p. 13. The Examiner then cites Kharraz Tavakol and alleges that a person of ordinary skill in the art would have found it obvious to identify a current intervention of "level-K received by the patient at the first care setting as taught by Kharraz Tavakol in the method as taught by Bardy, Larson et al., and Tonar et al. in combination with the motivation(s) of preventing delays in medical care and preventing patient dissuasion from treatment protocol compliance." Id. at p. 15. Applicant respectfully disagrees with the Examiner. The Applicant
submits that the Examiner has not established aprimafacie case of obviousness for at least the following reasons.
1.    No motivation to combine
The burden for establishing aprimafacie case of obviousness under 35 U.S.C. § 103(a) falls entirely upon the Examiner. See In re Piasecki, 745 F.2d 1468, 1471-72 (Fed. Cir. 1984). To establish aprimafacie case of obviousness, there must be some teaching, suggestion, or motivation, either in the references themselves or in the knowledge generally available to one of skill in the art, to modify the reference or to combine reference teachings. See Manual of Patent Examining Procedure ("M.P.E.P") at § 2143. There must also be a reasonable expectation of success. See id. The teaching or suggestion to make the claimed combination and the reasonable expectation of success must both be found in the prior art, and not based on the applicant's disclosure. In re Vaeck, 947 F.2d 488, 20 USPQ.2d 1438 (Fed. Cir. 1991). Although obviousness can be established by combining or modifying the teachings of the prior art, "[t]he mere fact that references
can
be combined or modified does not render the resultant combination obvious unless the results would have been predictable to one of ordinary skill in the art." M.P.E.P at § 2143.01(III) (emphasis in original). Furthermore, "[t]he proposed modification cannot render the prior art unsatisfactory for it intended purpose." M.P.E.P at § 2143.01(V). Lastly, to reject a claim based on the substitution rational, the Examiner has the burden to establish
(1) a finding that the prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components;
(2) a finding that the substituted components and their functions were known in the art;
(3) a finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable; and
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness
M.P.E.P at § 2143 B.
The Examiner alleges that "[o]ne of ordinary skill in the art could have substituted the detecting of pressure ulcer disease [in Larson] for the diagnosing of disease in Bardy." Office Action at p. 13. The Applicant respectfully disagrees. Here, the Examiner has not met the basic criteria to establish aprimafacie case of obviousness, and has not demonstrated that a person of ordinary skill in the art would have found suggestion or motivation in the references themselves, or in the knowledge generally available to a person of ordinary skill in the art, to modify the reference or to combine the reference teachings. Further, the Examiner has not met the simple substitution criteria and set out in the M.P.E.P at § 2143 B.
A person of ordinary skill in the art, when reading the disclosures of Bardy would not simply substitute the detection of pressure ulcer disease as allegedly found in Larson for the diagnosis of "other diseases" as described in Bardy due to the lack of any level of predictability.
See Bardy at [0095]. Specifically, a person of ordinary skill in the art, when reading Bardy as a whole, would be directed to a "system and method for providing diagnosis and monitoring of myocardial ischemia for use in automated patient care throughout disease onset, progression, regression, and status quo." Bardy at [0002]. Further, a person of ordinary skill in the art would be directed to Bardy seeks to detect "trends in regularly collected physiological and chemical data indicative of the onset, progression, regression, or status quo of myocardial ischemia diagnosed and monitored using an automated remote patient care system." Id. at [0008]. In fact, Bardy provides that "[o]ther benefits include an automated, expert system approach to the cross- referral, consideration, and potential finding or elimination of other diseases and health disorders with
similar or related etiological indicators and for those other disorders that may have an impact on myocardial ischemia
." Id (emphasis added). Here, the Examiner has not pointed to how myocardial ischemia is at all related to pressure ulcers let alone how a person of ordinary skill in the art would have been motivated to combined the disclosures of Bardy with Larson with predictability.
Further, the Examiner alleges that it would have been obvious to a person of ordinary skill in the art to substitute SEM measurements as provided by Tonar "for myocardial ischemia
measurements and myocardial ischemia threshold as disclosed by Bardy and Larson 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." Office Action at p. 14. Applicant respectfully disagrees.
The Examiner has not articulated all the elements for the simple substitution rationale as outline in the M.P.E.P at § 2143 B.
As described above, a person of ordinary skill in the art would not have been motivated to combined the teachings of Bardy and Larson. Further, and as described in Applicant's response dated April 21, 2020, Bardy and Tonar are directed to two different pathologies. Therefore the proposed modification of Bardy by Tonar renders Bardy unsatisfactory for its intended purpose. Specifically, and as demonstrated above, Bardy provides for the elimination of other diseases and health disorders with similar or related etiological indicators that may have an impact on myocardial ischemia. See Bardy at [0095]. The Examiner has not, at a minimum, shown that pressure ulcer has similar or related etiological indicators that may have an impact on myocardial ischemia. Accordingly, a person of ordinary skill in the art reading Bardy would not have substituted SEM values used for detecting pressure ulcers for measurements of myocardial ischemia with any level of predictability. As such, the Examiner's proposed modification renders Bardy unsatisfactory for its intended purpose, there is no suggestion or motivation to make the proposed modification, and the Examiner has not met the basic criteria to establish a prima facie case of obviousness.
2.    Improper use of hindsight
The M.P.E.P warns against relying on impermissible hindsight when carrying out the obviousness analysis. Specifically, the M.P.E.P states "to reach a proper determination under 35 U.S.C. 103, the examiner must step backward in time and into the shoes worn by the hypothetical 'person of ordinary skill in the art' when the invention was unknown and just before it was made ... ." Further, "[k]nowledge of applicant's disclosure must be put aside in reaching this determination . ..
Ilmp
ermissible hindsight must be avoided and the legal conclusion
must be reached on the basis of the facts
g
leaned from the prior art.
" M.P.E.P § 2142 (emphasis added).
Here, it appears that the Examiner has applied impermissible hindsight to improperly interpret the claimed subject matter. As discussed above, a person of ordinary skill in the art would have lacked the motivation to combine at least Bardy with Larson and Tonar. Since any motivation to combine 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 Bardy in view of Larson in view of Tonar and in further view of Kharraz Tavakol.
For at least the reasons cited above, the claims are not obvious over Bardy in view of Larson in view of Tonar and in further view of Kharraz Tavakol. Applicant understands the rejection to claim 21 under 35 U.S.C § 103 should be overcome in view of the above. "[I]f an independent claim is nonobvious under 35 U.S.C. § 103, then any claim depending therefrom is nonobvious." In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Thus, dependent claims 22 to 25 and 28 should also be allowable due to their dependence from amended claim 21. The Applicant reserves the right to submit further arguments shall the Examiner find claim 21 obvious.
Applicant respectfully requests the Examiner reconsider and withdraw the obviousness rejection of claims 21 to 25 and 28.
B.    Claims 26, 29, 30, 37, and 38
The Examiner rejects claims 26, 29, 30, 37, and 38, under 35 U.S.C. § 103 as being unpatentable over Bardy in view of Larson, in view of Tonar, further in view of Kharraz Tavakol as applied to claim 21, and further in view of U.S. Patent 6,738,798 to Ploetz et al. ("Ploetz").
See Office Action at p. 18. The Applicant respectfully disagrees.
"[I]f an independent claim is nonobvious under 35 U.S.C. § 103, then any claim depending therefrom is nonobvious." In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Without establishing claim 21 is obvious over Bardy in view of Larson, in view of Tonar, and further in view of Kharraz Tavakol, the Examiner has not established claims 26, 29, 30, 37, and 38 are
obvious over Bardy in view of Larson, in view of Tonar, further in view of Kharraz Tavakol, and further in view of Ploetz. The Applicant reserves the right to submit further arguments shall the Examiner find claim 21 obvious. Applicant respectfully requests the Examiner reconsider and withdraw the obviousness rejection of claims 26, 29, 30, 37, and 38.
C.    Claim 27
The Examiner rejects claim 27 under 35 U.S.C. § 103 as being unpatentable over Bardy in view of Larson, in view of Tonar, and further in view of Kharraz Tavakol as applied to claim 22, and further in view of U.S. Patent 9,028,407 to Bennett-Guerrero ("Bennett-Guerrero"). See Office Action at p. 25. The Applicant respectfully disagrees.
"[I]f an independent claim is nonobvious under 35 U.S.C. § 103, then any claim depending therefrom is nonobvious." In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Without establishing claim 21 is obvious over Bardy in view of Larson, in view of Tonar, and further in view of Kharraz Tavakol, the Examiner has not established claim 27 is obvious over Bardy in view of Larson, in view of Tonar, further in view of Kharraz Tavakol, and further in view of Bennett-Guerrero. The Applicant reserves the right to submit further arguments shall the Examiner find claim 21 obvious. Applicant respectfully requests the Examiner reconsider and withdraw the obviousness rejection of claim 21.
D.    Claims 31, 32, 34, and 39
The Examiner rejects claims 31, 32, 34, and 39 under 35 U.S.C. § 103 as being unpatentable over Bardy in view of Larson, in view of Tonar, further in view of Kharraz Tavakol, and further in view of Ploetz as applied to claim 30, and further in view of U.S. Patent 9,675,289 to Heaton ("Heaton"). See Office Action at p. 26. The Applicant respectfully disagrees.
"[I]f an independent claim is nonobvious under 35 U.S.C. § 103, then any claim depending therefrom is nonobvious." In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Without establishing claim 21 is obvious over Bardy in view of Larson, in view of Tonar, and further in view of Kharraz Tavakol, the Examiner has not established claims 31, 32, 34, and 39, are
obvious over Bardy in view of Larson, in view of Tonar, further in view of Kharraz Tavakol, further in view of Ploetz, and further in view of Heaton. The Applicant reserves the right to submit further arguments shall the Examiner find claim 21 obvious. Applicant respectfully requests the Examiner reconsider and withdraw the obviousness rejection of claims 31, 32, 34, and 39.
E.    Claim 33
The Examiner rejects claim 33 under 35 U.S.C. § 103 as being unpatentable over Bardy, in view of Larson, in view of Tonar, further in view of Kharraz Tavakol, and further in view of Ploetz as applied to claim 30, and further in view of U.S. Publication 2008/0015894 to Miller et al. ("Miller"). Applicant respectfully disagrees.
"[I]f an independent claim is nonobvious under 35 U.S.C. § 103, then any claim depending therefrom is nonobvious." In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Without establishing claim 21 is obvious over Bardy in view of Larson, in view of Tonar, and further in view of Kharraz Tavakol, the Examiner has not established claim 33 is obvious over Bardy in view of Larson, in view of Tonar, further in view of Kharraz Tavakol, further in view of Ploetz, and further in view of Miller. The Applicant reserves the right to submit further arguments shall the Examiner find claim 21 obvious. Applicant respectfully requests the Examiner reconsider and withdraw the obviousness rejection of claim 33.
F.    Claims 35 and 36
The Examiner rejects claims 35 and 36 under 35 U.S.C. § 103 as being unpatentable over Bardy in view of Larson, in view of Tonar, further in view of Kharraz Tavakol, further in view of Ploetz, further in view Heaton as applied to claim 32, and further in view of, and further in view of U.S. Patent No. 8,355,925 to Rothman et al. ("Rothman"). See Office Action at p. 32. Applicant respectfully disagrees.
"[I]f an independent claim is nonobvious under 35 U.S.C. § 103, then any claim depending therefrom is nonobvious." In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Without establishing claim 21 is obvious over Bardy in view of Larson, in view of Tonar, and further in
view of Kharraz Tavakol, the Examiner has not established claims 35 and 36 are obvious over Bardy in view of Larson, in view of Tonar, further in view of Kharraz Tavakol, further in view of Ploetz, further in view Heaton, and further in view of Rothman. The Applicant reserves the right to submit further arguments shall the Examiner find claim 21 obvious. Applicant respectfully requests the Examiner reconsider and withdraw the obviousness rejection of claims 35 and 36.
G.    Claims 40 and 43
The Examiner rejects claims 40 and 43 under 35 U.S.C. § 103 as being unpatentable over Bardy in view Larson, in view of Tonar, further in view of Kharraz Tavakol as applied to claim 21, and further in view of "Protocol for the successful treatment of pressure ulcers" to Brem et al. (The American Journal of Surgery, 188 (Suppl to July 2004): 9S-17S (2004)) ("Brem"). See Office Action at p. 34. The Applicant respectfully disagrees.
"[I]f an independent claim is nonobvious under 35 U.S.C. § 103, then any claim depending therefrom is nonobvious." In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Without establishing claim 21 is obvious over Bardy in view of Larson, in view of Tonar, and further in view of Kharraz Tavakol, the Examiner has not established claims 40 and 43 are obvious over Bardy in view Larson, in view of Tonar, further in view of Kharraz Tavakol, and further in view of Brem. The Applicant reserves the right to submit further arguments shall the Examiner find claim 21 obvious. Applicant respectfully requests the Examiner reconsider and withdraw the obviousness rejection of claims 40 and 43.
H.    Claim 41
The Examiner rejects claim 41 under 35 U.S.C. § 103 as being unpatentable over Bardy in view of Larson, in view of Tonar, further in view of Kharraz Tavakol as applied to claim 21, and further in view of U.S. Patent 5,367,789 to Lamont ("Lamont"). See Office Action at p. 35. The Applicant respectfully disagrees with the Examiner.
"[I]f an independent claim is nonobvious under 35 U.S.C. § 103, then any claim depending therefrom is nonobvious." In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Without
establishing claim 21 is obvious over Bardy in view of Larson, in view of Tonar, and further in view of Kharraz Tavakol, the Examiner has not established claim 41 is obvious over Bardy in view Larson, in view of Tonar, further in view of Kharraz Tavakol, and further in view of Lamont. The Applicant reserves the right to submit further arguments shall the Examiner find claim 21 obvious. Applicant respectfully requests the Examiner reconsider and withdraw the obviousness rejection of claim 41.
.    Claim 42
The Examiner rejects claim 42 under 35 U.S.C. § 103 as being unpatentable over Bardy, in view of Larson, in view of Tonar, further in view of Kharraz Tavakol as applied to claim 21, and further in view of U.S. Patent 6,634,045 to DuDonis et al. ("DuDonis"). See Office Action at pp. 36 to 37. The Applicant respectfully disagrees.
"[I]f an independent claim is nonobvious under 35 U.S.C. § 103, then any claim depending therefrom is nonobvious." In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Without establishing claim 21 is obvious over Bardy in view of Larson, in view of Tonar, and further in view of Kharraz Tavakol, the Examiner has not established claim 42 is obvious over Bardy in view Larson, in view of Tonar, further in view of Kharraz Tavakol, and further in view of DuDonis. The Applicant reserves the right to submit further arguments shall the Examiner find claim 21 obvious. Applicant respectfully requests the Examiner reconsider and withdraw the obviousness rejection of claim 42.
J.    Claim 44
The Examiner rejects claim 44 under 35 U.S.C. § 103 as being unpatentable over Bardy, in view of Larson, in view of Tonar, further in view of Kharraz Tavakol as applied to claim 21, and further in view of "Friction between human skin and medical textiles for decubitus prevention" to Rotaru et al. (Tribology International, 65:91-96 (2013)) ("Rotaru"). See Office Action at p. 38. The Applicant respectfully disagrees with the Examiner.
"[I]f an independent claim is nonobvious under 35 U.S.C. § 103, then any claim depending therefrom is nonobvious." In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Without
establishing claim 21 is obvious over Bardy in view of Larson, in view of Tonar, and further in view of Kharraz Tavakol, the Examiner has not established claim 44 is obvious over Bardy in view Larson, in view of Tonar, further in view of Kharraz Tavakol, and further in view of Rotaru. The Applicant reserves the right to submit further arguments shall the Examiner find claim 21 obvious. Applicant respectfully requests the Examiner reconsider and withdraw the obviousness rejection of claim 44.
K.    Claim 45
The Examiner rejects claim 45 under 35 U.S.C. § 103 as being unpatentable over Bardy, in view of Larson, in view of Tonar, further in view of Kharraz Tavakol as applied to claim 21, and further in view of U.S. Patent No. 8,011,041 to Hann ("Hann"). See Office Action at p. 39. The Applicant respectfully disagrees.
"[I]f an independent claim is nonobvious under 35 U.S.C. § 103, then any claim depending therefrom is nonobvious." In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Without establishing claim 21 is obvious over Bardy in view of Larson, in view of Tonar, and further in view of Kharraz Tavakol, the Examiner has not established claim 45 is obvious over Bardy in view Larson, in view of Tonar, further in view of Kharraz Tavakol, and further in view of Hann. The Applicant reserves the right to submit further arguments shall the Examiner find claim 21 obvious. Applicant respectfully requests the Examiner reconsider and withdraw the obviousness rejection of claim 45.
L.    Claims 46 and 47
The Examiner rejects claims 46 and 47 under 35 U.S.C. § 103 as being unpatentable over Bardy in view of Larson, in view of Tonar, further in view of Kharraz Tavakol as applied to claim 21, and further in view of "Prevention and treatment of pressure ulcers" to Thomas (J. Am. Med. Dir. Assoc., 7:46-59 (2006)) ("Thomas"). See Office Action at p. 40. The Applicant respectfully disagrees.
"[I]f an independent claim is nonobvious under 35 U.S.C. § 103, then any claim depending therefrom is nonobvious." In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Without
establishing claim 21 is obvious over Bardy in view of Larson, in view of Tonar, and further in view of Kharraz Tavakol, the Examiner has not established claims 46 and 47 are obvious over Bardy in view Larson, in view of Tonar, further in view of Kharraz Tavakol, and further in view of Thomas. The Applicant reserves the right to submit further arguments shall the Examiner find claim 21 obvious. Applicant respectfully requests the Examiner reconsider and withdraw the obviousness rejection of claims 46 and 47.
M.    Claim 48
The Examiner rejects claim 48 under 35 U.S.C. § 103 as being unpatentable over Bardy in view of Larson, in view of Tonar, further in view of Kharraz Tavakol 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 et al. (The Journal of Spinal Cord Medicine, 37(6):703-718 (2014) ("Liu"). See Office Action at p. 42. The Applicant respectfully disagrees.
"[I]f an independent claim is nonobvious under 35 U.S.C. § 103, then any claim depending therefrom is nonobvious." In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Without establishing claim 21 is obvious over Bardy in view of Larson, in view of Tonar, and further in view of Kharraz Tavakol, the Examiner has not established claim 48 is obvious over Bardy in view Larson, in view of Tonar, further in view of Kharraz Tavakol, and further in view of Liu. The Applicant reserves the right to submit further arguments shall the Examiner find claim 21 obvious. Applicant respectfully requests the Examiner reconsider and withdraw the obviousness rejection of claim 48.
N.    Claim 49
The Examiner rejects claim 49 under 35 U.S.C. § 103 as being unpatentable over Bardy in view of Larson, in view of Tonar, further in view of Kharraz Tavakol 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. (J. Am. Acad. Dermatol., 33:217-221 (1995)) ("Tur"). See Office Action at 43. The Applicant respectfully disagrees.
"[I]f an independent claim is nonobvious under 35 U.S.C. § 103, then any claim depending therefrom is nonobvious." In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Without establishing claim 21 is obvious over Bardy in view of Larson, in view of Tonar, and further in view of Kharraz Tavakol, the Examiner has not established claim 49 is obvious over Bardy in view Larson, in view of Tonar, further in view of Kharraz Tavakol, and further in view of Tur. The Applicant reserves the right to submit further arguments shall the Examiner find claim 21 obvious. Applicant respectfully requests the Examiner reconsider and withdraw the obviousness rejection of claim 49.
0.    Claim 50
The Examiner rejects claim 50 under 35 U.S.C. § 103 as being unpatentable over Bardy in view of Larson, in view of Tonar, further in view of Kharraz Tavakol 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. (Cureus 8(8):e730, pp. 1-6 (2016)) ("Truong").
"[I]f an independent claim is nonobvious under 35 U.S.C. § 103, then any claim depending therefrom is nonobvious." In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Without establishing claim 21 is obvious over Bardy in view of Larson, in view of Tonar, and further in view of Kharraz Tavakol, the Examiner has not established claim 50 is obvious over Bardy in view Larson, in view of Tonar, further in view of Kharraz Tavakol, and further in view of Truong. The Applicant reserves the right to submit further arguments shall the Examiner find claim 21 obvious. Applicant respectfully requests the Examiner reconsider and withdraw the obviousness rejection of claim 50.
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]