Office Action 1: Non-Final Rejection (2020-01-22)
Rejection types: 103 - Obviousness, 112 - Written Description/Enablement

CLAIMS:
We claim:

1\. A method of providing a continuity of care for a patient during transfer between care settings, the method comprising the steps of deciding to transfer a patient from a first care setting to a second care setting, performing a first assessment of the patient in the first care setting, preparing a transfer record of the assessment, and
transferring the transfer record with the patient to the second care setting.

2\. The method of claim 1, wherein the first assessment comprises performing a sub- epidermal moisture (SEM) scan of at least one body location of the patient.

3\. The method of claim 2, wherein the SEM scan comprises a plurality of measurements of an SEM value at the body location and calculation of a delta value from the plurality of SEM values.

4\. The method of claim 3, further comprising the step of:
performing a plurality of SEM scans of the patient at different times while in the first care setting, and
recording the delta values from each of the respective SEM scans, wherein the decision to transfer the patient is based partially on the delta values recorded while in the first care setting.

5\. The method of claim 4, wherein the transfer record comprises the delta values from a portion of the plurality of SEM scans of the patient taken at different times while in the first care setting.

6\. The method of claim 2, wherein the SEM scan is performed at all body locations identified for monitoring.

7\. The method of claim 1, wherein the first assessment comprises at least one 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.

8\. The method of claim 1, wherein the transfer record comprises at least one of a transaction type, a transaction date/time, a "to" location, and a "from" location.
9\. The method of claim 1, further comprising the steps of 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, creating a first data record that comprises the first delta value, reporting the first data record to a database, and
reporting the transfer record to the database.

10\. The method of claim 9, wherein:
the first data record comprises a patient identifier and a first date/time when the first SEM scan was performed, and
the transfer record comprises the patient identifier and a second date/time when the first assessment was performed.

11\. The method of claim 10, further comprising the steps of:
performing an SEM scan of the at least one body location of the patient and calculating a second delta value while in the second care setting, creating a second data record that comprises the patient identifier, the second delta value, and a third date/time when the second SEM scan was performed, and
reporting the second data record to a database.

12\. The method of claim 11, further comprising the step of:
querying the database to retrieve a portion of data records that comprise the delta values of the at least one body location of the patient.

13\. The method of claim 12, further comprising the step of:
formatting the retrieved delta values in date/time order, and
displaying the formatted delta values.

14\. The method of claim 10, further comprising the steps of:
creating an additional data record that comprises the patient identifier, a data element from the group of nutritional information, an implemented intervention, a risk assessment, a visual skin assessment, a care plan, a doctor's note, lean event, a vital sign, a body weight, and a lab result, and a date/time associated with the data element, and
reporting the additional data record to the database.

15\. The method of claim 13, wherein the formatted delta values is displayed in the form of a curve.

16\. The method of claim 15, 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.

17\. The method of claim 16, wherein acceleration is determined by the rate of change of the slope of the curve.

18\. The method of claim 16, wherein the decision to transfer the patient is based partially on one or more of the slope, the acceleration, the curve shape and associated characteristics, and the time-to-intercept of a selected threshold value.

19\. The method of claim 11, further comprising the steps of. performing an SEM scan of the at least one body location of the patient and calculating a third delta value while in the third care setting, creating a third data record that comprises the patient identifier, the third delta value, and a fourth date/time when the third SEM scan was performed, and
reporting the third data record to a database.

20\. The method of claim 19, 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. 41 42 43 US 166932975v1

OFFICE ACTION:
DETAILED ACTION
Notice of Pre-AIA  or AIA  Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07 November 2019 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements is being considered by the examiner.
Claim Objections
Claims 32 and 36 are objected to because of the following informalities:
Claim 32 recites “further comprising the step of:” when it should most likely recite “further comprising the steps of:”.
Claim 36 recites “The method of claim 23” when it should most likely recite “The method of claim 32”. If this is not the case, claim 36 would be rejected under 35 U.S.C. 112(b) for being indefinite because acceleration is not mentioned in any previous claim that claim 36 depends on.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b)  CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 32-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA  the applicant regards as the invention.
Claim 32 recites the limitation “the retrieved delta values” in line 2 of the claim.  There is insufficient antecedent basis for this limitation in the claim.
Claim 33 recites the limitation “the group of nutritional information” in line 3 of the claim.  There is insufficient antecedent basis for this limitation in the claim.
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.
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 21-25, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2002/0143262 to Bardy in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol et al.
As per claim 21, Bardy teaches a method of providing a continuity of care for a patient 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, (see: paragraph [0009] where information about the patient is constantly being recorded by an external or implantable medical device. These measurements are being recorded regardless of location, thus it can be considered recording these measurements at a second care setting)
--determining whether the value exceeds a threshold, (see: paragraph [0093] where patient status values are being determined to either stay within or cross a certain SD threshold)
--continuing to administer the current intervention if the value does not exceed the threshold, (see: paragraph [0093] where if the patient status indicates status quo, then no changes in treatment or diagnosis are indicated) and
--administering a new intervention of level-N if the value exceeds the threshold, where N has a value greater than K (see: paragraph [0093] where a slightly more aggressive diagnostic, and if appropriate, treatment program is undertaken for a more rapidly deteriorating condition where a change of 1.0 SD has occurred over the course of about 1 week. A new intervention of level-N (aggressive diagnostic treatment program) is being administered if the value (change away from status  quo value in SD) exceeds a threshold (SD threshold). N here has a value greater than K because the N treatment (aggressive diagnostic treatment program) is greater than the K treatment (base level treatment). Also see: paragraph [0092]).
Bardy teaches the aforementioned claim limitations. The difference between Bardy and the claimed invention is that while Bardy does disclose measurement values and values that are being compared to thresholds to determine if therapy needs to change, it does not explicitly teach SEM measurements, calculating a delta value, and determining if that delta value exceeds a threshold.
Bardy fails to specifically teach:
1) --identifying a current intervention of level-K received by the patient at the first care setting;
2) --Sub-Epidermal Moisture (SEM) measurements,
3) --calculating a delta value by a difference between two of the plurality of SEM measurements, and
4) --delta value as a value.
Tonar et al. teaches:
2) --Sub-Epidermal Moisture (SEM) measurements, (see: paragraph [0008] where there are SEM values)
3) --calculating a delta value by a difference between two of the plurality of SEM measurements, (see: paragraph [0008] where a difference between a max SEM value and min SEM value is determined) and
4) --delta value as a value (see: paragraph [0008] where a difference value (delta value) is being determined).
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 2) Sub-Epidermal Moisture (SEM) measurements, 3) calculate a delta value by a difference between two of the plurality of SEM measurements, and have the 4) delta value as a value as taught by Tonar et al. for myocardial ischemia measurements and myocardial ischemia threshold values as disclosed by Bardy 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, Bardy determines if values reach a certain threshold and then administers a new intervention for myocardial ischemia. Bardy is determining this intervention using measured body values, thus substituting the type of values from myocardial ischemia to SEM where SEM values are also body measurement values would have been obvious to a person of ordinary skill in the art. 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).
Kharraz Tavakol et al. teaches:
1) --identifying a current intervention of level-K received by the patient at the first care setting (see: paragraph [0013] where a patient’s medical history is being transferred from one setting to another. Also see: paragraph [0018] where patient’s progress after a treatment can be tracked allowing for a more effective treatment in the next patient-doctor meeting. A current intervention of level-K (medical history of the patient which includes the treatments performed on the patient) is being identified in this transferred information).
One of ordinary skill at the time of the invention was filed would have found it obvious to 1) identify a current intervention of level-K received by the patient at the first care setting as taught by Kharraz Tavakol et al. in the method as taught by Bardy and Tonar et al. in combination with the motivation(s) of preventing delays in medical care and preventing patient dissuasion from treatment protocol compliance (see: paragraph [0002] of Kharraz Tavakol et al.).
As per claim 22, Bardy, Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Kharraz Tavakol et al. further teaches wherein the current intervention of level-K is provided in a transfer record (see: paragraphs [0013] and [0018] where the patient’s information that is being transferred is considered to be a transfer record).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
As per claim 23, Bardy, Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 22, see discussion of claim 22. Bardy teaches values taken at different times while in the first care setting (see: paragraph [0009] where measures are being collected on a regular, periodic basis for storage in a database. There are multiple data/measurement sets being recorded here periodically (at different times) at a particular setting).
Tonar et al. teaches delta values calculated from a portion of the plurality of SEM scans of the patient (see: paragraph [0008] where a difference value (delta value) is  being determined. The plural scans and values aspect here was taught by Bardy. The calculation for a single delta value on a scan here is being taught into Bardy where multiple values are being recorded periodically).
Kharraz Tavakol et al. teaches the transfer record further comprises values (see: paragraphs [0013] and [0018] where the patient’s information that is being transferred is considered to be a transfer record. The patient’s past information and medical history (specific values) are within the transfer record (the patient’s information that is transferred)).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
As per claim 24, Bardy, Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 22, see discussion of claim 22. Kharraz Tavakol et al. further teaches wherein the transfer record further comprises results obtained from at least one of assessments (see: paragraphs [0013] and [0018] where there is patient’s information including medical history being transferred to another office electronically).
Tonar et al. teaches 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: FIGS 9A and 9B where there is a result of a visual representation (SEM measurement map of damaged tissue) of at least one body location 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 25, Bardy, Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 22, see discussion of claim 22. Tonar et al. further teaches wherein the 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 (see: FIGS 9A and 9B where there is a SEM measurement map (scan) of damaged tissue of at least one body location of the patient. This scan contains a plurality of SEM values at the body location of sternum. Also see: paragraph [0008] where there is a difference (delta) being calculated with the scan between a max and min SEM value).
Kharraz Tavakol et al. teaches a transfer record as a record, (see: paragraphs [0013] and [0018] where the patient’s information being transferred is the transfer record) and wherein said transfer record is stored on a database (see: paragraphs [0117] and [0128]).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
As per claim 28, Bardy, Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Tonar et al. further 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).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
Claims 26, 29-30, and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2002/0143262 to Bardy in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol et al. as applied to claim 21, and further in view of U.S. Patent No. 6,738,798 to Ploetz et al.
As per claim 26, Bardy, Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 25, see discussion of claim 25. Tonar et al. teaches SEM scan (see: FIG. 4 and paragraph [0008]).
Kharraz Tavakol et al. further teaches wherein: the transfer record further comprises a patient identifier (see: paragraphs [0036] and [0037] where the database includes an identifier for correlating patient and patient records).
The combination fails to specifically, further teach that the record further comprises a date and a time when said first scan was performed.
Ploetz et al. teaches that the record further comprises a date and a time when said first scan was performed (see: column 4, line 48 to column 5, line 13 where there is exam data including exam date and start/end time and this information is collected by the automated support central server).
One of ordinary skill at the time of the invention was filed would have found it obvious to have the record further comprises a date and a time when said first scan was performed as taught by Ploetz et al. in the method as taught by Bardy, Tonar et al., and Kharraz Tavakol et al. in combination with the motivation(s) of providing accurate and detailed records of the health status of a patient.
As per claim 29, Bardy, Tonar et al., Kharraz Tavakol et al., and Ploetz et al. in combination teach the method of claim 26, see discussion of claim 26. Bardy further teaches further comprising the steps of:
--performing measurements of the body location of the patient in the second care setting to obtain a second plurality of SEM measurements (see: paragraph [0009] where information about the patient is constantly being recorded by an external or implantable medical device. These measurements are being recorded regardless of location, thus it can be considered recording these measurements at a second care setting. A second plurality of measurements occurs after the first set of measurements are taken because the patient is constantly being recorded) and
--reporting the second data record to the database (see: paragraph [0009] where measures are being collected on a regular, periodic basis for storage in a database. The second data record would include the measures that were taken after a first set of measures during the periodic collection of measures) and
--second set of measurements and data (see: paragraph [0009] where measures are being collected on a regular, periodic basis for storage in a  database. There are multiple data/measurement sets being recorded here periodically including a second set).
Tonar et al. teaches:
--measurements as a SEM scan, (see: FIG. 4 and paragraph [0008])
--calculating a delta value, (see: paragraph [0008] where a difference between a max SEM value and min SEM value is determined)
--creating a data record that comprises the delta value, (see: paragraph [0008] where there is a difference (delta) being calculated with the scan between a max and min SEM value and this value is part of the record of the patient) and
--SEM scan (see: FIG. 4 and paragraph [0008]).
Kharraz Tavakol et al. teaches:
--creating a data record that comprises the patient identifier (see: paragraphs [0036] and [0037] where the database includes an identifier for correlating patient and patient records).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
Ploetz et al. teaches:
--creating a data record that comprises a date and time when the scan was performed (see: column 4, line 48 to column 5, line 13 where there is exam data including exam date and start/end time and this information is collected by the automated support central server).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 26, and incorporated herein.
As per claim 30, Bardy, Tonar et al., Kharraz Tavakol et al., and Ploetz et al. in combination teach the method of claim 29, see discussion of claim 29. Bardy teaches second set of measurements and data (see: paragraph [0009] where measures are being collected on a regular, periodic basis for storage in a database. There are multiple data/measurement sets being recorded here periodically including a second set).
Tonar et al. further 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).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
As per claim 37, Bardy, Tonar et al., Kharraz Tavakol et al., and Ploetz et al. in combination teach the method of claim 29, see discussion of claim 29. Bardy further teaches further comprising the steps of:
--performing measurements of the body location of the patient in the second care setting to obtain a third plurality of SEM measurements (see: paragraph [0009] where information about the patient is constantly being recorded by an external or implantable medical device. These measurements are being recorded regardless of location, thus it can be considered recording these measurements at a second number='10'care setting. A third plurality of measurements occurs after the second set of measurements are taken because the patient is constantly being recorded) and
--reporting the third data record to the database (see: paragraph [0009] where measures are being collected on a regular, periodic basis for storage in a database. The second data record would include the measures that were taken after a first set of measures during the periodic collection of measures) and
--third set of measurements and data (see: paragraph [0009] where measures are being collected on a regular, periodic basis for storage in a database. There are multiple data/measurement sets being recorded here periodically including a third set).
Tonar et al. teaches:
--measurements as a SEM scan, (see: FIG. 4 and paragraph [0008])
--calculating a delta value, (see: paragraph [0008] where a difference between a max SEM value and min SEM value is determined)
--creating a data record that comprises the delta value, (see: paragraph [0008] where there is a difference (delta) being calculated with the scan between a max and min SEM value and this value is part of the record of the patient) and
--SEM scan (see: FIG. 4 and paragraph [0008]).
Kharraz Tavakol et al. teaches:
--creating a data record that comprises the patient identifier (see: paragraphs [0036] and [0037] where the database includes an identifier for correlating patient and patient records).
number='11'The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
Ploetz et al. teaches:
--creating a data record that comprises a date and time when the scan was performed (see: column 4, line 48 to column 5, line 13 where there is exam data including exam date and start/end time and this information is collected by the automated support central server).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 26, and incorporated herein.
Additionally, claim limitations of claim 37 recite limitations similar to claim limitations already stated within claim 29 without adding any other functionalities. Repeating steps that do not add a new and unexpected result has no patentable significance (see: MPEP 2144.04 (VI)(B), Duplication of Parts). Simply repeating steps that were applied to one set of questions and applying those steps to another set of questions produces expected results, and as such, amounts to a mere duplication of parts conferring to no additional patentable weight.
As per claim 38, Bardy, Tonar et al., Kharraz Tavakol et al., and Ploetz et al. in combination teach the method of claim 37, see discussion of claim 37. Bardy teaches third set of measurements and data (see: paragraph [0009] where measures are being collected on a regular, periodic basis for storage in a database. There are multiple data/measurement sets being recorded here periodically including a third set).
number='12'Tonar et al. further 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).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
Additionally, claim limitations of claim 38 recite limitations similar to claim limitations already stated within claim 30 without adding any other functionalities. Repeating steps that do not add a new and unexpected result has no patentable significance (see: MPEP 2144.04 (VI)(B), Duplication of Parts). Simply repeating steps that were applied to one set of questions and applying those steps to another set of questions produces expected results, and as such, amounts to a mere duplication of parts conferring to no additional patentable weight.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2002/0143262 to Bardy in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol et al. as applied to claim 22, and further in view of U.S. Patent No. 9,028,407 to Bennet-Guerrero.
As per claim 27, Bardy, Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Tonar et al. further teaches SEM measurements (see: paragraph [0008] where there are SEM values).
The combination fails to further, specifically teach continuing to make a plurality of measurements at a pre-determined frequency corresponding to level-K if the delta number='13'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 Bardy, Tonar et al., and Kharraz Tavakol 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 31-32, 34, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2002/0143262 to Bardy in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol et al. and further in view of U.S. Patent No. 6,738,798 to Ploetz et al. as applied to claim 30, and further in view of U.S. Patent No. 9,675,289 to Heaton.
As per claim 31, Bardy, Tonar et al., Kharraz Tavakol et al., and Ploetz et al. in combination teach the method of claim 29, see discussion of claim 29. Tonar et al. further teaches delta values of the at least one body location of the patient (see: paragraph [0008] where a difference value (delta value) is being determined).
The combination fails to further, specifically teach the step of:
--querying the database to retrieve a portion of data records that comprise the values.
Heaton teaches the step of:
--querying the database to retrieve a portion of data records that comprise the 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 to retrieve a portion of data records that comprise the values as taught by Heaton in the method as taught by Bardy, Tonar et al., Kharraz Tavakol et al., and Ploetz et al. in combination with the motivation(s) of being a way to number='14'view and analyze stored data in a chronological form so that trends in data may be observed.
As per claim 32, Bardy, Tonar et al., Kharraz Tavakol et al., and Ploetz et al. in combination teach the method of claim 30, see discussion of claim 30. Tonar et al. further teaches delta values (see: paragraph [0008] where a difference value (delta value) is being determined).
The combination fails to further, specifically teach the step of:
1) --formatting the retrieved values in date and time order, and
2) --displaying the formatted values.
Heaton teaches the step of:
1) --formatting the retrieved values in date and time order, (see: column 30, lines 11-31 and FIG. 8 where there are values being retrieved, formatted by time and date, and displayed on a display) and
2) --displaying the formatted values (see: column 30, lines 11-31 and FIG. 8 where there are values being retrieved, formatted by time and date, and displayed on a display).
One of ordinary skill at the time of the invention was filed would have found it obvious to 1) format the retrieved values in date and time order and 2) display the formatted values as taught by Heaton in the method as taught by Bardy, Tonar et al., Kharraz Tavakol et al., and Ploetz et al. in combination with the motivation(s) of being a way to view and analyze stored data in a chronological form so that trends in data may be observed.
As per claim 34, Bardy, Tonar et al., Kharraz Tavakol et al., Ploetz et al., and Heaton in combination teach the method of claim 32, see discussion of claim 32. Tonar et al. further teaches delta values (see: paragraph [0008] where a difference value (delta value) is being determined).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
Heaton further teaches wherein the formatted values is displayed in the form of a curve (see: FIG. 8).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 32, and incorporated herein.
As per claim 39, Bardy, Tonar et al., Kharraz Tavakol et al., and Ploetz et al. in combination teach the method of claim 37, see discussion of claim 37. Tonar et al. further teaches delta values (see: paragraph [0008] where a difference value (delta value) is being determined).
The combination fails to 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 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 number='15'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 32, and incorporated herein.
Claims 31-32, 34, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2002/0143262 to Bardy in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol et al. and further in view of U.S. Patent No. 6,738,798 to Ploetz et al. as applied to claim 30, and further in view of U.S. 2008/0015894 to Miller et al.
As per claim 33, Bardy, Tonar et al., Kharraz Tavakol et al., and Ploetz et al. in combination teach the method of claim 29, see discussion of claim 29. The combination fails to further, specifically the steps of:
--creating an additional data record that comprises the patient identifier, a data element from the group of nutritional information, an implemented intervention, a risk assessment, a visual skin assessment, a care plan, a doctor's note, lean event, a vital sign, a body weight, and a lab result, and a date/time associated with the data element, and
--reporting the additional data record to the database.
Miller et al. teaches the steps of:
number='16'--creating an additional data record that comprises the patient identifier, a data element from the group of nutritional information, an implemented intervention, a risk assessment, a visual skin assessment, a care plan, a doctor's note, lean event, a vital sign, a body weight, and a lab result, and a date/time associated with the data element, (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
--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 have the steps of creating an additional data record that comprises the patient identifier, a data element from the group of nutritional information, an implemented intervention, a risk assessment, a visual skin assessment, a care plan, a doctor's note, lean event, a vital sign, a body weight, and a lab result, and a date/time associated with the data element, and reporting the additional data record to the database as taught by Miller et al. in the method as taught by Bardy, Tonar et al., Kharraz Tavakol et al., and Ploetz et al. in combination with the motivation(s) of monitoring all relevant patient information that affect a patient’s health status so that appropriate recommendations may be made.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2002/0143262 to Bardy in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol et al. further in view of U.S. Patent No. 6,738,798 to Ploetz et al. and 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, Bardy, Tonar et al., Kharraz Tavakol et al., Ploetz et al., and Heaton in combination teach the method of claim 32, see discussion of claim 32. Tonar et al. further teaches delta values (see: paragraph [0008] where a difference value (delta value) is being determined).
The combination fails to 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 number='17'taught by Bardy, Tonar et al., Kharraz Tavakol et al., Ploetz 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.).
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2002/0143262 to Bardy in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol et al. as applied to claim 23, and further in view of U.S. Patent No. 8,355,925 to Rothman et al.
As per claim 36, Bardy, Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 23, see discussion of claim 23. The combination fails to further teach wherein acceleration is determined by the rate of change of the slope of the curve.
Rothman et al. teaches wherein 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).
One of ordinary skill at the time of the invention was filed would have found it obvious to have wherein acceleration is determined by the rate of change of the slope of the curve as taught by Rothman et al. in the method as taught by Bardy, Tonar et al., and Kharraz Tavakol et al. 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.).
Claims 40 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2002/0143262 to Bardy in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol 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, Bardy, Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Bardy further teaches wherein a level-x intervention is selected from the treatment group (see: paragraphs [0092] and [0093] where a level of treatment is being provided to the patient).
The combination fails to specifically, further teach a level-0 intervention selected from a group consisting of providing good nutrition, standard mattress, turning every 24 hours, and a combination thereof.
Brem et al. teaches a level-0 intervention selected from a 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 level-0 intervention selected from a group consisting of providing good nutrition, standard mattress, turning every 24 hours, and a combination thereof as taught by Brem et al. for a treatment program of a certain diagnostic level as disclosed by Bardy, Tonar et al., and Kharraz Tavakol et al. number='18'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 teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted the heel boot treatment in for a treatment program because the boot is a level of treatment used to treat pressure ulcers. 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, Bardy, Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Bardy further teaches wherein a level-x intervention is treatment (see: paragraphs [0092] and [0093] where a level of treatment is being provided to the patient).
The combination fails to further specifically teach a level-3 intervention of applying dressing to the back or sides of patient's heel.
Brem et al. teaches a level-3 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. 2002/0143262 to Bardy in view of U.S. 2017/0007153 to Tonar et al. further in view of number='19'U.S. 2011/0191122 to Kharraz Tavakol 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, Bardy, Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Bardy further teaches wherein a level-x intervention is treatment (see: paragraphs [0092] and [0093] where a level of treatment is being provided to the patient).
The combination fails to further specifically teach a level-1 intervention of providing a heel boot to the patient.
Lamont teaches a level-1 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 intervention of providing a heel boot to the patient as taught by Lamont for a treatment program of a certain diagnostic level as disclosed by Bardy, Tonar et al., and Kharraz Tavakol 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 teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted the heel boot treatment in for a treatment program because the boot is a level of treatment used to treat pressure ulcers. 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. 2002/0143262 to Bardy in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol 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, Bardy, Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Bardy further teaches wherein a level-x intervention is treatment (see: paragraphs [0092] and [0093] where a level of treatment is being provided to the patient).
The combination fails to further specifically teach a level-2 intervention of changing the patient's support surface.
DuDonis et al. teaches a level-2 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 intervention of changing the patient's support surface as taught by DuDonis et al. for a treatment program of a certain diagnostic level as disclosed by Bardy, Tonar et al., and Kharraz Tavakol 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 teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted the heel boot treatment in for a treatment program because the boot is a level of treatment used to treat number='20'pressure ulcers. 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. 2002/0143262 to Bardy in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol 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, Bardy, Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Bardy further teaches wherein a level-x intervention is treatment (see: paragraphs [0092] and [0093] where a level of treatment is being provided to the patient).
The combination fails to further specifically teach a level-4 intervention of changing the patient's sheet cover to a low-friction sheet cover.
Rotaru et al. teaches a level-4 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 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 Bardy, Tonar et al., and Kharraz Tavakol et al. in combination since each individual element and its number='21'function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted the heel boot treatment in for a treatment program because the boot is a level of treatment used to treat pressure ulcers. 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. 2002/0143262 to Bardy in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol 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, Bardy, Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Bardy further teaches wherein a level-x intervention is treatment (see: paragraphs [0092] and [0093] where a level of treatment is being provided to the patient).
The combination fails to further specifically teach a level-5 intervention of providing a low-friction padded mattress surface for the patient's lower leg.
Hann teaches a level-5 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 intervention of number='22'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 Bardy, Tonar et al., and Kharraz Tavakol 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 teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted the heel boot treatment in for a treatment program because the boot is a level of treatment used to treat pressure ulcers. 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. 2002/0143262 to Bardy in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol et al. as applied to claim 21, and further in view of “Prevention and Treatment of Pressure Ulcers” to Thomas.
As per claim 46, Bardy, Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Bardy further teaches wherein a level-x intervention is treatment (see: paragraphs [0092] and [0093] where a level of treatment is being provided to the patient).
The combination fails to further specifically teach a level-6 intervention of turning the patient at a shorter interval than currently provided for.
Thomas teaches a level-6 intervention of turning the patient at a shorter interval than currently provided for (see: “Decrease Pressure, Friction, and Shear” of page number='23'47 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 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 Bardy, Tonar et al., and Kharraz Tavakol 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 teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted the heel boot treatment in for a treatment program because the boot is a level of treatment used to treat pressure ulcers. 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, Bardy, Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Bardy further teaches wherein a level-x intervention is treatment (see: paragraphs [0092] and [0093] where a level of treatment is being provided to the patient).
The combination fails to further specifically teach a level-7 intervention of applying a barrier cream to the patient's heel.
Thomas teaches a level-7 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 number='24'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. 2002/0143262 to Bardy in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol 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, Bardy, Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Bardy further teaches wherein a level-x intervention is treatment (see: paragraphs [0092] and [0093] where a level of treatment is being provided to the patient).
The combination fails to further specifically teach a level-8 intervention of applying a neuro-muscular stimulation to the patient's heel.
Liu teaches a level-8 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 intervention of applying a neuro-muscular stimulation to the patient's heel as taught by Liu for a number='25'treatment program of a certain diagnostic level as disclosed by Bardy, Tonar et al., and Kharraz Tavakol 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 teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted the heel boot treatment in for a treatment program because the boot is a level of treatment used to treat pressure ulcers. 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. 2002/0143262 to Bardy in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol 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, Bardy, Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Bardy further teaches wherein a level-x intervention is treatment (see: paragraphs [0092] and [0093] where a level of treatment is being provided to the patient).
The combination fails to further specifically teach a level-9 intervention of applying a topical cream to the patient's heel to enhance perfusion.
Tur et al. teaches a level-9 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).
number='26'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 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 Bardy, Tonar et al., and Kharraz Tavakol 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 teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted the heel boot treatment in for a treatment program because the boot is a level of treatment used to treat pressure ulcers. 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. 2002/0143262 to Bardy in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol 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, Bardy, Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Bardy further teaches wherein a level-x intervention is treatment (see: paragraphs [0092] and [0093] where a level of treatment is being provided to the patient).
number='27'The combination fails to further specifically teach a level-10 intervention of providing a silicon pad for the patient's lower leg.
Truong et al. teaches a level-10 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 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 Bardy, Tonar et al., and Kharraz Tavakol 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 teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted the heel boot treatment in for a treatment program because the boot is a level of treatment used to treat pressure ulcers. 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


NEXT OFFICE ACTION: DETAILED ACTION
Response to Amendment
The previous claim objections have been overcome.
The 112(b) rejections given to claims 32-33 have been overcome.
In light of the amended claims, the claims are rejected under 35 U.S.C. 103.
Notice to Applicant
In the amendment dated 04/21/2020, the following has occurred: claims 21-22, 31-34, 36, and 40-50 have been amended; claims 23-30, 35, and 37-39 have remained unchanged; and no new claims have been added.
Claims 21-50 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
Claim Objections:
The claims were amended to overcome the previous objections to the claims. Examiner withdraws the previous objections to the claims.
35 U.S.C. 112 Rejections:
The claims were amended to overcome the previous 112(b) rejections to the claims. Examiner withdraws the previous 112(b) rejections to the claims.
35 U.S.C. 103 Rejections:
Applicant directed some arguments towards some newly amended claim limitations. These arguments are deemed moot in view of the newly cited art.
Applicant argue that there is no motivation to combine with regards to the Bardy and Tonar references. Examiner disagrees. Examiner used a substitution rational to combine these references. Bardy deals with providing diagnosis and monitoring of diseases for use is automated patient care. While it does elaborate on providing diagnosis and monitoring for myocardial ischemia, it is not limited to this (see: paragraph [0008] of Bardy where other diseases may be diagnosed). The Tonar reference was simply substituted in to teach data relating to an “other disease”, in this case, SEM data.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning.  But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper.  See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, Examiner has used a KSR rationale and provided a reasonable motivation to combine.
With respect to claims 26, 29-30, and 37-38, Applicant argues that the Ploetz reference fails to teach the “the record further comprises a date and a time when said first scan was performed” limitation and that there is no correct motivation to combine this reference with the combination Bardy, Tonar, and Kharraz Tavakol. Examiner disagrees. Examiner first would like to point out that Applicant cited what they believed the Ploetz reference taught at best. However, Examiner cited column 4, line 48 to column 5, line 13 where dates and times for exams (records) were taught. Additionally, Examiner provided a motivation of providing accurate and detailed record of the health status of a patient considering that recording the dates and times of these events are very common especially in the medical field. Examiner is able to substitute this element from the Ploetz reference because one of ordinary skill in the art could have substituted this date and time element on a record for a record that does not explicitly state date and time to produce a predictable result of an accurate and detailed record (MPEP 2143).
With respect to claim 27, Applicant argues that there is no motivation to combine as well as stating what they believe the Bennett-Guerrero reference teaches at best. Examiner disagrees. Examiner cited column 6, lines 9-21 and explained, where necessary, why it met the claim (as can be seen below in the 35 U.S.C. 103 rejection section). Additionally, Examiner used a motivation to combine of enhancing, improving, or even optimizing battery life. This is reasonable to do considering both the Bardy reference and the Bennett-Guerrero reference deal with monitoring a patient and that the frequency at which the device monitors the patient can be influenced by the battery life of the device.
With respect to claims 31-32, 34, and 39, Applicant argues that there is no motivation to combine as well as stating what they believe the Heaton reference teaches at best. Examiner disagrees. With regards to these claims, including the amendments to these claims, Examiner cites and explains why the citations met these limitations (as can be seen below in the 35 U.S.C. 103 rejection section). Additionally, Examiner cites a motivation of “being one of a limited number of ways to retrieve stored data. Thus, one of ordinary skill in the art could have substituted this querying element for an element that does not explicitly state querying to access data in a record to produce a predictable result of accessing a record (MPEP 2143)”.
With respect to claim 33, Applicant argues that there is no motivation to combine as well as stating what they believe the Miller reference teaches at best. Examiner disagrees. Examiner cited paragraph [0121] and explained, where necessary, why it met the claim (as is shown below in the 35 U.S.C. 103 rejection section). Additionally, Examiner used a motivation to combine of “monitoring all relevant patient information that affect a patient’s health status so that appropriate recommendations may be made”. Thus, one of ordinary skill in the art could have substituted this monitoring element for an element within Bardy that discloses monitoring patient data (such as in paragraph [0009] of Bardy) to produce a predictable result of monitoring a patient and their data (MPEP 2143).
With respect to claims 35 and 36, Applicant argues that there is no motivation to combine as well as stating what they believe the Rothman reference teaches at best. Examiner disagrees. Examiner cited column 15, lines 29-43 and column 23, lines 18-29 and 51-59 (as can be seen below in the 35 U.S.C. 103 rejection section). The citation explains an analysis of slope values via derivation to determine an acceleration. Additionally, Examiner used a motivation to combine of “alerting a user if a patient is getting better or worse at an accelerating rate”. This is a fair reason to combine considering that the Bardy reference teaches monitoring a patient and it would be very useful to monitor a patient in the manner taught by Rothman to determine the status of the patient.
With respect to claims 40 and 43, Applicant argues that there is no motivation to combine as well as stating what they believe the Brem reference teaches at best. Examiner disagrees. With respect to claim 40, Examiner cited page 12S, point #7 (as can be seen below in the 35 U.S.C. 103 rejection section). This citation taught an intervention of providing good nutrition. With respect to claim 43, Examiner cited Table 1 of page 10S as well as page 13S (as can be seen below in the 35 U.S.C. 103 rejection section). The citation taught an intervention of application of a wound dressing. Additionally, Examiner used a substitution rationale as a motivation to combine considering that the Bardy reference already taught administering a new intervention when a threshold value is exceeded. Examiner is able to substitute this element from the Brem reference because one of ordinary skill in the art could have substituted these interventions for the intervention within the combination of references, including the Bardy reference, to produce a predictable result of providing an intervention to address a condition/disease (MPEP 2143).
With respect to claim 41, Applicant argues that there is no motivation to combine as well as stating what they believe the Lamont reference teaches at best. Examiner disagrees. With respect to claim 41, Examiner cited column 1, lines 14-17 (as can be seen below in the 35 U.S.C. 103 rejection section). This citation taught an intervention of providing a heel boot. Additionally, Examiner used a substitution rationale as a motivation to combine considering that the Bardy reference already taught administering a new intervention when a threshold value is exceeded. Examiner is able to substitute this element from the Lamont reference because one of ordinary skill in the art could have substituted these interventions for the intervention within the combination of references, including the Bardy reference, to produce a predictable result of providing an intervention to address a condition/disease (MPEP 2143).
With respect to claim 42, Applicant argues that there is no motivation to combine as well as stating what they believe the DuDonis reference teaches at best. Examiner disagrees. With respect to claim 42, Examiner cited column 3, lines 27-46 and column 5, lines 18-21 (as can be seen below in the 35 U.S.C. 103 rejection section). This citation taught an intervention of changing a support surface to a heel elevator support. Additionally, Examiner used a substitution rationale as a motivation to combine considering that the Bardy reference already taught administering a new intervention when a threshold value is exceeded. Examiner is able to substitute this element from the DuDonis reference because one of ordinary skill in the art could have substituted these interventions for the intervention within the combination of references, including the Bardy reference, to produce a predictable result of providing an intervention to address a condition/disease (MPEP 2143).
With respect to claim 44, Applicant argues that there is no motivation to combine as well as stating what they believe the Rotaru reference teaches at best. Examiner disagrees. Examiner cited pages 91 and 96 (as can be seen below in the 35 U.S.C. 103 rejection section). These citations taught an intervention of providing lower friction mattress sheets. Additionally, Examiner used a substitution rationale as a motivation to combine considering that the Bardy reference already taught administering a new intervention when a threshold value is exceeded. Examiner is able to substitute this element from the Rotaru reference because one of ordinary skill in the art could have substituted these interventions for the intervention within the combination of references, including the Bardy reference, to produce a predictable result of providing an intervention to address a condition/disease (MPEP 2143).
With respect to claim 45, Applicant argues that there is no motivation to combine as well as stating what they believe the Hann reference teaches at best. Examiner disagrees. Examiner cited column 5, lines 51-63 and column 3, lines 30-35 (as can be seen below in the 35 U.S.C. 103 rejection section). This citation taught an intervention of providing a low friction pad. Additionally, Examiner used a substitution rationale as a motivation to combine considering that the Bardy reference already taught administering a new intervention when a threshold value is exceeded. Examiner is able to substitute this element from the Hann reference because one of ordinary skill in the art could have substituted these interventions for the intervention within the combination of references, including the Bardy reference, to produce a predictable result of providing an intervention to address a condition/disease (MPEP 2143).
With respect to claims 46 and 47, Applicant argues that there is no motivation to combine as well as stating what they believe the Thomas reference teaches at best. Examiner disagrees. With respect to claim 46, Examiner cited page 47 (as can be seen below in the 35 U.S.C. 103 rejection section). This citation taught an intervention of providing a shorter interval for turning via frequent turning. With respect to claim 47, Examiner cited page 55, paragraph 3 (as can be seen below in the 35 U.S.C. 103 rejection section). The citation taught an intervention of using a barrier cream. Additionally, Examiner used a substitution rationale as a motivation to combine considering that the Bardy reference already taught administering a new intervention when a threshold value is exceeded. Examiner is able to substitute this element from the Thomas reference because one of ordinary skill in the art could have substituted these interventions for the intervention within the combination of references, including the Bardy reference, to produce a predictable result of providing an intervention to address a condition/disease (MPEP 2143).
With respect to claim 48, Applicant argues that there is no motivation to combine as well as stating what they believe the Liu reference teaches at best. Examiner disagrees. Examiner cited page 703 (as can be seen below in the 35 U.S.C. 103 rejection section). This citation taught an intervention of electrical stimulation enhanced pressure ulcer healing. Additionally, Examiner used a substitution rationale as a motivation to combine considering that the Bardy reference already taught administering a new intervention when a threshold value is exceeded. Examiner is able to substitute this element from the Liu reference because one of ordinary skill in the art could have substituted these interventions for the intervention within the combination of references, including the Bardy reference, to produce a predictable result of providing an intervention to address a condition/disease (MPEP 2143).
With respect to claim 49, Applicant argues that there is no motivation to combine as well as stating what they believe the Tur reference teaches at best. Examiner disagrees. Examiner cited page 217 (as can be seen below in the 35 U.S.C. 103 rejection section). This citation taught an intervention of an application of a topical cream. Additionally, Examiner used a substitution rationale as a motivation to combine considering that the Bardy reference already taught administering a new intervention when a threshold value is exceeded. Examiner is able to substitute this element from the Tur reference because one of ordinary skill in the art could have substituted these interventions for the intervention within the combination of references, including the Bardy reference, to produce a predictable result of providing an intervention to address a condition/disease (MPEP 2143).
With respect to claim 50, Applicant argues that there is no motivation to combine as well as stating what they believe the Truong reference teaches at best. Examiner disagrees. Examiner cited page 5, paragraphs 2-3 and 5 (as can be seen below in the 35 U.S.C. 103 rejection section). This citation taught an intervention of using silicon foam dressings. Additionally, Examiner used a substitution rationale as a motivation to combine considering that the Bardy reference already taught administering a new intervention when a threshold value is exceeded. Examiner is able to substitute this element from the Truong reference because one of ordinary skill in the art could have substituted these interventions for the intervention within the combination of references, including the Bardy reference, to produce a predictable result of providing an intervention to address a condition/disease (MPEP 2143).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 21 April 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.
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 21-25, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2002/0143262 to Bardy in view of U.S.2016/0278692 to Larson et al. in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol et al.
As per claim 21, Bardy teaches 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, (see: paragraph [0009] where information about the patient is constantly being recorded by an external or implantable medical device. These measurements are being recorded regardless of location, thus it can be considered recording these measurements at a second care setting)
--determining whether the value exceeds a threshold, (see: paragraph [0093] where patient status values are being determined to either stay within or cross a certain SD threshold)
--continuing to administer the current intervention if the value does not exceed the threshold, (see: paragraph [0093] where if the patient status indicates status quo, then no changes in treatment or diagnosis are indicated) and
--administering a new intervention of level-N if the value exceeds the threshold, where N has a value greater than K (see: paragraph [0093] where a slightly more aggressive diagnostic, and if appropriate, treatment program is undertaken for a more rapidly deteriorating condition where a change of 1.0 SD has occurred over the course of about 1 week. A new intervention of level-N (aggressive diagnostic treatment program) is being administered if the value (change away from status quo value in SD) exceeds a threshold (SD threshold). N here has a value greater than K because the N treatment (aggressive diagnostic treatment program) is greater than the K treatment (base level treatment). Also see: paragraph [0092]).
Bardy teaches the aforementioned claim limitations. The difference between Bardy and the claimed invention is that while Bardy does disclose measurement values and values that are being compared to thresholds to determine if therapy needs to change, it does not explicitly teach SEM measurements, calculating a delta value, and determining if that delta value exceeds a threshold.
Bardy may not specifically teach:
1) --identifying a current intervention of level-K received by the patient at the first care setting;
2) --Sub-Epidermal Moisture (SEM) measurements,
3) --calculating a delta value by a difference between two of the plurality of SEM measurements,
4) --PU intervention as an intervention; and
5) --delta value as a value.
Larson et al. teaches:
4) --PU intervention as an intervention (see: paragraph [0007] where there are PU interventions).
One of ordinary skill at the time of the invention was filed would have found it obvious to have the 4) PU intervention as an intervention as taught by Larson et al. in the method as taught by Bardy with the motivation(s) of preventing, detecting, and/or treating pressure ulcers (see: paragraph [0012] of Larson et al.). One of ordinary skill in the art could have substituted the detecting of pressure ulcer disease for the diagnosing of diseases in Bardy (see: paragraph [0008] of Bardy) to produce a predictable result (MPEP 2143).
Tonar et al. teaches:
2) --Sub-Epidermal Moisture (SEM) measurements, (see: paragraph [0008] where there are SEM values)
3) --calculating a delta value by a difference between two of the plurality of SEM measurements, (see: paragraph [0008] where a difference between a max SEM value and min SEM value is determined) and
5) --delta value as a value (see: paragraph [0008] where a difference value (delta value) is being determined).
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 2) Sub-Epidermal Moisture (SEM) measurements, 3) calculate a delta value by a difference between two of the plurality of SEM measurements, and have the 5) delta value as a value as taught by Tonar et al. 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. In the present case, Bardy and Larson et al. in combination determines if values reach a certain threshold and then administers a new intervention for myocardial ischemia. The combination of Bardy and Larson et al. is determining this intervention using measured body values, thus substituting the type of values from myocardial ischemia to SEM where SEM values are also body measurement values would have been obvious to a person of ordinary skill in the art. 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).
Kharraz Tavakol et al. teaches:
1) --identifying a current intervention of level-K received by the patient at the first care setting (see: paragraph [0013] where a patient’s medical history is being transferred from one setting to another. Also see: paragraph [0018] where patient’s progress after a treatment can be tracked allowing for a more effective treatment in the next patient-doctor meeting. A current intervention of level-K (medical history of the patient which includes the treatments performed on the patient) is being identified in this transferred information).
One of ordinary skill at the time of the invention was filed would have found it obvious to 1) identify a current intervention of level-K received by the patient at the first care setting as taught by Kharraz Tavakol et al. 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 (see: paragraph [0002] of Kharraz Tavakol et al.).
As per claim 22, Bardy, Larson et al., Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Larson et al. teaches PU intervention as an intervention (see: paragraph [0007] where there are PU interventions).
Kharraz Tavakol et al. further teaches wherein the current intervention of level-K is provided in a transfer record (see: paragraphs [0013] and [0018] where the patient’s information that is being transferred is considered to be a transfer record).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
As per claim 23, Bardy, Larson et al., Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 22, see discussion of claim 22. Bardy teaches values taken at different times while in the first care setting (see: paragraph [0009] where measures are being collected on a regular, periodic basis for storage in a database. There are multiple data/measurement sets being recorded here periodically (at different times) at a particular setting).
Tonar et al. teaches delta values calculated from a portion of the plurality of SEM scans of the patient (see: paragraph [0008] where a difference value (delta value) is being determined. The plural scans and values aspect here was taught by Bardy. The calculation for a single delta value on a scan here is being taught into Bardy where multiple values are being recorded periodically).
Kharraz Tavakol et al. teaches the transfer record further comprises values (see: paragraphs [0013] and [0018] where the patient’s information that is being transferred is considered to be a transfer record. The patient’s past information and medical history (specific values) are within the transfer record (the patient’s information that is transferred)).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
As per claim 24, Bardy, Larson et al., Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 22, see discussion of claim 22. Kharraz Tavakol et al. further teaches wherein the transfer record further comprises results obtained from at least one of assessments (see: paragraphs [0013] and [0018] where there is patient’s information including medical history being transferred to another office electronically).
Tonar et al. teaches 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: FIGS 9A and 9B where there is a result of a visual representation (SEM measurement map of damaged tissue) of at least one body location 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 25, Bardy, Larson et al., Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 22, see discussion of claim 22. Tonar et al. further teaches wherein the 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 (see: FIGS 9A and 9B where there is a SEM measurement map (scan) of damaged tissue of at least one body location of the patient. This scan contains a plurality of SEM values at the body location of sternum. Also see: paragraph [0008] where there is a difference (delta) being calculated with the scan between a max and min SEM value).
Kharraz Tavakol et al. teaches a transfer record as a record, (see: paragraphs [0013] and [0018] where the patient’s information being transferred is the transfer record) and wherein said transfer record is stored on a database (see: paragraphs [0117] and [0128]).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
As per claim 28, Bardy, Larson et al., Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Tonar et al. further 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).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
Claims 26, 29-30, and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2002/0143262 to Bardy in view of U.S.2016/0278692 to Larson et al. in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol et al. as applied to claim 21, and further in view of U.S. Patent No. 6,738,798 to Ploetz et al.
As per claim 26, Bardy, Larson et al., Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 25, see discussion of claim 25. Tonar et al. teaches SEM scan (see: FIG. 4 and paragraph [0008]).
Kharraz Tavakol et al. further teaches wherein: the transfer record further comprises a patient identifier (see: paragraphs [0036] and [0037] where the database includes an identifier for correlating patient and patient records).
The combination may not specifically, further teach that the record further comprises a date and a time when said first scan was performed.
Ploetz et al. teaches that the record further comprises a date and a time when said first scan was performed (see: column 4, line 48 to column 5, line 13 where there is exam data including exam date and start/end time and this information is collected by the automated support central server).
One of ordinary skill at the time of the invention was filed would have found it obvious to have the record further comprises a date and a time when said first scan was performed as taught by Ploetz et al. in the method as taught by Bardy, Larson et al., Tonar et al., and Kharraz Tavakol et al. in combination with the motivation(s) of providing accurate and detailed records of the health status of a patient. Thus, one of ordinary skill in the art could have substituted this date and time element on a record for a record that does not explicitly state date and time to produce a predictable result of an accurate and detailed record (MPEP 2143).
As per claim 29, Bardy, Larson et al., Tonar et al., Kharraz Tavakol et al., and Ploetz et al. in combination teach the method of claim 26, see discussion of claim 26. Bardy further teaches further comprising the steps of:
--performing measurements of the body location of the patient in the second care setting to obtain a second plurality of SEM measurements (see: paragraph [0009] where information about the patient is constantly being recorded by an external or implantable medical device. These measurements are being recorded regardless of location, thus it can be considered recording these measurements at a second care setting. A second plurality of measurements occurs after the first set of measurements are taken because the patient is constantly being recorded) and
--reporting the second data record to the database (see: paragraph [0009] where measures are being collected on a regular, periodic basis for storage in a database. The second data record would include the measures that were taken after a first set of measures during the periodic collection of measures) and
--second set of measurements and data (see: paragraph [0009] where measures are being collected on a regular, periodic basis for storage in a database. There are multiple data/measurement sets being recorded here periodically including a second set).
Tonar et al. teaches:
--measurements as a SEM scan, (see: FIG. 4 and paragraph [0008])
--calculating a delta value, (see: paragraph [0008] where a difference between a max SEM value and min SEM value is determined)
--creating a data record that comprises the delta value, (see: paragraph [0008] where there is a difference (delta) being calculated with the scan between a max and min SEM value and this value is part of the record of the patient) and
--SEM scan (see: FIG. 4 and paragraph [0008]).
Kharraz Tavakol et al. teaches:
--creating a data record that comprises the patient identifier (see: paragraphs [0036] and [0037] where the database includes an identifier for correlating patient and patient records).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
Ploetz et al. teaches:
--creating a data record that comprises a date and time when the scan was performed (see: column 4, line 48 to column 5, line 13 where there is exam data including exam date and start/end time and this information is collected by the automated support central server).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 26, and incorporated herein.
As per claim 30, Bardy, Larson et al., Tonar et al., Kharraz Tavakol et al., and Ploetz et al. in combination teach the method of claim 29, see discussion of claim 29. Bardy teaches second set of measurements and data (see: paragraph [0009] where measures are being collected on a regular, periodic basis for storage in a database. There are multiple data/measurement sets being recorded here periodically including a second set).
Tonar et al. further 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).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
As per claim 37, Bardy, Larson et al., Tonar et al., Kharraz Tavakol et al., and Ploetz et al. in combination teach the method of claim 29, see discussion of claim 29. Bardy further teaches further comprising the steps of:
--performing measurements of the body location of the patient in the second care setting to obtain a third plurality of SEM measurements (see: paragraph [0009] where information about the patient is constantly being recorded by an external or implantable medical device. These measurements are being recorded regardless of location, thus it can be considered recording these measurements at a second care setting. A third plurality of measurements occurs after the second set of measurements are taken because the patient is constantly being recorded) and
--reporting the third data record to the database (see: paragraph [0009] where measures are being collected on a regular, periodic basis for storage in a database. The second data record would include the measures that were taken after a first set of measures during the periodic collection of measures) and
--third set of measurements and data (see: paragraph [0009] where measures are being collected on a regular, periodic basis for storage in a database. There are multiple data/measurement sets being recorded here periodically including a third set).
Tonar et al. teaches:
--measurements as a SEM scan, (see: FIG. 4 and paragraph [0008])
--calculating a delta value, (see: paragraph [0008] where a difference between a max SEM value and min SEM value is determined)
--creating a data record that comprises the delta value, (see: paragraph [0008] where there is a difference (delta) being calculated with the scan between a max and min SEM value and this value is part of the record of the patient) and
--SEM scan (see: FIG. 4 and paragraph [0008]).
Kharraz Tavakol et al. teaches:
--creating a data record that comprises the patient identifier (see: paragraphs [0036] and [0037] where the database includes an identifier for correlating patient and patient records).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
Ploetz et al. teaches:
--creating a data record that comprises a date and time when the scan was performed (see: column 4, line 48 to column 5, line 13 where there is exam data including exam date and start/end time and this information is collected by the automated support central server).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 26, and incorporated herein.
Additionally, claim limitations of claim 37 recite limitations similar to claim limitations already stated within claim 29 without adding any other functionalities. Repeating steps that do not add a new and unexpected result has no patentable significance (see: MPEP 2144.04 (VI)(B), Duplication of Parts). Simply repeating steps that were applied to one set of questions and applying those steps to another set of questions produces expected results, and as such, amounts to a mere duplication of parts conferring to no additional patentable weight.
As per claim 38, Bardy, Larson et al., Tonar et al., Kharraz Tavakol et al., and Ploetz et al. in combination teach the method of claim 37, see discussion of claim 37. Bardy teaches third set of measurements and data (see: paragraph [0009] where measures are being collected on a regular, periodic basis for storage in a database. There are multiple data/measurement sets being recorded here periodically including a third set).
Tonar et al. further 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).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
Additionally, claim limitations of claim 38 recite limitations similar to claim limitations already stated within claim 30 without adding any other functionalities. Repeating steps that do not add a new and unexpected result has no patentable significance (see: MPEP 2144.04 (VI)(B), Duplication of Parts). Simply repeating steps that were applied to one set of questions and applying those steps to another set of questions produces expected results, and as such, amounts to a mere duplication of parts conferring to no additional patentable weight.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2002/0143262 to Bardy in view of U.S.2016/0278692 to Larson et al. in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol et al. as applied to claim 22, and further in view of U.S. Patent No. 9,028,407 to Bennet-Guerrero.
As per claim 27, Bardy, Larson et al., Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Tonar et al. further teaches SEM measurements (see: paragraph [0008] where there are SEM values).
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 Bardy, Larson et al., Tonar et al., and Kharraz Tavakol 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 31-32, 34, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2002/0143262 to Bardy in view of U.S.2016/0278692 to Larson et al. in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol et al. and further in view of U.S. Patent No. 6,738,798 to Ploetz et al. as applied to claim 30, and further in view of U.S. Patent No. 9,675,289 to Heaton.
As per claim 31, Bardy, Larson et al., Tonar et al., Kharraz Tavakol et al., and Ploetz et al. in combination teach the method of claim 29, see discussion of claim 29. Bardy teaches the second value of the at least one body location of the patient in the second data record (see: paragraph [0009] where there is at least one data record being reported to a database, including a second record. The data within this record is considered the second value).
Tonar et al. further teaches the delta value of the at least one body location of the patient in the transfer record (see: paragraph [0008] where a difference value (delta value) is being determined on at least one body location) and delta value as a value (see: paragraph [0008] where there is a difference (delta) being calculated with the scan between a max and min SEM value and this value is part of the record of the patient).
Thus, Bardy and Tonar disclose 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 as data.
The combination may not further, specifically teach the step of:
--querying the database for data to form retrieved delta values.
Heaton teaches the step of:
--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 Bardy, Larson et al., Tonar et al., Kharraz Tavakol et al., and Ploetz et al. in combination with the motivation(s) of being one of a limited number of ways to retrieve stored data. Thus, one of ordinary skill in the art could have substituted this querying element for an element that does not explicitly state querying to access data in a record to produce a predictable result of accessing a record (MPEP 2143).
As per claim 32, Bardy, Larson et al., Tonar et al., Kharraz Tavakol et al., and Ploetz et al. in combination teach the method of claim 31, see discussion of claim 31. Tonar et al. further teaches delta values (see: paragraph [0008] where a difference value (delta value) is being determined).
The combination may not further, specifically teach the step of:
1) --formatting the retrieved values in date and time order, and
2) --displaying the formatted values.
Heaton teaches the step of:
1) --formatting the retrieved values in date and time order, (see: column 30, lines 11-31 and FIG. 8 where there are values being retrieved, formatted by time and date, and displayed on a display) and
2) --displaying the formatted values (see: column 30, lines 11-31 and FIG. 8 where there are values being retrieved, formatted by time and date, and displayed on a display).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 31, and incorporated herein.
As per claim 34, Bardy, Larson et al., Tonar et al., Kharraz Tavakol et al., Ploetz et al., and Heaton in combination teach the method of claim 32, see discussion of claim 32. Tonar et al. further teaches delta values (see: paragraph [0008] where a difference value (delta value) is being determined).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
Heaton further teaches wherein the formatted values are displayed in the form of a curve (see: FIG. 8).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 31, and incorporated herein.
As per claim 39, Bardy, Larson et al., Tonar et al., Kharraz Tavakol et al., and Ploetz et al. in combination teach the method of claim 37, see discussion of claim 37. Tonar et al. further teaches delta values (see: paragraph [0008] where a difference value (delta value) is being determined).
The 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 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. 2002/0143262 to Bardy in view of U.S.2016/0278692 to Larson et al. in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol et al. and further in view of U.S. Patent No. 6,738,798 to Ploetz et al. as applied to claim 30, and further in view of U.S. 2008/0015894 to Miller et al.
As per claim 33, Bardy, Larson et al., Tonar et al., Kharraz Tavakol et al., and Ploetz et al. in combination teach the method of claim 29, see discussion of claim 29. Ploetz et al. further teaches a date/time associated with the data element (see: column 4, line 48 to column 5, line 13 where there is exam data including exam date and start/end time and this information is collected by the automated support central server).
The combination may not further, specifically the steps of:
1) --creating an additional data record that comprises the patient identifier, a 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
2) --reporting the additional data record to the database.
Miller et al. teaches the steps of:
1) --creating an additional data record that comprises the patient identifier, a 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, (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 that comprises the patient identifier, a 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 2) reporting the additional data record to the database as taught by Miller et al. in the method as taught by Bardy, Larson et al., Tonar et al., Kharraz Tavakol et al., and Ploetz et al. in combination with the motivation(s) of monitoring all relevant patient information that affect a patient’s health status so that appropriate recommendations may be made. Thus, one of ordinary skill in the art could have substituted this monitoring element for an element within Bardy that discloses monitoring patient data (such as in paragraph [0009] of Bardy) to produce a predictable result of monitoring a patient and their data (MPEP 2143).
Claims 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2002/0143262 to Bardy in view of U.S.2016/0278692 to Larson et al. in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol et al. further in view of U.S. Patent No. 6,738,798 to Ploetz et al. and 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, Bardy, Larson et al., Tonar et al., Kharraz Tavakol et al., Ploetz et al., and Heaton in combination teach the method of claim 32, see discussion of claim 32. Tonar et al. further teaches delta values (see: paragraph [0008] where a difference value (delta value) is being determined).
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 Bardy, Larson et al., Tonar et al., Kharraz Tavakol et al., Ploetz 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, Bardy, Larson et al., Tonar et al., Kharraz Tavakol et al., Ploetz et al., Heaton, and Rothman et al. in combination teach the method of claim 35, see discussion of claim 35. Rothman et al. 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. 2002/0143262 to Bardy in view of U.S.2016/0278692 to Larson et al. in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol 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, Bardy, Larson et al., Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Bardy further teaches wherein a level-x intervention is selected from the treatment group (see: paragraphs [0092] and [0093] where a level of treatment is being provided to the patient).
The combination may not specifically, further teach a level-0 PU intervention selected from a group consisting of providing good nutrition, standard mattress, turning every 24 hours, and a combination thereof.
Brem et al. teaches a level-0 PU intervention selected from a 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 level-0 PU intervention selected from a group consisting of providing good nutrition, standard mattress, turning every 24 hours, and a combination thereof as taught by Brem et al. for a treatment program of a certain diagnostic level as disclosed by Bardy, Larson et al., Tonar et al., and Kharraz Tavakol 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 teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted the heel boot treatment in for a treatment program because the boot is a level of treatment used to treat pressure ulcers. 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, Bardy, Larson et al., Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Bardy further teaches wherein a level-x intervention is treatment (see: paragraphs [0092] and [0093] where a level of treatment is being provided to the patient).
The combination may not further specifically teach a level-3 PU intervention of 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. 2002/0143262 to Bardy in view of U.S.2016/0278692 to Larson et al. in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol 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, Bardy, Larson et al., Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Bardy further teaches wherein a level-x intervention is treatment (see: paragraphs [0092] and [0093] where a level of treatment is being provided to the patient).
The combination may not further specifically teach a level-1 PU intervention of 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 program of a certain diagnostic level as disclosed by Bardy, Larson et al., Tonar et al., and Kharraz Tavakol 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 teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted the heel boot treatment in for a treatment program because the boot is a level of treatment used to treat pressure ulcers. 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. 2002/0143262 to Bardy in view of U.S.2016/0278692 to Larson et al. in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol 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, Bardy, Larson et al., Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Bardy further teaches wherein a level-x intervention is treatment (see: paragraphs [0092] and [0093] where a level of treatment is being provided to the patient).
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 program of a certain diagnostic level as disclosed by Bardy, Larson et al., Tonar et al., and Kharraz Tavakol 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 teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted the heel boot treatment in for a treatment program because the boot is a level of treatment used to treat pressure ulcers. 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. 2002/0143262 to Bardy in view of U.S.2016/0278692 to Larson et al. in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol 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, Bardy, Larson et al., Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Bardy further teaches wherein a level-x intervention is treatment (see: paragraphs [0092] and [0093] where a level of treatment is being provided to the patient).
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 Bardy, Larson et al., Tonar et al., and Kharraz Tavakol 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 teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted the heel boot treatment in for a treatment program because the boot is a level of treatment used to treat pressure ulcers. 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. 2002/0143262 to Bardy in view of U.S.2016/0278692 to Larson et al. in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol 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, Bardy, Larson et al., Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Bardy further teaches wherein a level-x intervention is treatment (see: paragraphs [0092] and [0093] where a level of treatment is being provided to the patient).
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 Bardy, Larson et al., Tonar et al., and Kharraz Tavakol 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 teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted the heel boot treatment in for a treatment program because the boot is a level of treatment used to treat pressure ulcers. 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. 2002/0143262 to Bardy in view of U.S.2016/0278692 to Larson et al. in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol et al. as applied to claim 21, and further in view of “Prevention and Treatment of Pressure Ulcers” to Thomas.
As per claim 46, Bardy, Larson et al., Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Bardy further teaches wherein a level-x intervention is treatment (see: paragraphs [0092] and [0093] where a level of treatment is being provided to the patient).
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 Bardy, Larson et al., Tonar et al., and Kharraz Tavakol 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 teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted the heel boot treatment in for a treatment program because the boot is a level of treatment used to treat pressure ulcers. 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, Bardy, Larson et al., Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Bardy further teaches wherein a level-x intervention is treatment (see: paragraphs [0092] and [0093] where a level of treatment is being provided to the patient).
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. 2002/0143262 to Bardy in view of U.S.2016/0278692 to Larson et al. in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol 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, Bardy, Larson et al., Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Bardy further teaches wherein a level-x intervention is treatment (see: paragraphs [0092] and [0093] where a level of treatment is being provided to the patient).
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 Bardy, Larson et al., Tonar et al., and Kharraz Tavakol 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 teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted the heel boot treatment in for a treatment program because the boot is a level of treatment used to treat pressure ulcers. 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. 2002/0143262 to Bardy in view of U.S.2016/0278692 to Larson et al. in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol 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, Bardy, Larson et al., Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Bardy further teaches wherein a level-x intervention is treatment (see: paragraphs [0092] and [0093] where a level of treatment is being provided to the patient).
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 Bardy, Larson et al., Tonar et al., and Kharraz Tavakol 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 teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted the heel boot treatment in for a treatment program because the boot is a level of treatment used to treat pressure ulcers. 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. 2002/0143262 to Bardy in view of U.S.2016/0278692 to Larson et al. in view of U.S. 2017/0007153 to Tonar et al. further in view of U.S. 2011/0191122 to Kharraz Tavakol 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, Bardy, Larson et al., Tonar et al., and Kharraz Tavakol et al. in combination teach the method of claim 21, see discussion of claim 21. Bardy further teaches wherein a level-x intervention is treatment (see: paragraphs [0092] and [0093] where a level of treatment is being provided to the patient).
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 Bardy, Larson et al., Tonar et al., and Kharraz Tavakol 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 teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted the heel boot treatment in for a treatment program because the boot is a level of treatment used to treat pressure ulcers. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action.  Accordingly, THIS ACTION IS MADE FINAL.  See MPEP § 706.07(a).  Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action.  In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action.  In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.

CITED REFERENCE SUMMARIES: Ref US20020143262A1: Claims:
A system for providing diagnosis and monitoring of myocardial ischemia for use in automated patient care, comprising: a comparison module comparing at least one recorded physiological measure to at least one other recorded physiological measure on a substantially regular basis to quantify a change in patient pathophysiological status for equivalent patient information; and an analysis module evaluating an absence, an onset, a progression, a regression, and a status quo of myocardial ischemia dependent upon the change in patient pathophysiological status.
a comparison module comparing at least one recorded physiological measure to at least one other recorded physiological measure on a substantially regular basis to quantify a change in patient pathophysiological status for equivalent patient information; and
an analysis module evaluating an absence, an onset, a progression, a regression, and a status quo of myocardial ischemia dependent upon the change in patient pathophysiological status.
A system according to claim 1 , further comprising: a diagnostic module comparing the change in patient pathophysiological status to an indicator threshold corresponding to a quantifiable physiological measure indicative of myocardial ischemia.
a diagnostic module comparing the change in patient pathophysiological status to an indicator threshold corresponding to a quantifiable physiological measure indicative of myocardial ischemia.
A system according to claim 1 , further comprising: a database module retrieving the at least one recorded physiological measure and the at least one other recorded physiological measure from monitoring sets stored in a database.
a database module retrieving the at least one recorded physiological measure and the at least one other recorded physiological measure from monitoring sets stored in a database.
A system according to claim 3 , further comprising: a server system collecting the at least one recorded physiological measure and the at least one other recorded physiological measure into each monitoring set recorded on a substantially continuous basis or derived therefrom.
a server system collecting the at least one recorded physiological measure and the at least one other recorded physiological measure into each monitoring set recorded on a substantially continuous basis or derived therefrom.
A system according to claim 4 , further comprising: at least one of an implantable medical device and an external medical device recording the at least one recorded physiological measure and the at least one other recorded physiological measure.
at least one of an implantable medical device and an external medical device recording the at least one recorded physiological measure and the at least one other recorded physiological measure.
A system according to claim 1 , further comprising: the analysis module evaluating an absence, an onset, a progression, a regression, and a status quo of diseases other than myocardial ischemia dependent upon the change in patient pathophysiological status.
the analysis module evaluating an absence, an onset, a progression, a regression, and a status quo of diseases other than myocardial ischemia dependent upon the change in patient pathophysiological status.
A system according to claim 1 , further comprising: a diagnostic module comparing at least one recorded quality of life measure to at least one other recorded quality of life measure on a substantially regular basis to qualify a change in patient pathophysiological status.
a diagnostic module comparing at least one recorded quality of life measure to at least one other recorded quality of life measure on a substantially regular basis to qualify a change in patient pathophysiological status.
A system according to claim 1 , further comprising: a stored stickiness indicator defined for at least one physiological measure corresponding to a temporal boundary on one of patient diagnosis and treatment; a diagnostic module timing each change in patient pathophysiological status for the equivalent patient information and determining one of a revised patient diagnosis and treatment responsive to each change in patient pathophysiological status with a timing exceeding the stickiness indicator.
a stored stickiness indicator defined for at least one physiological measure corresponding to a temporal boundary on one of patient diagnosis and treatment;
a diagnostic module timing each change in patient pathophysiological status for the equivalent patient information and determining one of a revised patient diagnosis and treatment responsive to each change in patient pathophysiological status with a timing exceeding the stickiness indicator.
A system according to claim 1 , further comprising: a diagnostic module comparing the change in patient pathophysiological status to a reference baseline comprising recorded physiological measures recorded during an initial time period.
a diagnostic module comparing the change in patient pathophysiological status to a reference baseline comprising recorded physiological measures recorded during an initial time period.
A system according to claim 1 , further comprising: a diagnostic module comparing the change in patient pathophysiological status to equivalent patient information from at least one of an individual patient, a peer group, and a overall patient population.
a diagnostic module comparing the change in patient pathophysiological status to equivalent patient information from at least one of an individual patient, a peer group, and a overall patient population.
A system according to claim 1 , further comprising: a diagnostic module grading the change in patient pathophysiological status on a fixed scale based on a degree of deviation from a pre-defined indicator threshold and performing a summation over a plurality of the graded changes to determine an overall change in patient pathophysiological status.
a diagnostic module grading the change in patient pathophysiological status on a fixed scale based on a degree of deviation from a pre-defined indicator threshold and performing a summation over a plurality of the graded changes to determine an overall change in patient pathophysiological status.
A system according to claim 1 , further comprising: a diagnostic module determining probabilistic weightings of the change in patient pathophysiological status on a statistical deviation and trends via linear fits from a pre-defined indicator threshold and performing a summation over a plurality of the probabilistic weightings to determine an overall change in patient pathophysiological status.
a diagnostic module determining probabilistic weightings of the change in patient pathophysiological status on a statistical deviation and trends via linear fits from a pre-defined indicator threshold and performing a summation over a plurality of the probabilistic weightings to determine an overall change in patient pathophysiological status.
A method for providing diagnosis and monitoring of myocardial ischemia for use in automated patient care, comprising: comparing at least one recorded physiological measure to at least one other recorded physiological measure on a substantially regular basis to quantify a change in patient pathophysiological status for equivalent patient information; and evaluating an absence, an onset, a progression, a regression, and a status quo of myocardial ischemia dependent upon the change in patient pathophysiological status.
comparing at least one recorded physiological measure to at least one other recorded physiological measure on a substantially regular basis to quantify a change in patient pathophysiological status for equivalent patient information; and
evaluating an absence, an onset, a progression, a regression, and a status quo of myocardial ischemia dependent upon the change in patient pathophysiological status.
A method according to claim 13 , further comprising: comparing the change in patient pathophysiological status to an indicator threshold corresponding to a quantifiable physiological measure indicative of myocardial ischemia.
comparing the change in patient pathophysiological status to an indicator threshold corresponding to a quantifiable physiological measure indicative of myocardial ischemia.
A method according to claim 13 , further comprising: retrieving the at least one recorded physiological measure and the at least one other recorded physiological measure from monitoring sets stored in a database.
retrieving the at least one recorded physiological measure and the at least one other recorded physiological measure from monitoring sets stored in a database.
A method according to claim 15 , further comprising: collecting the at least one recorded physiological measure and the at least one other recorded physiological measure into each monitoring set recorded on a substantially continuous basis or derived therefrom.
collecting the at least one recorded physiological measure and the at least one other recorded physiological measure into each monitoring set recorded on a substantially continuous basis or derived therefrom.
A method according to claim 16 , further comprising: recording the at least one recorded physiological measure and the at least one other recorded physiological measure with at least one of an implantable medical device and an external medical device.
recording the at least one recorded physiological measure and the at least one other recorded physiological measure with at least one of an implantable medical device and an external medical device.
A method according to claim 13 , further comprising: evaluating an absence, an onset, a progression, a regression, and a status quo of diseases other than myocardial ischemia dependent upon the change in patient pathophysiological status.
evaluating an absence, an onset, a progression, a regression, and a status quo of diseases other than myocardial ischemia dependent upon the change in patient pathophysiological status.
A method according to claim 13 , further comprising: comparing at least one recorded quality of life measure to at least one other recorded quality of life measure on a substantially regular basis to qualify a change in patient pathophysiological status.
comparing at least one recorded quality of life measure to at least one other recorded quality of life measure on a substantially regular basis to qualify a change in patient pathophysiological status.
A method according to claim 13 , further comprising: defining a stickiness indicator for at least one physiological measure corresponding to a temporal boundary on one of patient diagnosis and treatment; timing each change in patient pathophysiological status for the equivalent patient information; and determining one of a revised patient diagnosis and treatment responsive to each change in patient pathophysiological status with a timing exceeding the stickiness indicator.
defining a stickiness indicator for at least one physiological measure corresponding to a temporal boundary on one of patient diagnosis and treatment;
timing each change in patient pathophysiological status for the equivalent patient information; and
determining one of a revised patient diagnosis and treatment responsive to each change in patient pathophysiological status with a timing exceeding the stickiness indicator.
A method according to claim 13 , further comprising: comparing the change in patient pathophysiological status to a reference baseline comprising recorded physiological measures recorded during an initial time period.
comparing the change in patient pathophysiological status to a reference baseline comprising recorded physiological measures recorded during an initial time period.
A method according to claim 13 , further comprising: comparing the change in patient pathophysiological status to equivalent patient information from at least one of an individual patient, a peer group, and a overall patient population.
comparing the change in patient pathophysiological status to equivalent patient information from at least one of an individual patient, a peer group, and a overall patient population.
A method according to claim 13 , further comprising: grading the change in patient pathophysiological status on a fixed scale based on a degree of deviation from a pre-defined indicator threshold; and performing a summation over a plurality of the graded changes to determine an overall change in patient pathophysiological status.
grading the change in patient pathophysiological status on a fixed scale based on a degree of deviation from a pre-defined indicator threshold; and
performing a summation over a plurality of the graded changes to determine an overall change in patient pathophysiological status.
A method according to claim 13 , further comprising: determining probabilistic weightings of the change in patient pathophysiological status on a statistical deviation and trends via linear fits from a pre-defined indicator threshold; and performing a summation over a plurality of the probabilistic weightings to determine an overall change in patient pathophysiological status.
determining probabilistic weightings of the change in patient pathophysiological status on a statistical deviation and trends via linear fits from a pre-defined indicator threshold; and
performing a summation over a plurality of the probabilistic weightings to determine an overall change in patient pathophysiological status.
A computer-readable storage medium for a device holding code for performing the method according to claim 13 .
A system for analyzing a patient status for myocardial ischemia for use in automated patient care, comprising: a server system receiving a set of one or more physiological measures relating to patient information recorded on a substantially continuous basis or derived therefrom; a database module storing the physiological measures set into a patient care record for an individual patient into a database; and an analyzer analyzing one or more of the physiological measures in the physiological measures set relative to one or more other physiological measures to determine a pathophysiology indicating an absence, an onset, a progression, a regression, and a status quo of myocardial ischemia.
a server system receiving a set of one or more physiological measures relating to patient information recorded on a substantially continuous basis or derived therefrom;
a database module storing the physiological measures set into a patient care record for an individual patient into a database; and
an analyzer analyzing one or more of the physiological measures in the physiological measures set relative to one or more other physiological measures to determine a pathophysiology indicating an absence, an onset, a progression, a regression, and a status quo of myocardial ischemia.
A system according to claim 26 , further comprising: the analyzer analyzing the physiological measures in the physiological measures set relative to the other physiological measures to determine a pathophysiology indicating an absence, an onset, a progression, a regression, and a status quo of diseases other than myocardial ischemia.
the analyzer analyzing the physiological measures in the physiological measures set relative to the other physiological measures to determine a pathophysiology indicating an absence, an onset, a progression, a regression, and a status quo of diseases other than myocardial ischemia.
A system according to claim 26 , further comprising: the server system receiving a set of one or more quality of life measures relating to patient information recorded on a substantially continuous basis or derived therefrom; the database module storing the quality of life measures set into the patient care record for the individual patient into the database; and the analyzer analyzing the quality of life measures in the physiological measures set relative to the other quality of life measures to determine a pathophysiology indicating an absence, an onset, a progression, a regression, and a status quo of myocardial ischemia.
the server system receiving a set of one or more quality of life measures relating to patient information recorded on a substantially continuous basis or derived therefrom;
the database module storing the quality of life measures set into the patient care record for the individual patient into the database; and
the analyzer analyzing the quality of life measures in the physiological measures set relative to the other quality of life measures to determine a pathophysiology indicating an absence, an onset, a progression, a regression, and a status quo of myocardial ischemia.
A system according to claim 26 , further comprising: the server system receiving a set of one or more baseline physiological measures relating to patient information recorded during an initial time period or derived therefrom; the database module storing the baseline physiological measures set into the patient care record for the individual patient into the database; and the analyzer analyzing the physiological measures in the physiological measures set relative to the baseline physiological measures to determine a pathophysiology indicating an absence, an onset, a progression, a regression, and a status quo of myocardial ischemia.
the server system receiving a set of one or more baseline physiological measures relating to patient information recorded during an initial time period or derived therefrom;
the database module storing the baseline physiological measures set into the patient care record for the individual patient into the database; and
the analyzer analyzing the physiological measures in the physiological measures set relative to the baseline physiological measures to determine a pathophysiology indicating an absence, an onset, a progression, a regression, and a status quo of myocardial ischemia.
A system according to claim 26 , further comprising: a comparison module retrieving the other physiological measures from measures sets for at least one of an individual patient, a peer group, and a overall patient population.
a comparison module retrieving the other physiological measures from measures sets for at least one of an individual patient, a peer group, and a overall patient population.
A method for analyzing a patient status for myocardial ischemia for use in automated patient care, comprising: receiving a set of one or more physiological measures relating to patient information recorded on a substantially continuous basis or derived therefrom; storing the physiological measures set into a patient care record for an individual patient into a database; and analyzing one or more of the physiological measures in the physiological measures set relative to one or more other physiological measures to determine a pathophysiology indicating an absence, an onset, a progression, a regression, and a status quo of myocardial ischemia.
receiving a set of one or more physiological measures relating to patient information recorded on a substantially continuous basis or derived therefrom;
storing the physiological measures set into a patient care record for an individual patient into a database; and
analyzing one or more of the physiological measures in the physiological measures set relative to one or more other physiological measures to determine a pathophysiology indicating an absence, an onset, a progression, a regression, and a status quo of myocardial ischemia.
A method according to claim 31 , further comprising: analyzing the physiological measures in the physiological measures set relative to the other physiological measures to determine a pathophysiology indicating an absence, an onset, a progression, a regression, and a status quo of diseases other than myocardial ischemia.
analyzing the physiological measures in the physiological measures set relative to the other physiolog
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