Office Action 2: Final Rejection (2020-07-23)
Rejection types: 103 - Obviousness

CLAIMS:
IN THE CLAIMS

Please AMEND the claims as follows:

1-20. (Cancelled) 219

21\. (Currently Amended) A method of providing a continuity of care for a patient 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:
identifying a current PU intervention of level-K received by the patient at the first care setting;
making a plurality of Sub-Epidermal Moisture (SEM) measurements at a body location on the patient at the second care setting, calculating a delta value by a difference between two of the plurality of SEM measurements, determining whether the delta value exceeds a threshold, continuing to administer the current PU intervention if the delta value does not exceed the threshold, and
administering a new PU intervention of level-N if the delta value exceeds the threshold, where N has a value greater than K.

22\. (Currently Amended) The method of claim 21, wherein the current PU intervention of level- K is provided in a transfer record.

23\. (Previously Presented) The method of claim 22, wherein the transfer record further comprises delta values calculated from a portion of the plurality of SEM scans of the patient taken at different times while in the first care setting.
24\. (Previously Presented) The method of claim 22, wherein the transfer record further comprises results obtained from at least one of assessments selected from the group consisting of a risk assessment of the patient, a visual skin assessment of at least one body location of the patient, and an image of the at least one body location.

25\. (Previously Presented) The method of claim 22, wherein the transfer record further comprises results obtained from performing a first SEM scan of at least one body location of the patient while in the first care setting, wherein the first SEM scan comprises a plurality of measurements of an SEM value at the body location and calculation of a first delta value from the plurality of SEM values, and wherein said transfer record is stored on a database.

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

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

28\. (Previously Presented) The method of claim 21, wherein said delta value is calculated by a difference between a maximum SEM measurement and a minimum SEM measurement selected from the plurality of SEM measurements.

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

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

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

32\. (Currently Amended) The method of claim \[\[30\]\] 31 further comprising the steps of:
formatting the retrieved delta values in date and time order, and
displaying the formatted delta values.

33\. (Currently Amended) The method of claim 29, further comprising the steps of:
creating an additional data record that comprises the patient identifier, a data element, and a date/time associated with the data element, wherein the data element comprises one or more of a nutritional information, an implemented intervention, a risk assessment, a visual skin assessment, a care plan, a doctor's note, an event, a vital sign, a body weight, and a lab result, , and
reporting the additional data record to the database.

34\. (Currently Amended) The method of claim 32, wherein the formatted delta values \[\[is\]\] are displayed in the form of a curve.

35\. (Previously Presented) The method of claim 32, further comprising the step of analyzing the retrieved delta values to determine one or more of a slope, an acceleration, a curve shape and associated characteristics, and a time-to-intercept of a selected threshold value.

36\. (Currently Amended) The method of claim \[\[23\]\] 35, wherein the acceleration is determined by the rate of change of the slope of the curve.

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

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

39\. (Previously Presented) The method of claim 37, further comprising the step of querying the database to retrieve the delta values observed over time for a particular patient across multiple care settings and various episodes of care.

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

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

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

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

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

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

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

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

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

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

50\. (Currently Amended) The method of claim 21, wherein a level-10 PU intervention is providing a silicon pad for the patient's lower leg.
US 167747535v1 US 167747535v1

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.

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

NEXT OFFICE ACTION: DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection.  Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.  Applicant's submission filed on 12/22/2020 has been entered.
Response to Amendment
In light of the amended claims, the claims are rejected under 35 U.S.C. 103.
Notice to Applicant
In the amendment dated 12/18/2020, the following has occurred: claims 21 and 23-25 have been amended; claims 26-50 have remained unchanged; claim 22 was canceled; and no new claims have been added.
Claims 21 and 23-50 are pending.
Effective Filing Date: 11/16/2017
Notice of Pre-AIA  or AIA  Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
35 U.S.C. 103 Rejections:
Applicant made arguments directed towards the previously used art. These arguments are deemed moot in view of the newly cited art.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/22/2020 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA  35 U.S.C. 102 and 103 (or as subject to pre-AIA  35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary.  Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21, 23-26, 29, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al.
As per claim 21, Lachenbruch et al. teaches a method of providing a continuity of care for a patient at risk of developing pressure ulcers (PU) during transfer from a first care setting to a second care setting, the method comprising the steps of:
--making a plurality of Sub-Epidermal Moisture (SEM) measurements at a body location on the patient at the second care setting, (see: paragraph [0037] where one or more sensors 102 are positioned to collect information regarding the tissue status of the individual. The sensors here collect SEM data at a body location in any setting)
--calculating a delta value by a difference between two of the plurality of SEM measurements, (see: paragraph [0037] where one or more sensors 102 are positioned to collect information regarding the tissue status of the individual. The sensor collects information regarding SEM levels as a measure of impedance in dermal phase units. Impedance is also a measure of flow, thus it is measured using two points in order to determine the flow. An individual sensor itself would therefore include two measurements points in order to calculate the impedance. Accordingly, the measurement of an impedance itself is a delta value)
--determining whether the delta value exceeds a threshold (see: paragraph [0037] where the SEM information is transmitted to a server which receives and compares the received information with a threshold tissue status that is based on at least some demographic information for the individual. There is a determination here of if the delta value (SEM information including the impedance in DPU) exceeds a threshold)
--do nothing if the delta value does not exceed the threshold, (see: 206 and 208 of FIG. 2 where the received information (delta value) is checked against a threshold to determine if it has been exceeded. When it is not exceeded the method proceeds to update the threshold with received information) and
--do something if the delta value exceeds the threshold (see: 206 and 210 of FIG. 2 where the received information (delta value) is checked against a threshold to determine if it has been exceeded. When it is exceeded the method proceeds to provide a notification to the computing device).
Lachenbruch et al. teaches the above-mentioned claim limitations. The difference between Lachenbruch et al. and the claimed invention is that while Lachenbruch et al. does disclose SEM measurements and calculating if a threshold is exceeded form measured patient values, it does not explicitly teach a current intervention as well as the optionality to change the intervention based on the measurements. More specifically, Lachenbruch et al. may not further, specifically teach:
1) --identifying a current PU intervention of level-K received by the patient at the first care setting, wherein the current PU intervention of level-K is provided in a transfer record;
2) --do nothing by continuing to administer the current PU intervention, and
3) --do something by administering a new PU intervention of level-N, where N has a value greater than K.
Geleijnse et al. teaches:
1) --identifying a current PU intervention of level-K received by the patient at the first care setting, (see: paragraph [0048] where the patient’s current care level is determined) wherein the current PU intervention of level-K is provided in a transfer record; (see: paragraphs [0042] and [0067] where there is an EHR that is used to provide current and historic patient data. The EHR is the transfer record)
2) --do nothing by continuing to administer the current PU intervention, (see: paragraph [0031] where there is a level of recommendation of staying in the current level of care or to move to a different level of care) and
3) --do something by administering a new PU intervention of level-N, where N has a value greater than K (see: paragraph [0031] where there is a level of recommendation of staying in the current level of care or to move to a different level of care. Further see: paragraph [0043] where this may be a higher level of care).
One of ordinary skill at the time of the invention was filed would have found it obvious to 1) identify a current PU intervention of level-K received by the patient at the first care setting, wherein the current PU intervention of level-K is provided in a transfer record, 2) continue to administer the current PU intervention, and 3) administer a new PU intervention of level-N, where N has a value greater than K as taught by Geleseijnse et al. in the method as taught by Lachenbruch et al. with the motivation(s) of monitoring a patient’s condition and adjusting the level of care accordingly (see: paragraph [0002] of Geleijnse et al.).
As per claim 23, Lachenbruch et al. and Geleseijnse et al. in combination teach the method of claim 21, see discussion of claim 21. Lachenbruch et al. teaches values as delta values calculated from a portion of the plurality of SEM scans of the patient taken at different times while in the first care setting (see: paragraph [0037] where one or more sensors 102 are positioned to collect information regarding the tissue status of the individual. There are delta values (DMU values) here that include values derived from various scans taken a different times such as on different days).
Lachenbruch et al. may not further specifically teach wherein the transfer record further comprises values.
Geleseijnse et al. teaches wherein the transfer record further comprises values (see: paragraphs [0042] and [0067] where there is an EHR that is used to provide current and historic patient data).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
As per claim 24, Lachenbruch et al. and Geleseijnse et al. in combination teach the method of claim 21, see discussion of claim 21. Lachenbruch et al. further teaches results as results obtained from at least one of assessments selected from the group consisting of a risk assessment of the patient, a visual skin assessment of at least one body location of the patient, and an image of the at least one body location (see: paragraph [0003] where conventionally, visual detection is used be a caregiver to identify pressure ulcers which is a visual skin assessment of at least one body location of the patient).
Lachenbruch et al. may not further, specifically teach wherein the transfer record further comprises results.
Geleseijnse et al. teaches wherein the transfer record further comprises results (see: paragraphs [0042] and [0067] where there is an EHR that is used to provide current and historic patient data).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
As per claim 25, Lachenbruch et al. and Geleseijnse et al. in combination teach the method of claim 21, see discussion of claim 21. Lachenbruch et al. further teaches results as results obtained from performing a first SEM scan of at least one body location of the patient while in the first care setting, (see: paragraph [0037] where there are SEM scan measurements as well as a determined tissue status of the body location at a setting) wherein the first SEM scan comprises a plurality of measurements of an SEM value at the body location (see: paragraph [0037] where there is multiple measurements for a SEM scans a body location) and calculation of a first delta value from the plurality of SEM values (see: paragraph [0037] where one or more sensors 102 are positioned to collect information regarding the tissue status of the individual. The sensor collects information regarding SEM levels as a measure of impedance in dermal phase units. Impedance is also a measure of flow, thus it is measured using two points in order to determine the flow. An individual sensor itself would therefore include two measurements points in order to calculate the impedance. Accordingly, the measurement of an impedance itself is a delta value).
Lachenbruch et al. may not further, specifically teach wherein the transfer record further comprises results and wherein said transfer record is stored on a database.
Geleseijnse et al. teaches wherein the transfer record further comprises results (see: paragraphs [0042] and [0067] where there is an EHR that is used to provide current and historic patient data) and wherein said transfer record is stored on a database (see: paragraph [0053] where there is a data base 26 storing EHR of the patient).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
As per claim 26, Lachenbruch et al. and Geleseijnse et al. in combination teach the method of claim 25, see discussion of claim 25. Lachenbruch et al. further teaches patient information as the record further comprises a patient identifier and a date and a time when said first scan was performed (see: paragraphs [0024] and [0037] where there is day and time information for different SEM scans as well as the tissue measurements for the individual which are indicative of a patient (also identifies a patient)).
Lachenbruch et al. may not further, specifically teach wherein: the transfer record further comprises a patient information.
Geleseijnse et al. teaches wherein: the transfer record further comprises a patient information (see: paragraphs [0042] and [0067] where there is an EHR that is used to provide current and historic patient data).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
As per claim 29, Lachenbruch et al. and Geleseijnse et al. in combination teaches the method of claim 26, see discussion of claim 26. Lachenbruch et al. further teaches further comprising the steps of:
--performing a second SEM scan of the body location of the patient in the second care setting to obtain a second plurality of SEM measurements, (see: paragraph [0037] where there are scans taken on consecutive days, thus there is a second scan performed on the second day at a body location on the individual)
--calculating a second delta value, (see: paragraph [0037] where delta values are calculated for each day in DPU)
--creating a second data record that comprises the patient identifier, the second delta value, and a second date and time when the second SEM scan was performed, (see: claim 5 where the database is being updated with a subsequent tissue status for an individual. Also see: paragraphs [0024] and [0037] where there is day and time information for different SEM scans (including a second scan) as well as the tissue measurements for the individual which are indicative of a patient (also identifies a patient)) and
--reporting the second data record to the database (see: claim 5 where the database is being updated with a subsequent tissue status for an individual).
As per claim 37, Lachenbruch et al. and Geleseijnse et al. in combination teaches the method of claim 29, see discussion of claim 29. Lachenbruch et al. further teaches further comprising the steps of:
--performing a third SEM scan of the at least one body location of the patient in the second care setting to obtain a third plurality of SEM measurements (see: paragraph [0037] where there are scans taken on consecutive days, thus there is a third scan performed on the third day at a body location on the individual) and
--calculating a third delta value, (see: paragraph [0037] where delta values are calculated for each day in DPU)
--creating a third data record that comprises the patient identifier, the third delta value, and a third date and time when the third SEM scan was performed, (see: claim 5 where the database is being updated with a subsequent tissue status for an individual. Also see: paragraphs [0024] and [0037] where there is day and time information for different SEM scans (including a third scan) as well as the tissue measurements for the individual which are indicative of a patient (also identifies a patient)) and
--reporting the third data record to the database (see: claim 5 where the database is being updated with a subsequent tissue status for an individual).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. as applied to claim 21, further in view of U.S. Patent No. 9,028,407 to Bennet-Guerrero.
As per claim 27, Lachenbruch et al. and Geleseijnse et al. in combination teach the method of claim 21, see discussion of claim 21. Lachenbruch et al. further teaches SEM measurements (see: paragraph [0037] where there are SEM measurements).
The combination may not further, specifically teach continuing to make a plurality of measurements at a pre-determined frequency corresponding to level-K if the delta value does not exceed the threshold, and making a plurality of measurements at a pre-determined frequency corresponding to level-N if the delta value exceeds the threshold.
Bennett-Guerrero teaches:
--continuing to make a plurality of measurements at a pre-determined frequency corresponding to level-K if the delta value does not exceed the threshold, and making a plurality of measurements at a pre-determined frequency corresponding to level-N if the delta value exceeds the threshold (see: column 6, lines 9-21 where a change in the patient’s condition changes the frequency of measurements. If there is no change in the patient’s condition then these measurements would happen a lesser frequency such as once every 10 minutes in one embodiment. A plurality of measurements at a pre-determined frequency corresponding to level-K (once every 10 minutes) is occurring and it is changed to a different predetermined frequency corresponding to level-N (once every minute in one embodiment) if the patient’s condition changes (delta value exceeds a threshold)).
One of ordinary skill at the time of the invention was filed would have found it obvious to continue to make a plurality of measurements at a pre-determined frequency corresponding to level-K if the delta value does not exceed the threshold, and making a plurality of measurements at a pre-determined frequency corresponding to level-N if the delta value exceeds the threshold as taught by Bennett-Guerrero in the method as taught by Lachenbruch et al. and Geleseijnse et al. in combination with the motivation(s) of being beneficial for various reasons such as to enhance, improve, or even optimize battery life (see: column 6, lines 16-21 of Bennett-Guerrero).
Claims 28, 30, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. as applied to claim 21, further in view of U.S. 2017/0007153 to Tonar et al.
As per claim 28, Lachenbruch et al. and Geleseijnse et al. in combination teach the method of claim 21, see discussion of claim 21. The combination may not further, specifically teach wherein said delta value is calculated by a difference between a maximum SEM measurement and a minimum SEM measurement selected from the plurality of SEM measurements.
Tonar et al. teaches:
--wherein said delta value is calculated by a difference between a maximum SEM measurement and a minimum SEM measurement selected from the plurality of SEM measurements (see: paragraph [0008] where a difference between a max SEM value and min SEM value is determined).
One of ordinary skill at the time of the invention was filed would have found it obvious to have wherein said delta value is calculated by a difference between a maximum SEM measurement and a minimum SEM measurement selected from the plurality of SEM measurements as taught by Lachenbruch et al. and Geleseijnse et al. in combination in the method as taught by Tonar et al. with the motivation(s) of helping determine damaged tissue (see: paragraph [0002] of Tonar et al.).
As per claim 30, Lachenbruch et al. and Geleseijnse et al. in combination teach the method of claim 29, see discussion of claim 29. Lachenbruch et al. teaches second set of values and measurements (see: paragraphs [0024] and [0037] where there are multiple SEM scan measurements including a second set).
The combination may not further, specifically teach wherein said delta value is calculated by a difference between a maximum SEM measurement and a minimum SEM measurement selected from the plurality of SEM measurements.
Tonar et al. teaches:
--wherein said delta value is calculated by a difference between a maximum SEM measurement and a minimum SEM measurement selected from the plurality of SEM measurements (see: paragraph [0008] where a difference between a max SEM value and min SEM value is determined).
One of ordinary skill at the time of the invention was filed would have found it obvious to have wherein said delta value is calculated by a difference between a maximum SEM measurement and a minimum SEM measurement selected from the plurality of SEM measurements as taught by Lachenbruch et al. and Geleseijnse et al. in combination in the method as taught by Tonar et al. with the motivation(s) of helping determine damaged tissue (see: paragraph [0002] of Tonar et al.).
As per claim 38, Lachenbruch et al. and Geleseijnse et al. in combination teach the method of claim 37, see discussion of claim 37. Lachenbruch et al. teaches third set of values and measurements (see: paragraphs [0024] and [0037] where there are multiple SEM scan measurements including a second set).
The combination may not further, specifically teach wherein said delta value is calculated by a difference between a maximum SEM measurement and a minimum SEM measurement selected from the plurality of SEM measurements.
Tonar et al. teaches:
--wherein said delta value is calculated by a difference between a maximum SEM measurement and a minimum SEM measurement selected from the plurality of SEM measurements (see: paragraph [0008] where a difference between a max SEM value and min SEM value is determined).
One of ordinary skill at the time of the invention was filed would have found it obvious to have wherein said delta value is calculated by a difference between a maximum SEM measurement and a minimum SEM measurement selected from the plurality of SEM measurements as taught by Lachenbruch et al. and Geleseijnse et al. in combination in the method as taught by Tonar et al. with the motivation(s) of helping determine damaged tissue (see: paragraph [0002] of Tonar et al.).
Claims 31-32, 34, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. as applied to claim 29, further in view of U.S. Patent No. 9,675,289 to Heaton.
As per claim 31, Lachenbruch et al. and Geleseijnse et al. in combination teaches the method of claim 29, see discussion of claim 29. Lachenbruch et al. further teaches data as the delta value and the second delta value of the at least one body location of the patient in the transfer record and the second data record respectively (see: claim 5 where the tissue status stored in the database. Also see: paragraphs [0024] and [0037] where SEM delta value data (DPU data) is being retrieved and respectively displayed. The stored information here is the equivalent of a first and second record).
The combination may not further, specifically teach querying the database for data to form retrieved delta values.
Heaton teaches:
--querying the database for data to form retrieved delta values (see: FIG. 9 where there is a directory for storing and retrieving archived responses into and from the database. In order for the system here to access the database here, it would query the database in order to retrieve the necessary data).
One of ordinary skill at the time of the invention was filed would have found it obvious to query the database for data to form retrieved delta values as taught by Heaton in the method as taught by Lachenbruch et al. and Geleseijnse et al. in combination with the motivation(s) of being a way to store and retrieve information from a database (see: column 19, lines 44-45 of Heaton).
As per claim 32, Lachenbruch et al., Geleseijnse et al., and Heaton in combination teaches the method of claim 31, see discussion of claim 31. Lachenbruch et al. further teaches:
--formatting the retrieved delta values in date and time order, (see: paragraph [0037] where delta values are in DPU. Also see: paragraph [0024] where the delta values are retrieved and viewed as a graphical history) and
--displaying the formatted delta values (see: paragraph [0024] where the delta values are displayed).
As per claim 34, Lachenbruch et al., Geleseijnse et al., and Heaton in combination teaches the method of claim 32, see discussion of claim 32. Lachenbruch et al. further teaches delta values (see: paragraph [0037] where there are delta values in DPU).
Lachenbruch et al. and Geleseijnse et al. in combination may not further, specifically teach wherein the formatted values are displayed in the form of a curve.
Heaton further teaches wherein the formatted values are displayed in the form of a curve (see: FIG. 8).
One of ordinary skill at the time of the invention was filed would have found it obvious to have wherein the formatted values are displayed in the form of a curve as taught by Heaton in the method as taught by Lachenbruch et al. and Geleseijnse et al. in combination with the motivation(s) of being a way to display data in a graphical manner (see: FIG. 8 of Heaton).
As per claim 39, Lachenbruch et al., Geleseijnse et al., and Heaton in combination teaches the method of claim 37, see discussion of claim 37. Lachenbruch et al. further teaches delta values (see: paragraph [0037] where there are delta values in DPU).
Lachenbruch et al. and Geleseijnse et al. in combination may not further, specifically teach the step of
--querying the database to retrieve the values observed over time for a particular patient across multiple care settings and various episodes of care.
Heaton further teaches the step of querying the database to retrieve the values observed over time for a particular patient across multiple care settings and various episodes of care (see: FIG. 9 where there is a directory for storing and retrieving archived responses into and from the database. In order for the system here to access the database here, it would query the database in order to retrieve the necessary data. Additionally, the data here are past data values including values across multiple care settings and care episodes. These data values are retrieved regardless of setting and care episode).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 31, and incorporated herein.
Claims 33 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. as applied to claim 29, and further in view of U.S. 2008/0015894 to Miller et al.
As per claim 33, Lachenbruch et al. and Geleseijnse et al. in combination teaches the method of claim 29, see discussion of claim 29. Lachenbruch et al. further teaches a record as a record that comprises the patient identifier, a data element, and a date/time associated with the data element (see: paragraph [0024] where there is a display of data according to date and time. The information shown identifies the individual and is also considered to be a data element).
The combination may not further, specifically the steps of:
1) --creating an additional data record, wherein the data element comprises one or more of a nutritional information, an implemented intervention, a risk assessment, a visual skin assessment, a care plan, a doctor's note, an event, a vital sign, a body weight, and a lab result, and
2) --reporting the additional data record to the database.
Miller et al. teaches:
1) --creating an additional data record, wherein the data element comprises one or more of a nutritional information, an implemented intervention, a risk assessment, a visual skin assessment, a care plan, a doctor's note, an event, a vital sign, a body weight, and a lab result, (see: paragraph [0121] where there are results being recorded in a database and these results are being considered to be the additional data record. The results can include the name of the patient (patient identifier), recommendations or changes to the therapy regimen (a care plan), as well as a date and time associated with the recommendation or change) and
2) --reporting the additional data record to the database (see: paragraph [0121] where the results of the contact with the medical provider are recorded with the database).
One of ordinary skill at the time of the invention was filed would have found it obvious to 1) create an additional data record, wherein the data element comprises one or more of a nutritional information, an implemented intervention, a risk assessment, a visual skin assessment, a care plan, a doctor's note, an event, a vital sign, a body weight, and a lab result and 2) report the additional data record to the database as taught by Miller et al. in the method as taught by Lachenbruch et al. and Geleseijnse et al. in combination with the motivation(s) of updating a patient’s files (see: paragraph [0021] of Miller et al.).
Claims 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. further in view of U.S. Patent No. 9,675,289 to Heaton as applied to claim 32, and further in view of U.S. Patent No. 8,355,925 to Rothman et al.
As per claim 35, Lachenbruch et al., Geleseijnse et al., and Heaton in combination teaches the method of claim 32, see discussion of claim 32. Lachenbruch et al. further teaches delta values (see: paragraph [0037] where there are delta values in DPU).
The combination may not further, specifically teach the step of analyzing the retrieved values to determine one or more of a slope, an acceleration, a curve shape and associated characteristics, and a time-to-intercept of a selected threshold value.
Rothman et al. teaches:
--the step of analyzing the retrieved values to determine one or more of a slope, an acceleration, a curve shape and associated characteristics, and a time-to-intercept of a selected threshold value (see: column 15, lines 29-43 where a derivative in the slope is calculated and a determination is made based on this acceleration to see if the patient is declining at a faster rate. The change in the acceleration of the slope may trigger an alarm. Also see: column 23, lines 18-29 and 51-59).
One of ordinary skill at the time of the invention was filed would have found it obvious to have the step of analyzing the retrieved values to determine one or more of a slope, an acceleration, a curve shape and associated characteristics, and a time-to-intercept of a selected threshold value as taught by Rothman et al. in the method as taught by Lachenbruch et al., Geleseijnse et al., and Heaton in combination with the motivation(s) of alerting a user if a patient is getting better or worse at an accelerating rate (see: column 23, lines 51-59 of Rothman et al.).
As per claim 36, Lachenbruch et al., Geleseijnse et al., Heaton, and Rothman et al. in combination teach the method of claim 35, see discussion of claim 35. Lachenbruch et al., Geleseijnse et al., and Heaton in combination may not further, specifically teach wherein the acceleration is determined by the rate of change of the slope of the curve.
Rothman et al. further teaches wherein the acceleration is determined by the rate of change of the slope of the curve (see: column 15, lines 29-43 where a derivative in the slope is calculated and a determination is made based on this acceleration to see if the patient is declining at a faster rate. The change in the acceleration of the slope may trigger an alarm. Also see: column 23, lines 18-29 and 51-59).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 35, and incorporated herein.
Claims 40 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. as applied to claim 21, and further in view of “Protocol for the successful treatment of pressure ulcers” to Brem et al.
As per claim 40, Lachenbruch et al. and Geleseijnse et al. in combination teaches the method of claim 21, see discussion of claim 21. The combination may not specifically, further teach wherein a level-0 PU intervention is selected from the group consisting of providing good nutrition, standard mattress, turning every 24 hours, and a combination thereof.
Brem et al. teaches:
--wherein a level-0 PU intervention is selected from the group consisting of providing good nutrition, standard mattress, turning every 24 hours, and a combination thereof (see: page 12S, point #7 under “Protocol for the comprehensive treatment of pressure ulcers” where providing good nutrition is an option to address pressure ulcers. Also see: page 13S under “Aggressive nutritional supplementation for all malnourished/undernourished patients”).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a group consisting of providing good nutrition, standard mattress, turning every 24 hours, and a combination thereof as taught by Brem et al. for the group as disclosed by Lachenbruch et al. and Geleseijnse et al. in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al. and Geleseijnse et al. teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleseijnse et al. because they are types of treatment options. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
As per claim 43, Lachenbruch et al. and Geleseijnse et al. in combination teaches the method of claim 21, see discussion of claim 21. The combination may not teach wherein a level-3 PU intervention is applying dressing to the back or sides of patient’s heel.
Brem et al. teaches:
--a level-3 PU intervention of applying dressing to the back or sides of patient's heel (see: Table 1 of page 10S and “Effective wound-bed preparation of a moist wound healing environment” of page 13S where a wound dressing is being used as a treatment for pressure ulcers).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 40, and incorporated herein.
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. as applied to claim 21, and further in view of U.S. Patent No. 5,367,789 to Lamont.
As per claim 41, Lachenbruch et al. and Geleseijnse et al. in combination teaches the method of claim 21, see discussion of claim 21. The combination may not teach wherein a level-1 PU intervention is providing a heel boot to the patient.
Lamont teaches:
--a level-1 PU intervention of providing a heel boot to the patient (see: column 1, lines 14-17 where there is a heel boot that is used to treat foot ulcers).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-1 PU intervention of providing a heel boot to the patient as taught by Lamont for a treatment level as disclosed by Lachenbruch et al. and Geleseijnse et al. in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al. and Geleseijnse et al. teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleseijnse et al. because they are types of treatment options. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. as applied to claim 21, and further in view of U.S. Patent No. 6,634,045 to DuDonis et al.
As per claim 42, Lachenbruch et al. and Geleseijnse et al. in combination teach the method of claim 21, see discussion of claim 21. The combination may not further specifically teach a level-2 PU intervention of changing the patient's support surface.
DuDonis et al. teaches:
--a level-2 PU intervention of changing the patient's support surface (see: column 3, lines 27-46. Also see: column 5, lines 18-21. The support surface is being changed here from the bed using the heel elevator support).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-2 PU intervention of changing the patient's support surface as taught by DuDonis et al. for a treatment level as disclosed by Lachenbruch et al. and Geleseijnse et al. in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al. and Geleseijnse et al. teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleseijnse et al. because they are types of treatment options. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. as applied to claim 21, and further in view of “Friction between human skin and medical textiles for decubitus prevention” to Rotaru et al.
As per claim 44, Lachenbruch et al. and Geleseijnse et al. in combination teach the method of claim 21, see discussion of claim 21. The combination may not further specifically teach a level-4 PU intervention of changing the patient's sheet cover to a low-friction sheet cover.
Rotaru et al. teaches:
--a level-4 PU intervention of changing the patient's sheet cover to a low-friction sheet cover (see: Abstract on page 91 and “Conclusions” on page 96 where old hospital bedsheets are being swapped out with lower friction ones to treat pressure ulcers).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-4 PU intervention of changing the patient's sheet cover to a low-friction sheet cover as taught by Rotaru et al. for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al. and Geleseijnse et al. in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al. and Geleseijnse et al. teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleseijnse et al. because they are types of treatment options. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. as applied to claim 21, and further in view of U.S. Patent No. 8,011,041 to Hann.
As per claim 45, Lachenbruch et al. and Geleseijnse et al. in combination teach the method of claim 21, see discussion of claim 21. The combination may not further specifically teach a level-5 PU intervention of providing a low-friction padded mattress surface for the patient's lower leg.
Hann teaches:
--a level-5 PU intervention of providing a low-friction padded mattress surface for the patient's lower leg (see: column 5, lines 51-63 where there is a low-friction pad being used. Also see: column 3, lines 30-35).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-5 PU intervention of providing a low-friction padded mattress surface for the patient's lower leg as taught by Hann for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al. and Geleseijnse et al. in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al. and Geleseijnse et al. teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleseijnse et al. because they are types of treatment options. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Claims 46 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. as applied to claim 21, and further in view of “Prevention and Treatment of Pressure Ulcers” to Thomas.
As per claim 46, Lachenbruch et al. and Geleseijnse et al. in combination teach the method of claim 21, see discussion of claim 21. The combination may not further specifically teach a level-6 PU intervention of turning the patient at a shorter interval than currently provided for.
Thomas teaches:
--a level-6 PU intervention of turning the patient at a shorter interval than currently provided for (see: “Decrease Pressure, Friction, and Shear” of page 47 where the most common method for reducing pressure is frequent turning and positioning).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-6 PU intervention of turning the patient at a shorter interval than currently provided for as taught by Thomas for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al. and Geleseijnse et al. in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al. and Geleseijnse et al. teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleseijnse et al. because they are types of treatment options. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
As per claim 47, Lachenbruch et al. and Geleseijnse et al. in combination teach the method of claim 21, see discussion of claim 21.The combination may not further specifically teach a level-7 PU intervention of applying a barrier cream to the patient's heel.
Thomas teaches:
--a level-7 PU intervention of applying a barrier cream to the patient's heel (see: page 55, paragraph 3 where there is a cream containing 1% silver sulfadiazine being applied to improve clinical appearance of the wound and improve healing. The cream containing the silver sulfadiazine is the barrier cream. Also see: page 2, paragraph 2 of “Pressure Ulcer Prevention in the Hospital Setting Using Silicon Foam Dressings” to Truong et al. where silver sulfadiazine is an ingredient in barrier creams).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 46, and incorporated herein.
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. as applied to claim 21, and further in view of “A systematic review of electrical stimulation for pressure ulcer prevention and treatment in people with spinal cord injuries” to Liu.
As per claim 48, Lachenbruch et al. and Geleseijnse et al. in combination teach the method of claim 21, see discussion of claim 21. The combination may not further specifically teach a level-8 PU intervention of applying a neuro-muscular stimulation to the patient's heel.
Liu teaches:
--a level-8 PU intervention of applying a neuro-muscular stimulation to the patient's heel (see: “Results” on page 703 where ES enhanced PU healing).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-8 PU intervention of applying a neuro-muscular stimulation to the patient's heel as taught by Liu for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al. and Geleseijnse et al. in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al. and Geleseijnse et al. teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleseijnse et al. because they are types of treatment options. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. as applied to claim 21, and further in view of “Topical hydrogen peroxide treatment of ischemic ulcers in the guinea pig: Blood recruitment in multiple skin sites” to Tur et al.
As per claim 49, Lachenbruch et al. and Geleseijnse et al. in combination teach the method of claim 21, see discussion of claim 21. The combination may not further specifically teach a level-9 PU intervention of applying a topical cream to the patient's heel to enhance perfusion.
Tur et al. teaches:
--a level-9 PU intervention of applying a topical cream to the patient's heel to enhance perfusion (see: “Results” of page 217 where topical hydrogen peroxide cream was used to enhance vascular perfusion).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-9 PU intervention of applying a topical cream to the patient's heel to enhance perfusion as taught by Tur et al. for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al. and Geleseijnse et al. in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al. and Geleseijnse et al. teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleseijnse et al. because they are types of treatment options. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0338591 to Lachenbruch et al. in view of U.S. 2015/0186607 to Geleijnse et al. as applied to claim 21, and further in view of “Pressure Ulcer Prevention in the Hospital Setting Using Silicon Foam Dressings” to Truong et al.
As per claim 50, Lachenbruch et al. and Geleseijnse et al. in combination teach the method of claim 21, see discussion of claim 21. The combination may not further specifically teach a level-10 PU intervention of providing a silicon pad for the patient's lower leg.
Truong et al. teaches:
--a level-10 PU intervention of providing a silicon pad for the patient's lower leg (see: page 5, paragraphs 2, 3, and 5 where silicon foam dressings can be used as treatment to prevent pressure ulcers).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-10 PU intervention of providing a silicon pad for the patient's lower leg as taught by Truong et al. for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al. and Geleseijnse et al. in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Lachenbruch et al. and Geleseijnse et al. teaches a treatment used at a certain threshold level to treat an issue and one of ordinary skill in the art would have substituted a treatment in for the treatment of Geleseijnse et al. because they are types of treatment options. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Conclusion

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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