Office Action 10: Notice of Allowance (2025-03-17)

CLAIMS:
IN THE CLAIMS:

Please AMEND the claims as follows:

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1-20. (Cancelled)219

21\. (Currently Amended) A method of providing a continuity of care for a patient at risk of developing pressure ulcers (PU) during transfer from a first care setting to a second care setting, the method comprising the steps of:identifying a current PU intervention of level-K received by the patient at the first care setting, wherein the current PU intervention of level-K is provided in a transfer record, wherein the transfer record further comprises results obtained from performing a first SEM scan of at least one body location of the patient while in the first care setting, wherein the first SEM scan comprises a plurality of measurements of an SEM value at the body location and calculation of a first delta value from the plurality of SEM values, wherein if the current PU intervention of level-K is a level-0 PU intervention, the level-0 PU intervention comprises performing a daily SEM scan of at least one body location of the patient;
making a plurality of Sub-Epidermal Moisture (SEM) measurements at a body location on the patient at the second care setting, each SEM measurement comprising a measurement of biocapacitance,
calculating a delta value by a difference between a maximum SEM value and a minimum SEM value of the plurality of SEM measurements,
determining whether the delta value exceeds a threshold,
making a further plurality of SEM measurements at a pre-determined frequency corresponding to level-K if the delta value does not exceed the threshold, wherein the pre-determined frequency corresponding to level-K is longer than every 15 minutes and if the delta value does not exceed the threshold, recommending to continue\[\[ing\]\] to administer the current PU intervention of level-K based on the

Atty. Dkt. P34702US01/0100804.00306 Page 3 delta value, if the delta value does not exceed the threshold, wherein level-K corresponds to a risk level for pressure ulcer, or making the further plurality of SEM measurements at a pre-determined frequency corresponding to level-N if the delta value exceeds the threshold, where N has a value greater than K, wherein the pre-determined frequency corresponding to level-N is shorter than the pre-determined frequency corresponding to level-K and longer than or equal to every 15 minutes, and recommending to administer\[\[ing\]\] a new PU intervention of level-N based on the delta value, wherein level-N corresponds to a higher risk level for pressure ulcer than level-K.

22\. (Cancelled)

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

24\. (Previously Presented) The method of claim 21, wherein the transfer record further comprises results obtained from at least one of assessments selected from the group consisting of a risk assessment of the patient, a visual skin assessment of at least one body location of the patient, and an image of the at least one body location.

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

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

27\. (Cancelled)

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28\. (Cancelled)

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

30\. (Cancelled)

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

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

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

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

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

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

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

38\. (Cancelled)

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

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

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

Atty. Dkt. P34702US01/0100804.00306 Page 6

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

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

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

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

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

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

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

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

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

OFFICE ACTION:
DETAILED ACTION
Notice of Pre-AIA  or AIA  Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The IDSes received on 12/03/2024 and 02/27/2025 have been considered.
In light of Examiner’s Amendment, there are no 35 U.S.C. 101 rejections.
In light of the amendments, the claims have overcome the previous 35 U.S.C. 103 rejections.
Notice to Applicant
In the amendment dated 12/03/2024, the following has occurred: claim 21 has been amended; claims 23-26, 29, 31-37, and 39-50 have remained unchanged; claims 1-20, 22, 27-28, 30, and 38 remain canceled; and no new claims have been added.
Claims 21, 23-26, 29, 31-37, and 39-50 are pending.
Effective Filing Date: 11/16/2017
Response to Arguments
35 U.S.C. 103 Rejections:
Examiner has withdrawn the previous 103 rejection sin view of the amendments.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/03/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
EXAMINER'S AMENDMENT
An examiner’s amendment to the record appears below in order to maintain the claims overcoming 35 U.S.C. 101. Should the changes and/or additions be unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the payment of the issue fee.
Authorization for this examiner’s amendment was given in an interview with Alyson H. Nickols on 2/26/2025.
The application has been amended as follows:
21. (Currently Amended) A method of providing a continuity of care for a patient at risk of developing pressure ulcers (PU) during transfer from a first care setting to a second care setting, the method comprising the steps of:
identifying a current PU intervention of level-K received by the patient at the first care setting, wherein the current PU intervention of level-K is provided in a transfer record, wherein the transfer record further comprises results obtained from performing a first SEM scan of at least one body location of the patient while in the first care setting, wherein the first SEM scan comprises a plurality of measurements of an SEM value at the body location and calculation of a first delta value from the plurality of SEM values, wherein if the current PU intervention of level-K is a level-0 PU intervention, the level-0 PU intervention comprises performing a daily SEM scan of at least one body location of the patient;
making a plurality of Sub-Epidermal Moisture (SEM) measurements at a body location on the patient at the second care setting, each SEM measurement comprising a measurement of biocapacitance,
calculating a delta value by a difference between a maximum SEM value and a minimum SEM value of the plurality of SEM measurements,
determining whether the delta value exceeds a threshold,
making a further plurality of SEM measurements at a pre-determined frequency corresponding to level-K if the delta value does not exceed the threshold, wherein the pre-determined frequency corresponding to level-K is longer than every 15 minutes and if the delta value does not exceed the threshold, ing to administer the current PU intervention of level-K based on the delta value, wherein level-K corresponds to a risk level for pressure ulcer, or
making the further plurality of SEM measurements at a pre-determined frequency corresponding to level-N if the delta value exceeds the threshold, where N has a value greater than K, wherein the pre-determined frequency corresponding to level-N is shorter than the pre-determined frequency corresponding to level-K and longer than or equal to every 15 minutes, and ing a new PU intervention of level-N based on the delta value, wherein level-N corresponds to a higher risk level for pressure ulcer than level-K.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance:
The prior art of record fails to disclose the specific method features that are comprised of the combination of components as presented in the claimed invention. More specifically, the closest two pieces of art, Lachenbruch et al. (U.S. 2016/0338591) and Geleijnse et al. (U.S. 2015/0186607), fail to teach all of the limitations of independent claim 1 in combination.
Specifically, Lachenbruch et al. is directed to systems and methods for mitigating tissue breakdown. In one embodiment, an alert indicative of a change in tissue status is provided in response to a tissue status crossing a threshold.
As such, Lachenbruch et al. teaches some of the claimed limitations, but does not teach anything related to identifying a current intervention level, making a plurality of measurements at different frequencies depending on whether a threshold is exceeded or not, continuing administration of a current intervention, and calculating a delta value between a minimum and maximum SEM value. There is nothing in Lachenbruch et al. that would suggest this.
The second reference, Geleijnse et al., deals with a clinical support system and method. As such, while Geleijnse et al. does teach identifying a current intervention level and continuing administration of a current intervention, it too does not teach anything related to making a plurality of measurements at different frequencies depending on whether a threshold is exceeded or not and calculating a delta value between a minimum and maximum SEM value. There is nothing in Geleijnse et al. that would suggest this.
The prior art alone, or in combination, does not disclose or make obvious the claim set of the present invention.
With respect to eligibility under 35 U.S.C. 101, Examiner asserts that the present claims recite additional elements which, when integrated into the abstract idea, become a practical application. The claims adjust a treatment for a particular affliction.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee.  Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion

APPLICANT REBUTTAL: REMARKS
Claims 21, 23-26, 29, 31-37, and 39-50 are pending. Claims 1-20, 22, 27, 28, 30, and 38 are cancelled. Claim 21 is amended without prejudice to, or disclaimer of, the underlying subject matter. Support for the amendments may be found in the original claims and specification, e.g., at [0111], [0118]. No new matter enters by way of the present amendments. Reconsideration of the application based on the above amendments and following remarks is respectfully requested.
Rej
ections under 35 U.S.C.
&
A. Lachenbruch in view of Geleijnse, further in view of Tonar and further in view
of Bennett-Guerrero
The Examiner rejects claims 21, 23-26, 29, and 37 under 35 U.S.C. § 103 as allegedly
being unpatentable over US Publication 2016/0338591 to Lachenbruch et al. ("Lachenbruch") in view of US Publication 2015/0186607 to Geleijnse et al. ("Geleijnse"), further in view of US Publication 2016/0310034 to Tonar et al. ("Tonar"), and further in view of US Patent 9,028,407 to Bennett-Guerrero ("Bennett-Guerrero"). See Office Action at p. 7.
Specifically, the Examiner asserts that "Lachenbruch et al. teaches... do nothing if the delta value does not exceed the threshold... ." Office Action at page 9. The Examiner acknowledges that "while Lachenbruch et al. does disclose SEM measurements and calculating if a threshold is exceeded fUro]m measured patient values, it does not explicitly teach a current intervention as well as the optionality to change the intervention based on the measurements." Office Action at pages 9-10. Applicant thanks the Examiner for acknowledging that "Lachenbruch et al. may not further, specifically teach... making a further plurality of measurements at a pre-determined frequency corresponding to level-K, wherein the predetermined frequency corresponding to a level-K is longer than every 15 minutes ... continuing to administer the current PU intervention, and ... calculating a difference between a maximum SEM value and a minimum SEM value of the plurality of measurements" Office Action at page 10 (emphasis added).
The Examiner further alleges that "Geleinjse et al. teaches... continuing to administer the current PU intervention... ." Office Action at page 11. The Examiner alleges that Tonar recites "calculating a delta value by a difference between a maximum SEM value and a minimum SEM value of the plurality of measurements." Office Action at page 11. The Examiner also alleges that "Bennett-Guerrero teaches...making the further plurality of measurements at a pre-determined frequency corresponding to level-K...wherein the predetermined frequency corresponding to a level-K is longer than every 15 minutes, ...making the further plurality of measurements at a pre-determined frequency corresponding to level-N...wherein the pre-determined frequency corresponding to level-N is longer than or equal to every 15 minutes... ." Office Action at page 12.
Lastly, the Examiner alleges that combining Bennet-Guerrero with "the method as taught by Lachenbruch et al., Geleijnse et al., and Tonar in combination with the motivation(s) of being beneficial for various reasons such as to enhance, improve, or even optimize battery life." Office Action at page 13. Applicant respectfully disagrees.
Applicant respectfully submits that aprimafacie case of obviousness has not been established for amended claim 21 for at least the following two reasons: (a) Lachenbruch, Geleijnse, Tonar, and Bennett-Guerrero, alone or in combination, do not provide or suggest each and every element of amended claim 21 and (b) a person of ordinary skill in the art combining the cited references would not have arrived at the claimed subject matter with a reasonable expectation of success.
(a) Lachenbruch, Geleijnse, Tonar, and Bennett-Guerrero, alone or in combination, do not provide or suggest each and every element of amended claim 21
Applicant respectfully submits that Lachenbruch, Geleijnse, Tonar, and Bennett- Guerrero, alone or in combination, do not provide or suggest each and every element of amended claim 21.
It is well-established law for an obviousness rejection under 35 U.S.C. § 103 that the
references, either alone or combined, must provide all of the elements of the claim. The Office is required to make "a searching comparison of the claimed invention - including all its limitations
- with the teaching of the prior art." In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995), and CFMT v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003). When "[t]he prior art reference (or references when combined) [do] not teach or suggest all the claim limitations, ... [o]ffice personnel must explain why the difference(s) between the prior art and the claimed invention would have been obvious to one of ordinary skill in the art." M.P.E.P. at
§ 2141 (III).
The Examiner has not at least shown that the cited references, alone or in combination, provide or suggest "making a further plurality of SEM measurements at a pre-determined frequency corresponding to level-K if the delta value does not exceed the threshold, wherein the pre-determined frequency corresponding to level-K is longer than every 15 minutes...wherein level-K corresponds to a risk level for pressure ulcer." as is recited in amended claim 21.
The Examiner acknowledges that Lachenbruch "may not further, specifically teach:... making a further plurality of measurements at a pre-determined frequency corresponding to level-K if the delta value does not exceed a threshold, wherein the predetermined frequency corresponding to a level-K is longer than every 15 minutes...calculating a delta value by a difference between a maximum SEM value and a minimum SEM value of the plurality of measurements." Office Action at page 10. The Examiner further acknowledges that
Lachenbruch "may not further, specifically teach:...do nothing by continuing to administer the current PU intervention." Office Action at page 10.
Geleijnse does not remedy the deficiencies of Lachenbruch. The Examiner alleges that Geleijnse teaches "do nothing by continuing to administer the current PU intervention." Office Action at page 11. Applicant disagrees. At best, Geliejnse recites "decisions support... to assist the clinician to make educated decisions on the transition of the patient to a different level of care (or to better stay in the current level of care)... [c]ontrary to known solutions, these decision recommendations are based on longitudinal historic patient data and, preferably, predication models." See Geleijnse at [0013]. Applicant respectfully submits that Geliejnse does not recite "recommending to continue to administer the current PU intervention of level-K based on the delta value" as is recited in amended claim 21. (emphasis added). Indeed, one of skill in the art reading Geliejnse would understand that any recommendation to continue to administer an intervention is based on "longitudinal historic patient data and, preferably, predication models" not "based on the delta value" as is recited in amended claim 21. See Geliejnse at [0013]. Accordingly, Applicant respectfully submits that Geliejnse does not recite "recommending to continue to administer the current PU intervention of level-K based on the delta value" let alone "recommending to administer a new PU intervention of level-N based on the delta value" as is recited in amended claim 21. Furthermore, Geleijnse is silent as to "making a further plurality of SEM measurements at a pre-determined frequency corresponding to level-K if the delta value does not exceed the threshold, wherein the pre-determined frequency corresponding to level-K is longer than every 15 minutes...wherein level-K corresponds to a risk level for pressure ulcer." as is recited in amended claim 21.
The Examiner alleges Tonar teaches "calculating a delta value by a difference between a maximum SEM value and a minimum SEM value of the plurality of measurements." Office Action at page 11. However, the Examiner has not identified where Tonar recites "recommending to continue to administer the current PU intervention of level-K based on the delta value", "recommending to administer a new PU intervention of level-N based on the delta value", or "making a further plurality of SEM measurements at a pre-determined frequency
corresponding to level-K if the delta value does not exceed the threshold, wherein the pre- determined frequency corresponding to level-K is longer than every 15 minutes...wherein level- K corresponds to a risk level for pressure ulcer." as is recited in amended claim 21.
The Examiner alleges that Bennett-Guerrero teaches "one of ordinary skill...would have found it obvious to 2a) make a further plurality of measurements at a pre-determined frequency corresponding to level-K if the delta value does not exceed a threshold, wherein the predetermined frequency corresponding a level-K is longer than every 15 minutes, or 2b) making the further plurality of measurements at a pre-determined frequency corresponding to level-N if the delta value exceeds the threshold, where N has a value greater than K, wherein the pre- determined frequency corresponding to a level-N is longer than or equal to every 15 minutes, and administering a new PU intervention of level-N as taught by Bennet- Guerrero in the method as taught by Lachenbruch et al., Geleijnse et al., and Tonar et al. in combination with the motivation(s) of being beneficial for various reasons such as to enhance, improve, or even optimize battery life." Office Action at page 13. Applicant disagrees.
At best, Bennett-Guerrero recites that when a "patient's heart rate and respiratory rates slow, such as 10% lower than the median value obtained during day time, and the patient is subject to minimal movement as is consistent with sleep...the frequency of measurements of the patient chest incline can be
r
educed
,
such as every 15 minutes, in order to conserve battery life, enhance sensor longevity, etc." and is silent as to a frequency "longer than every 15 minutes" as is recited in claim 21. Bennet-Guerrero at Column 6 lines 53-59 (emphasis added). Further, the Examiner has alleged that Bennett-Guerrero "Column 26, lines 16-19 describes that the frequency can vary and be any beneficial/useful frequency...the frequency here could be longer than 15 minutes." Office Action at page 12. However, the Examiner has failed to provide any evidence in the cited art or in the general knowledge of one of skill in the art that would inform one of skill in the art that a beneficial/useful frequency would be "longer than every 15 minutes" as is recited in claim 21, let alone any explanation of how Bennett-Guerrero, which is directed to "the frequency of measurements of the patient chest incline," would provide any guidance as to
what a beneficial/useful frequency is for SEM measurements for "a patient at risk of developing pressure ulcers" as is recited in claim 21. See Bennett-Guerrero at Column 6, lines 53-59.
Applicant disagrees with the Examiner's inappropriate assertion that because "Bennet- Guerrero reference does indeed not limit the frequencies within its specification," the element of longer than every 15 minutes is "a number selected within the range of what is acceptable in Bennet-Guerrero." See Office Action at page 5. As stated above, when "[t]he prior art reference (or references when combined) [do] not teach or suggest all the claim limitations, ... [o]ffice personnel must explain why the difference(s) between the prior art and the claimed invention would have been obvious to one of ordinary skill in the art." M.P.E.P. at § 2141 (III) (emphasis added). Applicant submits that the Examiner has failed to articulate why a frequency "longer than every 15 minutes" would have been obvious to one of ordinary skill in the art.
Indeed, Applicant submits that one of skill in the art reading Bennet-Guerrero, for
example that "the frequency can of the measurements of the patient chest incline can be reduced, such as every 15 minutes..." would understand that Bennet-Guerrero recites a longest frequency of 15 minutes, and a preferred frequency of every 1 minute. See Bennett-Guerrero at Column 6, lines 53-59 (emphasis added). Applicant respectfully submits that the Examiner has provided no recitation in the art or in the common knowledge of one of skill in the art that "reduced" as recited in Bennett-Guerrero can be reasonably understood to be "longer than every 15 minutes" as is recited in claim 21. Applicant respectfully submits that Bennet-Guerrero is completely silent as to "making a further plurality of SEM measurements at a pre-determined frequency corresponding to level-K if the delta value does not exceed the threshold, wherein the pre- determined frequency corresponding to level-K is longer than every 15 minutes...wherein level- K corresponds to a risk level for pressure ulcer", let alone "making the further plurality of SEM measurements at a pre-determined frequency corresponding to level-N if the delta value exceeds the threshold, where N has a value greater than K, wherein the pre-determined frequency corresponding to level-N is shorter than the pre-determined frequency corresponding to level-K and longer than or equal to every 15 minutes, and administering a new PU intervention of level- N, wherein level-N corresponds to a higher risk level for pressure ulcer than level-K." as is
recited in amended claim 21 (emphasis added). Further, Applicant respectfully submits that Bennet-Guerrero is silent as to "recommending to continue to administer the current PU intervention of level-K based on the delta value" and "recommending to administer a new PU intervention of level-N based on the delta value" as is recited in amended claim 21.
For at least the above reasons, Lachenbruch, Geleijnse, Tonar, and Bennet-Guerrero,
alone or in combination, do not provide or suggest each and every element of amended claim 21. Accordingly, Applicant respectfully submits that the amended claim 21 is nonobvious over Lachenbruch, in view of Geleijnse, further in view of Tonar and Bennet-Guerrero.
(b) A person of ordinary skill in the art combining the cited references would not have arrived at the claimed subject matter with a reasonable expectation of success
Notwithstanding that Lachenbruch, Geleijnse, Tonar, and Bennet-Guerrero, alone or in combination, do not provide or suggest all the elements of amended claim 21, the Examiner alleges that there is motivation to combine Bennett-Guerrero with Lachenbruch, Tonar, and Geleijnse because the combination is "beneficial for various reasons such as to enhance, improve, or even optimize battery life." Office Action at 13. Applicant respectfully disagrees.
To establish aprimafacie case of obviousness, there must be some suggestion or
motivation, either in the references themselves or in the knowledge generally available to one of skill in the art, to modify the reference or to combine reference teachings. See M.P.E.P §2143.01. There must also be a reasonable expectation of success. See M.P.E.P §2143.02. Furthermore, if a proposed modification would render the prior art invention being modified unsatisfactory for its intended purpose then there is no suggestion or motivation to make the proposed modification. See M.P.E.P. §2143.01(V) Aprimafacie case of obviousness may also be rebutted by showing that the art, in any material respect, teaches away from the claimed invention. See M.P.E.P. §2144.05(III)
First, one of skill in the art reading Bennett-Guerrero would have no expectation of success in applying a frequency of Bennett-Guerrero's measurement of an incline angle of a subject's chest and reducing the frequency for beneficial/useful reasons related to measurement
of an incline angle of a subject's chest, e.g., to conserve battery life, to identify a "a pre- determined frequency" of "a further plurality of SEM measurements" that is "corresponding to" an identified level "wherein level-K corresponds to a risk level for pressure ulcer" or "wherein level-N corresponds to a higher risk level for pressure ulcer than level-I" as is required in amended claim 21. As stated in section (a) the Examiner has failed to provide any recitation or general knowledge of one of skill in that art that would inform one of skill in the art that a beneficial/useful frequency would be "longer than every 15 minutes" wherein "level-K corresponds to a risk level for pressure ulcer" or "wherein level-N corresponds to a higher risk level for pressure ulcer than level-K" as is recited in claim 21. Accordingly, one of ordinary skill in the art would understand that Bennett-Guerrero's disclosure of reducing measurement frequency (i.e., more frequent that every 15 minutes) is not a basis for predicting success of the claimed method steps of amended claim 21 for at least the reason that there is no suggestion or motivation to identify "a pre-determined frequency" of "a further plurality of SEM measurements" that is "corresponding to" an identified level "wherein level-K corresponds to a risk level for pressure ulcer" or "wherein level-N corresponds to a higher risk level for pressure ulcer than level-K" as is required in amended claim 21. Hence, there would not be a reasonable expectation of success to apply an element of Bennett-Guerrero's protocol in the methods of Lachenbruch, Geleijnse, and Tonar for reducing measurement frequency, much less a modified version of such a protocol to arrive at the method of claim 21, let alone to achieve an alleged comparable result.
Second, one of skill reading Bennett-Guerrero would understand that Bennett-Guerrero teaches away from taking measurements "longer than every 15 minutes," let alone a frequency "equal to every 15 minutes" for a patient at risk of injury. Indeed, Bennett-Guerrero recites a frequency of every one minute for a higher risk level. See Bennett-Guerrero at Column 6 lines 9- 10. As previously discussed in Section (a), Bennett-Guerrero recites a lowest frequency of 15 minutes, and the Examiner has failed to provide any evidence in Bennett-Guerrero or elsewhere that would inform one of skill in the art of what a "beneficial/useful" frequency would be for the measurement of SEM values to provide a "continuity of care for a patient at risk of developing
pressure ulcers (PU)" as is recited in claim 21. Office Action at page 13. Indeed, Bennett-Guerrero discloses the importance of more frequent measurements to "indicate that the patient is attempting to sit up, stand, and/or leave the hospital bed which could predispose the patient to injury" and "for a patient being enterally fed into the stomach, an indication/alarm may provide an indication as to whether the incline of the upper chest/abdomen is less than 30 degrees...relative to the floor." See Bennett-Guerrero at column 7, lines 7-25. In contrast, Applicant's disclosure addresses a "a continuity of care for a patient at risk of developing pressure ulcers (PU)" as is recited in claim 21. Therefore, even assuming arguendo that one of skill in the art would look to Bennet-Guerrero for a frequency of measurements as disclosed in Lachenbruch, Geleijnse, or Tonar, they would not arrive at the method of claim 21 as amended with any expectation of success to provide a "continuity of care for a patient at risk of developing pressure ulcers" as is recited in claim 21 based on the monitoring frequency for a patient at risk of changing incline.
For at least the above reasons, Lachenbruch, Geleijnse, Tonar, and Bennet-Guerrero,
alone or in combination, do not provide or suggest each and every element of amended claim 21. Accordingly, Applicant respectfully submits that the amended claim 21 is nonobvious over Lachenbruch, in view of Geleijnse, further in view of Tonar and Bennet-Guerrero.
For at least the above reasons, Applicant respectfully requests that the Examiner withdraw the rejection of claim 21 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Tonar, and further in view of Bennett-Guerrero. As claims 23-26, 29, and 37 depend from and include all elements of claim 21, Applicant submit that these claims are also nonobvious over Lachenbruch, in view of Geleijnse, further in view of Tonar and Bennet-Guerrero for the same reason. Applicant respectfully requests that the Examiner withdraw the rejection of claims 21, 23-26, 29, and 37 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Tonar, and further in view of Bennett-Guerrero.
B. Lachenbruch in view of Geleijnse, further in view of Tonar, Bennett-Guerrero,
and Heaton
The Examiner rejects claims 31, 32, 34, and 39 under 35 U.S.C. § 103 as allegedly being unpatentable over Lachenbruch in view of Geleijnse, further in view of Tonar, further in view of Bennett-Guerrero as applied to claim 29, and further in view of US Patent 9,675,289 to Heaton ("Heaton"). See Office Action at p. 18.
Specifically, the Examiner asserts that Heaton provides "querying the database for data for form retrieved delta values." Office Action at page 18. As such, the Examiner concludes that "[o]ne of ordinary skill at the time the invention as filed would have found it obvious to query the database for data to form retrieved delta values as taught by Heaton in the method as taught by Lachenbruch et al., Geleijnse et al., Berggen, and Bennett-Guerrero in combination with the motivation(s) of being a way to store and retrieve information from a database." Office Action at pages 18-19. Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Claims 29, 31, 32, 34 and 39 are dependent from claim 21, and incorporates the features of claim 21. Since the Examiner has not shown that amended claim 21 is obvious in view of Lachenbruch, Geleijnse, Tonar, Bennett-Guerrero, and Heaton does not remedy the deficiencies of these references as discussed in Section A above, claims 31, 32, 34 and 39 are also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner
withdraw the rejection of claims 31, 32, 34, and 39 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Tonar, and further in view of Bennett-Guerrero as previously applied to claim 29, and further in view of Heaton.
C. Lachenbruch in view of Geleijnse, further in view of Tonar, Bennett-Guerrero,
and Miller
The Examiner rejects claim 33 under 35 U.S.C. § 103 as allegedly being unpatentable
over Lachenbruch in view of Geleijnse, further in view of Tonar, and further in view of Bennett-
Guerrero as applied to claim 29, and further in view of US Publication 2008/0015894 to Miller et al. ("Miller"). See Office Action at p. 21. Specifically, the Examiner asserts that Miller provides "creating an additional 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..." Office Action at page 22. Thus, the Examiner concludes that "[o]ne of ordinary skill at the time of the invention was filed would have found it obvious to 1) create an additional data record, wherein the data element comprises 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." Office Action at page 22. Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Claims 29 and 33 are dependent from claim 21, and incorporate the features of claim 21. Since the Examiner has not shown that amended claim 21 is obvious in view of Lachenbruch, Geleijnse, Tonar, Bennet- Guerrero, and Miller does not remedy the deficiencies of these references as discussed in Section A above, claim 33 is also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner withdraw the rejection of claim 33 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Tonar and Bennett-Guerrero as previously applied to claim 29, and further in view of Miller.
D. Lachenbruch in view of Geleijnse, further in view of Tonar, Bennett-Guerrero,
Heaton, and Rothman
The Examiner rejects claims 35 and 36 under 35 U.S.C. § 103 as allegedly being
unpatentable over Lachenbruch in view of Geleijnse, further in view of Tonar, further in view of Bennett-Guerrero, further in view of Heaton as applied to claim 32, and further in view of US Patent 8,355,925 to Rothman et al. ("Rothman"). See Office Action at p. 23. Specifically, the
Examiner asserts that Rothman provides "the step of analyzing the retrieved values to determine one or more of a slope, an acceleration, a curve shape and associated characteristics, and a time- to-time intercept of a selected threshold value." Office Action at page 23. Thus, the Examiner concludes "[o]ne of ordinary skill at the time of the invention as 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...with the motivation(s) of alerting a user if a patient is getting better or worse at an accelerating rate." Id. Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Claims 32, 35, and 36 are dependent directly or indirectly from claim 21, and incorporates the features of amended claim 21. Since the Examiner has not shown that amended claim 21 is obvious in view of Lachenbruch, Geleijnse, Tonar, Bennet-Guerrero, and Rothman does not remedy the deficiencies of these references as discussed in Section A above, claims 35 and 36 are also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner
withdraw the rejection of claims 35 and 36 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Tonar, Bennett-Guerrero, and Heaton as previously applied to claim 32, and further in view of Rothman.
E. Lachenbruch in view of Geleijnse, further in view of Tonar, Bennett-Guerrero,
and Brem
The Examiner rejects claims 40 and 43 under 35 U.S.C. § 103 as allegedly being
unpatentable over Lachenbruch in view of Geleijnse, further in view of Tonar, further in view of Bennett-Guerrero as applied to claim 21, and further in view of "Protocol for the successful treatment of pressure ulcers" (Brem et al., The American Journal of Surgery, 188 (Suppl. to July 2004):9S-17S (2004)) ("Brem"). See Office Action at pp. 24-25. Specifically, the Examiner asserts that Brem provides "wherein the level-0 PU intervention further comprises an intervention selected from the group consisting of providing good nutrition, standard mattress,
turning every 24 hours, and a combination thereof." Office Action at page 25. Thus, the Examiner concludes that "it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute an intervention selected the group consisting of providing good nutrition, standard mattress, turning every 24 hours, and a combination thereof...because they are types of treatment options, making results predictable." Office Action at page 26. Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Claims 40 and 43 are dependent directly or indirectly from claim 21, and incorporates the features of amended claim 21. Since the Examiner has not shown that amended claim 21 is obvious in view of Lachenbruch, Geleijnse, Tonar, and Bennet-Guerrero as discussed in Section A above, claims 40 and 43 are also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner
withdraw the rejection of claims 40 and 43 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Tonar and Bennett-Guerrero as previously applied to claim 21, and further in view of Brem.
F. Lachenbruch in view of Geleijnse, further in view of Tonar, Bennett-Guerrero,
and Lamont
The Examiner rejects claim 41 under 35 U.S.C. § 103 as allegedly being unpatentable over Lachenbruch in view of Geleijnse, further in view of Tonar, further in view of Bennett- Guerrero as applied to claim 21, and further in view of US Patent 5,367,789 to Lamont ("Lamont"). See Office Action at pp. 26-27. Specifically, the Examiner asserts that Lamont provides "a level-1 PU intervention of providing a heel boot to the patient." Office Action at page 27. Thus, the Examiner concludes that "it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-1 PU intervention of providing a heel boot to the patient...because they are types of treatment options, making results predictable." Office Action at pages 27. Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Claim 41 is dependent from amended claim 21, and incorporates the features of amended claim 21. Since the Examiner has not shown that amended claim 21 is obvious in view of Lachenbruch, Geleijnse, Tonar, and Bennet-Guerrero, and Lamont does not remedy the deficiencies of these references as discussed in Section A above, claim 41 is also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner withdraw the rejection of claim 41 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Tonar and Bennett-Guerrero as applied to claim 21, and further in view of Lamont.
G. Lachenbruch in view of Geleijnse, further in view of Tonar, Bennett-Guerrero,
and DuDonis
The Examiner rejects claim 42 under 35 U.S.C. § 103 as allegedly being unpatentable over Lachenbruch in view of Geleijnse, further in view of Tonar, further in view of Bennett- Guerrero as applied to claim 21, and further in view of US Patent 6,634,045 to DuDonis et al. ("DuDonis"). See Office Action at p. 28. Specifically, the Examiner asserts that DuDonis provides "a level-2 PU intervention of changing the patient's support surface." Office Action at page 28. Thus, the Examiner concludes "it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-2 PU intervention of changing the patient's support surface as taught by DuDonis et al. for a treatment level as disclosed by Lachenbruch et al., Geleijnse et al., Tonar, and Bennett-Guerrero in combination." Office Action at page 28. Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Claim 42 is dependent from claim 21, and incorporates the features of claim 21. Since the Examiner has not shown that claim 21 is obvious in view of Lachenbruch, Geleijnse, Tonar, and Bennet-Guerrero, and
DuDonis does not remedy the deficiencies of these references as discussed in Section A above, claim 42 is also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner withdraw the rejection of claim 42 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Tonar and Bennett-Guerrero as applied to claim 21, and further in view of DuDonis.
H. Lachenbruch in view of Geleijnse, further in view of Tonar, Bennett-Guerrero,
and Rotaru
The Examiner rejects claim 44 under 35 U.S.C. § 103 as allegedly being unpatentable over Lachenbruch in view of Geleijnse, further in view of Tonar, further in view of Bennett- Guerrero as applied to claim 21, and further in view of "Friction between human skin and medical textiles for decubitus prevention" (Rotaru et al., Tribology International, 65:91-96 (2013)) ("Rotaru"). See Office Action at p. 29. Specifically, the Examiner asserts that Rotaru provides "a level-4 PU intervention of changing the patient's sheet cover to a low-friction sheet cover." Office Action at page 29. Thus, the Examiner concludes "it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-4 PU intervention of changing the patient's sheet cover to a low-friction sheet cover as taught by Rotaru et al. for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al., Geleijnse et al., Tonar, and Bennett-Guerrero in combination." See Office Action at pages 29-30. Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Claim 44 is dependent from amended claim 21, and incorporates the features of claim 21. Since the Examiner has not shown that amended claim 21 is obvious in view of Lachenbruch, Geleijnse, Tonar, and Bennet- Guerrero, and Rotaru does not remedy the deficiencies of these references as discussed in Section A above, claim 44 is also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner withdraw the rejection of claim 44 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Tonar and Bennett-Guerrero as applied to claim 21, and further in view of Rotaru.
I.  Lachenbruch in view of Geleijnse, further in view of Tonar, Bennett-Guerrero,
and Hann
The Examiner rejects claim 45 under 35 U.S.C. § 103 as allegedly being unpatentable over Lachenbruch in view of Geleijnse, further in view of Tonar, further in view of Bennett- Guerrero as applied to claim 21, and further in view of US Patent 8,011,041 to Hann ("Hann"). See Office Action at p. 30. Specifically, the Examiner asserts that Hann provides "a level-5 PU intervention of providing a low-friction padded mattress surface for the patient's lower leg." Office Action at page 31. Thus, the Examiner concludes "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 certain diagnostic level as disclosed by Lachenbruch et al., Geleijnse et al., Tonar, and Bennett-Guerrero in combination." Id. Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Claim 45 is dependent from amended claim 21, and incorporates the features of amended claim 21. Since the Examiner has not shown that amended claim 21 is obvious in view of Lachenbruch, Geleijnse, Tonar, Bennett-Guerrero, and Hann does not remedy the deficiencies of these references as discussed in Section A above, claim 45 is also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner withdraw the rejection of claim 45 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Tonar and Bennett-Guerrero as applied to claim 21, and further in view of Hann.
J. Lachenbruch in view of Geleijnse, further in view of Tonar, Bennett-Guerrero,
and Thomas
The Examiner rejects claims 46 and 47 under 35 U.S.C. § 103 as allegedly being
unpatentable over Lachenbruch in view of Geleijnse, further in view of Tonar, further in view of Bennett-Guerrero as applied to claim 21, and further in view of "Prevention and Treatment of Pressure Ulcers" (Thomas, J Am. Med. Dir. Assoc., 7:46-59 (2006)) ("Thomas"). See Office Action at p. 31. Specifically, the Examiner asserts that Thomas provides "a level-6 PU intervention of turning the patient at a shorter interval than currently provided for." Office Action at page 32. Thus, the Examiner concludes "it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-6 PU intervention of turning the patient at a shorter interval than currently provided for as taught by Thomas for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al., Geleijnse et al., Tonar, and Bennett-Guerrero in combination." Office Action at page 32. Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Claims 46 and 47 are dependent directly or indirectly from amended claim 21, and incorporates the features of claim 21. Since the Examiner has not shown that amended claim 21 is obvious in view of Lachenbruch, Geleijnse, Tonar, Bennett-Guerrero, and Thomas does not remedy the deficiencies of these references as discussed in Section A above, claims 46 and 47 are also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner
withdraw the rejection of claims 46 and 47 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Tonar and Bennett-Gerrero as applied to claim 21, and further in view of Thomas.
K. Lachenbruch in view of Geleijnse, further in view of Tonar, Bennett-Guerrero,
and Liu
The Examiner rejects claim 48 under 35 U.S.C. § 103 as allegedly being unpatentable over Lachenbruch in view of Geleijnse, further in view of Tonar, further in view of Bennett- Guerrero as applied to claim 21, and further in view of "A systematic review of electrical stimulation for pressure ulcer prevention and treatment in people with spinal cord injuries" (Liu et al., The Journal of Spinal Cord Medicine, 37(6):703-718 (2014)) ("Liu"). See Office Action at p. 33. Specifically, the Examiner asserts Liu provides "a level-8 PU intervention of applying a neuro-muscular stimulation to the patient's heel." Office Action at page 34. Thus, the Examiner concludes that "it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-8 PU intervention of applying a neuro- muscular stimulation to the patient's heel as taught by Liu for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al., Geleijnse et al., Tonar, and Bennett-Guerrero in combination." See Office Action at p. 34. Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Claim 48 is dependent from amended claim 21, and incorporates the features of amended claim 21. Since the Examiner has not shown that amended claim 21 is obvious in view of Lachenbruch, Geleijnse, Tonar, Bennett-Guerrero, and Liu does not remedy the deficiencies of these references as discussed in Section A above, claim 48 is also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner withdraw the rejection of claim 48 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Tonar and Bennett-Guerrero as applied to claim 21, and further in view of Liu.
L. Lachenbruch in view of Geleijnse, further in view of Tonar, Bennett-Guerrero,
and Tur
The Examiner rejects claim 49 under 35 U.S.C. § 103 as allegedly being unpatentable over Lachenbruch in view of Geleijnse, further in view of Tonar, further in view of Bennett- Guerrero as applied to claim 21, and further in view of "Topical hydrogen peroxide treatment of ischemic ulcers in the guinea pig: Blood recruitment in multiple skin sites" (Tur et al., J. Am. Acad. Dermatol., 33:217-221 (1995)) ("Tur"). See Office Action at p. 35. Specifically, the Examiner asserts Tur provides "a level-9 PU intervention of applying a topical cream to the patient's heel to enhance perfusion." Id. Thus, the Examiner concludes that "it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-9 PU intervention of applying a topical cream to the patient's heel to enhance perfusion as taught by Tur et al. for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al., Geleijnse et al., Tonar, and Bennett-Guerrero in combination." Id. Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Claim 49 is dependent from claim 21, and incorporates the features of amended claim 21. Since the Examiner has not shown that amended claim 21 is obvious in view of Lachenbruch, Geleijnse, Tonar, and Bennett- Guerrero, and Tur does not remedy the deficiencies of these references as discussed in Section A above, claim 49 is also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner withdraw the rejection of claim 49 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Tonar and Bennett-Guerrero as applied to claim 21, and further in view of Tur.
M. Lachenbruch in view of Geleijnse, further in view of Tonar, Bennett-Guerrero,
and Truong
The Examiner rejects claim 50 under 35 U.S.C. § 103 as allegedly being unpatentable over Lachenbruch in view of Geleijnse, further in view of Tonar, further in view of Bennett- Guerrero as applied to claim 21, and further in view of "Pressure Ulcer Prevention in the Hospital Setting Using Silicon Foam Dressings" (Truong et al., Cureus, 8(8):e730, pp. 1-6 (2016)) ("Truong"). See Office Action at p. 36. Specifically, the Examiner asserts that Truong provides "a level-10 PU intervention of providing a silicon pad for the patient's lower leg." Id. Thus, the Examiner concludes that "it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a level-10 PU intervention of providing a silicon pad for the patient's lower leg as taught by Truong for a treatment program of a certain diagnostic level as disclosed by Lachenbruch et al., Geleijnse et al., and Tonar in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements." See Office Action at p. 37. Applicant respectfully disagrees.
If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071 (Fed. Cir. 1988). Claim 50 is dependent from amended claim 21, and incorporates the features of amended claim 21. Since the Examiner has not shown that amended claim 21 is obvious in view of Lachenbruch, Geleijnse, Tonar, and Bennet-Guerrero, and Truong does not remedy the deficiencies of these references as discussed in Section A above, claim 50 is also nonobvious.
For at least the above reasons, Applicant respectfully requests that the Examiner withdraw the rejection of claim 50 under 35 U.S.C. § 103 over Lachenbruch in view of Geleijnse, further in view of Tonar and Bennett-Guerrero as applied to claim 21, and further in view of Truong.
CONCLUSION


CITED REFERENCE SUMMARIES: Ref US20160338591: Claims:
1. A method for tracking a change in tissue status comprising:
receiving at least some demographic information regarding an individual being monitored; receiving, from a sensor, information regarding a first tissue status for the individual; comparing the received information with a threshold tissue status selected at least in part based on the at least some demographic information regarding the individual; providing an alert indicative of a change in tissue status in response to determining that the received information exceeds the threshold tissue status.
2. The method of claim 1, wherein the at least some demographic information regarding the individual being monitored comprises at least one of an age of the individual, a medical condition of the individual, a sex of the individual, a weight of the individual, a medication provided to the individual, a smoking status of the individual, a mobility level of the individual, a medical device utilized by the individual, and an indication that the individual has previously had a tissue condition.
3. The method of claim 1, wherein the information regarding the first tissue status for the individual comprises a temperature of the tissue, a moisture level of the tissue, mechanical energy dissipation through the tissue, ultrasound or other high frequency information, light frequency information, or a biomarker in the tissue.
4. The method of claim 1, wherein providing the alert indicative of the change in tissue status comprises providing an alert to a caregiver via a computing device.
5. The method of claim 1, further comprising:
storing the received information regarding the first tissue status and the at least some information regarding an individual being monitored in a database; receiving, from the sensor, information regarding at least one subsequent tissue status for the individual; and updating the database with the at least one subsequent tissue status for the individual.
6. The method of claim 5, further comprising:
adjusting the threshold based on at least some of the information in the database.
7. The method of claim 5, further comprising providing a graphical history of tissue status over time based on the first tissue status and the at least one subsequent tissue status for the individual.
8. The method of claim 5, further comprising updating the database with an outcome for the individual.
9. The method of claim 1, further comprising making an adjustment to a person support apparatus upon which the individual is disposed.
10. A system comprising:
at least one sensor for sensing information regarding a tissue status for an individual; a server communicatively coupled to the at least one sensor for receiving the information regarding the tissue status for the individual from the at least one sensor, the server comprising a processor and a memory storing computer readable and executable instructions that, when executed by the processor, cause the server to compare the information regarding the tissue status to a threshold tissue status and provide at least one output based on the comparison; and at least one computing device communicatively coupled to the server for receiving the at least one output from the server.
11. The system of claim 10, wherein the sensor comprises a light source and an optical detector.
12. The system of claim 10, wherein the information regarding the tissue status for the individual comprises information regarding a change in light intensity at a predetermined wavelength.
13. The system of claim 12, wherein the at least one output comprises an instruction to make an adjustment to a person support apparatus upon which the individual is disposed, a notification to a caregiver, or an instruction to provide medication.
14. The system of claim 13, wherein the instruction to make the adjustment to the person support apparatus comprises an instruction to alter an angle of the person support apparatus, an instruction to reduce a pressure associated with the person support apparatus, or an instruction to alter a temperature of the person support apparatus.
15. The system of claim 12, wherein the at least one computing device is associated with a person support apparatus upon which the individual is disposed.
16. The system of claim 10, wherein the server receives at least some information regarding the individual, and the threshold tissue status depends at least in part on the at least some information regarding the individual.
17. The system of claim 16, wherein the server updates the threshold tissue status based on the information regarding the tissue status for the individual.
18. The system of claim 16, wherein the server updates the threshold tissue status based on an outcome for the individual.
19. The system of claim 16, wherein the at least some information regarding the individual comprises at least one of an age of the individual, a medical condition of the individual, a sex of the individual, a weight of the individual, a medication provided to the individual, a smoking status of the individual, a mobility level of the individual, a medical device utilized by the individual, and an indication that the individual has previously had a tissue condition.
20. The system of claim 10, wherein the information regarding the tissue status comprises information regarding a moisture level of the tissue, mechanical energy dissipation through the tissue, ultrasound or other high frequency information, light frequency information, or a biomarker in the tissue.
Ref US20150186607: Claims:
1. A clinical support system comprising a processor and a computer-readable storage medium, wherein the computer-readable storage medium contains instructions for execution by the processor, wherein the instructions cause the processor to perform the steps of:
obtaining current patient data descriptive of a patient, for whom a recommendation for a transition from a current care levels to one or more other care levels shall be provided, in the current care level, obtaining historic patient data of the patient obtained earlier in the current and/or other care levels, and computing two or more patient specific transition scores from said obtained current and historic patient data, wherein a patient specific transition score indicates a level of recommendation of a transition of the patient from the current care level to a different care level or to stay in the current care level.
2. The clinical support system as claimed in claim 1, wherein the instructions further cause the processor to compute said two or more patient specific transition scores by use of a prediction model predicting the patient's future health progress based on said obtained current and historic patient data.
3. The clinical support system as claimed in claim 1, wherein said historic patient data comprises historic transitions between different care levels including information on improvements and/or deteriorations of the patient's health status in response to said historic transitions.
4. (canceled)
5. The clinical support system as claimed in claim 1, wherein the instructions further cause the processor to identify the location of the current care level and to use the location of the current care level as an additional input in the computation of the two or more patient specific transition scores.
6. The clinical support system as claimed in claim 5, wherein the instructions further cause the processor to identify the location of the current care level by reading a location information from the current patient data or by deriving the location from features of the current patient data including the type, amount and/or content of the current patient data.
7. The clinical support system as claimed in claim 1, wherein the instructions further cause the processor to use the risk of readmission of the patient to the current care level as an additional input in the computation of the two or more patient specific transition scores.
8. (canceled)
9. The clinical support system as claimed in claim 1, wherein the instructions further cause the processor to use patient population data providing statistical information on historic transitions of other patients between different care levels including information on improvements and/or deteriorations of their health status in response to said historic transitions.
10. The clinical support system as claimed in claim 1, wherein the instructions further cause the processor to compute one or more disease specific health scores for the patient from said current and historic patient data and to use said one or more disease specific health scores in the computation of said two or more patient specific transition scores.
11. The clinical support system as claimed in claim 1, wherein the instructions further cause the processor to obtain patient data, health progression information and/or transmission scores of patients that had the same or a similar health status and/or health history as the current patient and to use the obtained patient data health progression information and/or transmission scores in the computation of the two or more patient specific transition scores.
12. The clinical support system as claimed in claim 1, wherein the instructions further cause the processor
to compute a general health score for the current care level from historic patient data of patients that have been in the current care level, to compute two or more general transition scores each indicating a level of recommendation of a transition of a patient from the current care level to a different care level or to stay in the current care level, and to combine said two or more general transition scores with said two or more patient specific transition scores to obtain two or more final transition scores.
13. The clinical support system as claimed in claim 12, wherein the instructions further cause the processor to apply a weighted combination of said general transition scores and said patient specific transition scores to obtain said final transition scores, the weights being determined manually or from the accuracy of past transition scores of the current patient, other patients and/or all patients.
14. A clinical support method comprising the steps of
obtaining current patient data descriptive of a patient, for whom a recommendation for a transition from a current care levels to one or more other care levels shall be provided, in the current care level, obtaining historic patient data of the patient obtained earlier in the current and/or other care levels, and computing two or more patient specific transition scores from said obtained current and historic patient data, wherein a patient specific transition score indicates a level of recommendation of a transition of the patient from the current care level to a different care level or to stay in the current care level.
15. A computer-readable non-transitory storage medium containing instructions for execution by a processor, wherein the instructions cause the processor to perform the steps of:
obtaining current patient data descriptive of a patient, for whom a recommendation for a transition from a current care levels to one or more other care levels shall be provided, in the current care level, obtaining historic patient data of the patient obtained earlier in the current and/or other care levels, and computing two or more patient specific transition scores from said obtained current and historic patient data, a patient specific transition score indicating a level of recommendation of a transition of the patient from the current care level to a different care level or to stay in the current care level.
16. Computer program comprising program code means for causing a computer to carry out the steps of the method as claimed in claim 14 when said computer program is carried out on the computer.
17. A clinical support system comprising:
means for obtaining current patient data descriptive of a patient, for whom a recommendation for a transition from a current care levels to one or more other care levels shall be provided, in the current care level, means for obtaining historic patient data of the patient obtained earlier in the current and/or other care levels, and means for computing two or more patient specific transition scores from said obtained current and historic patient data, wherein a patient specific transition score indicates a level of recommendation of a transition of the patient from the current care level to a different care level or to stay in the current care level.