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
In response to amendments, filed February 9, 2026, claims 9, 16, 26, 31, 34, and 38 have been amended. No claims have been cancelled or added. Claims 9, 13-26, 31, 34, 36 and 38 are pending, with 9, 13-15, 26, 31, 34, 36 and 38 withdrawn from consideration as being drawn to a nonelected invention.
Response to Arguments
Applicant’s arguments, see Remarks, filed February 9, 2026, with respect to the drawing objections and 35 USC 112b rejections have been fully considered and are persuasive in view of the amendments. The objection to the drawings and the rejections under 35 USC 112b have been withdrawn.
Applicant's arguments filed February 9, 2026 with respect to the prior art rejections as they pertain to claim 16 have been fully considered but they are not persuasive.
In response the applicant’s argument that the combination of Dayan/Hakozaki fails to disclose claim 16 limitations “b) administering a first intervention of level-0 if the first average TEWL value is below or equal to a first threshold, and c) administering a first intervention of level-N if the first average TEWL value is above the first threshold, where N is an integer and N has a value of 1 or greater,” Examiner respectfully disagrees. Hakozaki describes, in [0045], a trans-epidermal water loss (TEWL) threshold used to identify a portion of skin needing treatment. The first intervention of level-0 described in Hakozaki [0045] is when a target portion of skin does not currently exhibit signs of reduced barrier function (has a TEWL value below the threshold) and the user applies the low-pH composition to the target portion of skin for a preventative benefit. The first intervention of level-N described in Hakozaki [0045] is when a target portion of skin is identified as needing treatment by exhibiting impaired barrier function based on the TEWL value exceeding a threshold level and the user applies the low-pH composition to the target portion of skin for therapeutic effect.
Applicant’s arguments with respect to the prior art rejection of claim 17 have been considered but are moot because the new ground of rejection does not rely on the same reference combination applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. A new ground(s) of rejection is made in view of the combinations of Dayan (US 20080103207 A1)/Hakozaki (US 20200009123 A1)/Bates-Jenson (DOl:10.1111/wr.12548)/American (https://www.facs.org/media/32hdibi4/wound_pressure_ulcers.pdf). Any arguments still relevant based on the new grounds of rejection are addressed below.
In response the applicant’s argument that the combination of Dayan/Hakozaki fails to disclose “a) taking a second plurality of TEWL measurements in the patient at a first pre-determined frequency corresponding to the administered intervention level; b) determining a second average TEWL value of the second plurality of TEWL measurements;” Examiner respectfully disagrees. Dayan describes, in [0067] and [0072], the frequency of taking updated measurements of TEWL (based on mean water loss in g/m.sup.2 per hour), erythema, and skin conductance at 2 week intervals during the course of the 8 week treatment period.
Claim Rejections - 35 USC § 103
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.
Claim(s) 16, 19, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dayan (US 20080103207 A1) in view of Hakozaki (US 20200009123 A1).
Regarding claim 16, Dayan teaches a method of identifying and treating a patient at risk of tissue damage ([0009] “Methods of treating an aging-related skin condition, dry skin, skin irritation, skin wrinkles, a condition in which the skin barrier is compromised, damaged, or disordered, or combination thereof in a subject comprising administering a pharmaceutically acceptable amount of the composition are also included in the present invention”), the method comprising the steps of:
a) evaluating a patient for a risk of tissue damage upon admission to a care facility, wherein the evaluating step comprises: i) taking a first plurality of TEWL measurements in the patient; ii) determining a first average TEWL value of the initial set of TEWL measurements ([0067] “Measurements of TEWL, erythema, and skin conductance were taken on the intact and the insulted skin of the women at 2 week intervals during the course of the 8 week treatment period.” [0072] “TEWL was measured by mean water loss (g/m.sup.2 per hour)”). While Dayan uses TEWL measurements to determine effectiveness of a treatment, Dayan fails to disclose administering an intervention based on how TEWL compares with a threshold.
Hakozaki teaches a method of treating a skin barrier condition. Hakozaki discloses:
b) administering a first intervention of level-0 if the first average TEWL value is below or equal to a first threshold ([0045] “applying the low-pH composition to the target portion of skin… the target portion of skin may be identified as needing treatment if it exhibits a trans-epidermal water loss (TEWL) that exceeds a threshold level… a target portion of skin may be selected that does not currently exhibit signs of reduced barrier function, but the user desires to provide a preventative benefit, especially if the target portion of skin has previously exhibited signs of reduced barrier function.”); and c) administering a first intervention of level-N if the first average TEWL value is above the first threshold, where N is an integer and N has a value of 1 or greater ([0045] “The low-pH compositions herein include an effective amount of a vitamin B.sub.3 compound and are formulated for topical application to skin. The method involves identifying a target portion of skin on a person in need of treatment or where treatment is desired (e.g., skin that is exhibiting impaired barrier function) and applying the low-pH composition to the target portion of skin. … The target portion of skin may be identified according to known methods of identifying skin with impaired barrier function. … the target portion of skin may be identified as needing treatment if it exhibits a trans-epidermal water loss (TEWL) that exceeds a threshold level”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Dayan to include administering an intervention based on how TEWL compares with a threshold as disclosed in Hakozaki to better identify a target portion of skin on a person in need of treatment (Hakozaki [0045]).
Regarding claim 19, the combination of Dayan/Hakozaki discloses the method of claim 16, wherein the first intervention of level-N is selected from the group consisting of a barrier cream, a topical cream (Dayan: [0072] “application of either the 0.5% (wt/vol) ceramide NS composition;” Hakozaki: [0045] “applying the low-pH composition to the target portion of skin”).
Regarding claim 22, the combination of Dayan/Hakozaki discloses the method of claim 16, wherein the first average TEWL value is determined from a subset of the first plurality of TEWL measurements (Dayan: [0072] “TEWL was measured by mean water loss (g/m.sup.2 per hour) at baseline (i.e., before application of a composition) and at 2, 4, 6 and 8 weeks after application”).
Claim(s) 17-18, 20-21, and 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dayan (US 20080103207 A1) in view of Hakozaki (US 20200009123 A1), and in further view of Bates-Jenson (DOl:10.1111/wr.12548) and American (https://www.facs.org/media/32hdibi4/wound_pressure_ulcers.pdf).
Regarding claim 17, the combination of Dayan/Hakozaki discloses the method of claim 16, further comprising the steps of:
a) taking a second plurality of TEWL measurements in the patient at a first pre-determined frequency corresponding to the administered intervention level; b) determining a second average TEWL value of the second plurality of TEWL measurements (Dayan: [0067] “Measurements of TEWL, erythema, and skin conductance were taken on the intact and the insulted skin of the women at 2 week intervals during the course of the 8 week treatment period.” [0072] “TEWL was measured by mean water loss (g/m.sup.2 per hour) at baseline (i.e., before application of a composition) and at 2, 4, 6 and 8 weeks after application of either the 0.5% (wt/vol) ceramide NS composition in the vehicle or the vehicle to the skin.”).
c) determining whether the second average TEWL value exceeds (Dayan: [0072] “TEWL was measured by mean water loss (g/m.sup.2 per hour) at baseline (i.e., before application of a composition) and at 2, 4, 6 and 8 weeks after application;” Hakozaki: [0045] “the target portion of skin may be identified as needing treatment if it exhibits a trans-epidermal water loss (TEWL) that exceeds a threshold level”).
However, the combination of Dayan/Hakozaki fails to disclose a second threshold, second intervention of a higher level, and a second pre-determined frequency.
Bates-Jenson teaches the relationship between subepidermal moisture measured using surface electrical capacitance and visual skin assessment of pressure ulcers to inform treatment. Bates-Jenson discloses a second threshold (Pg 506, col 1 [1] “SEM [subepidermal moisture evaluates damage similarly to TEWL] was lowest for normal skin (37.1 TDC), and significantly higher for erythema (38.4 TDC), stage 1 PUs (39.3 TDC), and stage 2+ PUs (40.1 TDC) at the sacrum (Table 2, F (3,199) = 17.22, P < =0.0001).” Pg 507, col 1 [2] “SEM values of 39, 41, 43, and 45 TDC were examined as possible threshold values in multinomial logistic regression models.” Pg 506, col 2 [2] “Findings demonstrated the potential for SEM as a method of detecting pressure-induced tissue damage (Table 3).”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Dayan/Hakozaki to include multiple thresholds reflective of skin barrier and pressure injury damage as disclosed in Bates-Jenson to enable more accurate detection of damage based on an objective bio-physical measure, allowing for better evaluation of the progression of the condition (Bates-Jenson, pg 509, col 1 [6]).
The combination of Dayan/Hakozaki/Bates-Jenson discloses d) continuing to administer the first intervention if the second average TEWL value does not exceed the second threshold; e) continuing to take a plurality of TEWL measurements at the first pre-determined frequency if the second average TEWL value does not exceed the second threshold (Hakozaki: [0045] “applying the low-pH composition to the target portion of skin… a target portion of skin may be selected that does not currently exhibit signs of reduced barrier function [below the TEWL threshold of damage described in Hakozaki and the thresholds for damage outlined in Bates-Jenson], but the user desires to provide a preventative benefit, especially if the target portion of skin has previously exhibited signs of reduced barrier function.” Dayan: [0067] “Measurements of TEWL, erythema, and skin conductance were taken on the intact and the insulted skin of the women at 2 week intervals during the course of the 8 week treatment period.” [0072] “TEWL was measured by mean water loss (g/m.sup.2 per hour) at baseline (i.e., before application of a composition) and at 2, 4, 6 and 8 weeks after application”).
However, the combination of Dayan/Hakozaki/Bates-Jenson fails to disclose a second intervention of a higher level and a second pre-determined frequency.
American teaches a wound home skills kit for pressure ulcers. The combination of Dayan/Hakozaki/Bates-Jenson/American discloses:
f) administering a second intervention of level-M if the second average TEWL value exceeds the second threshold (Hakozaki: [0045] “the target portion of skin may be identified as needing treatment if it exhibits a trans-epidermal water loss (TEWL) that exceeds a threshold level;” Bates-Jenson: Pg 506, col 1 [1] “SEM [subepidermal moisture, similarly evaluates damage to that of TEWL] was lowest for normal skin (37.1 TDC), and significantly higher for erythema (38.4 TDC), stage 1 PUs (39.3 TDC), and stage 2+ PUs (40.1 TDC) at the sacrum (Table 2, F (3,199) = 17.22, P < =0.0001).” Pg 507, col 1 [2] “SEM values of 39, 41, 43, and 45 TDC were examined as possible threshold values in multinomial logistic regression models.” American: pg 7, Stage 1 interventions – “Use a barrier cream on skin around the wound… Use a clear film dressing to protect the wound;” pg 8, Stage 2 interventions – “Follow the steps in Stage 1” and “use an alginate or hydrocolloid dressing”), where M is an integer and M is greater than N (Dayan’s [0072] “application of either the 0.5% (wt/vol) ceramide NS composition” and Hakozaki’s [0045] “applying the low-pH composition to the target portion of skin” aligns with American Stage 1 intervention and are of lower-level intervention vs the Stage 2 interventions); and
g) taking a plurality of TEWL measurements at a second pre-determined frequency corresponding to level-M if the second average TEWL value exceeds the second threshold (Dayan: [0067] “Measurements of TEWL, erythema, and skin conductance were taken on the intact and the insulted skin of the women at 2 week intervals during the course of the 8 week treatment period.” Bates-Jenson: Pg 506, col 1 [1] “SEM [subepidermal moisture, similarly evaluates damage to that of TEWL] was … stage 1 PUs (39.3 TDC), and stage 2+ PUs (40.1 TDC).” Pg 507, col 1 [2] “SEM values of 39, 41, 43, and 45 TDC were examined as possible threshold values.” American: Stage 2 interventions include “Inspect the area [measure average TEWL value per Dayan/SEM per Bates-Jenson] at least twice a day” on pg 7).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Dayan/Hakozaki/Bates-Jenson to include a second intervention of a higher level and a second pre-determined frequency as disclosed in American to better care for slow healing or chronic pressure ulcers, watch for improvements, and prevent other pressure ulcers (American pg 2).
Regarding claim 18, the combination of Dayan/Hakozaki/Bates-Jenson/American discloses the method of claim 17, further comprising the steps of:
a) determining whether the second average TEWL value is less than a third threshold (Dayan: [0072] “TEWL was measured by mean water loss (g/m.sup.2 per hour) at baseline (i.e., before application of a composition) and at 2, 4, 6 and 8 weeks after application;” Hakozaki: [0045] “the target portion of skin may be identified as needing treatment if it exhibits a trans-epidermal water loss (TEWL) that exceeds a threshold level;” Bates-Jenson: Pg 506, col 1 [1] “SEM [subepidermal moisture, similarly evaluates damage to that of TEWL] was lowest for normal skin (37.1 TDC), and significantly higher for erythema (38.4 TDC), stage 1 PUs (39.3 TDC), and stage 2+ PUs (40.1 TDC).” Pg 507, col 1 [2] “SEM values of 39, 41, 43, and 45 TDC were examined as possible threshold values.”);
b) continuing to administer the first intervention if the second average TEWL value is not less than the third threshold; c) continuing to take a plurality of TEWL measurements at the first pre-determined frequency if the second average TEWL value is not less than the third threshold (Dayan: [0067] “Measurements of TEWL, erythema, and skin conductance were taken on the intact and the insulted skin of the women at 2 week intervals during the course of the 8 week treatment period.” [0072] “TEWL was measured by mean water loss (g/m.sup.2 per hour) at baseline (i.e., before application of a composition) and at 2, 4, 6 and 8 weeks after application.” Hakozaki: [0045] “The low-pH compositions herein include an effective amount of a vitamin B.sub.3 compound and are formulated for topical application to skin… the target portion of skin may be identified as needing treatment if it exhibits a trans-epidermal water loss (TEWL) that exceeds a threshold level [greater than threshold for erythema but lower than threshold for stage 1 outlined in Bates-Jenson],”);
d) administering a third intervention of level-L if the second average TEWL value is less than the third threshold and if the first intervention is not of level-0, where L is an integer and L is less than N (Hakozaki: [0045] “the target portion of skin may be identified as needing treatment if it exhibits a trans-epidermal water loss (TEWL) that exceeds a threshold level… a target portion of skin may be selected that does not currently exhibit signs of reduced barrier function, but the user desires to provide a preventative benefit, especially if the target portion of skin has previously exhibited signs of reduced barrier function [applying the low-pH composition to skin with values greater than the Bates-Jenson erythema threshold but lower than the Bates-Jenson threshold for stage 1]”.); and
e) taking a plurality of TEWL measurements at a pre-determined frequency corresponding to level-L if the second average TEWL value is less than the third threshold (Dayan: [0072] “TEWL was measured by mean water loss (g/m.sup.2 per hour) at baseline (i.e., before application of a composition) and at 2, 4, 6 and 8 weeks after application;” frequency shifts when determined to be Stage 2 per American).
Regarding claim 20, the combination of Dayan/Hakozaki/Bates-Jenson/American discloses the method of claim 17, wherein the second intervention of level-M is selected from the group consisting of a barrier cream, a composite dressing (American: pg 7, Stage 1 interventions – “Use a barrier cream on skin around the wound; pg 8, Stage 2 interventions – “Follow the steps in Stage 1” and “use an alginate or hydrocolloid dressing”).
Regarding claim 21, the combination of Dayan/Hakozaki/Bates-Jenson/American discloses the method of claim 18, wherein the third intervention of level-L is selected from the group consisting of a barrier cream, a topical cream (Dayan: [0072] “application of either the 0.5% (wt/vol) ceramide NS composition;” Hakozaki: [0045] “applying the low-pH composition to the target portion of skin”).
Regarding claim 23, the combination of Dayan/Hakozaki/Bates-Jenson/American discloses the method of claim 17, wherein the second average TEWL value is determined from a subset of the second plurality of TEWL measurements (Dayan: [0072] “TEWL was measured by mean water loss (g/m.sup.2 per hour) at baseline (i.e., before application of a composition) and at 2, 4, 6 and 8 weeks after application.”).
Regarding claim 24, the combination of Dayan/Hakozaki/Bates-Jenson/American discloses the method of claim 17, wherein the second threshold is equal to the first threshold (Dayan: [0072] “TEWL was measured by mean water loss (g/m.sup.2 per hour) at baseline (i.e., before application of a composition) and at 2, 4, 6 and 8 weeks after application;” Hakozaki: [0045] “the target portion of skin may be identified as needing treatment if it exhibits a trans-epidermal water loss (TEWL) that exceeds a threshold level; Bates-Jenson: Pg 506, col 1 [1] “SEM [subepidermal moisture, similarly evaluates damage to that of TEWL] was lowest for normal skin (37.1 TDC), and significantly higher for erythema (38.4 TDC), stage 1 PUs (39.3 TDC), and stage 2+ PUs (40.1 TDC); pg 507 col 2 [2] “Using SEM thresholds, the percent of observations with erythema, stage 1 PU, or stage 2 and greater PU the next week was 41% (SEM = 39 TDC)”).
Regarding claim 25, the combination of Dayan/Hakozaki/Bates-Jenson/American discloses the method of claim 18, wherein the third threshold is equal to the first threshold (Dayan: [0072] “TEWL was measured by mean water loss (g/m.sup.2 per hour) at baseline (i.e., before application of a composition) and at 2, 4, 6 and 8 weeks after application;” Hakozaki: [0045] “the target portion of skin may be identified as needing treatment if it exhibits a trans-epidermal water loss (TEWL) that exceeds a threshold level; Bates-Jenson: Pg 506, col 1 [1] “SEM [subepidermal moisture, similarly evaluates damage to that of TEWL] was lowest for normal skin (37.1 TDC), and significantly higher for erythema (38.4 TDC), stage 1 PUs (39.3 TDC), and stage 2+ PUs (40.1 TDC); pg 507 col 2 [2] “Using SEM thresholds, the percent of observations with erythema, stage 1 PU, or stage 2 and greater PU the next week was 41% (SEM = 39 TDC)”).
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on February 9, 2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/M.H./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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