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 .
Status of the Claims
The amendment filed 05/25/2026 has been entered. Claims 1, 6-20, 22-29 and 31 are pending and under consideration.
Response to Arguments
In response to applicant’s argument, see pages 2-4, with respect to 35 USC 103 rejections have been considered and are at least partially persuasive, but are moot in light of new rejection/interpretation
In response to applicant’s argument, see pages 4-5, with respect to dependent claims that applicant argues that the cited secondary reference does not teach the limitation recited in the dependent claims. However, applicant has not specifically addressed the examiner’s findings regarding the cited reference or identify any particular deficiency in the rejection. Therefore, the augment is not persuasive, and therefore the rejection is maintained for the reasons previously set forth in the previous rejection.
Claim Objections
Claims 26, 28 and 29 are objected to because of the following informalities:
Claim 26 line 1 recites “the communication module” which should read “the near field communication module”
Claim 28 line 1 recites “the communication module” which should read “the near field communication module”
Claim 29 line 3 recites “the communication module” which should read “the near field communication module”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 17-20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 17-20 depend from the claim 1, which recites that “wherein the electronic module is located beyond the periphery of the absorbent pad on a substrate”. Claims 17-18 further recite that (claim 17) wherein the electronic module is offset with respect to the absorbent pad; (Claim 18) wherein the electronic module is located towards a periphery of the absorbent pad; (Claim 19) wherein the electronic module is located beyond the periphery of the absorbent pad.; and (Claim 20) wherein the electronic module is located beyond the periphery of the absorbent pad on a substrate, which does not further limit the subject matter of clam 1 because the recited location is broader than, or otherwise encompasses, the location recited in claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 6-8, 11-15, 17-20, 22-28 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Askem et al (US 20150174304 A1) in view of Schoess et al (US 20190192066 A1)
Regarding claim 1, Askem substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
A wound dressing (figure 3a, dressing kit 90 further shown in figure 10a dressing kit 230) comprising:
an absorbent pad (figure 10a and [0286] dressing packaging 238);
at least one sensor for detecting wound data ([0409] the dressing can have one or more sensors that detecting wound data, e.g., saturation level); and
an electronic module (figure 10a and [0271] pump assembly 232 includes pcb or other pump controller) communicable with the at least one sensor,
wherein the absorbent pad, the at least one sensor and the electronic module are integrally formed in the wound dressing (figure 3a and 10a, the dressing packaging, the one or more sensors and the pump assembly are integrally formed in the wound dressing),
wherein the at least one sensor comprises a moisture sensor ([0409] one or more sensors could be moisture sensor provided within the dressing configured to map level of saturation within the dressing) array provided on or in the absorbent pad and adapted to map the progress of exudate in the absorbent pad, and
wherein the moisture sensor array comprises a plurality of moisture sensors radially offset with respect to the centre of the absorbent pad including a peripheral moisture sensor located towards a periphery of the absorbent pad such that radial positional offsetting of the moisture sensors causes a delay in diffusion of exudate to the moisture sensors so that travel of wound exudate can be mapped and/or measured, and
wherein the electronic module comprises a near field communications module configured to continuously communicate data, including the wound data, from the electronic module and wherein the electronic module is located beyond the periphery of the absorbent pad on a substrate (figure 3a and 10a and [0272 and 0273], the pump assembly on circuit board is located beyond the periphery of the dressing packaging 238).
Askem does not expressly teach the electronic module communicable with the at least one sensor;
wherein the at least one sensor comprises a moisture sensor array;
wherein the moisture sensor array comprises a plurality of moisture sensors radially offset with respect to the centre of the absorbent pad including a peripheral moisture sensor located towards a periphery of the absorbent pad such that radial positional offsetting of the moisture sensors causes a delay in diffusion of exudate to the moisture sensors so that travel of wound exudate can be mapped and/or measured, and
wherein the electronic module comprises a near field communications module configured to continuously communicate data, including the wound data, from the electronic module.
In the same field of endeavor, namely moisture assessment system and method for wound care, Schoess teaches the electronic module communicable with the at least one sensor (figure 9, control module 170 is communicable with sensor array 180);
wherein the at least one sensor comprises a moisture sensor array (figures 3 and 9 and [0064] array of moisture sensors 105);
wherein the moisture sensor array comprises a plurality of moisture sensors (figures 3, 9 and 12 and [0064] at least eight moisture sensors 105 located toward the periphery of substrate 102 and absorbent layer underneath absorbs the exudate and delays its outward diffusion from the center toward the periphery, thereby enables the mapping and measurement of exudate travel) radially offset with respect to the centre of the absorbent pad including a peripheral moisture sensor located towards a periphery of the absorbent pad such that radial positional offsetting of the moisture sensors causes a delay in diffusion of exudate to the moisture sensors so that travel of wound exudate can be mapped and/or measured ([0061]), and
wherein the electronic module comprises a near field communications module (figure 9 and [0073] NFC codec 172 configured to communicate one or more moisture level readings) configured to continuously communicate data, including the wound data, from the electronic module.
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 Askem to incorporate the teachings of Schoess and provides the moisture sensor array and the electronic module as claimed for the purpose of creating a map of wound moisture or exudate thereby monitoring wound status while wirelessly obtaining a moisture measurement as taught by Schoess ([0010, 0041 and 0064]).
Regarding claim 6, Askem, as modified by Schoess, teaches the wound dressing as claimed in claim 1.
The combination does not teach the peripheral sensor is located beyond the periphery of the absorbent pad.
However, Schoess teaches the peripheral sensor located about the periphery of the absorbent pad as presented in claim 1
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 Askem, as modified by Schoess, such that the peripheral sensor is located beyond the periphery of the absorbent pad, and such as the modification would have been an obvious matter of design choice involving a rearrangement of part and a routine design choice. A rearrangement of parts is generally recognized as being with the level of ordinary skill in the art (see MPEP 2144.04). In the instant case, one of skill in the art motivated to do so for the purpose of positioning plurality of the periphery sensors farther apart from the center and each other, which would reduce interferences in reading among the plurality of the periphery sensor. Furthermore, applicant has not shown unexpected result gleaming from the claimed position ([0023]), and therefore the claimed device is not patentably distinct from the prior art device.
Regarding claim 7, Askem, as modified by Schoess, teaches the wound dressing as claimed in claim 1.
The combination further teaches wherein the dressing system further comprises a diffusion barrier (Askem; figure 10a and [0288] absorbent layer 236 positioned underneath the sensor is configured to absorb and retain the exudate, which delays transport of exudate toward the sensor) to delay diffusion of wound exudate towards the sensor.
Regarding claim 8, Askem, as modified by Schoess, teaches the wound dressing as claimed in claim 7.
The combination further teaches wherein the diffusion barrier comprises a delay channel defined in the absorbent pad (Askem; figure 10a and [0028] the absorbent layer defines the diffusion path in and across the absorbent pad which partially diffusively isolate the moisture sensor from the absorbent layer).
Regarding claim 11, Askem, as modified by Schoess, teaches the wound dressing as claimed in claim 1.
The combination further teaches wherein the moisture sensors of the moisture sensor array are offset with respect to the center of the absorbent pad (Schoess; figure 3, the sensor array 105 positioned offset with respect to the center of the absorbent pad as claimed. Consequently, the sensor would have delayed activation until the exudate has spread to the periphery from the center, which would inherently be after 50% capacity has been reached) so that activation of the moisture sensors is delayed until after about 50% of the dressing system capacity is reached.
In the alternative, in the event that this interpretation is not envisaged by applicant, It would have been obvious to one of ordinary skill in the art to place the sensor such that the dressing would absorb exudate at least 50% before reaching the periphery sensors for the purpose of preventing the sensors from reporting a false saturation level before the fluid has been effectively absorbed by the absorbent layer.
Regarding claim 12, Askem, as modified by Schoess, teaches the wound dressing as claimed in claim 1.
The combination does not teach wherein the at least one sensor further comprises a pH sensor.
In the same field of endeavor, namely a moisture assessment system, Schoess teaches a wound dressing comprises a pH sensor ([0066]).
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 Askem, as modified by Schoess, to incorporate the teachings of Schoess and provide the at least one sensor as claimed for the purpose of monitoring wound healing over time or to identify that a wound is worsening or becoming infected as taught by Schoess ([0041]).
Regarding claim 13, Askem, as modified by Schoess, teaches the wound dressing as claimed in claim 1.
The combination further teaches wherein the at least one sensor further comprises a pressure sensor (Askem; [0380]).
Regarding claim 14, Askem, as modified by Schoess, teaches the wound dressing as claimed in claim 1.
The combination does not teach wherein the at least one sensor further comprises a bacterial sensor.
In the same field of endeavor, namely a moisture assessment system, Schoess teaches wherein the at least one sensor further comprises a bacterial sensor (figure 9 and [0008] bacteria sensor 182).
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 Askem, as modified by Schoess, to incorporate the teachings of Schoess and provide the at least one sensor as claimed for the purpose of monitoring wound healing over time or to identify that a wound is worsening or becoming infected as taught by Schoess ([0041]).
Regarding claim 15, Askem, as modified by Schoess, teaches the wound dressing as claimed in claim 1.
The combination further teaches wherein the sensor further comprises a temperature sensor (Askem; [abstract and 0019]).
Regarding Claim 17, Askem, as modified by Schoess, teaches the wound dressing as claimed in claim 1.
The combination further teaches wherein the electronic module is offset with respect to the absorbent pad (Askem; figure 3a and 10a, the pump assembly is located beyond the periphery of the dressing packaging 238 ).
Regarding Claim 18, Askem, as modified by Schoess, teaches the wound dressing as claimed in claim 17.
The combination further teaches wherein the electronic module is located towards a periphery of the absorbent pad (Askem; figure 3a and 10a, the pump assembly is located beyond the periphery of the dressing packaging 238).
Regarding Claim 19, Askem, as modified by Schoess, teaches the wound dressing as claimed in claim 18.
The combination further teaches wherein the electronic module is located beyond the periphery of the absorbent pad (Askem; figure 3a and 10a, the pump assembly is located beyond the periphery of the dressing packaging 238)
Regarding Claim 20, Askem, as modified by Schoess, teaches the wound dressing as claimed in claim 19.
The combination further teaches wherein the electronic module is located beyond the periphery of the absorbent pad on a substrate (Askem; figure 3a and 10a, the pump assembly is located beyond the periphery of the dressing packaging 238).
Regarding claim 22, Askem, as modified by Schoess, teaches the wound dressing as claimed in claim 1.
The combination does not teach wherein the near field communications module comprises a wireless communications module.
In the same field of endeavor, namely a moisture assessment system, Schoess teaches wherein the near field communications module comprises a wireless communications module (figure 9 [0010, 0012 and 0014] at least NFC 172 communicate with reader 220 wirelessly).
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 Askem, as modified by Schoess, to incorporate the teachings of Schoess and provides the near field communications module as claimed for the purpose of enabling remote wound care as taught by Schoess ([0022]).
Regarding claim 23, Askem, as modified by Schoess, teaches the wound dressing as claimed in claim 1.
The combination further teaches wherein the electronic module further comprises a power source for powering the electronic module (Askem; figure 10a, batteries 234)
Regarding claim 24, Askem, as modified by Schoess, teaches the wound dressing as claimed in claim 23
The combination further teaches wherein the power source comprises a battery (Askem; figure 10a, batteries 234).
Regarding claim 25, Askem, as modified by Schoess, teaches the wound dressing as claimed in claim 23
The combination further teaches wherein the dressing system further comprises a backing film on the absorbent pad (Askem; figure 10a, backing layer 244).
Regarding claim 26, Askem, as modified by Schoess, teaches the wound dressing as claimed in claim 1.
The combination further teaches wherein the communication module is configured to wirelessly communicate sensor data to a base station (Schoess; figure 9 and [0072-0073 and 0091] the coupon 201 is wirelessly communicate sensor data to reader 220 and computing device 150).
Regarding claim 27, Askem, as modified by Schoess, teaches the wound dressing as claimed in claim 26.
The combination further teaches wherein the base station is attended by a clinician (Schoess; [0022, 0039 and 0043] the wireless reader 220 and computing device 150 is attended by clinician).
Regarding claim 28, Askem, as modified by Schoess, teaches the wound dressing as claimed in claim 1.
The combination further teaches wherein the communications module is configured to wirelessly communicate sensor data to a handheld device configured to provide a clinician with continuous data for monitoring and analyzing wounds (Schoess; figure 9 and [0022, 0039, 0043, 0052 and 0090] the NFC module is configured to wirelessly communicate the data to a reader, e.g., smartphone configured to provide the moisture assessment information to a clinician).
Regarding claim 31, Askem, as modified by Schoess, teaches the wound dressing as claimed in claim 1.
The combination further teaches wherein the wound dressing further comprises a diffusion barrier (Askem; figure 10a and [0288] absorbent layer 236 positioned underneath the sensor is configured to absorb and retain the exudate, which delays transport of exudate toward the sensor) to delay diffusion of wound exudate towards the at least one sensor and the diffusion barrier comprises a delay channel (Askem; figure 10a and [0028] the absorbent layer defines the diffusion path in and across the absorbent pad which partially diffusively isolate the moisture sensor from the absorbent layer), to partially diffusively isolate the moisture sensor from the absorbent pad.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Askem et al (US 20150174304 A1) in view of Schoess et al (US 20190192066 A1), and in further view of Mody (US 20040191118 A1)
Regarding claim 9, Askem, as modified by Schoess, teaches the wound dressing as claimed in claim 7.
The combination further teaches wherein the absorbent pad comprises a first superabsorbent layer (Askem; [0211] the absorbent layer comprises super-absorbent material).
The combination does not teach the diffusion barrier comprises a second superabsorbent layer between the at least one sensor and behind the first superabsorbent layer.
In the same field of endeavor, namely a wetness indicator, Mody teaches a wetness indicator (figure 2, 18) comprises a diffusion barrier (figures 2 [0045], fluid barrier layer 22 comprising superabsorbent polymer increases fluid transmission time toward indicating agent 24, further illustrated in figure 9, the wetness indicator comprises barrier layer 72, i.e., second superabsorbent layer, attached absorbent pad 84, i.e., first superabsorbent layer) to delay diffusion of wound exudate towards the at least one sensor.
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 Askem, as modified by Schoess, to incorporate the teachings of Mody and provide the wound dressing as claimed, for the purpose of regulating fluid transmission time to reach the at least one sensor as taught by Mody ([0045]). The diffusion barrier ensures that the sensor response time is synchronized with the absorption rate of the absorbent article. For example, the barrier prevents the sensors from reporting a false saturation level before the fluid has been effectively absorbed by the absorbent layer.
Regarding claim 10, Askem, as modified by Schoess and Mody, teaches the wound dressing as claimed in claim 7.
The combination further teaches wherein the first superabsorbent layer comprises superabsorbent fiber layers (Askem; [0218]).
The combination does not teach wherein the second superabsorbent layer comprises superabsorbent fiber layers; though
Mody teaches the second superabsorbent layer comprises superabsorbent polymer dispersed in a polypropylene matrix ([0045]).
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 Askem, as modified by Schoess and Mody, to incorporate the teachings of Askem and substitutes the second superabsorbent layer of Mody (superabsorbent polymer dispersed in a polypropylene matrix) with another (superabsorbent fiber layer) as the modification would have been a simple substituting of known element with another to obtain predictable results (effectively absorbs and retains fluid that delays the fluid reach the sensor).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Askem et al (US 20150174304 A1) in view of Schoess et al (US 20190192066 A1), and in further view of Johnson (US 20150148762 A1)
Regarding claim 16, Askem, as modified by Schoess, teaches the wound dressing as claimed in claim 1.
The combination does not teach the sensor further comprises an inertial sensor.
However, in the same field of endeavor, namely a medical dressing, Johnson teaches a sensor further comprises an inertial sensor ([0161] “sensing means to determine changes in the position of the subject, including e.g. a position tracking device (such as GPS) and/or one or more motion detectors such as an accelerometer or pressure transducer providing an indication of movement of the subject”).
Johnson provides the sensing means to determine changes in the position of the subject in order to track and detect the movement of its wearer and notify the status of wearer to its caregiver, ie wandering or falls, ([0161]).
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 Askem, as modified by Schoess, to incorporate the teachings of Johnson and provide the inertial sensor, and one of skill in the art motivated to do so, for the purpose of providing tracking of wearer’s movement to the caregiver.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Askem et al (US 20150174304 A1) in view of Schoess et al (US 20190192066 A1), and in further view of Eggers (US 6801137 B2).
Regarding claim 29, Askem, as modified by Schoess, teaches the wound dressing as claimed in claim 1.
The combination further teaches wherein the wound dressing comprises a peripheral adhesive side border (Askem; [0238] adhesive fixation strips can be positioned around the peripheral edges of the dressing) configured to adhere the dressing to a patient,
The combination does not expressly teach wherein the communications module is configured to wirelessly communicate sensor data to a hand-held device that is configured to enable real-time bi-directional communication between the patient and a clinician.
In the same field of endeavor, namely bidirectional communication between a sensor unit and a monitor unit in patient monitoring, Eggers teaches wherein the communications module is configured to wirelessly communicate sensor data to a hand-held device that is configured to enable real-time bi-directional communication between the patient and a clinician (figure 6, col 1 lines 40-60, col 6 lines 45-56, the sensor unit and monitor units enables wireless bidirectional communication).
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 Askem, as modified by Schoess, to incorporate the teachings of Eggers and provide the communication module as claimed for the purpose of transmits a warning signal to the sensor unit that request the patient to take one of many other possible actions such as replacing batteries in the sensor unit as taught by Eggers (col 1 lines 40-60), or overriding false alarm from the control module.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.H./Examiner, Art Unit 3781
/PHILIP R WIEST/ Primary Examiner, Art Unit 3781
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