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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/06/2025 has been entered.
Status of the Claims
The amendment filed 11/06/2025 has been entered. Claims 1, 6-20 and 22-30 are pending and under consideration.
Response to Arguments
In response to applicant’s argument, see pages 1-3, with respect 35 USC 103 rejections have been considered and are at least partially persuasive, but are moot in light of new rejection/interpretation.
There are no distinct arguments directed to dependent claims.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the actuator of claim 30 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 11 and 30 are objected to because of the following informalities:
Claim 11 lines 3-4 recites “the dressing system” which should read “the wound dressing’s”
Claim 30 line 2 recites “the dressing system” which should read “the wound dressing”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: an actuator configured to control actuation of the dressing system in claim 30.
For the examination purpose, the limitation is being interpreted in its broadest reasonable interpretation.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 30 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 30 recites “an actuator” which renders the claim indefinite. The specification fails to provide support, i.e., specific structure description, physical characteristics, or examples (e.g., a switch, button, pump or motor), corresponding to this term (see specification [0057]). Without the support, one of ordinary skill in the art would not understand what it is. For the examination purpose, the examiner will interpret the limitation of an “actuator” in its broadest reasonable interpretation.
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.
Claims 1, 6-8, 11, 13, 15, 17-20 and 22-28 are rejected under 35 U.S.C. 103 as being unpatentable over Beadle et al (WO 2018/060417 A1) in view of Connolly et al (US 2008/0171957 A1) and Hunt (US 20220031231 A1, effectively filed 2017/11/15).
Regarding Claim 1 and claims dependent therefrom, Beadle 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 comprising:
an absorbent pad (figure 9, absorbent layer 922);
at least one sensor for detecting wound data ([0007], [0047] and figure 9, electronic assembly 950 comprising at least one sensor for detecting saturation); and
an electronic module communicable with the at least one sensor ([0070] and figure 9, electronic unit comprising circuit board include electronics including sensors, the electronic unit communicable with the sensor),
wherein the absorbent pad, the at least one sensor and the electronic module are integrally formed in the wound dressing (figure 9, absorbent pad 900 integrally formed with the electronics assembly 950),
wherein the at least one sensor comprises a moisture sensor 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 communications module configured to continuously communicate data, including the wound data, from the electronic module.
Beadle does not teach wherein the at least one sensor comprises a moisture sensor 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
In the same field of endeavor, namely a wound dressing and performance measured of such dressings, Connolly teaches wherein the at least one sensor (figure 1 and [0025], [0043]-[0045] and [0062] sensor array comprising plurality of electrode pairs 20ab, 22ab, 24ab and 26ab provided on the absorbent pads 15a-d, the sensor array configured to map and monitor hydration level across the dressing) comprises a moisture sensor 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 (figure 1 and [0025], [0043]-[0045] and [0062], electrode pairs 20ab, 22ab, 24ab and 26ab are disposed along the periphery of the absorbent pad, i.e., offset with respect to the center of the absorbent pad, The absorbent material (e.g., gauze 16a-d) absorbs the exudate and delays its outward diffusion from the center toward the periphery, thereby facilitating the mapping and measurement of exudate travel) 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
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 Beadle to incorporate the teachings of Connolly and provides the at least one sensor as claimed, and one of skill in the art motivated to do so, for the purpose of monitoring and mapping the moisture distribution throughout the dressing, providing an accurate assessment of hydration level across the pad, as taught by Connolly ([0043]-[0045]).
The combination does not teach wherein the electronic module comprises a communications module configured to continuously communicate data, including the wound data, from the electronic module.
In the same field of endeavor, namely an integrated sensor enabled wound monitoring, Hunt teaches wherein the electronic module comprises a communications module (figure 1a, [0009] [0172]-[0180] controller 24 includes communication device 30 is configured to periodically communicate measurement date from the controller over wireless interface, the measurement data obtained from sensor including wound status) configured to continuously communicate data, including 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 Beadle, as modified by Connolly, to incorporate the teachings of Hunt and provide the electronic module as claimed for the purpose of closely monitor wound healing progression as taught by Hunt ([0004]). Furthermore, it allows remote diagnostic and patient management, allowing clinicians to make timely treatment decision based on real-time data without requiring physically present near the patient.
Regarding Claim 6, Beadle, as modified by Connolly and Hunt, 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, Connolly teaches the peripheral sensor located on the periphery of the absorbent pad as presented in claim 1
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 Beadle, as modified by Connolly and Hunt, 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. 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, Beadle, as modified by Connolly and Hunt, teaches the wound dressing as claimed in claim 1.
The combination further teaches wherein the wound dressing further comprises a diffusion barrier (Beadle; figure 9 and [0040], absorbent layer 922 comprising superabsorbent material) to delay diffusion of wound exudate towards the at least one sensor (Beadle; the absorbent layer is configured to absorb and retains the exudate which inherently delays diffusion of the exudate to reach the electronic assembly 950 comprising the at least one sensor).
Regarding claim 8, Beadle, as modified by Connolly and Hunt, 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 (Beadle; figure 9 and [0040], the absorbent layer 922 is configured to diffuse wound exudate toward an electronic assembly thereby defining a delayed fluid channel between the wound and the electronic assembly 950).
Regarding claim 11, Beadle, as modified by Connolly and Hunt, 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 (Connolly; figure 1, sensor array comprising plurality of electrode pairs 20ab, 22ab, 24ab and 26ab are 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 13, Beadle, as modified by Connolly and Hunt, teaches the wound dressing as claimed in claim 1.
The combination further teaches wherein the at least one sensor further comprises a pressure sensor (Beadle; [0057] the sensor can include a pressure sensor).
Regarding Claim 15, Beadle, as modified by Connolly and Hunt, teaches the wound dressing as claimed in claim 1.
The combination further teaches wherein the sensor further comprises a temperature sensor (Beadle; [0057]).
Regarding Claim 17, Beadle, as modified by Connolly and Hunt, 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 (Beadle; figure 9 and [0061] “a portion of the electronics area can be offset from the absorbent area”).
Regarding Claim 18, Beadle, as modified by Connolly and Hunt, teaches the wound dressing as claimed in claim 1.
The combination further teaches wherein the electronic module is located towards a periphery of the absorbent pad (Beadle; figure 9 and [0061] “a portion of the electronics area can be offset from the absorbent area” electronic assembly 950 located toward the periphery of the absorbent pad 922).
Regarding Claim 19, Beadle, as modified by Connolly and Hunt, teaches the wound dressing as claimed in claim 1.
The combination does not teach wherein the electronic module is located beyond the periphery of the absorbent pad. However, Beadle teaches that the electronic module is located towards a periphery of the absorbent pad (Beadle; figure 9 and [0061] “a portion of the electronics area can be offset from the absorbent area” electronic assembly 950 located toward the periphery of the absorbent pad 922).
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 Beadle, as modified by Connolly and Hunt, to rearrange the electronic module from the periphery of the absorbent pad to beyond the periphery of the absorbent pad, since the modification would have involved a mere rearrangement of parts. Rearrangement of parts is generally recognized as being within the level of ordinary skill in the art In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (see MPEP 2144.04) In the instant case, one of skill in the art motivated to do so for the purpose of providing reduced profile of the pad. Furthermore, applicant has not shown unexpected result or criticality from having the electronic module located beyond the periphery of the absorbent pad ([0024]), and therefore the claimed device is not patentably distinct from the prior art device.
Regarding Claim 20, Beadle, as modified by Connolly and Hunt, teaches the wound dressing as claimed in claim 19.
The combination does not teach wherein the electronic module is located beyond the periphery of the absorbent pad on a substrate. However, Beadle teaches that the electronic module is located towards a periphery of the absorbent pad on a substrate(Beadle; figures 6 9 and [0061] “a portion of the electronics area can be offset from the absorbent area” electronic assembly 950 located toward the periphery of the absorbent pad 922, and the assembly include pcb 681).
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 Beadle, as modified by Connolly and Hunt, to rearrange the electronic module from the periphery of the absorbent pad to beyond the periphery of the absorbent pad on a substrate, since the modification would have involved a mere rearrangement of parts. Rearrangement of parts is generally recognized as being within the level of ordinary skill in the art In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (see MPEP 2144.04) In the instant case, one of skill in the art motivated to do so for the purpose of providing reduced profile of the pad. Furthermore, applicant has not shown unexpected result or criticality from having the electronic module located beyond the periphery of the absorbent pad ([0024]), and therefore the claimed device is not patentably distinct from the prior art device.
Regarding claim 22, Beadle, as modified Connolly and Hunt, teaches the wound dressing as claimed in claim 1.
The combination further teaches wherein the communications module comprise a wireless communication module (Hunt; figure 1a, [0009] [0172]-[0180] controller 24 includes communication device 30 is configured to periodically communicate measurement date from the controller over wireless interface, the measurement data obtained from sensor including wound status).
Regarding Claim 23, Beadle, as modified Connolly and Hunt, 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 (Beadle; [0007] “The electronic components can comprise one or more of a power source”)
Regarding Claim 24, Beadle, as modified Connolly and Hunt, teaches the dressing system as claimed in claim 23.
The combination further teaches wherein the power source comprises a battery (Beadle; [0055]-[0057], a power source for electronic module comprises one or more batteries).
Regarding Claim 25, Beadle, as modified Connolly and Hunt, teaches the dressing system as claimed in claim 21.
The combination further teaches wherein the dressing system further comprises a backing film on the absorbent pad (Beadle; figure 9, backing layer 913)
Regarding claim 26, Beadle, as modified Connolly and Hunt, teaches the wound dressing as claimed claim 1.
The combination further teaches wherein the communications module is configured to wirelessly communicate sensor data to a base station (Hunt; figure 1a, [0172]-[0178] communication device 30 is configured to be connected to computing device 40 via wireless interface, and transmit measurement data including wound status from sensor).
Regarding claim 27, Beadle, as modified Connolly and Hunt, teaches the wound dressing as claimed claim 26.
The combination further teaches wherein the base station is attended by a clinician (Hunt; figure 1a and [0172]-[0180] communication device 30 can be a tablet or smartphone that can be attended by clinician).
Regarding claim 28, Beadle, as modified, Connolly and Hunt, teaches the dressing system 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 (Hunt; figure 1a and [0172]-[0180] communication device 30 is configured to periodically communicate measurement data from the controller to computing device 40 including a tablet or smartphone which can be remotely monitored by a clinician)
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Beadle et al (WO 2018060417 A1) in view of Connolly et al (US 20080171957 A1) and Hunt (US 20220031231 A1, effectively filed 2017/11/15), and in further view of Mody (US 20040191118 A1).
Regarding claim 9, Beadle, as modified Connolly and Hunt, teaches the wound dressing as claimed claim 1.
The combination further teaches wherein the absorbent pad comprises a first superabsorbent layer (Beadle; figure 9 [0038] absorbent layer 922 includes form of a superabsorbent layer) and the diffusion barrier comprises a second superabsorbent layer between the at least one sensor and behind the first superabsorbent layer.
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 (figure 2 [0045], fluid barrier layer 22 comprising superabsorbent polymer increases fluid transmission time toward indicating agent 24) 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 Beadle, as modified by Connolly and Hunt, 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, Beadle, as modified Connolly, Hunt and Mody, teaches the wound dressing as claimed claim 9.
The combination further teaches wherein the first and second superabsorbent layers comprises a superabsorbent fiber layer (Beadle; [0041] absorbent layer is layer of non-woven cellulose fiber having super absorbent material).
The combination does not teach the second superabsorbent layer comprises a superabsorbent fiber layer as Mody teaches the second superabsorbent layer comprises superabsorbent polymer dispersed in a polypropylene matrix ([0045])
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 Beadle, as modified Connolly, Hunt and Mody, to incorporate the teachings of Beadle and substitutes the second superabsorbent layer of Mody (superabsorbent polymer dispersed in a polypropylene matrix) with another (non-woven cellulose fiber having super absorbent material) as the modification would have been a simple substituting of known element with another to obtain predictable results (effectively absorbs fluid and delays the fluid reach the sensor too quickly)
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Beadle et al (WO 2018060417 A1) in view of Connolly et al (US 20080171957 A1) and Hunt (US 20220031231 A1, effectively filed 2017/11/15), and in further view of Rovaniemi (US 20160166438 A1).
Regarding Claim 12, Beadle, as modified by Connolly and Hunt, 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.
However, in the same field of endeavor, namely a wound dressing with a sensor, Rovaniemi teaches a wound dressing comprises a pH sensor ([0063] and [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 Beadle, as modified by Connolly and Hunt, and provides the pH sensor, and one of skill in the art motivated to do so, for the purpose of monitoring healing process of the wound, as taught by Rovaniemi ([0066]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Beadle et al (WO 2018060417 A1) in view of Connolly et al (US 20080171957 A1), and in further view of Allin et al (US 20140298927 A1).
Regarding Claim 14, Beadle, as modified by Connolly and Hunt, 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.
However, in the same field of endeavor, namely sensor for reporting information regarding wound dressings, Allin teaches a wound dressing comprises a bacterial sensor ([0061]).
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 Beadle, as modified by Connolly and Hunt, to incorporate the teachings of Allin and provide a bacterial sensor, and one of skill in the art motivated to do so, for the purpose of indicating infection of the wound, as taught by Allin ([0038]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Beadle et al (WO 2018060417 A1) in view of Connolly et al (US 20080171957 A1) and Hunt (US 20220031231 A1, effectively filed 2017/11/15), and in further view of Johnson et al (US 20150148762 A1).
Regarding Claim 16, Beadle, as modified by Connolly and Hunt, teaches the dressing system 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 Beadle, as modified by Connolly and Hunt, 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 Beadle et al (WO 2018060417 A1) in view of Connolly et al (US 20080171957 A1) and Hunt (US 20220031231 A1), and in further view of Locke et al (US 20130053799 A1) and Eggers (US 6801137 B2).
Regarding claim 29, Beadle, as modified, Connolly and Hunt, teaches the dressing system as claimed in claim 1.
The combination does not teach wherein the wound dressing comprises a peripheral adhesive side border configured to adhere the dressing to a patient.
In the same field of endeavor, namely absorbent polymer dressings, Locke teaches wherein the wound dressing (figure 1, 100) comprises a peripheral adhesive side border ([0018] and figure 1, attachment device 120, e.g., pressure-sensitive adhesive that extends about a periphery of sealing member 114) configured to adhere the dressing to a patient.
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 Beadle, as modified by Connolly and Hunt, to incorporate the teachings of Locke and provide the wound dressing comprising the peripheral adhesive side boarder for the purpose of providing sealed space under the dressing as taught by Locke ([0005]) which helps maintain sterility and a moist wound environment that facilitates wound healing.
The combination is still silent as to 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 Beadle, as modified by Connolly and Locke, 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.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Beadle et al (WO 2018060417 A1) in view of Connolly et al (US 20080171957 A1) and Hunt (US 20220031231 A1), and in further view of Coulthard et al (US 20120109083 A1).
Regarding claim 30, Beadle, as modified, Connolly and Hunt, teaches the dressing system as claimed in claim 1.
The combination does not teach further comprising an actuator configured to control actuation of the wound dressing.
In the same field of endeavor, namely a reduced-pressure systems, dressing, Coulthard teaches a reduced pressure system (figs 9-11, 300) comprising an actuator ([0078] piezoelectric actuator is driven to act as a buzzer or vibrating alert system at times) configured to control actuation of the wound dressing.
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 Beadle, as modified by Connolly and Hunt, to incorporate the teachings of Coulthard and provides the actuator as claimed for the purpose of alert a user to an alarm condition, as taught by Coulthard ([0078]).
Conclusion
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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/SETH HAN/Examiner, Art Unit 3781
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