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 07/17/2025 has been entered. At entry, claims 1 and 6-25 are pending and under consideration.
Response to Arguments
Applicant's arguments filed 07/17/2025 have been fully considered but they are not persuasive.
Applicant argues that a person skill in the relevant arts would have no reason to combine the references because they solve different problems and are inherently incompatible with one another as Beadle describes a dressing with integrated electronics which are for maintaining a negative pressure in a dressing and which are kept free from moisture while Connolly describes passive dressing which has electrodes which may be connected to external electronics. Examiner respectfully disagrees. Both Beadle and Connelly are directed to wound dressings, a common technical field, and a person of ordinary skill in the art would recognize that incorporating the moisture sensor array of Connolly for mapping hydration level across the dressing as a function of time (see Connolly [0043]-[0045]) into Beadle (negative wound pressure therapy system intended to accelerate wound healing progress) would enhance the dressing’s functionality by enabling monitoring moisture level across the dressing. In the examiner’s view such a combination would provide improvement - monitoring wound healing progress and provide tailored healing session response to the reading - and yield predicable results, and therefore, prima facie case of obviousness exist and the combination is proper (please see MPEP 2143.02).
Applicant further argues that the Beadle and Connolly are inherently incompatible with one another because the electronics of Beadle is designed to remain moisture-free, while the moisture sensor array of Connolly requires exposure to moisture. The examiner recognizes that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In the instant case, the integration of moisture sensor array, as taught by Connolly, into Beadle does not render the Beadle unsuitable for its intended purpose. One of skill in the art would have recofnized that the moisture sensor array can be positioned within the absorbent pad, separate from the electronics of Beadle, and the proposed combination still map the moisture level across the dressing as intended by Connolly without disrupting the operation of Beadle.
Applicant further argues that Beadle actively teaches away from the presently claimed invention, because it is concerned with preventing moisture from reaching its electronics. Examiner respectfully disagrees. As noted above, a person of ordinary skill in the art would understand that the moisture sensor array of Connolly can be integrated into Beadle without compromising the dry electronics required for Beadle, i.e., separating moisture sensor array from the electronics, and therefore Beadle does not teach away from the claimed invention.
Applicant further argues that Rovaniemi does not teach or suggest that “a diffusion barrier causes a delay in diffusion of exudate to the moisture sensors so that travel of wound exudate can be mapped and/or measured”. The limitation addressed above is recited in claims 7-8 and taught by Beadle. Rovaniemi is introduced to teach pH sensor in claim 12, and thus the argument is not persuasive.
Applicant further argues that Tallent describes a larger moisture sensing system designed to be integrated within a bed- it is not a wound dressing or a wearable device at all, and is intended for a completely different purpose. In the examiner’s view, Tallent teaches the activation of the moisture sensors is delayed until after 50% of the system capacity ([0005] and [0025]) for the purpose of indicating the moisture level to the user in the timely manner, while Beadle and Connolly are intended to monitor moisture level within the wound bed. In the examiner’s view, incorporating the sensing algorithm of Tallent into Beadle and Connolly to activate the sensor after 50% is predictable to one of ordinary skill in the art to optimize timely alerts, as taught by Tallent (see MPEP 2143.01) Thus, the rejection is proper and maintained.
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, 6-10, 13, 15, 17-20 and 23-25 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).
Regarding Claim 1, Beadle teaches a wound dressing comprising:
an absorbent pad (figure 9, assemblies of dressing 900);
at least one sensor ([0007] and figure 9, electronic assembly 950 comprising at least one sensor for detecting wound data) for detecting wound data; and
an electronic module ([0007] and figure 9, an electronic assembly 950 with embedded sensors that communicate with one another) communicable with the sensor,
wherein the absorbent pad, the at least one sensor and the electronic module are integrally formed in the wound dressing (see figure 9, absorbent pad 900, which includes an electronics assembly 950 with at least sensor, is constructed as a single integral unit).
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.
However, in the same field of endeavor, namely a wound dressing and performance measured of such dressings, Connolly teaches a wound dressing (figure 1, dressing 10) comprises at least one sensor (figure 1 and [0025], [0043]-[0045] and [0062] sensor array comprising plurality of electrode pair 20-26 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 comprises a plurality of moisture sensors radially offset with respect to the centre of the absorbent pad including a peripheral moisture sensor (figure 1 and [0025], [0043]-[0045] and [0062], the electrode pairs 20-26 placed around the periphery of the absorbent pad, and positioned away from the center of the absorbent) 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 (figure 1 and [0025], [0043]-[0045] and [0062] when exudate is released onto the center of the absorbent pad, the absorbent material, such as gauze 16a-c, absorbs and slows diffusion of the exudate toward the periphery of the pad, as such having at least one pair of electrodes, for example electrodes 20a and b, at the periphery can map and measures the travel of wound exudate from the center to the periphery).
Connolly teaches providing the plurality of electrodes positioned on periphery of the dressing in order to allows a picture of moisture through the dressing which maps the hydration level across the dressing ([0043]-[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 to incorporate the teachings of Connolly and provides 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 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.
Regarding Claim 6, Beadle, as modified by Connolly, teaches the wound dressing as claimed in claim 1.
Beadle 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, 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, teaches the wound dressing as claimed in claim 1.
Beadle further teaches wherein the wound dressing further comprises a diffusion barrier (Beadle; figure 9, absorbent layer 951) to delay diffusion of wound exudate towards the at least one sensor (Beadle; at least absorbent layer 951 absorbs and retains the exudate that delays diffusion of the exudate reach the electronic assembly 950).
Regarding Claim 8, Beadle, as modified by Connolly, teaches the wound dressing as claimed in claim 7.
Beadle further teaches wherein the diffusion barrier comprises a delay channel defined in the absorbent pad (Beadle; figure 9, the absorbent layer 951 provide a fluid communication between the assembly 950 forming a channel and the absorbent layer 922 while the absorbent material of the layer absorbs and delay the diffusion of wound toward the assembly).
Regarding Claim 9, Beadle, as modified by Connolly, teaches the wound dressing as claimed in claim 7.
Beadle further teaches wherein the absorbent pad comprises a first superabsorbent layer (Beadle; figure 9, absorbent layers 922 [0038] “In some embodiments, the absorbent includes a shaped form of a superabsorber layer.”) and the diffusion barrier comprises a second superabsorbent layer (Beadle; figure 9 absorbent layer 951 [0038] “In some embodiments, the absorbent includes a shaped form of a superabsorber layer.”) between the sensor and the first superabsorbent layer (Beadle; figure 9, the absorbent layer 951 is disposed between the electronic assembly 950 and the absorbent layer 922).
Regarding Claim 10, Beadle, as modified by Connolly, teaches the wound dressing as claimed in claim 9.
Beadle further teaches wherein the first and second superabsorbent layers comprise superabsorbent fibre layers (Beadle; [0038] and [0040] “In some embodiments, the absorbent includes a shaped form of a superabsorber layer” “A number of materials exist that are able to absorb liquid when under negative pressure, for example superabsorber material”).
Regarding Claim 13, Beadle, as modified by Connolly, teaches the wound dressing as claimed in claim 1.
Beadle further teaches wherein the at least one sensor further comprises a pressure sensor ([0057]).
Regarding Claim 15, Beadle, as modified by Connolly, teaches the wound dressing as claimed in claim 1.
Beadle further teaches wherein the sensor further comprises a temperature sensor ([0057]).
Regarding Claim 17, Beadle, as modified by Connolly, teaches the wound dressing as claimed in claim 1.
Beadle 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, teaches the wound dressing as claimed in claim 1.
Beadle 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, teaches the wound dressing as claimed in claim 1.
Beadle 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, 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, teaches the wound dressing as claimed in claim 19.
Beadle 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, 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 23, Beadle, as modified by Connolly, teaches the wound dressing as claimed in claim 1.
Beadle 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 by Connolly, teaches the dressing system as claimed in claim 23.
Beadle 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 by Connolly, teaches the dressing system as claimed in claim 21.
Beadle further teaches wherein the dressing system further comprises a backing film on the absorbent pad (Beadle; figure 9, backing layer 913)
Claim 11 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 Tallent et al (US 20170309155 A1)
Regarding Claim 11, Beadle, as modified by Connolly teaches the wound dressing as claimed in claim 1.
Beadle further teaches wherein the moisture sensors of the moisture sensor array are offset with respect to the centre of the absorbent pad (Beadle; figure 9 and [0061] “a portion of the electronics area can be offset from the absorbent area”, the modified electronic assembly 950 comprising moisture sensor array is offset from the center of the absorbent pad 922)
Beadle does not teach activation of the moisture sensors is delayed until after about 50% of the dressing system capacity is reached.
However, in the same field of endeavor, namely a moisture sensor, Tallent teaches an incontinence detection system comprises a moisture sensor (figure 2, sensor 24 [0005] “sensor adapted to sense the presence of a threshold amount of moisture”) and activation of the moisture sensors is delayed until after about threshold of the dressing system capacity is reached ([0005] and [0025] the sensor is configured to be activated when sensing the presence of a threshold amount of moisture in the system).
Tallent provides the moisture sensor is configured to be activated with a threshold amount of moisture in the device in order to detect a certain amount of moisture present in the device ([0005]) which helps indicating amount of moisture present in the device to the user in a timely manner ([0003]).
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 Tallent and provide the moisture sensor is configured to delay activation until the dressing system capacity is reached at threshold amount, and one of skill in the art motivated to do so, for the purpose of indicating the amount of moisture being present in the dressing in a timely manner.
The combination does not explicitly teach the activation is delayed until it reaches 50% of the dressing system capacity is reached, though Tallent teaches the sensing threshold of the sensor is adjustable (Tallent; [0025]).
However, the sensing activation threshold is a result-effective variable that determines the sensor activation point based on the amount of moisture level in the dressing. Therefore the threshold is a design choice which would lead one or ordinary skill in the art to optimize the sensor threshold through routine experimentation. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Beadle, as modified by Connolly and Tallent, with a reasonable expectation of success, to provide the activation of sensor is delayed until after 50% of the dressing system capacity is reached as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In the instant case, one of skill in the art motivated to do so, for the purpose of indicating the present of moisture in the absorbent pad in a timely manner. Furthermore, applicant has not shown unexpected resulting gleaming from having claimed range ([0021]), and therefore the claimed device is not patentably distinct from the prior art.
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 in further view of Rovaniemi (US 20160166438 A1).
Regarding Claim 12, Beadle, as modified by Connolly, teaches the wound dressing as claimed in claim 1.
Beadle 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 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, teaches the wound dressing as claimed in claim 1.
Beadle 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, 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 in further view of Johnson et al (US 20150148762 A1).
Regarding Claim 16, Beadle, as modified by Connolly, teaches the dressing system as claimed in claim 1.
Beadle 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, 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.
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Beadle (WO 2018060417 A1) in view of Connolly et al (US 20080171957 A1), and in further view of Shamim et al (US 20180055359 A1, hereinafter ‘Shamim’).
Regarding Claims 21 and 22, Beadle, as modified by Connolly, teaches the dressing system as claimed in claim 1.
Beadle does not teach that the electronic module comprises a communications module for communicating the wound data from the electronic module to a clinician, and the communication module comprises a wireless communication module.
However, in the same field of endeavor, namely a wound dressing, Shamim teaches a dressing system (figure 5, bandage system 510) comprises a electronic module (figure 5, at least processor 535, antenna 534 and transmitter 536 among other components on reusable parts 531) comprises a communications module (figure 5, transmitter 536) for communicating the wound data from the electronic module to a clinician ([0056] “The smart bandage system 510 can wirelessly communicate 545 with a personal smart phone 550 to provide wound progression data in a patient's personal environment. This data can then be sent from the patient's smart phone 550 to a remote monitoring device or system 570 to remote health care providers using either the mobile network or the internet 560.”), and
wherein the communications module comprises a wireless communications module (Shamin; [0056] ”The smart bandage system 510 can wirelessly communicate 545”).
Shamin provides the communication module in order to update the status of wound progression data to remote health care provider ([0056]).
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 Allin, to incorporate the teachings of Shamin and provide wireless communication module, and one of skill in the art motivated to do so, for the purpose of providing wound data to clinician.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nicholas J Weiss can be reached at (571)270-1775. 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
/NICHOLAS J. WEISS/Supervisory Patent Examiner, Art Unit 3781