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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP 21218300.8, filed on 12/30/2023.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/12/2024 and 01/02/2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
[Page 3, Lines 21-23]: As written it reads “In this case, it is necessary to use photodiodes that emit light matched to the desiredtreatment”. However, to correct the typo “desiredtreatemnt” should be “desired treatment”.
[Page 3, Lines 33-34]: As written it reads “By preference, the second processor is amicrocontroller”. However, to correct the typo “amicrocontroller” should be “a microcontroller”.
[Page 4, Lines 28-31]: As written it reads “Radio waves based on mobile radio networks/GSM are at the frequencies 850 MHz, 900, MHz, 1800 MHz, and 1900 MHz pursuant to the GSM standards”. However, this is the first instance of the term “GSM”, therefore, the term should be spelled out to provide clarity.
[Page 5, Lines 8-11]: As written it reads “In this case, the camera can be cameras in smartphones, camera systems with CCD, or CMOS sensor systems with a communications interface”. However, this is the first instance of the terms “CCD” and “CMOS”, therefore, the terms should be spelled out to provide clarity.
[Page 7, Lines 34-37]: As written it reads “Possible algorithms may comprise k-means clustering, thresholding methods or neural networks, in particular convolutional neuralnetworks”. However, to correct the typo, “neuralnetworks” should be “neural networks”.
[Page 11, Lines 10-14]: As written it reads “The wound dressing 100 comprises a wound contact layer 101, a cover layer 102, and a treatment element 104, with the treatment element 102 being arranged between the wound contact layer 101 and the cover layer 102”. However, the treatment element was first denoted using the label 104, therefore, the phrase “the treatment element 102” represents a typo which should instead be “the treatment element 104”.
[Page 11, Lines 25-27]: As written it reads “Alternatively, the power source 106 can provide power by means of energyharvesting”. However, to correct the typo “energyharvesting” should be “energy harvesting”.
[Page 11, Lines 31-34]: As written it reads “The independently activatable regions 105 are preferably arranged in a plane parallel to the wound contact layer101”. However, to correct the typo “layer101” should be “layer 101”.
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 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) 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):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) 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) 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) except as otherwise indicated in an Office action. Such claim limitation(s) is/are: the image recording means in claims 1, 10, and 11.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. That being said, the states “wherein the image recording means comprises: a. a digital camera, b. a first processor, c. a second transceiver element configured to receive data from the first transceiver […]” [Claim 1]; “the image recording means comprises at least one digital camera and at least one first processor. In this case, the camera can be cameras in smartphones, camera 10 systems with CCD, or CMOS sensor systems with a communications interface” [Page 5, Lines 7-11] and “The image recording means 200 can be a Bluetooth- capable smartphone with a camera” [Page 12, Lines 26-27]. Therefore, the image recording means is being interpreted to be a digital camera which includes a processor and transceiver. Thus, claims 1, 10 and 11 are not subject to further rejection regarding the image recording means.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) (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).
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.
Claims 1-14 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 1, as written it reads “wherein the wound dressing (100) comprises a treatment element (104) which has at least two independently activatable regions, such that, either within a wound to be treated, a therapeutic effect is exerted only on a portion of the wound to be treated or that, within a wound site comprising the wound to be treated and the skin surrounding the wound, a therapeutic effect is exerted only on the wound”. However, it is unclear what “therapeutic effect” is being exerted on the portion of the wound to be treated or only the wound within the wound site or how the therapeutic effect is evaluated by the device. The examiner recommends clarifying what therapeutic effect the activation of the at least two independently activatable regions has on the wound/tissue.
Regarding claims 2-14, due to their dependence on claim 1, either directly or indirectly, these claims are subject to the reasoning provided therein. Additionally, these claims do not further define the therapeutic effect that the activation of the at least two independently activatable regions produces.
Regarding claim 6, as written it reads “wherein the at least two independently activatable regions each comprise at least one of the components selected from the group consisting of a photodiode, a photosensor, a light guide, a piezoelectric ultrasound emitter, a piezoelectric ultrasonic sensor, an electrically conductive element and a thermoelement”. However, the examiner notes that some of these components, specifically “a photosensor”, “a piezoelectric ultrasound emitter”, and a piezoelectric ultrasonic sensor”, are not necessarily treatment elements that can trigger a therapeutic effect. Therefore, it is unclear which component is actually intended to be included in the at least two independently activatable regions in order to provide a therapeutic effect.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Toong et al. US 2021/0268276 A1 “Toong”.
Regarding claim 1, Toong teaches “A device comprising a wound dressing (100) and an image recording means (200)” (“FIG. 10 illustrates another example of wound healing and monitoring system 102. In FIG. 10, patch 110 is applied to the skin 910 of the wound 920 on the arm of user 900, and an optional smart controller 140 (e.g., a smartphone) in communication with patch 110 is included. Smart controller 140 monitors biometrics from patch 110 wirelessly, to track the progress of healing of the target wound 920” [0092]; “In an example, a separate device, such as a smartphone or camera, is mounted on a surface or held by user 900 or held by a second person, and provides a view of the target area for patch 110 such that the user or a second person may accurately place patch 110 on the skin. In an example, a separate device, such as a smart phone or goggles, uses augmented reality features to display for user 900 certain additional images or markers in relation to one or both of the target location on the user and the real time location of patch 110 before affixing it to the user, such that these additional images or markers, or both, are used to assist the user in accurate placement at the target location” [0100]; “FIG. 12 illustrates patch 110 with multiple electrodes that are adapted to provide both stimulation and sensing in accordance with example inventions. Patch 110 includes a set of 14 positive electrodes 1512; and a set of 2 negative electrodes 1514. Patch 110 further includes a processor 1516 shown in a physical view and schematic view” [0138].
As shown in FIG. 10, the smart controller 140 is a smartphone which includes a camera. Additionally, FIG. 8 shows an example of the patch 110 positioned along the neck of a user. Therefore, FIGS. 8, 10 and 12 depict a device comprising a wound dressing (i.e. patch 110) and an image recording means (i.e. smart controller 140).);
“wherein the wound dressing (100) comprises a. a cover layer (102) arranged distant from the wound when the wound dressing (100) is used” (See patch 110 in [0092] and “System 102 includes a healing patch 110, which includes a securing mechanism 112 (e.g., adhesive layer), and one or more electrode pairs 114, with each pair having a positive electrode and a negative electrode (or multiple positive electrodes and a single negative electrode as disclosed below). Patch 110 further includes a power source 116, one or more sensors 115, a processor 118 and a flexible substrate 119.” [0082]. As shown in FIG. 8, the securing mechanism 112 attaches to the neck of the patient and the other components of the patch 110 (i.e. 114, 115, 116, 118 and 119) are attached opposite to the securing mechanism 112. Therefore, the wound dressing comprises a cover layer (i.e. on which the components 114, 115, 116, 118 and 119 are attached) arranged distance from the wound when the wound dressing is used.),
“b. a first transceiver element (103) capable of transmitting and receiving data” (See [0092]; “The communication of data and control between smart controller 140 and patch 110 may be by wireless through the use of Bluetooth Low Energy (“BLE”), Wi-Fi, or other means” [0093]. In this case, in order to communicate data between the smart controller 140 and the patch 110 wirelessly, each of these devices must include a transceiver element capable of transmitting and receiving data. Therefore, the wound dressing includes a first transceiver element capable of transmitting and receiving data.). and
“wherein the image recording means (200) comprises a. a digital camera” (See [0092] and [0100] above. Therefore, the smart controller 140 represents the image recording means which comprises a digital camera.),
“b. a first processor” (See [0092] above. In order for the smart controller 140 to monitor biometrics from patch 110 and track the progress of healing of the target wound, the smart controller 140 must include a processor. Therefore, the image recording means (i.e. smart controller 140) inherently includes a first processor.),
“c. a second transceiver element configured to receive data from the first transceiver transmit data to the first transceiver element (103)” (See [0092] and [0093] above. In this case, in order to communicate data between the smart controller 140 and the patch 110 wirelessly, each of these devices must include a transceiver element capable of transmitting and receiving data. Therefore, the image recording means includes a second transceiver element configured to receive data from the first transceiver transmit data to the first transceiver element.),
“wherein the wound dressing (100) comprises a treatment element (104) which has at least two independently activatable regions, such that, either within a wound to be treated, a therapeutic effect can be is exerted only on a portion of the wound to be treated or that, within a wound site comprising the wound to be treated and the skin surrounding the wound, a therapeutic effect can be is exerted only on the wound” (See [0138] above and “In operation, patch 110 selects one or more of positive electrodes 1512, connecting each to stimulation voltage circuit 1520 with the corresponding stimulation switch 1530. The stimulation voltage passes from stimulation voltage circuit 1520 to all of the selected positive electrodes 1512, then as a field to negative electrodes 1514, and back to stimulation voltage circuit 1520. In example inventions, patch 110 selects the subset of the available positive electrodes 1512 to optimize the stimulation of the underlying tissue. The selection is adjusted in the software or firmware of processor 1516 according to the positioning of patch 110 on or near the target area” [0139]. As shown in FIG. 12, the patch 112 includes 14 positive electrodes 1514 and 2 negative electrodes 1514. In this case, since the patch 110 selects a subset of the available positive electrodes 1512 to optimize stimulation of the underlying tissue (i.e. wound 920 in FIG. 10, for example), the wound dressing comprises a treatment element (i.e. electrodes 1512, 1514) which has at least two independently activatable regions (i.e. positive electrodes 1512). Therefore, since the patch 110 includes multiple electrodes (i.e. positive electrodes 1512 and negative electrodes 1514) to provide both stimulation and sensing, the wound dressing comprises a treatment element which has at least two independently activatable regions, such that, either within a wound to be treated, a therapeutic effect can be is exerted only on a portion of the wound to be treated or that, within a wound site comprising the wound to be treated and the skin surrounding the wound, a therapeutic effect can be is exerted only on the wound.).
Regarding claim 2, Toong discloses all features of the claimed invention as discussed with respect to claim 1 above, and Toong further teaches “wherein the treatment element (104) is in direct contact with a wound bed when the wound dressing (100) is used” (See FIG. 10 and [0100] as discussed in claim 1. As shown in FIG. 10, the patch 110 is positioned on the wound 920. Therefore, since a smartphone/camera or goggles are used to accurately position the patch 110 at the target location on the skin, the treatment element is in direct contact with a wound bed (i.e. wound 920) when the wound dressing is used.).
Regarding claim 3, Toong discloses all features of the claimed invention as discussed with respect to claim 1 above, and Toong further teaches “wherein the wound dressing (100) comprises a wound contact layer (101) arranged on a side facing the wound when the wound dressing (100) is used” (See [0082] as discussed in claim 1 above. As shown in FIG. 8, the patch 110 is attached to the neck of a patient through a securing mechanism 112 (e.g., adhesive layer). Therefore, the wound dressing comprises a wound contact layer (i.e. securing mechanism 112, for example) arranged on a side facing the wound when the wound dressing (i.e. patch 110) is used.).
Regarding claim 4, Toong discloses all features of the claimed invention as discussed with respect to claim 1 above, and Toong further teaches “wherein the treatment element (104) is arranged between the wound contact layer (101) and the cover layer (102)” (“In an example, patch 110 includes a layer of gel, such as hydrogel, between the electrode face of patch and the surface of the skin. The gel layer improves the impedance matching between the patch and the skin” [0090]. Therefore, since the patch 110 includes a layer of gel between the electrode face of the patch and the surface of the skin, the treatment element is arranged between the wound contact layer (i.e. securing mechanism 112) and the cover layer (i.e. opposite side of the patch 110).).
Regarding claim 5, Toong discloses all features of the claimed invention as discussed with respect to claim 2 above, and Toong further teaches “wherein the at least two independently activatable regions are arranged in a plane parallel to the wound bed” (See FIGS. 8, 10 and 12 and [0138] above. As shown in FIG. 8, the electrode pairs 114 are attached to the patch 110, the patch being positioned relative to the wound. FIG. 10 also shows the patch 110 positioned on the wound 920. Furthermore, FIG. 12, shows positive electrodes 1512 are arranged on the patch 110. Therefore, the at least two independently activatable regions (i.e. positive electrodes 1512) are arranged in a plane parallel to the wound bed (i.e. wound 920, for example).).
Regarding claim 6, Toong discloses all features of the claimed invention as discussed with respect to claim 1 above, and Toong further teaches “wherein the at least two independently activatable regions each comprise at least one of the components selected from the group consisting of a photodiode, a photosensor, a light guide, a piezoelectric ultrasonic emitter, a piezoelectric ultrasonic sensor, an electrically conductive element, and a thermoelement” (See [0138] and FIG. 12. Therefore, since the patch 110 includes 14 positive electrodes 1512 and 2 negative electrodes 1514, the at least two independently activatable regions each comprise at least one of the components selected from the group consisting of a photodiode, a photosensor, a light guide, a piezoelectric ultrasonic emitter, a piezoelectric ultrasonic sensor, an electrically conductive element, and a thermoelement, specifically an electrically conductive element (i.e. electrodes 1512, 1514).).
Regarding claim 7, Toong discloses all features of the claimed invention as discussed with respect to claim 1 above, and Toong further teaches “wherein the device is configured such that the data can be transmitted and received contactlessly by the first transceiver element (103) to the second transceiver element” (See [0092] and [0093] as discussed in claim 1 above. In this case, since wireless communication is performed between the smart controller 140 and the patch 110, the device is configured such that the data can be transmitted and received contactlessly by the first transceiver element (i.e. within patch 110) to the second transceiver element (i.e. within the smart controller 140).).
Regarding claim 8, Toong discloses all features of the claimed invention as discussed with respect to claim 1 above, and Toong further teaches “wherein the wound dressing (100) comprises at least one visible label on a side of the cover layer (102) facing away from the wound” (See [0100] as discussed in claim 1 above. Therefore, since a separate device uses augmented reality features to display for user 900 certain images or markers in relation to one or both of the target location on the user and the real time location of the patch 110 (i.e. markers on the patch 110), the wound dressing comprises at least one visible label on a side of the cover layer facing away from the wound.).
Regarding claim 9, Toong discloses all features of the claimed invention as discussed with respect to claim 1 above, and Toong further teaches “wherein the wound dressing (100) comprises a second processor” (“Patch 110 further includes a processor 1516 shown in a physical view and schematic view” [0138]. Therefore, the wound dressing comprises a second processor (i.e. processor 1516).).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 10-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toong et al. US 2021/0268276 A1 “Toong” as applied to claim 1 above, and further in view of Moore US 2019/0304089 A1 “Moore” and Hunt et al. US 2020/0352501 A1 “Hunt”.
Regarding claim 10, Toong discloses all features of the claimed invention as discussed with respect to claim 1 above, and Toong further teaches “wherein the first processor is configured to […] “to ascertain those independently activatable regions of the wound dressing (100) which are located over the area of the wound”, “to activate or selectively activate the independently activatable regions of the wound dressing (100) which are located over the area of the wound” (See [0139] as discussed in claim 1 above. Therefore, since the patch 110 selects one or more positive electrodes 1512 and stimulation voltage passes from the stimulation voltage circuit 1520 to all of the selected positive electrodes 1512 in order to optimize the stimulation of the underlying tissue, the first processor is configured to ascertain those independently activatable regions of the wound dressing (i.e. patch 110) which are located over the area of the wound and to activate or selectively activate the independently activatable regions of the found dressing which are located over the area of the wound.);
“wherein the instruction for activation or selective activation is transmitted from the image processing means to the wound dressing (100) by means of the second transceiver element and the first transceiver element” (See [0092] and [0093] as discussed in claim 1 above and “In an example, smart controller 140 adjusts the intensity of applied pulses, or the duration of application, or both, using data exchanged with patch 110 and its processor 118. The exchanged data includes data from the monitoring device or devices, described below included in wound healing and monitoring system 102” [0113]. Therefore, since the smart controller 140 adjusts the intensity of applied pulses using data exchanged with patch 110, the instruction for activation or selective activation is transmitted from the image processing means to the wound dressing (i.e. patch 110) by beams of the second transceiver element and the first transceiver element.).
However, Toong does not teach that the first processor is configured to “segment a first image, which comprises an image of the wound to be treated and which was recorded by the image recording means (200), such that the first image is divided into one or more segments and the one or more segments of the first image which represent the wound to be treated are labeled as area of the wound” or “to correlate a second image, which comprises an image of the wound dressing (100) on the wound to be treated and which was recorded by the image recording means (200), with the first image such that the position of the wound dressing (100) is determined relative to the area of the wound”.
Moore is within the same field of endeavor as the claimed invention because it involves a wound imaging system with a computer processor which identifies features of a wound with an active contouring module (See [Abstract]).
Moore teaches that the first processor is configured to “segment a first image, which comprises an image of the wound to be treated and which was recorded by the image recording means (200), such that the first image is divided into one or more segments and the one or more segments of the first image which represent the wound to be treated are labeled as area of the wound” (“The clinician 108 may use a mobile device 110, in conjunction with the wound imaging and diagnostic application, to capture, edit, and analyze images related to the tissue site 106.” [0035]; “In some embodiments, additional algorithms and techniques may be used to assist with wound segmentation. For example, a variety of probabilistic algorithms may also be utilized. Alternatively or additionally, wound texture analysis may be used to aid with wound segmentation. Such wound texture analysis techniques may include gray-level co-occurrence matrix (GLCM), wavelets, as well as other processes. As an example, a technique such as GLCM and/or wavelets may be used to identify certain features of a wound image such as textures, edges, etc., while techniques such as SVMs and/or ANNs may be used to analyze those identified features to determine wound regions. In one example, the identified features may correspond to regions that are red and not smooth, while further processing performed by an SVM, ANN, etc. classifies regions having those features as wound regions (i.e., correlating red and not smooth features to a wound region rather than healthy skin)” [0070].
Therefore, since the mobile device captures and analyzes images of the tissue site and additional algorithms are used to assist with wound segmentation in order to identify features of a wound image such as texture, edges, wound region and regions that are red and not smooth, the first processor is configured to segment a first image, which comprises an image of the wound to be treated and which was recorded by the image recording means (i.e. mobile device 110, see FIG. 1), such that the first image is divided into one or more segments (i.e. wound region and healthy skin, see [0070]) and the one or more segments of the first image which represent the wound to be treated (i.e. regions of red and not smooth features, see [0070]) are labeled as area of the wound.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Toong such that the first processor is configured to segment a first image, which comprises an image of the wound to be treated and which was recorded by the image recording means, such that the first image is divided into one or more segments and the one or more segments of the first image which represent the wound to be treated are labeled as area of the wound as disclosed in Moore, in order to effectively identify the features of the wound prior to performing treatment. Utilizing algorithms to perform wound segmentation is one of a finite number of techniques which can be used to identify features of a wound with a reasonable expectation of success. Thus, modifying the device of Toong such that the first processor is configured to segment a first image, which comprises an image of the wound to be treated and which was recorded by the image recording means, such that the first image is divided into one or more segments and the one or more segments of the first image which represent the wound to be treated are labeled as area of the wound as disclosed in Moore, would yield the predictable result of effectively identifying the features of the wound prior to performing treatment.
Toong in view of Moore does not teach that the first processor is configured to: “correlate a second image, which comprises an image of the wound dressing (100) on the wound to be treated and which was recorded by the image recording means (200), with the first image such that the position of the wound dressing (100) is determined relative to the area of the wound.”
Hunt is within the same field of endeavor as the claimed invention because it involves a wound monitoring and/or therapy apparatus with a wound dressing (see [Abstract]).
Hunt teaches “to correlate a second image, which comprises an image of the wound dressing (100) on the wound to be treated and which was recorded by the image recording means (200), with the first image such that the position of the wound dressing (100) is determined relative to the area of the wound” (“Such information can be provided via the mobile device 60 for storage on the remote computing device 50 as described herein (such as, via an app). In block 1106, assessment of the wound can be performed. For example, images of the wound can be taken by the mobile device 60 and uploaded to the remote computing device 50 as described herein” [0160]; “In block 1110, additional images of the clean and, if applicable, debrided wound can be taken and uploaded to the remote computing device. In block 1112, wound dressing 22 can be placed in or on wound of the patient. […] In block 1116, one or more selected therapies can be applied. In block 1118, images of the wound covered by the wound dressing 22 can be taken and uploaded. In block 1120, measurement data from the wound dressing 22 can be collected and stored, as described herein. This step can be performed as many times as suitable while the wound dressing 22 is applied to the patient. Upon completion of therapy, in block 1122, measurement data can be uploaded to the remote computing device 50 as described herein. In block 1124, images of healed wound can be taken” [0161].
Therefore, since images are taken before the placement of the wound dressing, while the wound dressing is covering the wound and after the wound has healed (i.e. and the wound dressing has been removed), such that an assessment of wound treatment can be performed, the first processor is configured to correlate a second image, which comprises an image of the wound dressing on the wound to be treated and which was recorded by the image recording means, with the first image such that the position of the wound dressing is determined relative to the area of the wound.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Toong in view of Moore such that the first processor is configured to correlate a second image, which comprises an image of the wound dressing on the wound to be treated and which was recorded by the image recording means, with the first image such that the position of the wound dressing is determined relative to the area of the wound as disclosed in Hunt in order to allow for accurate tracking of wound treatment. Obtaining images before, during and after the application of a wound dressing is one of a finite number of techniques which can be used to: 1) assess wound treatment and 2) correlate images such that the position of the wound dressing is determined relative to the area of the wound with a reasonable expectation of success. Thus, modifying the device of Toong in view of Moore such that the first processor is configured to correlate a second image, which comprises an image of the wound dressing on the wound to be treated and which was recorded by the image recording means, with the first image such that the position of the wound dressing is determined relative to the area of the wound as disclosed in Hunt would yield the predictable result of allowing for accurate tracking of wound treatment.
Regarding claim 11, Toong discloses all features of the claimed invention as discussed with respect to claim 11 above, and Toong further teaches “A method for controlling the treatment elements of the device of claim 1, comprising the steps:” (See [0092], [0100] and [0138] and “A method of treating a wound, the method comprising: affixing a patch externally on a dermis of a user so that the patch extends over the wound of the user, the patch comprising a flexible substrate, a processor directly coupled to the substrate, and electrodes directly coupled to the substrate; and activating the patch to initiate a treatment session, the activating comprising generating electrical stimuli via the electrodes that is directed at the wound” [Claim 1]. Therefore, Toong discloses a method for controlling the treatment elements of the device of claim 1.); […]
“transmitting to transmit an instruction from the image recording means (200) to the wound dressing (100) by means of the first transceiver element and the second transceiver element” (See [0092] and [0093] as discussed in claim 1 above, and [0113] as discussed in claim 10 above. Therefore, since the smart controller 140 adjusts the intensity of applied pulses using data exchanged with patch 110, the method performed by the device involves transmitting to transmit an instruction from the image recording means (200) to the wound dressing (100) by means of the first transceiver element (i.e. within patch 110) and the second transceiver element (i.e. smart controller 140).);
“ascertaining those independently activatable regions of the wound dressing (100) located over the area of the wound”, and “activating or selectively activating the independently activatable regions of the wound dressing (100) located over the area of the wound, wherein the instruction for activation or selective activation of the independently activatable regions of the wound dressing (100) is transmitted from the image processing means to the wound dressing (100) by means of the second transceiver element and the first transceiver element” (See [0139] as discussed in claim 1 above. Therefore, since the patch 110 selects one or more positive electrodes 1512 and stimulation voltage passes from the stimulation voltage circuit 1520 to all of the selected positive electrodes 1512 in order to optimize the stimulation of the underlying tissue, the method carried out by the device involves ascertaining those independently activatable regions of the wound dressing (i.e. patch 110) located over the area of the wound and activating or selectively activating the independently activatable regions of the wound dressing (100) located over the area of the wound, wherein the instruction for activation or selective activation of the independently activatable regions of the wound dressing (100) is transmitted from the image processing means to the wound dressing (100) by means of the second transceiver element and the first transceiver element.).
Toong does not teach “recording a first image comprising an image of the wound by means of the image recording means”, “segmenting the first image such that the first image is divided into one or more segments and the one or more segments of the first image which represent the wound to be treated are labeled as area of the wound”, “providing the wound dressing (100) and applying the wound dressing (100) to the wound to be treated”, “recording a second image comprising an image of the wound dressing (100) on the wound to be treated by means of the image recording means”, “correlating the first image and the second image such that the position of the wound dressing (100) is determined relative to the area of the wound”.
Moore teaches “recording a first image comprising an image of the wound by means of the image recording means” (“The clinician 108 may use a mobile device 110, in conjunction with the wound imaging and diagnostic application, to capture, edit, and analyze images related to the tissue site 106.” [0035]; “As previously discussed, the image capture device 302 may be used to capture images which may be incorporated into the wound imaging and diagnostic application. […] Wound images captured by the image capture device 302 may be used by the wound imaging and diagnostic application to determine and subsequently populate one or more wound dimension fields, as discussed with respect to FIG. 2” [0046]. Therefore, the method carried out by the device involves recording a first image comprising an image of the wound by means of the image recording means (i.e. mobile device 110/image capture device 302).);
“segmenting the first image such that the first image is divided into one or more segments and the one or more segments of the first image which represent the wound to be treated are labeled as area of the wound” (“In some embodiments, additional algorithms and techniques may be used to assist with wound segmentation. For example, a variety of probabilistic algorithms may also be utilized. Alternatively or additionally, wound texture analysis may be used to aid with wound segmentation. Such wound texture analysis techniques may include gray-level co-occurrence matrix (GLCM), wavelets, as well as other processes. As an example, a technique such as GLCM and/or wavelets may be used to identify certain features of a wound image such as textures, edges, etc., while techniques such as SVMs and/or ANNs may be used to analyze those identified features to determine wound regions. In one example, the identified features may correspond to regions that are red and not smooth, while further processing performed by an SVM, ANN, etc. classifies regions having those features as wound regions (i.e., correlating red and not smooth features to a wound region rather than healthy skin)” [0070].
Therefore, since the mobile device captures and analyzes images of the tissue site and additional algorithms are used to assist with wound segmentation in order to identify features of a wound image such as texture, edges, wound region and regions that are red and not smooth, the method involves segmenting the first image such that the first image is divided into one or more segments and the one or more segments of the first image which represent the wound to be treated are labeled as area of the wound.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Toong such that it involves recording a first image comprising an image of the wound by means of the image recording means, and segmenting the first image such that the first image is divided into one or more segments and the one or more segments of the first image which represent the wound to be treated are labeled as area of the wound as disclosed in Moore, in order to effectively identify the features of the wound prior to performing treatment. Utilizing algorithms to perform wound segmentation is one of a finite number of techniques which can be used to identify features of a wound with a reasonable expectation of success. Thus, modifying the method of Toong such that it involves recording a first image comprising an image of the wound by means of the image recording means, and segmenting the first image such that the first image is divided into one or more segments and the one or more segments of the first image which represent the wound to be treated are labeled as area of the wound as disclosed in Moore, would yield the predictable result of effectively identifying the features of the wound prior to performing treatment.
Toong in view of Moore does not teach “providing the wound dressing (100) and applying the wound dressing (100) to the wound to be treated”, “recording a second image comprising an image of the wound dressing (100) on the wound to be treated by means of the image recording means”, and “correlating the first image and the second image such that the position of the wound dressing (100) is determined relative to the area of the wound”.
Hunt teaches “providing the wound dressing (100) and applying the wound dressing (100) to the wound to be treated”, “recording a second image comprising an image of the wound dressing (100) on the wound to be treated by means of the image recording means” and “correlating the first image and the second image such that the position of the wound dressing (100) is determined relative to the area of the wound” (“In block 1110, additional images of the clean and, if applicable, debrided wound can be taken and uploaded to the remote computing device. In block 1112, wound dressing 22 can be placed in or on wound of the patient. In block 1114, controller 24 can be connected to the wound dressing 22, in cases where the wound dressing and controller are separate. The wound dressing can be initialized as described herein. In block 1116, one or more selected therapies can be applied. In block 1118, images of the wound covered by the wound dressing 22 can be taken and uploaded. In block 1120, measurement data from the wound dressing 22 can be collected and stored, as described herein. This step can be performed as many times as suitable while the wound dressing 22 is applied to the patient. Upon completion of therapy, in block 1122, measurement data can be uploaded to the remote computing device 50 as described herein. In block 1124, images of healed wound can be taken” [0161].
Therefore, since images are taken before the placement of the wound dressing, while the wound dressing is covering the wound and after the wound has healed (i.e. and the wound dressing has been removed), such that an assessment of wound treatment can be performed, the method involves providing the wound dressing (100) and applying the wound dressing (100) to the wound to be treated (See block 1112), recording a second image comprising an image of the wound dressing (100) on the wound to be treated by means of the image recording means (See block 1118) and correlating the first image and the second image such that the position of the wound dressing (100) is determined relative to the area of the wound (See block 1120, 1122, and 1124).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Toong in view of Moore such that it involves providing the wound dressing (100) and applying the wound dressing (100) to the wound to be treated, recording a second image comprising an image of the wound dressing (100) on the wound to be treated by means of the image recording means, and correlating the first image and the second image such that the position of the wound dressing (100) is determined relative to the area of the wound as disclosed in Hunt in order to allow for accurate tracking of wound treatment. Obtaining images before, during and after the application of a wound dressing is one of a finite number of techniques which can be used to: 1) assess wound treatment and 2) correlate images such that the position of the wound dressing is determined relative to the area of the wound with a reasonable expectation of success. Thus, modifying the method of Toong in view of Moore such that it involves providing the wound dressing (100) and applying the wound dressing (100) to the wound to be treated, recording a second image comprising an image of the wound dressing (100) on the wound to be treated by means of the image recording means, and correlating the first image and the second image such that the position of the wound dressing (100) is determined relative to the area of the wound as disclosed in Hunt would yield the predictable result of allowing for accurate tracking of wound treatment.
Regarding claim 12, Toong in view of Moore and Hunt discloses all features of the claimed invention as discussed with respect to claim 11 above, and Toong further teaches “wherein a number of the at least two independently activatable regions of the wound dressing (100) are configured to be activated or selectively activated if at least one additional specified condition is satisfied” (See [0139] and FIG. 10 as discussed in claim 1 above. Therefore, since the patch 110 selects the subset (i.e. one or more) of available positive electrodes 1512 to optimize stimulation of the underlying tissue (i.e. wound 920, see FIG. 10), a number of the at least two independently activatable regions of the wound dressing (100) are configured to be activated or selectively activated (i.e. by the patch 110) if at least one additional specified condition is satisfied (i.e. the positive electrode 1512 is positioned above the wound 920).).
Regarding claim 13, Toong in view of Moore and Hunt discloses all features of the claimed invention as discussed with respect to claim 12 above, and Toong further teaches “wherein the specified condition is an enablement by a user or a third person and/or a value of a parameter characterizing the property of the wound” (“A treatment is performed by a sequence of periodic pulses, which deliver charge into the body through electrodes 320. Some of the parameters of the treatment are fixed and some are user adjustable. The strength, duration and frequency may be user adjustable. The user may adjust these parameters as necessary for comfort and efficacy. The strength may be lowered if there is discomfort and raised if nothing is felt. The duration can be increased if the maximum acceptable strength results in an ineffective treatment” [0048]; “In examples, user 900 selects a protocol of electrical stimulation, to be applied by patch 110 to wound 920. The stimulation protocol may be automatically adjusted based on sensed parameters, adjusted by user 900 as the healing of wound 920 progresses, or as directed by a medical professional” [0103].
Therefore, since the user may select a protocol of electrical stimulation to be applied by the patch 110 to wound 920 and may adjust the electrical stimulation (i.e. strength, duration, and frequency) for comfort and efficacy, the specified condition, according to which a number of the at least two independently activatable regions of the wound dressing (100) are configured to be activated or selectively activated, is an enablement by a user or a third person and/or a value of a parameter characterizing the property of the wound (i.e. enablement by a user).).
Regarding claim 14, Toong in view of Moore and Hunt discloses all features of the claimed invention as discussed with respect to claim 11 above, and Hunt further teaches “wherein those independently activatable regions of the wound dressing (100) located over the area of the wound are ascertained by means of at least one visible label on a side of the cover layer (102) facing away from the wound” (“In some embodiments, the wound dressing 22 can include one or more indicators to communicate information to a user. The indicators can be visual, audible, haptic, or tactile. Communicated information can include measurement data, wound status, or the like” [0153]; and “As is illustrated, one or more sensors 26 connected by one or more electrical connections or tracks 27 are positioned on or embedded in the wound dressing 22. For example, the one or more sensors and connections can be positioned on the wound contact layer. Also illustrated is a connector 28 for connecting to wound dressing 22 to the controller 24. The connector 28 includes one or more electrical connections or tracks” [0163]; and “In some embodiments, one or more sensors of the wound dressing 22 or any other wound dressing disclosed herein can measure one or more of impedance, capacitance, electrical sensing, temperature, pH, pressure (such as, by using a strain gauge), elasticity of tissue (such as, by using an ultrasound sensor, piezoelectric transducer, or the like, blood flow (such as, by measuring the Doppler effect), color, or light” [0166].
Therefore, since the wound dressing 22 includes one or more visual, audible, haptic, or tactile indicators which communicate information such as wound status, those independently activatable regions of the wound dressing (100) (i.e. sensors 26) located over the area of the wound are ascertained by means of at least one visible label (i.e. indicator) on a side of the cover layer (102) facing away from the wound.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Toong in view of Moore such that those independently activatable regions of the wound dressing located over the area of the wound are ascertained by means of at least one visible label as disclosed in Hunt in order to efficiently indicate which of the independently activatable regions should be activated to provide treatment to the wound. Providing a visible label is one of a finite number of techniques which can be used to indicate the status of a wound, including which of the independently activatable regions (i.e. electrodes 1512 in Toong) are located over the wound with a reasonable expectation of success. Thus, modifying the method of Toong in view of Moore such that those independently activatable regions of the wound dressing located over the area of the wound are ascertained by means of at least one visible label as disclosed in Hunt would yield the predictable result of efficiently indicating which of the independently activatable regions should be activated to provide treatment to the wound.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Akbari et al. US 2020/0188180 A1 “Akbari” is pertinent to the applicant’s disclosure because it discloses “A wound covering includes a flexible main body, and a sensor element incorporated into the main body. The sensor element includes a mesh formed from a plurality of fibers, and is configured to undergo a change in appearance in response to a change in a parameter associated with wound exudate” [Abstract].
Shokoueinejad Maragheh et al. US 2016/0015962 A1 “Shokoueinejad Maragheh” is pertinent to the applicant’s disclosure because it discloses “A flexible patch is provided that is capable of emitting light in the UV, visible, and/or infrared electromagnetic spectrums. The patch contains a feedback process and system using one or more sensors and a controller on the patch to (1) accelerate the wound healing process by providing adaptable, controlled light exposure and electrical stimulation, (2) monitor the healing process for signs of infection (3) eliminate bacterial infections by sanitizing the infected site and (4) relaying the information wirelessly to a central location for storage and interpretation by a physician as well as by providing the ability to receive feedback and operating instructions from the physician from a remote location” [Abstract].
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/KAITLYN E SEBASTIAN/Examiner, Art Unit 3797
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