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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/04/2025 has been entered.
Response to Amendment
This action is in response to the remarks filed on 08/04/2025.
The amendments filed on 08/04/2025 have been entered. Applicant has presently canceled claims 51-52. Accordingly claims 21, 37-38, 48-50, and 53-59 are pending. Claims 21, 48, 50, 53, and 59 are presently amended.
Examiner notes that pending claim 50 appears to recite the limitations of previously pending claim 52 but has not been marked to reflect this amendment. Further the claim set should be marked to reflect the canceling of claims 51-52 rather than just simply deleting them entirely from the claim set.
The previous rejection of claims 21, 58, and 59 under 35 U.S.C 112(b) regarding the “region of skin” limitations has been withdrawn in light of applicant's amendments. However, the amendments do not resolve the indefiniteness related to the “red color” and “baseline skin color”. Therefore that rejection has been maintained as detailed below.
Response to Arguments
Applicant’s arguments, see Remarks, filed 08/04/2025, with respect to prior art rejection of claim 21 have been fully considered and are persuasive, in part, with respect to the indication of the presence of phlebitis. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Jersey-Willuhn et al.
Applicant's arguments regarding the 35 U.S.C. 103 rejection of independent claims 48 and 53 have been fully considered but they are not persuasive.
In particular, applicant argues, see page 7 of the Remarks, that Brownhill allegedly does not disclose sensing whether there is inflammation and whether the inflammation has spread. Examiner presumes that applicant is referencing the last two wherein clauses of claims 48 and 53. The detection of inflammation and the worsening of inflammation is merely an intended use of the claimed components such as the sensors and light sources of the claimed dressing. The intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant’s arguments regarding the Obma reference, see pages 8 of the Remarks, have been fully considered but they are not persuasive. Obma is merely relied on to teach skin color being relative to the baseline skin color. Obma was not relied on to substitute any of the sensors of Brownhill. Further, examiner notes that a motivation to combine the teachings of Obma with Brownhill was provided. Defining skin color relative to the baseline skin color as taught by Obma would allow for detecting skin color changes over time.
Claim Objections
Claims 21, 48, and 53 objected to because of the following informalities:
Regarding claim 21, the limitation “wherein the presence of phlebitis is [...]” in line 14 should be changed to –wherein [[the]] a presence of phlebitis is [...]--.
Regarding claim 48, the limitation “reflected from skin surface” in line 7 should be changed to –reflected from a skin surface--.
Regarding claims 48 and 53, the limitation “inflamation” in lines 20 and 17, respectively, appears to be a typographical error that should be changed to –inflammation--.
Appropriate correction is required.
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.
Claims 21, 58, and 59 are 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 21 recites the limitation “wherein a worsening of the phlebitis is indicated when the second light sensor is able to measure the red color reflected off the skin surface from light from the second light source” in lines 18-20 which renders the claim indefinite. The claim previously recites in lines 8-11 “obtaining a baseline skin color by the second light sensor measuring light from the second light source reflected off the skin surface between the second light source and the second light sensor”. It appears that the “red color” and the “baseline skin color” are meant to be different colors, yet they are obtained from the same skin surface and the same second light sensor using the same second light source. Therefore, it is unclear how different colors are obtained or whether multiple measurements are made perhaps overtime. Further clarification is required.
Claims dependent upon a claim rejected under 35 U.S.C. 112(b) are also rejected under the same statute because they each inherit the indefiniteness of the claim(s) they respectively depend upon.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 21, 58, 59, and 48-50, and 53-57 are rejected under 35 U.S.C. 103 as being unpatentable over Brownhill et al. (US 2019/0290496, 371 date November 13, 2018, hereinafter “Brownhill”) in view of Obma (US 2016/0242646, August 25, 2016) and Jersey-Willuhn et al. (US 2003/0216663, November 20, 2003, hereinafter “JW”).
Regarding claim 21, as best understood in light of the 35 U.S.C. 112(b) rejections stated above, Brownhill discloses a method of detecting and monitoring the rate of phlebitis of a wound site at a skin surface of a patient (“a wound dressing that incorporates a number of sensors or sensors separate from the wound dressing can be utilized in order to monitor characteristics of a wound as it heals or to identify one or more risk factors or conditions that may precipitate a wound. In some implementations” Abstract; also see “methods for the monitoring or treatment of wounds, for example using dressings in combination with negative pressure wound therapy.” [0001]), the method comprising:
covering the skin surface of the wound site with a dressing (“a wound dressing configured to be positioned in contact with a wound includes a substantially flexible substrate supporting one or more sensors.” Abstract; also see “It is to be understood that the term wound is to be broadly construed and encompasses open and closed wounds in which skin is torn, cut or punctured or where trauma causes a contusion, or any other superficial or other conditions or imperfections on the skin of a patient or otherwise that may benefit from reduced pressure treatment. A wound is thus broadly defined as any damaged region of tissue where fluid may or may not be produced.” [0038]) having a first light source spaced apart from a first light sensor by one distance and a second light source spaced apart from a second light sensor by an other distance (“a sub-set of five sensors can be used including sensors for [...] optical properties of the tissue, exudate, or foreign bodies (such as, 10 optical sensors, in 2?5 array, ?20 mm pitch” [0087]; also see “Suitable light sources, such as ultrabright light emitting diodes (LEDs), an optical detectors [sensors], or polyester optical filters can be used as components of the optical sensors to measure through optical properties of the tissue, exudate, or foreign bodies (such as, for tissue color differentiation) [...] a light source can be used with an optical detector nearby to detect the light which has diffused through the tissue” [0109]), the wound site being positioned between the first light source and the first light sensor and away from the second light source and the second light sensor (“allow the sensors to take measurements in the middle of the wound, at the edge or the wound, or on intact skin to measure changes between the various regions. In some embodiments, the wound contact layer or sensor array can be larger than the size of the wound to cover the entire surface area of the wound as well as the surrounding intact skin. The larger size of the wound contact layer or sensor array and the multiple sensors can provide more information about the wound area than if the sensor was only placed in the center of the wound or in only one area at a time” [0087]; examiner notes that the sensors placed at e.g., intact skin are the second light source the second light sensor and the wound site is away from this area of intact skin);
obtaining a baseline skin color by the second light sensor measuring light from the second light source (“Suitable light sources, such as ultrabright light emitting diodes (LEDs), an optical detectors, or polyester optical filters can be used as components of the optical sensors to measure through optical properties of the tissue, exudate, or foreign bodies (such as, for tissue color differentiation). For example, because surface color can be measured from reflected light, a color can be measured from light which has passed through the tissue first for a given geometry.” [0109]) reflected off the skin surface between the second light source and the second light sensor (“allow the sensors to take measurements in the middle of the wound, at the edge or the wound, or on intact skin to measure changes between the various regions” [0087]);
detecting light from the first and second light sources, respectively, reflected off the skin surface from the first and second sensors (“Suitable light sources, such as ultrabright light emitting diodes (LEDs), an optical detectors, or polyester optical filters can be used as components of the optical sensors to measure through optical properties of the tissue, exudate, or foreign bodies (such as, for tissue color differentiation). For example, because surface color can be measured from reflected light, a color can be measured from light which has passed through the tissue first for a given geometry.” [0109]; also see [0104]);
wherein the presence of a condition (“identify one or more risk factors or conditions that may precipitate a wound” [0084]) is indicated (“At least one of the controller or the processing device can be configured to indicate, based on the one or more conditions associated with the wound, that the wound is healing. The controller can be configured to wirelessly communicate with at least one of the one or more sensors or the processing device. The controller can be configured to be in electrical communication with at least one of the one or more sensors or the processing device through electrical wiring. The processing device can include a personal computer (PC), a tablet format computing device, a smartphone, or a custom computing device. Data collected by the one or more sensors can be configured to be communicated to the cloud.” [0007]) when a red color relative to the baseline skin color is detected by the first light sensor from the first light source reflected off the skin surface (“because surface color can be measured from reflected light, a color can be measured from light which has passed through the tissue first for a given geometry. This can include color sensing from diffuse scattered light, from a light source (such as, white, RGB, IR LED, or the like) in contact with the wound or skin. In some embodiments, a light source can be used with an optical detector nearby to detect the light which has diffused through the tissue. The optical sensors can image with diffuse internal light or surface reflected light. A suitable optical detector, such as a photodiode, can be used. For example, an optical detector can have a red, green, blue, clear (RGBC) spectral response (or sensitivity ratios on the channels) as illustrated in FIG. 3Q. In some cases, a Rhom BH1745NUC color sensor can be used.” [0109]), and
wherein a worsening of the condition is indicated when the second light sensor is able to measure the red color reflected off the skin surface from the second light source (“A wound dressing that incorporates a number of sensors or sensors separate from the wound dressing can be utilized in order to monitor characteristics of a wound as it heals or to identify one or more risk factors or conditions that may precipitate a wound. Collecting data from the wounds that heal well, and from those that do not, can provide useful insights towards identifying measurements or measurands to indicate one or more conditions, including whether a wound is on a healing trajectory, whether the dressing needs to be adjusted, whether therapy parameters needs to be adjusted, or the like.” [0084]; also see “allow the sensors to take measurements in the middle of the wound, at the edge or the wound, or on intact skin to measure changes between the various regions. In some embodiments, the wound contact layer or sensor array can be larger than the size of the wound to cover the entire surface area of the wound as well as the surrounding intact skin. The larger size of the wound contact layer or sensor array and the multiple sensors can provide more information about the wound area than if the sensor was only placed in the center of the wound or in only one area at a time [...] Any one or more sensors described herein can be placed or positioned to obtain measurements of any location in the wound or the skin” [0087]).
Although Brownhill discloses obtaining a baseline skin color, Brownhill is silent on skin color being relative to the baseline skin color. Examiner notes that the while the claim does not require the detection of any red color this feature is being examined fully for the sake of compact prosecution.
However, Obma teaches, in the same field of endeavor, skin color being relative to the baseline skin color (“a sensor to monitor and detect skin color or changes in skin color as compared to a baseline. The skin color sensor would comprise a light-emission component such as a light emitting diode (“LED”) coupled with light receiving component for the detection of the skin surface color based on skin reflectivity.” [0064]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Brownhill with skin color being relative to the baseline skin color as taught by Obma in order to be able to detect changes in skin color ([0064] of Obma).
Although Brownhill discloses the presence of various conditions being indicated as claimed as stated above, Brownhill does not explicitly disclose wherein the presence of phlebitis is indicated.
However, JW teaches, in the same field of endeavor, wherein the presence of phlebitis is indicated (“An infusion system has a capability to monitor infusion complications such as extravasation, tissue necrosis, infiltration, phlebitis, and blood clots. The infusion system has at least partially transparent flexible film barrier dressing in a flexible membrane that incorporates a plurality of sensors capable of detecting tissue condition and a control unit capable of coupling to the film barrier dressing that monitors signals from the sensors. A device is capable of executing non-invasive physiological measurements to characterize physiologic information from cross-sectional surface and subcutaneous tissue to detect the presence or absence of tissue conditions such as infiltration or extravasation during intravascular infusion. In some examples, the device utilizes depth-selective methods to sense, detect, quantify, monitor, and generate an alert notification of tissue parameters.” Abstract).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Brownhill with wherein the presence of phlebitis is indicated as taught by JW in order to provide early assessment of complication and quick response to reduce or eliminate damage and save a vein effected by phlebitis ([0019] of JW).
Regarding claim 58, Brownhill modified by Obma and JW discloses the limitations of claim 21 as stated above and Brownhill further discloses linearly aligning the first light source and the first light sensor; linearly aligning the second light source and the second light sensor (“As shown in FIGS. 3A and 3H, a sub-set of five sensors can be used including sensors for temperature (such as, 25 thermistor sensors, in a 5×5 array, −20 mm pitch), pulse oximetry or SpO2 (such as, 4 or 5 SpO2 sensors, in a single line from the center of the wound contact layer to the edge thereof, 10 mm pitch), optical properties of the tissue, exudate, or foreign bodies (such as, 10 optical sensors, in 2×5 array, −20 mm pitch; not all 5 sensors in each row of the array need be aligned), pH (such as, by measuring colour of a pH sensitive pad, optionally using the same optical sensors as for tissue colour), and conductivity (such as, 9 conductivity contacts, in a 3×3 array, −40 mm pitch).” [0087]; also see Fig. 3A and corresponding description), the wound site not disposed between the second light source and the second light sensor (“allow the sensors to take measurements in the middle of the wound, at the edge or the wound, or on intact skin” [0087]).
Regarding claim 59, Brownhill modified by Obma and JW discloses the limitations of claim 21 as stated above. In particular, Obma was relied on to teach measuring color relative to the baseline skin color. As best understood in light of the 35 U.S.C. 112(b) rejection stated above, Brownhill further discloses measuring the skin color between the second light source and the second light sensor (“allow the sensors to take measurements in the middle of the wound, at the edge or the wound, or on intact skin” [0087])) to determine if the measured color is red (“because surface color can be measured from reflected light, a color can be measured from light which has passed through the tissue first for a given geometry. This can include color sensing from diffuse scattered light, from a light source (such as, white, RGB, IR LED, or the like) in contact with the wound or skin. In some embodiments, a light source can be used with an optical detector nearby to detect the light which has diffused through the tissue. The optical sensors can image with diffuse internal light or surface reflected light. A suitable optical detector, such as a photodiode, can be used. For example, an optical detector can have a red, green, blue, clear (RGBC) spectral response (or sensitivity ratios on the channels) as illustrated in FIG. 3Q. In some cases, a Rhom BH1745NUC color sensor can be used.” [0109]).
Claims 48-50, and 53-57 are rejected under 35 U.S.C. 103 as being unpatentable over Brownhill in view of Obma.
Regarding claim 48, Brownhill discloses a dressing adapted to monitor progress rate of inflammation at a wound site (“a wound dressing that incorporates a number of sensors or sensors separate from the wound dressing can be utilized in order to monitor characteristics of a wound as it heals or to identify one or more risk factors or conditions that may precipitate a wound” Abstract), comprising:
a substrate configured for placement over a region of skin encompassing the wound site on a patient (“a wound dressing configured to be positioned in contact with a wound includes a substantially flexible substrate supporting one or more sensors.” Abstract; also see “It is to be understood that the term wound is to be broadly construed and encompasses open and closed wounds in which skin is torn, cut or punctured or where trauma causes a contusion, or any other superficial or other conditions or imperfections on the skin of a patient or otherwise that may benefit from reduced pressure treatment. A wound is thus broadly defined as any damaged region of tissue where fluid may or may not be produced.” [0038]);
one light source and one light sensor fixedly attached to the substrate, the one light sensor spaced apart from the one light source by one distance, the one light sensor configured to receive light from the one light source reflected from skin surface of the patient (“a sub-set of five sensors can be used including sensors for [...] optical properties of the tissue, exudate, or foreign bodies (such as, 10 optical sensors, in 2?5 array, ?20 mm pitch” [0087]; also see “Suitable light sources, such as ultrabright light emitting diodes (LEDs), an optical detectors [sensors], or polyester optical filters can be used as components of the optical sensors to measure through optical properties of the tissue, exudate, or foreign bodies (such as, for tissue color differentiation) [...] a light source can be used with an optical detector nearby to detect the light which has diffused through the tissue” [0109]);
an other light source and an other light sensor fixedly attached to the substrate, the other light sensor separated from the other light source by an other distance, the other light sensor configured to receive light from the other light source reflected from the skin surface of the patient (“a sub-set of five sensors can be used including sensors for [...] optical properties of the tissue, exudate, or foreign bodies (such as, 10 optical sensors, in 2?5 array, ?20 mm pitch” [0087]; also see “Suitable light sources, such as ultrabright light emitting diodes (LEDs), an optical detectors [sensors], or polyester optical filters can be used as components of the optical sensors to measure through optical properties of the tissue, exudate, or foreign bodies (such as, for tissue color differentiation) [...] a light source can be used with an optical detector nearby to detect the light which has diffused through the tissue” [0109]);
wherein when the substrate is placed over the region of skin encompassing the wound site, the wound site is positioned between the one light source and the one light sensor (“allow the sensors to take measurements in the middle of the wound, at the edge or the wound, or on intact skin to measure changes between the various regions. In some embodiments, the wound contact layer or sensor array can be larger than the size of the wound to cover the entire surface area of the wound as well as the surrounding intact skin. The larger size of the wound contact layer or sensor array and the multiple sensors can provide more information about the wound area than if the sensor was only placed in the center of the wound or in only one area at a time” [0087];
wherein, a baseline skin color of the patient is measured by the other light sensor from light from the other light source reflected off the skin surface of the patient for the region (“Suitable light sources, such as ultrabright light emitting diodes (LEDs), an optical detectors, or polyester optical filters can be used as components of the optical sensors to measure through optical properties of the tissue, exudate, or foreign bodies (such as, for tissue color differentiation). For example, because surface color can be measured from reflected light, a color can be measured from light which has passed through the tissue first for a given geometry.” [0109]), the other light sensor adapted to measure shift in the skin color (“allow the sensors to take measurements in the middle of the wound, at the edge or the wound, or on intact skin to measure changes between, the various regions” [0087]);
wherein inflamation at the wound site is detected (“identify one or more risk factors or conditions that may precipitate a wound” [0084] when the one light sensor measures a shift in the skin color from light from the one light source reflected off the skin surface of the region (“allow the sensors to take measurements in the middle of the wound, at the edge or the wound, or on intact skin to measure changes between the various regions. In some embodiments, the wound contact layer or sensor array can be larger than the size of the wound to cover the entire surface area of the wound as well as the surrounding intact skin. The larger size of the wound contact layer or sensor array and the multiple sensors can provide more information about the wound area than if the sensor was only placed in the center of the wound or in only one area at a time [...] Any one or more sensors described herein can be placed or positioned to obtain measurements of any location in the wound or the skin” [0087]); and
wherein a worsening of the inflammation is indicated when the other light sensor measures the shift in skin color (“A wound dressing that incorporates a number of sensors or sensors separate from the wound dressing can be utilized in order to monitor characteristics of a wound as it heals or to identify one or more risk factors or conditions that may precipitate a wound. Collecting data from the wounds that heal well, and from those that do not, can provide useful insights towards identifying measurements or measurands to indicate one or more conditions, including whether a wound is on a healing trajectory, whether the dressing needs to be adjusted, whether therapy parameters needs to be adjusted, or the like.” [0084]) from light from the other light source reflected off the skin surface of the region (“allow the sensors to take measurements in the middle of the wound, at the edge or the wound, or on intact skin to measure changes between the various regions. In some embodiments, the wound contact layer or sensor array can be larger than the size of the wound to cover the entire surface area of the wound as well as the surrounding intact skin. The larger size of the wound contact layer or sensor array and the multiple sensors can provide more information about the wound area than if the sensor was only placed in the center of the wound or in only one area at a time [...] Any one or more sensors described herein can be placed or positioned to obtain measurements of any location in the wound or the skin” [0087]).
Although Brownhill discloses establishing a baseline skin color, Brownhill is silent on skin color being relative to the baseline skin color of the patient. Examiner notes that the while this apparatus claim does not require the detection of any shift or any baseline skin color this feature is being examined fully for the sake of compact prosecution.
However, Obma teaches, in the same field of endeavor, skin color being relative to the baseline skin color of the patient (“a sensor to monitor and detect skin color or changes in skin color as compared to a baseline. The skin color sensor would comprise a light-emission component such as a light emitting diode (“LED”) coupled with light receiving component for the detection of the skin surface color based on skin reflectivity.” [0064]).
Therefore, before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Brownhill with skin color being relative to the baseline skin color of the patient as taught by Obma in order to be able to detect changes in skin color ([0064] of Obma).
Regarding claim 49, Brownhill modified by Obma discloses the limitations of claim 48 as stated above and Brownhill further discloses wherein the progress rate of the inflammation can be tracked by the time it took for the shift in skin color relative to the baseline skin color from when measured by the one light sensor to when measured by the other light sensor (“Power management Real Time Clock (RTC) to allow accurate data logging, and correlation with other measurands” [0126]).
Regarding claim 50, Brownhill modified by Obma discloses the limitations of claim 48 as stated above. Although Brownhill suggests wherein the one distance and the other distance has the same length; wherein the one light source and the other light source are spaced apart from each other by a light source distance and the one light sensor and the other light sensor are spaced apart from each other by a light sensor distance, the light source distance and the light sensor distance each have the same length as the one distance and the other distance such that the one light source, the other light source, the one light sensor and the other light sensor are disposed in a square or a rectangular array. (see square or rectangular arrangement in Fig. 3A and corresponding description), Brownhill does not explicitly disclose wherein the one distance and the other distance has the same length; wherein the one light source and the other light source are spaced apart from each other by a light source distance and the one light sensor and the other light sensor are spaced apart from each other by a light sensor distance, the light source distance and the light sensor distance each have the same length as the one distance and the other distance such that the one light source, the other light source, the one light sensor and the other light sensor are disposed in a square or a rectangular array.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange the components such that the one light source and the one light sensor are spaced apart by the one distance and the other distance having the same length; wherein the one light source and the other light source are spaced apart from each other by a light source distance and the one light sensor and the other light sensor are spaced apart from each other by a light sensor distance, the light source distance and the light sensor distance each have the same length as the one distance and the other distance such that the one light source, the other light source, the one light sensor and the other light sensor are disposed in a square or a rectangular array, since it has been held that rearranging parts of an invention involves only routine skill in the art.
Regarding claim 53, Brownhill discloses a dressing adapted to monitor progression rate of inflammation of a wound site (“a wound dressing that incorporates a number of sensors or sensors separate from the wound dressing can be utilized in order to monitor characteristics of a wound as it heals or to identify one or more risk factors or conditions that may precipitate a wound” Abstract), comprising:
a substrate configured for placement over a region of skin encompassing the wound site on a patient (“a wound dressing configured to be positioned in contact with a wound includes a substantially flexible substrate supporting one or more sensors.” Abstract; also see “It is to be understood that the term wound is to be broadly construed and encompasses open and closed wounds in which skin is torn, cut or punctured or where trauma causes a contusion, or any other superficial or other conditions or imperfections on the skin of a patient or otherwise that may benefit from reduced pressure treatment. A wound is thus broadly defined as any damaged region of tissue where fluid may or may not be produced.” [0038]);
one light source and first and second light sensors fixedly attached to the substrate (“Suitable light sources, such as ultrabright light emitting diodes (LEDs), an optical detectors, or polyester optical filters can be used as components of the optical sensors to measure through optical properties of the tissue, exudate, or foreign bodies (such as, for tissue color differentiation). For example, because surface color can be measured from reflected light, a color can be measured from light which has passed through the tissue first for a given geometry. This can include color sensing from diffuse scattered light, from a light source (such as, white, RGB, IR LED, or the like) in contact with the wound or skin. In some embodiments, a light source can be used with an optical detector nearby to detect the light which has diffused through the tissue. The optical sensors can image with diffuse internal light or surface reflected light. A suitable optical detector, such as a photodiode, can be used.” [0109]; also see [0087] and Fig. 3A and corresponding description), the one light source positioned between the first and second light sensors and spaced apart from the first light sensor by a first distance and spaced apart from the second light sensor by a second distance, the first and second light sensors configured to receive light from the one light source (“because surface color can be measured from reflected light, a color can be measured from light which has passed through the tissue first for a given geometry. This can include color sensing from diffuse scattered light, from a light source (such as, white, RGB, IR LED, or the like) in contact with the wound or skin. In some embodiments, a light source can be used with an optical detector nearby to detect the light which has diffused through the tissue” [0109]; also see Fig. 3A and corresponding description);
wherein the wound site is positioned between the one light source and one of the first and second light sensors when the substrate is placed over the region of skin encompassing the wound site (“allow the sensors to take measurements in the middle of the wound, at the edge or the wound, or on intact skin to measure changes between the various regions” [0087]) such that skin color of the patient is measured by the one of the first and second light sensors to establish a baseline skin color of the patient for the region (“Suitable light sources, such as ultrabright light emitting diodes (LEDs), an optical detectors, or polyester optical filters can be used as components of the optical sensors to measure through optical properties of the tissue, exudate, or foreign bodies (such as, for tissue color differentiation). For example, because surface color can be measured from reflected light, a color can be measured from light which has passed through the tissue first for a given geometry.” [0109]);
wherein the first and second light sensors each are adapted to measure shift in the skin color (“allow the sensors to take measurements in the middle of the wound, at the edge or the wound, or on intact skin to measure changes between the various regions” [0087]);
wherein the inflamation is detected (“identify one or more risk factors or conditions that may precipitate a wound” [0084] by the shift in skin color by the one of the first and second light sensors that did not establish the baseline skin color (“allow the sensors to take measurements in the middle of the wound, at the edge or the wound, or on intact skin to measure changes between the various regions. In some embodiments, the wound contact layer or sensor array can be larger than the size of the wound to cover the entire surface area of the wound as well as the surrounding intact skin. The larger size of the wound contact layer or sensor array and the multiple sensors can provide more information about the wound area than if the sensor was only placed in the center of the wound or in only one area at a time [...] Any one or more sensors described herein can be placed or positioned to obtain measurements of any location in the wound or the skin” [0087]); and
wherein a worsening of inflammation is indicated when the shift in skin color (“A wound dressing that incorporates a number of sensors or sensors separate from the wound dressing can be utilized in order to monitor characteristics of a wound as it heals or to identify one or more risk factors or conditions that may precipitate a wound. Collecting data from the wounds that heal well, and from those that do not, can provide useful insights towards identifying measurements or measurands to indicate one or more conditions, including whether a wound is on a healing trajectory, whether the dressing needs to be adjusted, whether therapy parameters needs to be adjusted, or the like.” [0084]) progresses to and is measured by the other of the first and other light sensors (“allow the sensors to take measurements in the middle of the wound, at the edge or the wound, or on intact skin to measure changes between the various regions. In some embodiments, the wound contact layer or sensor array can be larger than the size of the wound to cover the entire surface area of the wound as well as the surrounding intact skin. The larger size of the wound contact layer or sensor array and the multiple sensors can provide more information about the wound area than if the sensor was only placed in the center of the wound or in only one area at a time [...] Any one or more sensors described herein can be placed or positioned to obtain measurements of any location in the wound or the skin” [0087]).
Although Brownhill discloses establishing a baseline skin color, Brownhill is silent on skin color being relative to the baseline skin color of the patient.
However, Obma teaches, in the same field of endeavor, skin color being relative to the baseline skin color of the patient (“a sensor to monitor and detect skin color or changes in skin color as compared to a baseline. The skin color sensor would comprise a light-emission component such as a light emitting diode (“LED”) coupled with light receiving component for the detection of the skin surface color based on skin reflectivity.” [0064]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Brownhill with skin color being relative to the baseline skin color of the patient as taught by Obma in order to be able to detect changes in skin color ([0064] of Obma).
Regarding claim 54, Brownhill modified by Obma discloses the limitations of claim 53 as stated above. Brownhill does not explicitly disclose wherein the first distance is equal in length to the second distance.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange the components such that the first distance is equal in length to the second distance, since it has been held that rearranging parts of an invention involves only routine skill in the art.
Regarding claim 55, Brownhill modified by Obma discloses the limitations of claim 53 as stated above and Brownhill further discloses wherein the first distance and the second distance each are about 1mm to about 100mm (“As shown in FIGS. 3A and 3H, a sub-set of five sensors can be used including sensors for temperature (such as, 25 thermistor sensors, in a 5×5 array, −20 mm pitch), pulse oximetry or SpO2 (such as, 4 or 5 SpO2 sensors, in a single line from the center of the wound contact layer to the edge thereof, 10 mm pitch), optical properties of the tissue, exudate, or foreign bodies (such as, 10 optical sensors, in 2×5 array, −20 mm pitch; not all 5 sensors in each row of the array need be aligned), pH (such as, by measuring colour of a pH sensitive pad, optionally using the same optical sensors as for tissue colour), and conductivity (such as, 9 conductivity contacts, in a 3×3 array, −40 mm pitch).” [0087]; also see Fig. 3A and corresponding description).
Regarding claim 56, Brownhill modified by Obma discloses the limitations of claim 53 as stated above and Brownhill further discloses wherein the one sensor and the other sensor each continuously measure the skin color (“The control module can be customized to have various features depending on the sensors used in the sensor array and the data collected by the sensors. In some embodiments, the control module can be comfortable enough and small enough to be worn continuously for several weeks.” [0123]) at predefined intervals (“Ability to change sample rates and intervals (useful for SpO2) for each sensor” [0126]).
Regarding claim 57, Brownhill modified by Obma discloses the limitations of claim 53 as stated above and Brownhill further discloses wherein the one light sensor, the one light source and the other light sensor are linearly aligned along the substrate (“As shown in FIGS. 3A and 3H, a sub-set of five sensors can be used including sensors for temperature (such as, 25 thermistor sensors, in a 5×5 array, −20 mm pitch), pulse oximetry or SpO2 (such as, 4 or 5 SpO2 sensors, in a single line from the center of the wound contact layer to the edge thereof, 10 mm pitch), optical properties of the tissue, exudate, or foreign bodies (such as, 10 optical sensors, in 2×5 array, −20 mm pitch; not all 5 sensors in each row of the array need be aligned), pH (such as, by measuring colour of a pH sensitive pad, optionally using the same optical sensors as for tissue colour), and conductivity (such as, 9 conductivity contacts, in a 3×3 array, −40 mm pitch).” [0087]; also see Fig. 3A and corresponding description).
Claims 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Brownhill in view of Obma as applied to claim 48 above and further in view of Ozawa et al. (US 2021/0153754, corresponding PCT filed July 27, 2018, hereinafter “Ozawa”).
Regarding claim 37, Brownhill modified by Obma discloses the limitations of claim 48 as stated above but fails to disclose further comprising a wiring harness configured to supply power to, and data communication with, the one light source and the one light sensor, the wiring harness further including a quick-disconnect connector along the wiring harness, adjacent the substrate. Although Brownhill does disclose multiple wire connection that can connect the sensor portion with a controller or control module, which also includes a power source (see Fig. 3b and corresponding description, e.g. [0095]-[0096]; also see [0123]).
However, Ozawa teaches, in an analogous field of endeavor (e.g. biosensor arrangements e.g. see Abstract), further comprising a wiring harness configured to supply power to, and data communication with, the one light source and the one light sensor, the wiring harness further including a quick-disconnect connector along the wiring harness, adjacent the substrate (“When the auxiliary supporters 11 to 15 are removed, it is not preferred that connecting wires such as wire harnesses connecting the biosensors 20 to 23 to a controller and a power supply are cut. To avoid this, the wire harnesses of the embodiment include connectors that allow dividing each wire harness into one and the other portions and reconnecting them with each other. By using such connecting wires such as wire harnesses with connectors, it is possible to temporarily remove the auxiliary supporters 11 to 15 and reattach the auxiliary supporters 11 to 15 to the seat 1.” [0117]; also see [0125]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Brownhill with further comprising a wiring harness configured to supply power to, and data communication with, the one light source and the one light sensor, the wiring harness further including a quick-disconnect connector along the wiring harness, adjacent the substrate as taught by Ozawa in order to be able to be able to temporarily remove and reattach components to the dressing ([0117] of Ozawa).
Regarding claim 38, Brownhill modified by Obma and Ozawa discloses the limitations of claim 37 as stated above. In particular, Ozawa was relied on to teach the wiring harness. Ozawa further teaches, in an analogous field of endeavor, wherein the wiring harness is further configured to supply power to, and data communication with, the other light source and the other light sensor (“biosensors 20 to 23” [0117]; also see [0125]). Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Brownhill with wherein the wiring harness is further configured to supply power to, and data communication with, the other light source and the other light sensor as taught by Ozawa in order to be able to temporarily remove and reattach components to the dressing ([0117] of Ozawa).
Conclusion
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/A.A./Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797