DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This action is in response to the remarks filed on 04/20/2026. Claims 2-3, 5-10, 21, 23, 25 and 26, 31-32, and 34-47 are pending and claims 46-47 are newly added. Claims 4, 11-20, 22, 24, 27-30, and 33 are cancelled.
The objection to the drawings under 37 CFR 1.83(a) for the drawings to show every feature of the invention specified in the claims has been withdrawn in light of the applicant’s amendments to cancel the claim.
The rejection of claim 2 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paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter has been withdrawn in light of the applicant’s amendments to the claim.
The rejection of claims under 35 U.S.C. 101 has been withdrawn in light of the applicant’s amendments to the claim and the remarks.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 2-3, 5-10, 21, 23, 25, 26, 31-32, 34, 36-38, 40-43, and 45-47 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chhibber et al (US20070064985A1) in view of Olsen (WO2007005714A2, below citations are from the equivalent of US20080029708A1) and Fright et al (US 20090213213).
Regarding claim 2, Chhibber teaches a handheld fluorescence-based imaging system for obtaining diagnostic data regarding a wound site (see re-produced fig. 2A below; and “subject 101, or part of it, that is captured in the images include both skin and non-skin portions or features, such as hair, clothing, eyes, lips, nostrils, etc. Furthermore, some of the objects surrounding the subject 101 may also be captured in the images. Therefore, the pixels in the first white-light and UV images” [0047]; “camera and that the subject is allowed to reach full fluorescence under UV illumination” [0049]), the system comprising:
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an excitation light source configured to emit excitation light including at least one wavelength or wavelength band configured to cause at least one biomarker associated with bacteria in and around the wound an on a surface of surrounding skin to fluoresce (“captured by the camera and that the subject is allowed to reach full fluorescence under UV illumination” [0049]; “the UV light sources 120 are turned on to send a flash of UV light to the subject 101. The flash of UV light should include a band of UV wavelengths the can causes the skin associated with the subject 101 to fluoresce” [0050]; “captured fluorescence coming from an inflamed pore upon illumination by a UV flash” [0064]; “each skin pixel in the first UV image that has color and intensity values falling within predetermined ranges for each of the plurality of types of pores, determining a size of a pore by examining surrounding skin pixels” claim 20);
an optical sensor configured to detect fluorescence emissions from the at least one biomarker in and around the wound and the surface of the surrounding skin (“an image acquisition device 110, at least one light source 120 coupled to the image acquisition device 110” [0037]; “first UV image is captured by the sensor 114” [0050]; “each skin pixel in the first UV image that has color and intensity values falling within predetermined ranges for each of the plurality of types of pores, determining a size of a pore by examining surrounding skin pixels” claim 20);
a display user control of fluorescence-based imaging (“skin condition can be displayed on a user interface” [0012]); and
a processor (e.g., computing device, microprocessor [0013] etc.) configured to:
receive bacterial fluorescence data based on the detected fluorescence emissions from the at least one biomarker (“skin pixel has a white color and an intensity value exceeds 130, the skin pixel is likely one of a group of contiguous pixels that have captured fluorescence coming from an inflamed pore upon illumination by a UV flash. To confirm, surrounding skin pixels are also examined to see if some of them are also white in color and have intensity values over 130. If none or few of the pixels satisfy this criteria, the first skin pixel is not associated with an inflamed pore. Otherwise, an inflamed pore is identified, and in step 1330, the number of skin pixels associated with the inflamed pore is determined as a measure for the shape and size of the pore” [0064]; “skin condition includes at least one type of pores selected from the group consisting of: inflamed pores, bacteriostatic pores, sluggish oil flow, and deeply inflamed pores” also see claim 21 of Chhibber), and
based on the bacterial colonies identified, map a biodistribution of bacteria in and around the wound and on the surface of the surrounding skin, and (“identify skin pixels in all of the images of the subject 101 during subsequent processing, module 720 may include a further step 850 in which a skin map or skin mask is generated. In one embodiment of the present invention, as shown in FIG. 10(e), the skin map 1050 includes a matrix or data group having a plurality of elements, each corresponding to a pixel in any of the white-light or UV images of the subject 101” [0059]; “intensity values are computed from the pixel values associated with each pixel in one of the UV images” [0063]; “an inflamed pore is identified, and in step 1330, the number of skin pixels associated with the inflamed pore is determined as a measure for the shape and size of the pore, and an average of the intensity value associated with the number of skin pixels is computed as a quantitative indication of the severity of the pore” [0064]);
output to the display a color image indicative of the bacteria in and around the wound site and on the surface of the surrounding skin (“in all of the images of the subject 101 during subsequent processing, module 720 may include a further step 850 in which a skin map or skin mask is generated” [0059]).
Although displays having touchscreen functionality (i.e., touchscreen camera) is obvious, widely well-known and commercially available, Chhibber does not mention the digital camera 110, (or 200) having touchscreen functionality; and mapped biodistribution of bacteria, based on the bacterial autofluorescence data, identify presence of bacterial colonies in and around the wound and on the surface of the surrounding skin.
However, in the same field of endeavor, Olsen teaches digital camera with integrated ultraviolet (UV) response (title). The camera channels provide full color, single color, multi-color or mono chromatic (black and white) capability in any wavelength range from ultraviolet (UV) to infrared (IR). Color filters, if desired, may be on an image sensor or within the optical component layer or a combination of both. The camera channels may also provide color capability by utilizing the semiconductor absorption properties in a pixel [0040]. Digital camera apparatus that includes one or more input devices [0193]. Input devices include but are not limited to buttons, knobs, switches, keyboards, keypads, track ball, mouse, pen and tablet, light pen, touch screens [0847].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with touchscreen as taught by because it helps to improved image quality ([0012] of Olsen).
The combination above does not mention the biodistribution of bacteria; based on the bacterial autofluorescence data, identify presence of bacterial colonies in and around the wound and on the surface of the surrounding skin.
However, in the same field of endeavor, Fright teaches monitoring dermatological surface features such as wounds, ulcers, sores, lesions [0002]. The area of a wound may be calculated by calculating the pixel area of wound 7 from a captured image and multiplying by a known scaling factor. This technique may be effective where camera 1 can be oriented normal to the wound 7 and where wound 7 is generally planar. This technique offers a simple solution in such cases. [0062]. The outline of the wound may be determined utilising image processing techniques. [0069]. Measurements of other wound information may also be made. The colour of the wound and the size of particular coloured regions may also be calculated. These measurements may require a colour reference target to be placed within the image capture area for accurate colour comparison to be made [0074].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with biodistribution of bacteria; based on the bacterial autofluorescence data, identify presence of bacterial colonies in and around the wound and on the surface of the surrounding skin as taught by Fright because it provides a simple, inexpensive and repeatable method ([0008] of Fright).
Regarding claims 3 and 43, Chhibber teaches wherein the processor is further configured to generate one or more color-coded image maps of the fluorescence intensities (“each pixel in the white-light and UV image includes values associated with the three color channels, which are referred to sometimes in this document as pixel values. The pixel values may range, for example, between 0 and 255.” [0045]; “an inflamed pore is identified, and in step 1330, the number of skin pixels associated with the inflamed pore is determined as a measure for the shape and size of the pore, and an average of the intensity value associated with the number of skin pixels is computed as a quantitative indication of the severity of the pore.” [0064]).
Regarding claim 5, Chhibber teaches wherein the processor is further configured to determine a fluorescence area of the wound site based on the bacterial autofluorescence (“bacterial fluorescence captured fluorescence coming from an inflamed pore upon illumination by a UV flash. To confirm, surrounding skin pixels are also examined to see if some of them are also white in color and have intensity values over 130. If none or few of the pixels satisfy this criteria, the first skin pixel is not associated with an inflamed pore. Otherwise, an inflamed pore is identified, and in step 1330, the number of skin pixels associated with the inflamed pore is determined as a measure for the shape and size of the pore, and an average of the intensity value associated with the number of skin pixels is computed as a quantitative indication of the severity of the pore.” [0064])).
Regarding claims 6 and 7, Chhibber teaches wherein the processor is further configured to display the track changes to the fluorescence area of the wound site over time (“display the skin analysis result in a timeline showing changes of selected skin analysis results over time for the same subject 101” [0072]).
Regarding claims 8 and 9, Chhibber teaches wherein the processor is configured to generate, record, and output one or more reports based on the bacterial fluorescence data and fluorescence area of the wound include the identification of wound parameters and the tracking of the wound parameters over time (“display selected skin analysis result as compared with previous results related to the same skin condition for the same subject 101.” [0072]).
Regarding claim 10, Chhibber teaches further comprising a white light source configured to emit white light for white light imaging of the wound and the surface of the surrounding skin (“light sources 120 are configured to illuminate the subject 101 with white light, and another portion of the light sources 120 are configured to emit ultraviolet (UV) light.” [0039]) the optical sensor (“the image acquisition device 110 is part of a digital camera 200 having an image sensor 112 and an optical assembly 114 in front of the image sensor 112 and configured to” [0038]) configured to detect light reflected by the wound site and the processor is further configured to receive reflection data based on the detected light reflected by the wound site (“an image acquisition device 110, at least one light source 120 coupled to the image acquisition device 110” [0037]; “first UV image is captured by the sensor 114” [0050]).
Regarding claim 21, Chhibber teaches the processor is further configured to identify an indication of at least one of wound infection, wound healing, and wound healing failure based at least in part on the bacterial fluorescence data (“display selected skin analysis result as compared with previous results related to the same skin condition for the same subject 101” [0072]).
Regarding claim 23, Chhibber teaches wherein the color image indicative of the mapped biodistribution of bacteria in and around the wound and on the surface of the surrounding skin comprises a fluorescence image of the wound (“identify skin pixels in all of the images of the subject 101 during subsequent processing, module 720 may include a further step 850 in which a skin map or skin mask is generated” [0059]; “the skin pixel is likely one of a group of contiguous pixels that have captured fluorescence coming from an inflamed pore upon illumination by a UV flash” [0064]).
Regarding claims 25 and 40, Chhibber teaches further comprising a filter configured to exclude reflected excitation light from the one or more color-coded image maps of fluorescence intensities based on the detected autofluorescence emissions (“at least a portion of the flash light sources have UV transmission filters installed thereon, and at least a portion of the flash light sources have infrared absorption filters installed thereon” claim 40 of Chhibber).
Regarding claim 26, Chhibber teaches further comprising a plurality of light sources configured to elicit absorption data from tissue components of the wound (“living organisms fluoresce upon excitation through the absorption of light, a phenomenon known as autofluorescence, it has been shown that different organisms can be classified through their Stokes shift values. Stokes shift is the difference between peak wavelength or frequency of an absorption spectrum and peak wavelength or frequency of an emission spectrum” [0051]).
Regarding claim 31, Chhibber teaches wherein the processor is further configured to output measurements related to a shape or a size of the wound site (“pixels are also examined to determine the size and shape of a skin area having the skin condition” [0063]).
Regarding claim 32, Chhibber teaches wherein:
the excitation light source is a first excitation light source of a plurality of excitation light sources (e.g., “light sources 120”), each excitation light source of the plurality of excitation light sources is configured to emit excitation light including at least one wavelength or wavelength band (“ light sources 120 are configured to illuminate the subject 101 with white light, and another portion of the light sources 120 are configured to emit ultraviolet (UV) light” [0039]) configured to cause at least one biomarker associated with bacteria in and around the wound and on the surface of the surrounding skin (“a band of UV wavelengths the can causes the skin associated with the subject 101 to fluoresce,” [0050]), and the optical sensor is centrally positioned relative to the plurality of light sources (“ digital camera 200 having an image sensor 112 and an optical assembly 114 in front of the image sensor 112 and configured to form an image of the subject 101 on the image sensor 114” [0038]).
Regarding claims 34 and 38, Chhibber teaches wherein the processor is configured to output an image of raw fluorescence detected by the optical sensor to the display (“red-green-blue (RGB) color space, pixels that have the red channel (channel 1) values in the range of 105-255, the green channel (channel 2) values in the range of 52-191, and the blue channel (channel 3)” [0054]; also see [0060]-[0061], [0067]).
Regarding claim 37, Chhibber teaches a handheld fluorescence-based imaging system for obtaining diagnostic data regarding a wound site (see re-produced fig. 2A below; and “subject 101, or part of it, that is captured in the images include both skin and non-skin portions or features, such as hair, clothing, eyes, lips, nostrils, etc. Furthermore, some of the objects surrounding the subject 101 may also be captured in the images. Therefore, the pixels in the first white-light and UV images” [0047]; “camera and that the subject is allowed to reach full fluorescence under UV illumination” [0049]), the system comprising:
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first and second excitation light sources, each of the first and second excitation light sources being configured to emit excitation light selected to elicit emission of bacterial autofluorescence from bacteria in and around the wound and a surface of surrounding skin, wherein each of the first and second excitation light sources is configured to emit excitation light having a wavelength of 405 nm±10nm (“captured by the camera and that the subject is allowed to reach full fluorescence under UV illumination” [0049]; “the UV light sources 120 are turned on to send a flash of UV light to the subject 101. The flash of UV light should include a band of UV wavelengths the can causes the skin associated with the subject 101 to fluoresce” [0050]; “captured fluorescence coming from an inflamed pore upon illumination by a UV flash” [0064]);
a white light source configured to illuminate the wound and the surrounding skin with white light (“camera 200 are white light sources and the light sources 120” [0041]; “each skin pixel in the UV image that is determined to correspond to a specified skin condition, surrounding skin pixels are examined for the specified skin condition to determine a size of a skin area having the specified skin condition” [0011]);
an optical sensor positioned between the first and second excitation light sources, the optical sensor configured to (“an image acquisition device 110, at least one light source 120 coupled to the image acquisition device 110” [0037]; “first UV image is captured by the sensor 114” [0050]; also see fig. 2 e.g.);
detect the bacterial autofluorescence emissions from the wound and the surface of the surrounding skin, and detect signals reflected from the wound and the surface of the surrounding skin in response to illumination of the wound and the surface of the surrounding skin with the white light emitted by the white light source (“skin pixel has a white color and an intensity value exceeds 130, the skin pixel is likely one of a group of contiguous pixels that have captured fluorescence coming from an inflamed pore upon illumination by a UV flash. To confirm, surrounding skin pixels are also examined to see if some of them are also white in color and have intensity values over 130. If none or few of the pixels satisfy this criteria, the first skin pixel is not associated with an inflamed pore. Otherwise, an inflamed pore is identified, and in step 1330, the number of skin pixels associated with the inflamed pore is determined as a measure for the shape and size of the pore” [0064]; “skin condition includes at least one type of pores selected from the group consisting of: inflamed pores, bacteriostatic pores, sluggish oil flow, and deeply inflamed pores” also see claim 21 of Chhibber);
a display user control of fluorescence-based imaging (“skin condition can be displayed on a user interface” [0012]); and
a processor (e.g., computing device, microprocessor [0013] etc.) configured to:
receive reflection data based on the detected reflected signals and output a white light image of the wound and the surface of the surrounding skin based on the reflection data,
receive bacterial autofluorescence data based on the detected autofluorescence emissions, based on the bacterial autofluorescence data, identify presence of bacteria in an image of the wound (“skin pixel has a white color and an intensity value exceeds 130, the skin pixel is likely one of a group of contiguous pixels that have captured fluorescence coming from an inflamed pore upon illumination by a UV flash. To confirm, surrounding skin pixels are also examined to see if some of them are also white in color and have intensity values over 130. If none or few of the pixels satisfy this criteria, the first skin pixel is not associated with an inflamed pore. Otherwise, an inflamed pore is identified, and in step 1330, the number of skin pixels associated with the inflamed pore is determined as a measure for the shape and size of the pore” [0064]; “skin condition includes at least one type of pores selected from the group consisting of: inflamed pores, bacteriostatic pores, sluggish oil flow, and deeply inflamed pores” also see claim 21 of Chhibber), and
map a bacteria to locations in and around the wound and on the surface of the surrounding skin, (“a color value and an intensity value associated with each of the skin pixels in the UV image” [0011]; “ intensity values are computed from the pixel values associated with each pixel in one of the UV images” [0063]; “an inflamed pore is identified, and in step 1330, the number of skin pixels associated with the inflamed pore is determined as a measure for the shape and size of the pore, and an average of the intensity value associated with the number of skin pixels is computed as a quantitative indication of the severity of the pore” [0064]);
output to the display a color image indicative of the biodistribution of bacteria at the wound site (see e.g., figs 2, 6, 10 and 15).
Although displays having touchscreen functionality (i.e., touchscreen camera) is obvious, widely well-known and commercially available, Chhibber does not mention the digital camera 110, (or 200) having touchscreen functionality; and mapped biodistribution of bacteria, based on the bacterial autofluorescence data, identify presence of bacterial colonies in and around the wound and on the surface of the surrounding skin.
However, in the same field of endeavor, Olsen teaches digital camera with integrated ultraviolet (UV) response (title). The camera channels provide full color, single color, multi-color or mono chromatic (black and white) capability in any wavelength range from ultraviolet (UV) to infrared (IR). Color filters, if desired, may be on an image sensor or within the optical component layer or a combination of both. The camera channels may also provide color capability by utilizing the semiconductor absorption properties in a pixel [0040]. Digital camera apparatus that includes one or more input devices [0193]. Input devices include but are not limited to buttons, knobs, switches, keyboards, keypads, track ball, mouse, pen and tablet, light pen, touch screens [0847].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with touchscreen as taught by because it helps to improved image quality ([0012] of Olsen).
The combination above does not mention the biodistribution of bacteria; based on the bacterial autofluorescence data, identify presence of bacterial colonies in and around the wound and on the surface of the surrounding skin.
However, in the same field of endeavor, Fright teaches monitoring dermatological surface features such as wounds, ulcers, sores, lesions [0002]. The area of a wound may be calculated by calculating the pixel area of wound 7 from a captured image and multiplying by a known scaling factor. This technique may be effective where camera 1 can be oriented normal to the wound 7 and where wound 7 is generally planar. This technique offers a simple solution in such cases. [0062]. The outline of the wound may be determined utilising image processing techniques. [0069]. Measurements of other wound information may also be made. The colour of the wound and the size of particular coloured regions may also be calculated. These measurements may require a colour reference target to be placed within the image capture area for accurate colour comparison to be made [0074].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with biodistribution of bacteria; based on the bacterial autofluorescence data, identify presence of bacterial colonies in and around the wound and on the surface of the surrounding skin as taught by Fright because it provides a simple, inexpensive and repeatable method ([0008] of Fright).
Regarding claim 41, Chhibber teaches a handheld fluorescence-based imaging system for acquiring data regarding a wound site (see re-produced fig. 2A below; and “subject 101, or part of it, that is captured in the images include both skin and non-skin portions or features, such as hair, clothing, eyes, lips, nostrils, etc. Furthermore, some of the objects surrounding the subject 101 may also be captured in the images. Therefore, the pixels in the first white-light and UV images” [0047]; “camera and that the subject is allowed to reach full fluorescence under UV illumination” [0049]), the system comprising:
a housing configured to be held in a user's hand (see e.g., camera below in figs and pertinent part of the description);
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an excitation light source connected to the housing the excitation light source being configured to emit excitation light selected to elicit emission of bacterial autofluorescence from bacteria in and around the wound and on a surface of surrounding skin, wherein the excitation light source is configured to emit excitation light having a wavelength of 405 nm ± 10 nm; (“captured by the camera and that the subject is allowed to reach full fluorescence under UV illumination” [0049]; “the UV light sources 120 are turned on to send a flash of UV light to the subject 101. The flash of UV light should include a band of UV wavelengths the can causes the skin associated with the subject 101 to fluoresce” [0050]; “captured fluorescence coming from an inflamed pore upon illumination by a UV flash” [0064]);
an optical sensor contained in the housing and configured to detect the bacterial autofluorescence emissions from in and around the wound and the surface of the surrounding skin (“an image acquisition device 110, at least one light source 120 coupled to the image acquisition device 110” [0037]; “first UV image is captured by the sensor 114” [0050]; also see fig. 2 e.g.);
a processor (e.g., computing device, microprocessor [0013] etc.) configured to:
receive bacterial autofluorescence data based on the detected autofluorescence emissions, based on the bacterial autofluorescence data, identify presence of bacteria in an image of the wound (“skin pixel has a white color and an intensity value exceeds 130, the skin pixel is likely one of a group of contiguous pixels that have captured fluorescence coming from an inflamed pore upon illumination by a UV flash. To confirm, surrounding skin pixels are also examined to see if some of them are also white in color and have intensity values over 130. If none or few of the pixels satisfy this criteria, the first skin pixel is not associated with an inflamed pore. Otherwise, an inflamed pore is identified, and in step 1330, the number of skin pixels associated with the inflamed pore is determined as a measure for the shape and size of the pore” [0064]; “skin condition includes at least one type of pores selected from the group consisting of: inflamed pores, bacteriostatic pores, sluggish oil flow, and deeply inflamed pores” also see claim 21 of Chhibber), and
map a bacteria to locations in and around the wound and on the surface of the surrounding skin, (“a color value and an intensity value associated with each of the skin pixels in the UV image” [0011]; “ intensity values are computed from the pixel values associated with each pixel in one of the UV images” [0063]; “an inflamed pore is identified, and in step 1330, the number of skin pixels associated with the inflamed pore is determined as a measure for the shape and size of the pore, and an average of the intensity value associated with the number of skin pixels is computed as a quantitative indication of the severity of the pore” [0064]);
output to the display a color image indicative of the biodistribution of bacteria at the wound site (see e.g., figs 2, 6, 10 and 15).
a filter configured to prevent the inclusion of reflected excitation light in the determination of fluorescence intensities for the one or more regions of interest of the wound site (“at least a portion of the flash light sources have UV transmission filters installed thereon, and at least a portion of the flash light sources have infrared absorption filters installed thereon” claim 40 of Chhibber); and
a display connected to the housing and configured to receive the output from the processor (see e.g., figs 2, 6, 10 and 15).
Although displays having touchscreen functionality (i.e., touchscreen camera) is obvious, widely well-known and commercially available, Chhibber does not mention the digital camera 110, (or 200) having touchscreen functionality; and mapped biodistribution of bacteria, based on the bacterial autofluorescence data, identify presence of bacterial colonies in and around the wound and on the surface of the surrounding skin.
However, in the same field of endeavor, Olsen teaches digital camera with integrated ultraviolet (UV) response (title). The camera channels provide full color, single color, multi-color or mono chromatic (black and white) capability in any wavelength range from ultraviolet (UV) to infrared (IR). Color filters, if desired, may be on an image sensor or within the optical component layer or a combination of both. The camera channels may also provide color capability by utilizing the semiconductor absorption properties in a pixel [0040]. Digital camera apparatus that includes one or more input devices [0193]. Input devices include but are not limited to buttons, knobs, switches, keyboards, keypads, track ball, mouse, pen and tablet, light pen, touch screens [0847].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with touchscreen as taught by because it helps to improved image quality ([0012] of Olsen).
The combination above does not mention the biodistribution of bacteria; based on the bacterial autofluorescence data, identify presence of bacterial colonies in and around the wound and on the surface of the surrounding skin.
However, in the same field of endeavor, Fright teaches monitoring dermatological surface features such as wounds, ulcers, sores, lesions [0002]. The area of a wound may be calculated by calculating the pixel area of wound 7 from a captured image and multiplying by a known scaling factor. This technique may be effective where camera 1 can be oriented normal to the wound 7 and where wound 7 is generally planar. This technique offers a simple solution in such cases. [0062]. The outline of the wound may be determined utilising image processing techniques. [0069]. Measurements of other wound information may also be made. The colour of the wound and the size of particular coloured regions may also be calculated. These measurements may require a colour reference target to be placed within the image capture area for accurate colour comparison to be made [0074].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with biodistribution of bacteria; based on the bacterial autofluorescence data, identify presence of bacterial colonies in and around the wound and on the surface of the surrounding skin as taught by Fright because it provides a simple, inexpensive and repeatable method ([0008] of Fright).
Regarding claim 42, Chhibber teaches wherein the system is configured to display one or more of optical wavelength information, fluorescence intensity information, and reflectance intensity information with spatial dimensions of the imaged wound site (see e.g., fig. 9 and the associated pars.).
Regarding claims 36 and 45, Chhibber teaches wherein the excitation light source includes a first light and a second light, and wherein at least one of the first and second is configured to emit blue excitation light (“white-light and UV images includes values associated with three colors” [0009]; “Having more than one flash light sources 120 allows more uniform exposure of the subject 101 to light during imaging and to allow different light sources to be configured to emit different colors or wavelengths of light,” [0039]; “ the first white-light image being in a first color space, such as the red-green-blue (RGB) color space, pixels that have the red channel” [0054]).
Although light sources as light emitting diode (LED) are obvious, widely well-known and commercially available, Chhibber does not mention plurality of light sources 120 as parts of the digital camera 200 being LEDs.
However, in the same field of endeavor, Olsen teaches digital camera with integrated ultraviolet (UV) response (title). The camera channels provide full color, single color, multi-color or mono chromatic (black and white) capability in any wavelength range from ultraviolet (UV) to infrared (IR). Color filters, if desired, may be on an image sensor or within the optical component layer or a combination of both. The camera channels may also provide color capability by utilizing the semiconductor absorption properties in a pixel [0040]. Digital camera apparatus that includes one or more input devices [0193]. Input devices include but are not limited to buttons, knobs, switches, keyboards, keypads, track ball, mouse, pen and tablet, light pen, touch screens [0847]. FIG. 2 shows an example of a digital camera 2, and components thereof. The digital camera includes a digital camera subsystem 200, a circuit board 110, setting controls and/or one or more additional input devices etc) 120, a power supply 130 [0324]. one or more illumination devices (e.g., one or more light emitting diodes (LEDs) with high output intensity [0613]. the one or more illumination devices are in the form of one or more LED's (e.g., one or more high power LED's) [0617].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with LED as taught by because it helps to improved image quality ([0012] of Olsen).
Regarding claim 46, the above noted combination teaches all the limitations of the claim except for identify wound margins.
However, in the same field of endeavor, Fright teaches monitoring dermatological surface features such as wounds, ulcers, sores, lesions [0002]. The area of a wound may be calculated by calculating the pixel area of wound 7 from a captured image and multiplying by a known scaling factor. This technique may be effective where camera 1 can be oriented normal to the wound 7 and where wound 7 is generally planar. This technique offers a simple solution in such cases. [0062]. The outline of the wound may be determined utilising image processing techniques. [0069]. Measurements of other wound information may also be made. The colour of the wound and the size of particular coloured regions may also be calculated. These measurements may require a colour reference target to be placed within the image capture area for accurate colour comparison to be made [0074].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with identify wound margins as taught by Fright because it provides a simple, inexpensive and repeatable method ([0008] of Fright).
Regarding claim 47, the above noted combination teaches all the limitations of the claim except for the processor is further configured to identify wound margins in the color image.
However, in the same field of endeavor, Fright teaches monitoring dermatological surface features such as wounds, ulcers, sores, lesions [0002]. The area of a wound may be calculated by calculating the pixel area of wound 7 from a captured image and multiplying by a known scaling factor. This technique may be effective where camera 1 can be oriented normal to the wound 7 and where wound 7 is generally planar. This technique offers a simple solution in such cases. [0062]. the image may be identified automatically based on colour, light intensity etc. The outline 13 is preferably user defined by drawing the outline on a touch display screen displaying the image [0064]. The outline of the wound may be determined utilising image processing techniques [0069]. Measurements of other wound information may also be made. The colour of the wound and the size of particular coloured regions may also be calculated. These measurements may require a colour reference target to be placed within the image capture area for accurate colour comparison to be made [0074].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with identify wound margins in the color image as taught by Fright because it provides a simple, inexpensive and repeatable method ([0008] of Fright).
Claims 35, 39 and 44 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chhibber in view of Olson and Fright, and further in view of Aprahamian (US6393315B1).
Regarding claims 35, 39 and 44, the above noted combination teaches all the limitations of the claim except for mapping bacterial autofluorescence data and reflectance data onto white light images of the wound and the surrounding skin.
However, in the same field of endeavor, Aprahamian teaches detecting and mapping inflamed zones in living tissues. The method includes subjecting the tissues to be analyzed to a luminous excitation with a predetermined spectral domain, acquiring at least the raw fluorescence signal of the porphyrins for a plurality of measurement points, and in determining, for each measurement point, the intensity of the fluorescence for the wavelengths characteristic of endogenous porphyrins (abst). The superposition of this latter image on a normal photographic image permits precisely locating the inflammation zone (col. 6 lines 15-18).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with mapping bacterial autofluorescence data and reflectance data onto white light images of the wound site as taught by Aprahamian because doing so improves the contrast between healthy tissues and inflamed tissues (col. 5 lines 36-37 of Aprahamian).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-10, 21, 23, 25, 26 and 31-45 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-3, 5-9, and 13-20 of copending Application No. 19025440 (reference application) and claims 2-3, 6-7, 9-17 of copending Application No. 19/024,995. Although the claims at issue are not identical, they are not patentably distinct from each other because the above noted claims practically directed to similar or obvious inventions of wound detecting with fluorescence (i.e., UV bacterial infection, etc.).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SERKAN AKAR/ Primary Examiner, Art Unit 3797
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