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
The action is in response to the remarks filed on 2/3/2026. Claims 1, 3-18, 20-25 and 27-34 remain pending. Claims 2, 19, and 26 are cancelled.
The objections to the claims have been withdrawn in light of the applicant’s amendments to the claims.
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 1, 3-16 and 25 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 1 recites the limitation of “wherein each of the camera…are is directly mounted on and external to the portable” (in line 7) which the “camera” appears to refer back to the “camera” in line 4. As best understood, there is ONLY ONE camera being recited and it is not clear what is meant by “wherein each of the camera…are is directly mounted on and external to the portable” (in line 7) as if there were more than ONE cameras.
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 1, 3 6-7, and 9-16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chhibber et al (US20070064985A1) in view of Kollias et al (US20050195316A1) and Fright et al (WO2007043899A1 with which the US equivalent US20090213213A1 is cited below).
Regarding claim 1, Chhibber teaches a portable imaging system for visualizing bacteria of a wound in situ (see re-produced figs 1-2 and the associated pars.) comprising:
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positioning a portable frame of a portable imaging system relative to the wound (“digital camera 200, including, for example, two flash light sources 120 on two sides of the camera, a flash light source 120 on top of the camera, and optionally another flash light source 120 at the bottom of the camera” [0039]; notice those flashes light sources being added on to the portable frame of the off-the-shelf digital camera which is positioned relative to the subject/wound),
wherein the portable imaging system includes a camera configured to detect in situ fluorescence of the wound (see re-produced figs 1-2 and the associated pars.) and an excitation light source configured to emit excitation light having at least one predefined wavelength (“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]) and cause at least one biomarker associated with the wound target to fluoresce in situ (“flash of UV light should include a band of UV wavelengths the can causes the skin associated with the subject 101 to fluoresce” [0050]), and
wherein the camera configured to detect in situ fluorescence of the wound (“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]) and the excitation light source configured to emit the excitation light having the at least one predefined wavelength are mounted on and external to the portable frame (“digital camera 200, including, for example, two flash light sources 120 on two sides of the camera, a flash light source 120 on top of the camera, and optionally another flash light source 120 at the bottom of the camera” [0039]) for hands-free operation of the imaging system and the portable frame is movable relative to the wound to adjust a field of view of the camera (off-the-shelf digital camera, such as the one shown in FIG. 2C” [0041] with portable frame is movable relative to the wound to adjust a field of view of the camera, as shown in figs 1-2 and the associated pars.),
operating the portable imaging system in a hands-free manner (off-the-shelf digital camera, such as the one shown in FIG. 2C” [0041] with portable frame is movable relative to the wound to adjust a field of view of the camera, as shown in figs 1-2 and the associated pars.) to:
illuminate the wound with the excitation light having the at least one predefined wavelength to cause at least one biomarker associated with the wound to fluoresce (“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]); and
detect, in real time, one or more signals emitted by the at least one biomarker while the at least one biomarker is in situ in (“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]).
Although, Chhibber’s convention off the shelf digital cameras known to have the common features of power source for the excitation light source; hands-free operation of the imaging system; portable frame and in real time of detection which are all apparent features of digital cameras as also shown above. Yet, if one argues that these features are not explicitly taught (which the office does not concede), Kollias reference is brought in for the explicit teachings for these features and to expedite the prosecution under the compact prosecution initiatives.
In the same field of endeavor, Kollias teaches a self-contained, portable apparatus and corresponding method for capturing, displaying and analyzing images of a person includes a housing for containing a digital camera, a light source capable of providing at least two different wavelengths of light, a touch-screen display and a computer for controlling the camera, the light source and the display (abst). Kollias further teaches power source for the excitation light source (“power packs 92, 92, 93, 93, 91, and 91” [0070]); hands-free operation of the imaging system (“the person whose image is to be captured is positioned relative to the camera and a plurality of images is automatically captured with the camera” [0009]); portable frame (“The apparatus has a housing, a camera mounted in the housing for capturing the images of the person a and means for illuminating mounted in the housing for providing light for capturing the images of the person” [0008]) and in real time of detection (“The real time image is therefore, in some respects, like a mirror. To initiate an imaging session, a computer program may be used to inform the user, either through visually displayed instructions or auditory instructions, to position their face such that it substantially fills the display frame and is centered therein” [0087]).
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 known features of an off the shelf digital camera to have a power source for the excitation light source; hands-free operation of the imaging system; portable frame and in real time of detection as taught by Kollias because improved means of viewing their skin with digital camera, in order to provide them additional insight into the condition of their skin. Such insight allows them to make more informed decisions regarding the purchase of skin care products ([0007] of Kollias).
If one still argues that the features of each of the camera mounted on and external to the portable frame are not explicitly taught (which the office does not concede), Fright reference is brought in for the explicit teachings for these features and to expedite the prosecution under the compact prosecution initiatives.
The above noted combination does not point out the specifics of the camera and an excitation light source mounted on and external to the portable frame.
However, in the same field of endeavor, Fright teaches various techniques have been used to monitor wounds, ulcers, sores, lesions, tumour etc [0002]. Apparatus for performing the method may take a variety of forms ranging from a stationary system (having a stationary camera or a handheld camera connected wirelessly or by a cable) to a fully portable unit. Portable units in the form of PDAs, cell phones, notebooks, ultramobile PCs etc. including an integrated or plug-in camera allow great flexibility, especially for medical services outside of hospitals [0070]. FIG. 10 shows an apparatus sensors are provided. The apparatus 50 includes a PDA 51, with housing 52 containing a camera 53, laser generator 54 provided in a separate module, within the PDA 51 or in a plugin card. When external to the PDA, the positioning module may be connected to the PDA via any suitable wired or wireless connection [0083].
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 as taught by Fright because it is an object of the invention to provide an apparatus that is simple, portable, inexpensive and easy to use or which at least provides the public with a useful choice ([0008] of Fright).
Regarding claim 3, Chhibber teaches wherein the at least one biomarker is selected from the group consisting of bacteria, fungi, yeast, spores, virus, microbes, parasites, connective tissues, tissue components, exudates, pH, blood vessels, reduced nicotinamide adenine dinucleotide (NADH), flavin adenine dinucleotide (FAD), microorganisms, vascular endothelial growth factor (VEGF), endothelial growth factor (EGF), epithelial growth factor, epithelial cell membrane antigen (ECMA), hypoxia inducible factor (HIF-1), carbonic anhydrase IX (CAIX), laminin, fibrin, fibronectin, fibroblast growth factor, transforming growth factors (TGF), fibroblast activation protein (FAP), tissue inhibitors of metalloproteinases (TIMPs), nitric oxide synthase (NOS), inducible and endothelial NOS, lysosomes in cells, macrophages, neutrophils, lymphocytes, hepatocyte growth factor (HGF), anti-neuropeptides, neutral endopeptidase (NEP), granulocyte-macrophage colony stimulating factor (GM-CSF), neutrophil elastases, cathepsins, arginases, fibroblasts, endothelial cells and keratinocytes, keratinocyte growth factor (KGF), macrophage inflammatory protein-2 (MIP-2), macrophage inflammatory protein-2 (MIP-2), and macrophage chemoattractant protein-1 (MCP-1), polymorphonuclear neutrophils (PMN), myofibroblasts, interleukin-1 (IL-1), tumour necrosis factor (TNF), nitric oxide (NO), c- myc, beta-catenin, endothelial progenitor cells (EPCs), matrix metalloproteinases (MMPs) and MMP inhibitors (“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” [0064]).
Further, Kollias teaches visually enhance the appearance of pigmentation, the bacteria p. acnes, and horns [0006]. This type of photography produces bright images of the distribution of coproporphyrin produced by the bacteria P. acnes and of horns. What is meant by a “horn” is a mixture of sebaceous lipids, keratinocytes, and possibly sebocytes impacted in open comedones and blackheads on the skin. By using substantially only blue light that is within the Soret absorption band of porphyrins, the fluorescence emission of coproporphyrin is maximized. Excitation in this range also yields bright emission images of the distribution of “horns” because the fluorescence yield of horns is higher when excited in the blue region of the spectrum [0044].
Regarding claim 6, Chhibber teaches detecting a presence or a location of one or more strains of bacteria based on the detected fluorescence (“living organisms fluoresce upon excitation through the absorption of light, a phenomenon known as autofluorescence… autofluorescence of the skin and image processing technologies to provide automated detection and analysis of subsurface skin condition” [0051]; “fluorescence coming from an inflamed pore upon illumination by a UV flash” [0064]).
Further, Kollias teaches (“bright images of the distribution of coproporphyrin produced by the bacteria P. acnes and of horns.” [0044]; “fluorescence emission of porphyrins from p. acnes” [0045]).
Regarding claim 7, Chhibber teaches wherein the one or more bacterial strains is at least one strain selected from the group consisting of: bacteria of the Staphylococcus genus, bacteria of the Staphylococcus aureus species, Pseudomonas aeruginosa, Listeria monocytogenes, Enterobacter sakazakii, Campylobacter species bacteria, coliform bacteria, Escherichia coli bacteria, Propionibacterium acnes, and Salmonella (“fluorescence coming from an inflamed pore (Propionibacterium acnes) upon illumination by a UV flash” [0064]).
Further, Kollias teaches (“bright images of the distribution of coproporphyrin produced by the bacteria P. acnes and of horns.” [0044]; “fluorescence emission of porphyrins from p. acnes” [0045]).
Regarding the claim 9, Chhibber teaches directly or indirectly visualizing bacteria in the wound in real time by viewing fluorescence emitted by the at least one biomarker associated with the wound (“selected skin condition can be displayed on a user interface” [0012]; “to visually display the UV damage in an enhanced view, a UV damage enhanced white light image is formed in step 1150 that has a plurality of pixels each corresponding to a respective pixel in the first white-light image.” [0061]).
Regarding claim 10, Chhibber teaches further engaging a filter to block the excitation light (“UV bandpass filter as compared with transmission spectra of other white-light filters.” [0019]; also see [0041]).
Regarding claim 11, Chhibber teaches of the wavelengths of 400 nm to 450 nm (“The flash of white light preferably has wavelengths that span across a full spectrum of visible light (i.e., wavelength from about 380 to about 700 nm)” [0051]).
Further, Kollias teaches a photograph that is taken of the subject using visible light (e.g., light having a wavelength from about 400 to about 700 nm).
Regarding claim 12, Chhibber teaches wound is illuminated with one or more of blue excitation light and violet excitation light (“acquiring a white-light image and an ultraviolet (UV) image of a portion of a body surface, such as a person's face, each of the white-light and UV images” abst).
Further, Kollias teaches taking a blue fluorescence photograph of the subject [0041]. Camera 11 to acquire a blue fluorescence photograph, a standard photograph, a polarized photograph, and an ultraviolet A photograph [0066].
Regarding claim 13, Chhibber teaches wherein the camera is a video camera and detecting fluorescence of the at least one biomarker with the camera includes capturing the fluorescence with an imaging sensor of the video camera (as it is widely known in the imaging and image processing, the video is made up of series of images show to make a video. Chhibber clearly teaches “The images captured by the sensor 114 and the images used by the computing device 130”. Further, it is also widely known that off the shelf conventional digital cameras have video features).
Further, Kollias teaches a real time moving image captured by the camera 211 in video mode which permits the user to interactively view and position their face in front of the camera for centering and focusing and optimally capturing their facial image [0095]. FIGS. 6 and 7 show the basic process shown in FIG. 5, in greater detail, namely, the step of positioning and preparing 306 to capture images includes powering 318 the fluorescent lights, powering 320 the flash charger and displaying 322 the camera video output on the monitor 270 so that the subject S may ascertain their position relative to the camera 322 [0102].
Regarding claim 14, Chhibber teaches comprising powering the excitation light source of the portable imaging system with a rechargeable battery pack (off the shelf conventional digital cameras are known to have rechargeable battery pack).
Further, Kollias teaches capture images includes powering 318 the fluorescent lights, powering 320 the flash charger and displaying 322 the camera video output [0094].
Regarding claim 15, Chhibber teaches switching between a fluorescent imaging mode of the portable imaging system in which the excitation light source is emitting excitation light and a standard imaging mode of the portable imaging system in which the excitation light source is not emitting light and a white light source is emitting white light (“acquiring a white-light image and an ultraviolet (UV) image of a portion of a body surface” abst; “a portion of the 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]).
Further, Kollias teaches control button 228 a controls the fluorescent lighting 217 a, 217 b (on/off and/or dim down/brighten), which illuminates the subject S in a darkened room and allows the subject S to position his or her face before the camera (as shown in thumbnail 224 a). (In order to control the wavelengths of light in which images are taken, it is preferable to have reduced ambient illumination, e.g., due to room lighting) [0089]. Once positioned, the subject is instructed to turn off the fluorescent lights and/or to close their eyes to prevent the flashes from being seen. Once the subject S indicates a ready state, e.g., by pressing a button, e.g., 228 c for taking pictures or by the system sensing that the subject S has turned off the fluorescent lights, the image set can be captured 308 by sequentially taking pictures utilizing different flashes and filters [0093].
Regarding claim 16, Chhibber teaches illuminating the wound with white light emitted by the portable imaging system; and
capturing an image of the wound illuminated by the white light with the camera (“acquiring a white-light image and an ultraviolet (UV) image of a portion of a body surface” abst; “a portion of the 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]).
Claims 4-5 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chhibber et al (US20070064985A1) in view of Kollias et al (US20050195316A1) and Fright further in view of Boyden et al (US 20080059070).
Regarding the claims 4-5, Chhibber teaches all the claimed limitations except for using the detected fluorescence to guide debridement of the wound (hence intended limitation).
However, in the same field of endeavor, Boyden teaches autofluorescent imaging and ablation (abst). Devices for fluorescent-based imaging and ablation of medical targets [0013]. A remote portion may provide for monitoring of the lumen-based device or data collection or analysis. The remote portion may be at a separate location within the body of the subject, or outside the body of the subject [0043]. One or more energy sources 110 are programmable, remote-controlled, wirelessly controlled, and or feedback-controlled [0062]. Electromagnetic energy selected to induce a fluorescent response from a target area in the lesion; a sensor 120 configured to detect the fluorescent response; control circuitry 130 coupled to the sensor 120 and responsive to identify the target area; and a second energy source 110 responsive to the control circuitry 130 and configured to emit energy selected to at least partially ablate the target area [0036]. Detect the auto-fluorescent response; control circuitry 130 coupled to the sensor 120 and responsive to identify a target area in real time [0041].
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 hands-free, and real-time operation along with “to guide debridement of the wound” as taught by Boyden because it would help with prevention, and/or amelioration of a variety of diseases and disorders ([0013] of Boyden).
Claim 25 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chhibber et al (US20070064985A1) in view of Kollias et al (US20050195316A1) and Fright further in view of Duckworth et al (“A clinically affordable non-contact wound measurement device.” Proceedings of Rehab Engineering Society of North America (RESNA) 2007).
Regarding claim 25, Chhibber teaches comprising securely fixing the camera to an external portion of the portable frame (see the camera being fixed to the housing in figs 1-3).
Further Duckworth also teaches The Sony-Ericsson P900 phone was chosen as the hand-held platform for the prototype device. A touch-screen interface, camera, and Bluetooth were all features available on this phone which were necessary to build the application. The phone (along with its camera) is mounted in a dock to which 4 laser diodes (used for structured lighting), 8 white LEDs (used for scene illumination), and batteries to supply the lights are also mounted. The complete hand-held device is shown from top in Figure 1 (pg. 2). Fig. 1. shows an image of the device from the top side. The mobile computing platform, the P900, is mounted to a clear acrylic docking station. Batteries to power the LEDs are contained within the handle to the left of the dock. Batteries to power the laser diodes are mounted to the underside of the dock. Laser diodes are mounted in a square around the P900.
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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 securely fixing the camera to an external portion of the portable frame as taught by Duckworth because it makes the accuracy and precision of the measurement dependent of the user which means intra- and inter-rater reliability increases (intro of Duckworth).
Claims 17-18, 20-24 and 27-34 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chhibber et al (US20070064985A1) in view of Kollias et al (US20050195316A1) in view of Duckworth et al (“A clinically affordable non-contact wound measurement device.” Proceedings of Rehab Engineering Society of North America (RESNA) 2007), and further in view of Boyden et al (US 20080059070) and Fright.
Regarding claim 17, Chhibber teaches method of visualizing bacteria in a wound in situ, comprising:
directly mounting a camera configured to detect in situ fluorescence of the wound and an excitation light source configured to emit excitation light on an external portion of a portable frame of a portable imaging system (“FIG. 2A also shows a plurality of light sources 120 as parts of the digital camera 200, including, for example, two flash light sources 120 on two sides of the camera, a flash light source 120 on top of the camera, and optionally another flash light source 120 at the bottom of the camera” [0039]; notice that the flash and the camera are mounted on the external portion of a portable housing frame);
positioning the portable frame with the camera and the excitation light source fixed thereto relative to the wound (see re-produced figs 1-2 and the associated pars.);
positioninq a filter relative to one or more of an imaginq sensor of the camera and the excitation light source (“Each of the UV light sources 120 can be one converted from light source 300 by changing a low-pass filter 310 in front of the light source 300 into a UV filter 310” [0041]);
operating the portable imaging system in a hands-free manner (off-the-shelf digital camera, such as the one shown in FIG. 2C” [0041] with portable frame is movable relative to the wound to adjust a field of view of the camera, as shown in figs 1-2 and the associated pars.) to illuminate the wound with the excitation light emitted by the excitation light source and having the at least one predefined wavelength to cause at least one biomarker associated with the wound to fluoresce in situ (“digital camera 200, including, for example, two flash light sources 120 on two sides of the camera, a flash light source 120 on top of the camera, and optionally another flash light source 120 at the bottom of the camera” [0039]);
visualizing, in real time, bacteria in the wound by viewing fluorescence emitted by the at least one biomarker associated with the wound while the at least one biomarker is in situ (“to visually display the UV damage in an enhanced view, a UV damage enhanced white light image is formed” [0061]; “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]); and
using the fluorescence emitted by the at least one biomarker associated with the wound (“to visually display the UV damage in an enhanced view, a UV damage enhanced white light image is formed” [0061]; “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]).
As clearly shown above Chhibber in an interpretation teaches the limitations of: mounting a camera…on an external portion of a portable frame; positioning the portable frame with the camera and the excitation light source; hands-free manner; visualizing, in real time. Yet, if one argues otherwise (which the office does not concede), and in an effort to provide compact prosecution, Duckworth and Boyden references are brought in to also show the teachings of these limitations.
In the same field of endeavor, Duckworth teaches the Sony-Ericsson P900 phone was chosen as the hand-held platform for the prototype device. A touch-screen interface, camera, and Bluetooth were all features available on this phone which were necessary to build the application. The phone (along with its camera) is mounted in a dock [i.e., frame] to which 4 laser diodes (used for structured lighting), 8 white LEDs (used for scene illumination), and batteries to supply the lights are also mounted. The complete hand-held device is shown from top in Figure 1 (pg. 2). Fig. 1. shows an image of the device from the top side. The mobile computing platform, the P900, is mounted to a clear acrylic docking station. Batteries to power the LEDs are contained within the handle to the left of the dock. Batteries to power the laser diodes are mounted to the underside of the dock. Laser diodes are mounted in a square around the P900.
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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 camera and an excitation light source mounted on and external to the portable frame as taught by Duckworth because it makes the accuracy and precision of the measurement dependent of the user which means intra- and inter-rater reliability increases (intro of Duckworth).
The above noted combination does not point out the specifics of guiding debridement of the wound (hence intended limitation) and limitations in an interpetation of hands-free manner; visualizing, in real time.
However, in the same field of endeavor, Boyden teaches autofluorescent imaging and ablation (abst). Devices for fluorescent-based imaging and ablation of medical targets [0013]. A remote portion may provide for monitoring of the lumen-based device or data collection or analysis. The remote portion may be at a separate location within the body of the subject, or outside the body of the subject [0043]. One or more energy sources 110 are programmable, remote-controlled, wirelessly controlled, and or feedback-controlled [0062]. Electromagnetic energy selected to induce a fluorescent response from a target area in the lesion; a sensor 120 configured to detect the fluorescent response; control circuitry 130 coupled to the sensor 120 and responsive to identify the target area; and a second energy source 110 responsive to the control circuitry 130 and configured to emit energy selected to at least partially ablate the target area [0036]. Detect the auto-fluorescent response; control circuitry 130 coupled to the sensor 120 and responsive to identify a target area in real time [0041].
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 hands-free, and real-time operation along with “to guide debridement of the wound” as taught by Boyden because it would help with prevention, and/or amelioration of a variety of diseases and disorders ([0013] of Boyden).
If one still argues that the features of directly mounting a camera on an external portion of a portable frame are not explicitly taught (which the office does not concede), Fright reference is brought in for the explicit teachings for these features and to expedite the prosecution under the compact prosecution initiatives.
However, in the same field of endeavor, Fright teaches various techniques have been used to monitor wounds, ulcers, sores, lesions, tumour etc [0002]. Apparatus for performing the method may take a variety of forms ranging from a stationary system (having a stationary camera or a handheld camera connected wirelessly or by a cable) to a fully portable unit. Portable units in the form of PDAs, cell phones, notebooks, ultramobile PCs etc. including an integrated or plug-in camera allow great flexibility, especially for medical services outside of hospitals [0070]. FIG. 10 shows an apparatus sensors are provided. The apparatus 50 includes a PDA 51, with housing 52 containing a camera 53, laser generator 54 provided in a separate module, within the PDA 51 or in a plugin card. When external to the PDA, the positioning module may be connected to the PDA via any suitable wired or wireless connection [0083].
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 as taught by Fright because it is an object of the invention to provide an apparatus that is simple, portable, inexpensive and easy to use or which at least provides the public with a useful choice ([0008] of Fright).
Regarding the claim 18, Chhibber teaches directly visualizing the bacteria in the wound by viewing fluorescence emitted by the at least one biomarker associated with the wound with the unaided eye (“pixels that have captured fluorescence coming from an inflamed pore upon illumination by a UV flash… 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 the claim 20, Chhibber teaches detecting the fluorescence emitted by the at least one biomarker associated with the wound with the camera of the portable imaging system (“captured fluorescence coming from an inflamed pore upon illumination by a UV flash” [0064]).
Regarding the claim 21, Chhibber teaches wherein visualizing bacteria in the wound by viewing fluorescence emitted by the at least one biomarker associated with the wound includes indirectly visualizing the bacteria in the wound by viewing fluorescence emitted by the at least one biomarker associated with the wound and detected with the imaging sensor of the camera of the portable imaging system on a viewing screen (“selected skin condition can be displayed on a user interface” [0012]; “to visually display the UV damage in an enhanced view, a UV damage enhanced white light image is formed in step 1150 that has a plurality of pixels each corresponding to a respective pixel in the first white-light image.” [0061]).
Regarding claim 22, Chhibber teaches detecting a presence or a location of one or more strains of bacteria based on the detected fluorescence (“living organisms fluoresce upon excitation through the absorption of light, a phenomenon known as autofluorescence… autofluorescence of the skin and image processing technologies to provide automated detection and analysis of subsurface skin condition” [0051]; “fluorescence coming from an inflamed pore upon illumination by a UV flash” [0064]).
Regarding claim 23, Chhibber teaches wherein positioning a filter relative to one or more of the imaging sensor of the camera and the excitation light source comprises positioning an emissions a filter to block the excitation light (“UV bandpass filter as compared with transmission spectra of other white-light filters.” [0019]; also see [0041]).
Regarding claim 24, Chhibber teaches wound is illuminated with one or more of blue excitation light and violet excitation light (“acquiring a white-light image and an ultraviolet (UV) image of a portion of a body surface, such as a person's face, each of the white-light and UV images” abst).
Regarding claim 27, Chhibber teaches method of visualizing bacteria in a wound in situ, comprising:
mounting an image acquisition device of a portable imaging system configured to detect in situ fluorescence of the wound and an excitation light source of the portable imaging system configured to emit excitation light, on an external surface of a portable frame, wherein the image acquisition device comprises one or more of a digital camera, a video recorder, a camcorder, a computer, a tablet, and a cellular telephone with a built-in digital camera (“FIG. 2A also shows a plurality of light sources 120 as parts of the digital camera 200, including, for example, two flash light sources 120 on two sides of the camera, a flash light source 120 on top of the camera, and optionally another flash light source 120 at the bottom of the camera” [0039]; notice that the flash and the camera are mounted on the external portion of a portable housing frame);
positioning the portable frame and the image acquisition device relative to the wound (see re-produced figs 1-2 and the associated pars.);
illuminate the wound with the excitation light emitted by the excitation light source of the portable imaging system to cause at least one biomarker associated with the wound to fluoresce (“digital camera 200, including, for example, two flash light sources 120 on two sides of the camera, a flash light source 120 on top of the camera, and optionally another flash light source 120 at the bottom of the camera” [0039]) and;
detecting with the image acquisition device, in real time, one or more fluorescence signals emitted by the at least one biomarker while the at least one biomarker is in situ in the wound (“to visually display the UV damage in an enhanced view, a UV damage enhanced white light image is formed” [0061]; “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]).
As clearly shown above Chhibber in an interpretation teaches the limitations of: mounting a camera…on an external portion of a portable frame; positioning the portable frame with the camera and the excitation light source; detecing, in real time. Yet, if one argues otherwise (which the office does not concede), and in an effort to provide compact prosecution, Duckworth and Boyden references are brought in to also show the teachings of these limitations.
In the same field of endeavor, Duckworth teaches the Sony-Ericsson P900 phone was chosen as the hand-held platform for the prototype device. A touch-screen interface, camera, and Bluetooth were all features available on this phone which were necessary to build the application. The phone (along with its camera) is mounted in a dock [i.e., frame] to which 4 laser diodes (used for structured lighting), 8 white LEDs (used for scene illumination), and batteries to supply the lights are also mounted. The complete hand-held device is shown from top in Figure 1 (pg. 2). Fig. 1. shows an image of the device from the top side. The mobile computing platform, the P900, is mounted to a clear acrylic docking station. Batteries to power the LEDs are contained within the handle to the left of the dock. Batteries to power the laser diodes are mounted to the underside of the dock. Laser diodes are mounted in a square around the P900.
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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 camera and an excitation light source mounted on and external to the portable frame as taught by Duckworth because it makes the accuracy and precision of the measurement dependent of the user which means intra- and inter-rater reliability increases (intro of Duckworth).
The above noted combination does not point out the specifics of limitations in an interpretation of detecting, in real time; and positioninq a filter relative to one or more of an imaginq sensor of the camera and the excitation light source.
However, in the same field of endeavor, Boyden teaches autofluorescent imaging and ablation (abst). Devices for fluorescent-based imaging and ablation of medical targets [0013]. A remote portion may provide for monitoring of the lumen-based device or data collection or analysis. The remote portion may be at a separate location within the body of the subject, or outside the body of the subject [0043]. One or more energy sources 110 are programmable, remote-controlled, wirelessly controlled, and or feedback-controlled [0062]. Electromagnetic energy selected to induce a fluorescent response from a target area in the lesion; a sensor 120 configured to detect the fluorescent response; control circuitry 130 coupled to the sensor 120 and responsive to identify the target area; and a second energy source 110 responsive to the control circuitry 130 and configured to emit energy selected to at least partially ablate the target area [0036]. Detect the auto-fluorescent response; control circuitry 130 coupled to the sensor 120 and responsive to identify a target area in real time [0041]. Autofluorescence may be detected using excitation wavelengths of 250-400 nm and examined at an emission wavelength of 495 nm and higher through, for example, a long pass optical filter [0195].
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 hands-free, and real-time operation along with “to guide debridement of the wound” as taught by Boyden because it would help with prevention, and/or amelioration of a variety of diseases and disorders ([0013] of Boyden).
Regarding the claim 28, Chhibber teaches all the claimed limitations except for using the detected fluorescence to guide debridement of the wound (hence intended limitation).
However, in the same field of endeavor, Boyden teaches autofluorescent imaging and ablation (abst). Devices for fluorescent-based imaging and ablation of medical targets [0013]. A remote portion may provide for monitoring of the lumen-based device or data collection or analysis. The remote portion may be at a separate location within the body of the subject, or outside the body of the subject [0043]. One or more energy sources 110 are programmable, remote-controlled, wirelessly controlled, and or feedback-controlled [0062]. Electromagnetic energy selected to induce a fluorescent response from a target area in the lesion; a sensor 120 configured to detect the fluorescent response; control circuitry 130 coupled to the sensor 120 and responsive to identify the target area; and a second energy source 110 responsive to the control circuitry 130 and configured to emit energy selected to at least partially ablate the target area [0036]. Detect the auto-fluorescent response; control circuitry 130 coupled to the sensor 120 and responsive to identify a target area in real time [0041].
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 hands-free, and real-time operation along with “to guide debridement of the wound” as taught by Boyden because it would help with prevention, and/or amelioration of a variety of diseases and disorders ([0013] of Boyden).
Regarding the claim 29, Chhibber teaches positioning the excitation light source of the portable imaging system relative to the wound (see fig. 1 and the associated pars.).
Regarding the claim 30, Chhibber teaches projecting an image comprising the detected fluorescence and the wound to a display (“electronics for outputting captured digital images to the computing device 130 for analysis, etc.” [0040]; “outputting/displaying the results of skin analysis includes a submodule 1500 for displaying the results with a GUI” [0070]).
Regarding the claim 31, in an interpretation, the above noted combination teaches all the claimed limitations except for directly mounting both the image acquisition device and the excitation light source to the external surface of the portable frame.
However, to provide compact prosecution, in the same field of endeavor, Fright is brought in for the teaching of various techniques have been used to monitor wounds, ulcers, sores, lesions, tumour etc [0002]. Apparatus for performing the method may take a variety of forms ranging from a stationary system (having a stationary camera or a handheld camera connected wirelessly or by a cable) to a fully portable unit. Portable units in the form of PDAs, cell phones, notebooks, ultramobile PCs etc. including an integrated or plug-in camera allow great flexibility, especially for medical services outside of hospitals [0070]. FIG. 10 shows an apparatus sensors are provided. The apparatus 50 includes a PDA 51, with housing 52 containing a camera 53, laser generator 54 provided in a separate module, within the PDA 51 or in a plugin card. When external to the PDA, the positioning module may be connected to the PDA via any suitable wired or wireless connection [0083].
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 as taught by Fright because it is an object of the invention to provide an apparatus that is simple, portable, inexpensive and easy to use or which at least provides the public with a useful choice ([0008] of Fright).
Regarding the claim 31, the above noted combination teaches all the claimed limitations except for directly mounting both the image acquisition device and the excitation light source to the external surface of the portable frame.
Regarding the claims 32 and 34, the above noted combination teaches all the claimed limitations except for blocking passage of excitation light reflected from the wound and surrounding tissue to an image sensor of the image acquisition device with the filter.
However, in the same field of endeavor, Boyden teaches autofluorescent imaging (abst). Autofluorescence may be detected using excitation wavelengths of 250-400 nm and examined at an emission wavelength of 495 nm and higher through, for example, a long pass optical filter [0195].
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 filters as taught by Boyden because it would help with prevention, and/or amelioration of a variety of diseases and disorders ([0013] of Boyden).
Regarding the claim 33, Chhibber teaches positioning the filter between the excitation light source and the wound, and further comprises passing the excitation light through the filter (“Each of the UV light sources 120 can be one converted from light source 300 by changing a low-pass filter 310 in front of the light source 300 into a UV filter 310.” [0041]).
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
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/SERKAN AKAR/ Primary Examiner, Art Unit 3797