DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/11/2025 has been entered.
Response to Amendment
This action is in response to the remarks filed on 08/11/2025. The amendments filed on 08/11/2025 have been entered. Accordingly, claims 1-22 remain pending with claims 2-22 being new claims.
The rejection of claims under 35 USC 112 have been withdrawn in light of the applicant’s amendments to the claims
Claim Objections
Claim 10 is objected to because of the following informalities:
Claim 10 recites the limitation of “and/or” which in an interpretation may cause ambiguity as to the limitation following the “and/or” required or not. Therefore, it is suggested to recite either one of the “and” or “or”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1-22 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.
Claims 1, 10 and 22 recites the limitation of “spatially co-register wound data, based on the detected signals, relative to at least one of wound topography, wound anatomy, wound area, wound depth, wound volume, wound margins, and/or necrotic tissue” which is not clear how and/or what is being co-registered with what. In other words, as per the claim, wound data is “spatially co-registered” but it is not clear how these data being spatially co-registered.
The specification in the pertinent parts recite (which the word “co-register” ONLY occurs three time in the entire specification)
“The target object 10 may be marked with a mark 11 to allow for multiple images to be taken of the object and then being co-registered for analysis. The mark 11 may involve, for example, the use of exogenous fluorescence dyes of different colours which may produce multiple distinct optical signals when illuminated by the light sources 5 and be detectable within the image of the object 10 and thus may permit orientation of multiple images (e.g., taken over time) of the same region of interest by co-registering the different colours and the distances between them” [0075]
a different fluorescent ink color from separate indelible fluorescent ink pens, which may be provided as a kit to the clinical operator, may be placed near the wound margin or boundary on the normal skin surface. These colors may be imaged by the device using the excitation light and a multispectral band filter that matches the emission wavelength of the four ink spots. Image analysis may then be performed, by co-registering the fiduciary markers for inter-image alignment. Thus, the user may not have to align the imaging device between different imaging sessions [0100].
Accordingly, as best understood from the specification, “Image analysis may then be performed, by co-registering the fiduciary markers for inter-image alignment”. Yet, it is still not clear how or what is being “spatially co-registered”.
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, 5-14 and 16-22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bandic et al (US20080194928) in view of Godse et al (Microphotography: A Simple But Elegant Technique For Telediagnosis of Malaria, JK Science, Vol. 10 No. 3, July-September 2008) and in the alternative Ebner et al (Mobile teledermatology: a feasibility study of 58 subjects using mobile phones; Journal of Telemedicine and Telecare 2008; 14: 2–7, published online January 1, 2008) and further in view of Boyden et al (US 20080059070).
Regarding the claim 1 (as the claim best understood in light of the 35 USC 112 rejections above), Bandic teaches a portable, handheld device for outputting a representation of a wound in tissue (See re-produced fig. 1 below and also “the device 108 may be sized to permit a user to operate the device 108 in a handheld fashion. The device 108 may sized for portability. The device 108 may adapted for single-handed operation” [0057]), the device comprising:
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a housing configured to receive and secure a wireless communication device therein (“the device may be embodied as in FIGS. 4 A & B [re-produced below], but it may have multiple other embodiments in any shape and/or size, such as a mirror, a large device adapted to image a large area, a PDA, a scanner, a mobile communication device, and the like.” [0057]), the housing having a first surface a second surface opposite the first surface (see fig. 4 also the PDA, a scanner, a mobile communication device known to have a first surface a second surface opposite the first surface);
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at least one light source configured to emit excitation light, the at least one light source being configured to illuminate a target surface with excitation light (“In FIG. 4 A, the illumination source is visible as a ring of LED's around a central detection area” [0057]), the target surface including a wound in tissue (“the device 108 may be adapted for use as a component of a minimally invasive medical device associated with laparoscopy, cytoscopy, ureteroscopy, arthroscopy, endoscopy, dermoscopy, gynecology, urology, dentistry, natural orifice insertion analysis such as through ears, mouth, anus, nose, and external breast cancer analysis through the skin, and the like. For example, the system may be able to process the data and to appear on a video monitor or other display in a surgical suite or other medical setting” [0059]; “the device 108 may be an imaging device 108 for performing digital spectroscopic imaging of the skin. Incident unpolarized light may be delivered, either vertically or on an angle alpha from vertical, from an unpolarized light source associated with the device 108, such as a white light, diffuse light, monochromatic light, light of multiple single wavelengths, and the like, to a target skin structure… For example, scars, keloids, hypertrophic scars, and stria all have organizations of collagen fibers that are different from normal skin. Since collagen is a primary determinant of cutaneous wound repair, it may be of interest to monitor changes in collagen structure and concentration” [0064], also see [0065]);
a spectral filtering mechanism configured to filter one or more different discrete spectral bandwidths of the light from the target surface (“The sensor may be adapted to absorb any wavelength of light, such as near IR or visible wavelengths. The sensor may be adapted to automatically filter out particular wavelengths” [0047]; “the reflected light may be filtered to examine a collection of wavelengths” [0066]);
a power supply contained in the housing and configured to provide power to the at least one light source (“the device 108 may be powered by any suitable source, such as an electric power plug, a battery, solar power, USB power, and the like. A user may initiate power to the device 108 in order to begin acquiring images.” [0053]); and
a wireless communication device comprising (“FIGS. 4 A & B, but it may have multiple other embodiments in any shape and/or size… a PDA, a scanner, a mobile communication device [wireless communication device in a housing], and the like.” [0057]):
an image acquisition device having a sensor configured to detect signals responsive to illumination of the target surface, each signal indicative of at least one of endogenous fluorescence, exogenous fluorescence, absorbance, and reflectance from bacteria, fungus, yeast, and/or other microorganisms in the target surface (“a skin state 158 may comprise processing and analyzing 154 the reflected light to obtain images for visual and spectroscopic analysis. Analysis 154 may be facilitated by examining the wavelength and other characteristics of the reflected light. For example, if the incident light is white light, the reflected light may be filtered to examine a collection of wavelengths or a single wavelength and, ultimately, a specific skin structure fluorescence… an LED may be used to excite targeted fluorophores and chromophores. In this example, fluorescence of deeper layers may be extracted. The reflected light in this example may also be filtered to isolate a specific fluorescence.” [0066]);
a processor configured to receive the detected signals (“FIGS. 4 A & B, but it may have multiple other embodiments in any shape and/or size… a PDA, a scanner, a mobile communication device [mobile phones, PDAs etc. known to have their own processors to receive and process images.], and the like.” [0057]; “For example, scars, keloids, hypertrophic scars, and stria all have organizations of collagen fibers that are different from normal skin. Since collagen is a primary determinant of cutaneous wound repair, it may be of interest to monitor changes in collagen structure and concentration” [0064], also see [0065]), and to output a representation of the spatially co-registered wound data (“[0052] the form of the data captured may be compatible with any standard image processing and manipulation software and techniques which multiple images may be captured as a movie or a movie may be constructed from combining multiple images.
[0066] monochromatic or semi-monochromatic light, such as provided by an LED may be used to excite targeted fluorophores and chromophores. Varying the wavelength of the illuminating light may enable detection of biophysical properties from various depths within the skin. Algorithms 150 may be used to obtain information from data obtained by either method by processing and analyzing one or more wavelengths of light to form a spectroscopic, polarization-based image. In an embodiment, the combination of both techniques may enable the elimination of the reflection from the surface of the skin [i.e., wound]”, also see [0014], [0065]-[0066], [0070]); and
a display configured to display output by the processor (“The device 108 may have a display for viewing the area to be imaged. For example, a user may use the display with positioning tools to obtain exact images over time, such as a series of images taken over different days. The display may be integral to the device 108 or may be a separate display. For example, the device 108 may be connected to a monitor, such as that of a computer, using a wired connection or a wireless connection. In an embodiment, a user interface 102 to the device 108 may display a real time view of the imaging.” [0054]).
Although all the limitations of the claim believed to be taught by the above reference, in an interpretation, if one argues that cell phone (mobile devices, i.e., device 108 as taught by the Bandic) is not explicitly showing the claimed features which are inherent and known properties of the known mobile devices, the below reference clearly showing those features.
However, in the same field of endeavor, Godse teaches hand held cell phone with housing receiving wireless communication device having a first surface and a second surface (“A photograph was taken with a 2 megapixel camera of Nokia N 76 mobile phone.” pg. 156) and light source coupled to the housing to emit a field of excitation light and to illuminate a target surface (“Mobile for teledermatology (5),and Java-enabled 3G mobile phone for monitoring the vital biosignals of patients in ICU/CCU, such as ECG, RESP, SpO2, EtCO2 are available” pg. 155 left col.), battery to power the light source, camera and processor of the cell phone to detect signals responsive to illumination of the target surface, and processor to receive the detected signals and to output a representation of the target surface based on the detected signals (“The images of the parasitized RBCs were transferred to computer via blue tooth and then e-mailed via internet to our collaborators” pg. 156 also see see re-produced fig below),
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wherein the processor is further configured to store, in a memory of the wireless communication device. Then display the representation of the target surface output by the processor, wherein the image acquisition device is configured to receive the signals responsive to the illumination of the target surface from a direction of the first surface of the housing, and the display is visible from a direction of the second surface of the housing (“a mobile telephone (cell phone) with an in-built microscope, and a notch to place the slide of blood smear of a patient… The device will be a sophisticated mobile microscope with a advanced digital camera to capture microphotographs…The digitized image can then be sent via internet to an expert for an accurate diagnosis of malaria. This approach opened up our vision for tele diagnosis” pg. 155).
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 cell phone having claimed features as taught by Godse because it would provide simplicity, cost effectiveness and sensitivity (5-10 parasites/µl) of the microscopic technique makes it a globally accepted method (pg. 155).
Further, Ebner also teaches teledermatology based on images from a mobile phone camera and face-to-face (FTF) dermatology (summary). For each subject, a form was completed to capture skin lesion, including self-treatment of the lesion [wound as seen in fig. 2]. Each subject was given a mobile phone (Nokia 6230i, Nokia, Espoo, Finland) with a built-in camera (1280×1024 pixel resolution). Subjects were taught how to use the camera and asked to take three photographs of their skin lesions using the mobile phone camera. The captured images were stored in JPEG format and transferred to a PC via the Nokia Connectivity (methods section). Each image was re-sized to 800×600 pixels using a standard package (Image Viewer version 1.0). Images were stored on a database and were evaluated using a proprietary web application designed for telediagnosis (teleconsultation section). Figure 2 An 80-year-old male patient with erysipelas on the left lower leg. The wound images were taken with the mobile phone camera.
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 a database, detected signal data spatially co-registered relative to at least one of wound topography as taught by Ebner because mobile teledermatology has great value for individuals in the industrialized world in accordance with the concept of a 'person-centred health system and become a tool for improving self-examination (Discussion section of Ebner).
The combination noted above (as the claims best understood) does not teach the particulars of the spatially co-register wound data, based on the detected signals, relative to at least one of wound topography, wound anatomy, wound area, wound depth, wound volume, wound margins, and necrotic tissue.
However, in the same field of endeavor, Boyden teaches excitation wavelengths of 395-445 nm and autofluorescence detected at wavelengths of 490-690 nm. Simultaneously or subsequently, reflected light at 550 nm (green) and at 610 nm (red) may be collected and combined with the autofluorescence data to form a composite image [0226].
[0138] analyzing, evaluating a fluorescent response in reference to baseline fluorescence, background fluorescence, expected fluorescence, normal fluorescence, reference fluorescence.
[0140] A location [i.e., a direction, an area, a depth, a site, or a size, etc.] may be defined by spatial coordinates and/or temporal coordinates. A location may be defined as precisely as the cellular level, for example, or as broadly as a general area, or a general direction. Methods of determining a target location may be the microbial cell contamination remaining in a wound following a sterile wash.
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 spatially co-register wound data as taught by Boyden because mixed red-green-blue fluorescent representations of various bacteria as taught by because speed and accuracy are paramount ([0373] of Boyden).
Regarding the claims 2 and 13, the above combination teaches all the claimed limitations except for mixed red-green-blue fluorescent representations of various bacteria and tissue components present in the wound.
However, in the same field of endeavor, Boyden teaches mixed red-green-blue fluorescent representations of various bacteria and tissue components present in the wound and wherein the processor is configured to analyze the red-green-blue fluorescent representations in order to recognize and classify various components of the wound, based on the received signals or the output representation (“reflected light at 550 nm (green) and at 610 nm (red) may be collected and combined with the autofluorescence data to form a composite image. As such, the ratios of green/red and green/autofluorescence may be greater in squamous dysplasia” [0226]), including:
a location of at least one of bacteria, fungus, yeast, and other microorganisms present in the wound (“the device emits electromagnetic energy at wavelengths sufficient to induce fluorescence of reagents applied to the wound to selectively detect pathogens, such as, for example, a chemical dye or an antibody or aptamer conjugated to a fluorescent tag. Pathogens may include bacteria, fungi and/or viruses.” [0167]),
at least one of a population, a quantity, a distribution, a colonization, a contamination, a critical colonization, an infection, and an extent of at least one of bacteria, fungus, yeast, and other microorganisms when present in the wound (“the device emits electromagnetic energy at wavelengths sufficient to induce fluorescence of reagents applied to the wound to selectively detect pathogens, such as, for example, a chemical dye or an antibody or aptamer conjugated to a fluorescent tag. Pathogens may include bacteria, fungi and/or viruses.” [0167]), and
at least one of a presence, a location, a distribution, and an extent of at least one of collagen, elastin, connective tissue, blood, bone, exudate, stromal tissue, granulation tissue, and other tissue, cells, molecules, and fluids indicative of wound infection and/or healing present in the wound ([0168]-[0172]).
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 mixed red-green-blue fluorescent representations of various bacteria as taught by because speed and accuracy are paramount ([0373] of Boyden).
Regarding the claims 3 and 14, the above combination teaches all the claimed limitations. Specifically, Bandic teaches processor is further configured to calculate red and green fluorescence intensities, and using the calculated intensities (“The device 108 may also employ specific targeted wavelengths, such as in the red, green, and blue areas, to identify key features, based on spectroscopic and quantitative analysis of skin lesions” [0041]): produce image maps of fluorescence intensities in the wound, displayed in color (“a one-to-one mapping of pixel image distribution between the diffusion light image, corresponding to an electromagnetic signal, and reflected polarized light, corresponding to an electrical signal image, may be made with a distribution of the intensity of the spectroscopic data for the same area” [0063]);
Although may not be required, Boyden further teaches and/or identify the presence and biodistribution of bacteria within the wound (“a first input includes data representative of the target fluorescent response. Data representative of the target fluorescent response may include, but is not limited to, one or more measurements of electromagnetic energy, and/or one or more measurements of one or more temporal-spatial locations of the target fluorescent response. As used herein, the term "temporal-spatial locations" may include one or more temporal locations and/or one or more spatial locations. Data representative of a target fluorescent response may include, but is not limited to, a clustering of fluorescent responses that would otherwise be considered a normal response in the absence of clustering, or with limited clustering, or non-significant clustering. In illustrative embodiments, clustering might include cells forming a plaque, bacterial cells forming a colony, blood cells forming a clot, malaria-infected red blood cells aggregating, among others” [0303]).
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 the presence and biodistribution of bacteria within the wound as taught by because speed and accuracy are paramount ([0373] of Boyden).
Regarding the claims 4 and 15, the above combination teaches all the claimed limitations. Specifically, Bandic teaches the processor is further configured to temporally co-register one or more of absorbance data, reflectance data, endogenous fluorescence data, and exogenous fluorescence data based on the detected signals in the representation of the wound (“excitation and emission maxima of biological molecules that exhibit endogenous fluorescence, such as amino acids, structural proteins, enzymes and coenzymes, vitamins and vitamin derivates, lipids, porphyrins, and the like. To detect the presence of specific molecules in the skin, a user may shine a light of a specified wavelength” [0044]; also see fig. 5 and the associated pars.).
Regarding the claims 5 and 16, Bandic teaches the device comprises a cellular telephone including a digital camera or a tablet including a digital camera (“a sensor for detecting reflected light from the skin may be embodied in optics resident in a CCD camera, CMOS-based imaging system, digital camera, webcam, camera embedded in a communications device such as a cell phone or iPhone, PDA (Personal Digital Assistant), a watch or other wearable device for continuous monitoring of the skin as in a sports-type indication, a third party device 109, a scanner, and the like” [0047]).
Regarding the claims 6 and 17, Bandic teaches wound assessment system comprising the portable, handheld device of claim 1, wherein the system further comprises a system processor, and wherein the system processor is configured to compare representations of the wound (“a method and system for obtaining dermal biophysical properties may comprise performing a spectral analysis of image data acquired from the degree of polarization of reflections of incident light from skin structures, wherein the property is… blistering disease, congenital dermal syndrome, (sub)-cutaneous mycoses, melasma, vascular condition, rosacea, spider vein, texture, skin ulcer, wound healing, post-operative tracking, melanocytic lesion” [0014]; See re-produced fig. 1 below and also “the device 108 may be sized to permit a user to operate the device 108 in a handheld fashion. The device 108 may sized for portability. The device 108 may adapted for single-handed operation” [0057]; also see fig. 5 and the associated pars.) wherein the for comparison are stored in the database (“device may be adapted to interact with a physical interface to download image data to update a record of at least one of a practitioner, a spa, a salon, cosmetic sales, a cosmetics manufacturer, a clinical trials database, and a third party database” [0018]; also see [0049], [0071], [0077], [0079]-[0097]).
Regarding the claims 7 and 18, Bandic teaches wherein at least one of the processor and the system processor is configured to identify at least one of a wound cleaning protocol, a wound debridement protocol, a wound sampling protocol, a wound treatment protocol, and other wound intervention strategy based at least in part on a comparison of a substantially real-time representation of the wound based on the detected signals and stored representations of the wound (“the user interface 102 may organize and index images captured by date, area of concern, skin state, and the like. For example and without limitation, as seen in the FIG. 5, four images captured from the same area of concern are indexed by their number within the series. In an embodiment, the user interface 102 may show in real time the field of view on the skin being imaged as well as populate the user interface 102 with the images once taken or once submitted by the user. The user interface 102 may keep track of the first image, latest image, next image, and the like. The user interface 102 may allow users to shuffle through image s and use the” [0090]; also see [0091]-[0099]).
Regarding the claims 8 and 19, Bandic teaches processor and the system processor is configured to identify an indication of at least one of wound infection, wound healing, and a wound healing failure based at least in part on a comparison of a substantially real-time representation of the wound based on the detected signals and stored prior representations of the wound wound (“a method and system for obtaining dermal biophysical properties may comprise performing a spectral analysis of image data acquired from the degree of polarization of reflections of incident light from skin structures, wherein the property is… blistering disease, congenital dermal syndrome, (sub)-cutaneous mycoses, melasma, vascular condition, rosacea, spider vein, texture, skin ulcer, wound healing, post-operative tracking, melanocytic lesion” [0014]; also see fig. 5 and the associated pars.).
Regarding the claims 9 and 20-21, Bandic teaches wherein at least one of the processor and the system processor is configured to identify a change in at least one of a location, a population, a distribution, a colonization, a contamination, a critical colonization, and an infection, of at least one of bacteria, fungus, yeast, and other microorganisms present in the wound and at least one of a presence, a location, a distribution, and an extent of at least one of macromolecular activity, enzyme activity, growth factor activity, growth receptor activity, GSH, collagen, elastin, connective tissues, blood, bone, exudate, stromal tissue, granulation tissue, and other tissue, cells, molecules, and fluids indicative of at least one of wound infection, wound healing, and failure to heal based on a comparison of a substantially real-time representation of the wound based on the detected signals and stored prior representations of the wound (see fig. 5 and the associated pars. along with [0014] [0049], [0071], [0077], [0079]-[0097]).
Regarding the claim 10, Bandic teaches a portable device for filtering light emitted by a wound in tissue (See re-produced fig. 1 below and also “the device 108 may be sized to permit a user to operate the device 108 in a handheld fashion. The device 108 may sized for portability. The device 108 may adapted for single-handed operation” [0057]; the reflected light may be filtered to examine a collection of wavelengths [0066]), the device comprising:
a housing configured to receive and secure at least a portion of a wireless communication device therein, the housing having a first surface a second surface opposite the first surface (“the device may be embodied as in FIGS. 4 A & B [re-produced below], but it may have multiple other embodiments in any shape and/or size, such as a mirror, a large device adapted to image a large area, a PDA, a scanner, a mobile communication device, and the like.” [0057]), the housing having a first surface a second surface opposite the first surface (see fig. 4 also the PDA, a scanner, a mobile communication device known to have a first surface a second surface opposite the first surface);
at least one light source configured to emit excitation light, the at least one light source configured to illuminate a target surface with the excitation light, the target surface including a wound in tissue (“In FIG. 4 A, the illumination source is visible as a ring of LED's around a central detection area” [0057]), the target surface including at least a portion of a wound and an area around the wound (“the device 108 may be adapted for use as a component of a minimally invasive medical device associated with laparoscopy, cytoscopy, ureteroscopy, arthroscopy, endoscopy, dermoscopy, gynecology, urology, dentistry, natural orifice insertion analysis such as through ears, mouth, anus, nose, and external breast cancer analysis through the skin, and the like. For example, the system may be able to process the data and to appear on a video monitor or other display in a surgical suite or other medical setting” [0059]; “the device 108 may be an imaging device 108 for performing digital spectroscopic imaging of the skin. Incident unpolarized light may be delivered, either vertically or on an angle alpha from vertical, from an unpolarized light source associated with the device 108, such as a white light, diffuse light, monochromatic light, light of multiple single wavelengths, and the like, to a target skin structure… For example, scars, keloids, hypertrophic scars, and stria all have organizations of collagen fibers that are different from normal skin. Since collagen is a primary determinant of cutaneous wound repair, it may be of interest to monitor changes in collagen structure and concentration” [0064], also see [0065]);
a power supply contained in the housing and configured to provide power to the at least one light source (“the device 108 may be powered by any suitable source, such as an electric power plug, a battery, solar power, USB power, and the like. A user may initiate power to the device 108 in order to begin acquiring images.” [0053]);
a wireless communication device comprising an optical sensor configured to detect signals responsive to illumination of the target surface, each signal indicative of at least one of endogenous fluorescence, exogenous fluorescence, absorbance, and reflectance from bacteria, fungus, yeast, and/or other microorganisms in the target surface (“FIGS. 4 A & B, but it may have multiple other embodiments in any shape and/or size… a PDA, a scanner, a mobile communication device [wireless communication device in a housing], and the like.” [0057]; “an LED may be used to excite targeted fluorophores and chromophores. In this example, fluorescence of deeper layers may be extracted. The reflected light in this example may also be filtered to isolate a specific fluorescence.” [0066]);
a processor configured to receive the detected signals (“FIGS. 4 A & B, but it may have multiple other embodiments in any shape and/or size… a PDA, a scanner, a mobile communication device [mobile phones, PDAs etc. known to have their own processors to receive and process images.], and the like.” [0057]; “For example, scars, keloids, hypertrophic scars, and stria all have organizations of collagen fibers that are different from normal skin. Since collagen is a primary determinant of cutaneous wound repair, it may be of interest to monitor changes in collagen structure and concentration” [0064], also see [0065]), and to output a representation of the spatially co-registered wound data (“[0052] the form of the data captured may be compatible with any standard image processing and manipulation software and techniques which multiple images may be captured as a movie or a movie may be constructed from combining multiple images.
[0066] monochromatic or semi-monochromatic light, such as provided by an LED may be used to excite targeted fluorophores and chromophores. Varying the wavelength of the illuminating light may enable detection of biophysical properties from various depths within the skin. Algorithms 150 may be used to obtain information from data obtained by either method by processing and analyzing one or more wavelengths of light to form a spectroscopic, polarization-based image. In an embodiment, the combination of both techniques may enable the elimination of the reflection from the surface of the skin [i.e., wound]”, also see [0014], [0065]-[0066], [0070]); and
a display configured to display the representation of a wound output by the processor, wherein the representation of the wound comprises co-registered fluorescence intensity data and reflectance data (“The device 108 may have a display for viewing the area to be imaged. For example, a user may use the display with positioning tools to obtain exact images over time, such as a series of images taken over different days. The display may be integral to the device 108 or may be a separate display. For example, the device 108 may be connected to a monitor, such as that of a computer, using a wired connection or a wireless connection. In an embodiment, a user interface 102 to the device 108 may display a real time view of the imaging.” [0054]).
The combination noted above (as the claims best understood) does not teach the particulars of the spatially co-register wound data, based on the detected signals, relative to at least one of wound topography, wound anatomy, wound area, wound depth, wound volume, wound margins, and necrotic tissue.
However, in the same field of endeavor, Boyden teaches excitation wavelengths of 395-445 nm and autofluorescence detected at wavelengths of 490-690 nm. Simultaneously or subsequently, reflected light at 550 nm (green) and at 610 nm (red) may be collected and combined with the autofluorescence data to form a composite image [0226].
[0138] analyzing, evaluating a fluorescent response in reference to baseline fluorescence, background fluorescence, expected fluorescence, normal fluorescence, reference fluorescence.
[0140] A location [i.e., a direction, an area, a depth, a site, or a size, etc.] may be defined by spatial coordinates and/or temporal coordinates. A location may be defined as precisely as the cellular level, for example, or as broadly as a general area, or a general direction. Methods of determining a target location may be the microbial cell contamination remaining in a wound following a sterile wash.
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 spatially co-register wound data as taught by Boyden because mixed red-green-blue fluorescent representations of various bacteria as taught by because speed and accuracy are paramount ([0373] of Boyden).
Regarding the claim 11, Bandic teaches wherein the optical sensor is positioned to receive the signals responsive to the illumination of the target surface from a direction of the first surface of the housing, and wherein the display is visible from a direction of the second surface of the housing (“sensor for detecting reflected light from the skin may be embodied in optics resident in a CCD camera, CMOS-based imaging system, digital camera, webcam, camera embedded in a communications device such as a cell phone or iPhone, PDA (Personal Digital Assistant), a watch or other wearable device for continuous monitoring” [0047]; “the device 108 may be sized to permit a user to operate the device 108 in a handheld fashion. The device 108 may sized for portability. The device 108 may adapted for single-handed operation. For example, the device may be embodied as in FIGS. 4 A & B, but it may have multiple other embodiments in any shape and/or size, such as a mirror, a large device adapted to image a large area, a PDA, a scanner, a mobile communication device, and the like. In FIG. 4 A, the illumination source is visible as a ring of LEDs around a central detection area” [0057]; also see camera in figs. 3-4).
Regarding the claim 22, Bandic teaches a portable device for outputting a representation of a wound in tissue (See re-produced fig. 1 below and also “the device 108 may be sized to permit a user to operate the device 108 in a handheld fashion. The device 108 may sized for portability. The device 108 may adapted for single-handed operation” [0057]; the reflected light may be filtered to examine a collection of wavelengths [0066]), the device comprising:
a housing configured to receive and secure at least a portion of a wireless communication device therein, the housing having a first surface a second surface opposite the first surface (“the device may be embodied as in FIGS. 4 A & B [re-produced below], but it may have multiple other embodiments in any shape and/or size, such as a mirror, a large device adapted to image a large area, a PDA, a scanner, a mobile communication device, and the like.” [0057]), the housing having a first surface a second surface opposite the first surface (see fig. 4 also the PDA, a scanner, a mobile communication device known to have a first surface a second surface opposite the first surface);
at least one light source configured to emit excitation light, the at least one light source configured to illuminate a target surface with the excitation light, the target surface including a wound in tissue (“In FIG. 4 A, the illumination source is visible as a ring of LED's around a central detection area” [0057]), the target surface including at least a portion of a wound and an area around the wound (“the device 108 may be adapted for use as a component of a minimally invasive medical device associated with laparoscopy, cytoscopy, ureteroscopy, arthroscopy, endoscopy, dermoscopy, gynecology, urology, dentistry, natural orifice insertion analysis such as through ears, mouth, anus, nose, and external breast cancer analysis through the skin, and the like. For example, the system may be able to process the data and to appear on a video monitor or other display in a surgical suite or other medical setting” [0059]; “the device 108 may be an imaging device 108 for performing digital spectroscopic imaging of the skin. Incident unpolarized light may be delivered, either vertically or on an angle alpha from vertical, from an unpolarized light source associated with the device 108, such as a white light, diffuse light, monochromatic light, light of multiple single wavelengths, and the like, to a target skin structure… For example, scars, keloids, hypertrophic scars, and stria all have organizations of collagen fibers that are different from normal skin. Since collagen is a primary determinant of cutaneous wound repair, it may be of interest to monitor changes in collagen structure and concentration” [0064], also see [0065]);
a spectral filtering mechanism configured to filter one or more different discrete spectral bandwidths of the light from the target surface (“The sensor may be adapted to absorb any wavelength of light, such as near IR or visible wavelengths. The sensor may be adapted to automatically filter out particular wavelengths” [0047]; “the reflected light may be filtered to examine a collection of wavelengths” [0066]);
a wireless communication device comprising an image sensor configured to detect signals responsive to illumination of the target surface, each signal indicative of at least one of endogenous fluorescence, exogenous fluorescence, absorbance, and reflectance from bacteria, fungus, yeast, and/or other microorganisms in the target surface (“FIGS. 4 A & B, but it may have multiple other embodiments in any shape and/or size… a PDA, a scanner, a mobile communication device [wireless communication device in a housing], and the like.” [0057]; “an LED may be used to excite targeted fluorophores and chromophores. In this example, fluorescence of deeper layers may be extracted. The reflected light in this example may also be filtered to isolate a specific fluorescence.” [0066]);
a processor configured to receive the detected signals (“FIGS. 4 A & B, but it may have multiple other embodiments in any shape and/or size… a PDA, a scanner, a mobile communication device [mobile phones, PDAs etc. known to have their own processors to receive and process images.], and the like.” [0057]; “For example, scars, keloids, hypertrophic scars, and stria all have organizations of collagen fibers that are different from normal skin. Since collagen is a primary determinant of cutaneous wound repair, it may be of interest to monitor changes in collagen structure and concentration” [0064], also see [0065]), and to output a representation of the spatially co-registered wound data (“[0052] the form of the data captured may be compatible with any standard image processing and manipulation software and techniques which multiple images may be captured as a movie or a movie may be constructed from combining multiple images.
[0066] monochromatic or semi-monochromatic light, such as provided by an LED may be used to excite targeted fluorophores and chromophores. Varying the wavelength of the illuminating light may enable detection of biophysical properties from various depths within the skin. Algorithms 150 may be used to obtain information from data obtained by either method by processing and analyzing one or more wavelengths of light to form a spectroscopic, polarization-based image. In an embodiment, the combination of both techniques may enable the elimination of the reflection from the surface of the skin [i.e., wound]”, also see [0014], [0065]-[0066], [0070]); and
a display configured to display the representation of a wound in tissue output by the processor (“The device 108 may have a display for viewing the area to be imaged. For example, a user may use the display with positioning tools to obtain exact images over time, such as a series of images taken over different days. The display may be integral to the device 108 or may be a separate display. For example, the device 108 may be connected to a monitor, such as that of a computer, using a wired connection or a wireless connection. In an embodiment, a user interface 102 to the device 108 may display a real time view of the imaging.” [0054]).
The combination noted above (as the claims best understood) does not teach the particulars of the spatially co-register wound data, based on the detected signals, relative to at least one of wound topography, wound anatomy, wound area, wound depth, wound volume, wound margins, and necrotic tissue.
However, in the same field of endeavor, Boyden teaches excitation wavelengths of 395-445 nm and autofluorescence detected at wavelengths of 490-690 nm. Simultaneously or subsequently, reflected light at 550 nm (green) and at 610 nm (red) may be collected and combined with the autofluorescence data to form a composite image [0226].
[0138] analyzing, evaluating a fluorescent response in reference to baseline fluorescence, background fluorescence, expected fluorescence, normal fluorescence, reference fluorescence.
[0140] A location [i.e., a direction, an area, a depth, a site, or a size, etc.] may be defined by spatial coordinates and/or temporal coordinates. A location may be defined as precisely as the cellular level, for example, or as broadly as a general area, or a general direction. Methods of determining a target location may be the microbial cell contamination remaining in a wound following a sterile wash.
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 spatially co-register wound data as taught by Boyden because mixed red-green-blue fluorescent representations of various bacteria as taught by because speed and accuracy are paramount ([0373] of Boyden).
Double Patenting
Claim 1 of this application is patentably indistinct from claim 126 of Application No. 12992040; and also claim 2 of the Application No. 17856487 Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
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
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