DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 3-15, drawn to method for wound image analysis, classified in (A61B5/01 or A61B5/445).cpc.
II. Claims 16-26, drawn to imaging system for acquiring data, classified in (A61B5/0071 or G01N21/6486).cpc.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the apparatus as claimed can be used to practice another and materially different process without the particulars of the apparatus (e.g., optical sensor, etc.).
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
(c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(d) the prior art applicable to one invention would not likely be applicable to another invention;
(e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Dragan Plavsic on 5/7/2026 a provisional election was made without traverse to prosecute the invention of II, claims 16-26. Affirmation of this election must be made by applicant in replying to this Office action. Claims 3-15 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 16-17, 21 and 25 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Chhibber et al (US20070064985A1).
Regarding claim 16, Chhibber teaches an imaging system for acquiring data and generating output regarding a wound (“captured fluorescence coming from an inflamed pore upon illumination by a UV flash” [0064]; “skin condition includes at least one type of pores selected from the group consisting of: inflamed pores, bacteriostatic pores, sluggish oil flow, and deeply inflamed pores.” claim 21 of Chhibber), comprising:
an optical sensor configured to obtain one or more wound images from a patient responsive to illumination (“digital camera 200 having an image sensor 112 and an optical assembly 114 in front of the image sensor 112 and configured to form an image of the subject 101 on the image sensor 114” [0038]), wherein the one or more wound images contain spectral data including fluorescence characteristics and/or reflectance characteristics (“The flash of white light preferably has wavelengths that span across a full spectrum of visible light or a substantial portion of it. At about the same time, the shutter of the camera is opened at step 860 so that the first white-light image is captured by the sensor 114. Module 710 further includes a step 870 in which the first white-light and UV images” [0052]); and
a processor (“computing device includes a microprocessor and a memory device coupled to the microprocessor, and the modules include software programs stored as program instructions” [0013]) configured to:
analyze the one or more wound images to determine wound component metrics, based on the spectral data, wherein the wound component metrics comprise one or more of infection, inflammation, granulation, slough, necrotic tissue, hypergranulation, undermining, topology, epithelialization, and tissue margins (“peak wavelength or frequency of an absorption spectrum and peak wavelength or frequency of an emission spectrum …autofluorescence of the skin and image processing technologies to provide automated detection and analysis of subsurface skin condition” [0051]), and
generate an output indicative of wound status, wherein the output is based at least in part on the wound components (“results associated with at least one selected skin condition can be displayed on a user interface… skin condition for the person are displayed next to each other for comparison” [0012]; “ pores or a type of pores as the skin conditions for display, the GUI according to submodule 1500 may display a color image of the subject with all pores or the selected type of pores highlighted as, for example, bright white dots on the color image. Different pores may also be highlighted using different colors. At the same time or on the same screen, a pore count for all of the pores found, and/or for each of different types of pores are listed.” [0071]).
Regarding claim 17, Chhibber teaches further comprising a display for displaying a representation of the output indicative of wound status (“skin condition for the person are displayed next to each other for comparison” [0012]; “submodule 1500 may also display selected skin analysis result as compared with previous results related to the same skin condition for the same subject 101” [0072]).
Regarding claim 21, Chhibber teaches further comprising a housing configured to removably receive at least a portion of a wireless communication device (“the computing device 130 and the display 140 as parts of a laptop computer [as known to have wireless communication modules] and a printer 150 placed under the laptop computer” [0042]).
Regarding claim 25, Chhibber teaches wherein the wound topology is based, at least in part, on one or more of wound area, wound volume, wound depth, wound shape, wound margins, and wound topography (“skin pixel identified to be associated with a certain skin condition, the surrounding pixels are also examined to determine the size and shape of a skin area having the skin condition. In the case of melanoma, the shape and size of an affected skin area can be used to help determine the type and amount of skin” [0063]).
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 18-20, 22 and 26 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chhibber in view of Prokoski (US20100191541A1).
Regarding claim 18, Chhibber teaches all the claimed limitations except for a thermal sensor configured to detect thermal information regarding the wound.
However, in the same field of endeavor, Prokoski teaches invention generally relates to the use of infrared imaging and, in particular, to the use of three dimensional infrared anatomical imaging [0002]. Classification of thermal, elevation, and color features by origin [skin fold, vascular structure, lymphatic structure, hair, scar, wound, mole] and characteristics [shape, size, position, orientation] relative to a standard model, leads to an encoding of the imaged area of the body unique to the subject [0085]. Infrared cameras the imaged pattern is determined by the temperature and emissivity of each surface point [0090]. This method produces consistent standardized infrared and surface topographic images for any portion of the body or the whole body for any person. It thereby enables automated change detection from images of the same subject taken at different times for wound care management [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 thermal sensor as taught by Prokoski because monitor wound healing of more frequent routine scanning, plus automated detection of significant changes from prior imaging provides earlier and more accurate detection of serious conditions ([0235] of Prokoski).
Regarding claim 19, Chhibber teaches further comprising at least one excitation light source configured to illuminate the wound with excitation light (“The flash of white light preferably has wavelengths that span across a full spectrum of visible light or a substantial portion of it. At about the same time, the shutter of the camera is opened at step 860 so that the first white-light image is captured by the sensor 114. Module 710 further includes a step 870 in which the first white-light and UV images” [0052]),
wherein the optical sensor is configured to detect signals resulting from the illumination of the wound with the excitation light (“The flash of white light preferably has wavelengths that span across a full spectrum of visible light or a substantial portion of it. At about the same time, the shutter of the camera is opened at step 860 so that the first white-light image is captured by the sensor 114. Module 710 further includes a step 870 in which the first white-light and UV images” [0052]).
Regarding claim 20, Chhibber teaches all the claimed limitations except for detect thermal information and to output a representation of the wound, the representation including two or more of wound status, wound topology, and at least one temperature associated with the wound.
However, in the same field of endeavor, Prokoski teaches invention generally relates to the use of infrared imaging and, in particular, to the use of three dimensional infrared anatomical imaging [0002]. Classification of thermal, elevation, and color features by origin [skin fold, vascular structure, lymphatic structure, hair, scar, wound, mole] and characteristics [shape, size, position, orientation] relative to a standard model, leads to an encoding of the imaged area of the body unique to the subject [0085]. Infrared cameras the imaged pattern is determined by the temperature and emissivity of each surface point [0090]. This method produces consistent standardized infrared and surface topographic images for any portion of the body or the whole body for any person. It thereby enables automated change detection from images of the same subject taken at different times for wound care management [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 thermal sensor as taught by Prokoski because monitor wound healing of more frequent routine scanning, plus automated detection of significant changes from prior imaging provides earlier and more accurate detection of serious conditions ([0235] of Prokoski).
Regarding claim 22, Chhibber teaches all the claimed limitations except for generate output indicative of wound status based at least in part on the detected thermal information.
However, in the same field of endeavor, Prokoski teaches invention generally relates to the use of infrared imaging and, in particular, to the use of three dimensional infrared anatomical imaging [0002]. Classification of thermal, elevation, and color features by origin [skin fold, vascular structure, lymphatic structure, hair, scar, wound, mole] and characteristics [shape, size, position, orientation] relative to a standard model, leads to an encoding of the imaged area of the body unique to the subject [0085]. Infrared cameras the imaged pattern is determined by the temperature and emissivity of each surface point [0090]. This method produces consistent standardized infrared and surface topographic images for any portion of the body or the whole body for any person. It thereby enables automated change detection from images of the same subject taken at different times for wound care management [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 thermal sensor as taught by Prokoski because monitor wound healing of more frequent routine scanning, plus automated detection of significant changes from prior imaging provides earlier and more accurate detection of serious conditions ([0235] of Prokoski).
Regarding claim 26, Chhibber teaches all the claimed limitations except for wherein the processor is further configured to develop a wound treatment plan, based on the output.
However, in the same field of endeavor, Prokoski teaches invention generally relates to the use of infrared imaging and, in particular, to the use of three dimensional infrared anatomical imaging [0002]. Classification of thermal, elevation, and color features by origin [skin fold, vascular structure, lymphatic structure, hair, scar, wound, mole] and characteristics [shape, size, position, orientation] relative to a standard model, leads to an encoding of the imaged area of the body unique to the subject [0085]. Infrared cameras the imaged pattern is determined by the temperature and emissivity of each surface point [0090]. This method produces consistent standardized infrared and surface topographic images for any portion of the body or the whole body for any person. It thereby enables automated change detection from images of the same subject taken at different times for wound care management [0083]. The 3D/IR imaging and standardization system also provides an enabling technology for searchable medical image database libraries. Automated comparison of standardized imagery from a specific patient against a library of standardized images from many previous patients facilitates. Automated comparison of image sequences from a specific patient over a span of time can be compared against sequences from previous patients who had the same medical need and received the same treatment or other treatment. Comparison results are used to aid prognosis or suggest changes in treatment [0084].
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 develop a wound treatment plan, based on the output as taught by Prokoski because monitor wound healing of more frequent routine scanning, plus automated detection of significant changes from prior imaging provides earlier and more accurate detection of serious conditions ([0235] of Prokoski).
Claims 23 and 24 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chhibber in view of Kurtz (US20060241495).
Regarding claim 23, Chhibber teaches wherein the wound topology metric (“skin condition using only information in the skin pixels in the first white light and UV images. Module 730 may include submodules 732 for performing UV damage and skin tone analysis, and submodules 734 for locating and quantifying localized skin conditions, such as one or more types of pores, wrinkles, moles, pigmentation” [0048]).
Chhibber teaches all the claimed limitations except for the epithelialization metric.
However, in the same field of endeavor, Kurtz teaches wound healing monitoring and treatment (title). Monitoring device for examining the state of tissues, and in particular a device that examines the condition of collagen structures within tissue using a light based diagnostic device in close proximity with the skin of a patient [0001]. As wounds heal, they normally progress through a sequence of overlapping interactive phases, starting with coagulation and progressing through inflammation, proliferation (which includes granulation, angiogensis, and epithelialization), and remodeling [0006]. Wound healing also progresses through a series of overlapping phases, starting with coagulation (haemostasis), inflammation, proliferation (which includes collagen synthesis, angiogenesis, epithelialization, granulation, and contraction), and remodeling. Haemostasis, or coagulation, is the process by which blood flow is stopped after the initial wounding, and results in a clot, comprising fibrin, fibronectin, and other components, which then act as a provisional matrix for the cellular migration involved in the later healing phases. Many of the processes of proliferation, such as epithelialization and angiogenesis (creation of new blood vessels) require the presence of the extracellular matrix (ECM) in order to be successful [0045].
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 epithelialization metric as taught by Kurtz because it would help the clinician to use this information to improve the patient care. For example, the clinician could determine that collagen forming in the ECM lacks sufficient structural integrity (relative to bundle length, diameter, density, orientation) for proper granulation, and then that the fibroblasts need directed stimulation. ([0083] of Kurtz).
Regarding claim 24, Chhibber teaches all the claimed limitations except for wherein the epithelialization metric is based, at least in part, on detecting a presence of nicotinamide adenine dinucleotide plus hydrogen (NADH) in or around the wound.
However, in the same field of endeavor, Kurtz teaches wound healing monitoring and treatment (title). Monitoring device for examining the state of tissues, and in particular a device that examines the condition of collagen structures within tissue using a light based diagnostic device in close proximity with the skin of a patient [0001]. As wounds heal, they normally progress through a sequence of overlapping interactive phases, starting with coagulation and progressing through inflammation, proliferation (which includes granulation, angiogensis, and epithelialization), and remodeling [0006]. Wound healing also progresses through a series of overlapping phases, starting with coagulation (haemostasis), inflammation, proliferation (which includes collagen synthesis, angiogenesis, epithelialization, granulation, and contraction), and remodeling. Haemostasis, or coagulation, is the process by which blood flow is stopped after the initial wounding, and results in a clot, comprising fibrin, fibronectin, and other components, which then act as a provisional matrix for the cellular migration involved in the later healing phases. Many of the processes of proliferation, such as epithelialization and angiogenesis (creation of new blood vessels) require the presence of the extracellular matrix (ECM) in order to be successful [0045]. Device of the present invention might be used to detect and image tissues laden with bio-chemicals associated with wound healing. For example, the device could be used to look for bio-chemical marker concentrations of actin, hydroxylproline nitrates, or NADH or MMPs (matrix metallo-proteinases), which are associated with various aspects of healing progress or inhibition (including infection) [0079].
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 epithelialization metric as taught by Kurtz because it would help the clinician to use this information to improve the patient care. For example, the clinician could determine that collagen forming in the ECM lacks sufficient structural integrity (relative to bundle length, diameter, density, orientation) for proper granulation, and then that the fibroblasts need directed stimulation. ([0083] of Kurtz).
Conclusion
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/SERKAN AKAR/ Primary Examiner, Art Unit 3797
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