DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Drawing Objections
Applicant’s arguments, see Remarks and Amended Claim Set, filed 9/17/2025, with respect to the drawing objections regarding now deleted subject matter of claim 6 have been fully considered and are persuasive. The objection to the drawings has been withdrawn.
112(b) Rejections
Applicant’s arguments, see Remarks and Amended Claim Set, filed 9/17/2025, with respect to the rejections under 35 U.S.C. 112(b) regarding now deleted subject matter of claim 6 have been fully considered and are persuasive. The rejection under 35 U.S.C. 112(b) of claim 6 has been withdrawn.
103 Rejections
Applicant’s arguments with respect to claims 1-7, 9-14, and 18-22 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.
Claims 1-5 and 7-11 are rejected under 35 U.S.C. 103 over the combination of Zuluage ‘460, Gareau, and Kostenich. Claim 6 is rejected under 35 U.S.C. 103 over the combination of Zuluage ‘460, Gareau, Kostenich, and Harris. Claim 12 is rejected under 35 U.S.C. 103 over the combination of Zuluage ‘460, Gareau, Kostenich, and Toledano. Claims 13, 14, 18, and 21 are rejected under 35 U.S.C. 103 over the combination of Zuluage ‘460, Gareau, Kostenich, and Toledano. Claims 19-20 are rejected under 35 U.S.C. 103 over the combination of Zuluage ‘460, Gareau, Kostenich, Toledano, and Chachisvilis. Claim 22 is rejected under 35 U.S.C. 103 over the combination of Zuluage ‘460, Gareau, and Kostenich.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5 and 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Zuluaga (U.S. Pub. No. 2009/0099460), hereinafter “Zuluaga ‘460,” in further view of Gareau et al. (U.S. Pub. No. 2016/0166194), hereinafter “Gareau,” in further view of Kostenich et al. (U.S. Pub. No. 2021/0338119), hereinafter “Kostenich.”
Regarding claim 1, Zuluaga ‘460 discloses a device (1) to support dermatological diagnosis for a recognition of a skin lesion (L) including to evaluate a nature of a skin lesion (L) (processing system comprising the computer/controller produces a processed objective evaluation of the characteristics of potentially cancerous tumors on externally exposed body surfaces, e.g., skin, [0034], [0066], [0078], [0118], [0121]-[0122]; visualization unit [0050]-[0052]; detection unit/spectrometer, [0048], [0060]-[0061], [0077]-[0078], [0091], [0107], [0116]-[0120]), said device comprising:
- vision module (2) including at least one sensor (4) configured to acquire an image of the skin lesion (L) of a patient (visualization unit includes a digital camera configured to capture images of potentially cancerous tumors on externally exposed body surfaces, e.g., skin, [0034], [0050]-[0052]),
- a spectroscopy module (3) including at least one spectroscope (3) configured to acquire a spectral response of the skin lesion (L) in a determined visible and infrared band (detection unit includes a spectrometer configured to acquire spectral response data of potentially cancerous tumors on externally exposed body surfaces, e.g., skin, in a determined visible and infrared band, [0034], [0048], [0060]-[0061], [0077]-[0078], [0091], [0107], [0116]-[0120]),
- at least one housing (I1, I2, I3) including said vision module (2) and said spectroscopy module (3) (visualization/viewer unit housing, detector unit/spectrometer housing, and/or base unit, [0065]-[0066], [0068]-[0069], [0074]-[0082], [0093]-[0094], Figs. 3, 8-13),
- at least one electronic control unit (E) (processing unit including a computer and/or one or more controllers, [0062]-[0066]) configured for:
- controlling said vision module (2) and said spectroscopy module (3) (processing unit controls the mechanical and optical components of the medical examination device, [0062]-[0066], [0087]-[0088]; the medical examination device includes the visualization unit and the fiber-optic wand/detector unit of the spectrometer, [0070]-[0078]),
- storing a plurality of data acquired by means of said vision and spectroscopy modules (2, 3), including one or more images acquired by means of said vision module (2) and one or more spectral responses acquired by means of said spectroscopy module (3) (processing unit stores the data acquired from the medical examination device, [0062]-[0066], [0087]-[0088]; the medical examination device includes the visualization unit, acquiring image data. and the fiber-optic wand/detector unit of the spectrometer, acquiring spectral response data, [0070]-[0078]),
- sending said plurality of acquired data to a processing system (SE, SI) (acquired/stored image and spectral response data is provided to a computer/controller to process the data, [0062]-[0066], [0078], [0081]-[0088]),
- receiving an objective evaluation result of the skin lesion (L) processed by said processing system (SE, SI) as a result of an integration of the plurality of acquired data performed by said processing system (SE, SI) (processing system comprising the computer/controller produces a processed objective evaluation of the characteristics of potentially cancerous tumors on externally exposed body surfaces, e.g., skin, [0034], [0066], [0078], [0118], [0121]-[0122]), and
- showing said objective evaluation result on a display screen (22, 23) in such a way that said device (1) is configured to acquire by means of said vision module (2) and said spectroscopy module (3) a plurality of input data about the skin lesion (L) to be analyzed, based on different physical principles, and to provide a visualization of a single output result representative of objective information about the characteristics of the skin lesion (L) to be analyzed (processing system comprising the computer/controller produces a processed objective evaluation of the characteristics of potentially cancerous tumors on externally exposed body surfaces, e.g., skin, using the image data from the visualization unit and the spectral response data from the spectrometer, [0034], [0066], [0078], [0118], [0121]-[0122]; base unit housing incorporates a display screen upon which the results of the analysis are displayed, [0095], [0101]-[0121], Figs. 14-19),
wherein said at least one housing comprises:
a first housing (I1) including said vision module (2) therewithin and provided with a gripping portion (12) which is configured to provide an ergonomic grip by an operator during use of the vision module (2) (position/height/orientation of the visualization/viewer unit housing may be adjusted using an enlarged handle and tilt/lock adjustment, [0080], [0093], Fig. 9; see also visualization/viewer unit housing including protruding grips on each side of the visualization/viewer unit for the user to move the visualization unit attached to an articulated arm, Figs. 11-13; note the limitation “to provide an ergonomic grip by an operator” is merely a purpose and/or intended use for the claimed “first housing” and therefore does not have patentable weight as it does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.),
a second housing (I2) separate and distinct from the first housing (I1) and movable relative thereto (position/height/orientation of the visualization/viewer unit housing may be adjusted using an enlarged handle and tilt/lock adjustment relative to the separate and distinct base unit, [0080], [0093], Fig. 9; see also visualization/viewer unit housing including protruding grips on each side of the visualization/viewer unit for the user to move the visualization unit attached to an articulated arm relative to the separate and distinct base unit, Figs. 11-13), the second housing (I2) being in communication with the first housing (I1) and including therein said spectroscopy module (3), the display screen (23), and said at least one electronic control unit (E), wherein the display screen (23) is in communication with vision module (2) and the spectroscopy module (3) and the at least one electronic control unit (E) (detector unit/spectrometer and processing unit are housed within the base unit, which is connected to the visualization/viewer unit housing via cables/data lines, [0065]-[0066], [0068]-[0069], [0074]-[0082], [0094], Figs. 8-10; base unit housing incorporates a display screen upon which the results of the analysis are displayed, [0095], [0101]-[0121], Figs. 14-19; processing system comprising the computer/controller in the base unit housing produces a processed objective evaluation of the characteristics of potentially cancerous tumors on externally exposed body surfaces, e.g., skin, using the image data from the visualization unit and the spectral response data from the spectrometer, [0034], [0066], [0078], [0118], [0121]-[0122]), and is configured to control both the vision module (2) and the spectroscopy module (3) via the at least one electronic control unit (E) (processing unit controls the mechanical and optical components of the medical examination device, [0062]-[0066], [0087]-[0088]; the medical examination device includes the visualization unit and the fiber-optic wand/detector unit of the spectrometer, [0070]-[0078]), wherein the first housing is free of any display screen (base unit housing incorporates a display screen upon which the results of the analysis are displayed and the visualization/view unit housing does not have a display screen incorporated thereupon, [0076], [0095], [0101]-[0121], Figs. 14-19),
wherein the spectroscopy module (3) comprises an optical connection system (10) to convey light emitted by a first light source (9) towards the skin lesion (L) and to convey light reflected by the skin lesion (L) towards the at least one spectroscope (8), the optical connection system (10) comprising two optical fiber branches (101, 102) respectively connected to the at least one spectroscope (8) and to the first light source (9) (fiber optic wand or probe is connected via a first optical fiber connected to the illumination source, and a second optical fiber connected to the detector unit/spectroscope, [0045], [0061], [0075], [0077]-[0078], Figs. 1-3, 7-8) and whose distal end is provided with a gripping portion (104) (detector unit/spectrometer is connected on its distal end to a fiber optic wand/probe which comprises a handle/grip via at least one optical fiber, [0057]-[0058], [0089]-[0090], [0116], Figs. 3-6, 8, 9-13).
However, while Zuluaga ‘460 discloses a first housing (I1) including said vision module (2) therewithin and provided with a gripping portion (12) which is configured to provide an ergonomic grip by an operator during use of the vision module (2), a second housing (I2) separate and distinct from the first housing (I1) and movable relative thereto, the second housing (I2) being in communication with the first housing (I1) and including therein said spectroscopy module (3), the display screen (23), and said at least one electronic control unit (E), wherein the display screen (23) is in communication with vision module (2) and the spectroscopy module (3) and the at least one electronic control unit (E), and is configured to control both the vision module (2) and the spectroscopy module (3) via the at least one electronic control unit (E), wherein the first housing is free of any display screen, and a first light source, as detailed above, Zuluaga ‘460 does not appear to disclose a first housing (I1) configured for handheld use and including said vision module (2) therewithin and provided with a gripping portion (12) which is configured to provide an ergonomic grip by an operator during the handheld use of the vision module (2), which is adapted to be placed in contact with an area of the patient’s skin including the skin lesion (L), a second housing (I2) separate and distinct from the first housing (I1) and freely movable relative thereto, the second housing (I2) being in communication with the first housing (I1),wherein the first housing is free of any display screen, and wherein the vision module (2) includes a second light source (5) separate and distinct from, and different than, the first light source (9).
However, in the same field of endeavor of imaging device evaluation of skin tissue, Gareau teaches a first housing (I1) configured for handheld use (fixture is provided with an assembly that can be manipulated with one hand, [0062], Figs. 1A-1B) and including said vision module (2) therewithin (fixture contains a camera, [0041]-[0043], Fig. 1A) and provided with a gripping portion (12) which is configured to provide an ergonomic grip by an operator during the handheld use of the vision module (2) (fixture is provided with an assembly that can be manipulated with one hand, [0062], Figs. 1A-1B; fixture contains a camera for imaging, [0041]-[0043], Fig. 1A; note the limitation “to provide an ergonomic grip by an operator during the handheld use of the vision module (2)” is merely a purpose and/or intended use for the claimed “first housing” and therefore does not have patentable weight as it does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.), which is adapted to be placed in contact with an area of the patient’s skin including the skin lesion (L) (fixture has a plate that is positioned against a subject’s skin lesion, [0043], [0062]),
a second housing (I2) separate and distinct from the first housing (I1) and freely movable relative thereto (fixture includes a cable to attach to a remote second processor and other components to the apparatus, [0060]-[0061], Figs. 1A and 1B; remote second processor includes a computer system for controlling the fixture, [0071]-[0076]), the second housing (I2) being in communication with the first housing (I1) (remote second processor of the computer system is in communication with the fixture via the cable, [0060]-[0061], [0071]-[0076], Figs. 1A and 1B), wherein the first housing is free of any display screen (fixture may include display via an LCD screen in the fixture or, alternatively, may include display via a monitor or computer screen, [0060]-[0061], [0071], [0073]-[0075]; it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have omitted the display via an LCD screen in the fixture as MPEP 2144.04 II. A. provides that omission of an element and its function is obvious if the function of the element is not desired. Here the display via an LCD screen in the fixture is not desired and display via a monitor or computer screen remote from the fixture is desired. See also In re Larson, 340 F.2d 965, 144 USPQ 347 (CCPA 1965) (Omission of additional framework and axle which served to increase the cargo carrying capacity of prior art mobile fluid carrying unit would have been obvious if this feature was not desired.); and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (deleting a prior art switch member and thereby eliminating its function was an obvious expedient), and
wherein the vision module (2) includes a second light source (camera has a dedicated LED light source, [0041]-[0044], Fig. 1A).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Gareau’s known technique of providing a camera and a dedicated light source for the camera in a handheld housing with a grip and plate for pressing to a skin lesion connected via a cable to a remote computer system to Zuluaga ‘460’s known apparatus providing a visualization/viewer unit housing for a camera connected via cables/data lines to a detector unit/spectrometer and processing unit housed within a base unit with a light source shared between the visualization/viewer unit and detector unit/spectrometer to achieve the predictable result that adapting the fixture such that it can be hand held and freely positioned or pressed against the subject’s skin including the skin lesion improves the imaging “so that the lesion stays in one plane (the distal imaging plane) when the image is obtained.” See e.g., Gareau, [0043].
However, while Zuluaga ‘460 discloses the optical connection system comprises two optical fiber branches respectively connected to the at least one spectroscope and to the light source, the two optical fiber branches having a distal end provided with a gripping portion as detailed above, Zuluaga ’460 in further view of Gareau does not appear to teach the two optical fiber branches converging into a single optical fiber.
However, in the same field of endeavor of spectroscopy, Kostenich teaches the optical connection system comprises two optical fiber branches respectively connected to the at least one spectroscope and to the light source, the two optical fiber branches converging into a single optical fiber (a first optical light guide/optical fiber cable for guiding light response to a light detector and a second optical light guide/optical fiber cable for guiding illumination light from the illumination source converge into a single optical light guide/optical fiber cable, [0117], Fig. 7E).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Kostenich’s known technique of converging the spectroscope and light source fibers into a single optical fiber to Zuluaga ‘460 in further view of Gareau’s known apparatus having spectroscope and light source fibers to achieve the predictable result that the size and complexity of the fiber optic cable is reduced wherein the illumination light to and the reflected light from the target region pass through a common optical fiber rather than separate optical fibers in a bundle. See, e.g., Desjardins et al. (U.S. Pub. No. 2021/0052173), [0028], [0067].
Regarding claim 2, Zuluaga ‘460 discloses said at least one sensor (4) is an RGB camera (visualization unit includes a digital camera configured to capture fluorescence or white light reflectance, i.e., RGB/color camera, [0050]-[0052]) sensitive in visible frequencies (430-770Thz) (white light wavelength of 400-700 nm, i.e., 428.275-749.48 Thz, [0048]), and configured to acquire the image of the skin lesion (L) (visualization unit captures images of potentially cancerous tumors on externally exposed body surfaces, e.g., skin, [0034], [0050]-[0052]).
Regarding claim 3, Gareau further teaches the second light source of said vision module (2) includes:
- a lighting system consisting of a plurality of LED devices (5) configured to illuminate the area of the patient’s skin including the skin lesion (L) to be analyzed (camera dedicated light source consists of a plurality of LEDs configured to illuminate the area of the patient’s skin including the skin lesion, [0041]-[0044], [0058], Fig. 1A), and
- at least one polarization filter (6) configured to provide for a visualization of deepest layers of the patient’s skin, eliminating surface reflections due to reflection of light on a corneal layer of the patient’s skin (polarizing filter to condition light reflected by the lesion, [0058]; note the limitation “provide for a visualization of deepest layers of the patient’s skin, eliminating surface reflections due to reflection of light on a corneal layer of the patient’s skin” is merely a purpose and/or intended use for the claimed “polarization filter” and therefore does not have patentable weight as it does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; see also evidence in Kostenich paragraphs [0019] and [0105] that it is well-known to a PHOSITA that cross-polarization filters remove specular reflections).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Gareau’s known technique of providing a dedicated light source for the camera that illuminates the skin and skin lesion and a polarization filter to Zuluaga ‘460’s known apparatus with a light source shared between the visualization/viewer unit and detector unit/spectrometer to achieve the predictable result that LED light sources provide an inexpensive and widely available light source for illuminating the skin and skin lesion. See, e.g., Gareau, [0041]-[0044].
Regarding claim 4, while Zuluaga ‘460 in further view of Gareau teaches a polarization filter. Zuluaga ‘460 in further view of Gareau does not appear to teach two polarization filters (6) configured with a cross-polarization direction at 90° between them.
However, in the same field of endeavor of spectroscopy, Kostenich teaches two polarization filters (6) configured with a cross polarization direction at 90° between them (a polarization filter that is cross-polarized relative to a polarized illuminator, e.g., two cross polarized filter elements, [0019], [0105]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Kostenich’s known technique of using two polarizing filters configured such that they are cross-polarized to Zuluaga ‘460 in further view of Gareau’s known apparatus having a cross-polarization filter to achieve the predictable result that such an arrangement provides well-known components to filter out specular reflection from the tissue thereby ensuring only diffusely reflect light is detected by the light detectors and providing a high signal to background ratio, see, e.g., Kostenich, [0105], [0147].
Regarding claim 5, Zuluaga ‘406 does not appear to teach a hollow spacer element (7) is associated with said vision module (2), said spacer element (7) is adapted to be placed in contact with the patient’s skin and configured to define, during use of the device (1) with the spacer element contacting the patient’s skin and encompassing at least a portion of the skin lesion (L) to be analyzed, a known distance from the area of the patient’s skin including the skin lesion (L) to be analyzed, in order to ensure a focusing of the area formed by said at least one sensor (4).
However, in the same field of endeavor of imaging device evaluation of skin tissue, Gareau teaches a hollow spacer element (7) is associated with said vision module (2) (camera fixture has a hollow spacer/nose cone and mounted plate, [0043], Figs. 1A and 1B), said spacer element (7) is adapted to be placed in contact with the patient’s skin and configured to define, during use of the device (1) with the spacer element contacting the patient’s skin and encompassing at least a portion of the skin lesion (L) to be analyzed, a known distance from the area of the patient’s skin including the skin lesion (L) to be analyzed, in order to ensure a focusing of the area formed by said at least one sensor (4) (spacer provides an optimal distance between the illuminating and imaging apparatus/fixture and the lesion when the plate and spacer is pressed against the subject’s skin and skin lesion during imaging using the camera, [0043]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Gareau’s known technique of providing a camera and a dedicated light source for the camera and a spacer for pressing to a the skin and skin lesion to Zuluaga ‘460’s known apparatus providing a visualization/viewer unit housing for a camera connected with a light source shared between the visualization/viewer unit and detector unit/spectrometer to achieve the predictable result that adapting the fixture such that it can be hand held and freely positioned or pressed against the subject’s skin including the skin lesion improves the imaging “so that the lesion stays in one plane (the distal imaging plane) when the image is obtained.” See e.g., Gareau, [0043].
Regarding claim 7, Zuluaga ‘460 discloses said spectroscopy module (3) further comprises:
- a system comprising one or more specific optical elements for focusing and dispersion of the light signal to be analyzed (conditioning and filtering the spectral data transmitted through the collection fiber including lenses and/or filters, [0061]).
Regarding claim 9, Zuluaga ‘460 discloses said at least one electronic control unit (E) is configured to control said vision and spectroscopy modules (2, 3) by means of a graphic interface viewable on the display screen (23) (base unit housing incorporates a display screen upon which a user interface is displayed to control the visualization unit and the fiber optic wand/detector unit via the controllers of the processing unit, [0062]-[0066], [0095], [0101]-[0121], Figs. 7-19).
Regarding claim 10, Zuluaga ‘460 discloses said processing system (SE) is arranged externally to said at least one housing (I1, I2, I3) (processing unit can be and/or be connected to a computer/controller external to the visualization unit and the fiber optic wand/detector unit and/or part of a base unit separate from the visualization unit and the fiber optic wand/detector unit, [0062]-[0066], [0078], [0081]-[0088], Figs. 7-15).
Regarding claim 11, Zuluaga ‘460 discloses said at least one electronic control unit (E) is further configured to process said data acquired by means of said vision and spectroscopy modules (2, 3) with help from said processing system (SI), arranged internally to said at least one housing (I1, I2, I3) (processing unit comprises a computer/controller internal to the base unit housing that processes the data acquired by the visualization unit and the fiber optic wand/detector unit, [0062]-[0066], [0078]. [0081]-[0088], Figs. 7-15), and to produce a processed result containing objective information about the characteristics of the skin lesion (L) to be analyzed (processing system comprising the computer/controller produces a processed objective evaluation of the characteristics of potentially cancerous tumors on externally exposed body surfaces, e.g., skin, [0034], [0066], [0078], [0118], [0121]-[0122]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Zuluaga ‘460 in further view of Gareau in further view of Kostenich as applied to claim 5 above, and further in view of Harris et al. (U.S. Pub. No. 2009/0189972), hereinafter “Harris.”
Regarding claim 6, Gareau further teaches said first housing (I1) has an L-shape with one leg of the L-shape being the gripping portion for the handheld use and the other leg of the L-shape housing the at least one sensor (4) and the second light source (5) (fixture has an L-shape with one leg of the L-shape being the gripping portion for the handheld use and the other leg of the L-shape housing the camera and the LED camera dedicated light source, [0041]-[0044], [0062], Figs. 1A and 1B).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Gareau’s known technique of providing a camera and a dedicated light source for the camera in a handheld housing with a grip and plate for pressing to a skin lesion to Zuluaga ‘460’s known apparatus providing a visualization/viewer unit housing for a camera with a light source shared between the visualization/viewer unit and detector unit/spectrometer to achieve the predictable result that adapting the fixture such that it can be hand held and freely positioned or pressed against the subject’s skin including the skin lesion improves the imaging “so that the lesion stays in one plane (the distal imaging plane) when the image is obtained.” See e.g., Gareau, [0043].
However, Zuluaga ‘460 in further view of Gareau in further view of Kostenich does not appear to teach said spacer element (7) is configured to be moved axially.
However, in the same field of endeavor of imaging device evaluation of skin tissue, Harris teaches said spacer element (7) is configured to be moved axially (lens barrel is configured to be moved axially by manually turning the head on the lower threaded end of the camera body, [0249]-[0250], Figs. 14-15).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Harris’ known technique of disposing a spacer/barrel at the skin contacting surface that has an adjustable distance between the camera sensor and the skin to Zuluaga ‘406 in further view of Gareau in further view of Kostenich known apparatus providing an optical camera system for imaging the skin to achieve the predictable result that the user can manually adjust the focal distance to the skin by turning the threaded end of the spacer/barrel to better image the target region while preventing ambient light infiltration. See, e.g., Harris, [0249]-[0250].
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Zuluaga ‘460 in further view of Gareau in further view of Kostenich as applied to claim 11 above, and further in view of Toledano et al. (U.S. Pub. No. 2021/0251492), hereinafter “Toledano.”
Regarding claim 12, Zuluaga ‘460 discloses said electronic control unit (E) is further configured to process said acquired data on a basis of algorithms (processing unit comprises a computer/controller internal to the base unit housing that processes the data acquired by the visualization unit and the fiber optic wand/detector unit, [0062]-[0066], [0078]. [0081]-[0088], Figs. 7-15) in order to integrate data sent by the electronic control unit (E) and to produce an objective classification of a nature of the analyzed skin lesion (L) (processing system comprising the computer/controller produces a processed objective evaluation of the characteristics of potentially cancerous tumors on externally exposed body surfaces, e.g., skin, [0034], [0066], [0078], [0118], [0121]-[0122]).
However, while Zuluaga ‘460 discloses the computer/controller is configured to process said acquired data using algorithms, Zuluaga ‘460 in further view of Kostenich does not appear to teach the algorithms are machine learning algorithms.
However, in the same field of endeavor of multimodal evaluation of skin tissue, Toledano teaches to process said acquired data on a basis of machine learning algorithms, in order to integrate data sent by the electronic control unit (E) and to produce an objective classification of a nature of the analyzed skin lesion (L) (differentiate/identify precancerous/cancerous tissue, [0046]; machine learning classifiers to identify tissue state, [0054], [0059]; thermal, RGB, and/or hyperspectral imaging analysis to identify tissue state, [0049]-[0053]; differentiate/identify tissue state/type for skin tissue, [0083]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Toledano’s known technique of using machine learning classifier as analysis algorithms for determining the nature of skin tissue to Zuluaga ‘460 in further view of Gareau in further view of Kostenich’s known apparatus using analysis algorithms for determining the nature of skin tissue to achieve the predictable result that utilizing a machine learning classifier allows for greater efficiency and accuracy in predicting the tissue state/type through tailoring the algorithm to the most relevant variables and predictors from the obtained parameters of the collected data. See e.g., Toledano, [0160].
Claims 13, 14, 18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Zuluaga ‘460 in further view of in further view of Gareau in further view of Kostenich as applied to claim 1 above, and further in view of Toledano.
Regarding claim 13, Zuluaga ‘460 discloses said at least one electronic control unit (E) (processing unit including a computer and/or one or more controllers, [0062]-[0066]) is configured for:
- controlling said vision module (2) and said spectroscopy module (3) (processing unit controls the mechanical and optical components of the medical examination device, [0062]-[0066], [0087]-[0088]; the medical examination device includes the visualization unit and the fiber-optic wand/detector unit of the spectrometer, [0070]-[0078]),
- storing a plurality of data acquired by means of said vision and spectroscopy modules (2, 3) processing unit stores the data acquired from the medical examination device, [0062]-[0066], [0087]-[0088]; the medical examination device includes the visualization unit, acquiring image data. and the fiber-optic wand/detector unit of the spectrometer, acquiring spectral response data, [0070]-[0078]),
- sending said plurality of acquired data to the processing system (SE, SI) (acquired/stored image and spectral response data is provided to a computer/controller to process the data, [0062]-[0066], [0078], [0081]-[0088]),
- receiving an objective evaluation result of the skin lesion (L) processed by said processing system (SE, SI), as a result of the integration of the plurality of acquired data performed by said processing system (SE, SI) (processing system comprising the computer/controller produces a processed objective evaluation of the characteristics of potentially cancerous tumors on externally exposed body surfaces, e.g., skin, [0034], [0066], [0078], [0118], [0121]-[0122]), and
- showing said objective evaluation result on the display screen (22, 23) (processing system comprising the computer/controller produces a processed objective evaluation of the characteristics of potentially cancerous tumors on externally exposed body surfaces, e.g., skin, using the image data from the visualization unit and the spectral response data from the spectrometer, [0034], [0066], [0078], [0118], [0121]-[0122]; base unit housing incorporates a display screen upon which the results of the analysis are displayed, [0095], [0101]-[0121], Figs. 14-19).
However, Zuluaga ‘460 in further view of Kostenich does not appear to teach further sensors (21), based on physical principles different from those of the vision and spectroscopy modules (2, 3), so as to strengthen a precision of a final output classification of the skin lesion (L),
wherein said further sensors (21) comprise a thermography module (40),
wherein said at least one electronic control unit (E) is configured for:
- controlling said further sensors (21),
- storing a plurality of data acquired by means of said further sensor (2, 3, 21),
- sending said plurality of acquired data to the processing system (SE, SI),
- receiving an objective evaluation result of the skin lesion (L) processed by said processing system (SE, SI), as a result of the integration of the plurality of acquired data performed by said processing system (SE, SI) and
- showing said objective evaluation result on the display screen (22, 23).
However, in the same field of endeavor of multimodal evaluation of skin tissue, Toledano teaches further sensors (21), based on physical principles different from those of the vision and spectroscopy modules (2, 3), so as to strengthen a precision of a final output classification of the skin lesion (L) (differentiate/identify precancerous/cancerous tissue, [0046]; thermal, RGB, and/or hyperspectral imaging analysis to identify tissue state, [0049]-[0053]; thermal images are captured using short-wave infrared imaging device, [0049], the infrared imaging device is an infrared video camera, [0086]; differentiate/identify tissue state/type for skin tissue, [0083]; note the limitation “so as to strengthen a precision of a final output classification of the skin lesion (L)” is merely a purpose and/or intended use for the claimed “further sensors” and therefore does not have patentable weight as it does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.),
wherein said further sensors (21) comprise a thermography module (40) (thermal images are captured using short-wave infrared imaging device, [0049], the infrared imaging device is an infrared video camera, [0086]),
wherein said at least one electronic control unit (E) (processor, [0088]-[0092]) is configured for:
- controlling said further sensors (21) (processor is configured to acquire tissue images, [0088]-[0092], thermal, RGB, and/or hyperspectral imaging analysis to identify tissue state, [0049]-[0053]),
- storing a plurality of data acquired by means of said further sensor (2, 3, 21) (processor is configured to acquire tissue images, [0088]-[0092], thermal, RGB, and/or hyperspectral imaging analysis to identify tissue state, [0049]-[0053]; image data is stored in memory, [0135]),
- sending said plurality of acquired data to the processing system (SE, SI) (processor is configured to receive the acquired tissue images for analysis, [0088]-[0095]),
- receiving an objective evaluation result of the skin lesion (L) processed by said processing system (SE, SI), as a result of the integration of the plurality of acquired data performed by said processing system (SE, SI) (differentiate/identify precancerous/cancerous tissue, [0046]; machine learning classifiers to identify tissue state, [0054], [0059]; thermal, RGB, and/or hyperspectral imaging analysis to identify tissue state, [0049]-[0053]; differentiate/identify tissue state/type for skin tissue, [0083]; temperature profile/graph/curve describing thermal recovery of healthy/normal tissue and cancerous tissue is compared to distinguish between the healthy/normal tissue and cancerous tissue, [0132], [0137], [0170]. [0179], [0185]), and
- showing said objective evaluation result on the display screen (22, 23) ((differentiate/identify precancerous/cancerous tissue, [0046]; machine learning classifiers to identify tissue state, [0054], [0059]; thermal, RGB, and/or hyperspectral imaging analysis to identify tissue state, [0049]-[0053]; differentiate/identify tissue state/type for skin tissue, [0083]; temperature profile/graph/curve describing thermal recovery of healthy/normal tissue and cancerous tissue is compared to distinguish between the healthy/normal tissue and cancerous tissue such that the tissue state/type is determined an output for display, [0132], [0137], [0170]. [0179], [0185]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Toledano’s known technique of using thermal imaging in conjunction with RGB and/or multi-spectral images for analyzing skin tissue to Zuluaga ‘460 in further view of Gareau in further view of Kostenich’s known apparatus of using color camera images and spectroscopy for analyzing skin tissue to achieve the predictable result that providing thermal imaging data increases the accuracy and specificity of the tissue type or state identification and location. See e.g., Toledano, [0182].
Regarding claim 14, Zuluaga ‘460 in further view of Kostenich does not appear to teach said further sensors (21) further comprise one or more of the following modules: an impedance analyzer, another vision module operating in a shortwave infrared region in order to obtain images that emphasize vascularization of an area including the skin lesion.
However, in the same field of endeavor of multimodal evaluation of skin tissue, Toledano teaches said further sensors (21) further comprise one or more of the following modules: an impedance analyzer, another vision module operating in a shortwave infrared region in order to obtain images that emphasize vascularization of an area including the skin lesion (thermal images are captured using short-wave infrared imaging device, [0049], the infrared imaging device is an infrared video camera, [0086]; differentiate/identify tissue state/type for skin tissue, [0083]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Toledano’s known technique of using thermal imaging in conjunction with RGB and/or multi-spectral images for analyzing skin tissue to Zuluaga ‘460 in further view of Gareau in further view of Kostenich’s known apparatus of using color camera images and spectroscopy for analyzing skin tissue to achieve the predictable result that providing thermal imaging data increases the accuracy and specificity of the tissue type or state identification and location. See e.g., Toledano, [0182].
Regarding claim 18, Zuluaga ‘460 in further view of Kostenich does not appear to teach said thermography module (40) includes:
- at least one thermal interaction instrument (42), configured to cool down a skin region comprising the skin lesion (L) to be analyzed; and
- at least one thermal camera (63), configured to obtain one or more thermographic images of the skin lesion (L) to be analyzed.
However, in the same field of endeavor of multimodal evaluation of skin tissue, Toledano teaches aid thermography module (40) includes:
- at least one thermal interaction instrument (42), configured to cool down a skin region comprising the skin lesion (L) to be analyzed (cooling source for active cooling of the tissue, [0071], [0073], [0083], [0085], [0090]; differentiate/identify tissue state/type for skin tissue, [0083]); and
- at least one thermal camera (63), configured to obtain one or more thermographic images of the skin lesion (L) to be analyzed (the infrared imaging device is an infrared video camera, [0086]; differentiate/identify tissue state/type for skin tissue, [0083]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Toledano’s known technique of using thermal imaging and active cooling in conjunction with RGB and/or multi-spectral images for analyzing skin tissue to Zuluaga ‘460 in further view of Gareau in further view of Kostenich’s known apparatus of using color camera images and spectroscopy for analyzing skin tissue to achieve the predictable result that providing thermal imaging data increases the accuracy and specificity of the tissue type or state identification and location. See e.g., Toledano, [0182].
Regarding claim 21, Zuluaga ‘460 in further view of Kostenich does not appear to teach said at least one electronic control unit (E) is configured for:
- controlling an acquisition of temperature profiles describing a thermal recovery of a healthy skin region and of the skin region containing the skin lesion (L), both cooled down by means of the thermal interaction instrument (42);
- sending the acquired data to the processing system (SE, SI),
- automatically comparing said temperature profiles; and
- automatically processing an output result representative of the objective information about the characteristics of the skin lesion of interest.
However, in the same field of endeavor of multimodal evaluation of skin tissue, Toledano teaches said at least one electronic control unit (E) (processor, [0088]-[0092]) is configured for:
- controlling an acquisition of temperature profiles describing a thermal recovery of a healthy skin region and of the skin region containing the skin lesion (L), both cooled down by means of the thermal interaction instrument (42) (temperature profile/graph/curve describing thermal recovery of healthy/normal tissue and cancerous tissue, [0132], [0137], [0170]. [0179], [0185]; thermal recovery profile is of warming after active cooling of the tissue, [0066], [0090], Fig. 2B; differentiate/identify tissue state/type for skin tissue, [0083]; processor is configured to acquire tissue images, [0088]-[0092]),
- sending the acquired data to the processing system (SE, SI) (processor is configured to receive the acquired tissue images for analysis, [0088]-[0095]),
- automatically comparing said temperature profiles (temperature profile/graph/curve describing thermal recovery of healthy/normal tissue and cancerous tissue is compared to distinguish between the healthy/normal tissue and cancerous tissue, [0132], [0137], [0170]. [0179], [0185]); and
- automatically processing an output result representative of the objective information about the characteristics of the skin lesion of interest (temperature profile/graph/curve describing thermal recovery of healthy/normal tissue and cancerous tissue is compared to distinguish between the healthy/normal tissue and cancerous tissue such that the tissue state/type is determined an output for display, [0132], [0137], [0170]. [0179], [0185]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Toledano’s known technique of using thermal imaging and active cooling in conjunction with RGB and/or multi-spectral images for analyzing skin tissue to Zuluaga ‘460 in further view of Gareau in further view of Kostenich’s known apparatus of using color camera images and spectroscopy for analyzing skin tissue to achieve the predictable result that providing thermal imaging data increases the accuracy and specificity of the tissue type or state identification and location. See e.g., Toledano, [0182].
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Zuluaga ‘460 in further view of Gareau in further view of Kostenich in further view of Toledano as applied to claim 18 above, and further in view of Chachisvilis et al. (U.S. Pub. No. 2016/0310023), hereinafter “Chachisvilis.”
Regarding claim 19, Zuluaga ‘460 in further view of Kostenich does not appear to teach said thermal interaction instrument (42) has a housing (53) comprising an operating head (54) and a handle (55) and a Peltier device (59) configured to cool down a contact region between the operating head (54) and the skin region to be analyzed.
However, in the same field of endeavor of thermography evaluation of potentially cancerous tissue, Toledano teaches said thermal interaction instrument (42) has a device (59) configured to cool down a contact region of the skin region to be analyzed (cooling source for active cooling of the tissue, [0071], [0073], [0083], [0085], [0090]; differentiate/identify tissue state/type for skin tissue, [0083]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Toledano’s known technique of using thermal imaging and active cooling in conjunction with RGB and/or multi-spectral images for analyzing skin tissue to Zuluaga ‘460 in further view of Gareau in further view of Kostenich’s known apparatus of using color camera images and spectroscopy for analyzing skin tissue to achieve the predictable result that providing thermal imaging data increases the accuracy and specificity of the tissue type or state identification and location. See e.g., Toledano, [0182].
However, Zuluaga ‘460 in further view of Kostenich in further view of Toledano does not appear to teach said thermal interaction instrument (42) has a housing (53) comprising an operating head (54) and a handle (55) and a Peltier device (59) configured to cool down a contact region between the operating head (54) and the skin region to be analyzed.
However, in the same field of endeavor of thermography evaluation of potentially cancerous tissue, Chachisvillis teaches said thermal interaction instrument (42) has a housing (53) comprising an operating head (54) and a handle (55) and a Peltier device (59) configured to cool down a contact region between the operating head (54) and the skin region to be analyzed (Peltier thermoelectric cooler incorporated into the device inner or outer member skin contacting surface such that the Peltier cooler contacts and cools the skin, [0171]; the device comprises an outer member, i.e., a housing, that is configured to be a handle and/or be held by the user’s hand and has a skin contacting surface, [0004]-[0006], [0073]-[0074], [0098], [0104]-[0114], [0120], [0122], [0138], [0227]-[0228], Figs.1-2, 4A-4B, 5, 8-9; the imaging, spectroscopy, and thermography sensors and the pressure-modulating or temperature modulating devices may be part either the outer member or inner member, the outer or inner member and their respective skin contacting surfaces forming the operating head, [0147]-[0176], Figs. 2-9).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Chachisvillis’ known technique of disposing a Peltier device for active cooling of the skin tissue region on the skin contacting surface of a member of a hand-held thermal measurement, spectroscopy, and/or imaging device to Zuluaga ‘460 in further view of Gareau in further view of Kostenich in further view of Toledano’s known apparatus having an active cooling device for cooling the skin tissue region for thermographic imaging as part of a thermography, spectroscopy, and/or imaging device to achieve the predictable result that monitoring thermal recovery after cooling improves the determination of disease states of skin regions compared to normal skin regions. See, e.g., Chachisvillis, [0171], [0214], [0226]-[0230].
Regarding claim 20, Zuluaga ‘460 in further view of Kostenich in further view of Toledano does not appear to teach said operating head (54) comprises an interface contact plate (60) connected in a removeable way to the housing (53) to provide for disinfection between different measurements.
However, in the same field of endeavor of thermography evaluation of potentially cancerous tissue, Chachisvillis teaches said operating head (54) comprises an interface contact plate (60) connected in a removeable way to the housing (53) to provide for disinfection between different measurements (outer and/or inner member, i.e., the operating head, comprises a separable component that is removeably connected to the skin contacting surface of the outer and/or inner member, [0037], [0105]-[0111], Figs. 3A-B; note the limitation “to provide for disinfection between different measurements” is merely a purpose and/or intended use for the claimed “interface contact plate” and therefore does not have patentable weight as it does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Chachisvillis’ known technique of applying a separable component between the device skin contacting surface and the skin to Zuluaga ‘460 in further view of Gareau in further view of Kostenich in further view of Toledano’s known apparatus having a skin cooling device to achieve the predictable result that the separable component can facilitate the positioning and adhesion of the device to the skin in a desired location. See, e.g., Chachisvillis, [0109].
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Zuluaga ‘460 in further view of Gareau in further view of Kostenich.
Regarding claim 22, Zuluaga ‘460 discloses a system to support dermatological diagnosis for the recognition of skin lesion (L) (processing system comprising the computer/controller produces a processed objective evaluation/identification of the characteristics of potentially cancerous tumors on externally exposed body surfaces, e.g., skin, [0034], [0066], [0078], [0118], [0121]-[0122]), comprising the device (1) according to claim 1 (see rejection of claim 1 above) including the processing system (SE, SI) (processing system comprising the computer/controller produces a processed objective evaluation of the characteristics of potentially cancerous tumors on externally exposed body surfaces, e.g., skin, [0034], [0066], [0078], [0118], [0121]-[0122]) configured to receive the data acquired by said device (1) (processing unit stores the data acquired from the medical examination device, [0062]-[0066], [0087]-[0088]; the medical examination device includes the visualization unit, acquiring image data. and the fiber-optic wand/detector unit of the spectrometer, acquiring spectral response data, [0070]-[0078]) and to process a final evaluation result of the skin lesion analyzed (processing system comprising the computer/controller produces a processed objective evaluation of the characteristics of potentially cancerous tumors on externally exposed body surfaces, e.g., skin, [0034], [0066], [0078], [0118], [0121]-[0122]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wang et al. (U.S. Pub. No. 2007/0103683) discloses two optical fiber branches respectively connected to the at least one spectroscope and to the light source, the two optical fiber branches converging into a single optical fiber.
Norris et al. (U.S. Pub. No. 2011/0066035) discloses two optical fiber branches respectively connected to the at least one spectroscope and to the light source, the two optical fiber branches converging into a single optical fiber.
Milner et. al. (U.S. Pub. No. 2008/0291463) discloses two optical fiber branches respectively connected to the at least one spectroscope and to the light source, the two optical fiber branches converging into a single optical fiber.
Chen et al. (U.S. Pub. No. 2005/0140982) discloses two optical fiber branches respectively connected to the at least one spectroscope and to the light source, the two optical fiber branches converging into a single optical fiber.
Chen et al. (U.S. Patent No. 6,549,801) discloses two optical fiber branches respectively connected to the at least one spectroscope and to the light source, the two optical fiber branches converging into a single optical fiber.
Zuluaga (U.S. Pub. No. 2009/0062662) discloses a dermatological diagnosis device for evaluating objective characteristics of potentially precancerous or cancerous lesions/tumors comprising a color camera and a spectrometer.
Fukazawa et al. (U.S. Pub. No. 2020/0154988) discloses a dermatological diagnosis device for evaluating objective characteristics of potentially precancerous or cancerous lesions/tumors comprising a color camera and a spectrometer.
Mullani et al. (U.S. Pub. No. 2021/0137633) discloses a dermatological skin lesion imaging and diagnosis device comprising a threaded cap to adjust the axial depth of a spacer element such that the focus depth of the imaging device can be adjusted.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/J.M./Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798