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 Amendment
This action is in response to the remarks filed on 5/10/2026.
The amendments filed on 5/10/2026 have been entered. Accordingly claims 1-14 remain pending.
The claim rejections under35 USC 112 have been withdrawn in light of the amendments and the applicant’s remarks.
Claim Objections
Claim 14 is objected to because of the following informalities:
Claim 14 appears to be written in an independent form, yet also refers back to the other independent claim 7. In an interpretation, claim 14 may be construed as an independent claim; and in another interpretation it may also be construed as a dependent claim. In order to prevent any foreseeable ambiguity, it is suggested to bring the entire claim 7 in to the claim 14 to have the claim construed as a proper independent claim; or, correct the dependency of claim 14 (as shown in other depending claims e.g., claim 13, claim 2, etc.) to have the claim construed as a proper dependent claim.
Appropriate correction is required.
Claim Interpretation
Claims 7, 8 and 14 recite the newly amended limitation of “when the skin is illuminated” which in an interpretation it may be construed as a conditional limitation where the limitations followed by the conditional limitations may not be given a full weight in light of the below decisions as for considering the other case scenario of “when the skin is” NOT being illuminated.
In the recent Ex parte Gopalan decision, the PTAB addressed a claim where all of the features were recited in a conditional manner. A first step of “identifying … an outlier” was performed if “traffic is outside of a prediction interval.” A second step of “identifying” was performed “only when a count of outliers … is greater than or equal to two, and exceeds an anomaly threshold.” These were the only two elements of the independent claim. Thus, if the traffic is never outside Gopalan’s prediction interval, then the steps of the method are never performed.
However, the PTAB distinguished Schulhauser and noted that this construction “would render the entire claim meaningless.” Gopalan at p. 5. The Board went on to state, “Although each of these steps is conditional, they are integrated into one method or path and do not cause the claim to diverge into two methods or paths, as in Schulhauser. Thus, we conclude that the broadest reasonable interpretation of claim 1 requires the performance of both steps…” Id. at p. 6.”
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-2, 5-8 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Dacosta (US20200104998A1) in view of Luong (US 20150297912 A1) and Stewart (US 20210353148).
Regarding claim 1, Dacosta teaches an arrangement for skin characterization, wherein the arrangement comprises a measurement device, and the measurement device comprises a radiation-emitting device which illuminates a skin region with radiation (paragraphs 0054 and 0067 with Fig.1; imaging device 1 with light sources 5), and the radiation-emitting device comprises:
- one or more first emitters which emit radiation in a UV wavelength range of 200 nm - 400 nm (paragraphs 0067, 0075 and 0089; UV light source, wherein UV is defined as <400nm),
- one or more second emitters which emit radiation in a visible wavelength range of 400 nm - 750nm (paragraphs 0067, 0075 and 00839; visible light source, wherein visible light is defined as 400-700nm),
- one or more third emitters which emit radiation in a near-infrared wavelength range of 750 nm - 900 nm (paragraphs 0067, 0075 and 0089; near-infrared light source, wherein near-infrared is defined as 700 - 900nm),
wherein the device also comprises one or more radiation detectors which measure a reflected radiation spectrum from the skin region as the skin region is illuminated by the radiation- emitting device, and the one or more radiation detectors measure the reflected radiation spectrum in the UV wavelength range, the visible wavelength range and the near- infrared wavelength range (paragraph 0067, 0077, and 0079, with Fig.1; imaging device comprises an image sensor for hyperspectral imaging, which implies light detection over the whole illuminated range).
the arrangement further comprising a control unit configured to (“device further comprises a processor configured to receive the detected signals, to analyze data from the detected signals using pixel intensity, and to output data regarding a bacterial load of the target” claim 1 of Dacosta):
- select one or more treatment wavelengths, one or more treatment intensities, and one or more treatment durations based on the reflected radiation spectrum (“the device may be used for differentiating the presence and/or location of different bacterial … based on the different autofluorescence emission signatures of different bacterial species, including those within the 490-550 nm and 610-640 nm emission wavelength bands when excited by violet/blue light, such as light around 405 nm. Other combinations of wavelengths may be used to distinguish between other species on the images. This information may be used to select appropriate treatment, such as choice of antibiotic.” [0131]; “select the optimum excitation and emission wavelength bandwidths for use” [0166]; “Antibacterial treatment (topical Mupirocin three times daily, for a total of 1 day) was applied to the wound site when the red FL intensity peaked. The anti-microbial effect of the treatment was monitored over time using the handheld device to acquire daily WL and FL images of the wound after treatment. The wounds were monitored for a total of 10 days” [0122]); and
- command the measurement device to illuminate the skin region with radiation at each of the one or more treatment wavelengths at the corresponding one or more treatment intensities for a duration which equals the corresponding treatment duration (“the device may be used for differentiating the presence and/or location of different bacterial … based on the different autofluorescence emission signatures of different bacterial species, including those within the 490-550 nm and 610-640 nm emission wavelength bands when excited by violet/blue light, such as light around 405 nm. Other combinations of wavelengths may be used to distinguish between other species on the images. This information may be used to select appropriate treatment, such as choice of antibiotic.” [0131]; “select the optimum excitation and emission wavelength bandwidths for use” [0166]; “Antibacterial treatment (topical Mupirocin three times daily, for a total of 1 day) was applied to the wound site when the red FL intensity peaked. The anti-microbial effect of the treatment was monitored over time using the handheld device to acquire daily WL and FL images of the wound after treatment. The wounds were monitored for a total of 10 days” [0122]).
As can be clearly seen above, Dacosta taches all the claimed invention. If in an interpretation, one argues otherwise (which the office does not concede), Luong is brought in to show the teachings in an effort to provide compact prosecution.
However, in the same field of endeavor, Luong teaches the device for cosmetic treatment by light according to the invention can comprise at least two groups of LEDs emitting respectively at two different wavelengths. When two types of LED emitting at two different wavelengths are used in a concomitant manner, it is necessary to guarantee a precise power of luminous radiation per unit of exposed skin for each type of wavelength. The device according to the invention makes it possible to precisely tailor the emission power of each LED so as to ensure a controlled luminous intensity on the area of skin to be treated. It then becomes possible to ensure the homogeneity of the radiations of the two types of LED over the area to be treated without necessarily using the same number of LEDs of each type [0052]. Exposing an area of skin to a first luminous radiation by means of ten LEDs emitting light beams at the wavelength of 590 nm with an intensity of 2.1 mW/cm.sup.2 of exposed skin, and simultaneously, exposing the area of skin to a second luminous radiation by means of four LEDs emitting light beams at the wavelength of 870 nm with an intensity of 0.5 mW/cm.sup.2 of exposed skin [0055].
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 controlling/commanding to illuminate skin with treatment wavelengths, treatment intensities, and treatment durations based on the reflected radiation spectrum as taught by Luong because exists a need for a device for cosmetic treatment by light which makes it possible to ensure optimal intensity of the light on the area to be treated and which is compact and inexpensive ([0012] of Luong).
Further, also in the same field of endeavor, Stewart teaches systems and methods for simultaneous medical imaging and therapy. More particularly, light of specified wavelength and intensity is applied both to generate useful images and to treat certain conditions [0002]. The selected wavelength of a light source is not limited and can be one or more of ultraviolet (UV), visible (VIS), near infrared (NIR), visible-near infrared (VIS-NIR), shortwave infrared (SWIR), extended shortwave infrared (eSWIR), and near infrared-extended shortwave infrared (NIR-eSWIR) ranges. These correspond to wavelengths of about 180 nm to about 380 nm (UV), about 380 nm to about 720 nm (VIS), about 400 nm to about 1100 nm (VIS-NIR), about 850 nm to about 1800 nm (SWIR), about 1200 nm to about 2450 nm (eSWIR), and about 720 nm to about 2500 nm (NIR-eSWIR) [0026]. Tuning is accomplished by increasing or decreasing the intensity or duration at which the individual light elements are powered [0028].
It would also 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 controlling/commanding to illuminate skin with treatment wavelengths, treatment intensities, and treatment durations based on the reflected radiation spectrum as taught by Stewart because it would be desirable to combine the diagnostic and imaging capabilities of various light spectra with the therapeutic capabilities of the same or similar spectra ([0005] of Stewart).
Regarding claim 2, Dacosta teaches wherein the device comprises a proximity sensor for measuring the distance between the skin region and the radiation-emitting device (“The device may include a method or apparatus 8 to use an optical means (e.g., use of compact miniature laser diodes that emit a collimated light beam) to measure and determine the distance between the imaging device and the object 10” [0067]).
Regarding claims 5 and 11, Dacosta teaches wherein the device comprises a 3D camera for measuring the topography of the skin region (“provide 3D stereoscopic fluorescence imaging that may provide, for example, topography-specific information about bacterial infection of curved surfaces” [0090]).
Regarding claims 6 and 12, Dacosta teaches wherein the device comprises a colour sensor for measuring the colour of the skin region (“color photography to capture the general appearance of a wound under white light illumination” [0042]).
Regarding claims 7 and 14 (as the claims best understood in light of the 35 USC 112 rejections above), Dacosta teaches a method for characterizing and treating skin (paragraphs 0054 and 0067 with Fig.1; imaging device 1 with light sources 5), comprising:
- illuminating a first skin region in a UV wavelength range of 200 nm - 400 nm, and with radiation in a visible wavelength range of 400 nm - 750 nm and with radiation in a near- infrared wavelength range of 750 nm - 900 nm, and measuring a first reflected radiation spectrum from the first skin region when the first skin region is illuminated (“excitation/illumination light sources with specific wavelength characteristics in the ultraviolet (UV), visible (VIS), far-red, near infrared (NIR) and infrared (IR) ranges may also be used, and may be composed of a LED array” [0075]),
- illuminating a reference skin region with radiation in the UV wavelength range, the visible wavelength range and the near-infrared wavelength range, and measuring a second reflected radiation spectrum from the reference skin region when the reference skin region is illuminated (“excitation/illumination light sources with specific wavelength characteristics in the ultraviolet (UV), visible (VIS), far-red, near infrared (NIR) and infrared (IR) ranges may also be used, and may be composed of a LED array” [0075]), and
- comparing the first reflected radiation spectrum to the second reflected radiation spectrum (“variation in measurements of wound areas between images taken under WL and FL were compared.” [0113]).
- select one or more treatment wavelengths, one or more treatment intensities, and one or more treatment durations based on the reflected radiation spectrum (“the device may be used for differentiating the presence and/or location of different bacterial … based on the different autofluorescence emission signatures of different bacterial species, including those within the 490-550 nm and 610-640 nm emission wavelength bands when excited by violet/blue light, such as light around 405 nm. Other combinations of wavelengths may be used to distinguish between other species on the images. This information may be used to select appropriate treatment, such as choice of antibiotic.” [0131]; “select the optimum excitation and emission wavelength bandwidths for use” [0166]; “Antibacterial treatment (topical Mupirocin three times daily, for a total of 1 day) was applied to the wound site when the red FL intensity peaked. The anti-microbial effect of the treatment was monitored over time using the handheld device to acquire daily WL and FL images of the wound after treatment. The wounds were monitored for a total of 10 days” [0122]); and
- command the measurement device to illuminate the skin region with radiation at each of the one or more treatment wavelengths at the corresponding one or more treatment intensities for a duration which equals the corresponding treatment duration (“the device may be used for differentiating the presence and/or location of different bacterial … based on the different autofluorescence emission signatures of different bacterial species, including those within the 490-550 nm and 610-640 nm emission wavelength bands when excited by violet/blue light, such as light around 405 nm. Other combinations of wavelengths may be used to distinguish between other species on the images. This information may be used to select appropriate treatment, such as choice of antibiotic.” [0131]; “select the optimum excitation and emission wavelength bandwidths for use” [0166]; “Antibacterial treatment (topical Mupirocin three times daily, for a total of 1 day) was applied to the wound site when the red FL intensity peaked. The anti-microbial effect of the treatment was monitored over time using the handheld device to acquire daily WL and FL images of the wound after treatment. The wounds were monitored for a total of 10 days” [0122]).
As can be clearly seen above, Dacosta taches all the claimed invention. If in an interpretation, one argues otherwise (which the office does not concede), Luong is brought in to show the teachings in an effort to provide compact prosecution.
However, in the same field of endeavor, Luong teaches the device for cosmetic treatment by light according to the invention can comprise at least two groups of LEDs emitting respectively at two different wavelengths. When two types of LED emitting at two different wavelengths are used in a concomitant manner, it is necessary to guarantee a precise power of luminous radiation per unit of exposed skin for each type of wavelength. The device according to the invention makes it possible to precisely tailor the emission power of each LED so as to ensure a controlled luminous intensity on the area of skin to be treated. It then becomes possible to ensure the homogeneity of the radiations of the two types of LED over the area to be treated without necessarily using the same number of LEDs of each type [0052]. Exposing an area of skin to a first luminous radiation by means of ten LEDs emitting light beams at the wavelength of 590 nm with an intensity of 2.1 mW/cm.sup.2 of exposed skin, and simultaneously, exposing the area of skin to a second luminous radiation by means of four LEDs emitting light beams at the wavelength of 870 nm with an intensity of 0.5 mW/cm.sup.2 of exposed skin [0055].
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 controlling/commanding to illuminate skin with treatment wavelengths, treatment intensities, and treatment durations based on the reflected radiation spectrum as taught by Luong because exists a need for a device for cosmetic treatment by light which makes it possible to ensure optimal intensity of the light on the area to be treated and which is compact and inexpensive ([0012] of Luong).
Further, also in the same field of endeavor, Stewart teaches systems and methods for simultaneous medical imaging and therapy. More particularly, light of specified wavelength and intensity is applied both to generate useful images and to treat certain conditions [0002]. The selected wavelength of a light source is not limited and can be one or more of ultraviolet (UV), visible (VIS), near infrared (NIR), visible-near infrared (VIS-NIR), shortwave infrared (SWIR), extended shortwave infrared (eSWIR), and near infrared-extended shortwave infrared (NIR-eSWIR) ranges. These correspond to wavelengths of about 180 nm to about 380 nm (UV), about 380 nm to about 720 nm (VIS), about 400 nm to about 1100 nm (VIS-NIR), about 850 nm to about 1800 nm (SWIR), about 1200 nm to about 2450 nm (eSWIR), and about 720 nm to about 2500 nm (NIR-eSWIR) [0026]. Tuning is accomplished by increasing or decreasing the intensity or duration at which the individual light elements are powered [0028].
It would also 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 controlling/commanding to illuminate skin with treatment wavelengths, treatment intensities, and treatment durations based on the reflected radiation spectrum as taught by Stewart because it would be desirable to combine the diagnostic and imaging capabilities of various light spectra with the therapeutic capabilities of the same or similar spectra ([0005] of Stewart).
Regarding claim 8, Dacosta teaches wherein the method comprises the step of measuring a distance between the skin region and the radiation-emitting device when the skin is being illuminated (“The device may include a method or apparatus 8 to use an optical means (e.g., use of compact miniature laser diodes that emit a collimated light beam) to measure and determine the distance between the imaging device and the object 10” [0067]) and the step of adjusting the illumination intensity if the measured distance changes (“a method or apparatus 9 (e.g., a pivot) to permit the manipulation and orientation of the excitation light sources 5, 8 so as to manoeuvre these sources 5,8 to change the illumination angle of the light striking the object 10 for varying distances” [0067])
Regarding claim 13, Dacosta teaches wherein the method comprises the step of measuring the temperature of the skin region (“device may be configured to display color images, image maps, or other maps of user selected parameters such as, for example, bacteria location and/or biodistribution, collagen location, location and differentiation between live tissues and dead tissues, differentiation between bacterial species, location and extent of blood, bone, exudate, temperature and wound area/size” [0061]).
Claims 3-4 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Dacosta in view of Luong (US 20150297912 A1) and Stewart as applied to above claims and further in view of Potyrailo (US 20200345300).
Regarding claims 3 and 9, Dacosta teaches all the limitations of the claims except for the device comprises a temperature sensor for measuring the ambient temperature.
However, in the same field of endeavor, Potyrailo teaches A sensor system includes a first sensor to detect environmental conditions of an environment in operational contact with a subject, a second sensor to detect physiological parameters of the subject in operational contact with an asset, and a control unit comprising one or more processors communicatively coupled with the first sensor and the second sensor (abst). Processors of the control unit receive an environmental signal from the environmental sensor indicative of the environmental conditions. Nonlimiting examples of the environmental conditions measured and/or detected by the environmental sensor can include gas, particle matter contaminants (PM), ultraviolet radiation exposure (UV), ambient temperature, ambient pressure, ambient relative humidity, and
sensor acceleration [0030]. Sensors can be near-infrared sensors, ultraviolet sensors,
infrared sensors, visible light sensors, fiber-optic sensors, reflection sensors, multivariable sensors, or single-output sensors. The sensor may generate electrical or optical stimuli in response to measured fluid [0037].
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 temperature sensor for measuring the ambient temperature as taught by because of the lack of needed accuracy, existing sensors are problematic to utilize for control of environmental conditions and/or assets that are operated by subjects ([0003] of Dacosta).
Regarding claims 4 and 10, Dacosta teaches all the limitations of the claims except for wherein the device comprises a humidity sensor for measuring the ambient humidity.
However, in the same field of endeavor, Potyrailo teaches A sensor system includes a first sensor to detect environmental conditions of an environment in operational contact with a subject, a second sensor to detect physiological parameters of the subject in operational contact with an asset, and a control unit comprising one or more processors communicatively coupled with the first sensor and the second sensor (abst). Processors of the control unit receive an environmental signal from the environmental sensor indicative of the environmental conditions. Nonlimiting examples of the environmental conditions measured and/or detected by the environmental sensor can include gas, particle matter contaminants (PM), ultraviolet radiation exposure (UV), ambient temperature, ambient pressure, ambient relative humidity, and
sensor acceleration [0030]. Sensors can be near-infrared sensors, ultraviolet sensors,
infrared sensors, visible light sensors, fiber-optic sensors, reflection sensors, multivariable sensors, or single-output sensors. The sensor may generate electrical or optical stimuli in response to measured fluid [0037].
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 humidity sensor for measuring the ambient humidity as taught by because of the lack of needed accuracy, existing sensors are problematic to utilize for control of environmental conditions and/or assets that are operated by subjects ([0003] of Dacosta).
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SERKAN AKAR/ Primary Examiner, Art Unit 3797
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