CTNF 18/718,467 CTNF 95210 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Information Disclosure Statement The information disclosure statement (IDS) submitted on June 11, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Drawings The drawings filed on June 11, 2024 are accepted. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. 07-34-01 Claims 2, 8, 12 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 2 recites the limitation “the indication of whether the wound is infected.” It is unclear if referring back to “an indication of the degree of infection.” It is interpreted that is does and should read, “the indication of the degree of infection”. The language should remain consistent and clear. Claims 8, 12 and 14 have the same issues. There is insufficient antecedent basis for this limitation in the claim. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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 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. 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 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 – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention. 07-15 AIA Claim s 1-11 and 13-15 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Radhakrishnan et al. (US 2021/0106231 A1) (“Radhakrishnan”) . Regarding claim 1 , Radhakrishnan discloses A device, comprising (Abstract and entire document) : a light source that emits emission light to a wound at a plurality of wavelengths ([0042], “The imaging module 102 comprises a plurality of light sources 108 configured to emit excitation radiation in a predetermined range of wavelengths.”) ; a camera that detects backscattered light generated based on the emission light ([0043], “The imaging module 102 further comprises a detector 114 configured to synchronously capture time- resolved fluorescence emission spectra, time-resolved reflectance, and time-resolved transmittance spectra at multiple spectral bands from the sample 112”) ; a memory that stores instructions ([0075] discussing memory and computers, etc.) ; and a processor that executes the instructions, wherein, when executed by the processor, the instructions cause the device to ([0044], “The image processing module 104 comprises an image processor 116 to perform spatial and temporal resolution of the fluorescence emission spectra, reflectance, and transmission spectra to obtain a plurality of spectral parameters.” And [0075] discussing computers, instructions, etc.) : record an image based on the backscattered light ([0050 – 0051], and [0058 – 0059], discussing a reflectance image) ; quantify a degree of infection of the wound based on the image ([0066] - [0070] discussing classification and quantification of wound and infection based on the image, see further [0081], “At block 506, amount of each pathogen across the wound region is quantified.”) , and output an indication of the degree of infection ([0072] display) . Regarding claim 2 , Radhakrishnan discloses The device of claim 1, further comprising: an interface used to output at least one of a visual signal or an audible signal as the indication of whether the wound is infected ([0072] display, screen) . Regarding claim 3 , Radhakrishnan discloses The device of claim 1, further comprising: a filter that filters the backscattered light before the device records the image ([0047 – 0048], “the imaging module 102 may comprise optical filters, polarizers, optical lenses, mirrors, and homogenizers”) . Regarding claim 4 , Radhakrishnan discloses The device of claim 1, further comprising: an interface used to select a range of wavelengths of the backscattered light to use in detecting the backscattered light ([0046] discussing selecting the wavelength and see also [0034], [0065], “In an example, a machine learning approach is followed to build and update the pathogen detection model. In said example, features are extracted prior to starting the analysis. In one instance, the features include excitation wavelength, emission wavelength, time dependent fluorescence emission wavelength, and amplitude. Typically, both decay rate and emission peak position changes with respect to time. The extracted features are obtained from a reference database comprising excitation wavelengths, emission wavelengths, time and amplitude of the emitted signal which also include ratio of different emission peaks on multi-wavelength excitation, time dependent fluorescence response of biomolecules and their ratios.” And [0073]) . Regarding claim 5 , Radhakrishnan discloses The device of claim 1, wherein, when executed by the processor, the instructions cause the device further to: apply a regression model to the image; and quantify the degree of infection based on an output of the regression model ([0065 - 0066]) . Regarding claim 6 , Radhakrishnan discloses The device of claim 1, further comprising: a thermographic sensor configured to capture a thermographic profile of the wound ([0037], “The device may also be used for monitoring wound healing and wound closure. The device may also be used to study wound parameters, such as wound size, wound depth, wound temperature distribution, tissue classification, biofilm information, degree of contamination, tissue oxygenation and blood flow.”) . Regarding claim 7 , Radhakrishnan discloses A method for quantifying a degree of an infection, comprising (Abstract and entire document) : emitting, by a light source of a device, emission light to a wound at a plurality of wavelengths ([0042], “The imaging module 102 comprises a plurality of light sources 108 configured to emit excitation radiation in a predetermined range of wavelengths.”) ; detecting, by a camera of the device, backscattered light generated based on the emission light ([0043], “The imaging module 102 further comprises a detector 114 configured to synchronously capture time-resolved fluorescence emission spectra, time-resolved reflectance, and time-resolved transmittance spectra at multiple spectral bands from the sample 112”) ; recording an image based on the backscattered light ([0050 – 0051], and [0058 – 0059], discussing a reflectance image) ; quantifying a degree of infection of the wound based on the image ([0066] - [0070] discussing classification and quantification of wound and infection based on the image, see further [0081], “At block 506, amount of each pathogen across the wound region is quantified.”) , and outputting, from the device, an indication of whether the wound is infected ([0072] display) . Regarding claim 8 , Radhakrishnan discloses The method of claim 7, further comprising: at least one of displaying a visual signal or outputting an audible signal as the indication of whether the wound is infected ([0072] display, screen) . Regarding claim 9 , Radhakrishnan discloses The method of claim 7, further comprising: filtering the backscattered light before recording the image ([0047 – 0048], “the imaging module 102 may comprise optical filters, polarizers, optical lenses, mirrors, and homogenizers”) . Regarding claim 10 , Radhakrishnan discloses The method of claim 7, further comprising: accepting a selection of wavelengths of the backscattered light to use in recording the image ([0046] discussing selecting the wavelength and see also [0034], [0065], “In an example, a machine learning approach is followed to build and update the pathogen detection model. In said example, features are extracted prior to starting the analysis. In one instance, the features include excitation wavelength, emission wavelength, time dependent fluorescence emission wavelength, and amplitude. Typically, both decay rate and emission peak position changes with respect to time. The extracted features are obtained from a reference database comprising excitation wavelengths, emission wavelengths, time and amplitude of the emitted signal which also include ratio of different emission peaks on multi-wavelength excitation, time dependent fluorescence response of biomolecules and their ratios.” And [0073]) . Regarding claim 11 , Radhakrishnan discloses The method of claim 7, further comprising: applying a regression model to the image; and quantifying the degree of infection of the wound based on an output of the regression model ([0065 - 0066]) . Regarding claim 13 , Radhakrishnan discloses The method of claim 7, further comprising: emitting the emission light to a surface other than the wound, detecting backscattered light generated based on the emission light emitted to the surface other than the wound, and recording a reference image based on the surface other than the wound ([0037], [0103], FIG. 1-24, the images include regions of the skin that is not the wound, for example, look at FIG. 16a and 16b, showing the wound and the surrounding regions, for reference) . Regarding claim 14 , Radhakrishnan discloses The method of claim 7, wherein the output of the indication of whether the wound is infected is output as a time-series of a plurality of indications of whether the wound is infected over a period of time ([0054], [0093], and FIG. 24 for example discussing wound monitoring over time) . Regarding claim 15 , Radhakrishnan discloses The method of claim 7, further comprising: normalizing a spectrum of the backscattered light before recording the image based on the backscattered light ([0047 – 0048], “the imaging module 102 may comprise optical filters, polarizers, optical lenses, mirrors, and homogenizers”) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA The factual inquiries set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. 07-21-aia AIA Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Radhakrishnan in view of Kinsler et al. (US 2021/0345942 A1) (“Kinsler”) . Regarding claim 12 , Radhakrishnan discloses The method of claim 7, Radhakrishnan fails to disclose wherein outputting the indication of whether the wound is infected comprises outputting an indication of whether the wound is infected for each of a plurality of subsets of pixel values used to generate the image. However, in the same field of endeavor, Kinsler teaches wherein outputting the indication of whether the wound is infected comprises outputting an indication of whether the wound is infected for each of a plurality of subsets of pixel values used to generate the image ([0053], “The cameras 10, 12 can be called two dimensional (2D) cameras as they output 2D images of the colour of the skin of the subject 2. Each camera 10, 12 outputs data indicating the colour detected by the camera at each pixel.”) . It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the method as taught by Radhakrishnan to include wherein outputting the indication of whether the wound is infected comprises outputting an indication of whether the wound is infected for each of a plurality of subsets of pixel values used to generate the image as taught by Kinsler to deliver accurate results ([0053], “In each case the imaging geometry and spectral response on the imaging system can be quantified in order to deliver accurate, precise and reliable mapping between information captured at each pixel and the total skin surface of the patient”). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern). 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Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /J.A.T./Examiner, Art Unit 3791 Application/Control Number: 18/718,467 Page 2 Art Unit: 3791 Application/Control Number: 18/718,467 Page 3 Art Unit: 3791 Application/Control Number: 18/718,467 Page 4 Art Unit: 3791 Application/Control Number: 18/718,467 Page 5 Art Unit: 3791 Application/Control Number: 18/718,467 Page 6 Art Unit: 3791 Application/Control Number: 18/718,467 Page 7 Art Unit: 3791 Application/Control Number: 18/718,467 Page 8 Art Unit: 3791 Application/Control Number: 18/718,467 Page 9 Art Unit: 3791
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