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
Applicant's arguments filed 12/19/2025 have been fully considered but they are not persuasive.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Lachenbruch discloses, at paragraph [0102], that “[i]n operation, light from light source 504 passes through the skin tissue and is received and detected by light detector 506 (Block 550 of FIG. 35). The depth…at which the tissue is inspected depends on the separation distance…between the light source and the detector.” Hank discloses a plurality of excitation light sources may transmit at least two of a light with a 660 nm wavelength, a light with at 950 wavelength nm, or a light with an 800 nm wavelength wherein the processor may be configured to measure a spectral response of the tissue, to quantitate blood capillary refill rates, to determine a likelihood of the tissue developing a pressure ulcer (see paragraph [0044]). Therefore, it would have obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the depth sensing device as disclosed by Lachenbruch with the device as taught by Hank.
In response to applicant's argument that “While Hanks mentions that its excitation light sources may transmit light at particular wavelengths including about 660 nm, 800 nm, or 950 nm, Hanks uses these wavelengths in the context of flap perfusion and oxygenation algorithms, not for generating depth data per wavelength or for big-data learning to determine pressure-ulcer stage and depth,” a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
For example, Hank discloses a plurality of excitation light sources may transmit at least two of a light with a 660 nm wavelength, a light with a 950 wavelength nm, or a light with a 800 nm wavelength wherein the processor may be configured to measure a spectral response of the tissue, to quantitate blood capillary refill rates, to determine a likelihood of the tissue developing a pressure ulcer (see paragraph [0044]) and predicting the stage of at least one pressure ulcer in the subject as stage 1, stage 2, stage 3, or stage 4 (see paragraph [0040]).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a depth camera used to reconstruct the three-dimensional state and depth of a pressure ulcer and “training a big data learning model (e.g., machine-learning model) using a large dataset of depth data”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Note however, the examiner cannot find anywhere in applicant’s specification a discussion on “training a big data learning model (e.g., machine-learning model) using a large dataset of depth data” and much less the terms “training”, “data learning model”, “machine-learning model” and “large dataset.”
Applicant’s arguments with respect to claims 1 and 9 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.
Applicant argues on pages 11 and 12 of the remarks filed 12/19/2025 that “Nothing in Lachenbruch indicates that its camera is a depth camera, that it produces depth data per wavelength, or that it is capable of non-invasive depth measurement of tissue.” Examiner respectfully disagrees.
As identified in the Office Action, Lachenbruch notes that “…it is known that the early warning signs of a pressure ulcer can occur beneath the externally visible surface of the stratum corneum. Hence, the phrases “region of skin”, “target region”, “target site” and their equivalents and analogues are not limited to an area of the skin surface, but also include tissue beneath that area that can exhibit signs of a pressure ulcer or its precursors.” (See paragraph [0043]). Lachenbruch further discloses various useful wavelengths to include a wavelength at 955 nm wherein high intensity of reflection at 955 nm indicates the presence of water, therefore tissue damage, whereas low intensity of reflection at 955 nm indicates the absence of water, therefore healthy tissue (see paragraphs [0054] through [0058]). Thus, Lachenbruch discloses producing depth data per wavelength, or the capability of non-invasive depth measurement of tissue.
The amended features are taught by newly found reference Munoz (Pub. No.: US 2016/0157725). Munoz discloses achieving 3D surface imaging through depth sensors (paragraph [0089]), hyperspectral image/data is processed to provide a spectral map of pressure ulcers (paragraph [0121]), transmits sensor data to a cloud-based service (paragraph [0134]), wherein a cloud-based software service can be provided that performs interfaces with a machine learning program to analyze the sensor data against a data model to analyze multiple sets of sensor data per patient to provide time-based progression/regression information (paragraph [0135]).
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 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.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Lachenbruch et al. (Pub. No.: US 2017/0224271) in view of Munoz (Pub. No.: US 2016/0157725).
Consider claims 1, 9, Lachenbruch discloses a depth data-based pressure ulcer diagnosis system (100) (paragraph [0038], Fig. 1, pressure ulcer detection system) using a multispectral light source (paragraph [0095], Fig. 30, illuminating at 415 nm and 435 nm), the system comprising:
a light emission unit (110) (paragraph [0041], Figs. 1, 2, light source 90) for emitting light on skin of a body part for assessing pressure ulcers (paragraph [0041], Figs. 1, 2, light source 90 dedicated to the pressure ulcer detection);
a measurement unit (120) (paragraph [0045], Figs. 1, 2, camera 96) for measuring light transmittance using a reflected light reflected when the light emission unit (110) emits light to the skin of the body part for assessing pressure ulcers (paragraph [0045], Figs. 1, 2, camera is configured to measure the intensity of the reflected light and to make the outcome of the measurement available to processor 72); the measurement unit (120) comprising a depth camera (paragraph [0042], Figs. 1, 2, camera 96 or collector wherein a collector is a camera designed to be sensitive to visible light or infrared wavelength band) and being configured to configure the light transmittance as depth data of skin characteristics per wavelength of the multispectral light (paragraph [0095], Fig. 30, illuminating target sites and reference sites at 415 nm and 435 nm); and
a pressure ulcer diagnosis unit (130) (paragraph [0045], Fig. 1, processor 72) for assessing the state of pressure ulcers on the basis of the light transmittance measured in the measurement unit (120);
the pressure ulcer diagnosis unit (130) being configured to assess a state of a pressure ulcer on the basis of the depth data (paragraph [0045], Fig. 1, processor 72 carries out an evaluation) including quantitatively assessing the state of the pressure ulcer to determine a progression stage through big data learning utilizing a difference in the light transmittance and non-invasively assessing a depth of a pressure ulcer incidence (paragraph [0077], Method 6 is similar to method 5 but accounts for how the dissimilarity in spectral content progresses over time, as in method 2, see paragraph [0060], Table 5).
Lachenbruch does not specifically disclose the light emission unit (110) being configured to emit, onto the skin of the body part, multispectral light having a plurality of wavelengths in a range of 600 to 900 nm and to selectively output the plurality of wavelengths according to an absorption wavelength characteristic of biological tissues;
Munoz discloses the light emission unit (110) (paragraphs [0071] through [0073], LED or laser) being configured to emit, onto the skin of the body part, multispectral light having a plurality of wavelengths in a range of 600 to 900 nm (paragraphs [0071] through [0073], emits light at a wavelength in a range of about 400 nm to about 2,500 nm) and to selectively output the plurality of wavelengths according to an absorption wavelength characteristic of biological tissues (paragraph [0108], performs a tissue oxygenation analysis and/or results in a tissue oxygenation map of the area of interest and paragraph [0121], hyperspectral image/data is processed to provide a spectral map of pressure ulcers);
Munoz further discloses the pressure ulcer diagnosis unit (130) being configured to assess a state of a pressure ulcer including quantitatively assessing the state of the pressure ulcer to determine a progression stage through big data learning utilizing a difference in the light transmittance and non-invasively assessing a depth of a pressure ulcer incidence (paragraph [0134], transmits sensor data to a cloud-based service wherein a cloud-based software service can be provided that performs interfaces with a machine learning program to analyze the sensor data against a data model to analyze multiple sets of sensor data per patient to provide time-based progression/regression information, see paragraph [0135]).
Therefore, it would have obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the depth data-based pressure ulcer diagnosis system as disclosed by Lachenbruch with the system as taught by Munoz to provide a microvascular analysis (e.g., a three dimensional reconstruction of the microvascular) of the region of interest, the degree of inflammation at the region of interest, and/or a texture color analyzed image (Munoz, paragraph [0121]).
Consider claims 2, 10, the combination of Lachenbruch and Munoz discloses wherein the light emission unit (110) emits light to the skin of the body part for assessing pressure ulcers (paragraph [0045], Fig. 3, illuminates the target site to include the skin, see paragraph [0043]), and is configured with a multi- wavelength light source device enabling a selective wavelength (paragraph [0049], illumination is carried out at one or more wavelengths) according to an absorption wavelength characteristic of biological tissues (paragraphs [0054] to [0057], wavelength corresponding to peak absorption of radiation by characteristic of biological tissues).
Consider claims 3, 11, Lachenbruch discloses wherein the light emission unit (110) is configured with the multi-wavelength light source device enabling the selective wavelength according to the absorption wavelength characteristic of biological tissues (see rejection above).
Lachenbruch does not specifically disclose emitting light with a wavelength of 600 to 900 nm.
Munoz discloses emitting light with a wavelength of 600 to 900 nm (paragraphs [0070] through [0073], emits light at a wavelength in a range of about 400 nm to about 2,500 nm).
Therefore, it would have obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the light emission unit as disclosed by Lachenbruch with the light source as taught by Munoz to emit visible light and/or near infrared light enabling a more compact, energy efficient, processing efficient, coherent light source for optical imaging (Munoz, paragraphs [0070], [0071]).
Consider claims 4, 12, the combination of Lachenbruch and Munoz discloses wherein the light emission unit (110) (paragraph [0081], Fig. 20, optical signal generator and receiver 334) comprises: a light source unit (111) (paragraph [0081], Fig. 20, fiber 338) for emitting multispectral light sources of wavelengths different from each other to the same skin area for assessing pressure ulcers (paragraphs [0049], [0095], Fig. 30, illumination is carried out at one or more wavelengths);
a body unit (112) (paragraph [0083], Fig. 20, topper 22) where the light source unit (111) is disposed for emitting the multispectral light sources of wavelengths different from each other (paragraph [0083, Fig. 20, at least a portion of the optical fiber can be embedded in the topper); and
a controller (113) (paragraph [0085], controller 58) is used to control light radiation of the light source unit (111), which is disposed on the body unit (112), to emit the multispectral light sources of wavelengths different from each other (paragraph [0085], Fig. 20, controller 58 controls the optical signal generator and receiver 334 and provides a control signal to initiate transmission of a portion of electromagnetic spectrum through optical fiber 338 and the transparent region 336 onto the patient's skin).
Consider claims 5, 6, 13, 14, the combination of Lachenbruch and Munoz discloses wherein the measurement unit (120) measures the light transmittance using the reflected light reflected when the light emission unit (110) emits light to the skin of the body part for assessing pressure ulcers and the light transmittance is configured as depth data of skin characteristics per wavelength of the multispectral light sources (paragraph [0045], Figs. 1, 2, camera is configured to measure the intensity of the reflected light to include skin surface and tissue beneath the skin surface, see paragraph [0043], sensitive to a particular wavelength band, e.g. visible light or infrared, see paragraph [0042]).
Consider claims 7, 8, 15, 16, the combination of Lachenbruch and Munoz discloses wherein the pressure ulcer diagnosis unit (130) assesses the state of pressure ulcers on the basis of the light transmittance measured in the measurement unit (120) and assesses pressure ulcers from depth data where the state of pressure ulcers is quantitatively assessed to determine a progression stage through big data learning utilizing a difference in the light transmittance (paragraph [0077], Method 6 is similar to method 5 but accounts for how the dissimilarity in spectral content progresses over time, as in method 2, see paragraph [0060], Table 5).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GERALD JOHNSON whose telephone number is (571)270-7685. The examiner can normally be reached Monday-Friday 8am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carey Michael can be reached at (571)270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Gerald Johnson/
Primary Examiner, Art Unit 3797