The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Specification
The disclosure is objected to because of the following informalities:
On page 15, line 8, the word “virginal” should state “vaginal”.
In paragraph 48, the second to last sentence is missing a word. For example, “The feature information of the cervix may include at least one of the presence, size, and ___ of the cervix.”
Appropriate correction is required.
Drawings
The drawings are objected to for the following reasons:
In Figure 8, the steps should be 810, 830 and 850, based on paragraph s 30-31 of the original specification.
Figure 10 fails to comply with 37 CFR 1.84(p)(5) because they do not include the reference 215a mentioned in paragraph 40 of the original specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 1-3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over KR 101672219 B1 (herein, KR’1) in view of Hellstrom et al. (WO 2013049491), and further in view of KR 102574402 B1 (herein, KR’2; having priority to KR 20220079175 with date June 28, 2022)
KR’1 discloses an apparatus for inactivating viruses in a human body (“according to the present invention, a sterilizing rod in which a light source is installed can be inserted into the … vagina to easily sterilize the body bacteria at home” – see Abstract), comprising:
A body unit (see sterilizing rod 10 in all figures) including a light emitting unit (see wavelength generating unit(s) 30 and/or light source(s) 12 in all figures; it is additionally noted that KR’1 teaches the use of ultraviolet (UV) wavelengths – “In general, bacteria are weak against ultraviolet light and can be sterilized by exposure to ultraviolet LED / laser for more than a few minutes” and “using a light source including RED, GREEN, BLUE, IR, ultraviolet LED” see “Technical Field”) and formed to be capable of inserting into the human body (“The sterilizing rod 10, the transparent cover portion 20, and the transparent cover portion 20 can be used to sterilize the inside and outside of the … vagina” – see second paragraph after “Description of Embodiments”);
An operating unit coupled to the body unit to control the light emitting unit (see handle 11, which operation of the handle controls the entire device, which includes the light sources).
However, KR’1 fails to clearly state that there is a diffusor associated with the light sources, or that the light sources are rectangular polyhedral shapes.
Hellstrom teaches a catheter type device for light treatment (see Figure 3 and paragraphs 82-83), where the tip 2 has smooth exterior shape and serves for insertion of the catheter in the patient (see paragraph 82). “The tip 2 may include a camera or other vision device 20 with vision illumination sources 22” (see paragraph 82) and “one or more light sources 13 for patient light treatment or antimicrobial use are located in the tube 14”:
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It can be seen in the figures reproduced above that the light sources 13 for light treatment or antimicrobial use are rectangular polyhedral shapes disposed on a substrate. Also, claim 12 of Hellstrom teaches that the light sources 13 may be ultraviolet.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to include the specifically shaped light sources and substrate, as illustrated above from Hellstrom, within the system and methods of KR’1 as a mere matter of design choice, noting that KR’1 illustrates a plurality of light sources along the length of the device, and the figures of KR’1 appear to show either rectangular polyhedral sources or sources located on a cylindrical substrate. However, to utilize a rectangular substrate and source as illustrated by Hellstrom in place of those shown and taught in KR’1 would be obvious to one of ordinary skill in the art because the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (KSR, 550 U.S. at 416, 82 USPQ2d at 1395).
It is noted that Hellstrom teaches that “Light sources may furthermore utilize LEDs, lasers, flash lamps, incandescent or gas discharge lamps, or OLEDs. Light beam geometry from light sources may be narrow, wide or diffuse” (see paragraph 70, emphasis added). In order for the light beam geometry to be diffuse, it would be obvious to one of ordinary skill in the art to provide a diffusor over the light source. However, Hellstrom does not explicitly teach a diffusor on an upper portion of the light emitting unit.
KR’2 teaches a light module for a light treatment device for use on a human body (see Abstract). “Disclosed is a light combination module for a human body care device comprising an LED module including an LED substrate on which a plurality of LED elements are installed and a microlens unit installed by being spaced apart from the LED substrate and provided with a lens unit corresponding to each LED element” (see Abstract). Specifically, Figure 2 illustrates an LED module, where “in the microlens unit 200, each lens unit 210 converts the light of the LED element 110 according to an irradiation pattern such that light generated from the LED element 110 is condensed or diffused to a human body part” (see 5th page, second-to-last paragraph, and Figure 2 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to use a light diffuser over the LEDs/sources, as taught by KR’2, and to provide this over the light sources of KR’1 as combined with Hellstrom in order to provide diffuse light as taught by Hellstrom, where Hellstrom fails to teach how diffuse light is created and KR’2 fills in this gap.
Regarding claim 2, it can be readily seen from Figure 2 and 6 of KR’2 that the diffusor is coupled with a housing formed along an edge of the substrate.
Regarding claim 3, it can be readily seen from Figure 2 and 6 of KR’2 that the diffusor is disposed in a film form (i.e., a micro lens) on a light transmission part of the body unit.
Regarding claim 7, it is noted that KR’2 teaches that an LED module may a plurality of LEDs that may be “combined in various ways according to the purpose of care” (see 3rd page, second-to-last paragraph). The plurality of LEDs may include elements “that irradiates light of wavelengths of UVA (320-400 nm), UVB (290-320 nm), and UVC (200-0 nm)” (see 4th page, paragraph beginning “The fourth LED element 114…”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to use any particular LED color/wavelength “according to the purpose of care”.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over KR’1 in view of Hellstrom and KR’2 as applied to claim 1 above, and further in view of Rosen et al. (WO 2022/266554 – herein Rosen’1).
KR’1 in combination with Hellstrom and KR’2 is described above with respect to claim 1. While KR’1 and Hellstrom each include an imager at the distal end of the probes, there is no specific teaching that there is also UV light sources at that location on a same substrate.
Rosen’1 teaches an endoscope irradiation device for inactivating pathogens (see Abstract). “The device 10 includes a UVC light source 22 … [that] emits far UVC light for inactivating pathogens found on internal tissues and organs in humans or other animals… The LED module 28 also includes an imaging device 32 for imaging in the body of the animal when the device 10 is in use, thereby providing a view of the tissue or organ being illuminated to the practitioner” (see paragraph 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide UV treatment lights at the front of the device, alongside the imaging device, as illustrated and taught by Rosen’1, and to include this feature in the combination of KR’1 with Hellstrom and KR’2, thereby allowing for imaging via the leading edge of the probe (as is taught by each of Rosen’1, KR’1 and Hellstrom), but to also allow for treatment directly in front of the device where the imaging occurs, as opposed to only providing treatment to the sides.
Regarding claim 5, it is noted that KR’1 teaches that “The sterilizing rod 12 is provided with an image sensor 14 and a sterilization position detection is detected by reading an image taken by the image sensor 14 to selectively activate the light source 12 according to the situation” (see 3rd page, first paragraph) and “The sterilization efficiency is improved in a short period of time because the bacterial species is identified while the sterilizing position is accurately detected by the image analysis taken by the image sensor 14 and the light source 12 suitable for the bactericidal sterilization is selectively activated in the control unit” (see 4th page, 4th full paragraph). However, KR’1 does not teach an indicator when the correct position is achieved. Rosen’1 teaches that “the probe 12 includes a distance sensor 66 that may be integrated with the LED module 28 or separate from the module 28 to detect distance of the LED 24 from the infected area 62. The sensor 62 it is interconnected by way of a controller or equivalent to an indicator 68 to signal the practitioner optimal distance has been achieved and irradiation of the infected area of 62 may now begin” (see paragraph 35). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide an indicator, as taught by Rosen’1, within the system of KR’1 “to signal the practitioner optimal distance has been achieved and irradiation of the infected area of 62 may now begin” (see paragraph 35), and/or to signal that irradiation has begun if/when the “selectively activated” teaching of KR’1 is automatic activation.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over KR’1 in view of Hellstrom and KR’2 as applied to claim 1 above, and further in view of Rosen et al. (US Patent Pub. No. 2020/0215214 - herein Rosen’2).
KR’1 as combined with Hellstrom and KR’2 is described above with respect to claim 1. However, none of these references explicitly teach a button on their handles for activating the treatment light sources.
Rosen’2 teaches a device for disinfecting various surfaces, including parts of the human body (see at least paragraph 38). Rosen’2 teaches that “The device may utilize a variety of means to generate power to power or energize a UVC light source (disposed in the body or unit)… the device may activate or deactivate through the actuation of a switch, button, etc.” (see paragraphs 20 and 29). Also see paragraph 24 which states that “Thus, a user may actuate the device via a push of a button and then the device will operate for the predetermined period of time (without further input or holding of the button by the user) and then automatically shut off”; which teaches control of an emission pattern of light from UV LEDs.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to include a button for activation of disinfecting light sources such as UV lights, as taught by Rosen’2 (see at least Abstract), and to incorporate an activation button within the system and methods of KR’1 in combination with Hellstrom and KR’2 in order to provide a practitioner with the ability to control the device, since each of these lack a user activatable feature. Such a feature would improve the utility and ease of use.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over KR’1 in view of Rosen’1.
KR’1 discloses an apparatus for inactivating viruses in a human body (“according to the present invention, a sterilizing rod in which a light source is installed can be inserted into the … vagina to easily sterilize the body bacteria at home” – see Abstract), comprising:
A body unit (see sterilizing rod 10 in all figures) that includes a light emitting unit (see wavelength generating unit(s) 30 and/or light source(s) 12 in all figures; it is additionally noted that KR’1 teaches the use of ultraviolet (UV) wavelengths – “In general, bacteria are weak against ultraviolet light and can be sterilized by exposure to ultraviolet LED / laser for more than a few minutes” and “using a light source including RED, GREEN, BLUE, IR, ultraviolet LED” see “Technical Field”) and formed to be capable of inserting into the human body (“The sterilizing rod 10, the transparent cover portion 20, and the transparent cover portion 20 can be used to sterilize the inside and outside of the … vagina” – see second paragraph after “Description of Embodiments”);
An operating unit that is coupled to the body unit and includes a controller for electrically controlling the light emitting unit (see handle 11; “a control unit (not shown) including an operation unit for controlling the light source 12, the image sensor 14 and the wavelength generation unit 30, the image output unit, and the power supply unit is integrally formed on one side of the handle 11” – see 3rd page, second paragraph).
Additionally, it is noted that KR’1 teaches that “according to the present invention, a sterilizing rod in which a light source is installed can be inserted into the … vagina to easily sterilize the body bacteria at home” (see Abstract), which makes it obvious that one would be capable of using this device for sterilizing the cervix. Also, KR’1 teaches that “The sterilization efficiency is improved in a short period of time because the bacterial species is identified while the sterilizing position is accurately detected by the image analysis taken by the image sensor 14 and the light source 12 suitable for the bactericidal sterilization is selectively activated in the control unit” (see 4th page, 4th full paragraph), which teaches activation by the controller based on the image sensor.
However, KR’1 fails to teach an image sensor and a plurality of UV LEDs on a same substrate.
Rosen’1 teaches an endoscope irradiation device for inactivating pathogens (see Abstract). “The device 10 includes a UVC light source 22 … [that] emits far UVC light for inactivating pathogens found on internal tissues and organs in humans or other animals… The LED module 28 also includes an imaging device 32 for imaging in the body of the animal when the device 10 is in use, thereby providing a view of the tissue or organ being illuminated to the practitioner” (see paragraph 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide UV treatment lights at the front of the device, alongside the imaging device, as illustrated and taught by Rosen’1, and to include this feature in the combination of KR’1 with Hellstrom and KR’2, thereby allowing for imaging via the leading edge of the probe (as is taught by each of Rosen’1, KR’1 and Hellstrom), but to also allow for treatment directly in front of the device where the imaging occurs, as opposed to only providing treatment to the sides.
Regarding claim 9, it is clear from Figure 3 of Rosen’1 that the imager 32 is located in the center, with UVC light sources 24 radially arranged around the imager.
Claims 10-12 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over KR’1 in view of Rosen’1 as applied to claim 8 above, and further in view of Jeong et al. (WO 2021/085987).
KR’1 in combination with Rosen’1 is described above with respect to claim 8. However, neither of these references teach the use of machine learning to analyze the image data.
Regarding claims 10 and 15, Jeong teaches “uterine cervical image acquisition apparatus which acquires and displays images of a uterine cervix, and in some cases can automatically diagnose the onset of a disease related to the uterine cervix” (see Abstract). “[T]he cervical cancer diagnostic model generates diagnostic information on whether or not cervical cancer has occurred according to one or more diagnostic criteria selected by the reader among the color, the size of the cervix in the cervix image” (see the 8th page, 6th paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to use a machine learning system to automatically diagnose the cervix, as taught by Jeong, and to include this in the system of KR’1 with Rosen’1 in order to expedite the determination and provide improved accuracy, thereby alleviating the need for the user to have experience in cervical diagnosis.
Regarding claims 11 and 17, Jeong teaches that “[T]he cervical cancer diagnostic model generates diagnostic information on whether or not cervical cancer has occurred according to one or more diagnostic criteria selected by the reader among the color, the size of the cervix in the cervix image” (see the 8th page, 6th paragraph).
Regarding claims 12 and 16, Jeong teaches that “[T]he cervical cancer diagnostic model generates diagnostic information on whether or not cervical cancer has occurred according to one or more diagnostic criteria selected by the reader among the color, the size of the cervix in the cervix image” (see the 8th page, 6th paragraph). Additionally, “It may include a cervical cancer diagnostic model that generates and displays diagnostic information on whether or not cervical cancer has occurred” (see the 8th page, 5th paragraph). Therefore, displaying the diagnostic information is based on criteria such as “the size of the cervix”.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over KR’1 in view of Rosen’1 as applied to claim 8 above, and further in view of Kuon et al. (WO 2011/017706).
KR’1 in combination with Rosen’1 is described above with respect to claim 8. However, neither of these references teach comparing the image data to a reference or relying on age.
Kuon teaches a method for examining a cervix with a cervical, fetal-membrane, and amniotic examination and assessment device (see Abstract). “The device 10 can objectively and automatically assess a state of a cervix and amniotic membrane of a patient by acquiring visual images and quantifying visual characteristics and parameters (such as color, shape, size, texture, etc.) of features of the cervix and/or by comparing the features and calculated parameters to parameters of other stored images. More specifically, the device 10 can automatically and objectively categorize a … infection state of the cervix, … as well as cervical shape (morphology), color, size or area, and cervical abnormalities (e.g., dysplasia, distocia, incompetence, inflammation, cervicitis, etc.). The device 10 can also determine boundaries of the cervix and any infected areas or other features by computing and analyzing visible and non-visible light intensity, infrared intensity, and visible color variations using the image processing software” (see paragraph 33). “[C]omputer 18 can execute a neural network program with inputs from the image processing software (such as analyses of light intensities, reflection, phosphorescence, and luminescence from the cervix and anomalous regions, areas of the cervix and anomalous regions, number of anomalous regions, shape of the cervix and anomalous regions, color distributions of the cervix and anomalous regions, and any other visual data or parameters calculable from the images), in order to classify the image according to … infection vs. non-infection, displasia vs. non-displasia, etc. by comparing the image to other images captured and stored from other patients” (see paragraph 29, emphasis added as it illustrates comparing features with a reference). Finally, “The computer 18 can display the cervical image (captured and pixilated), along with visual boundary markings of the cervix and any other features on the display screen 22” (see paragraph 26), which displaying reads on “generates a signal for operating an indicator”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize image processing and neural networks to automatically process image data and acquire diagnostic end results for display/indications, as taught by Kuon, with the system and methods of KR’1 as combined with Rosen’1 to improve image capture and assessment (see paragraph 33).
Regarding claim 14, it is noted that Kuon teaches that “The neural network program can also use other input parameters not taken directly by the camera 24, such as cervical texture and patient demographics or other patient clinical data.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that “patient demographics” could include age, among other attributes.
Conclusion
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/JAMES KISH/ Primary Examiner, Art Unit 3792