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
Response to Arguments
The applicant remarks directed to the objections to the specification and drawings are overcome due to the amendments.
On page 11 of the remarks, the applicant states that “With regard [to] claim 15, the Examiner has correctly noticed that KR’1 and Rosen’1 do not teach ‘the use of machine learning to analyze the image data’.” The applicant then argues that the incorporation of Jeong fails to teach the claimed subject matter because Jeong teaches machine learning for “automatically diagnosing the cervix for alleviating the need for the user to have experience in cervical diagnosis”. In this regard, it is noted that the amendments to the claims have added that the machine learning model extracts feature information that includes at least one of size or location, whereas prior to the amendment, the claim broadly required the machine learning be controlled by “a controller that extract feature information of the image of the cervix”, with no further specificity. As such, Jeong read on the previously presented claims, and any changes to the rejections below are due to the narrowed claim language of claim 15.
Due to changes to claim 15 as indicated above, the scope of claim 16 has also changed. Additionally, claims 18-23 are newly presented. Therefore, any changed rejections or additionally cited references are due to the amendments to the claims.
Claim Rejections - 35 USC § 112
Second Paragraph
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18 and 23 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 18 is rejected because “the predetermined reference value” lacks antecedent basis.
Claim 23 is rejected because recitation of "an image sensor" doesn't make sense at "inserted into a vagina capture an image of a cervix". It appears that at least one word is missing between “vagina” and “capture”.
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 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Cong et al. (CN 106039592 A) in view of Levitz et al. (WO 2019/239414).
Cong teaches an intelligent photon therapeutic apparatus and control method thereof, including an apparatus for inactivating viruses in human body, comprising:
an image sensor (see “camera module” stated in Abstract) configured to be inserted into a vagina to capture an image of a cervix (see “the structure is simple, the use is convenient, working ultraviolet radiator, emits ultraviolet light irradiation to vaginal”, see page 5 near the top);
a controller (see a controller described in the Abstract, which acquires image data and analyzes the image data) configured to extract feature information including at least one of a size or a location of the cervix from the image using a machine learning model (it is noted that the controller of Cong does not teach machine learning to analyze the image, nor analysis for at least one of a size or location), and control ultraviolet light irradiation so that irradiation is enabled when the feature information indicates that the apparatus is positioned to irradiate the cervix (see the Abstract, which teaches that ultraviolet irradiation is controlled based upon the analysis by the controller, “the controller analyzing the tissue image with a preset degree of different infection of tissue treating environment, judging shooting infection level of the tissue, and according to the degree of infestation control ultraviolet radiator, sending the preset radiation dose and, if not, then shutdown, the control method”); and
a light emitting unit including at least one light source configured to irradiate- ultraviolet light under control of the controller (see the same quote immediately above from the Abstract, “the controller analyzing the tissue image with a preset degree of different infection of tissue treating environment, judging shooting infection level of the tissue, and according to the degree of infestation control ultraviolet radiator, sending the preset radiation dose and, if not, then shutdown, the control method”).
However, as noted, the controller of Cong is not taught as utilizing machine learning, nor is it taught for determining at least one of size or location of the cervix.
Levitz teaches a system and method for “capturing at least one image of a cervical tissue in-vivo; identifying a region of interest (ROI) in said cervical tissue within said at least one image; detecting at least a portion of a vaginal speculum within said at least one image; and determining a position of said portion of said vaginal speculum relative to said ROI” (see Abstract). As stated in paragraph 96, the image processing module may employ machine learning algorithms and may include a convolutional neural network that has been trained via “multiple cervical images of different sizes, taken from different angles and orientations, under varying lighting conditions, and with different forms of occlusion and interferences.” Paragraph 112 provides more description of determination of a distance between the vaginal probe and the cervical tissue, and teaches that “Following a determination of incorrect positioning, system 100 may be configured for issuing an alert to the clinician performing the cervicography to reposition the speculum. The alert to the clinician may be, e.g., a visual, auditory, and/or verbal alert, communicated through display 116a and/or speaker 116c. Following the issuance of the alert, system 100 may be configured for re-evaluating the positioning of the speculum, before issuing an appropriate indication to the clinician to proceed with the procedure.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize machine learning to determine distance of a probe to the cervix of a patient, as taught by Levitz, and to utilize this within the system and methods of Cong in order to ensure or assist a user in providing proper placement of a probe within the vagina (as described in the last three sentences of paragraph 112 of Levitz) because Levitz states that “in addition to cervicography, the working principles of the present invention may be applied in other types of diagnostic and therapeutic treatments, which may benefit from improved consistency and reliability of visualization in imaging results” (see paragraph 76).
Regarding claim 16, Levitz teaches that “Following a determination of incorrect positioning, system 100 may be configured for issuing an alert to the clinician performing the cervicography to reposition the speculum. The alert to the clinician may be, e.g., a visual, auditory, and/or verbal alert, communicated through display 116a and/or speaker 116c. Following the issuance of the alert, system 100 may be configured for re-evaluating the positioning of the speculum, before issuing an appropriate indication to the clinician to proceed with the procedure” (see paragraph 112).
Regarding claim 20, it is noted that
Claims 18-19, 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Cong in view of Levitz as applied to claim15 above, and further in view of Hetz (WO 2019/165302).
Cong in combination with Levitz is described above with regard to claim 15. However, there is no discussion of stopping irradiation of ultraviolet light based on the position of the device.
Hetz teaches systems and method relate to administering phototherapy. An embodiment in Figure 8 illustrates a handheld probe, and teaches that “While the probe (e.g., probe 80) can be used for surface treatments/on the exterior of the body, in various embodiments the probe is used for the delivery of coherent light to the inner core of the body not reachable by transdermal or transepithelial means”, where this can be used to deliver light to the interior of the body by any reasonable means and/or through any suitable orifice, including “(2) transvaginal insertion, which allows treatment of the vaginal canal, the cervix” (see paragraph 195). “When used with imaging modalities that scan the body of the patient being treated, the probe may be used to automatically target the tissues to be treated while adjusting the energy of the phototherapy accordingly (e.g., via automatic control by the computer control unit or recommended steps provided by the computer control unit)” (see paragraph 204). “[T]he computer control unit may signal the operator as to the depth and alignment of the insertion of the probe, and further signal the operator as to any position adjustments that should be made as the treatment progresses” (see paragraph 228).” If the computer control unit allows optical recognition of the endoscope's field of view (e.g., as described above with reference to FIG. 6), the computer control unit may signal the operator as to the ongoing positioning of the probe based upon its determination as to the current location of the tissues to be treated relative to the probe” (see paragraph 230). “If the computer control unit can track the position of the probe, the computer control unit may use information about the position of the probe to do one or more of the following: (1) advise the operator as to whether the probe is properly placed and/or oriented for the desired treatment plan; (2) warn the operator and/or disable the probe if it determines that the probe is not in the proper placement/orientation to administer the desired phototherapy” (see paragraph 233, emphasis added).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to automatically disable the probe if the probe is determine to not be in the proper placement for phototherapy, as taught by Hetz, and to utilize this mechanism within the system of Cong as combined with Levitz in order to ensure safety of adjacent tissue that is not desired for irradiation.
Regarding claim 19, it is noted that Hetz teaches that the controller may disable the probe, or warn the operator, if it determines that the probe is not in the proper placement/orientation to administer the desired phototherapy (see paragraph 233).
Regarding claim 21, it is noted that Cong teaches a controller that may determine the proper dose and control delivery thereof (see the same quote immediately above from the Abstract, “the controller analyzing the tissue image with a preset degree of different infection of tissue treating environment, judging shooting infection level of the tissue, and according to the degree of infestation control ultraviolet radiator, sending the preset radiation dose and, if not, then shutdown, the control method”). Hetz teaches disabling the probe via a controller if the position is not favorable/desired.
Specifically with regard to claim 23, Cong teaches an intelligent photon therapeutic apparatus and control method thereof, including an apparatus for inactivating viruses in human body, comprising:
an image sensor (see “camera module” stated in Abstract) configured to be inserted into a vagina to capture an image of a cervix (see “the structure is simple, the use is convenient, working ultraviolet radiator, emits ultraviolet light irradiation to vaginal”, see page 5 near the top);
a controller (see a controller described in the Abstract, which acquires image data and analyzes the image data) configured to extract feature information including at least one of a size or a location of the cervix from the image using a machine learning model (it is noted that the controller of Cong does not teach machine learning to analyze the image, nor analysis for at least one of a size or location), and control ultraviolet light irradiation so that irradiation is disabled when the feature information indicates that the apparatus is not positioned to irradiate the cervix (it is noted that the controller of Cong does not teach to disable the irradiation at least one of a size or location); and
a light emitting unit including at least one light source configured to irradiate- ultraviolet light under control of the controller (see the same quote immediately above from the Abstract, “the controller analyzing the tissue image with a preset degree of different infection of tissue treating environment, judging shooting infection level of the tissue, and according to the degree of infestation control ultraviolet radiator, sending the preset radiation dose and, if not, then shutdown, the control method”).
However, as noted, the controller of Cong is not taught as utilizing machine learning, nor is it taught for determining at least one of size or location of the cervix.
Levitz teaches a system and method for “capturing at least one image of a cervical tissue in-vivo; identifying a region of interest (ROI) in said cervical tissue within said at least one image; detecting at least a portion of a vaginal speculum within said at least one image; and determining a position of said portion of said vaginal speculum relative to said ROI” (see Abstract). As stated in paragraph 96, the image processing module may employ machine learning algorithms and may include a convolutional neural network that has been trained via “multiple cervical images of different sizes, taken from different angles and orientations, under varying lighting conditions, and with different forms of occlusion and interferences.” Paragraph 112 provides more description of determination of a distance between the vaginal probe and the cervical tissue, and teaches that “Following a determination of incorrect positioning, system 100 may be configured for issuing an alert to the clinician performing the cervicography to reposition the speculum. The alert to the clinician may be, e.g., a visual, auditory, and/or verbal alert, communicated through display 116a and/or speaker 116c. Following the issuance of the alert, system 100 may be configured for re-evaluating the positioning of the speculum, before issuing an appropriate indication to the clinician to proceed with the procedure.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize machine learning to determine distance of a probe to the cervix of a patient, as taught by Levitz, and to utilize this within the system and methods of Cong in order to ensure or assist a user in providing proper placement of a probe within the vagina (as described in the last three sentences of paragraph 112 of Levitz) because Levitz states that “in addition to cervicography, the working principles of the present invention may be applied in other types of diagnostic and therapeutic treatments, which may benefit from improved consistency and reliability of visualization in imaging results” (see paragraph 76).
However, Cong nor Levitz teaches to disable therapy when it is indicated that the probe is out of position.
Hetz teaches systems and method relate to administering phototherapy (see full description of Hetz above in the rejection of claim 18). “If the computer control unit can track the position of the probe, the computer control unit may use information about the position of the probe to do one or more of the following: (1) advise the operator as to whether the probe is properly placed and/or oriented for the desired treatment plan; (2) warn the operator and/or disable the probe if it determines that the probe is not in the proper placement/orientation to administer the desired phototherapy” (see paragraph 233, emphasis added).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to automatically disable the probe if the probe is determined to not be in the proper placement for phototherapy, as taught by Hetz, and to utilize this mechanism within the system of Cong as combined with Levitz in order to ensure safety of adjacent tissue that is not desired for irradiation.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Cong in view of Levitz as applied to claim15 above, and further in view of Kuon et al. (WO 2011/017706).
Cong in combination with Levitz is described above with regard to claim 15. However, neither of these references teach comparing the image data to a reference for determination of size.
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 data relating to size, as taught by Kuon, with the system and methods of Cong as combined with Levitz to improve image capture and assessment (see paragraph 33).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Cong in view of Levitz as applied to claim15 above, and further in view of Hellstrom et al. (WO 2013049491).
Cong in combination with Levitz is described above with regard to claim 15. However, there is no discussion of a substrate upon which a plurality of UV LEDs are placed.
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. As can be seen, each individual substrate comprises at least two light sources on opposing sides thereof.
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 Cong in combination with Levitz as a mere matter of design choice, noting that Cong teaches the use of ultraviolet light irradiation via a light emitting unit without stating that it is located on a substrate. However, to utilize a substrate with a light source thereon as illustrated by Hellstrom for the purposes of the irradiation probe of Cong 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).
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 JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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/JAMES KISH/ Primary Examiner, Art Unit 3792
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