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 .
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 3/31/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 18 is objected to because of the following informalities:
Regarding claim 18, the limitation “the plurality of lenses” is stated in lines 6-7. It appears to be a duplicate phrase.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 –
(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.
Claims 1-2, 4-5, 8, 12, 15-18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al. (U.S. Pub. No. 20030064025) hereinafter Yang.
Regarding claim 1, Yang teaches:
A method for cervical or vaginal cancer detection (abstract; note that in [0023], [0056], and [0101], teaches to “The invention further applies to any organs and systems of human and animal bodies that can be treated with fluorescence-gene/drug therapies, and have autofluorescence emission from the natural tissue components of these organs and systems, or can be used in the early diagnosis of diseases such as cancer by using and quantitatively detecting fluorescently labeled antibodies or markers specific for a certain type of cancer such as breast, prostate, etc.”, which teaches to the intended use of cervical or vaginal cancer as “any organs” capable of being treated with fluorescence therapies cover the intended use), the method comprising:
during a pelvic examination, illuminating a tissue with a blue light, the tissue including at least one of a cervix uteri or vaginal wall ([0023], [0056], and [0101], teach to the use in any organ in the body capable of being illuminated with fluorescence, which one of ordinary skill in the art would reasonably apply to the cervix uteri or vaginal wall without modification; [0006], blue light illumination; [0015], blue light; [0055]; [0087]; [0102], BFP blue fluorescent proteins; [0122]-[0123]; illumination wavelengths of [0113] and [0130], overlap the wavelengths of blue light),
wherein the blue light has a wavelength of between 390 nm and 480 nm ([0130], wavelengths overlap the claimed range),
the blue light selected to induce a fluorescence in at least one biomarker in cells of the tissue, resulting in fluoresced tissue ([0009]-[0010]; [0014]-[0015]; [0020]-[0034], fluorescence biomarkers of tissue; [0055]-[0057]; [0081]; [0085]-[0092]; [0101]-[0109]; [0122]-[0126]);
identifying, in the image, an indication of cancer based on the fluoresced tissue ([0056], diagnosis of cancer; [0092]-[0093], cancers; [0099]; [0101], cancer; [0112], tumors).
Regarding claim 2, Yang teaches all of the limitations of claim 1. Yang further teaches:
wherein the at least one biomarker includes DNA ([0123], GFP biomarker may include DNA).
Regarding claim 4, Yang teaches all of the limitations of claim 1. Yang further teaches:
wherein the blue light has the wavelength of 430 nm ([0130], light wavelength includes 400-2500 nm which includes 430 nm).
Regarding claim 5, Yang teaches all of the limitations of claim 1. Yang further teaches:
wherein identifying the indication of cancer includes identifying the indication of cancer based on a total amount of the fluoresced tissue ([0056], diagnosis of cancer; [0092]-[0093], cancers; [0099] “methods of the invention can detect, localize, track and image the vectors which also express fluorescent components.”; [0101], cancer. Diagnostics based upon the individual targeting of cancer cells provide cancer indication based upon the total amount of tissue and early diagnosis; [0112], tumors; [0164]-[0165], area of fluorescence and detection of the mapping of the regions in which the target is located provides for related diagnostics based upon the total amount of fluoresced tissue).
Regarding claim 8, Yang teaches all of the limitations of claim 1. Yang further teaches:
wherein identifying the indication of cancer includes identifying the indication of cancer based on a fluorescence wavelength of the fluoresced tissue ([0056], diagnosis of cancer; [0092]-[0093], cancers; [0099] “methods of the invention can detect, localize, track and image the vectors which also express fluorescent components.”; [0101], cancer. Diagnostics based upon the individual targeting of cancer cells provide cancer indication; [0112], tumors; [0164]-[0165], area of fluorescence and detection of the mapping of the regions in which the target is located. Because the cancer diagnosis is based upon the selected fluorescence components fluorescing at the selected wavelength ([0040], [0046]), identifying of the cancer is based upon a wavelength of the tissue).
Regarding claim 12, Yang teaches all of the limitations of claim 1. Yang further teaches:
further comprising, using the indication of cancer, administering a therapeutic agent to a patient ([0017], drug delivery; [0021], drug delivery to the target region; [0023]; [0056], drugs; [0081]; [0088]-[0089]; [0090]; [0092], drug delivery or gene therapy for cancer; [0098]; [0101]).
Regarding claim 15, Yang teaches all of the limitations of claim 1. Yang further teaches:
further comprising capturing an image of the tissue including the fluoresced tissue([0013]; [0019]; [0027]-[0028]; [0038]; [0043]; [0061]; [0081], images and display; [0115] and [0118], image and display).
Regarding claim 16, Yang teaches all of the limitations of claim 15. Yang further teaches:
wherein capturing the image includes capturing the image using one or more fluorescent detectors ([0013]; [0015], camera forms a fluorescent detector; [0020], camera system; [0081],CCD camera for fluorescent imaging; [0087]; [0090]; [0115] and [0118], image and display).
Regarding claim 17, Yang teaches all of the limitations of claim 15. Yang further teaches:
further comprising displaying the image on a display of an imaging device ([0013], display; [0019]; [0027]-[0028]; [0038]; [0043]; [0061]; [0081], images and display; [0115] and [0118], image and display).
Regarding claim 18, Yang teaches:
An imager for identification of cervical or vaginal cancer (abstract; note that in [0023], [0056], and [0101], teaches to “The invention further applies to any organs and systems of human and animal bodies that can be treated with fluorescence-gene/drug therapies, and have autofluorescence emission from the natural tissue components of these organs and systems, or can be used in the early diagnosis of diseases such as cancer by using and quantitatively detecting fluorescently labeled antibodies or markers specific for a certain type of cancer such as breast, prostate, etc.”, which teaches to the intended use of cervical or vaginal cancer as “any organs” capable of being treated with fluorescence therapies cover the intended use; [0113]-[0119]), the imager comprising:
a light support supporting a plurality of lights, at least one of the plurality of lights including a blue light having a wavelength of between 390 nm and 480 nm [0006], blue light illumination; [0014], light transfer; [0015], blue light; [0034]-[0036], light source; [0053]; [0055]; [0060]; [0063]; [0087]; [0102], BFP blue fluorescent proteins; [0122]-[0123]; [0126]; [0128], figure 5; [0133], light sources form a plurality of lights; [0137]; illumination wavelengths of [0113] and [0130], overlap the wavelengths of blue light and the claimed range);
a camera arranged to capture an image of a tissue illuminated by at least one of the plurality of lights ([0015]; [0020]; [0031]; [0037], CCD; [0063]; [0081], CCD camera; [0084]; [0087]; [0115]; [0126]-[0128]); and
a light strip including a plurality of lenses arranged with the plurality of lights, the plurality of lenses ([0029], lens and filter system; [0034]; [0036]; [0063]; [0126]; [0128]; [0153]).
Regarding claim 20, Yang teaches all of the limitations of claim 18. Yang further teaches:
further comprising an optical element support including at least one filter between the plurality of lights and the tissue ([0029], filter system; [0034], wavelength selective optical filters; [0126]-[0127]; [0153]-[0156]; [0167]-[0168], emission filter in the light source;).
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.
Claim 3 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Yang as applied to claim 1 above, and further in view of Muller et al. (U.S. Pub. No. 20160038076) hereinafter Muller.
Regarding claim 3, primary reference Yang teaches all of the limitations of claim 1. Primary reference Yang further fails to teach:
wherein the at least one biomarker includes at least one of NAD, FAD, or collagen
However, the analogous art of Muller of a tissue property analysis system and device (abstract) teaches:
wherein the at least one biomarker includes at least one of NAD, FAD, or collagen ([0074] “and light scattering from diffuse reflectance spectra and elastin, collagen, NADH, FAD, porphyrin and vitamin A concentrations from fluorescence spectra”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluorescence imaging system of Yang to incorporate the biomarkers as taught by Muller because typical signs of cancer include increased FAD and the particular imaged fluorescence biomarker provide higher quality determination of different cancer properties (Muller, [0074]).
Regarding claim 11, primary reference Yang teaches all of the limitations of claim 1. Primary reference Yang further fails to teach:
wherein identifying the indication of cancer includes highlighting features of the tissue that allow a clinician to distinguish between pre-cancerous, cancerous, and normal tissue
However, the analogous art of Muller of a tissue property analysis system and device (abstract) teaches:
wherein identifying the indication of cancer includes highlighting features of the tissue that allow a clinician to distinguish between pre-cancerous, cancerous, and normal tissue ([0065], detect and stage cervical cancer provides for a determination of pre-cancerous, cancerous and normal tissue; [0066]-[0070]; [0074]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluorescence imaging system of Yang to incorporate the determination of cancer stage as taught by Muller because it is important to distinguish invasive cancer from non-invasive cancer-in-situ, because the treatment options are radically different (Muller, [0062]).
Claim 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Yang as applied to claim 1 above, and further in view of Themelis (U.S. Pub. No. 20200252554) hereinafter Themelis.
Regarding claim 6, primary reference Yang teaches all of the limitations of claim 1. Primary reference Yang further fails to teach:
wherein identifying the indication of cancer includes identifying the indication of cancer based on a brightness of the fluoresced tissue
However, the analogous art of Themelis of an image processing device for tissue regions of interest (abstract) teaches:
wherein identifying the indication of cancer includes identifying the indication of cancer based on a brightness of the fluoresced tissue ([0035], “Thus, above a certain predetermined threshold of fluorescence intensity or brightness, there is a high certainty that high fluorescence intensity marks a tumor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluorescence imaging system of Yang to incorporate the brightness intensity threshold as taught by Themelis because the amount of fluorescence based upon a marker show how many cells are within the region and provides an analogue for determination of a tumor (Themelis, [0035]).
Regarding claim 7, primary reference Yang teaches all of the limitations of claim 1. Primary reference Yang further fails to teach:
wherein identifying the indication of cancer includes identifying the indication of cancer based on a location of the fluoresced tissue
However, the analogous art of Themelis of an image processing device for tissue regions of interest (abstract) teaches:
wherein identifying the indication of cancer includes identifying the indication of cancer based on a location of the fluoresced tissue ([0035], “Thus, above a certain predetermined threshold of fluorescence intensity or brightness, there is a high certainty that high fluorescence intensity marks a tumor.” This is based upon an area within the region of interest in which there is a high fluorescence, and therefore identifies cancer based upon the location of the tissue being in a tumor concentration).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluorescence imaging system of Yang to incorporate the region of interest location-based intensity threshold as taught by Themelis because the amount of fluorescence based upon a marker show how many cells are within the region and provides an analogue for determination of a tumor (Themelis, [0035]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Yang as applied to claim 1 above, and further in view of Futatsugi et al. (U.S. Pub. No. 20180146845) hereinafter Futatsugi.
Regarding claim 9, primary reference Yang teaches all of the limitations of claim 1. Primary reference Yang further fails to teach:
further comprising, after capturing the image of the tissue, processing the image of the tissue, wherein processing the image of the tissue includes at least one of filtering, adjusting a brightness, polarizing, or adjusting a contrast of the image
However, the analogous art of Futatsugi of a tissue illumination and measurement device (abstract) teaches:
further comprising, after capturing the image of the tissue, processing the image of the tissue, wherein processing the image of the tissue includes at least one of filtering, adjusting a brightness, polarizing, or adjusting a contrast of the image ([0074]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluorescence imaging system of Yang to incorporate the adjustment of image processing of contrast and brightness as taught by Futatsugi because it provides better delineation of tumor tissue regions, leading to improved clinical outcomes in interventional procedures (Futatsugi, [0074]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Yang as applied to claim 1 above, and further in view of Sanchez et al. (U.S. Pub. No. 20220007943) hereinafter Sanchez.
Regarding claim 10, primary reference Yang teaches all of the limitations of claim 1. Primary reference Yang further fails to teach:
further comprising preparing the tissue, including applying acetic acid to the tissue
However, the analogous art of Sanchez of a optical probe for measuring tissue (abstract) teaches:
further comprising preparing the tissue, including applying acetic acid to the tissue ([0083], acetic acid).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluorescence imaging system of Yang to incorporate the acetic acid applied to tissue as taught by Sanchez because it provides additional contrast for imaging (Sanchez, [0083]).
Claims 13-14 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Yang as applied to claims 1 or 18 above, and further in view of Segawa et al. (U.S. Pub. No. 20210290036) hereinafter Segawa.
Regarding claim 13, primary reference Yang teaches all of the limitations of claim 1. Primary reference Yang further fails to teach:
wherein the blue light includes a first blue light having a first wavelength and the image includes a first image, and further comprising:
illuminating the tissue with a second wavelength of light; and
capturing a second image illuminated by the second wavelength of light, wherein identifying the indication of cancer includes identifying the indication of cancer using the first image and the second image
However, the analogous art of Segawa of an imaging system with different focal lengths (abstract) teaches:
wherein the blue light includes a first blue light having a first wavelength and the image includes a first image ([0039]-[0040], first light source includes a blue LED which forms a first blue light with a first blue wavelength utilized to generate a first image as in [0037]), and further comprising:
illuminating the tissue with a second wavelength of light ([0041], second light with a different narrow band of wavelength which includes a blue component at 410 nm); and
capturing a second image illuminated by the second wavelength of light, wherein identifying the indication of cancer includes identifying the indication of cancer using the first image and the second image ([0037], first and second image signals provide for first and second images; [0128], see use in tumor detection which teaches to primary reference Yang).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluorescence imaging system of Yang to incorporate the blue light second image as taught by Segawa because the presence or absence of cancer cells may be diagnosed by irradiating the tissue in which 5-ALA has been taken up with the blue light (Segawa, [0041]).
Regarding claim 14, the combined references of Yang and Segawa teach all of the limitations of claim 13. Primary reference Yang further fails to teach:
wherein the second wavelength of light is between 390 nm and 480 nm
However, the analogous art of Segawa of an imaging system with different focal lengths (abstract) teaches:
wherein the second wavelength of light is between 390 nm and 480 nm ([0041], second wavelength in 410 nm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluorescence imaging system of Yang and Segawa to incorporate the blue light wavelength as taught by Segawa because the presence or absence of cancer cells may be diagnosed by irradiating the tissue in which 5-ALA has been taken up with the blue light (Segawa, [0041]).
Regarding claim 19, the combined references of Yang and Segawa teach all of the limitations of claim 18. Primary reference Yang further fails to teach:
wherein the blue light includes a first blue light and the wavelength includes a first wavelength, and further comprising a second blue light having a second wavelength
However, the analogous art of Segawa of an imaging system with different focal lengths (abstract) teaches:
wherein the blue light includes a first blue light and the wavelength includes a first wavelength, and further comprising a second blue light having a second wavelength ([0039]-[0040], first light source includes a blue LED which forms a first blue light with a first blue wavelength; [0041], second light with a different narrow band of wavelength which includes a blue component at 410 nm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluorescence imaging system of Yang to incorporate the blue light second image as taught by Segawa because the presence or absence of cancer cells may be diagnosed by irradiating the tissue in which 5-ALA has been taken up with the blue light (Segawa, [0041]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN A FRITH whose telephone number is (571)272-1292. The examiner can normally be reached M-Th 8:00-5:30 Second Fri 8:00-4:30.
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, Keith Raymond can be reached at 571-270-1790. 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.
/SEAN A FRITH/Primary Examiner, Art Unit 3798