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 .
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.
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 7 and 15 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 7 recites the limitation "brightness spectrum" in line 23. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation “selecting a bottom part of the brightness spectrum”. It is unclear what the brightness spectrum is in reference to and whether the bottom part refers to a bottom portion of an image or a bottom portion of a scale. For purposes of examination, the limitation will be construed as the darkest pixels in an image. However, further clarification is required.
Claim 15 recites the limitation “the excitation light source comprises one or more of parathyroid tissue exhibiting autofluorescence and fluorescent probes exhibiting fluorescence at similar intensity as the autofluorescence”. It is unclear how the excitation light source comprises the parathyroid tissue and fluorescent probes, as the Specification recites the light source comprising an “an excitation light source and a white light source” (pg. 9). For purposes of examination, the limitation will be construed as the excitation light source target being at least a parathyroid tissue exhibiting autofluorescence and fluorescent probes exhibiting fluorescence at similar intensity as the autofluorescence. However, further clarification is required.
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, 5, 6, 9-10, 14, and 16-18 rejected under 35 U.S.C. 103 as being unpatentable over Yu (US20160262602A1) in view of Westwick (US20220211258A1).
Regarding Claim 1,
A method for visualization of faint fluorescence in surgery, the method comprising:
emitting excitation light from an excitation light source onto an operation area containing a faint fluorescence source as well as white light from a white light source (corresponding disclosure in at least [0007], where there is both a fluorescence and white light source from the excitation light “exposing the surgical field with white light and fluorescence excitation light” as well as [0098] “The white light and the fluorescence excitation light may be provided from a single source (i.e. the same light source provides both white light and the fluorescence excitation light)”),
capturing one or more fluorescence images of the operation area at a wavelength range of fluorescence light emitted by the faint fluorescence source as well as one or more white light images, (corresponding disclosure in at least [0102], where the images are captured at the wavelength range of the fluorescence light “ A dichroic mirror 86 (acting as a beam splitter) reflects light having wavelengths shorter than 700 nm (visible light) towards the color video camera apparatus 88 and transmits light having wavelengths longer than 700 nm towards the NIR light camera apparatus 90. The color video camera 88 is fitted to a 400-650 nm bandpass filter to capture the visible light spectrum. The NIR light camera 90 is fitted to a 790-830 nm bandpass filter to capture the NIR light fluoresced by the dye”) ,
performing image processing on the one or more fluorescence images wherein a contrast between the fluorescence light emitted by the faint fluorescence source and background is increased (corresponding disclosure in at least [0035], where image processing is completed “The image processing required to composite the color video image with the NIR fluorescence video image may be performed by any suitable image processing technique” and further in [0067], where the background is increased “selective imaging of an area of interest in the surgical field may be achieved by the user selecting fluorescence imaging condition(s) to increase the intensity of the fluorescence pseudo-color at an area of interest relative to a part that is outside the area of interest”),
creating one or more composite images by overlaying the one or more fluorescence images over the one or more white light images (corresponding disclosure in at least [0037], where a composite image is formed by overlaying one image over another “registration or alignment of the two video images in relation to each other may be required to properly overlay the fluorescence image onto the color image. This can be accomplished by any suitable image processing technique”).
Yu does not teach creating one or more false color fluorescence images visible in the visible light spectrum from the one or more fluorescence images.
Westwick, in a similar field of endeavor, teaches a similar concept (fluorescent imaging) of creating one or more false color fluorescence images visible in the visible light spectrum from the one or more fluorescence images (corresponding disclosure in at least [0112], where a false color fluorescent image is made “a false color overlay of the un-enhanced fluorescence image on a white light image of the tissue of the subject that was generated at approximately the same time as the fluorescence image”),
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated creating the false color fluorescence images and overlaying them over white light images as taught by Westwick. One of the ordinary skill in the art would have been motivated to incorporate this because the image provides a higher intensity for better viewing of the are of interest.
Regarding Claim 5, Yu and Westwick teach the limitations of Claim 1 and Yu further teaches wherein the white light images and the fluorescence images are captured one of simultaneously or alternately (corresponding disclosure in at least [0011], where the images are captured simultaneously “ the method comprises, via an endoscope that is inserted into the patient's body, receiving a color image of a surgical field; and also via the endoscope, simultaneously receiving a fluorescence image of the surgical field as viewed through the endoscope” and further in [0097], where the white light image is specified (the image is from a white light) “ Broad spectrum white light is used to illuminate the surgical field to produce color video images (also known as visible light imaging or RGB imaging)”).
Regarding Claim 11, Yu and Westwick teach the limitations of Claim 7 and Westwick further teaches wherein the image processing on the one or more fluorescence images comprises at least one of masking specular reflection, noise suppression and normalization (corresponding disclosure in at least [0097], where processing steps for the fluorescent images include noise suppression (denoising) and normalization “one or more processing steps may be performed between the generation of the fluorescence image by the fluorescence imager and the performance of step 102 of method 100. Examples of such processing steps include scaling, trimming, denoising, and normalizing”).
Regarding Claim 6, Yu and Westwick teach the limitations of Claim 11 and Westwick further teaches wherein the normalization comprises a percentile correction (corresponding disclosure in at least [0079], where there is a percentile correction (there is a threshold percentage for the intensity of the image) “The threshold intensity may be determined based on the range of intensity values in the image. The threshold intensity value can be a predefined percentage of the maximum fluorescence intensity in the image”).
Regarding Claim 9, Yu and Westwick teach the limitations of Claim 1, and Yu further teaches wherein the image processing comprises creating a virtual region of interest in one or more of the white light image and the fluorescence image, wherein the fluorescence image is cut off outside the region of interest (corresponding disclosure in at least [0041] and Figure 2, where there is a region of interest (the oval window) where the fluorescence imaging is cut off from anywhere outside the region “the top left panel shows a color image of the surgical field as viewed through a laparoscope. The top right panel shows the NIR fluorescence emission image as viewed through the laparoscope (shown in lime green pseudo-color). The bottom panel shows the merger of the two images, i.e. the fluorescence image is overlaid the color image. In this instance, the fluorescence image overlay is limited to an oval window over the color image. By limiting the fluorescence image overlay to this oval window portion of the color image, contrasting visualization of the biliary structures is improved”)
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Figure 2 of Yu
Regarding Claim 10, Yu and Westwick teach the limitations of Claim 9 and Yu further teaches wherein the region of interest is created by using manual control elements in order to control one or more of the placement and shape of the region of interest (corresponding disclosure in at least [0042], where the user manually controls the region of interest “the user can select the size of the fluorescence image overlay window portion to make it bigger or smaller”).
Regarding Claim 14, Yu and Westwick teach the limitations of Claim 1 and Westwick further teaches wherein specular reflections are detected using high intensity information in the white light images, wherein areas comprising the specular reflections are deleted from the region of interest (corresponding disclosure in at least [0099], where the specular reflections are detected and deleted (a denoising step takes place where the noise from reflected light is deleted) “a denoising step is performed on the fluorescence image prior to generating the enhanced fluorescence image. In examples in which the threshold intensity is determined dynamically, the denoising step can be performed either before or after the threshold intensity is determined. The denoising step can smooth images before contrast enhancement and can also remove small singular noisy areas, which can be areas that are unusually brighter than surrounding areas and can result from external light reflectance, sensor noise, and other well-known sources”).
Regarding Claim 16,
Yu teaches a system for the visualization of faint fluorescence in surgery, the system comprising: a controller comprising an image processor comprising hardware (corresponding disclosure in at least [0096], where there is an image processor comprising hardware “The imaging system may also provide other additional functions such as printing images onto paper medium or storing the video images on a mass storage device (such as CD, DVD, solid-state drive, or hard drive). The imaging system may provide various other conventional image processing capabilities”),
a light source configured to produce excitation light and white light (corresponding disclosure in at least [0098], where there is a light source for excitation and white light “The white light and the fluorescence excitation light may be provided from a single source (i.e. the same light source provides both white light and the fluorescence excitation light)”,
and an image sensor configured to capture fluorescence images and white light images (Corresponding disclosure in at least [0014], where there is a sensor for capturing the images “ the apparatus comprises an imaging system comprising one or more digital image sensors for capturing near-infrared and visible color images”), wherein the controller is configured to control the operation of the light source and the image sensor and to:
emit excitation light from an excitation light source onto an operation area containing a faint fluorescence source as well as white light from a white light source (corresponding disclosure in at least [0007], where there is both a fluorescence and white light source from the excitation light “exposing the surgical field with white light and fluorescence excitation light” as well as [0098] “The white light and the fluorescence excitation light may be provided from a single source (i.e. the same light source provides both white light and the fluorescence excitation light)”),
capture one or more fluorescence images of the operation area at a wavelength range of fluorescence light emitted by the faint fluorescence source as well as one or more white light images (corresponding disclosure in at least [0102], where the images are captured at the wavelength range of the fluorescence light “ A dichroic mirror 86 (acting as a beam splitter) reflects light having wavelengths shorter than 700 nm (visible light) towards the color video camera apparatus 88 and transmits light having wavelengths longer than 700 nm towards the NIR light camera apparatus 90. The color video camera 88 is fitted to a 400-650 nm bandpass filter to capture the visible light spectrum. The NIR light camera 90 is fitted to a 790-830 nm bandpass filter to capture the NIR light fluoresced by the dye”),
perform image processing on the one or more fluorescence images and creating one or more color fluorescence images from the one or more fluorescence images, wherein a contrast between the fluorescence light emitted by the faint fluorescence source and background is increased (corresponding disclosure in at least [0067], where the background is increased “selective imaging of an area of interest in the surgical field may be achieved by the user selecting fluorescence imaging condition(s) to increase the intensity of the fluorescence pseudo-color at an area of interest relative to a part that is outside the area of interest”)
And create one or more composite images by overlaying the one or more fluorescence images over the one or more white light images (corresponding disclosure in at least [0037], where a composite image is formed by overlaying one image over another “registration or alignment of the two video images in relation to each other may be required to properly overlay the fluorescence image onto the color image. This can be accomplished by any suitable image processing technique”).
Yu does not teach creating one or more false color fluorescence images visible in the visible light spectrum from the one or more fluorescence images.
Westwick, in a similar field of endeavor, teaches a similar concept (fluorescent imaging) of creating one or more false color fluorescence images visible in the visible light spectrum from the one or more fluorescence images (corresponding disclosure in at least [0112], where a false color fluorescent image is made “a false color overlay of the un-enhanced fluorescence image on a white light image of the tissue of the subject that was generated at approximately the same time as the fluorescence image”),
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated creating the false color fluorescence images and overlaying them over white light images as taught by Westwick. One of the ordinary skill in the art would have been motivated to incorporate this because the image provides a higher intensity for better viewing of the area of interest.
Regarding Claim 17, Yu and Westwick teach the limitations of Claim 16 and Yu further teaches wherein the one or more image sensors comprising a first image sensor configured to capture the one or more white light images and a second image sensor configured to capture the one or more fluorescent images (corresponding disclosure in at least [0093], where there can be two sensors, one for the fluorescence one for white light (the visible color sensor) “The visible light and NIR fluorescence are captured by an imaging system and processed for display on a display screen. The imaging system comprises one or more digital image sensors for capturing the images. The imaging system may have multiple image sensors (e.g. one for visible color and another for NIR light)”.
Regarding Claim 18,
Yu teaches a non-transitory computer-readable storage medium storing instructions (corresponding disclosure in at least [0096], where there is a storage medium “The imaging system may also provide other additional functions such as printing images onto paper medium or storing the video images on a mass storage device (such as CD, DVD, solid-state drive, or hard drive)” that cause a computer to at least perform:
emitting excitation light from an excitation light source onto an operation area containing a faint fluorescence source as well as white light from a white light source (corresponding disclosure in at least [0007], where there is both a fluorescence and white light source from the excitation light “exposing the surgical field with white light and fluorescence excitation light” as well as [0098] “The white light and the fluorescence excitation light may be provided from a single source (i.e. the same light source provides both white light and the fluorescence excitation light)”),
capturing one or more fluorescence images of the operation area at a wavelength range of fluorescence light emitted by the faint fluorescence source as well as one or more white light images (corresponding disclosure in at least [0102], where the images are captured at the wavelength range of the fluorescence light “ A dichroic mirror 86 (acting as a beam splitter) reflects light having wavelengths shorter than 700 nm (visible light) towards the color video camera apparatus 88 and transmits light having wavelengths longer than 700 nm towards the NIR light camera apparatus 90. The color video camera 88 is fitted to a 400-650 nm bandpass filter to capture the visible light spectrum. The NIR light camera 90 is fitted to a 790-830 nm bandpass filter to capture the NIR light fluoresced by the dye”),
perform image processing on the one or more fluorescence images and creating one or more color fluorescence images from the one or more fluorescence images, wherein a contrast between the fluorescence light emitted by the faint fluorescence source and background is increased (corresponding disclosure in at least [0067], where the background is increased “selective imaging of an area of interest in the surgical field may be achieved by the user selecting fluorescence imaging condition(s) to increase the intensity of the fluorescence pseudo-color at an area of interest relative to a part that is outside the area of interest”),
and creating one or more composite images by overlaying the one or more fluorescence images over the one or more white light images (corresponding disclosure in at least [0037], where a composite image is formed by overlaying one image over another “registration or alignment of the two video images in relation to each other may be required to properly overlay the fluorescence image onto the color image. This can be accomplished by any suitable image processing technique”).
Yu does not teach creating one or more false color fluorescence images visible in the visible light spectrum from the one or more fluorescence images.
Westwick, in a similar field of endeavor, teaches a similar concept (fluorescent imaging) of creating one or more false color fluorescence images visible in the visible light spectrum from the one or more fluorescence images (corresponding disclosure in at least [0112], where a false color fluorescent image is made “a false color overlay of the un-enhanced fluorescence image on a white light image of the tissue of the subject that was generated at approximately the same time as the fluorescence image”),
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated creating the false color fluorescence images and overlaying them over white light images as taught by Westwick. One of the ordinary skill in the art would have been motivated to incorporate this because the image provides a higher intensity for better viewing of the are of interest
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Yu (US20160262602A1) and Westwick (US20220211258A1) as applied in claim 1, and in further view of Zhu (US20160324420A1).
Regarding Claim 2, Yu and Westwick teach the limitations of Claim 1, but do not teach wherein the fluorescence images are captured using an image sensor at one or more of high gain settings and exposure.
Zhu, in a similar field of endeavor, teaches a similar concept (fluorescent imaging) of wherein the fluorescence images are captured using an image sensor at one or more of high gain settings and exposure (corresponding disclosure in at least [0031], where there is an image sensor at high gain settings “ a Gen III image intensifier is adapted to a CCD or CMOS image sensor to electronically amplify (near infra-red fluorescence) NIRF signals (with gains as much as 106) and to convert them into green (550 nm) phosphor signals that can be collected by a conventional integrating CCD or CMOS image sensor”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated using an image sensor with high gain settings as taught by Zhu. One of the ordinary skill in the art would have been motivated to incorporate this because increasing the gain provides better image resolution for viewing.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Yu (US20160262602A1) and Westwick (US20220211258A1) as applied in claim 7, and in further view of Gono (US20030176768A1).
Regarding Claim 3, Yu and Westwick teach the limitations of Claim 1 and further teaches the contrast between the fluorescence light emitted by the faint fluorescence source and the background ([0048] of Yu), but do not teach wherein the contrast between the fluorescence light emitted by the faint fluorescence source and the background is increased by applying an inverse gamma correction.
Gono, in a similar field of endeavor, teaches a similar concept (fluorescent imaging) of applying an inverse gamma correction (corresponding disclosure in at least [0249], where inverse gamma correction is performed “The RGB data input to the color conversion processing circuit 230 a is converted by the LUTs 262 a, 262 b, and 262 c, for each band data. Here, inverse γ correction, non-linear contrast conversion, etc., is performed”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the inverse gamma correction as taught by Gono. One of the ordinary skill in the art would have been motivated to incorporate this because the correction helps to adjust the brightness level of the images for better overall visualization.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Yu (US20160262602A1) and Westwick (US20220211258A1) as applied in claim 6, and in further view of Huang (US20220401078A1).
Regarding Claim 7, Yu and Westwick teach the limitations of Claim 6, but do not teach wherein correction comprises one or more of: cutting off the darkest 1 to 2 % and the brightest 1 to 2 % of the pixels of the fluorescence image, and selecting a bottom part of the brightness spectrum and spreading the brightness information contained therein over the full brightness spectrum.
Huang, in a similar field of endeavor, teaches a similar concept (image processing using pixels) of wherein correction comprises one or more of: cutting off the darkest 1 to 2 % and the brightest 1 to 2 % of the pixels of the fluorescence image, and selecting a bottom part of the brightness spectrum and spreading the brightness information contained therein over the full brightness spectrum (corresponding disclosure in at least [0048], where a small percentage of the pixels (5%, which includes 1-2%) are removed from the brightest and/or darkest, with the median values being interpreted as the bottom part of the brightness spectrum “bright vessel walls and dark vessel lumens of small vessels) within each ROI, in some examples, a small percentage (e.g., 5, %, 10%) of either strongest and/or weakest signals are excluded so that only the medium (e.g., median 80%, 90%) values are averaged as the mean signal value. In some examples, the signals eliminated may correspond to the brightest and/or darkest pixels in the ROIs”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated cutting off the brightest and darkest pixels of the image then selecting a bottom brightness spectrum to spread the information as taught by Huang. One of the ordinary skill in the art would have been motivated to incorporate this because this normalization and filtering of unusually dark/bright pixels provides a more accurate image without outliers due to potential noise and artifacts.
Regarding Claim 8, the combined references noted above teach the limitations of Claim 7, and further teaches wherein the bottom part of the brightness spectrum includes one of 0% to 20%, 0% to 10%, or 0% to 5%, of the brightness spectrum of the input images (corresponding disclosure in at least [0048], where the bottom part of the brightness includes 5%, which encompasses the 0-5% range “bright vessel walls and dark vessel lumens of small vessels) within each ROI, in some examples, a small percentage (e.g., 5, %, 10%) of either strongest and/or weakest signals are excluded so that only the medium (e.g., median 80%, 90%) values are averaged as the mean signal value. In some examples, the signals eliminated may correspond to the brightest and/or darkest pixels in the ROIs”) of the input fluorescence images (corresponding disclosure in at least [0034] of Yu)
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Yu (US20160262602A1) and Westwick (US20220211258A1) as applied in claim 1, and in further view of Scheib (US20200015906A1).
Regarding Claim 11, the combined references noted above teach the limitations of Claim 9, and further comprising automatically repositioning the region of interest after a movement, in order to realign the region of interest in relation to the faint fluoresecent source in the one or more composite images.
The combined references do not teach the automatic repositioning of the region of interest after a movement.
Scheib, in a similar field of endeavor, teaches a similar concept (fluorescence visualization) of automatic repositioning of the region of interest after a movement (corresponding disclosure in at least [0172], where there is automatic repositioning of the region of interest after movement (the control circuit will automatically reposition to capture the critical structure, or the region of interest) “the control circuit can keep the tagged critical structures within the image sensor's view (the block 1719) by automatically adjusting the zoom and/or repositioning the image sensor to recapture the tagged critical structures within the image sensor's view”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated automatic repositioning of the region of interest after movement as taught by Sheib. One of the ordinary skill in the art would have been motivated to incorporate this because the targeted region can then be consistently monitored.
Regarding Claim 12, the combined references teach the limitations of Claim 11, and Scheib further teaches wherein the automatically repositioning is performed by an algorithm, which is trained to recognize a shape of an organ comprising the faint fluorescence source, wherein the region of interest is realigned in relation to the organ (corresponding disclosure in at least [0171], where there is an algorithm (the surgical visualization system employs an algorithm) “FIG. 23 depicts an algorithm 1710 for a surgical visualization system. Various surgical visualization systems disclosed herein can utilize the algorithm 1710 of FIG. 23”, and further in [0172], where the system recognizes the shape for realignment (the system recognizes the shape, or the critical structure, which comprises the fluorescent source) “the control circuit can keep the tagged critical structures within the image sensor's view (the block 1719) by automatically adjusting the zoom and/or repositioning the image sensor to recapture the tagged critical structures within the image sensor's view” and further in [0128], where the recognized shape is an organ (the algorithm will automatically reposition to the critical structure, which comprises the organ “Hyperspectral imaging technology may provide a visualization system that can provide a way to identify critical structures such as ureters and/or blood vessels, for example, especially when those structures are obscured by fat, connective tissue, blood, or other organs, for example” and further in [0103] ,where the fluorescence of the critical structure is mentioned “ a fluoroscopy visualization technology, such as fluorescent indosciedine green (ICG), for example, can be utilized to illuminate a critical structure 201”).
Regarding Claim 13, the combined references teach the limitations of Claim 11, and Scheib further teaches repositioning is performed by image analysis on the white light image in order to identify an image region with a predominantly red wavelength spectrum, wherein the region of interest is realigned in relation to or set as the image region with a predominantly red wavelength spectrum (corresponding disclosure in at least [0125]-[0128], where there is image analysis completed, which identifies various wavelength ranges via spectral imaging and further in [0143], where the identified structures include those in the visible light spectrum, which encompasses the red wavelength spectrum “the wave 1224 a targets the obscuring tissue 1203, the wave 1224 b targets a first critical structure 1201 a (e.g. a vessel), and the wave 1224 c targets a second critical structure 1201 b (e.g. a cancerous tumor). The wavelengths of the waves 1224 a, 1224 b, 1224 c can be in the visible light, NIR, or SWIR spectrum of wavelengths”).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Yu (US20160262602A1) and Westwick (US20220211258A1) as applied in claim 1, and in futher view of Paras (“Near-infrared autofluorescence for the detection of parathyroid glands”, 2011, Journal of Biomedical Optics”, 16(6)).
Regarding Claim 15, Yu and Westwick teach the limitations of Claim 1 but do not teach wherein the excitation light source comprises one or more of parathyroid tissue exhibiting autofluorescence and fluorescent probes exhibiting fluorescence at similar intensity as the autofluorescence.
Paras, in a similar field of endeavor, teaches a similar concept (fluorescent imaging) wherein the excitation light source comprises one or more of parathyroid tissue exhibiting autofluorescence and fluorescent probes exhibiting fluorescence at similar intensity as the autofluorescence (corresponding disclosure in at least [pg. 3, par. 1], where autofluorescence is present in the parathyroid tissue “More importantly, NIR autofluorescence can be used to identify parathyroid glands, regardless of thyroid or parathyroid disease”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the parathyroid tissue exhibiting autofluorescence as taught by Paras. One of the ordinary skill in the art would have been motivated to incorporate this because the autofluorescence is used to detect the structures of interest.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19079695 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference claim 9 further recites the image processing comprises creating a virtual region of interest in one or more of the white light image and the fluorescence image, wherein the fluorescence image is cut off outside the region of interest.
Claims 1 (alternatively), 2-8, 10-16, and 18 are rejected on the ground on nonstatuatory double patenting as being unpatentable over claims 1-6, 8-15 of U.S. Patent No. 19076071 in view of Yu.
Regarding instant claim 1,
Reference claim 1 recites the elements of instant claim 1, but fails to explicitly recite wherein a contrast between the fluorescence light emitted by the faint fluorescence source and background is increased.
Yu further teaches wherein a contrast between the fluorescence light emitted by the faint fluorescence (corresponding disclosure in at least [0067], where the background is increased “selective imaging of an area of interest in the surgical field may be achieved by the user selecting fluorescence imaging condition(s) to increase the intensity of the fluorescence pseudo-color at an area of interest relative to a part that is outside the area of interest”),
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated increasing the contrast between the fluorescence and the background as taught by Yu. One of the ordinary skill in the art would have been motivated to incorporate this because increasing the contrast gives better visualization of the targeted region as the background becomes darker.
Regarding instant claim 2,
Reference claim 8 recites the elements of instant claim 2.
Regarding instant claim 3,
Reference claim 9 recites the elements of instant claim 3.
Regarding instant claim 4,
Reference claim 10 recites the elements of instant claim 4.
Regarding instant claim 5,
Reference claim 11 recites the elements of instant claim 5.
Regarding instant claim 6,
Reference claim 12 recites the elements of instant claim 6.
Regarding instant claim 7,
Reference claim 13 recites the elements of instant claim 7.
Regarding instant claim 8,
Reference claim 14 recites the elements of instant claim 8.
Regarding instant claim 9,
Reference claim 1 recites the elements of instant claim 9.
Regarding instant claim 10,
Reference claim 2 recites the elements of instant claim 10.
Regarding instant claim 11,
Reference claim 3 recites the elements of instant claim 11.
Regarding instant claim 12,
Reference claim 4 recites the elements of instant claim 12.
Regarding instant claim 13,
Reference claim 5 recites the elements of instant claim 13.
Regarding instant claim 14,
Reference claim 6 recites the elements of instant claim 14.
Regarding instant claim 15,
Reference claim 15 recites the elements of instant claim 15.
Regarding instant claim 16,
Reference claim 16 recites the elements of instant claim 1, but fails to explicitly recite wherein a contrast between the fluorescence light emitted by the faint fluorescence source and background is increased.
Yu further teaches wherein a contrast between the fluorescence light emitted by the faint fluorescence (corresponding disclosure in at least [0067], where the background is increased “selective imaging of an area of interest in the surgical field may be achieved by the user selecting fluorescence imaging condition(s) to increase the intensity of the fluorescence pseudo-color at an area of interest relative to a part that is outside the area of interest”),
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated increasing the contrast between the fluorescence and the background as taught by Yu. One of the ordinary skill in the art would have been motivated to incorporate this because increasing the contrast gives better visualization of the targeted region as the background becomes darker.
Regarding instant Claim 18,
Reference claim 17 recites the elements of instant claim 1, but fails to explicitly recite wherein a contrast between the fluorescence light emitted by the faint fluorescence source and background is increased.
Yu further teaches wherein a contrast between the fluorescence light emitted by the faint fluorescence (corresponding disclosure in at least [0067], where the background is increased “selective imaging of an area of interest in the surgical field may be achieved by the user selecting fluorescence imaging condition(s) to increase the intensity of the fluorescence pseudo-color at an area of interest relative to a part that is outside the area of interest”),
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated increasing the contrast between the fluorescence and the background as taught by Yu. One of the ordinary skill in the art would have been motivated to incorporate this because increasing the contrast gives better visualization of the targeted region as the background becomes darker.
This is a provisional nonstatutory double patenting rejection because the patentably
indistinct claims have not in fact been patented.
Conclusion
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/K.E.K./ Examiner, Art Unit 3797
/SERKAN AKAR/ Primary Examiner, Art Unit 3797
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