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 Objections
Claim 14 is objected to because of the following informalities:
Claim 14 should be amended to recite either --A non-transitory computer-readable medium-- or –Non-transitory computer-readable media--.
Appropriate correction is required.
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 4, and 9-13 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 4 recites “the contribution of a specific one of the two or more fluorescent dyes is left”. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 should be amended to depend from claim 7, as claim 5 from which claim 9 depends does not provide proper antecedence for the recitation of “the overlay” recited in claim 9.
Claim 10 recites “each successive sequence of images”. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites “wherein the controller is configured to run at least one artificial intelligence model trained to perform the determination of the respective local distributions of the two or more different fluorescence dyes, or into several artificial intelligence models that have each been trained on at least one of several different dyes, to which the fluorescent images of the sequence of images are input”. The recitation appears to include a grammatical error. For purposes of the examination the limitation is being interpreted to mean that the fluorescent images are input into several artificial intelligence models.
Claims 11-13 are rejected based on their respective dependencies on claim 10.
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, 3-11, and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fengler, et al., US 20170209050 A1.
Regarding claim 1, Fengler teaches a method of medical multi-dye fluorescence imaging ([0007] discloses fluorescence imaging methods), the method comprising:
capturing fluorescent images of an operating field in which two or more different fluorescent dyes are present ([0062] describes imaging regions of interest using fluorescent imaging agents) in successive sequences of images with a surgical or diagnostic imaging device ([0065] discloses the method may comprise administration of a fluorescence imaging agent or other imaging agent to the subject, and generation or acquisition of the time series of fluorescence images prior to processing the image data),
each sequence of images alternating through different modes of excitation lighting adapted for at least one each of two or more of the two or more different dyes ([0129]-[0130] describe different illumination modes, including a combination mode, indicating that the visible light output and the fluorescence light output are pulsed so that different wavebands are illuminating the area to be imaged at different times, with [0007] discloses that the imaging system may include an excitation light provider that emits excitation light in a plurality of non-overlapping excitation wavebands for causing the object to emit fluorescent light), and
processing the captured images of each successive sequence of images in combination with each other ([0014] discloses processing the received image signals to generate images from the received image signals), the processing comprising:
determining the respective local distributions of the two or more different fluorescence dyes causing the observed different distributions of brightness in the two or more different fluorescent images of the sequence ([0071]-[0071], and [0074] disclose localization of lymph nodes in lymphatic mapping using the responses from the fluorophores); and
producing one or more images displaying the determined local distributions of the two or more different fluorescent dyes separately ([0170] describe displaying the white light images and the fluorescence images, indicating that the fluorescence images can then be individually or collectively combined with the full color, visible (white) light image for display. In another variation, the intensity of the fluorescence signal in a fluorescence image can be normalized by scaling the brightness (luma) of each of the fluorescence images with the co-registered reflected red light image signal (i.e., the red portion of the full visible (white) light image), and then displayed with a color map selected to emphasize specific ranges of fluorescence intensity).
Regarding claim 3, Fengler further teaches wherein the processing further comprising using linear combinations of the two or more fluorescent images with regard to their respective brightness distributions ([0074] discloses that the NIR fluorescent positive LNs (e.g., using ICG) may be represented as a black and white NIR fluorescence image(s) for example and/or as a full or partial color (white light) image, full or partial desaturated white light image, an enhanced colored image, an overlay (e.g., fluorescence with any other image), a composite image (e.g., fluorescence incorporated into another image) which may have various colors, various levels of desaturation or various ranges of a color to highlight/visualize certain features of interest),
the linear combinations being performed with weighting factors determined from known or measured relative fluorescence response strengths (see figs. 3A and 3B) of the two or more different fluorescent dyes at the two or more different modes of excitation, the weighting factors chosen such as to separate the responses of the two or more fluorescent dyes from each other ([0170] states that “the intensity of the fluorescence signal in a fluorescence image can be normalized by scaling the brightness (luma) of each of the fluorescence images with the co-registered reflected red light image signal (i.e., the red portion of the full visible (white) light image), and then displayed with a color map selected to emphasize specific ranges of fluorescence intensity”).
Regarding claim 4, Fengler further teaches wherein, in each linear combination, the contribution of a specific one of the two or more fluorescent dyes is left, whereas the contributions of the other one or more fluorescent dye or dyes is or are eliminated ([0074] discloses that the NIR fluorescent positive LNs (e.g., using ICG) may be represented as a black and white NIR fluorescence image(s) for example and/or as a full or partial color (white light) image, full or partial desaturated white light image, an enhanced colored image, an overlay (e.g., fluorescence with any other image), a composite image (e.g., fluorescence incorporated into another image) which may have various colors, various levels of desaturation or various ranges of a color to highlight/visualize certain features of interest. Meaning the contributions of certain dyes are highlighted with respect to other dyes).
Regarding claim 5, Fengler further teaches wherein each of the different modes of excitation lighting comprises activating a different set of one or more fluorescence excitation lighting sources that are each adapted to produce fluorescence excitation lighting for a different one of the two or more different dyes ([0086] The excitation light provider may include one or more light sources (e.g., 214a-214d) that emit light in multiple wavebands for fluorescence excitation. The multiple wavebands are preferably non-overlapping or sufficiently separated from each other such that a single multi-band fluorescence excitation blocking filter can be used).
Regarding claim 6, Fengler further teaches wherein at least one of the fluorescence excitation lighting sources is activated or kept activated continuously ([0130] discloses that continuous illumination modes for the various types of fluorescence illumination modes).
Regarding claim 7, Fengler further teaches comprising, in each sequence of images, additionally capturing at least one white light image under white light illumination ([0107] discloses that the first sensor 1220 may be configured to detect NIR-I and/or NIR-II light for the fluorescence image and second sensor 1230 may be a color image sensor with a CFA or a monochrome image sensor configured to detect visible light for the white light image), and producing a composite image of the at least one white light image with an overlay of the determined distribution or distributions of at least one of the two or more different fluorescent dyes ([0074] discloses that “The NIR fluorescent positive LNs (e.g., using ICG) may be represented as a black and white NIR fluorescence image(s) for example and/or as a full or partial color (white light) image, full or partial desaturated white light image, an enhanced colored image, an overlay (e.g., fluorescence with any other image), a composite image (e.g., fluorescence incorporated into another image) which may have various colors, various levels of desaturation or various ranges of a color to highlight/visualize certain features of interest”).
Regarding claim 8, Fengler further teaches wherein the white light illumination is activated continuously ([0130] discloses that continuous illumination modes for the various types of white light illumination modes).
Regarding claim 9, Fengler further teaches wherein the overlay is performed using a false color representation having a different color for each of the different fluorescent dyes ([0128] discloses that the displayed and/or recorded fluorescence emission image data may be monochrome (e.g., black and white or grayscale) or pseudo-colored (e.g., via a color map based on intensity or some other signal parameter) and may be displayed and/or recorded in a monochrome or pseudo-colored fashion at high definition (HD) or ultra-high definition (UHD or 4K) resolution (or other suitable resolution).
Regarding claim 10, Fengler teaches a system for medical multi-dye fluorescence imaging (the abstract discloses “A fluorescence imaging system for imaging an object, the system includes a white light provider that emits white light, an excitation light provider that emits excitation light in a plurality of excitation wavebands for causing the object to emit fluorescent light”), the system comprising:
a controller comprising hardware ([0014] discloses at least one controller and image processor),
a plurality of light sources controlled by the controller ([0014] discloses that the controller controls the light sources), the plurality of light sources comprising two or more fluorescence excitation illumination light sources configured to provide excitation illumination ([0009] discloses at least four excitation light sources),
wherein each of the two or more fluorescence excitation illumination light sources is configured to generate a different excitation lighting ([0017] disclose excitation light source emissions at different wavelengths) adapted to a different one of two or more different pre-selected fluorescence dyes ([0046] FIG. 3A is a table summarizing exemplary fluorescence excitation/emission wavebands and exemplary fluorophores (imaging agents). FIG. 3B is a plot of absorption and emission spectra for selected fluorophores described in FIG. 3A),
at least one imaging unit comprising a first image sensor sensitive for fluorescence light from the two or more different pre-selected fluorescence dyes ([0008] discloses an image sensor assembly that receives the transmitted reflected white light and the fluorescent light), the controller being configured to:
control the plurality of fluorescence excitation illumination light sources by activating the two or more different fluorescence excitation illumination light sources in successive sequences of activations, each sequence of activations alternating through different modes of excitation lighting adapted for at least one each of two or more of the two or more different dyes ([0129]-[0130] describe different illumination modes, including a combination mode, indicating that the visible light output and the fluorescence light output are pulsed so that different wavebands are illuminating the area to be imaged at different times, with [0007] discloses that the imaging system may include an excitation light provider that emits excitation light in a plurality of non-overlapping excitation wavebands for causing the object to emit fluorescent light),
receive first image data from the first image sensor in synchronization with the successive sequences of activations of the two or more different fluorescence excitation illumination light sources, process the first image data of each successive sequence of images in combination with each other ([0014] discloses the system may include at least one image processor that receives image signals from the image sensor assembly and processes the received image signals to generate images from the received image signals),
the processing comprising determining the respective local distributions of the two or more different fluorescence dyes ([0071], [0074] disclose localization of lymph nodes in lymphatic mapping using the responses from the fluorophores) causing the observed different distributions of brightness in the two or more different fluorescent images of the sequence and produce one or more images displaying the determined local distributions of the two or more different fluorescent dyes separately ([0170] describe displaying the white light images and the fluorescence images, indicating that the fluorescence images can then be individually or collectively combined with the full color, visible (white) light image for display. In another variation, the intensity of the fluorescence signal in a fluorescence image can be normalized by scaling the brightness (luma) of each of the fluorescence images with the co-registered reflected red light image signal (i.e., the red portion of the full visible (white) light image), and then displayed with a color map selected to emphasize specific ranges of fluorescence intensity).
Regarding claim 11, Fengler in view of Wood teaches all the limitations of claim 10 above.
Fengler further teaches wherein the plurality of light sources further comprising a white illumination light source configured to provide white light illumination ([0014] discloses that the controller may cause the white light provider to emit white light and the image processor may generate a white light image based on image signals associated with the reflected white light from the object),
the imaging unit further comprising a second image sensor sensitive in a visible light spectrum ([0107] discloses that the first sensor 1220 may be configured to detect NIR-I and/or NIR-II light for the fluorescence image and second sensor 1230 may be a color image sensor with a CFA or a monochrome image sensor configured to detect visible light for the white light image), wherein the controller is further configured to:
control the white illumination light source by activating the white illumination light source such as to, within each successive sequence of activations, alternating through different modes of excitation lighting as well as white light illumination ([0129]-[0130] describe different illumination modes including pulsing the excitation lights to output different wavebands such that the illumination modes are separated by time. Meaning the illumination of the different wavebands are pulsed at different times during the combination mode of illumination and [0007] states that The imaging system may include an excitation light provider that emits excitation light in a plurality of non-overlapping excitation wavebands for causing the object to emit fluorescent light. The illumination mode is also for white light source),
receive second image data from the second image sensor in synchronization with the successive activations of the white illumination light source ([0014] discloses that the image processor may separate image signals from the image sensor assembly into a first set of image signals associated with the reflected white light), and
produce a composite image by overlaying the one or more images displaying the determined local distributions of the two or more different fluorescent dyes over a white light illumination image derived from the second image data ([0074] discloses that “The NIR fluorescent positive LNs (e.g., using ICG) may be represented as a black and white NIR fluorescence image(s) for example and/or as a full or partial color (white light) image, full or partial desaturated white light image, an enhanced colored image, an overlay (e.g., fluorescence with any other image), a composite image (e.g., fluorescence incorporated into another image) which may have various colors, various levels of desaturation or various ranges of a color to highlight/visualize certain features of interest”).
Regarding claim 13, Fengler further teaches wherein the controller is configured to use linear combinations of the two or more fluorescent images with regard to their respective brightness distributions ([0074] discloses that the NIR fluorescent positive LNs (e.g., using ICG) may be represented as a black and white NIR fluorescence image(s) for example and/or as a full or partial color (white light) image, full or partial desaturated white light image, an enhanced colored image, an overlay (e.g., fluorescence with any other image), a composite image (e.g., fluorescence incorporated into another image) which may have various colors, various levels of desaturation or various ranges of a color to highlight/visualize certain features of interest), the linear combinations being done with weighting factors determined from known or measured relative fluorescence response strengths of the two or more different fluorescent dyes at the two or more different modes of excitation (see figs. 3A and 3B), the weighting factors chosen such as to separate the responses of the two or more fluorescent dyes from each other ([0170] states that “the intensity of the fluorescence signal in a fluorescence image can be normalized by scaling the brightness (luma) of each of the fluorescence images with the co-registered reflected red light image signal (i.e., the red portion of the full visible (white) light image), and then displayed with a color map selected to emphasize specific ranges of fluorescence intensity”).
Regarding claim 14, Fengler teaches non-transitory computer-readable storage medium storing instructions ([0125] discloses a recorder 140b (e.g., hard disk, flash memory, other tangible non-transitory computer readable medium, etc.) that cause a computer ([0114] discloses computer and processor) to at least perform:
capturing fluorescent images of an operating field in which two or more different fluorescent dyes are present ([0062] describes imaging regions of interest using fluorescent imaging agents) in successive sequences of images with a surgical or diagnostic imaging device ([0065] discloses the method may comprise administration of a fluorescence imaging agent or other imaging agent to the subject, and generation or acquisition of the time series of fluorescence images prior to processing the image data),
each sequence of images alternating through different modes of excitation lighting adapted for at least one each of two or more of the two or more different dyes ([0129]-[0130] describe different illumination modes, including a combination mode, indicating that the visible light output and the fluorescence light output are pulsed so that different wavebands are illuminating the area to be imaged at different times, with [0007] discloses that the imaging system may include an excitation light provider that emits excitation light in a plurality of non-overlapping excitation wavebands for causing the object to emit fluorescent light), and
processing the captured images of each successive sequence of images in combination with each other ([0014] discloses processing the received image signals to generate images from the received image signals), the processing comprising:
determining the respective local distributions of the two or more different fluorescence dyes causing the observed different distributions of brightness in the two or more different fluorescent images of the sequence ([0071]-[0071], and [0074] disclose localization of lymph nodes in lymphatic mapping using the responses from the fluorophores); and
producing one or more images displaying the determined local distributions of the two or more different fluorescent dyes separately ([0170] describe displaying the white light images and the fluorescence images, indicating that the fluorescence images can then be individually or collectively combined with the full color, visible (white) light image for display. In another variation, the intensity of the fluorescence signal in a fluorescence image can be normalized by scaling the brightness (luma) of each of the fluorescence images with the co-registered reflected red light image signal (i.e., the red portion of the full visible (white) light image), and then displayed with a color map selected to emphasize specific ranges of fluorescence intensity).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Fengler, et al., US 20170209050 A1 in view of Valdes, et al., US 20160278678 A1.
Regarding claim 2, Fengler teaches all the limitations of claim 1 above.
Fengler does not teach wherein the processing further comprising inputting the fluorescent images of the sequence of images into at least one artificial intelligence model trained to perform the determination of the respective local distributions of the two or more different fluorescence dyes, or into several artificial intelligence models that have each been trained on at least one of several different dyes.
However, within the same field of endeavor, Valdes teaches hyperspectral imaging for quantifying fluorophore emissions (abstract), wherein the processing further comprising inputting the fluorescent images of the sequence of images into at least one artificial intelligence model trained to perform the determination of the respective local distributions of the two or more different fluorescence dyes, or into several artificial intelligence models that have each been trained on at least one of several different dyes ([0193] The optical properties of tissue at each pixel as determined in Operation in Spatial-Frequency-Modulated Reflectance Mode, the hemoglobin, oxyhemoglobin, and deoxyhemoglobin concentrations as determined above under Operation in Hyperspectral Reflectance Imaging Mode, the surface fluorophore concentrations as determined by qFI as describe above, the depth and quantity-at-depth information as determined in the section entitled Operation in Quantitative Depth-Resolved Imaging qDFI Mode above for each pixel are all provided to a trainable classifier such as a neural network classifier, kNN classifier, or in an alternative embodiment an SVM classifier; the classifier is implemented as classification routines in memory 178 and executed on the processor. The classifier is trained to provide a classification indicative of a probability that tumor exists at a location in tissue corresponding to that pixel. Classification results for each pixel are entered into a tissue classification map that is then displayed to the surgeon).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Fengler, wherein the processing further comprising inputting the fluorescent images of the sequence of images into at least one artificial intelligence model trained to perform the determination of the respective local distributions of the two or more different fluorescence dyes, or into several artificial intelligence models that have each been trained on at least one of several different dyes, as taught by Valdes, for accurately resolving regions of interest in fluorescence imaging ([0167], [0178]) for improved tumor localization ([0023]).
Regarding claim 12, Fengler teaches all the limitations of claim 10 above.
Fengler does not teach wherein the controller is configured to run at least one artificial intelligence model trained to perform the determination of the respective local distributions of the two or more different fluorescence dyes, or into several artificial intelligence models that have each been trained on at least one of several different dyes, to which the fluorescent images of the sequence of images are input.
However, within the same field of endeavor, Valdes teaches hyperspectral imaging for quantifying fluorophore emissions (abstract), wherein the controller is configured to run at least one artificial intelligence model trained to perform the determination of the respective local distributions of the two or more different fluorescence dyes, or into several artificial intelligence models that have each been trained on at least one of several different dyes, to which the fluorescent images of the sequence of images are input ([0193] The optical properties of tissue at each pixel as determined in Operation in Spatial-Frequency-Modulated Reflectance Mode, the hemoglobin, oxyhemoglobin, and deoxyhemoglobin concentrations as determined above under Operation in Hyperspectral Reflectance Imaging Mode, the surface fluorophore concentrations as determined by qFI as describe above, the depth and quantity-at-depth information as determined in the section entitled Operation in Quantitative Depth-Resolved Imaging qDFI Mode above for each pixel are all provided to a trainable classifier such as a neural network classifier, kNN classifier, or in an alternative embodiment an SVM classifier; the classifier is implemented as classification routines in memory 178 and executed on the processor. The classifier is trained to provide a classification indicative of a probability that tumor exists at a location in tissue corresponding to that pixel. Classification results for each pixel are entered into a tissue classification map that is then displayed to the surgeon).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Fengler, wherein the controller is configured to run at least one artificial intelligence model trained to perform the determination of the respective local distributions of the two or more different fluorescence dyes, or into several artificial intelligence models that have each been trained on at least one of several different dyes, to which the fluorescent images of the sequence of images are input, as taught by Valdes, for accurately resolving regions of interest in fluorescence imaging ([0167], [0178]) for improved tumor localization ([0023]).
Double Patenting
The nonstatutory provisional 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 provisional 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2, 5-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18/511,209 (U.S. P.G. Pub. No. 20240268647 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations recited in the claims mentioned above of the instant application are also recited in the claims mentioned above of the copending application.
Conclusion
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/FAROUK A BRUCE/ Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/ Supervisory Patent Examiner, Art Unit 3797
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