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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the:
In claim 8: c) filtering a third multispectral reflection light signal to receive at the first camera a second signal comprising light at said second one or more selected wavelengths; and (the embodiment of fig 5A accounts for only two multispectral reflections light signals, i.e. the signals into camera 120 and 128, while the signal into camera 130 is not a multispectral reflection light signal)
must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 4-6, 14 are objected to because of the following informalities:
Claims 1 and 14 use multiple variations of “multicolored”, i.e. “multicoloured”. Applicant should use a single variant.
Claims 4-6 recite “The method according of claim 1…”, grammatically incorrect.
Claim 14 recites “; and and a controller configured to:…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112b
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 1, 3, 4, 8-10, 12–14, 16, 19, 20, and dependent claims 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 1 (also in claim 14) contains multiple inconsistencies in nomenclature and the identification of signals such that taken together arises to indefiniteness.
Referring to fig 5A, Claim 1 recites two signals which are created from the top beam splitter to be received at camera 120 as the first signal and at camera 128 as the second signal. There is inconsistent nomenclature between these signals and within the second signal itself, i.e.
at step b) “a first multispectral band reflection signal” vs.
at step i) “a second multispectral reflection light signal”; but additionally,
at step j) the second signal uses yet a different label, “filtered second multispectral light signal”.
It is unclear if the differences in labels are to provide any limiting of scope. If not, the same nomenclature should be used, e.g. either “multispectral band reflection signal” or “multispectral reflection light signal”.
Claim 1 is considered indefinite since it does not properly correspond to an embodiment in the specification (fig 3 or fig 5A) since the functions described in the claim would apply only for a first camera having at least one first camera (as is correctly claimed in claim 14), i.e. two first cameras (120 and 128 as in fig 5A). Claim 1 specifies only one first camera and therefore the generation of the color and filtered images is not compatible with the embodiment shown in fig 5A (which has two first cameras 120 and 128) and also incompatible with the embodiment of fig 3 which shows only one first camera (color camera 56) but does not process the narrow band images as described in claim 1. This discrepancy was confirmed in an interview with applicants (Idan Frydman, Ginat Muginstein, and Roy Gross) on 10/15/2025, i.e. that the recitation of “first camera” is in error by being limited to only a single camera. Therefore, “first camera” will be interpreted as two first cameras, 120 and 128 as seen in the embodiment of fig 5A.
Claim 1 as interpreted to read on the viable embodiment of fig 5A, two first cameras, 120 and 128 but then later requires “a second multispectral reflection light signal to receive at said first camera”. This recitation of “receive at said first camera” is indefinite since there are, e.g. the embodiment shown in fig 5A, considered to be two first cameras, 120 and 128. It is unclear which first camera must receive this signal, making the claim indefinite.
Claims 8 and 9 are indefinite for the same reason, i.e. the recitation of “the first camera”. It will be interpreted as provided in the prior art rejection for these claims, i.e. filtering the white light to generate an additional narrow band image, until applicant has resolved the multiple layers of
Claim 14 also explicitly allows for multiple first cameras and therefore is also indefinite for the same reason.
Claim 3 recites “second multispectral light signal” which is indefinite as it does not exactly refer to a previously recited element and therefore could refer to either the “second multispectral reflection light signal” or the “filtered second multispectral light signal” of claim 1, each of which could potentially differ in scope.
Claim 4 recites “The method of claim 1, wherein said first property is oxygen level, and the first one or more wavelengths include at least two wavelengths selected from green light at 520-560 nm”. It is unclear what it means to select two wavelengths selected from green light at 520-560 nm, i.e. why two green wavelengths of light are selected. The apparent relevant section of the specification at 0079 describes determining oxygen saturation using two wavelengths of light, but one from green (520-560 nm) and one with red (600-750 nm) or red (600-750 nm) with infrared (850-100(sic) nm – should read 1000). Neither of these are using two green wavelengths. It will be interpreted as including a green light at 520-560 nm.
Claim 9 recites “second multispectral reflection light signal” and “second multispectral light signal”. Therefore these recitations could potentially be considered different and distinct claim elements and are therefore indefinite.
Claim 9 recites “filtering said second multispectral reflection light signal to receive at said first camera also a second signal comprising light at the second one or more selected wavelengths”. It is unclear what this signal is since a previous “second signal” was recited in parent claim 1, and duplicates the recitation. Additionally, it is unclear what the “also” refers to, i.e. the filtering or receiving.
Claim 10 recites the limitation "multispectral reflection light". There is insufficient antecedent basis for this limitation in the claim. This term could be confused with “a second multispectral reflection light signal” (step i) and “filtered second multispectral light signal” (step j).
Claim 12 recites “method of claim 11”. Claim 11 has been cancelled. It will be interpreted as method of claim 1.
Claim 13 requires white light imaging at the second camera, i.e. monochrome CCD camera 125 in fig 5A since it has been established this embodiment of claim 1 refers to fig 5A. But it is unclear how a white light image is generated using the monochrome CCD camera. It will be interpreted as provided in the rejection.
Claim 14 recites “a filter configured to filter one or more wavelengths from a multispectral reflection light signal; and a controller configured to: a) control said multispectral light source to illuminate said tissue with multispectral band light”. It is unclear the scope distinction between the “multispectral reflection light signal” and “multispectral band light”. Applicant is required to state on the record the distinction. It will be interpreted as the same element.
Claim 16 recites the limitation "second multispectral light signal". There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "multispectral source". There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites “a white light camera”. It is unclear the relationship between the white light camera and the other cameras previously recited in parent claim 14, since this recitation of the white light camera is an additional and distinct camera, but claim 1 already has recited two first cameras as white light cameras (i.e. embodiment of fig 5A showing multispectral camera 120 and physician’s camera 128). This recitation of “white light camera” therefore requires a third white light camera, which does not appear to be described in any embodiments. It appears this claim is attempting to simply further narrow the scope of one of the two first cameras, therefore, it will be interpreted as referring to one of the two first cameras previously claimed.
Claim 20 recites “a white light reflection signal”. It is unclear the relationship between the white light reflection signal and the other signals previously recited in claim 14. It appears this claim is attempting to simply further narrow the scope of one of the white light reflection signals, therefore it will be interpreted as referring to a previously claimed reflection signal.
Claim 20 recites “a white light image”. It is unclear the relationship between the white light image and the other images previously recited in claim 14. It appears this claim is attempting to simply further narrow the scope of one of the images, therefore it will be interpreted as referring to a previously claimed light images.
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(s) 1-3, 5, 7-10, 12-16, 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kubo US20150257635 and further in view of Ozawa US20120302847 and Nie US20120123205 .
Kubo discloses for claim 1, “A method for diagnosing a biological tissue, comprising:
a) illuminating said tissue with multispectral band light (light source 3; fig 1; 0020 describes light source emitting white light for color imaging and excitation light 700 nm – 740 nm as monochrome light);
b) receiving, at a first camera (image-acquisition device 55; fig 1; 0022 describes device 55 is such as a color CCD), a first multispectral band reflection signal from said biological tissue (0022 “the white light transmitted through the dichroic mirror 52; an image-acquisition device 55, such as a color CCD, that captures the white light focused by the focusing lens 53”);
c) generating a multicolored image from said first signal (0022 describes generating a white light image: “The image processor 6 includes a white-light-image generating portion (return-light-image generating portion) 61 that generates a white-light image (return-light image) from the white-light image information S1 obtained by the image-acquisition device 55”);
d) illuminating said biological tissue with a monochromatic light (0020 describes the excitation narrow band light, i.e. monochromatic light with wavelength between 700 and 740 nm along with filter 57; fig 1);
e) receiving, at a second camera, a monochromatic signal from said biological tissue (0022 describes capturing the fluorescence, i.e. monochromatic signal at the monochrome camera 56; fig 1);
f) generating a monochromatic image from said monochromatic signal (0023 describes generating a fluorescence image, i.e. a monochromatic image)”.
Kubo does not disclose
g) selecting a first property of said biological tissue;
h) selecting one or more first wavelengths based on said first property;
i) filtering a second multispectral reflection light signal to receive at said first camera, a second signal comprising light at said one or more first wavelengths;
j) generating a first image from said filtered second multispectral light signal”.
Ozawa teaches in the same field of endeavor, selective imaging of oxygen saturation (i.e. the selected first property of biological tissue) based on particular narrowband wavelengths of light (figs 11, 13; 0081-0082). Kubo previously disclosed filtering a narrowband wavelength of light from the multispectral light to produce a monochromatic image (see d) – f) above). Additionally, Nie teaches in the same field of endeavor, a relevant imaging configuration with a color camera and two special image cameras with dichroic mirrors and short pass filters (fig 1A), as an exemplary configuration of Kubo modified by Ozawa allowing for multiple narrow band images. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Ozawa into the invention of Kubo in order to configure the method e.g. as claimed, specifically, by adding the additional narrowband imaging in the configuration exemplified by Nie because it provides way to image oxygen saturation at a particular vascular depth (Ozawa: 0048) using a configuration that allows broad band imaging with multiple narrow band imaging in a single device (Nie: fig 1A).
Kubo does not disclose
“k) merging said first image with said multicolored image to create a first merged image;
l) merging said multicolored image with said monochromatic image to form a second merged image; and
m) presenting said first merged image and the second merged image on a display”.
Ozawa further discloses merging a normal light image with a narrowband image 0071 in order to enhance structures better depicted in the normal light image and spectral characteristics in the narrowband image. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Ozawa into the invention of Kubo in order to configure the method e.g. as claimed, specifically by combining the normal light image with the narrowband images, i.e. the monochromatic image and the first image because it enhances the structures of the imaged vessels (Ozawa: 0071 A first special image is produced by combining the normal light image with the first blue-enhanced image subjected to the frequency filtering. The shapes of the superficial blood vessels are enhanced in the first special image).
Modified Kubo discloses for claim 2, “The method of claim 1, wherein filtering the one or more first wavelengths is by an optical filter, placed in front of said first camera (Nie: fig 1 shows shortpass filters 114b and 116b in front of cameras 122a and 122b for the narrowband imaging)”.
Modified Kubo discloses for claim 3, “The method of claim 1, wherein filtering the one or more first wavelengths is by selecting said one or more wavelengths from said second multispectral light signal (Ozawa: fig 2 shows providing specific wavelengths of light from the light source in order to image for oxygen saturation at a desired vascular depth; 0048)”.
Modified Kubo discloses for claim 5, “The method of claim 1, wherein said first property is deoxyhemoglobin level, and the first one or more wavelengths is at least one wavelength selected from red light at 600 - 700 nm (Ozawa: 0048 laser LD4 generates fourth narrowband light N4 having a center wavelength of 650 nm)”.
Modified Kubo discloses for claim 7, “The method of claim 5, wherein said second signal is received by illuminating said biological tissue with a laser at the selected wavelength and generating the first image is generating a monochromatic image (Ozawa: fig 2 shows providing specific wavelengths of light using e.g. laser LD1 from the light source in order to image for oxygen saturation at a desired vascular depth; 0048)”.
Kubo does not disclose for claim 8, “The method of claim 1, further comprising:
a) selecting a second property of the biological tissue (Ozawa: vascular depth figs 11, 13; 0081-0082);
b) selecting one or more second wavelengths based on said second property (Ozawa: vascular depth figs 11, 13; 0080-0082, in particular 0080 describes the depth relationship with wavelength);
c) filtering a third multispectral reflection light signal to receive at the first camera a second signal comprising light at said second one or more selected wavelengths (Kubo: 0020-0022 describes the excitation narrow band light, i.e. monochromatic light with wavelength between 700 and 740 nm along with filter 57; fig 1);
d) generating a second image from said third multispectral reflection light signal (Kubo: 0023 describes generating a fluorescence image, i.e. a monochromatic image); and
e) merging said second image with the multicolored image to create a third merged image(Ozawa: 0071 describes combining a normal white light image with a narrow band image) ; and
f) presenting said third merged image on a display” (Ozawa: e.g. fig 15 showing normal light image combined with a narrow band image).
Modified Kubo discloses for claim 9, “The method of claim 1, further comprising:
a) selecting a second property of the biological tissue (Ozawa: vascular depth figs 11, 13; 0081-0082);
b) selecting one or more second wavelengths based on said second property (Ozawa: vascular depth figs 11, 13; 0080-0082, in particular 0080 describes the depth relationship with wavelength);
c) filtering said second multispectral reflection light signal to receive at said first camera also a second signal comprising light at the second one or more selected wavelengths (Kubo: 0020-0022 describes the excitation narrow band light, i.e. monochromatic light with wavelength between 700 and 740 nm along with filter 57; fig 1); and
d) generating a second image from said second multispectral light signal (Kubo: 0023 describes generating a fluorescence image, i.e. a monochromatic image);
e) merging said second monochromatic image with said first combined image to create a fourth combined image (Ozawa: 0071 describes combining a normal white light image with a narrow band image); and
f) presenting said fourth combined image on a display (Ozawa: e.g. fig 15 showing normal light image combined with a narrow band image)”.
Kubo discloses for claim 10, “The method of claim 1, wherein said multispectral reflection light is white light (0019 describes illumination unit 4 radiating excitation light and white light)”.
Modified Kubo discloses for claim 12, “The method of claim 11, wherein illuminating said tissue with monochromatic light is by a laser source (Ozawa: 0048 discloses narrow band illumination with laser LD1)”.
Modified Kubo discloses 13, “The method of claim 1, further comprising: receiving, at a second camera, a white light reflection signal from the biological tissue; and generating and presenting a white light image (Kubo: 0020-0023 describes the excitation narrow band light, i.e. monochromatic light with wavelength between 700 and 740 nm along with filter 57; fig 1 and the imaging and generation of the corresponding image with the narrow band light)”.
Modified Kubo (as in claim 1) discloses for claim 14, “A system for diagnosing a biological tissue, comprising:
at least one multispectral light source (Kubo: light source 3; fig 1; 0020 describes light source emitting white light for color imaging);
a monochromatic light source (Kubo: light source 3; fig 1; 0020 describes light source emitting white light for color imaging and excitation light 700 nm – 740 nm as monochrome light);
at least one first multispectral camera (Kubo: image-acquisition device 55; fig 1; 0022 describes device 55 is such as a color CCD);
a second camera (Kubo: 0022 describes capturing the fluorescence, i.e. monochromatic signal at the monochrome camera 56; fig 1);
a filter configured to filter one or more wavelengths from a multispectral reflection light signal (Nie: fig 1B; 0082 describes providing a bandpass filter 120 for the third electronic imaging device 122a); and
a controller (Kubo: image processor 6; fig 1; 0023-0024 describes the control for generating the images) configured to:
a) control said multispectral light source to illuminate said tissue with multispectral band light (Kubo: 0020 describes the light source 3 white light emitted from lamp 32);
b) receive, from a first camera (Kubo: image-acquisition device 55; fig 1; 0022 describes device 55 is such as a color CCD), a first multispectral band reflection signal from said biological tissue (Kubo: 0022 “the white light transmitted through the dichroic mirror 52; an image-acquisition device 55, such as a color CCD, that captures the white light focused by the focusing lens 53”);
c) generate a multicoloured image from said first signal (Kubo: 0022 describes generating a white light image: “The image processor 6 includes a white-light-image generating portion (return-light-image generating portion) 61 that generates a white-light image (return-light image) from the white-light image information S1 obtained by the image-acquisition device 55”);
d) control said monochromatic light source to illuminate said biological tissue with a monochromatic light (Kubo: 0020 describes the excitation narrow band light, i.e. monochromatic light with wavelength between 700 and 740 nm along with filter 57; fig 1);
e) receive at said second camera, a monochromatic signal from said biological tissue (Kubo: 0022 describes capturing the fluorescence, i.e. monochromatic signal at the monochrome camera 56; fig 1);
f) generate a monochromatic image from said monochromatic signal (Kubo: 0023 describes generating a fluorescence image, i.e. a monochromatic image);
g) select a first property of said biological tissue (Ozawa: selective imaging of oxygen saturation, i.e. the selected first property of biological tissue; figs 11, 13; 0081-0082);
h) select one or more first wavelengths based on said first property (Ozawa: selective imaging of oxygen saturation, i.e. the selected first property of biological tissue based on particular narrowband wavelengths of light; figs 11, 13; 0081-0082);
i) control said filter to filter a second multispectral reflection light signal to receive at said first camera a second signal comprising light at said one or more first wavelengths (Nie: fig 1B; 0082 describes providing a bandpass filter 120 for the third electronic imaging device 122a to filter for the wavelength band based on the selected property, i.e. oxygen saturation);
j) generate a first image from said filtered second multispectral light signal (Ozawa: fig 7, 9; 0068 describes the generation of the first blue-enhanced image via the first special image producing section 90);
k) merge said first image with said multicolored image to create a first merged image (Ozawa: 0071 describes the generation of an image combining the normal light image with a narrowband image subjected to the frequency filtering; e.g. first special image 100 comprising normal light image merged with vascular enhancement);
l) merge said multicolored image with said monochromatic image to form a second merged image (Ozawa: 0075 describes the generation of the second special image based on white light with a narrowband image subjected to the frequency filtering; e.g. second special image 103 comprising normal light image merged with oxygen saturation information); and
m) present said first merged image and the second merged image on a display (Ozawa: 0047 describes displaying the generated images)”.
Modified Kubo discloses for claim 15, “The system of claim 14, wherein filtering the one or more first wavelengths is by an optical filter, placed in front of said first camera (Nie: fig 1B; 0082 describes providing a bandpass filter 120 for the third electronic imaging device 122a).
Modified Kubo discloses for claim 16, “The system of claim 14, wherein filtering the one or more first wavelengths is by selecting said one or more wavelengths from said second multispectral light signal (Kubo discloses image-acquisition device 55; fig 1; 0022 modified via the filter of Nie, fig 1B)”.
Modified Kubo discloses for claim 18, “The system of claim 14, wherein said monochromatic light source is a laser source (Ozawa: 0048 discloses narrow band illumination with laser LD1)”.
Kubo discloses for claim 19, “The system of claim 14, wherein said multispectral source is a white light source (light source 3; fig 1; 0020 describes light source emitting white light for color imaging)”.
Kubo discloses for claim 20, “The system of claims 14, further comprising:
a white light camera (Kubo: image-acquisition device 55; fig 1; 0022 describes device 55 is such as a color CCD) and wherein the controller is further configured to:
receive, at said white light camera, a white light reflection signal from said biological tissue (Kubo: light source 3; fig 1; 0020 describes light source emitting white light for color imaging); and
generate and present a white light image (Kubo: 0022 describes generating a white light image: “The image processor 6 includes a white-light-image generating portion (return-light-image generating portion) 61 that generates a white-light image (return-light image) from the white-light image information S1 obtained by the image-acquisition device 55”)”.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kubo, Ozawa, and Nie as applied to claim 1 above, and further in view of Saito US20120116192 .
Kubo does not disclose for claim 4, “The method of claim 1, wherein said first property is oxygen level, and the first one or more wavelengths include at least two wavelengths selected from green light at 520-560 nm”. Saito teaches in the same field of endeavor, oxygen saturation level imaging by using imaging signals corresponding to multiple reflected light having different wavelengths in the range of 460 nm to 700 nm including reflected light having two or more wavelength ranges where the light absorption coefficient changes according to the blood hemoglobin oxygen saturation level and reflected light having one or more wavelength ranges where light absorption coefficient does not change 0062. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Saito into the invention of Kubo in order to configure the method e.g. as claimed because it enables information on the blood amount and the oxygen saturation level to be obtained while reducing the effects produced by the blood vessel depth (0062).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kubo, Ozawa, and Nie as applied to claim 1 above, and further in view of Chen US20180020932 .
Kubo does not disclose for claim 6, “The method of claim 1, wherein said first property is perfusion of biological surfaces level, and the first one or more wavelengths is a single wavelength selected form 630-850 nm”. Chen teaches in the same field of endeavor, spectral imaging with wavelengths between 400 – 700 nm (0061). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Chen into the invention of Kubo in order to configure the method e.g. as claimed because it “reveals the underlying blood flow physiology and correlates both to the motion of the sample and also movement of blood flow and perfusion 0061.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAE K WOO whose telephone number is (571)272-0837. The examiner can normally be reached M-F 8:30-2:30p, 6p-9p.
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/Jae Woo/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
10/24/2025