DETAILED ACTION
Summary
Claims 1-22 are pending in the application. Claims 1-22 are rejected under 35 USC 103.
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 12 objected to because of the following informalities:
Claim 12 recites “a narrow-band LED source” in line 3. It should recite “a narrow-band light-emitting diode (LED) source”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 9-10, 12-14, and 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Ikenaga et al (U.S PGPub 2019/0170647 A1) in view of Frangioni (U.S PGPub 2005/0182321 A1).
Regarding Claim 1, Ikenaga teaches a medical multi-dye fluorescence imaging system (Abstract) comprising:
a controller (Fig. 2, 139) comprising hardware [0039],
a plurality of light sources (Fig. 4, 1431+1433) controlled by the controller [0035]+[0083],
at least one imaging unit comprising a first image sensor sensitive in a visible light spectrum (Fig. 4, 1051) [0092] and a second image sensor sensitive in one or more of a far red and a near infrared light spectrum (Fig. 4, 1052) [0092],
the controller [0039] being configured to:
receive first image data from the first image sensor and second image data from the second image sensor and combine the first and second image data into composite images in which fluorescent images are overlayed over back- ground images [0100],
control the plurality of light sources according to a first lighting mode for at least one first predetermined fluorescent dye fluorescing in the visible light spectrum [0078]+[0088], the first lighting mode comprising:
activating a first light source of the plurality of light sources configured to produce excitation light for the at least one first predetermined dye in the visible light spectrum [0088],
activate a second light source of the plurality of light sources configured to produce light in one of the far red and the near infrared light spectrum [0089]-[0090].
While it is implied that the first image data is overlaid on the second image data in the first lighting mode, Ikenaga fails to explicitly teach overlay the first image data from the first image sensor over the second image data from the second image sensor.
Frangioni teaches a system for NIR and visible light imaging (Abstract). This system overlays images data with fluorescence in the visible spectrum with NIR image data [0120]-[0122].
It would have been obvious to one of ordinary skill in the art before the effective filing date to overlay the first image data from the first image sensor over the second image data from the second image sensor, as taught by Frangioni, because this provides better functional images of the subject, as recognized by Frangioni [0004].
Regarding Claim 9, the combination of references teaches the invention substantially as claimed. Ikenaga further teaches wherein the at least one imaging unit is a video endoscope [0027]+[0029] having imaging optics [0031] and the first and second image sensors [0031]+[0092].
Regarding Claim 10, the combination of references teaches the invention substantially as claimed. Ikenaga further teaches wherein the at least one imaging unit comprises one or more camera heads (Fig. 4, 105) comprising the first and second image sensors (Fig. 4, 1052+1051) [0092], and exchangeable optical devices [0093].
Regarding Claim 12, the combination of references teaches the invention substantially as claimed. Ikenaga further teaches wherein the first light source for producing excitation light comprises one of a laser source [0050].
Regarding Claim 13, the combination of references teaches the invention substantially as claimed. Ikenaga further teaches wherein one or more of the first light source [0050] and/or filters [0092]+[0094] being tuned to excite pre-specified fluorescent dyes [0052]+[0088].
Regarding Claim 14, the combination of references teaches the invention substantially as claimed. Ikenaga further teaches a light source unit (Fig. 4, 143) comprising the plurality of light sources (Fig. 4, 1431+1433) [0083].
Regarding Claim 18, Ikenaga teaches a method of medical multi-dye fluorescence imaging (Abstract) comprising:
receiving first image data from a first image sensor (Fig. 4, 1051) [0092] and second image data from a second image sensor Fig. 4, 1052) [0092] and combining the first and second image data into composite images in which fluorescent images are overlayed over background images [0100],
controlling a plurality of light sources according to a first lighting mode for at least one first predetermined fluorescent dye fluorescing in the visible light spectrum [0078]+[0088], the first lighting mode comprising:
activating a first light source of the plurality of light sources configured to produce excitation light for the at least one first predetermined dye in the visible light spectrum [0088],
activating a second light source of the plurality of light sources configured to produce light in one of a far red and a near infrared light spectrum [0089]-[0090].
While it is implied that the first image data is overlaid on the second image data in the first lighting mode, Ikenaga fails to explicitly teach overlaying the first image data from the first image sensor over the second image data from the second image sensor.
Frangioni teaches a system for NIR and visible light imaging (Abstract). This system overlays images data with fluorescence in the visible spectrum with NIR image data [0120]-[0122].
It would have been obvious to one of ordinary skill in the art before the effective filing date to overlay the first image data from the first image sensor over the second image data from the second image sensor, as taught by Frangioni, because this provides better functional images of the subject, as recognized by Frangioni [0004].
Regarding Claim 19, the combination of references teaches the invention substantially as claimed. Ikenaga further teaches wherein in a second lighting mode for a second predetermined dye fluorescing in the far red and/or the near infrared spectrum [0100], the method further comprising:
generating white illumination light [0050]+[0100] and a second narrow band fluorescence excitation light in the far red or near infrared spectrum [0100]
taking background image data with the first image sensor sensitive in the visible spectrum and taking fluorescent image data with the second image sensor sensitive in the far red or the near infrared spectrum [0100], and
wherein the far red or the near infrared spectrum fluorescent image data are overlaid over the visible spectrum background image data [0100].
Regarding Claim 20, the combination of references teaches the invention substantially as claimed. Ikenaga further teaches filtering light having the wavelength of the first fluorescence excitation light from the first light source out from light impinging on the first image sensor (Fig. 4, 1055) [0092]+[0094], and letting through light having the wavelength of a second fluorescence excitation light onto the second image sensor [0096] (the second excitation light would be an infrared light, and the filter lets infrared light onto the image sensor).
Regarding Claim 21, the combination of references teaches the invention substantially as claimed. Ikenaga further teaches wherein in the second lighting mode, the method comprising filtering light having the wavelength of the second narrow band fluorescence excitation light out from light impinging on the second image sensor [0094].
Regarding Claim 22, the combination of references teaches the invention substantially as claimed. Ikenaga further teaches wherein in the first lighting mode, the method comprising generating light from the second light source in a wavelength range lying at least partially outside second fluorescence excitation wavelength bands being filtered out from impinging on the second image sensor [0089]+[0094] (the notch filter only blocks the wavelength of excitation light, whereas the infrared light source emits light with a portion outside of the excitation band)
Claims 2-8, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ikenaga in view of Frangioni as applied to claim 1 above, and further in view of Stith et al. (U.S PGPub 2022/0007942 A1).
Regarding Claim 2, the combination of references teaches the invention substantially as claimed. Ikenaga further teaches wherein the controller is further configured to control the plurality of light sources according to a second lighting mode for at least one second predetermined fluorescent dye fluorescing in one of the far red and the near infrared light spectrum [0100], the second lighting mode comprising:
activating a light source of the plurality of light sources configured to produce excitation light for the at least one second predetermined dye in one of the far red and the near infrared light spectrum [0100],
activating a light source of the plurality of light sources configured to produce white illumination light [0050]+[0100], and
overlaying the second image data from the second image sensor over the first image data from the first image sensor [0100].
Ikenaga fails to explicitly teach a third light source and a fourth light source.
Stith teaches an imaging system for imaging different fluorescent agents (Abstract). This system uses a third light source for excitation light (Fig. 1, 118) and a fourth light source for white light [0044] (Fig. 1, 116) [0053]-[0054].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have a third and fourth light source, as taught by Stith, because different fluorescing imaging agents require being illuminated at different wavelengths, and having additional light sources allows the system to be used in a greater number of fluorescent imaging procedures, as recognized by Stith [0004]+[0055].
Regarding Claim 3, the combination of references teaches the invention substantially as claimed. Ikenaga further teaches wherein the at least one imaging unit comprising at least one of: at least one first filter configured and located to prevent excitation light from the first light source from reaching the first image sensor; and at least one second filter configured and located to prevent excitation light from the third light source from reaching the second image sensor (Fig. 4, 1055) [0092]+[0094].
Regarding Claim 4, the combination of references teaches the invention substantially as claimed. Ikenaga further teaches wherein the second light source being configured to emit light in a spectrum lying at least partially outside of any frequencies filtered out by the at least one second filter [0089]+[0094] (the notch filter only blocks the wavelength of excitation light, whereas the infrared light source emits light with a portion outside of the excitation band).
Regarding Claim 5, the combination of references teaches the invention substantially as claimed. Ikenaga further teaches wherein at least one of the at least one first filter and the at least one second filter being movable into and out of a beam path for the first image sensor and the second image sensor, respectively [0094] (the notch filter is detachable, which means it is moveable into and out of a beam path for the second sensor).
Regarding Claim 6, the combination of references teaches the invention substantially as claimed. Ikenaga further teaches wherein in the first lighting mode, the controller being configured to activate the light source as the second light source [0089]-[0090].
Ikenaga fails to explicitly teach a third light source.
Stith teaches an imaging system for imaging different fluorescent agents (Abstract). This system uses a third light source for excitation light (Fig. 1, 118) and a fourth light source for white light [0044] (Fig. 1, 116) [0053]-[0054].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the second light source of Ikenaga with a third light source, as taught by Stith, as the substitution for one known method of generating infrared light with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using the third light source to generate excitation light in the infrared wavelength are reasonably predictable..
Regarding Claim 7, the combination of references teaches the invention substantially as claimed. Ikenaga further teaches wherein at least one of: the at least one imaging unit having the at least one first filter and not having the at least one second filter [0094] (the system is capable of choosing a single filter based on the targeted fluorescent dye, if the dye is a visible light dye it would not have the second filter [0126]); and/or the at least one second filter movable out of the light path for the second image sensor [0094] (the notch filter is detachable, which means it is moveable into and out of a beam path for the second sensor).
Regarding Claim 8, the combination of reference teaches the invention substantially as claimed. Ikenaga further teaches wherein the at least one imaging unit comprising at least two interchangeable camera units [0098]-[0099] (as both imaging sensors 1051+1052 are CCD or CMOS, they are “interchangeable devices), the at least two interchangeable camera units comprising a first camera unit having at least one filter configured and arranged for the first lighting mode and a second camera unit having at least one filter configured and arranged for the second lighting mode [0098]-[0099] (the camera units each have filters and they are used for the different lighting modes (RGB filter 211 and infrared filter 213).
Regarding Claim 15, the combination of references teaches the invention substantially as claimed. Ikenaga further teaches wherein at least one of the second light source and the fourth light source (Fig. 4, 1433 can be considered a second light source, 1431 can be considered a fourth light source) is located in one of a light source unit (Fig. 4, 143) [0083].
Regarding Claim 16, the combination of references teaches the invention substantially as claimed. Ikenaga further teaches wherein at least one of the at least one first filter and/or the at least one second filter is one of a single, double or triple notch filter (Fig. 4, 1055) [0092]+[0094 (the notch filter is a single notch filter).
Regarding Claim 17, the combination of references teaches the invention substantially as claimed. Ikenaga further teaches wherein at least one of the first and second filters is located in at least one of a camera head and an exchangeable optical device [0094].
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ikenaga in view of Frangioni as applied to claim 10 above, and further in view of Bala (U.S PGPub 2005/0113641 A1).
Regarding Claim 11, the combination of references teaches the invention substantially as claimed. Ikenaga further teaches wherein the exchangeable optical devices comprise at least one of optics for endoscopic procedures [0093].
Ikenaga fails to explicitly teach the optics (i.e. lens barrel) is a telescope.
Bala teaches an endoscope system (Abstract). This system has a telescopic endoscope lens barrel [0002].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combine system to use a telescopic design, as taught by Bala, because this allows the lens to remain in focus throughout the operating range, as recognized by Bala [0002].
Response to Arguments
Applicant's arguments filed 1/6/2026 have been fully considered but they are not persuasive.
Applicant’s arguments, see pages 9-10, filed 1/6/2026, with respect to the rejection under 35 USC 112(b) related to the phrase “narrow-band” have been fully considered and are persuasive. The rejection under 35 USC 112(b) of claims 12 and 16 has been withdrawn.
Applicant argues that Claim 1 is not taught by the combination or Ikenaga and Frangioni. The Examiner disagrees. Ikenaga teaches capturing images simultaneously in the visible light spectrum and the near-infrared light spectrum [0092]. This system teaches obtaining fluorescent images in the visible light band [0078], while also obtaining background images in the near infrared spectrum (i.e. light received through the biological window and emitted at the same time as the visible light used for obtaining the visible light fluorescence) [0078]+[0088]-[0090]. Frangioni is relied on to teach the processing of a composite image. In Frangioni, a dye image is combined with a non-dye image to aid with the surgical procedure [0120]-[0122]. One of ordinary skill would recognize that, as the teachings of Ikenaga teach the visible light image is the dye based image, and the NIR image is the non-dye image, the combination would result in the visible light image being overlaid on the NIR image, thereby generating the composite image as claimed. Therefore, the combination of Ikenaga and Frangioni suggest the claimed invention to one of ordinary skill in the art, and the rejection under 35 USC 103 is maintained.
Applicant argues that Imaizumi does not teach the features of claim 11. However, Imaizumi was not relied on to teach claim 11, and the argument is moot.
Claim 18 remains rejected under 35 USC 103 for similar reasons detailed above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SEAN D MATTSON/Primary Examiner, Art Unit 3798