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 1-5 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 recites the limitation "the first filter is located in front of the near-infrared image acquisition mechanism, “the near-infrared light source is located in front of the first filter”, “the second filter is located in front of the near-infrared light source”, “a first polarizer, which is located in front of the first filter and behind the near-infrared light source”, “a second polarizer, which is located in front of the second filter”.
These limitations are indefinite because it is unclear which part of each component is the “front” side and the “back” side. Further defining which side of each component is intended as the front or back (e.g., based on the travel direction of light), or which components are between each other, would clarify the arrangement of parts and resolve the indefiniteness of the claim 1.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Butte et. al. (WO 2019191497 A1) and further in view of Zhang et. al. (CN214180383U) and Powers et. al. (US 20190208998A1).
Regarding claim 1, Butte teaches “An imaging device” (Para [0004], imaging device); “for AMI diagnosis”, ( Para[ 0194], Diagnostic tests can be used to enhance the use of therapeutic products, such as those disclosed herein or other known agents. The development of therapeutic products with a corresponding diagnostic test, such as a test that uses diagnostic imaging,); “comprising an imaging part” (Fig. 7A, Para [0102], camera, SP filter, Polarized ND filter. For a single camera design, a visible light filter, neutral density filter or LCD filter or any other optical element which passively or actively reduce the total amount of light passing through) e.g., 23 in FIG. 7A, is required to step down the intensity of the white light, while passing the NIR. In some embodiments, a shutter (e.g. LCD shutter, or ‘filter wheel,’ electronic variable optical attenuator (EVOA), an optical ‘chopper’, or a combination of polarizers can be synchronized to the excitation signal in order to selectively attenuate the visible light, but not the NIR.); “and a light source part,” (Para [0006], a light source configured to emit excitation light to induce fluorescence from the sample).
The recitation “wherein the light source part is configured to excite indocyanine green in a sample to produce a fluorescent light,” is a capability of the light source. However, Butte teaches a light source configured to emit fluorescence within Para [0006].
The recitation “the imaging part is configured to acquire a near-infrared image of the sample and comprises a near-infrared image acquisition mechanism” is also interpreted as a capability. However, this limitation is taught by Butte (Fig. 7A, VID/NIR lens coupled to camera).
Further taught by Butte, “and a first filter, the first filter is located in front of the near-infrared image acquisition mechanism,” (Fig. 7, SP filter);
“the light source part comprises a near-infrared light source” (Abstract, a light source configured to emit infrared light, [0084] At least one of the illumination source and the excitation source can be a visible, red, infrared (IR) near-infrared (NIR), ultraviolet, or blue light);
“and a second filter,” ((Para, [0085], The excitation light source can comprise a laser or a wide and source (e.g., light emitting diode (LED)) coupled to a band pass filter.);
“the near-infrared light source is located in front of the first filter,” (7A, laser in front of first filter.);
“the second filter is located in front of the near-infrared light source,” Fig. 7A, dichronic short pass, [0085], The excitation light source can comprise a laser or a wide band source (e.g., light emitting diode (LED)) coupled to a band pass filter.));
“the imaging part further comprises a first polarizer,” (Fig. 16, [0102] In some embodiments, for a single camera design, a visible light filter, neutral density filter or LCD filter or any other optical element which passively or actively reduce the total amount of light passing through) e.g., 23 in FIG. 7A, is required to step down the intensity of the white light, while passing the NIR. In some embodiments, a shutter (e.g. LCD shutter, or ‘filter wheel,’ electronic variable optical attenuator (EVOA), an optical ‘chopper’, or a combination of polarizers can be synchronized to the excitation signal in order to selectively attenuate the visible light, but not the NIR.);
“which is located in front of the first filter and behind the near-infrared light source, (Fig. 7A, [0102] In some embodiments, for a single camera design, a visible light filter, neutral density filter or LCD filter or any other optical element which passively or actively reduce the total amount of light passing through) e.g., 23 in FIG. 7A, is required to step down the intensity of the white light, while passing the NIR. In some embodiments, a shutter (e.g. LCD shutter, or ‘filter wheel,’ electronic variable optical attenuator (EVOA), an optical ‘chopper’, or a combination of polarizers.);
“the light source part further comprises a second polarizer, which is located in front of the second filter,” (Para [0135], and Fig. 7A, 23, polarized, and Para [0102], or a combination of polarizers. In FIG. 6B, the LC attenuator polarizes (e.g., accepts linearly polarized light, rejecting other axis, as the LC is sandwiched between two polarizers)).
For the purpose of examination, the polarizer of Butte is interpreted as located in front of the filter and the filter is interpreted as located in front of the light source, with respect to the travel direction of the light.
Further taught by Butte, “the near-infrared image acquisition mechanism, the first filter, the first polarizer, the near-infrared light source, the second filter and the second polarizer are located on a same light path,” (Fig. 7A);
“light holes are formed in a center of the near-infrared light source, a center of the second filter and a center of the second polarizer and communicated in a front-back direction, the fluorescent light produced by the sample enters the imaging part via the light holes,” (Paras [0006] and [0115], In some embodiments, the light source comprises: a laser or narrow-band light source; an optical light guide coupled to the laser or narrow-band light source; a collimating lens into which the light guide ends; a laser clean-up filter; a dielectric mirror; a diffuser; a hole; or a combination thereof. In some embodiments, the hole is configured to let pass at least part of the infrared light. The system of any one of the preceding claims, wherein excitation by the infrared light is substantially coaxial to the fluorescence or visible light collected from the sample. In some embodiments, the hole is in a near-infrared mirror. In some embodiments, the hole is shaped and sized to allow evenly distributed illumination of the sample within a field of view of a microscope. Para [0115], The coaxially light injection mechanism can comprise a through hole in one or more of the plurality of optics. It is understood that any type of optical transmission mechanism can be used in any of the embodiments of this system. The optical transmission mechanism can be configured to transmit infrared or near infrared light. The optical light can comprise a spliced or unspliced optical fiber. The diameter of the optical fiber can depend on the amount of power and the number of emitters in the excitation source, including the physics of collection optics.)
The plurality of optics comprising a through hole for the light mechanism in addition to the hole positioned to allow evenly distributed illumination corresponds to the light holes in the center as claimed.
Butte does not teach “the first polarizer and the second polarizer are both linear polarizers, and linear polarization directions of the first polarizer and the second polarizer are perpendicular to each other”.
However, Zhang teaches “the first polarizer and the second polarizer are both linear polarizers, and linear polarization directions of the first polarizer and the second polarizer are perpendicular to each other”. (Pages 2 and 3, first linear polarizer and a second linear polarizer whose light vector vibration directions are orthogonal to each other, The light vector vibration direction of the first linear polarizer 21 is the horizontal direction, and the light vector vibration of the second linear polarizer 22 The direction is the vertical direction.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Butte to incorporate the teachings of Zhang, wherein the both polarizers are linear polarizers which are perpendicular to each other. Doing so with a near-infrared light source whose position corresponds to the second linear polarizer allows for uniform illumination as taught by Zhang on page 4.
Further taught by Butte, “the first filter is a bandpass filter” (Para [0089], (It is understood that the short pass filter can alternatively be a bandpass or notch filter.)
Butte teaches a wavelength of approximately 700nm but does not explicitly teach “and has a central wavelength of 832 nm and a bandwidth of 37 nm”.
However, Powers teaches Fluorescent imaging systems in addition to “and has a central wavelength of 832 nm and a bandwidth of 37 nm”. (Para [0035] The second filter 180, e.g., an emission filter, may be used to isolate a signal emitted by the fluorophore from the excitation light source 115 with included first filter 175 as well as external sources centered near the excitation wavelength 780 nm. In some embodiments, an emission filter for ICG imaging may transmit wavelength between approximately 810 nm and 840 nm. For example, an emission filter may be an 832 nm center-wavelength bandpass filter with 38 nm bandwidth and high transmission (e.g., up to approximately 90%) of light in the passing region, and high blocking outside of the passing region (e.g., optical density approximately equal to or greater than 5). In embodiments, the second filter 180, or emission filter, may be alignable with the sensor 120 of the duodenoscope 105).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Butte to include the teachings of Powers and have the filter have a wavelength of 832 and a bandwidth of 37nm, to allow the isolation of a signal emitted by the fluorophore from the excitation light source as taught by Powers.
The claimed values and the prior art values are close enough that one skilled in the art would have expected them to have the same properties, per MPEP 2144.05 (I).
Further taught by Butte “the second filter is a bandpass filter or a short wave-pass filter,” (Para [0006], the plurality of optics comprises a dichroic shortpass beam splitter).
Butte does not explicitly teach “ in a case where the second filter is the bandpass filter, the second filter has a central wavelength of 769 nm and a bandwidth of 41 nm; in a case where the second filter is a short wave-pass filter, the second filter has a cut-off wavelength of 800-810 nm; the near-infrared light source has a central wavelength of 780 nm,”.
However, Powers teaches “in a case where the second filter is the bandpass filter, the second filter has a central wavelength of 769 nm and a bandwidth of 41 nm; in a case where the second filter is a short wave-pass filter, the second filter has a cut-off wavelength of 800-810 nm; the near-infrared light source has a central wavelength of 780 nm,” (Para [0035] The second filter 180, e.g., an emission filter, may be used to isolate a signal emitted by the fluorophore from the excitation light source 115 with included first filter 175 as well as external sources centered near the excitation wavelength 780 nm. In some embodiments, an emission filter for ICG imaging may transmit wavelength between approximately 810 nm and 840 nm. For example, an emission filter may be an 832 nm center-wavelength bandpass filter with 38 nm bandwidth and high transmission (e.g., up to approximately 90%) of light in the passing region, and high blocking outside of the passing region (e.g., optical density approximately equal to or greater than 5). In embodiments, the second filter 180, or emission filter, may be alignable with the sensor 120 of the duodenoscope 105.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Butte to include the teachings of Powers to have the filter have a wavelength between 800-810 and a central wavelength of 780nm. Having this wavelength range is good for imaging within a device as taught within Powers.
The claimed values and the prior art values are close enough that one skilled in the art would have expected them to have the same properties, per MPEP 2144.05 (I).
The limitation “when the AMI diagnosis needs to be performed on a suspected AMI patient, an indocyanine green saline solution with a concentration of 2.5-5 mg/ml is injected into the suspected AMI patient, the total amount of the ICG saline solution injected into the suspected AMI patient is determined according to the total weight of the suspected AMI patient, 0.5 mg of the ICG saline solution needs to be injected per kilogram, then, the suspected AMI patient, as the sample, stands at a preset position in front of the second polarizer, at this moment, the sample is located at an imaging center of the near-infrared image acquisition mechanism, the near-infrared image acquisition mechanism and the near-infrared light source are switched on, the near-infrared light source emits a beam with a central wavelength of 780 nm to the second filter, the beam is filtered by the second filter to allow a near-infrared beam within the wavelength range thereof to be emitted out and transmitted to the second polarizer, the second polarizer allows the emission of a modulated beam in the linear polarization direction thereof, then, the modulated beam is irradiated onto the sample, on one hand, ICG in the body of the sample is excited to produce the fluorescent light, and on the other hand, a reflected light is generated due to the specular reflection of the sample, the fluorescent light and the reflected light form a mixed light, which sequentially passes through the light holes in the center of the second polarizer, the center of the second filter and the center of the near-infrared light source is transmitted to the first polarizer, the first polarizer allows the light, in the linear polarization direction and the mixed light is passed through and irradiated onto the first filter, a irradiated light is filtered and allow light with a wavelength of 813-850 nm to pass through the near-infrared image acquisition mechanism, the near-infrared image acquisition mechanism acquires a light signal, generates a fluorescent image, and displays the near-infrared fluorescent image” recites a method of operation. Modified Butte teaches all of the positively claimed features of the device and therefore is capable of performing the claimed method steps (see MPEP 2114).
Regarding claim 4, Modified Butte teaches all of claim 1 as above in addition to “wherein the near-infrared image acquisition mechanism is a near-infrared camera.” (Para [0014], NIR camera).
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Butte et. al. (WO 2019191497 A1), Zhang et. al. (CN214180383U), and Powers et. al. (Us 20190208998A1) as applied to claim 1 above and in further view of Matsuda et. al. (WO 2015114950 A1).
Regarding claim 2, Modified Butte teaches all of claim 1 as above but does not explicitly teach “wherein the near-infrared light source has an illuminance of not less than 1000lx.”
Matsuda teaches a image capture device which has an imaging unit in addition to “wherein the near-infrared light source has an illuminance of not less than 1000lx.” (Description of embodiments Para [5], As an example, it is possible to consider the brightness at which the illuminance of the shooting target is 1000 to 10000 lx.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Butte to incorporate the teachings of Matsuda wherein the near-infrared light source has an illuminance of not less than 1000Ix. Having the correct illuminances improves color reproducibility and Matsuda teaches an optimal illuminance range if 1000 to 10000Ix which includes the claimed value.
Regarding claim 3, Modified Butte teaches all of claim 1 as above but does not explicitly teach “wherein the near-infrared light source has an illuminance greater than 1500lx.” (Description of embodiments Para [5], As an example, it is possible to consider the brightness at which the illuminance of the shooting target is 1000 to 10000 lx.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Butte to incorporate the teachings of Matsuda wherein the near-infrared light source has an illuminance greater than 1500 lx. Having the correct illuminances improves color reproducibility and Matsuda teaches an optimal illuminance range if 1000 to 10000Ix which includes the claimed value.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Butte et. al. (WO 2019191497 A1), Zhang et. al. (CN214180383U), and Powers et. al. (Us 20190208998A1) as applied to claim 1 above and in further view of Kang et. al. (KR 20140096773).
Regarding claim 5, modified Butte teaches all of claim 1 above in addition Butte teaches “wherein the first filter, the first polarizer and the near-infrared light source are all mounted on the near-infrared acquisition mechanism,” (Para [0102] In some embodiments, for a single camera design, a visible light filter, neutral density filter or LCD filter or any other optical element which passively or actively reduce the total amount of light passing through) e.g., 23 in FIG. 7A, is required to step down the intensity of the white light, while passing the NIR. In some embodiments, a shutter (e.g. LCD shutter, or ‘filter wheel,’ electronic variable optical attenuator (EVOA), an optica l‘chopper’, or a combination of polarizers).
Butte does not teach “and the second filter and the second polarizer are both mounted on the near-infrared light source.”.
Kang teaches measuring fluorescence, which can measure skin autofluorescence in order to perform evaluation on various diseases by measuring skin in addition to “and the second filter and the second polarizer are both mounted on the near-infrared light source.” (Pages 11 and 13, Fig. 5, Meanwhile, mounting holes may be formed in the through holes 531, 532, 533, and 534 formed in the pyramid-shaped holder so that a light source, a photodetector, a polarizer, a cross polarizer, and an optical filter are mounted in position. 511 and 512 light sources, 515 and 516 polarizers, 519, and 520 Optical filters.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Butte to incorporate the teachings of Kang wherein the second filter, polarizer are both mounted on the near-infrared light source. Doing so allows fixing to a measuring scanner (camera) as taught by Kang which increases ease of use and decreases the number of components needing to be mounted together at the end to function as one.
Conclusion
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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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