DETAILED ACTION
This office action is responsive to original claims filed on 09/26/2024. Presently, Claims 1 - 10 remain pending.
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 § 102
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 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, 5 and 7-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ikeshita et al (US 20180093104 A1; hereafter Ikeshita).
With regard to Claim 1, Ikeshita discloses an image processing device comprising a processor comprising hardware (Ikeshita, Para 0022; “… the present technology provides a light irradiation device equipped with a light irradiation unit …”), the processor being configured to:
generate a white light image based on a white light which is made of a light having a wavelength band of visible light range (Ikeshita, Para 0106; “The natural light observation camera that is a second imaging unit 31 images surgical field 50 observed with the light from a lighting for natural light 40.”);
generate an absorption band light image (Ikeshita, Para 0104; “… a first imaging unit for imaging an image by the fluorescence emitted from a cell into which a photosensitive compound capable of generating singlet oxygen has been incorporated …”) indicating an absorption degree of a light having a wavelength band of Soret band which is absorbed by a drug accumulated in a target region for treatment (Ikeshita, Para 0103; “… irradiating a cell into which a photosensitive compound capable of generating singlet oxygen has been incorporated with a pulse laser having a wavelength within a Soret band …”); and
generate a display image based on the white light image and the absorption band light image (Ikeshita, Para 0122; “… the PDD/PDT image is superimposed on the natural light observation image by matching the positions so that an image (fusion image) can be formed.”).
With regard to Claim 5, Ikeshita discloses the image processing device according to Claim 1, wherein the processor is further configured to switch between a white light observation mode in which the white light image is displayed in a display and an absorption band light observation mode in which a display image including an absorption band light image is displayed in the display (Ikeshita, Para 0119; “… two images can be displayed on one monitor while switching between the two images.”).
With regard to Claim 7, Ikeshita discloses a phototherapy system (Ikeshita, Abstract; “The present invention provides a light irradiation method using a pulse laser, which can be applied to technology of PDD and/or PDT, and a system for treating a tumor, which has an enhanced tumoricidal effect.”) comprising:
a white light emitter configured to emit a white light made of a light having a wavelength band of visible light range (Ikeshita, Para 0106; “Herein, as lighting for natural light 40, a usually used shadowless lamp can be used …”);
an absorption band light emitter configured to emit an absorption band light made of a light having a wavelength band of Soret band (Ikeshita, Para 0099; “The light irradiation device of the present technology is equipped with … a pulse laser having a wavelength within a Soret band.”) which is absorbed by a drug accumulated in a target region for treatment (Ikeshita, Para 0108; “If the PDD is performed, irradiation of a surgical field is performed with the light that excites the above-described photosensitive compound, …”);
an image processing device configured to generate an image based on either the white light or the absorption band light (Ikeshita, Para 0118; “a natural light observation camera and a camera for PDD observation/PDT are also connected to a camera controller/image processing device, these cameras are controlled by a camera controller, the obtained image is processed in an image processing device, …”); and
a display configured to display the image generated by the image processing device (Ikeshita, Para 0118; “the image data of the camera controller/image processing device is displayed on monitors 1 and 2.”), the image processing device comprising a processor comprising hardware, the processor being configured to:
generate a white light image based on the white light (Ikeshita, Para 0106; “The natural light observation camera that is a second imaging unit 31 images surgical field 50 observed with the light from a lighting for natural light 40.”);
generate an absorption band light image indicating an absorption degree of the light having the wavelength band of the Soret band (Ikeshita, Para 0104; “… a first imaging unit for imaging an image by the fluorescence emitted from a cell into which a photosensitive compound capable of generating singlet oxygen has been incorporated …”), and
generate a display image based on the white light image and the absorption band light image (Ikeshita, Para 0122; “… the PDD/PDT image is superimposed on the natural light observation image by matching the positions so that an image (fusion image) can be formed.”).
With regard to Claim 8, Ikeshita discloses an image processing method comprising:
generating a white light image based on a white light which is made of a light having a wavelength band of visible light range (Ikeshita, Para 0106; “The natural light observation camera that is a second imaging unit 31 images surgical field 50 observed with the light from a lighting for natural light 40.”);
generating an absorption band light image (Ikeshita, Para 0104; “… a first imaging unit for imaging an image by the fluorescence emitted from a cell into which a photosensitive compound capable of generating singlet oxygen has been incorporated …”) indicating an absorption degree of a light having a wavelength band of Soret band which is absorbed by a drug accumulated in a target region for treatment (Ikeshita, Para 0103; “… irradiating a cell into which a photosensitive compound capable of generating singlet oxygen has been incorporated with a pulse laser having a wavelength within a Soret band …”); and
generating a display image based on the white light image and the absorption band light image (Ikeshita, Para 0122; “… the PDD/PDT image is superimposed on the natural light observation image by matching the positions so that an image (fusion image) can be formed.”).
With regard to Claim 9, Ikeshita discloses a non-transitory computer-readable recording medium with an executable program stored thereon (As discussed in Claim 1 above, Ikeshita discloses an image processing device. A person having ordinary skill in the art would understand that the device in Ikeshita includes a non-transitory computer-readable recording medium with an executable program stored thereon, the program causing a computer to execute to image acquisition steps described in Ikeshita.), the program causing a computer to execute:
generating a white light image based on a white light which is made of a light having a wavelength band of visible light range (Ikeshita, Para 0106; “The natural light observation camera that is a second imaging unit 31 images surgical field 50 observed with the light from a lighting for natural light 40.”);
generating an absorption band light image (Ikeshita, Para 0104; “… a first imaging unit for imaging an image by the fluorescence emitted from a cell into which a photosensitive compound capable of generating singlet oxygen has been incorporated …”) indicating an absorption degree of a light having a wavelength band of Soret band which is absorbed by a drug accumulated in a target region for treatment (Ikeshita, Para 0103; “… irradiating a cell into which a photosensitive compound capable of generating singlet oxygen has been incorporated with a pulse laser having a wavelength within a Soret band …”); and
generating a display image based on the white light image and the absorption band light image (Ikeshita, Para 0122; “… the PDD/PDT image is superimposed on the natural light observation image by matching the positions so that an image (fusion image) can be formed.”).
With regard to Claim 10, Ikeshita discloses a phototherapy method comprising:
administering a drug for phototherapy to a target region for treatment (Ikeshita, Para 0098; “In the photosensitive compound, for example, in talaporfin (Laserphyrin), if talaporfin is administered to a tumor cell as talaporfin sodium of a pharmaceutical preparation for injection, talaporfin accumulates in a tumor cell.”);
applying an absorption band light to the target region for treatment to obtain an absorption band light image that indicates an absorption degree of the absorption band light (Ikeshita, Para 0108; “If the PDD is performed, irradiation of a surgical field is performed with the light that excites the above-described photosensitive compound, …”), the absorption band light including a wavelength band of Soret band (Ikeshita, Para 0099; “The light irradiation device of the present technology is equipped with … a pulse laser having a wavelength within a Soret band.”) and having a wavelength band lower than an excitation wavelength of the drug (Ikeshita, Para 0073; “Specifically, the wavelength of the pulse laser is 300 nm or more to 500 nm or less”; Para 0074; “In the conventional PDT, the irradiation is performed with a laser at 664±2 nm if talaporfin is used, and with a laser at 630 nm if porfimer is used.” The Soret band of 300-500 nm is lower than the excitation wavelength of 630 or 664 nm for the drugs.);
generating a display image that includes the absorption band light image (Ikeshita, Para 0120; “In FIG. 5, an example of an image taken by a camera for PDD observation/PDT is shown. Tumor 53 is observed by fluorescence.”);
displaying the display image (Ikeshita, Para 0118; “the image data of the camera controller/image processing device is displayed on monitors 1 and 2.”);
observing the absorption band light image to confirm an amount of accumulation of the drug (Ikeshita, Para 0121; “This PDD/PDT image shows only the tumor cells to which photosensitive compound has accumulated, therefore, the surgeon can easily know the presence or absence of tumor cells.”); and
applying a treatment light onto the target region for treatment to cause the drug that is bound to the target region for treatment to react (Ikeshita, Para 0142; “Into the dish B, talaporfin at 10 μg/ml was added. After each dish was incubated for 24 hours, the irradiation with a pulse laser having a wavelength of 405 nm, … was performed for 30 minutes.” Fig.8 shows that the treatment light causes the drug to react and significantly kill the cultured cells.).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Ikeshita, in view of Kaku et al (US 20140316283 A1; hereafter Kaku).
With regard to Claim 2, Ikeshita discloses all the limitations of Claim 1 as discussed above. Ikeshita does not clearly and explicitly disclose wherein the processor is further configured to
divide a blue signal by a green signal to standardize a signal value of the blue signal, the blue signal being based on a light having a wavelength band of blue color, the green signal being is based on a light having a wavelength band of green color, and
generate the absorption band light image using the standardized signal value of the blue signal.
Kaku in the same field of endeavor discloses disclose wherein the processor is further configured to
divide a blue signal by a green signal to standardize a signal value of the blue signal, the blue signal being based on a light having a wavelength band of blue color, the green signal being is based on a light having a wavelength band of green color (Kaku, Para 0059; “the B/G ratio indicates a brightness ratio of pixels at the same position between the blue signal B and the green signal G.”), and
generate the absorption band light image using the standardized signal value of the blue signal (Kaku, Para 0059; “The B/G image generation section 61 generates a B/G image having a brightness ratio B/G (B/G ratio) between the blue signal B and the green signal G.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ikeshita, as suggested by Kaku, in order to generate an image based on the ratio of blue signal over green signal. One of ordinary skill in the art would have been motivated to make the modification for the benefit of reliably visualizing the blood vessels to be observed (Kaku, Para 0070; “by extracting only an image of the blood vessel to be observed from the B/G image and generating a blood vessel enhancement image or suppression image using the extracted blood vessel image, only the blood vessel portion to be observed can be reliably enhanced/suppressed without eliminating the information of portions other than the blood vessel, for example, the information of unevenness of a part to be observed.”).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Ikeshita, in view of Kaku, further in view of Hayashi et al (US 20010049473 A1; hereafter Hayashi).
With regard to Claim 3, Ikeshita discloses all the limitations of Claim 1 as discussed above. Ikeshita does not clearly and explicitly disclose wherein the processor is further configured to
divide a blue signal by a sum of a signal value of the blue signal, a signal value of a red signal, and a signal value of a green signal to standardize the signal value of the blue signal, the blue signal being based on a light having a wavelength band of blue color, the red signal being based on a light having a wavelength band of red color, the green signal being based on a light having a wavelength band of green color, and
generate the absorption band light image using the standardized signal value of the blue signal.
Kaku in the same field of endeavor discloses wherein the processor is further configured to
divide a blue signal by a signal value of a green signal to standardize the signal value of the blue signal, the blue signal being based on a light having a wavelength band of blue color, the green signal being based on a light having a wavelength band of green color (Kaku, Para 0059; “the B/G ratio indicates a brightness ratio of pixels at the same position between the blue signal B and the green signal G.”), and
generate the absorption band light image using the standardized signal value of the blue signal (Kaku, Para 0059; “The B/G image generation section 61 generates a B/G image having a brightness ratio B/G (B/G ratio) between the blue signal B and the green signal G.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ikeshita, as suggested by Kaku, in order to generate an image based on the ratio of blue signal over green signal. One of ordinary skill in the art would have been motivated to make the modification for the benefit of reliably visualizing the blood vessels to be observed (Kaku, Para 0070; “by extracting only an image of the blood vessel to be observed from the B/G image and generating a blood vessel enhancement image or suppression image using the extracted blood vessel image, only the blood vessel portion to be observed can be reliably enhanced/suppressed without eliminating the information of portions other than the blood vessel, for example, the information of unevenness of a part to be observed.”).
Ikeshita and Kaku do not explicitly and clearly disclose including a signal value of the blue signal and a signal value of a red signal in the denominator of the division operation.
Hayashi in the same field of endeavor explicitly and clearly discloses including a signal value of the blue signal and a signal value of a red signal in the denominator of the division operation (Hayashi, Para 0235; “the signal processing circuit 421 forms the pseudo color image signals based on a relative value of the signal intensity corresponding to the blue wavelength range, i.e., the value of the signal intensity corresponding to the blue wavelength range when divided by the total signal intensity.”) (Hayashi, Para 0248; “The fluorescence image 41 is displayed with pseudo colors, such that the display color varies in accordance with the relative value of the signal intensity B3, i.e., the value of the signal intensity B3 when divided by the total signal intensity W3.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ikeshita and Kaku, as suggested by Hayashi, in order to generate an image based on the ratio of blue signal over the sum of blue, red and green signals. One of ordinary skill in the art would have been motivated to make the modification for the benefit of performing a division operation to cancel off the variance in distance (Hayashi, Para 0171; “in this structure, the non-uniformity Iλex of the irradiance of the excitation light, depending upon sites, is canceled.”) and avoiding division error by using a large denominator (Hayashi, Para 0224; “As it is quite rare that the value of the total signal intensity W2 becomes zero, an operation error due to division by the value of zero hardly occurs.”).
With regard to Claim 4, Ikeshita discloses all the limitations of Claim 1 as discussed above. Ikeshita does not clearly and explicitly disclose wherein the processor is further configured to
divide a blue signal by a sum of a signal value of a red signal, and a signal value of a green signal to standardize the signal value of the blue signal, the blue signal being based on a light having a wavelength band of blue color, the red signal being based on a light having a wavelength band of red color, the green signal being based on a light having a wavelength band of green color, and
generate the absorption band light image using the standardized signal value of the blue signal.
Kaku in the same field of endeavor discloses wherein the processor is further configured to
divide a blue signal by a signal value of a green signal to standardize the signal value of the blue signal, the blue signal being based on a light having a wavelength band of blue color, the green signal being based on a light having a wavelength band of green color (Kaku, Para 0059; “the B/G ratio indicates a brightness ratio of pixels at the same position between the blue signal B and the green signal G.”), and
generate the absorption band light image using the standardized signal value of the blue signal (Kaku, Para 0059; “The B/G image generation section 61 generates a B/G image having a brightness ratio B/G (B/G ratio) between the blue signal B and the green signal G.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ikeshita, as suggested by Kaku, in order to generate an image based on the ratio of blue signal over green signal. One of ordinary skill in the art would have been motivated to make the modification for the benefit of reliably visualizing the blood vessels to be observed (Kaku, Para 0070; “by extracting only an image of the blood vessel to be observed from the B/G image and generating a blood vessel enhancement image or suppression image using the extracted blood vessel image, only the blood vessel portion to be observed can be reliably enhanced/suppressed without eliminating the information of portions other than the blood vessel, for example, the information of unevenness of a part to be observed.”).
Ikeshita and Kaku do not explicitly and clearly disclose including a signal value of a red signal in the denominator of the division operation.
Hayashi in the same field of endeavor explicitly and clearly discloses including a signal value of a red signal in the denominator of the division operation (Hayashi, Para 0155; “… divided by the fluorescence sum component (for example, G+R), which is the sum of the short wavelength component (for example, the green wavelength component G) and the long wavelength component …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ikeshita and Kaku, as suggested by Hayashi, in order to generate an image based on the ratio of blue signal over the sum of red and green signals. One of ordinary skill in the art would have been motivated to make the modification for the benefit of as yet another option for keeping the denominator for the division large and thus avoiding operation error (Hayashi, Para 0155; “the value of the denominator can be kept large. Therefore, the occurrence of an operation error due to division by the value of zero can be restrained”).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Ikeshita, in view of Prasad et al (US 20170050045 A1; hereafter Prasad).
With regard to Claim 6, Ikeshita discloses all the limitations of Claim 1 as discussed above. Ikeshita further discloses wherein
the wavelength band of the Soret band is equal to or smaller than 450 nm (Ikeshita, Para 0073; “a wavelength included in a Soret band … the upper limit of the wavelength is preferably 450 nm or less, more preferably 420 nm, and furthermore preferably 415 nm or less”).
Ikeshita does not clearly and explicitly disclose that a wavelength band for causing excitation of the drug is equal to or greater than 680 nm.
Prasad in the same field of endeavor discloses that a wavelength band for causing excitation of the drug is equal to or greater than 680 nm (Prasad, Para 0038; “The incident light (i.e., electromagnetic radiation) is coherent, pulsed electromagnetic radiation. The incident light is also referred to herein as a laser wave. The incident light has a wavelength of from 700 nm to 1.4 microns …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ikeshia, as suggested by Prasad, in order to use light of the range of wavelength for exciting the drug. One of ordinary skill in the art would have been motivated to make the modification for the benefit of exciting the accumulated drug in deep tissue (Prasad, Para 0023; “Application of NIR radiation, followed by in situ up-conversion to visible light, provides deep tissue penetration for PDT, thus addressing a major hurdle in the current treatment of remote and thick tissues.”).
Conclusion
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/L.Z./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798