DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
CLAIM INTERPRETATION
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Such claim limitations is/are:
“an imaging unit … that disperses the white light from the endoscope into light of a plurality of wavelength ranges and acquires a base-image-generation image signal to be used to generate the base image and an oxygen-saturation-calculation image signal to be used to calculate the oxygen saturation, based on the dispersed light of the plurality of wavelength ranges.” (Claim 12)
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“an imaging unit … that disperses the white light from the endoscope into light of a plurality of wavelength ranges and acquires a base-image-generation image signal to be used to generate the base image and an oxygen-saturation-calculation image signal to be used to calculate the oxygen saturation, based on the dispersed light of the plurality of wavelength ranges.” (Claim 12): As identified by the Specification, the following is recognized as the corresponding structure to the imaging unit: “The tip part 12d of the endoscope 12 is provided with an illumination optical system 30 and an imaging optical system 31. The illumination optical system 30 has an illumination lens 32. The illumination light propagating through the light guide 25 is applied to the observation target via the illumination lens 32. The imaging optical system 31 has an objective lens 35 and an imaging sensor 36. Light from the observation target irradiated with the illumination light is incident on the imaging sensor 36 via the objective lens 35. As a result, an image of the observation target is formed on the imaging sensor 36.” Or equivalents thereof.
If applicant wishes to provide explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claim 1, the claim(s) recites “calculate the threshold value based on at least oxygen saturations in the threshold value calculation region, the oxygen saturations in the threshold value calculation region being calculated in accordance with a threshold value calculation operation.” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“generate a base image;”
“generate an oxygen saturation image in an oxygen saturation mode, the oxygen saturation image including a high-oxygen-saturation region and a low-oxygen-saturation region, the high-oxygen-saturation region being a region in which an oxygen saturation exceeds a threshold value and in which a color tone of the base image is controlled by a first color tone control method, the low-oxygen-saturation region being a region in which the oxygen saturation is less than or equal to the threshold value and in which the color tone of the base image is controlled by a second color tone control method different from the first color tone control method;”
“in a threshold value determination mode for determining the threshold value, display a threshold value calculation region on a display”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities and generic postsolution activity.
Furthermore, processors and displays are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of determining a threshold value for oxygen saturation to categorize information in a display and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself. Dependent claims 2-12 also do not add significantly more to the exception as they merely add details to the mental steps, add details to the extrasolution data gathering steps, add general field of use components to facilitate the extrasolution data gathering, and add mental steps.
Regarding Claim 13, the claim(s) recites “calculating the threshold value based on at least oxygen saturations in the threshold value calculation region, the oxygen saturations in the threshold value calculation region being calculated in accordance with a threshold value calculation operation.” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“generating a base image;”
“generating an oxygen saturation image in an oxygen saturation mode, the oxygen saturation image including a high-oxygen-saturation region and a low-oxygen-saturation region, the high-oxygen-saturation region being a region in which an oxygen saturation exceeds a threshold value and in which a color tone of the base image is controlled by a first color tone control method, the low-oxygen-saturation region being a region in which the oxygen saturation is less than or equal to the threshold value and in which the color tone of the base image is controlled by a second color tone control method different from the first color tone control method;”
“in a threshold value determination mode for determining the threshold value, displaying a threshold value calculation region on a display”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities and generic postsolution activity.
Furthermore, processors and displays are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of determining a threshold value for oxygen saturation to categorize information in a display and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2, 4, and 9-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shigeta (US 2016/0287061) in view of Saito (US 2012/0157768) as noted in Applicant IDS dated 9/04/2024.
Regarding Claim 1, while Shigeta teaches a processor device (Abstract, [0056], [0069], [0076]-[0077] processor device 16, Figs. 15-19, [0101]-[0109]) comprising:
a processor ([0077] digital signal processor 56) configured to:
generate a base image ([0101] “While calculating the oxygen saturation as described above, the special processing section 63 generates an image signal as a base (hereinafter, referred to as a base image signal) of the oxygen saturation image using the color conversion processing section 76, the color enhancement processing section 77, and the structure enhancement processing section 78.”);
generate an oxygen saturation image in an oxygen saturation mode ([0102] “The oxygen saturation image generation section 79 generates an oxygen saturation image 92 showing the oxygen saturation of the observation target, as shown in FIG. 19, using a base image signal 91 shown in FIG. 17 and the oxygen saturation S.sub.W2 in the second period W2 obtained as a result of correcting the change equal to or greater than the threshold value Th to the threshold value Th by the oxygen saturation correction section 75 as shown in FIG. 18.”), the oxygen saturation image including a high-oxygen-saturation region and a low-oxygen-saturation region, the high-oxygen-saturation region being a region in which an oxygen saturation exceeds a threshold value and in which a color tone of the base image is controlled by a first color tone control method (Figs. 17-19, [0101]-[0103] oxygen saturation image generated in Fig. 18, incorporated into displayed oxygen saturation image 92 of Fig. 19, includes regions categorized by oxygen saturation level with the capability of showing a high-oxygen-saturation region and a low-oxygen-saturation region, where color conversion is applied based on the magnitude of oxygen saturation of the target in the image, where color conversion based on a magnitude of oxygen saturation necessitates the existence of thresholds for modifying the conversion, and the color conversion is recognized as a color tone control method), the low-oxygen-saturation region being a region in which the oxygen saturation is less than or equal to the threshold value ([0101]-[0103] with color conversion applied to a low oxygen saturation region by the application of the color conversion to the entire image); and
in a threshold value determination mode for determining the threshold value, display a threshold value calculation region on a display and calculate the threshold value based on at least oxygen saturations in the threshold value calculation region ([0096] the oxygen saturation evaluation is first performed at first time period W1, making the initial image generated at W1 as a threshold value calculation region, [0055] the observed image displayed on a display, [0109] where the calculations performed at first time period W1 are then used to determine the threshold value based on the oxygen saturations in the image), the oxygen saturations in the threshold value calculation region being calculated in accordance with a threshold value calculation operation ([0109] “In the first embodiment described above, the threshold value Th that is used for the comparison with the amount of change Δ in the oxygen saturation correction section 75 is fixed. However, the threshold value Th can be made variable. For example, it is preferable to set the threshold value Th based on the distribution of the oxygen saturation S.sub.W1 in the first period W1. In this case, it is preferable to change the threshold value Th according to the statistical value of the oxygen saturation S.sub.W1 in the first period W1, such as an average value, a median, a maximum value, or a minimum value.”).
Shigeta fails to teach the low-oxygen-saturation region being a region in which the color tone of the base image is controlled by a second color tone control method different from the first color tone control method.
However Saito teaches an endoscope-based oxygen saturation calculator (Abstract, Figs. 11-12, [0091]-0095]) with a threshold dividing between high-oxygen-saturation and a low-oxygen-saturation Fig. 11, ([0091]-[0095] where 60% oxygen saturation acts as a threshold dividing between high-oxygen-saturation and a low-oxygen-saturation),
where images are then divided into high-oxygen-saturation region being a region in which an oxygen saturation exceeds a threshold value and in which a color tone of the base image is controlled by a first color tone control method, and low-oxygen-saturation region being a region in which the oxygen saturation is less than or equal to the threshold value and in which the color tone of the base image is controlled by a second color tone control method different from the first color tone control method (Figs. 11, [0091]-[0092] a threshold value for oxygen saturation provided to divide a base image, where a color tone of the base image is controlled by a first color tone control method for high oxygen saturation values controlled by a second color tone control method different from the first color tone control method for low oxygen saturation values, Fig. 12, [0094]-[0095] this control method applied to regions of the base image, [0097] the gains described are controlling color tones).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the color tone control method of Saito as a specific method of achieving Shigeta’s color conversion for oxygen saturation values ([0102]) where the colors are converted to emphasize areas of abnormality (Saito: [0092]).
Regarding Claim 2, Shigeta and Saito teach the processor device according to claim 1, and Shigeta teaches wherein the processor is configured to: calculate the oxygen saturations in the threshold value calculation region at a timing at which the threshold value calculation operation is performed, and calculate the threshold value based on a representative value of the oxygen saturations in the threshold value calculation region (See Claim 1 Rejection, calculate the oxygen saturations in the threshold value calculation region at a timing W1 and calculate the threshold value based on a representative value of the oxygen saturations in the threshold value calculation region such as statistical values of “an average value, a median, a maximum value, or a minimum value.”).
Regarding Claim 4, Shigeta and Saito teach the processor device according to claim 2, wherein the threshold value calculation region includes a normal site (See Claims 1 and 2 Rejection, Shigeta: Fig. 19, white regions in the image correspond to normal oxygen saturation values, darker shaded regions in the middle of the image are hypoxic, Saito: Fig. 12, [0094]-[0095] the imaged region includes a normal region 100 and a hypoxic region below 60% oxygen saturation 101).
Regarding Claim 9, Shigeta and Saito teach the processor device according to claim 1, wherein
in a case that the first color tone control method is a method for maintaining the color tone of the base image regardless of the oxygen saturation, the second color tone control method is a method for changing the color tone of the base image in accordance with the oxygen saturation, and
in a case that the first color tone control method is a method for changing the color tone of the base image in accordance with the oxygen saturation, the second color tone control method is a method for maintaining the color tone of the base image regardless of the oxygen saturation (See Claim 1 Rejection, Saito teaches the former where the gain is applied as 1 in the first color tone control method for high oxygen saturation values, maintaining the color tone of these regions of the base image, and the gain is modulated for different color components in the second color tone control method for low oxygen saturation values, changing the color tone of these regions in the base image).
.
Regarding Claim 10, Shigeta and Saito teach an endoscope system comprising:
the processor device according to claim 1 (See Claim 1 Rejection); and
Shigeta further teaches
a light source device that emits first illumination light, second illumination light, and third illumination light in a specific range ([0057] semiconductor light sources, [0058] lights output with specific ranges in mind, [0060], [0073]), the first illumination light including a short-wavelength-side wavelength range in which an absorption coefficient changes in accordance with a change in oxygen saturation of blood hemoglobin ([0055], [0060] blue light B is emitted as the short wavelength side wavelength band for an illumination white light in normal observation mode, [0063]-[0064], [0067] applying the short pass filter SPF causes this same illumination light to emit at a first emission mode in the oxygen saturation observation mode, with B1 blue light, G1 green light, and R1 red light, [0080] where a first illumination light occurs at a first emission mode in a first period W1, [0081]-[0091]), wherein
the processor is configured to:
generate a base image based on a second illumination light image that is based on the second illumination light ([0081]-[0084], [0101] where the generated image signal from the B1 blue light, G1 green light, and R1 red light is considered a base image, the base image is generated from a second illumination light image of the first emission mode in a second period W2);
calculate the oxygen saturation based on a first illumination light image that is based on the first illumination light, the second illumination light image, and a third illumination light image that is based on the third illumination light ([0081], [0093]-[0095] the third illumination light image is generated from the illumination of the second emission mode in the second period W2, [0091]-[0092] where oxygen saturation is calculated from the values of the first emission mode and the second emission mode after position correction, [0020], [0090], [0105] where the position shift between can be applied for the first group image signal / image from the first emission mode in the first period and the second group image signal / image from the first emission mode in the second period).
Regarding Claim 11, Shigeta and Saito teach an endoscope system comprising:
the processor device according to claim 1 (See Claim 1 Rejection); and
Shigeta further teaches
a light source device that emits first illumination light and second illumination light ([0057] semiconductor light sources, [0060] describes a first illumination light for normal observation mode, [0073]), the first illumination light including a long-wavelength-side wavelength range in which an absorption coefficient changes in accordance with a change in oxygen saturation of blood hemoglobin ([0055], [0062] blue light B is emitted as the long-wavelength-side wavelength band for normal observation mode, [0063]-[0064], [0068] applying the long pass filter LPF enables this same illumination light to pass at a second emission mode in the oxygen saturation observation mode, the blue light BL being long-wavelength-side wavelength range), wherein
the processor is configured to:
generate the base image based on a second illumination light image that is based on the second illumination light ([0055], [0060] blue light B is emitted as the short wavelength side wavelength band for an illumination white light in normal observation mode, [0063]-[0064], [0067] applying the short pass filter SPF causes this same illumination light to emit at a first emission mode in the oxygen saturation observation mode, with B1 blue light, G1 green light, and R1 red light, [0101] where the generated image signal from the B1 blue light, G1 green light, and R1 red light is considered a base image); and
calculate the oxygen saturation based on a first illumination light image and the second illumination light image, the first illumination light image being based on the first illumination light ([0081]-[0082], [0091]-[0095] oxygen saturation calculated based on the light images of B1, G1, R1, B2, R2, and G2).
Regarding Claim 12, Shigeta and Saito teach an endoscope system comprising:
the processor device according to claim 1 (See Claim 1 Rejection);
a light source device that supplies white light to an endoscope ([0057] semiconductor light sources, [0060]-[0062], [0067]-[0069] supplies white light to an endoscope); and
an imaging unit that is to be attached to the endoscope and that disperses the white light from the endoscope into light of a plurality of wavelength ranges ([0069]-[0071])
and acquires a base-image-generation image signal to be used to generate the base image ([0055], [0060], [0063]-[0064], [0067], emit light at a first emission mode in the oxygen saturation observation mode, with B1 blue light, G1 green light, and R1 red light, [0101] where the acquired generated image signal from the B1 blue light, G1 green light, and R1 red light is considered a base image) and an oxygen-saturation-calculation image signal to be used to calculate the oxygen saturation ([0055], [0062]-[0064], [0068] illumination light to pass at a second emission mode in the oxygen saturation observation mode, with B2 blue light, G2 green light, and R2 red light), based on the dispersed light of the plurality of wavelength ranges ([0081]-[0082], [0091]-[0095] oxygen saturation calculated based on the light images of B1, G1, R1, B2, R2, and G2).
Regarding Claim 13, while Shigeta teaches a method for operating a processor device (Abstract, [0056], [0069], [0076]-[0077] processor device 16, Figs. 15-19, [0101]-[0109]), the method comprising the steps of, by a processor:
generating a base image ([0101] “While calculating the oxygen saturation as described above, the special processing section 63 generates an image signal as a base (hereinafter, referred to as a base image signal) of the oxygen saturation image using the color conversion processing section 76, the color enhancement processing section 77, and the structure enhancement processing section 78.”);
generating an oxygen saturation image in an oxygen saturation mode ([0102] “The oxygen saturation image generation section 79 generates an oxygen saturation image 92 showing the oxygen saturation of the observation target, as shown in FIG. 19, using a base image signal 91 shown in FIG. 17 and the oxygen saturation S.sub.W2 in the second period W2 obtained as a result of correcting the change equal to or greater than the threshold value Th to the threshold value Th by the oxygen saturation correction section 75 as shown in FIG. 18.”), the oxygen saturation image including a high-oxygen-saturation region and a low-oxygen-saturation region, the high-oxygen-saturation region being a region in which an oxygen saturation exceeds a threshold value and in which a color tone of the base image is controlled by a first color tone control method (Figs. 17-19, [0101]-[0103] oxygen saturation image generated in Fig. 18, incorporated into displayed oxygen saturation image 92 of Fig. 19, includes regions categorized by oxygen saturation level with the capability of showing a high-oxygen-saturation region and a low-oxygen-saturation region, where color conversion is applied based on the magnitude of oxygen saturation of the target in the image, where color conversion based on a magnitude of oxygen saturation necessitates the existence of thresholds for modifying the conversion, and the color conversion is recognized as a color tone control method), the low-oxygen-saturation region being a region in which the oxygen saturation is less than or equal to the threshold value ([0101]-[0103] with color conversion applied to a low oxygen saturation region by the application of the color conversion to the entire image);
in a threshold value determination mode for determining the threshold value, displaying a threshold value calculation region on a display and calculating the threshold value based on at least oxygen saturations in the threshold value calculation region ([0096] the oxygen saturation evaluation is first performed at first time period W1, making the initial image generated at W1 as a threshold value calculation region, [0055] the observed image displayed on a display, [0109] where the calculations performed at first time period W1 are then used to determine the threshold value based on the oxygen saturations in the image), the oxygen saturations in the threshold value calculation region being calculated in accordance with a threshold value calculation operation ([0109] “In the first embodiment described above, the threshold value Th that is used for the comparison with the amount of change Δ in the oxygen saturation correction section 75 is fixed. However, the threshold value Th can be made variable. For example, it is preferable to set the threshold value Th based on the distribution of the oxygen saturation S.sub.W1 in the first period W1. In this case, it is preferable to change the threshold value Th according to the statistical value of the oxygen saturation S.sub.W1 in the first period W1, such as an average value, a median, a maximum value, or a minimum value.”).
Shigeta fails to teach the low-oxygen-saturation region being a region in which the color tone of the base image is controlled by a second color tone control method different from the first color tone control method.
However Saito teaches an endoscope-based oxygen saturation calculator (Abstract, Figs. 11-12, [0091]-0095]) with a threshold dividing between high-oxygen-saturation and a low-oxygen-saturation Fig. 11, ([0091]-[0095] where 60% oxygen saturation acts as a threshold dividing between high-oxygen-saturation and a low-oxygen-saturation),
where images are then divided into high-oxygen-saturation region being a region in which an oxygen saturation exceeds a threshold value and in which a color tone of the base image is controlled by a first color tone control method, and low-oxygen-saturation region being a region in which the oxygen saturation is less than or equal to the threshold value and in which the color tone of the base image is controlled by a second color tone control method different from the first color tone control method (Figs. 11, [0091]-[0092] a threshold value for oxygen saturation provided to divide a base image, where a color tone of the base image is controlled by a first color tone control method for high oxygen saturation values controlled by a second color tone control method different from the first color tone control method for low oxygen saturation values, Fig. 12, [0094]-[0095] this control method applied to regions of the base image, [0097] the gains described are controlling color tones).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the color tone control method of Saito as a specific method of achieving Shigeta’s color conversion for oxygen saturation values ([0102]) where the colors are converted to emphasize areas of abnormality (Saito: [0092]).
Claim(s) 3 and 5-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shigeta in view of Saito and further in view of Yamamoto (US 2018/0235527).
Regarding Claim 3, while Shigeta and Saito teach the processor device according to claim 2, wherein the threshold value is calculated based on the representative value of the oxygen saturations in the threshold value calculation region (See Claim 2 Rejection) and oxygen saturation is calculated based on a correction oxygen saturation factor (See Claim 2 Rejection, [0099]-[0100], [0107] changes in oxygen saturation over a time period are compared to a threshold, correction applied based on the magnitude of the change in relation to the threshold), their combined efforts fail to teach the threshold value is calculated based on the representative value of the oxygen saturations in the threshold value calculation region and a correction oxygen saturation.
However Yamamoto teaches an endoscope imaging system for oxygen saturation calculation (Abstract) comprising a correction step during pre-imaging applied for oxygen saturation values ([0063]-[0064], [0077]-[0085], [0180]) where the oxygen saturation correction is performed to correct for individual differences ([0180]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to perform the pre-imaging oxygen saturation correction of Yamamoto before identifying a threshold value in Shigeta as a way to ensure that the representative value found in Shigeta is based on suitably accurate data for the specific individual.
Regarding Claim 8, Shigeta and Saito teach the processor device according to claim 3, wherein the correction oxygen saturation is determined based on dynamics of an observation target or individual differences between patients (See Claim 3 Rejection).
Regarding Claim 5, Shigeta and Saito teach the processor device according to claim 1, wherein the processor is configured to: in a case of accepting the threshold value calculation operation, perform first processing and second processing, the first processing being for calculating the oxygen saturations in the threshold value calculation region as threshold-value-calculation oxygen saturations at a timing at which the threshold value calculation operation is performed (See Claim 1 Rejection, processing performed at first period W1, identifying oxygen saturation values for calculating a representative value), the second processing being for calculating the threshold value, the threshold value being calculated based on the threshold-value-calculation oxygen saturations calculated in the threshold value calculation operation (See Claim 1 Rejection, processing performed at first period W1, calculating a representative value with identified oxygen saturation values), their combined efforts fail to teach
in a case of accepting the threshold value calculation operation performed a plurality of times and accepting a confirmation operation performed after the threshold value calculation operation is performed the plurality of times, perform the first processing and second processing, where the second processing being for calculating the threshold value is in response to the confirmation operation being performed, and the threshold value being calculated based on the threshold-value-calculation oxygen saturations is calculated in each threshold value calculation operation.
However Yamamoto teaches an endoscope imaging system for oxygen saturation calculation (Abstract) comprising pre-imaging steps applied for oxygen saturation values ([0063]-[0064], [0077]-[0085], [0180]) where the pre-imaging steps may be performed multiple times ([0112]-[0113]) and the pre-imaging completion may require a confirmation operation ([0091]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to perform the pre-imaging oxygen saturation steps of Yamamoto before identifying a threshold value in Shigeta as a way to apply oxygen saturation correction before finding the representative values to ensure that the representative values found in Shigeta are based on suitably accurate data for the specific individual. Furthermore, it would be obvious to apply the pre-imaging steps a plurality of times and with a verification step as taught by Yamamoto to ensure that the oxygen saturation correction has been performed correctly and with suitable results to achieve an accurate threshold for the specific individual.
Regarding Claim 6, Shigeta, Saito, and Yamamoto teach the processor device according to claim 5, wherein the threshold value is calculated based on a plurality-of-operation representative value and a correction oxygen saturation, the plurality-of-operation representative value being obtained from representative values of the threshold-value-calculation oxygen saturations calculated in respective threshold value calculation operations (See Claim 5 Rejection, Shigeta and Saito’s threshold value performed with a plurality of found representative values in pre-imaging and with oxygen saturation correction as taught by Yamamoto).
Regarding Claim 7, Shigeta, Saito, and Yamamoto teach the processor device according to claim 5, wherein the threshold value calculation region includes a normal site or a hypoxic site (See Claims 1 and 5 Rejection, Shigeta: Fig. 19, white regions in the image correspond to normal oxygen saturation values, darker shaded regions in the middle of the image are hypoxic, Saito: Fig. 12, [0094]-[0095] the imaged region includes a normal region 100 and a hypoxic region below 60% oxygen saturation 101).
Conclusion
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
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