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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 14 November 2025 has been entered.
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 – 10 and 12 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 (line 15) and Claim 12 (line 14) each recite the term “a first medical image” in line 15. It is unclear if this is intended to be the same or different that the first medical image previously recited in the claim. For the purposes of examination, the term “a first medical image” is deemed to claim “the first medical image”. Claims 2 – 10 are similarly rejected due to their dependence on Claim 1.
Claim 1 (line 21 - 22) and Claim 12 (line 20 - 21) each recite the term “control the light source device and the image pickup optical system by a specific operation to switch”. The term is a relative term which renders the claim indefinite. The term “specific” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the scope of “specific” are unclear, as it is unknown whether “specific” refers to a targeted operation, a physical manipulation, or some other form of precision. Looking to the applicant’s specification at [0074] “specific operation” may be one of “observation environment switching unit 88 sets the magnification ratio to the second magnification ratio by giving an instruction to automatically operate the zoom operation part 12h”, “observation environment switching unit 88 displays a message (notification) of "Please set the magnification ratio to 60 times or more" on the display 18”, or “A user looks at the message displayed on the display 18 and operates the zoom operation part 12h to perform an operation for setting the magnification ratio to the second magnification ratio (60 times or more)”. It is unclear which aspect of these different alternative operations is “specific”. For the purposes of examination, the term “control the light source device and the image pickup optical system by a specific operation to switch” is deemed to claim “control the light source device and the image pickup optical system by an operation to switch”. Claims 2 – 10 are similarly rejected due to their dependence on Claim 1.
Claim 1 (last 3 lines) and Claim 12 (last 3 lines) each recite the limitation "the number of pixels having a red pixel value equal to or greater than a predetermined red threshold value in a red image of the first medical image". There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited “number of pixels”, and it is unclear to which pixels the term refers. For the purposes of examination, the term "the number of pixels having a red pixel value equal to or greater than a predetermined red threshold value in a red image of the first medical image" is deemed to claim “a number of pixels in a red image of the first medical image having a red pixel value equal to or greater than a predetermined red threshold value.” Claims 2 – 10 are similarly rejected due to their dependence on Claim 1.
Claim 9 recites the term “wherein the specific operation includes a user's operation performed according to a notification that promotes switching to the second observation environment, or automatic switching to the second observation environment.” The term is a relative term which renders the claim indefinite. The term “specific” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Further, it is unclear what about the “user’s operation” is specific, and whether the “user’s operation” is intended to be actually physically switching the observation environment. For the purposes of examination, the term “wherein the specific operation includes a user's operation performed according to a notification that promotes switching to the second observation environment, or automatic switching to the second observation environment” is deemed to claim “wherein the operation includes a user’s execution of an environment switching operation to the second observation environment using the image pickup optical system and the light source device according to a notification that promotes switching to the second observation environment, or the processor’s execution of an automatic environment switching operation to the second observation environment using the image pickup optical system and the light source device.”
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 – 10 and 12 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 recites a device, which is one of the statutory categories of invention (Step 1). The claim is then analyzed to determine whether they are directed to any judicial exception (Step 2A, Prong 1).
Regarding Claim 12, the claim recites "an act or step, or series of acts or steps" to operate an image processing device, and is therefore a process, which is a statutory category of invention (Step 1). The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Each of Claims 1 – 10 and 12 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1 – 10 and 12 recites at least one step or instruction for observations, evaluations, judgments, and opinions, which are grouped as a mental process under the 2019 PEG. The claimed invention involves making observations, evaluations, judgments, and opinions, which are concepts performed in the human mind under the 2019 PEG.
Accordingly, each of Claims 1 – 10 and 12 recites an abstract idea.
Specifically, Claims 1 – 10 and 12 recite (underlined are observations, judgments, evaluations, or opinions, which are grouped as a mental process under the 2019 PEG) (additional elements bolded, see Step 2A, prong 2);
Claim 1:
An endoscope system comprising:
a light source device configured to emit normal light and special light each having difference spectral characteristics;
an endoscope having an image pickup optical system including an objective lens and a zoom lens, the image pickup optical system being configured to change a magnification ratio of an object to be observed; and
a processor configured to:
control the light source device and the image pickup optical system to obtain a first medical image of the object to be observed in a first observation environment in which the object to be observed is enlarged at a first magnification ratio and illuminated with the normal light
calculate a switching determination index value, which is used to determine whether or not to switch the first observation environment to a second observation environment in which the object to be observed is enlarged at a second magnification ratio higher than a first magnification ratio and illuminated with the special light,
determine whether or not to switch the first observation environment to the second observation environment on the basis of the switching determination index value; and
control the light source device and the image pickup optical system by a specific operation to switch from the first observation environment to the second observation environment in a case where it is determined that switching to the second observation environment is to be performed,
wherein the switching determination index value is a red feature quantity representing a red component of the object to be observed, the red feature quantity being the number of pixels having a red pixel value equal to or greater than a predetermined red threshold value in a red image of the first medical image.
Claim 12:
A method of operating an endoscope system that includes a light source device configured to emit normal light and special light each having difference spectral characteristics and an endoscope having an image pickup optical system including an objective lens and a zoom lens, the image pickup optical system being configured to change a magnification ratio of an object to be observed, the method comprising:
a step of controlling the light source device and the image pickup optical system to obtain a first medical image of the object to be observed in a first observation environment in which the object to be observed is enlarged at a first magnification ratio and illuminated with the normal light
a step of calculating a switching determination index value, which is used to determine whether or not to switch the first observation environment to a second observation environment in which the object to be observed is enlarged at a second magnification ratio higher than the first magnification ratio and illuminated with a special light, on the basis of a first medical image
a step of determining whether or not to switch the first observation environment to the second observation environment on the basis of the switching determination index value; and
a step of controlling the light source device and the image pickup optical system by a specific operation to switching from the first observation environment to the second observation environment in a case where it is determined that switching to the second observation environment is to be performed,
wherein the switching determination index value is a red feature quantity representing a red component of the object to be observed, the red feature quantity being the number of pixels having a red pixel value equal to or greater than a predetermined red threshold value in a red image of the first medical image.
(observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
These underlined limitations describe a mathematical calculation and/or a mental process, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a human with the aid of a pen and paper, or by using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps. For example, in Independent Claims 1 and 12, these limitations include:
Evaluate a switching determination index value
Observation and judgment whether or not to switch the first observation environment to a second observation environment in which the object to be observed is enlarged at a second magnification ratio higher than a first magnification ratio and illuminated with the special light,
Observation and judgment whether or not to switch the first observation environment to the second observation environment on the basis of the switching determination index value
Observation and judgment that switching to the second observation environment is to be performed
all of which are grouped as mental processes or mathematical calculations under the 2019 PEG.
Similarly, Dependent Claims 2 – 10 include the following abstract limitations, in addition the aforementioned limitations in Independent Claims 1 and 12 (underlined observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG):
determines that switching to the second observation environment is not to be performed in a case where the red feature quantity is smaller than a lower limit of a red feature quantity range or a case where the red feature quantity is equal to or larger than an upper limit of the red feature quantity range
observation and judgment that switching to the second observation environment is or is not to be performed in a case where the red feature quantity is smaller than a lower limit of a red feature quantity range or a case where the red feature quantity is equal to or larger than an upper limit of the red feature quantity range
perform disease state processing, which is related to a state of a disease, on the basis of a second medical image obtained from image pickup of the object to be observed in the second observation environment
observation and judgment of disease state processing, which is related to a state of a disease, on the basis of a second medical image obtained from image pickup of the object to be observed in the second observation environment
calculating an index value related to a stage of the disease
evaluating an index value related to a stage of the disease
determining the stage of the disease
observation and judgment of the stage of the disease
determining whether or not the disease has pathologically remitted on the basis of the second medical image.
observation and judgment whether or not the disease has pathologically remitted on the basis of the second medical image.
determine whether or not the disease has pathologically remitted on the basis of the second medical image.
Observation and judgment to evaluate a bleeding index value, which represents a degree of bleeding of the object to be observed, or a degree of irregularity of superficial blood vessels
determine whether or not the disease has pathologically remitted on the basis of the bleeding index value or the degree of irregularity of the superficial blood vessels.
observation and judgment of whether or not the disease has pathologically remitted on the basis of the bleeding index value or the degree of irregularity of the superficial blood vessels.
determines that the disease has pathologically remitted in a case where the bleeding index value is equal to or smaller than a threshold value for bleeding and the degree of irregularity of the superficial blood vessels is equal to or smaller than a threshold value for the degree of irregularity
observation and judgment that the disease has pathologically remitted in a case where the bleeding index value is equal to or smaller than a threshold value for bleeding and the degree of irregularity of the superficial blood vessels is equal to or smaller than a threshold value for the degree of irregularity
determines that the disease has not pathologically remitted in a case where any one of a condition in which the bleeding index value exceeds the threshold value for bleeding or a condition in which the degree of irregularity of the superficial blood vessels exceeds the threshold value for the degree of irregularity is satisfied.
observation and judgment that the disease has not pathologically remitted in a case where any one of a condition in which the bleeding index value exceeds the threshold value for bleeding or a condition in which the degree of irregularity of the superficial blood vessels exceeds the threshold value for the degree of irregularity is satisfied.
Certain methods of directing human activity
wherein the specific operation includes a user's operation performed according to a notification that promotes switching to the second observation environment
specific operation includes a user's operation performed according to a notification that promotes judgment to choose to redirect observation attention to the second observation environment.
all of which are grouped as mental processes, mathematical calculations, or certain methods of directing human activity under the 2019 PEG.
Accordingly, as indicated above, each of the above-identified claims recite an abstract idea.
Step 2A, Prong 2
The above-identified abstract ideas in each of Independent Claims 1 and 12 (and their respective Dependent Claims) are not integrated into a practical application under 2019 PEG because the additional elements (identified above in Independent Claims 1 and 12), either alone or in combination, generally link the use of the above-identified abstract ideas to a particular technological environment or field of use. More specifically, the additional elements of:
“processor”
“endoscope”
“light source device”
“image pickup optical system”
“objective lens”
“zoom lens”
Additional elements recited include a “processor”, “endoscope”, “light source device”, “image pickup optical system”, “objective lens”, and “zoom lens” in the Independent Claims 1 and 12, and their dependent claims. These components are recited at a high level of generality, i.e., as a generic processor performing a generic function of processing data (the controlling, calculating, and determining). These generic hardware component limitations for “processor”, “endoscope”, “light source device”, “image pickup optical system”, “objective lens”, and “zoom lens” are no more than mere instructions to apply the exception using generic computer and hardware components. As such, these additional elements do not impose any meaningful limits on practicing the abstract idea.
Further additional elements from Independent Claims 1 and 12 and their dependent claims include pre-solution activity limitations, such as:
a light source device configured to emit normal light and special light each having difference spectral characteristics;
an endoscope having an image pickup optical system including an objective lens and a zoom lens, the image pickup optical system being configured to change a magnification ratio of an object to be observed;
control the light source device and the image pickup optical system to obtain a first medical image of the object to be observed in a first observation environment in which the object to be observed is enlarged at a first magnification ratio and illuminated with the normal light
control the light source device and the image pickup optical system by a specific operation to switch from the first observation environment to the second observation environment
wherein the switching determination index value is a red feature quantity representing a red component of the object to be observed, the red feature quantity being the number of pixels having a red pixel value equal to or greater than a predetermined red threshold value in a red image of the first medical image.
wherein the first observation environment includes illuminating the object to be observed with normal light or special light or displaying a color difference-expanded image in which a color difference in a plurality of ranges to be observed of the object to be observed expands on a display, and
the second observation environment includes illuminating the object to be observed with special light.
wherein the first magnification ratio is less than 60 times and the second magnification ratio is 60 times or more.
wherein the bleeding index value is the number of pixels having pixel values equal to or smaller than a threshold value for blue in a blue image of the second medical image, and
the degree of irregularity is the number of pixels of a region in which a density of the superficial blood vessels included in the second medical image is equal to or higher than a threshold value for density.
These pre-solution measurement elements are insignificant extra-solution activity, setting up the parameters of the system, and serve as data-gathering for the subsequent steps.
The “processor”, “endoscope”, “light source device”, “image pickup optical system”, “objective lens”, and “zoom lens” as recited in Independent Claims 1 and 12 and their dependent claims are generically recited computer and hardware elements which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract ideas identified above in Independent Claims 1 and 12 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer processor as claimed. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in Independent Claims 1 and 12 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, Independent Claims 1 and 12 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B –
None of Claims 1 – 10 and 12 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “processor”, “endoscope”, “light source device”, “image pickup optical system”, “objective lens”, and “zoom lens” as recited in Independent Claims 1 and 12 and their dependent claims.
The additional elements of the “processor”, “endoscope”, “light source device”, “image pickup optical system”, “objective lens”, and “zoom lens” Claims 1 – 10 and 12, as discussed with respect to Step 2A Prong Two, amounts to no more than mere instructions to apply the exception using generic computer and hardware components. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, the “processor” is described generically in [0098], with optional exemplars including a “central processing unit (CPU) that is a general purpose processor functioning as various processing units by executing software (program); a programmable logic device (PLD) that is a processor of which the circuit configuration can be changed after manufacture, such as a field programmable gate array (FPGA); a dedicated electrical circuit that is a processor having circuit configuration designed exclusively to perform various types of processing; and the like.” The processor is presented as interchangeable generic black box computing units in embodiments.
Per Applicant’s specification, regarding the “endoscope”, an endoscope is recited with specificity in the applicant’s specification. However, for the inventive concept, in [0096], applicant notes that “The present invention has been applied to the endoscope system for processing an endoscopic image, which is one of medical images, but the present invention can also be applied to medical image processing systems for processing medical images other than an endoscopic image.” Applicant further describes Figure 28, where the apparatus required for “inspection”, which is the function of an endoscope, is generally “various inspection apparatuses” by which “medical images” can be received. This indicates that the “endoscope”, as claimed in the limitation, that performs the generic tasks of illuminating, picking up, and magnifying an image is no more than mere instructions to apply the exception using a generic camera computer component. As claimed, a specialized endoscope is not necessary. As such, this additional element does not impose any meaningful limits on practicing the claimed abstract idea.
Per Applicant’s specification, the “light source device” is described generically at [0022] as “light source device 14” comprising “light source 20” that includes “four color LEDs, that is, a violet light emitting diode (V-LED) 20a, a blue light emitting diode (B-LED) 20b, a green light emitting diode (G-LED) 20c, and a red light emitting diode (R-LED) 20d. The “light source device” is shown as “light source device 14” in figure 1 with diodes in Figure 2.
Per Applicant’s specification, the “image pickup optical system” is described at [0029] as “The image pickup optical system 30b includes an objective lens 42, a zoom lens 43, and an image pickup sensor 44”. It is shown as generic “image pickup optical system 30b” block in Figure 2.
Per Applicant’s specification, the “objective lens” and “zoom lens” are described on at [0029] as part of the “image pickup optical system 30b, and “Light, which is emitted from the object to be observed since the object to be observed is irradiated with illumination light, is incident on the image pickup sensor 44 through the objective lens 42 and the zoom lens 43”, and “The zoom lens 43 is a lens that is used to enlarge the object to be observed, and is moved between a telephoto end and a wide end in a case where the zoom operation part 12h is operated.” The “objective lens” and “zoom lens” are shown as generic block element “objective lens 42” and “zoom lens 43” in the chart of Figure 2.
Accordingly, in light of Applicant’s specification, the claimed terms “processor”, “endoscope”, “light source device”, “image pickup optical system”, “objective lens”, and “zoom lens”. are reasonably construed as a generic computing and hardware devices. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “processor”, “endoscope”, “light source device”, “image pickup optical system”, “objective lens”, and “zoom lens”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1 – 10 and 12 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the apparatus and method of Claims 1 – 10 and 12 are directed to applying an abstract idea as identified above on a general-purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1 – 10 and 12 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements for Step 2A Prong 2 in Independent Claims 1 and 12 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1 – 10 and 12 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1 – 10 and 12 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1 – 10 and 12 are not patent eligible and are rejected under 35 U.S.C. 101.
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.
Claims 1 – 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kaku, et. al., (United States Patent Application Publication US 2012/0190922 A1), hereinafter Kaku, in view of Kubo (United States Patent Application Publication US 2019/0069769 A1), hereinafter Kubo, further in view of Kamon, (United States Patent Application Publication US 2018/0214004 A1), hereinafter Kamon.
Regarding Claims 1 and 12, Kaku discloses
For Claim 1:
An endoscope system ([0040] “endoscope system” 10; Fig 1) comprising:
a processor (Fig 4, “image processor” 14a) configured to:
For Claim 12:
A method of operating an endoscope system (Fig 4, “conceptual block diagram showing a processor of the endoscope system shown in Fig 1”; [0015] and [0133])
For both Claims 1 and 12:, Kaku discloses:
a light source device ([0040] “a light source device 16”) configured to emit normal light ([0073] “…the light source device 16…the normal light observation using white light”) and special light ([0073] “light source device 16…special light observation….”) each having different spectral characteristics ([0071] - [0073] “normal light observation using white light as observation light is possible when the 445LD 60 is turned on and the 405LD 62 is turned off”, “special light observation using white light and narrowband BV light as observation light…when the 445LD 60 and the 405LD 62 are both turned on.”);
an endoscope having an image pickup optical system ([0042] “an electronic endoscope which photoelectrically captures an image using an imaging device such as a CCD sensor 48.”; Fig 1, “endoscope 12”) including a lens ([0054] “imaging lens 46 on the light-receiving surface of the CCD sensor 48”), the image pickup optical system being configured to change a magnification ratio of an object to be observed ([0178] “…adjustment of the imaging magnification in the endoscope 12”); and
control the light source device and the image pickup optical system to obtain a first medical image of the object to be observed ([0100] “special light observation image generated in the image processing portion 78b”; Fig. 2; Fig. 4; [0005] “…system uses a light source device…and an endoscope which captures images…”; [0078]) in a first observation environment in which the object to be observed is enlarged at a first magnification ratio ([0137] “in the actual diagnosis using the endoscope system 10, it is general to first perform screening at a low magnification (perform a broad observation as the scope portion 42 is moved)”)(Examiner notes that the first observation environment is the initial “screening” inspection performed with the endoscope with lower magnification) and illuminated with the normal light (Fig 4; [0086] “the normal light image generating section 76 reads out the R image, G image and B image from images stored in the image storage section 74…(at the time of low power lighting) to enable the normal light observation image using the pseudo white light for the observation to be obtained.”; [0087] – [0088] “…enable the simultaneously or substantially simultaneously captured normal light observation image and special light observation image to be obtained.” )
calculate a switching determination index value ([0185] “blood vessel matching with a vascular pattern is detected”; [0179] “matching result”), which is used to determine whether or not to switch ([0185] “Therefore, when a blood vessel matching with a vascular pattern is detected, the imaging magnification in the endoscope 12 may be automatically increased to a predetermined value to enable a more detailed observation.”) the first observation environment ([0137] “in the actual diagnosis using the endoscope system 10, it is general to first perform screening at a low magnification (perform a broad observation as the scope portion 42 is moved)”)(Examiner notes that the first observation environment is the initial “screening” inspection performed with the endoscope with lower magnification) to a second observation environment ([0016] “diagnosis support”; [Fig 4] “support image generation portion” 78c; [0100] “The support image generation portion 78c is a portion in which a blood vessel or pit which was detected by pattern matching of the special light observation image generated in the image processing portion 78b as matching with a cancerous vascular or pit pattern is enhanced in accordance with the instruction from the support information generating section 90”; [0239] “…the support information generating section 90 issues an instruction to the endoscope 12 to increase the imaging magnification to a value corresponding to the invasion depth”); in which the object to be observed is enlarged at a second magnification ratio higher than the first magnification ratio ([0185] “Therefore, when a blood vessel matching with a vascular pattern is detected, the imaging magnification in the endoscope 12 may be automatically increased to a predetermined value to enable a more detailed observation.”; [0138] “(…60x, and 80x)”) and illuminated with the special light ([0167] “…(automatic adjustment of the operating conditions of the endoscope 12 and the light source device 16”; [0177] “…adjusting the imaging conditions in the special light observation so that a lesion on the image can be more easily observed...light source device 16”) on the basis of a first medical image ([0100] “special light observation image generated in the image processing portion 78b”)
determine whether or not to switch the first observation environment to the second observation environment on the basis of the switching determination index value ([0137] “…first perform screening at a low magnification…and enlarge, precisely examine and further make a qualitative diagnosis when an area deemed to be affected is detected by the screening”; ([0185] “Therefore, when a blood vessel matching with a vascular pattern is detected, the imaging magnification in the endoscope 12 may be automatically increased to a predetermined value to enable a more detailed observation.”); and
control the light source device and the image pickup optical system by a specific operation ([0185] “Therefore, when a blood vessel matching with a vascular pattern is detected, the imaging magnification in the endoscope 12 may be automatically increased to a predetermined value to enable a more detailed observation.”; [0138] “(…60x, and 80x)”; [0167] “…(automatic adjustment of the operating conditions of the endoscope 12 and the light source device 16”; [0177])(Examiner notes the 112(B) interpretation above of specific operation as an operation) to switch from the first observation environment to the second observation environment ([0137] “screening” to [0016] “diagnosis support”; [0185] ”…the imaging magnification in the endoscope 12 may be automatically increased to a predetermined value to enable a more detailed observation.”; [0167] “…(automatic adjustment of the operating conditions of the endoscope 12 and the light source device 16”; [0177]) in a case where it is determined that switching to the second observation environment is to be performed ([0179] “matching result”; [0185] “Therefore, when a blood vessel matching with a vascular pattern is detected, the imaging magnification in the endoscope 12 may be automatically increased to a predetermined value to enable a more detailed observation.”; [0177]),
wherein the switching determination index value ([0179] “matching result”) is a red feature quantity (Fig 5, “Microvascular pattern classification”, including Type 3b; [0120] “In the vascular pattern classification type…type 3b is a pattern of crushed vessels and red spots”) (Examiner notes that a “pattern of crushed vessels and red spots” includes a quantity of differentiable red features, which appear in the 7 spots in Fig 5.) representing a red component of the object to be observed (Fig 5, “Microvascular pattern classification”; [0117] “…the vascular pattern classification and pit pattern classification for each of the sites to be diagnosed, such as esophagus, stomach, small intestine, and large intestine”).
Kaku does not disclose the red feature quantity being the number of pixels having a red pixel value equal to or greater than a predetermined red threshold value in a red image of the first medical image or including an objective lens and a zoom lens. Kaku does broadly disclose capabilities to obtain images at multiple zoom factors, including (“20x, 40x, 60x, and 80x”) [0138] with a “CCD sensor” with an “imaging lens” [0226], but it does not particularly specify that these are performed by individual objective and zoom lenses in the overall “imaging lens”.
Kubo teaches an endoscope system (including observation light and optical image capture unit) that switches the observation mode lighting from one mode to another based on red pixel values in an image determined to exceed a threshold, indicating bleeding in a region. Specifically for Claims 1 and 12 the red feature quantity being the number of pixels having a red pixel value equal to or greater than a predetermined red threshold value in a red image of the first medical image (Fig 8, “Is size of bleeding region equal to or more than first predetermined value” S2; Fig 9, “R Pixel value”; [0078] “…compares pixel values of respective pixels of red color in the endoscope image due to bleeding with a predetermined value THRI, calculates the size of a bleeding region from the number of pixels…determines whether or not the size of the bleeding region is equal to or more…at the time of the white light mode.”; [0079] “switches the observation image generation mode from a present observation image generation mode to the other observation image generation mode based on a determination result of the comparison determination section 44a”; [0115] “switching the illumination mode to the illumination mode for the deep blood vessel mode”; [0062] …deep blood vessel mode.. R light, the IR light and the B light are emitted.”, “…white light mode…subject is irradiated with a white light.”)
Kaku and Kamon both disclose and teach endoscope systems that switch the image capture environment based on image processing of red features, Kaku with lighting and magnification adjustment on the endoscope based on pattern recognition of observed red features, and Kubo with lighting adjustment based on red pixel values of observed red features (bleeding). Kubo provides a motivation to combine at [0008] with “Under white light, the whole blood is displayed in a red color tone, so that it is difficult to recognize the bleeding point visually, but by switching an observation mode to an observation mode that enables observation of a blood vessel in a mucosal deep part by using light in a red band, the surgeon can visually recognize the bleeding point.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that using a value for the red pixel in an image to determine switching for bleed would be useful to recognize bleeding patterns in the body using a clear quantitative indicator, which would be useful to obtain indicators of bleeding more consistently than by human visual observation alone. Kaku also discloses at [0174] that “Image processing may be performed by any known method”, which could include pixel value analysis. It would have been predictable to use the red pixel value threshold for observation mode switching taught in Kubo in any similar feature analysis on an image in an endoscopic image capture and processing system, as it would continue to operate with the function of finding red features in an endoscopic image to signal switching the observation environment lighting to better observe the bleeding structure.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the red feature pattern recognition (associated with bleeding) for observation mode switching disclosed in Kaku with the red pixel value threshold (associated with bleeding) for observation mode switching taught by Kubo, creating a single endoscopic system that can use red pixel values thresholds for the system to recognize bleeding in order to signal switching observation modes allow the human operator to more easily examine the bleeding region.
Kubo does not teach including an objective lens and a zoom lens. Kamon teaches an endoscope system that includes an image acquisition unit that acquires endoscopic images at multiple magnifications using an objective and a zoom lens to calculate blood vessel information [Abstract], [0048]. Specifically for Claims 1 and 12, Kamon teaches an image pickup optical system (Fig 2, [0056] “an imaging optical system 30b”) including an objective lens (Fig 2, “objective lens 46” of “imaging optical system 30b”) and a zoom lens (Fig 2, “zoom lens 47” of “imaging optical system 30b”)
Kaku and Kamon both disclose and teach image capture with an endoscope having a lens. Kamon provides a motivation to combine at [0056] with “The zoom lens 47 is moved freely between the telephoto end and the wide end by operating the zoom operation unit 13b, thereby enlarging or reducing the observation target formed on the imaging sensor 48.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that the magnification could be performed within a lens assembly over an imaging sensor using an objective lens and a zoom lens, which would be useful to mechanically control obtaining images at different optically-implemented magnifications.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine endoscope with a CCD image acquisition unit and “imaging lens” that can capture at multiple zoom levels disclosed in Kaku with the image acquisition unit having specifically objective and zoom optical lenses taught by Kamon, creating a single endoscope system with an image acquisition unit that can use different optical lenses when adjusting the magnification of image capture.
Regarding Claim 2, Kaku in view of Kubo, further in view of Kamon discloses, as described above, The endoscope system according to claim 1. For the remainder of claim 2, Kaku discloses
wherein the processor (Fig 4, “image processor” 14a) determines that switching to the second observation environment ([Fig 4] “support image generation portion” 78c, [0239] “…the support information generating section 90 issues an instruction to the endoscope 12 to increase the imaging magnification to a value corresponding to the invasion depth”) is not to be performed in a case where the red feature quantity (Fig 5, “Microvascular pattern classification”, including Type 3b; [0120] “In the vascular pattern classification type…type 3b is a pattern of crushed vessels and red spots”) (Examiner notes that a “pattern of crushed vessels and red spots” includes a quantity of differentiable red features, which appear in the 7 spots in Fig 5.) is smaller than a lower limit of a red feature quantity range ([0144] “..and the former is deemed not to match with the latter when the determined degree of matching is less than the threshold”) or a case where the red feature quantity (Fig 5, “Microvascular pattern classification”, including Type 3b; [0120] “In the vascular pattern classification type…type 3b is a pattern of crushed vessels and red spots”) (Examiner notes that a “pattern of crushed vessels and red spots” includes a quantity of differentiable red features, which appear in the 7 spots in Fig 5.) is equal to or larger than an upper limit of the red feature quantity range ([0144] ”…the degree of matching between a vascular or pit pattern and an extracted blood vessel or pit may be determined by a known method so that the former is deemed to match with the latter when the determined degree of matching is equal to or larger than an appropriately set threshold”), and determines that switching to the second observation environment ([Fig 4] “support image generation portion” 78c, [0239] “…the support information generating section 90 issues an instruction to the endoscope 12 to increase the imaging magnification to a value corresponding to the invasion depth”) is to be performed in a case where the red feature quantity is in the red feature quantity range ([0179] “matching result” or [0144] “matching”; [0185] “Therefore, when a blood vessel matching with a vascular pattern is detected, the imaging magnification in the endoscope 12 may be automatically increased to a predetermined value to enable a more detailed observation.”; Vascular pattern, Fig 5, “Microvascular pattern classification”, including Type 3b with red spots).
Regarding Claim 3, Kaku in view of Kubo, further in view of Kamon discloses, as described above, The endoscope system according to claim 1. For the remainder of claim 3, Kaku discloses
wherein the first observation environment ([0137] “screening”) includes illuminating the object to be observed with normal light (Fig 4, initial screening images enter “DSP” 72 to “Image Storage” 74 to “Normal Light Image Generation” 76, explained in [0081] – [0083]; [0071] “…the light emitted by the excitation of the fluorescent body 24 is combined with part of the B light from the 445LD 60 which was not absorbed in the fluorescent body 24 to form pseudo white light (profile B), which enables the normal light observation using white light as the observation light to be performed.”;) or special light (Fig 4, initial screening images enter “DSP” 72 to “Image Storage” 74 to “Special Light Image Generation” 78, explained in [0081] – [0083]; [0072] “When both of the 445LD 60 and the 405LD 62 are turned on, narrowband BV light shown by profile A is added to the observation light, thus enabling imaging with special light”) or displaying a color difference-expanded image in which a color difference in a plurality of ranges to be observed of the object to be observed expands on a display ([0091] “ …color enhancement for giving a color difference between a blood vessel and a mucous membrane on the screen by enhancing in a direction in which the color difference between the blood vessel and mucous membrane is to be more accentuated than the average colors of the image so that the blood vessel can be more easily seen”), and
the second observation environment ([0016] “diagnosis support”; [Fig 4] “support image generation portion” 78c) includes illuminating the object to be observed with special light ([0183] “Therefore, if a blood vessel matching with a vascular pattern is detected, the ratio of the light quantity of the 405LD 62 may be increased to a predetermined value so that microvessels can be more easily observed.; [0072] “When both of the 445LD 60 and the 405LD 62 are turned on, narrowband BV light shown by profile A is added to the observation light, thus enabling imaging with special light.”) (Examiner notes that detecting a vascular pattern switches the observation environment from the first “screening” observation environment to the second ”diagnosis support” observation environment, as previously described in Claim 1.)
Regarding Claim 4, Kaku in view of Kubo, further in view of Kamon discloses, as described above, The endoscope system according to claim 1. For the remainder of claim 4, Kaku discloses wherein the first magnification ratio is less than 60 times ([0137] “…in the actual diagnosis using the endoscope system 10, it is general to first perform screening at a low magnification…”[0138] “…a plurality of magnifications set in the endoscope system 10 (e.g., 20x, 40x…)” and the second magnification ratio is 60 times or more ([0137] “…and enlarge, precisely examine and further make a qualitative diagnosis when an area deemed to be affected is detected by the screening.” [0138] “(…60x, and 80x)”.
Regarding Claim 5, Kaku in view of Kubo, further in view of Kamon discloses, as described above, The endoscope system according to claim 1. For the remainder of claim 5, Kaku discloses
wherein the processor (Fig 4, “image processor” 14a) is further configured to perform disease state processing (Fig 4, “Processor” 14a functions shown within dotted square enclosure, “Image Processing”, “Matching”, etc.; [0016] from “…the image processing device” to “…the image processing device to perform support operations for diagnosis support based on the result of the pattern matching”), which is related to a state of a disease (Figs 5 – 8, with numeric and alphanumeric staging systems for vascular and pit characteristics associated with levels of cancer invasion depth.) (Examiner notes that increased cancer invasion depth corresponds to more severe level, or stage, of disease.), on the basis of a second medical image ([0237] “enhanced special light observation image”, which is an image obtained in the second environment conditions of the observation site with features matched with pattern recognition) obtained from image pickup of the object to be observed in the second observation environment ([Fig 4] “support image generation portion” 78c, [0239] “…the support information generating section 90 issues an instruction to the endoscope 12 to increase the imaging magnification to a value corresponding to the invasion depth”), and
the disease state processing (Fig 4, “Processor” 14a functions shown within dotted square enclosure, “Image Processing”, “Matching”, etc.; [0016] from “…the image processing device” to “…the image processing device to perform support operations for diagnosis support based on the result of the pattern matching”) includes at least one of calculating an index value related to a stage of the disease (Fig 4, “Processor” 14a, “image Processing 78c”, image is compared to the vascular (and pit) disease state models such as that of Figs 5 – 8; [0104] “The method of extracting blood vessels and pits is not particularly limited and various known methods can be used”. (Examiner notes that the image is assigned, or indexed an numeric or alphanumeric value corresponding to the closest disease state match from Figs 5 – 8. The calculation step is the pattern matching “method of extracting blood vessels” algorithm used to compare the observation image with the stored comparative disease state templates), determining the stage of the disease (Figs 5 – 8, with numeric and alphanumeric staging systems for vascular and pit characteristics associated with levels of cancer invasion depth.) (Examiner notes that increased cancer invasion depth corresponds to more severe level, or stage, of disease.), or determining whether or not the disease has pathologically remitted (Figs 5 – 8, with numeric and alphanumeric staging systems for vascular and pit characteristics associated with levels of greater or lesser cancer invasion depth.) (Examiner notes that decreased cancer invasion depth corresponds to less severe disease, bringing a previously imaged disease closer to a remitted state. Additionally, if the observation does not note a vascular pattern of note upon first environment screening, the instruction for pattern matching, or switching determination index value will not trigger a switch to the second observation environment. The lack of pathological tissue would be outside the pattern matching scales such that the former disease state would be remitted) on the basis of the second medical image ([0237] “enhanced special light observation image”, which is an image obtained in the second environment conditions of the observation site with features matched with pattern recognition).
Regarding Claim 6, Kaku in view of Kubo, further in view of Kamon discloses, as described above, The endoscope system according to claim 5. For the remainder of claim 6, Kaku discloses
wherein the processor (Fig 4, “image processor” 14a) is further configured to:
calculate a bleeding index value (Metric for bleeding index value found by comparing the obtained endoscope 10 images using Fig 5, “Microvascular pattern classification”, including Type 3b, ([0144] “..and the former is deemed not to match with the latter when the determined degree of matching is less than the threshold”), which represents a degree of bleeding of the object to be observed or a degree of irregularity of superficial blood vessels (Fig 5, “Microvascular pattern classification” [0121] “In this microvessel pattern classification, the invasion depth of esophageal cancer successively increases from type 1 toward type 4”; Fig 6., [0124] “The pit pattern classification in Hiroshima University is the classification using the pit patterns shown in Fig. 6. This pattern classification additionally evaluates the microvascular patterns”. [0126] “In this pit pattern classification, the invasion depth of colorectal cancer successively increases from A type to C type and in C type, the invasion depth of colorectal cancers successively increases from 1 toward 3.” Fig 7., “Sano’s capillary pattern classification”, [ ;Fig 8., “Vascular pattern classification in the Jikei University School of Medicine”)(Examiner notes that the vascular patterns in these classification systems exhibit irregularity of the superficial blood vessels, in that the vessels are, for example in [0120] “extended, branched, and enlarged, and have an increase in density”) and
determine whether or not the disease has pathologically remitted on the basis of the bleeding index value or the degree of irregularity of the superficial blood vessels (Metric for bleeding index value and irregularity of the superficial blood vessels found by comparing the obtained endoscope 10 images using Fig 5, “Microvascular pattern classification”, including Type 3b, ([0144] “..and the former is deemed not to match with the latter when the determined degree of matching is less than the threshold”), (Examiner notes that decreased cancer invasion depth corresponds to less severe disease, bringing a previously imaged disease closer to a remitted state. Additionally, if the observation does not note a vascular pattern of note upon first environment screening, the instruction for pattern matching, or switching determination index value will not trigger a switch to the second observation environment. The lack of pathological tissue would be outside the pattern matching scales such that the former disease state would be remitted).
Regarding Claim 7, Kaku in view of Kubo, further in view of Kamon discloses, as described above, The endoscope system according to claim 6. For the remainder of claim 7, Kaku discloses
wherein the processor (Fig 4, “image processor” 14a) determines that the disease has pathologically remitted (Figs 5 – 8, with numeric and alphanumeric staging systems for vascular and pit characteristics associated with levels of lesser cancer invasion depth.) (See previously Examiner note in Claim 6 the pathologically remitted limitation) in a case where the bleeding index value is equal to or smaller than a threshold value for bleeding and the degree of irregularity of the superficial blood vessels is equal to or smaller than a threshold value for the degree of irregularity (Metric for bleeding index value and irregularity of the superficial blood vessels found by comparing the obtained endoscope 10 images using Fig 5, “Microvascular pattern classification”, including Type 3b, ([0144] “..and the former is deemed not to match with the latter when the determined degree of matching is less than the threshold”), and determines that the disease has not pathologically remitted (Figs 5 – 8, with numeric and alphanumeric staging systems for vascular and pit characteristics associated with levels of greater cancer invasion depth.) (See previously Examiner note in Claim 6 regarding the pathologically remitted limitation) in a case where any one of a condition in which the bleeding index value exceeds the threshold value for bleeding or a condition in which the degree of irregularity of the superficial blood vessels exceeds the threshold value for the degree of irregularity is satisfied (Metric found by comparing the obtained endoscope 10 images to Fig 5, “Microvascular pattern classification”, including Type 3b, [0144] ”…the degree of matching between a vascular or pit pattern and an extracted blood vessel or pit may be determined by a known method so that the former is deemed to match with the latter when the determined degree of matching is equal to or larger than an appropriately set threshold”).
Regarding Claim 8, Kaku in view of Kubo, further in view of Kamon discloses, as described above, The endoscope system according to claim 6. For the remainder of claim 8, Kaku discloses
wherein the bleeding index value (Metric for bleeding index value and irregularity of the superficial blood vessels found by comparing the obtained endoscope 10 images using Fig 5, “Microvascular pattern classification”, including Type 3b; “The method of extracting blood vessels and pits is not particularly limited and various known methods can be used”) is the number of pixels having pixel values equal to or smaller than a threshold value for blue ([0095] “The image processing portion 78b first allocated the G image to R pixels corresponding to the display and the narrowband BV image to G pixels and B pixels corresponding to the display”; [0105] “…a region having a different color may be extracted as the blood vessel or pit”) in a blue image of the second medical image ([0093] “…B image (i.e. image captured with the narrowband BV light)), and
the degree of irregularity (Metric for irregularity of the superficial blood vessels found by comparing the obtained endoscope 10 images using Fig 5, “Microvascular pattern classification”, including Type 3b; “The method of extracting blood vessels and pits is not particularly limited and various known methods can be used”) is the number of pixels of a region ([0158] “..the area ratio of blood vessels or pits in the image) in which a density of the superficial blood vessels included in the second medical image is equal to or higher than a threshold value for density ([0157] “…the amount of density of blood vessels or pits extracted from the special light observation image in the extracting section 84 may be detected in the matching section 86 or the extracting section 84 so that the matching section 86 can perform vascular matching or pit matching only when the amount of blood vessels or pits exceeds a predetermined threshold).
Regarding Claim 9, Kaku in view of Kubo, further in view of Kamon discloses, as described above, The endoscope system according to claim 1, wherein the specific operation. For the remainder of claim 9, Kaku discloses
includes a user's operation performed ([0198] “…the doctor to perform the same adjustment of the imaging conditions as the foregoing automatic adjustment of the imaging conditions in accordance with the matching result) according to a notification that promotes switching to the second observation environment ([0197] “Suggestion of preferred imaging conditions is to display on the monitor 18 a message for prompting or recommending changes for preferred imaging conditions suitable to the matching result”), or automatic switching to the second observation environment ([0185] “Therefore, when a blood vessel matching with a vascular pattern is detected, the imaging magnification in the endoscope 12 may be automatically increased to a predetermined value to enable a more detailed observation.”).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kaku in view of Kubo, further in view of Kamon, further in view of “Detection of Ulcerative Colitis From Colonoscopy Images” by Kaçmaz et. al., hereinafter Kaçmaz.
Regarding Claim 10, Kaku in view of Kubo, further in view of Kamon discloses as described above, The endoscope system according to claim 5. For the remainder of Claim 10, Kaku discloses wherein the disease ([0118] “cancer”)
Kaku does not disclose is ulcerative colitis. While Kaku does not specifically disclose ulcerative colitis, Kaku does disclose that it is open to use a variety of diagnostic pattern matching methods, either custom or from literature, with “[0118] Various known types of cancer pattern classification specific to the diagnostic sites (observation sites) that were published in literatures and articles can be used for the vascular pattern classification and pit pattern classification…associated with the cancer invasion depth” and [0133] “In practice of the invention, a doctor skilled in the diagnosis of the cancer invasion depth using the endoscope system 10 may prepare vascular pattern classification or pit pattern classification from images actually used in the invasion depth diagnosis and store the prepared pattern classification in the pattern storage section 82 instead of using known types of pattern classification published in literatures and articles.”
Kaçmaz teaches a screening method for detecting and classifying the ulcerative colitis using features from a series of colonoscopy images including healthy tissue and tissue with ulcerative colitis. Specifically for Claim 10, Kaçmaz teaches wherein the disease is ulcerative colitis ([Abstract] “Ulcerative colitis (UC)….using only 5 features, UC images were classified correctly by 95%”… “This study demonstrated the feasibility of the development of software tools for aiding the physicians in the diagnosis of colon diseases”; page 2, left column, paragraph 3, “”five levels for disease severity as healthy, mild, moderate, severe, and wounded”). Kaçmaz teaches a series of 200 colonoscopy images (100 normal, 100 UC), part of which are shown in Figure 1 and Figure 2 on page 3. These images and UC features are an image collection that can be used for pattern-matching for diagnosing ulcerative colitis. Regarding ulcerative colitis, Kaçmaz teaches ([Abstract] “Ulcerative colitis (UC) is the inflammation of the part that covers the inner surface of the colon. It is a disease with ulcers and open wounds.”)
Regarding active stage or remission, Kaçmaz additionally teaches, [Page 3, V. Discussion and Evaluation, “…in future studies, both these feature extraction methods and other feature extraction methods can be added to determine whether the disease is in active stage or in remission”.
Kaçmaz teaches that features from normal and ulcerative colitis images obtained from colonoscopy imaging, which contain such features as ulcers and open wounds, can be pattern-matched to diagnose bowel disease. This is the same function as Kaku’s “pattern classifications specific to the diagnostic sites” of Figs 5 – 8 used for “pattern matching” to diagnose disease. As described above, Kaku discloses that a different teaching set of images or type of pattern classification “specific to the diagnostic sites…published in literature and articles” can be used for the function of vascular pattern classification. Therefore, Kaku discloses a motivation to substitute a different set of exemplar images or pattern classification appropriate to the diagnosed disease of interest. While Kaku’s disclosure is for cancer, and Kaçmaz’s teaching is for ulcerative colitis, the features of interest for Kaçmaz’s images include bowel images with open wounds (which include bleeding). Additionally, Kaçmaz teaches motivation for a link between the ulcerative colitis pattern matching methodology and pattern matching methodology for digestive system cancers on page 2, “the texture analysis methods here have been used not only on colonoscopy images but also in automatic detection algorithms proposed for the early diagnosis of gastric cancer and esophageal cancer”. Therefore, a person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that pattern matching algorithms for comparing bleeding in imaged tissue to cancer images would also be useful for comparing bleeding in imaged tissue to ulcerative colitis images.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the “Microvascular pattern classification” model of Kaku with Kaçmaz’s taught set of 200 coloscopy images (100 Normal and 100 UC) and ulcerative colitis features in the “5 features and classified colonoscopy images”, creating a single endoscope imaging system that can recognize red features associated with performing ulcerative colitis diagnosis.
Response to Arguments
Applicant's arguments filed 14 November 2025 have been fully considered but they are not persuasive to overcome the 35 U.S.C. 101, 35 U.S.C. 102, and 35 U.S.C. 103 rejections. In regard to the 35 U.S.C. 101 analysis:
The applicant argues at [Page 8, “Rejection Under 35 U.S.C. 101” Section, Paragraph 2 – Paragraph 5] that the amended claims incorporate structural elements of the endoscope system into the switching function, define the “red feature quantity” with a pixel value, and provide a specific technical means for solving a technical problem. While the amended claims do incorporate structural elements of the endoscope system, and the red feature quantity is defined regarding pixel value, the “switching” functional action to these structures is optional as recited in the claim. There is a conditional limitation in Claim 1 of “determine whether or not to switch the first observation environment to the second observation environment” and a conditional limitation “in a case where it is determined that switching to the second observation environment is to be performed”. Therefore, there is the situation in which the switching action is determined not to occur for the scope of the claim to be satisfied, and then there is no action performed by the technology beyond the abstract idea of determining if an action should be performed. For that conditional case, the limitations concerning actually switching and set a magnification ratio…performed do not physically occur. In that case, the remaining elements of the claim are all abstract ideas and extra-solution activity, thereby not patent eligible per 35 U.S.C 101. The argument is not persuasive.
The applicant argues at [Page 8, Bottom] that the claimed features provide a concrete technical solution to a problem by quantitatively evaluating the redness by a pixel could and automatically or semi-automatically switching the magnification for observation. The “switching” is not recited as particularly an “automatic” or “semi-automatic” control on the physical endoscope technology system itself. Rather, the description of a “specific operation” associated with switching as recited in Claims 1 and 12 is described in Applicant’s specification at [0074] as either
a. “observation environment switching unit 88 sets the magnification ratio to the second magnification ratio by giving an instruction to automatically operate the zoom operation part 12h”,
b. “observation environment switching unit 88 displays a message (notification) of "Please set the magnification ratio to 60 times or more" on the display 18” (requiring no concrete action on the user’s part to actually control the system), or
c. “A user looks at the message displayed on the display 18 and operates the zoom operation part 12h to perform an operation for setting the magnification ratio to the second magnification ratio (60 times or more)”.
As currently recited, the claims do not clearly tie the “switching operation” to control of the structural elements of the endoscope system by necessarily quantitatively evaluating the redness as a pixel count. The argument is not persuasive.
In regard to the 35 U.S.C. 102 and 35. U.S.C. 103 analysis:
Applicant’s arguments with respect to claims 1 – 10 and 12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791