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 .
Information Disclosure Statement
Information Disclosure Statement (IDS) submitted on 05/22/2025 has been entered and fully considered by the examiner.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to a “device” and a which describes one of the four statutory categories of patentable subject matter, i.e., a machine.
Claim 15 is directed to a “method” which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Claim 18 is directed towards a “product” which describes one of the four statutory categories of patentable subject matter, i.e. an item of manufacture.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One:
Claims 1, 15, and 18 recite (“sets forth” or “describes”) the abstract idea of a mental process, substantially as follows: “calculate fluorescence intensity information based on the fluorescence image data; receive correlation relationship information between the fluorescence intensity information and invasion information in a biological tissue; and generate heat invasion information based on the fluorescence intensity information and the correlation relationship information”.
In claims 1, 15 and 18, the above recited steps can be practically performed in the human mind, with the aid of a pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. If a person were to visually examine, i.e., perform an observation, of the fluorescent images, they can calculated the amount of intensity in their head, and based on the correlation data stored in their brain they can detect and determine the level of heat invasion of the tissue based on the fluorescence intensity of the image. There is nothing recited in the claim to suggest an undue level of complexity in how the intensity is being measured, or the level of heat invasion is determined. Therefore, a person would be able to perform the above cited steps mentally or with a generic computer.
Prong Two: Claims 1, 15, and 18 do not include additional elements that integrate the mental process into a practical application.
This judicial exception is not integrated into a practical application. In particular, the claims recites (1) additional steps of generating a fluorescence image.
The steps in (1) represent merely data gathering or pre-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality with conventionally used tools (see below Step IIB for further details).
As a whole, the additional elements merely serve to gather and feed information to the abstract idea and to output a notification based on the abstract idea, while generically implementing it on conventionally used tools. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the estimated bio-information is not outputted in any way such that a practical benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1, 15, and 18 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the claims recite additional steps of represent mere data gathering or pre/extra-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality. Mere insignificant conventional extra-solution activity cannot provide an inventive concept. The claims hence are The not patent eligible.
Dependent Claims
The following dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons:
defining the heat invasion information (claims 4-5, 10-14, 16-17, 19-20).
The following dependent claims merely further describe the extra-solution activities and therefore, do not amount to significantly more than the judicial exception or integrate the abstract idea into a practical application for similar reasons:
details of the fluorescent image obtained (claim 2 and 8);
describing light which was used to acquire the imaged tissue (claim 3);
generating light to acquire data and displaying the image (claim 6-7);
describing different types of images being generated (claim 9); and
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 5, 8, 10, 11, and 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alfano et al. (U.S. Publication No. 2002/0002337) hereinafter “Alfano”.
Regarding claim 1, Alfano discloses a control device for heat invasion observation [see abstract and clam 16 of Alfano] comprising:
a processor comprising hardware, [see [0018], and [0043] of Alfano] configured to:
generate fluorescence image data based on an image pickup signal; [see [0043] disclosing generating a fluorescence map based on the signal received using the processor and software]
calculate fluorescence intensity information based on the fluorescence image data; [see [0011] and [0018] disclosing determining the fluorescence intensity over time]
receive correlation relationship information between the fluorescence intensity information and invasion information in a biological tissue; and [see [0013] of Alfano]
generate heat invasion information based on the fluorescence intensity information and the correlation relationship information. [see [0061]; the size and depth of the burned wound can be detected]
Regarding claim 2, Alfano further discloses that the processor configured to obtain the image pickup signal based on an image of fluorescence generated from a heat invasion area in a biological tissue. [see [0011] of Alfano]
Regarding claim 5, Alfano further discloses that the fluorescence intensity information includes heat invasion degree distribution information indicating a distribution of fluorescence intensities generated from respective locations in a heat invasion area. [see [0043] and [0061] and FIGs. 6-8 of Alfano disclose displaying a distribution of the intensities due to heat invasion on the tissue. [0039] further discloses that the degree of damage can be also determined based on the intensity of fluorescence detected]
Regarding claim 8, Alfano further discloses that the processor is configured to generate a display image data based on the fluorescence image data and the heat invasion information. [see [0043 and [0061] and FIGs. 6-8 of Alfano]
Regarding claim 10, Alfano further discloses that the invasion information is a heat invasion depth; and the heat invasion information is heat invasion depth information. [see [0061]; the size and depth of the burned wound can be detected]
Regarding claim 11, Alfano further discloses that the correlation relationship information indicates a positive correlation indicating that the heat invasion depth in the biological tissue at which the fluorescence intensity is generated is deeper when the fluorescence intensity is more intense. [see [0015]-[0016]; the higher intensity fluorescent emission indicates presence of more collagen and more damage. [0061] further discloses a relationship between the intensity of the fluorescent signal and the depth of the burn]
Regarding claim 15, Alfano discloses a heat invasion observation method [see abstract of Alfano] comprising:
generating fluorescence image data based on an image pickup signal; [see [0043] disclosing generating a fluorescence map based on the signal received using the processor and software]
calculating fluorescence intensity information based on the fluorescence image data; [see [0011] and [0018] disclosing determining the fluorescence intensity over time]
receiving a correlation relationship information between the fluorescence intensity information and an invasion information by heat in a biological tissue; and [see [0013] of Alfano]
generating heat invasion information based on the fluorescence intensity information and the correlation relationship information. [see [0061]; the size and depth of the burned wound can be detected]
Regarding claim 16, Alfano further discloses that the invasion information is a heat invasion depth; and the invasion heat information is heat invasion depth information. [see [0061]; the size and depth of the burned wound can be detected]
Regarding claim 17, Alfano further discloses that the correlation relationship information indicates a positive correlation indicating that the heat invasion depth in the biological tissue at which the fluorescence intensity is generated is deeper when the fluorescence intensity is more intense. [see [0015]-[0016]; the higher intensity fluorescent emission indicates presence of more collagen and more damage. [0061] further discloses a relationship between the intensity of the fluorescent signal and the depth of the burn]
Regarding claim 18, Alfano further discloses that a non-transitory computer-readable storage medium storing instructions that cause a computer [see [0042]; the method is performed by a computer which inherently includes a memory and operates using algorithms stored on the memory] to at least perform:
generate fluorescence image data based on an image pickup signal; [see [0043] disclosing generating a fluorescence map based on the signal received using the processor and software]
calculate fluorescence intensity information based on the fluorescence image data [see [0011] and [0018] disclosing determining the fluorescence intensity over time]
receive correlation relationship information between the fluorescence intensity information and an invasion information by heat in a biological tissue; and [see [0013] of Alfano]
generate heat invasion information based on the fluorescence intensity information and the correlation relationship information. [see [0061]; the size and depth of the burned wound can be detected]
Regarding claim 19, Alfano further discloses that wherein the invasion information is a heat invasion depth; and the invasion heat information is heat invasion depth information. [see [0061]; the size and depth of the burned wound can be detected]
Regarding claim 20, Alfano further discloses that the correlation relationship information indicates a positive correlation indicating that the heat invasion depth in the biological tissue at which the fluorescence intensity is generated is deeper when the fluorescence intensity is more intense. [see [0015]-[0016]; the higher intensity fluorescent emission indicates presence of more collagen and more damage. [0061] further discloses a relationship between the intensity of the fluorescent signal and the depth of the burn]
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3, 4, 6, 7, 9, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Alfano et al. (U.S. Publication No. 2002/0002337) hereinafter “Alfano” in view of Mitsutaka et al. (JP Publication No. 2017023604A) hereinafter “Mitsutaka”.
Regarding claim 3, Alfano discloses all the limitations of claim 1 [see rejection of claim 1 above]
Alfano however, does not expressly disclose that the processor is configured to pick up an image of light including band components at 500 to 600 nm generated from a fluorescence image.
Mitsutaka, directed towards detection of burn and damage level in the tissue ablated [see abstract of Mistutaka] further discloses that the processor is configured to pick up an image of light including band components at 500 to 600 nm generated from a fluorescence image. [see page 3, third paragraph discloses generation of white light which includes 500-600nm range wavelengths]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Alfano such that the processor is configured to pick up an image of light including band components at 500 to 600 nm generated from a fluorescence image according to the teachings of Mitsutaka in order to generate an observation image of the site to visually show the level of damage [see page 3, third paragraph of the page]
Regarding claim 4, Alfano discloses all the limitations of claim 1 [see rejection of claim 1 above]
Alfano further discloses that the fluorescence intensity information includes heat invasion range information [see [0039] of Alfano disclosing that the degree of damage can be determined]
Alfano does not expressly disclose indicating a high fluorescence area where a predetermined fluorescence intensity or higher in an area where the fluorescence image data.
Mitsutaka further discloses that the method further teaches including a high fluorescence area where a predetermined fluorescence intensity or higher in an area where the fluorescence image data. [see page 16, last paragraph of the page]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Alfano such that it includes indicating a high fluorescence area where a predetermined fluorescence intensity or higher in an area where the fluorescence image data according to the teachings of Mitsutaka in order to detect and highlight the areas that need attention [see page 16, last paragraph of the page of Mitsutatka]
Regarding claim 6, Alfano discloses all the limitations of claim 1 [see rejection of claim 1 above]
Alfano does not disclose that the processor is configured to: generate white light image data based on an image of return light from the biological tissue irradiated with white light; generate display image data based on the white light image data and the heat invasion range information.
Mitsutaka further discloses that the processor is configured to: generate white light image data based on an image of return light from the biological tissue irradiated with white light; [see page 3, third paragraph discloses generation of white light] generate display image data based on the white light image data and the heat invasion range information. [see page 16 second paragraph of Mitsutaka]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Alfano such that the processor is configured to: generate white light image data based on an image of return light from the biological tissue irradiated with white light; generate display image data based on the white light image data and the heat invasion range information according to the teachings of Mitsutaka in order to generate an observation image of the site to visually show the level of damage [see page 3, third paragraph of the page]
Regarding claim 7, Alfano discloses all the limitations of claim 1 [see rejection of claim 1 above]
Alfano does not disclose that the processor is configured to: generate white light image data based on an image of return light from the biological tissue irradiated with white light; generate display image data based on the white light image data and the heat invasion range information.
Mitsutaka further discloses that the processor is configured to: generate white light image data based on an image of return light from the biological tissue irradiated with white light; [see page 3, third paragraph discloses generation of white light] generate display image data based on the white light image data and the heat invasion range information. [see page 16 second paragraph of Mitsutaka]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Alfano such that the processor is configured to: generate white light image data based on an image of return light from the biological tissue irradiated with white light; generate display image data based on the white light image data and the heat invasion range information according to the teachings of Mitsutaka in order to generate an observation image of the site to visually show the level of damage [see page 3, third paragraph of the page]
Regarding claim 9, Alfano discloses all the limitations of claim 1 [see rejection of claim 1 above]
Alfano does not disclose that the processor is configured to: generate pre-treatment fluorescence image data before the biological tissue is treated by an energy device; generate post-treatment fluorescence image data after the biological tissue is treated by the energy device; extract difference information of fluorescence intensities that change before and after the biological tissue is processed by the energy device based on the pre-treatment fluorescence image data and the post-treatment fluorescence image data; and generate the heat invasion information from the extracted difference information of fluorescence intensities.
Mitsutaka further discloses that the processor is configured to: generate pre-treatment fluorescence image data before the biological tissue is treated by an energy device; [see page 15, last paragraph to page 16, second paragraph of Mitsutaka] generate post-treatment fluorescence image data after the biological tissue is treated by the energy device; [see page 16, third paragraph to fifty paragraph of Mitsutaka] extract difference information of fluorescence intensities that change before and after the biological tissue is processed by the energy device based on the pre-treatment fluorescence image data and the post-treatment fluorescence image data; [see page 16, last paragraph of the page ]and generate the heat invasion information from the extracted difference information of fluorescence intensities.[see page 16, last paragraph continued in page 17 of Mitsutaka]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Alfano such that the processor is configured to: generate pre-treatment fluorescence image data before the biological tissue is treated by an energy device; generate post-treatment fluorescence image data after the biological tissue is treated by the energy device; extract difference information of fluorescence intensities that change before and after the biological tissue is processed by the energy device based on the pre-treatment fluorescence image data and the post-treatment fluorescence image data; and generate the heat invasion information from the extracted difference information of fluorescence intensities according to the teachings of Mitsutaka in order to determine the amount of burn in the tissue during the treatment [see page 16, last paragraph of the page]
Regarding claim 12, Alfano discloses all the limitations of claim 1 [see rejection of claim 1 above]
Alfano does not disclose that the processor is configured to: determine whether the fluorescence intensity generated from a heat invasion area is equal to or higher than a predetermined threshold; and responsive to determining the fluorescence intensity generated from the heat invasion area is equal to or higher than a predetermined threshold, generate a notice information to notify the fluorescence intensity generated from the heat invasion area is equal to or higher than a predetermined threshold.
Mitsutaka further discloses that the processor is configured to: determine whether the fluorescence intensity generated from a heat invasion area is equal to or higher than a predetermined threshold; [see page 16, last paragraph of the page] and responsive to determining the fluorescence intensity generated from the heat invasion area is equal to or higher than a predetermined threshold, generate a notice information to notify the fluorescence intensity generated from the heat invasion area is equal to or higher than a predetermined threshold. [see page 16, last paragraph discloses notification of the completion of cauterization]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Alfano such that the processor is configured to: determine whether the fluorescence intensity generated from a heat invasion area is equal to or higher than a predetermined threshold; and responsive to determining the fluorescence intensity generated from the heat invasion area is equal to or higher than a predetermined threshold, generate a notice information to notify the fluorescence intensity generated from the heat invasion area is equal to or higher than a predetermined threshold according to the teachings of Mitsutaka in order to determine the amount of burn in the tissue during the treatment [see page 16, last paragraph of the page]
Regarding claim 13, Alfano further discloses the heat invasion information is heat invasion depth information; [see [0061]; the size and depth of the burned wound can be detected]and the processor is configured to:
Mitsutaka further disclose determine whether the heat invasion depth in the fluorescence image data reaches a predetermined depth or more based on the heat invasion depth information; and [see page 16, last paragraph of the page] responsive to determining the heat invasion depth in the fluorescence image data reaches a predetermined depth or more, generate a notice information to notify the heat invasion depth in the fluorescence image data reaches a predetermined depth or more. [see page 16, last paragraph discloses notification of the completion of cauterization]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Alfano such that determine whether the heat invasion depth in the fluorescence image data reaches a predetermined depth or more based on the heat invasion depth information; and responsive to determining the heat invasion depth in the fluorescence image data reaches a predetermined depth or more, generate a notice information to notify the heat invasion depth in the fluorescence image data reaches a predetermined depth or more according to the teachings of Mitsutaka in order to determine the amount of burn in the tissue during the treatment [see page 16, last paragraph of the page]
Regarding claim 14, Alfano discloses a heat invasion observation system [see abstract of Alfano] comprising:
the control device according to claim 1; [see rejection of claim 1]
a storage [see [0042]; the method is performed by a computer which inherently includes a memory] that stores the correlation relationship information; [see [0013] of Alfano]and
a light source configured to emit exciting light for exciting a substance contain in a heat invasion area in the fluorescence image data. [see [0058]; xenon lamp source]
Alfano does not disclose an energy device configured to cauterize the biological tissue;
Mitsutaka further discloses an energy device configured to cauterize the biological tissue; [see page 12, second paragraph of the page; cautery probe 50]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Alfano such that it includes an energy device configured to cauterize the biological tissue according to the teachings of Mitsutaka in order to determine the amount of burn in the tissue during the treatment [see page 16, last paragraph of the page]
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARJAN - SABOKTAKIN whose telephone number is (303)297-4278. The examiner can normally be reached M-F 9 am-5pm CT.
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/MARJAN SABOKTAKIN/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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