DETAIL OFFICE ACTIONS
The United States Patent & Trademark Office appreciates the response filed for the current application that is submitted on 11/04/2025. The United States Patent & Trademark Office reviewed the following documents submitted and has made the following comments below.
Amendment
Applicant submitted amendments on 11/04/2025. The Examiner acknowledges the amendment and has reviewed the claims accordingly.
Priority
Acknowledgment is made that this application is a CON of application no.
PCT/JP2022/009693 filed on 03/07/2022, which further claim for domestic priority under 35 U.S.C.119 (e) based on the provisional applications 63/221,128 & 63/222,252 filed on 07/13/2021 & 07/15/2021 respectively.
Information Disclosure Statement
The IDS dated 10/07/2025 has been considered and placed in the application file.
Overview
Claims 1-16 are pending in this application and have been considered below.
Claims 1-16 are rejected.
Applicant Arguments:
In regards to the argument on Argument 1, Applicant/s state/s “the title has been amended to recite, in clean form: A SYSTEM FOR PREDICTING HEAT DAMAGE DURING ENDOSCOPIC PROCUDURES. Withdrawal of the objection to the title is respectfully requested.” therefore, the objection of the specification should be withdrawn (See Remarks, page 7, paragraph 5).
In regards to the argument on Argument 2, Applicant/s state/s “Wibowo teaches pre-operative planning from CT/radiomics (e.g., Fig. 1 overview of detection/segmentation/modeling and dose calculation) and thus does not determine risk from images acquired during energy delivery.” therefore, the rejection of 35 U.S.C. 103 should be withdrawn (See Remarks, page 8, paragraph 3).
In regards to the argument on Argument 3, Applicant/s state/s “Borsic models necrotized tissue volume via simulated vapor pathways and bioheat/Arrhenius calculations. Borsic likewise computes outcomes and does not perform risk determination from an image captured during output.” therefore, the rejection of 35 U.S.C. 103 should be withdrawn (See Remarks, page 8, paragraph 3).
In regards to the argument on Argument 4, Applicant/s state/s “Wibowo and Borsic do not teach or suggest: ‘ acquire, in real-time, an image during output that is an image during the energy output and in which the at least one energy device and the at least one biological tissue are imaged’, as recited in amended claim 1” therefore, the rejection of 35 U.S.C. 103 should be withdrawn (See Remarks, page 8, paragraph 4).
In regards to the argument on Argument 5, Applicant/s state/s “Therefore, claims 2-14 are not obvious over the cited references for at least the reasons discussed above with respect to claim 1.” therefore, the rejection of 35 U.S.C. 103 should be withdrawn (See Remarks, page 9, paragraph 1).
Examiner’s Responses:
In response to Argument 1, Applicant’s arguments, see Remarks, filed 11/04/2025, with respect to the objection of the specification been fully considered and are persuasive. Therefore, the objection has been withdrawn due to the amendment.
In response to Argument 2, Applicant’s arguments, see Remarks, filed 11/04/25, with respect to the rejection(s) of claims claim 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn due to the amendment. However, upon further consideration, a new ground(s) of rejection is made for Claim 1 and its dependent claims under 35 U.S.C. 103 in view of Wibowo (US Patent Publication 20210038314 A1 hereafter referred to as Wibowo) in view of Borsic (US Patent Publication 20190371474 A1 hereafter referred to as Borsic) in further view of Shelton IV et al (US Patent Publication 20210196425 A1 hereafter referred to as Shelton 2).
The Examiner finds that Wibowo teaches on the amended claim language “processor” and “the processor being configured to” in Claim 1 with the amendment changing the scope of the “in real time, an image during output”.
Specifically, Wibowo teaches a processor that completes method steps in ¶0050 and ¶0051. Applicant argues that ‘Wibowo does not determine risk from images acquired during energy delivery.” However, the Examiner interprets that Wibowo teaches the main concept of a system the utilizes a processor that stores a trained model to estimate heat diffusion in a tissue region where the energy device is being used, the additional details of the function and characteristics of the main concepts as stated above by the applicant in the amendments is taught by Borsic and Shelton 2 in the details of the rejection below. The Examiner will maintain prior art Wibowo and details of the rejection are below.
In response to Argument 3, Applicant’s arguments, see Remarks, filed 11/04/25, with respect to the rejection(s) of claim 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn due to the amendment. However, upon further consideration, a new ground(s) of rejection is made for Claim 1 and its dependent claims under 35 U.S.C. 103 in view of Wibowo (US Patent Publication 20210038314 A1 hereafter referred to as Wibowo) in view of Borsic (US Patent Publication 20190371474 A1 hereafter referred to as Borsic) in further view of Shelton IV et al (US Patent Publication 20210196425 A1 hereafter referred to as Shelton 2).
The Examiner finds that Borsic teaches on the amended claim language “determining a risk for heat damage” in Claim 1 with the amendment changing the scope of the “in real time, an image during output”.
Specifically, Borsic teaches determining the risk for heat damage in healthy tissues in ¶0004, and Fig 2, 230, with the goal of predicting the actual ablation values of the tissues more correctly in ¶0021. Applicant argues that “Borsic likewise computes outcomes and does not perform risk determination from an image captured during output”. However, the Examiner interprets that Borsic teaches the main concept of predicting the likelihood of healthy issue being damaged due to vapor heat during a procedure, the additional details of the function and characteristics of the main concepts as stated above by the applicant in the amendments is taught by Shelton 2 in the details of the rejection below. The Examiner will maintain prior art Wibowo and details of the rejection are below.
In response to Argument 4, Applicant’s arguments, see Remarks, filed 11/04/25, with respect to the rejection(s) of claim 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn due to the amendment. However, upon further consideration, a new ground(s) of rejection is made for Claim 1 and its dependent claims under 35 U.S.C. 103 in view of Wibowo (US Patent Publication 20210038314 A1 hereafter referred to as Wibowo) in view of Borsic (US Patent Publication 20190371474 A1 hereafter referred to as Borsic) in further view of Shelton IV et al (US Patent Publication 20210196425 A1 hereafter referred to as Shelton 2).
The Examiner finds that Borsic and Wibowo teach on the amended claim language “determining a risk for heat damage” “processor” and “the processor being configured to” in in Claim 1 with the amendment changing the scope of the “in real time, an image during output”.
Specifically, Borsic teaches determining the risk for heat damage in healthy tissues in ¶0004, and Fig 2, 230, with the goal of predicting the actual ablation values of the tissues more correctly in ¶0021. Wibowo teaches a processor that completes method steps in ¶0050 and ¶0051. Applicant argues that ‘Wibowo and Borsic do not teach or suggest: ‘ acquire, in real-time, an image during output that is an image during the energy output and in which the at least one energy device and the at least one biological tissue are imaged’, as recited in amended claim 1” However, the Examiner interprets that Wibowo and Borsic teaches the main concept of a system the utilizes a processor that stores a trained model to estimate heat diffusion in a tissue region for the purpose of predicting the risk of heat damage where the energy device is being used in the human body, the additional details of the function and characteristics of the main concepts as stated above by the applicant in the amendments is taught by Shelton 2 in the details of the rejection below. The Examiner will maintain prior art Wibowo and Borsic and details of the rejection are below.
In response to Argument 5, Applicant’s arguments, see Remarks, filed 11/04/25, with respect to the rejection(s) of claims 2-14 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn due to the amendment. However, upon further consideration, a new ground(s) of rejection is made for Claims 2-14 and its dependent claims under 35 U.S.C. 103 in view of Wibowo (US Patent Publication 20210038314 A1 hereafter referred to as Wibowo) in view of Borsic (US Patent Publication 20190371474 A1 hereafter referred to as Borsic) in further view of Shelton IV et al (US Patent Publication 20210196425 A1 hereafter referred to as Shelton 2). See rejection below.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the
plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification.
Under MPEP 2143.03, "All words in a claim must be considered in judging the patentability
of that claim against the prior art." In re Wilson, 424 F.2d 1382, 1385, 165 USPQ 494, 496 (CCPA 1970). As a general matter, the grammar and ordinary meaning of terms as understood by one having ordinary skill in the art used in a claim will dictate whether, and to what extent, the language limits the claim scope. Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. In addition, when a claim requires selection of an element from a list of alternatives, the prior art teaches the element if one of the alternatives is taught by the prior art. See, e.g., Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288, 1298, 92 USPQ2d 1163, 1171 (Fed. Cir. 2009).
Claim 1 recite “or ” then listing “training device tissue image or a training tissue image”.
Since “or” is disjunctive, any one of the elements found in the prior art is sufficient to reject the claim. While citations have been provided for completeness and rapid prosecution, only one element is required. Because, on balance, it appears the disjunctive interpretation enjoys the most specification support and for that reason the disjunctive interpretation (one of A, B OR C) is being adopted for the purposes of this Office Action. Applicant’s comments and/or amendments relating to this issue are invited to clarify the claim language and the prosecution history.
Claim 7 recite “or ” then listing “which is an instruction to decrease the energy output from
present energy output or an instruction to stop the energy output”. Since “or” is disjunctive, any one of the elements found in the prior art is sufficient to reject the claim. While citations have been provided for completeness and rapid prosecution, only one element is required. Because, on balance, it appears the disjunctive interpretation enjoys the most specification support and for that reason the disjunctive interpretation (one of A, B OR C) is being adopted for the purposes of this Office Action. Applicant’s comments and/or amendments relating to this issue are invited to clarify the claim language and the prosecution history.
Claim 8 recite “or ” then listing “recommendation to decrease the energy output from present
energy output or recommendation to stop the energy output”. Since “or” is disjunctive, any one of the elements found in the prior art is sufficient to reject the claim. While citations have been provided for completeness and rapid prosecution, only one element is required. Because, on balance, it appears the disjunctive interpretation enjoys the most specification support and for that reason the disjunctive interpretation (one of A, B OR C) is being adopted for the purposes of this Office Action. Applicant’s comments and/or amendments relating to this issue are invited to clarify the claim language and the prosecution history.
Claim 9 recite “or ” then listing “training device tissue image or a training tissue image”.
Since “or” is disjunctive, any one of the elements found in the prior art is sufficient to reject the claim. While citations have been provided for completeness and rapid prosecution, only one element is required. Because, on balance, it appears the disjunctive interpretation enjoys the most specification support and for that reason the disjunctive interpretation (one of A, B OR C) is being adopted for the purposes of this Office Action. Applicant’s comments and/or amendments relating to this issue are invited to clarify the claim language and the prosecution history.
Claim 14 recite “or ” then listing “at least one energy device or the captured image”. Since
“or” is disjunctive, any one of the elements found in the prior art is sufficient to reject the claim. While citations have been provided for completeness and rapid prosecution, only one element is required. Because, on balance, it appears the disjunctive interpretation enjoys the most specification support and for that reason the disjunctive interpretation (one of A, B OR C) is being adopted for the purposes of this Office Action. Applicant’s comments and/or amendments relating to this issue are invited to clarify the claim language and the prosecution history.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102
and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness
rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 7-9, 11, 14 and 15-16 are rejected under 35 U.S.C. 103 as unpatentable over Wibowo (US Patent Publication 20210038314 A1 hereafter referred to as Wibowo) in view of Borsic (US Patent Publication 20190371474 A1 hereafter referred to as Borsic) in further view of Shelton IV et al (US Patent Publication 20210196425 A1 hereafter referred to as Shelton 2).
Regarding Claim 1, Wibowo teaches a system (Wibowo ¶0003, ¶0009, ¶0049 discloses a system in a clinical setting) comprising:
a processor (Wibowo ¶0050 discloses a processor) the processor being configured to (Wibowo ¶0050 discloses a processor that carries out steps):
based on a trained model (Wibowo ¶0045 discloses a heat transfer model, ¶0047 discloses a trained CNN) that is stored in a memory (Wibowo ¶0050 discloses a memory device and instructions stored) and trained to estimate a heat diffusion region (Wibowo ¶0044 discloses calculating an ablation does and heat diffusion region) and a specific tissue region from a training device tissue image or a training tissue image (Wibowo ¶0034 discloses determining an ROI of a specific region and excluding irrelevant regions), the training device tissue image being an image in which at least one energy device (Wibowo ¶0052 discloses multiple types of ablations energy devices) that receives energy supply to output energy and that is outputting energy (Wibowo ¶0037 discloses the anatomy being affected by thermal energy) and at least one biological tissue are imaged (Wibowo Fig 1, 20-30, ¶0003 disclose tumors being imaged which reside in biological tissue), the training tissue image being an image in which the at least one biological tissue is imaged (Wibowo Fig 2, 10 discloses an input CT image), the heat diffusion region being a region in which heat diffusion from the at least one energy device (Wibowo ¶0047 discloses the comparison of ablation zones) to the at least one biological tissue is caused by energy output from the at least one energy device (Wibowo ¶0047, ¶0053 discloses energy output to the tissue from the energy device), and the specific tissue region being a region in the at least one biological tissue (Wibowo ¶0034 discloses determining an ROI of a specific region containing a tumor and excluding irrelevant regions) ; and
acquire (Wibowo Figs 3A-3C disclose captured images) the energy output (Wibowo ¶0047, ¶0053 discloses energy output to the tissue from the energy device) and in which the at least one energy device (Wibowo ¶0052 discloses multiple types of ablations energy devices) and the at least one biological tissue are imaged (Wibowo Fig 1, 20-30, ¶0003 disclose tumors being imaged which reside in biological tissue),
perform a process (Wibowo ¶0018 discloses preforming a process) based on the trained model (Wibowo ¶0045 discloses a heat transfer model, ¶0047 discloses a trained CNN) to estimate the heat diffusion region (Wibowo ¶0044 discloses calculating an ablation does and heat diffusion region) and the specific tissue region (Wibowo ¶0034 discloses determining an ROI of a specific region and excluding irrelevant regions),
on a specific tissue (Wibowo ¶0034 discloses determining an ROI of a specific region and excluding irrelevant regions) by the energy output from the at least one energy device (Wibowo ¶0047, ¶0053 discloses energy output to the tissue from the energy device) from the estimated heat diffusion region (Wibowo ¶0044 discloses calculating an ablation does and heat diffusion region) and the estimated specific tissue region (Wibowo ¶0034 discloses determining an ROI of a specific region and excluding irrelevant regions).
Wibowo does not explicitly teach for determining a risk for heat damage, comprising hardware, perform a process, determine a risk for heat damage.
Borsic is in the same field of noninvasive surgical techniques. Further, Borsic teaches determining a risk for heat damage (Borsic ¶0004 discloses determining the likelihood of healthy tissue being damaged due to vapor heat), comprising hardware (Borsic ¶0041 and ¶0081 discloses hardware for the implementation of machine executable instructions), perform a process (Borsic ¶0028 and ¶0031 discloses performing image guides surgery) determine a risk for heat damage (Borsic ¶0004 discloses determining the likelihood of healthy tissue being damaged).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wibowo by incorporating the ability for the machine learning algorithm to be able to predict the heat damage of the surrounding tissue based on the tissue type and characteristics and threshold of temperature the tissue can withstand and produce instructions to stop or decrease the heat being applied to the tissue based on the prediction, as taught by Borsic, to make an invention that can automatically detect the likelihood of damage of the surrounding tissue; thus, one of ordinary skilled in the art would be motivated to combine the references since an object of the present invention is to alert the medical profession as to the location and effect of the probe during the procedure so that the medical profession can make adjustments (Borsic, ¶0029).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Wibowo and Borsic in combination do not explicitly disclose during an endoscopic treatment, in real time, an image during output, from the image during output.
Shelton 2 is in the same field of machine learning in surgical settings. Further, Shelton 2 teaches during an endoscopic treatment (Shelton 2 ¶0001, ¶0192, ¶0286, and Fig 19 2239 discloses an endoscope used in the surgical system), in real time, an image during output (Shelton 2 Fig 1 and ¶0191 discloses the surgical visualization in real time that includes an imaging device, 120, that can be provided to the clinician) that is an image during (Shelton 2 ¶0191 discloses the surgical visualization in real time) from the image during output (Shelton 2 Fig 1 and ¶0191 discloses the surgical visualization in real time that includes an imaging device, 120, that can be provided to the clinician).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wibowo in view of Borsic by incorporating an endoscopic procedure that acquires images in real time so that a clinician can assess the surgical procedure in real time, as taught by Shelton 2, to make an invention that can assist physicians in reducing heat damage to the surrounding tissues; thus, one of ordinary skilled in the art would be motivated to combine the references since an object of the present invention is to enable smarter decisions with critical anatomy detection and avoidance technology (Shelton 2, ¶0182).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 2, Wibowo in view of Borsic in view of Shelton 2 teaches the system as defined in claim
wherein the processor determines (Wibowo ¶0050 discloses a processor that carries out steps) that there is the risk for heat damage (Borsic ¶0004 discloses determining the likelihood of healthy tissue being damaged due to vapor heat) in a case where a distance between the specific tissue region and the heat diffusion region (Borsic ¶0058 discloses the distance the vapor from ablation will travel relative to the treatment area) is a threshold (Borsic ¶0072 discloses the threshold being higher or lower depending on the condensation of the specific tissues) or smaller, the threshold being preliminarily set (Borsic ¶0049 discloses the power level of the probe being set before the procedure). See Claim 1 for rationale, its parent claim.
Regarding Claim 3, Wibowo in view of Borsic in view of Shelton 2 teaches the system as defined in claim 1,
wherein the threshold is different (Borsic ¶0049 discloses the power level of the probe being set before the procedure) depending on a tissue type of the specific tissue (Borsic ¶0072 discloses the threshold being higher or lower depending on the condensation of the specific tissues). See Claim 1 for rationale, its parent claim.
Regarding Claim 7, Wibowo in view of Borsic in view of Shelton 2 teaches the system as defined in claim 1,
wherein the processor (Wibowo ¶0050 discloses a processor that carries out steps) outputs (Borsic ¶0037, ¶0040 and Fig 8, 816 discloses input/ output capabilities), based on a result of the determination (Borsic ¶0004 discloses determining the likelihood of healthy tissue being damaged due to vapor heat), an energy output adjustment instruction (Borsic ¶0049 discloses changing the applied power and duration of the probe), which is an instruction to decrease the energy output from present energy output (Borsic ¶0075 discloses using a lesser quantity of heat of the tissue) or an instruction to stop the energy output (Borsic ¶0031 discloses stopping the ablation), to a generator that controls an amount of energy supply to the at least one energy device (Borsic ¶0031 discloses an energy control and regulator of the alation device power) based on the energy output adjustment instruction (Borsic ¶0049 discloses changing the applied power and duration of the probe). See Claim 1 for rationale, its parent claim.
Regarding Claim 8, Wibowo in view of Borsic in view of Shelton 2 teaches the system as defined in claim 1,
wherein the processor (Wibowo ¶0050 discloses a processor that carries out steps) presents recommendation (Borsic ¶0079 discloses alerting the physician if there is a problem with the procedure) to decrease (Borsic ¶0075 discloses using a lesser quantity of heat of the tissue) the energy output from present energy output (Borsic ¶0049 discloses automated inputs consisting selection of power level) or recommendation (Borsic ¶0079 discloses alerting the physician if there is a problem with the procedure) to stop the energy output (Borsic ¶0031 discloses stopping the ablation) based on a result of the determination (Borsic ¶0037, ¶0040 and Fig 8, 816 discloses input/ output capabilities). See Claim 1 for rationale, its parent claim.
Regarding Claim 9, Wibowo in view of Borsic in view of Shelton 2 teaches the system as defined in claim 1, wherein
the trained model (Wibowo ¶0045 discloses a heat transfer model, ¶0047 discloses a trained CNN) is trained to estimate (Wibowo ¶0044 discloses calculating an ablation does and heat diffusion region , from training energy output information (Wibowo ¶0048 discloses training data from after ablation) of the at least one energy device (Wibowo ¶0052 discloses multiple types of ablations energy devices), the training device tissue image, or the training tissue image (Wibowo ¶0048 discloses the training images being images of tumors and adjacent tissues), the heat diffusion region in which the heat diffusion (Wibowo ¶0044 discloses calculating an ablation does and heat diffusion region) from the at least one energy device (Wibowo ¶0052 discloses multiple types of ablations energy devices) to the at least one biological tissue (Wibowo Fig 1, 20-30, ¶0003 disclose tumors being imaged which reside in biological tissue) is caused and the specific tissue region (Wibowo ¶0034 discloses determining an ROI of a specific region and excluding irrelevant regions), and
the processor performs a process (Wibowo ¶0050 discloses a processor that carries out steps) based on the trained model (Wibowo ¶0045 discloses a heat transfer model, ¶0047 discloses a trained CNN) to estimate the heat diffusion region (Wibowo ¶0044 discloses calculating an ablation does and heat diffusion region) and the specific tissue region (Wibowo ¶0034 discloses determining an ROI of a specific region and excluding irrelevant regions) from the energy output information (Wibowo ¶0037 discloses the anatomy being affected by thermal energy) of the at least one energy device (Wibowo ¶0052 discloses multiple types of ablations energy devices) and the captured image (Wibowo Figs 3A-3C disclose captured images). See Claim 1 for rationale, its parent claim.
Regarding Claim 11, Wibowo in view of Borsic in view of Shelton 2 teaches The system as defined in claim 1,
wherein the at least one energy device (Wibowo ¶0052 discloses multiple types of ablations energy devices) is an ultrasonic device (Wibowo ¶0052 discloses the energy device could be an ultrasound device). See Claim 1 for rationale, its parent claim.
Regarding Claim 14, Wibowo in view of Borsic in view of Shelton 2 teaches the system as defined in claim 1,
wherein
the trained model (Wibowo ¶0045 discloses a heat transfer model, ¶0047 discloses a trained CNN) is trained to estimate tissue heat-transfer characteristics (Borsic ¶0040- ¶0041 discloses predicting the physical characteristics of the tissue) from training energy output information (Wibowo ¶0037 discloses the anatomy being affected by thermal energy) of the at least one energy device (Wibowo ¶0052 discloses multiple types of ablations energy devices), the training device tissue image, or the training device tissue image (Wibowo ¶0048 discloses the training images being images of tumors and adjacent tissues), and
the processor performs a process (Wibowo ¶0050 discloses a processor that carries out steps) based on the trained model (Wibowo ¶0045 discloses a heat transfer model, ¶0047 discloses a trained CNN) stored in the memory (Wibowo ¶0050 discloses a memory device and instructions stored) to estimate the tissue heat-transfer characteristics (Borsic ¶0040- ¶0041 discloses predicting the physical characteristics of the tissue) from the energy output information (Wibowo ¶0037 discloses the anatomy being affected by thermal energy) of the at least one energy device (Wibowo ¶0052 discloses multiple types of ablations energy devices) or the captured image (Wibowo Figs 3A-3C disclose captured images). See Claim 1 for rationale, its parent claim.
Regarding Claim 15, Wibowo teaches storing a program (Wibowo ¶0050 discloses a memory device and instructions stored)
Acquiring (Wibowo Figs 3A-3C disclose captured images) in which at least one energy device (Wibowo ¶0052 discloses multiple types of ablations energy devices) that receives energy supply to output energy and that is outputting energy (Wibowo ¶0037 discloses the anatomy being affected by thermal energy) and at least one biological tissue are imaged (Wibowo Fig 1, 20-30, ¶0003 disclose tumors being imaged which reside in biological tissue), the training tissue image being an image in which the at least one biological tissue is imaged (Wibowo Fig 2, 10 discloses an input CT image);
performing a process (Wibowo ¶0018 discloses preforming a process) based on the trained model (Wibowo ¶0045 discloses a heat transfer model, ¶0047 discloses a trained CNN) to estimate the heat diffusion region (Wibowo ¶0044 discloses calculating an ablation does and heat diffusion region) in which heat diffusion from the energy device (Wibowo ¶0047 discloses the comparison of ablation zones) to the biological tissue is caused by the energy output from the energy device (Wibowo ¶0047, ¶0053 discloses energy output to the tissue from the energy device), and a specific tissue region in the biological tissue (Wibowo ¶0034 discloses determining an ROI of a specific region containing a tumor and excluding irrelevant regions), from a training device tissue image (Wibowo ¶0048 discloses a set of training data may include annotated 3D image data of tumors and adjacent tissue) in which the at least one energy device (Wibowo ¶0052 discloses multiple types of ablations energy devices) that is outputting energy (Wibowo ¶0037 discloses the anatomy being affected by thermal energy) and the at least one biological tissue are imaged (Wibowo Fig 2, 10 discloses an input CT image) or from a training tissue image in which the at least one biological tissue is imaged (Wibowo ¶0048 discloses a set of training data may include annotated 3D image data of tumors and adjacent tissue) to estimate the heat diffusion region (Wibowo ¶0044 discloses calculating an ablation does and heat diffusion region) and the specific tissue region (Wibowo ¶0034 discloses determining an ROI of a specific region containing a tumor and excluding irrelevant regions);
determining, from the estimated heat diffusion region (Wibowo ¶0044 discloses calculating an ablation does and heat diffusion region) and the estimated specific tissue region(Wibowo ¶0034 discloses determining an ROI of a specific region containing a tumor and excluding irrelevant regions) on a specific tissue (Wibowo ¶0034 discloses determining an ROI of a specific region and excluding irrelevant regions) by the energy output from the at least one energy device (Wibowo ¶0047, ¶0053 discloses energy output to the tissue from the energy device).
Wibowo does not explicitly teach for determining a risk for heat damage, a risk for heat damage.
Borsic is in the same field of noninvasive surgical techniques. Further, Borsic teaches for determining a risk for heat damage (Borsic ¶0004 discloses determining the likelihood of healthy tissue being damaged due to vapor heat) a risk for heat damage (Borsic ¶0004 discloses determining the likelihood of health tissue being damaged).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wibowo by incorporating the ability for the machine learning algorithm to be able to predict the heat damage of the surrounding tissue based on the tissue type and characteristics and threshold of temperature the tissue can withstand and produce instructions to stop or decrease the heat being applied to the tissue based on the prediction, as taught by Borsic, to make an invention that can automatically detect the likelihood of damage of the surrounding tissue; thus, one of ordinary skilled in the art would be motivated to combine the references since an object of the present invention is to alert the medical profession as to the location and effect of the probe during the procedure so that the medical profession can make adjustments (Borsic, ¶0029).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Wibowo and Borsic in combination do not explicitly disclose a non-transitory computer-readable storage medium, during an endoscopic treatment, the program being configured to cause a computer to at least execute, an image, in real time, an image during output, the image during output being an image during energy output, from the image during output.
Shelton 2 is in the same field of machine learning in surgical settings. Further, Shelton 2 teaches a non-transitory computer-readable storage medium (Shelton 2 ¶0341 discloses a non-transitory computer readable medium) during an endoscopic treatment (Shelton 2 ¶0001, ¶0192, ¶0286, and Fig 19 2239 discloses an endoscope used in the surgical system) , the program being configured to cause a computer to at least execute (Shelton 2 ¶0587 discloses a back end computing system that is configured to store and execute algorithms) an image, in real time, an image during output (Shelton 2 Fig 1 and ¶0191 discloses the surgical visualization in real time that includes an imaging device, 120, that can be provided to the clinician), the image during output (Shelton 2 Fig 1 and ¶0191 discloses the surgical visualization in real time that includes an imaging device, 120, that can be provided to the clinician) being an image during energy output (Shelton 2 ¶0191 discloses the surgical visualization in real time) from the image during output (Shelton 2 Fig 1 and ¶0191 discloses the surgical visualization in real time that includes an imaging device, 120, that can be provided to the clinician).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wibowo in view of Borsic by incorporating an endoscopic procedure that acquires images in real time so that a clinician can assess the surgical procedure in real time, as taught by Shelton 2, to make an invention that can assist physicians in reducing heat damage to the surrounding tissues; thus, one of ordinary skilled in the art would be motivated to combine the references since an object of the present invention is to enable smarter decisions with critical anatomy detection and avoidance technology (Shelton 2, ¶0182).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 16, Wibowo teaches a method (Wibowo ¶0003-¶0006 discloses a method)
acquiring (Wibowo Figs 3A-3C disclose captured images) in which at least one energy device (Wibowo ¶0052 discloses multiple types of ablations energy devices) that receives energy supply to output energy and that is outputting energy (Wibowo ¶0037 discloses the anatomy being affected by thermal energy) and at least one biological tissue are imaged (Wibowo Fig 1, 20-30, ¶0003 disclose tumors being imaged which reside in biological tissue)
performing a process (Wibowo ¶0018 discloses preforming a process) based on the trained model (Wibowo ¶0045 discloses a heat transfer model, ¶0047 discloses a trained CNN) to estimate the heat diffusion region (Wibowo ¶0044 discloses calculating an ablation does and heat diffusion region) in which heat diffusion from the energy device (Wibowo ¶0047 discloses the comparison of ablation zones) to the biological tissue is caused by the energy output from the energy device (Wibowo ¶0047, ¶0053 discloses energy output to the tissue from the energy device), and a specific tissue region in the biological tissue (Wibowo ¶0034 discloses determining an ROI of a specific region containing a tumor and excluding irrelevant regions), from a training device tissue image (Wibowo ¶0048 discloses a set of training data may include annotated 3D image data of tumors and adjacent tissue) in which the at least one energy device (Wibowo ¶0052 discloses multiple types of ablations energy devices) that is outputting energy (Wibowo ¶0037 discloses the anatomy being affected by thermal energy) and the at least one biological tissue are imaged (Wibowo Fig 2, 10 discloses an input CT image) or from a training tissue image in which the at least one biological tissue is imaged (Wibowo ¶0048 discloses a set of training data may include annotated 3D image data of tumors and adjacent tissue) to estimate the heat diffusion region (Wibowo ¶0044 discloses calculating an ablation does and heat diffusion region) and the specific tissue region (Wibowo ¶0034 discloses determining an ROI of a specific region containing a tumor and excluding irrelevant regions),
determining, from the estimated heat diffusion region (Wibowo ¶0044 discloses calculating an ablation does and heat diffusion region) and the estimated specific tissue region(Wibowo ¶0034 discloses determining an ROI of a specific region containing a tumor and excluding irrelevant regions), on a specific tissue (Wibowo ¶0034 discloses determining an ROI of a specific region and excluding irrelevant regions) by the energy output from the at least one energy device (Wibowo ¶0047, ¶0053 discloses energy output to the tissue from the energy device).
Wibowo does not explicitly teach for determining a risk for heat damage, a risk for heat damage.
Borsic is in the same field of noninvasive surgical techniques. Further, Borsic teaches for determining a risk for heat damage (Borsic ¶0004 discloses determining the likelihood of healthy tissue being damaged due to vapor heat) a risk for heat damage (Borsic ¶0004 discloses determining the likelihood of health tissue being damaged).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wibowo by incorporating the ability for the machine learning algorithm to be able to predict the heat damage of the surrounding tissue based on the tissue type and characteristics and threshold of temperature the tissue can withstand and produce instructions to stop or decrease the heat being applied to the tissue based on the prediction, as taught by Borsic, to make an invention that can automatically detect the likelihood of damage of the surrounding tissue; thus, one of ordinary skilled in the art would be motivated to combine the references since an object of the present invention is to alert the medical profession as to the location and effect of the probe during the procedure so that the medical profession can make adjustments (Borsic, ¶0029).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Wibowo and Borsic in combination do not explicitly disclose during an endoscopic treatment, an image, in real time, an image during output, the image during output, being an image during energy output, from the image during output.
Shelton 2 is in the same field of machine learning in surgical settings. Further, Shelton 2 teaches during an endoscopic treatment (Shelton 2 ¶0001, ¶0192, ¶0286, and Fig 19 2239 discloses an endoscope used in the surgical system) an image, in real time, an image during output (Shelton 2 Fig 1 and ¶0191 discloses the surgical visualization in real time that includes an imaging device, 120, that can be provided to the clinician) the image during output (Shelton IV et al 2 Fig 1 and ¶0191 discloses the surgical visualization in real time that includes an imaging device, 120, that can be provided to the clinician) being an image during energy output (Shelton IV et al 2 ¶0191 discloses the surgical visualization in real time) from the image during output (Shelton IV et al 2 Fig 1 and ¶0191 discloses the surgical visualization in real time that includes an imaging device, 120, that can be provided to the clinician).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wibowo in view of Borsic by incorporating an endoscopic procedure that acquires images in real time so that a clinician can assess the surgical procedure in real time, as taught by Shelton 2, to make an invention that can assist physicians in reducing heat damage to the surrounding tissues; thus, one of ordinary skilled in the art would be motivated to combine the references since an object of the present invention is to enable smarter decisions with critical anatomy detection and avoidance technology (Shelton 2, ¶0182).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Claims 4-6, 10, and 12-13 are rejected under 35 U.S.C. 103 as unpatentable over Wibowo in view of Borsic in view of Shelton 2 in further view of Shelton, IV et al. (US Patent Publication US 20190201084 A1 hereafter referred to as Shelton).
Regarding Claim 4, Wibowo in view of Borsic in view of Shelton 2 teaches the system as defined in claim 1, wherein the captured image (Wibowo Figs 3A-3C disclose captured images).
Wibowo in view of Borsic in view of Shelton 2 does not explicitly teach is a plurality of endoscope images that are different in timing to capture respective images.
Shelton is in the same field of noninvasive surgical techniques. Further, Shelton teaches is a plurality of endoscope images (Shelton ¶0199 discloses sample rate image obtained from an endoscope) that are different in timing to capture respective images (Shelton ¶0360 discloses capturing a series of images at a determined sample rate).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wibowo in view of Borsic in view of Shelton 2 by incorporating the application on endoscopic images captured at a sample rate with special light and focusing on images that show evidence of denaturation, and the jaw and gripping function as taught by Shelton, to make an invention that can specifically focus and treat one type of tissue in an endoscopic procedure; thus, one of ordinary skilled in the art would be motivated to combine the references since an object of the present invention is to minimize patient trauma by using ultrasonic surgical instruments which can provide substantially simultaneous cutting of tissue and hemostasis by coagulation (Shelton, ¶0160).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 5, Wibowo in view of Borsic in view of Shelton 2 in view of Shelton teaches the system as defined in claim 4, wherein
the processor (Wibowo ¶0050 discloses a processor that carries out steps)
estimates the heat diffusion region (Wibowo ¶0044 discloses calculating an ablation does and heat diffusion region) and the specific tissue region (Wibowo ¶0034 discloses determining an ROI of a specific region and excluding irrelevant regions) from each of the plurality of endoscope images (Shelton ¶0199 discloses sample rate image obtained from an endoscope) , and
outputs time at which heat diffusion reaches the specific tissue region (Borsic ¶0061-¶0062 discloses the time as being a variable in the bioheat equation) as a result of prediction based on a plurality of the heat diffusion regions (Wibowo ¶0044 discloses calculating an ablation does and heat diffusion region) and a plurality of the specific tissue regions that are estimated (Wibowo ¶0034 discloses determining an ROI of a specific region and excluding irrelevant regions) from each of the plurality of endoscope images (Shelton ¶0199 discloses sample rate image obtained from an endoscope). See rational for Claim 4, its parent claim.
Regarding Claim 6, Wibowo in view of Borsic in view of Shelton 2 in view of Shelton teaches the system as defined in claim 5, wherein the processor (Wibowo ¶0050 discloses a processor that carries out steps) determines the risk for heat damage (Borsic ¶0004 discloses determining the likelihood of healthy tissue being damaged due to vapor heat) before the time as the result of the prediction (Borsic ¶0066-¶0067 discloses the length of time of the tissues being exposed to the heat as being part of the model), and outputs a result of the determination (Borsic ¶0037, ¶0040 and Fig 8, 816 discloses input/ output capabilities). See rational for Claim 4, its parent claim.
Regarding Claim 10, Wibowo in view of Borsic in view of Shelton 2 teaches the system as defined in claim 1, wherein the at least one energy device (Wibowo ¶0052 discloses multiple types of ablations energy devices) and that receives the energy supply from a generator to perform the energy output (Borsic ¶0031 discloses an energy control and regulator of the alation device power).
Wibowo in view of Borsic in view of Shelton 2 does not explicitly teach is a device that includes two jaws, capable of gripping a tissue, from the two jaws.
Shelton is in the same field of noninvasive surgical techniques. Further, Shelton teaches is a device that includes two jaws (Shelton ¶0603 discloses one or both jaws on an electrosurgical device) capable of gripping a tissue (Shelton ¶0536 discloses a clamping operation by the jaws) from the two jaws (Shelton ¶0603 discloses one or both jaws on an electrosurgical device).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wibowo in view of Borsic in view of Shelton 2 by incorporating the application on endoscopic images captured at a sample rate with special light and focusing on images that show evidence of denaturation, and the jaw and gripping function as taught by Shelton, to make an invention that can specifically focus and treat one type of tissue in an endoscopic procedure; thus, one of ordinary skilled in the art would be motivated to combine the references since an object of the present invention is to minimize patient trauma by using ultrasonic surgical instruments which can provide substantially simultaneous cutting of tissue and hemostasis by coagulation (Shelton, ¶0160).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 12, Wibowo in view of Borsic in view of Shelton 2 teaches the system as defined in claim 1,
wherein the captured image (Wibowo Figs 3A-3C disclose captured images) includes white burns (Borsic ¶0035 discloses damage to the blood vessels).
Wibowo in view of Borsic in view of Shelton 2 does not explicitly teach due to heat denaturation.
Shelton is in the same field of noninvasive surgical techniques. Further, Shelton teaches due to heat denaturation (Shelton ¶0159 discloses heat denaturation due to vibration at high frequencies).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wibowo in view of Borsic in view of Shelton 2 by incorporating the application on endoscopic images captured at a sample rate with special light and focusing on images that show evidence of denaturation, and the jaw and gripping function as taught by Shelton, to make an invention that can specifically focus and treat one type of tissue in an endoscopic procedure; thus, one of ordinary skilled in the art would be motivated to combine the references since an object of the present invention is to minimize patient trauma by using ultrasonic surgical instruments which can provide substantially simultaneous cutting of tissue and hemostasis by coagulation (Shelton, ¶0160).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 13, Wibowo in view of Borsic in view of Shelton 2 teaches the system as defined in claim 1, wherein the captured image includes (Wibowo Figs 3A-3C disclose captured images).
Wibowo in view of Borsic in view of Shelton 2 does not explicitly teach an endoscope image captured with special light that is different from normal light.
Shelton is in the same field of noninvasive surgical techniques. Further, Shelton teaches an endoscope image (Shelton ¶0199 discloses sample rate image obtained from an endoscope) captured with special light (Shelton ¶0261 discloses a light scattering method) that is different from normal light (Shelton ¶0261 discloses how scattered light differs from normal light).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wibowo in view of Borsic in view of Shelton 2 by incorporating the application on endoscopic images captured at a sample rate with special light and focusing on images that show evidence of denaturation, and the jaw and gripping function as taught by Shelton, to make an invention that can specifically focus and treat one type of tissue in an endoscopic procedure; thus, one of ordinary skilled in the art would be motivated to combine the references since an object of the present invention is to minimize patient trauma by using ultrasonic surgical instruments which can provide substantially simultaneous cutting of tissue and hemostasis by coagulation (Shelton, ¶0160).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
55. THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
56. A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
57. Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL LYNN ROBERTS whose telephone number is (571)272-6413. The examiner can normally be reached Monday- Friday 7:30am- 5:00pm. 32. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. 33. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Oneal Mistry can be reached on 313-446-4912. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 34. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RACHEL L ROBERTS/Examiner, Art Unit 2674
/ONEAL R MISTRY/Supervisory Patent Examiner, Art Unit 2674