DETAILED ACTION
The Applicant’s filing, received 02 June 2026, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
Status of the Claims
Claims 1-20 are pending.
Claims 1-20 are rejected.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
There are no domestic applications for which benefit is claimed.
Foreign applications for which benefit of priority is claimed:
JAPAN 2021-161791, filed 30 September 2021.
Unless otherwise noted, the effective filing date of the claimed invention is 30 September 2021.
Claim Objections
The objections to claims 9, 11, 16, and 18 in the Office action mailed 25 March 2026 have been withdrawn in view of the amendment received 02 June 2026.
Claim Rejections - 35 USC § 101
The amendment received 02 June 2026 has been fully considered, however after further consideration, the rejection of claims 1-20 under 35 U.S.C. 101 in the Office action mailed 25 March 2026 has been maintained with modification in view of the amendment, as noted below.
The rejection has been modified to incorporate the amended claim limitations.
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. The claims recite: (a) mathematical concepts, (e.g., mathematical relationships, formulas or equations, mathematical calculations); and (b) mental processes, i.e., concepts performed in the human mind, (e.g., observation, evaluation, judgement, opinion).
Claim Interpretations
Independent claims 1, 19, and 20 recite the limitation(s) “acquire” or “acquiring,” for example, “acquire a first incision line…” or “acquiring a first incision line….” The term “acquire/acquiring” is interpreted to mean setting and/or determining, e.g., setting/determining a first incision line (e.g., see Specification at para. [0031]; & Fig. 6).
Independent claims 1, 19, and 20 recite the limitation ‘render/rendering the three-dimensional organ image … to generate a rendering image ….’ The broadest reasonable interpretation of the term ‘render/rendering’ encompasses mathematical processes (e.g., linear algebra, trigonometry, and geometry) for converting 3D coordinates into 2D screen coordinates (e.g., as shown in Fig. 4, the three-dimensional organ 42 is rendered as a two-dimensional image 46).
Subject matter eligibility evaluation in accordance with MPEP 2106.
Eligibility Step 1: Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter?
Claims 1-18 recite an incision simulation device comprising a processor (i.e., a machine and/or a manufacture); claim 19 recites an incision simulation method (i.e., a process); and claim 20 recites a non-transitory storage medium (i.e., a machine and/or a manufacture).
Therefore, these claims are encompassed by the categories of statutory subject matter, and thus, satisfy the subject matter eligibility requirements under step 1.
[Step 1: YES]
Eligibility Step 2A: First it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in Prong Two whether the recited judicial exception is integrated into a practical application of that exception.
Eligibility Step 2A Prong One: In determining whether a claim is directed to a judicial exception, examination is performed that analyzes whether the claim recites a judicial exception, i.e., whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim.
Independent claim 1 recites a device comprising a processor that is configured to execute the abstract ideas recited in independent claim 19, as noted below.
Independent claim 19 recites the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
acquiring a first incision line (i.e., mental processes, e.g., determining and/or choosing);
acquiring a first depth of incision to the first incision line (i.e., mental processes, e.g., determining and/or choosing);
calculating a first excision region based on the first incision line and the first depth (i.e., mental processes and mathematical concepts, e.g., performing calculations);
acquiring a second incision line (i.e., mental processes, e.g., determining and/or choosing);
acquiring a second depth of incision to the second incision line (i.e., mental processes, e.g., determining and/or choosing);
calculating a second excision region based on the first excision region, the second incision line, and the second depth, wherein the second depth is determined with a surface after the excision of the first excision region as a starting point regardless of a shape of the first excision region (i.e., mental processes and mathematical concepts, e.g., performing calculations);
identifying a first region included in the first excision region and the second excision region (i.e., mental processes, e.g., observation and/or evaluation); and
rendering the three-dimensional organ image in a state in which first region is excluded to generate a rendering image that shows a surface in contact with an outer edge of the first region in a region corresponding to the outer edge of the first region (i.e., mathematical concepts, e.g., linear algebra, trigonometry, and geometry).
Independent claim 20 recites a non-transitory storage medium storing a program that causes a computer to execute the abstract ideas recited in independent claim 19, as noted above.
Dependent claims 2-18 further recite the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas, as noted below.
Dependent claim 2 further recites:
calculate the second excision region based on a third depth and the second incision line (i.e., mental processes and mathematical concepts), and
the third depth is a depth based on a depth of the first excision region and the second depth at a designated position on the second incision line (i.e., mental processes).
Dependent claim 3 further recites:
the third depth is a sum of the depth of the first excision region and the second depth (i.e., mental processes and mathematical concepts).
Dependent claim 4 further recites:
calculate a depth at each position of the second incision line based on the third depth (i.e., mental processes and mathematical concepts), and
calculate the second excision region based on the depth at each position of the second incision line (i.e., mental processes and mathematical concepts).
Dependent claim 5 further recites:
the depth at each position of the second incision line is shallower from the designated position toward an end of the second incision line at each position on the second incision line (i.e., mental processes).
Dependent claim 6 further recites:
calculate a second incision width at each position of the second incision line based on the depth at each position of the second incision line (i.e., mental processes and mathematical concepts), and
calculate the second excision region based on the second incision width (i.e., mental processes and mathematical concepts).
Dependent claim 7 further recites:
the second incision width at each position of the second incision line is narrower from the designated position toward an end of the second incision line at each position on the second incision line (i.e., mental processes).
Dependent claim 8 further recites:
a depth at each position of the second incision width is shallower from a position on the second incision line toward an end of the second incision width (i.e., mental processes), and
calculate the second excision region based on the depth at each position of the second incision width (i.e., mental processes and mathematical concepts).
Dependent claim 9 further recites:
the designated position on the second incision line is an intermediate portion of the second incision line (i.e., mental processes).
Dependent claim 10 further recites:
the designated position on the second incision line is a middle point of the second incision line (i.e., mental processes).
Dependent claim 11 further recites:
calculate a depth at each position of the first incision line based on the first depth (i.e., mental processes and mathematical concepts), and
calculate the first excision region based on the depth at each position of the first incision line (i.e., mental processes and mathematical concepts).
Dependent claim 12 further recites:
the depth at each position of the first incision line is shallower from a position of the first depth toward an end of the first incision line at each position on the first incision line (i.e., mental processes).
Dependent claim 13 further recites:
calculate a first incision width at each position of the first incision line based on the depth at each position of the first incision line (i.e., mental processes and mathematical concepts), and
calculate the first excision region based on the first incision width (i.e., mental processes and mathematical concepts).
Dependent claim 14 further recites:
the first incision width at each position of the first incision line is narrower from a position of the first depth toward an end of the first incision line at each position on the first incision line (i.e., mental processes).
Dependent claim 15 further recites:
a depth at each position of the first incision width is shallower from a position on the first incision line toward an end of the first incision width (i.e., mental processes), and
calculate the first excision region based on the depth at each position of the first incision width (i.e., mental processes and mathematical concepts).
Dependent claim 16 further recites:
the position of the first depth of the first incision line is an intermediate portion of the first incision line (i.e., mental processes).
Dependent claim 17 further recites:
the position of the first depth of the first incision line is a middle point of the first incision line (i.e., mental processes).
Dependent claim 18 further recites:
the first region is a region where at least one of a region showing a blood vessel system, a region showing a lymphatic system, a region showing a nervous system, or a region showing a lesion part is excluded (i.e., mental processes).
The abstract ideas recited in the claims are evaluated under the broadest reasonable interpretation (BRI) of the claim limitations when read in light of and consistent with the specification. As noted in the foregoing section, the claims are determined to contain limitations that can practically be performed in the human mind with the aid of a pen and paper (e.g., identifying a first region included in the first excision region and the second excision region), and therefore recite judicial exceptions from the mental process grouping of abstract ideas. Additionally, the recited limitations that are identified as judicial exceptions from the mathematical concepts grouping of abstract ideas (e.g., calculating a second excision region based on the first excision region, the second incision line, and the second depth) are abstract ideas irrespective of whether or not the limitations are practical to perform in the human mind.
Therefore, claims 1-20 recite an abstract idea.
[Step 2A Prong One: YES]
Eligibility Step 2A Prong Two: In determining whether a claim is directed to a judicial exception, further examination is performed that analyzes if the claim recites additional elements that when examined as a whole integrates the judicial exception(s) into a practical application (MPEP 2106.04(d)). A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The claimed additional elements are analyzed to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d)(I); MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim fails to integrate the abstract idea into a practical application (MPEP 2106.04(d)(III)).
In the instant application, the claims provide additional elements of an image and a processor for performing calculations based on the image, and the subsequent steps only perform analysis and/or calculations using the image. However, the claims do not recite any limitations to which the final measurement result, i.e., the rendered image, is practically applied.
The judicial exceptions identified in Eligibility Step 2A Prong One are not integrated into a practical application because of the reasons noted below.
Dependent claims 3, 5, 7, 9, 10, 12, 14, and 16-18 do not further recite any elements in addition to the judicial exception, and thus are part of the judicial exception.
The additional elements in independent claim 1 include:
a device comprising a processor; and
a three-dimensional image showing an organ.
The additional elements in independent claim 19 include:
a three-dimensional image showing an organ.
The additional elements in independent claim 20 include:
a non-transitory storage medium storing a program that causes a computer to execute a process; and
a three-dimensional image showing an organ.
The additional elements in dependent claims 2, 4, 6, 8, 11, 13, and 15 include:
a processor (claims 2, 4, 6, 8, 11, 13, and 15).
The additional elements of a device comprising a processor (claims 1, 2, 4, 6, 8, 11, 13, and 15); and a non-transitory storage medium storing a program that causes a computer to execute a process (claim 20); invoke a computer and/or computer-related components merely as tools for use in the claimed process, and therefore are not an improvement to computer functionality itself, or an improvement to any other technology or technical field, and thus, do not integrate the judicial exceptions into a practical application (MPEP 2106.04(d)(1)).
The additional element of a three-dimensional image showing an organ (claims 1, 19, and 20) is merely part of the pre-solution activity of gathering data for use in the claimed process – a nominal addition to the claims that does not meaningfully limit the claims, and therefore does not add more than insignificant extra-solution activity to the judicial exceptions (MPEP 2106.05(g)).
Thus, the additionally recited elements merely invoke a computer and/or computer related components as tools; and/or amount to insignificant extra-solution activity; and as such, when all limitations in claims 1-20 have been considered as a whole, (i.e., the analysis takes into consideration all the claim limitations and how those limitations interact and impact each other when evaluating whether the exception is integrated into a practical application), the claims are deemed to not recite any additional elements that would integrate a judicial exception into a practical application, and therefore claims 1-20 are directed to an abstract idea (MPEP 2106.04(d)).
[Step 2A Prong Two: NO]
Eligibility Step 2B: Because the claims recite an abstract idea, and do not integrate that abstract idea into a practical application, the claims are probed for a specific inventive concept. The judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05). Identifying whether the additional elements beyond the abstract idea amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they amount to significantly more than the judicial exception (MPEP 2106.05A i-vi).
The claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exception(s) because of the reasons noted below.
Dependent claims 3, 5, 7, 9, 10, 12, 14, and 16-18 do not further recite any elements in addition to the judicial exception(s).
The additional elements recited in independent claims 1, 19, and 20 and dependent claims 2, 4, 6, 8, 11, 13, and 15 are identified above, and carried over from Step 2A Prong Two along with their conclusions for analysis at Step 2B. Any additional element or combination of elements that was considered to be insignificant extra-solution activity at Step 2A Prong Two was re-evaluated at Step 2B, because if such re-evaluation finds that the element is unconventional or otherwise more than what is well-understood, routine, conventional activity in the field, this finding may indicate that the additional element is no longer considered to be insignificant; and all additional elements and combination of elements were evaluated to determine whether any additional elements or combination of elements are other than what is well-understood, routine, conventional activity in the field, or simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, per MPEP 2106.05(d).
The additional elements of a device comprising a processor (claims 1, 2, 4, 6, 8, 11, 13, and 15); and a non-transitory storage medium storing a program that causes a computer to execute a process (claim 20); are conventional computer components and/or functions (see MPEP at 2106.05(b) and 2106.05(d)(II) regarding conventionality of computer components and computer processes).
The additional element of a three-dimensional image showing an organ (claims 1, 19, and 20) is conventional. Evidence of conventionality is shown by Schenk et al. ("Planning of Image-Guided Interventions in the Liver." in IEEE Pulse, Sept.-Oct. 2011, vol. 2, no. 5, pp. 48-55, as cited in the Office action mailed 25 March 2026). Schenk et al. reviews image-guided interventions in the liver using computer-aided treatment planning (page 48) and shows a patient-specific model of liver anatomy (Figure 1) that was generated from a CT image (Figure 1(a)), and that provides a 3-D visualization of all relevant structures, including the tumors and their relative location to the portal venous system, hepatic veins, and hepatic artery (Figure 1(b)).
Therefore, when taken alone (i.e., individually), all additional elements in claims 1-20 do not amount to significantly more than the above-identified judicial exception(s). Even when evaluated as an ordered combination, the additional elements fail to transform the exception(s) into a patent-eligible application of that exception. Thus, claims 1-20 are deemed to not contribute an inventive concept, i.e., amount to significantly more than the judicial exception(s) (MPEP 2106.05(II)).
[Step 2B: NO]
Response to Arguments
The Applicant’s arguments/remarks received 02 June 2026 have been fully considered, but are not persuasive.
The Applicant states on page 11 (as filed) of the Remarks that claim 1 has been amended to explicitly recite “render the three-dimensional organ image in a state in which first region is excluded to generate a rendering image that shows a surface in contact with an outer edge of the first region in a region corresponding to the outer edge of the first region” and this claimed rendering operation, as amended, cannot be practically performed in the human mind. The Applicant further states that in particular, the claim requires computer-based processing of a three-dimensional organ image, including exclusion of a defined region and generation of a rendering image that visualizes a specific surface at a corresponding location in the rendered output, and that such operations involve manipulation of volumetric image data and spatial relationships within a three-dimensional coordinate space, which necessarily require specialized image processing techniques and computing resources. The Applicant further states on page 12 (top) that accordingly, the claimed invention does not recite a mental process that can be performed mentally or with pen and paper, but rather, it is directed to a specific technological operation for processing and visualizing medical imaging data, and therefore, the claims do not recite an abstract idea under Step 2A, Prong One.
These arguments/remarks are not persuasive, because first, claims can recite a judicial exception even if they are claimed as being performed on a computer (MPEP 2106.04(a)(2)(III)(C)). Second, the newly added limitation reciting “render the three-dimensional organ image in a state in which first region is excluded to generate a rendering image that shows a surface in contact with an outer edge of the first region in a region corresponding to the outer edge of the first region” is not identified as a mental process in the above rejection, but rather, is identified as a mathematical concept for the reasons discussed in the rejection. It is noted, however, that while a computational process of converting 3D coordinates into 2D screen coordinates is a purely mathematical process, the process could be interpreted to also be practical to perform in the human mind with the aid of pen and paper depending on the complexity of the 3D object being rendered. Third, it is noted that claim 1 does recite other limitations that are identified as mental processes at Step 2A Prong One, e.g., setting a first and second incision line.
The Applicant states on page 12 (para. 3) that paragraph [0072] of the published specification describes the technical problem of significantly increased computational costs caused by changes in organ surface shape (e.g., hollow space) during continuous incision simulation. The Applicant further states that to resolve the problem of increased computational cost and processing burden, the claimed invention avoids recalculating the second excision region based on the actual modified 3D surface (including the hollow created after the first excision), and instead, the claimed invention simplifies the calculation process by using a depth-based approach, as recited in claim 1: “calculate a second excision region based on the first excision region, the second incision line, and the second depth, wherein the second depth is determined with a surface after the excision of the first excision region as a starting point regardless of a shape of the first excision region”. The Applicant further states on page 12 (bottom) and page 13 (top) that accordingly, by calculating the second excision region regardless of the shape of the first excision region, the claimed invention significantly reduces the computational cost associated with continuous incision simulation, and that this constitutes a concrete technical improvement in the fields of medical image processing and computer-assisted surgical simulation and the improvement in the technical fields is indications of integration to a practical application of an incision simulation device.
These arguments/remarks are not persuasive, because first, at Step 2A Prong Two, Examiners evaluate integration into a practical application by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application, using one or more of the considerations introduced in subsection I at 2106.04(d) of the MPEP, and discussed in more detail in MPEP §§ 2106.04(d)(1), 2106.04(d)(2), 2106.05(a) through (c) and 2106.05(e) through (h). As noted in the rejection above, when all limitations in claims 1-20 have been considered as a whole (i.e., the analysis takes into consideration all the claim limitations and how those limitations interact and impact each other when evaluating whether the exception is integrated into a practical application), they are deemed to not recite any additional elements that would integrate a judicial exception into a practical application (MPEP 2106.04(d)). Second, regarding the Applicant’s argument that “the claimed invention significantly reduces the computational cost associated with continuous incision simulation, and that this constitutes a concrete technical improvement,” it is noted that reducing the computational cost (e.g., the amount of time, memory, and processing power needed to solve a problem) by using different calculations is not an improvement to computer functionality itself, or an improvement to any other technology or technical field, but rather, is a purported improvement to the abstract idea itself.
The Applicant states on page 13 (para. 2) of the Remarks that moreover, claim 1 is not merely a generic recitation of a system for performing basic functions, rather, claim 1 introduces a specific and non-conventional technical arrangement in which the incision simulation device (i) calculates a second excision region based on the first excision region, the second incision line, and the second depth, wherein the second depth is determined with a surface after the excision of the first excision region as a starting point regardless of a shape of the first excision region, and (ii) render the three-dimensional organ image in a state in which first region is excluded to generate a rendering image that shows a surface in contact with an outer edge of the first region in a region corresponding to the outer edge of the first region. The Applicant further states that such arrangement is not well-understood, routine, or conventional, and therefore imposes meaningful limitations that amount to significantly more.
These arguments/remarks are not persuasive, because first, a conclusion of whether a claim is eligible at Step 2B requires that all relevant considerations be evaluated, which comprises steps of: (1) carrying over the identification of any additional element(s) in the claim from Step 2A Prong Two; (2) carrying over the conclusions from Step 2A Prong Two on the considerations discussed in MPEP §§ 2106.05(a) - (c), (e) (f) and (h); (3) re-evaluating any additional element or combination of elements that was considered to be insignificant extra-solution activity per MPEP § 2106.05(g), because if such re-evaluation finds that the element is unconventional or otherwise more than what is well-understood, routine, conventional activity in the field, this finding may indicate that the additional element is no longer considered to be insignificant; and (4) evaluating whether any additional element or combination of elements are other than what is well-understood, routine, conventional activity in the field, or simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, per MPEP § 2106.05(d). As noted in the rejection above, when all additional elements in claims 1-20 have been evaluated individually and in an ordered combination at Eligibility Step 2B, they are deemed to not contribute an inventive concept, i.e., amount to significantly more than the judicial exceptions (MPEP 2106.05(II)). Second, it is noted that the limitations provided in the Applicant’s foregoing argument are limitations that comprise the judicial exceptions identified at Step 2A Prong One in the above rejection, and thus, are not limitations (i.e., additional elements) that are carried over from Step 2A Prong Two to Step 2B for further evaluation.
Claim Rejections - 35 USC § 103
The rejection of claims 1-20 under 35 U.S.C. 103 as being unpatentable over Nakao et al. in the Office action mailed 25 March 2026 has been withdrawn in view of the amendment received 02 June 2026.
Response to Arguments
The Applicant’s arguments/remarks received 02 June 2026 have been fully considered, and are persuasive.
The Applicant states on page 14 (bottom) of the Remarks that Nakao, either alone or in combination, does not disclose or suggest the features highlighted in amended claim as provided in the Remarks on page 14. The Applicant points to paragraph [0086] and Fig. 3 of Nakao, further states on page 15 of the Remarks that Nakao is limited to procedural guidance and visualization of sequential cutting operations, and does not describe any computation of excision regions, nor relationships between such regions, and in particular, Nakao fails to disclose calculate a second excision region based on the first excision region, the second incision line, and the second depth, wherein the second depth for calculating the second excision region is determined with a surface after the excision of the first excision as a starting point regardless of a shape of the first excision region. The Applicant further states on page 16 (top) that paragraph [0086] of Nakao describes how deep to insert the scalpel, however the depth information in Nakao is associated with each cut independently, and there is no teaching or suggestion that the depth for a subsequent cut is determined relative to a surface generated after a prior excision, nor does Nakao disclose that such determination is performed regardless of the shape of the first excision region. The Applicant further states (para. 2) that as such, Nakao does not disclose the feature “the second depth is determined with a surface after the excision of the first excision region as a starting point regardless of a shape of the first excision region” as recited in claim 1. The Applicant further states (para. 3) that in addition, Nakao merely describes a surgical planning system that presents guidance information such as where to place a scalpel, in what direction to move it, and how deep to cut, in other words, the cited disclosure is directed to a procedural progression of cutting operations, including deformation of an organ as a scalpel advances, and the surfaces shown in Nakao arise from cutting trajectories and cross-sectional exposure during the cutting process, however, Nakao does not disclose, teach, or suggest rendering the three-dimensional organ image in a state in which first region is excluded to generate a rendering image that shows a surface in contact with outer edge of the first region in a region corresponding to the outer edge of the first region. The Applicant further states on page 17 (top) that based on the foregoing rationales, Nakao fails to disclose at least the distinguishing features at issue.
These arguments/remarks are persuasive.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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.
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/S.W.B./Examiner, Art Unit 1687
/Joseph Woitach/Primary Examiner, Art Unit 1687
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