DETAILED ACTION
The United States Patent & Trademark Office appreciates the response filed for the current application that is submitted on 08/05/2026. The United States Patent & Trademark Office reviewed the following documents submitted and has made the following comments below.
Amendment
Applicant submitted amendments on 08/05/2026. The Examiner acknowledges the amendment and has reviewed the claims accordingly.
Priority
Applicant claims the benefit of Foreign Priority from Application No EP 23171634.1, filed 05/04/2023. Claims 1-19 have been afforded the benefit of this filing date.
Information Disclosure Statement
The IDS dated 05/01/2024 and 05/06/2026 have been considered and placed in the application file.
Overview
Claims 1-19 are pending in this application.
Claims 1-19 are rejected.
Applicant Arguments:
In regards to the argument on Argument 1, Applicant/s state/s “The Examiner objected to figure 1 of the drawings. This objection has been rendered moot by the drawing replacement sheet. Accordingly, Applicants request the Examiner to reconsider and withdraw this objection.” (See Remarks Pg 11, paragraph 4) therefore the drawing rejection should be withdrawn.
In regards to Argument 2, Applicant/s state/s “The Office Action further objects to the drawing of Fig. 4, asserting that reference characters "29" and "30" are both used to designate a centroid. However, reference character "29" designates a surface (page 19, [0068]), and reference character "30" designates an outer surface (page 19, [0068]). Accordingly, Applicants request the Examiner to reconsider and withdraw this objection.” (See Remarks Pg 12, paragraph 1) therefore the drawing rejection should be withdrawn.
In regards to Argument 3, Applicant/s state/s “the claimed method accounts for minor variations in the cutting surface due to limited accuracy of the clinician performing the cut, such that the tumor is not damaged or the removal incomplete. See page 10, [0032] of the instant application, for example. Accuracy at a level that is beyond that of a clinician is prima facie evidence of technological tasks that the human mind is not equipped to perform.” (See Remarks Pg 13, paragraph 1) therefore the 35 USC§ 101 rejection should be withdrawn.
In regards to Argument 4, Applicant/s state/s “claim 1, considered as a whole, is directed to effect a particular treatment/medical condition as discussed above with respect to the discussion regarding a mental process. In particular, claim 1 recites "determining at least one cutting parameter including selecting a surface point on a chosen section of a surface of the respective selected functional segment such that a cutting surface is accessible during the resection." Accordingly, even if part of claim 1 were directed to an abstract idea, the claim as a whole integrates additional elements into a practical application and is therefore, patent eligible subject matter. Since claim 1 is not directed to an abstract idea, and is integrated into a practical application, the claim is eligible subject matter under 35 USC§ 101. Therefore, claims 2-19 are also patent eligible at least by virtue of their dependency from claim 1.” (See Remarks Pg 13-14, paragraph 3 and paragraph 1) therefore the 35 USC§ 101 rejection should be withdrawn.
In regards to Argument 5, Applicant/s state/s “Chen discloses an algorithm to provide a starting point, Chen's focus is on preserving as much volume of the liver as possible as opposed to finding a starting point of a cutting surface. Moreover, Chen is not concerned with and does not address selecting a point "such that a cutting surface is accessible during the resection," as recited in amended claim 1. Hill fails to cure the deficiency of Chen.” (See Remarks Pg 15, paragraph 2) therefore the 35 USC§ 103 rejection should be withdrawn.
In regards to Argument 6, Applicant/s state/s “Applicants note that the cited art fails to disclose or suggest "determining at least one cutting parameter including selecting a surface point on a chosen section of a surface of the respective selected functional segment such that a cutting surface is accessible during the resection," as recited by claim 1. For at least the reasons above, a prima facie case of obviousness cannot be established with regard to claim 1. Consequently, a prima facie case of obviousness cannot be established with regard to claims 2-19, at least by virtue of their dependency from claim 1.” (See Remarks Pg 15, paragraph 3-4) therefore the 35 USC§ 103 rejection should be withdrawn.
Examiner’s Responses:
In response to Argument 1, Applicant’s arguments, see Remarks, filed 08/05/2026, with respect to the objection of Figure 1 have been fully considered but the objection to Figure 1 is maintained because there was no replacement Figure 1 submitted.
In response to Argument 2, Applicant’s arguments, see Remarks, filed 08/05/2026, with respect to the objection of Figure 4 have been fully considered and the objections to Fig 4 is withdrawn due to amendments made in the specification.
In response to Arguments 3 and 4, Applicant’s arguments, see Remarks, filed 08/05/2026, with respect to the 35 USC§ 101 have been fully considered and are persuasive, therefore the 35 USC§ 101 rejection is withdrawn.
In response to Arguments 5 and 6, Applicant’s arguments, see Remarks, filed 08/05/2026, with respect to the rejection(s) of claims 1-19 under 35 U.S.C. 103 has been fully considered but are moot in view of amendments. Therefore, the rejection has been withdrawn due to the amendment. However, upon further consideration, a new ground(s) of rejection is made under 35 U.S.C. 103 in view of Chen et al (US Patent Publication US 2016/0143697 A1 hereafter referred to as Chen) in view of Hill et al. (US Patent Publication US 2021/0282858 A1 hereafter referred to as Hill) in further view of Lang et al (US Patent Publication US 2021/0192759 hereafter referred to as Lang).
10. The Examiner finds that Chen, in view of Hill, teaches on the amended claim language. Chen teaches determining a cutting parameter by selecting a surface point on a resection surface in ¶0042, ¶0049, ¶0057, ¶0058, while Hill still teaches the 3-dimensional medical imaging data set in ¶0065. Applicant argues “Chen discloses an algorithm to provide a starting point; Chen's focus is on preserving as much volume of the liver as possible as opposed to finding a starting point of a cutting surface. Moreover, Chen is not concerned with and does not address selecting a point "such that a cutting surface is accessible during the resection," as recited in amended claim 1. Hill fails to cure the deficiency of Chen.” The Examiner finds that during prosecution; claims must be given their broadest reasonable interpretation while reading claim language in light of the specification as it would be interpreted by one of ordinary skill in the art. In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). In construing the meaning of claims terms, caution must be taken not to import limitations from the specification as “[i]t is the claims that measure the invention.” See SRI Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121 (Fed. Cir. 1985) (en banc) The Examiner interprets that under broadest reasonable interpretation “cutting parameter” and “functional segment” have no special definition in the claims, and therefore “cutting parameter” can be interpreted as the shape of the resected area as taught by Chen in ¶0073 and “ functional segment” can be interpreted as a resection surface as taught by Chen in ¶0042. Therefore, the Examiner interprets that Chen in view of Hill teaches the main concept of using a 3-dimensional medical imaging dataset to determine the most accurate and efficient plan for liver resection surgery planning, the additional details of the functions of the main concepts as stated above by the applicant in the amendments is taught by Lang in the details of the rejection below. The Examiner will maintain prior art Chen and Hill, and details of the rejection are below.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the process of Fig 1 as described in the specification, as the boxes in the flow chart that describe the process are not labeled with a description, the way they are currently labeled with numbers is not sufficient. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing, MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 2 recite “at least one of” then listing “the cutting parameter or the cutting surface are provided as a part of the proposed liver resection plan, or the cutting parameter is modified by an input acquired from a user and at least one of the resulting modified cutting parameter or a modified cutting surface described by parametrizing the given equation using the modified cutting parameter are provided as another part of the proposed liver resection plan.” Since “at least one of” 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 3 recite “at least one of” then listing “generating a graphical representation of the cutting surface and outputting the graphical representation of the cutting surface to the user prior to the acquisition of the input from the user; or generating a graphical representation of the modified cutting surface and outputting the graphical representation of the modified cutting surface to the user.” Since “at least one of” 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 4 recite “at least one of” then listing “of a distance of a cutting surface from a vein that is segmented in the medical image dataset or a distance of the functional segment from a further one of the functional segments that is not selected for complete removal.” Since “at least one of” 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 11 recite “at least one of” then listing “a volume of the segmented tumor or a maximum diameter of the segmented tumor reaches or exceeds a respective threshold, or when a distance of the segmented tumor to a vein that is segmented in the medical image dataset reaches or falls below a respective threshold.” Since “at least one of” 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 12 recite “at least one of” then listing “at least one measure for risk or a severity of an intervention is determined for the proposed liver resection plan and provided as a part of the proposed liver resection plan.” Since “at least one of” 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 1-19 are rejected under 35 U.S.C. 103 as unpatentable over Chen et al (US Patent Publication US 2016/0143697 A1 hereafter referred to as Chen) in view of Hill et al. (US Patent Publication US 2021/0282858 A1 hereafter referred to as Hill) in further view of Lang et al (US Patent Publication US 2021/0192759 hereafter referred to as Lang).
Regarding Claim 1, Chen teaches a computer implemented method for planning a liver resection (Chen ¶0002, ¶0005 discloses computer aided planning of liver resection surgery), comprising:
comprising a depiction of a liver of a patient (Chen ¶0012 and Fig 3A-C discloses three-dimensional (3D) visualization of several features within a liver based on segmentation of CT images of the liver), the depicted liver comprising a tumor (Chen Fig 3A, 304 discloses a tumor being a feature in the liver).
segmenting multiple functional segments of the liver (Chen ¶0037 and Fig 2b disclose segmenting the liver into different segments)
segmenting the tumor (Chen ¶0012 discloses the segmented images including the tumor)
selecting at least one of functional segments (Chen ¶0042 discloses choosing between a plurality of resection surfaces) that comprise the tumor or functional segments into which the tumor extends (Chen Fig 19C discloses the plurality of resection surfaces the tumor that overlaps into multiple sections), based on the segmentation of the tumor (Chen ¶0012 discloses the segmented images including the tumor) and the segmentation of the functional segments (Chen ¶0037 and Fig 2b disclose segmenting the liver into different segments);
selecting for the respective selected functional segment (Chen ¶0042 discloses choosing between a plurality of resection surfaces), if a complete removal or a partial removal (Chen ¶0051, ¶0056, ¶0058 discloses what ratio of the liver lobe will be removed into comparison to the whole liver and the risk evaluation if the volume removed is too great) of the selected functional segment (Chen ¶0042 discloses choosing between a plurality of resection surfaces) is to be performed in a proposed liver resection plan (Chen ¶0002, ¶0005 discloses computer aided planning of liver resection surgery), wherein selecting for the respective selected functional segment (Chen ¶0042 discloses choosing between a plurality of resection surfaces) is based on the segmented tumor (Chen ¶0033 discloses the selection and positioning of the resection segments being based on the tumor by minimizing the local area around the tumor); and
determining at least one cutting parameter including selecting a surface point (Chen ¶0049, ¶0057, ¶0058 discloses choosing and moving points on the resection surface ¶0073 discloses the shape of the resection surface being the initial parameter based on a free form or triangular shape) on a chosen section of a surface of the respective selected functional segment such (Chen ¶0042 discloses choosing between a plurality of resection surfaces)
providing the proposed liver resection plan (Chen ¶0042 discloses the planar resection surface is chosen 618 the simulation is finalized, and the resection plan is saved).
Chen does not explicitly disclose receiving a three-dimensional medical image dataset, in the medical image dataset, in the medical image dataset.
Hill is in the same field of image analysis to determine a surgical plan for removal of diseased tissue. Further, Hill teaches receiving a three-dimensional medical image dataset (Hill ¶0065 discloses the anatomy (A) is preoperatively or intraoperatively imaged using imaging techniques such as, but not limited to CT, x-ray, MRI, etc, which result in three dimensional images of the subject) in the medical image dataset (Hill ¶0065 discloses the anatomy (A) is preoperatively or intraoperatively imaged using imaging techniques such as, but not limited to CT, x-ray, MRI, etc, which result in three dimensional images of the subject) in the medical image dataset (Hill ¶0065 discloses the anatomy (A) is preoperatively or intraoperatively imaged using imaging techniques such as, but not limited to CT, x-ray, MRI, etc, which result in three dimensional images of the subject).
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 Chen by applying the algorithm on 3d image datasets to determine the distance between adjacent segments in the 3d images to determine if complete removal as taught by Hill, to make an invention that can automatically segment and detect the need for complete or partial removal and determine the best cutting strategy for the surgery based off of the 3d medical images; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need to address the following challenges including; tumors can have complex geometries for which straight cutting planes are not particularly suitable. Furthermore, aside from post-operatively examining the tumor margins, there is no measure of the quality of a tumor cutting plan, nor is there means to numerically compare one cutting plan to another. (Hill, ¶0005).
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.
Chen and Hill in combination do explicitly disclose that a cutting surface is accessible during the resection.
Lang is in the same field of image analysis to determine a surgical plan. Further, Lang teaches that a cutting surface is accessible during the resection (Lang ¶0249, ¶0251 discloses that the surgical field including the surgical area in which the cutting surface may be projected onto to be accessible and visible).
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 Chen in view of Hill by adding the rule of the cutting surface being accessible during resection as taught by Lang, to make an invention that can determine the best cutting strategy for the surgery that is accessible to the physician based off of the 3d medical images; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need to allow the surgeon to see the live data of the patient, e.g. the surgical field, while at the same time observing virtual data of the patient and/or virtual surgical instruments or implants with a predetermined position and/or orientation using the display of the OHMD unit. (Lang, ¶0096).
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, Chen in view of Hill in further view of Lang teaches the computer implemented method of claim 1, wherein the selecting for the respective selected functional segment (Chen ¶0042 discloses choosing between a plurality of resection surfaces), if a complete removal or a partial removal (Chen ¶0051, ¶0056, ¶0058 discloses what ratio of the liver lobe will be removed into comparison to the whole liver and the risk evaluation if the volume removed is too great) of the selected functional segment (Chen ¶0042 discloses choosing between a plurality of resection surfaces), and the method further comprises:
wherein determining the at least one cutting parameter (Chen ¶0073 discloses the shape of the resection surface being the initial parameter based on a free form or triangular shape) that parametrizes a given equation to describe the cutting surface (Chen ¶0061-¶0063 discloses an equation for calculating the triangular based resection surface) for surgically cutting out the tumor (Chen ¶0061 and 19A discloses the resection surface with the tumor) based on the segmented tumor(Chen ¶0033 discloses the selection and positioning of the resection segments being based on the tumor by minimizing the local area around the tumor), wherein either
at least one of the cutting parameter (Chen ¶0073 discloses the shape of the resection surface being the initial parameter based on a free form or triangular shape) or the cutting surface (Chen ¶0061-¶0063 discloses an equation for calculating the triangular based resection surface) are provided as a part of the proposed liver resection plan (Chen ¶0042 discloses the planar resection surface is chosen 618 the simulation is finalized and the resection plan is saved), or
the cutting parameter is modified by an input acquired from a user (Chen ¶0058, ¶0053, ¶0054 discloses the user modifying the freeform resection surface but editing the points) and at least one of the resulting modified cutting parameter (Chen ¶0058, ¶0053, ¶0054 discloses the user modifying the freeform resection surface) or a modified cutting surface (Chen ¶0058, ¶0053, ¶0054 discloses the user modifying the freeform resection surface but editing the points) described by parametrizing the given equation using the modified cutting parameter (Chen ¶0061-¶0063 discloses an equation for calculating the triangular based resection surface) are provided as another part of the proposed liver resection plan (Chen ¶0042 discloses the planar resection surface is chosen 618 the simulation is finalized and the resection plan is saved). See Claim 1 for rationale, its parent claim.
Regarding Claim 3, Chen, in view of Hill in further view of Lang teaches the computer implemented method of claim 2, further comprising at least one of:
generating a graphical representation of the cutting surface (Chen ¶0060 and Fig 18 disclose a graphical representation of the cutting surface) and outputting the graphical representation of the cutting surface to the user prior to (Chen Fig 15 1508, 1510, and 1512 disclose presenting the results to the user before the surface is updated by the user) acquisition of the input from the user (Chen ¶0058, ¶0053, ¶0054 discloses the user modifying the freeform resection surface but editing the points); or
generating a graphical representation of the modified cutting surface (Chen ¶0060 and Fig 18 disclose a graphical representation of the cutting surface ¶0058, ¶0053, ¶0054 discloses the user modifying the freeform resection surface but editing the points on the graphical surface) and outputting the graphical representation of the modified cutting surface to the user (Chen ¶0056 discloses the user testing out different cutting surfaces before a decision is made and the resection surface being dynamically updated). See Claim 1 for rationale, its parent claim.
Regarding Claim 4, Chen in view of Hill in further view of Lang teaches the computer implemented method of claim 1, wherein the selecting for the respective selected functional segment (Chen ¶0042 discloses choosing between a plurality of resection surfaces), if a complete removal or a partial removal (Chen ¶0051, ¶0056, ¶0058 discloses what ratio of the liver lobe will be removed into comparison to the whole liver and the risk evaluation if the volume removed is too great) of the selected functional segment (Chen ¶0042 discloses choosing between a plurality of resection surfaces) is to be performed in a proposed liver resection plan (Chen ¶0002, ¶0005 discloses computer aided planning of liver resection surgery), is based on at least one of a distance of the cutting surface from a vein that is segmented (Chen ¶0030, ¶0033 and Fig 21A and 21B disclose the distance between the vein and the tumor based on the safety margin which is based on the distance from the cutting surface) in the medical image dataset (Hill ¶0065 discloses the anatomy (A) is preoperatively or intraoperatively imaged using imaging techniques such as, but not limited to CT, x-ray, MRI, etc, which result in three dimensional images of the subject) or a distance of the functional segment (Hill ¶0087, ¶0102 discloses the dimensions including length of the diseased region with respect to the outermost contour) from a further one of the functional segments that is not selected for complete removal (Hill ¶0020,. Fig 8 discloses using the healthy anatomy adjacent to the diseased region to determine the alignment of the coordinate system used for determining the cutting segment for the diseased region). See Claim 1 for rationale, its parent claim.
Regarding Claim 5, Chen in view of Hill in further view of Lang teaches the computer implemented method of claim 2, wherein the determining the at least one cutting parameter (Chen ¶0073 discloses the shape of the resection surface being the initial parameter based on a free form or triangular shape) includes:
determining a tumor region (Chen Fig 3A, 304 discloses a tumor being a feature in the liver, 19A discloses the resection surface with the tumor) of the medical image dataset (Hill ¶0065 discloses the anatomy (A) is preoperatively or intraoperatively imaged using imaging techniques such as, but not limited to CT, x-ray, MRI, etc, which result in three dimensional images of the subject)comprising the tumor or a part of the tumor (Chen Fig 17 1706, 1708 discloses the triangle cutting surfaces being evaluated for the tumor area and the safety margin around the tumor) extending into the respective selected functional segment (Chen Fig 19C discloses the plurality of resection surfaces the tumor that overlaps into multiple sections) based on the segmentation of the tumor (Chen ¶0012 discloses the segmented images including the tumor),
selecting a surface point on a chosen section of a surface of the respective selected functional segment (Chen ¶0049, ¶0057, ¶0058 discloses choosing and moving points on the resection surface), wherein the surface of the respective selected functional segment (Chen ¶0042 discloses choosing between a plurality of resection surfaces) is given by the segmentation of the respective selected functional segment (Chen ¶0033 discloses the selection and positioning of the resection segments being based on the tumor by minimizing the local area around the tumor), and the chosen section of the surface forms an outer surface of the liver (Chen Fig 16A-16C discloses the cutting surface and how the movement of the points interacts with the outer surface of the liver through boundary lines) or faces towards a further one of the selected functional segments (Hill ¶0020,. Fig 8 discloses using the healthy anatomy adjacent to the diseased region to determine the alignment of the coordinate system used for determining the cutting segment for the diseased region)for which a complete removal is selected (Hill ¶0079, ¶0116 discloses to define the cutting boundary (CB) that enables intact removal of the complete diseased region (DR) (as a single piece, en bloc) and that minimizes the volume of surrounding non diseased tissue that is removed along with the diseased region (DR))in the proposed liver resection plan (Chen ¶0002, ¶0005 discloses computer aided planning of liver resection surgery), and
determining the at least one cutting parameter (Chen ¶0058, ¶0053, ¶0054 discloses the user modifying the freeform resection surface but editing the points) in such that the cutting surface separates a resected part of (Chen ¶0073 and Fig 21E discloses the resection surface separating the tumor and the vein into multiple resection surfaces) the respective selected functional segment (Chen ¶0042 discloses choosing between a plurality of resection surfaces), the resected part comprises the tumor region (Chen Fig 3A, 304 discloses a tumor being a feature in the liver, 19A discloses the resection surface with the tumor) and the selected surface point (Chen ¶0049, ¶0057, ¶0058 discloses choosing and moving points on the resection surface) to be removed according to the proposed liver resection plan (Chen ¶0002, ¶0005 discloses computer aided planning of liver resection surgery), from a remaining part of the respective selected functional segment to remain (Chen ¶0051, discloses what ratio of the liver lobe will be removed into comparison to the whole liver and the volume of the liver that needs to remain) according to the proposed liver resection plan (Chen ¶0002, ¶0005 discloses computer aided planning of liver resection surgery). See Claim 1 for rationale, its parent claim.
Regarding Claim 6, Chen in view of Hill in further view of Lang teaches the computer implemented method of claim 5, wherein determining the tumor region (Chen Fig 3A, 304 discloses a tumor being a feature in the liver, 19A discloses the resection surface with the tumor)determines the tumor region by determining vertices of a convex hull (Hill ¶0135 discloses a plurality of cutting surfaces arranged in a hull (HCS). In one implementation, the hull is a convex hull, in which a set of points (p) are defined as the smallest convex polygon enclosing all of the points (p) in the set)
for the segmented tumor (Chen ¶0033 discloses the selection and positioning of the resection segments being based on the tumor by minimizing the local area around the tumor) and by shifting the vertices away from a centroid of the convex hull (Hill ¶0141 discloses the centroid of the diseased region (DR) array is set at the origin (x0 , Yo, z0)) by a given safety margin (Chen ¶0060 and Fig 18 disclose adjusting the position of the vertices to guarantee the safety margin) to provide tumor region vertices (Chen ¶0060 and Fig 18 disclose the vertices R0- R3 being vertices used to optimize the local area around the tumor). See Claim 1 for rationale, its parent claim.
Regarding Claim 7, Chen in view of Hill in further view of Lang teaches the computer implemented method of claim 6, wherein the determining the at least one cutting parameter (Chen ¶0073 discloses the shape of the resection surface being the initial parameter based on a free form or triangular shape) further includes:
determining further vertices (Chen ¶0060 and Fig 18 disclose other vertices such as Q1, Q2) that are vertices of the convex hull comprising the tumor region (Chen ¶0060 and Fig 18 disclose a triangle based algorithm that creates a similar resection shape as a convex hull to determine tumor resection area) and the selected surface point (Chen ¶0049, ¶0057, ¶0058 discloses choosing and moving points on the resection surface), selecting further vertices that are also tumor region vertices (Chen ¶0060 and Fig 18 disclose the vertices R0- R3 being vertices used to optimize the local area around the tumor), and
fitting the cutting surface (Hill Fig 9a, ¶0067 discloses fitting the cutting surface) to the selected further vertices (Chen ¶0060 and Fig 18 disclose the vertices R0- R3 being vertices used to optimize the local area around the tumor) such that none of the selected further vertices are located in the remaining part (Hill Fig 9a, ¶0067 discloses fitting the cutting surface so that the cutting surface encompasses the diseased region as a whole and all points are included) of the respective selected functional segment (Chen ¶0042 discloses choosing between a plurality of resection surfaces). See Claim 1 for rationale, its parent claim.
Regarding Claim 8, Chen in view of Hill in further view of Lang teaches the computer implemented method of claim 5, wherein the selected surface point is selected (Chen ¶0049, ¶0057, ¶0058 discloses choosing and moving points on the resection surface) such that a distance between the selected surface point and the tumor region is minimized (Chen ¶0073 and Fig21E disclose the resection surface corresponding to the safety margin at its minimal 1mm and ¶0033 discloses the safety margin is the smallest distance that any point on the resection surface may come into proximity with the feature, which in this case is the tumor). See Claim 1 for rationale, its parent claim.
Regarding Claim 9, Chen in view of Hill in further view of Lang teaches the computer implemented method of claim 5, wherein the selected surface point is selected (Chen ¶0049, ¶0057, ¶0058 discloses choosing and moving points on the resection surface) such that a distance between the selected surface point and the tumor region is minimized (Chen ¶0073 and Fig21E disclose the resection surface corresponding to the safety margin at its minimal 1mm and ¶0033 discloses the safety margin is the smallest distance that any point on the resection surface may come into proximity with the feature, which in this case is the tumor). See Claim 1 for rationale, its parent claim.
Regarding Claim 9, Chen in view of Hill in further view of Lang teaches the computer implemented method of claim 2, wherein the given equation defines the cutting surface (Chen ¶0061-¶0063 discloses an equation for calculating the triangular based resection surface) to be a paraboloid (Hill ¶0134 discloses the cutting surface to be a paraboloid). See Claim 1 for rationale, its parent claim.
Regarding Claim 10, Chen in view of Hill in further view of Lang teaches the computer implemented method (Chen ¶0002, ¶0005 discloses computer aided planning of liver resection surgery) of claim 1, wherein a surface of the respective selected functional segment is given by the segmentation of the respective selected functional segment (Chen ¶0037 and Fig 2b disclose segmenting the liver into different segments), the method further comprising:
determining a minimum distance between the segmented tumor (Chen ¶0073, ¶0030 discloses the minimum distance being 1mm between the tumor and resection surface or segment) and a section of the surface that either forms an outer surface of the liver (Chen Fig 16A-16C discloses the cutting surface and how the movement of the points interacts with the outer surface of the liver through boundary lines) or that is adjacent to a further selected segment (Hill ¶0020, Fig 8 discloses using the healthy anatomy adjacent to the diseased region to determine the alignment of the coordinate system used for determining the cutting segment for the diseased region), for which a complete removal is selected (Hill ¶0079, ¶0116 discloses to define the cutting boundary (CB) that enables intact removal of the complete diseased region (DR) (as a single piece, en bloc) and that minimizes the volume of surrounding non diseased tissue that is removed along with the diseased region (DR)); and
selecting the complete removal (Hill ¶0079, ¶0116 discloses to define the cutting boundary (CB) that enables intact removal of the complete diseased region (DR) (as a single piece, en bloc) and that minimizes the volume of surrounding non diseased tissue that is removed along with the diseased region (DR)) of the respective selected functional segment (Chen ¶0042 discloses choosing between a plurality of resection surfaces) when the determined minimum distance reaches or exceeds a respective threshold (Chen ¶0073, ¶0030 discloses the minimum distance being between 1mm and 2mm between the tumor and resection surface or segment). See Claim 1 for rationale, its parent claim.
Regarding Claim 11, Chen in view of Hill in further view of Lang teaches the computer implemented method (Chen ¶0002, ¶0005 discloses computer aided planning of liver resection surgery) of claim 1, wherein the complete removal of the respective selected functional segment is selected (Chen ¶0051, ¶0056, ¶0058 discloses what ratio of the liver lobe will be removed into comparison to the whole liver and the risk evaluation if the volume removed is too great) when at least one of
a volume of the segmented tumor or a maximum diameter of the segmented tumor reaches or exceeds a respective threshold (Chen ¶0051 discloses that a minimum volume should be left of close to 1/2 of the liver volume or the resection becomes dangerous), or
when a distance of the segmented tumor to a vein that is segmented(Chen ¶0030, ¶0033 and Fig 21A and 21B disclose the distance between the vein and the tumor based on the safety margin which is based on the distance from the cutting surface) in the medical image dataset (Hill ¶0065 discloses the anatomy (A) is preoperatively or intraoperatively imaged using imaging techniques such as, but not limited to CT, x-ray, MRI, etc, which result in three dimensional images of the subject) reaches or falls below a respective threshold (Chen ¶0073 discloses the vein is between 1mm and 2mmm away from the tumor). See Claim 1 for rationale, its parent claim.
Regarding Claim 12, Chen in view of Hill in further view of Lang teaches the computer implemented method (Chen ¶0002, ¶0005 discloses computer aided planning of liver resection surgery) of claim 1, wherein at least one of at least one measure for risk or a severity of an intervention is determined for the proposed liver resection plan (Chen ¶0051 discloses measuring the remaining volume of the whole liver and suggesting not performing the surgery as part of the plan if the remaining volume is too low) and provided as a part of the proposed liver resection plan (Chen ¶0042 discloses the planar resection surface is chosen 618 the simulation is finalized and the resection plan is saved). See Claim 1 for rationale, its parent claim.
Regarding Claim 13, Chen in view of Hill in further view of Lang teaches a data processing system (Chen ¶0075 discloses an algorithm to process the data) configured to perform (Chen ¶0008 discloses a computer performing the algorithm) the computer implemented method (Chen ¶0002, ¶0005 discloses computer aided planning of liver resection surgery) of claim 1. See Claim 1 for rationale, its parent claim.
Regarding Claim 14, Chen in view of Hill in further view of Lang teaches a non-transitory computer-readable medium comprising instructions, when executed by a system, causes the system to perform (Hill ¶0074, ¶0184, discloses non-transitory memory storing the instructions for implementing the described automated planning techniques) the method (Chen ¶0002, ¶0005 discloses computer aided planning of liver resection surgery) of claim 1. See Claim 1 for rationale, its parent claim.
Regarding Claim 15, Chen in view of Hill in further view of Lang teaches a non-transitory computer-readable medium comprising instructions, when executed by a system, causes the system to perform(Hill ¶0074, ¶0184, discloses non-transitory memory storing the instructions for implementing the described automated planning techniques) the method (Chen ¶0002, ¶0005 discloses computer aided planning of liver resection surgery) of claim 2. See Claim 1 for rationale, its parent claim.
Regarding Claim 16, Chen in view of Hill in further view of Lang teaches the computer implemented method of claim 3, wherein the graphical representation of the cutting surface (Chen ¶0060 and Fig 18 disclose a graphical representation of the cutting surface) is a superposition of a representation of the medical image dataset(Hill ¶0065 discloses the anatomy (A) is preoperatively or intraoperatively imaged using imaging techniques such as, but not limited to CT, x-ray, MRI, etc, which result in three dimensional images of the subject) and a representation of the cutting surface (Chen Fig 16A-16C and 19C discloses the superposition of the cutting surface over the medical data images). See Claim 1 for rationale, its parent claim.
Regarding Claim 17, Chen in view of Hill in further view of Lang teaches the computer implemented method of claim 4, wherein the cutting surface is determined by parametrizing a given equation (Chen ¶0061-¶0063 discloses an equation for calculating the triangular based resection surface) by a cutting parameter (Chen ¶0073 discloses the shape of the resection surface being the initial parameter based on a free form or triangular shape) based on the segmented tumor(Chen ¶0033 discloses the selection and positioning of the resection segments being based on the tumor by minimizing the local area around the tumor). See Claim 1 for rationale, its parent claim.
Regarding Claim 18, Chen, in view of Hill in further view of Lang teaches the computer implemented method of claim 4, wherein the determining the at least one cutting parameter (Chen ¶0073 discloses the shape of the resection surface being the initial parameter based on a free form or triangular shape) includes:
determining a tumor region (Chen Fig 3A, 304 discloses a tumor being a feature in the liver, 19A discloses the resection surface with the tumor) of the medical image dataset(Hill ¶0065 discloses the anatomy (A) is preoperatively or intraoperatively imaged using imaging techniques such as, but not limited to CT, x-ray, MRI, etc, which result in three dimensional images of the subject) comprising the tumor or a part of the tumor (Chen Fig 17 1706, 1708 discloses the triangle cutting surfaces being evaluated for the tumor area and the safety margin around the tumor) extending into the respective selected functional segment (Chen Fig 19C discloses the plurality of resection surfaces the tumor that overlaps into multiple sections) based on the segmentation of the tumor (Chen ¶0012 discloses the segmented images including the tumor),
wherein the surface of the respective selected functional segment (Chen ¶0042 discloses choosing between a plurality of resection surfaces) is given by the segmentation of the respective selected functional segment (Chen ¶0033 discloses the selection and positioning of the resection segments being based on the tumor by minimizing the local area around the tumor), and the chosen section of the surface forms an outer surface of the liver (Chen Fig 16A-16C discloses the cutting surface and how the movement of the points interacts with the outer surface of the liver through boundary lines) or faces towards a further one of the selected functional segments(Hill ¶0020,. Fig 8 discloses using the healthy anatomy adjacent to the diseased region to determine the alignment of the coordinate system used for determining the cutting segment for the diseased region) for which a complete removal is selected (Hill ¶0079, ¶0116 discloses to define the cutting boundary (CB) that enables intact removal of the complete diseased region (DR) (as a single piece, en bloc) and that minimizes the volume of surrounding non diseased tissue that is removed along with the diseased region (DR)) in the proposed liver resection plan (Chen ¶0002, ¶0005 discloses computer aided planning of liver resection surgery), and
determining the cutting parameter (Chen ¶0058, ¶0053, ¶0054 discloses the user modifying the freeform resection surface but editing the points) in such that the cutting surface separates a resected part of (Chen ¶0073 and Fig 21E discloses the resection surface separating the tumor and the vein into multiple resection surfaces) the respective selected functional segment (Chen ¶0042 discloses choosing between a plurality of resection surfaces), the resected part comprises the tumor region (Chen Fig 3A, 304 discloses a tumor being a feature in the liver, 19A discloses the resection surface with the tumor) and the selected surface point (Chen ¶0049, ¶0057, ¶0058 discloses choosing and moving points on the resection surface) to be removed according to the proposed liver resection plan (Chen ¶0002, ¶0005 discloses computer aided planning of liver resection surgery), from a remaining part of the respective selected functional segment to remain (Chen ¶0051, discloses what ratio of the liver lobe will be removed into comparison to the whole liver and the volume of the liver that needs to remain) according to the proposed liver resection plan (Chen ¶0002, ¶0005 discloses computer aided planning of liver resection surgery). See Claim 1 for rationale, its parent claim.
Regarding Claim 19, Chen in view of Hill in further view of Lang teaches the computer implemented method of claim 18, wherein determining the tumor region (Chen Fig 3A, 304 discloses a tumor being a feature in the liver, 19A discloses the resection surface with the tumor)determines the tumor region by determining vertices of a convex hull (Chen ¶0060 and Fig 18 disclose a triangle based algorithm that creates a similar resection shape as a convex hull to determine tumor resection area) for the segmented tumor(Chen ¶0033 discloses the selection and positioning of the resection segments being based on the tumor by minimizing the local area around the tumor) and by shifting the vertices away from a centroid of the convex hull by a given safety margin (Chen ¶0060 and Fig 18 disclose adjusting the position of the vertices to guarantee the safety margin) to provide tumor region vertices (Chen ¶0060 and Fig 18 disclose the vertices R0- R3 being vertices used to optimize the local area around the tumor). See Claim 1 for rationale, its parent claim.
Reference Cited
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
US Patent Pub US-20150063668-A1 to You et al. discloses a three-dimensional virtual liver surgery planning system.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL ROBERTS whose telephone number is (571)272-6413. The examiner can normally be reached Monday- Friday 7:30am- 5:00pm.
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.
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.
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
Prosecution Insights