DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant's submission filed on 02/26/2026 has been entered. Currently claims 20-23 and 39-54 are pending.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 20, 22, 23, 39, 44, 46-48, and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Stopek (US20140228858A1) and in view of Herth FJF et al. Thorax 2015;70: 326–332. (hereinafter “Herth”) and further in view of Vining (US20100328305A1) and Lo et al., “Vessel-guided airway tree segmentation: A voxel classification approach” Medical Image Analysis, Volume 14, Issue 4, 2010, Pages 527-538, ISSN 1361-8415, (hereinafter “Lo”)
Regarding claim 20, Stopek teaches receiving, by a medical imaging system having at least one processing device (fig. 1 computing device 120 [0039]), image data of a patient anatomy ([0046] patient image data is received);
segmenting the image data to generate an anatomical model from image data ([0047] the pathway planning module processes images of the patient by segmentation and creates a 3D model of a desired portion of the CT image, such as the lungs);
receiving, at the processing device, input from an operator input device (fig. 4 user interface for adding a target for developing a pathway [0065]) the input defining a pathway model within an image space defined by the three-dimensional image data (fig. 4 the user interface 400 of the pathway planning module that allows the clinician to select to create a new pathway plan, the localizer 410 and the image 430 allows for the viewing of the 3D image data [0065]-[0067]) and associated with an anatomical passageway of the patient anatomy ([0058] the images may be of the bronchial trees or the trachea); and generating a hybrid model of the patient anatomy from the pathway model and from the anatomical model (fig. 5B-5C a model of the pathway and the three dimensional model is created [0071]).
However, Stopek is silent regarding a pathway model within a portion of an image space defined by the three-dimensional image data that is outside the anatomical model and inside an anatomical passageway of the patient anatomy that is present in the three-dimensional data.
In the same medical imaging field of endeavor, Herth teaches a pathway model within a portion of an image space defined by the three-dimensional image data that is outside the anatomical that is present in the three-dimensional data (pg. 327 Planning Stage based on a user’s input to mark and segment a target, the system calculates the path to the lesion location outside the airway wall; this means part of the pathway model is outside the anatomical model of the airways but still within the CT image data space (see fig. 2)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Stopek with the additional pathway model process of Herth, as this would allow an improvement to the accessibility of peripheral nodules via the bronchoscopic route while remaining safe and feasible (see Herth pg. 331).
However the combination of references are still silent regarding receiving three-dimensional image data of a patient anatomy.
In the same imaging field of endeavor, Vining teaches receiving three-dimensional image data of a patient anatomy ([0046] the images are stacked to form a three dimensional volume).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify images patient data of modified Stopek with the 3D volume data of Vining, as this would help facilitate interactive three-dimensional volume (see Vining Abstract).
However the combination of references are silent regarding a portion of the image spaced that is outside the anatomical model and inside an anatomical passageway.
In the same imaging field of endeavor, Lo teaches a portion of the image spaced that is outside the anatomical model and inside an anatomical passageway (pg. 528 segmentation results in missing branches due to leakage. These missing branches would be outside the segmentation model while still being inside an anatomical passageway).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the branches missing in the segmentation of Lo with the navigational framework of defining pathway model modified Stopek, as both inventions relate to medical image data processing, and would yield the predictable result of defining the pathway model in a portion of the image data that is outside the segmentation portion but still within the anatomical passageway to one of ordinary skill in the art. One of ordinary skill in the art would be able to perform such a combination, and the results of modified Stopek defining a pathway model that’s outside a segmentation model while still being inside an anatomical passageway.
Regarding claim 22, modified Stopek teaches the method of claim 20, wherein Stopek further teaches the anatomical model is a surface model ([0047] the 3D model employs surface rendering).
Regarding claim 23, modified Stopek teaches the method of claim 20, wherein Stopek further teaches determining a termination point of the anatomical model wherein the pathway model is defined beginning from the termination point (see fig. 5C the anatomical model ends where the pathway model begins).
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Regarding claim 39, modified Stopek teaches the method of claim 20, but fails to explicitly disclose wherein the input from the operator input device comprises navigational directions for virtual movement within the image space defined by the three-dimensional image data.
However in the same medical image processing, Vining teaches wherein the input from the operator input device comprises navigational directions for virtual movement within the image space defined by the three-dimensional image data ([0101] the user controls the flight using mouse buttons).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the navigation system of modified Stopek with the flight options of Vining, as this would allow users to examine CT data in a way which is analogous to real bronchoscopy (see Vining [0101]). This would allow for a fly through without risk to the patient.
Regarding claim 44, Stopek teaches a system for processing medical images, the system comprising:
an operator input device ([0049] input device 129)
a memory configured for storing image data of at least a portion of a patient anatomy (fig. 1 memory 126 contains patient data [0045])
a processing device in communication with the memory, the processing device configured to execute instructions to perform operations comprising (fig. 1 computing device 120 [0043])
receiving, by a medical imaging system having at least one processing device (fig. 1 computing device 120 [0039]), image data of a patient anatomy ([0046] patient image data is received);
segmenting the image data to generate an anatomical model from image data ([0047] the pathway planning module processes images of the patient by segmentation and creates a 3D model of a desired portion of the CT image, such as the lungs);
receiving, at the processing device, input from an operator input device (fig. 4 user interface for adding a target for developing a pathway [0065]) the input defining a pathway model within an image space defined by the three-dimensional image data (fig. 4 the user interface 400 of the pathway planning module that allows the clinician to select to create a new pathway plan, the localizer 410 and the image 430 allows for the viewing of the 3D image data [0065]-[0067]) and associated with an anatomical passageway of the patient anatomy ([0058] the images may be of the bronchial trees or the trachea); and generating a hybrid model of the patient anatomy from the pathway model and from the anatomical model (fig. 5B-5C a model of the pathway and the three dimensional model is created [0071]).
However, Stopek is silent regarding a pathway model within a portion of an image space defined by the three-dimensional image data that is outside the anatomical model and inside an anatomical passageway of the patient anatomy that is present in the three-dimensional data.
In the same medical imaging field of endeavor, Herth teaches a pathway model within a portion of an image space defined by the three-dimensional image data that is outside the anatomical that is present in the three-dimensional data (pg. 327 Planning Stage based on a user’s input to mark and segment a target, the system calculates the path to the lesion location outside the airway wall; this means part of the pathway model is outside the anatomical model of the airways but still within the CT image data space (see fig. 2)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Stopek with the additional pathway model process of Herth, as this would allow an improvement to the accessibility of peripheral nodules via the bronchoscopic route while remaining safe and feasible (see Herth pg. 331).
However the combination of references are still silent regarding receiving three-dimensional image data of a patient anatomy.
In the same imaging field of endeavor, Vining teaches receiving three-dimensional image data of a patient anatomy ([0046] the images are stacked to form a three dimensional volume).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify images patient data of modified Stopek with the 3D volume data of Vining, as this would help facilitate interactive three-dimensional volume (see Vining Abstract).
However the combination of references are silent regarding a portion of the image spaced that is outside the anatomical model and inside an anatomical passageway.
In the same imaging field of endeavor, Lo teaches a portion of the image spaced that is outside the anatomical model and inside an anatomical passageway (pg. 528 segmentation results in missing branches due to leakage. These missing branches would be outside the segmentation model while still being inside an anatomical passageway).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the branches missing in the segmentation of Lo with the navigational framework of defining pathway model modified Stopek, as both inventions relate to medical image data processing, and would yield the predictable result of defining the pathway model in a portion of the image data that is outside the segmentation portion but still within the anatomical passageway to one of ordinary skill in the art. One of ordinary skill in the art would be able to perform such a combination, and the results of modified Stopek defining a pathway model that’s outside a segmentation model while still being inside an anatomical passageway.
Regarding claim 46, modified Stopek teaches the system of claim 44, wherein Stopek further teaches the anatomical model is a surface model ([0047] pathway planning module employs surface rendering)
Regarding claim 47, modified Stopek teaches the system of claim 44, Stopek teaches determining a termination point of the anatomical model wherein the pathway model is defined beginning from the termination point (see fig. 5C the anatomical model ends where the pathway model begins).
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Regarding claim 48, modified Stopek teaches the system of claim 44, but fails to explicitly disclose wherein the input from the operator input device comprises navigational directions for virtual movement within the image space defined by the three-dimensional image data.
However in the same medical image processing, Vining teaches wherein the input from the operator input device comprises navigational directions for virtual movement within the image space defined by the three-dimensional image data ([0101] the user controls the flight using mouse buttons).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the navigation system of modified Stopek with the flight options of Vining, as this would allow users to examine CT data in a way which is analogous to real bronchoscopy (see Vining [0101]). This would allow for a fly through without risk to the patient.
Regarding claim 53, Stopek teaches a computer-readable storage medium storing instructions that, when executed by one or more processors, cause the one or more processors to perform (fig. 1 computing device 120):
receiving, by a medical imaging system having at least one processing device (fig. 1 computing device 120 [0039]), image data of a patient anatomy ([0046] patient image data is received);
segmenting the image data to generate an anatomical model from image data ([0047] the pathway planning module processes images of the patient by segmentation and creates a 3D model of a desired portion of the CT image, such as the lungs);
receiving, at the processing device, input from an operator input device (fig. 4 user interface for adding a target for developing a pathway [0065]) the input defining a pathway model within an image space defined by the three-dimensional image data (fig. 4 the user interface 400 of the pathway planning module that allows the clinician to select to create a new pathway plan, the localizer 410 and the image 430 allows for the viewing of the 3D image data [0065]-[0067]) and associated with an anatomical passageway of the patient anatomy ([0058] the images may be of the bronchial trees or the trachea); and generating a hybrid model of the patient anatomy from the pathway model and from the anatomical model (fig. 5B-5C a model of the pathway and the three dimensional model is created [0071]).
However, Stopek is silent regarding a pathway model within a portion of an image space defined by the three-dimensional image data that is outside the anatomical model and inside an anatomical passageway of the patient anatomy that is present in the three-dimensional data.
In the same medical imaging field of endeavor, Herth teaches a pathway model within a portion of an image space defined by the three-dimensional image data that is outside the anatomical that is present in the three-dimensional data (pg. 327 Planning Stage based on a user’s input to mark and segment a target, the system calculates the path to the lesion location outside the airway wall; this means part of the pathway model is outside the anatomical model of the airways but still within the CT image data space (see fig. 2)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Stopek with the additional pathway model process of Herth, as this would allow an improvement to the accessibility of peripheral nodules via the bronchoscopic route while remaining safe and feasible (see Herth pg. 331).
However the combination of references are still silent regarding receiving three-dimensional image data of a patient anatomy.
In the same imaging field of endeavor, Vining teaches receiving three-dimensional image data of a patient anatomy ([0046] the images are stacked to form a three dimensional volume).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify images patient data of modified Stopek with the 3D volume data of Vining, as this would help facilitate interactive three-dimensional volume (see Vining Abstract).
However the combination of references are silent regarding a portion of the image spaced that is outside the anatomical model and inside an anatomical passageway.
In the same imaging field of endeavor, Lo teaches a portion of the image spaced that is outside the anatomical model and inside an anatomical passageway (pg. 528 segmentation results in missing branches due to leakage. These missing branches would be outside the segmentation model while still being inside an anatomical passageway).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the branches missing in the segmentation of Lo with the navigational framework of defining pathway model modified Stopek, as both inventions relate to medical image data processing, and would yield the predictable result of defining the pathway model in a portion of the image data that is outside the segmentation portion but still within the anatomical passageway to one of ordinary skill in the art. One of ordinary skill in the art would be able to perform such a combination, and the results of modified Stopek defining a pathway model that’s outside a segmentation model while still being inside an anatomical passageway.
Claims 21 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Stopek as modified by Herth, Vining, and Lo as applied to claims 20 and 44, and further in view of Thompson et al., (US20180158201A1).
Regarding claim 21, modified Stopek teaches the method of claim 20, but fails to explicitly disclose wherein the anatomical model is a line model.
However in the same imaging field of endeavor, Thompson teaches wherein the anatomical model is a line model (fig. 6b depicts centerline model G of the veins [0058]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the anatomic model of modified Stopek with the line modeling of Thompson, as this would provide a practical method to provide guidance to a surgical guidance and provides advantages over open surgery and haptics (see Thompson [0089]).
Regarding claim 45, modified Stopek teaches the system of claim 44, but fails to explicitly disclose wherein the anatomical model is a line model.
However in the same imaging field of endeavor, Thompson teaches wherein the anatomical model is a line model (fig. 6b depicts centerline model G of the veins [0058]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the anatomic model of modified Stopek with the line modeling of Thompson, as this would provide a practical method to provide guidance to a surgical guidance and provides advantages over open surgery and haptics (see Thompson [0089]).
Claims 40-42, 49-51, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Stopek as modified by Herth, Vining, and Lo as applied to claims 20, 44, and 53 above, and further in view of Yu et al., (US 20150119638 A1) and Viswanathan (US7627361B2).
Regarding claim 40, modified Stopek teaches the method of claim 20, but fails to explicitly disclose wherein the hybrid model comprises a proximal centerline derived from the anatomical model and a distal centerline derived from the pathway model.
In the same imaging field of endeavor, Yu teaches wherein the hybrid model comprises a proximal centerline derived from the anatomical model (fig. 25 A there are center line coordinates representing the center of the lumen, which are then connected with the centerline 2507, and these coordinates are from the three-dimensional space [0191]-[0193]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Stopek with the modeling of Yu, as this would enhance navigational capabilities (see Yu [0196]).
However, the combination of references is silent regarding a distal centerline derived from the pathway model.
In the same imaging field of endeavor, Viswanathan teaches a distal centerline derived from the pathway model (claim 1 “identifying a plurality of spaced apart nodes that define a center line along a desired path).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to apply the centerline to the pathway model of Viswanathan to the method of modified Stopek, as this would allow the facilitation of quick and easy navigation along a desired path through a body lumen (see col. 1 line 34-37). One of ordinary skill would understand this combination of Yu and Viswanathan with Stopek modified by Stopek would result in the centerline of Yu being more proximal than Viswanathan when applied to the model of fig. 5C in Stopek (see below).
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Regarding claim 41, modified Stopek teaches the method of claim 40, wherein Stopek teaches the anatomical passageway has a first diameter and the distal model is associated with the anatomical passageway, and wherein the proximal model is associated with a second anatomical passageway having a second diameter, the second diameter being larger than the first diameter (see annotated fig. 5A, a proximal portion of a first part of the anatomical passageway has a larger diameter than the diameter of a distal portion of a second anatomical passageway).
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Regarding claim 42, modified Stopek teaches the method of claim 20, but fails to explicitly disclose wherein the hybrid model comprises a centerline derived from the anatomical model.
In the same imaging field of endeavor, Yu teaches wherein the hybrid model comprises a centerline derived from the anatomical model (fig. 25 A there are center line coordinates representing the center of the lumen, which are then connected with the centerline 2507, and these coordinates are from the three-dimensional space [0191]-[0193]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Stopek with the modeling of Yu, as this would enhance navigational capabilities (see Yu [0196]).
However, the combination of references is silent regarding a distal centerline derived from the pathway model.
In the same imaging field of endeavor, Viswanathan teaches a centerline derived from the pathway model (claim 1 “identifying a plurality of spaced apart nodes that define a center line along a desired path).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to apply the centerline to the pathway model of Viswanathan to the method of modified Stopek, as this would allow the facilitation of quick and easy navigation along a desired path through a body lumen (see col. 1 line 34-37).
Regarding claim 49, modified Stopek teaches the system of claim 44, but fails to explicitly disclose wherein the hybrid model comprises a proximal centerline derived from the anatomical model and a distal centerline derived from the pathway model.
In the same imaging field of endeavor, Yu teaches wherein the hybrid model comprises a proximal centerline derived from the anatomical model (fig. 25 A there are center line coordinates representing the center of the lumen, which are then connected with the centerline 2507, and these coordinates are from the three-dimensional space [0191]-[0193]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of modified Stopek with the modeling of Yu, as this would enhance navigational capabilities (see Yu [0196]).
However, the combination of references is silent regarding a distal centerline derived from the pathway model.
In the same imaging field of endeavor, Viswanathan teaches a distal centerline derived from the pathway model (claim 1 “identifying a plurality of spaced apart nodes that define a center line along a desired path).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to apply the centerline to the pathway model of Viswanathan to the system of modified Stopek, as this would allow the facilitation of quick and easy navigation along a desired path through a body lumen (see col. 1 line 34-37). One of ordinary skill would understand this combination of Yu and Viswanathan with Stopek modified by Stopek would result in the centerline of Yu being more proximal than Viswanathan when applied to the model of fig. 5C in Stopek (see below).
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Regarding claim 50, modified Stopek teaches the system of claim 49, wherein Stopek further teaches the anatomical passageway has a first diameter and the distal model is associated with the anatomical passageway, and wherein the proximal model is associated with a second anatomical passageway having a second diameter, the second diameter being larger than the first diameter (see annotated fig. 5A, a proximal portion of a first part of the anatomical passageway has a larger diameter than the diameter of a distal portion of a second anatomical passageway).
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Regarding claim 51, modified Stopek teaches the system of claim 44, but fails to explicitly disclose wherein the hybrid model comprises a centerline derived from the anatomical model.
In the same imaging field of endeavor, Yu teaches wherein the hybrid model comprises a centerline derived from the anatomical model (fig. 25 A there are center line coordinates representing the center of the lumen, which are then connected with the centerline 2507, and these coordinates are from the three-dimensional space [0191]-[0193]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Stopek with the modeling of Yu, as this would enhance navigational capabilities (see Yu [0196]).
However, the combination of references is silent regarding a distal centerline derived from the pathway model.
In the same imaging field of endeavor, Viswanathan teaches a centerline derived from the pathway model (claim 1 “identifying a plurality of spaced apart nodes that define a center line along a desired path).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to apply the centerline to the pathway model of Viswanathan to the method of modified Stopek, as this would allow the facilitation of quick and easy navigation along a desired path through a body lumen (see col. 1 line 34-37).
Regarding claim 54, modified Stopek teaches the method of claim 53, but fails to explicitly disclose wherein the hybrid model comprises a centerline derived from the anatomical model.
In the same imaging field of endeavor, Yu teaches wherein the hybrid model comprises a centerline derived from the anatomical model (fig. 25 A there are center line coordinates representing the center of the lumen, which are then connected with the centerline 2507, and these coordinates are from the three-dimensional space [0191]-[0193]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Stopek with the modeling of Yu, as this would enhance navigational capabilities (see Yu [0196]).
However, the combination of references is silent regarding a distal centerline derived from the pathway model.
In the same imaging field of endeavor, Viswanathan teaches a centerline derived from the pathway model (claim 1 “identifying a plurality of spaced apart nodes that define a center line along a desired path).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to apply the centerline to the pathway model of Viswanathan to the method of modified Stopek, as this would allow the facilitation of quick and easy navigation along a desired path through a body lumen (see col. 1 line 34-37).
Claims 43 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Stopek as modified by Herth, Lo, and Vining as applied to claim 20 and 44 above, and further in view of Yu.
Regarding claim 43, modified Stopek teaches the method of claim 20, wherein Stopek further teaches the hybrid model comprises a proximal model portion and a distal portion (see annotated fig. 5C), both the proximal and distal model portions being derived from the anatomical model (see annotated fig. 5C, the proximal and distal portions would be part of the anatomical model), and the hybrid model further comprising a navigational pathway model portion derived from the pathway model (fig. 5C the hybrid model includes a pathway plan) and extending between the proximal and distal model portions (see annotated fig. 5C).
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However, the combination of references are still silent regarding a centerline.
In the same imaging field of endeavor, Yu teaches a centerline model (fig. 25 A there are center line coordinates representing the center of the lumen, which are then connected with the centerline 2507, and these coordinates are from the three-dimensional space [0191]-[0193]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Stopek with the modeling of Yu, as this would enhance navigational capabilities (see Yu [0196]). One of ordinary skill would understand that this centerline model would apply to the proximal and distal model portions, and thus read upon the limitation wherein the hybrid model comprises a proximal centerline model portion and a distal centerline model portion, both the proximal and distal centerline model portions being derived from the anatomical model, the hybrid model further comprising a navigational pathway model portion derived from the pathway model and extending between the proximal and distal centerline model portions.
Regarding claim 52, modified Stopek teaches the system of claim 44, wherein Stopek further teaches the hybrid model comprises a proximal model portion and a distal portion (see annotated fig. 5C), both the proximal and distal model portions being derived from the anatomical model (see annotated fig. 5C, the proximal and distal portions would be part of the anatomical model), and the hybrid model further comprising a navigational pathway model portion derived from the pathway model (fig. 5C the hybrid model includes a pathway plan) and extending between the proximal and distal model portions (see annotated fig. 5C).
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However, the combination of references are still silent regarding a centerline.
In the same imaging field of endeavor, Yu teaches a centerline model (fig. 25 A there are center line coordinates representing the center of the lumen, which are then connected with the centerline 2507, and these coordinates are from the three-dimensional space [0191]-[0193]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of modified Stopek with the modeling of Yu, as this would enhance navigational capabilities (see Yu [0196]). One of ordinary skill would understand that this centerline model would apply to the proximal and distal model portions, and thus read upon the limitation wherein the hybrid model comprises a proximal centerline model portion and a distal centerline model portion, both the proximal and distal centerline model portions being derived from the anatomical model, the hybrid model further comprising a navigational pathway model portion derived from the pathway model and extending between the proximal and distal centerline model portions.
Response to Arguments
Applicant's arguments filed 02/26/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s argument a), Applicant argues that Stopek fails to teach or suggest “the input defining a pathway model”, stating that Stopek simply selects a target and clicks a path button.
Examiner disagrees. The claims as written do not require manually drawing a pathway, rather the input only needs to result in a defined pathway model. As such, the pathway plan that results from the input from the user from Stopek would read upon the limitation of the input defining a pathway model, as the input of Stopek results in defining a pathway model.
Regarding Applicant’s argument b) Applicant argues that the rejection fails to facially assert that either Herth or Lo teaches “the input defining a pathway model within a portion of an image spaced defined by the three-dimensional image data that is … inside an anatomical passageway of the patient anatomy that is present in the three-dimensional image data.
In addition, Applicant has argued that it cannot be obvious to modify the “tunnel path” of Herth with the teaches of Lo to be “inside an anatomical passageway of the patient anatomy that is present in the three-dimensional image data”.
In addition, Applicant has further argued that Lo does not teach segmentation that results in missing branches due to leakage, and actually teaches that when segmentation is performed conservatively in order prevent any leakage, branches will typically be missing. And that Lo does not teach or suggest “receiving, at the processing device, input form an operator input device, the input defining model”, and that it does not remedy the deficiencies of Stopek and Herth.
Examiner disagrees. The rejection does not rely upon Herth for teaching an anatomical passageway. Rather Herth is relied upon for teaching a pathway extending beyond the anatomical model, while Lo is relied upon for teaching portions of an anatomical passageway that exists outside segmentation model while remaining part of the actual anatomy.
Second, applicant’s arguments against Herth’s tunnel path does not address the actual basis of the rejection. Examiner agrees that Herth’s path extends through tissue and is not itself an anatomical passageway, however, the rejection relies upon the combined teachings of Herth and Lo rather than Herth or Lo alone.
Third, applicant’s arguments regarding Lo are directed to teachings that the Examiner did not rely upon. Lo is not relied upon for teaching pathway generation or operator input. Those teachings are supplied by Stopek. Lo is simply relied upon for teachings that portions of the anatomical airway may be omitted from a segmentation result while remaining actual airway structures. While Applicant correctly notes that Lo teaches missing branches resulting from conservative segmentation intended to avoid leakage, the reasons the branches are omitted are not material to the rejection. The rejection relies upon the fact that there are omitted airway branches outside the segmentation model while remaining inside the actual airway passageway. Thus Lo teaches a portion of image space that is outside the anatomical model while simultaneously remaining inside the actual airway passageway.
When the pathway planning teachings of Stopek and Herth are applied to the omitted airway regions taught by Lo, the resulting pathway model would be located in a portion of image space that is outside the anatomical model while remaining within an anatomical passageway.
Regarding Applicant’s argument c), Applicant has argued that the combination of Stopek, Herth, Vining, and Lo relies on impermissible hindsight, and uses the Applicant’s own disclosure as a roadmap and that the cited references do not pertain to the problem of image segmentation failing to identify narrow passages and the solution of generation a hybrid model based in part on the claim limitations.
Examiner disagrees. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). One of ordinary skill in the art would have recognized that applying known pathway-planning techniques to known anatomical regions unintendedly omitted from segmentation would predictably allow pathway planning through portions of the anatomy that remain visible in image data but are absent from segmentation result. The rejection therefore relies upon the combined teachings of the prior art and the predictable results obtainable from their combination, rather than applicant’s disclosure..
Regarding claim 39, applicant has argued that Vining does not teach that the “flight” defines a pathway model, let alone generating a hybrid model of the patient anatomy from the flight and anatomical model. In addition, Applicant has argued that the Examiner has failed to provide any reasoning as to why it would have been obvious to one of ordinary skill in the art to define a pathway model from the “flight” of Vining, and then use that in generating a hybrid model of the patient anatomy form the pathway model from the anatomical model.
Examiner disagrees. Vining has not been relied for teaching the pathway model, the hybrid model, or generation of the hybrid model. Those teachings are supplied by the combination of Stopek, Herth, and Lo as set forth in the rejection. Vining is relied upon solely for an input from the operator input device comprises navigational directions for virtual movement within the image space. It is this combination of an input device that is capable of navigational direction for virtual movement within the image space as taught by Vining with the pathway planning system of modified Stopek that teaches the limitations of claim 39. It would have been obvious to utilize the navigational input techniques of Vining with the pathway planning environment of modified Stopek, as both references are directed to user-guided navigation through three-dimensional anatomical image data. The resulting combination teaches receiving operator input that defines a pathway model, wherein the input comprises navigational directions for virtual movement within the image space.
For these reasons, the claims remain rejected. The remaining claims are rejected for substantially the same reasons as above.
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.
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/MICHAEL YIMING FANG/ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798
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