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 .
Status of Claims
Applicant’s amendments filed 06/22/2026 have been entered. Claims 1-3, 5-7, 9-11, 13-15, 17, 19 and 20 are pending and currently under consideration for patentability under 37 CFR 1.104. New rejection and response to arguments found below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 14, 17, and all dependent claims thereof are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Applicant has amended independent claims 1, 14, and 17 to each recite, “generate a virtual image which is registered to the real-time images, which indicates the at least one structure located below the surface of the anatomical target based on the 3D model, and which shows an internal view of th3e at least one structure located below the surface of the anatomical target base don’t he 3D model.” It is noted Applicant did not indicate where the new language is supported in the specification. After a cursory search, it appears the language constitutes new matter.
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.
Claims 1-3, 6, 7, 11, 14, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manzke et al. (WO 2012/172474) in view of Higgins et al. (U.S. 2009/0156895), Lee et al. (U.S. 2015/0141814), and Tanaka (U.S. 2016/0038004).
Higgins et al. incorporates Method for Continuous Guidance of Endoscopy at paragraphs [0165],[0179]
With respect to claim 1, Manzke et al. teaches a system for visualizing an anatomical target, the system comprising:
an imaging device (120) configured to collect real-time images of the anatomical target;
a three-dimensional model (111) generated from pre-operative images or intra-operative images of at least one structure located below a surface of the anatomical target, such that the at least one structure is not visible in the real-time images from the imaging device (page 7, lines 7-16; page 8 lines 3-6);
an image processing module configured to:
generate an overlay from the 3D model registered to the real-time images, wherein the overlay indicates the at least one structure in the anatomical target (page 8, lines 7-15; page 10 line 18-page 11 line 17, FIG. 9).
However, Manzke et al. does not explicitly teach indicating a depth of the structures below the surface. Manzke et al. further does not teach generating a virtual image to show an internal view of the at least one blood vessel.
With respect to claim 1, Higgins et al. teaches a system for visualizing an anatomical target, the system comprising:
an image processor (para [0132]) configured to compute a depth of at least one structure relative to the at least a 3D model and to generate an overlay from the 3D model registered to real-time images (para [0115] of Higgins et al. see also FIG. 1 of Method for Continuous Guidance of Endoscopy), wherein the overlay indicates the at least one structure located below the surface of the anatomical target and indicates the depth of the at least one structure below the surface of the anatomical target (see paragraphs [0113]-[0118] of Higgins et al., see also FIG. 2 of Method for Continuous Guidance of Endoscopy).
With respect to claim 1, Lee et al. teaches a system for visualizing internal anatomy of an anatomical target configured to generate a virtual image (see para [0095], [0161], [0164]-[0169], [0178]-[0180]) showing an internal view of the at least one structure below the surface located below the surface of the anatomical region (FIG. 8B); and
a display (130) device configured to display the virtual image
With respect to claim 1, Tanaka teaches an image processor configured to: compute a depth of at least one structure, wherein the overlay is registered to the real-time images, displays the at least one structure located below the surface of the anatomical target not visible in the real-time images, and indicates the depth of the at least one structure below the surface of the anatomical target, wherein the depth of the at least one structure below the surface is indicated relative to a position of a tool other than the imaging device in the real-time images (para [0033]-[0039]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of invention to utilize the depth indication of Higgins et al. in the system of Manzke et al. in order to provide the user with additional cues that convey obstacle locations and ROI depths of sample so that the physician can freely navigate in the virtual world, perceiving the depth of sample and possible obstacle locations at any pose orientation (para [0115] of Higgins et al.).
Further, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Manzke et al. to include the visualization showing an internal view of the blood vessel as taught by Lee et al. in order to provide a means of accurately measuring the degree of stenosis in a body lumen (para [0003] of Lee et al.).
Finally, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Manzke et al. to indicate the depth of the at least one structure below the surface of the anatomical target relative to a position of a tool other than the imaging device in the real-time images so that when the user desires to perform a procedure without damaging the specific part, it is possible to prompt the user to carefully perform the procedure (para [0041] of Tanaka).
With respect to claim 2, Higgins et al. teaches the image processor is further configured to indicate the depth of the at least one structure located below the surface of the anatomical target by one of a color, texture or size of the structure rendered (para [0114]).
With respect to claim 3, Higgins et al. teaches the image processor is further configured to indicate the depth of the at least one structure located below the surface of the anatomical target by a color gradient where color intensity is proportional to depth (para [0114]).
With respect to claim 6, Tanaka teaches the image processor is further configured to indicate the depth of the at least one structure located below the surface of the anatomical region within a shaped area in a vicinity of a tool tip (FIG. 11).
With respect to claim 7, Manzke et al. teaches an image guidance module configured to robotically guide the imaging device along a path corresponding to the structure below the surface of the anatomical target (FIG. 10).
With respect to claim 9, Manzke et al. teaches a display (118).
With respect to claim 9, Lee et al. teaches the image processor is further configured to generate at least one of (i) a virtual 3D fly-through image of the at least one structure below the surface located below the surface of the anatomical region and (ii) a virtual 3D cross-section image of the at least one structure below the surface located below the surface of the anatomical region; and the display device is further configured to display (i) the virtual 3D fly- through image of the at least one structure below the surface located below the surface of the anatomical region and (ii) the virtual 3D cross-section image of the at least one structure below the surface located below the surface of the anatomical region (FIG. 8B).
With respect to claim 10, Lee et al. teaches the image processor is further configured to: receive a selection of a point on the at least one structure below located below the surface of the anatomical region, and generate an internal view of the at least one structure at the selected point based on the 3D model, wherein the internal view includes at least one of (i) a virtual 3D fly-through image of the at least one structure at the selected point and (ii) a virtual 3D cross-section image of the at least one structure at the selected point; and the display device further configured to display the internal view of the at least one structure (FIG. 8B).
With respect to claim 11, Higgins et al. teaches the at least one structure is at least one blood vessel (aorta, para [0117]).
With respect to claim 14, Manzke et al. teaches a method for visualizing an anatomical target, the system comprising:
collecting, by an imaging device (120), real-time images of the anatomical target;
providing a three-dimensional model (111) generated from pre-operative images or intra-operative images of at least one structure located below a surface of the anatomical target, such that the at least one structure is not visible in the real-time images from the imaging device (page 7, lines 7-16; page 8 lines 3-6);
generating an overlay from the 3D model registered to the real-time images, wherein the overlay indicates the at least one structure in the anatomical target (page 8, lines 7-15; page 10 line 18-page 11 line 17, FIG. 9).
However, Manzke et al. does not explicitly teach indicating a depth of the structures below the surface. Manzke et al. further does not teach generating a virtual image to show an internal view of the at least one blood vessel.
With respect to claim 14, Higgins et al. teaches a method for visualizing an anatomical target, the system comprising:
providing a three-dimensional model generated from at least one of pre-operative images or intra-operative images of at least one structure located below a surface of the anatomical target, such that the at least one structure is not visible in real-time images (para [0113]-[0118] for example);
computing a depth of the at least one structure relative to the anatomical target using at least the 3D model (para [0113]-[0118] for example); and
generating an overlay from the 3D model registered to real-time images (para [0115] of Higgins et al. see also FIG. 1 of Method for Continuous Guidance of Endoscopy), which indicates the at least one structure located below the surface of the anatomical target and indicates the depth of the at least one structure below the surface of the anatomical target (see paragraphs [0113]-[0118] of Higgins et al., see also FIG. 2 of Method for Continuous Guidance of Endoscopy).
With respect to claim 14, Lee et al. teaches a method for visualizing an anatomical target, the method comprising generating a virtual image (see para [0095], [0161], [0164]-[0169], [0178]-[0180]) showing an internal view of the at least one structure below the surface located below the surface of the anatomical region (FIG. 8B); and
displaying (130) the virtual image (para [0181]).
With respect to claim 14, Tanaka teaches an image processor configured to: compute a depth of at least one structure, wherein the overlay is registered to the real-time images, displays the at least one structure located below the surface of the anatomical target not visible in the real-time images, and indicates the depth of the at least one structure below the surface of the anatomical target, wherein the depth of the at least one structure below the surface is indicated relative to a position of a tool other than the imaging device in the real-time images (para [0033]-[0039]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of invention to utilize the depth indication of Higgins et al. in the system of Manzke et al. in order to provide the user with additional cues that convey obstacle locations and ROI depths of sample so that the physician can freely navigate in the virtual world, perceiving the depth of sample and possible obstacle locations at any pose orientation (para [0115] of Higgins et al.).
Further, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Manzke et al. to include the visualization showing an internal view of the blood vessel as taught by Lee et al. in order to provide a means of accurately measuring the degree of stenosis in a body lumen (para [0003] of Lee et al.).
Finally, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Manzke et al. to indicate the depth of the at least one structure below the surface of the anatomical target relative to a position of a tool other than the imaging device in the real-time images so that when the user desires to perform a procedure without damaging the specific part, it is possible to prompt the user to carefully perform the procedure (para [0041] of Tanaka).
With respect to claim 15, Lee et al. teaches generating at least one of (i) a virtual 3D fly-through image of the at least one structure below the surface located below the surface of the anatomical region and (ii) a virtual 3D cross-section image of the at least one structure below the surface located below the surface of the anatomical region as the internal view; and displaying (i) the virtual 3D fly-through image of the at least one structure below the surface located below the surface of the anatomical region and (ii) the virtual 3D cross-section image of the at least one structure below the surface located below the surface of the anatomical region. (FIG. 8B)
With respect to claim 17, Manzke et al. teaches a non-transitory computer-readable storage medium having stored a computer program comprising instructions, which, when executed by at least one processor, cause the at least one processor to:
control an imaging device (120) to collect real-time images of the anatomical target;
generate a three-dimensional model (111) from pre-operative images or intra-operative images of at least one structure located below a surface of the anatomical target, such that the at least one structure is not visible in the real-time images from the imaging device (page 7, lines 7-16; page 8 lines 3-6);
generate an overlay from the 3D model registered to the real-time images, wherein the overlay indicates the at least one structure in the anatomical target (page 8, lines 7-15; page 10 line 18-page 11 line 17, FIG. 9).
However, Manzke et al. does not explicitly teach indicating a depth of the structures below the surface. Manzke et al. further does not teach generating a virtual image to show an internal view of the at least one blood vessel.
With respect to claim 17, Higgins et al. teaches a non-transitory computer-readable storage medium having stored a computer program comprising instructions, which, when executed by at least one processor, cause the at least one processor to:
generate a three-dimensional model from at least one of pre-operative images or intra-operative images of at least one structure located below a surface of the anatomical target, such that the at least one structure is not visible in real-time images (para [0113]-[0118] for example);
compute a depth of the structure relative to the anatomical target using at least the 3D model (para [0113]-[0118] for example)
generate an overlay from the 3D model registered to real-time images (para [0115] of Higgins et al. see also FIG. 1 of Method for Continuous Guidance of Endoscopy), wherein the overlay indicates the at least one structure located below the surface of the anatomical target and indicates the depth of the at least one structure below the surface of the anatomical target (see paragraphs [0113]-[0118] of Higgins et al., see also FIG. 2 of Method for Continuous Guidance of Endoscopy).
With respect to claim 17, Lee et al. teaches a non-transitory computer-readable storage medium having stored a computer program comprising instructions, which, when executed by at least one processor, cause the at least one processor to: generate a virtual image (see para [0095], [0161], [0164]-[0169], [0178]-[0180]) showing an internal view of the at least one structure below the surface located below the surface of the anatomical region (FIG. 8B); and
display (130) the virtual image (para [0181]).
With respect to claim 17, Tanaka teaches an image processor configured to: compute a depth of at least one structure, wherein the overlay is registered to the real-time images, displays the at least one structure located below the surface of the anatomical target not visible in the real-time images, and indicates the depth of the at least one structure below the surface of the anatomical target, wherein the depth of the at least one structure below the surface is indicated relative to a position of a tool other than the imaging device in the real-time images (para [0033]-[0039]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of invention to utilize the depth indication of Higgins et al. in the system of Manzke et al. in order to provide the user with additional cues that convey obstacle locations and ROI depths of sample so that the physician can freely navigate in the virtual world, perceiving the depth of sample and possible obstacle locations at any pose orientation (para [0115] of Higgins et al.).
Further, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Manzke et al. to include the visualization showing an internal view of the blood vessel as taught by Lee et al. in order to provide a means of accurately measuring the degree of stenosis in a body lumen (para [0003] of Lee et al.).
Finally, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Manzke et al. to indicate the depth of the at least one structure below the surface of the anatomical target relative to a position of a tool other than the imaging device in the real-time images so that when the user desires to perform a procedure without damaging the specific part, it is possible to prompt the user to carefully perform the procedure (para [0041] of Tanaka).
With respect to claim 20, Lee et al. teaches the image processor is further configured to: receive a selection of a point on the at least one structure below located below the surface of the anatomical region, wherein the internal view includes at least one of (i) a virtual 3D fly-through image of the at least one structure at the selected point and (ii) a virtual 3D cross-section image of the at least one structure at the selected point (FIG. 8B).
Claim 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manzke et al. (WO 2012/172474) in view of Higgins et al. (U.S. 2009/0156895), Lee et al. (U.S. 2015/0141814), and Tanaka (U.S. 2016/0038004) as applied to claims 1 above and further in view of Higgins et al. (U.S. 2008/0207997).
Manzke et al. in view of Higgins et al. teaches a system as set forth above. However, Manzke et al. in view of Higgins et al. does not teach in response to a cursor over the overlay, indicating the depth of the at least one structure located below the surface of the anatomical region by an alphanumeric label indicating the depth.
With respect to claim 5, Higgins et al. teaches an image processor configured to, in response to a cursor over the overlay, indicate the depth of the at least one structure located below the surface of the anatomical region by an alphanumeric label indicating the depth (para [0033] number 3).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to further include in response to a cursor over the overlay, indicating the depth of the at least one structure located below the surface of the anatomical region by an alphanumeric label indicating the depth as taught by Higgins et al. in order to provide the physician with additional guidance information (para [0033] of Higgins et al.).
Claims 13 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manzke et al. (WO 2012/172474) in view of Higgins et al. (U.S. 2009/0156895), Lee et al. (U.S. 2015/0141814), and Tanaka (U.S. 2016/0038004) as applied to claims 1 and 17 above and further in view of Popovic (WO 2012/035492).
Manzke et al. in view of Higgins et al. teaches a system as set forth above. However, Manzke et al. in view of Higgins et al. does not teach an image guidance processor configure to robotically guide the imaging device along a path corresponding to the at least one strucure.
With respect to claim 13, Popovic teaches an image guidance module comprising a robot and wherein the image guidance processor is further configured to control the robot to robotically guide the imaging device along the path corresponding to the at least one structure located below the surface of the anatomical target. (9:1-10).
With respect to claim 19, Popovic teaches an analogous non-transitory computer-readable storage medium configured to cause at least one processor to robotically guide the imaging device along a path corresponding to the at least one structure (8:29-9:10).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Manzke et al in view of Higgins et al. to further include an image guidance processor configure to robotically guide the imaging device in the manner taught by Popovic in order to prevent issues that cause handling errors, prolonging the surgery, or causing misidentification of in vivo structures (2:13-14 of Popovic).
Response to Arguments
Applicant's arguments filed 06/22/2026 have been fully considered but they are not persuasive.
On page 7 Applicant argues claim 1 as filed specified that this overlay (which is reflected in the “virtual image”) is registered to the real-time images. This is not persuasive. The virtual image is distinct and separate from the overlay. That the overlay is supported in the original claim language is not sufficient support for the virtual image.
On page 8, Applicant argues registration between the virtual image and the real-time images is provided in the written description of the application as filed at least in claims 1, 14, 17; Abstract; page 3, lines 3-21; page 9, lines 12-21; page 12, lines 2-12; page 16, lines 21-23; page 18, lines 17-18. These all appear to be references to the overlay image, which as set forth above is separate and distinct from the virtual image. It is noted that Applicant explicitly left out the discussion of the virtual image at page 17, lines 4-5. This portion of the disclosure specifically does not disclose the virtual image being registered to real-time images. As such the rejection of claims 1, 14, 17 and all dependent claims thereof under 35 U.S.C. 112(a) is maintained.
On page 10 Applicant argues “[t]he overlay map in MANZKE is not a virtual image in the context taught in the instant application. HIGGINs registers a pre-computed virtual image to a real-time image, but the pre-computed virtual image in HIGGINS is also not a virtual image as in claim 1. And LEE is not concerned with registration.” One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
On page 10 Applicant argues no document cited for claim 1 teaches the added features of indicating depth of the at least one structure below the surface relative toa position of a tool other than the imaging device in the real-time images. It is noted that Tanaka is relied upon to teach these limitations.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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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/ALEXANDRA L NEWTON/Primary Examiner, Art Unit 3799
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