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 .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 11,147,635 to Sganga et al. “Sganga”.
As for Claim 3, Sganga discloses a medical imaging and navigation system and method for providing guidance for an interventional device during an interventional procedure (Abstract) comprising obtaining pre-operative imaging data to identify one or more structures, characteristics and a target in the image volume (Column 2, Line 50-Column 3, Lines 30; Column 4, Lines 20-38; Column 10, Lines 55-65 and Column 15, Lines 10-55). If the patient is eligible for the procedure based on the aforementioned structures/characteristics to the target, Sganga’s system and method identifies the vessels through which the interventional device will need to pass to reach the targeted location using determined waypoints (Column 15, Lines 45-55 and Column 18, Lines 1-40). Sganga explains that a CT scan can be used to determine if a subject is eligible to undergo the procedure by determining certain information including, without limitation, location of the large vessel occlusion stroke, the vessels through which the intravascular device (e.g. catheter, other device, etc.) will need to pass to reach the targeted location of the stroke, the length, angle or origin and/or other details regarding each vessel along a designated path and/or the like (Column 15, Lines 45-55). If a decision is made to perform the procedure, certain steps can be performed manually by the practitioner including arrangement of robotic assembly components (e.g. catheter/wire/sheath) (Column 15, Lines 55-65). Such disclosures are considered to read on an “itinerary” with a number of steps for insertion of the interventional device through the anatomy to the target tissue in its broadest reasonable interpretation and determining the type of interventional device for performing the procedure based on, at least in part a configuration and characteristics of the structures along the itinerary in its broadest reasonable interpretation. Further regarding other “types of devices”, Sganga discloses wherein the interventional device can be a catheter, sheath, wire, or the like (Column 5, Lines 45-50) and while the application is primarily focused on treatment of ischemic stroke and the removal of clots, the various systems and methods can be used in a variety of other applications where robotic systems are used to guide catheters or other devices through an intraluminal anatomical network of a subject. For example, the various systems and devices include arterial angioplasty, arterial stenting, arterial thrombectomy, arterial embolization, insertion of flow diverters for treatment of an aneurysm, etc. (Column 9, Lines 1-24). Examiner notes that if the subject is eligible for the procedure, Sganga’s system and method would include a selection (e.g. by the practitioner) of the specific type of device (e.g. catheter) for the particular treatment application such that the type of device can reach the target based on the determined characteristics and structures in its broadest reasonable interpretation. As for the steps of obtaining an intraoperative image and registration, Sganga also provides intra-operative imaging data to locate the device and provide additional navigation guidance (Column 9, Lines 35-65; Column 11, Lines 25-47 and Column 35, Lines 10-55) and in order to relate the pre-operative image data and intraoperative image data, Sganga’s system performs 2D/3D registration (Column 21, Line 65-Column 22, Line 10).
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.
Claim(s) 2, 4-15 and 17-21 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Sganga in view of U.S. Publication No. 2018/0214006 to Akimoto et al. “Akimoto”.
As for Claims 2, 4, 13 and 17-18, Sganga discloses a medical imaging and navigation system and method for providing guidance for an interventional device during an interventional procedure (Abstract) comprising obtaining pre-operative imaging data (e.g. from a first imaging system; MRI, CT, X-ray, etc.) to identify one or more structures, characteristics and a target in the image volume (Column 2, Line 50-Column 3, Lines 30; Column 4, Lines 20-38; Column 10, Lines 55-65 and Column 15, Lines 10-55). If the patient is eligible for the procedure based on the aforementioned structures/characteristics to the target, Sganga’s system and method identifies the vessels through which the interventional device will need to pass to reach the targeted location using determined waypoints (Column 15, Lines 45-55 and Column 18, Lines 1-40). Sganga explains that in one embodiment, a CT scan can be used to determine if a subject is eligible to undergo the procedure by determining certain information including, without limitation, location of the large vessel occlusion stroke, the vessels through which the intravascular device (e.g. catheter, other device, etc.) will need to pass to reach the targeted location of the stroke, the length, angle or origin and/or other details regarding each vessel along a designated path and/or the like (Column 15, Lines 45-55). If a decision is made to perform the procedure, certain steps can be performed manually by the practitioner including arrangement of robotic assembly components (e.g. catheter/wire/sheath) (Column 15, Lines 55-65). Such disclosures are considered to read on an “itinerary” with a number of steps for insertion of the interventional device through the anatomy to the target tissue in its broadest reasonable interpretation and determining the type of interventional device for performing the procedure based on, at least in part a configuration and characteristics of the structures along the itinerary in its broadest reasonable interpretation. As for the steps of obtaining an intraoperative image and registration, Sganga also provides intra-operative imaging data (e.g. from a second imaging device) to locate the device and provide additional navigation guidance (Column 9, Lines 35-65; Column 11, Lines 25-47 and Column 35, Lines 10-55) and in order to relate the pre-operative image data and intraoperative image data, Sganga’s system performs 2D/3D registration (Column 21, Line 65-Column 22, Line 10).
However, Sganga does not expressly disclose where a 3D model is formed of a structure in the 2D image and displayed adjacent to the 2D image as now claimed.
Akimoto teaches from within a similar field of endeavor with respect to anatomical imaging systems and methods where a 3D model is generated from a 2D image (Paragraphs [0098]-[0099], [0105], [0138], [0141] and [0167]; Fig. 5). Figs. 3C-D depict the model being displayed adjacent to image data (also see Paragraphs [0141],
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Accordingly, one skilled in the art would have been motivated to have modified the system and method described by Sganga to generate and display a 3D model adjacent to image data as described by Akimoto in order to enhance the user’s visualization of the patent’s anatomy and improve navigation. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
As for Claims 5 and 19, Sganga explains wherein the pathway and waypoint information is displayed on the medical image (Column 4, Lines 15-37) which is considered to read on an overlay in its broadest reasonable interpretation.
Regarding Claims 6 and 8, Sganga explains the system is configured to allow for a user to manually specify and/or modify the desired path and/or one or more waypoints along the desired path in order to account for any unseen complications (Column 35, Line 55-Column 36, Line 20).
As for Claim 7, Sganga explains wherein the processor is configured to analyze the pre-operative image data to determine the characteristics of the structures within the body to the desired target (Column 3, Lines 10-50).
With respect to Claim 9, Sganga discloses wherein the system is configured to output visual outputs to describe the next steps (e.g. turn right/left, rotate, move forward, retract, etc.) (Column 14, Lines 50-67) which is considered to read on “the form” of the device after determining the characteristics in its broadest reasonable interpretation.
As for Claims 10 and 20, Sganga discloses a system and method for providing guidance for an interventional procedure as described above. Sganga itinerary includes instructions on which branch or direction the device should be moved to next (Column 14, Lines 50-65) and in some embodiments include pathway instructions such as “aortic arch to left internal carotid artery to the point of bifurcation to MCA” (Column 17, Lines 40-65). Examiner notes one skilled in the art would have been motivated to have created multiple itinerary steps for any bifurcation encountered during navigation to the desired target as such a modification merely involves repeating the aforementioned instructions.
Regarding Claim 11, Sganga discloses where characteristics include vascular tortuosity (Column 3, Lines 20-40) and other details regarding each vessel along a designated path (Column 15, Lines 45-55).
With respect to Claim 12, Examiner notes that the designated path would be displayed including the bifurcation in its broadest reasonable interpretation.
As for Claim 14, Sganga discloses where images are obtained in real time during the aforementioned procedure with itinerary steps (Column 9, Lines 40-60).
With respect to Claim 15, Sganga discloses where the intraoperative and pre-operative imaging systems can be the same as described above. One skilled in the art would have been motivated to have generated the model from any 2D intraoperative image in the modified system and method in order to provide current anatomical model data to the practitioner to enhance the navigation.
As for Claim 21, Akimoto explains the model may be continually updated as new intraoperative images are input (Paragraphs [0346]). Such disclosures are considered to read on forming a model as part of the plan (e.g. including itinerary steps) as described above in its broadest reasonable interpretation.
Response to Arguments
Applicant’s arguments with respect to claim(s) 2-15 and 17-21 have been considered but are moot in view of the updated grounds of rejection necessitated by amendment. However, Examiner will address Applicant’s remarks which may still pertain to the current rejection. For example, Applicant argues there is no disclosure of a determination of a particular type, form or size of device to be used in the performance of the procedure as required by claim 3 (REMARKS, page 10). Examiner respectfully notes claim 3 does not disclose a size or form of the device and merely requires a method step of determination a type of interventional device for performing the procedure based upon anatomy in pre-operative image data (e.g. configuration and characteristics of the structures along the itinerary). Sganga discloses wherein the interventional device can be a catheter, sheath, wire, or the like (Column 5, Lines 45-50) and while the application is primarily focused on treatment of ischemic stroke and the removal of clots, the various systems and methods can be used in a variety of other applications where robotic systems are used to guide catheters or other devices through an intraluminal anatomical network of a subject. For example, the various systems and devices include arterial angioplasty, arterial stenting, arterial thrombectomy, arterial embolization, insertion of flow diverters for treatment of an aneurysm, etc. (Column 9, Lines 1-24). Examiner notes that if the subject is eligible for the procedure (e.g. based upon anatomy in preoperative data), Sganga’s system and method would include a selection (e.g. by the practitioner) of the specific type of device (e.g. catheter) for the particular treatment application such that the type of device can reach the target based on the determined characteristics and structures in its broadest reasonable interpretation.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L COOK whose telephone number is (571)270-7373. The examiner can normally be reached M-F approximately 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER L COOK/Primary Examiner, Art Unit 3797
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