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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 is rejected because it is unclear if a vessel diameter image is the distance image as claimed. Furthermore, it is unclear if “an image” (line 15) is the same as the blood vessel image and/or the distance image as claimed.
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.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over NPL “Motor neuroprosthesis implanted with neurointerventional surgery improves capacity for activities of daily living tasks in severe paralysis: a first in-human experience” to Oxley et al. “Oxley” in view of U.S. Publication No. 2023/0326127 to Zhong et al. “Zhong” and U.S. Publication No. 2019/0090749 to Leuthardt et al. “Leuthardt”.
As for Claims 1, 3 and 5, Oxley discloses a system and method to implant a device within a patient’s brain to improve functional independence in patients with severe paralysis due to brain, spinal cord, peripheral nerve or muscle dysfunction including ALS (Abstract: Background and Methods; Fig 1 and corresponding descriptions). Oxley explains the neuroprosthesis uses an endovascular stent-electrode array to transmit electrocorticography signals from the motor cortex for digital device control (Page 103) and is positioned using 3D digital subtraction angiography co-registered with pre-surgical MRI marked with motor cortex deployment targets (Page 103). Examiner notes the registered MRI and angiography images are considered to read on the claimed limitations of generating a vessel diameter image indicating a size of a vessel diameter in the brain from a brain blood vessel image obtained by capturing an image of a blood vessel of the brain and a distance image indicating a distance in its broadest reasonable interpretation. Furthermore, Oxley’s target is within the superior sagittal sinus, immediately adjacent to the precentral gyrus in order to activate the primary motor cortex that occurs with attempted limb movement (Fig. 1 and corresponding descriptions) and is considered to read on the claimed limitation of identifying a target position corresponding to nerve activity which is a measurement target in the brain based on an image related to at least one of a functional region of the brain and arrangement of nerve in the brain and generate a distance image indicating a distance from the identified target position in its broadest reasonable interpretation.
However, Oxley does not expressly disclose where a candidate position is identified for the stent device that satisfies a prescribed standard of blood vessel diameter and distance from the target position as claimed. It follows; Oxley does not emphasize this candidate position with an intensified manner on the image indicating the brain.
Zhong teaches from within a similar field of endeavor with respect to systems and methods for identifying stent placement (Abstract; Paragraph [0009]) where a candidate location is displayed with emphasis (e.g. virtual stent) so the user can select an appropriate target stent position (Paragraphs [0009], [0072]-[0074] and [0094]-[0096]).
Accordingly, one skilled in the art would have been motivated to have modified the targeted location for Oxley’s neuroprosthesis to provide and display at least one candidate position that satisfies a prescribed standard as described by Zhang in order to optimize the treatment target location. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Further regarding the “intensified manner” limitation, Oxley depicts a brain image with a highlighted yellow region to depict the activation brain region(s) associated with the targeted treatment (Fig. 1 and corresponding descriptions). Accordingly, one skilled in the art would have been motivated to have modified the co-registered MRI and angiography images with highlighted regions in order to enhance the stent positioning. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
As for the limitations the functional image, while the art of record reads on an image showing a target position that is “related to” a function region of the brain, Oxley does not expressly disclose a functional brain image.
Leuthardt teaches from within a similar field of endeavor with respect to determining a brain target location for therapeutic intervention (Abstract) where functional MRI images are used to depict the functional organization of the brain (Paragraph [0003]) to enable mapping for localization of therapeutic interventions such as neuromodulation, surgical ablation, implants, etc. (Paragraphs [0006], [0096] and [0118]). Figs. 28A-B depict motor related functional network (Paragraph [0076]-[0077] and
Accordingly, one skilled in the art would have been motivated the registered images described by Oxley to include functional MRI images described by Leuthard in order to improve the implant targeting. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
As for Claim 2 and 4, Examiner notes the modified images described above would include indicate a distance from an activation region of nerve activity in the brain and a nerve fiber end point to be measured in the brain along with visualizing the activation region in its broadest reasonable interpretation.
With respect to Claims 6-7, Zhong discloses steps to calculate the vessel diameter in order to determine an average lumen diameter in the candidate region (Paragraphs [0084]-[0085], [0089] and Fig. 6B and corresponding descriptions). Examiner also notes Fig. 6B depicts a character indicating a vessel diameter in its broadest reasonable interpretation. Examiner notes one skilled in the art would have been motivated to have displayed vessel diameter information on the co-registered images described by Oxley in order to visualize the candidate location.
Regarding Claim 8, Zhong discloses an embodiment where multiple stent candidate locations are depicted in an ascending/descending order in order for the user to select the desired stenting location (Paragraphs [0094]-[0096]). Accordingly, one skilled in the art would have been motivated to have modified the co-registered images described by Oxley to display multiple stent candidate positions that meet a standard as described by Zhong in order to optimize the implant location targeting.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oxley, Zhong and Leuthardt as applied to claim 1 above, and further in view of U.S. Publication No. 2024/0285345 to Lamba et al. “Lamba”.
With respect to Claim 9, Oxley, Zhong and Leuthardt disclose a medical image processing system and method for identifying a target position for a stent implant based on, at least in part, vessel diameter (e.g. if stent will fit) and proximity to brain anatomy target as described above. However, the modified system does not expressly disclose a scenario of displaying an alternative candidate position if and when no position satisfies the processor’s goal.
Lamba teaches from within a similar field of endeavor with respect to surgical systems and methods where “candidate placements” are determined by the system and the “best scoring candidate” is chosen for a task (Paragraph [0148]). Lamba also explains that if no candidates meet a minimum score, the system may publish the best scorning candidate or a set of the best scoring candidates to provide the surgical team with a choice of options (Paragraph [0148]).
Accordingly, one skilled in the art would have been motivated to have modified the processing means described by Oxley, Zhong and Leuthardt with Lamba’s processing technique to present the surgical team with a set of best scorning candidate options as if and when candidates fail to meet a minimum standard in order to allow the surgical team to consider alternative candidates for a surgical placement. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
As for Claim 10, Examiner notes the modified system described above displaying the best available set of candidates for selection is a suitable equivalent to the user lowering (e.g. correcting) the standard to see candidates which meet a new standard. Furthermore, Zhong provides a user interface for the user to adjust configurations (Paragraphs [0060], [0083], [0095], [0096]) and one skilled in the art would have been motivated to allow the user to adjust any system configuration including the target standards in order to provide at least one suggestion to the user.
Claim(s) 10 is/are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Oxley, Zhong and Leuthardt as applied to claim 1 above, and further in view of Lamba and U.S. Publication No. 2023/0022929 to Wright et al. “Wright”.
With respect to Claim 10, Oxley, Zhong and Leuthardt disclose a medical image processing system and method for identifying a target position for a stent implant based on, at least in part, vessel diameter (e.g. if stent will fit) and proximity to brain anatomy target as described above. However, the modified system does not expressly disclose changing the prescribed standard if no candidates are produced.
Lamba teaches from within a similar field of endeavor with respect to surgical systems and methods where “candidate placements” are determined by the system and the “best scoring candidate” is chosen for a task (Paragraph [0148]). Lamba also explains that if no candidates meet a minimum score, the system may publish the best scorning candidate or a set of the best scoring candidates to provide the surgical team with a choice of options (Paragraph [0148]).
Accordingly, one skilled in the art would have been motivated to have modified the processing means described by Oxley, Zhong and Leuthardt with Lamba’s processing technique to present the surgical team with a set of best scorning candidate options as if and when candidates fail to meet a minimum standard in order to allow the surgical team to consider alternative candidates for a surgical placement. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Examiner notes the modified system described above displaying the best available set of candidates for selection is a suitable equivalent to the user lowering (e.g. correcting) the standard to see candidates which meet a new standard. Furthermore, Zhong provides a user interface for the user to adjust configurations (Paragraphs [0060], [0083], [0095], [0096]) and one skilled in the art would have been motivated to allow the user to adjust any system configuration including the target standards in order to provide at least one suggestion to the user.
Nonetheless, Wright teaches from within a similar field of endeavor with respect to computer assisted surgical systems and methods (Abstract) where parameters may be adjusted to change the number of candidates (Paragraph [0041]).
Accordingly, one skilled in the art would have been motivated to allow the user to adjust any system configuration including the target standards in order to provide at least one suggestion to the user. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Conclusion
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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