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 .
Information Disclosure Statement
The information disclosure statement (IDS) filed on January 16, 2024, has been considered by the examiner.
Drawings
Figure 1 is objected to as depicting a block diagram without “readily identifiable” descriptors of each block, as required by 37 CFR 1.84(n). Rule 84(n) requires “labeled representations” of graphical symbols, such as blocks; and any that are “not universally recognized may be used, subject to approval by the Office, if they are not likely to be confused with existing conventional symbols, and if they are readily identifiable.” In the case of Fig. 1, the blocks are not readily identifiable per se and therefore require the insertion of text that identifies the function of that block. That is, each vacant block should be provided with a corresponding label identifying its function or purpose.
Figure 5-6 and 9 are objected to as being illegible due to blurriness.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The limitations, under their broadest reasonable interpretation, cover mental processes (concepts performed in a human mind, including observation, evaluation, judgment, opinion, organizing human activity and/or mathematical concepts and calculations).
Claims 1 and 11 recite a method for determining an optimal position for an epidural electrode. This judicial exception is not integrated into a practical application because the steps do not add meaningful limitations to be considered specifically applied to a particular technological problem to be solved .The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps of the claimed invention can be done mentally and no additional features in the claims would preclude them from being performed as such except for the generic computer elements at high level of generality (i.e., processor, memory).
According to the USPTO guidelines, a claim is directed to non-statutory subject matter if:
STEP 1: the claim does not fall within one of the four statutory categories of invention (process, machine, manufacture or composition of matter), or
STEP 2: the claim recites a judicial exception, e.g. an abstract idea, without reciting additional elements that amount to significantly more than the judicial exception, as determined using the following analysis:
STEP 2A (PRONG 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Using the two-step inquiry, it is clear that the independent Claims 1 and 11 are directed to an abstract idea as shown below:
STEP 1: Do the claims fall within one of the statutory categories?
YES. Independent claims 1 and 11 are directed to a method for optimizing the placement of an implantable electrode.
STEP 2A (PRONG 1): Is the claim directed to a law of nature, a natural phenomenon or an abstract idea?
YES, the claims are directed toward a mental processes (i.e. abstract idea).
With regard to STEP 2A (PRONG 1), the guidelines provide three groupings of subject matter that are considered abstract ideas:
Mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations;
Certain methods of organizing human activity – fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions); and
Mental processes – concepts that are practicably performed in the human mind (including an observation, evaluation, judgment, opinion).
Independent Claims 1 and 11 comprise mental processes and that can be practicably performed in the human mind (or generic computers or components configured to perform the method) and, therefore, an abstract idea.
Regarding independent Claim 1, the limitations recite:
determining the position of a lumbosacral enlargement of the spinal cord in the three-dimensional model based at least in part on the at least one medical image (the step of determining a position of the lumbosacral enlargement can be performed in the human mind as an observation),
determining an optimal placement of an implantable electrode, wherein the optimal placement maximizes coverage of the lumbosacral enlargement by the implantable electrode (the step of determining an optimal placement may be performed as an evaluation).
Regarding independent Claim 11, the limitations recite:
identifying, based on the at least one medical image, at least one nerve root exiting the vertebral column (the step of tracing a identifying a nerve root can be performed in the human mind as an observation.),
and back-tracing the at least one nerve root to determine a position of at least one spinal cord segment (the step of back-tracing a nerve root can be performed in the human mind as an evaluation. The instant specification states that a person may manually trace and determine the position of a spinal cord segment (see paragraph [0069], “The process of nerve root tracing and estimating spinal cord L1-S1 segments is referred to as spinal cord neuroanatomical mapping in this study and was performed manually by an expert analyst.”),
determining the position of a lumbosacral enlargement of the spinal cord in the three-dimensional model based at least in part on the position of the at least one spinal cord segment (the step of determining a position of the lumbosacral enlargement can be performed in the human mind as an observation),
determining an optimal placement of an implantable electrode, wherein the optimal placement maximizes coverage of the lumbosacral enlargement by the implantable electrode (the step of determining an optimal placement may be performed as an evaluation).
These limitations, as drafted, is a simple process that, under their broadest reasonable interpretation, covers performance of the limitations in the mind or by a human. The Examiner notes that under MPEP 2106.04(a)(2)(III), the courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). As the Federal Circuit explained, "methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas the ‘basic tools of scientific and technological work’ that are open to all.’" 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972)). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 ("‘[M]ental processes[] and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work’" (quoting Benson, 409 U.S. at 67, 175 USPQ at 675)); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978) (same).
As such, a person could mentally observe an image, determine the position of the lumbosacral enlargement, and determine the best position for an implantable electrode. A person could observe an image, identify and trace a nerve root, identify a corresponding spinal segment in the lumbosacral area, and then determine the best position for an implantable electrode. Thus, the claims recite a mental process.
STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the judicial exception into a practical application? NO, the claims do not recite additional elements that integrate the judicial exception into a practical application.
With regard to STEP 2A (prong 2), whether the claim recites additional elements that integrate the judicial exception into a practical application, the guidelines provide the following exemplary considerations that are indicative that an additional element (or combination of elements) may have integrated the judicial exception into a practical application:
an additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
While the guidelines further state that the exemplary considerations are not an exhaustive list and that there may be other examples of integrating the exception into a practical application, the guidelines also list examples in which a judicial exception has not been integrated into a practical application:
an additional element merely recites the words “apply it” (or an equivalent) with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea;
an additional element adds insignificant extra-solution activity to the judicial exception; and
an additional element does no more than generally link the use of a judicial exception to a particular technological environment or field of use.
Independent Claims 1 and 11 do not recite any of the exemplary considerations that are indicative of an abstract idea having been integrated into a practical application.
Claims 1 and 11 disclose:
receiving at least one medical image of a spinal cord and surrounding vertebral column (insignificant pre-solution activity of gathering data);
constructing, using a computer, a three-dimensional model of at least a portion of the spinal cord, the three-dimensional model based at least in part on the at least one medical image (insignificant pre-solution activity of generating data).
These limitations are recited at a high level of generality (i.e. as a general action or change being taken based on the results of the acquiring step) and amounts to mere post solution actions, which is a form of insignificant extra-solution activity. Further, the claims are claimed generically and are operating in their ordinary capacity such that they do not use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? No, the claims do not recite additional elements that amount to significantly more than the judicial exception.
With regard to STEP 2B, whether the claims recite additional elements that provide significantly more than the recited judicial exception, the guidelines specify that the pre-guideline procedure is still in effect. Specifically, that examiners should continue to consider whether an additional element or combination of elements:
adds a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; or
simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Claims 1 and 11 do not recite any additional elements that are not well-understood, routine or conventional. The use of a generic computer elements are routine, well-understood and conventional process that is performed by computers. Claims 1 and 11 both recite the limitation of ‘constructing, using a computer, a three-dimensional model of at least a portion of the spinal cord, the three-dimensional model based at least in part on the at least one medical image’. Generating a 3D model of the spinal cord using a computer is well-known and conventional in the field of medical image analysis. For example, see Lavrov, (US Pub No 2022/0387114) and Grill (US Pub No 2018/0104479, Fig. 4A), which both teach constructing a three-dimensional model of a spinal cord based on a medical image.
Thus, since Claims 1 and 11 are: (a) directed toward an abstract idea, (b) do not recite additional elements that integrate the judicial exception into a practical application, and (c) do not recite additional elements that amount to significantly more than the judicial exception, it is clear that Claims 1 and 11 are not eligible subject matter under 35 U.S.C 101.
Regarding Claim 2: the additional limitations do not integrate the mental process into a practical application or add significantly more to the mental process. The limitation(s) “wherein determining the optimal placement includes identifying, using the three-dimensional model, a portion of the vertebral column surrounding the lumbosacral enlargement” falls into the mental processes grouping of abstract ideas. A person may reasonably identify a vertebrae corresponding to a spinal segment. Furthermore, it is well known in the art that the vertebrae T11-L1 generally surround the lumbosacral enlargement.
Regarding Claim 3: the additional limitations do not integrate the mental process into a practical application or add significantly more to the mental process. The limitation(s) “identifying, based on the at least one medical image, at least one nerve root exiting the vertebral column and back-tracing the at least one nerve root to determine a position of at least one spinal cord segment in the lumbosacral enlargement” falls into the mental processes grouping of abstract ideas. A person may reasonably observe an image, identify a nerve root, and then back-trace the nerve to determine the position of a spinal cord segment. Furthermore, the instant specification teaches that a person is capable of performing this process (see paragraph [0069]).
Regarding Claims 4 and 14: the additional limitations do not integrate the mental process into a practical application or add significantly more to the mental process. The limitation(s) “wherein back-tracing the at least one nerve root to determine a position of at least one spinal cord segment includes determining the position of at least one L1-S1 spinal cord segment” falls into the mental processes grouping of abstract ideas. A person may reasonably observe an image, identify a nerve root, and then back-trace the nerve to determine the position of a spinal cord segment. Furthermore, the instant specification teaches that a person is capable of performing this process (see paragraph [0069]).
Regarding Claim 5: the additional limitations do not integrate the mental process into a practical application or add significantly more to the mental process. The limitation(s) “wherein the at least one medical image is a plurality of axial images of the spinal cord captured at different vertebral levels” falls into pre-solution activity of gathering data.
Regarding Claim 6: the additional limitations do not integrate the mental process into a practical application or add significantly more to the mental process. The limitation(s) “calculating a cross-section area of the lumbosacral enlargement in each of the plurality of axial images, identifying a location on the spinal cord having a maximal cross-section area based at least in part on the plurality of axial images, and determining the position of the lumbosacral enlargement based at least in part on the location on the spinal cord having the maximal cross-section area” falls into the mathematical concepts grouping of abstract ideas. Furthermore, a person may reasonably estimate the cross-sectional area of a spinal cord with the assistance of pen and paper.
Regarding Claim 7: the additional limitations do not integrate the mental process into a practical application or add significantly more to the mental process. The limitation(s) “identifying, using the plurality of axial images, a conus tip of the spinal cord, and wherein determining the position of the lumbosacral enlargement is based at least in part on a distance between the conus tip and the location on the spinal cord having the maximal cross-section area” falls into the mental processes grouping of abstract ideas. A person may identify a conus tip through observation, and then determine the position of a lumbosacral enlargement based on an evaluation.
Regarding Claim 8 and 16: the additional limitations do not integrate the mental process into a practical application or add significantly more to the mental process. The limitation(s) “wherein the implantable electrode is a paddle electrode, and wherein optimal placement maximizes coverage of the lumbosacral enlargement by the paddle electrode” merely specify the type of electrode claimed in Claim 1. Furthermore, a person may determine where an optimal placement of an electrode may be by observing the model.
Regarding Claim 9 and 17: the additional limitations do not integrate the mental process into a practical application or add significantly more to the mental process. The limitation(s) “wherein coverage of the lumbosacral enlargement is determined by calculating a volume of the lumbosacral enlargement and determining a percentage of the volume of the lumbosacral enlargement overlaid by the paddle electrode” falls into the mathematical concepts grouping of abstract ideas.
Regarding Claim 10 and 18: the additional limitations do not integrate the mental process into a practical application or add significantly more to the mental process. The limitation(s) “identifying a position on the vertebral column corresponding to the position of the lumbosacral enlargement” falls into the mental processes grouping of abstract ideas. A person may reasonably identify a vertebrae corresponding to a spinal segment.
Regarding Claim 12: the additional limitations do not integrate the mental process into a practical application or add significantly more to the mental process. The limitation(s) “wherein the at least one medical image is a plurality of non-identical medical images” falls into pre-solution activity of gathering data.
Regarding Claim 13: the additional limitations do not integrate the mental process into a practical application or add significantly more to the mental process. The limitation(s) “wherein the at least one medical image is a plurality of axial MRI images of the spinal cord captured at different vertebral levels” falls into pre-solution activity of gathering data.
Regarding Claim 15: the additional limitations do not integrate the mental process into a practical application or add significantly more to the mental process. The limitation(s) “wherein back-tracing the at least one nerve root to determine a position of at least one spinal cord segment includes determining the position of the L1-S1 spinal cord segments” falls into the mental processes grouping of abstract ideas. A person may reasonably observe an image, identify a nerve root, and then back-trace the nerve to determine the position of a spinal cord segment. Furthermore, the instant specification teaches that a person is capable of performing this process (see paragraph [0069]).
Regarding Claim 19: the additional limitations do not integrate the mental process into a practical application or add significantly more to the mental process. The limitation(s) “wherein the three-dimensional model is a computational model” is well-understood and conventional in the art.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Lavrov et al. (US Pub No 2022/0387114), hereinafter Lavrov, in view of Grahn et al. (US Pub No 2021/0052889), hereinafter Grahn.
As to Claim 1, Lavrov teaches a method of optimizing electrode placement for spinal cord epidural stimulation (see paragraph [0003], “Spinal cord stimulation (“SCS”) including, epidural stimulation, dorsal column, spinal rootlet, and dorsal root ganglion (“DRG”) stimulation are adjustable and effective non-opioid analgesic solutions with demonstrated efficacy”, and see paragraph [0020], “These systems and methods can improve the accuracy of spinal cord therapies and treatments, including the placement of SCS implant), the method comprising:
receiving at least one medical image of a spinal cord and surrounding vertebral column (see paragraph [0040], “The method also includes accessing medical image data for a subject using the computer system”, and see Fig. 8, wherein the medical image data comprises a spinal cord surrounding vertebral column);
constructing, using a computer, a three-dimensional model of at least a portion of the spinal cord, the three-dimensional model based at least in part on the at least one medical image (see paragraph [0035], “Using the anatomical measurement data and the medical image data, augmented spinal cord anatomy model data are generated with the computer system, as indicated at step 106”, and see paragraph [0053], “the systems and methods described in the present disclosure generate anatomically accurate augmented 2D or 3D models of the spinal cord (e.g., including spinal nerve, rootlet, tract) and vertebrae”);
determining the position of a lumbosacral enlargement of the spinal cord in the three-dimensional model based at least in part on the at least one medical image (see paragraph [0035], “As one non-limiting example, an image can be input to a suitably trained machine learning algorithm, generating output as augmented spinal cord anatomy model data, which may include location outputs with respect to vertebrae”, and see paragraph [0056], “Spinal cord anatomies that can be localized and/or targeted using the systems and methods described in the present disclosure include, but are not limited to, specific spinal cord segments (e.g., cervical, thoracic, and lumbar segments”), and see Fig. 2, where a model comprising spinal cord segments L2-S2 segments are shown, and it is well-known in the art that the lumbosacral enlargement comprises spinal cord segments L2-S2) ;
and determining an optimal placement of an implantable electrode (see paragraph [0040], “In addition, for spinal cord stimulation applications with spinal leads or arrays spanning multiple segments, the augmented spinal cord anatomy data can be analyzed to suggest optimum locations for inserting the lead or array.”).
Lavrov teaches that an implantable electrode may be placed over the lumbosacral enlargement (see Fig. 2, where a paddle electrode is implanted over spinal cord segments L2-S2). However, Lavrov fails to explicitly teach the optimal placement maximizes coverage of the lumbosacral enlargement by the implantable electrode.
However, in an analogous art, Grahn teaches a method for delivering epidural stimulation (see paragraph [0003], “In particular, the techniques described herein involve the use of epidural electrical stimulation (EES) systems to activate motor function in limbs”) which comprises:
determining the position of a lumbosacral enlargement of the spinal cord (see paragraph [0031], “The one or more features of the at least one vertebra can include an intervertebral spinous process length for the L2 vertebra, and the one or more features of the spinal cord can include a length of a spinal cord segment corresponding to the L2 vertebra”, where the Examiner notes that the L2 spinal cord segment is a segment of the lumbosacral enlargement. The instant specification states that ‘determining the position of a lumbosacral enlargement’ may comprise identifying at least one segment of the lumbosacral enlargement, and it is well known that the L2 spinal cord segment is a segment of the lumbosacral enlargement),
and determining an optimal placement of an implantable electrode wherein the optimal placement maximizes coverage of the lumbosacral enlargement by the implantable electrode (see paragraph [0065], “Even small (e.g., a few millimeters) offset between position of the electrode on the spinal cord and the dorsal root entry zones can significantly impact the therapeutic impact of EES. To determine the locations of the dorsal root entry zones, or other targeted structures of the spinal cord, correlations between features (anatomical landmarks) of a subject's vertebrae and features of the spinal cord can be utilized to estimate the locations of the targeted structures. These correlations can be used to facilitate precise implantation of electrodes or other devices at specific locations of the spinal cord (e.g., dorsal root entry zones for targeted spinal segments), even without the need to perform a laminectomy”).
Thus, it would have been obvious to one of ordinary skill in the art to combine the implant positioning method taught by Lavrov with the teachings of Grahn such that the implant has maximum contact with the lumbosacral enlargement. The motivation for doing so would be to maximize the therapeutic effects of the implant (see paragraph [0065]). Thus, it would have been obvious to combine the teachings of Grahn with the teachings of Lavrov in order to obtain the invention as claimed in Claim 1.
As to Claim 2, Lavrov in view of Grahn teaches wherein determining identifying, using the three-dimensional model, a portion of the vertebral column surrounding the lumbosacral enlargement (see Lavrov, paragraph [0033], “FIGS. 4A-4C show spinal cord anatomic parameters and measurements results. FIG. 4A shows an example schematic representation of vertebral spine and spinal cord with measured parameters. Examples of dorsal segments correspond to cervical C4, C5, C6; thoracic T6, T7; and lumbar L1, L2 L3, segments are shown”, and see Fig. 4A, where the vertebral column segments L2-L3 corresponding to the lumbosacral enlargement are shown).
As to Claim 8, Lavrov teaches the implantable electrode may be a paddle electrode (see Fig. 2, where a paddle electrode is shown implanted over the lumbosacral enlargement). However, Lavrov fails to explicitly teach that the optimal placement maximizes coverage of the lumbosacral enlargement by the paddle electrode.
Grahn teaches using a paddle electrode (see Fig. 4A), and that an optimal placement maximizes coverage of the lumbosacral enlargement (see paragraph [0065], “Even small (e.g., a few millimeters) offset between position of the electrode on the spinal cord and the dorsal root entry zones can significantly impact the therapeutic impact of EES. To determine the locations of the dorsal root entry zones, or other targeted structures of the spinal cord, correlations between features (anatomical landmarks) of a subject's vertebrae and features of the spinal cord can be utilized to estimate the locations of the targeted structures. These correlations can be used to facilitate precise implantation of electrodes or other devices at specific locations of the spinal cord (e.g., dorsal root entry zones for targeted spinal segments), even without the need to perform a laminectomy”).
Thus, it would have been obvious to one of ordinary skill in the art to combine the implant positioning method taught by Lavrov with the teachings of Grahn such that the implant has maximum contact with the lumbosacral enlargement. The motivation for doing so would be to maximize the therapeutic effects of the implant (see paragraph [0065]). Thus, it would have been obvious to combine the teachings of Grahn with the teachings of Lavrov in order to obtain the invention as claimed in Claim 8.
As to Claim 10, Lavrov in view of Grahn teaches wherein determining identifying a position on the vertebral column surrounding the lumbosacral enlargement (see Lavrov, paragraph [0033], “FIGS. 4A-4C show spinal cord anatomic parameters and measurements results. FIG. 4A shows an example schematic representation of vertebral spine and spinal cord with measured parameters. Examples of dorsal segments correspond to cervical C4, C5, C6; thoracic T6, T7; and lumbar L1, L2 L3, segments are shown” and see Fig. 4A, where the position on the vertebral column segments L2-L3 corresponding to the lumbosacral enlargement are shown).
Claims 3-5, 11-16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Lavrov et al. (US Pub No 2022/0387114), hereinafter Lavrov, in view of Grahn et al. (US Pub No 20210052889), hereinafter Grahn, and further in view of Cadotte et al. (D.W. Cadotte, et al., “Characterizing the Location of Spinal and Vertebral Levels in the Human Cervical Spinal Cord”, American Journal of Neuroradiology, Apr 2015), hereinafter Cadotte.
As to Claim 3, Lavrov in view of Grahn fails to teach wherein determining the position of the lumbosacral enlargement includes identifying, based on the at least one medical image, at least one nerve root exiting the vertebral column and back-tracing the at least one nerve root to determine a position of at least one spinal cord segment in the lumbosacral enlargement.
However, in an analogous art of medical image analysis, Cadotte teaches a method for determining the position of spinal cord segments (see pg. 803, Abstract, “We provide a novel, quantitative solution to map vertebral and spinal cord levels”),
which comprises identifying a nerve root exiting the vertebral column (see pg. 804, “To determine the distance from the PMJ to each set of spinal nerve rootlets, 2 individuals with specialized knowledge of spinal cord anatomy manually marked the dorsal nerve rootlets of segments C3–C8 at the edge of the spinal cord where the rootlets meet the CSF by using 3DSlicer”),
and back-tracing the at least one nerve root to determine a position of at least one spinal cord segment (see pg. 804, “To perform these markings, we visualized the spinal cord and cervical nerve rootlets in 3 planes (axial, sagittal, and coronal) and followed these nerve rootlets as they transition into cervical nerve roots and traverse the respective intervertebral foramen.”).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the back-tracing taught by Cadotte in order to determine the position of the lumbosacral enlargement. The motivation for doing so would be to provide accurate positions of spinal cord segments in spite of intersubject differences. Cadotte teaches on pg. 804, “The diversity of human anatomy offers 2 principal sources of variability: 1) intersubject differences in spinal column anatomy, and2)intersubject differences in spinal cord segments relative to a fixed point in the brain stem. The work presented here considers these 2 sources of diversity across a cohort of healthy individuals and presents a unique solution, a “spinal level map,” which can be applied in advanced MR imaging assessment of the human cervical cord.” Thus, it would have been obvious to combine the nerve root tracing taught by Cadotte with the teachings of Lavrov and Grahn in order to obtain the invention as claimed in Claim 3.
As to Claim 4, Lavrov in view of Grahn teaches determining the position of at least one L1-S1 spinal segment (see Lavrov, paragraph [0033], “FIGS. 4A-4C show spinal cord anatomic parameters and measurements results. FIG. 4A shows an example schematic representation of vertebral spine and spinal cord with measured parameters. Examples of dorsal segments correspond to cervical C4, C5, C6; thoracic T6, T7; and lumbar L1, L2 L3, segments are shown”). Lavrov in view of Grahn fails to teach that these segments are obtained through back-tracing. However, Cadotte teaches a method for determining the position of spinal cord segments (see pg. 803, Abstract, “We provide a novel, quantitative solution to map vertebral and spinal cord levels”),
which comprises back-tracing the at least one nerve root to determine a position of at least one spinal cord segment (see pg. 804, “To perform these markings, we visualized the spinal cord and cervical nerve rootlets in 3 planes (axial, sagittal, and coronal) and followed these nerve rootlets as they transition into cervical nerve roots and traverse the respective intervertebral foramen”).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the back-tracing taught by Cadotte in order to determine the position of the lumbosacral enlargement. The motivation for doing so would be to provide accurate positions of spinal cord segments in spite of intersubject differences (see Cadotte, pg. 804). Thus, it would have been obvious to combine the nerve root tracing taught by Cadotte with the teachings of Lavrov and Grahn in order to obtain the invention as claimed in Claim 4.
As to Claim 5, Lavrov and Grahn fail to teach wherein the at least one medical image is a plurality of axial images of the spinal cord captured at different vertebral levels.
However, Cadotte teaches obtaining a plurality of axial images at a plurality of vertebral levels (see pg. 804, “To perform these markings, we visualized the spinal cord and cervical nerve rootlets in 3 planes (axial, sagittal, and coronal) and followed these nerve rootlets as they transition into cervical nerve roots and traverse the respective intervertebral foramen”, and see Fig. 1, shown below, where a plurality of axial images are shown).
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Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the axial images taught by Cadotte with the teachings of Lavrov and Grahn. The motivation for doing so would be to use the axial images to determine the position of spinal cord segments. Cadotte teaches a method for determining the position of spinal cord segments (see pg. 803, Abstract, “We provide a novel, quantitative solution to map vertebral and spinal cord levels accounting”),
which comprises back-tracing the at least one nerve root to determine a position of at least one spinal cord segment (see pg. 804, “To perform these markings, we visualized the spinal cord and cervical nerve rootlets in 3 planes (axial, sagittal, and coronal) and followed these nerve rootlets as they transition into cervical nerve roots and traverse the respective intervertebral foramen”). This method allows for spinal cord segments to be obtained accurately, in spite of intersubject differences (see Cadotte, pg. 804, “The diversity of human anatomy offers 2 principal sources of variability: 1) intersubject differences in spinal column anatomy, and2)intersubject differences in spinal cord segments relative to a fixed point in the brain stem. The work presented here considers these 2 sources of diversity across a cohort of healthy individuals and presents a unique solution, a “spinal level map,” which can be applied in advanced MR imaging assessment of the human cervical cord”). Thus, it would have been obvious to combine the axial images taught by Cadotte with the teachings of Lavrov and Grahn in order to obtain the invention as claimed in Claim 5.
As to Claim 11, Lavrov teaches a method of optimizing electrode placement for spinal cord epidural stimulation (see paragraph [0003], “Spinal cord stimulation (“SCS”) including, epidural stimulation, dorsal column, spinal rootlet, and dorsal root ganglion (“DRG”) stimulation are adjustable and effective non-opioid analgesic solutions with demonstrated efficacy”, and see paragraph [0020], “These systems and methods can improve the accuracy of spinal cord therapies and treatments, including the placement of SCS implant), the method comprising:
receiving at least one medical image of a spinal cord and surrounding vertebral column (see paragraph [0040], “The method also includes accessing medical image data for a subject using the computer system”, and see Fig. 8, wherein the medical image data comprises a spinal cord surrounding vertebral column);
determine a position of at least one spinal cord segment (see paragraph [0011], “FIGS. 4A-4C show spinal cord anatomic parameters and measurements results. FIG. 4A shows an example schematic representation of vertebral spine and spinal cord with measured parameters. Examples of dorsal segments correspond to cervical C4, C5, C6; thoracic T6, T7; and lumbar L1, L2 L3, segments are shown”)
constructing, using a computer, a three-dimensional model of at least a portion of the spinal cord, the three-dimensional model based at least in part on the at least one medical image (see paragraph [0035], “Using the anatomical measurement data and the medical image data, augmented spinal cord anatomy model data are generated with the computer system, as indicated at step 106”, and see paragraph [0053], “the systems and methods described in the present disclosure generate anatomically accurate augmented 2D or 3D models of the spinal cord (e.g., including spinal nerve, rootlet, tract) and vertebrae”);
determining the position of a lumbosacral enlargement of the spinal cord in the three-dimensional model based at least in part on the position of the at least one spinal cord segment (see paragraph [0035], “As one non-limiting example, an image can be input to a suitably trained machine learning algorithm, generating output as augmented spinal cord anatomy model data, which may include location outputs with respect to vertebrae”, and see paragraph [0056], “Spinal cord anatomies that can be localized and/or targeted using the systems and methods described in the present disclosure include, but are not limited to, specific spinal cord segments (e.g., cervical, thoracic, and lumbar segments”), and see Fig. 2, where a model comprising spinal cord segments L2-S2 segments are shown, and it is well-known in the art that the lumbosacral enlargement comprises spinal cord segments L2-S2) ;
and determining an optimal placement of an implantable electrode (see paragraph [0040], “In addition, for spinal cord stimulation applications with spinal leads or arrays spanning multiple segments, the augmented spinal cord anatomy data can be analyzed to suggest optimum locations for inserting the lead or array.”).
Lavrov teaches that an implantable electrode may be placed over the lumbosacral enlargement (see Fig. 2, where a paddle electrode is implanted over spinal cord segments L2-S2). However, Lavrov fails to explicitly teach the optimal placement maximizes coverage of the lumbosacral enlargement by the implantable electrode.
However, in an analogous art, Grahn teaches a method for delivering epidural stimulation (see paragraph [0003], “In particular, the techniques described herein involve the use of epidural electrical stimulation (EES) systems to activate motor function in limbs”) which comprises:
determining the position of a lumbosacral enlargement of the spinal cord based at least in part on the position of the at least one spinal cord segment (see paragraph [0031], “The one or more features of the at least one vertebra can include an intervertebral spinous process length for the L2 vertebra, and the one or more features of the spinal cord can include a length of a spinal cord segment corresponding to the L2 vertebra),
and determining an optimal placement of an implantable electrode wherein the optimal placement maximizes coverage of the lumbosacral enlargement by the implantable electrode (see paragraph [0065], “Even small (e.g., a few millimeters) offset between position of the electrode on the spinal cord and the dorsal root entry zones can significantly impact the therapeutic impact of EES. To determine the locations of the dorsal root entry zones, or other targeted structures of the spinal cord, correlations between features (anatomical landmarks) of a subject's vertebrae and features of the spinal cord can be utilized to estimate the locations of the targeted structures. These correlations can be used to facilitate precise implantation of electrodes or other devices at specific locations of the spinal cord (e.g., dorsal root entry zones for targeted spinal segments), even without the need to perform a laminectomy”).
Thus, it would have been obvious to one of ordinary skill in the art to combine the implant positioning method taught by Lavrov with the teachings of Grahn such that the implant has maximum contact with the lumbosacral enlargement. The motivation for doing so would be to maximize the therapeutic effects of the implant (see paragraph [0065]).
Both Lavrov and Grahn fail to teach identifying, based on the at least one medical image, at least one nerve root exiting the vertebral column and back-tracing the at least one nerve root to determine a position of at least one spinal cord segment.
However, Cadotte teaches a method for determining the position of spinal cord segments (see pg. 803, Abstract, “We provide a novel, quantitative solution to map vertebral and spinal cord levels accounting”),
which comprises back-tracing the at least one nerve root to determine a position of at least one spinal cord segment (see pg. 804, “To perform these markings, we visualized the spinal cord and cervical nerve rootlets in 3 planes (axial, sagittal, and coronal) and followed these nerve rootlets as they transition into cervical nerve roots and traverse the respective intervertebral foramen”).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the back-tracing taught by Cadotte in order to determine the position of the spinal cord segment. The motivation for doing so would be to provide accurate positions of spinal cord segments in spite of intersubject differences (see Cadotte, pg. 804). Thus, it would have been obvious to combine the nerve root tracing taught by Cadotte with the teachings of Lavrov and Grahn in order to obtain the invention as claimed in Claim 11.
As to Claim 12, both Lavrov and Grahn fails to explicitly teach the at least one medical image is a plurality of non-identical medical images.
However, Cadotte teaches obtaining a plurality of non-identical medical images (see pg. 804, “To perform these markings, we visualized the spinal cord and cervical nerve rootlets in 3 planes (axial, sagittal, and coronal) and followed these nerve rootlets as they transition into cervical nerve roots and traverse the respective intervertebral foramen”, and see Fig. 1, shown below, where a plurality of non-identical, axial images are shown).
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Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the non-identical images taught by Cadotte with the teachings of Lavrov and Grahn. The motivation for doing so would be to use the axial images to determine the position of spinal cord segments (see pg. 803, Abstract, and see pg. 804). Thus, it would have been obvious to combine the axial images taught by Cadotte with the teachings of Lavrov and Grahn in order to obtain the invention as claimed in Claim 12.
As to Claim 13, both Lavrov and Grahn fails to explicitly teach the at least one medical image is a plurality of axial MRI images of the spinal cord captured at different vertebral levels. However, Cadotte teaches obtaining a plurality of axial images at a plurality of vertebral levels (see pg. pg. 804, “To perform these markings, we visualized the spinal cord and cervical nerve rootlets in 3 planes (axial, sagittal, and coronal)”, and see Fig. 1, where a plurality of axial images are shown).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the axial images taught by Cadotte with the teachings of Lavrov and Grahn. The motivation for doing so would be to use the axial images to determine the position of spinal cord segments (see pg. 803, Abstract, and see pg. 804). Thus, it would have been obvious to combine the axial images taught by Cadotte with the teachings of Lavrov and Grahn in order to obtain the invention as claimed in Claim 13.
As to Claim 14, Lavrov in view of Grahn teaches determining the position of at least one L1-S1 spinal cord segment. (see Lavrov, paragraph [0033], “FIGS. 4A-4C show spinal cord anatomic parameters and measurements results. FIG. 4A shows an example schematic representation of vertebral spine and spinal cord with measured parameters. Examples of dorsal segments correspond to cervical C4, C5, C6; thoracic T6, T7; and lumbar L1, L2 L3, segments are shown”).
Lavrov in view of Grahn fails to teach that these segments are obtained through backtracking. However, Cadotte teaches a method for determining the position of spinal cord segments (see pg. 803, Abstract, “We provide a novel, quantitative solution to map vertebral and spinal cord levels accounting”),
which comprises back-tracing the at least one nerve root to determine a position of at least one spinal cord segment (see pg. 804, “To perform these markings, we visualized the spinal cord and cervical nerve rootlets in 3 planes (axial, sagittal, and coronal) and followed these nerve rootlets as they transition into cervical nerve roots and traverse the respective intervertebral foramen”).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the back-tracing taught by Cadotte in order to determine the position of the lumbosacral enlargement. The motivation for doing so would be to provide accurate positions of spinal cord segments in spite of intersubject differences (see Cadotte, pg. 804). Thus, it would have been obvious to combine the nerve root tracing taught by Cadotte with the teachings of Lavrov and Grahn in order to obtain the invention as claimed in Claim 14.
As to Claim 15, Lavrov in view of Grahn teaches determining the position of the L1-S1 spinal cord segment. (see Lavrov, Fig. 3, where segments L1-S2 are shown).
Lavrov in view of Grahn fails to teach that these segments are obtained through backtracking. However, Cadotte teaches a method for determining the position of spinal cord segments (see pg. 803, Abstract, “We provide a novel, quantitative solution to map vertebral and spinal cord levels accounting”),
which comprises back-tracing the at least one nerve root to determine a position of at least one spinal cord segment (see pg. 804, “To perform these markings, we visualized the spinal cord and cervical nerve rootlets in 3 planes (axial, sagittal, and coronal) and followed these nerve rootlets as they transition into cervical nerve roots and traverse the respective intervertebral foramen”).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the back-tracing taught by Cadotte in order to determine the position of the lumbosacral enlargement. The motivation for doing so would be to provide accurate positions of spinal cord segments in spite of intersubject differences (see Cadotte, pg. 804). Thus, it would have been obvious to combine the nerve root tracing taught by Cadotte with the teachings of Lavrov and Grahn in order to obtain the invention as claimed in Claim 15.
As to Claim 16, Lavrov teaches the implantable electrode may be a paddle electrode (see Fig. 2, where a paddle electrode is shown implanted over the lumbosacral enlargement). However, Lavrov fails to explicitly teach that the optimal placement maximizes coverage of the lumbosacral enlargement by the paddle electrode.
Grahn teaches using a paddle electrode (see Fig. 4A), and that an optimal placement maximizes coverage of the lumbosacral enlargement (see paragraph [0065], “Even small (e.g., a few millimeters) offset between position of the electrode on the spinal cord and the dorsal root entry zones can significantly impact the therapeutic impact of EES. To determine the locations of the dorsal root entry zones, or other targeted structures of the spinal cord, correlations between features (anatomical landmarks) of a subject's vertebrae and features of the spinal cord can be utilized to estimate the locations of the targeted structures. These correlations can be used to facilitate precise implantation of electrodes or other devices at specific locations of the spinal cord (e.g., dorsal root entry zones for targeted spinal segments), even without the need to perform a laminectomy”).
Thus, it would have been obvious to one of ordinary skill in the art to combine the implant positioning method taught by Lavrov and Cadotte with the teachings of Grahn such that the implant has maximum contact with the lumbosacral enlargement. The motivation for doing so would be to maximize the therapeutic effects of the implant (see Grahn, paragraph [0065]). Thus, it would have been obvious to combine the teachings of Grahn with the teachings of Lavrov and Cadotte in order to obtain the invention as claimed in Claim 16.
As to Claim 18, Lavrov in view of Grahn and Cadotte teaches wherein determining identifying a position on the vertebral column surrounding the lumbosacral enlargement (see Lavrov, paragraph [0033], “FIGS. 4A-4C show spinal cord anatomic parameters and measurements results. FIG. 4A shows an example schematic representation of vertebral spine and spinal cord with measured parameters. Examples of dorsal segments correspond to cervical C4, C5, C6; thoracic T6, T7; and lumbar L1, L2 L3, segments are shown” and see Fig. 4A, where the position on the vertebral column segments L2-L3 corresponding to the lumbosacral enlargement are shown).
As to Claim 19, Lavrov in view of Grahn and Cadotte teach the three-dimensional model is a computational model (see Lavrov, paragraph [0035], “Using the anatomical measurement data and the medical image data, augmented spinal cord anatomy model data are generated with the computer system…As one non-limiting example, an image can be input to a suitably trained machine learning algorithm, generating output as augmented spinal cord anatomy model data, which may include location outputs with respect to vertebrae”).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Lavrov et al. (US Pub No 2022/0387114), hereinafter Lavrov, in view of Grahn et al. (US Pub No 2021/0052889), hereinafter Grahn, and further in view of Cadotte et al. (D.W. Cadotte, et al., “Characterizing the Location of Spinal and Vertebral Levels in the Human Cervical Spinal Cord”, American Journal of Neuroradiology, Apr 2015), hereinafter Cadotte, and further in view of Yiannakas et al. (Yiannakas, M.C., et al., “Gray vs. White Matter Segmentation of the Conus Medullaris: Reliability and Variability in Healthy Volunteers”, Journal of Neuroimaging, 2019), hereinafter Yiannakas.
As to Claim 6, Lavrov in view of Grahn and Cadotte fails to teach determining the position of the lumbosacral enlargement includes calculating a cross-section area of the lumbosacral enlargement in each of the plurality of axial images, identifying a location on the spinal cord having a maximal cross-section area based at least in part on the plurality of axial images, and determining the position of the lumbosacral enlargement based at least in part on the location on the spinal cord having the maximal cross-section area. Cadotte teaches obtaining axial images of a spinal cord, but fails to explicitly each calculating a cross-sectional area from each axial image.
However, in an analogous art, Yiannakas teaches a method of segmenting the conus medullaris (see pg. 6, “In this work, the feasibility of tissue-specific segmentation of the CM is assessed in vivo using a clinical 3T MRI”, where CM stands for conus medullaris), which comprises:
obtaining multiple axial images of a spinal cord (see pg. 7, “A 3D slab-selective fast field-echo (3D-FFE) sequence with fat suppression was acquired in the axial-oblique plane (i.e. slices perpendicular to the longitudinal axis of the cord)”),
identifying a location on the spinal cord having a maximal cross-section area based at least in part on the plurality of axial images (see pg. 28, caption under Figure 1., “In each case, the slice with the largest cross-sectional area between T11-L1 (lumbosacral enlargement; LSE) was identified”),
and determining the position of the lumbosacral enlargement based at least in part on the location on the spinal cord having the maximal cross-section area (see pg. 8, “The slice with the largest cord CSA between T11-L1 vertebral bodies was identified for each subject as the LSE slice”, where ‘CSA’ stands for cross-sectional area, and ‘LSE’ stands for lumbosacral enlargement).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of identifying the lumbosacral enlargement taught by Yiannakas with the teachings of Lavrov, Grahn, and Cadotte. The motivation for doing so would be to better identify the lumbosacral enlargement despite inter-subject variability . Yiannakas teaches on pgs. 6 and 17, “Given the positional variation of the lower SC relative to the spine, the identification of the lumbosacral enlargement (LSE) has been suggested as an intrinsic imaging biomarker for alignment and assessments of neurological segments relevant for the functioning of the lower limbs and the LUT…In summary, obtaining tissue-specific CM volume measures in vivo using a clinical 3T system is possible and the presented spine and SC metrics should be used in future studies of neurological disease while working on improving further methods to address the reported inter-subject variability, hence improve the sensitivity and statistical power of the CM morphometric assessments”. Thus, it would have been obvious to combine the teachings of Yiannakas with the teachings of Lavrov, Grahn, and Cadotte in order to obtain the invention as claimed in Claim 6.
As to Claim 7, Lavrov in view of Grah and Cadotte fails to teach identifying, using the plurality of axial images, a conus tip of the spinal cord, and wherein determining the position of the lumbosacral enlargement is based at least in part on a distance between the conus tip and the location on the spinal cord having the maximal cross-section area.
However, in an analogous art, Yiannakas teaches obtaining multiple axial images of a spinal cord (see pg. 7, “A 3D slab-selective fast field-echo (3D-FFE) sequence with fat suppression was acquired in the axial-oblique plane (i.e. slices perpendicular to the longitudinal axis of the cord)”),
Identifying a conus tip of the spinal cord (see pg. 8-9, “the tip of the CM was defined as the last axial slice on which the cord could still be visible, with the two preceding slices showing the cord with a larger diameter (superiorly) 8 and no cord at all (inferiorly)”, where CM stands for conus medullaris),
and wherein determining the position of the lumbosacral enlargement is based at least in part on a distance between the conus tip and the location on the spinal cord having the maximal cross-section area (see pg. 28, “In each case, the slice with the largest cross-sectional area between T11-L1 (lumbosacral enlargement; LSE) was identified (slice 0), and all the remaining consecutive slices moving caudally from the LSE slice towards the tip of the conus medullaris”).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of identifying the lumbosacral enlargement taught by Yiannakas with the teachings of Lavrov, Grahn, and Cadotte. The motivation for doing so would be to better identify the lumbosacral enlargement despite inter-subject variability (see Yiannakas pg. 17). Thus, it would have been obvious to combine the teachings of Yiannakas with the teachings of Lavrov, Grahn, and Cadotte in order to obtain the invention as claimed in Claim 7.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Lavrov et al. (US Pub No 2022/0387114), hereinafter Lavrov, in view of Grahn et al. (US Pub No 2021/0052889), hereinafter Grahn, further in view of Yiannakas et al. (Yiannakas, M.C., et al., “Gray vs. White Matter Segmentation of the Conus Medullaris: Reliability and Variability in Healthy Volunteers”, Journal of Neuroimaging, (2019)), hereinafter Yiannakas, and further in view of Alonso et al. (Alonso F, et al., “Electric Field Comparison between Microelectrode Recording and Deep Brain Stimulation Systems-A Simulation Study”, Brain Sci., 2018), hereinafter Alonso.
As to Claim 9, neither Lavrov nor Grahn calculating a volume of the lumbosacral enlargement and determining a percentage of the volume of the lumbosacral enlargement overlaid by the paddle electrode. Lavrov teaches implanting a paddle electrode over the lumbosacral enlargement (see Lavrov, Fig. 2, where a paddle electrode is shown implanted over the lumbosacral enlargement), and Grahn teaches maximizing coverage (see Grahn, Fig. 4A and paragraph [0065]), but both fail to teach obtaining a total volume of the lumbosacral enlargement or determining a percentage of coverage.
Yiannakas teaches determining the position of the lumbosacral enlargement (see pg. 28, “In each case, the slice with the largest cross-sectional area between T11-L1 (lumbosacral enlargement; LSE) was identified”),
and determining the total volume of the lumbosacral enlargement (see pg. 24, Table 24, where the total volume of the grey matter and white matter of the lumbosacral enlargement is shown).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of identifying and quantifying the lumbosacral enlargement taught by Yiannakas with the teachings of Lavrov and Grahn. The motivation for doing so would be to better identify the lumbosacral enlargement despite inter-subject variability (see Yiannakas pg. 17).
Lavrov in view of Grahn and Yiannakas fails to teach determining a percentage of the volume of the lumbosacral enlargement overlaid by the paddle electrode. However, in an analogous art, generating calculating coverage of an electrode (see Section 2.4, pg. 6, “For the 3D patient-specific simulations, the volume within the 0.2 V/mm isosurface was calculated, i.e., the VTA. The volumes for the DBS and the MER lead were compared by calculating the Sørensen-Dice coefficient (DC) [24]. The volume overlap between two structures was rated”). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the coverage calculation taught by Alonso with the teachings of Lavrov, Grahn, and Yiannakas. The motivation for doing so would be to predict the volume of tissue activated so that the optimal position of the electrode can be predicted. Alonso teaches in Section 1., pgs. 1-2, “Due to difficulties in the visualization of some structures with conventional magnetic resonance imaging (MRI), a common procedure to confirm or refine the localization of the target before the insertion ..Computer models using FEM [8,9] have been widely used to investigate the influence of the stimulation parameters and surrounding tissue properties in DBS. The electric field (EF), i.e., the potential’s first derivative, can be used to approximate the volume of tissue activated (VTA)”. Thus, it would have been obvious to combine the teachings of Alonso with the teachings of Lavrov, Grahn, and Yiannakas in order to obtain the invention as claimed in Claim 9.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Lavrov et al. (US Pub No 2022/0387114), hereinafter Lavrov, in view of Grahn et al. (US Pub No 2021/0052889), hereinafter Grahn, and further in view of Cadotte et al. (D.W. Cadotte, et al., “Characterizing the Location of Spinal and Vertebral Levels in the Human Cervical Spinal Cord”, American Journal of Neuroradiology, Apr 2015), hereinafter Cadotte, further in view of Yiannakas et al. (Yiannakas, M.C., et al., “Gray vs. White Matter Segmentation of the Conus Medullaris: Reliability and Variability in Healthy Volunteers”, Journal of Neuroimaging, 2019), hereinafter Yiannakas, and further in view of Alonso et al. (Alonso F, et al., “Electric Field Comparison between Microelectrode Recording and Deep Brain Stimulation Systems-A Simulation Study”, Brain Sci., 2018), hereinafter Alonso.
As to Claim 17, Lavrov, Grahn, and Cadotte fail to teach calculating a volume of the lumbosacral enlargement and determining a percentage of the volume of the lumbosacral enlargement overlaid by the paddle electrode. Lavrov teaches implanting a paddle electrode over the lumbosacral enlargement (see Lavrov, Fig. 2, where a paddle electrode is shown implanted over the lumbosacral enlargement), and Grahn teaches maximizing coverage (see Grahn, Fig. 4A and paragraph [0065]), but both fail to teach obtaining a total volume of the lumbosacral enlargement or determining a percentage of coverage.
Yiannakas teaches determining the position of the lumbosacral enlargement (see pg. 28, “In each case, the slice with the largest cross-sectional area between T11-L1 (lumbosacral enlargement; LSE) was identified”),
and determining the total volume of the lumbosacral enlargement (see pg. 24, Table 24, where the total volume of the grey matter and white matter of the lumbosacral enlargement is shown).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of identifying and quantifying the lumbosacral enlargement taught by Yiannakas with the teachings of Lavrov, Grahn, and Cadotte. The motivation for doing so would be to better identify the lumbosacral enlargement despite inter-subject variability (see Yiannakas pg. 17).
Lavrov in view of Grahn, Cadotte, and Yiannakas fails to teach determining a percentage of the volume of the lumbosacral enlargement overlaid by the paddle electrode. However, in an analogous art, generating calculating coverage of an electrode (see Section 2.4, pg. 6, “For the 3D patient-specific simulations, the volume within the 0.2 V/mm isosurface was calculated, i.e., the VTA. The volumes for the DBS and the MER lead were compared by calculating the Sørensen-Dice coefficient (DC) [24]. The volume overlap between two structures was rated”). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the coverage calculation taught by Alonso with the teachings of Lavrov, Grahn, Cadotte, and Yiannakas. The motivation for doing so would be to predict the volume of tissue activated so that the optimal position can be predicted. Alonso teaches in Section 1., pgs. 1-2, “Due to difficulties in the visualization of some structures with conventional magnetic resonance imaging (MRI), a common procedure to confirm or refine the localization of the target before the insertion ...Computer models using FEM [8,9] have been widely used to investigate the influence of the stimulation parameters and surrounding tissue properties in DBS. The electric field (EF), i.e., the potential’s first derivative, can be used to approximate the volume of tissue activated (VTA)”. Thus, it would have been obvious to combine the teachings of Alonso with the teachings of Lavrov, Grahn, Cadotte, and Yiannakas in order to obtain the invention as claimed in Claim 17.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Grill et al. (US Pub No 2018/0104479) teaches a method for optimizing patient parameters for spinal cord stimulation which comprises obtaining a patient specific 3D model of the spinal cord.
Xu et al. (CN Pub No 109124763) teaches obtaining images of a lumbosacral region of a patients spine and then generating a 3D model of the lumbosacral region.
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/S.T./Examiner, Art Unit 2664
/JENNIFER MEHMOOD/Supervisory Patent Examiner, Art Unit 2664
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