Prosecution Insights
Last updated: April 19, 2026
Application No. 18/100,454

EPIDURAL STIMULATION AND SPINAL STRUCTURE LOCATING TECHNIQUES

Final Rejection §101§102§112
Filed
Jan 23, 2023
Examiner
HOEKSTRA, JEFFREY GERBEN
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Mayo Foundation for Medical Education and Research
OA Round
2 (Final)
54%
Grant Probability
Moderate
3-4
OA Rounds
4y 3m
To Grant
95%
With Interview

Examiner Intelligence

Grants 54% of resolved cases
54%
Career Allow Rate
272 granted / 499 resolved
-15.5% vs TC avg
Strong +41% interview lift
Without
With
+40.8%
Interview Lift
resolved cases with interview
Typical timeline
4y 3m
Avg Prosecution
81 currently pending
Career history
580
Total Applications
across all art units

Statute-Specific Performance

§101
9.0%
-31.0% vs TC avg
§103
27.3%
-12.7% vs TC avg
§102
37.5%
-2.5% vs TC avg
§112
22.9%
-17.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 499 resolved cases

Office Action

§101 §102 §112
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 . Notice of Amendment This communication is responsive to the amendment(s) and/or argument(s) filed 10/31/25. The previous ground(s) of objection and/or rejection is/are withdrawn. The following new and/or reiterated ground(s) of rejection is/are set forth hereinbelow. Information Disclosure Statement The information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. 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. Claim 28 is 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 28 depends from cancelled claim 25, rendering the scope of the claim indeterminate. For the purposes of examination on the merits and consistent with the instant Specification, claim 28 is being treated as depending from claim 17. 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 17, 18, 20-24, and 28-42 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to an abstract idea (the process of determining, estimating and accessing vertebral and spinal cord structures may be considered a mental process) without significantly more. For independent claim 17, the claim(s) recite(s) a process of determining values for one or more features of at least one vertebra of a spine of a subject; estimating values for the spinal cord features; and estimating locations of one or more structures of the spinal cord of the subject based on the values for the one or more features of the at least one vertebra. As broadly as claimed these steps may be reasonably considered as the judicial exception of a mental process performable within the human mind, including by observation, evaluation, judgement and opinion forming, or by a human using pen and paper (see MPEP 2106.04(a)(2) subsection III). For example, at least, these limitations are nothing more than a medical professional examining patient records, evaluating patient spinal anatomy/physiology, and estimating locations of spinal cord structure(s) in their mind. Even in light of the instant Specification, no structure appears explicitly, implicitly, inherently and/or even inferentially required by the claims. It remains that the inventive concept of claim 1 reads on mental processes that occur when a surgeon or medical professional accesses a dorsal root entry zone of the spine during an epidural which one of ordinary skill int the art, or even a layperson, would recognize would not be done without an estimated location based on anatomy/physiology This judicial exception is not integrated into a practical application because the process steps as broadly as claimed are not tied to nor required to be performed, executed, or programmed on a special purpose computer. Further, the judicial exception is not even required to be performed on or tied to a mere generic processing device, controller, or the like. Conversely, the process as claimed does not appear to require any structure(s) at all for accomplishing the method. The claim(s) include the additional element of physically accessing the one or more dorsal root entry zones using their estimated locations, which is well-known, routine and conventional post solution activity that is not are sufficient to amount to significantly more than the judicial exception. No structure(s) are recited for said physical access as no structure(s) are . Depending claims 18, 22-24, 28, 29, 31, and 35-42 inherit and do not remedy the non-statutory deficiencies noted above because, despite furth specifying steps relating to estimating dorsal root entry zone spinal cord locations based on estimating spinal column anatomical feature values, they may reasonably be considered to be performed mentally without practical application or amounting to significantly more than the judicial exception. Depending claim 20, 32, 33, and 34 inherit and do not remedy the non-statutory deficiencies noted above because, despite furth specifying electrodes are placed and/or stimulate, this additional element may reasonably be considered insignificant, well-known, routine and conventional post-solution activity that does not introduce a practical application of the abstract idea or amount to significantly more than the judicial exception of an abstract idea performable mentally and/or by hand. Depending claims 21 inherits and does not remedy the non-statutory deficiencies noted above because the additional element of drilling holes into vertebrae may be considered pre- or post- solution activity that is still achievable by the hands of a medical professional without practical application or amounting to significantly more than the judicial exception of the abstract idea. Depending claim 30 inherits and does not remedy the non-statutory deficiencies noted above because the additional element of acquiring images relating to estimating spinal cord locations of and measuring values therefrom may reasonably be considered to be performed mentally by a medical professional looking at, for example at least, an x-ray image or screen, not amounting to significantly more than judicial exception of an abstract idea performable mentally and without practical application. Claim Rejections - 35 USC § 102 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim(s) 17, 18, 20-24, and 28-42 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Howard et al (WO 2013/116377 A1, hereinafter Howard). For claim 17, Howard discloses a method, comprising: determining values for one or more features of at least one vertebra of a spine of a subject (Figs 12A-13B) ([0033-0044] [0098-0117]), wherein the one or more features of the at least one vertebra comprise at least one of an intervertebral length, a midvertebrae foramen length, vertebral bone length, or an intervertebral spinous process length (Figs 12A-13B) ([0033-0044] [0098-0117]); estimating values for one or more features of a spinal cord of the subject based on the values for the one ore more features of the at least one vertebra (Figs 12A-13B) ([0033-0044] [0098-0117]), wherein the one or more features of the spinal cord comprise at least one of a length of a spinal cord segment, a transverse diameter of a spinal cord segment, or a width of a spinal cord segment at a dorsal root entry (Figs 12A-13B) ([0033-0044] [0098-0117]); estimating locations of one or more dorsal root entry zones of the spinal cord of the subject based on the values for the one or more features of the at least one vertebra (Figs 12A-13B) ([0033-0044] [0098-0117]); and physically accessing the one or more dorsal root entry zones of the spinal cord of the subject using their estimated locations (Figs 12A-13B) ([0033-0044] [0098-0117]). For claim 18, Howard discloses the method of claim 17, comprising estimating the locations of the one or more dorsal root entry zones of the spinal cord without physically accessing the spinal cord (MR images) (Figs 12A-13B) ([0033-0044] [0098-0117]). For claim 20, Howard discloses the method of claim 17, further comprising locating one or more electrodes on the spinal cord at or proximate to the one or more dorsal root entry zones (Figs 12A-13B) ([0033-0044] [0098-0117]). For claim 21, Howard discloses the method of claim 17, wherein physically accessing the one or more dorsal root entry zones of the spinal cord comprises drilling one or more holes into one or more vertebrae of the subject (Figs 12A-13B) ([0033-0044] [0098-0117]). For claim 22, Howard discloses the method of claim 17, wherein the subject is a mammal (Figs 12A-13B) ([0033-0044] [0098-0117]). For claim 23, Howard discloses the method of claim 17, wherein the subject is a human (Figs 12A-13B) ([0033-0044] [0098-0117]). For claim 24, Howard discloses the method of claim 17, wherein the subject is a swine ([0083]). For claim 28, Howard discloses the method of claim 17, wherein the one or more features of the at least one vertebra comprise an intervertebral spinous process length for the L2 vertebra, and the one or more features of the spinal cord comprise a length of a spinal cord segment corresponding to the L2 vertebra (Figs 12A-13B) ([0033-0044] [0098-0117]). For claim 29, Howard discloses the method of claim 17, wherein the one or more features of the at least one vertebra comprise an intervertebral spinous process length for the L2 vertebra of the subject (Figs 12A-13B) ([0033-0044] [0098-0117]). For claim 30, Howard discloses the method of claim 17, wherein determining the values for the one or more features of the at least one vertebra of the spine of the subject comprises: acquiring one or more images of the spine that depict a plurality of vertebral bones of the subject (Figs 12A-13B) ([0033-0044] [0098-0117]); and measuring the values for the one or more features of the at least one vertebra from the one or more images of the spine (Figs 12A-13B) ([0033-0044] [0098-0117]). For claim 31, Howard discloses the method of claim 17, wherein the at least one vertebra is in the lumbar region of the subject's spine (Figs 12A-13B) ([0033-0044] [0098-0117], especially [0111]). For claim 32, Howard discloses the method of claim 17, wherein accessing the one or more dorsal root entry zones of the spinal cord of the subject using their estimated locations comprises placing electrodes on the spinal cord at or near the one or more dorsal root entry zones (Figs 12A-13B) ([0033-0044] [0098-0117]); further comprising stimulating the spinal cord using the placed electrodes (Figs 12A-13B) ([0033-0044] [0098-0117]). For claim 33, Howard discloses the method of claim 17, further comprising providing epidural electrical stimulation (EES) to the spinal cord via electrodes placed proximate to the one or more dorsal root entry zones (Figs 12A-13B) ([0033-0044] [0098-0117]). For claim 34, Howard discloses the method of claim 33, wherein providing EES to the spinal cord comprises providing selective orientation or steering of an electric field based on a location, a trajectory, or an orientation of a dorsal root (Figs 12A-13B) ([0033-0044] [0098-0117]). For claim 35, Howard discloses the method of claim 17, wherein the one or more features of the at least one vertebra comprise an intervertebral length (Figs 12A-13B) ([0033-0044] [0098-0117]), wherein the values for the one or more features of the spinal cord of the subject are estimated using a value of the intervertebral length (Figs 12A-13B) ([0033-0044] [0098-0117]). For claim 36, Howard discloses the method of claim 17, wherein the one or more features of the at least one vertebra comprise a midvertebrae foramen length (Figs 12A-13B) ([0033-0044] [0098-0117]), wherein the values for the one or more features of the spinal cord of the subject are estimated using a value of the midvertebrae foramen length (Figs 12A-13B) ([0033-0044] [0098-0117]). For claim 37, Howard discloses the method of claim 17, wherein the one or more features of the at least one vertebra comprise a vertebral bone length(Figs 12A-13B) ([0033-0044] [0098-0117]), wherein the values for the one or more features of the spinal cord of the subject are estimated using a value of the vertebral bone length(Figs 12A-13B) ([0033-0044] [0098-0117]). For claim 38, Howard discloses the method of claim 17, wherein the one or more features of the at least one vertebra comprise an intervertebral spinous process length (Figs 12A-13B) ([0033-0044] [0098-0117])., wherein the values for the one or more features of the spinal cord of the subject are estimated using a value of the intervertebral spinous process length (Figs 12A-13B) ([0033-0044] [0098-0117]).. For claim 39, Howard discloses the method of claim 17, wherein the one or more features of the spinal cord comprise a length of a spinal cord segment (Figs 12A-13B) ([0033-0044] [0098-0117]), wherein the locations of the one or more dorsal root entry zones are estimated using a value of the length of the spinal cord segment (Figs 12A-13B) ([0033-0044] [0098-0117]). For claim 40, Howard discloses the method of claim 17, wherein the one or more features of the spinal cord comprise a transverse diameter of a spinal cord segment (Figs 12A-13B) ([0033-0044] [0098-0117]), wherein the locations of the one or more dorsal root entry zones are estimated using a value of the transverse diameter of the spinal cord segment (Figs 12A-13B) ([0033-0044] [0098-0117]). For claim 41, Howard discloses the method of claim 17, wherein the one or more features of the spinal cord comprise a width of a spinal cord segment at a dorsal root entry (Figs 12A-13B) ([0033-0044] [0098-0117]), wherein the locations of the one or more dorsal root entry zones are estimated using a value of the width of the spinal cord segment at a dorsal root entry (Figs 12A-13B) ([0033-0044] [0098-0117]). For claim 42, Howard discloses the method of claim 17, where the locations of the one or more dorsal root entry zones are further estimated using the values for the one or more features of the at least one vertebra (Figs 12A-13B) ([0033-0044] [0098-0117]). Response to Arguments Applicant's arguments filed 10/31/25 regarding the 101 rejection have been fully considered but they are not persuasive. Applicant argues the following: “physically accessing the one or more dorsal root entry zones of the spinal cord of the subject using their estimated locations” does not qualify as a mental process and the Director’s guidance re: Ex parte Dejardins emphasizes that 102, 103 and 112 are the traditional and appropriate tools to limit patent protection to its proper scope so the 101 should be withdrawn. The Examiner respectfully disagrees, maintains the new rejection in view of the claim amendments set forth hereinabove, and notes in response the following: Although physically accessing a dorsal root entry zone requires a physical act and not be a mental process, that physical act is a well-known, routine, and conventional medical activity/procedure comprising insignificant post-solution activity. The inventive concept appears to rest on the estimating steps which may be performed mentally. As broadly as claimed the estimations may occur mentally by a medical professional examining a patient and/or patient records to evaluate a physical access location for an epidural. No structures are required for the access and/or the estimating steps. It remains that the inventive concept of claim 1 reads on mental processes that occur when a surgeon or medical professional accesses a dorsal root entry zone of the spine during an epidural which one of ordinary skill int the art, or even a layperson, would recognize would not be done without an estimated location based on anatomy/physiology. the Examiner agrees with Applicants assertions regarding the Director’s emphasis and Ex parte Desjardins, however, the as broadly as claimed the subject matter reads on mental processes that occur when a surgeon or medical professional accesses a dorsal root entry zone of the spine which would not be done without an estimate location based on anatomy/physiology and further, particularly in line with Ex parte Dejardins, Applicant has not provided any 1.132 declaration for consideration but is encouraged to do so. Applicant's arguments filed 10/31/25 regarding the 102 rejection have been fully considered but they are not persuasive. Applicant argues the following: “Howard discloses techniques for determining "the peripheral arc length, S" along a portion of the spinal cord between a pair of dorsal root entry zones, but Howard does not disclose estimating values for the specific features of a spinal cord using the values of the specific features of at least one vertebra, or estimating locations of one or more dorsal root entry zones using the specific spinal cord features recited in claim 17.” The Examiner respectfully disagrees, maintains the new rejection in view of the claim amendments set forth hereinabove, and notes in response the following: The Examiner agrees that Howard is concerned with determination of peripheral arc length of the spinal cord portion between a pair of dorsal root entry zones. As evidenced in Howard and reproduced with emphasis below, Howard is further concerned with anatomical spinal MRI imaging comprising spinal and vertebral structures and sizes and that contain at least the “estimating values for the specific features of a spinal cord using the values of the specific features of at least one vertebra, or estimating locations of one or more dorsal root entry zones using the specific spinal cord features recited in claim 17”, including at least “wherein the one or more features of the at least one vertebra comprise at least one of an intervertebral length, a midvertebrae foramen length, vertebral bone length, or an intervertebral spinous process length” and “wherein the one or more features of the spinal cord comprise at least one of a length of a spinal cord segment, a transverse diameter of a spinal cord segment, or a width of a spinal cord segment at a dorsal root entry”. Howard explicitly states at least the following: “0100] One axial and sagittal image from each patient was selected for analysis. The available images covered the range T4 through T10 from high-resolution MR scans of both male (ages 17 to 77 years) and female (ages 20 to 84 years) patients. The imaging studies had been ordered by clinicians to rule out pathological processes affecting the spine, and in all cases studied no pathological abnormalities were noted. All of the subjects were imaged in the supine position in a straight posture without any bending or flexing of the legs, hips or spine. Of the selected slices, 70% (n = 35) were at either T7 or T8 which will be the preferred location for positioning the array in most patients. The remaining images were distributed above and below that zone to help insure a representative assessment. [0101] With reference to Figure 12A, the bi-lateral locations of the dorsal root entry zones, Pi and P.sub.3, were identified by neurosurgeons on each of the 50 axial slices, and the linear separation, A, between them was measured relative to the calibration scale bar on each image. The distance, B, between the center of that line and the dorsal-most point of the spinal cord, P.sub.2, was also measured, as were the maximum sagittal and coronal diameters of the spinal cord (i.e., the minor and major axis diameters, respectively). The resulting data were then archived for subsequent analysis, with the primary goal being to determine the peripheral arc length, S, connecting the points Pi, P.sub.2 and P.sub.3. [0102] The cross section of the spinal cord in the thoracic region is roughly oval in shape, but with an irregular circumference that departs from an ellipse. S was estimated by computing the hypotenuse to the triangle formed by A/2 and B: S.sub.H ~ 2 .Math. [(A/2).sup.2 + B.sup.2] ".sup.2. Because the actual arc rises just above that hypotenuse, S.sub.H slightly underestimates S. Alternatively, with reference to Figure 12B, S was estimated by way of the circular arc length: S.sub.R ~ r .Math. Θ, where r is the estimated value of radial distance between the geometric center of the spinal cord and the points Pj and P.sub.3, and Θ is the angular separation between those lines. Because the actual arc lies below the circumscribing path of S.sub.R, this calculation slightly overestimates S. [0103] Thus, S.sub.H < S < S.sub.R. Measurements to confirm this and establish the most likely value of S within that range can then be made directly on a magnified view of an axial image, using a flexible rule and the appropriate scaling factor to determine the distance along the span. The estimate of S, as determined across the entire patient population, can be used as a design guide for the membrane length of the patch. The value of "r" determined from the measured major and minor axis diameters, can then be used to establish the radius of curvature for the array membrane. [0104] The measured values of A and B in mm were as follows: All patients (n = 50), 5.8 ± 0.8, 1 .5 ± 0.4; males (n = 34), 5.9 ± 0.8, 1 .5 ± 0.4; females (n = 16), 5.5 ± 0.7, 1 .5 ± 0.4 The relative uncertainties (standard deviation ÷ mean) in the values of A and B across all patients was 14% and 27%, respectively. The value of A across all male patients was approximately 2% larger than the mean for all patients, and that for the female patients was approximately 5% smaller. The calculated value of ¾ = 6.5 ± 1.2 mm. The difference between the largest mean value of S.sub.H (8.8 mm) and the smallest (5.1 mm) was 3.7 mm— approximately three times the size of the standard deviation (1.2 mm), indicating that this is a dimension of the neuroanatomy in which significant outliers occur. [0105] The sagittal and coronal diameters of the spinal cord in each of the 50 axial images were 6.2 ± 0.6 mm and 8.3 ± 0.8 mm respectively. Thus, the mean radius and quadratured-sum uncertainty of the spinal cord is r = 3.6 ± 0.5 mm. Upon review of other results, it seemed most conservative to take r = 4.1 mm to be the working value of the mean radius. Using θ ~ 95°, ¾ = 6.8 ± 1.0 mm, where the uncertainty is given by the quadratured sum of those measured for r and estimated for 0. [0106] The calculated values of S.sub.H and S.sub.R were compared against physical measurements made with a flexible rule laid carefully along the dorsal arc pathway of images expanded 3-fold. The length of the dorsal arc span between the rootlet entry zones was estimated to be S = 6. 7 ± 1.0 mm. [0107] Thus, if the width of an electrode array was were 6.7 - 1.0 = 5.7 mm, then it would be a good fit to the spinal cords of at least 68% (1 σ) of the patients receiving the implant. The problem would come with the outliers at the high and low ends of the distribution of arc lengths. Providing three different widths of 8 mm, 6 mm and 4 mm would be suitable for substantially all the adult population. The largest size device would have additional electrode contacts and leads. Alternatively, custom arrays could be fabricated for individual patients using patient-specific arc length measurements. [0108] The mean radius of the spinal cord across all patients was r = 3.6 ± 0.5 mm. A nominal mean value of r = 4.1 mm would be suitable for curvature of the array. Opting for a slightly larger radius of curvature reduces the risk of spinal cord compression that might arise from too small a sizing.” “[0112] Figure 13B shows an example of a coronal image on which the relevant anatomical features are identified. Imaging was obtained in the coronal plane. Three-dimensional multiplanar reconstruction software was used on a Carestream PACS station to aid in measurement. The T10 and Tl 1 nerve roots were identified. A cranial caudal measurement was made in a plane parallel to the spinal canal between the dorsal-root entry zones (DREZ) of T10 and Tl 1 . (The exact position of the entry zones was confirmed by assessing sequential axial images to identify the most cranial aspect of the nerve originating from the spinal cord.) As shown in Figure 13 A, the difference between this measurement on the neutral and flexed images is a measure of spinal cord contraction/expansion along the rostral-caudal axis. Next, a cranial caudal measurement was made from the DREZ of the T10 nerve root along the same plane as the prior measurement, to the level of a plane orthogonal to the spinal canal at the level of the inferior T10 pedicles. The latter were selected as a reference point of the bony canal inside of which the spinal cord moves. The difference between these measurements represents cord movement within the bony canal. [0113] A cranial caudal measurement of the change in conus tip position was made. To accurately accomplish this, the position of the conus tip was first identified on the neutral images with reference to a landmark within the bony spinal canal at the same cranial-caudal level. This landmark was then identified on flexed imaging and a cranial caudal measurement was made from that level to the level of the new conus position. This represents movement of spinal cord within the canal. [0114] Results were as follows. The spinal cord should move rostral ly during flexion and should lie in its most caudal location when the patient is in the neutral position. The measured change in the pedicle-to-spinal cord DREZ distance across all patients between the neutral and flexion positions ranged from 1.9 mm to 18.0 mm, with a mean and standard deviation of 8.5 ± 6.0 mm. The inter-DREZ distance across all patients between the neutral and flexion positions ranged from -2.0 mm to + 6.7 mm, with a mean and standard deviation of 3.5 ± 2.6 mm. The mean and standard deviation for the rostral-caudal conus movement was found to be 6.4 ± 4.1 mm within an overall range of 1 .1 to 1 1 .4 mm. The fractional variations in these findings (standard deviation ÷ mean) are very large, 71 %, 74% and 64% respectively. This reflects the wide variability in the capacity of individual subjects to maximally flex the spine, as well as possible inter-subject variability in spinal cord mechanical characteristics. These findings highlight the need for the device to accommodate larger patient-to-patient variations in spinal cord dynamic movement properties. [0115] The ratio of the spinal cord's mean stretch-to-mean axial movement over a full flexion cycle was 3.5 mm/8.5 mm ~ 40%. On average across all patients, it required 1 mm of net axial displacement of the cord to stretch it 0.4 mm in length. A spinal cord stimulator device should accommodate a total rostral-caudal motion of up to ~ 2 cm of the cord/membrane relative to the fixation point, i.e., 1 cm rostral and 1 cm caudal from the neutral position. [0116] A prototype device of the type shown in Figure 14 (loop area ~ 160 mm.sup.2) was used to test the available range of motion. It was placed on a custom-designed silicone surrogate spinal cord specimens that was positioned inside an anthropomorphic spinal canal phantom. The device was able to accommodate this level of motion without lift-off of either end of the membrane when the surrogate reached the 1 cm rostral and caudal extremes of displacement. [0117] Since there were large variations (70%) in the magnitude of that motion from patient to patient, there will be a spectrum of spinal cord strains associated with flexion-driven motion of the cord. Having suitable axial compliance within the electrode bearing portion of the device will reduce the risk of potential irritation of the pial surface in patients where the intraparenchymal strains are large. In patients with small levels of strain, there would be little relative motion between cord and the array, meaning that there would be small risk of any skidding between them. The net axial travel of the spinal cord relative to the fixation point is within the range that can be accommodated without lift-off of the electrode bearing portion of the device.“ 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 Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. Jeffrey G. Hoekstra Primary Examiner Art Unit 3791 /JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
Read full office action

Prosecution Timeline

Jan 23, 2023
Application Filed
Jun 29, 2025
Non-Final Rejection — §101, §102, §112
Oct 31, 2025
Response Filed
Jan 11, 2026
Final Rejection — §101, §102, §112
Apr 07, 2026
Interview Requested
Apr 14, 2026
Applicant Interview (Telephonic)
Apr 16, 2026
Examiner Interview Summary

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Prosecution Projections

3-4
Expected OA Rounds
54%
Grant Probability
95%
With Interview (+40.8%)
4y 3m
Median Time to Grant
Moderate
PTA Risk
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