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 .
Response to Arguments
Applicant's arguments filed 06/25/2026 have been fully considered but they are not persuasive.
On page 2 of 6 Applicant states:
Skelton does not disclose the element of "arranging the one or more sensing elements such that the one or more sensing elements align with a direction of deformation of the sensor." The Office Action expressly concedes this point, stating that "Skelton et al. fails to recite arranging the one or more sensing elements such that the one or more sensing elements align with a direction of deformation of the sensor."
This is correct as Applicant notes the office action concedes “Skelton fails to recite
arranging the one or more sensing elements such that the one or more sensing elements align
with a direction of deformation of the sensor."
Next, on page 3 of 6, 1st full paragraph, Applicant first asserts “Positional feedback devices for body posture and orientation are not spinal cord stimulation nor implantable neurostimulation devices. While Simonetti teaches a flexible strip with resistive ink and conductive patterns, its sensing elements are used to derive orientation and posture information over broad body areas (e.g., back, limbs), and the device is not integrated with stimulating elements configured to deliver electrical stimulation proximate the spinal cord as required by claim 67.” Applicant argument is unpersuasive since there is no requirement that analogous art overlap in a certain multitude of aspects or all aspects. Next, in the same paragraph Applicant asserts “Simonetti's strip may bend, but there is no teaching that its sensing elements are aligned with a deformation axis of a sensor that is intended to track spinal deformation and be part of an integrated spine-movement sensor/stimulator system.” Here, it is nice to see Applicant concedes Simonetti discloses bending of the sensor. It should be noted the bending is aligned with an undefined axis of the sensor. The second part of the statement - being part of an integrated spine-movement sensor/stimulator system is again rebutted since there is no requirement that analogous art overlap in a certain multitude of aspects or all aspects as noted above.
Next, on page 3 of 6, last paragraph through page 4 of 6, line 2 Applicant
asserts:
Skelton already provides its own sensing mechanism for adjusting therapy, namely accelerometer-based sensing correlated to spinal cord movement and position. The rejection does not identify any teaching in Skelton suggesting that its sensing approach is deficient or that it should be replaced or materially modified to use a deformation-aligned strip sensor. Nor does it identify any teaching in Simonetti suggesting adaptation of its posture-feedback strip into an implantable or therapy-coupled spinal cord stimulation system. The only apparent reason to make the proposed modification is knowledge of Applicants' disclosure.
First, one of ordinary skill in the art would appreciate the alternative use of Simonetti’s sensor to Skelton’s sensor, or even the benefits of a redundancy sensing system. Secondly, with respect to Applicant’s “implantable or therapy-coupled spinal cord stimulation system, again there is no requirement that analogous art overlap in a certain multitude of aspects or all aspects as noted above. Lastly, the “only apparent reason” comment appears to be a hindsight argument. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Next on page 4 of 6, 1st full paragraph Applicant cites the PCT written Opinion. Although the examiner reviewed the opinion, the examiner conducted a search and found relevant art and analogous art that provided a reasonable obviousness rejection as seen in the rejection below.
Next on page 4 of 6, the last seven lines through page 5 of 6, line 3 Applicant asserts “there is still no articulated reason with rational underpinning for combining
Simonetti's posture-feedback device with Skelton's spinal cord stimulation system in the specific manner required by claim 67.” Although Applicant may characterize the prior art references as they wish – however that characterization does not sway the examiner from viewing the references as analogous art since both can measure or sense movement of the spine.
Accordingly, this action is made FINAL.
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.
Claims 67-73 and 84 are rejected under 35 U.S.C. 103 as being unpatentable over Skelton et al. (U.S. Patent Application Publication 2013/0289652) in view Simonetti et al. (U.S. Patent Application Publication 2017 /0311874).
Regarding claim 67, Skelton et al. disclose a method of detecting movement of a spine,
and stimulating specific regions of the spinal cord, the method comprising:
providing a sensor having one or more sensing elements (the more of "the one or more one or more sensing electrodes carried by leads 16," see [0027] and figure 2) to sense movement of the spine (see [00 l 8]-[0020], and [0024 ]-[0025] for example); providing one or more stimulating elements (the more of "the one or more stimulation electrodes carried by leads 16," see [0027] and figure 2) configured to electrically stimulate an area proximate the spine (see [0027]);
detecting, via the sensor, a movement of the spine (see [0018]-[0020], [0024]-[0025], and [0027] for example);
modulating an electrical stimulus provided by the one or more stimulating elements at an area proximate the spine in response to the detected movement (see abstract, and especially [0020]).
Skelton et al. fail to recite arranging the one or more sensing elements such that the one or more sensing elements align with a direction of deformation of the sensor.
Like Skelton et al., Simonetti et al. disclose an elongate device (see figures 11, and 20) for measuring or sensing movement of the spine ( see [0017], [0029] for example) and teach arranging the one or more sensing elements such that the one or more sensing elements align with a direction of deformation of the sensor by sensing/measuring bending of the sensor(s) in order to provide a known and workable manner of sensing movement of the spine (see [0017], [0029] and figures 9, 11, and 20]).
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Skelton et al., as taught by Simonetti et al., to arrange the one or more sensing elements such that the one or more sensing elements align with a direction of deformation of the sensor by sensing/measuring bending of the sensor(s) in order to provide a known and workable manner of sensing movement of the spine.
Regarding claim 68, Skelton et al. disclose the claimed invention including the one or
more sensing elements each include a first set of sensing elements and a second set of
sensing elements, Skelton et al. accomplishes this by 1) disclosing at least two pairs/sets
of vertically separated sensing electrodes, and/or 2) disclosing at least two pairs/sets of
horizontally separated sensing electrodes, see figure 2.
Regarding claim 69, Skelton et al. disclose the claimed invention including the first set
of sensing elements is aligned with the second set of sensing elements when the sensor is
in the initial state (see figure 2).
Regarding claim 70, Skelton et al. disclose the claimed invention including the first set
of sensing elements is off set from the second set of sensing elements when the sensor
detects movement (see figure 2).
Regarding claims 71-73, Skelton et al. show the invention but fail to recite:
1) the sensor includes a resistive layer disposed between a substrate and the one or more sensing elements { claim 71},
2) the substrate is a flexible substrate {claim 72}, and
3) the resistive layer is formed via deposition of conductive ink on the substrate {claim 73}.
Like Skelton et al., Simonetti et al. disclose an elongate device (see figures 11, and 20) for measuring or sensing movement of the spine ( see [0017], [0029] for example) and further teach making the sensor from a conductive, but resistive ink deposited (deposition) on a flexible substrate (bendable insulative layer) (see 0 150]) in order to make a known and workable sensor that senses movement by deflecting/deforming in order to sense movements of the spine (see [0017], [0029] and figures 9, 11, and 20]).
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Skelton et al., as taught by Simonetti et al., to make the sensor from a conductive, but resistive ink deposited (deposition) on a flexible substrate (bendable insulative layer) (see 0 150]) in order to make a known and workable sensor that senses movement by deflecting/deforming in order to sense movements of the spine.
Regarding claim 84, Skelton et al. disclose the claimed invention including one or more
gaps are disposed between each of the one or more sensing elements (see figure 2).
Claim 85 is rejected under 35 U. S.C. 103 as being unpatentable over Skelton et al. (U.S. Patent Application Publication 2013/0289652) in view Simonetti et al. (U.S. Patent Application Publication 2017 /0311874) as applied to claim 67 above, and further in
view of Von Marcard et al. (U.S. Patent Application Publication 2015/0366489).
Regarding claim 85, Skelton et al. (in view of Simonetti et al.) show the invention but fail to recite the movement of the spine includes torsion or flexion of the spine.
Like both Skelton et al. and Simonetti et al., Von Marcard et al. disclose device/system and method for measuring movement of the spine and/or spinal cord and teach the sensing/detecting measure movements of the spine (and/or spinal cord) categorized as "twist of the spinal column" (see [0003 ], [0007], [0010 ], [0012] and figures 6-7 for example) and flexion of the spine ("bending," see [003 7] and figures 6-7) in order to provide a known and workable manner of providing feedback on the movement of the spine (and/or spinal cord).
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Skelton et al. in view of Simonetti et al., as taught by Von Marcard et al., to the sensing/detecting measure movements of the spine (and/or spinal cord) categorized as "twist of the spinal column" and flexion of the spine in order to provide a known and workable manner of providing feedback on the movement of the spine (and/or spinal cord).
Allowable Subject Matter
Claims 74-83 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
THIS ACTION IS MADE FINAL. 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 AARON F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AARON F ROANE/Primary Examiner, Art Unit 3792
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