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 .
This Office action is responsive to an amendment filed December 12, 2025. Claims 21-40 are pending. Claims 1-20 have been canceled. Claims 21 & 34 have been amended.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 21-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Runney et al. (US 2012/0095360) (“Runney” hereinafter) in view of Woods et al. (US 2006/0241720) (“Woods” hereinafter).
In regards to claim 21, Runney discloses a method comprising:
during a spinal surgery (see at least par 0049), operating a neuromonitoring system 10 in a somatosensory evoked potential (SSEP) mode (see at least par 0007, 0051, 0062 & 0070-0071);
while operating the neuromonitoring system 10 in the SSEP mode:
providing a user interface (GUI) showing an anatomical diagram of a body 105 (see at least fig. 16 and par 0050, 0052, 0065 & 0067);
determining a SSEP baseline (see at least par 0074);
performing SSEP stimulation at a plurality of different SSEP stimulation sites (see at least par 0070-0071 & 0075);
performing SSEP recording at only two SSEP recording sites (i.e., for detecting “possible mechanical insult,” see par 0084) of a plurality of recording sites (see at least fig. 10A and par 0059 & 0071-0084), wherein the two SSEP recording sites comprise one subcortical recording location 292 (see par 0075) referenced to one cortical recording location 293 (see par 0084, which reads “if in response to stimulation of the left ulnar nerve, the peripheral response from Erb's Point showed no change in amplitude or latency, the subcortical response showed a decrease in amplitude, and the cortical response showed a decrease in amplitude, the event box 206 (shown in FIG. 25) would show either a yellow or a red indicator as well as the text "Possible mechanical insult”); and,
coloring a representation (i.e., alert or warning) according to a comparison of one or more attributes (i.e., amplitude and latency) of an SSEP recording relative to one or more attributes (i.e., amplitude and latency) of the SSEP baseline (see at least Table 7 and par 0071 & 0082).
Runney discloses a method, as described above, that fails to explicitly teach a method comprising coloring a representation of a limb on the anatomical diagram of the body.
Runney as modified by Stone comprising a method, as described above, that fails to explicitly teach a method comprising coloring a representation of a limb on the anatomical diagram of the body.
However, Woods teaches that it is known to provide a method comprising coloring a representation of a limb on the anatomical diagram of the body (see at least figs. 2A-B and par 0009, 0012, 0030, 0033-0034 & 0061).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Runney comprising coloring a representation of a limb on the anatomical diagram of the body as taught by Woods since such a modification would amount to applying a known technique (i.e., as taught by Woods) to a known device (i.e., as taught by Runney) ready for improvement to achieve a predictable result such as providing depictions that aid in somatosensory evoked potential (SSEP) mapping (see at least abstract of Woods) so as to enhance stimulation results output with a color display of green, yellow or red corresponding to the relative safety level determined by the system (see at least par 0065 of Runney)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 22, Runney discloses the method of claim 21, wherein the one or more attributes (i.e., amplitude and latency) include amplitude and latency (see at last par 0071).
In regards to claim 23, Runney discloses the method of claim 21, further comprising:
comparing a first amplitude of the SSEP recording relative to a baseline amplitude of the SSEP baseline (see at least par 0082);
comparing a first latency of the SSEP recording relative to a baseline latency of the SSEP baseline (see at least par 0082); and
comprising coloring a representation (i.e., alert or warning) green responsive to determining that both:
the first amplitude has a less than 50% change in amplitude relative to the baseline amplitude; and
the first latency has a less than 10% increase relative to the baseline latency (see at least Table 7 and par 0065 & 0071).
Runney discloses a method, as described above, that fails to explicitly teach a method comprising coloring a representation of a limb on the anatomical diagram of the body.
However, Woods teaches that it is known to provide a method comprising coloring a representation of a limb on the anatomical diagram of the body (see at least figs. 2A-B and par 0012, 0033-0034 & 0061).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Runney comprising coloring a representation of a limb on the anatomical diagram of the body as taught by Woods since such a modification would amount to applying a known technique (i.e., as taught by Woods) to a known device (i.e., as taught by Runney) ready for improvement to achieve a predictable result such as providing depictions that aid in somatosensory evoked potential (SSEP) mapping (see at least abstract of Woods) so as to enhance stimulation results output with a color display of green, yellow or red corresponding to the relative safety level determined by the system (see at least par 0065 of Runney)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 24, Runney discloses the method of claim 23, further comprising:
comparing a second amplitude of the SSEP recording to a baseline amplitude of the SSEP baseline (see at least par 0083-0084);
comparing a second latency of the SSEP recording relative to a baseline latency of the SSEP baseline (see at least par 0083-0084); and
coloring the representation (i.e., alert or warning) yellow responsive to determining that either:
the second amplitude has a more than 50% change in amplitude relative to the baseline amplitude; or
the second latency has a greater than 10% increase relative to the baseline latency (see at least Table 7 and par 0071 & 0082).
Runney discloses a method, as described above, that fails to explicitly teach a method comprising coloring the representation of the limb on the anatomical diagram of the body.
However, Woods teaches that it is known to provide a method comprising coloring the representation of the limb on the anatomical diagram of the body (see at least figs. 2A-B and par 0012, 0033-0034 & 0061).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Runney comprising coloring the representation of the limb on the anatomical diagram of the body as taught by Woods since such a modification would amount to applying a known technique (i.e., as taught by Woods) to a known device (i.e., as taught by Runney) ready for improvement to achieve a predictable result such as providing depictions that aid in somatosensory evoked potential (SSEP) mapping (see at least abstract of Woods) so as to enhance stimulation results output with a color display of green, yellow or red corresponding to the relative safety level determined by the system (see at least par 0065 of Runney)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 25, Runney discloses the method of claim 21, further comprising: wherein the plurality of different SSEP stimulation sites include only four SSEP stimulation sites (i.e., the left and right Posterior Tibial nerve and/or the left and right ulnar nerve, see at least par 0070, with only two recording electrodes 24 for SSEP for each peripheral nerve, see fig. 10A and par 0059).
In regards to claim 26, Runney discloses the method of claim 21, wherein the only two SSEP recording sites include a first recording location (such as, by way of example only, C2 vertebra, Cp3 scalp, Cp4 scalp, Erb's point, Popliteal Fossa) referenced to another recording location (such as, by way of example only, C2 vertebra, Cp3 scalp, Cp4 scalp, Erb's point, Popliteal Fossa) (see at least par 0070).
In regards to claim 27, Runney discloses the method of claim 21, wherein the plurality of different SSEP stimulation sites include:
a left posterior tibial nerve SSEP stimulation site;
a right posterior tibial nerve SSEP stimulation site;
a left ulnar nerve SSEP stimulation site; and
a right ulnar nerve SSEP stimulation site (see at least par 0070 & 0072).
In regards to claim 28, Runney discloses the method of claim 21, wherein an electrode 23 provides a ground reference (see at least par 0057).
In regards to claim 29, Runney discloses the method of claim 21, wherein the neuromonitoring system 10 includes a patient module 14, a controller 12, and a plurality of electrodes (22, 24) (see at least figs. 1-2 and par 0050 & 0052-0054); and
wherein the method further comprises:
communicatively coupling the patient module 14 with the controller 12 (see at least figs. 1-2 and par 0050 & 0052-0054);
placing each of the plurality of electrodes (22, 24) (see at least fig. 1 and par 0050) at either
(i) each one of the plurality of different SSEP stimulation sites (such as by way of example only, the left and right Posterior Tibial nerve and/or the left and right Ulnar nerve) (see at least par 0059, 0070, 0073 & 0082-0083), or
(ii) each one of the two SSEP recording sites (such as, by way of example only, C2 vertebra, Cp3 scalp, Cp4 scalp, Erb's point, Popliteal Fossa) (see at least par 0070); and
coupling the plurality of electrodes (22, 24) to the patient module 14 (see at least fig. 1 and par 0050).
In regards to claim 30, Runney discloses the method of claim 29, further comprising: coupling a test probe to the patient module 14 or coupling a surgical tool clip 18 to the patient module 14 (see at least fig. 1 and par 0050 & 0056).
In regards to claim 31, Runney discloses the method of claim 29, further comprising: mounting the patient module 14 to a rail (see at least par 0053).
In regards to claim 32, Runney discloses the method of claim 29, wherein the communicatively coupling includes communicatively coupling the patient module 14 with the controller 12 using a USB cable 44; or
wherein the communicatively coupling includes wirelessly communicatively coupling the patient module 14 with the controller 12 (see at least par 0052-0054).
In regards to claim 33, Runney discloses the method of claim 21, wherein providing the user interface (GUI) showing the anatomical diagram of the body 105 includes:
showing an electromyography (EMG) user interface (GUI) element (i.e., test selection tab for each of the test functions, see par 0066) on the user interface (GUI); and
wherein the method further includes:
responsive to detecting actuation of the EMG user interface (GUI) element (i.e., test selection tab for each of the test functions, see par 0066),
operating the neuromonitoring system 10 in an EMG mode (see at least par 0051-0053 & 0056).
In regards to claim 34, Runney discloses a system comprising:
a patient module 14 (see at least fig. 1 and par 0050 & 0052-0054);
a controller 12 comprising a display 34 (see at least fig. 1 and par 0050 & 0052-0054); and
a plurality of electrodes (22, 24) (see at least fig. 1 and par 0050),
wherein the controller 12 is configured to, during a spinal surgery (see at least par 0049):
provide, at the display 34 (see at least par 0052),
an SSEP user interface (GUI) showing an anatomical diagram of a body 105 (see at least fig. 16 and par 0052 & 0067);
determine an SSEP baseline (see at least par 0074);
cause the patient module 14 to perform SSEP stimulation at one or more of a plurality of different SSEP stimulation sites using one or more stimulating electrodes (22, 24) of the plurality of electrodes (22, 24) (see at least par 0070-0071 & 0075);
cause the patient module 14 to perform SSEP recording at only two SSEP recording sites (i.e., for detecting “possible mechanical insult,” see par 0084) using two recording electrodes (22, 24) of the plurality of electrodes (22, 24) (see at least fig. 10A, par 0059 and par 0059 & 0071-0084), wherein the two SSEP recording sites comprise one subcortical recording location 292 (see par 0075) referenced to one cortical recording location 293 (see par 0084, which reads “if in response to stimulation of the left ulnar nerve, the peripheral response from Erb's Point showed no change in amplitude or latency, the subcortical response showed a decrease in amplitude, and the cortical response showed a decrease in amplitude, the event box 206 (shown in FIG. 25) would show either a yellow or a red indicator as well as the text "Possible mechanical insult”); and
at the SSEP user interface (GUI), color a representation (i.e., alert or warning) according to a comparison of one or more attributes (i.e., amplitude and latency) of the SSEP recording relative to one or more attributes (i.e., amplitude and latency) of the SSEP baseline (see at least Table 7 and par 0071 & 0082).
Runney discloses a system, as described above, that fails to explicitly teach a system wherein the controller is configured to color a representation of a limb on the anatomical diagram of the body.
However, Woods teaches that it is known to provide a system wherein the controller (see at least par 0030 & 0033) is configured to color a representation of a limb on the anatomical diagram of the body (see at least figs. 2A-B and par 0012, 0033-0034 & 0061).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Runney wherein the controller is configured to color a representation of a limb on the anatomical diagram of the body as taught by Woods since such a modification would amount to applying a known technique (i.e., as taught by Woods) to a known device (i.e., as taught by Runney) ready for improvement to achieve a predictable result such as providing depictions that aid in somatosensory evoked potential (SSEP) mapping (see at least abstract of Woods) so as to enhance stimulation results output with a color display of green, yellow or red corresponding to the relative safety level determined by the system (see at least par 0065 of Runney)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 35, Runney discloses the system of claim 34, wherein the controller 12 is further configured to:
color a representation (i.e., alert or warning) green responsive to determining that both:
an SSEP amplitude of the SSEP recording has a less than 50% change in amplitude relative to a baseline SSEP amplitude of the SSEP baseline; and
an SSEP latency of the SSEP recording has a less than 10% increase in latency relative to a baseline SSEP latency of the SSEP baseline (see at least Table 7 and par 0071 & 0082). Runney discloses a system, as described above, that fails to explicitly teach a system wherein the controller is further configured to color a representation of a limb on the anatomical diagram of the body. However, Woods teaches that it is known to provide a system wherein the controller (see at least par 0030 & 0033) is further configured to color a representation of a limb on the anatomical diagram of the body (see at least figs. 2A-B and par 0012, 0033-0034 & 0061). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Runney wherein the controller is configured to color a representation of a limb on the anatomical diagram of the body as taught by Woods since such a modification would amount to applying a known technique (i.e., as taught by Woods) to a known device (i.e., as taught by Runney) ready for improvement to achieve a predictable result such as providing depictions that aid in somatosensory evoked potential (SSEP) mapping (see at least abstract of Woods) so as to enhance stimulation results output with a color display of green, yellow or red corresponding to the relative safety level determined by the system (see at least par 0065 of Runney)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 36, Runney discloses the system of claim 34, wherein the controller 12 is further configured to:
color a representation (i.e., alert or warning) yellow responsive to determining that either:
an SSEP amplitude of the SSEP recording has a more than 50% change in amplitude relative to the baseline amplitude of the SSEP baseline; or
an SSEP latency of the SSEP recording has a greater than 10% increase in latency relative to a baseline SSEP latency of the SSEP baseline (see at least Table 7 and par 0071 & 0082). Runney teaches that it is known to provide a system, as described above, that fails to explicitly teach a system wherein the controller is configured to color a representation of a limb on the anatomical diagram of the body. However, Woods teaches that it is known to provide a system wherein the controller (see at least par 0030 & 0033) is configured to color a representation of a limb on the anatomical diagram of the body (see at least figs. 2A-B and par 0009, 0012, 0033-0034 & 0061). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Runney wherein the controller is configured to color a representation of a limb on the anatomical diagram of the body as taught by Woods since such a modification would amount to applying a known technique (i.e., as taught by Woods) to a known device (i.e., as taught by Runney) ready for improvement to achieve a predictable result such as providing depictions that aid in somatosensory evoked potential (SSEP) mapping (see at least abstract of Woods) so as to enhance stimulation results output with a color display of green, yellow or red corresponding to the relative safety level determined by the system (see at least par 0065 of Runney)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 37, Runney discloses the system of claim 34, further comprising: a USB cable 44 coupling the patient module 14 and the controller 12 (see at least par 0052-0054).
In regards to claim 38, Runney discloses the system of claim 34, further comprising: a test probe 116 (see at least par 0091-0092) or a surgical tool clip 18 (see at least fig. 1 and par 0050).
In regards to claim 39, Runney discloses the system of claim 34, wherein to provide the SSEP user interface (GUI) showing the anatomical diagram of the body 105 includes to:
show an electromyography (EMG) user interface (GUI) element (i.e., test selection tab for each of the test functions, see par 0066) on the SSEP user interface (GUI) (see at least fig. 31 and par 0066 & 0092-0094); and
wherein the controller 12 is further configured to:
responsive to detecting actuation of the EMG user interface (GUI) element (i.e., test selection tab for each of the test functions, see par 0066), operate the neuromonitoring system 10 in an EMG mode (see at least par 0051-0053 & 0056).
In regards to claim 40, Runney discloses the system of claim 34, wherein the patient module 14 comprises:
a controller port 50 configured for coupling the patient module 14 with the controller 12 (see at least par 0054-0058);
one or more electrical connectors for electrically coupling the patient module 14 with the plurality of electrodes (22, 24) (see at least par 0054-0058);
SSEP stimulating circuitry for delivering SSEP stimulation with the one or more stimulating electrodes 22 (see at least fig. 10A and par 0073, 0075, 0081 & 0087); and
SSEP recording circuitry for recording with the two recording electrodes 24 (see at least fig. 10A and par 0059).
Response to Arguments
Applicant's arguments filed December 12, 2025 have been fully considered but they are not persuasive. Applicant contends that the prior art fails to teach a method comprising a controller configured to cause the patient module to perform SSEP recording at only two SSEP recording sites using two recording electrodes of the plurality of electrodes, wherein the two SSEP recording sites comprise one subcortical recording location referenced to one cortical recording location. However, the Office submits that Runney teaches that it is known to make SSEP recordings at only two SSEP recording sites (i.e., one subcortical and the other cortical) in order to determine “possible mechanical insult,” and alert the surgeon, see par 0084 thereof.
In view of the foregoing, the rejections over at least Runney are maintained.
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 RENE T TOWA whose telephone number is (313)446-6655. The examiner can normally be reached Mon-Fri, 9:00 AM-5:00 PM.
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/RENE T TOWA/Primary Examiner, Art Unit 3791
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