DETAILED ACTION
This Office Action is in response to the communication dated 28 October 2025 concerning Application No. 18/366,157 filed on 07 August 2023.
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 .
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 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.
Status of Claims
Claims 1-14 are pending and currently under consideration for patentability; claims 1, 10, and 11 have been amended; claims 12-14 have been added as new claims.
Response to Arguments
Applicant’s arguments with respect to claims 1-11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant has amended the independent claims to recite wherein the reference waveform is a waveform of the subject detected under a predetermined condition before acquiring the waveform corresponding to the change over time in the evoked potential of the subject based on stimulation. The Examiner has addressed the amended limitations in the updated text of the rejection below.
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.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Raviv et al. (US 4,649,482) in view of McGinnis et al. (US 2006/0276720 A1).
Regarding claims 1, 10, and 11, Raviv describes a neural monitoring system, a processing apparatus, and a non-transitory computer-readable storage medium (Abstract: “an apparatus for monitoring and operating on brain input activity signals”) comprising
a stimulation device configured to generate a stimulation signal corresponding to stimulation applied to a subject (col 3:16-21)
a processing apparatus (col 3:22-4:4) configured to
acquire a waveform corresponding to a change over time in an evoked potential of the subject based on the stimulation (col 10:17-39)
cause a display device to display an index indicating any one of a plurality of colors (col 9:46-60), based on an amplitude value of the waveform and an amplitude change rate (col 8:52-59, 10:17-39, 17:10-26), the amplitude value being acquired based on a predetermined rule, the amplitude change rate being a ratio of the amplitude value to an amplitude value of a reference waveform (col 17:36-63)
Regarding claims 1, 10, and 11, although Raviv describes using a reference electrode for comparison purposes, Raviv does not explicitly disclose wherein the reference waveform is a waveform of the subject detected under a predetermined condition before acquiring the waveform corresponding to the change over time in the evoked potential of the subject based on stimulation. However, McGinnis also describes a neural monitoring system ([0006]) including acquiring a reference waveform of a subject detected under a predetermined condition before acquiring a waveform corresponding to a change over time in the evoked potential of the subject based on stimulation ([0014], [0047]). As McGinnis is also directed toward neural monitoring and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use a subject’s previously acquired waveform as a reference, similar to what is described by McGinnis, when using the system described by Raviv, as doing so advantageously allows the resulting system to normalize a subject’s responses to the subject’s own reference values.
Regarding claim 2, Raviv describes wherein the processing apparatus is further configured to cause the display device to display the index together with the waveform (figures 5 and 7).
Regarding claim 3, Raviv describes wherein the processing apparatus is further configured to cause the display device to display the index together with a change over time in one of the amplitude value and the amplitude change rate (figures 5 and 7).
Regarding claim 4, Raviv describes wherein the processing apparatus is further configured to select a color of the index based on the amplitude value and select the color of the index based on the amplitude change rate (col 9:61-10:2, 17:10-26). Although Raviv does not explicitly disclose wherein the processing apparatus selects the color based on the amplitude change rate “in a case where the color of the index is not able be selected based on only the amplitude value,” the Examiner respectfully submits that, as Raviv describes that the user may select the colors, textures, and graphics as necessary for a preferred display, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to select the color based on an the amplitude or the amplitude change rate, based on the user’s preference, as doing so advantageously allows the user to generate whichever color map is desired.
Regarding claim 5, Raviv describes wherein the index is a graphic (col 9:46-10:2; figure 5, scale 46; figure 7, scale 46), and the processing apparatus is further configured to change a shape of the graphic in a case where the amplitude value of the reference waveform is less than a threshold (col 9:46-10:2, figures 5 and 7, the graphic at any point on map 44 changes in accordance with the amplitude of the evoked potential at that point; col 8:4-11, live time display of data; col 16:38-50, threshold activation protocol).
Regarding claim 6, Raviv describes wherein the processing apparatus is further configured to change the shape of the graphic based on an instruction of changing the threshold (col 9:46-10:2, figures 5 and 7, the graphic at any point on map 44 changes when the amplitude of the evoked potential at that point deviates beyond the range of amplitudes coded to that graphic).
Regarding claim 7, Raviv describes wherein the index is a graphic and the processing apparatus is further configured to change a shape of the graphic based on an instruction of changing a color of the index (col 9:46-10:2, figures 5 and 7).
Regarding claim 8, Raviv describes wherein the index is a graphic (col 9:46-10:2, figures 5 and 7), and the processing apparatus is further configured to change a shape of the graphic based on an instruction of changing a correlation between a color of the index and at least one of the amplitude value and the amplitude change rate col (col 9:46-10:2, 17:36-63).
Regarding claim 9, McGinnis describes wherein the display device is provided in a field of view of a surgical microscope ([0038], [0063]).
Regarding claims 12-14, although neither Raviv nor McGinnis explicitly disclose wherein the index is displayed according to a predetermined correlation for combinations of the amplitude value of the waveform and the amplitude change rate, Raviv provides an extensive discussion of how the user can select the color coding and generate a customized topological map for a particular location on the user, for a particular set of frequencies, for a particular set of amplitudes, and the like (col 9:9-10:68), including for combinations of the above criteria. Based on this, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to configure the color coding used by Raviv such that particular colors were associated with a predetermined correlation of the amplitude values and the amplitude change rates, as doing so advantageously allows the resulting maps to display the effect of these parameters on the evoked response of the subject.
Statement on Communication via Internet
Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant:
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
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 Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM 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, Carl Layno, can be reached by telephone at 571-272-4949. 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 at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3792