Prosecution Insights
Last updated: October 04, 2026
Application No. 18/807,303

INSTRUMENT FOR DETECTING AUDITORY EVOKED NEURAL RESPONSES

Final Rejection §103§112
Filed
Aug 16, 2024
Priority
Aug 18, 2023 — EU 23192154.5
Examiner
CERIONI, DANIEL LEE
Art Unit
Tech Center
Assignee
Interacoustics A/S
OA Round
2 (Final)
64%
Grant Probability
Moderate
3-4
OA Rounds
1y 5m
Est. Remaining
92%
With Interview

Examiner Intelligence

Grants 64% of resolved cases
64%
Career Allowance Rate
502 granted / 778 resolved
+4.5% vs TC avg
Strong +28% interview lift
Without
With
+28.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
70 currently pending
Career history
849
Total Applications
across all art units

Statute-Specific Performance

§101
9.9%
-30.1% vs TC avg
§103
42.9%
+2.9% vs TC avg
§102
12.7%
-27.3% vs TC avg
§112
32.3%
-7.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 778 resolved cases

Office Action

§103 §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 . 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. Notice of Amendment In response to the amendment(s) filed on 8/12/26, amended claim(s) 1-3, 5-12, 14, 17-18, and 20, and canceled claim(s) 4, 13, 15-16, and 19 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth: 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(s) 1-3, 5-12, 14, 17-18, and 20 is/are 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. For claim 1, the claim terms “an F-value” (line 16) and “an F-value” (line 19) are ambiguous. It is unclear whether the same term is being referred to or whether these are supposed to be different terms. The claim is examined under the former interpretation. For claim 11, the claim terms “an F-value” (line 13) and “an F-value” (line 17) are ambiguous. It is unclear whether the same term is being referred to or whether these are supposed to be different terms. The claim is examined under the former interpretation. Dependent claim(s) 2-3, 5-10, 12, 14, 17-18, and 20 fail to cure the ambiguity of independent claim(s) 1 and 11, thus claim(s) 1-3, 5-12, 14, 17-18, and 20 is/are rejected under 35 U.S.C. 112(b). Claim Rejections - 35 USC § 103 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. Claim(s) 1-2, 5-12, 17-18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2003/0144601 to Prichep in view of U.S. Patent No. 6,200,273 to Sininger et al. (hereinafter “Sininger”). For claim 1, Prichep discloses an instrument for detecting evoked responses according to a test protocol (Abstract) (also see para [0014] and [0020]), where the instrument comprises at least one output unit (10) (Fig. 1) (para [0014]) comprising a transducer (“stimulus transducer,” para [0014]), the output unit being configured to receive at least one stimulus or plurality of consecutive stimuli (para [0014] and [0020]) and to provide said at least one stimulus or plurality of consecutive stimuli to a test subject (para [0014]) (also see Fig. 1 and para [0015]), at least one recording unit (15) (Fig. 1) (para [0015]) comprising one or more sensors (“biosensor,” para [0015]) for measuring one or more evoked responses of the test subject, in response to said provided at least one stimulus or plurality of consecutive stimuli (para [0015]), a processor (20) (Fig. 1) (para [0018]) configured to receive and analyse said measured one or more evoked responses (para [0018]), where said processor is configured to determine a probability, p, of whether each of said responses is driven by an underlying background noise during operation of said instrument (para [0034]), and where the analysis unit is configured to determine said probability, p, based on an F-value of the measured one or more evoked responses determined as a ratio between a variance of an average one or more evoked responses and a variance of a residual background noise (para [0034]). Prichep does not expressly disclose wherein the processor is configured to determine said probability, p, based on an F-value of the measured one or more evoked responses determined as a ratio between a statistical degrees of freedom (DOF) of a variance of the average one or more evoked responses and a statistical DOF of a variance of a residual background noise for a plurality of frequencies of interest. However, Sininger teaches determining a probability, p, based on an F-value of the measured one or more evoked responses determined as a ratio between a statistical degrees of freedom (DOF) of a variance of the average one or more evoked responses and a statistical DOF of a variance of a residual background noise for a plurality of frequencies of interest (col. 5, lines 26-45). It would have been obvious to a skilled artisan to modify Prichep wherein the processor is configured to determine said probability, p, based on an F-value of the measured one or more evoked responses determined as a ratio between a statistical degrees of freedom (DOF) of a variance of the average one or more evoked responses and a statistical DOF of a variance of a residual background noise for a plurality of frequencies of interest, in view of the teachings of Sininger, for the obvious advantage of improving the accuracy of evoked response detection by correcting biases just for the samples being measured and not for an entire population. For claim 2, Prichep further discloses wherein said one or more sensors is configured to measure one or more evoked responses comprising a ratio of stimulus evoked average response variance to the residual background noise variance (para [0033]-[0034]). For claim 5, Prichep further discloses wherein the processor is configured to estimate a power of the residual background noise at each of the plurality of frequencies of interest by averaging the power of the residual background noise at neighboring frequencies to said frequencies of interest (para [0023]). For claim 6, Prichep further discloses wherein said processor is configured to adaptively determine said probability during operation of said instrument (“adaptive optimum filtering algorithm,” Abstract). For claim 7, Prichep further discloses wherein said at least one stimulus or plurality of consecutive stimuli comprises acoustic stimuli such as clicks, narrow-band chirps, auditory change complex (ACC) type stimuli, and/or speech signals, and/or comprises electrical stimulations (para [0013]). For claim 8, Prichep further discloses wherein said measured one or more evoked responses comprises auditory brainstem responses (ABR), cortical auditory potentials (CAP), or auditory steady-state responses (ASSR), or otoacoustic emissions (OAE), or any response relying on averaging to reduce the underlying background noise to detect a target signal (para [0010]). For claim 9, Prichep further discloses wherein said processor is configured to determine a hearing ability of the test subject in response to (Examiner’s Note: conditional claim language) said probability being below a predetermined threshold (para [0049]) (also see [0034]). For claim 10, Prichep does not expressly disclose wherein said at least one stimulus or plurality of consecutive stimuli is amended in response to said determined probability. However, Garcia wherein said at least one stimulus or plurality of consecutive stimuli is amended in response to said determined probability (para [0038]). It would have been obvious to a skilled artisan to modify Prichep wherein said at least one stimulus or plurality of consecutive stimuli is amended in response to said determined probability, in view of the teachings of Garcia, for the obvious advantage of reaching the threshold for the probability, which is what Prichep already wants to do (see para [0034] of Prichep). For claim 11, Prichep discloses a method of detecting evoked responses (Abstract), where the method comprises: generating at least one stimulus or a plurality of consecutive stimuli according to a test protocol (para [0014] and [0020]), providing said at least one stimulus or plurality of consecutive stimuli to a test subject (para [0014]) (also see Fig. 1 and para [0015]), arranging one or more sensors on the test subject (para [0015]), measuring one or more evoked responses of the test subject, in response to said provided at least one stimulus or plurality of consecutive stimuli (para [0015]), receiving and analysing said measured one or more evoked responses (para [0018]), by a processor (20) (Fig. 1) (para [0018]), determining a probability, p, of whether each of said responses is driven by an underlying background noise during operation of said instrument by determining said probability, p, based on an F-value of the measured one or more evoked responses determined as a ratio between a variance of an average one or more evoked responses and a variance of a residual background noise, each with the statistical degrees of freedom v and r, respectively (para [0034]). Prichep does not expressly disclose wherein said probability, p, is determined based on an F-value of the measured one or more evoked responses determined as a ratio between a statistical degrees of freedom (DOF) of a variance of the average one or more evoked responses and a statistical DOF of a variance of a residual background noise for a plurality of frequencies of interest. However, Sininger teaches determining a probability, p, based on an F-value of the measured one or more evoked responses determined as a ratio between a statistical degrees of freedom (DOF) of a variance of the average one or more evoked responses and a statistical DOF of a variance of a residual background noise for a plurality of frequencies of interest (col. 5, lines 26-45). It would have been obvious to a skilled artisan to modify Prichep wherein the processor is configured to determine said probability, p, based on an F-value of the measured one or more evoked responses determined as a ratio between a statistical degrees of freedom (DOF) of a variance of the average one or more evoked responses and a statistical DOF of a variance of a residual background noise for a plurality of frequencies of interest, in view of the teachings of Sininger, for the obvious advantage of improving the accuracy of evoked response detection by correcting biases just for the samples being measured and not for an entire population. For claim 12, Prichep further discloses a data processing system comprising a processor (“microprocessor,” para [0018]) and program code (“software program means,” para [0018]) for causing the processor to perform at least some of the steps, including the step of determining a probability, p, of the method of claim 11 (see rejection of claim 11). For claim 17, Prichep further discloses wherein the processor is configured to estimate a power of the residual background noise at each of a plurality of frequencies of interest by averaging the power of the residual background noise at neighboring frequencies to said frequencies of interest (para [0023]). For claim 18, Prichep further discloses wherein the processor is configured to estimate a power of the residual background noise at each of the plurality of frequencies of interest by averaging the power of the residual background noise at neighboring frequencies to said frequencies of interest (para [0023]). For claim 20, Prichep further discloses wherein said analysis unit is configured to adaptively determine said probability during operation of said instrument(“adaptive optimum filtering algorithm,” Abstract). Allowable Subject Matter Claim(s) 3 and 14 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b), set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Response to Arguments Applicant’s arguments filed 8/12/26 have been fully considered. With respect to the specification, Applicant’s amendments and arguments are persuasive and thus the objection is withdrawn. With respect to the claim objections, Applicant’s amendments and arguments are persuasive and thus the objections are withdrawn. With respect to the 112 rejections, Applicant’s amendments and arguments are persuasive and thus the rejections are withdrawn. With respect to the 103 rejections, Applicant’s arguments have been considered but are moot because the arguments do not address the new grounds of rejection necessitated by Applicant’s amendments presented in the response filed 8/12/26. 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 DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT. 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, Jennifer Robertson can be reached at (571) 272-5001. 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. /DANIEL L CERIONI/Primary Examiner, Art Unit 3791
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Prosecution Timeline

Aug 16, 2024
Application Filed
May 12, 2026
Non-Final Rejection mailed — §103, §112
Aug 12, 2026
Response Filed
Sep 04, 2026
Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
64%
Grant Probability
92%
With Interview (+28.0%)
3y 6m (~1y 5m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 778 resolved cases by this examiner. Grant probability derived from career allowance rate.

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