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 .
Election/Restrictions
Applicant's election with traverse of group II in the reply filed on 24 June 2026 is acknowledged. The traversal is on the ground(s) that the duty to make claims different per 37 CFR 1.75 caused the underlying basis for restriction. This is not found persuasive. The claims were amended so that the system claims no longer required a cochlear implant sub-system, but instead an implant sub-system. However, the process as claimed could still be practiced by another and materially different apparatus, not requiring a sub-system configured to operate electrodes of an electrode array as a source and a sink and operate electrodes of the electrode array as read electrodes.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1 – 7 and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 24 June 2026.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 8 – 20 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 – 19 of U.S. Patent No. USPN 11,590,343. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present application and the ‘343 claim measuring a feature resulting from an electrical phenomenon. The claims of the current application are more broad than the ‘343 patent. Therefore, the claims of the ‘343 patent anticipate the claims of the current application.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 8 – 11, 13, 14, 18 – 20, and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Polak (US PGTPUB 2020/0375667).
Regarding claim 8, Polak discloses a method, comprising: establishing an electrical phenomenon within a cavity of a human (e.g. ABSTRACT, ¶ 2, 8 – 13); measuring a feature resulting from the electrical phenomenon (e.g. ¶ 8 – 13); and identifying the presence of an occurrence based on the measurement of the feature (e.g. ABSTRACT potential trauma response is identified when at least one measurement difference value exceeds a defined difference value).
Regarding claim 9, Polak discloses the cavity is a cochlea of the human (e.g. ¶ 20).
Regarding claim 10, Polak discloses the electrical phenomenon is established by applying electrical current to an electrode of a cochlear implant electrode array located in a cochlea of the human (e.g. ¶ 13, 24 – 26).
Regarding claim 11, Polak discloses the action of measuring includes measuring, at a first electrode and a second electrode of an intra-cochlea electrode array, a voltage induced by flowing current at a plurality of temporal locations and the action of identifying includes identifying that a change between voltage measurements at the first electrode and the second electrode has occurred between the temporal locations (e.g. ¶ 21, 24).
Regarding claim 13, Polak discloses the cavity is a cochlea of the human;the electrical phenomenon is an electric field generated within the cochlea utilizing a cochlear implant (e.g. ¶ 20).
Regarding claim 14¸ Polak discloses the feature is a voltage that is measured with the cochlear implant, induced by the electric field, at two intra-cochlea measurement electrodes that are part of the cochlear implant, wherein respective voltages are measured relative to a common reference electrode and the measurement electrodes are spaced symmetrically about the reference electrode (e.g. ¶ 21).
Regarding claim 18, Polak discloses the action of establishing the electrical phenomenon includes causing current to flow from a third electrode of an intra-cochlea electrode array to a fourth electrode of the intra- cochlea electrode array at a plurality of temporal locations (e.g. ¶ 21 – 24).
Regarding claim 19, Polak discloses the third electrode is disposed at an apical end of the intra-cochlea electrode array, and the fourth electrode is disposed basally of the third electrode (e.g. ¶ 21 – 24).
Regarding claim 20, Polak discloses the action of causing current to flow and measuring the voltage is executed during the first and second temporal locations while advancing the intra-cochlea electrode array into the cochlea of the recipient (e.g. ¶ 24 – 26).
Regarding claim 22, Polak discloses the action of identifying the presence of the occurrence is executed in real time (e.g. ¶ 7).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 12 and 15 – 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Polak.
Regarding claims 12 and 15 – 17, Polak discloses identifying the presence of an occurrence based on voltage measurements, but doesn’t specifically recite the presence of asymmetry in the voltage measurements. However, asymmetry in voltage measurements as biomarkers is well known in the art. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Polak with identifying the presence of asymmetry in voltage measurements, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
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 McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3796
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