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
Claims 12, 14-15, 27-30, 32, and 34-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/8/25.
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.
Claims 11, 16, 18, 26, 31, 36, 38, and 40 are rejected under 35 U.S.C. 102a1 as being anticipated by Corndorf (8102999). Corndorf discloses the following claimed elements
-an implantable medical device (e.g. figure 1, col. 22, lines 47-51, etc.; pacemaker, defibrillator, neural stimulator, sensor to detect the external transmission signals, and stimulator)
--the system and method using microprocessors and software, necessarily requiring a computer readable medium with instructions (e.g. col. 6, lines 20-45, col. 9, lines 1-20, etc.)
--obtaining/receiving an input command to control the device (e.g. col. 22, lines 47-51 to place the device in standby; col. 23, lines 37-40, request to power up back-door circuitry, etc.)
--determine whether a bypass scenario occurs by comparing the command for control of the medical device with a current context in which the medical device is operating (e.g. determining whether the backdoor is open or closed, where a current context is having the magnet next to the Hall-effect sensor that means the backdoor is open, col. 23, lines 40-49, etc.)
--perform a verification based on the command responsive to determining a bypass scenario did not occur (e.g. the backdoor is closed or now closed, therefore requiring verification/authentication of any external device; col. 23, lines 4-9, 45-49; col. 10, lines 25-27, etc. of verifying the input command data to authorize the external device) and not allowing the medical device to transfer data if the verification/authentication fails (claims 18, 38, etc.).
--bypass verification responsive to determining a bypass scenario occurred (e.g. cols. 22-23, putting the device in backdoor mode so no authentication is required—col. 22, lines 19-24, 65-66, etc.). This meets the claimed “consistent context scenario” or current context as the command is compared with a context in which the medical device is operating and will consistently bypass verification when in the backdoor mode. A command to open the backdoor to sense for a magnetic signal is compared with the current context the medical device is operating in—whether a magnet is next to the medical device (e.g. col 23, lines 34-49, etc.)—to allow for the backdoor to open.
--for claims 16/36, the first sensor is the communication sensor/circuitry for sensing the input command to be put in backdoor mode (e.g. col. 23, lines 34-40, etc.), a second sensor to obtain data to determine the current context is the Hall-effect sensor to determine the current context of whether the magnet is next to the sensor or not.
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 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Corndorf. Corndorf discloses the claimed invention and that the system may be a neurostimulator and deliver stimulation when in the backup mode (e.g. col. 22, lines 43-51, etc.), but does not specifically state that the neurostimulation is to the auditory nerve. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Corndorf, with the neurostimulation being auditory stimulation when in backup mode, as is well known and common knowledge in the art (mpep 2144I, 2144.03), since it would provide the predictable results of providing verification/authentication of external control of the medical device, and bypassing the verification when needed, in an auditory neurostimulation device, such as a cochlear stimulator, to aid deaf people in hearing while still providing protection to them from hackers.
Response to Arguments
Applicant's arguments filed 4/23/26 have been fully considered but some of them are not persuasive. The 101 rejection has been withdrawn as the claims contain a limitation of controlling the medical device based on the command and a human mind cannot control a medical device. The 102 rejection has not been withdrawn and the new/amended claim limitations are addressed above in the 102 rejection.
Allowable Subject Matter
Claims 13, 17, 19, 37, 39, and 41 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
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 George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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, Benjamin Klein can be reached at 571-270-5213. 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.
/George R Evanisko/Primary Examiner, Art Unit 3792 7/28/26
Prosecution Insights