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 .
Response to Arguments
Applicant's arguments filed 5/29/26 have been fully considered but they are not persuasive.
The argument that Osario does not contain any system, function, and/or step to delivering stimulation, sensing the pupil diameter after the stimulation and then “controlling administration of the stimulation therapy based on the obtained change of measurement in pupil size” is not persuasive. Osario discloses, and the 102 rejection points out, that his system operates in a “closed loop” stimulation feedback (e.g. paras. 39, 6, etc.), which means that the stimulation is controlled based on sensed parameters. Osario discloses using sensed autonomic parameters/indices--pupil diameter (e.g. 39, 88, 107, 117-119, 35, etc.)--and therefore does meet the limitation of “controlling administration of the stimulation therapy based on the obtained change of measurement in pupil size”.
Osario also discloses in figure 6B, element 670, paragraph 126, that the stimulation is modified/changed based on the test results of the autonomic parameters/indices, where the indices use pupil diameter. This stimulation and testing is “on-going” and can be made repeatedly after milliseconds (e.g. paras. 62, 120, etc.) and therefore any change in stimulation in element 670, results in further sensing of the pupil diameter due to that stimulation and further testing, which then results in further modifying/adjusting of the stimulation (e.g. element 670) due to pupil diameter.
The argument that the 103 rejection fails to satisfy the evidentiary standard required under MPEP 2144.03 is not persuasive and not aligned with 2144. As stated in 2144I and 2144.03: “The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992); see also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings); Ex parte Clapp, 227 USPQ 972 (Bd. Pat. App. & Inter. 1985) (examiner must present convincing line of reasoning supporting rejection); and Ex parte Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. 1993) (reliance on logic and sound scientific reasoning)”; and “Official notice unsupported by documentary evidence may be taken by the examiner where the facts asserted to be well-known, or to be common knowledge in the art, are "capable of such instant and unquestionable demonstration as to defy dispute." In re Ahlert, 424 F.2d 1088, 1091, 165 USPQ 418, 420 (CCPA 1970) (citing In re Knapp Monarch Co., 296 F.2d 230, 132 USPQ 6 (CCPA 1961))”.
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.
Claims 3-5 and 21-23 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.
Claims 3-5 are vague and it is unclear what element is performing the determining and if those devices in claims 3-5 are being positively claimed/recited or if they are meant as intended/functional use recitations where the determining just has to be capable of being performed/determined in those devices. If the devices are meant to be positively recited, it is suggested to first state the system “further comprises” those devices before they are used for the “determining” function. In claim 5, “via data communicated wirelessly…system” is vague and unclear if the claim is positively reciting this as a function of a particular system element or not. The examiner has interpreted these claims as containing a system or method only needing to be capable of performing the intended use recitations.
Claims 21-23 uses passive voice, “is performed…” and it is unclear if the claim is positively reciting a method step. It is suggested to use active voice, such as “performing the determining at an external…”. The examiner has interpreted these claims as containing a system or method only needing to be capable of performing the intended use recitations.
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 1, 6, 14-19, 24, and 31-35 are rejected under 35 U.S.C. 102a1 as being anticipated by Osorio (2011/0251468). Osorio meets the claimed limitations as follows:
--an implantable nerve stimulator (e.g. figure 1, element 110; para. 36, etc.) for delivering stimulation pulses using multiple electrodes (e.g. figure 1, element 126, 128, 130; figure 2, element 220; paras. 36-39, etc.)
--a pupillometry sensor to measure pupil size and change in size (e.g. paras. 88, 117, 35 etc.), with the nerve stimulator controller coupled to the sensor (e.g. figures 2 and 5, controller at element 215; paras. 48-49, etc.) configured to
--cause the stimulator to deliver vague pulses to the first and second electrodes (e.g. paras. 35, 38-39, open and closed loop stimulation; para. 107, etc.)
--measure by the pupil sensor a change in the size of the pupil due to the stimulation (e.g. paras. 88, 107, 117, etc.) and
--control stimulation based on the change in pupil size (e.g. paras. 39, 107, 126, figure 6b, element 670, etc.).
For claims 14-16 and 31-33, Osorio also discloses that HRV can be measured to adjust the therapy (e.g. paras. 66, 106, 115, 126, etc.). For claims 17 and 34, as the device does deliver monophasic or biphasic stimulation it must obtain a selection of the electrodes to deliver the therapy (e.g. para. 50, etc.). For claim 35, the system does have an external programmer which does allow a remote operator to adjust stimulation parameters (e.g. paras. 40, 63-64, etc.).
Claim Rejections - 35 USC § 103
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.
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.
Claims 2-5, 10-13, 20-23, and 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Osorio in view of Hogg et al (2023/0285745). Osorio as discussed above discloses the claimed invention to work in a feedback loop to find the appropriate stimulation parameters for the first and second electrodes to set/store the parameters so that the pulse generator can effectively stimulate the patient, and using measurements of the pupil diameter or change in size as part of the feedback. As the applicant has disclosed in their paragraph 52, the afferent stimulation/action potential caused by the stimulation of the vagus nerve causes a slight increase in pupil size, which Osorio’s detecting that the stimulation pulse causes a change in pupil size is therefore necessarily a determination of whether the electrical stimulation causes an action potential in afferent fibers based on the change of pupil size. Osorio does not disclose that the change in size is stored as the minimum threshold parameter for the first and second electrodes (e.g. claim 2, 13, 20, and 30, etc.), that the change in size of the pupils are determined when the stimulation is started and stopped in relation to the timing of the pulse train (e.g. claims 10-11 and 27-28, etc.), or if the pupil size does not change—i.e. no determination of an action potential in the afferent nerve—to subsequently increase a stimulation parameter to obtain more measurements of pupil size change (e.g. claims 12 and 29, etc.). Hogg discloses that to find the proper parameters for the electrodes used in stimulation, that change in pupil size is used during and at the end of stimulation so that if the stimulation is effective the parameters are set/stored, and if the stimulation is not effective, then the stimulation is increased and further measurement of changes in pupil size are taken to determine the most effective stimulation parameters (e.g. paras. 1351-1362, etc.). 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 Osorio, with providing stimulation that causes a change in pupil size to be measured during and at the end of stimulation so that if the stimulation is effective the parameters for the electrodes are set/stored, and if the stimulation is not effective, then the stimulation is increased and further measurement of changes in pupil size are taken, as taught by Hogg, since it would provide the predictable results of determining effective parameters for stimulation that do not under stimulate or overstimulate the patient. For claims 3-5 and 21-23, as the system of Osorio discloses that external and internal components can do the processing/determining (e.g. figures 2-4, etc.), the prior art of Osorio is capable of meeting the intended/functional use recitations of being done by a computer, wireless discrete controller, cloud computing, etc.
Claims 7-9 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Osorio. Osorio discloses the claimed invention and using multiple sensors simultaneously, such as EMG and pupil size, to determine the most effective stimulation parameters, but does not disclose specifically obtaining the EMG during stimulation to set the maximum value of the stimulation (e.g. claims 7 and 25) and using the controller to control light sources to the pupils to obtain a nominal pupil size or constant level of light to the eyes to monitor changes in pupil sizes (e.g. claims 8-9 and 26). 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 (and is admitted prior art as the applicant has not specifically pointed out the errors in the examiner’s findings and/or provided evidence of non-obviousness) to have modified the system and method as taught by Osorio, with obtaining the EMG during stimulation to set the maximum value of the stimulation or using the controller to control light sources to the pupils to obtain a nominal pupil size or constant level of light to the eyes to monitor changes in pupil sizes, as is well known and common knowledge in the art (mpep 2144I, 2144.03) since it would provide the predictable results of allowing the feedback loop to easily sense muscle movement side effects due to too great of stimulation so that level of stimulation is not further delivered, and providing conventional pupillometry sensors having light sources that are controlled so the amount of light provided to the eye constant so that ambient light does not interfere with the measurements and the change in pupil size can be accurately detected.
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 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.
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/George R Evanisko/Primary Examiner, Art Unit 3792 8/6/26
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