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 .
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-18 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). In claim 1, line 2, “implanted in a subject…” sounds as if there is a claimed connection to the human body as this limitation is claiming the nerve stimulator in the body. It is suggested to use functional terms such as “implantable” or “configured to be implanted”.
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 1-35 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.
In claim 1, line 2, “implanted in a subject…” is vague and sounds more like a method step than a structural limitation. In addition, apparatus claims cannot claim connection to the human body. It is suggested to use functional language such as “configured to be implanted” or “implantable” and the examiner has interpreted the claim and prior art as requiring a nerve stimulator that is implantable or configured to be implanted. In line 3, “based on transmitting electrical stimulation pulses” is vague and unclear if the stimulator is producing the pulses or some other element is producing them, and if that other element is being positively claimed/recited. It is suggested to use “by transmitting…”. In line 4, “via one or more electrodes” is inferentially included and it is unclear if the applicant is positively reciting/claiming the electrodes or if the electrodes are meant to be an intended/functional use recitation. If the electrodes are meant to be positively recited/claimed, it is suggested to insert them in line 2, such as “a nerve stimulator implantable in a subject, having one or more electrodes, and configured to…”. In line 5, “sensor associated with the subject” is vague and unclear if the applicant is trying to claim a connection to the body. It is suggested to delete “associated with the subject and”. In line 6, “wherein the nerve stimulator comprises a controller communicatively coupled to the nerve stimulator” is vague and circular. If the nerve stimulator has the controller, then it is communicatively coupled to itself.
In claim 2, line 5, “store, in memory” is vague and inferentially including the memory. It is unclear if the memory is being positively recited/claimed or is meant as an intended/functional use. If the memory is meant to be positively claimed, it is suggested to first state that the system “further comprises a memory” before it is further used.
Claims 10 and 13 use similar language and are therefore vague.
Claims 3-5 are vague and seem to conflict with claim 2. Claim 2 states the determining is done by the nerve stimulator controller. However claims 3-5 seem to suggest that the determining is “performed” at different devices, such as a smart phone, wirelessly connected controller, cloud computing, etc. 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. In claims 3 and 4, “corresponding to…” is vague as it is unclear if the actual devices listed (computer, smart phone, wirelessly connected controller, etc.) are being recited, or if something similar to, but not necessarily being those devices are being recited. 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.
In claim 14, line 4, “and use…when determining therapeutic effects” is vague and unclear if the claim is setting forth that therapeutic effects are being determined or not. No element has been set forth to determine therapeutic effects and therefore it is unclear how the biomarker data is “used”.
Claim 31 uses similar language and is vague as it is unclear if a method step is being recited.
In claim 16, “stimulation administered” is vague as it is unclear if this is referencing the stimulation pulse used in claim 1 or something different. If it is the same, then “the stimulation pulse” should be used in claim 16.
Claim 33 uses similar language and is vague.
In claim 17, line 2, “one or electrode” is misworded. In line 3, “to deliver electrical stimulation pulse” is vague as this term is also used in claim 1. It is unclear if they are the same or not—and if it is meant to be a pulse or pulses.
Claim 34 uses similar language and is vague.
Claim 18 uses similar language for the stimulation pulse and is vague.
In claim 19, line 2, “providing a nerve stimulation implanted…” is vague as it is unclear if the implantation is being positively recited or not. Method steps must use active voice to positively recite a step. It is suggested to state “implanting a nerve stimulator” or deleting “implanted”. In line 3, “based on transmitting electrical stimulation pulses” is vague and unclear if the stimulator is producing the pulses or some other element is producing them, and if that other element is being positively claimed/recited. It is suggested to use “by transmitting…”.
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…”. In claims 21 and 22, “corresponding to…” is vague as it is unclear if the specific element such as the smart phone is being recited or if something similar will do. The examiner has interpreted these claims as containing a system or method only needing to be capable of performing the intended use recitations.
In claims 22 and 23, “(implanted)” is vague as it is unclear if the limitations in the parentheses are needed in the prior art/claim.
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 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
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.
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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 2/14/26