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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/12/2025 has been entered.
Response to Arguments
Applicant's arguments filed 12/15/2025 have been fully considered but they are not persuasive.
Applicant argues, “Perez, alone and in combination with Thacker, fails to teach or suggest "programming a signal generator to deliver an electrical signal to a spinal cord of the patient" as now recited.”
Examiner respectfully disagrees. Under broadest reasonable interpretation, the limitation, “programming a signal generator to deliver an electrical signal to a spinal cord of the patient via at least one implanted signal delivery element positioned proximate to a target location” requires that an implanted signal delivery element is positioned near a target location to where an electrical signal is delivered, as least indirectly, to a spinal cord of the patient. In other words, positioning the implanted signal delivery element in a location where the spinal cord would receive an electrical signal at least indirectly would read on the above recited limitation.
This is taught by Perez, which teaches programming a signal generator (fig. 40: 4005; [1578]) to deliver an electrical signal [1578] to a spinal cord of the patient ([1005]: area of interest i.e. target dermatomes includes back (posterior) T2-T12 and/or C5-T1 dermatomes, which are known to be part of the spinal cord, specifically the thoracic section; [1002-1003]: stimulation applied to an area of interest and dermatomes provide stimulation to spinal nerve ganglion) via at least one implanted signal delivery element ([1578-1579]: EDP comprises electrodes which are implanted are stimulate target dermatomes) positioned proximate to a target location ([1005]: area of interest such as the back T2-T12 dermatomes are considered as being proximate to a target location; [1063]: stimulating T2-T1 and preferably T5-T10 dermatomes activate stimulation that relays at the level of the spinal cord).
Perez further teaches that stimulating target dermatomes [1578] may include back dermatomes [1005], for instance, T5-T10 dermatomes [1063] which activate somatovisceral reflexes that relay at the level of the patient’s spinal cord [1063], which would provide at least indirect stimulation to the patient’s spinal cord, since the T5-T10 dermatomes are known to correspond to the thoracic section of the spinal cord.
However, even if Perez fails to explicitly teach “programming a signal generator to deliver an electrical signal to a spinal cord of the patient via at least one implanted signal delivery element positioned proximate to a target location”, it would have been obvious to modify Perez in view of Thacker to provide programming a signal generator to deliver an electrical signal to a spinal cord of the patient via at least one implanted signal delivery element positioned proximate to a target location.
Thacker teaches spinal cord modulation [0023] and teaches programming a signal generator (110) to deliver an electrical signal [0025] to a spinal cord [0115] of a patient [0115] via at least one implanted (fig. 1A; [0025]) signal delivery element [0115] positioned proximate to a target location ([0115]: signal delivery device may be placed at or near the spinal cord midline, such as off-midline at T2 to address dermatomes T2 and up, and therefore would stimulate the spinal cord).
Thacker further teaches treating Diabetic Truncal Neuropathy by modulating vertebral levels ranging from T1-T12 (Table 1-continued on pg. 16), and that the implantable system provides simplified signal delivery for a long-term basis [0033].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method of treating a patient having an elevated HbA1c level taught by Perez, to provide programming a signal generator to deliver an electrical signal to a spinal cord of the patient via at least one implanted signal delivery element positioned proximate to a target location, as taught by Thacker, because Diabetic Truncal Neuropathy can be treated by modulating vertebral levels ranging from T1-T12, and the implantable system provides simplified signal delivery for a long-term basis.
Information Disclosure Statement
The information disclosure statement filed 03/10/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
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.
Claims 98-107, 110-115, and 118-121 are rejected under 35 U.S.C. 103 as being unpatentable over Perez et al. (US 2018/0085580) in view of Thacker et al. (US 2013/0066411).
In re claim 98, Perez discloses a method of treating a patient having an elevated HbA1c level [0723], the method comprising:
in response to the patient having the elevated HbA1c level [0723], *programming a signal generator (fig. 40: 4005; [1578]) to deliver an electrical signal [1578] to a spinal cord of the patient ([1005]: area of interest i.e. target dermatomes includes back (posterior) T2-T12 and/or C5-T1 dermatomes, which are known to be part of the spinal cord, specifically the thoracic section; [1002-1003]: stimulation applied to an area of interest and dermatomes provide stimulation to spinal nerve ganglion) via at least one implanted signal delivery element ([1578-1579]: EDP comprises electrodes which are implanted are stimulate target dermatomes) positioned proximate to a target location ([1005]: area of interest such as the back T2-T12 dermatomes are considered as being proximate to a target location; [1063]: stimulating T2-T1 and preferably T5-T10 dermatomes activate stimulation that relays at the level of the spinal cord at least indirectly since the T5-T10 dermatomes are known to correspond to the thoracic spine),
wherein the electrical signal reduces the patient's HbA1c level [0182].
Perez fails to teach wherein the electrical signal reduces the patient’s HbA1c level without generating paresthesia in the patient
Thacker teaches spinal cord modulation [0023], and teaches
a signal delivery device (fig. 1A: signal delivery device 110; [0115]) which delivers electrical signals [0025],
wherein electrical signal treats the patient’s Diabetic Truncal Neuropathy (Table 1-continued: Diabetic Truncal Neuropathy is modulated at vertebral levels T1-T12) without generating paresthesia in the patient ([0050-0051]: applying a high frequency waveform over a wide amplitude range prevents undesirable sensations such as paresthesia).
Thacker further teaches that most patients prefer the absence of paresthesia because the sensation of paresthesia may be uncomfortable or painful when the patient changes positions or adjusts signal amplitude [0051].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method of treating a patient having an elevated HbA1c level taught by Perez, to provide wherein the electrical signal treats the patient without generating paresthesia in the patient, as taught by Thacker, because most patients prefer the absence of paresthesia because the sensation of paresthesia may be uncomfortable or painful when the patient changes positions or adjusts signal amplitude.
*Regarding the limitation, “programming a signal generator to deliver an electrical signal to a spinal cord of the patient via at least one implanted signal delivery element positioned proximate to a target location”, Perez teaches that electrodes may be fully implanted at target dermatome(s) [1578], and teaches that an area of interest includes a desired back dermatome [1005]. Furthermore, Perez teaches that it’s preferred to stimulate T5-T10 dermatomes because they activate somatovisceral reflexes that relay at the level of the patient’s spinal cord [1063]. Therefore, Perez teaches that stimulation may be applied via an implanted signal delivery element that is positioned proximate to a target location, by having the electrodes implanted proximate to a patient’s T5-T10 dermatomes, which correspond to the thoracic region of the spine, so that an electrical signal is delivered to a spinal cord of the patient.
However, in the case that Perez doesn’t teach “programming a signal generator to deliver an electrical signal to a spinal cord of the patient via at least one implanted signal delivery element positioned proximate to a target location”, it would have been obvious to modify Perez in view of Thacker to provide programming a signal generator to deliver an electrical signal to a spinal cord of the patient via at least one implanted signal delivery element positioned proximate to a target location.
Thacker teaches spinal cord modulation [0023] and teaches programming a signal generator (110) to deliver an electrical signal [0025] to a spinal cord [0115] of the patient [0115] via at least one implanted (fig. 1A; [0025]) signal delivery element [0115] positioned proximate to a target location ([0115]: signal delivery device may be placed at or near the spinal cord midline, such as off-midline at T2 to address dermatomes T2 and up).
Thacker further teaches that Diabetic Truncal Neuropathy is treated by modulating vertebral levels ranging from T1-T12 (Table 1-continued), and the implantable system provides simplified signal delivery for a long-term basis [0033].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method of treating a patient having an elevated HbA1c level taught by Perez, to provide programming a signal generator to deliver an electrical signal to a spinal cord of the patient via at least one implanted signal delivery element positioned proximate to a target location, as taught by Thacker, because Diabetic Truncal Neuropathy can be treated by modulating vertebral levels ranging from T1-T12, and the implantable system provides simplified signal delivery for a long-term basis.
In re claim 99, the proposed combination yields (all mapping directed to Perez unless otherwise stated) wherein the electrical signal reduces the patient's HbA1c level relative to the patient's HbA1c level prior to administration of the electrical signal to the patient's spinal cord [0182].
In re claim 100, the proposed combination yields (all mapping directed to Perez unless otherwise stated) wherein the electrical signal reduces the patient's HbA1c level by at least about 1% [0182].
In re claim 101, the proposed combination yields (all mapping directed to Perez unless otherwise stated) wherein the electrical signal reduces the patient's HbA1c level by at least about 3% [1540].
In re claim 102, the proposed combination yields (all mapping directed to Perez unless otherwise stated) wherein the electrical signal reduces the patient's HbA1c level by at least about 5% [1540].
In re claim 103, the proposed combination yields (all mapping directed to Perez unless otherwise stated) wherein the electrical signal reduces the patient's HbA1c level by at least about 5% [1540].
The proposed combination fails to yield wherein the electrical signal reduces the patient's HbA1c level by at least about 10%.
At the time the instant application was filed it would be obvious to try to provide wherein the electrical signal reduces the patient's HbA1c level by at least about 10%. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed decrease in HbA1c level is not disclosed as being crucial or unexpected.
Even if the proposed combination fails to yield “wherein the electrical signal reduces the patient's HbA1c level by at least about 10”, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the electrical signal reduces the patient's HbA1c level by at least about 10%, 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.
In re claim 104, the proposed combination yields (all mapping directed to Perez unless otherwise stated) wherein the electrical signal has a frequency in a frequency range of from 1.2 kHz to 100 kHz ([1372]: 1Hz to 10,00Hz is within claimed range of 1.2kHz to 100kHz; [0337]).
Additionally, at the time the instant application was filed it would be obvious to try to provide wherein the electrical signal has a frequency in a frequency range of from 1.2 kHz to 100 kHz. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed frequency range is not disclosed as being crucial or unexpected.
Even if the proposed combination fails to yield “wherein the electrical signal has a frequency in a frequency range of from 1.2 kHz to 100 kHz”, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the electrical signal has a frequency in a frequency range of from 1.2 kHz to 100 kHz, 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.
In re claim 105, the proposed combination yields (all mapping directed to Perez unless otherwise stated) wherein the frequency range is from 5 kHz to 15 kHz [1372].
Additionally, at the time the instant application was filed it would be obvious to try to provide wherein the frequency range is from 5 kHz to 15 kHz. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed frequency range is not disclosed as being crucial or unexpected.
Even if the proposed combination fails to yield “wherein the frequency range is from 5 kHz to 15 kHz”, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the frequency range is from 5 kHz to 15 kHz, 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.
In re claim 106, the proposed combination yields (all mapping directed to Perez unless otherwise stated) wherein the electrical signal has a pulse width in a pulse width range of from 10 microseconds to 166 microseconds [1078, 1372].
Additionally, at the time the instant application was filed it would be obvious to try to provide wherein the electrical signal has a pulse width in a pulse width range of from 10 microseconds to 166 microseconds. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed pulse width is not disclosed as being crucial or unexpected.
Even if the proposed combination fails to yield “wherein the electrical signal has a pulse width in a pulse width range of from 10 microseconds to 166 microseconds”, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the electrical signal has a pulse width in a pulse width range of from 10 microseconds to 166 microseconds, 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.
In re claim 107, the proposed combination yields (all mapping directed to Perez unless otherwise stated) wherein the frequency range is from 5 kHz to 25 kHz ([1372]: 10,000Hz is within 5kHz to 25kHz) and
wherein the electrical signal has
a pulse width in a pulse width range of from 20 microseconds to 100 microseconds ([1372]: 10 μs to 10 ms), and
an amplitude in an amplitude range of from 1 mA to 10 mA [1165, 0337].
Additionally, at the time the instant application was filed it would be obvious to try to provide wherein the electrical signal has a pulse width in a pulse width range of from 20 microseconds to 100 microseconds and an amplitude in an amplitude range of from 1 mA to 10 mA. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed pulse width and amplitude are not disclosed as being crucial or unexpected.
Even if the proposed combination fails to yield “wherein the electrical signal has a pulse width in a pulse width range of from 20 microseconds to 100 microseconds and an amplitude in an amplitude range of from 1 mA to 10 mA”, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the electrical signal has a pulse width in a pulse width range of from 20 microseconds to 100 microseconds and an amplitude in an amplitude range of from 1 mA to 10 mA, 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.
In re claim 110, the proposed combination yields (all mapping directed to Perez unless otherwise stated) wherein the elevated HbA1c level is associated with the patient having Type 2 diabetes ([0723]: monitoring HbA1c treats diabetes; [1022]: T7 dermatome treats type 2 diabetes; [1542]).
In re claim 111, regarding the limitation, “a method of treating a patient having an elevated HbA1c level, the method comprising: in response to the patient having the elevated HbA1c level, delivering an electrical signal to a spinal cord of the patient via at least one implanted signal delivery element positioned proximate to a target location, wherein the electrical signal does not generate paresthesia in the patient, and wherein the electrical signal reduces the patient's HbA1c level,” see in re claim 98 above.
In re claim 112, the proposed combination yields (all mapping directed to Perez unless otherwise stated) wherein the electrical signal reduces the patient's HbA1c level by at least about 3% relative to a baseline HbA1c level prior to delivering the electrical signal to the patient's spinal cord [1540].
In re claim 113, the proposed combination yields (all mapping directed to Perez unless otherwise stated) wherein the electrical signal reduces the patient's HbA1c level by at least about 5% relative to a baseline HbA1c level prior to delivering the electrical signal to the patient's spinal cord [1540].
The proposed combination fails to yield wherein the electrical signal reduces the patient's HbA1c level by at least about 7% relative to a baseline HbA1c level prior to delivering the electrical signal to the patient's spinal cord.
At the time the instant application was filed it would be obvious to try to provide wherein the electrical signal reduces the patient's HbA1c level by at least about 7% relative to a baseline HbA1c level prior to delivering the electrical signal to the patient's spinal cord. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed decrease in HbA1c level is not disclosed as being crucial or unexpected.
Even if the proposed combination fails to yield “wherein the electrical signal reduces the patient's HbA1c level by at least about 7% relative to a baseline HbA1c level prior to delivering the electrical signal to the patient's spinal cord”, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the electrical signal reduces the patient's HbA1c level by at least about 7% relative to a baseline HbA1c level prior to delivering the electrical signal to the patient's spinal cord, 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.
In re claim 114, regarding the limitation, “wherein the electrical signal has a frequency within a frequency range of from 1.2 kHz to 100 kHz”, see in re claim 104 above.
In re claim 115, the proposed combination yields (all mapping directed to Perez unless otherwise stated)
wherein the frequency range is from 5 kHz to 50 kHz [1170, 1372] and
wherein the electrical signal has
a pulse width in a pulse width range of from 10 microseconds to 166 microseconds [0337], and
an amplitude in an amplitude range of from 1 mA to 10 mA [0337].
Additionally, at the time the instant application was filed it would be obvious to try to provide wherein the frequency range is from 5 kHz to 50 kHz and wherein the electrical signal has a pulse width in a pulse width range of from 10 microseconds to 166 microseconds, and an amplitude in an amplitude range of from 1 mA to 10 mA. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed frequency range, pulse width, and amplitude are not disclosed as being crucial or unexpected.
Even if the proposed combination fails to yield “wherein the frequency range is from 5 kHz to 50 kHz and wherein the electrical signal has a pulse width in a pulse width range of from 10 microseconds to 166 microseconds, and an amplitude in an amplitude range of from 1 mA to 10 mA”, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the frequency range is from 5 kHz to 50 kHz and wherein the electrical signal has a pulse width in a pulse width range of from 10 microseconds to 166 microseconds, and an amplitude in an amplitude range of from 1 mA to 10 mA, 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.
In re claim 118, regarding the limitation, “wherein the elevated HbA1c level is associated with the patient having Type 2 diabetes”, see in re claim 110 above.
In re claim 119, the proposed combination yields (all mapping directed to Perez unless otherwise stated) further comprising:
measuring the patient's HbA1c level [0723] via a patient sensor [1337-1338, 0723]; and
adjusting at least one parameter of the electrical signal based on the measured HbA1c level ([0723]: hemoglobin A1C is used as input to titrate therapy and adjustments to stimulation are made manually or automatically by the electro-dermal patch device; [1337-1338]).
In re claim 120, regarding the limitation, “a method of treating a patient having Type 2 diabetes, the method comprising: in response to the patient having elevated HbA1c levels…, programming a signal generator to deliver a paresthesia- free electrical signal to a spinal cord of the patient at least one implanted signal delivery element positioned proximate to a target location” see in re claim 98 above.
Regarding the limitation “…in response to the patient having elevated HbA1c levels as a result of the patient's Type 2 diabetes”, see in re claim 110 above.
Regarding the limitation “wherein the electrical signal reduces the patient's HbA1c levels relative to a baseline of the patient's HbA1c level prior to receiving the electrical signal”, see in re claim 99 above.
In re claim 121, regarding the limitation, “wherein the electrical signal has a frequency within a frequency range of from 1.2 kHz to 100 kHz”, see in re claim 104 above.
Regarding the limitation, “a pulse width in a pulse width range of from 10 microseconds to 166 microseconds, and an amplitude in an amplitude range of from 1 mA to 10 mA”, see in re claim 115 above.
Claims 108-109, 116-117, and 122 are rejected under 35 U.S.C. 103 as being unpatentable over Perez et al. (US 2018/0085580) in view of Thacker et al. (US 2013/0066411) in view of Cakmak (US 2019/0046795).
In re claim 108, the proposed combination fails to yield wherein the implanted signal delivery element is positioned to deliver the electrical signal to neurons of an intermediolateral cell column.
Cakmak teaches decreasing blood glucose level in order to treat hyperglycemia [0001] and teaches wherein a signal delivery element (fig. 6A: 101; [0074]) is positioned to deliver an electrical signal [0017, 0074] to neurons of an intermediolateral cell column ([0017]: electrical stimulation is directed to sympathetic nerves, which are innervated by pre-ganglionic neurons located in the intermediolateral column of the spinal cord reduces blood glucose i.e. decreases a patient's HbA1c level).
Cakmak further teaches that stimulating the sympathetic nerves decreases liver glycogen content [0017] and causes an increased release by glucose [0017].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the implanted signal delivery element yielded by the proposed combination to be positioned to deliver the electrical signal to neurons of an intermediolateral cell column, as taught by the signal delivery element of Cakmak, because doing so decreases liver glycogen content and causes an increased release by glucose.
In re claim 109, the proposed combination in re claim 108 above yields wherein the electrical signal modulates sympathetic interneurons and/or sympathetic preganglionic neurons to reduce the patient's HbA1c level.
In re claim 116, regarding the limitation, “wherein the electrical signal is delivered to neurons of an intermediolateral cell column”, see in re claim 108 above.
In re claim 117, regarding the limitation, “wherein the electrical signal modulates sympathetic interneurons and/or sympathetic preganglionic neurons to reduce the patient's HbA1c level”, see in re claim 109 above.
In re claim 122, regarding the limitation, “wherein electrical signal modulates sympathetic interneurons and/or sympathetic preganglionic neurons to reduce the patient's HbA1c level”, see in re claim 109 above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Dosch et al. (US 2009/0312255) discloses managing diabetes (abstract) by stimulating intercostal and/or subcostal nerves of spinal nerves (abstract) including thoracic segments T8-T12 (abstract) and teaches determining average glucose levels [0137].
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796