Prosecution Insights
Last updated: October 04, 2026
Application No. 19/066,714

SIMULTANEOUS MULTI-SITE VAGUS NERVE NEUROMODULATION FOR IMPROVED GLYCEMIC CONTROL SYSTEM AND METHODS

Non-Final OA §102§103§112
Filed
Feb 28, 2025
Priority
Apr 12, 2018 — provisional 62/656,787 +2 more
Examiner
COLLARD JR, DWANE EDWARD
Art Unit
Tech Center
Assignee
Reshape Lifesciences Inc.
OA Round
1 (Non-Final)
0%
Grant Probability
At Risk
1-2
OA Rounds
10m
Est. Remaining
0%
With Interview

Examiner Intelligence

Grants only 0% of cases
0%
Career Allowance Rate
0 granted / 1 resolved
-60.0% vs TC avg
Minimal +0% lift
Without
With
+0.0%
Interview Lift
resolved cases with interview
Typical timeline
2y 5m
Avg Prosecution
21 currently pending
Career history
16
Total Applications
across all art units

Statute-Specific Performance

§101
12.2%
-27.8% vs TC avg
§103
51.3%
+11.3% vs TC avg
§102
17.4%
-22.6% vs TC avg
§112
10.4%
-29.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1 resolved cases

Office Action

§102 §103 §112
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 Objections Claim 75 objected to because of the following informalities: “the first therapy program”, line 2 and “the activity” depend on claim 73 but are not recited until claim 74. Appropriate correction is required. For the purpose of continued examination, claim 75 is interpreted to depend from claim 74. Claim 82 objected to because of the following informalities: "the first or second signal", line 1, typographical error. There is insufficient antecedent basis for this limitation in the claim. For the purpose of continued examination, claim 82 is interpreted to depend from claim 74. Claim 84 objected to because of the following informalities: “the first electrical signal is off time is applied”, line 1, typographical error. Appropriate correction is required. 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 73-96 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. Regarding claim 73, lines 4-6; claim 87, lines 3-4; claim 89 line 4; a first distal end is connected to a second distal end from the same first lead assembly; by definition, a lead must have a distal end and a proximal end unless the distal end of lead is at least bifurcated. Regarding claims 81 & 88, lines 1-2 recite “a sensor” connected to the implantable pulse generator; it is unclear if “a sensor” is the same glucose monitor recited in claims 73 & 87 or if a second distinct sensor is required by the claimed invention. Regarding claim 85, lines 1-2 recite “on time signal frequency”; it is unclear if one and/or the other refers to the neurostimulation signal frequency for treatment or frequency of on time periods; “adjusts signal up” and “adjust signal down” is unclear which on time signal is adjusted. Regarding claim 96, lines 1-2 recite "the first electrical signal"; there is insufficient antecedent basis for this limitation in the claim, and it is unclear which claim 96 depends on. Dependent claims 74-80, 82-84, 86, 90-95 inherit the same deficiencies. The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 84 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. “off time is applied when blood glucose levels are detected between 80 mg/dL and 110 mg/dL”, lines 1-2, unclear if claim 84 is meant to further limit claim 83 based on specific use of terminology and/or from typographical errors. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Dependent claim 85 inherits the same deficiencies. 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim(s) 73-82, 89-95 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Butera et al (US Pre Grant Publication 2016/0256683 A1). Regarding claim 73, Butera teaches a system for treating a patient with impaired glucose regulation, the system comprising: at least two electrodes (103A & 103B; Fig. 1), wherein the at least two electrodes include a first electrode and a second electrode [0039], wherein the first electrode is operably connected to a first distal end of a first lead assembly (electrode leads, Fig. 1), wherein an implantable pulse generator (101, Fig. 1) is operably connected to a second distal end of the first lead assembly [0039], wherein the second electrode is operably connected to a first distal end of a second lead assembly (electrode leads, Fig. 1), wherein the implantable pulse generator is operably connected to a second distal end of the second lead assembly ([0039], Fig. 1), wherein at least one of the electrodes is adapted to be placed on a first target nerve or organ (103A & 103B, Fig. 1) ([0039]; cuff electrode); the implantable pulse generator comprising a power module (battery of 101, Fig. 1) ([0040]; stimulus generator 101 can be battery powered and a voltage or current source) and a programmable therapy delivery module (102, Fig. 1) ([0040]; programmable logic 102); and an external component (500, Fig. 5) ([0041]; control unit 106 implemented as computing device 500) comprising a communication system ([0041]; communication link) and a programmable storage (504, Fig. 5) and communication module (516, Fig. 5) and a glucose monitor (10, Fig. 1) capable of communicating with the system for treating a patient with impaired glucose regulation ([0042]; 104 operably coupled to 106 using communication link; measured blood glucose can control device 100). Regarding claim 74, Butera teaches the system of claim 73, wherein the programmable therapy delivery module is configured to deliver a first therapy program ([0065-0066]; closed loop mode with programmable interface) comprising a first electrical signal treatment applied to the first target nerve (greater splanchnic nerve, Fig. 1) [0047] or organ, wherein the first electrical signal has a frequency selected to initiate activity on the first target nerve or organ ([0049]; kilohertz high frequency alternating current; 1kHz – 100kHz). Regarding claim 75, Butera teaches the system of claim 73, wherein programmable storage (504, Fig. 5) and communication module (516, Fig. 5) is configured to store the first therapy program ([0075]; processing unit 506 executes program code stored in system memory 504) and to communicate the first therapy program to the implantable pulse generator ([0041]; communication link) and wherein the activity is an electrical stimulation [0050] or an electrical block. Regarding claim 76, Butera teaches the system of claim 75, wherein the programmable therapy delivery module is configured to deliver a second therapy program (implicit, [0065-0066]; various programmable configurations stored on computing device 500 necessitates a plurality of therapy programs) comprising a second electrical signal treatment ([0047]; electrical stimulation via electrode 103B) applied to a second target nerve (hepatic branch of vagus nerve, Fig. 1) or organ, and wherein the second electrical signal has a frequency selected to upregulate or down-regulate activity (hepatic branch, Fig. 1) ([0050-0051]; 1 Hz – 200Hz) on the second target nerve or organ, wherein the frequency is selected to either up-regulate or down-regulate activity on the second target nerve or organ based on opposing the activity initiated on the first target nerve ([0052], Fig. 4; hepatic branch vagus nerve 402 stimulation upregulates activity opposing greater splanchnic nerve 404 activity) or organ. Regarding claim 77, Butera teaches he system of claim 73, wherein the at least one electrode is adapted to be placed on a first organ selected from the spleen, stomach, duodenum, pancreas, liver and ileum ( [0039]; electrodes implanted in the subject’s body and therefore are capable of being placed at these locations.). Regarding claim 78, Butera teaches the system of claim 73, wherein the at least one electrode is adapted to be placed at a first nerve selected from a vagus nerve, a splanchnic nerve, a hepatic branch of the vagus nerve ([0045], Fig. 1; hepatic branch of vagus nerve), a celiac branch of the vagus nerve, and combinations thereof. Regarding claim 79, Butera teaches the system of claim 73, wherein the programmable therapy delivery module is configured to deliver the first electrical signal having a frequency of at least 200 Hz ([0049]; KHFAC 1kHz- 100kHz). Regarding claim 80, Butera teaches the system of claim 73, wherein the programmable storage and communication module is configured to deliver the first therapy program to the implantable pulse generator, wherein the first therapy program comprises an electrical signal treatment applied intermittently multiple times in a day and over multiple days (implicit, [0065]; closed loop control configured to turn on/off automatically in response to subject’s blood glucose level; [0048]; KHFAC repeatedly turned on/off without causing damage while inhibiting activity; closed loop control system using multiple KHFAC signals to maintain blood glucose levels in a patient necessarily requires a system that is capable of providing treatment over at least two days when therapy is programmed before sleep), wherein the electrical signal has a frequency selected to downregulate activity on the first target nerve ([0049]; KHFAC 1kHz- 100kHz inhibits neural activity) or organ and has an on time and an off time (Fig. 4), wherein the off time is selected to allow at least a partial recovery of the activity of the target nerve or organ ([0052], Fig. 4; hepatic branch 402; stimulus off allows stops neural inhibition and decreases blood glucose). Regarding claim 81, Butera teaches the system of claim 73, further comprising a sensor (glucose 104, Fig. 1) operably connected to the implantable pulse generator ([0042]; various configurations of operable connectivity), wherein the sensor detects an increase or decrease of blood glucose from a threshold level ([0065]; user sets or adjusts blood glucose level set point(s)). Regarding claim 82, Butera teaches the system of claim 73, wherein the first or second signal has a frequency between 0.01 Hz and less than 200 Hz ([0051]; 1 Hz – 200 Hz). Regarding claim 89, Butera teaches a method of improving glycemic control of a subject, the method comprising: placing, on a first target nerve or organ (greater splanchnic nerve, Fig. 1), a first electrode portion (103B, Fig.1), wherein the electrode portion is operably connected to an implantable pulse generator (101, Fig. 1) by a lead assemblies connecting at a first distal end to the electrode portion (electrode leads, Fig. 1) and at a second distal end to the implantable pulse generator [0039]; and a glucose monitor (104, Fig. 1) capable of communicating with the system for treating a patient with impaired glucose regulation ([0042]; 104 operably coupled to 106 using communication link; measured blood glucose can control device 100). Regarding claim 90, Butera teaches the method of claim 89, wherein the electrode portion comprises at least two electrodes ([0039]; bipolar or tripolar electrode). Regarding claim 91, Butera teaches the method of claim 90, wherein the first electrode of the at least two electrodes is adapted to be placed on the first target nerve ([0039]; suggests bipolar/tripolar cuff electrode for nerve placement) or organ. Regarding claim 92, Butera teaches the method of claim 89, wherein the implantable pulse generator comprises a power module (battery of 101, Fig. 1) ([0040]; stimulus generator 101 can be battery powered and a voltage or current source) and a programmable therapy delivery module (102, Fig. 1) ([0040]; programmable logic 102). Regarding claim 93, Butera teaches the method of claim 92, wherein the programmable therapy delivery module is configured to deliver at least one therapy program ([0065-0066]; closed loop mode with programmable interface) comprising a first electrical signal treatment applied to the first target nerve (greater splanchnic nerve, Fig. 1) [0047] or organ. Regarding claim 94, Butera teaches the method of claim 93, wherein the first electrical signal has a frequency selected to initiate activity on the first target nerve ([0049]; kilohertz high frequency alternating current; 1kHz – 100kHz) or organ, wherein the activity comprises a neural stimulation [0050] or a neural block. Regarding claim 95, Butera teaches the method of claim 89, further comprising the step of receiving, at the implantable pulse generator (101, Fig. 1), the at least one therapy program (implicit, [0041]; control unit transmits user or programmable inputs to IPG 101) via a communication system ([0041]; communication link) of an external component (computing device 500, Fig. 5), wherein the external component comprises the communication system and a programmable storage (504, Fig. 5) and communication module (516, Fig. 5), wherein the programmable storage and communication module is configured to store the at least one therapy program ([0041]; user or programmable inputs to control unit necessitates programming to be stored in programmable storage). 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. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 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) 83-88, 96 is/are rejected under 35 U.S.C. 103 as being unpatentable over Butera et al (US Pre Grant Publication 2016/0256683 A1), in view of Puleo et al (International Publication WO 2019/173518 A1). Regarding claim 83, Butera further teaches a method of improving glycemic control of a subject, the method comprising: applying the first electrical signal to the first target nerve or organ of the subject having impaired glucose regulation using the system of claim 73, wherein the first electrical signal initiates a neural stimulation (greater splanchnic nerve, Fig. 1) [0047] or a neural block, wherein the first electrical signal is applied followed by an off time during which the first electrical signal is not applied to the nerve ([0040], Fig. 4; hepatic branch of vagus nerve 402 on at ~0 min and off at ~68 min). Butera does not disclose wherein the off time is initiated when blood glucose levels are detected between 80 mg/dL and 110 mg/dL, wherein the first electrical signal is applied multiple times per day to alter the blood glucose levels. However, Puleo teaches a system and a method for glucose regulation using neuromodulation techniques. Puleo is analogous to the claimed invention because it is reasonably pertinent to the problem of modulating glucose levels through neurostimulation. Puleo further teaches wherein the off time is initiated when blood glucose levels are detected between 80 mg/dL and 110 mg/dL ([00112]; hypoglycemia 70-110 mg/dL), wherein the first electrical signal is applied multiple times per day to alter the blood glucose levels ([00104], [00106]; circulating glucose concentration above predetermined range then controller initiates energy application to a region with modulation parameters associated with a reduction in circulating glucose). It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Butera with an off time that is initiated when blood glucose levels are detected between 80 mg/dL and 110 mg/dL and the first electrical signal is applied multiple times per day to alter the blood glucose levels as taught by Puleo. One of ordinary skill in the art would have been motivated to make these modifications to maintain a patient’s blood glucose levels within a normal range by adjusting neurostimulation parameters such as on/off times associated with a desired response (Puleo, [00106], [00112]). Regarding claim 84, Butera in view of Puleo, teaches the method of claim 83, and Butera further teaches wherein the first electrical signal is off time is applied ([0040], Fig. 4; hepatic branch of vagus nerve 402 on at ~0 min and off at ~68 min) but does not disclose when blood glucose levels are detected between 80 mg/dL and 110 mg/dL. However, Puleo teaches when blood glucose levels are detected between 80 mg/dL and 110 mg/dL ([00112]; hypoglycemia 70-110 mg/dL). It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the method, as taught by Butera and Puleo, when blood glucose levels are detected between 80 mg/dL and 110 mg/dL. One of ordinary skill in the art would have been motivated to make these modifications to maintain a patient’s blood glucose levels within a normal range by adjusting neurostimulation parameters such as on/off times associated with a desired response (Puleo, [00106], [00112]). Regarding claim 85, Butera teaches the method of claim 84, and further teaches wherein the glucose monitor initiates the on time signal frequency ([0065], Fig. 4; logic controller configured to turn on/off at blood glucose level set points), Butera does not disclose wherein the on time frequency adjusts signal up or adjust signal down when blood glucose levels are below 80 mg/dL or above 110 mg/dL and wherein the frequency initiated can be the same, lower or greater than the previous on time signal, as claimed. However, Puleo teaches wherein the on time frequency adjusts signal up or adjust signal down ([00104]; treatment delivered at higher frequency for shorter duration) when blood glucose levels are below 80 mg/dL ([00112]; 50-70 mg/dL insulin shock) or above 110 mg/dL and wherein the frequency initiated can be the same, lower or greater than the previous on time signal (implicit; frequency initiated must be one of these options), It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Butera with an on time frequency that adjusts signal up or adjust signal down when blood glucose levels are below 80 mg/dL or above 110 mg/dL and the frequency initiated can be the same, lower or greater than the previous on time signal, as taught by Puleo. One of ordinary skill in the art would have been motivated to make these modifications to maintain a patient’s blood glucose levels within a normal range by adjusting neurostimulation parameters such as on/off times and frequencies associated with a desired response (Puleo, [00106], [00112]). Regarding claim 86, Butera in view of Puleo, teaches the method of claim 83, and Butera further teaches comprising administering an agent that improves glucose control ([0055]; system could enhance efficacy of oral therapies used for subjects with type II diabetes), wherein the agent increases an amount of insulin and/or increases a sensitivity of cells to insulin (implicit, [0055]; oral therapies for subjects with type II diabetes suggests lowering blood glucose levels; insulin and insulin resistance treatments are well known to one of ordinary skill in the art). It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the method, as taught by Buterra and Puleo, with an agent that improves glucose control, wherein the agent increases an amount of insulin and/or increases a sensitivity of cells to insulin. One of ordinary skill in the art would have been motivated to make these modifications to enhance the efficacy of glucose regulation treatment by administering oral therapies in conjunction with neuromodulation techniques (Butera, [0055]). Regarding claim 87, Butera teaches a method of making a system for treating a patient with impaired glucose regulation comprising: connecting a first electrode (103B, Fig.1) to a first distal end of a first lead assembly (electrode leads, Fig. 1); connecting a second distal end of the first lead assembly [0039] to an implantable pulse generator (101, Fig. 1); connecting a second electrode (103A, Fig. 1) to a first distal end of a second lead assembly (electrode leads, Fig. 1); connecting a second distal end of the second distal assembly to the implantable pulse generator ([0039], Fig. 1), wherein the first electrode is adapted to be placed on a first target nerve (greater splanchnic nerve, Fig. 1) or organ; configuring a programmable therapy delivery module of the implantable pulse generator to deliver a first therapy program ([0065-0066]; closed loop mode with programmable interface) comprising a first electrical signal treatment applied to the first target nerve or organ; and configuring a programmable storage and communication module of an external component (500, Fig. 5) ([0041]; control unit 106 implemented as computing device 500) to store the first therapy program ([0075]; processing unit 506 executes program code stored in system memory 504) and to communicate the first therapy program to the implantable pulse generator ([0041]; communication link); and configuring a glucose monitor (104, Fig. 1) to communicate with the system for treating a patient with impaired glucose regulation ([0042]; 104 operably coupled to 106 using communication link; measured blood glucose can control device 100), a frequency selected to upregulate or down- regulate activity on the second target nerve (hepatic branch, Fig. 1) ([0050-0051]; 1 Hz – 200Hz) or organ, wherein the frequency is selected to either up-regulate or down-regulate activity on the second target nerve or organ based on opposing the activity initiated on the first target nerve or organ ([0052], Fig. 4; hepatic branch vagus nerve 402 stimulation upregulates activity opposing greater splanchnic nerve 404 activity). Butera does not disclose wherein the programmable therapy delivery module is configured to deliver a second therapy program comprising a second electrical signal treatment applied to a second target nerve or organ, and wherein the second electrical signal has a frequency, as claimed. However, Puleo teaches wherein the programmable therapy delivery module is configured to deliver a second therapy program (00106-00107]; plurality of modulation programs and modes; site specific modulation parameters for different treatment sites) comprising a second electrical signal treatment ([00107]; modes include instructions for executing a set of modulation parameters associated with a particular treatment site) applied to a second target nerve or organ ([00107]; pancreas), and wherein the second electrical signal has a frequency ([00107]; activation associated with different frequency range). It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Butera with a programmable therapy delivery module configured to deliver a second therapy program comprising a second electrical signal treatment applied to a second target nerve or organ, and wherein the second electrical signal has a frequency, as taught by Puleo. One of ordinary skill in the art would have been motivated to make these modifications to improve glucose regulation treatment by storing and executing site specific instructions that an operator normally would have to manually input into the system (Puleo, [00107]). Regarding claim 88, Butera in view of Puleo teaches the method of claim 87, and Butera further teaches comprising connecting a sensor to the implantable pulse generator ([0042], Fig. 1; glucose sensor 104 operably coupled to stimulus generator 101). It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the method, as taught by Butera and Puleo, with connecting a sensor to the implantable pulse generator, as taught by Butera. One of ordinary skill in the art would have been motivated to make these modifications to control the neuromodulation system by measuring a patient’s blood glucose levels with a glucose sensor and altering parameters based on readings (Butera, [0042]). Regarding claim 96, Butera teaches the method of claim 95, further teaches comprising the step of, applying the first electrical signal treatment to the first target nerve or organ of the subject having impaired glucose regulation, wherein the first electrical signal treatment is applied continuously followed by an off time of a plurality of off times (implicit, [0065]) during which the first electrical signal is not applied to the first target nerve ([0052], Fig. 4) or organ, wherein the plurality of off times are applied multiple times per day (implicit, [0065]). Butera does not teach when blood glucose levels are detected by the glucose monitor to be between 80 mg/dL and 110 mg/dL. However, Puleo teaches wherein the plurality of off times are applied multiple times per day ([00104]; treatment delivered every three hours) when blood glucose levels are detected by the glucose monitor to be between 80 mg/dL and 110 mg/dL ([00112]; hypoglycemia 70-110 mg/dL). It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Butera with a plurality of off times that are applied multiple times per day when blood glucose levels are detected by the glucose monitor to be between 80 mg/dL and 110 mg/dL, as taught by Puleo. One of ordinary skill in the art would have been motivated to make these modifications to maintain a patient’s blood glucose levels within a normal range by adjusting neurostimulation parameters such as on/off times and frequencies associated with a desired response (Puleo, [00106], [00112]). Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Patel (International Publication WO 2017/197272 A1) discloses a neuromodulation system for pairing vagus nerve stimulation to activate or inhibit neural activity [0006]; kilohertz electrical stimulation frequencies 1 kHz- 100kHz [0012]; plurality of probes configured for neural inhibition and stimulation [0043]; KES stimulation for glucose regulation [0052]. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWANE COLLARD whose telephone number is (571)272-6553. The examiner can normally be reached M-F 9 am-6 pm. 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, Ben 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. /DWANE COLLARD/Examiner, Art Unit 3792 /William J Levicky/ Primary Examiner, Art Unit 3796
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Prosecution Timeline

Feb 28, 2025
Application Filed
Aug 11, 2026
Non-Final Rejection mailed — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
0%
Grant Probability
0%
With Interview (+0.0%)
2y 5m (~10m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1 resolved cases by this examiner. Grant probability derived from career allowance rate.

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