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 § 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 and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No 2012/0010677 granted to Wenzel et al (hereinafter “Wenzel”).
In reference to claim 1, Wenzel discloses a system for treating hypoglycemia [e.g. abstract] in a subject, the system comprising: a first electrode [e.g. electrode 144] adapted to be placed on and deliver electrical signal to a first nerve or organ [e.g. paragraph 0020]; optionally a second electrode [e.g. electrode 144’] adapted to be placed on and deliver electrical signal to a second nerve or organ [e.g. paragraph 0022]; an implantable pulse generator [e.g. stimulation device 100] operably connected to the first and/or the second electrode, wherein the implantable pulse generator comprises a power module [e.g. battery 276] and a programmable therapy delivery module [e.g. paragraph 0054], wherein the programmable therapy delivery module is configured to deliver at least one therapy program comprising a first therapy program and optionally a second therapy program [e.g. paragraphs 0023, 0024, 0031], wherein the first therapy program comprises a first electrical signal treatment applied to the first nerve or organ through the first electrode [e.g. paragraphs 0023, 0024, 0031], wherein the second therapy program comprises a second electrical signal treatment applied to the second nerve or organ through the second electrode [e.g. paragraphs 0023, 0024, 0031], and wherein the first and/or the second electrical signal are each configured to initiate activity on the first and/or the second nerve or organ respectively [e.g. paragraphs 0023, 0024, 0031], and wherein the activity is a neural stimulation or a neural block [e.g. paragraph 0031]; and an external component [e.g. external device 254] comprising a communication system [e.g. communication link 256] and a programmable storage and communication module [e.g. microcontroller 220], wherein programmable storage and communication module are configured to store the at least one therapy program and to communicate the at least one therapy program to the implantable pulse generator [e.g. paragraph 0041].
In reference to claim 2, Wenzel discloses wherein the first and/or the second electrical signal are each independently configured to upregulate or down-regulate activity respectively on the first and/or second target nerve or organ [e.g. paragraph 0031].
In reference to claim 3, Wenzel discloses wherein the first and the second electrical signals are applied concurrently, or simultaneously, or intermittently, or during substantially the same times, or during substantially different times, or in a coordinated fashion [e.g. paragraphs 0031-0032].
In reference to claim 4, Wenzel discloses wherein the first and/or the second electrical signal treatments are each continuously applied to the first target nerve or organ and/or the second target nerve or organ respectively [e.g. paragraphs 0031-0032].
In reference to claim 5, Wenzel discloses further comprising a glucose sensor configured to continuously monitor plasma glucose of the subject, wherein the glucose sensor is operably connected to the implantable pulse generator and the external component [e.g. paragraph 0086].
In reference to claim 6, Wenzel discloses wherein the glucose sensor is configured to detect an increase or decrease of plasma glucose from a pre- determined threshold level [e.g. paragraphs 0085-0086].
In reference to claim 8, Wenzel discloses wherein the first nerve or organ and the second nerve or organ are each independently selected from the group consisting of the vagus nerve, anterior vagus nerve, posterior vagus nerve, hiatus on posterior nerve, hepatic branch of vagus nerve, celiac branch of vagus nerve, splanchnic nerve, renal nerve, renal artery, sympathetic nerves, baroreceptors, glossopharyngeal nerve [e.g. paragraph 0003], duodenum,jejunum, ileum, small bowel, colon, stomach, esophagus, liver, spleen, pancreas, and combinations thereof.
In reference to claim 9, Wenzel discloses a method of treating hypoglycemia in a subject, the method comprising: applying a first electrical signal to a first nerve or organ of the subject using the system of claim 1, wherein the first electrical signal initiates a neural stimulation or a neural block; and optionally applying a second electrical signal to a second nerve or organ of the subject using the system of claim 1, wherein the second electrical signal initiates a neural stimulation or a neural block [e.g. paragraph 0031].
In reference to claim 10, Wenzel discloses wherein the first and the second electrical signals are applied concurrently, or simultaneously, or intermittently, or during substantially the same times, or during substantially different times, or in a coordinated fashion [e.g. paragraphs 0031-0032].
Allowable Subject Matter
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The closest prior art of Wenzel fails to disclose where the pulse generator is trigger to deliver electrode treatment when the plasma glucose is below a first pre-determined threshold and where the implantable pulse generator ceases to deliver treatment when the plasma glucose is above a second pre-determined threshold
Claims 11-13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The closest prior of Wenzel fails to disclose the claims ranges of treatment being configured to increase the plasma glucose level by at least about 5 mg/dL in about 10 minutes, by at least about 10 mg/dL in about 20 minutes, by at least about 20 mg/dL in about 30 minutes.
Claim 14 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The closest prior art of Wenzel fails to disclose where the electrical signals are applied continuously during an on time followed by an off time.
Claims 15 and 16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The closest prior art of Wenzel fails to disclose wherein the on times are applied multiple times per day when plasma glucose level is of or below about 50 mg/dL, of or below about 60 mg/dL, of or below about 70 mg/dL, of or below about 80 mg/dL and wherein the off times are applied multiple times per day when plasma glucose level is of or above about 80 mg/dL, of or above about 90 mg/dL, of or above about 100 mg/dL, of or above about 110 mg/dL.
Claims 17-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The closest prior art of Wenzel fails to discloses wherein the first electrical signal has a frequency of about 0.01 Hz to about 200 Hz or 200 Hz to about 10k Hz and wherein the second electrical signal has a frequency of about 0.01 Hz to about 200 Hz or 200 Hz to about 10k Hz.
Conclusion
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/NADIA A MAHMOOD/Primary Examiner, Art Unit 3796