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 6 objected to because of the following informalities: In claim 6 line1, “patent” should be replaced with patient”. Appropriate correction is required.
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 1-7, 10-14, 16, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thornton et al (U.S. Patent Application Publication Number: US 2017/0021174 A1, hereinafter “Thornton”).
Regarding claims 1, 10, 19 and 20, Thornton teaches a system for monitoring an implantable pulse generator (e.g. Fig.3, [0050]) comprising:
an implantable pulse generator (e.g. 104 Fig.3, [0050], [0143])) configured to generate a current;
an electrode (e.g. 212,212a Fig.3, [0052]) configured to apply the current to an anatomical element that comprises one or more vagal trunks (e.g. Fig. 3, [0050], [0133], [0143]: anterior trunk and/or posterior trunk of the vagus nerve);
a processor (e.g. [0079]); and
a memory (e.g. [0061]) storing data for processing by the processor, the data, when processed, causes the processor to:
monitor patient feedback using at least one device (e.g. [0089]: glucose levels monitored (e.g. [0089]);
generate an activation signal when the patient feedback reaches a threshold (e.g. [0089]: a sensor may measure the amount of glucose in the blood and initiate an upregulating signal to a nerve or organ in order to modify GLP1 production if the amount of glucose exceeds a certain threshold); and
transmit the activation signal to the implantable pulse generator to cause the implantable pulse generator to generate the current, thereby causing the electrode to apply the current to the anatomical element (e.g. [0089]).
Regarding claim 2, Thornton teaches at least one current parameter of the current is adjusted based on the patient feedback (e.g. [0089] Fig. 12).
Regarding claim 3, Thornton teaches the patient feedback comprises at least one of a glucose level (e.g. [0089]), exercise activity, user input, and meal activity.
Regarding claim 4, Thornton teaches the patient feedback comprises a glucose level and the at least one device comprises a continuous glucose monitor configured to track and record the glucose level (e.g. [0089]).
Regarding claim 5, Thornton teaches the threshold comprises a glucose threshold (e.g. [0089]).
Regarding claims 6, 7, 13 and 16, Thornton teaches the patient feedback comprises at least one of an exercise and an activity level and the at least one device comprises at least one of an activity sensor and a user device, wherein the user device is configured to receive user input, wherein the patient feedback comprises a meal activity, wherein the at least one device comprises at least one of a meal sensor and the user device, and wherein the meal sensor is configured to sense at least one of peristaltic movement, gastric emptying, type of food ingested, and stomach sounds and the user device is configured to receive user input (e.g. [0089]: the sensor may measure strain or the presence of food entering the duodenum (therefore gastric emptying) and apply an upregulating signal to the duodenum, small bowel, ileum, splanchnic nerve, or celiac branch of the vagus nerve, [0124],[0142]).
Regarding claims 11-14, Thornton teaches determining if the patient feedback comprises a glucose level and meets a threshold, wherein the threshold comprises a glucose threshold. wherein the implantable pulse generator generates the current when the patent feedback meets the threshold and the at least one device comprises a continuous glucose monitor configured to track and record the glucose level (e.g. [0089]).
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.
Claims 6, 9, 13, 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Thornton et al (U.S. Patent Application Publication Number: US 2017/0021174 A1, hereinafter “Thornton”) in view of Koya et al (U.S. Patent Application Publication Number: US 2019/0125227 A1, hereinafter “Koya”).
Regarding claims 6, 9, 13, 15 and 18, Thornton teaches the invention as claimed and while they teach that the patient feedback comprises of meal activity as discussed above, they do not specifically teach that the patient feedback comprises at least one of an exercise and an activity level and the at least one device comprises at least one of an activity sensor and a user device, wherein the user device is configured to receive user input and wherein the activity sensor comprises at least one of a wearable device configured to track an activity, a heart rate monitor, an accelerometer, an altimeter, a blood oxygen level monitor, a bioimpedance sensor, and a skin temperature sensor and the patient feedback comprises an exercise activity, and wherein the at least one device comprises at least one of an activity sensor, a digital calendar, and user input.
In a similar field of endeavor, Koya teaches a system for monitoring an implantable pulse generator comprising an electrode to provide stimulation based on activity levels sensed by an activity sensor (e.g. [0089]: A graded therapy may use patient activity as an input for the neuromodulation therapy. The patient activity may be input by a person such as the patient or other user, or may be sensed by an activity sensor 103 that may include an accelerometer, a gyroscope, a GPS sensor, a cardiovascular activity sensor, a respiratory sensor, or any other activity tracker or combination thereof). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Thornton to include an activity sensor and user input as feedback as taught by Koya in order to provide the predictable results of providing a more effective and customized therapy.
Claims 7, 8, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Thornton et al (U.S. Patent Application Publication Number: US 2017/0021174 A1, hereinafter “Thornton”) in view of Duval et al (U.S. Patent Application Publication Number: US 2019/0216384 A1, hereinafter “Duval”).
Regarding claim 7, 8,16 and 17, Thornton teaches the claimed invention as discussed above and while they teach a meal activity sensor that senses gastric emptying (e.g. [0089]: the sensor may measure strain or the presence of food entering the duodenum) as discussed above, they do not specifically teach that the meal sensor is configured to sense stomach sounds and comprises at least one of an electromyography and a microphone.
In a similar field of endeavor, Duval teaches a system for monitoring an implantable pulse generator (e.g. 110Fig.1, [0025]) comprising an electrode to provide stimulation based on sensors that measure stomach activity such as stomach sounds and comprises at least one of an electromyography and a microphone (e.g. [0026]: electrogastrography (EGG), acoustical sensors/microphones). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Thornton to also include sensors to send gastric activity or gastric sounds as taught by Duval in order to provide the predictable results of a more effective therapy based on the movement of food through the gastrointestinal tract.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Guzman et al (U.S. Patent Application Publication Number: US 2007/0027484 A1, hereinafter “Guzman”) teaches a method for stimulating a portion of a vagus nerve of a patient to treat a pancreatic disorder (e.g. Abstract) that comprises low blood-glucose level, high blood-glucose level, abnormal level of digestion enzymes, heart-rate fluctuations due to hormonal imbalance, hypoglycemia, hyperglycemia, Type 1 diabetes or Type 2 diabetes by monitoring blood glucose levels (e.g. claim1-4, 12).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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