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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/09/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Reference number 728 in figure 14E is not in the description.
Reference number 840 in figure 15 is not in the description.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Para 0005, line 1, “a method of a method” should read “a method”.
Para 0062, line 6, “PPG sensor capture” should read “PPG sensor captures”.
Para 0075, line 1, “from the using various” should read “from the motor using various”.
Para 0078, lines 12-13, “The faster the soft start the higher the inrush current” should read “The faster the soft start, the higher the inrush current”.
Para 0082, line 7, “is associate” should read “is associated”.
Para 0091, lines 13-14, “affects” should read “affect”.
Appropriate correction is required.
Claim Objections
Claim 13 is objected to because of the following informalities:
Claim 13, line 13, “actuating a pump” should read “actuating the pump”.
Appropriate correction is required.
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 1, 6, 8, 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Tyson (US 20180147343 A1) in view of Williams et al (US 20240355447 A1) and further in view of Uber et al (US 20150051487 A1).
Regarding claim 1, Tyson discloses a device (100) configured to be implanted in a subject (para 0023-24), the device comprising: a sensing module (120); a therapeutic module (130+112+116) coupled to the sensing module(fig 1), the therapeutic module comprising: a drug reservoir (130); and a pump (116); and a battery (140) coupled to the sensing module and the therapeutic module (para 0026), configured to provide power to the sensing module and the therapeutic module (para 0034-35); wherein: the sensing module is configured to detect a biological event in the subject and, upon detection of the biological event, send a signal to the therapeutic module (para 0023, 0025 and 0036); and the therapeutic module is configured to receive the signal from the sensing module and, upon receiving the signal, administer a drug to the subject from the drug reservoir via the pump (para 0034 and 0055-56, fig 4).
Tyson fails to explicitly disclose said sensing module comprising at least two of: an accelerometer; an electrocardiogram (ECG) sensor; a photoplethysmogram (PPG) sensor; a temperature sensor; and a microphone but teaches that said sensing module includes one or more sensors configured to sense one or more biometric parameters of the patient such as respiration rate (e.g., peak to peak), tidal volume, blood oxygen level, ratio of CO.sub.2 and O.sub.2, heart rate, blood pressure (para 0025).
However, Williams et al disclose a delivery device (300) comprising a sensing module (338) wherein the sensing module comprising a photoplethysmography (PPG), an accelerometer, and a temperature sensor (para 0079).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the sensing module of Tyson to include a photoplethysmography (PPG), an electrocardiogram (ECG) sensor and/or a temperature sensor as taught by Williams et al. This would provide the benefit of measuring the patient's heart rate and temperature needed to detect biological event (para 0079).
Tyson fails to disclose said pump is a reciprocating pump but teaches the pump 116 can be an active pump, such as an electrostatic pump, a piezoelectric pump, an electrochemical pump, a thermal pump, or a combination thereof; a passive pump, such as an osmotic pump, a spring-powered pump (para 0030).
However, Uber et al disclose an infusion system (817, fig 8D) comprising a pump (815) that is a reciprocating pump (abstract and 0074-77).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the pump of Tyson to be a reciprocating pump as taught by Uber et al. This would provide the benefit of having a static flow rate and a continuous output of the fluid to the subject (para 0009).
Regarding claim 6, Tyson in view of Williams et al and Uber et al discloses the device of claim 1,
Uber et al further disclose wherein the reciprocating pump (815) comprises: a motor (814) having a unidirectional rotation (para 0077); and a reciprocating actuation mechanism (814, para 0077).
Regarding claim 8, Tyson in view of Williams et al and Uber et al discloses the device of claim 1,
Tyson discloses said device further comprising a wireless communications chip (160, para 0039 and 0050).
Regarding claim 9, Tyson in view of Williams et al and Uber et al discloses the device of claim 1,
Tyson further discloses wherein: the biological event is an opioid overdose; and the drug is naloxone (para 0025 and 0043).
Regarding claim 12, Tyson in view of Williams et al and Uber et al discloses the device of claim 1,
Tyson further discloses wherein the device is configured to be fully implanted in the subject's chest (para 0024).
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Tyson (US 20180147343 A1) in view of Williams et al (US 20240355447 A1) and further in view of Uber et al (US 20150051487 A1) and in view of Whitehurst et al (US 20110276110 A1).
Regarding claim 2, Tyson in view of Williams et al and Uber et al discloses said device further comprising a controller (170) operably coupled to the sensing module and the therapeutic module (para 0034) but fails to teach the controller comprising at least one of: a digital-to-analog (DAC) converter coupled to a switch; or a direct current (DC) to DC converter.
However, Whitehurst et al disclose an implantable medical device (200) comprising a controller with a direct current (DC) to DC converter (210, para 0034).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the controller of Tyson to comprise a direct current (DC) to DC converter. This would provide the benefit of regulating the driving voltage by generating a compliance voltage which can be supplied directly to the battery (para 0042).
Regarding claim 3, Tyson in view of Williams et al and Uber et al and Whitehurst et al discloses the device of claim 2,
Tyson discloses said device further comprising a housing (110) comprising a cavity (110a-b); wherein the sensing module, therapeutic module, battery, and controller are disposed in the cavity (fig 1).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Tyson (US 20180147343 A1) in view of Williams et al (US 20240355447 A1) and further in view of Uber et al (US 20150051487 A1) and in view of Kiani et al (US 20200405226 A1).
Regarding claim 4, Tyson in view of Williams et al and Uber et al discloses the limitations of claim 1 as discussed above but fails to teach wherein an accelerometer is part of an inertial measurement (IMU) sensor comprising: a gyroscope; and a magnetometer.
However, Kiani et al disclose a system to monitor and to deliver therapeutic drug (1804) comprising a sensor including an accelerometer, a gyroscope, and a magnetometer (para 0283).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the sensing module of Tyson to have an inertial measurement (IMU) sensor including an accelerometer, a gyroscope, and a magnetometer. This would provide the benefit of a having a sensor that senses linear acceleration, angular velocity, and sometimes magnetic fields to determine the user's position and orientation in three-dimensional space (para 0283).
Regarding claim 5, Tyson in view of Williams et al and Uber et al discloses the device of claim 4,
Kiani et al disclose wherein the sensing module comprises: the inertial measurement (IMU) sensor including an accelerometer, a gyroscope, and a magnetometer;
Williams et al disclose wherein the sensing module comprises the electrocardiogram (ECG) sensor; the photoplethysmogram (PPG) sensor; and the temperature sensor.
Thus, the modified sensing module of Tyson comprises the inertial measurement (IMU) sensor; the electrocardiogram (ECG) sensor; the photoplethysmogram (PPG) sensor; and the temperature sensor.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Tyson (US 20180147343 A1) in view of Williams et al (US 20240355447 A1) and further in view of Uber et al (US 20150051487 A1) and in view of Tran (US 20210106281 A1).
Regarding claim 7, Tyson in view of Williams et al and Uber et al discloses the limitations of claim 1 as discussed above but fails to teach said device further comprising: a wireless charging pad electrically coupled to the battery; wherein the battery is rechargeable.
However, Tran discloses an implantable medical system comprising a battery and a wireless charging pad electrically coupled to the battery; wherein the battery is rechargeable (para 0006 and 0031).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Tyson to have a wireless charging pad electrically coupled to the battery; wherein the battery is rechargeable. This would provide the benefit of wirelessly charging the battery in the implanted device and this would reduce the need to remove the device from the subject to charge the battery (para 0031).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Tyson (US 20180147343 A1) in view of Williams et al (US 20240355447 A1) and further in view of Uber et al (US 20150051487 A1) and in view of Dobbles et al (US 20200330684 A1).
Regarding claim 10, Tyson in view of Williams et al and Uber et al discloses the limitations of claim 1 as discussed above but fails to teach wherein: the biological event is hypoglycemia; and the drug is glucagon.
Tyson discloses the disclosure is not intended to be exhaustive or to limit the present technology to the precise forms disclosed herein (para 0101).
However, Dobbles et al discloses a device (10) comprising a sensor (12) configured to detect a biological event wherein the biological event is hypoglycemia (para 0170 and 0286); and the drug is glucagon (para 0286).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Tyson to be used to monitor insulin overdose and to cause glucagon to be delivered to the subject as taught by Dobbles et al (para 0286).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Tyson (US 20180147343 A1) in view of Williams et al (US 20240355447 A1) and further in view of Uber et al (US 20150051487 A1) and in view of Hartlaub (US 20020087113 A1).
Regarding claim 11, Tyson in view of Williams et al and Uber et al discloses the limitations of claim 1 as discussed above but fails to teach wherein the device is configured to be fully implanted in the subject's abdomen.
However, Hartlaub discloses an implantable device (105) configured to be fully implanted in the subject's abdomen (para 0011 and 0038).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Tyson to be configured to be fully implanted in the subject's abdomen as taught by Hartlaub. The abdomen is a location appropriate for a therapy that interferes as little as practicable with normal patient activity (para 0011).
Claims 13 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Tyson (US 20180147343 A1) in view of Tran (US 20210106281 A1).
Regarding claim 13, Tyson discloses a method (fig 4) of using a device (100); the device comprising: a sensing module (120); a therapeutic module (130+112+116) comprising: a drug reservoir (130) containing a drug (para 0028); and a pump (116); and a battery (140) configured to provide power to the device (para 0026); wherein the device is fully implanted in a subject (para 0024); the method comprising: measuring the subject's respiratory rate, heart rate, blood oxygen saturation, and with the sensing module (para 0025); while measuring, detecting a biological event in the subject; and upon detecting the biological event, actuating a pump to administer the drug from the drug reservoir to the subject (para 0034 and 0055-56, fig 4).
Tyson fails to teach said battery is rechargeable and fails to teach said method includes measuring the subject’s temperature.
However, Tran discloses an implantable medical system comprising a battery wherein the battery is rechargeable (para 0006 and 0036) and a method using said system includes measuring the subject’s temperature with said sensing module (para 0009 and para 0147).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Tyson to have said battery to be rechargeable and have the sensing module measures the subject’s temperature. This would provide the benefit of having said battery to be rechargeable to reduce the need to remove the device from the subject to charge the battery (para 0031) and having said sensing module to also measure the subject’s temperature which is needed when detecting a biological event (para 0147).
Regarding claim 16, Tyson in view of Tran discloses the method of claim 13, wherein actuating the pump comprises administering to the subject about 500 uL of the drug (para 0028, 0.5cc is 500ul) but fails to teach said drug is administered in about 5 seconds.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Tyson to administer said drug in about 5 seconds since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Tyson would not operate differently with the claimed diameter and since the pump comprises administering to the subject about 500 uL of the drug (para 0028, 0.5cc is 500ul), the device would function appropriately having the claimed time. Further, applicant places no criticality on the time claimed, indicating simply that the module can administer 500 μL of a liquid medicine in about 5 seconds. (specification pp. [0069]).
Regarding claim 17, Tyson in view of Tran discloses the method of claim 13,
Tran discloses said method further comprising recharging the rechargeable battery via inductive coupling (para 0009 and 0115).
Regarding claim 18, Tyson in view of Tran discloses the method of claim 13,
Tyson discloses said method further comprising refilling the drug reservoir with the drug (para 0080).
Regarding claim 19, Tyson in view of Tran discloses the method of claim 13,
Tyson discloses said method further comprising, upon detecting the biological event, sending a wireless signal to an external device alerting the external device about the biological event (para 0032-34).
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Tyson (US 20180147343 A1) in view of Tran (US 20210106281 A1) and further in view of Jacobson (US 20220401640 A1).
Regarding claim 14, Tyson in view of Tran discloses the limitations of claims 13 as discussed above but fails to teach wherein actuating the pump comprises modulating a current pulse to the pump.
Tyson discloses the pump 116 can be an active pump, such as an electrostatic pump, a piezoelectric pump, an electrochemical pump, a thermal pump, or a combination thereof; a passive pump, such as an osmotic pump, a spring-powered pump (para 0030).
However, Jacobson discloses an infusion pump (10) comprising a pump (66+343) wherein actuating the pump comprises modulating a current pulse to the pump (para 0097-98).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the actuating pump of Tyson to comprise modulating a current pulse to the pump. This would provide the benefit of having the fluid flowing from the pump in a series of spaced-apart pulses rather than an uninterrupted flow (para 0077).
Regarding claim 15, Tyson in view of Tran and Jacobson discloses the method of claim 14,
Jacobson further discloses wherein modulating the current pulse comprises converting a control signal from a digital signal to an analog signal; and controlling a switch with the analog signal; wherein the switch controls the current pulse to the pump (para 0118).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Tyson (US 20180147343 A1) in view of Uber et al (US 20150051487 A1).
Regarding claim 20, Tyson discloses a system (100) configured to be implanted in a subject (para 0023-24), the system comprising: a housing (110) comprising a cavity (110a-b); a sensing module (120) disposed in the cavity (fig 1), the sensing module comprising at least two of: a respiratory rate sensor (120a-b); a heart rate sensor ; a blood oxygen saturation sensor; a temperature sensor; and a microphone (para 0025, sensor 120 is configured to measure the patient heart rate),
a pump (116) coupled to the sensing module and disposed at least partially in the cavity (fig 1), the reciprocating pump configured to administer a medicine to the subject (para 0030); and a battery (140) disposed in the cavity and coupled to the sensing module and the reciprocating pump (fig 1 and para 0026 and 0034), the battery being configured to provide power to the sensing module and the pump (para 0034).
Tyson fails to disclose said pump is a reciprocating pump but teaches said pump 116 can be an active pump, such as an electrostatic pump, a piezoelectric pump, an electrochemical pump, a thermal pump, or a combination thereof; a passive pump, such as an osmotic pump, a spring-powered pump (para 0030).
However, Uber et al disclose an infusion system (817, fig 8D) comprising a pump (815) that is a reciprocating pump (abstract and 0074-77).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the pump of Tyson to be a reciprocating pump as taught by Uber et al. This would provide the benefit of having a static flow rate and a continuous output of the fluid to the subject (para 0009).
Conclusion
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 09/03/2026
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