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 47 is objected to because of the following informalities: Starting on line 1, the recitation “a programmable medical device that includes that includes (a) a housing…” should read “a programmable medical device that includes (a) a housing…”. 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.
Claim 32 is 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. The claim is considered indefinite because it cannot be ascertained how the claimed invention can exactly “improve drug administration to authorized users with limited motor skills or dysphagia.” For a claim to state improvement is taking place, the improvement must be quantifiable and definitive. It is recommended by the examiner to replace the term “to improve” with terms such as “for the use of” or “for application of”. For the purpose of this examination, the claim will be considered as though the aforementioned recommended terms are used instead of “to improve”.
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 1-7, 12-17, 19, 20, 24-28, 32-41 and 46-47 are rejected under 35 U.S.C. 103 as being unpatentable over Greenspan (US 11173097 B2) in view of Xie (WO 2019140670 A1).
Greenspan teaches a system for secured medication dispensing comprising:
(a) a housing that includes at least one compartment configured to store a drug (shown in Figure 5 and 16),
(b) a drug delivery unit mounted within the housing that is configured to store a therapeutic dose of the drug from the at least one compartment and dispense the therapeutic dose to an authorized user (drum housing 930 shown in Figure 17),
(c) at least one biometric reader configured to capture a physical feature of the authorized user (biometric identifier 314 shown in Figure 5).
A control circuit (controller 304)
Greenspan does not teach:
(d) a sensor configured to detect an angle at which the medical device is being held by the authorized user, and
(e) the control circuit configured to
(i) communicate with the sensor and verify that the angle detected by the sensor is within a preset range of angles and, when the angle is verified as falling within the preset range of angles,
(ii) provide power to the at least one biometric reader and the drug delivery unit, wherein once the at least one biometric reader captures the physical feature of the authorized user and the control circuit verifies that the physical feature belongs to the authorized user, the control circuit instructs the drug delivery unit to dispense the therapeutic dose of the drug from the drug delivery unit to the authorized user.
Xie teaches system of characteristic identification comprising:
a sensor configured to detect an angle at which the medical device is being held by the authorized user (gravity sensor S101 described in abstract), and
a control circuit configured to
(i) communicate with the sensor and verify that the angle detected by the sensor is within a preset range of angles and, when the angle is verified as falling within the preset range of angles (described in abstract, paragraph 0008 and 0009 wherein communication via a control circuit would have to take place for the gravity sensor and biometric characteristic identification sensor to interact),
(ii) provide power to the at least one biometric reader and the drug delivery unit (described in abstract, paragraph 0008 and 0009).
Regarding Claim 1, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the sensor and control circuit of Xie to the medication dispensing system of Greenspan. The result would be wherein once the at least one biometric reader captures the physical feature of an authorized user and the control circuit verifies that the physical feature belongs to the authorized user the control circuit instructs the drug delivery unit to dispense the therapeutic dose of the drug from the drug delivery unit to the authorized user. This would be for the purpose of further preventing tampering or misuse of the medication dispensing system of Greenspan. For example, the angle detection can be used as a secret, secondary lock system where an authorized user would know to tilt the dispensing system in a certain direction in order to gain access via the biometric sensor. One of ordinary skill in the art could apply the sensor and control circuit of Xie to the medication dispensing system of Greenspan without undue experimentation. Further, the application of the sensor and control circuit of Xie to the medication dispensing system of Greenspan would produce the predictable results of dispensing medication to prescribed patients via a secured dispensing system.
Regarding Claim 2, Greenspan further teaches a circuit board configured to control and monitor an operation of the medical device, wherein the control circuit is mounted to the circuit board (described in Column 11 lines 36-45).
Regarding Claim 3, Greenspan further teaches a driving unit within the housing, the driving unit configured to drive one or more components of the drug delivery unit to administer the drug to the authorized user (stepper motor 940 and drive shaft 942 described in column 24 lines 42-53); and a battery mounted within the housing and configured to supply the circuit board and the driving unit with operating power (battery 316 described in column 14 lines 53-64).
Regarding Claim 4, Greenspan further teaches a charging dock configured to mechanically engage with the housing and charge the battery mounted within the housing (column 25 line 59-67 describes the battery being rechargeable, the ability to recharge would have to be performed using a docking system wherein a connector, or dock, must exist between an external power supply that provides charge and the battery being charged).
Regarding Claim 5, Greenspan further teaches a charging port on the housing configured to communicate with an external power source and charge the battery mounted within the housing (column 25 line 59-67 describes the battery being rechargeable, such an ability would most ideally be performed via a charging port for the dispensing system of Greenspan).
Regarding Claim 6, Greenspan further teaches wherein the device includes a locking device disposed on a face of the housing and configured to prevent the authorized user and an unauthorized user from accessing the drug in the at least one compartment (described in column 14 lines 1-32).
Regarding Claim 7, Greenspan further teaches wherein the control circuit is configured to actuate the driving unit to drive the one or more components of the drug delivery unit to administer the therapeutic dose of the drug to the authorized user when the verification is successful and when a pre-defined time interval is met (described in column 15 line 17-37).
Regarding Claim 12, Greenspan further teaches at least one transceiver configured for wireless communication with a global positioning system, wherein the control circuit is configured to determine a location of the medical device including at least one of a life-saving drug product and an antidote based on geolocation data received from the global positioning system (GPS) (performed via GPS module 306, described in column 15 lines 4-16).
Regarding Claim 13, Greenspan further teaches wherein the at least one compartment includes: a tray having plural chambers, wherein each chamber is configured to store the therapeutic dose of the drug in oral dosage form, wherein the tray is configured to rotate when driven by the driving unit, and an opening to allow the therapeutic dose to be dispensed when one of the plural chambers is aligned with the opening (described in column 24 lines 21-34, 42-51).
Regarding Claim 14, Greenspan does not explicitly teach wherein the locking device is integrated into the housing and is configured to allow access to the at least one compartment when interfacing with an authorized key. However, column 10 lines 52-67 describes an override protocol that would enable unlocking of the dispensing system without necessary biometric identification. This can also be considered to have the same functionality as a key. Therefore, Greenspan implicitly teaches an authorized key for allowing access to housing through the locking device.
Regarding Claim 15, Greenspan further teaches wherein the at least one compartment is a tablet hopper configured to store plural units of the drug in oral dosage form, wherein one oral dosage form of the drug contains the therapeutic dose (hopper 920), and wherein the one or more components of the drug delivery unit includes: a door that is configured to be driven by the driving unit to allow one or more oral dosage forms of the drug to be dispensed from the at least one compartment when the driving unit is actuated by the control circuit (pill hopper gate 932 described in column 24 lines 42-53).
Regarding Claim 16, Greenspan further teaches wherein the authorized key is an electronic key (column 10 liens 52-67 describes a pharmacy to remotely unlock the dispensing system, meaning such a key would be electronically transmitted).
Regarding Claim 17, Greenspan does not explicitly teach wherein the authorized key is a physical key. However, column 24 lines 3-14 describes an authorizing physician or pharmacy providing instructions to unlock the medication dispensing system, meaning that there is a non-electronic way to unlock the medication dispensing system. A physical key is a commonly known alternative for unlocking, especially when there isn’t an electronic method to unlock. It would have been obvious to one of ordinary skill in the art to utilize and/or modify the medical dispensing system of Greenspan such that it can be unlocked using a physical key.
Regarding Claim 19, Greenspan further teaches wherein the at least one biometric reader is configured to capture the authorized user’s fingerprint, and wherein the control circuit is configured to verify an identity of the authorized user by comparing the captured fingerprint to a stored fingerprint of the authorized user (column 13 lines 5-23 describes a fingerprint being used as biometric data).
Regarding Claim 20, Greenspan further teaches wherein the at least one biometric reader is configured to capture an ocular biometry of the authorized user, and wherein the control circuit is configured to verify an identity of the authorized user by comparing the captured ocular biometry to a stored ocular biometry of the authorized user (column 13 lines 5-23 describes a retina scan being used as biometric data).
Regarding Claim 24, Greenspan further teaches wherein the housing is configured for portability by the authorized user (described in column 4 lines 16-23).
Regarding Claim 25, Greenspan further teaches a transceiver configured for communication with a wireless network (communication module 308 described in column 12 lines 31-40, network shown in Figure 1).
Regarding Claim 26, Greenspan further teaches wherein the transceiver is configured to wirelessly communicate with a remote device associated with the authorized user (shown in Figures 1 and 3).
Regarding Claim 27, Greenspan further teaches wherein the remote device includes a second sensor that obtains vital measurements from the authorized user (blood tester 312 described in column 13 lines 24-67).
Regarding Claim 28, Greenspan further teaches wherein the remote device of the authorized user is configured to send the vital measurements of the authorized user to a third-party remote device (described in column 13 lines 24-67).
Regarding Claim 32, Greenspan does not explicitly teach wherein the medical device is configured to improve drug administration to authorized users with limited motor skills or dysphagia. However, column 13 lines 5-23 states that the minimum input needed from a user is providing biometric information. Since the claimed invention has similar biometric information being provided by users with limited motor skills or dysphagia, it is interpreted that a person with limited motor skills and/or dysphagia would be able to provide biometric information such as a fingerprint. Therefore, Greenspan implicitly teaches wherein the medical device is configured to improve drug administration to authorized users with limited motor skills or dysphagia.
Regarding Claim 33, Greenspan further teaches a system comprising:
(a) a medical device having a compartment configured to store one or more therapeutic doses of a drug, (shown in Figures 5 and 16)
a drug delivery unit configured to dispense at least one therapeutic dose of the drug to an authorized user (shown in Figure 17),
at least one biometric reader configured to capture a physical feature of the authorized user (biometric identifier 314 shown in Figure 5),
a control circuit (controller 304),
(b) a device configured to measure the authorized user’s vitals and communicate with the medical device (blood tester 312 described in column 13 lines 24-67), and
(c) a remote device configured to
(i) wirelessly communicate with the control circuit of the medical device and
(ii) execute an application program interface that allows the authorized user and a third-party to monitor a status of the medical device and adjust at least one of settings and control parameters of the medical device (all described in column 8 line 41-column 10 line 23).
Greenspan does not teach:
a sensor configured to measure an angle at which the medical device is being held,
the control circuit configured to:
(i) verify that the angle detected by the sensor is within a preset range of angles and, when the angle at which the medical device is being held is verified as falling with the preset range of angles,
(ii) provide power to the at least one biometric reader and the drug delivery unit, wherein once the at least one biometric reader captures the physical feature of the authorized user and the control circuit verifies that the physical feature belongs to the authorized user, the control circuit instructs the drug delivery unit to dispense the therapeutic dose of the drug from the drug delivery unit to the authorized user;
Xie teaches system of characteristic identification comprising:
a sensor configured to measure an angle at which the medical device is being held (gravity sensor S101 described in abstract), and
a control circuit configured to:
(i) verify that the angle detected by the sensor is within a preset range of angles and, when the angle at which the medical device is being held is verified as falling with the preset range of angles (described in abstract, paragraph 0008 and 0009 wherein communication via a control circuit would have to take place for the gravity sensor and biometric characteristic identification sensor to interact),
(ii) provide power to the at least one biometric reader and the drug delivery unit, wherein once the at least one biometric reader captures the physical feature of the authorized user and the control circuit verifies that the physical feature belongs to the authorized user (described in abstract, paragraph 0008 and 0009);
Regarding Claim 33, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the sensor and control circuit of Xie to the system of Greenspan. The result would make it so the control circuit instructs the drug delivery unit to dispense the therapeutic dose of the drug from the drug delivery unit to the authorized user when both the preset range of angles is met and the biometric reader verifies the authorized user. This would be for the purpose of further preventing the tampering or misuse of the system of Greenspan. For example, the angle detection can be used as a secret, secondary lock system where an authorized user would know to tilt the dispensing system in a certain direction in order to gain access via the biometric sensor. One of ordinary skill in the art could apply the sensor and control circuit of Xie to the system of Greenspan without undue experimentation. Further, the application of the sensor and control circuit of Xie to the system of Greenspan would produce the predictable results of dispensing medication to prescribed patients via a secured dispensing system.
Regarding Claim 34, Greenspan further teaches the remote device is configured to: receive status information from the medical device; and from the status information: determine a number of therapeutic doses remaining to be dispensed; determine whether the housing has been compromised or damaged (described in column 6 lines 1-19).
Regarding Claim 35, Greenspan further teaches a sensor configured to obtain vital measurements from the authorized user (described in column 13 lines 24-67).
Regarding Claim 36, Greenspan further teaches wherein the remote device is configured to wirelessly receive the vital measurements from the authorized user and determine, via the application program interface, whether the authorized user requires emergency care (described in column 4 lines 55-67 and column 13 lines 24-67).
Regarding Claim 37, Greenspan does not teach wherein the remote device is configured to send automatically send notification to emergency services or a physician when the vital measurements indicate that the authorized user requires emergency care. However, they do teach automatically sending a notification to a physician or pharmacist in an emergency situation (column 15 lines 6-16). It would have been obvious to one of ordinary skill in the art to modify the system of Greenspan such that it further notifies emergency services and provides GPS location tracking so that services can reach the location of the system of Greenspan.
Regarding Claim 38, Greenspan further teaches at least one transceiver located within the storage unit and configured for wireless communication with a global positioning system, wherein the control circuit is configured to determine a location of the storage unit based on geolocation data received from the global positioning system (GPS) (performed via GPS module 306 and communication module 308 shown in Figure 5, described in column 15 lines 4-16).
Regarding Claim 39, Greenspan further teaches wherein the at least one biometric reader is configured to capture a facial image of the authorized user, and wherein the control circuit is configured to verify an identity of the authorized user by comparing features of the captured facial image to features of a stored facial image of the authorized user (column 13 lines 5-23 describes facial recognition being used as biometric data).
Regarding Claim 40, Greenspan further teaches wherein the transceiver is configured to wirelessly communicate with a secondary remote device associated with a secondary user (shown in Figures 1 and 3).
Regarding Claim 41, Greenspan further teaches wherein the device comprises at least one tamper detection sensor that is configured to detect at least an attempt at unauthorized access to the at least one compartment of the drug delivery unit (tamper detection mechanism described in column 14 lines 14-52).
Regarding Claim 46, Greenspan further teaches wherein the device comprises a destruction unit located within the housing, the destruction unit being configured to mechanically and/or chemically destroy an amount of drug remaining in the at least one compartment once a tampering attempt has occurred (described in column 26 lines 4-14).
Regarding Claim 47, Greenspan further teaches a drug dispensing method comprising:
(a) a housing having at least one compartment configured to store a drug (shown in Figure 17),
(b) a drug delivery unit mounted within the housing (shown in Figure 5, 16 and 17),
(c) at least one biometric reader (biometric identifier 314 shown in Figure 5),
(e) a control circuit connected to the drug delivery unit and the at least one biometric reader (controller 304 in Figure 5), the method comprising:
(iv) verifying, by the control circuit, an identity of the authorized user based on a physical feature captured by the at least one biomarker reader (described in column 13 lines 5-23), and
(iv) instructing, by the control circuit, the drug delivery unit to dispense the therapeutic dose of the drug to the authorized user when the identity of the authorized user is verified (column 13 lines 5-23).
Greenspan does not teach:
(d) a sensor connected to the controller and configured to measure an angle at which the medical device is being held and
(i) detecting, by the sensor, an angle at which the medical device is being held by the authorized user,
(ii) verifying, by the control circuit, that the angle detected by the sensor is within a preset range of acceptable angles,
(iii) powering, by the control circuit, the at least one biometric and the drug delivery unit,
Instructing to dispense when the angle detected by the sensor is held is verified as falling with the preset range of acceptable angles.
Xie teaches a method of characteristic identification comprising:
a sensor configured to measure an angle (gravity sensor S101 described in abstract), and
a control circuit configured to:
(i) verify that the angle detected by the sensor is within a preset range of angles and, when the angle at which a device is being held is verified as falling with the preset range of angles (described in abstract, paragraph 0008 and 0009 wherein communication via a control circuit would have to take place for the gravity sensor and biometric characteristic identification sensor to interact),
(ii) provide power to the at least one biometric reader, wherein the at least one biometric reader captures the physical feature of the authorized user and the control circuit verifies that the physical feature belongs to the authorized user (described in abstract, paragraph 0008 and 0009).
Regarding Claim 47, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the sensing and controlling steps of Xie to the drug dispensing method of Greenspan. The result would make it so the control circuit instructs the drug delivery unit to dispense the therapeutic dose of the drug from the drug delivery unit to the authorized user when both the preset range of angles is met and the biometric reader verifies the authorized user. This would be for the purpose of further preventing the tampering or misuse of the drug dispensing method of Greenspan. For example, the angle detection can be used as a secret, secondary lock system where an authorized user would know to tilt the dispensing system in a certain direction in order to gain access via the biometric sensor. One of ordinary skill in the art could apply the sensing and controlling steps of Xie to the method of Greenspan without undue experimentation. Further, the application of the sensing and controlling steps of Xie to the method of Greenspan would produce the predictable results of dispensing medication to prescribed patients via a secured dispensing system.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Greenspan (US 11173097 B2) in view of Xie (WO 2019140670 A1) and in further view of Stephen (US 20200303044 A1).
Greenspan in view of Xie teaches the claim limitations of Claim 1 as above.
They do not teach wherein the at least one biometric reader is configured to capture a lip pattern of the authorized user, and wherein the control circuit is configured to verify an identity of the authorized user by comparing the captured lip pattern to a stored lip pattern of the authorized user.
Stephen teaches a biometric identifier that includes lip pattern identification (described in paragraph 0029).
Regarding Claim 21, it would have been prima facie obvious to one of ordinary skill in the art to apply a lip pattern identifier as a biometric identifier in the medication dispensing system of Greenspan. The result would expand biometric identification capabilities of the medication dispensing system of Greenspan. One of ordinary skill in the art could apply the lip pattern identifier of Stephen to the medication dispensing system of Greenspan without undue experimentation. Further, the application of the lip pattern identifier of Stephen to the medication dispensing system of Greenspan would produce the predictable results of identifying an authorized user and dispensing medication to them.
Claim 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Greenspan (US 11173097 B2) in view of Xie (WO 2019140670 A1) and in further view of Arric (US 20190392936 A1).
Greenspan in view of Xie teaches the claim limitations of Claim 1 as above. They do not teach a dosage splitting unit configured to split the therapeutic dose of the drug stored in the at least one compartment into smaller dosages.
Arric teaches a system for medication management comprising a dosage splitting unit configured to split the therapeutic dose of the drug stored in the at least one compartment into smaller dosages (performed via pill cutting carrier described in paragraph 0059).
Regarding Claim 22, it would have been prima facie obvious to one of ordinary skill in the art to apply the dosage splitting unit taught by Arric to the medication dispensing system of Greenspan. The result would enable the system of Greenspan to divide a pill being dispensed into a smaller dose if needed by a prescription. One of ordinary skill in the art could apply the dosage splitting unit of Arric to the medication dispensing system of Greenspan without undue experimentation. Further, the application of the dosage splitting unit of Arric to the medication dispensing system of Greenspan would produce the predictable results splitting medication to an appropriate dose prior to dispensing it.
Regarding Claim 23, Arric further teaches wherein the dosage splitting unit includes a blade (cutting blade or razor 109). It would have been further obvious to include this when applying the dosage splitting unit of Arric to the medication dispensing system of Greenspan for the purpose of cutting pills into a prescribed dose.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Greenspan (US 11173097 B2) in view of Xie (WO 2019140670 A1) and in further view of Blackburn (US 20140074283 A1).
Greenspan in view of Xie teaches the claim limitations of Claim 1 as above. They do not teach a sterilization unit configured to sterilize the drug delivery unit or a mouthpiece before and/or after dispensing the therapeutic dose of the drug.
Blackburn teaches a drug delivery system comprising a sterilization unit configured to sterilize the drug delivery unit or a mouthpiece before and/or after dispensing the therapeutic dose of the drug (described in paragraph 0060).
Regarding Claim 29, it would have been prima facie obvious to one of ordinary skill in the art to apply the sterilization unit taught by Blackburn to the medication dispensing system of Greenspan. The result would allow sanitization of the drug delivery system in the medication dispensing system of Greenspan to prevent cross-contamination of drug products being dispensed. One of ordinary skill in the art could apply the sterilization unit of Blackburn to the medication dispensing system of Greenspan without undue experimentation. Further, the application of the sterilization unit of Blackburn to the medication dispensing system of Greenspan would produce the predictable results of cleanly dispensing multiple drugs as prescribed.
Claim 44 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Greenspan (US 11173097 B2) in view of Xie (WO 2019140670 A1) and in further view of Puolitaival (US 20190133884 A1).
Greenspan in view of Xie teaches the claim limitations of Claim 1 as above. They do not teach wherein the medical device comprises at least one storage condition monitoring sensor configured to detect environmental conditions in the at least one compartment configured to store the drug.
Puolitaival teaches a storage condition monitoring sensor (humidity sensor described in abstract and paragraph 0049)
Regarding Claim 44, it would have been prima facie obvious to one of ordinary skill in the art to apply the storage monitoring sensor of Puolitaival to the medication dispensing system of Greenspan. The result would allow monitoring of the environment and ambient conditions that a drug being dispensed is within for the purpose of minimizing the potential for contamination. One of ordinary skill in the art could apply the storage monitoring sensor of Puolitaival to the medication dispensing system of Greenspan without undue experimentation. Further, the application of the storage monitoring sensor of Puolitaival to the medication dispensing system of Greenspan would produce the predictable results of safely dispensing drugs as prescribed.
Regarding Claim 45, Puolitaival further teaches wherein the at least one storage condition monitoring sensor is either a temperature sensor configured to detect the temperature in the at least one compartment configured to store the drug or is a humidity sensor configured to detect the humidity or moisture levels in the at least one compartment configured to store the drug (humidity sensor described in paragraph 0049). It would have been further obvious to incorporate this when applying the storage monitoring sensor of Puolitaival to the medication dispensing system of Greenspan for the purpose of ensuring a drug being dispensed does not have potential for contamination.
Allowable Subject Matter
Claims 8-11 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: the medication dispensing system of Greenspan (US 11173097 B2) does not teach a life-saving drug product disposed in a storage unit located in the housing.
Claim 18 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: the medication dispensing system of Greenspan (US 11173097 B2) does not teach wherein the drug delivery unit includes a mouthpiece configured to fit in the user’s mouth and dispense the therapeutic dose of the drug directly into the authorized user’s mouth.
Claims 30-31 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: the medication dispensing system of Greenspan (US 11173097 B2) does not teach wherein the medical device comprises two biometric readers, one biometric reader being located at or near the distal end of the housing and configured to capture a facial feature of the authorized user and the other biometric reader being located on the mouthpiece and configured to capture a lip pattern of the authorized user.
Claims 42-43 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: the medication dispensing system of Greenspan (US 11173097 B2) does not teach wherein the at least one compartment is a pressurized chamber, and the at least one tamper detection sensor is a pressure sensor configured to monitor the pressure of the at least one compartment, and wherein the control circuit is configured to receive pressure readings from the pressure sensor and compare the received pressure reading to a threshold to determine whether the at least one compartment has been tampered.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIRAJ T PATEL whose telephone number is (571)272-9330. The examiner can normally be reached M-F 8:00-5:00.
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/M.T.P./Examiner, Art Unit 3655
/JACOB S. SCOTT/Supervisory Patent Examiner, Art Unit 3655
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