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
Claims 1, 11, 20, and dependent claims are objected to because of the following informalities:
Claim 1 recites "responsive to receiving the request and biometric information and confirmation that the patient is authorized user to operate the drug delivery device." The phrase "authorized user" is grammatically incorrect. The claim should read "an authorized user."
Claim 11 recites "responsive to receiving the request and biometric information and confirmation that the patient is authorized user to operate the drug delivery device." The phrase "authorized user" is grammatically incorrect. The claim should read "an authorized user."
Claim 20 recites "responsive to receiving the request and biometric information and confirmation that the patient is authorized user to operate the drug delivery device." The phrase "authorized user" is grammatically incorrect. The claim should read "an authorized user."
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, 9-10, 11-15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Keenan et al. (US 2009/0143733A1; hereinafter “Keenan”) in view of Hickle (US 2005/0010165A1).
In relation to independent claim 1, this claim recites a system, comprising: a control unit operably connected to a drug delivery device and a drug control device, and configured to cause the drug control device to capture biometric information from a person, wherein the control unit is configured to: receive, via the drug control device, biometric information captured by the drug control device and a request for the drug delivery device to administer a dose of a medication; confirm, based on the biometric information, that a patient associated with the biometric information is authorized to operate the drug delivery device to self-administer the medication; and responsive to receiving the request and biometric information and confirmation that the patient is authorized user to operate the drug delivery device to self-administer the medication; obtain, via one or more sensors associated with the drug delivery device, one or more signals indicative of a state of the patient and different than the biometric information; determine, based at least in part on the one or more signals, whether the state of the patient satisfies a predetermined criteria for allowing the patient to self-administer the medication; and cause the drug delivery device to administer the dose of the medication to the patient when the state of the patient satisfies the predetermined criteria.
A system, comprising: a control unit operably connected to a drug delivery device and a drug control device, and configured to cause the drug control device to capture biometric information from a person, wherein the control unit is configured to: receive, via the drug control device, biometric information captured by the drug control device and a request for the drug delivery device to administer a dose of a medication; confirm, based on the biometric information, that a patient associated with the biometric information is authorized to operate the drug delivery device to self-administer the medication.
Keenan discloses a patient-controlled analgesia device with a biometric authentication system. Specifically, Keenan discloses: "A patient-controlled analgesia device generally includes: a patient controlled analgesia pump and a biometric authentication system. The biometric authentication system generally includes a biometric pump controller coupled to the patient controlled analgesia pump that activates the patient controlled analgesia pump to deliver analgesia and a biometric switch adapted to receive a biometric input and operably coupled to the biometric pump controller to activate the biometric pump controller." (Keenan, Abstract) Keenan further discloses: "[t]he biometric authentication processor 30 compares the received biometric input to the stored biometric identifier. If the received biometric input matches the stored biometric identifier, the biometric input is authenticated, and the biometric pump controller 14 will output a signal that activates the PCA pump 12 to dispense analgesia." (Keenan ¶ [0030].)
and responsive to receiving the request and biometric information and confirmation that the patient is authorized user to operate the drug delivery device to self-administer the medication: obtain, via one or more sensors associated with the drug delivery device, one or more signals indicative of a state of the patient and different than the biometric information ; determine, based at least in part on the one or more signals, whether the state of the patient satisfies a predetermined criteria for allowing the patient to self-administer the medication; and cause the drug delivery device to administer the dose of the medication to the patient when the state of the patient satisfies the predetermined criteria.
Keenan discloses authenticating the patient before drug delivery, but to the extent Keenan does not expressly disclose obtaining signals indicative of the state of the patient (different than the biometric info) and using those signals to satisfy a predetermined criteria before allowing self-administration, Hickle fills this gap. Hickle discloses an integrated patient interface system that monitors patient conditions and locks out patient drug requests if the conditions are outside safety parameters. Specifically, Hickle discloses: "[a] first patient monitoring system includes one or more patient health monitors 252 which monitor a patient's physiological conditions. Such monitors can include a known pulse oximeter 258... a known capnometer 184... and a known non-invasive blood pressure monitor 262". (Hickle ¶ [0114].) Hickle further discloses: "In a preferred embodiment of the invention, the patient controlled drug dosage request system 254 has lock-out capabilities that prevent patient self-administration of drugs under certain circumstances. For example, access to self-administration will be prevented by electronic controller 14 under circumstances where patient physiology parameters or machine state parameters are or are predicted to be outside of the stored safety data set parameters." (Hickle ¶ [0119].)
Motivation to combine.
Based on the above teachings, it would have been obvious to combine Keenan with Hickle because both references are directed to patient-controlled drug delivery systems and improving patient safety. A person of ordinary skill in the art would have been motivated to incorporate Hickle's physiological monitoring and lock-out system into Keenan's biometric PCA device to ensure that an authorized patient is also in a physiologically safe state (e.g., not over-sedated) before the pump administers the requested medication, thereby preventing dangerous overdoses.
In relation to claim 2, this claim depends from claim 1 and further recites: [t]he system of Claim 1, wherein determining whether the state of the patient satisfies the predetermined criteria comprises: determining, based on the one or more signals, that the patient is in a conscious state and allowed to self-administer the medication, wherein the drug delivery device is caused to administer the dose based on determining that the patient is in the conscious state and allowed to self-administer the medication.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
determining whether the state of the patient satisfies the predetermined criteria comprises: determining, based on the one or more signals, that the patient is in a conscious state and allowed to self-administer the medication, wherein the drug delivery device is caused to administer the dose based on determining that the patient is in the conscious state and allowed to self-administer the medication.
Hickle discloses determining the patient's conscious state and controlling drug delivery based on that state. Specifically, Hickle discloses: "[a] second patient monitoring system monitors a patient's level of consciousness by means of an automated consciousness query (ACQ) system 256 in accordance with the invention." (Hickle ¶ [0115].) Hickle further discloses: "[i]f the latency period is determined by controller 14... to be outside of a safe range, the physician is notified... If no action is taken by the physician within a pre-set time period, controller 14 commands the decrease in level of sedation/analgesia/amnesia". (Hickle ¶ [0116].) Furthermore, Hickle discloses preventing patient self-administration if physiology parameters (which includes consciousness) are outside safety data sets. (Hickle ¶ [0119].)
Motivation to combine.
Based on the above teachings, it would have been obvious to combine the base combination of Keenan and Hickle because Hickle explicitly teaches monitoring consciousness to ensure the patient is safely able to receive more drugs. A person of ordinary skill in the art would have been motivated to incorporate Hickle's consciousness monitoring into the base system to ensure that the patient is conscious and alert enough to safely self-administer medication.
In relation to claim 3, this claim depends from claim 1 and further recites: [t]he system of claim 1, further comprising: the drug control device, wherein the drug control device is a hand held control device, and the request and biometric information are captured via the drug control device within a predetermined period of time of each other.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
the drug control device, wherein the drug control device is a hand held control device, and the request and biometric information are captured via the drug control device within a predetermined period of time of each other.
Keenan discloses a handheld drug control device that captures biometric info and the request simultaneously. Specifically, Keenan discloses: "[i]t is desirable for the biometric switch 16 to be ergonomically designed for hand-held use by a patient, with the patient's thumb resting atop the biometric switch 16 adjacent the biometric input device 28." (Keenan ¶ [0024].) Keenan further discloses: "When analgesia is desired, the patient presses his or her thumb down on the biometric fingerprint reader in a manner similar to how a patient would depress a button in a typical PCA device. This causes the biometric authentication system... to receive a biometric input." (Keenan ¶ [0030].) Because the fingerprint scan acts as the button press, they are captured within a predetermined period of time (simultaneously).
Motivation to combine.
Based on the above teachings, it would have been obvious to combine the base combination of Keenan and Hickle because Keenan explicitly teaches the handheld device configuration. A person of ordinary skill in the art would have been motivated to use Keenan's handheld biometric switch to provide a convenient, ergonomic interface for the patient to request medication.
In relation to claim 4, this depends from claim 3 and further recites: [t]he system of Claim 3, wherein the drug delivery device comprises a control configured to receive a user input to initiate the request, and to determine a magnitude of the user input, and wherein causing the drug delivery device to administer the dose of the medication to the patient comprises causing the drug delivery device to administer an amount of the medication based on the magnitude of the user input.
Base rejection incorporated.
The rejection of claim 3 is incorporated herein.
wherein the drug delivery device comprises a control configured to receive a user input to initiate the request, and to determine a magnitude of the user input, and wherein causing the drug delivery device to administer the dose of the medication to the patient comprises causing the drug delivery device to administer an amount of the medication based on the magnitude of the user input.
Hickle discloses a control configured to receive a user input to determine the magnitude of the request and administer medication based on that magnitude. Specifically, Hickle discloses: "[t]he patient interface system of FIG. 11 also includes a drug dosage request device 254 which allows the patient direct control of drug dosage. This is accomplished by the patient activating a switch or button to request electronic controller 14 to command the increase or decrease in the amount of drug he or she is receiving." (Hickle ¶ [0117].) Hickle further discloses: "[d]rug dosage request switch 311 is integrated into finger support portion 309 and is in the form of a rocker switch whereby depressing the top portion 310a of said switch will effect an increase in the delivery of sedative, analgesic and/or amnestic whereas depressing the bottom portion 310b of said rocker switch will effect a decrease in drug delivery at an appropriate set percentage (e.g., ±10%)". (Hickle ¶ [0123].)
Motivation to combine.
Based on the above teachings, it would have been obvious to combine the base combination of Keenan and Hickle because Hickle teaches a proportional request switch (magnitude of input) to give the patient fine control over their pain relief. A person of ordinary skill in the art would have been motivated to incorporate Hickle's magnitude-based dosage control into the handheld device to allow the patient to adjust the exact amount of medication they need.
In relation to claim 5, this claim depends from claim 3 and further recites: [t]he system of Claim 3, wherein the drug control device comprises the one or more sensors, and the one or more sensors are activated after the request and biometric information are received by the drug control device.
Base rejection incorporated.
The rejection of claim 3 is incorporated herein.
wherein the drug control device comprises the one or more sensors, and the one or more sensors are activated after the request and biometric information are received by the drug control device.
Hickle discloses integrating sensors into the handheld drug control device. Specifically, Hickle discloses: "[i]n a preferred embodiment of the invention, one or more patient vital sign monitoring devices 252, ACQ system devices 256, and a drug dosage request device 254 are mechanically integrated in a cradle or gauntlet device 55 (FIG. 2) constructed to accommodate and otherwise fit around a patient's hand and wrist." (Hickle ¶ [0122].) To the extent Hickle does not explicitly state the sensors are activated *after* the request, this is an obvious design choice. A person of ordinary skill in the art would have recognized that activating sensors (such as blood pressure cuffs) only upon a drug request conserves power and reduces continuous patient discomfort.
Motivation to combine.
For an artisan skilled in the art, it would have been obvious to combine the base combination of Keenan and Hickle because Hickle teaches integrating the sensors and the request device into a single handheld unit. A person of ordinary skill in the art would have been motivated to activate the sensors upon receiving the request to verify the patient's current state immediately prior to dispensing the medication, ensuring safety while conserving battery life.
In relation to claim 6, this depends from claim 3 and further recites: [t]he system of Claim 3, wherein the drug control device comprises a fingerprint reader and the biometric information comprises a representation of at least a portion of a fingerprint captured by the fingerprint reader.
Base rejection incorporated.
The rejection of claim 3 is incorporated herein.
wherein the drug control device comprises a fingerprint reader and the biometric information comprises a representation of at least a portion of a fingerprint captured by the fingerprint reader.
Keenan discloses a fingerprint reader. Specifically, Keenan discloses: "[t]he biometric switch 16 includes a biometric input device 28, such as a fingerprint scanner, adapted to receive a biometric input, such as a fingerprint, which is preferably a thumbprint." (Keenan ¶ [0023].)
Motivation to combine.
It would have been obvious to combine the base combination of Keenan and Hickle because Keenan explicitly teaches using a fingerprint reader. A person of ordinary skill in the art would have been motivated to use a fingerprint reader as the biometric input because it is a reliable, widely available, and highly accurate method of authentication.
In relation to claim 9, this claim depends from claim 1 and further recites: [t]he system of Claim 1, wherein confirming that the patient is authorized to operate the drug delivery device to self-administer the medication comprises: determining an identity of the patient; determining an amount of the medication received by the patient over a period of time; and determining that the amount satisfies a threshold amount for the period of time.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein confirming that the patient is authorized to operate the drug delivery device to self-administer the medication comprises: determining an identity of the patient; determining an amount of the medication received by the patient over a period of time; and determining that the amount satisfies a threshold amount for the period of time.
Keenan discloses determining the identity of the patient via biometrics and checking dosing limits over time. Specifically, Keenan discloses: "[t]he biometric authentication processor 30 compares the received biometric input to the stored biometric identifier... affirmatively authenticating the identity of the individual requesting the analgesia." (Keenan ¶ [0030].) Keenan further discloses: "[d]osing processor 34 cooperates with biometric authentication processor 30 to ensure that analgesia is dispensed only upon authorized request in accordance with a prescription set by the clinician. That is, dosing processor 34 operates to ensure that any requests, including authorized requests, occurring during the lockout interval, as described above, are ignored, thereby minimizing the likelihood of oversedation." (Keenan ¶ [0031].)
Motivation to combine.
It would have been obvious to combine the base combination of Keenan and Hickle because Keenan explicitly teaches using dosing limits (lockout intervals and prescription limits) to authorize drug delivery. A person of ordinary skill in the art would have been motivated to incorporate these dosing thresholds to prevent the patient from receiving a toxic amount of medication over a given period of time.
In relation claim 10, this claim depends from claim 1 and further recites: [t]he system of Claim 1, wherein the control unit is further configured to: receive a second request for the drug delivery device to administer another dose of the medication; determine, based on the second request, that the patient is not authorized to self-administer another dose of the medication from the drug delivery device; and responsive to determining that the patient is not authorized to self-administer another dose: provide sensory information to the patient indicating that another dose will not be administered responsive to the second request; and prevent the drug delivery device from administering another dose of the medication to the patient.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the control unit is further configured to: receive a second request for the drug delivery device to administer another dose of the medication; determine, based on the second request, that the patient is not authorized to self-administer another dose of the medication from the drug delivery device; and responsive to determining that the patient is not authorized to self-administer another dose: provide sensory information to the patient indicating that another dose will not be administered responsive to the second request; and prevent the drug delivery device from administering another dose of the medication to the patient.
Keenan discloses receiving second requests and preventing administration during a lockout interval. Specifically, Keenan discloses: "[i]f a patient presses the button before the lockout interval has elapsed, the PCA pump simply ignores the request." (Keenan ¶ [0006].) Hickle discloses providing sensory information to the patient. Specifically, Hickle discloses: "ACQ system 256 comprises a query initiate device 264... Query initiate device 264 may be any type of a stimulus such as a speaker which provides an auditory command to the patient... and/or a vibrating mechanism". (Hickle ¶ [0115].) It would be an obvious design choice to use Hickle's sensory feedback system to inform the patient that their second request has been denied.
Motivation to combine.
For an artisan skilled in the art, it would have been obvious to combine the base combination of Keenan and Hickle because providing feedback to a user when an input is rejected is a fundamental principle of user interface design. A person of ordinary skill in the art would have been motivated to use Hickle's auditory or vibratory feedback mechanisms to alert the patient that their second request was denied by Keenan's lockout processor, thereby reducing patient confusion and frustration.
In relation to independent claim 11, this claim recites: [a] machine-implemented method, comprising: receiving, via a drug control device operably connected to a drug delivery device, biometric information captured by the drug control device and a request for the drug delivery device to administer a dose of a medication; confirming, based on the biometric information , that a patient associated with the biometric information is authorized to operate the drug delivery device to self-administer the medication; and responsive to receiving the request and biometric information and confirmation that the patient is authorized user to operate the drug delivery device to self-administer the medication: obtaining, via one or more sensors associated with the drug delivery device, one or more signals indicative of a state of the patient and different than the biometric information; determining, based at least in part on the one or more signals, whether the state of the patient satisfies a predetermined criteria for allowing the patient to self-administer the medication; and causing the drug delivery device to administer the dose of the medication to the patient when the state of the patient satisfies the predetermined criteria.
A machine-implemented method, comprising: receiving, via a drug control device operably connected to a drug delivery device, biometric information captured by the drug control device and a request for the drug delivery device to administer a dose of a medication; confirming, based on the biometric information , that a patient associated with the biometric information is authorized to operate the drug delivery device to self-administer the medication; and responsive to receiving the request and biometric information and confirmation that the patient is authorized user to operate the drug delivery device to self-administer the medication: obtaining, via one or more sensors associated with the drug delivery device, one or more signals indicative of a state of the patient and different than the biometric information; determining, based at least in part on the one or more signals, whether the state of the patient satisfies a predetermined criteria for allowing the patient to self-administer the medication; and causing the drug delivery device to administer the dose of the medication to the patient when the state of the patient satisfies the predetermined criteria.
Claim 11 is a method claim that mirrors the system limitations of claim 1. Keenan discloses the biometric authentication steps, and Hickle discloses the physiological monitoring and lockout steps, as discussed above with respect to claim 1.
Motivation to combine.
The motivation to combine Keenan and Hickle to perform the method steps is identical to the motivation to combine them in the system claim 1.
In relation to claim 12, this claim depends from claim 11 and further recites: The machine-implemented method of Claim 11, wherein determining whether the state of the patient satisfies the predetermined criteria comprises: determining, based on the one or more signals, that the patient is in a conscious state and allowed to self-administer the medication, wherein the drug delivery device is caused to administer the dose based on determining that the patient is in the conscious state and allowed to self-administer the medication.
wherein determining whether the state of the patient satisfies the predetermined criteria comprises: determining, based on the one or more signals, that the patient is in a conscious state and allowed to self-administer the medication, wherein the drug delivery device is caused to administer the dose based on determining that the patient is in the conscious state and allowed to self-administer the medication.
Claim 12 is a method claim that mirrors the system limitations of claim 2. Hickle discloses determining the conscious state of the patient, as discussed above with respect to claim 2.
Motivation to combine.
The motivation to combine Keenan and Hickle to perform the method steps is identical to the motivation to combine them in the system claim 2.
In relation to claim 13, this claim depends from claim 11 and further recites: The machine-implemented method of Claim 11, wherein the drug control device is a handheld control device, the method further comprising: capturing the request and biometric information via the drug control device within a predetermined period of time of each other.
Base rejection incorporated.
The rejection of claim 11 is incorporated herein.
wherein the drug control device is a handheld control device, the method further comprising: capturing the request and biometric information via the drug control device within a predetermined period of time of each other.
Claim 13 is a method claim that mirrors the system limitations of claim 3. Keenan discloses the handheld device and simultaneous capture, as discussed above with respect to claim 3.
Motivation to combine.
The motivation to combine Keenan and Hickle to perform the method steps is identical to the motivation to combine them in the system claim 3.
In relation to claim 14, this claim depends from claim 13 and further recites: [t]he machine-implemented method of Claim 13, further comprising: determining a magnitude of a user input received by the drug delivery device; wherein causing the drug delivery device to administer the dose of the medication to the patient comprises causing the drug delivery device to administer an amount of the medication based on the magnitude of the user input.
Base rejection incorporated.
The rejection of claim 13 is incorporated herein.
further comprising: determining a magnitude of a user input received by the drug delivery device; wherein causing the drug delivery device to administer the dose of the medication to the patient comprises causing the drug delivery device to administer an amount of the medication based on the magnitude of the user input.
Claim 14 is a method claim that mirrors the system limitations of claim 4. Hickle discloses determining the magnitude of the user input, as discussed above with respect to claim 4.
Motivation to combine.
The motivation to combine Keenan and Hickle to perform the method steps is identical to the motivation to combine them in the system claim 4.
In relation to claim 15, this claim depends from claim 13 and further recites: [t]he machine-implemented method of Claim 13, wherein the drug control device comprises a fingerprint reader, the method further comprises: capturing the biometric information by capturing a representation of at least a portion of a fingerprint captured by the fingerprint reader.
Base rejection incorporated.
The rejection of claim 13 is incorporated herein.
wherein the drug control device comprises a fingerprint reader, the method further comprises: capturing the biometric information by capturing a representation of at least a portion of a fingerprint captured by the fingerprint reader.
Claim 15 is a method claim that mirrors the system limitations of claim 6. Keenan discloses the fingerprint reader, as discussed above with respect to claim 6.
Motivation to combine.
The motivation to combine Keenan and Hickle to perform the method steps is identical to the motivation to combine them in the system claim 6.
In relation to claim 18, this claim depends from claim 11 and further recites: [t]he machine-implemented method of Claim 11, wherein confirming that the patient is authorized to operate the drug delivery device to self-administer the medication comprises: determining an identity of the patient; determining an amount of the medication received by the patient over a period of time; and determining that the amount satisfies a threshold amount for the period of time.
Base rejection incorporated.
The rejection of claim 11 is incorporated herein.
wherein confirming that the patient is authorized to operate the drug delivery device to self-administer the medication comprises: determining an identity of the patient; determining an amount of the medication received by the patient over a period of time; and determining that the amount satisfies a threshold amount for the period of time.
Claim 18 is a method claim that mirrors the system limitations of claim 9. Keenan discloses the dosing thresholds, as discussed above with respect to claim 9.
Motivation to combine.
The motivation to combine Keenan and Hickle to perform the method steps is identical to the motivation to combine them in the system claim 9.
In relation to claim 19, this claim depends from claim 11 and further recites: [t]he machine-implemented method of Claim 11, the method further comprising: receiving a second request for the drug delivery device to administer another dose of the medication; determining, based on the second request, that the patient is not authorized to self-administer another dose of the medication from the drug delivery device; and responsive to determining that the patient is not authorized to self-administer another dose: providing sensory information to the patient indicating that another dose will not be administered responsive to the second request; and preventing the drug delivery device from administering another dose of the medication to the patient.
Base rejection incorporated.
The rejection of claim 11 is incorporated herein.
the method further comprising: receiving a second request for the drug delivery device to administer another dose of the medication; determining, based on the second request, that the patient is not authorized to self-administer another dose of the medication from the drug delivery device; and responsive to determining that the patient is not authorized to self-administer another dose: providing sensory information to the patient indicating that another dose will not be administered responsive to the second request; and preventing the drug delivery device from administering another dose of the medication to the patient.
Claim 19 is a method claim that mirrors the system limitations of claim 10. Keenan and Hickle disclose the lockout and sensory feedback, as discussed above with respect to claim 10.
Motivation to combine.
The motivation to combine Keenan and Hickle to perform the method steps is identical to the motivation to combine them in the system claim 10.
In relation to independent claim 20, this claim recites: [a] non-transitory machine-readable medium storing instructions thereon that, when executed by a machine, cause the machine to perform operations, comprising: receiving, via a drug control device operably connected to a drug delivery device, biometric information captured by the drug control device and a request for the drug delivery device to administer a dose of a medication; confirming, based on the biometric information, that a patient associated with the biometric information is authorized to operate the drug delivery device to self-administer the medication; and responsive to receiving the request and biometric information and confirmation that the patient is authorized user to operate the drug delivery device to self-administer the medication: obtaining, via one or more sensors associated with the drug delivery device, one or more signals indicative of a state of the patient and different than the biometric information; determining, based at least in part on the one or more signals, whether the state of the patient satisfies a predetermined criteria for allowing the patient to self-administer the medication; and causing the drug delivery device to administer the dose of the medication to the patient when the state of the patient satisfies the predetermined criteria.
A non-transitory machine-readable medium storing instructions thereon that, when executed by a machine, cause the machine to perform operations, comprising: receiving, via a drug control device operably connected to a drug delivery device, biometric information captured by the drug control device and a request for the drug delivery device to administer a dose of a medication; confirming, based on the biometric information, that a patient associated with the biometric information is authorized to operate the drug delivery device to self-administer the medication; and responsive to receiving the request and biometric information and confirmation that the patient is authorized user to operate the drug delivery device to self-administer the medication: obtaining, via one or more sensors associated with the drug delivery device, one or more signals indicative of a state of the patient and different than the biometric information; determining, based at least in part on the one or more signals, whether the state of the patient satisfies a predetermined criteria for allowing the patient to self-administer the medication; and causing the drug delivery device to administer the dose of the medication to the patient when the state of the patient satisfies the predetermined criteria.
Claim 20 is a computer-readable medium claim that mirrors the system limitations of claim 1. Keenan discloses the biometric authentication steps, and Hickle discloses the physiological monitoring and lockout steps, as discussed above with respect to claim 1.
Motivation to combine.
The motivation to combine Keenan and Hickle to execute the instructions on a machine is identical to the motivation to combine them in the system claim 1.
Claims 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Keenan et al. (US 2009/0143733A1; hereinafter “Keenan”) in view of Hickle (US 2005/0010165A1), as discussed above, and in further view of Sethi et al. (US 2010/0249555A1; hereinafter “Sethi”).
In relation to claim 7, this claim depends from claim 1 and further recites: [t]he system of Claim 1, wherein determining whether the state of the patient satisfies a predetermined criteria comprises: determining a discomfort level associated with the patient based on the one or more signals; and determining that the discomfort level is greater than a threshold discomfort level.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
determining whether the state of the patient satisfies a predetermined criteria comprises: determining a discomfort level associated with the patient based on the one or more signals; and determining that the discomfort level is greater than a threshold discomfort level.
To the extent the base combination does not expressly disclose determining a discomfort level and comparing it to a threshold, Sethi fills this gap. Sethi discloses determining a pain/discomfort level based on physiological signals and using thresholds to manage pain medication. Specifically, Sethi discloses: "[i]n an embodiment, physiological parameters, such as one or more vital signs of a patient may be used to monitor effectiveness of pain management... Accordingly, the effect of pain or pain medication may cause the patient's physiological parameters, such as blood pressure, pulse rate, respiration rate, respiration effort, or other parameter, alone or in combination, to change." (Sethi ¶ [0003].) Sethi further discloses comparing measurements to a reference: "If the determined physiological measurement (or measurements) is found to differ from the reference measurement, for example, exceed or be less than an acceptable range of values for the reference, a signal may be generated at step 540... Such a signal may be transmitted to a pain management controller 413... that may automatically control dispensation of pain medication to a patient". (Sethi ¶ [0095].)
Motivation to combine.
It would have been obvious to combine the base combination of Keenan and Hickle with Sethi because Sethi explicitly teaches quantifying patient pain/discomfort using physiological signals to control drug delivery. A person of ordinary skill in the art would have been motivated to incorporate Sethi's discomfort threshold logic into the base system to ensure the patient actually requires the medication (i.e., is experiencing sufficient pain) before allowing self-administration, thereby preventing abuse or overmedication.
In relation to claim 16, this claim depends from claim 11 and further recites: [t]he machine-implemented method of Claim 11, wherein determining whether the state of the patient satisfies a predetermined criteria comprises: determining a discomfort level associated with the patient based on the one or more signals; and determining that the discomfort level is greater than a threshold discomfort level.
Base rejection incorporated.
The rejection of claim 11 is incorporated herein.
wherein determining whether the state of the patient satisfies a predetermined criteria comprises: determining a discomfort level associated with the patient based on the one or more signals; and determining that the discomfort level is greater than a threshold discomfort level.
Claim 16 is a method claim that mirrors the system limitations of claim 7. Sethi discloses determining a discomfort level based on physiological signals and thresholds, as discussed above with respect to claim 7.
Motivation to combine.
The motivation to combine Keenan, Hickle, and Sethi to perform the method steps is identical to the motivation to combine them in the system claim 7.
Claims 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Keenan et al. (US 2009/0143733A1; hereinafter “Keenan”) in view of Hickle (US 2005/0010165A1) and Sethi et al. (US 2010/0249555A1; hereinafter “Sethi”), as discussed above, and in further view of Moon et al. (WO 2010135518A1; hereinafter “Moon”).
In relation to claim 8, this claim depends from claim 7 and further recites: [t]he system of Claim 7, wherein the one or more sensors comprise: a motion sensor for detecting movement of the patient; and one or more physiological monitors for measuring a physiological condition, including: heart rate, blood pressure, electrocardiographic signal, electroencephalographic signal, or oxygen level, wherein the control unit is configured to: detect movement of the patient using the motion sensor; measure the physiological condition of the patient using the one or more physiological monitors; and determine the discomfort level based on the detected movement of the patient satisfying a movement threshold and the physiological condition satisfying a physiological threshold.
Base rejection incorporated.
The rejection of claim 7 is incorporated herein.
wherein the one or more sensors comprise: a motion sensor for detecting movement of the patient; and one or more physiological monitors for measuring a physiological condition, including: heart rate, blood pressure, electrocardiographic signal, electroencephalographic signal, or oxygen level, wherein the control unit is configured to: detect movement of the patient using the motion sensor; measure the physiological condition of the patient using the one or more physiological monitors; and determine the discomfort level based on the detected movement of the patient satisfying a movement threshold and the physiological condition satisfying a physiological threshold.
Hickle discloses the physiological monitors (heart rate, blood pressure, oxygen level). (Hickle ¶ [0114].) To the extent the base combination does not expressly disclose using a motion sensor and combining movement thresholds with physiological thresholds, Moon fills this gap. Moon discloses a system that monitors both motion and vital signs to determine the patient's state. Specifically, Moon discloses: "The invention provides a body-worn monitor that measures a patient's vital signs (e.g. blood pressure, SpO2, heart rate, respiratory rate, and temperature) while simultaneously characterizing their activity state (e.g. resting, walking, convulsing, falling)." (Moon; Abstract.) Moon further discloses using motion sensors and thresholds: "The system includes at least two motion-detecting sensors (e.g. analog or digital accelerometers) ... A second processing component... receives the vital sign and motion parameter and determines: (i) a first alarm condition, calculated by comparing the vital sign to an alarm threshold; (ii) a second alarm condition, calculated from the motion parameter". (Moon; page 4, starting in line 26)
Motivation to combine.
For an artisan skilled in the art, it would have been obvious to combine the base combination of Keenan, Hickle, and Sethi with Moon because Moon teaches that physiological parameters can be corrupted or misinterpreted without accounting for patient motion. A person of ordinary skill in the art would have been motivated to incorporate Moon's motion sensors and combined motion/physiological thresholds into the system to accurately determine the patient's true discomfort level, distinguishing between actual pain and mere physical activity.
In relation to claim 17, this claim depends from claim 16 and further recites: The machine-implemented method of Claim 16, wherein the one or more sensors comprise a motion sensor for detecting movement of the patient and one or more physiological monitors for measuring a physiological condition, the method further comprising: detecting movement of the patient using the motion sensor; measuring the physiological condition of the patient using the one or more physiological monitors, wherein the physiological condition comprises a heart rate, a blood pressure, a electrocardiographic signal, an electroencephalographic signal, or an oxygen level; and determining the discomfort level based on the detected movement of the patient satisfying a movement threshold and the physiological condition satisfying a physiological threshold.
Base rejection incorporated.
The rejection of claim 16 is incorporated herein.
wherein the one or more sensors comprise a motion sensor for detecting movement of the patient and one or more physiological monitors for measuring a physiological condition, the method further comprising: detecting movement of the patient using the motion sensor; measuring the physiological condition of the patient using the one or more physiological monitors, wherein the physiological condition comprises a heart rate, a blood pressure, a electrocardiographic signal, an electroencephalographic signal, or an oxygen level; and determining the discomfort level based on the detected movement of the patient satisfying a movement threshold and the physiological condition satisfying a physiological threshold.
Claim 17 is a method claim that mirrors the system limitations of claim 8. Hickle and Moon disclose the physiological and motion sensors and thresholds, as discussed above with respect to claim 8.
Motivation to combine.
The motivation to combine Keenan, Hickle, Sethi, and Moon to perform the method steps is identical to the motivation to combine them in the system claim 8.
Conclusion
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
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