DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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.
Claims 1-12, 14, 15, and 19 are 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.
in relation to claim 1, the phrase "the criteria" in line 10, lacks proper antecedent basis. The claim introduces "meets criteria of a proper insulin injection" (line 9) without utilizing the introductory article “a”. Correction is respectfully required;
in relation to claim 2, the phrase "a patient body" in line 5 creates a lack of clarity because claim 1 introduces "a user" in line 7. Accordingly, it is not clear whether the user of claim 1 is the patient that claim 2 refers to. Moreover, claiming “a patient body” appears to raise a section 101 issue for claiming non-statutory subject matter. Correction and clarification are respectfully required;
in relation to claim 3, the phrases “a patient” in line 3 and “the patient” in line 4 lack proper antecedent basis because claim 1 introduces "a user" in line 7. Accordingly, it is not clear whether the user of claim 1 is the patient that claim 3 refers to. Correction is respectfully required;
in relation to claims 9 and 10, the phrase “the determination indicating that the criteria is not satisfied” lacks proper antecedent basis. Claim 1 does not disclose a step for “determining that the criteria is not satisfied”. Claim 1 only discloses the step of: “outputting information indicative of whether the criteria is satisfied based on the determination”. Correction is respectfully required.
in relation to claim 11, the phrases “a patient” in line 2 lack proper antecedent basis because claim 1 introduces "a user" in line 7. Accordingly, it is not clear whether the user of claim 1 is the patient that claim 11 refers to. Correction is respectfully required;
in relation to claim 14, the phrase "a patient body" in line 4 creates a lack of clarity because claim 1 introduces "a user" in line 7. Accordingly, it is not clear whether the user of claim 1 is the patient that claim 14 refers to. Moreover, claiming “a patient body” appears to raise a section 101 issue for claiming non-statutory subject matter. Correction and clarification are respectfully required;
in relation to claim 15, the phrases “a patient” in line 3 and the two phrases “the patient” in line 4 lack proper antecedent basis because claim 1 introduces "a user" in line 7. Accordingly, it is not clear whether the user of claim 1 is the patient that claim 3 refers to. Correction is respectfully required;
in relation to claim 19, the phrase “the determination indicating that the criteria is not satisfied” lacks proper antecedent basis. Claim 13 does not disclose a step for “determining that the criteria is not satisfied”. Claim 13 only discloses the step of: “outputting information indicative of whether the criteria is satisfied based on the determination”. Correction is respectfully 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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jafari et al. (US 9,971,874B2; hereinafter “Jafari”) in view of Saint et al. (US 9,672,328; hereinafter “Saint”).
In relation to claim 1, Jafari discloses a system for medication adherence monitoring (Abstract) comprising:
• One or more processors and processor-readable media:
"one or more processors each configured to execute instructions; and one or more nontransitory storage mediums configured to provide stored instructions to the one or more processors"
(Claim 17).
• Wearable device disposed on an arm of a user:
"a housing configured to be worn on a user's wrist or forearm"
(Claim 17; also see Fig. 1).
• Identifying at least one gesture based on user activity data:
"detecting the user performed a first action based on the first motion signal segment" and "detecting the user performed a second action based on the second motion signal segment" (Claim 1).
• Outputting information based on the determination:
"in response to the determination that the first medication was taken by the user, causing presentation of an indication to the user or transmitting an indication to an external device that the first medication was taken by the user" (Claim 1).
Jafari does not explicitly disclose (1) a system for controlling delivery of therapy specifically for diabetes or insulin injection, and (2) determining whether the injection meets criteria of a proper insulin injection. However, Saint discloses a medicine administering system for insulin injection (column 7, lines 50-52). Saint teaches:
• Insulin injection context:
Saint explicitly discloses that "the medicine includes insulin" (Claim 2). The Background section of the specification discusses "[d]iabetes mellitus, also referred to as diabetes, is a metabolic disease associated with high blood sugar due to insufficient production or use of insulin by the body" (column 1, lines 25-27).
• Criteria for proper insulin injection:
Saint discloses distinguishing between a prime dose and a therapy dose. The Summary section of the specification states: "the injection device is able to detect and record dose sizes that are dispensed (e.g., primed or injected to the patient), and to distinguish between a prime dose and a therapy dose" (column 2, lines 64-67). Moreover, claim 1 teaches "determining a type of dispensing event as a priming event or an injection event for the one or more dose data in the dose dispensing sequence that includes detecting a rate at which the medicine is dispensed for each dispensing event."
• Determining whether injection meets proper criteria:
Claim 1 discloses: "upon a determination that the rate at which the medicine is dispensed is slower than a predetermined dispensing rate threshold, identifying the dispensing event as the priming event, and upon a determination that the dispensed rate is faster than the predetermined dispensing rate threshold, identifying the dispensing event as the injection event."
Based on the above comments, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the wearable gesture recognition system of Jafari with the insulin injection monitoring and criteria evaluation of Saint. Both references are in the field of medication adherence monitoring. A person of ordinary skill would have been motivated to apply Jafari's wearable gesture recognition system to the specific application of insulin injection monitoring as taught by Saint because (1) insulin therapy requires strict adherence to dosing schedules, making adherence monitoring particularly valuable, (2) the combination would have provided redundant verification of proper injection technique by correlating arm gestures with injection pen data, and (3) Saint explicitly recognizes the need for distinguishing proper therapy doses from priming doses, which aligns with the goal of ensuring proper medication administration (column 2, lines 64-67).
In relation to claim 13, the claim is rejected under 35 U.S.C. § 103 as being unpatentable over Jafari in view of Saint for the same reasons as Claim 1. Claim 13 is a method claim that recites the same method steps performed by the system of Claim 1, and the same analysis applies.
In relation to claim 20, Claim 20 is rejected under 35 U.S.C. § 103 as being unpatentable over Jafari in view of Saint for the same reasons as Claims 1 and 13. Claim 20 recites the same method steps but is directed to a non-transitory processor-readable medium. Jafari explicitly discloses "one or more non-transitory storage mediums configured to provide stored instructions to the one or more processors" (Claim 17), and the same analysis for the method steps applies.
In relation to claims 2 and 14, Jafari discloses identifying gestures from user activity data obtained from a wearable device on the user's arm. Jafari teaches identifying general medication-taking gestures including:
• "the first action comprises the user opening a container containing the first medication" (Claim 10).
• "the second action comprises the user moving a hand to the user's mouth" (Claim 10).
Jafari does not explicitly disclose the specific insulin injection-related gestures of (1) setting a dose amount or type (2) moving the injection device closer to the body, and (3) holding the injection device at a specific position or orientation. However, Saint discloses:
• Gesture to set dose amount:
The Abstract discloses "a sensor unit to detect a dispensed dose based on positions and/or movements of the dose setting and dispensing mechanism." Claim 1 further states: "the dose knob is rotatable to cause the shaft to move to a position proportional to a set dose of the medicine."
• Movement patterns for injection:
Saint's Claim 1 distinguishes injection events from priming events based on "detecting a rate at which the medicine is dispensed for each dispensing event," which inherently involves the user moving the device to the injection site and holding it during injection.
Based on the above comments, it would have been obvious to one of ordinary skill in the art to adapt Jafari's wearable gesture recognition system to identify the specific injection-related gestures taught by Saint. A skilled artisan would have been motivated to train the gesture recognition algorithms of Jafari to recognize the distinct motions associated with preparing and performing an insulin injection (dose setting, moving to site, injecting) to create a more robust and detailed monitoring system.
In relation to claims 3 and 15, Jafari discloses using time-based criteria: "the determination that the first medication was taken by the user is further based on a time associated with the sensing of the second motion signal segment having occurred within a predetermined amount of time after the beginning of the time period" (Claim 2). Jafari does not disclose criteria specific to insulin injections, such as (1) Number of clicks for dose setting, (2) Basal/bolus insulin timing based on time of day, or (3) Meal consumption between injections. However, Saint explicitly discloses:
• Time elapsed between injections:
The Summary section of the specification states: "the information comprises the quantity and time of each administered bolus of the medicament" (column 3, lines 21-22). Claim 3 discloses "the time data includes a specific time of occurrence of the dispensing event, or a relative time associated with a beginning, a duration, or a conclusion of the dispensing event."
• Bolus insulin:
The Summary section of the specification explicitly references "bolus" dosing: "the pen can automatically store information associated with each delivered bolus" (column 3, lines 25-26).
• Dose setting mechanism:
The Abstract discloses "a sensor unit to detect a dispensed dose based on positions and/or movements of the dose setting and dispensing mechanism."
Based on the above comments, it would have been obvious to incorporate the specific insulin injection criteria from Saint into the monitoring system of Jafari. The motivation is to enhance the clinical relevance of the wearable monitoring system by incorporating criteria like dose amount, timing relative to meals, and insulin type (basal/bolus), thereby creating a comprehensive diabetes management tool.
In relation to claims 4 and 16, Jafari teaches:
• Outputting alerts:
"alerting the user with an audible or visible signal to take the first medication" (Claim 14).
• Alert for potential double-dosing:
"issuing an alert in response to a time associated with the sensing of the fourth motion signal segment occurring within a predetermined amount of time of a time associated with the sensing of the second motion signal segment" (Claim 22).
Saint also discloses alert features. The Summary of the specification states: "control and messaging (e.g., alert) features to affect the patient's operation of the device" (column 3, lines 9-11). Claim 16 discloses: "one or both of the injection pen device or the mobile communication device include a visual, auditory, or haptic signaling unit to produce an alert based on the processed dose data." Claim 18 further discloses: "generate a drug confusion alert indicative of (a) a potential drug interaction or (b) an incorrect delivery of the drug."
Based on the above comments, Jafari already discloses the fundamental concept of outputting an alert based on its analysis of medication-taking gestures. The specific context of alerting for an improper insulin injection is a direct and obvious application of Jafari's teaching when combined
with the insulin-specific criteria of Saint. The motivation is to make the system useful and safe by actively warning the user of a potential error in their therapy administration.
In relation to claim 5, Jafari discloses a wearable device for medication adherence monitoring worn on a user's wrist or forearm (Fig. 1). The device includes:
• Accelerometers:
"the motion sensor includes one or more accelerometers, such as, but not limited to, MEMS-based accelerometers" (Column 7, lines 31-33).
• Gyroscopes:
"the motion sensor includes one or more gyroscopes, such as, but not limited to, MEMS-based gyroscopes" (Col. 7, lines 53-55).
• Six degrees of freedom (IMU):
"motion sensor may have six degrees of freedom, capable of measuring both acceleration and rotation for x-axis 121, y-axis 122, and z-axis 123" (Column 8, lines 5-7).
Based on the above comments, since this enhancement was well-known in the art at the time of filing, its application in the invention would have been considered an obvious alternative in the design of the system.
In relation to claims 6 and 17, Jafari discloses receiving signals from external devices, including RFID tags: "obtaining an indication that the user is in proximity to an RFID tag attached to a container containing the first medication" (Claim 12). This teaches the concept of receiving confirmation signals from devices associated with medication containers. Jafari does not explicitly disclose receiving confirmation from an injection device or a device coupled to an injection device. However, Saint discloses an injection pen with sensors that communicate with a companion device. The Abstract states: "a sensor unit to detect a dispensed dose based on positions and/or movements of the dose setting and dispensing mechanism, and an electronics unit in communication with the sensor unit to process the detected dispensed dose and time data associated with a dispensing event and to wirelessly transmit the dose data to a user's device." This provides confirmation of the injection by detecting and recording doses.
Based on the above comments, it would have been obvious to combine Jafari's wearable monitoring system with Saint's injection pen confirmation system. The motivation is to provide redundant verification of the injection, increasing the reliability of the adherence monitoring system by correlating wearable gesture data with direct injection confirmation from the pen.
In relation to claim 7, Jafari discloses that the system includes a patient device with processors. The wearable device itself contains "one or more processors each configured to execute instructions"
(Claim 17). Additionally, Jafari teaches communication with "an external device" (Abstract), which could be a patient's smartphone or other computing device. Saint explicitly discloses a "companion device" such as a smartphone that includes processors (Column 9, lines 42-44). Claim 12 states: "the mobile communication device includes one or more of the following devices: a smartphone, a tablet, a wearable computing device including a smartwatch or smartglasses, a computer including a laptop or a desktop computer." The Summary section of the specification states: "[t]he companion device can include a software application having a dose calculator" (starting in column 2, line 67).
Based on the above comments, the combination of Jafari and Saint renders this claim obvious. Both references teach patient devices with processors, either as the wearable device itself or as a companion smartphone. The motivation is to provide the computational power needed to process
gesture data and injection criteria.
In relation to claims 8 and 18, Jafari explicitly discloses a double-dosing prevention feature:
• "in response to the determination that the first medication was taken by the user,
scheduling a reminder for the user to take the first medication" (Claim 16).
• "issuing an alert in response to a time associated with the sensing of the fourth motion
signal segment occurring within a predetermined amount of time of a time associated
with the sensing of the second motion signal segment" (Column 4, lines 6-10).
This teaches detecting when a user is attempting to take medication too soon after a previous dose and issuing an alert. Moreover, Saint discloses tracking the time of each administered bolus. The Summary section of the specification states: "the information comprises the quantity and time of each administered bolus of the medicament" (column 3, lines 21-22). Claim 16 discloses alert features: "a visual, auditory, or haptic signaling unit to produce an alert based on the processed dose data."
In summary, Jafari already teaches the core functionality of detecting and alerting for potential double dosing. When combined with Saint's insulin-specific context, the system would have alerted the user that they had already injected insulin if they attempted to inject again before the scheduled time for the subsequent injection. Based on the above comments, since this enhancement was well-known in the art at the time of filing, its application in the invention would have been considered an obvious alternative in the design of the system.
In relation to claims 9 and 19, Jafari discloses providing feedback to the user, including "causing presentation of an indication to the user" (Claim 1) and scheduling reminders (Claim 16). Moreover, Saint discloses a dose calculator that can recommend appropriate doses. The Summary section of the specification states: "[t]he companion device can include a software application having a dose calculator that can suggest the dose the patient should set on the injection device" (starting in column 2, line 67). Claim 18 discloses alerts for issues: "generate a drug confusion alert indicative of (a) a potential drug interaction or (b) an incorrect delivery of the drug."
Based on the above comments, it would have been obvious to extend the feedback capabilities of the combined system to include corrective guidance. When the system determines that the injection criteria are not satisfied, providing data indicative of a modification to correct the impropriety is a logical
extension of the alert functionality. The motivation is to not only warn the user of an error but also guide them toward the correct action, thereby improving therapy efficacy and patient safety.
In relation to claim 10, Jafari discloses outputting information to external devices (Abstract, Claim 1). Moreover, Saint discloses a system where the injection pen and companion device communicate wirelessly. The Abstract states: "an electronics unit in communication with the sensor unit to process the detected dispensed dose and time data associated with a dispensing event and to wirelessly transmit the dose data to a user's device." The Summary section of the specification states the system includes "control and messaging (e.g., alert) features to affect the patient's operation of the device" (column 3, 9-11).
Given the bidirectional communication capabilities taught by Saint and the determination of improper injection criteria, it would have been obvious to one of ordinary skill in the art to extend the system to send control signals to the injection device. The motivation is to provide an additional layer of safety by preventing improper injections automatically, which is particularly valuable for patients who may not respond to alerts in time.
In relation to claim 11, Jafari discloses providing feedback to the user, including scheduling reminders for subsequent medication intake (Claim 16). Moreover, Saint discloses:
• Insulin type:
Claim 2 states: "the medicine includes insulin."
• Dose amount:
The Summary section of the specification states: "[t]he companion device can include a software application having a dose calculator that can suggest the dose the patient should set on the injection device" (starting in column 2, line 67).
• Time interval between injections:
The Summary section of the specification states: "the information comprises the quantity and time of each administered bolus of the medicament" (column 3, lines 21-22).
Based on the above comments, it would have been obvious to extend the feedback capabilities of Jafari's system to include the detailed instructional data available in Saint's system. The motivation is to provide a comprehensive guidance tool for the patient, proactively guiding the user on correct insulin
type, dose, and timing, thereby improving patient outcomes and safety.
In relation to claim 12, Jafari discloses "transmitting an indication to an external device that the first medication was taken by the user" (Abstract, Claim 1). Moreover, Saint discloses communication with a mobile device. The Summary section of the specification states: "control and messaging (e.g., alert) features to affect the patient's operation of the device" (column 3, 9-11). Additionally, the Summary discusses transferring patient records: "a patient record of dosing could be transferred with the patient from one care team (e.g. paramedics) to a second care team (e.g. ER staff). This information could be transferred by transferring a device with the patient or sending the data to the cloud based medical record for the patient" (column 3, lines 34-39).
Based on the above facts, it would have been obvious to transmit the instructional data to a caregiver's device. The motivation is to involve the caregiver in the patient's therapy management, which is particularly important for pediatric patients, the elderly, or any patient requiring assistance.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783