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 § 103
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.
Claim(s) 1-3, 5, 8-11, 16-17, 19-24, 26-27, 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (WO 2020068623 A1) in view of Penders et al. (US 2018/0000405 A1).
With regard to claim 1, Lee discloses A system for out-patient treatment (Fig. 1), the system comprising: an infusion pump (114, [0026]) for delivering a therapeutic to a patient; a wearable device (100, [0017], can be formed a system that is a wearable injector) configured to be worn by the patient at least one of: (a) before delivery of the therapeutic ([0017] if formed as a wearable delivery system attached to the patient body) and (b) during delivery of the therapeutic ([0017] if formed as a wearable delivery system attached to the patient body or if it formed as a hand-held injector using flexible tubing delivery set that would be attached to the patient during delivery of the therapeutic), the wearable device comprising one or more sensors (116 and 118) configured to acquire sensor data related to detection of patient vital signs ([0032], senses a biological condition by sensing change in level of a biochemical and second sensor can sense core or skin temperature but is not limited to sensing only these conditions); and a wireless communication module (120, [0036]) disposed on the wearable device (100) and configured for remote wireless communication with a healthcare provider based on the acquired sensor data ([0036] wireless communication to a healthcare provider at external computing unit 104).
However, Lee does not explicitly disclose the wireless communication module configured to send an alarm if the communication is disrupted.
Penders teaches a similar wearable device (Fig. 3a, and 3b) comprising sensors configured to acquire sensor data related to detection of patient vital signs (12 sensors, [0007], [0015], [0016]). Penders then further teaches a wireless transmitter to communicate with a health care provider ([0013], [0073], [0077]) and further that an alarm may be sent if the wireless communication is disrupted ([0086], wireless network status is indicated by a set of lights indicating connection or disconnection).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Lee with the alarm if communication is disrupted as taught by Penders for the purpose of indicating important information to a user ([0086]).
With regard to claim 2, Lee discloses wherein the infusion pump comprises the therapeutic (in reservoirs 106 and 108).
With regard to claim 3, Lee discloses wherein the therapeutic is known to trigger an immune inflammatory response in the patient, potentially leading to an increased risk factors of (a) cytokine release syndrome (CRS) ([0023]) or (b) neurotoxicity (NT).
With regard to claim 5, Lee discloses wherein the therapeutic comprises at least one of (a) an immunotherapy drug that activates patient T cells to fight cancer ([0023]), (b) an immunotherapy drug including blinatumomab ([0023]), and (c) an immunotherapy drug including acepatamab.
With regard to claim 8, Lee discloses wherein the at least one sensor of the wearable device comprises an optical sensor ([0029]) that is configured to measure oxygen of the patient ([0028]).
With regard to claim 9, Lee discloses wherein the at least one sensor of the wearable device is configured to measure at least one indicator of cytokine release syndrome selected from: (a) heart rate (HR) ([0028]), (b) axillary temperature, (c) respiratory rate (RR), (d) oxygen saturation ([0028]), and (e) blood pressure (BP) ([0028]).
With regard to claim 10, Lee discloses wherein the at least one sensor continuously ([0028], configured to operate continuously over a duration of drug delivery and provide real-time measurements of the biological condition) measures at least one of: (a) heart rate ([0028]), (b) temperature ([0032]), (c) respiratory rate, and (d) oxygen saturation ([0028]).
With regard to claim 11, Lee discloses wherein the wireless communication module (120) of the wearable device is configured to at least one of (a) send messages to the healthcare provider in real time ([0036]), (b) send periodic messages to the healthcare provider based on an interval of a predetermined number of second, minutes, or hours, ([0036]) (c) send periodic messages every ten minutes ([0036]), (d) send an alarm message when oxygen of the patient drops below a predetermined threshold.
With regard to claim 16, Lee discloses further comprising an axillary temperature sensor (second sensor 118 can be a temperature sensor ([0032])) for detecting a temperature of the patient during delivery of the therapeutic ([0032]), the axillary temperature sensor communicatively coupled to the wearable device (see Fig. 1).
With regard to claim 17, Lee discloses where in the axillary temperature sensor includes a wireless communication module configured to communicate with the wireless communication module of the wearable device ([0031]).
With regard to claim 19, Lee discloses wherein the healthcare provider comprises a mobile device ([0016], smartphone) configured for wireless communication with the wireless communication module of the wearable device ([0036]).
With regard to claim 20, Lee discloses further comprising a patient-assigned wireless device comprising a mobile application ([0016], mobile device of healthcare provider 104 can communicate with a patient-assigned wireless device “other computer devices associated with the patient 102”) configured to support audio and/or video communication with the mobile device of the healthcare provider (a computing device would be capable of supporting audio and/or video).
With regard to claim 21, Lee discloses A computer-implemented method for out-patient treatment with immunotherapy that activates T cells of a patient to kill cancer ([0012]), the method comprising: receiving, at a processor (Fig. 1, element 120), sensor data (from sensors 116 and 118) in response to the processor executing a sensor data receiving module ([0032]); and generating, using a processor, warning data, based on the sensor data, in response to the processor executing a warning data generation module, wherein a content of the sensor data is based on a likelihood that the immunotherapy will trigger increased risk factors of cytokine release syndrome (0013]-[0015], [0046]).
However, Lee does not explicitly disclose the wireless communication module configured to send an alarm if the communication is disrupted.
Penders teaches a similar wearable device (Fig. 3a, and 3b) comprising sensors configured to acquire sensor data related to detection of patient vital signs (12 sensors, [0007], [0015], [0016]). Penders then further teaches a wireless transmitter to communicate with a health care provider ([0013], [0073], [0077]) and further that an alarm may be sent if the wireless communication is disrupted ([0086], wireless network status is indicated by a set of lights indicating connection or disconnection).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Lee with the alarm if communication is disrupted as taught by Penders for the purpose of indicating important information to a user ([0086]).
With regard to claim 22, Lee discloses further comprising: transmitting, using a processor, the sensor data to at least one of (a) a healthcare provider device in response to the processor executing a sensor data transmission module ([0036]), and (b) to a patient device, wherein the sensor data is representative of vital signs of the patient ([0016], mobile device of healthcare provider 104 can communicate with a patient-assigned wireless device “other computer devices associated with the patient 102”).
With regard to claim 23, Lee discloses further comprising: transmitting, using a processor, the warning data to a healthcare provider device (in response to the processor executing a warning data transmission module ([0046]) or (b) when the sensor data exceeds a threshold value, in response to the processor executing a warning data transmission module.
With regard to claim 24, Lee discloses further comprising: transmitting, using a processor, audio/video data between a patient device and a healthcare provider smartphone via a cellular connection ([0016], mobile device of healthcare provider 104 can communicate with a patient-assigned wireless device “other computer devices associated with the patient 102”) in response to the processor executing an audio/video data transmission module ([0049]).
With regard to claim 26, Lee discloses further comprising: transmitting, using a processor, patient-initiated call input data to at least one of: a healthcare provider, or a health management system, in response to the processor executing a patient-initiated call input receiving module ([0049]).
With regard to claim 27, Lee discloses wherein a healthcare provider phone (smartphone, [0016]) is configured to emit a loud audible alarm ([0046], [0049]), based on the warning data, at a periodic interval until a health care provider responds ([0046], [0049]).
With regard to claim 29, Lee discloses wherein the sensor data is representative of at least one indicator of cytokine release syndrome selected from: heart rate (HR) ([0028]), axillary temperature, respiratory rate (RR), oxygen saturation ([0028]), and blood pressure (BP) ([0028]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (WO 2020068623 A1) in view of Penders et al. (US 2018/0000405 A1) and in further view of Nesbitt et al. (WO 2007/033025 A2).
With regard to claim 18, Lee discloses sensing blood pressure ([0028]).
However, Lee/Penders do not disclose a blood pressure cuff.
Nesbitt teaches a system for treating CRS similar to Lee ([54]) and further teaches the use of a blood pressure cuff ([31], [43]) for detecting a blood pressure of the patient during delivery of the therapeutic, wherein the blood pressure cuff is communicatively coupled to the wearable device ([43]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Lee/Penders with the blood pressure cuff as taught by Nesbitt for the purpose of providing a well-known alternative for measuring blood pressure ([31]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 5, 8-11, 16-24 ,26-27, 29 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783
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