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 7-10, 13 & 18-19 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 claims 7 & 18, the limitation “determining, based on the location setting exceeding a distance range, that the battery capacity is insufficient to power the medical device for a predetermined period of time” is vague. It is unclear to Examiner that how is the “distance range” able to determine the capacity of the battery that sufficient or insufficient to power of the medical device for certain period of time?
In addition, it is unclear to the Examiner that the limitation “exceeding a distance range” with respect to a first mode location (away from home, i.e., clinical location or hospital...) or a second mode (at home care location)? If the second mode is being associated with a home care location (as mentioned in claim 8), in this case, the medical device should be in the distance range; however, the claim 7 states that the location is exceeding a distance range.
In claims 8 & 18-19, the limitation “the alerting sequence matches home alerting escalation rules” is vague. It is unclear to Examiner that what the kind of alerting sequence that being matched with home alerting escalation rule? What kind of rule at home?
The claims 9-10 are being rejected due to their dependency.
In claim 13, the limitation “determining, based on the location setting exceeding a distance range over determine quantity of medication is to be dispensed, that the quantity of medication is insufficient to follow a current medication dispensing protocol of the medical device” is vague. It is unclear to Examiner that how is the “distance range” being exceeded so that the system can be determined the quantity of the medication whether enough or not enough for dispensing protocol?
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 5-6, 11-12, 14-15, 17 & 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Istoc (US 2016/0051749).
Regarding claim 1, Istoc discloses a medical device 112 (infusion pump) comprising:
one or more processors 200; and
memory 206 including instructions that, when executed by the one or more processors 200, cause the medical device to:
monitor, using one or more sensors (GPS or environmental sensor 210), a geofence parameter (GPS signal, para [0031]) of the medical device;
determine a change in a location setting of the medical device based on the geofence parameter, para [0031;
automatically switch, responsive to the changed location setting, an operation mode of the medical device from a first mode (e.g., first set of program instructions or called as safe zone, para [0031]) currently programmed for care of a patient to a second mode (e.g., second set of program instructions, para [0031]), the second mode using different parameters than the first mode to control the medical device, para [0031-0032]; and
restrict access (e.g., approved protocols, para [0032]) to an element of the medical device in the second mode (away from the safe zone) that is accessible in the first mode (para [0032], Accordingly, the infusion pump can be programmed to enable access to programming specific to the clinical trial when the infusion pump or infusion pump and controller are within the safe zone as reported by the GPS receiver. Devices operating within the safe zone will be able to operate on unapproved or experimental protocols with the GPS enabled safeguard that if the device is removed from the safe zone, operation of the device will automatically revert to approved protocols. Thus, a GPS enabled infusion system can help mitigate any risk associated with potential misuse or accidental use of a clinical trial device outside of a specified protocol.)
Regarding claim 5, wherein switching the operation mode of the medical device comprises one of: switching from a clinician based functional module to a non-clinician based functional module and switching from a non-clinician based functional module to a clinician based functional module, see Fig. 4.
Regarding claim 6, wherein the medical device comprises an infusion device (infusion pump 112) and wherein the one or more sensors comprises one of a global positioning system receiver (GPS), a radio frequency receiver, a Bluetooth receiver and a cellular receiver, para [0029], and wherein the operation mode is associated with a pumping mechanism administering a fluid to the patient, para [0031-0034].
Regarding claim 11, wherein switching the operation mode of the medical device comprises switching a user interface module from information associated with the first mode to information associated with the second mode, see Fig. 4, para [0038-0039].
Regarding claim 12, wherein the user interface module is a simplified patient user interface configured for use by one of a patient and a non-trained user associated with the patient, Fig. 4.
Regarding claims 14, 15, 17 & 19, they encompass the same scope of the invention as to that of device claims 1, 6, 11 except they are drafted in method format instead of apparatus format. The claim(s) is/are therefore rejected for the same reason as set forth above.
It is noted that Examiner believes that device and method claims are not patentable distinguish from each other. In other words, if the device/apparatus claim (or method claim) is unpatentable and rejected over the prior art, the evidence or admission may be used in a rejection under method claim (or device/apparatus claim) as well. Therefore, device and method claims are examined together. However, if Applicant believes that the device and method claims are patentable distinguishable, then the claims would be subject to further Election/Restriction.
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 2 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Istoc (US 2016/0051749) in view of Sun et al. (US 2015/0160788).
Istoc discloses all claimed subject matter as required. Istoc fails to disclose that the restricting access in the second mode comprises hiding an operating parameter of the medical device that is visible in the first mode.
Sun discloses a portable computing device comprising: a processor, a computer program code provides a restricting access in a second mode (Fig. 4b) hiding an operating parameter of an electronic device that is visible in a first mode (Fig. 4a).
Giving such a teaching by Sun, a person having ordinary skill in the art, prior to the effective filling data of the claimed invention, would have easily recognized that modifying the device of Istoc, with obtaining a computer program code being configured to restricting access in a second mode hiding an operating parameter of an electronic device that is visible in a first mode, as taught by Sun, would provide the benefit to hide an operating parameter from unauthorize person to access in certain operations.
Claims 2 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Istoc (US 2016/0051749) in view of Bhaskaran et al. (US 9,542,547).
Istoc discloses all claimed subject matter as required. Istoc fails to disclose that the restricting access in the second mode comprises hiding an operating parameter of the medical device that is visible in the first mode.
Bhaskaran discloses a portable computing device comprising: a processor, a controller 320 is configured to restricting access comprises hiding an operating parameter (input component) of the portable computing device that is visible in the first mode, col. 6, lines 33-45.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Istoc with obtaining a function of restricting access in hiding an operating parameter, as taught by Bhaskaran, in order to hiding an operating parameter (input component) from unauthorize person to access in certain operation inputs.
Claims 3-4 & 16 are rejected under 35 U.S.C. 103 as being unpatentable over Istoc (US 2016/0051749) in view of Poutiatine et al. (US 2007/0186923).
Istoc discloses all claimed subject matter as required. Istoc fails to disclose that wherein the restricting access comprises locking a door of the medical device that is unlocked in the first mode.
Poutiatine discloses a medical device comprising: a processor, a memory, wherein the device has a programmable lockout feature for locking a door of the medical device, see abstract and paras [0021, 0281]; wherein the restricting accesses comprises disabling a button 244, Fig. 21.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Istoc with obtaining a function of locking a door of the medical device or/and a button lockout, as taught by Poutiatine, in order to secure and inaccessible to unauthorized user.
Claims 7-10 & 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Istoc (US 2016/0051749) and further in view of Scarpaci et al. (US 9,078,971).
Regarding claims 7-8 & 18-19, Istoc discloses all claimed subject matter as required. Istoc further discloses that wherein the instructions, when executed by the one or more processors, further cause the medical device to: determine a battery capacity of a battery powering the medical device (e.g., the controller or sensor status that can be shown on the display include a battery life, para [0028]); generate an alert according to an alerting sequence associated with the second mode (a home care location, away from safe zone) (e.g., upon leaving the safe zone creates an alarm condition that requests the user to verify resumption of basal delivery, para [0034].
Istoc fails to disclose that determine, based on the location setting exceeding a distance range, that the battery capacity is insufficient to power the medical device for a predetermined period of time; and generate an alert according to an alerting sequence associated with the second mode.
Scarpaci discloses a batter operation function comprising determining the battery capacity is insufficient to power a medical device for a predetermined period of time in certain mode to operation; generating an alert according to an alerting sequency (dimming the display screen after a given period from the alert/warning) associated with the certain mode, col. 123, lines 25-49 & col. 124, lines 14-24.
Giving such a teaching by Scarpaci, a person having ordinary skill in the art, prior to the effective filling data of the claimed invention, would have easily recognized that modifying the device of Istoc, with providing a function of determining that the battery capacity being insufficient to power of the medical device of a period of time in certain treatment, and generating an alert according to an alerting sequency associated with a certain mode (in this case, second mode in Istoc), would provide the benefit to alert an user to make sure provide enough battery/power in certain treatment to prevent disrupt from lost power.
Regarding claim 9, Istoc in view fo Scarpaci discloses all claimed subject matter as required. Istoc discloses that wherein instructions, when executed by one or more processor, further cause the medical device to: adjust power (via adjust light, ambient noise, para [0030]) provided from the battery to a component of the medical device.
Regarding claim 10, Istoc in view fo Scarpaci discloses all claimed subject matter as required. Istoc discloses that the component of the medical device is one of a wireless transceiver and a pump motor.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Istoc (US 2016/0051749).
Regarding claim 20, Istoc discloses a medical device 112 (infusion pump) comprising:
a housing 112;
a wireless transceiver, para [0021];
a pump motor 216 is inherently included in the infusion pump for delivering drug; wherein the pump motor mounted within the housing, wherein a force from the pump motor causes delivery of a fluid from a fluid source 218 to a patient;
a location sensor 210 (GPS) configured to provide information associated with a location of the infusion pump;
a person skilled in the art would recognize that: a battery (para [0028]) conductively coupled with: (a) the wireless transceiver to provide power to communicate messages via the wireless transceiver; (b) the pump motor to provide power to activate the pump motor, and (c) the location sensor to provide power to activate the location sensor;
one or more processors 200 conductively coupled with the battery; and
memory 206 including instructions that, when executed by the one or more processors 200, cause the medical device to:
monitor, using one or more sensors (GPS or environmental sensor 210), a geofence parameter (GPS signal, para [0031]) of the medical device;
determine a change in a location setting of the medical device based on the geofence parameter, para [0031;
automatically switch, responsive to the changed location setting, an operation mode of the medical device from a first mode (e.g., first set of program instructions or called as safe zone, para [0031]) currently programmed for care of a patient to a second mode (e.g., second set of program instructions, para [0031]), the second mode using different parameters than the first mode to control the medical device, para [0031-0032]; and
restrict access (e.g., approved protocols, para [0032]) to an element of the medical device in the second mode (away from the safe zone) that is accessible in the first mode (para [0032], Accordingly, the infusion pump can be programmed to enable access to programming specific to the clinical trial when the infusion pump or infusion pump and controller are within the safe zone as reported by the GPS receiver. Devices operating within the safe zone will be able to operate on unapproved or experimental protocols with the GPS enabled safeguard that if the device is removed from the safe zone, operation of the device will automatically revert to approved protocols. Thus, a GPS enabled infusion system can help mitigate any risk associated with potential misuse or accidental use of a clinical trial device outside of a specified protocol.)
Claims 1, 5-6, 14, 15, 17 & 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Nyquist (US 2019/0046035) in view of Istoc (US 2016/0051749).
Regarding claim 1, Nyquist discloses a medical device AMD 105 comprising:
one or more processors 402; and
memory 404 including instructions that, when executed by the one or more processors, cause the medical device to:
monitor, using one or more sensors (GPS), a geofence parameter (GPS signal) of the medical device (see Fig. 2, para [0085], ... At 204, the AMD can receive information corresponding to a geographic location of the patient... In other examples, the AMD can receive geographic location information using on or more sensors or circuits of the AMD). Note: the limitation “geofence parameter” is equivalent to a geofence location information that being detected from the GPS signal.
determine a change in a location setting (first mode or second mode, in Fig. 2) of the medical device based on the geofence parameter (in Fig. 2, at step 204, receiving location information, step 206, if the AMD receives geographic location information at in clinic, then the AMD transitions from the first mode to a second mode, para [0086]);
automatically switch, responsive to the changed location setting, an operation mode of the medical device from a first mode currently programmed for care of a patient to a second mode, the second mode using different parameters than the first mode to control the medical device (para [0086] At 206, if the received information corresponding to the geographic location of the patient indicates that the patient is at a medical care facility (in certain examples, for a specified amount of time, such as 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours (e.g., greater than a typical commute past, delivery to, brief stop, work shift or visiting period), days, or one or more other time periods configured to reduce false positives for non-medical treatment events), at 208, the AMD can transition from the first monitoring mode to a second monitoring mode. The second monitoring mode can include an in-clinic monitoring mode, a monitoring mode that consumes more power than the first monitoring mode, or one or more other monitoring modes that monitors the patient at a higher resolution or with increased sensitivity ... In an example, the AMD can transition from the first monitoring mode to the second monitoring mode when the patient enters or is at the medical care facility).
Nyquist does not disclose that restrict access to an element of the medical device in the second mode that is accessible in the first mode.
Istoc discloses a medical device comprising: a processor, a memory, a sensor, i.e., GPS to detect a geofence parameter of the medical device; wherein the processor is configured to automatically switch, responsive to the changed to location setting an operation mode of the medical device from a first mode to a second mode; restrict access to an element of the medical device in the second mode that is accessible in the first mode (para [0032], Accordingly, the infusion pump can be programmed to enable access to programming specific to the clinical trial when the infusion pump or infusion pump and controller are within the safe zone as reported by the GPS receiver. Devices operating within the safe zone will be able to operate on unapproved or experimental protocols with the GPS enabled safeguard that if the device is removed from the safe zone, operation of the device will automatically revert to approved protocols. Thus, a GPS enabled infusion system can help mitigate any risk associated with potential misuse or accidental use of a clinical trial device outside of a specified protocol.)
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Nyquist with obtaining a function of restricting access to an element of the medical device in the second mode that is assessable in the first mode, as taught by Istoc, in order to mitigate any risk associated with potential misuse or accidental use of a clinical trial device outside of a specified protocol.
Regarding claim 5, Nyquist in view of Istoc discloses all claimed subject matter as required. Nyquist discloses that wherein switching the operation mode of the medical device comprises one of: switching from a clinician based functional module (second monitoring mode at hospital, or at medical care facility) to a non-clinician based functional module (non-medical treatment event, or first monitoring mode, or ambulatory or prehospitalization mode) and switching from a non-clinician based functional module to a clinician based functional module, paras [0085-0086].
Regarding claim 6, Nyquist in view of Istoc discloses all claimed subject matter as required. Nyquist discloses that, wherein the medical device comprises an infusion device and wherein the one or more sensors comprises one of a global positioning system receiver, a radio frequency receiver, a Bluetooth receiver and a cellular receiver, and wherein the operation mode is associated with a pumping mechanism administering a fluid to the patient, paras [0013, 0030, 0042, 0089], also see claim 9 in Nyquist.
Regarding claims 14, 15, 17 & 19, they encompass the same scope of the invention as to that of device claims 1, 6, 11 except they are drafted in method format instead of apparatus format. The claim(s) is/are therefore rejected for the same reason as set forth above.
Regarding claim 20, Nyquist discloses a medical device, i.e., an infusion pump 105, comprising: a housing 106; a wireless transceiver 115; a pump motor (in inherently included in the infusion 105) mounted within the housing 106, wherein a force/plunger from the pump motor causes delivery of a fluid from a fluid source to a patient;
a location sensor (geographic sensor, paras [0073, 0075, 0085]) configured to provide information associated with a location of the infusion pump;
a battery conductively coupled with:
a) the wireless transceiver to provide power to communicate messages via the wireless transceiver (e.g., para [0069], the first monitoring mode configured to optimize the usable battery life of an AMD 105. In a second monitoring mode, the AMD 105 provides detection or transmission of physiologic information from the patient 101 to the external system 125 using more power than the first monitor mode; in para [0078], the external system 125 can send information to, or receive information from, the AMD 105 or the via the communication link 115. Examples of the information can include real-time or stored physiological data from the patient 101, diagnostic data, such as detection of cardiac arrhythmias or ev3ents of worsening heart failure, responses to therapies delivered to the patient 101, or device operation status of the AMD 105 or a wearable device (e.g., battery status, load impedance, etc....).
(b) the pump motor to provide power to activate the pump motor, and
(c) the location sensor to provide power to activate the location sensor (e.g., para [0069], the first monitoring mode (detected by the location sensor) configured to optimize the usable battery life of an AMD 105; .... In a second monitoring mode, the AMD 105 provides detection or transmission of physiologic information from the patient 102 to the external system 125 using the power than the first monitoring mode);
one or more processors conductively coupled with the battery; and
memory including instructions that, when executed by the one or more processors, cause the infusion pump to: monitor, using the location sensor, a geofence parameter (geofence location information) of the infusion pump, the geofence parameter comprising one of a location and environment of the infusion pump (Fig. 2, para [0085], At 204, the AMD can receive information corresponding to a geographic location of the patient... In other example, the AMD can receive geographic location information using one or more sensor or circuits of the AMD);
determine a change in the location of the infusion pump based on the geofence parameter (either at home or at clinical facility)r;
automatically switch, responsive to the changed location setting, an operation mode of the infusion pump from a first mode currently programmed for care of a patient to a second mode, the second mode using different parameters than the first mode to control the infusion pump (e.g. Fig. 2, para [0086], at step 208, the AMD can transition from the first monitoring mode to a second monitoring mode. The second monitoring mode can include an in-clinic monitoring mode, and monitoring mode that consumes more power than the first monitoring mode, or one or more other monitoring modes that monitors the patient at higher resolution or with increased sensitivity... In an example, the AMD can transition from the first monitoring mode to the second monitoring mode when the patient enters or is at the medical care facility.
Nyquist fails to disclose that restricting access to an element of the infusion pump in the second mode that is accessible in the first mode.
Istoc discloses a medical device comprising: a processor, a memory, a sensor, i.e., GPS to detect a geofence parameter of the medical device; wherein the processor is configured to automatically switch, responsive to the changed to location setting an operation mode of the medical device from a first mode to a second mode; restrict access to an element of the medical device in the second mode that is accessible in the first mode (para [0032], Accordingly, the infusion pump can be programmed to enable access to programming specific to the clinical trial when the infusion pump or infusion pump and controller are within the safe zone as reported by the GPS receiver. Devices operating within the safe zone will be able to operate on unapproved or experimental protocols with the GPS enabled safeguard that if the device is removed from the safe zone, operation of the device will automatically revert to approved protocols. Thus, a GPS enabled infusion system can help mitigate any risk associated with potential misuse or accidental use of a clinical trial device outside of a specified protocol.)
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Nyquist with obtaining a function of restricting access to an element of the medical device in the second mode that is assessable in the first mode, as taught by Istoc, in order to mitigate any risk associated with potential misuse or accidental use of a clinical trial device outside of a specified protocol.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
Prosecution Insights