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 § 102
The following is a quotation of the appropriate
graphs 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.
Claim(s) 1-16 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Flaherty (US 2004/0092878).
Regarding claim 1, Flaherty discloses an infusion delivery device (Fig. 1, 10 ¶[0042]-[0051]) comprising:
a fluid reservoir (Fig. 2-3 & 18a-b, 30, ¶[0043]) having a proximal end (see annotated figure below), a distal end (see annotated figure below), and a plunger disposed inside the fluid reservoir and moveable therein (Fig. 18a-b, where 236 is within 30 and 236 is slidably received on the end of the lead screw of 30, ¶[0063]);
a fluid path in fluid communication with the fluid reservoir (see 70 and 72 in communication with 30 via 36, Fig. 3; the end wall of the reservoir includes an outlet 36 connected through a lumen 72 to the exit port assembly 70, ¶[0056]);
at least one pressure sensor interfacing at least one of the fluid reservoir or the fluid path (the device can include a reservoir pressure transducer, ¶[0051]); and
a processor in communication with the at least one pressure sensor (50, Fig. 2; a reservoir pressure transducer for transmitting information to the local processor 50, ¶[0051]) and a non-transitory computer-readable medium having encoded thereon instructions (the local processor 50 includes all the computer programs and electronic circuitry needed ... the local processor 50 includes programming, electronic circuitry, and memory to properly activate the dispenser at the needed time intervals, ¶[0049]; reasonably assuming the processor's memory is a non-transitory computer-readable medium) that, when executed by the processor, cause the processor to:
monitor one or more pressure signals (¶[0051], where the pressure transducer relays information regarding the pressure for indication on how and when to activate the dispenser); and
determine an end of the fluid reservoir based on the one or more pressure signals (¶[0051], where the pressure transducer can measure when the reservoir is empty or how much fluid is being dispensed).
Regarding claim 2, Flaherty discloses the infusion delivery device of claim 1, wherein the end of the fluid reservoir corresponds to an end of a usable-dose zone, wherein the end of the usable-dose zone is based on an accuracy of an infusion dosage (¶[0051], where the pressure transducer or reservoir volume transducer transmits data to the processor 50 including how and when to activate the dispenser as well as other factor, meaning the infusion dosage and end of reservoir volume are related and sent to the processor in the device).
Regarding claim 3, Flaherty discloses the infusion delivery device of claim 2, Flaherty discloses wherein the instructions, when executed by the processor, cause the processor to adjust operation by one or more of preventing a user from administering doses and notifying the user that the infusion delivery device is at or near the end of the usable-dose zone (¶[0048]-[0051], where the two way communication includes input and output from the infusion delivery meaning there is at least some notification between the infusion device and the controller where the user interface is located).
Regarding claim 4, Flaherty discloses the infusion delivery device of claim 1, wherein the end of the fluid reservoir is relative to an initial fill volume of the fluid reservoir (¶[0051], where the pressure transducer operates by indicating how or when to activate the dispenser, flow and reservoir conditions meaning the reservoir end or empty indication would be based on the initial fluid in the reservoir).
Regarding claim 5, Flaherty discloses the infusion delivery device of claim 1, wherein the end of the fluid reservoir is based on an error between an actual volume of medicament in the fluid reservoir (AV) to an expected volume of medicament in the fluid reservoir (EV), wherein the error exceeds a predetermined threshold (¶[0051], where the transducer sends data including leak or empty information to indicate if there is an error with the reservoir and the reservoir volume, this data is the actual volume versus the expected volume as a leak would indicate a change in the expected volume, furthermore, the transducer detects dispensation levels such as too much or too little fluid being dispensed).
Regarding claim 6, Flaherty discloses the infusion delivery device of claim 5, wherein the AV is calculated based on the one or more pressure signals (¶[0051], where the transducer(s) pass data related to the volume or pressure of the reservoir to the processor based on the initial volume or pressure and the current volume or pressure to determine if there is a leak or if the reservoir is close to being empty).
Regarding claim 7, Flaherty discloses the infusion delivery device of claim 5, wherein the EV is pre-programmed in the non- transitory computer-readable medium (¶[0051], where the pressure transducer and processor detect an initial amount of fluid and has a determined amount flow that is proper for the device and will send give a notification if the device is dispensing properly, leaking, or empty based on the initial volume).
Regarding claim 8, Flaherty discloses a method for an infusion delivery device (¶[0042]-[0051]) comprising:
monitoring one or more pressure signals in an infusion delivery device (¶[0051], where the pressure transducer relays information regarding the pressure for indication on how and when to activate the dispenser), wherein the infusion delivery device comprises:
a fluid reservoir (Fig. 2-3 & 18a-b, 30, ¶[0043]) having a proximal end (see annotated figure below), a distal end (see annotated figure below), and a plunger disposed inside the fluid reservoir and moveable therein (Fig. 18a-b, where 236 is within 30 and 236 is slidably received on the end of the lead screw of 30, ¶[0063]);
a fluid path in fluid communication with the fluid reservoir (see 70 and 72 in communication with 30 via 36, Fig. 3; the end wall of the reservoir includes an outlet 36 connected through a lumen 72 to the exit port assembly 70, ¶[0056]); and
at least one pressure sensor interfacing at least one of the fluid reservoir or the fluid path (50, Fig. 2; a reservoir pressure transducer for transmitting information to the local processor 50, ¶[0051]); and
determining an end of the fluid reservoir based on one or more pressure signals (¶[0051], where the pressure transducer determines the end of the reservoir).
Regarding claim 9, Flaherty discloses the method of claim 8, wherein the end of the fluid reservoir corresponds to an end of a usable-dose zone, wherein the end of the usable-dose zone is based on an accuracy of an infusion dosage (¶[0051], where the pressure transducer or reservoir volume transducer transmits data to the processor 50 including how and when to activate the dispenser as well as other factor, meaning the infusion dosage and end of reservoir volume are related and sent to the processor in the device).
Regarding claim 10, Flaherty discloses the method of claim 9, further comprising adjusting operation by one or more of preventing a user from administering doses and notifying the user that the infusion delivery device is at or near the end of the usable-dose zone (¶[0048]-[0051], where the two way communication includes input and output from the infusion delivery meaning there is at least some notification between the infusion device and the controller where the user interface is located).
Regarding claim 11, Flaherty discloses the method of claim 8, wherein the end of the fluid reservoir is relative to an initial fill volume of the fluid reservoir (¶[0051], where the pressure transducer operates by indicating how or when to activate the dispenser, flow and reservoir conditions meaning the reservoir end or empty indication would be based on the initial fluid in the reservoir).
Regarding claim 12, Flaherty discloses the method of claim 8, wherein the end of the fluid reservoir is based on an error between an actual volume of medicament in the fluid reservoir (AV) to an expected volume of medicament in the fluid reservoir (EV), wherein the error exceeds a predetermined threshold (¶[0051], where the transducer sends data including leak or empty information to indicate if there is an error with the reservoir and the reservoir volume, this data is the actual volume versus the expected volume as a leak would indicate a change in the expected volume, furthermore, the transducer detects dispensation levels such as too much or too little fluid being dispensed).
Regarding claim 13, Flaherty discloses the method of claim 12, wherein the AV is calculated based on the one or more pressure signals (¶[0051], where the transducer(s) pass data related to the volume or pressure of the reservoir to the processor based on the initial volume or pressure and the current volume or pressure to determine if there is a leak or if the reservoir is close to being empty).
Regarding claim 14, the method of claim 12, wherein the EV is pre-programmed in the infusion delivery device (¶[0051], where the pressure transducer and processor detect an initial amount of fluid and has a determined amount flow that is proper for the device and will send give a notification if the device is dispensing properly, leaking, or empty based on the initial volume).
Regarding claim 15, Flaherty discloses an infusion management system (Fig. 1-3, ¶[0042]-[0051]) comprising:
an infusion delivery device (Fig. 1-3) comprising:
a fluid reservoir (Fig. 2-3 & 18a-b, 30, ¶[0043]) having a proximal end (see annotated figure below), a distal end (see annotated figure below), and a plunger disposed inside the fluid reservoir and moveable therein (Fig. 18a-b, where 236 is within 30 and 236 is slidably received on the end of the lead screw of 30, ¶[0063]);
a fluid path in fluid communication with the fluid reservoir (see 70 and 72 in communication with 30 via 36, Fig. 3; the end wall of the reservoir includes an outlet 36 connected through a lumen 72 to the exit port assembly 70, ¶[0056]);
at least one pressure sensor interfacing at least one of the fluid reservoir or the fluid path (the device can include a reservoir pressure transducer, ¶[0051]); and
a processor in communication with the at least one pressure sensor (50, Fig. 2; a reservoir pressure transducer for transmitting information to the local processor 50, ¶[0051]) and a non-transitory computer-readable medium having encoded thereon instructions (the local processor 50 includes all the computer programs and electronic circuitry needed ... the local processor 50 includes programming, electronic circuitry, and memory to properly activate the dispenser at the needed time intervals, ¶[0049]; reasonably assuming the processor's memory is a non-transitory computer-readable medium) that, when executed by the processor, cause the processor to:
monitor one or more pressure signals (¶[0048-[0051]); and
determine an end of the fluid reservoir based on the one or more pressure signals (¶[0051], where the pressure transducer relays information regarding the pressure for indication on how and when to activate the dispenser); and
at least one controller (Fig. 1, 100) in communication with the infusion delivery device, wherein the at least one controller is configured to exchange data or instructions with the infusion delivery device (¶[0044], where the controller is in communication with the device 10 including the processor and wireless receiver for the exchange of data).
Regarding claim 16, Flaherty discloses the infusion management system of claim 15, wherein the at least one controller comprises a user interface for communicating with a user (¶[0047], where the controller has an LCD to display to the user).
Regarding claim 18, Flaherty discloses the infusion management system of claim 15, wherein the processor is configured transmit one or more notifications to the at least one controller (¶[0046]-[0048], where the device 100 communicates with 60 and 50 to control the device using inputs or outputs and is a two-way communication, notifications, i.e. user output, are also part of the communication device and infusion device data transmission).
Regarding claim 19, Flaherty discloses the infusion management system of claim 15, wherein the at least one controller (Fig. 1, 100) comprises a dedicated wireless controller (Fig. 1, where the controller is a dedicated wireless controller for the infusion device).
Regarding claim 20, Flaherty discloses the infusion management system of claim 15, wherein the end of the fluid reservoir corresponds to an end of a usable-dose zone, wherein the end of the usable-dose zone is based on an accuracy of an infusion dosage (¶[0051], where the pressure transducer or reservoir volume transducer transmits data to the processor 50 including how and when to activate the dispenser as well as other factor, meaning the infusion dosage and end of reservoir volume are related and sent to the processor in the device).
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) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Flaherty (US 2004/0092878) in view of Drew (US 2011/0152756).
Regarding claim 17, Flaherty discloses the infusion management system of claim 15, Flaherty does not specifically teach wherein the at least one controller comprises a smart phone.
Drew teaches an implantable fluid delivery device that includes memory, a processor, pump and controller. Drew teaches a smart phone can be a controller for the user interface (programmer may be ... a cellular phone, para [0038]). Modifying the device of Flaherty would not change the function of the device as a smart phone is a two-way communication device like the controller of Flaherty and would be a simple substitution.
Accordingly, it would have been obvious to a person having ordinary skill in the art to apply the cellular phone of Drew on the touchscreen controller of Flaherty, in order to provide a familiar and easy to understand interface.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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