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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 21 February 2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 21 February 2025. As directed by the amendment: claims 1-3, 9, 12, 14, 15, and 22 have been amended, claim 34 has been canceled. Thus claims 1-33 are presently pending in this application.
Response to Arguments
Applicant’s arguments with respect to the claims 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.
Applicant argues on Pages 9 and 10 that the door of Gillespie does not enclose a portable pump and Gillespie does not teach such a pump. The examiner respectfully disagrees. A syringe on its own can be interpreted as a basic manual reciprocating pump.
Claim Objections
Claims 1, 5, 7, and 28 are objected to because of the following informalities:
Claim 1 recites “the pump” in line 9. This should instead recite “the portable pump”.
Claims 5 and 7 recite the limitation "the portable infusion pump". This should instead recite “the portable pump” which was introduced in claim 1.
Claim 28 recites the limitation "the pump". This should instead recite “the portable infusion pump” which was introduced in claim 12.
Appropriate correction is required.
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 10 and 21-23 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.
Claim 10 recites the limitation “stronger communications hardware”. It is unclear what the communications hardware is stronger than. For the purpose of examination this is being interpreted as “additional communications hardware” which was introduced in claim 9.
Claim 21 recites the limitation "the pump infusion history". There is insufficient antecedent basis for this limitation in the claim.
Claims 22 and 23 recite the limitation “the controller/container”. There is insufficient antecedent basis for this limitation in the claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6-13, 15-16, 19, 21-25, and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gillespie (US 7,018,361 B2).
Regarding claim 1, Gillespie et al. discloses a multi-function, modular pump system comprising: a stationary docking station (10 Fig 1) comprising: at least one security feature comprising an enclosure (34 Fig 1) and at least one of a physical key (See the key inserted into the lock 38 as shown in Fig 1) configured to be used with a mechanical lock (38 Fig 1, the lock is better shown in Fig 2 without the key inserted) with a key opening (See the rectangular key opening in Fig 2), a passcode entry, or a clinician badge, the security feature being configured to enclose and prevent unauthorized removal of or access to (Col 6 lines 42-43 “A lock 38 is provided with the door 36 to prevent unauthorized access to the syringe assembly 14”) a portable pump attachable to the docking station and a medication reservoir container configurable to be in fluid communication with and form part of the pump (the portable pump and the medication reservoir are not positively recited due to the “configured to enclose and prevent unauthorized removal of or access to” language introducing the portable pump, however, the syringe 14 is a type of pump and the barrel of the syringe is a medication reservoir container); a pump mount (52 Fig 2) configured to engage and stabilize the portable pump within the docking station, allow the portable pump to maintain infusion continuity when removed, and enable non-technical disengagement of the portable pump from the docking station when authorized (the barrel clamp 52 Fig 2 holds the syringe in place as shown in Fig 1, allows the syringe to be removed and still function as a syringe, and the disengagement is non-technical); and a stationary external user interface (16 Fig 1, Col 7 lines 38-42 “The user interface 16 generally includes a display screen 60, a first control panel 62 and a second control panel 64, and associated electrical components and computer software contained within the housing 12 to operate the pump 10.”) configured to allow a user who is a clinician to control the portable pump when the portable pump is attached to the docking station (Col 7 lines 63-64 “The first control panel 62 generally has a start button 66, a stop button 68”, Col 6 lines 64-67 “The syringe plunger 48 is driven by the drive mechanism to force medication from the syringe barrel 46 through a tube (not shown) and to a patient.”) and review pump run status, event history, and settings (Col 7 lines 63-66 “The first control panel 62 generally has a start button 66, a stop button 68 and an alarm/alert button 70. The second control panel 64 generally has a settings panel 72, a history button 74 and a data port 76.”); the portable pump comprising an infusion pump configurable to be separable from the docking station and, when separated, function independently for ambulatory use, (the portable pump is not positively recited, however, the syringe 14 is a type of pump that would function independently when separated) the portable pump further comprising: a battery and a power input structure connected to the battery; a portable user interface (because the portable pump is not positively recited, these features associated with the pump are also not positively recited, the claim limitation is met because the docking station is fully capable of attaching to a portable pump, such as a syringe, with a battery and a power input structure connected to the battery and a portable user interface); and the medication reservoir container (the medication interface reservoir container is not positively recited, however the barrel of the syringe is a medication reservoir container).
Regarding claim 2, Gillespie et al. discloses the system of Claim 1. Gillespie et al. further discloses wherein the stationary docking station further comprises a machine interface (20 Figs 2 and 14) configured to allow control signals and other information to pass between the external user interface and the enclosed, engaged portable pump (Col 12 lines 24-38, the motor receives a control signal and other information such as force required to move the plunger is passed).
Regarding claim 3, Gillespie et al. discloses the system of Claim 2. Gillespie et al. further discloses wherein the stationary docking station further comprises a power module (90 Fig 4A) configured to provide power to both the enclosed portable pump and the stationary docking station (the battery unit 90 provides power to pump 10 which also provides power to the syringe in the form of the motor pushing of the plunger, Abstract “A motor is positioned within the housing (12) and is operably connected to an electrical contact (94) disposed in the recess (33).”).
Regarding claim 6, Gillespie et al. discloses the system of claim 1. Gillespie et al. further discloses further comprising an extending patient control (299 Fig 2) configured to provide a bolus dose (Col 13 lines 34-38 “a user can further control the infusion therapy wherein the user can push the button to deliver additional doses of medication”).
Regarding claim 7, Gillespie et al. discloses the system of Claim 1. Gillespie et al. further discloses wherein the portable infusion pump is configurable for use in portable mode and secured mode (the portable infusion pump is not positively recited; however, the syringe of Gillespie et al. can be removed from the docking station for use in portable mode, which is just as a syringe, and in secured mode which is as shown in Fig 1).
Regarding claim 8, Gillespie et al. discloses the system of Claim 7. Gillespie et al. further discloses wherein in portable mode, the portable pump operates independently of the stationary docking station (the portable infusion pump is not positively recited; however, when the syringe of Gillespie et al. is removed from the docking station for use in portable mode, it could operate independently which is just as a syringe).
Regarding claim 9, Gillespie et al. discloses the system of claim 7. Gillespie et al. further discloses wherein in secured mode, the portable pump cooperates with the stationary docking station (As shown in Figs 1 and 14), and the system supports additional functionality comprising one or more of additional communications hardware (Col 15 lines 1-10 “enhanced communication capabilities”, “the pump 10 can communicate wirelessly with other devices such as a pharmacy computer or personal digital assistants (PDA) carried by hospital personnel.”) and sensor support.
Regarding claim 10, Gillespie et al. discloses the system of claim 9. Gillespie et al. further discloses wherein additional communications hardware comprises Wi-Fi communications or cellular communications (Col 15 lines 1-10 “enhanced communication capabilities”, “the pump 10 can communicate wirelessly with other devices such as a pharmacy computer or personal digital assistants (PDA) carried by hospital personnel.”).
Regarding claim 11, Gillespie et al. discloses the additional communications hardware. The sensor support is part of an alternative grouping in claim 9, and the sensor support is not relied upon for the rejection, as such, the limitations further limiting the sensor support is not required for the rejection.
Regarding claim 12, Gillespie et al. discloses a modular pump system comprising: a portable infusion pump (the syringe assembly 14 Fig 1) configurable for independent operation in a first mode (the syringe of can be removed from the docking station for independent operation in a first mode, which is just as a syringe) and having a medication container incorporated therewith (the barrel of the syringe is a medication container); and a pump docking module (10 Fig 1) configured to securely enclose the portable infusion pump and medication container (As shown in Fig 1), the pump docking module comprising a user interface (16 Fig 1) and configured to operatively and persistently communicate with the portable infusion pump while the portable infusion pump is enclosed therein (the sensors including the occlusion sensor 22 persistently communicates with the syringe, Col 12 lines 28-31 “The load cell 210 measures a reactive force from the force pushing against the load beam 212. The circuitry associated with the load cell 210 converts the force to a usable signal.”).
Regarding claim 13, Gillespie et al. discloses the system of Claim 12. Gillespie et al. further discloses wherein the pump docking module is configured to engage and stabilize the portable infusion pump therein (As shown in Fig 1, the syringe 14 is engaged and stabilized in 10 Fig 1), allowing the portable infusion pump to maintain infusion continuity when removed, and enable rapid disengagement when authorized (when the key unlocks lock 38 Fig 1 the syringe can be removed by lifting 52 Fig 2).
Regarding claim 15, Gillespie et al. discloses the system of Claim 12. Gillespie et al. further discloses wherein the pump docking module user interface is configured to assume interactive control and display responsibilities of the portable infusion pump when that pump is enclosed within the docking module (Col 7 lines 42-45 “The display screen 60 displays all of the general operating parameters of the pump 10”, “a touch screen for data to be inputted into the pump 10 by a user”).
Regarding claim 16, Gillespie et al. discloses the system of Claim 12. Gillespie et al. further discloses wherein the pump docking module locks to secure the portable infusion pump and medication container within the module (Col 6 lines 41-46 “A lock 38 is provided with the door 36 to prevent unauthorized access to the syringe assembly 14. The lock 38 is required because oftentimes drugs such as morphine are infused by the pump 10 and can be unfortunately subject to theft.”) and can be unlocked by one or more of: a physical key (See the key shown inserted into lock 38 in Fig 1), a passcode entry, and a clinician badge.
Regarding claim 19, Gillespie et al. discloses the system of Claim 12. Gillespie et al. further discloses further comprising a patient bolus cord configured to communicate to the portable infusion pump directly or through the pump docking module (Col 13 lines 38-40 “The PCA button typically has a cord that can be plugged into the pump 10 as is generally known.”).
Regarding claim 21, Gillespie et al. discloses the system of claim 12. Gillespie et al. further discloses wherein the pump docking module interface is configured to obtain and display the pump infusion history, including total medication delivered over time, timing of patient bolus requests and delivered patient boluses (Col 15 lines 14-17 “The user interface 16 has memory that stores information regarding pump history such as medications delivered, dosage, time, date etc.”).
Regarding claim 22, Gillespie et al. discloses the system of Claim 12. Gillespie et al. further discloses wherein the portable infusion-pump and pump docking module, when integrated, communicate to each other through a wired connection upon pump mounting into the controller/container (the wires do not connect to wiring in the pump/syringe but the syringe communicates to the docking module through the wired sensors upon pump mounting, Col 12 lines 39-42 “The system 24 generally includes a syringe plunger position sensor 230 and a syringe barrel size sensor 232.”).
Regarding claim 23, Gillespie et al. discloses the system of Claim 12. Gillespie et al. further discloses wherein the portable infusion pump and pump docking module, when integrated, communicate to each other through a wireless connection upon pump mounting into the controller/container (the sensors communicate with the syringe wirelessly, such as the linear plunger position sensor 230 Fig 15).
Regarding claim 24, Gillespie et al. discloses the system of Claim 12. Gillespie et al. further discloses wherein the pump docking module includes a communication means configured to communicate from the system to a networked electronic health system (Col 15 lines 2-4 “For example, the pump 10 can communicate wirelessly with other devices such as a pharmacy computer”).
Regarding claim 25, Gillespie et al. discloses the system of Claim 12. Gillespie et al. further discloses wherein the pump docking module is configured to hold and secure medication presented in a bag, semi-rigid container or syringe (the syringe 14 Fig 1).
Regarding claim 30, Gillespie et al. discloses the system of claim 12. Gillespie et al. further discloses further comprising a processor (Col 14 lines 3-4 “Circuits 302, 304, and 306 are designed to provide a status change in signal to the microprocessor”), mode algorithm (The table in Fig 33 would require an algorithm to determine the condition based on the circuit reading), and mode indicator (the part of the user interface that indicates a status of the PCA button), collectively configured to modify the mode indicator to inform a user of the present mode, the modes linked to at least route of delivery or family of medication (Col 14 lines 64-67 “Thus, if one of the wires associated with the PCA button 299 becomes frayed and eventually breaks, a specific reading can be sensed by the user interface to indicate the PCA button 299 requires replacement.” The PCA button is part of a route of delivery).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Gillespie (US 7,018,361 B2).
Regarding claim 4, Gillespie et al. teaches the system of claim 2. Gillespie et al. further teaches wherein the external user interface comprises a touch-screen (Col 7 lines 44-45 “The display screen 60 also acts as a touch screen”).
However, Gillespie et al. is silent to the touchscreen fills more than half of an outer surface of the stationary docking station, however, it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04 IV A. The touch-screen of Gillespie et al. would not perform differently if it were to be sized to fill more than half of an outer surface of the stationary docking station.
Claims 5 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Gillespie (US 7,018,361 B2) in view of Klein (US 2007/0121230 A1).
Regarding claim 5, Gillespie et al. discloses the system of claim 3. However, Gillespie et al. fails to disclose wherein the battery of the portable infusion pump is rechargeable and the power input structure is configured to interface with the power module and a charging structure in the stationary docking station to recharge the battery (while the portable infusion pump and its battery are not positively recited, the interface and charging structure are components of the docking station).
Klein teaches a portable infusion pump (1 Fig 14) has a battery ([0106] “Sleeve 25 may require a power source such as a small battery”) that is rechargeable ([0065] “recharging the energy storage device”) and the power input structure ([0065] “an energy storage device coupled to an inductive device”) is configured to interface with the power module and a charging structure in the stationary docking station (100 Fig 14) to recharge the battery ([0065] “inductively couple to an inductive recharging device”, [0137] “When the syringe engages in the docking station as shown in FIG. 10b, the charger coil 180 extending from the reader will engage, abut or otherwise couple to the inductive charger coil 181 on the docking station to allow for inductive coupling and charging of the battery”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the system of Gillespie et al. to include the limitations as taught by Klein to include rechargeable sensors in the syringe to provide the ability to identify drugs within the syringe (abstract).
Regarding claim 18, Gillespie et al. discloses the system of Claim 12. Gillespie et al. further discloses wherein a power submodule within the pump docking module (90 Fig 4A) is configured to convert AC power (Col 3 lines 48-50 “A DC power source signal is provided by said AC power outlet and rectifying circuitry.”), power the docking module features (Abstract “An infusion pump (10) is configured to be powered by […] a rechargeable battery source.”).
However, Gillespie et al. fails to disclose wherein a power submodule within the pump docking module is configured to power and recharge a battery of the portable infusion pump.
Klein teaches a power submodule within the pump docking module is configured to power and recharge a battery of the portable infusion pump ([0137] “When the syringe engages in the docking station as shown in FIG. 10b, the charger coil 180 extending from the reader will engage, abut or otherwise couple to the inductive charger coil 181 on the docking station to allow for inductive coupling and charging of the battery”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the system of Gillespie et al. to include the limitations as taught by Klein to include rechargeable sensors in the syringe to provide the ability to identify drugs within the syringe (abstract).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Gillespie (US 7,018,361 B2) in view of Powers et al. (US 2011/0028937 A1).
Regarding claim 14, Gillespie et al. discloses the system of claim 12. Gillespie et al. further teaches the pump docking module user interface comprising a touch screen (Col 7 lines 44-45 “The display screen 60 also acts as a touch screen”) that provides interactive control and display responsibilities of the portable infusion pump when that pump is mounted within the pump docking module (Col 7 lines 42-45 “The display screen 60 displays all of the general operating parameters of the pump 10”, “a touch screen for data to be inputted into the pump 10 by a user”).
However, Gillespie et al. fails to teach the touch screen is color.
Powers et al. teaches a touch screen is color ([0026] “a color LCD display with a touch-sensitive input device, such as a capacitive or resistive touch screen overlay 107 (see FIG. 3).”). It would have been obvious to one of ordinary skill in the art to make the touch screen color as color improves clarity.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Gillespie (US 7,018,361 B2) in view of Lacy (US 2015/0198283 A1).
Regarding claim 17, Gillespie et al. discloses the system of Claim 12. Gillespie et al. further discloses wherein the pump docking module is secured to an IV pole (Col 6 lines 51-53“The pole clamp 42 can have various designs and is adapted to mount the pump 10 on a pole assembly such as used in a hospital setting.”).
However, Gillespie et al. fails to disclose such that it is releasable only by one or more of a physical key, a passcode entry, and a clinician badge.
Lacy teaches a medical device (105 Fig 1) is secured to IV pole (101 Fig 1) such that it is releasable only by one or more of a physical key (620 Fig 6a, [0054] “prevents removal of pole clamp 10 from a pole by unauthorized personnel, or even thieves, who do not possess key 620.”), a passcode entry, and a clinician badge. It would have been obvious to one of ordinary skill in the art at the time of effective filing to secure the docking module of Gillespie et al. with the limitations as taught by Lacy to prevent tampering or theft [0054].
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Gillespie (US 7,018,361 B2) in view of Adams et al. (US 2018/0311433 A1).
Regarding claim 20, Gillespie et al. discloses the system of Claim 12. However, Gillespie et al. fails to disclose wherein a patient bolus control wirelessly communicates to the portable infusion pump and includes a battery rechargeable by the pump docking module.
Adams et al. teaches a patient bolus control (300 Fig 3) wirelessly communicates to the portable infusion pump ([0045] “Any suitable communication protocol can be used to communicate from dose request device 300 to a medicament delivery device. Wired and/or wireless connections can be employed by the communication interface 308.”) and includes a battery ([0069] “The dose request device 300 can include any suitable energy storage component(s), such as a chemical battery”) rechargeable by the pump docking module ([0069] “The energy storage component(s), if present, can be disposable or rechargeable. Rechargeable energy storage component(s) can be recharged by any suitable means, such as via a hard wired communication link, or by another wired connection, which may be transient.”, while Adams et al. does not disclose the battery being rechargeable by the docking module specifically, the disclosure of “recharged by any suitable means includes the docking module, the docking module of Barnes is already configured to charge the portable infusion pump so one of ordinary skill would be able to further configure the docking module to also charge the patient bolus control). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the system of Gillespie et al. to include a patient bolus control with the limitations as taught by Adams et al. to permit a patient to safely self-medicate [0004] and for this to be more convenient without wiring.
Claims 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Gillespie (US 7,018,361 B2) in view of Bollish et al. (US 2005/0177096 A1).
Regarding claim 26, Gillespie et al. discloses the system of claim 12. However, Gillespie et al. fails to disclose wherein the pump docking module includes electronics and software to interface to external sensors comprising at least one of SpO2, EtCO2, minute ventilation and patient vital signs sensors, and wherein external sensor output is available through an externally-accessible interface of the pump docking module.
Bollish et al. teaches wherein the pump docking module includes electronics and software to interface ([0067] “(5) it monitors and controls the overall operation of the patient care system 90, including the integration of signals from monitor modules”) to external sensors ([0073] “the sampling device 96 can include a sensor”) comprising at least one of SpO2, EtCO2, minute ventilation and patient vital signs sensors, ([0073] “for directly analyzing the expired air and sending a signal via the line 142 or via a wireless communication system (not shown) to the ETCO2 monitor unit.” “the ETCO2 display 160 displays a numeric value for the ETCO2 after expiration and before inhalation preferably in units of mm Hg or %.”) and wherein external sensor output is available through an externally-accessible interface of the docking module (the sensor output is shown on screen 102 Fig 2 of Bollish et al., this would be analogous to the external screen 36A/B Fig 4 of Barnes). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the system of Gillespie et al. to include sensor support as taught by Bollish et al. “for directly analyzing the expired air and sending a signal via the line 142 or via a wireless communication system (not shown) to the ETCO2 monitor unit.” [0073] “For the detection of potential respiratory depression associated with the administration of narcotic analgesics, sedatives, or anesthetics. [0006]
Regarding claim 27, modified Gillespie et al. teaches the system of claim 26. Modified Gillespie et al. further teaches wherein external sensor output is digested by an algorithm operable in the system (Bollish et al.- [0074] “the ETCO.sub.2 monitor or interface unit includes a waveform analysis algorithm to analyze the ETCO.sub.2 waveform and affect operation of the pump based upon certain waveform characteristics as are known in the art.”) to notify the pump user and/or automatically stop the portable infusion pump under defined conditions of respiratory depression (Bollish et al.- [0081] “in response to an out-of-range ETCO.sub.2 measurement in a PCA patient, the microprocessor controller 264 ceases all further administration of analgesics until after the unacceptably low or high ETCO.sub.2 value and/or respiration rate situation is resolved,”).
Claims 28 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Gillespie (US 7,018,361 B2) in view of Borges et al. (US 2015/0224252 A1).
Regarding claim 28, Gillespie et al. discloses the system of claim 12. However, Gillespie et al. fails to disclose further comprising a database and at least one signal associating within the system: the pump, a particular user of the pump, that user's medication, and the medication order.
Borges et al. teaches a system comprising a database ([0017] “a medical facility server”, “drug libraries”) and at least one signal associating within the system: the pump, a particular user of the pump, that user's medication, and the medication order ([0021] “a transfer of data between one or more of the infusion pumps 20 and the control unit upon coupling of an infusion pump and the control unit 25. The data may vary and may include, for example, the patient's name, hospital identification number, and other information such as the patient's age, weight, condition, and allergies. The data may also include, for example, the patient's MAR (medication administration record), a drug identifier, a drug concentration, a diluent fluid identifier, a dose or flow rate, other pumping-related parameters, contra-indicated medications/conditions, alarm conditions, etc.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the system of Gillespie et al. to include the limitations as taught by Borges et al. to provide the caregiver with the necessary information to care for the patient [0017].
Regarding claim 29, modified Gillespie et al. teaches the system of claim 28. Gillespie et al. further teaches further comprising a bar code scanner or near field sensing system (Col 15 lines 6-8 “The pump 10 can be equipped with various types of readers to receive patient information such as from swipe cards or bar-coded identification bracelets.”)
Claims 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Gillespie (US 7,018,361 B2) in view of Borges et al. (US 2015/0224252 A1) and Goetz et al. (US 2010/0265072 A1).
Regarding claim 31, modified Gillespie et al. teaches the system of claim 29. However, modified Gillespie et al. is silent to wherein the pump docking module is further configured to indicate a current delivery mode using color coding.
Goetz et al. teaches wherein the pump docking module is further configured to indicate a current delivery mode using color coding ([0120] “user interface screen 120 may illustrate the current dosing program (e.g., step 192) with a first color and the second dosing program (e.g., steps 180) with a second color.”). It would have been obvious to one of ordinary skill of the art at the time of effective filing for the docking module to be configured as taught by Goetz et al. to distinguish more visibly two different delivery modes.
Regarding claim 32, modified Gillespie et al. teaches the system of claim 29. However, modified Gillespie et al. fails to teach wherein an outer surface of one or more of the portable infusion pump and the pump docking module is configured to indicate a current delivery mode using color coding.
Goetz et al. teaches wherein an outer surface (the screen 120) of the pump docking module is configured to indicate a current delivery mode using color coding ([0120] “user interface screen 120 may illustrate the current dosing program (e.g., step 192) with a first color and the second dosing program (e.g., steps 180) with a second color.”). It would have been obvious to one of ordinary skill of the art at the time of effective filing for the docking module to be configured as taught by Goetz et al. to distinguish more visibly two different delivery modes.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Gillespie (US 7,018,361 B2) in view of Batch (US 2006/0200369 A1).
Regarding claim 33, Gillespie et al. discloses the system of claim 12. Gillespie et al. further discloses the pump docking module (10 Fig 1) is configured to securely house the portable infusion pump (14,20 Fig 1) and has a door (36 Fig 1) of the pump docking module: locking, opening, closing, and unlocking (Col 6 lines 42-43 “A lock 38 is provided with the door 36 to prevent unauthorized access to the syringe assembly 14.”).
However, Gillespie et al. fails to disclose electronically recognizing and logging at least one of the following actions for a door of the pump docking module: locking, opening, closing, and unlocking.
Batch teaches a system “keeps a medication transaction log that may include the time, Clinician ID, Patient ID, Drug ID, and other information associated with the movement and use of a controlled item.” [0058]. It would have been obvious to one of ordinary skill in the art at the time of effective filing for the system of Gillespie et al. to electronically recognize and log at least one of the following actions for a door of the pump docking module: locking, opening, closing, and unlocking as these are “movement and use of a controlled item” the motivation is “to facilitate internal workflow or auditing studies.” [0058]
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Vargas whose telephone number is (571)270-3873. The examiner can normally be reached Mon-Fri 4:00 PM-9:00 PM EST.
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783