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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 49-57 and 69-74 in the reply filed on 06 April 2026 is acknowledged. Claims 58-68 is/are withdrawn as being directed toward a non-elected invention.
Claim Rejections - 35 USC § 102
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.
Claim(s) 49-50, 55-57, 69-71, and 74 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publication No. 2007/0060871 (“Istoc”).
Regarding Claim 49, Istoc discloses an infusion pump system (100, 200), comprising:
a portable infusion pump (200 – Par. 33) configured to be worn by a user (Par. 14), the portable infusion pump comprising:
a fluid container (re: “reservoir” – Clm. 1) configured to store a fluid to be delivered to the user;
a pumping mechanism (210, 208) configured to drive the delivery of the fluid from the fluid container to the user via a fluid delivery tube (Par. 4); and
communications circuitry (204), the communications circuitry comprising an antenna (Par. 47, 45 – while no antenna is specifically discussed, the presence of an “antenna” is understood to light of the disclosed “transceiver” function of the communication circuity to send and receive wireless connection signals via various protocols, e.g. RF, BLUETOOTH, ZIGBEE, “wireless” LAN, and “wireless” Ethernet, understood to receive an antenna for function to allow the connection of the display and/or glucose sensor arrangements); and
a separable display (100) configured to transmit (via 304), to the communications circuitry of the portable infusion pump when the separable display is coupled to the portable infusion pump, a fluid delivery protocol (re: “instructions”), the separable display further configured to be separated from the portable infusion pump after transmission of the fluid delivery protocol to the portable infusion pump (see Fig. 2), the fluid delivery protocol defining one or more parameters for delivering the fluid to the user (Par. 51, 47, 10, 31, 57).
Regarding Claim 50, Istoc discloses that the portable infusion pump is disposable (Par. 54). Furthermore, Examiner notes that “disposable” is not a structural limitation, but rather only a limitation which governs the intended use of the pump module, whereby any pump module is capable of being “disposable” based on user intent and accepted protocol.
Regarding Claim 55, Istoc discloses the system may include a catheter or infusion set (Par. 4).
Regarding Claim 56, Istoc discloses the portable infusion pump includes a waterproof housing, and wherein at least the fluid container, the pumping mechanism, and the communication circuitry are disposed within the waterproof housing (Par. 54).
Regarding Claim 57, Istoc discloses the portable infusion pump comprises an alert system for generating an alert upon detection of an error during the delivery of the fluid to the user, the alert comprising one or more of an audio, visual, and tactile alert (Par. 16, 46, 55, 59, 62).
Regarding Claim 69, Istoc discloses the portable infusion pump is adapted to:
receive at least one fluid delivery protocol from the display when the display is coupled to the portable infusion pump (Par. 10, 31);
deliver, based on the at least one fluid delivery protocol, a fluid to a user (Par. 8);
measuring one or more fluid delivery parameters associated with the delivery of the fluid (Par. 16, 59, 63);
establishing a wireless connection with the display (Par. 47, 51); and
transmitting the one or more fluid delivery parameters to the display (Par. 47, 51).
Regarding Claim 70, Istoc discloses the portable infusion pump is adapted to: detect an error in the delivery of the fluid to the user; and stop the delivery of the fluid to the user (Par. 16, 46, 59, 60, 62).
Regarding Claim 71, Istoc discloses the portable infusion pump is adapted to: transmit the error to the display when the display is in wireless communication with the portable infusion pump; and display information associated with the error via the display (re: the alarms can be provided on the second module/display instead of the first module/pump such that the various errors/alerts must be understood to be transmitted to the display for alerting the user – see Par. 16).
Regarding Claim 74, in the instant case while the invention of Istoc does not disclose any fluid capacity of the container it must be understood that the device is configured to hold “less than or equal to 100 mL of the fluid” since this range is unbounded and covers every conceivable volume from 0mL to 100mL. Specifically, presuming, arguendo, that the maximum fill capacity of the reservoir of Istoc is greater than 100mL it is still configured to hold a volume less than that as the fluid supply becomes used/exhausted. If the maximum fill capacity of the reservoir of Istoc is 100mL or less then it will always hold 100mL or less from filling until the volume is completely exhausted.
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.
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.
Claim(s) 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2007/0060871 (“Istoc”) as applied above, and further in view of U.S. Publication No. 2016/0213843 (“Despa”).
Regarding Claim 51, Istoc discloses the communications circuitry comprises a variety of wireless protocols (Par. 17, 45, 61), but fails to explicitly specify any specifically “low energy communications circuitry” such as NFC, BLE, or the like. However, Despa discloses that such wireless protocols for data exchange may include BLUETOOTH, ZIGBEE, or BLE amongst other alternatives (Par. 34). It would have been obvious for one having ordinary skill in the art at the time the invention was made to utilize BLE transmission protocols (re: BLUETOOTH Low Energy) in the invention of Istoc, as disclosed by Despa, in order to reduce battery consumption and allow the device to operate for a longer duration in between charges as compared to more energy intensive wireless transmission protocols.
Claim(s) 52 and 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2007/0060871 (“Istoc”) as applied above, and further in view of U.S. Publication No. 2015/0011970 (“Kamen”).
Regarding Claim 52, Istoc discloses the invention substantially as claimed except that that the display includes an “attachment sensor” for indicating to the display unity when it is attached to the pump module so that it may transmit the fluid delivery protocol when a signal from the attachment sensor indicates that the separable display is physically coupled to the portable infusion pump. However, Kamen discloses a modular pumping system comprising a device module (800) and controller module (802) configured to be paired together to provide wireless communication of control data therebetween (Par. 117), wherein the system includes an “attachment sensor” in the form of an NFC protocol transmitter/receiver arrangement that allows a user to “touch” (i.e. bring the two components into contact with one another) to initiate a pairing mode establishing the wireless communication of data between the two devices (Par. 370). It would have been obvious for one having ordinary skill in the art at the time the invention was made to utilize an NFC touch/attachment protocol arrangement in the invention of Istoc, as disclosed by Kamen, such that attachment/contact between the two components is sensed via the NFC arrangement which then establishes the pairing and wireless data transmission between the two modules, as disclosed by Kamen, to ensure that the two components can only be paired to exchange data when both devices are physically present together thereby ensuring that the pump module cannot be remotely paired with a display/controller other than the one in the possession of the user to prevent improper programming of the pump module (for example by an authorized user). Here, the NFC protocol can be considered to comprise an “attachment” sensor since it determines the touch/contact/attachment between the two modules to initiate the pairing function and permit the transmission of data between the two devices.
Regarding Claim 54, here the NFC system described by Kamen as would have been obvious to apply to the invention of Istoc in order to provide a layer of security which requires both devices to by physically present in close contact with one another before they can be paired and initiate data transmission, may be considered a “proximity sensor”, wherein this “proximity” constitutes a physically contacting “proximity”.
Claim(s) 52, 54, and 72 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2007/0060871 (“Istoc”) as applied above, and further in view of U.S. Patent No. 5,376,070 (“Purvis”).
Regarding Claim 52, Istoc discloses the invention substantially as claimed except that that the display includes an “attachment sensor” for indicating to the display unity when it is attached to the pump module so that it may transmit the fluid delivery protocol when a signal from the attachment sensor indicates that the separable display is physically coupled to the portable infusion pump. However, Purvis discloses a module pumping system (10) comprising a pumping module (12) and a display/programming module (14) wherein the system includes attachment/proximity sensors (38/48, 40/50) which are configured to transmit the fluid delivery protocol only when the arrangement is physically coupled (Col. 4, Ln. 1-65), thereby serving as “attachment sensors” needed to initiate the wireless data transmission.
It would have been obvious for one having ordinary skill in the art at the time the invention was made to utilize a wireless data transmission protocol in the invention of Istoc that utilizes an optical sensor arrangement between the display and pump, the sensor arrangement relying upon attachment between the two modules to provide for communicative alignment between the sensors, as disclosed by Purvis, in order to provide a secure data exchange signal that requires the physical presence of both the pump module and controller to operate, whereby coupling of the two devices ensures that proper alignment between the sensing arrangements is maintained.
Regarding Claim 54, Istoc discloses the invention substantially as claimed except that that the system includes a proximity sensor arrangement. As discussed above, Purvis discloses a sensor arrangement (38/48, 40/50) that requires close proximity between the respective sensing components in order to configure the system to transmit data between the controller module and the pumping module. Here, the attachment/contact described by Purvis which is required to provide communication between the sensors/data transmission elements, may be considered a “proximity sensor” since it requires the two components to be placed into a contacting, “predetermined distance” in order to permit data exchange.
Regarding Claim 72, Istoc discloses the invention substantially as claimed except that that the device includes an “attachment sensor” which is configured to detect that the pump module and display module are physically coupled to one another and upon such a determination establish a wireless connection therebetween and disconnect the connection when the pump module is not physically coupled to the display module. However, as discussed above, Purvis describes a system which uses an attachment sensor arrangement (38/48, 40/50) to be operated upon physical coupling of the two modules in order to initiate a wireless connection to exchange operational protocols, whereby disconnection of the coupling will be understood to cause the wireless connection to disconnect since the sensor arrangement will no longer be in alignment, alignment being necessary to convey the communicating signals therebetween.
It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the system of Istoc to utilize an optical based wireless communication protocol to determine attachment between the pump module and the display module and initiate a wireless exchange of infusion protocol data upon connection and cease upon disconnection, as disclosed by Purvis, in order to provide a secure data exchange signal that requires the physical presence of both the pump module and controller to operate, whereby coupling of the two devices ensures that proper alignment between the sensing arrangements is maintained.
Claim(s) 52, 53, 54, and 72 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2007/0060871 (“Istoc”) as applied above, and further in view of WO 2008/024814 (“Moberg”).
Regarding Claim 52, Istoc discloses the invention substantially as claimed except that that the display includes an “attachment sensor” for indicating to the display unity when it is attached to the pump module so that it may transmit the fluid delivery protocol when a signal from the attachment sensor indicates that the separable display is physically coupled to the portable infusion pump. However, Moberg discloses a module pumping system (Fig. 2) wherein the device may comprise various sensors including “contact sensors” for “providing a detectable signal or state upon proper connection of other components in the infusion device” in order to allow operation of the device only upon proper connection (Par. 215).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the system of Istoc to include an attachment sensor arrangement which determines proper attachment of the pump module and control module, as disclosed by Moberg, in order to ensure that the two modules are correctly connected and interfaced before attempting the programmed operations of the device, i.e. transmitting the delivery protocol instructions, thereby ensuring that the instructions are properly transmitted and received to minimize error.
Regarding Claim 53, Istoc discloses the invention substantially as claimed except that that the physical coupling includes a “magnetic coupling”. While Istoc does contemplate various attachment mechanisms (Par. 34) including sliding parts, screwing components, snapping parts, hook and loop fasteners, adhesives, “and the like”, magnetics are not explicitly contemplated by Istoc. However, Moberg discloses a related module pumping assembly (see Fig. 2, 3), wherein the two module components can be provided with magnetic couplings such that they may utilize magnets to help align and connect the module components (Abstract). It would have been obvious for one having ordinary skill in the art at the time the invention was made to include a magnetic coupling to the modules of Istoc, as disclosed by Moberg, in order to utilize a known, effective connection means which utilizes magnetic force to align two module components to obtain a predictable and expected outcome.
Regarding Claim 54, Istoc discloses the invention substantially as claimed except that that the system includes a proximity sensor arrangement. Moberg discloses a modular pumping assembly (Fig. 2) wherein the system includes a proximity sensor arrangement configured to restrict the operation of the device until the components are indicated to be in a proper, predetermined distance from one another (Par. 215). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the invention of Istoc with a proximity sensor, as disclosed by Moberg, in order to ensure that the two modules are properly positioned within a functional distance from one another before transmission of instruction can occur thereby ensuring that communication between the two modules can be properly maintained to assist in proper transfer of the protocols while avoiding data loss or corrupted instructions.
Regarding Claim 72, Istoc discloses the invention substantially as claimed except that that the device includes an “attachment sensor” which is configured to detect that the pump module and display module are physically coupled to one another and upon such a determination establish a wireless connection therebetween and disconnect the connection when the pump module is not physically coupled to the display module. However, Moberg discloses a modular pumping system (Fig. 2) which includes various attachment sensor arrangements (Par. 215) for determining when the modules are properly assembled, restricting operation of the device unless proper attachment is determined, and ceasing operation of the device when detachment occurs (Par. 215).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the system of Istoc to include an attachment sensor arrange whose activation is necessary by attaching the modules together for the two modules will perform their programmed function, i.e. establishing a wireless connection therebetween and transmitting data and ceasing their function, i.e. disconnecting the wireless connection therebetween, upon disconnection, as disclosed by Moberg, in order to ensure that wireless communication only occurs when the two modules are connected to one another thereby helping to ensure the efficacy of the protocol transmission.
Claim(s) 73 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2007/0060871 (“Istoc”) as applied above, and further in view of U.S. Publication No. 2011/0152770 (“DiPerna”).
Regarding Claim 73, Istoc discloses the invention substantially as claimed except that that pump comprises a fill port for filling the fluid container/reservoir. However, DiPerna discloses a related pump (10) having a fill port (34) to permit filling/refilling of the pump container/reservoir (76 – Par. 162). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the system of Istoc with a fill port, as disclosed by DiPerna, in order to permit the pump to replenished with fluid as needed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 05/19/2026
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