DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/28/26 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 21, 24-27, 29-33 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Skyggebjerg (US 2008/0208627 A1) in view of Brukalo et al. (US 2008/0312585 A1) and in further view of Flaherty et al. (US 2002/0040208 A1).
With regard to claim 21 and 29, Skyggebjerg discloses A method for pairing a remote control assembly (Fig. 5 ,element 100) and a wearable infusion pump assembly (200, also see Fig. 1-3 showing an exemplary wearable pump infusion device [0039] where element 200 is equivalent to element 5 which connects with element 2 together to form the wearable infusion pump assembly), the wearable infusion pump assembly (the following limitations are part of a functional recitation in the preamble and therefore are not positively recite. Thus the structures do not explicitly need to be taught by the prior art. However, to further prosecution, references will be made when applicable or explicitly taught in the prior art) having a reusable housing assembly (5) , a disposable housing (2) assembly, a switch assembly ([0047], a keypad can be located on the pump unit 5/200 for taking input from the user. Further [0048] teaches the user may have to activate the pump in order to make the local sensor operatable which needs to be done in order to place the pump unit in a pairing mode to be detected by the remote assembly) configured to effectuate a functionality of an infusion pump assembly, a processor (210), and a computer readable medium coupled to the processor (CPU’s [0047]), the computer readable medium including a plurality of instructions stored thereon which, when executed by the processor, cause the processor to perform operations ([0047]), the method comprising:
releasably engaging the reusable housing assembly to the disposable housing assembly ([0039]);
receiving a pairing initiation signal from the switch assembly indicative of a pairing event ([0048] pump unit can be activated by a user in one of the embodiments to make the local sensor operable allowing for the pump unit to be read by the remote control assembly such that when the pump unit is inserted into the remote control assembly, the pairing process can start);
monitoring for receipt of a pairing request from a remote control assembly ([0048] remote assembly includes a user interface showing the initiation of a pair request see also Fig. 6b where the connection between the pump and the remote control assembly is indicated and acknowledged on the screen of the remote control assembly);
if the pairing request is received, providing a pairing request acknowledgment message to the remote control assembly (see Fig. 6b), wherein the pairing request acknowledgement message uniquely identifies the wearable infusion pump assembly ([0049] sensors 290 and 105 cooperate to acknowledge when the two devise are connected in order to initiate pairing. Further, [0014] teaches that the local unit/pump unit has a unique ID code that is read by the remote assembly);
monitoring for receipt of a pairing confirm request from the remote control assembly ([0049], also see Fig. 6c);
and if the pairing confirm request is received, providing a pairing confirm acknowledgment message to the remote control assembly ([0049]. “pairing successful” message).
However, while Skyggebierg teaches that the pump unit may need to be activated prior to pairing in order to enable to pairing sensor to activate and that a keyboard can be placed on the pump unit. Skyggebierg does not explicitly disclose that the switch assembly is depressed by a user in order to initiate a pairing event.
Brukalo teaches the pairing process between a remote controller (200) and an infusion pump (300) where the infusion pump includes a screen like mentioned in Skyggebierg. The screen components of the pump unit are shown in Fig. 7 of Brukalo. The infusion pump unit further includes a display with buttons which can form a switch assembly such that when a user depresses the switch assembly a pairing initiation signal indicates a pairing event ([0054], a setup button 614 is pressed to send the pump into a pairing mode shown in screen 630 which allows for the remote device to search for the pump unit ([0054]). Thus while Skyggebierg teaches that a screen with buttons can be on the pump mechanism and further that the pump mechanism may need to be activated prior to allowing for pairing, Brukao more explicitly teaches a pump unit with a screen that has buttons for initiating a pairing signal.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Skyggebjerg with the push buttons as the switch assembly on the infusion pump as taught by Brukalo for the purpose of providing user feed back on both the infusion device and remote controller to confirm the pairing event was successful ([0054]). This type of pairing process is also potentially safer for the user and prevents incorrect device pairing ([0002]).
However, Skyggebjerg/Brukalo do not teach that the disposable assembly of the pumping mechanism assembly includes the reservoir. Rather the reservoir is located in the reusable portion.
Flaherty teaches a two part pump mechanism assembly (fig. 9) similar to that of Skyggebjerg. The pump assembly has a reusable portion (93) that includes the electronic components and a disposable portion (94) that includes the reservoir (30) that is also attached to the patient and has a delivery needle similar to that of Skyggebjerg.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Skyggebjerg/Brukalo with the reservoir in the disposable portion as taught by Flaherty for the purpose of creating a simply and easy to manufacture component that can be tossed after use for easy of operation ([0013]).
With regard to claim 24 and 32, Skyggebjerg discloses wherein the functionality includes a separation detection functionality, the method further comprising: transmitting a ping signal to the remote control assembly ([0050]/[0017], pump unit sends ID codes to the remote assembly during a certain time window); monitoring for receipt of a reply signal from the remote control assembly in response to the ping signal ([0050]/[0017], remote unit wait to receive ID codes from the pump units and sends a reply signal to pair if a single ID code is sent); and if the reply signal is not received within a defined period of time (reply signal is not sent when two ID codes have been received and the pairing is aborted and a new time window must be opened to pair the devices), rendering a separation alarm ([0117], an indication is sent to the user).
However, Skyggebjerg does not disclose the indication is an audible one. However, Skyggebjerg teaches in reference to Fig. 4, the processor can include a means for generating an audible signal ([0042]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art at the time of the invention to modify the device of Skyggebjerg with the audible component for alerting a user of different situations as taught by Fig. 4 of Skyggebjerg for the purpose of providing an alternative to the indication disclosed in [0117] as a substitution of one type of indication for another is well known in the art and would not alter the overall function of the device.
With regard to claim 25 and 33, Skyggebjerg discloses further comprising the steps of: receiving an alarm override signal from the switch assembly indicative of a desire to silence the separation alarm [0017], a new time window is opened after the separation of the two devices is determined, this is considered a signal to override the alarm); and silencing the separation alarm (a new time window would restart the pairing process and thus inherently silence any indications or alarms from the previous attempt).
With regard to claim 26 and 30, Skyggebjerg discloses wherein providing a pairing confirm acknowledgment message to the remote control assembly further includes providing a serial number of the wearable infusion pump assembly ([0049], unique code).
With regard to claim 27 and 31, Skyggebjerg discloses further comprising: administering a bolus quantity of the infusible fluid via the wearable infusion pump assembly ([0006], [0051], [0024]).
Claim 22 and 23 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Skyggebjerg (US 2008/0208627 A1) in view of Brukalo et al. (US 2008/0312585 A1) and in further view of Flaherty et al. (US 2002/0040208 A1) and Merno et al. (US 2005/0245878 A1).
With regard to claim 22, Skyggebjerg discloses wherein the computer readable medium further includes a second plurality of instructions stored thereon which, when executed by the processor, the method further comprising: receiving an initiation signal from the switch assembly indicative of a bolus infusion event ([0024], programmed by the user); receiving a dose signal from the switch assembly indicative of at least a portion of a bolus quantity of the infusible fluid ([0024]).
However, Skyggebjerg/Brukalo/Flaherty does not disclose rendering an audible quantity signal in response to the dose signal; and receiving an approval signal from the switch assembly indicative of a concurrence with the audible quantity signal.
Merno teaches a drug delivery device similar in structure having a wearable pumping device with a reusable and disposable components and further teaches delivery of boluses to the patient that further includes rendering an audible quantity signal in response to the dose signal ([0105]); and receiving an approval signal from the switch assembly indicative of a concurrence with the audible quantity signal ([0105]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art at the time of the invention to modify the device of Skyggebjerg/Brukalo/Flaherty with the audible signals as taught by Merno for the purpose of alerting a user to the delivery of medications in order to help with compliance ([0105]).
With regard to claim 23, Skyggebjerg discloses further comprising administering the bolus quantity of infusible fluid ([0024], [0051]).
Claim 28 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Skyggebjerg (US 2008/0208627 A1) in view of Brukalo et al. (US 2008/0312585 A1) and in further view of Flaherty et al. (US 2002/0040208 A1) and Connelly et al. (US 6,589,229 B1).
With regard to claim 28, Skyggebjerg/Brukalo/Flaherty discloses the claimed invention except for rotation of the disposable and reusable housing.
Connelly teaches a similar wearable pump device that includes two housing units (reusable portion 34 and disposable portion 32) and further teaches rotating the reusable housing assembly and the disposable housing relative to each other (Col. 12, lines 13-62; “reusable portion is rotated down into place”).
Therefore, it would be prima facie obvious for one of ordinary skill in the art at the time of the invention to modify the device of Skyggebjerg/Brukalo/Flaherty with the rotatable housing units as taught by Connelly for the purpose of providing an alternative way to secure the two housings as is well-known in the art and does not alter the overall function of the device (Col 12, lines 13-62).
Claim 41 and 42 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Skyggebjerg (US 2008/0208627 A1) in view of Brukalo et al. (US 2008/0312585 A1) and in further view of Flaherty et al. (US 2002/0040208 A1) and Bremner (US 2011/0119745 A1).
With regard to claim 41 and 42, Skyggebjerg discloses the use of a button on the keypad of the remote unit as well the pump unit having a keypad and needing activation for pairing (as described above in the rejection of claim 1 and 29).
However, Skyggebjerg/Brukalo/Flaherty do not teach the switches are depressed simultaneously.
Bremner teaches pairing two different devices (client device and host device, [0008]) via simultaneously pushing a pair of buttons for a defined period in order to effectuate the pairing of the two devices ([0008]). Because Skyggebjerg/Brukalo also teaches the use of a switch/button on the remote unit as well as a switch/button on the pump unit to effectuate a pairing process, it would be prima facie obvious that the buttons could be pressed simultaneously as taught by Bremner.
Therefore, it would be prima facie obvious for one of ordinary skill in the art at the time of the invention to modify the device of Skyggebjerg/Brukalo/Flaherty with the simultaneous depression of the switches as taught by Bemner for the purpose of guaranteeing authentication of the devices and identifies each of the devices ([0008]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 21-33 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 previously argued the combination of Skyggebjerg in view of Brukalo and stated that Skyggebjerg taught automatic pairing when the pump unit was attached to the docking cavity of the remote unit and thus would not require or have motivation to have a switch assembly that would initiate pairing. However, as cited above while some embodiments of Skyggebjerg does teach automatic pairing, there are other embodiments where the pump unit itself needs to be activated in order for the contact sensor to be turned on and be read by the remote unit ([0048]) and further Skyggebjerg teaches that in some embodiments the pump unit would also have a screen and keypad for user input ([0047]), therefore not all teachings of Skyggebjerg suggest that pairing is automatic. Therefore, it would still be reasonable to modify Skyggebjerg with the teachings of Brukalo.
Conclusion
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/Lauren P Farrar/Primary Examiner, Art Unit 3783
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