DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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).
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]), 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 including a reservoir (230) with an infusible fluid, a switch assembly (290) 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 starts pairing mode when switch 290 recognizes connection with the remote assembly);
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);
if the pairing request is received, providing a pairing request acknowledgment message to the remote control assembly, 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);
monitoring for receipt of a pairing confirm request from the remote control assembly ([0049]);
and if the pairing confirm request is received, providing a pairing confirm acknowledgment message to the remote control assembly ([0049]. “pairing successful” message).
However, Skyggebierg does not disclose that the switch assembly is depressed bya user in order to initiate a pairing event.
Brukalo teaches the pairing process between a remote controller and an infusion pump ({0053], [0054]) that is designed to be worn on the body. The infusion pump 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], buttons 304 and 310 are highlighted and an ok button 314 is selected to move the infusion pump into a setup mode with initiates the pair process because the after the ok button is pushed this starts the search process to find a remote controller in the vicinity of the infusion pump. The remote controller can then also have a screen such that it can confirm the pairing process which is then related back to the infusion pump).
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]).
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 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 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 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 Connelly et al. (US 6,589,229 B1).
With regard to claim 28, Skyggebjerg/Brukalo 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 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).
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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783