DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed before March 16, 2013 is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment and Request for Continued Examination (RCE) filed on 06/08/26 have been entered in the case. Claims 25, 27 & 30 are pending for examination; claims 28-29, 31-33 & 35-45 are withdrawn and claims 1-24, 26, 34 are cancelled.
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 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.
Claims 25, 27 & 30 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Frikart et al. (US 2007/0233206) in view of Reinke et al. (US 2011/0124996) & Bengtsson et al. (US 2009/0069868)
Regarding claim 25, Frikart discloses a medical device system in Fig. 2 comprising:
A computer 8;
An infusion pump 1 for delivery of an infusible fluid, whereby the infusion pump completes all decision making and controls the delivery of infusible fluid (e.g., the infusion pump has a display 15, operator control means 16… the insulin pumps are known and do not require further description here with regard to their operation for releasing insulin to a patient, para [0016];
A measurement device 10 for measuring blood glucose and generating blood glucose readings; and
A remote interface 3 is a smart phone, para [0016], having a display and it is well-known in the art that the smart phone provides a touch screen; the remote interface 3 in wireless communication with the infusion pump 1 (see arrow 2) and the measurement device10 (see arrow 13);
The remote interface 3 configured to receive blood glucose readings from the measurement device 10 through the infusion pump 1, see arrows 2 & 13 also see Note below
Note: para [0016], ... the areas 44 and 45, which indicate messages and values from the insulin pump. ... This can be done such that each message sent to the appliance 3 by the insulin pump 1 is sent automatically, or the application on the appliance 3 may be in the form such it makes a decision regarding whether the message is a message which is relevant to the remote monitoring of the insulin pump 1 and which needs to be forwarded or whether it is another message which is merely displayed on the display 4 of the appliance 3 and at most stored therein.
The para [0020], ... A blood sugar measured value or an alarm message from the blood sugar meter 10 is therefore transmitted to the insulin pump 1. There, an evaluation and possibly a reaction from the insulin pump may occur, but this is not considered in more detail here. What is relevant within the context of the present invention is that the insulin pump 1 now, as one alternative, forwards each message 12 from the blood sugar meter 10 to the communication appliance 3 via the short-range radio link 2. ... Messages from the blood sugar meter 10 are therefore forwarded to the third party via the infusion pump 1.
The claim 8 in Frikart states that: A method for monitoring a medical appliance, comprising the following steps: producing a message in the medical appliance, transmitting the message wirelessly via a short range radio link to a communication appliance which is designed for wireless connection setup to a telephone or radio paging network, and forwarding the message via the telephone or radio paging network to a further wireless communication appliance connected to the same telephone or radio paging network.
Claim 10 in Firkart states that: ... wherein the medical appliance is a blood sugar meter and produces messages on the basis of at least one of blood sugar measured values or a meter event. Claim 13 in Frikart states that: ... the measured value was sent via a short-range radio link from blood sugar meter to the infusion pump.
Having said in paras [0016, 0020], claims 8, 10 & 13 above, the remote interface 3 configured to receive blood glucose readings from the measurement device 10 through the infusion pump 1.
PNG
media_image1.png
706
1324
media_image1.png
Greyscale
The infusion pump and the remote interface are paired (set up a connection) using Bluetooth radio link, or other suitable communication link, paras [0016 & 0019]. It is well-known in the art that using near field communication to replace for the Bluetooth communication since both of Bluetooth and NFC are both short range wireless technology that use radio wave. Also see the modification by Bengtsson below.
Firkart further discloses that the remote interface 3 configured to receive user input through a display/touchscreen to (interact/communicate with) the infusion pump 1. For example: the communication appliance 3 is a mobile telephone or a smart phone, which executes an appropriate application for receiving and displaying the message from the insulin pump… The communication application 3 accepts the message from the insulin pump and autogenerates a message which can be sent via the mobile telephone network, … The area 41 shows the symbol bar for the operating system and for the application via the display 4, para [0016]). In addition, the para [0020] states that: ... This may involve one-way communication from the blood sugar meter to the insulin pump 1 or two-way communication between the appliances. In other words, the two-way communication between the appliances, i.e., remote interface and the infusion pump.
Frikart further discloses that wherein the remote interface communicates to the computer through an internet connection 6 & 7.
Note: Incase applicant disagrees with Examiner’s statement above (e.g., the remote interface is configured to provide a user interface to the infusion pump), For purpose of further explanation, Examiner assumes that Frikart does not disclose that the remote interface is configured to provide a user interface to the infusion pump. The medical device system in Firkart can be modified by Reinke, as below.
Reinke discloses a medical device system comprising: an infusion pump 24, a remote interface 10 comprising a display 11 (it is well-known in the art that nowadays, the display is a touch screen), wherein the remote interface 11 configured to receive user input through the display (e.g., para [0056], … the therapy module 80 (of the remote interface 10) is programmed to provide an insulin pump reminder on the user interface 11 that uses the same reminder terminology as issued by the insulin pump 24; para [0059], … the user obtains information and warnings relating to the plurality of diabetes device 20 (including the insulin pump 24, see Fig. 1) from the portable device 10; para [0064], … the user is able to use a portable device 10 to control pump functions of the insulin pump 24… The user also uses to adjust bolus delivery properties of the insulin pump 24 such as bolus delivery velocity from the portable device 10…, para [0064]).
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the medical device system of Frikart, with providing function of using the remote interface being to provide a user interface to the infusion pump, as taught by Reinke, in order to allow a user to control the insulin pump via the remote interface.
Bengtsson discloses a medical device system comprising: a remote interface 410 in wireless communication with an infusion pump 420; wherein the infusion pump 420 and the remote interface 410 are paired using near field communication (NFC), paras [0065-0066, 0068-0070] and Figs. 6 & 8A-9D.
In regard to the claimed limitation “whereby the infusion pump will not communicate with the remote interface other than that with which the infusion pump is paired”, Bengtsson states in para [0009] that: to provide the desired security the two devices intended to work together will normally be "paired" by exchange of information between the two devices, this allowing the information sent between the two devices to be specifically coded and thus only accepted by the correspondingly coded device. As appears, when a specific remote controller is to be paired with a specific delivery device it is of utmost importance that it is in fact the two devices which are intended to be paired that are actually paired--and not that the remote controller is accidentally being paired with a neighboring delivery. During a pairing process other information may also be transmitted between the two devices, e.g., the controller may be provided with information as to the type of delivery device in case different types of delivery devices are intended to be used with a given remote controller. In other words, the two devices do not communicate with each other until both of devices are paired. At this point, the infusion pump only communicates with the paired remote interface. The infusion pump does not communicate with unpaired device(s).
In addition, the Figs. 8A-8K & para [0068] describe steps of a pairing procedure between an infusion pump unit and a remote interface. For example: Figs. 8A-8C shows that a new infusion pump unit that has not been paired nor communicate with a remote interface unit yet. When assembled, the pump unit is ready for pairing which is indicated by a beep signal (FIG. 8E). Activating the pairing mode allows pairing of the remote (FIG. 8F). Holding the remote close to the pump starts the pairing using NFC, either automatically or by pressing a key. Pump beeps to confirm pairing and pump unit information is transmitted by RF to the remote unit (FIG. 8G). When paired the remote unit displays residual insulin and type, this indicating that the units have been paired and information has been properly received from the pump unit. After pressing "Accept" the remote displays "pump paired" and sounds a confirmation beep (FIG. 8J) after which the remote displays e.g., the currently active rate (FIG. 8K). Based on the Figs. 8A-8K and the statement in the para [0068] above, the infusion pump only communicates with the remote interface when both devices have been paired. In other words, the infusion pump only communicates with the paired remote interface but does not communicate with other unpaired devices.
For reasons above, Bengtsson firmly discloses the limitation that the infusion pump will not communicate with a remote interface other than that with which the infusion pump is paired.
Because Bluetooth (or infrared) and near field communication are being used to pair or to connect in between two or more devices in short range wireless communication, it would have been obvious to one skilled in the art to substitute one short-range wireless technology, i.e., Bluetooth/infrared for the other, i.e., near field communication-NFC to achieve the predictable result of the two devices being communicated in short distance.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the medical device system of Frikart with using near field communication (NFC) for pairing in between the infusion pump and the remote interface; and both of infusion pump and remote interface are not being communicated until being paired in between the two devices, as taught by Bengtsson, in order to secure certain data, e.g., during pairing of the two devices (see abstract in Bengtsson), and to protect against inadvertent pairing of units can be provided, (para [0017] in Bengtsson).
Regarding claim 27, Frikart in view of Reinke & Bengtsson discloses the invention substantially as claimed. Bengtsson further discloses that the infusion pump comprising: a disposable portion (replaceable cartridge, para [0023], or needle, cannula, para [0051]) and a reusable portion (pump unit, i.e., processor means, PCB, pump actuation, contact sensors 588, 589, battery 586, signal generation means 585, ... para [0059] and Fig. 4).
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the infusion pump device of Frikart in view of Reinke & Bengtsson with including a disposable portion and reusable portion, as taught by Bengtsson, in order to change the disposable portion such as the needle, cannula or reservoir for safety issue and keep the reusable portion for saving cost.
Regarding claim 30, Frikart in view of Reinke & Bengtsson discloses the invention substantially as claimed except for the limitation that a third medical device in wireless communication with the infusion pump, wherein the remote interface communicates to the third medical device through the infusion pump.
Reinke discloses a third medical device 22a/b, 23 & 31. As seen in Fig. 1 in Reinke, the remote interface 10 communicates directly to the third medical device but does not need go through the infusion pump.
As discussed in the claim 25 above, Frikart discloses a medical device system in Fig. 2 comprising: an infusion pump 1; a measurement device 10, i.e., blood sugar meter 10; a remote interface 3; wherein the remote interface 3 communicates to the measurement device 10 through the infusion pump 1 (e.g., the infusion pump 1 forwards each message 12 from the blood sugar meter 10 to the communication appliance 3, i.e., the remote interface 3 via the short-range radio link 2, para [0020]).
Therefore, a person having ordinary skill in the art would have easily recognizes that modifying the medical device system of Frikart in view of Reinke & Bengtsson with providing a third medical device, as suggested by Reinke and combining a concept of communication in the remove interface to the third medical device via the infusion pump, as taught in Frikart, in attempt to provide another option of communication for exchange date, as a person with ordinary skill has good reason to pursue the know options within his or her technical grasp.
Response to Arguments
Applicant's arguments filed 06/08/26 have been fully considered but they are not persuasive.
Applicant argues that Frikart fails to teach or suggest wherein the remote interface communicates to the measurement device through the infusion pump. Applicant further states that: in Frikart, the blood sugar meter 10 sends messages 12 to the infusion pump 1, and the insulin pump sends those messages 12 to the communication appliance 3, but there is no teaching or suggestion of the remote interface 3 communicating to the blood sugar meter 10 through the insulin pump 10.
In response, Firkart discloses that the insulin pump 1 forwards each message 12 from the blood sugar meter 10 to the communication application 3 via infusion pump 1. Messages from the blood sugar meter 10 are forwarded to the third party (the remote interface 3) via the infusion pump, para [0020] and see Fig. 2.
Frikart states in para [0020], claims 10 & 13 below that:
PNG
media_image2.png
613
549
media_image2.png
Greyscale
PNG
media_image3.png
114
540
media_image3.png
Greyscale
PNG
media_image4.png
94
526
media_image4.png
Greyscale
Having said in the para [0020] above, a blood sugar measured value or an alarm message from the blood sugar meter 10 is therefore transmitted to the insulin pump 1. ... the insulin pump 1 now, as one alternative, forwards each message 12 from the blood sugar meter 10 to the communication appliance 3 via the short-range radio link 2.... Messages from the blood sugar meter 10 are therefore forwarded to the third party via the infusion pump 1.
The claims 10 & 13 further states that: the blood sugar meter produces messages (e.g., the blood sugar measured values) was sent to the insulin pump; wherein each message 12 (e.g., the blood sugar measured values) from the blood sugar meter 10 to the communication appliance 3 (remote interface 3) via the infusion pump, para [0020] above.
Therefore, Firkart clearly discloses the limitation, i.e., the blood sugar meter 10 sends messages 12 (e.g., the blood sugar measured values) to the infusion pump 1, and the insulin pump sends those messages 12 (e.g., the blood sugar measured values) to the communication appliance 3.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
Prosecution Insights