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 filed on 02/06/26 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 Claims 25, 27 & 30 are pending for examination; claims 28-29, 31-33 & 35-45 are withdrawn and claims 1-24, 26, 34 are cancelled.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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 25, 27 & 30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Nowhere in the elected Fig. 19 (in the Remarks 08/15/23) has described the limitation, i.e., the wireless communications are from the remote interface to the measurement device through the infusion pump, as recited in the claim 25. Based on the limitation above, the remote interface is as a sender, and the measurement device is a receiver. It is contradicted with the limitation, i.e., a remote interface (equivalent to a receiver) configured... to receive blood glucose readings from the measurement device (equivalent to a sender), as recited in lines 8-10 in claim 25.
In addition, the elected Fig. 19 shows that the remote interface 1900 is in wireless communication with (to/from) a measurement device 1904/1906 through an infusion pump 1902. Based on the Fig. 19, the wireless communication (indirectly) in between the remote interface 1900 and the measurement device 1904/1906 can be either one-way or both ways. For example: the wireless communications could be from the remote interface 1900 to the measurement device 1904/1906 via infusion pump 1902; or the wireless communications could be from the measurement device 1904/1906 to the remote interface 1900 via infusion pump 1902.
Conclusion: nowhere in the original specification has described that the remote interface only communicates to the measurement device; wherein the remote interface (equivalent to a sender) and the measurement device (equivalent to a receiver).
Claims 27 & 30 are being rejected due to their dependency.
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 25, 27 & 30 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.
The limitation “the remote interface configured ... to receive blood glucose readings from the measurement device” is vague. In line 14-15 of claim 25, it states that the wireless communications are from the remote interface to the measurement device through the infusion pump. In other words, the remote interface communicates indirectly with the measurement device (via the infusion pump). However, the limitation above can be read that the remote interface receives directly (communicates directly) the blood glucose values from measurement device. Therefore, it is confusing to the Examiner that the remote interface is whether receive blood glucose readings (directly or indirectly) from the measurement device .
The limitation above should be changed to --- the remote interface configured ... to receive blood glucose readings from the measurement device through the infusion pump ---.
Claims 27 & 30 are being rejected due to their dependency.
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 Bengtsson et al. (US 2009/0069868) and Reinke et al. (US 2011/0124996).
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, see arrow 13;
Note: the limitation, i.e., the remote interface configured ... to receive blood glucose reading from the measurement device, does not specifically require the remove interface to receive blood glucose date directly or indirectly from the measurement device. Therefore, the limitation above is broadly interpreted that: the remote interface configured to receive the blood glucose reading values (directly) from the measurement device.
The infusion pump and the remote interface are paired (set up a connection) using Bluetooth radio link, para [0016]. 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]). Note: In case the applicant disagrees with Examiner’s statement above, the medical device system in Firkart can be modified by Reinke, as below.
With regarding to the limitation, i.e., the wireless communications are from the remote interface to the measurement device through the infusion pump, as mentioned in the above, this limitation involves 112, 1st and 2nd paragraph issues. For examining purpose, the Examiner interprets that: the remote interface in wireless communication with the measurement device through the infusion pump. In this case, Firkart discloses that the insulin pump 1 forwards each message 12 from the blood sugar meter 10 to the communication application or remote interface 3 via the short-range radio link 3… 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. Therefore, Firkart clearly discloses the limitation, i.e., the remote interface in wireless communication with the measurement device through the infusion pump.
Firkart further discloses that wherein the remote interface communicates to the computer 8 through an internet connection 6 & 7.
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 Galasso 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).
Note: Incase applicant disagrees with Examiner’s statement above, the medical device system in Firkart can be modified by Reinke, as below. Assumming that Frikart does not disclose that the remote interface is configured to provide a user interface to the infusion pump.
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 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.
Regarding claim 27, Frikart n view of Bengtsson & Reinke 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 n view of Bengtsson & Reinke 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 Bengtsson & Reinke 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 Bengtsson & Reinke 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 02/06/26 have been fully considered but they are not persuasive.
Applicant argues that Frikart fails to teach or suggest wherein the wireless communications are from the remote interface communicates to the measurement device through the infusion pump.
In response, as mentioned, the limitation above involves 112, 1st and 2nd paragraph issues. With the best knowledges, the Examiner interprets or assumes that: the remote interface in wireless communication with the measurement device through the infusion pump. In this case, Firkart discloses that the insulin pump 1 forwards each message 12 from the blood sugar meter 10 to the communication application or remote interface 3 via the short-range radio link 3… 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. Therefore, Firkart clearly discloses the limitation, i.e., the remote interface in wireless communication with the measurement device through the infusion pump.
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
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 QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached M-F 7:30 am-4:00 pm.
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/QUYNH-NHU H. VU/Primary Examiner, Art Unit 3783