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 .
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 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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Esenaliev (Pub. No.: 2016/0192867 A1) in view of Say (Pub. No.: 2010/0292553 A1), Mehta (Pub. No.: 2017/0124853 A1) and Brewer (Pub. No.: 2017/0203030 A1).
1) In regard to claim 1, Esenaliev discloses the claimed analyte monitoring system (fig. 15), comprising:
an analyte monitoring device configured to measure analyte concentrations of a user and transmit analyte data based on the measured analyte concentrations (fig. 15: glucose sensor);
a first smart device comprising a smartwatch (fig. 15: wrist watch);
a second smart device comprising a smartphone (fig. 15: cell phone), wherein:
the analyte monitoring device transmits the analyte data to the first smart device and the second smart device (fig. 15 shows the sensor transmits the data to the watch, and ¶0108 discloses the sensor can transmit the data to the cell phone);
the first smart device and the second smart device are configured to receive the analyte data and convert the analyte data into an output displayed on a display of the first smart device and a display of the second smart device (¶0108 discloses the watch and phone may display the sensor data).
Esenaliev does not explicitly disclose the first smart device is configured to generate one or more alarms when the analyte data reaches a predetermined threshold, and the second smart device is configured to generate the one or more alarms only upon determining that the user is not cognitively aware of the one or more alarms generated by the first smart device or a diabetic state relating to the one or more alarms, wherein determining that the user is not cognitively aware of the one or more alarms or a diabetic state relating to the one or more alarms is based on user interaction with the first smart device, the second smart device, or the first smart device and the second smart device.
However, Say discloses it is known for a monitoring system to have a first smart device to be configured to generate one or more alarms when the analyte data reaches a predetermined threshold (¶0070),
Therefore, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was filed to allow the system of Esenaliev to transmit the signal to both the devices, as taught by Say.
One skilled in the art would be motivated to modify Esenaliev as described above in order to provide the information to multiple devices.
Furthermore, Mehta discloses it is known for a diabetic monitoring system (¶0033 discloses a glucose level monitor) to have a smart device to be configured to generate one or more alarms only upon determining a device is non-responsive of a diabetic state relating to the one or more alarms, wherein determining that the user is non-responsive of a diabetic state relating to the one or more alarms is based on a device interaction with the first smart device, the second smart device, or the first smart device and the second smart device (¶0100 discloses when a device is non-responsive the wearable device may do a number of retires).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was filed to allow the system of Esenaliev to retransmit a signal in response to determining a device is non-responsive, as taught by Mehta.
One skilled in the art would be motivated to modify Esenaliev as described above in order to get the user attention regarding the emergency alert.
Lastly, Brewer discloses it is known for a diabetic monitoring system to determine whether a person with diabetes (PWD) to be non-responsive based on a severe hypoglycemic event, and in response to the severe hypoglycemic event to transmit a signal to a remote service (¶0067).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was filed to allow the system of Esenaliev to determine if a user is not cognitively aware, as taught by Brewer.
One skilled in the art would be motivated to modify Esenaliev as described above in order to detect a known state of diabetic patients.
2) In regard to claim 2 (dependent on claim 1), Esenaliev, Say, Mehta and Brewer further disclose the analyte monitoring system of claim 1, wherein the second smart device is further configured to receive analyte data from the analyte monitoring device while not in signal communication with the first smart device (Esenaliev and fig. 18).
3) In regard to claim 3 (dependent on claim 1), Esenaliev, Say, Mehta and Brewer further disclose the analyte monitoring system of claim 1, wherein the first smart device is configured to generate the one or more alarms when the analyte data reaches a predetermined threshold in a first form, and the second smart device is configured to generate the one or more alarms in a second form (Say ¶0070).
4) In regard to claim 4 (dependent on claim 3), Esenaliev, Say, Mehta and Brewer further disclose the analyte monitoring system of claim 3, wherein the first smart device is further configured to display, on the display of the first smart device, the one or more alarms, and the second smart device is configured to generate an audible or tactile indication of the one or more alarms (Say ¶0070).
5) In regard to claim 5 (dependent on claim 3), Esenaliev, Say, Mehta and Brewer further disclose the analyte monitoring system of claim 3.
Esenaliev, Say, Mehta and Brewer do not explicitly disclose the first smart device is configured to generate an audible or tactile indication of the one or more alarms, and the second smart device is configured to display, on the display of the second smart device, the one or more alarms if the user does not acknowledge the one or more alarms presented on the display of the first smart device.
However, official notice is taken by the examiner that both the concept and advantage is known for a monitoring system to forward the alarm from the first device to the second device id the user does not acknowledge the alarm from the first device.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was filed to allow the system of Esenaliev to forward the alarm to the second device if the user does not acknowledge the alarm on the first device.
One skilled in the art would be motivated to modify Esenaliev as described above in order to add redundancy in the system, thereby, allowing the user to be alerted by the second device if he/she is not around the first device.
6) In regard to claim 6 (dependent on claim 1), Esenaliev, Say, Mehta and Brewer further disclose the analyte monitoring system of claim 1, wherein the smartwatch is configured to receive the analyte data directly from the analyte monitoring device (Esenaliev fig. 15).
7) In regard to claim 7 (dependent on claim 1), Esenaliev, Say, Mehta and Brewer further disclose the analyte monitoring system of claim 1, wherein the one or more alarms are suppressed based on determining that the user is cognitively aware of the one or more alarms or a diabetic state relating to the one or more alarms (Say ¶0276).
8) In regard to claim 8 (dependent on claim 7), Esenaliev, Say, Mehta and Brewer further disclose the analyte monitoring system of claim 7, wherein determining that the user is cognitively aware of the one or more alarms is further based on user-entered data on the first or second smart devices, or user self-treatment (Say ¶0276).
9) In regard to claim 9 (dependent on claim 1), Esenaliev, Say, Mehta and Brewer further disclose the analyte monitoring system of claim 1.
Esenaliev, Say, Mehta and Brewer does not explicitly disclose wherein the first or second smart device comprises at least one application configured to communicate with a second application on the analyte monitoring device to provide alerts to a user.
However, official notice is taken by the examiner that both the concept and advantage is known for a system device to utilize an application downloaded on a user device to communicate with a monitoring device.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was filed to allow the system of Esenaliev to utilize an application on a user device to communicate with an application on a monitoring device.
One skilled in the art would be motivated to modify Esenaliev as described above in order to allow a user device to communicate with a third-party device.
10) In regard to claim 10 (dependent on claim 9), Esenaliev, Say, Mehta and Brewer further disclose the analyte monitoring system of claim 9, wherein the second application on the analyte monitoring device comprises a continuous glucose monitor application (Esenaliev ¶0108 discloses the monitoring device monitors a user glucose; thus, it is clear a software program (i.e., application) is programmed in the memory of the device to monitor a user glucose level).
11) In regard to claim 11, claim 11 is rejected and analyzed with respect to claim 1 and the references applied.
12) In regard to claim 12 (dependent on claim 11), claim 12 is rejected and analyzed with respect to claim 2 and the references applied.
13) In regard to claim 13 (dependent on claim 11), claim 13 is rejected and analyzed with respect to claim 3 and the references applied.
14) In regard to claim 14 (dependent on claim 13), claim 14 is rejected and analyzed with respect to claim 4 and the references applied.
15) In regard to claim 15 (dependent on claim 14), claim 15 is rejected and analyzed with respect to claim 5 and the references applied.
16) In regard to claim 16 (dependent on claim 11), claim 16 is rejected and analyzed with respect to claim 6 and the references applied.
17) In regard to claim 17 (dependent on claim 11), claim 17 is rejected and analyzed with respect to claim 7 and the references applied.
18) In regard to claim 18 (dependent on claim 17), claim 18 is rejected and analyzed with respect to claim 8 and the references applied.
19) In regard to claim 19 (dependent on claim 11), claim 19 is rejected and analyzed with respect to claim 9 and the references applied.
20) In regard to claim 20, claim 20 is rejected and analyzed with respect to claim 1 and the references applied.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,315,614. Although the claims at issue are not identical, they are not patentably distinct from each other because the Patent claim together met all of the claim subject matter of current claim. Furthermore, Patent is a sub-genus of the examined application and, therefore, a patent of the genus would, necessarily, extend the rights of the sub-genus should the genus be issued as a patent.
Conclusion
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/CURTIS J KING/Primary Examiner, Art Unit 2685
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