DETAILED ACTION
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 9-25 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.
Claims 9 and 17 recite that “the process for stabilizing the analyte sensor is performed for a predetermined time following reception of the interrupt signal”. The specifications fail to provide support for such a feature. In particular, the disclosure ([0156] of the printed publication) notes that when a sensor is first inserted, the sensor may need to equilibrate or stabilize, and that it can be desirable to wait an amount of time after insertion to allow the sensor to equilibrate in vivo. Alternatively, the sensor electronics can perform an initialization process aid in stabilizing the sensor by applying a voltage that is higher than the normal bias voltage to the sensor. It does not state that the process is performed for a predetermined time, nor does it measure the duration of that process from the reception of the interrupt signal. Moreover, the only example of the interrupt signal that is disclosed happens when the electronics module is removed from the storage packaging in which a magnet is embedded ([0139-0140]). However, the removal of the electronics module is not the same as sensor insertion.
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 2 and 9-25 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.
As to claims 2, 10, and 18, the claims recite processing measurement values “to determine at least one of analyte measurement trends, estimated glucose values, or other indicia of blood glucose levels”. It is unclear what comprises “other indicia of blood glucose levels”, and as it is open-ended, the metes and bounds of the recited claim cannot be determined. It is unclear what quantities constitute “indicia” of blood glucose levels beyond the two recited alternatives, and the specification does not provide any definition of said indicia.
Claims 9 and 17 recite that “the process for stabilizing the analyte sensor is performed for a predetermined time following reception of the interrupt signal”. As previously noted, the sole example of the interrupt signal relates to when the sensor electronics module is being removed from its storage, not to when the sensor is deployed into the user. Accordingly, it is unclear how the interrupt signal could be used to perform the process for stabilizing the analyte sensor when the sensor may not even be deployed into the user.
Claims 4, 12, and 20 recite “a time period between consecutive periodic communications of the data associated with one or more measurement values is approximately five minutes or less”. The claims from which they depend recite a “periodic transmission”, not “periodic communications”. It is unclear whether the “periodic communications” refer back to the “periodic transmission” or to additional, distinct communications, and the term lacks antecedent basis.
Claim 25 recites that the electronics unit is configured to “cause the analyte sensor to start performing the measurements indicative of the level of the at least one analyte of the user” and to “receive the one or more measurement values during the sensor session”. Claim 17, from which claim 25 depends, already requires that the electronics unit cause the sensor to start performing measurements and receive them. It is unclear whether claim 25 requires a second distinct process or whether it is merely re-stating the operations of claim 17.
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.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 10,231,653 in view of Fennell (US 2012/0088995).
Claim 1 of the ‘653 patent recites a method of placing a sensor electronics module in a storage mode, the module comprising electronics configured to process and transmit data from a continuous analyte sensor, the method comprising a storage mode that powers down the electronic components, places a switch of the module in a first state, monitoring for an interrupt signal from the switch, place the switch in a second state, send an interrupt signal in response to placing the switch in the second state, initiate a validation routine in response to receipt of the interrupt signal, and deactivate the storage mode based on the validation routine indicating that the interrupt signal is valid. Claim 3 recites that the switch is a reed switch.
Thus, the ‘653 patent teaches the method counterpart to the recited system of a sensor electronics unit coupled to the analyte sensor, a magnetically actuated switch of that unit, an interrupt signal sent by that switch when the magnet is removed from proximity, and the unit powering up its electronics in response to the validated interrupt signal, meeting the instant claims with the exception of the display device, the initiation of a sensor session in which the analyte sensor is caused to begin measuring and the measurement values are received, and the periodic transmission of data using Bluetooth.
Fennell teaches an analyte monitoring system comprising a display device (120) having a display (122), an on body electronics (110) electrically coupled to an in vivo analyte sensor (101) ([0023]), where the electronics perform analyte measurements with the sensor autonomously once the battery is connected ([0042]), measure each sample at a predetermined time interval ([0044]) and at least periodically broadcast the data to be received by the display device ([0030]), using Bluetooth ([0032]). It would have been obvious to a person having ordinary skill in the art to modify the claims of ‘653 patent with Fennell to begin analyte measurement operations once the device has been removed from the packaging.
Claims 9-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 10,231,653 in view of Fennell (US 2012/0088995), and further in view of Shah (US 2007/0173712).
The combination of ‘653 and Fennell addresses the limitations recited with the exception of the sensor stabilization process, the stabilization period, and the withholding of measurement data until stabilization completes. Shah teaches a glucose sensing system with stabilization circuitry (Abstract) in which the process is applied for a predetermined time ([0006]) prior to utilizing the sensor signal ([0075]). It would have been obvious to modify the above combination with Shah to allow the measured glucose values to be used only after stabilization is achieved to prevent confusion of the user from inaccurate measurements.
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.
Claims 1-8 are is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fennell (US 2012/0088995) in view of Pizzuto (US 2009/0058575).
As to claim 1, Fennell teaches an analyte monitoring system (Abstract), comprising: a display device (120); an analyte sensor configured to perform measurements indicative of a level of at least one analyte of a user ([0023]); and a sensor electronics unit (110) communicatively coupled to the analyte sensor ([0023]), wherein: the sensor electronics unit is configured to: during the sensor session: cause the analyte sensor to start performing the measurements ([0042]); and receive, from the analyte sensor, one or more measurement values that are indicative of the level of the at least one analyte of the user, subsequent to causing the analyte sensor to start performing the measurements ([0044]); and initiate periodic transmission of data associated with the one or more measurement values using Bluetooth wireless technology ([0030], [0032]); and the display device is configured to receive the periodic transmission of the data associated with the one or more measurement values from the sensor electronics unit using Bluetooth wireless technology ([0030], [0032]).
Fennell fails to expressly teach that the sensor electronics unit is configured to initiate a sensor session based on after an interrupt signal is received from a magnetic-based switch of the sensor electronics unit. Pizzuto teaches a magnetic-based switch for an in vivo sensing device (Abstract, [0002]) comprising a Hall-effect latch containing a magnetic sensor ([0017]) which allows for a transition out of an unpowered storage state and into powered operation. It would have been obvious to modify Fennell with Pizzuto to utilize a magnetic-based switch to save battery usage before the sensor is deployed.
As to claim 2, Fennell teaches the sensor electronics unit is configured to process the one or more measurement values to determine at least one of analyte measurement trends, estimated glucose values, or other indicia of blood glucose levels ([0008]).
As to claim 3, the examiner takes official notice that it is well known in the art to have the display device configured to initiate an alarm based at least on the data associated with the one or more measurement values, particularly as glucose sensing devices are used for real-time determinations of current and/or impending hypo/hyperglycemic events.
As to claim 4,Fennell teaches that a time period between consecutive periodic communications of the data associated with the one or more measurement values is approximately five minutes or less ([0030] – broadcast real time data, [0059] – each measurement cycle being one minute; the broadcasting in real-time of each measurement cycle means that it is being transmitted approximately every minute).
As to claim 5, Fennell teaches that the analyte is glucose, and the analyte sensor is a transcutaneous glucose sensor ([0028], [0035]).
As to claim 6, Pizzuto teaches the magnetic-based switch is configured to send the interrupt signal when a magnet is not within a threshold proximity to the magnetic-based switch (claim 1).
As to claim 7, Pizzuto teaches that switch is configured to activate and deactivate the device based on the interrupt signal ([0016]). In addition, Fennell explicitly teaches a battery isolation switch that can be used to prolong its shelf life prior to use ([0043], [0046]). It would have been obvious to further modify Fennell with Pizzuto to utilize the switch to deactivate a low power or a storage mode based on the interrupted signal as it would be obvious to substitute a known component for another.
As to claim 8, Pizzuto teaches the device is configured to prevent re-entry of the low power mode or the storage mode once the low power mode or the storage mode is deactivated ([0017] – “When the magnetic field is removed from the latch's vicinity, the latch will maintain this opposite logic state. In effect, the latch "remembers" and maintains the logic state corresponding to the last magnetic field which exceeded its threshold level in either direction”).
Claims 9-25 are is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fennell (US 2012/0088995) in view of Pizzuto (US 2009/0058575), and further in view of Shah (US 2007/0173712).
As to claims 9 and 17, Fennell teaches an analyte monitoring system (Abstract), comprising: a display device (120); an analyte sensor configured to perform measurements indicative of a level of at least one analyte of a user ([0023]); and a sensor electronics unit (110) communicatively coupled to the analyte sensor ([0023]), wherein: the sensor electronics unit is configured to: cause the analyte sensor to start performing the measurements ([0042]), subsequent to causing the analyte sensor to start performing the measurements, initiate periodic transmission of data associated with one or more measurement values that are indicative of the level of the at least one analyte of the user using Bluetooth wireless technology ([0030], [0032]), and the display device is configured to receive the periodic transmission of the data associated with one or more measurement values from the sensor electronics unit using Bluetooth wireless technology ([0030], [0032]).
Fennell fails to expressly teach an interrupt signal received from a magnetic-based switch of the sensor electronics unit. Pizzuto teaches a magnetic-based switch for an in vivo sensing device (Abstract, [0002]) comprising a Hall-effect latch containing a magnetic sensor ([0017]) which allows for a transition out of an unpowered storage state and into powered operation. It would have been obvious to modify Fennell with Pizzuto to utilize a magnetic-based switch to save battery usage before the sensor is deployed.
The above combination fails to expressly teach that the sensor electronics unit is configured to begin a process for stabilizing the analyte sensor after an interrupt signal is received, and that the sensor electronics unit is configured to delay the periodic transmission until the process for stabilizing the sensor completes, and that the process for stabilizing the sensor is performed for a predetermined time following reception of the interrupt signal. Shah teaches a glucose sensing system with stabilization circuitry (Abstract) in which the process is applied for a predetermined time ([0006]) prior to utilizing the sensor signal ([0075]). It would have been obvious to modify the above combination with Shah to allow the measured glucose values to be used only after stabilization is achieved to prevent confusion of the user from inaccurate measurements. It would have been obvious to modify the above combination with Shah to allow the measured glucose values to be used only after stabilization is achieved to prevent confusion of the user from inaccurate measurements.
As to claims 10 and 18, Fennell teaches the sensor electronics unit is configured to process the one or more measurement values to determine at least one of analyte measurement trends, estimated glucose values, or other indicia of blood glucose levels ([0008]).
As to claims 11 and 19, the examiner takes official notice that it is well known in the art to have the display device configured to initiate an alarm based at least on the data associated with the one or more measurement values, particularly as glucose sensing devices are used for real-time determinations of current and/or impending hypo/hyperglycemic events.
As to claims 12 and 20,Fennell teaches that a time period between consecutive periodic communications of the data associated with the one or more measurement values is approximately five minutes or less ([0030] – broadcast real time data, [0059] – each measurement cycle being one minute; the broadcasting in real-time of each measurement cycle means that it is being transmitted approximately every minute).
As to claims 13 and 21, Fennell teaches that the analyte is glucose, and the analyte sensor is a transcutaneous glucose sensor ([0028], [0035]).
As to claims 14 and 22, Pizzuto teaches the magnetic-based switch is configured to send the interrupt signal when a magnet is not within a threshold proximity to the magnetic-based switch (claim 1).
As to claims 15 and 23, Pizzuto teaches that switch is configured to activate and deactivate the device based on the interrupt signal ([0016]). In addition, Fennell explicitly teaches a battery isolation switch that can be used to prolong its shelf life prior to use ([0043], [0046]). It would have been obvious to further modify Fennell with Pizzuto to utilize the switch to deactivate a low power or a storage mode based on the interrupted signal as it would be obvious to substitute a known component for another.
As to claims 16 and 24, Pizzuto teaches the device is configured to prevent re-entry of the low power mode or the storage mode once the low power mode or the storage mode is deactivated ([0017] – “When the magnetic field is removed from the latch's vicinity, the latch will maintain this opposite logic state. In effect, the latch "remembers" and maintains the logic state corresponding to the last magnetic field which exceeded its threshold level in either direction”).
As to claim 25, Pizzuto teaches the sensor electronics unit is further configured to start a sensor session after the interrupt signal is received from the magnetic-based switch. Pizzuto’s switch signal places the sensing electronics into powered operation, beginning the period during which the sensor is in use (claim 1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bohm (US 2012/0078071) teaches a continuous analyte monitoring system is switched between low power mode and a higher power operational mode by a reed switch, which sends an interrupt signal that is confirmed by a validation routine before the storage mode is deactivated and the electronics are powered up.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/ Primary Examiner, Art Unit 3791 9/22/26
