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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/10/23 has been considered by the examiner.
Amendment Entered
In response to the amendment filed on December 31, 2025, amended claims 1, 3-7, 9, 10, 12, 13, 15, 16 and 18-20 have has been entered. Claims 2, 8, 11, and 17 have been cancelled. New claims 21-23 have been added.
Response to Arguments
Applicant's remarks and amendments with respect to the rejections under U.S.C. 101 have been fully considered. While Examiner agrees that the claimed invention does not explicitly recite mathematical calculations, after considering the amendments, Examiner argues that nothing from the claims, accompanying specification, and/or drawings suggest that the method steps cannot be practically performed mentally, or using pen/paper. Applicant argues the invention is not an abstract idea. Examiner notes that although the claims include a transmitter, analyte sensor, processor, etc., no physical aspect of the wearable device mentioned in the claims is novel. The claims merely recite data gathering/outputting steps. Applicant further argues the claims integrate into a practical application. Examiner notes that according to MPEP 2106.04(d)(2), the practical application consists of administering a specific medication in response to the collected data. Alternately, a practical application would consist of incorporating additional structure to the detection system. Accordingly, Examiner maintains that the identified judicial exception recites a mental process that is not integrated into a practical application. As such, the 35 USC 101 rejections are maintained. Examiner suggests incorporating more structure to the claim or a medication administration step. Please see corresponding rejection heading below for more detailed analysis.
Applicant’s remaining arguments filed with respect to the 102 rejections raised in the previous office action were fully considered, but are moot in view of the current combination of references that were necessitated by amendment. Please see prior art section below for more detail, updated citations (Belliveau reference), and updated obviousness rationale.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3, 4-7, 9, 10, 12-16 and 18-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a sensor system for in vivo use. Thus, claim 1 is directed towards a machine, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
“detecting that a wireless signal has changed from an undeployed state to a deployed state, the wireless signal generated by the transmitter; after detecting that the wireless signal has changed from the undeployed state to the deployed state, monitoring whether the wireless signal remains in the deployed state for at least a stability threshold time period”
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“a sensor enclosure; an analyte sensor extending from the sensor enclosure; a transmitter positioned at an applicator for inserting the analyte sensor, the transmitter configured to generate a wireless signal: a receiver positioned within the sensor enclosure, the receiver configured to receive the wireless signal through the sensor enclosure and at least one processor; and transitioning the sensor system from a sleep mode to an active mode for beginning a sensor session only if the wireless signal remains in the deployed state for at least the stability threshold time period, and otherwise configuring the sensor system to a second mode”
These are generic sensor components, and are conventional means for detecting analytes. These appear to be nothing more than generic sensor components and, as such, do not integrate the judicial exception into a practical application. Furthermore, executing an action based on the wireless signal pertains to mere extra-solution activity, which does not integrate the judicial exception into a practical application and/or recite significantly more. See MPEP 2106.05(g).
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Rather, Examiner takes official notice that they are widely known structural components that have been set forth in prior analyte monitoring systems. See Shah [par. 2, 8, 246, 247], which teaches these sensor components.
In view of the above, independent claim 1 fails to recite patent-eligible subject matter under 35 U.S.C. 101.
Independent claims 16 and 20 are also not patent eligible for substantially similar reasons.
Dependent claims 3, 4-7, 9, 10, 12-15 and 18, 19 and 21-23 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Thus, claims 1, 3, 4-7, 9, 10, 12-16 and 18-23 are rejected under 35 U.S.C. 101.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 4, 6, 7, 9, 10, 12-16 and 18-23 are rejected under 35 U.S.C. 103 as being unpatentable over Shah (U.S. Patent Application Publication 2019/0336055 A1) and in further view of Belliveau (U.S. Patent Application Publication 2018/0182491 A1)
Shah and Belliveau were applied in Applicant’s IDS and the previous office action
Regarding claim 1, Shah teaches a sensor system for in vivo use [par. 2, 8], the sensor system comprising: a sensor enclosure [fig. 10A, element 1004; par. 246, 247]; an analyte sensor [fig. 10A, element 1016] extending from the sensor enclosure; a transmitter [fig. 10A, element 1006; par. 167, 246], the transmitter configured to generate a wireless signal [par. 167]: a receiver positioned within the sensor enclosure, the receiver configured to receive the wireless signal through the sensor enclosure [par. 29 “a processor configured to receive the sensor signal”; par. 167, 246] and at least one processor positioned within the sensor enclosure [par. 167, 246], the at least one processor configured to perform operations comprising: detecting that the wireless signal generated by the transmitter has changed from an undeployed state to a deployed state [fig. 3, step 304; par. 176; Examiner notes the undeployed state may be unconnected, and the deployed state may be the existence of a connection]; after detecting that the wireless signal has changed from the undeployed state to the deployed state, monitoring whether the wireless signal remains in the deployed state for at least a stability threshold time period [par. 176; Examiner notes there is monitoring of an elapsed time with consecutive successful communication sessions and elapsed time since an unsuccessful attempt]; and transitioning the sensor system from a sleep mode to an active mode for beginning a sensor session only if the wireless signal remains in the deployed state for at least the stability threshold time period, and otherwise configuring the sensor system to a second mode [par. 232 “ In some examples, the system may shift out of the hibernation mode after a specified period of time (e.g., after expiration of a warm-up period.)”]
However, Shah does not teach a transmitter positioned at an applicator for inserting the analyte sensor
Belliveau teaches a transmitter positioned at an applicator for inserting the analyte sensor [par. 278]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Shah, to incorporate a transmitter positioned at an applicator for inserting the analyte sensor, to verify that the sensor has been inserted correctly and is working properly, as evidence by Belliveau [par. 278].
Regarding claim 3, Shah further teaches the wireless signal comprises at least one of a magnetic signal, an inductive signal, or an optical signal [fig. 2, element 218; par. 184]
Regarding claim 4, Shah further teaches the detecting that the wireless signal has changed from the undeployed state to the deployed state comprising: determining, at a first time that the wireless signal is in the undeployed state at least in part by determining that the wireless signal is present; and determining, at a second time, that the wireless signal is in the deployed state at least in part by determining that the wireless signal is absent, the second time being after the first time [par. 176].
Regarding claim 6, Shah further teaches the operations further comprising determining an estimated analyte value for a host using a sensor output generated by the analyte sensor when the sensor system is in the active mode [par. 176, 185].
Regarding claim 7, Shah further teaches the operations further comprising establishing a communication connection with an external device before the wireless signal has remained in the deployed state for at least the stability threshold time period [par. 176, 185].
Regarding claim 9, Shah further teaches determining that a startup time period has passed since the detecting that the wireless signal has changed from the undeployed state to the deployed state [par. 176].
Regarding claim 10, Shah further teaches determining that more than a failure threshold time period has passed since the detecting that the wireless signal has changed from the undeployed state to the deployed state, the failure threshold time period being greater than the stability threshold time period [par. 176]
Regarding claim 12, Shah further teaches determining that a startup threshold time period has passed since the detecting that the wireless signal has changed from the undeployed state to the deployed state and that the wireless signal has not remained in either the undeployed state or in the deployed state for more than the stability threshold time period; and initiating a communication connection with an external device [par. 176, 237]
Regarding claim 13, Shah further teaches determining an estimated analyte value for a host using the analyte sensor and transmitting the estimated analyte value via the communication connection with the external device [par. 176, 202].
Regarding claim 14, Shah further teaches determining that a sensor output generated by the analyte sensor meets a first insertion condition [par. 232, 243].
Regarding claim 15, Shah further teaches after determining that the sensor output meets the first insertion condition, initiating a communication connection with an external device [par. 241, 242, 243].
Regarding claim 16, Shah teaches a method for operating an analyte sensor system comprising an in vivo analyte sensor [fig. 10A, element 1016; par. 2, 8], the method comprising: providing an applicator to inserting the in vivo analyte sensor into a host [par. 257], detecting, by at least one processor [fig. 10A, element 1006, par. 167, 246] of the analyte sensor system, that a wireless signal has changed from an undeployed state to a deployed state, the wireless signal being provided to the sensor electronics through a sensor enclosure [fig. 10A, element 1004; par. 246, 247] of the analyte sensor system [fig. 3, step 304; par. 176]; after detecting that the wireless signal has changed from the undeployed state to the deployed state, monitoring, by the sensor electronics, whether the wireless signal remains in the deployed state for at least a stability threshold time period [par. 176; Examiner notes there is monitoring of an elapsed time without a successful establishment of a communication]; and transitioning the analyte sensor system to an active mode based at least in part on whether the wireless signal remains in the deployed state for at least the stability threshold time period [fig. 3, step 206; par. 182, 183; par. 232 “ In some examples, the system may shift out of the hibernation mode after a specified period of time (e.g., after expiration of a warm-up period.)”].
However, Shah does not teach the applicator including electronics configured to generate a wireless signal:
Belliveau teaches the applicator including electronics configured to generate a wireless signal: [par. 278]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Shah, to incorporate the applicator including electronics configured to generate a wireless signal, to verify that the sensor has been inserted correctly and is working properly, as evidence by Belliveau [par. 278].
Regarding claim 18, Shah further teaches receiving the wireless signal using at least one of a magnetic signal sensor, an inductive signal sensor, or an optical signal sensor [par. 123, 158].
Regarding claim 19, Shah further teaches the detecting that the wireless signal has changed from the first state to the second state comprising: determining, at a first time that the wireless signal is in the first state at least in part by determining that the wireless signal is present; and determining, at a second time, that the wireless signal is in the second state at least in part by determining that the wireless signal is absent, the second time being after the first time [par. 176, 233, 234].
Regarding claim 20, Shah further teaches a non-transitory machine readable medium comprising instructions thereon [par. 159, 464] that, when executed by an analyte sensor system [fig. 10A; par. 2, 8], cause the analyte sensor system to perform operations comprising: detecting that a wireless signal has changed from a undeployed state to a deployed state, the wireless signal being provided to sensor electronics [fig. 10A, element 1006] of the analyte sensor system through a sensor enclosure [fig. 10A, element 1004] of the analyte sensor system [fig. 3, step 304; par. 176]; after detecting that the wireless signal has changed from the undeployed state to the deployed state, monitoring whether the wireless signal remains in the deployed state for at least a stability threshold time period [par. 176; Examiner notes there is monitoring of an elapsed time without a successful establishment of a communication]; and transitioning the analyte sensor system to an active mode based at least in part on whether the wireless signal remains in the deployed state for at least the stability threshold time period [fig. 3, step 206; par. 182, 183; par. 232 “ In some examples, the system may shift out of the hibernation mode after a specified period of time (e.g., after expiration of a warm-up period.)”].
However, Shah does not teach a wireless signal generated from electronics at an applicator for inserting a sensor within a host
Belliveau teaches a wireless signal generated from electronics at an applicator for inserting a sensor within a host [par. 278]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Shah, to incorporate a wireless signal generated from electronics at an applicator for inserting a sensor within a host, to verify that the sensor has been inserted correctly and is working properly, as evidence by Belliveau [par. 278].
Regarding claim 21, Shah further teaches the second mode is a sleep mode or a failure state [par. 187, 188].
Regarding claims 22 and 23, Shah further teaches the analyte sensor system is configured to operate in a sleep mode or a failure mode if not transitioned to the active mode [par. 187, 188]
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Shah and Belliveau and in further view of Stetson (U.S. Patent Application Publication 2017/0343695 A1).
Stetson was applied in the previous office action
Regarding claim 5, Shah and Belliveau teach a sensor system for in vivo use as disclosed above.
However, Shah and Belliveau do not teach determining, at a first time, that the wireless signal is in the first state at least in part by determining that the wireless signal has a first magnetic polarity; and determining, at a second time, that the wireless signal is in the second state at least in part by determining that the wireless signal has a second magnetic polarity different than the first magnetic polarity, the second time being after the first time.
Stetson teaches determining, at a first time, that the wireless signal is in the first state at least in part by determining that the wireless signal has a first magnetic polarity; and determining, at a second time, that the wireless signal is in the second state at least in part by determining that the wireless signal has a second magnetic polarity different than the first magnetic polarity, the second time being after the first time [par. 1102-1104]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Shah and Belliveau, to incorporate determining, at a first time, that the wireless signal is in the first state at least in part by determining that the wireless signal has a first magnetic polarity; and determining, at a second time, that the wireless signal is in the second state at least in part by determining that the wireless signal has a second magnetic polarity different than the first magnetic polarity, the second time being after the first time, for transmitting and deciphering multiple signals simultaneously, as evidence by Stetson [par. 1104].
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached on 5712724233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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