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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 29, 2026 has been entered.
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 July 29, 2026, amended claims 1, 16 and 20 have has been entered.
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 (Halac 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:
generate a wireless signal
detecting that the wireless signal generated by the transmitter has changed from an undeployed state to a deployed state
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
These limitations set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites after insertion of the analyte sensor, physical removal of the applicator from the sensor enclosure affects a change in the wireless signal from an undeployed state to a deployed state, 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, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The change in signal after sensor insertion and transitioning from a sleep mode to active mode does not provide an improvement to the technological field, the system does not effect a particular treatment or effect a particular change based on the model, nor does the method use a particular machine to perform the Abstract Idea. Examiner adds that administering antiepileptic medications is analogous to “administering a suitable medication to a patient”, which is further explained in MPEP 2106.04(d)(2)
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
sealed sensor enclosure
analyte sensor extending from the sensor enclosure
transmitter positioned at an applicator for inserting the analyte sensor
a receiver positioned within the sensor enclosure, the receiver configured to receive the wireless signal through the sensor enclosure
at least one processor positioned within the sensor enclosure,
The providing and recording steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the providing and recording steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter
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.
Therefore, claims 1, 3, 4-7, 9, 10, 12-16 and 18-23 are not patent eligible under 35 USC 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) and Halac (U.S. Patent Application Publication 20190342637 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].
However, Shah does not teach a sealed sensor system, wherein, after insertion of the analyte sensor, physical removal of the applicator from the sensor enclosure affects a change in the wireless signal from an undeployed state to a deployed state
Halac teaches a sealed sensor system wherein, after insertion of the analyte sensor, physical
removal of the applicator from the sensor enclosure affects a change in the wireless signal from an undeployed state to a deployed state [par. 9, 246, 340-342] 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 wherein, after insertion of the analyte sensor, physical removal of the applicator from the sensor enclosure affects a change in the wireless signal from an undeployed state to a deployed state, for determining if implantation has occurred, as evidence by Halac [par. 342]
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].
However, Shah does not teach wherein, after insertion of the analyte sensor, physical removal of the applicator from the sensor enclosure affects a change in the wireless signal from an undeployed state to a deployed state
Halac teaches wherein, after insertion of the analyte sensor, physical removal of the applicator
from the sensor enclosure affects a change in the wireless signal from an undeployed state to a deployed state [par. 9, 246, 340-342] 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 wherein, after insertion of the analyte sensor, physical removal of the applicator from the sensor enclosure affects a change in the wireless signal from an undeployed state to a deployed state, for determining if implantation has occurred, as evidence by Halac [par. 342]
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].
However, Shah does not teach wherein the wireless signal is received through a sealed sensor enclosure, and wherein, after inserting the sensor within the host, physical removal of the applicator from the sensor enclosure affects a change in the wireless signal from the undeployed state to the deployed state
Halac teaches wherein the wireless signal is received through a sealed sensor enclosure, and
wherein, after inserting the sensor within the host, physical removal of the applicator from the sensor enclosure affects a change in the wireless signal from the undeployed state to the deployed state [par. 9, 246, 340-342] 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 wherein, after insertion of the analyte sensor, physical removal of the applicator from the sensor enclosure affects a change in the wireless signal from an undeployed state to a deployed state, for determining if implantation has occurred, as evidence by Halac [par. 342]
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, Belliveau and Halac 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, Belliveau and Halac teach a sensor system for in vivo use as disclosed above.
However, Shah, Belliveau and Halac 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, Belliveau and Halac, 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE L ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8:30am-5pm, alt F 8:30am-5pm.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
