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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 18th, 2025 has been entered.
Amendment Entered
In response to the amendment filed on December 18th, 2025, amended claims 21 and 46 are entered. Claims 41-45 remain withdrawn from consideration. Claims 21-24, 26, 28, 30-32, 34-40, 46-49, and 51-55 are currently under examination.
Response to Arguments
Applicant’s arguments, filed on December 18th, 2025, with respect to the rejections under 35 U.S.C. 101 have been fully considered but are not persuasive. The rejections have been maintained, and further clarified in view of the amendment.
At Pg. 9 of the Reply, Applicant argues that Claim 21 “is directed to a particular machine that improves operation of the sensor system by performing an unconventional cross-sensor correlation and a corrective action that includes modifying use of data in determining a glucose concentration. Thus, as a whole, claim 21 is directed to a practical application”. Examiner respectfully disagrees. Although the applicant has amended Claim 21 in order to add the limitations of “wherein the corrective action comprises modifying use of the first data in determining the glucose concentration”, the amended limitations still fail to integrate the idea into practical application.
The claimed limitations still set forth a judicial exception because the steps describe concepts performed in the human mind (including observations, evaluations, judgments, opinions). Thus, the claims are drawn to a Mental Process, which is an Abstract Idea. Although the corrective action has been further amended to comprise “modifying use of the first data in determining the glucose concentration”, this amounts to nothing more than a further step of data analysis. Simple modification of data fails to integrate the idea into practical application. The current claims do not have any limitations drawn to performing any decisions, procedures, or steps in response to the modification of data. The claim limitations simply calculate, correlate, compensate, and now further modify data. Therefore, there is nothing outside of the abstract idea that shows integration into practical application or significantly more.
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 21-24, 26, 28, 30-32, 34-40, 46-49, and 51-55 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.
Claim 21 recites “wherein the corrective action comprises modifying use of the first data in determining the glucose concentration” in lines 22-23. However, the specification does not disclose the term “modifying use of the first data in determining the glucose concentration” nor state the relationship between “modifying use of the first data in determining the glucose concentration” and the “corrective action”.
Claim 46 recites “wherein the corrective action comprises modifying use of data associated with the transcutaneous analyte sensor signal in determining an analyte concentration” in lines 23-25. However, the specification does not disclose the term “modifying use of data associated with the transcutaneous analyte sensor signal in determining an analyte concentration” nor state the relationship between “modifying use of data associated with the transcutaneous analyte sensor signal in determining an analyte concentration” and the “corrective action”.
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 21-24, 26, 28, 30-32, 34-40, 46-49, and 51-55 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Each of Claims 21-24, 26, 28, 30-32, 34-40, 46-49, and 51-55 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 1
Claims 21-24, 26, 28, 30-32, 34-40, 46-49, and 51-55 recite a sensor system and an analyte sensing system. Thus, the claims are directed to a machine, which is one of the statutory categories of invention.
Step 2A, Prong 1
Each of Claims 21-24, 26, 28, 30-32, 34-40, 46-49, and 51-55 recites at least one step or instruction for detecting fluctuations in a signal, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. The steps underlined below describe an observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG. Accordingly, each of Claims 21-24, 26, 28, 30-32, 34-40, 46-49, and 51-55 recites an abstract idea.
Specifically, Claim 21 recites:
a glucose sensor configured to generate a glucose signal related to a glucose concentration in a host;
a second sensor configured to generate a second signal related to a position of the host;
sensor electronics operably connected to the glucose sensor and the second sensor, wherein the sensor electronics is configured to generate first data from the glucose signal and second data from the second signal; and
a processor configured to compensate for a fluctuation in the glucose signal generated by the glucose sensor using at least the second signal generated by the second sensor by at least:
determining, based at least on the second signal generated by the second sensor, movement of the host into a first position;
detecting the fluctuation in the glucose signal generated by the glucose sensor;
correlating the second signal generated by the second sensor with the fluctuation in the glucose signal generated by the glucose sensor to determine whether the fluctuation in the glucose signal generated by the glucose sensor was caused by the movement of the host into the first position,
wherein the second signal is correlated with the fluctuation in the glucose signal based at least on a portion of the second signal indicating a lack of movement of the host for a period of time followed by movement of the host into the first position after the period of time; and
compensating for the fluctuation based at least on correlating the second signal with the fluctuation in the glucose signal, wherein the compensating comprises: performing a corrective action, wherein the corrective action comprises modifying use of the first data in determining the glucose concentration.
Specifically, Claim 46 recites:
a transcutaneous analyte sensor;
an accelerometer;
sensor electronics operably coupled to the transcutaneous analyte sensor and the accelerometer to receive a transcutaneous analyte sensor signal from the transcutaneous analyte sensor and an accelerometer signal from the accelerometer; and
a processor configured to:
determine, based at least on the accelerometer signal, movement of the accelerometer into a first position;
detect a fluctuation in the transcutaneous analyte sensor signal;
correlate the accelerometer signal with the fluctuation in the transcutaneous analyte sensor signal to determine whether the fluctuation in the transcutaneous analyte sensor signal was caused by the accelerometer moving into the first position, wherein the accelerometer signal is correlated with the fluctuation in the transcutaneous analyte sensor signal based at least on a portion of the accelerometer signal indicating a lack of movement of a host for a period of time followed by movement of the host into the first position after the period of time;
determining, based at least on correlating the accelerometer signal with the fluctuation in the transcutaneous analyte sensor signal, the fluctuation in the transcutaneous analyte sensor signal was caused by the accelerometer moving into the first position; and
compensating for the fluctuation based at least on determining the fluctuation in the transcutaneous analyte sensor signal was caused by the accelerometer moving into the first position, wherein the compensating includes performing a corrective action, wherein the corrective action comprises modifying use of data associated with the transcutaneous analyte sensor signal in determining an analyte concentration.
Further, dependent Claims 22-24, 26, 28, 30-32, 34-40, 47-49, and 51-55 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claims 21 and 46 (and their respective dependent Claims 22-24, 26, 28, 30-32, 34-40, 47-49, and 51-55) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in bold), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: glucose sensor, second sensor, sensor electronics, processor, accelerometer, three-axis accelerometer, three-axis compass, display device, as recited in independent Claim 21 and its dependent claims; and a transcutaneous analyte sensor, an accelerometer, sensor electronics, processor, display device, and three-axis accelerometer as recited in independent Claim 46 and its dependent claims are generically recited computer elements, which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claims 21 and 46 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., processor as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer.
Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 21 and 46 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 21 and 46 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 21-24, 26, 28, 30-32, 34-40, 46-49, and 51-55 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: glucose sensor, second sensor, sensor electronics, processor, accelerometer, three-axis accelerometer, three-axis compass, display device, as recited in independent Claim 21 and its dependent claims; and a transcutaneous analyte sensor, an accelerometer, sensor electronics, processor, display device, and three-axis accelerometer as recited in independent Claim 46 and its dependent claims.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
Applicant’s specification (e.g. paragraphs [0060-0064]) which discloses that the processor(s) comprise generic computer components that are configured to perform the generic computer functions (e.g. determining, detecting, correlating, and compensating) that are well-understood, routine, and conventional activities previously known to the pertinent industry;
Applicant’s specification (e.g. paragraphs [0050-0060]) which discloses that the sensors and sensor electronics comprise generic computer components that are configured to perform the generic computer functions of as sensor (data-gathering: generating signals and collecting data) that are well-understood, routine, and conventional activities previously known to the pertinent industry;
Applicant’s specification (e.g. paragraphs [0052-0054]) which discloses that the display(s) comprise generic computer components that are configured to perform the generic computer functions of a display (data-outputting: displaying an output) that are well-understood, routine, and conventional activities previously known to the pertinent industry;
Applicant’s Background in the specification; and
The non-patent literature of record in the application.
Accordingly, in light of Applicant’s specification, the claimed term processor is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the processor. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 21-24, 26, 28, 30-32, 34-40, 46-49, and 51-55 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the sensing systems of Claims 21-24, 26, 28, 30-32, 34-40, 46-49, and 51-55 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 21-24, 26, 28, 30-32, 34-40, 46-49, and 51-55 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 21 and 46 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 21-24, 26, 28, 30-40, and 46-53 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 21-24, 26, 28, 30-32, 34-40, 46-49, and 51-55 amounts to significantly more than the abstract idea itself. Accordingly, Claims 21-24, 26, 28, 30-32, 34-40, 46-49, and 51-55 are not patent eligible and rejected under 35 U.S.C. 101.
Conclusion
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/CHANEL J JHIN/Examiner, Art Unit 3791