DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. According to the Amendment, filed 28 April 2026, the status of the claims is as follows:
Claims 2-21 are previously presented; and
Claim 1 is cancelled.
Response to Arguments
3. Applicant’s arguments, see Remarks, pp. 6-7, filed 28 April 2026, with respect to the rejection of claims 2-21 under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, i.e. abstract idea, without significantly more, have been fully considered, but they are not persuasive.
Applicant contends, see Remarks, pp. 6-7, the following:
The claimed features provide a technical solution rooted in operation of a physical, in vivo analyte sensor and require using a "membrane impedance" (a physical/electrical property of the sensor membrane) in a specific control scheme to mitigate a known sensor artifact that impacts the operation of a sensor. The claimed sensor system is not directed to merely a mental process. For example, according to paragraphs [0566] and [0567] of the Application Publication:
Consider an example in which the analyte is glucose and the analyte sensor is a continuous glucose sensor. If the host lies on or otherwise applies pressure to the sensor insertion site, the continuous glucose sensor may alert the user to a perceived low glucose condition although such a condition may not actually exist. This can reduce the trust of the host in the continuous glucose sensor. Also, if the compression low occurs while the host is sleeping, the continuous glucose sensor may awaken the user unnecessarily A compression low may be accompanied by a reduction in the membrane impedance. The device can be programmed to detect a compression low if the analyte concentration drops at a rate of change greater than a rate of change threshold while the resistance of the sensor membrane also drops.
Thus, the claims are directed to improvements in sensor technology that improve sensor accuracy and reliability during physiological compression events, and appropriately responds to such detected events.
Further, determining whether "a membrane impedance meets a membrane impedance condition" necessarily involves the processor measuring/deriving impedance of the sensor membrane and cannot be practically performed as a mental process, and are as a result, integrated into a practical application.
However, respectfully, this argument is not persuasive. The mental process limitations are:
determining, based at least in part on the analyte current signal, the analyte current signal exhibits a rate of reduction greater than a rate of reduction threshold;
determining a membrane impedance meets a membrane impedance condition; and
executing, in response to determining the analyte current signal exhibits a rate of reduction greater than the rate of reduction threshold and determining the membrane impedance meets the membrane impedance condition, a compression low response action.
Based on broadest reasonable interpretation, these limitations are directed to receiving data and performing a mathematical operation, which can be done mentally or using pen and paper. The claims do not recite additional limitations that would integrate the mental processor into a practical application. The limitation “executing, in response to determining the analyte current signal exhibits a rate of reduction greater than the rate of reduction threshold and determining the membrane impedance meets the membrane impedance condition, a compression low response action”, based on broadest reasonable interpretation, can encompass a mental step of executing a decision action by a person. The phrase “a compression low response action” is too generic and abstract without more description of what this action performs in the real world. Thus, Applicant’s stated “improvements in sensor technology that improve sensor accuracy and reliability during physiological compression events” has not been realized in the real world as the claim remains in abstraction.
Further, “determining a membrane impedance meets a membrane impedance condition” does not necessarily involve the processor measuring/deriving impedance of the sensor membrane. The determination can be performed by the human mind through observation of membrane impedance data and decision making of whether the impedance data meets a threshold condition.
For these reasons, the rejection is maintained below.
4. Applicant’s arguments, see Remarks, pp. 7-9, filed 28 April 2026, with respect to the rejection of claims 2-5, 8-15, and 18-21 under 35 U.S.C. 103 as being unpatentable over Vanslyke et al., U.S. Patent Application Publication No. 2015/0351672 A1 (“Vanslyke”), in view of Patterson, U.S. Patent No. 8,940,542 B2 (“Patterson”), have been fully considered, and are persuasive. Therefore, the rejection has been withdrawn.
Information Disclosure Statement
5. The information disclosure statement (IDS) submitted on 01 May 2026 was filed after the mailing date of the Non-Final Office Action on 26 January 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 101
6. 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.
7. Claims 2-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, i.e. abstract idea, without significantly more.
Step 1 of the Patent Subject Matter Eligibility Guidance (see MPEP 2106.03):
Claims 2-11 are directed to a “system”, which describes one of the four statutory categories of patentable subject matter, i.e. a machine.
Claims 12-21 are directed to a “method”, which describes one of the four statutory categories of patentable subject matter, i.e. a process.
Step 2A of the Revised Patent Subject Matter Eligibility Guidance (see MPEP 2106.04):
Claim(s) 2-11, recite the following mental process:
determining, based at least in part on the analyte current signal, a rate of reduction of the analyte concentration is greater than a rate of reduction threshold;
determining a membrane impedance meets a membrane impedance condition; and
executing, in response to determining the rate of reduction of the analyte
concentration is greater than the rate of reduction threshold and determining the membrane impedance meets the membrane impedance condition, a compression low response action.
Based on broadest reasonable interpretation, these limitations are directed to receiving data and performing a mathematical operation, which can be done mentally or using pen and paper.
This judicial exception is not integrated into a practical application because the additional limitations of “an analyte sensor comprising a working electrode and a reference electrode, wherein the analyte sensor is configured to generate an analyte current signal indicative of an analyte concentration in a host” and “receiving the analyte current signal generated by the analyte sensor” in claim 1 add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the mental process. Furthermore, “a processor configured to perform operations” in claim 1 is merely a part of a computer to be used as a tool to perform the mental process.
Claim(s) 12-21, recite the following mental process:
determining, based at least in part on the analyte current signal, the analyte current signal exhibits a rate of reduction greater than a rate of reduction threshold;
determining a membrane impedance meets a membrane impedance condition; and
executing, in response to determining the analyte current signal exhibits a rate of reduction greater than the rate of reduction threshold and determining the membrane impedance meets the membrane impedance condition, a compression low response action.
Based on broadest reasonable interpretation, these limitations are directed to receiving data and performing a mathematical operation, which can be done mentally or using pen and paper.
This judicial exception is not integrated into a practical application because the additional limitations of “receiving an analyte current signal generated by the analyte sensor, the analyte current signal indicative of the analyte concentration in the host;” in claim 12 add insignificant pre-solution activity, i.e. data gathering, to the abstract idea that merely collects data to be used by the mental process.
Step 2B of the Patent Subject Matter Eligibility Guidance (see MPEP 2106.05):
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception, when considered separately and in combination.
Analyzing the additional claim limitations individually, the additional limitations that are not directed to the mental process are “an analyte sensor comprising a working electrode and a reference electrode, wherein the analyte sensor is configured to generate an analyte current signal indicative of an analyte concentration in a host” and “receiving the analyte current signal generated by the analyte sensor” in claim 1, “wherein the analyte sensor further comprises a membrane; and wherein the membrane impedance is associated with the membrane of the analyte sensor” in claim 10, “receiving an analyte current signal generated by the analyte sensor, the analyte current signal indicative of the analyte concentration in the host;” in claim 12, and “wherein the analyte sensor further comprises a membrane; and wherein the membrane impedance is associated with the membrane of the analyte sensor” in claim 21. Such limitations are conventional and routine in the art (see Vanslyke et al., U.S. Patent Application Publication No. 2015/0351672 A1, which is discussed below in the rejection under 35 U.S.C. 103), and add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the abstract idea.
The additional limitation “a processor configured to perform operations” in claim 1 is merely a part of a computer to be used as a tool to perform the mental process.
The additional limitations of dependent claims 3-10 and 13-20 are merely directed to and further narrow the scope of the mental process.
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Their collective functions merely provide computer implementation of the abstract idea using collected data without: improvement to the functioning of a computer or to any other technology or technical field; applying the mental process with, or by use of, a particular machine; effecting a transformation or reduction of a particular article to a different state or thing; applying or using the mental process in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment; or adding a specific limitation other than what is well-understood, routine, conventional activity in the field.
Allowable Subject Matter
8. Claims 2-21 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office Action.
9. The following is a statement of reasons for the indication of allowable subject matter:
As to Claims 2-21, neither Vanslyke, Patterson, nor the prior art of record teaches the analyte sensor system of base claim 2, and the method of base claim 12, including the following, in combination with all other limitations of the base claim:
determining, based at least in part on the analyte current signal, a rate of reduction of the analyte concentration is greater than a rate of reduction threshold;
determining a membrane impedance meets a membrane impedance condition; and
executing, in response to determining the rate of reduction of the analyte concentration is greater than the rate of reduction threshold and determining the membrane impedance meets the membrane impedance condition, a compression low response action.
Conclusion
10. THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 06/29/2026
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