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 .
Election/Restrictions
Applicant’s election of invention I in the reply filed on 16 March 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 18 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 16 March 2026.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 112
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 1-17 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.
First recited in claim 1, the claims use the term “value” to refer to both single numerical values and also to refer to categories or sets of values, with no distinction between the two types of “value”. Claim 1 defines a “set” composed of two values, where it is unclear if the set is actually only two values, or a set of matching pairs of values of two types of parameters. Still further, as the “first parameter value” is experimentally obtained, it is unclear how the set composed of only two values could exist when the actual quantity of the first value is entirely dependent upon what has been measured. These interchangeable uses of “value” are used throughout the claims - see, for example, claim 2, where the first value is “interpolated” to find the second value even though the set only comprises the first and second values, or claim 6 which indicates that the two values in the set are obtained from “tests” without any indication of how more than one test could be used to find two values, or claim 7, where “some” of the pair-data in the set is adjustable even though the set is only composed of two values. Clarification is required.
Claim 11 recites that “an adjustment of the at least some of the pair-data is a fixed value” – it is entirely unclear whether this calls for a fixed value to be applied to the data, or if all of affected the data is set to be this fixed value, or if this “fixed value” is used in some other manner to achieve “adjustment”. Clarification is required.
Claim 13 recites “the first parameter value or the second parameter value is set with at least one threshold, when the first parameter value or the second parameter value exceeds the threshold”. It is unclear if the intent is to use the same threshold for both the first parameter value and the second parameter value, or if only one threshold is included it applies only to one of the parameters. Further, the recitation of “the threshold” does not properly match “at least one threshold”. Clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Estes (US 2013/0245981).
Regarding claim 1, Estes discloses an analyte detection device, comprising:
a shell (paragraphs [0182], [0183] – the housing);
a sensor comprising an internal part and an external part, wherein the internal part is used to penetrate into a subcutaneous skin to obtain a first parameter value (element 102; paragraph [0182]-[0183]);
a memory in which at least one predetermined pair-data set composed of the first parameter value and a second parameter value is prestored, wherein the second parameter value is associated with an in vivo analyte parameter information (paragraph [0238]; figure 14);
a processor programmed to call the predetermined pair-data set from the memory, and obtaining the second parameter value based on the first parameter value by index (paragraph [0143], [0195], [0236]-[0238]);
a transmitter used to transmit the first parameter value and/or the second parameter value to a remote equipment (element 104; paragraphs [0188]-[0189]); and
a battery, which is used to provide electric energy (paragraph [0188] sets forth that details of the sensor electronics are incorporated by reference from US 2009/0240120, which discloses a battery in paragraph [0107]).
Regarding claim 2, Estes further discloses that the first parameter value is interpolated to obtain the second parameter value (paragraphs [0105], [0238]).
Regarding claim 3, Estes further discloses that the first parameter value is a current value or a voltage value (paragraphs [0237]-[0238]).
Regarding claim 4, Estes further discloses that the second parameter value comprises a blood glucose concentration value (paragraphs [0237]-[0238]).
Regarding claim 5, Estes further discloses that the predetermined pair-data set is at least partially derived from in vivo tests (paragraphs [0016]-[0018]).
Regarding claim 6, Estes further discloses that the predetermined pair-data set is at least partially derived from in vitro tests (paragraphs [0016]-[0018]).
Regarding claim 7, Estes further discloses that at least some of pair-data in the predetermined pair-data set is adjustable (paragraph [0019]).
Regarding claim 8, Estes further discloses that an adjustment of the at least some of the pair-data is based at least on time parameter differences partly (paragraph [0074]).
Regarding claim 9, Estes further discloses that an adjustment of the at least some of the pair-data is based at least on physical characteristics of the sensor partly (paragraph [0220]-[0221]).
Regarding claim 10, Estes further discloses that the physical characteristics of the sensor comprise at least one of a membrane thickness, an active enzyme area, an active enzyme volume or a resistance of an electrode (paragraph [0220]).
Regarding claim 11, Estes further discloses that an adjustment of the at least some of the pair-data is a fixed value (paragraph [0255]).
Regarding claim 12, Estes further discloses that an adjustment of the at least some of the pair-data is changed in a linear manner (paragraph [0281]).
Regarding claim 13, Estes further discloses that the first parameter value or the second parameter value is set with at least one threshold, when the first parameter value or the second parameter value exceeds the threshold, the remote equipment sends an alert indication (paragraph [0266]).
Regarding claim 14, as “a user or non-user” encompasses all potential persons, the threshold of Estes is inherently set by a user or non-user.
Regarding claim 15, Estes further discloses that the transmitter, the memory, the sensor, the processor and the battery are located in the shell (figure 1).
Regarding claim 16, Estes further discloses that the transmitter, the sensor and the battery are located in the shell (paragraph [0188]), and the memory and/or the processor are located in the remote equipment (paragraph [0189]).
Regarding claim 17, Estes further discloses that at least two of the transmitter, the processor and the memory are integrated (paragraphs [0188], [0189]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 2010/0223023 to Kamath
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/KAREN E TOTH/Examiner, Art Unit 3791
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