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 with traverse of Species B in the reply filed on 26 June 2026 is acknowledged. The traversal is on the ground(s) that there would not be a burden in expanding the search to include this plurality of nonoverlapping structures because it would be “more efficient” to examine a plurality of unrelated areas. This is not found persuasive because the time and resources allotted for examination of a single invention cannot be stretched to examine a plurality of inventions without inherently resulting in serious burden.
The requirement is still deemed proper and is therefore made FINAL.
Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 26 June 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 Objections
Claims 4 and 10 are objected to because of the following informalities:
Claim 4 recites “wherein the housing comprises”; as claim 1 already defines aspects of the housing, claim 4 should define that the housing further comprises. Similar issues are found in at least claim 10.
Appropriate correction is required.
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 1-14 and 16-17 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.
Claim 1 refers to “the IR temperature sensor device”; there is insufficient antecedent basis for this limitation in the claim. Claim 1 defines only “an infrared (IR) temperature sensor”, not a sensor device. If the intent is to refer to the same component it should be labeled as such.
Claim 6 recites that “the contact temperature sensor is part of the IR temperature sensor”; per claim 4, the contact temperature sensor is in contact with the IR temperature sensor. It is unclear how both of these conditions can be met.
Claim 7 recites that “the processor is further configured to receive the temperature sensor signals from the IR temperature sensor”; claim 1 already defines “a processor configured to receive… temperature sensor signals from the IR temperature sensor device”. It is unclear if the intent is for these to be different signals, a different processor, or if the clause is redundant. Clarification is required.
Claim 8 recites that “the processor is further configured to receive the analyte sensor signals from the transcutaneous analyte sensor”; claim 1 already defines “a processor configured to receive analyte sensor signals from the transcutaneous analyte sensor”. It is unclear if the intent is for these to be different signals, a different processor, or if the clause is redundant. Clarification is required.
Claim 8 further recites that the processor is configured to “determine the temperature of the lower side of the housing or of the temperature of the skin based on the received temperature sensor signals received from the IR temperature sensor and from the contact temperature sensor”. Per claim 1, the IR temperature sensor is used to detect the temperature of the lower side of the housing or of the skin; as claim 1 already defines that these values are detected by the IR sensor, it is entirely unclear how these same values are subsequently “determined” using different inputs. Clarification is required.
Claim 11 recites that “the calibrated signals compensate for changing temperatures detected by the contact temperature sensor”; it is unclear of “compensate for” is an active task being performed by the invention as claimed, perhaps something it is configured to do, though this is not recited with any specificity if this is a task the system is configured to perform, or if this merely describes an inherent characteristic of the data. Further, “changing temperatures” appears to describe something taking place over time, not something that can be defined as part of a system. Where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims. See MPEP 2173.06.
Claim 12 defines a method using the device of claims 1/4, which includes “determining the temperature of the lower side of the housing or of the temperature of the skin based on the received temperature sensor signals from the IR temperature sensor and from the contact temperature sensor”. Per claim 1, the IR temperature sensor is used to detect the temperature of the lower side of the housing or of the skin; as claim 1 already defines that these values are detected by the IR sensor, it is entirely unclear how these same values are subsequently “determined” using different inputs. 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, 2, 13, 14, 16, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bohm (US 2012/0078071).
Regarding claim 1, Bohm discloses an analyte sensor system, comprising:
a transcutaneous analyte sensor (paragraph [0121]);
a housing having a lower side configured to be attached to the skin of a patient (figure 2C);
an infrared (IR) temperature sensor configured to detect the temperature (i) of the lower side of the housing, or (ii) of the skin through a hole in the lower side of the housing (paragraph [0260]);
wherein the IR temperature sensor faces without contact the lower side of the housing or is spaced from the skin (figure 12C); and
an electronics unit comprising a processor configured to receive analyte sensor signals from the transcutaneous analyte sensor and temperature sensor signals from the IR temperature sensor device (paragraph [0117]).
Regarding claim 2, Bohm further discloses that the IR temperature sensor is mounted on a circuit board (paragraph [0181]).
Regarding claim 13, Bohm further discloses that the lower side of the housing comprises the hole, the hole defining a temperature detection area of the skin, whereby the IR temperature sensor can detect the temperature of the skin below the hole (figure 12C).
Regarding claim 14, Bohm further discloses a “detection cell” that includes the IR temperature sensor, a part of the lower side of the housing that includes the hole, and separating walls that seal off the detection cell from the remaining interior space of the housing (figure 12C, the area comprising both elements 1210 and 1200C is defined by the part of the lower housing which includes the whole and the vertical walls around element 1210 separating it from the remainder of element 240).
Regarding claim 16, Bohm further discloses a display configured to communicate with the electronics unit (paragraph [0109]).
Regarding claim 17, Bohm further discloses that the transcutaneous analyte sensor is a glucose sensor (paragraph [0121]).
Claim Rejections - 35 USC § 103
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bohm in view of Nadikattu (US 11094420).
Regarding claim 3, Bohm does not disclose the IR sensor being a passive infrared (PIR) sensor. Nadikattu teaches a temperature sensor configured to be attached to skin of a patient comprising a passive infrared sensor (column 2, lines 55-66). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Burnette with a PIR temperature sensor, as taught by Nadikattu, as IR sensing can be active or passive and Nadikattu teaches that use of passive IR is known for sensing temperatures in similar skin-mounted devices.
Claim(s) 4-10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bohm in view of Burnette (US 2017/0281092).
Regarding claim 4, Bohm does not disclose the housing further comprising a contact temperature sensor. Burnette teaches an analyte sensor system comprising a transcutaneous analyte sensor (paragraph [0047]), a housing having a lower side configured to be attached to the skin of a patient (figure 2C), an infrared (IR) temperature sensor configured to detect a temperature (paragraph [0098]), a contact temperature sensor in contact with (i) a part of the housing carrying the IR temperature sensor, (ii) a circuit board, or (iii) the IR temperature sensor (paragraph [0098]), and an electronics unit comprising a processor configured to receive analyte sensor signals from the transcutaneous analyte sensor and temperature sensor signals from the IR temperature sensor device (paragraphs [0059]-[0061]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Bohm with an additional contact temperature sensor, as taught by Burnette, in order to monitor operating conditions of the system.
Regarding claim 5, Burnette’s contact temperature sensor is selected from the group consisting of a thermoelement, a thermistor, and a resistance temperature detector (paragraph [0098]).
Regarding claim 6, Burnette’s contact temperature sensor is part of the IR temperature sensor (paragraph [0098]).
Regarding claim 7, Bohm further discloses that the processor comprises a memory (paragraph [0125]) and wherein the processor is configured to:
receive the temperature sensor signals from the IR temperature sensor (paragraph [0126]), and
determine the temperature of the lower side of the housing or of the temperature of the skin based on the received temperature sensor signals received from the IR temperature sensor (paragraphs [0255]-[0260]).
Bohm does not disclose determining the temperature being also based on the temperature sensor signal from the contact temperature sensor. Burnette further teaches the processor being further configured to determine a temperature of a lower side of the housing or the temperature of the skin based on the received temperature signals from both the IR temperature sensor and the contact temperature sensor (paragraph [0098]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Bohm, as modified, using both IR temperature signal and contact temperature signal to determine the temperature, as further taught by Burnette, in order to increase the accuracy of determination.
Regarding claim 8, Bohm further discloses that the processor is further configured to:
receive the analyte sensor signals from the transcutaneous analyte sensor (paragraph [0126]),
determine an analyte concentration based on the analyte sensor signals and the determined temperature (paragraphs [0255], [0260]), and
communicate the analyte concentration to a display (paragraph [0109]). The Examiner notes that, as modified, this “determined” temperature would be that determined in claim 7 from which this depends.
Regarding claim 9, Burnette further teaches that the processor is further configured to compare the determined temperature with a first reference temperature and issue a notification if the determined temperature is above the first predetermined reference temperature (paragraph [0097]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Bohm, as modified, and further configured the processor to issue a notification if a determined temperature is above a reference temperature, as further taught by Burnette, in order to prevent unsafe operating conditions.
Regarding claim 10, Burnette further teaches that the processor is configured to calibrate the temperature sensor signals from the IR temperature sensor with the temperature sensor signals from the contact temperature sensor and temperature sensor calibration data to determine the temperature of the lower side of the housing or the temperature of the skin (paragraph [0098], [0119]-[0121]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Bohm, as modified, and calibrated the IR temperature signals with contact temperature sensor signals, as further taught by Burnette, in order to increase the accuracy of subsequent calculations.
Regarding claim 12, Bohm further discloses a method of determining an analyte concentration using an analyte sensor system according to claim 4, the method comprising:
receiving the temperature sensor signals from the IR temperature sensor (paragraph [0260]),
determining the temperature of the lower side of the housing or of the temperature of the skin based on the received temperature sensor signals (paragraph [0255], [0260]),
receiving the analyte sensor signals from the transcutaneous analyte sensor within a predetermined time interval after receiving the temperature sensor signals from the IR temperature sensor and from the contact temperature sensor (paragraphs [0126], [0255]-[0260]),
determining an analyte concentration based on the analyte sensor signals and the determined temperature of the lower side of the housing or of the temperature of the skin (paragraphs [0255], [0260]), and
communicating the analyte concentration to a display (paragraph [0109]).
Bohm does not disclose the method further comprising receiving the temperature sensor signal from the contact temperature sensor or determining the temperature of the lower side of the housing using both the received temperature sensor signals from the IR temperature sensor and the contact temperature sensor.
Burnette further teaches a method of determining an analyte concentration using an analyte sensor system according to claim 4 as modified above, the method comprising:
receiving the temperature sensor signals from the IR temperature sensor and from the contact temperature sensor (paragraph [0098]),
determining the temperature of the lower side of the housing or of the temperature of the skin based on the received temperature sensor signals from the IR temperature sensor and from the contact temperature sensor (paragraph [0098]), and
determining an analyte concentration based on the analyte sensor signals and the determined temperature of the lower side of the housing or of the temperature of the skin (paragraphs [0098], [0119]-[0121]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have followed Bohm, as modified above, and further included receiving the contact temperature sensor signals and using them in determining the temperature, as further taught by Burnette, in order to increase the accuracy of subsequent calculations.
Conclusion
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/KAREN E TOTH/Examiner, Art Unit 3791
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