DETAILED ACTION
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-3-6 are pending.
This action is Final.
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 3-6 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.
Regarding claim 3, the limitations
“wherein the determining of the sensitivity A based on the average sensitivity comprises:
when a difference between the first sensitivity and the average sensitivity falls within a specific range, determining the first sensitivity as the sensitivity A; and
when the difference falls outside the specific range, determining a result of applying a second weight to the average sensitivity as the sensitivity A”
renders the claim indefinite. The claim is to a method which depends on claim 1. Claim 1 step of determining the Sensitivity A has no step relating to any processing, such as deriving a difference between the first sensitivity and the average sensitivity, to invoke the contingency clause being set forth by the “when” limitation. As it appears this contingency clause is never invoked the method is indefinite. For examination purposes, claim 3 limitations will be met by the art teaching the claim upon which it depends, while the limitations are considered, they do not hold any patentable weight by further limiting the claimed method. Claim 4 is rejected for depending on claim 3.
Regarding claim 5, the limitations “generating and outputting a glucose value from the sensor data based on the final sensitivity…determining a new sensitivity from the sensitivity A according to whether a glucose value obtained from the offset value and the sensitivity A falls within a specific range” renders the claim indefinite. It is unclear if the “a glucose value” claimed twice are the same or different. As the second instance includes “obtained” but there is no claim step of obtaining the value, it is not clear if this is the same as the generating and outputting. For these reasons the metes and bounds of the claim are unclear, which renders the claim indefinite.
Regarding claim 6, the limitations “determining a new sensitivity from the sensitivity A according to whether a glucose value obtained from the offset value and the sensitivity A falls with a specified range…generating and outputting a glucose value from the sensor data based on the final sensitivity” renders the claim indefinite. It is unclear if the “a glucose value” claimed twice are the same or different. As the first instance includes “obtained” but there is no claim step of obtaining the value, it is not clear if this is the same as the later generating and outputting step. For these reasons the metes and bounds of the claim are unclear, which renders the claim indefinite.
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, 3-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s):
Claim 1
determining a first sensitivity from sensor data at the time of calibrating the sensitivity and a reference glucose value, based on the offset value (mental process/mathematical concepts)
determining the final sensitivity by adjusting the first sensitivity (mental process/mathematical concepts)
wherein the determining of the final sensitivity comprises: obtaining an average sensitivity by applying a first weight to average sensor data obtained by averaging the plurality of sensor data, an average glucose value obtained by averaging a plurality of glucose values, and the first sensitivity (mental process/mathematical concepts);
determining sensitivity A based on the average sensitivity (mental process/mathematical concepts); and
determining the sensitivity A as the final sensitivity (mental process/mathematical concepts)
generating a glucose value from the sensor data based on the final sensitivity (mental process/mathematical concepts)
Claim 5
determining a first sensitivity from sensor data at the time of calibrating the sensitivity and a reference glucose value, based on the offset value (mental process/mathematical concepts);
determining the final sensitivity by adjusting the first sensitivity (mental process/mathematical concepts), and
generating a glucose value from the sensor data based on the final sensitivity (mental process/mathematical concepts),
wherein the determining of the final sensitivity comprises: obtaining an average sensitivity by applying a first weight to average sensor data obtained by averaging the plurality of sensor data, an average glucose value obtained by averaging a plurality of glucose values, and the first sensitivity (mental process/mathematical concepts);
determining sensitivity A based on the average sensitivity (mental process/mathematical concepts);
determining a new sensitivity from the sensitivity A according to whether a glucose value obtained from the offset value and the sensitivity A falls within a specific range (mental process/mathematical concepts); and
determining any one of the sensitivity A and the new sensitivity as the final sensitivity (mental process/mathematical concepts)
Claim 6
based on the offset value, determining a first sensitivity from sensor data at the time of calibrating the sensitivity and a reference glucose value (mental process/mathematical concepts);
obtaining an average sensitivity by applying a first weight to average sensor data obtained by averaging the plurality of sensor data, an average glucose value obtained by averaging a plurality of glucose values, and the first sensitivity (mental process/mathematical concepts);
determining sensitivity A based on the average sensitivity (mental process/mathematical concepts);
determining a new sensitivity from the sensitivity A according to whether a glucose value obtained from the offset value and the sensitivity A falls with a specified range (mental process/mathematical concepts);
determining the new sensitivity as the final sensitivity (mental process/mathematical concepts)
generating a glucose value from the sensor data based on the final sensitivity (mental process/mathematical concepts),.
These claim limitations fall within the identified groupings of abstract ideas:
Mathematical Concepts:
mathematical relationships
mathematical formulas or equations
mathematical calculations
Mental Processes
concepts performed in the human mind (including an observation, evaluation, judgment, opinion)
This judicial exception is not integrated into a practical application because:
Under the step 2A, analysis is conducted on the additional features of the claim. Under this analysis, the additional features beyond the judicial exception are:
Claim 1
a method performed by a controller of a terminal communicating with a sensor transmitter configured to be attached to a user for calibrating a sensitivity for glucose measurement, the controller comprising at least one processor (field of use, including processor structures used as a tool)
receiving, from the sensor transmitter, a plurality of sensor data each corresponding to a current value measured by a sensor of the sensor transmitter, the sensor being configured to be inserted into a skin of the user (field of use, including insignificant data gathering)
obtaining an offset value for determining a final sensitivity (insignificant data gathering)
outputting a glucose value from the sensor data based on the final sensitivity (insignificant post solution)
Claim 5
a method performed by a controller of a terminal communicating with a sensor transmitter configured to be attached to a user for calibrating a sensitivity for glucose measurement, the controller comprising at least one processor (field of use, including processor structures used as a tool)
receiving, from the sensor transmitter, a plurality of sensor data each corresponding to a current value measured by a sensor of the sensor transmitter, the sensor being configured to be inserted into a skin of the user (field of use, including insignificant data gathering)
obtaining an offset value for determining a final sensitivity (insignificant data gathering)
outputting a glucose value from the sensor data based on the final sensitivity (insignificant post solution)
Claim 6
a method performed by a controller of a terminal communicating with a sensor transmitter configured to be attached to a user for calibrating a sensitivity for glucose measurement, the controller comprising at least one processor (field of use, including processor structures used as a tool)
receiving, from the sensor transmitter, a plurality of sensor data each corresponding to a current value measured by a sensor of the sensor transmitter, the sensor being configured to be inserted into a skin of the user (field of use, including insignificant data gathering)
obtaining an offset value for determining a final sensitivity (insignificant data gathering);
outputting a glucose value from the sensor data based on the final sensitivity (insignificant post solution)
These features in the claim do not integrate the exception into a practical application of the exception as the additional elements in the claim do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is no more than a drafting effort designed to monopolize the exception.
Limitation concepts that are indicative of integration into a practical application:
Improvements to the functioning of a computer, or to any other technology or technical field - see MPEP 2106.05(a)
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c)
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception - see MPEP 2106.05(e) and Vanda Memo
Limitation concepts that are not indicative of integration into a practical application:
Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f)
Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g)
Generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.05(h)
Under Step 2B, the claim limitations are evaluated for an inventive concept. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, when considered separately and in combination, they do not add significantly more to the exception. Analyzing the additional claim limitations individually, the additional limitation that is not directed to the abstract idea are the same as those identified above in step 2A. Such limitations related to obtaining data are recognized by the courts as routine data gathering in order to input data to the mathematical algorithm/mental process, and thus, do not add a meaningful limitation to the method as it would be routinely used by those of ordinary skill in the art in order to apply the mathematical algorithm. The structure of these sensors are also well-known, routine, conventional in view of US 20070027385, US 20080287761, US 2010/0268477, US 2020/0121231, US 2023/0039204, and in general measure the expected analyte related data signals. The computer structures cited above are claimed as performing generic computer functions routinely used in computer applications. Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. The additional limitations recited in the dependent claims are directed to further details of the exception(s) (A more specific abstraction is still an abstraction). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Therefore, analyzing the claims as an ordered combination under the Mayo/Alice analysis the features claimed are directed to patent ineligible limitations.
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.
Claims 1, 3-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mueller, JR. et al. (Mueller, US 2010/0268477).
Regarding claim 1, Mueller teaches a method performed by a controller of a terminal communicating with a sensor transmitter configured to be attached to a user for calibrating a sensitivity for glucose measurement, the controller comprising at least one processor (see at least Figure 2, [0064]), the method comprising:
receiving, from the sensor transmitter, a plurality of sensor data each corresponding to a current value measured by a sensor of the sensor transmitter, the sensor being configured to be inserted into a skin of the user (see at least Figure 2, [0071], [0057]-[0062]);
obtaining an offset value for determining a final sensitivity (see at least Figures 13/15, [0011], [0094]-[0103], [0111]-[0114] e.g. offset value 0 or 3);
determining a first sensitivity from sensor data at the time of calibrating the sensitivity and a reference glucose value, based on the offset value (see at least Figures 13/15, [0098] includes any sensitivity ratio (SR) e.g. the MSPSR/MLRSR with offset 0 or 3);
determining the final sensitivity by adjusting the first sensitivity (see at least Figure 15, new SR as time proceeds incorporating past SR, see [0140]-[0144]); and
generating and outputting a glucose value from the sensor data based on the final sensitivity (see at least Figure 2, [0062], [0064], [0125]),
wherein the determining of the final sensitivity comprises:
obtaining an average sensitivity by applying a first weight to average sensor data obtained by averaging the plurality of sensor data, an average glucose value obtained by averaging a plurality of glucose values, and the first sensitivity (see at least [0131], [0140]-[0141]));
determining sensitivity A based on the average sensitivity (see at least Figure 15, MLRSR for current time); and
determining the sensitivity A as the final sensitivity (see at least Figure 15, MLRSR for current time).
Regarding claim 3, Mueller teaches wherein the determining of the sensitivity A based on the average sensitivity comprises: when a difference between the first sensitivity and the average sensitivity falls within a specific range, determining the first sensitivity as the sensitivity A; and when the difference falls outside the specific range, determining a result of applying a second weight to the average sensitivity as the sensitivity A (contingent limitations met by the rejection of claim 1 as the contingent limitations do not limit a positive claimed process that makes such difference determinations).
Regarding claim 4, Mueller teaches wherein the second weight increases over time to increase a reflection ratio of the average sensitivity to the sensitivity A (further limit the contingent features of claim 3, see rejection of claim 1).
Regarding claim 5, Mueller teaches a method performed by a controller of a terminal communicating with a sensor transmitter configured to be attached to a user for calibrating a sensitivity for glucose measurement, the controller comprising at least one processor (see at least Figure 2, [0064]), the method comprising:
receiving, from the sensor transmitter, a plurality of sensor data each corresponding to a current value measured by a sensor of the sensor transmitter, the sensor being configured to be inserted into a skin of the user (see at least Figure 2, [0071], [0057]-[0062]);
obtaining an offset value for determining a final sensitivity (see at least Figures 13/15, [0011], [0094]-[0103], [0111]-[0114] e.g. offset value 0 or 3);
determining a first sensitivity from sensor data at the time of calibrating the sensitivity and a reference glucose value, based on the offset value (see at least Figures 13/15, [0098] includes any sensitivity ratio (SR) e.g. the MSPSR/MLRSR with offset 0 or 3);
determining the final sensitivity by adjusting the first sensitivity (see at least Figure 15, new SR as time proceeds incorporating past SR, see [0140]-[0144]), and
generating and outputting a glucose value from the sensor data based on the final sensitivity (see at least Figure 2, [0062], [0064], [0125]),
wherein the determining of the final sensitivity comprises:
obtaining an average sensitivity by applying a first weight to average sensor data obtained by averaging the plurality of sensor data, an average glucose value obtained by averaging a plurality of glucose values, and the first sensitivity (see at least [0131], [0140]-[0141]);
determining sensitivity A based on the average sensitivity (see at least Figure 15, MLRSR for current time);
determining a new sensitivity from the sensitivity A according to whether a glucose value obtained from the offset value and the sensitivity A falls within a specific range (contingent limitation that is not required to be invoked and does not bear patentable weight e.g. glucose value never enters such range);
determining any one of the sensitivity A and the new sensitivity as the final sensitivity (see at least Figure 15, MLRSR for current time).
Regarding claim 6, Mueller teaches a method performed by a controller of a terminal communicating with a sensor transmitter configured to be attached to a user for calibrating a sensitivity for glucose measurement, the controller comprising at least one processor (see at least Figure 2, [0064]), the method comprising:
receiving, from the sensor transmitter, a plurality of sensor data each corresponding to a current value measured by a sensor of the sensor transmitter, the sensor being configured to be inserted into a skin of the user (see at least Figure 2, [0071], [0057]-[0062]);
obtaining an offset value for determining a final sensitivity (see at least Figures 13/15, [0011], [0094]-[0103], [0111]-[0114] e.g. offset value 0 or 3);
based on the offset value, determining a first sensitivity from sensor data at the time of calibrating the sensitivity and a reference glucose value (see at least Figures 13/15, [0098] includes any sensitivity ratio (SR) e.g. the MSPSR/MLRSR with offset 0 or 3);
obtaining an average sensitivity by applying a first weight to average sensor data obtained by averaging the plurality of sensor data, an average glucose value obtained by averaging a plurality of glucose values, and the first sensitivity (see at least [0131], [0140]-[0141]));
determining sensitivity A based on the average sensitivity (see at least Figure 15, MLRSR for current time);
determining a new sensitivity from the sensitivity A according to whether a glucose value obtained from the offset value and the sensitivity A falls within a specific range (contingent limitation that is not required to be invoked and does not bear patentable weight e.g. glucose value never enters such range);
determining the new sensitivity as the final sensitivity (further limits a contingent limitation that is not required to be invoked and does not bear patentable weight e.g. glucose value never enters such range); and
generating and outputting a glucose value from the sensor data based on the final sensitivity (further limits a contingent limitation that is not required to be invoked and does not bear patentable weight e.g. glucose value never enters such range; see also at least Figure 2, [0062], [0064], [0125]).
Response to Arguments
The examiner acknowledges applicant’s submission of amendments to the claims, drawings, and specification filed 8/12/2026; and IDS filed 7/31/2026.
Applicant’s arguments regarding the drawing objections have been fully considered and are persuasive due to the amendments to the drawings and specification; the objections are withdrawn.
Applicant’s arguments regarding the specification objections have been fully considered and are persuasive due to the amendments to the drawings and specification; the objections are withdrawn.
Applicant’s arguments regarding the claim rejections under 35 U.S.C. 112(b) have been fully considered and are partially persuasive due to the amendments to the claims; the rejections are updated to account for the amendments to the claims.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 101 have been fully considered but are not persuasive. Applicant argues that the claimed method does not recite any mathematical concepts, and that data is from a sensor of a sensor transmitter. The examiner respectfully disagrees as mathematical concepts are claimed as addressed in the rejection, and the new additions amount to data gathering/field of use of the claimed algorithm. Applicant argues that the claims amount to a practical application by improving sensors by calibrating with an offset but does not point to any discussion in the disclosure as filed, such that this amounts to attorney arguments. The examiner respectfully disagrees as the art of record uses offset in calibration as well, so the alleged improvement argues is known. Additionally, the improvement cannot be the exception itself. Applicant argues the at the claim does not recite mental processes. The examiner respectfully disagrees as mental process of observations or completing mathematical algorithms can be completed with pen and paper and still meet the mental process designation. Applicant argues claims 3-4, but a more specific abstraction is still an abstraction. The rejections are respectfully maintained as presented in the updated rejections to account for the amendments to the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20070027385, US 20080287761, US 2020/0121231, US 2023/0039204 teach related concepts to the disclosure related to sensitivity determinations.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571)272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL R BLOCH/ Primary Examiner, Art Unit 3791
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