DETAILED ACTION
Note: 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 without traverse of claims 1-16 in the reply filed on December 17, 2025 is acknowledged. Claims 17-40 are withdrawn from consideration.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under U.S.C. 120, 121, or 365 is acknowledged. The prior-filed applications (16/009922 filed on 6/15/2018; and 62/520852 filed on 6/16/2017) are acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 14, 2023 has been considered by the examiner.
Claim Objections
Claim 5 is objected to because of the following informalities:
There is no period at the end of claim 5.
Appropriate correction is required.
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 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a method of calibrating an analyte sensor using one or more reference measurements. Thus, the claim is directed to a method/process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
“A method of calibrating an analyte sensor using one or more reference measurements, the method comprising… determining that the RM1 is unexpected; after determining that the RM1 is unexpected…determining that the RM2 is unexpected; after determining that the RM2 is unexpected…accepting one or more of the RM2 and the RM3 as calibration points; and calibrating the analyte sensor using at least one or more of the RM2 and the RM3 as calibration points.”
These limitations describe a mathematical calculation. Furthermore, the limitations also describe a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, or using simple pen/paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“…receiving a first reference analyte measurement (RM 1)… receiving a second reference analyte measurement (RM2)… receiving a third reference analyte measurement (RM3)”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant extra-solution activity, i.e., mere data gathering steps necessary to perform the identified judicial exception do not integrate the claims into a practical application. See MPEP 2106.05(g).
The additional limitations also do not add significantly more to the identified judicial exception because they relate to widely-understood, conventional, and routine techniques for obtaining data (analyte measurements). Examiner notes that receiving a first/second/third reference analyte measurement is recited at a high level of generality and, as such, these limitations do not recite significantly more.
Dependent claims 2-16 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, claims 1-17 are not patent eligible under 35 USC 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Brister et al. (US PG Pub. No. 2006/0019327 A1) (hereinafter “Brister”).
Brister was cited in applicant’s IDS filed on August 14, 2023.
With respect to claim 1, Brister teaches a method of calibrating an analyte sensor using one or more reference measurements (par.0266-270 “Calibration of an analyte sensor… reference analyte value is used to calibrate the data signal”), the method comprising: receiving a first reference analyte measurement (RM 1) (par.0266 “a reference analyte value is used to calibrate the data signal”); determining that the RM1 is unexpected (par.0270 “reference data can be subjected to "outlier detection" wherein the accuracy of a received reference analyte data is evaluated as compared to time-corresponding sensor data”); after determining that the RM1 is unexpected, receiving a second reference analyte measurement (RM2) (par.0270 “If the data is not within the predetermined threshold, then the receiver can be configured to request additional reference analyte data”); and calibrating the analyte sensor using at least one or more of the RM2 and the RM3 as calibration points (par.0270 “If the additional reference analyte data confirms (e.g., closely correlates to) the first reference analyte data, then the first and second reference values are assumed to be accurate and calibration of the sensor is adjusted or re-initialized”).
Although Brister does not explicitly teach determining that the RM2 is unexpected; after determining that the RM2 is unexpected, receiving a third reference analyte measurement (RM3); accepting one or more of the RM2 and the RM3 as calibration points, further modification to incorporate this feature would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed for the following reasons. First, Brister expressly teaches that the receiver can be configured to request additional reference analyte data when the prior received data is not within a predetermined threshold (par.0270); and considers “other methods of outlier detection are possible” (par.0270, last sentence). Accordingly, PHOSITA would have had predictable success further modifying Brister to receive additional/third reference analyte measurements in the event that the prior data (first/second reference values) are not within the predetermined threshold for the purpose of calibrating the analyte sensor while considering other methods of outlier detection, as expressly suggested by Brister (par.0270). Moreover, Examiner argues that modifying Brister to incorporate receiving an additional/third reference analyte measurement upon determining that the RM2 is unexpected would have been prima facie obvious to PHOSITA when the invention was filed since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
With respect to claim 2, Brister teaches after determining that the RM2 is unexpected, accepting the RM1 (par.0266-0270).
With respect to claim 3, Brister teaches after determining that the RM2 is unexpected, rejecting the RM1 (par. 0266-0270).
With respect to claim 4, Brister suggests wherein accepting one or more of the RM2 and the RM3 as calibration points comprises accepting both the RM2 and the RM3 as calibration points (par. 0266-0270).
With respect to claim 5, Brister suggests wherein calibrating the analyte sensor uses at least the RM2 and the RM3 as calibration points (par. 0266-0270).
With respect to claim 6, Brister suggests wherein accepting one or more of the RM2 and the RM3 as calibration points comprises storing one or more of the RM2 and the RM3 in a calibration point memory (par.0266-0270).
With respect to claim 7, Brister suggests wherein calibrating the analyte sensor comprises calibrating a conversion function used to convert sensor data received from the analyte sensor into a sensor analyte measurement (par.0266-0270).
With respect to claim 8, Brister suggests wherein: an analyte monitoring system comprises the analyte sensor a transceiver; and the transceiver is used to receive the RM1, determine that the RM1 is unexpected, receive the RM2, determine that the RM2 is unexpected, receive the RM3, accept the one or more of the RM2 and the RM3 as calibration points, and calibrate the analyte sensor using the at least one or more of the RM2 and the RM3 as calibration points (par.0266-0270).
With respect to claim 9, Brister suggests using the analyte sensor to generate and convey sensor data indicative of an amount or concentration of an analyte in proximity to an analyte indicator of the analyte sensor; using the transceiver to receive the sensor data conveyed by the analyte sensor; using the transceiver to use the sensor data to calculate a first sensor analyte measurement (SM1) without the RM1 as a calibration point; and using the transceiver to use the sensor data to calculate a second sensor analyte measurement (SM2) with the RM1 as a calibration point (par.0266-0284).
With respect to claim 10, Brister suggests wherein determining that the RM2 is unexpected comprises comparing the RM2 with the SM1 and comparing the RM2 with the SM2 (par.0266-0284).
With respect to claim 11, Brister suggests wherein determining that the RM2 is unexpected comprises determining that a difference between the RM2 and the SM1 is not within a threshold amount and determining that a difference between the RM2 and the SM2 is not within a threshold amount (par.0266-0284).
With respect to claim 12, Brister suggests using the analyte sensor to generate and convey sensor data indicative of an amount or concentration of an analyte in proximity to an analyte indicator of the analyte sensor; using the transceiver to receive the sensor data conveyed by the analyte sensor; using the transceiver to use the sensor data to calculate a first sensor analyte measurement (SM1) without the RM2 as a calibration point; and using the transceiver to use the sensor data to calculate a second sensor analyte measurement (SM2) with the RM2 as a calibration point (par.0266-0284).
With respect to claim 13, Brister suggests wherein accepting one or more of the RM2 and the RM3 as calibration points comprises: determining that the difference between the RM3 and the SM1 is within the threshold amount; and determining that the RM3 is closer to the SM1 than to the SM2 (par.0266-0284).
With respect to claim 14, Brister suggests wherein accepting one or more of the RM2 and the RM3 as calibration points comprises accepting the RM3 as a calibration point and not accepting the RM2 as a calibration point (par.0266-0284).
With respect to claim 15, Brister suggests wherein calibrating the analyte sensor uses at least the RM3 as a calibration point and does not use the RM2 as a calibration point (par.0266-0284).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Brister, as applied to claim 12 above, in view of Petrich et al. (US PG Pub. No. 2014/0242622 A1) (hereinafter “Petrich”).
With respect to claim 16, Brister teaches a method of calibrating an analyte sensor using one or more reference measurements, as set forth above.
However, Brister does not teach the limitations further recited in claim 16.
Petrich teaches using a light source of the analyte sensor to emit excitation light that interacts with indicator molecules of an analyte indicator of the analyte sensor, wherein using the analyte sensor to generate the sensor data comprises using a photodetector of the analyte sensor to generate a measurement indicative of a level of emission light emitted by the indicator molecules (par.0143 “analyte detector 136 also can include an analyte photodetector 146 for absorbing detection light 148… light source 140 and/or the analyte photodetector 146 can be… a light-emitting diode or photodiode”).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Brister to incorporate a light source, photodetector, etc. in the manner claimed in order to detect one or more analytes in a sample, as evidence by Petrich (par.0003). Additionally, both Brister and Petrich relate to the same narrow field of endeavor (analyte calibration techniques, see rejection headings above and Petrich par.0020), thereby providing added motivation for PHOSITA to combine these teachings to arrive at the claimed invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-16 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,723,565. Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of one another.
Conclusion
No claim is allowed.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791