DETAILED ACTION
Note: The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s arguments filed in the reply on February 26, 2026 were received and fully considered. Claims 1 and 11 were amended. The current action is FINAL. Please see prior art rejections and response to arguments section below for more detail.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 26, 2026 has been considered by the examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-4, 7-14, and 17-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Valdes et al. (US PG Pub. No. 2012/0108934 A1) (hereinafter “Valdes”), Cosentino et al. (US PG Pub. No. 2007/0231846 A1) (hereinafter “Cosentino”), and MacLaughlin (US PG Pub. No. 2010/0331631 A1).
Valdes and Cosentino were applied in the previous office action.
With respect to claims 1 and 11, Valdes teaches an analyte monitoring device and method configured to receive analyte data from a plurality of analyte sensors (par.0065 “plurality of sensor modules… can receive a plurality of data streams from a plurality of sensor modules 8”), the analyte monitoring device comprising: wireless communication circuitry (par.0061 “wireless communication between the sensor electronics module 8 and the PC 20”) configured to: receive first sensor data, wherein the first sensor data is indicative of a first analyte level in a subject from a first analyte sensor (par.0050 “The module 8 continuously measures analyte concentration in a host and provides a data stream… representative of the host’s analyte concentration”); and one or more processors coupled with a memory (processor 482 and SRAM 488; see Fig. 4), the memory storing instructions that, when executed by the one or more processors, cause the one or more processors to: determine, based on the first sensor use information, a first setting associated with the first analyte sensor, wherein the first sensor use information is an identifier of the first analyte sensor (par.0007 “the device is configured for toggling between a first mode allowing for display of glucose concentration values associated with the continuous glucose sensor and a second mode preventing display of glucose concentration values associated with the continuous glucose sensor”; Note: toggling between first/second display modes is based on data derived from a particular analyte sensor, which impliedly has a unique identifier, model number, etc. as is widely known in the art); configure, based on the first setting, a graphical user interface of the analyte monitoring device for displaying the first sensor data and a first user interface setting (par.0007 “the device is configured for toggling between a first mode allowing for display of glucose concentration values associated with the continuous glucose sensor and a second mode preventing display of glucose concentration values associated with the continuous glucose sensor”; par.0059 “display a graphical representation of the analyte concentration”);
However, Valdes does not explicitly teach receive first sensor use information; and receive second sensor use information and second sensor data, wherein the second sensor data is indicative of a second analyte level in the subject from a second analyte sensor; determine, based on the second sensor use information, a second setting associated with the second analyte sensor, wherein the second sensor use information is an identifier of the second analyte sensor… wherein selection of the first user interface setting is configured to adjust a display of an alarm associated with the first analyte sensor; and configure, based on the second setting, the graphical user interface for displaying the second sensor data and a second user setting, wherein selection of the second user setting is configured to adjust display of sensor information associated with the second analyte sensor.
Cosentino teaches using sensor identifiers for different analyte sensors in order to allow for subsequent transmission of sensor data, displaying, etc. (par.0071, 0091, 0150-0152, 0180).
MacLaughlin teaches receive first sensor use information; and receive second sensor use information and second sensor data; determine, based on the second sensor use information, a second setting associated with the second sensor… wherein selection of the first user interface setting is configured to adjust a display of an alarm associated with the first sensor; and configure, based on the second setting, the graphical user interface for displaying the second sensor data and a second user setting, wherein selection of the second user setting is configured to adjust display of sensor information associated with the second sensor (par.0052-70 “user may initiate an application for viewing an organizing physiological data… of various physiological parameters… graphical buttons may correspond to specific functions that may be selected by the user… may display and organize physiological data, and may further provide various alerts…the user may also access the alerts option 302, which may allow the user to customize alert settings by selecting different parameters for various types of alerts… the user may have options to customize parameters for various types of alerts”; see also Figs. 9-11).
Therefore, it would have been prima facie obvious to person having ordinary skill in the art at the time of invention to modify Valdes to incorporate unique identifiers for additional analyte sensors, as desired, for the purpose of toggling between first/second display modes for each desired analyte sensor, as suggested by Valdes (par.0007), and Cosentino (par.0180). Valdes also discloses communication between multiple different analyte sensors (par.0066), thereby providing added motivation for PHOSITA to look to other teachings that utilize identifiers for transmitting data streams derived from multiple analyte sensors (Cosentino). Additionally, PHOSITA would have had predictable success at the time of invention modifying Valdes to allow for the user to select various interface settings, in the manner recited, in order to organize various physiological parameters, alerts, etc. as desired by the particular patient, as evidence by MacLaughlin (par.0052-70, see also Figs. 9-10).
With respect to claims 2 and 12, Valdes teaches the first analyte sensor is a first sensor type and the second analyte sensor is a second sensor type (par.0066 “multiple different analyte sensors… glucose sensor and a temperature sensor”).
With respect to claims 3 and 13, Valdes teaches wherein the first sensor type is different from the second sensor type (par.0066 “multiple different analyte sensors… glucose sensor and a temperature sensor”).
With respect to claims 4 and 14, Valdes teaches the first sensor type is a first model of a sensor and the second sensor type is a second model of a sensor (par.0066 “multiple different analyte sensors… glucose sensor and a temperature sensor”; Note: it is understood that a glucose sensor and a temperature sensor are different models, as they are obtaining different types of information).
With respect to claims 7 and 17, Valdes teaches wherein the first setting comprises a first configuration setting and the second setting comprises a second configuration setting (par.0007 “the device is configured for toggling between a first mode allowing for display of glucose concentration values associated with the continuous glucose sensor and a second mode preventing display of glucose concentration values associated with the continuous glucose sensor”).
With respect to claims 8 and 18, Valdes teaches wherein the first configuration setting comprises a first display setting for the first analyte level on the graphical user interface and the second configuration setting comprises a second display setting for the second analyte level on the graphical user interface (par.0007 “the device is configured for toggling between a first mode allowing for display of glucose concentration values associated with the continuous glucose sensor and a second mode preventing display of glucose concentration values associated with the continuous glucose sensor”).
With respect to claims 9 and 19, Valdes teaches wherein the first configuration setting comprises a first user interface setting for the first analyte level and the second configuration setting comprises a second user interface setting for the second analyte level (par.0007 “the device is configured for toggling between a first mode allowing for display of glucose concentration values associated with the continuous glucose sensor and a second mode preventing display of glucose concentration values associated with the continuous glucose sensor”).
With respect to claims 10 and 20, Valdes teaches wherein the first user interface setting controls a first visualization of the first analyte level on the graphical user interface and the second user interface setting controls a second visualization of the second analyte level on the graphical user interface (par.0007 “the device is configured for toggling between a first mode allowing for display of glucose concentration values associated with the continuous glucose sensor and a second mode preventing display of glucose concentration values associated with the continuous glucose sensor”).
Claims 5, 6, 15, and 16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Valdes, Cosentino, and MacLaughlin, as applied to claims 1 and 11 above, in further view of Hayter (US PG Pub. No. 2009/0036760 A1).
Hayter was applied in the previous office action.
With respect to claims 5, 6, 15, and 16, Valdes, Cosentino, and MacLaughlin teach an analyte monitoring device and method configured to receive analyte data from a plurality of analyte sensors, as established above.
However, Valdes, Cosentino, and MacLaughlin do not teach the limitations further recited in claims 5, 6, 15, and 16.
Regarding claims 5 and 15, Hayter teaches wherein the first analyte sensor is a glucose sensor and the second analyte sensor is a ketone sensor (par.0025-26 “the analyte monitoring system may be configured to monitor a variety of analytes… Analytes that may be monitored include… glucose… ketones”).
Regarding claims 6 and 16, Hayter teaches wherein the first analyte level comprises a glucose value and the second analyte level comprises a ketone value (par.0025-26 “the analyte monitoring system may be configured to monitor a variety of analytes… Analytes that may be monitored include… glucose… ketones”).
Therefore, it would have been prima facie obvious to PHOSITA at the time of invention to modify Valdes, Cosentino, and MacLaughlin to incorporate glucose and ketone sensors in order to monitor additional analytes as desired, as evidence by Hayter (par.0025-26).
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11576593. Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of one another.
Response to Arguments
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action have been considered, but are moot in view of the current combination of references that were necessitated by amendment. Please see prior art rejection section for updated citations (new MacLaughin reference) and updated obviousness rationale.
Applicant's arguments filed with respect to the double patenting rejections raised in the previous office action have been fully considered, but they are not persuasive. Examiner maintains that instant claims 1-20, as amended, are not patentably distinct from claims 1-16 of US Patent No. 11576593 as they are believed to be obvious variants. Therefore, these rejections are maintained.
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
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