DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
2nd Non-Final
As a result of the June 1, 2026 interview with the applicant, rejections under 35 USC 112 are hereby withdrawn.
Some Double Patenting rejections are made herewith. Since these rejections could have been in a previous action, the present action is made nonfinal.
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 19-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,205,511 in view of Colvin, Jr. (US 6,304,766).
Re claim 19:
Instant claim 19 is as follows:
“An analyte monitoring system for monitoring a first analyte type and a second analyte type different from the first analyte type, the system comprising: an integrated sensor and sensor electronics assembly comprising a sensor, wherein the sensor comprises a portion configured to be transcutaneously positioned in the body of a user, and wherein the integrated sensor and sensor electronics assembly is configured to sense levels of the first analyte type and the second analyte type; one or more processors; and non-transitory memory comprising one or more software functions stored thereon that, when executed by the one or more processors, causes the one or more processors to:select a software function of the one or more software functions based on a configuration of the integrated sensor and sensor electronics assembly;process data indicative of the levels of the first analyte type and the second analyte type using the selected software function.”
Claim 1 of the ‘511 patent is as follows:
“1. A computer-implemented method comprising: wirelessly transmitting, by an integrated sensor and sensor electronics assembly, data related to a configuration of the integrated sensor and sensor electronics assembly, wherein the integrated sensor and sensor electronics assembly comprises an on-body patch device configured for wireless communication with a reader device, and wherein the data comprises a sensor version of the integrated sensor and sensor electronics assembly; receiving, by the reader device the data related to the configuration of the integrated sensor and sensor electronics assembly, wherein the reader device comprises one or more processors and a memory coupled thereto, the memory storing one or more software functions for glucose monitoring; determining, by the one or more processors of the reader device, whether the integrated sensor and sensor electronics assembly is compatible with the one or more software functions by comparing the sensor version of the integrated sensor and sensor electronics assembly with a predetermined list; and selecting a software function of the one or more software functions based on the sensor version of the integrated sensor and sensor electronics assembly.”
The overall invention is in the same close category for both. The key aspect of “selecting a software function of the one or more software functions based on the sensor version of the integrated sensor and sensor electronics assembly” is common as well and most of the language of the instant claim has analogues in the claims of the patent.
A key difference is that in the instant claim, there are two analytes of different types.
Colvin, Jr. teaches (see for example claim 65) that a sensor embedded under the skin can sense two different analyte types.
In view of Colvin, Jr.’s teaches, it would have been obvious to detect two different analyte types as a matter of course for the sake of better measuring of a person’s health.
Re claims 20-33: The ‘511 patent uses codes for compatibility checking and further it is apparent that identifiers would be necessary. Various dependent claims are minor and ordinary recitations of features implied or obvious from the independent claim.
Claims 19-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-20 of U.S. Patent No. 11,783,941 in view of Colvin, Jr. (US 6,304,766).
Re claim 19:
Instant claim 19 is as follows:
“An analyte monitoring system for monitoring a first analyte type and a second analyte type different from the first analyte type, the system comprising: an integrated sensor and sensor electronics assembly comprising a sensor, wherein the sensor comprises a portion configured to be transcutaneously positioned in the body of a user, and wherein the integrated sensor and sensor electronics assembly is configured to sense levels of the first analyte type and the second analyte type; one or more processors; and non-transitory memory comprising one or more software functions stored thereon that, when executed by the one or more processors, causes the one or more processors to: select a software function of the one or more software functions based on a configuration of the integrated sensor and sensor electronics assembly; process data indicative of the levels of the first analyte type and the second analyte type using the selected software function.”
Claim 12 of the ‘941 patent is as follows:
“A system comprising: an integrated sensor and sensor electronics assembly comprising a glucose sensor, wherein the glucose sensor comprises a portion configured to be transcutaneously positioned in the body of a user and to sense glucose levels of the user; a reader device comprising: a first wireless receiver adapted to receive: data related to a configuration of the integrated sensor and sensor electronics assembly, wherein the data related to the configuration comprises an identification code associated with the integrated sensor and sensor electronics assembly; data indicative of an analyte level of a user from the integrated sensor and sensor electronics assembly; and one or more processors; and non-transitory memory comprising one or more software functions stored thereon that, when executed by the one or more processors, causes the one or more processors to: determine, based at least in part on the identification code, whether the integrated sensor and sensor electronics assembly is compatible with the reader device; process the data indicative of the analyte level of the user received from the integrated sensor and sensor electronics assembly using a software function correlated with the configuration of the integrated sensor and sensor electronics assembly; and display the processed data indicative of the analyte level of the user; a drug delivery device comprising a second wireless receiver adapted to receive the data indicative of the analyte level of the user.”
The overall invention is in the same close category for both. The ‘941 patent recites “using a software function correlated with the configuration of the integrated sensor and sensor electronics assembly” which is similar to “select a software function of the one or more software functions based on a configuration of the integrated sensor and sensor electronics assembly” from the instant claim.
A key difference is that in the instant claim, there are two analytes of different types.
Colvin, Jr. teaches (see for example claim 65) that a sensor embedded under the skin can sense two different analyte types.
In view of Colvin, Jr.’s teaches, it would have been obvious to detect two different analyte types as a matter of course for the sake of better measuring of a person’s health.
Re claims 20-33: The ‘941 patent has compatibility checking and this requires identifiers. Various dependent claims are minor and ordinary recitations of features implied or obvious from the independent claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL A HESS whose telephone number is (571)272-2392. The examiner can normally be reached Monday through Friday, from 9 AM to 5 PM.
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, Michael G. Lee can be reached at (571)272-2398. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL A HESS/Primary Examiner, Art Unit 2876
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