DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s preliminary amendments filed on 03/19/2024 are acknowledged.
Claims 21-40 are pending for examination. Claims 1-20 are cancelled.
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 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 38-39 of U.S. Patent No. 9,642,568. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 38-39 of ‘568 anticipate or recited similar limitations as claims 21-22 of present application.
Claim 21 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 34 of U.S. Patent No. 9,943,256 in view of Curry (USPGPUB 2009/0024015 – applicant cited). In regard to claim 21 of present application, claims 34 of ‘256 recites all the claimed limitations except the first substrate and having a proximal portion that is configured to be disposed externally to a body of a user and a distal portion configured for internal placement in the body of the user and the second substrate and having a proximal portion that is configured to be disposed externally to the body of the user and a distal portion configured for internal placement in the body of the user. Curry teaches an implantable glucose sensor (elements 10 and 30, Figs. 1-5) comprises a flexible substrate having opposite first and second surfaces (element 20, Figs. 1-4), an optical glucose sensor disposed on the flexible substrate ([0010]; [0026]), and a non-optical glucose sensor disposed on the flexible substrate (electrodes 14, 16 and 20, Figs. 1-4; [0010]) and proximal portions configured to be disposed externally to a body of a user (element 36, Figs. 2-3) and distal portions configured for internal placement in the body of the user (element 10, Figs. 2-3). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the sensor (claim 34 of ‘256) to incorporate the implantable configuration of the device with integrated optical and non-optical glucose sensors as taught by Curry, since both sensors are glucose sensors including optical and non-optical glucose sensors. The rationale would have been to obtain glucose information from internal tissue of the user.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-11, 15-23 of U.S. Patent No. 10,194,845. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-3, 6-11, 15-23 of ‘845 anticipate or recited similar limitations as claims 21-40 of present application.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,229,384. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-20 of ‘384 anticipate or recited similar limitations as claims 21-40 of present application.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,931,145. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-19 of ‘145 anticipate or recited similar limitations as claims 21-40 of present application.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mastrototaro et al. (USPGPUB 2008/0161664 - applicant cited) teaches a glucose sensor redundancy comprises the use of two different types of sensors which may offer the ideal redundancy needed to assure failsafe performance of the system that relies heavily on accurate sensor readings and the types of sensor includes electro-enzymatic based, chemical based, optical based or the like ((0048-0050]; claims 1 and 4). Gratzl et al. (USPGPUB 2004/0180391- - applicant cited) teaches an orthogonal redundant glucose sensor with sensor housed in a housing (multiple redundancies of electrochemical and optical sensor probes integrated in the sensor probe 10, [0090-0096]) and position the sensor(s) into tissue either with ([(0264]) or without wire(s) (Figs. 2-4 and associated descriptions).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHU CHUAN LIU whose telephone number is (571)270-5507. The examiner can normally be reached M-Th (6am-6pm).
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, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHU CHUAN LIU/Primary Examiner, Art Unit 3791