DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,370,318. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent discloses a supplemental device for attachment to an injection device, the supplemental device having a sleep mode and an active mode (claim 1; Col. 43, lines 15-17), and comprising: a housing (Col. 43, line 18); an electromechanical switch having an open state and a closed state (Col. 43, lines 19-20), the electromechanical switch comprising a switching member and a spring configured to bias the electromechanical switch into the open state (Col. 43, lines 20-22); and two electrical contacts disposed on an inner wall of the electromechanical switch, the two electrical contacts configured to be engaged by corresponding electrical contacts on the switching member (Col. 43, lines 23-26) , wherein the two electrical contacts and/or the corresponding electrical contacts on the switching member are sprung contacts (Col. 43, lines 26-28); and a processor configured to: place the supplemental device into the sleep mode (Col. 43, lines 35-36); monitor the electromechanical switch while the supplemental device is in the sleep mode; and change a mode of the supplemental device from the sleep mode to the active mode in response to detecting a change in a state of the electromechanical switch (Col. 43, lines 37-42).
Regarding claim 3, the subject matter is known from claim 2 of the patent.
Regarding claim 4, the subject matter is known from claim 1 of the patent (Col. 43, lines 30-36).
Regarding claim 5, the subject matter is known from claim 3 of the patent.
Regarding claim 6, the subject matter is known from claim 4 of the patent.
Regarding claim 7, the subject matter is known from claim 5 of the patent.
Regarding claim 8, the subject matter is known from claim 6 of the patent.
Regarding claim 9, the subject matter is known from claim 7 of the patent.
Regarding claim 10, the subject matter is known from claim 8 of the patent.
Regarding claim 11, the subject matter is known from claim 9 of the patent.
Regarding claim 12, the subject matter is known from claim 13 of the patent.
Regarding claim 13, the subject matter is known from claim 16 of the patent.
Regarding claim 14, the subject matter is known from claim 17 of the patent.
Regarding claim 15, the subject matter is known from claim 18 of the patent.
Regarding claim 16, the subject matter is known from claim 13 of the patent (Col. 45, lines 4-10).
Regarding claim 17, the subject matter is known from claim 19 of the patent.
Regarding claim 18, the subject matter is known from claim 20 of the patent.
Regarding claim 19, the subject matter is known from claim 10 of the patent. It is noted that claim 2, from which claim 10 depends, teaches the “supplemental device for attachment to an injection device….” Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to provide the injection device along with the supplemental device of the patent to allow the assembly to be used as designed along with the claimed injection device. Claim 19 would therefore teach the same subject matter as claim 10 of the patent.
Regarding claim 20, the subject matter is known from claim 12 of the patent. It is noted that claim 2, from which claim 12 depends, teaches the “supplemental device for attachment to an injection device….” Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to provide the injection device along with the supplemental device of the patent to allow the assembly to be used as designed along with the claimed injection device. Claim 20 would therefore teach the same subject matter as claim 12 of the patent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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