DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 24, 31, and 38 are objected to because of the following informalities:
Claim 24, line 1, “bent” should read “bend”.
Claim 31, line 1, “bent” should read “bend”.
Claim 38, line 1, “bent” should read “bend”.
Appropriate correction is required.
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 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,274,668 (Cho). Although the claims at issue are not identical, they are not patentably distinct from each other because:
U.S. App. No. 19/073399
Cho
Claim 21
Claim 1 and 8
Claim 22
Claim 2
Claim 23
Claim 3
Claim 24
Claim 4
Claim 25
Claim 5
Claim 26
Claim 7
Claim 27
Claim 1
Claim 28
Claim 1 and 8
Claim 29
Claim 2
Claim 30
Claim 3
Claim 31
Claim 4
Claim 32
Claim 5
Claim 33
Claim 7
Claim 34
Claim 1
Claim 35
Claim 1 and 8
Claim 36
Claim 2
Claim 37
Claim 3
Claim 38
Claim 4
Claim 39
Claim 5
Claim 40
Claim 7
Allowable Subject Matter
Claims 21-40 would be allowable if rewritten or amended to overcome the rejection(s) under double patenting, set forth in this Office action.
The following is an examiner's statement of reasons for allowance: the prior art fails to disclose, in combination with other limitations of the claims, a method including providing an inserter for an analyte monitoring system including a needle hub with an injection molded piece surrounding a needle that is oriented non-parallel with respect to a longitudinal axis of the injection molded piece and where the injection molded piece has a metal core that is coincident with the longitudinal axis, as recited in each independent claim.
The reasons for allowance of the claims is clear from the written record of prosecution. Attention is specifically drawn to US 2017/0196487 (Feldman) which teaches a related inserter (100) having a needle hub 101 with a needle (114) and an analyte sensor (112). The needle is oriented non-parallel with respect a longitudinal axis of the injection molded piece (FIG. 1; P0058). However, the injection molded piece is plastic and is devoid of a metal core that is coincident with longitudinal axis.
As discussed above, Feldman does not anticipate applicant's claimed invention. Furthermore, there does not appear to be a reason, absent hindsight, to modify the injection molded piece of Feldman, alone or in combination, to include the metal core. Therefore, the cited references taken singly or in combination do not anticipate or make obvious applicant's claimed invention.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled "Comments on Statement of Reasons for Allowance."
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TODD J SCHERBEL whose telephone number is (571)270-7085. The examiner can normally be reached Mon - Fri 9:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TJ SCHERBEL
Primary Examiner
Art Unit 3771
/TODD J SCHERBEL/Primary Examiner, Art Unit 3771
Prosecution Insights