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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 20 February 2026 has been entered.
Remarks
Applicant's arguments filed 20 February 2026 have been fully considered. Applicant’s attempt to hold the a nonstatutory double patenting (NSDP) in abeyance is not fully responsive.
MPEP 804 states “[a] complete response to a … [NSDP] rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims, or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required… As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only compliance with objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated."
Here, the applicant rolled a dependent claim limitation into the independent claim. The dependent claim limitation was not rejected with art, rather it was only under NSDP rejection. The applicant has not filed a TD, nor did they reply to rebut the NSDP rejections. Accordingly, the 20 February 2026 response was not fully responsive. The examiner is using their discretion to accept the response as adequate. Continued attempts to hold NSDP rejections in abeyance will not be met with the same discretion.
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, 4-15, 18-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,311,459 in view of Valentini (4,576,211). Valentini shows the claimed location of the one-way valve opening of the cannula in relation to its two ends and in relation to the aspiration housing, as claimed. See the art rejection below. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize the teachings of Valentini as an obvious rearrangement of parts for the purpose of venting the syringe and vial during connection to allow for easier operation. The rest of the limitations are broader than the patent. Additionally, see Sanders 2015/0297839) for swapping one known seal arrange for another, i.e. selecting the collet is an obvious engineering design choice.
Claims 2-3, 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,311,459 in view of Valentini (4,576,211) further in view of Sanders 2015/0297839) which teaches another seal arrangement for swapping one known seal arrange for another, i.e. selecting the collet is an obvious engineering design choice.
Claims 1, 4-15, 18-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,806,309 in view of Valentini (4,576,211). Valentini shows the claimed location of the one-way valve opening of the cannula in relation to its two ends and in relation to the aspiration housing, as claimed. See the art rejection below. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize the teachings of Valentini as an obvious rearrangement of parts for the purpose of venting the syringe and vial during connection to allow for easier operation. The rest of the limitations are broader than the patent.
Claims 2-3, 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,806,309 in view of Valentini (4,576,211) further in view of Sanders 2015/0297839) which teaches another seal arrangement for swapping one known seal arrange for another, i.e. selecting the collet is an obvious engineering design choice.
Allowable Subject Matter
Claims 1-26 would be allowable once the NSDP rejection is overcome.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Timothy P. Kelly whose telephone number is (571)270-7615. The examiner can normally be reached from 8:30 a.m. to 4:30 p.m. (ET) on Monday, Thursday, and Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Craig M Schneider can be reached at (571) 272-3607. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Timothy P. Kelly/Primary Examiner, Art Unit 3753