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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 18, 2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on December 18, 2025. As directed by the amendment: no claims have been amended, no claims have been added, no claims have been canceled. Thus claims 11-27 are presently pending in this application, and claims 18-20 remain withdrawn.
Response to Arguments
Applicant’s arguments, see Remarks, filed December 18, 2025, have been fully considered but they are not persuasive. On pgs. 6-8 of the Remarks, applicant argues that Shimizu fails to disclose the limitations of independent claims 11 and 21 since Shimizu does not disclose or suggest medical devices, medical delivery devices, or components thereof. The examiner respectfully disagrees and notes that "for a component… having free ends" constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by the structural limitations. The examiner submits that the device of Shimizu meets the structural limitations of the claim as explained in the rejections of independent claims 11 and 21 in the final office action mailed 11/19/2025. The runner provides a structure capable of supporting a component that comprises at least two elongated members, thus it is capable of supporting a component of a medical delivery device that comprises at least two elongated members. Therefore, the Shimizu reads on all limitations of independent claims 11 and 21.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 11-16 and 21-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shimizu (WO 2011007626).
Regarding claim 11, Shimizu discloses a support element (Fig. 9A, runner 103) for a component of a medical delivery device that comprises at least two elongated members directed generally in a common direction and having free ends (Annotated Fig. 9A below, runner 103 supports a component 105 with at least two elongated members directed generally in a common direction and having free ends. Examiner notes: "for a component… having free ends" constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by the structural limitations. The examiner submits that the device of Shimizu meets the structural limitations of the claim, and the runner is capable of supporting a component of a medical delivery device that comprises at least two elongated members), wherein the support element is configured to connect and support the at least two elongated members from being entangled (Annotated Fig. 9A, runner 103 connects and supports the elongated members from being entangled), where the support element is detachable prior to final assembly of the medical delivery device (Figs. 9A-B and Pg. 1, para. 3, the runner is detached from the component 105 prior to the final assembly of the device).
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Annotated Fig. 9A of Shimizu
Regarding claim 12, Shimizu discloses the support element according to claim 11, wherein the support element is arranged adjacent the free ends of the at least two elongated members (Annotated Fig. 9A, the runner 103 connects to the component 105 at the free ends of the elongated members).
Regarding claim 13, Shimizu discloses the support element according to claim 11, wherein the support element is integrated with the elongated members when the component is manufactured (Fig. 9A and pg. 2 para. 2, the runner 103 is formed integrally with the component 105).
Regarding claim 14, Shimizu discloses the support element according to claim 13, wherein the support element is molded in one piece with the component (Fig. 9A and pg. 2 para. 2, the runner 103 is integrally molded with the component 105).
Regarding claim 15, Shimizu discloses the support element according to claim 11, further provided with detachment areas adjacent the elongated members (Annotated Fig. 9A and Fig. 9B, runner 103 has gate portions 109 adjacent the free ends of the elongated members).
Regarding claim 16, Shimizu discloses the support element according to claim 15, wherein the detachment areas are arranged with lesser structural material than the rest of the support element (Fig. 9B, gate portions 109 are made with lesser structural material than the rest of the runner 103).
Regarding claim 21, Shimizu discloses a support element (Fig. 9A, runner 103) for a component configured to surround and support a plunger rod of a medical delivery device, the component having at least two elongated members directed generally in a common direction and having free ends (Annotated Fig. 9A below, runner 103 surrounds and supports a component 105 with at least two elongated members directed generally in a common direction and having free ends. Examiner notes: "configured to surround… having free ends" constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by the structural limitations. The examiner submits that the device of Shimizu meets the structural limitations of the claim, and the runner is capable of surrounding and supporting a plunger rod of a medical delivery device that comprises at least two elongated members), wherein the support element is configured to connect and support the at least two elongated members of the component (Annotated Fig. 9A, runner 103 connects and supports the elongated members), and wherein the support element is detachable prior to final assembly of the medical delivery device (Figs. 9A-B and Pg. 1, para. 3, the runner is detached from the component 105 prior to the final assembly of the device).
Regarding claim 22, Shimizu discloses the support element according to claim 21, wherein the support element is further configured to prevent the at least two elongated members of the component from being entangled when placed together in bulk (Annotated Fig. 9A, runner 103 connects and supports the elongated members from being entangled, when placed together with other components in bulk).
Regarding claim 23, Shimizu discloses the support element according to claim 22, wherein the support element is arranged adjacent the free ends of the at least two elongated members (Annotated Fig. 9A, the runner 103 connects to the component 105 at the free ends of the elongated members).
Regarding claim 24, Shimizu discloses the support element according to claim 22, wherein the support element is integrated with the elongated members when the component is manufactured (Fig. 9A and pg. 2 para. 2, the runner 103 is formed integrally with the component 105).
Regarding claim 25, Shimizu discloses the support element according to claim 24, wherein the support element is molded in one piece with the component (Fig. 9A and pg. 2 para. 2, the runner 103 is integrally molded with the component 105).
Regarding claim 26, Shimizu discloses the support element according to claim 22, further provided with detachment areas adjacent the elongated members (Annotated Fig. 9A and Fig. 9B, runner 103 has gate portions 109 adjacent the free ends of the elongated members).
Regarding claim 27, Shimizu discloses the support element according to claim 26, wherein the detachment areas are arranged with lesser structural material than the rest of the support element (Fig. 9B, gate portions 109 are made with lesser structural material than the rest of the runner 103).
Allowable Subject Matter
Claim 17 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 17, Shimizu discloses the support element according to claim 11.
Shimizu is silent to a component of a medical delivery device comprising the support element according to claim 11. No reference was found that would have made it obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Shimizu to satisfy these limitations in combination with the claim 11, from which claim 17 depends.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH D GRASMEDER whose telephone number is (571)272-0258. The examiner can normally be reached M-F 8 am-5 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BHISMA MEHTA can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783