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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/26/2025 has been entered.
Response to Arguments
Applicant's arguments filed 11/26/2025 have been fully considered.
Regarding the Interview Summary, the examiner agrees with Applicant’s characterization of the interview.
Regarding the prior 112 rejections, Applicant’s arguments are convincing. The amendments to the claims obviate the rejections and the rejection have therefore been withdrawn.
Regarding claim 1, Applicant argues that the amendment to the claim overcomes the rejections over Wei in view of Klimt, Horvath, Marshall, Kaufman, and/or Alphas. This arguments is convincing. However, upon further consideration, in light of the amendments, claim 1 is rejected over Horvath in view of Trosborg.
Regarding claim 23, Applicant’s arguments are convincing and the rejection is therefore withdrawn.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 8, 27-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horvath (US 2009/0069755) in view of Trosborg (US 2018/0110932).
Regarding claim 1, Horvath discloses a needle hub (fig. 6D annotated below) comprising a body having an open end for coupling with a medication delivery pen device (fig. 2), said body having a sidewall with an outer surface with an outer dimension (fig. 6D), and an inner surface with an inner dimension (fig. 6D), wherein the sidewall comprises a first region extending around said open end, wherein the first region is defined by a first surface extending from said open end and along said inner surface of the sidewall in a longitudinal direction of the hub, the first region has a first inner diameter (see fig. 6D annotated below), a second region, distal to the first region (see fig. 6D annotated below), a third region, distal to the second region, wherein the third region is threaded and has a third inner diameter less than the first inner diameter (see fig. 6D annotated below), and an inclined beveled edge along the inner surface of the sidewall, wherein the first surface terminates at the inclined beveled edge (see fig. 6D, annotated below), and a tower extending from the body and having a sidewall with an outer surface, an inner surface, and having an outer dimension less than said outer dimension of said body, and an and wall defining a skin contacting surface (fig. 6D).
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As discussed above, Horvath shows the second region as shown in the annotated figure, however it is not clear if the second region is actually un-threaded as claimed, or if the figure is showing a cross-section of the region in which the thread does not exist. Trosborg teaches a needle hub having a sidewall having a first region having a first inner diameter, a third region being threaded and having an inner diameter smaller than the first inner diameter, and a second region between the first region and the third region, the second region being un-threaded and having an inner diameter less than the first inner diameter (fig. 1(a)). The second portion assists in guiding the distal end of the pen injector into alignment with the threaded portion so that the threads will readily engage when the pen and needle hub are twisted relative to each other. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second portion of Horvath to have an un-threaded length as taught by Trosborg to provide a guiding surface to assist in guiding the distal portion of the pen injector into engagement with the threads for easy connection of the hub to the pen.
Regarding claim 8, Horvath shows, in a different embodiment than the one discussed above, an outer face of the end wall of the tower including an outer ring at an outer edge of the end wall and having an axial face that is inclined with respect to ta center axis of the needle hub, and an inner ring at a center portion of the end wall and having an axial face spaced inwardly from the outer ring with respect to the center axis, said inner ring and said outer ring defining a skin contact surface and defining a recess between the inner ring and outer ring (see fig. 10B, annotated below). This configuration reduces the pressure exerted against the patient’s skin and thereby increases patient comfort during injection (page 3, para. 0046). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tower of fig. 6D of Horvath to have the configuration shown in fig. 10B to provide reduced pressure on the skin during injection and therefore decreased pain.
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Regarding claim 27, in the combination described above with regard to claim 1, the second surface extends from the inclined beveled edge ( see fig. 6D annotated above).
Regarding claim 28, Horvath discloses a plurality of recesses formed in the outer surface, the recesses extending form the top end of the sidewall toward the open end (fig. 6B), wherein the recesses terminate proximally of the beveled edge (fig. 6D).
Regarding claim 29, Horvath discloses a plurality of recesses formed in the outer surface, the recesses extending form the top end of the sidewall toward the open end (fig. 6B).
Regarding claim 30, the plurality of recesses extend along the outer surface of the sidewall in the second region and the third region (figs. 6B, 6D).
Claim(s) 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horvath in view of Trosborg as applied to claim 1 above and further in view of Marshall et al (US 2012/0071835).
Regarding claim 9, Horvath discloses an inner shield 470 of the tower (fig. 4; page 1, para. 0010), the inner shield including a shell body with a sidewall having an inner surface with a first dimension to couple to the tower (fig. 4), a top wall, and a top portion extending from the top wall of the body, the top portion having a sidewall with an inner surface with a second dimension less than the first dimension (fig. 4).
Claim 9 further calls for the outer surface of the sidewall to have a friction surface configured for gripping by a user. Marshall teaches a shield having an outer surface with a friction surface (fig. 5) to allow the user to easily grasp and remove the shield. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer surface of the shield taught by Horvath to include a friction surface as taught by Marshall to assist the user in grasping and removing the shield.
Regarding claim 10, Horvath discloses an inner shield 470 (fig. 4), but fails to teach a plurality of flat sidewalls each having projecting members. Marshall teaches a shield for a pen needle, the shield comprising a plurality of substantially flat sidewalls 34 (sidewalls are smooth) with a surface facing outwardly from the inner shield, each of the side walls having a projecting member 38 for gripping the inner shield (fig. 6). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Wei to include a shield having substantially flat sidewalls and projecting members as taught by Marshall to protect the user from accidental sticks and allow the user to easily remove the cap when ready for use.
Regarding claim 11, Marshall further teaches that the sidewalls have a substantially convex curvature, and each projection member has an inclined major face (outwardly facing face) and an inclined minor face (inwardly facing face). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include this feature in the combination described above so that the cap can be readily grasped by the used for removal.
Regarding claim 12, Horvath discloses an outer cover with a body having a sidewall with an outer surface and an inner surface, the inner surface having an inner dimension to receive the needle hub (fig. 4), and a top section having an inner dimension less than the inner dimension of the body of the outer cover (fig. 4), the outer surface having a friction surface (fig. 3: ribs).
Allowable Subject Matter
Claims 23-26, 33, 34 are allowed.
Claims 31, 32 are 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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, 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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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783