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 .
Response to Arguments
Applicant's arguments filed 7/15/2026 have been fully considered.
Regarding the objection to the drawings, Applicant’s arguments are convincing. The amendments to the claims overcome the objection and the objection is therefore withdrawn.
Regarding the rejections under 112(b) and 112(d), Applicant’s arguments are convincing. The amendments to the claims clarify the claims and the objections are therefore withdrawn.
Regarding the rejection of claim 1 over Abry, Applicant’s arguments are convincing. The rejection is therefore withdrawn.
Regarding the rejection of claim 15 over Abry, Applicant’s arguments are not convincing. Applicant argues that Abry fails to teach that when the needle cover is removed the hook is configured to slide along an outer surface of the tip to assist in peeling the inner shield off the tip. Abry teaches this as can be seen in fig. 2, wherein the hook contacts the tip of the syringe and abuts the inner shield located thereon.
Regarding the rejections over Hasumi, Applicant’s arguments are convincing. The rejection is therefore withdrawn.
Claim Objections
Claim 15 is objected to because of the following informalities: claim 15 recites “a barrel extending a proximal face to a distal face”. This should read – from a proximal face to a distal face. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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) 1-6, 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aptar Stelmi SAS (JP 2016511677 A). For ease of discussion, please refer to document provide by Applicant on 5/7/2026 including English translation.
Regarding claim 1, Aptar Stelmi SAS discloses a needle cover 200 for protecting a needle 110 mounted on a tip of a medical injection device 100, wherein the tip extends from a distal end of the medical injection device (fig. 2), the needle cover, comprising: an inner shield 210 extending along a longitudinal axis, and an outer shield 220 surrounding at least partially the inner shield, and operatively connected to said inner shield (fig. 2), the needle cover being characterized in that: when the needle cover is positioned on the tip of the medical injection device, a proximal surface of the inner shield contacts a distal end of the tip of the medical injection device (fig. 3), and the proximal surface of the inner shield is configured to create an axial compression in a longitudinal direction on the distal end of the tip of the medical injection device (page 17, para. 0022).
Regarding claim 2, Aptar Stelmi SAS discloses that the proximal surface of the inner shield 210 is configured to contact a distalmost surface of the distal end of the tip of the medical injection device (fig. 3).
Regarding claim 3, Aptar Stelmi SAS discloses that inner shield 210 is configured to create an axial compression on the distal end of the tip of the medical injection device (page 17, para. 0022; fig. 3), and further shows a gap between the inner surface of the inner shield and the injection device (fig. 3) which provides a reduced radial compression of the inner shield on the distal end of the medical injection device.
Regarding claim 4, Aptar Stelmi SAS discloses that a proximal-most surface of the inner shield 210 is configured to contact a distalmost surface of the distal end of the tip of the medical injection device (fig. 3).
Regarding claim 5, Aptar Stelmi SAS discloses that the inner shield is made of a deformable material (rubber: page 6, para. 0008).
Regarding claim 6, Aptar Stelmi SAS discloses that the inner shield 210 is configured to receive at least a portion of the needle 110 (fig. 3).
Regarding claim 14, Aptar Stelmi SAS discloses a medical injection device, comprising: a barrel 101 extending a proximal face to a distal face (fig. 2), wherein a tip 102 is provided on the distal face of the barrel (fig. 2); and a needle cover 200 for protecting a needle 110 mounted on the tip of the medical injection device (fig. 2), the needle cover, comprising: an inner shield 210 extending along a longitudinal axis, and an outer shield 220 surrounding at least partially the inner shield, and operatively connected to said inner shield (fig. 2), the medical injection device being characterized in that: when the needle cover is positioned on the tip of the medical injection device, a proximal surface of the inner shield contacts a distal end of the tip of the medical injection device (fig. 3), and the proximal surface of the inner shield is configured to create an axial compression on the distal end of the tip of the medical injection device (page 17, para. 0022).
Claim(s) 15, 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abry (US 2014/0101912).
Regarding claim 15, Abry discloses a medical injection device, comprising: a barrel 10 extending from a proximal face to a distal face (fig. 2), wherein a tip is provided on the distal face of the barrel (fig. 2); and a needle cover 12, 51 for protecting a needle mounted on the tip of the medical injection device (fig. 2), the needle cover, comprising: an inner shield 12 extending along a longitudinal axis, and an outer shield 51 surrounding at least partially the inner shield, and operatively connected to said inner shield (fig. 2), the medical injection device being characterized in that: the outer shield includes at least one hook 55 that assists in removing the inner shield from the tip of the medical injection device when the needle cover is removed from the medical injection device (para. 0072), and wherein, when the needle cover is removed from the tip of the medical injection device, the at least one hook is configured to slide along an outer surface of the tip to assist in peeling the inner shield off of the tip (fig. 2: hooks contact the outer surface of the distal tip and abut the proximal surface of the inner shield).
Regarding claim 19, Abry discloses that hook is positioned on a proximal end of the outer shield (fig. 2).
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) 7, 9-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aptar Stelmi SAS as applied to claim 1 above, and further in view of Abry.
Claim 7 differs from Aptar Stelmi SAS in calling for the outer shield to include at least one hook that assists in removing the inner shield from the tip of the medical injection device when the needle cover is removed from the medical injection device. Abry teaches an injection device comprising a cover having an inner shield and an outer shield wherein the outer shield includes a hook 55 that assists in removing the inner shield from the tip of the medical device when the needle cover is removed from the injection device (page 4, para. 0066, 0072; fig. 2). 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 shield of Aptar Stelmi SAS to include a hook to assist in removing the inner shield from the tip of the medical device as taught by Abry to ensure that the shield is easily removed as intended to reduce the chance of an accidental stick.
Regarding claim 9, Abry teaches that the shield is formed of plastic (page 3, para. 0048), and the hooks being relatively small elements formed from a thin portion of material would result in the hook being made of a flexible material that allows the at least one hook to bend under pressure.
Regarding claim 10, Abry further teaches that the hook is angled inwardly relative to the longitudinal axis of the inner shield and distally relative to a proximal portion of the tip of the medical injection device (fig. 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the hooks in the claimed configuration as taught by Abry to provide a surface to abut the inner shield and apply the removal force thereto.
Regarding claim 11, Abry further teaches that the hook is configured to contact a shoulder 9 defined on the tip of the medical injection device when the needle cover is positioned on the tip of the medical injection device (fig. 2). 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 Aptar Stelmi SAS to include the hooks configured to contact a shoulder defined on the tip of the medical injection device as taught by Abry to provide an abutment surface that indicates that the shield is fully placed onto the injection device to ensure secure attachment thereto.
Regarding claim 12, Abry further teaches that the hook is positioned on a proximal end of the outer shield (fig. 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the hooks on the proximal end of the outer shield as taught by Abry to provide a surface for gripping the inner shield for ease of removal of the shield.
Regarding claim 13, Abry further teaches that when the needle cover is removed from the tip of the medical injection device, the at least one hook is configured to slide along an outer surface of the tip to assist in peeling the inner shield off of the tip (fig. 2). 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 to ensure that the hooks cannot become dislodged from the inner shield thereby ensuring that the inner shield is removed from the needle as desired.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Aptar Stelmi SAS in view of Abry as applied to Claim 7 above, and further in view of Bauss et al (US 20190217018).
Claim 8 differs from the teachings above in calling for the at least one hook to comprise three or four hooks formed on the outer shield. Bauss relates to injection devices having two coaxial, nested needle shields (Fig. 4) and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Bauss teaches that the hooks/barbs (54) by which the outer shield (52) grabs the inner shield (50b) to pull the inner shield off the needle tip (16c) can include three or four hooks formed on the outer shield (six are shown), which a person of ordinary skill in the art would understand improves the likelihood that the outer shield will successfully pull the inner shield off the needle in the event there are defects in any of the hooks/barbs. It would have been obvious, before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains, to construct the outer shield of Aptar Stelmi SAS in view of Abry so that the at least one hook comprises three or four hooks formed on the outer shield, because Bauss teaches doing so in a closely related device, which a person of ordinary skill in the art would understand improves the likelihood that the outer shield will successfully pull the inner shield off the needle in the event there are defects in any of the hooks/barbs.
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 5/7/2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(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 LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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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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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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