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 7/6/2026 have been fully considered.
Regarding claims 1 and 7, Applicant argues that Vitello fails to teach a tamper evidence ring having a lower portion and an upper portion connected by a bridge, wherein each portion has a portion of the antenna. The examiner agrees that Vitello does not teach this in combination with the inner and outer shields as currently recited in claim 1. However, upon further consideration, in light of the amendments, a new ground(s) of rejection is made in view of Vitello (US 6,585,691) which teaches a tamper ring 13 similar to that of Vitello ‘592, and further including an inner shield 18 and an outer shield 14.
Claim Objections
Claims 1, 3, 7 are objected to because of the following informalities:
Claim 1 recites “A needle cover for protecting a needle mounted on a tip of a medical injection device, wherein the tip extends from a distal end of the medical injection device, the needle cover, comprising: …”. The last comma in this section appears to be a typo, rendering the claim unclear. This should read … the needle cover comprising:.
Claim 2 lists alternatives, and claim 3 which depends from claim 2 recites “the RFID tag is overmolded…”. It is not clear if claim 3 is a conditional claim, e.g., if the ring comprises an RFID tag, the RFID tag is overmolded, or if claim 3 intends to limit the claim to the RFID tag and further limit the tag.
Claim 7 recites “a needle cover for protecting a needle mounted on a tip of a medical injection device, the needle cover, comprising: …”. The last comma in this section appears to be a typo, rendering the claim unclear. This should read … the needle cover comprising:.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole 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. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 5, 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vitello (US 6,585,691) [hereinafter Vitello ‘691] in view of Vitello (US 9,311,592) [hereinafter Vitello ‘592].
Regarding claim 1, the limitation “for protecting a needle mounted on a tip of a medical injection device, wherein the tip extends from a distal end of the medical injection device” is interpreted to be an intended use of the cover wherein the needle and medical injection device are not positively recited. Vitello ‘691 discloses a cover capable of protecting a needle mounted on a medical injection device, the cover comprising: an inner shield 18 extending along a longitudinal axis, and an outer shield 14 surrounding at least partially the inner shield (fig. 11), and operatively connected to said inner shield (col. 8, lines 3-5), wherein the needle cover further comprises a tamper evidence ring 13 that identifies whether the needle cover has been removed from the tip of the medical injection device (col. 8, lines 38-48), and wherein the tamper evidence ring comprises a lower portion 20 and an upper portion 16 connected by a bridge 22 (fig. 4).
Claim 1 differs from wherein each of the lower portion and the upper portion include a portion of an antenna. Vitello ‘592 teaches a tamper ring of similar construction to that of Vitello ‘691 and further wherein each of the lower portion and the upper portion include a portion of an antenna so that separation of the upper portion from the lower portion breaks the antenna to indicate that the cap has been tampered with (figs. 16, 16A; col. 15, lines 1-19). 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 tamper ring of Vitello ‘592 to include an antenna in each of the upper portion and the lower portion as taught by Vitello ‘592 to provide an indication that the cap has been tampered with.
Regarding claim 2, Vitello ‘592 further teaches that the tamper evidence ring comprises a radio frequency identification (RFID) tag (col. 15, lines 1-5) that can be scanned to provide and indication that the cap has been tampered with even when the tampering is not evident to the eye. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the device described above with regard to claim 1 to include an RFID tag as taught by Vitello ‘592 to provide an indication of tampering and reduce human error.
Regarding claim 3, Vitello ‘592 further teaches that the RFID tag is overmolded with the tamper evidence ring (col. 15, lines 1-3).
Regarding claim 5, Vitello ‘592 further teaches that a conductive bridge is established between the antenna portions of the lower portion and the upper portion of the tamper evidence ring (fig. 16A: portion of antenna 204 located on bridge 34). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a conductive bridge on the bridge portion as taught by Vitello ‘592 to provide a breakable connection that can be detected when the cap is tampered with.
Regarding claim 6, Vitello ‘691 discloses a bridge 22 that establishes a breakable connection between the tamper evidence ring and the medical injection device (fig. 4).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vitello ‘691 in view of Vitello ‘592 in view of Brunel (US 7,094,223).
Regarding claim 7, Vitello ‘691 discloses a medical injection device comprising a barrel 11 extending from a proximal face to a distal face, wherein a tip 4 is provided on the distal face of the barrel (fig. 13), and a cover 10 mounted on the tip of the medical injection device (fig. 14), the cover comprising: an inner shield 18 extending along a longitudinal axis, and an outer shield 14 surrounding at least partially the inner shield (fig. 11), and operatively connected to said inner shield (col. 8, lines 3-5), wherein the needle cover further comprises a tamper evidence ring 13 that identifies whether the needle cover has been removed from the tip of the medical injection device (col. 8, lines 38-48), and wherein the tamper evidence ring comprises a lower portion 20 and an upper portion 16 connected by a bridge 22 (fig. 4).
Claim 7 differs from wherein each of the lower portion and the upper portion include a portion of an antenna. Vitello ‘592 teaches a tamper ring of similar construction to that of Vitello ‘691 and further wherein each of the lower portion and the upper portion include a portion of an antenna so that separation of the upper portion from the lower portion breaks the antenna to indicate that the cap has been tampered with (figs. 16, 16A; col. 15, lines 1-19). 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 tamper ring of Vitello ‘592 to include an antenna in each of the upper portion and the lower portion as taught by Vitello ‘592 to provide an indication that the cap has been tampered with.
Claim 7 further differs from Vitello ‘691 in calling for a needle mounted on the tip of the injection device, and the needle cover protecting the needle. Brunel teaches an injection device comprising a tamper evident cover that covers a needle attached to the distal tip of the injection device (fig. 7). It would have been obvious to modify the injection device of Vitello ‘691 to include the needle on the distal end of the injection device, the cover protecting the needle as taught by Brunel to increase ease of use of the injection device as a needle does not need to be attached after removal of the cover.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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