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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 28, 2026 has been entered.
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.
Claim(s) 1, 4-5, 7-8, 10-11, 13-17, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schader et al. (US 2018/0369497 A1).
With regard to claims 1, 7, 8, and 14, Schader et al. teach an injection device (Fig. 1a, [0045]) comprising: a needle (Fig. 5 member 17); a needle sleeve surrounding the needle, the needle sleeve having an aperture and being arranged such that the needle extends through the aperture during an injection process (Fig. 2 sleeve 13, aperture 38, [0077]); and a needle obscuring element reversibly movable between a first position and a second position relative to the needle sleeve, wherein the needle obscuring element is coupled to the needle sleeve when in the first position and when in the second position, and wherein the needle obscuring element is arranged to cover a larger portion of the aperture when in the second position than when in the first position (member 19, first position shown in Figs. 2 and 6, second position shown in Figs. 5 and 7), wherein the needle obscuring element is biased towards the second position, wherein the needle obscuring element comprises a plurality of flaps arranged within the needle sleeve, wherein the plurality of flaps are pivotally coupled to the needle sleeve such that the plurality of flaps can pivot between the first position and the second position (curved tips of members 19 are flaps which are biased to pivot about a living hinge, see exemplary transition from Figs. 6-7, see Reference Figure 1 below), wherein each respective flap of the plurality of flaps is biased towards the second position by a respective resilient member, and wherein each respective resilient member either:(i) comprises a protrusion extending from the respective flap that contacts an inner surface of the needle sleeve to exert a force on the inner surface of the needle sleeve, or (ii) is coupled to the needle sleeve and contacts the respective flap to exert a force on the respective flap to push the plurality of flaps into the second position (Reference Figure 1 below), and wherein the needle obscuring element is arranged to move from the first position to the second position in response to removal of a cap from the needle sleeve of the injection device (see transition from Fig. 2 to Fig. 5 when cap including at least 70 is removed, [0071]).
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With regard to claim 4, see [0059], needle 17 and housing 11 can be locked (Fig. 1b).
With regard to claim 5, see [0058], housing 11 and sleeve 13 can be locked (Fig. 1b).
With regard to claim 10, see Fig. 5.
With regard to claim 11, see [0071] and at least Fig. 5, members 19 are attached to the inner wall of 13 and are taken as integrally formed as they are integrated together. The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
With regard to claims 13 and 20, see Fig. 2 cap 70 and shield members including at least 40 and 41.
With regard to claim 15, see Fig. 2 member 15 ([0045]).
With regard to claims 16 and 17, see [0077].
Claim(s) 1, 4-5, 7-8, 10-11, 13-17, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gillespie, III et al. (US 2010/0185148 A1).
With regard to claims 1, 7, 8, and 14, Gillespie, III et al. teach an injection device \ comprising: a needle (Fig. 3 member 61); a needle sleeve surrounding the needle, the needle sleeve having an aperture and being arranged such that the needle extends through the aperture during an injection process (Figs. 5 member 40); and a needle obscuring element reversibly movable between a first position and a second position relative to the needle sleeve, wherein the needle obscuring element is coupled to the needle sleeve when in the first position and when in the second position (Figs. 4 and 5 members 44), and wherein the needle obscuring element is arranged to cover a larger portion of the aperture when in the second position than when in the first position (see the difference between Fig. 4A and 5D, [0056]), wherein the needle obscuring element is biased towards the second position, wherein the needle obscuring element comprises a plurality of flaps arranged within the needle sleeve, wherein the plurality of flaps are pivotally coupled to the needle sleeve such that the plurality of flaps can pivot between the first position and the second position (the bulged tips of 44 are flaps which are biased to pivot about a living hinge, see exemplary transition from Figs. 4A-5D, [0056]-[0058], see Reference Figure 2 below), wherein each respective flap of the plurality of flaps is biased towards the second position by a respective resilient member, and wherein each respective resilient member either: (i) comprises a protrusion extending from the respective flap that contacts an inner surface of the needle sleeve to exert a force on the inner surface of the needle sleeve, or (ii) is coupled to the needle sleeve and contacts the respective flap to exert a force on the respective flap to push the plurality of flaps into the second position (see Reference Figure 2 below), and wherein the needle obscuring element is arranged to move from the first position to the second position in response to removal of a cap from the needle sleeve of the injection device ([0058]).
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With regard to claims 4 and 16, the housing is taken as 36 which is fixed to the syringe/needle (Fig. 3, [0050]), 44, which is part of the sleeve, moves into 36 (Fig. 5D).
With regard to claims 5 and 17, 32 is considered as the housing and is fixed to 40, the syringe/needle moves relative to 40 to expose the needle (Figs. 3-5D).
With regard to claim 10, see Figs. 5.
With regard to claim 11, see Fig. 11. The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
With regard to claims 13 and 20, see Fig. 4A cap 42 shield 60.
With regard to claim 15, see Fig. 3 member 46.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The features of the references are reconsidered in light of the amendments to the claims. The previous rejections under 35 U.S.C. 112 are withdrawn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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