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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4-5, 7-8, 10-11, 13-17, and 19-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 has been amended to recite “wherein the needle obscuring element is arranged to move from the second position to the first position in response to insertion of at least a part of the cap into the needle sleeve of the injection device.” The cited portions of the specification for support appear to recite “In yet other examples, the needle obscuring element 30 is not held in the first position, but is movable between the second position and first position. (Pg. 22)” Specific examples are not disclosed and the specification at the time of filing does not appear to recite that the movement occurs in response to insertion of at least a part of the cap. The disclosure also appears to indicate that in situations where the element moves from the second position to the first position it is not held in the first position; this appears contradict the earlier claim recitations that the removal of the cap (holding the element in the first position) moves the element from the first to the second position.
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 19-20 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 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 (members 19 are flaps which are biased to pivot about a living hinge, see exemplary transition from Figs. 6-7), 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]), and wherein the needle obscuring element is arranged to move from the second position to the first position in response to insertion of at least a part of the cap into the needle sleeve of the injection device (the flaps are capable of being moved back outwards in conjunction with insertion of at least part of the cap).
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 claims 7, 8, and 19, members 19 are flaps which are biased to pivot about a living hinge (see exemplary transition from Figs. 6-7).
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 19-20 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 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 (members 44 are flaps which are biased to pivot about a living hinge, see exemplary transition from Figs. 4A-5D, [0056]-[0058]), 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]), and wherein the needle obscuring element is arranged to move from the second position to the first position in response to insertion of at least a part of the cap into the needle sleeve of the injection device (insertion of 42 moves 44 into the first position, [0058]).
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 past 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 claims 7, 8, and 19, members 44 are flaps which are biased to pivot about a living hinge (see exemplary transition from Figs. 4A-5D, [0056]-[0058]).
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 Examiner finds Schader et al. to teach the new limitations as rejected above. Previous objections to the drawings are withdrawn in light of the amendments.
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 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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