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 § 103
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.
Claim(s) 1-10, 12, and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Perche et al. (WO 2015/044561 A1) in view of Newton et al. (WO 2017/223354 A1).
With regard to claims 1, 4-7, and 10, Perche et al. teach a needle cover for protecting a needle mounted on a tip of a barrel of a medical injection device, wherein the tip extends from a distal face of the barrel, the needle cover comprising: an inner needle shield extending along a longitudinal axis, comprising an inner proximal connection part configured to sealingly contact the tip of the barrel (Fig. 25 member 20); and at least one actuator (see Reference Figure 1 below in addition to the citations, Fig. 25 includes 30 and 38), said at least one actuator comprising: a first portion extending radially outwardly and the longitudinal axis (Fig. 25 portion 30); and a second portion extending from the first portion at a junction (Fig. 25 portion 38, from junction between 65 and 66); and a proximal inner surface which is tilted relative to the longitudinal axis (Fig. 25 members 40), wherein the first portion extends radially outwardly along a length to the second portion (Fig. 26); wherein the at least one actuator is radially movable inwardly relative to the longitudinal axis to slidingly engage the proximal inner tilted surface with the distal face of the barrel so as to cause the needle cover to move in a distal direction along the tip by a wedge effect (see transition from Fig. 25 -26), wherein before the at least one actuator is moved radially inwardly, at the junction, the second portion extends in a direction parallel to the longitudinal axis (Fig. 25), and wherein after the at least one actuator is moved radially inwardly, at the junction, the second portion extends radially inwardly relative to the longitudinal axis (Fig. 26). Perche et al. do not disclose an outer needle shield. However, Newton et al. teach a needle shield within a cap which has a soft inner shield and a rigid outer shield to protect the needle from damage and prevent accidental needle sticks, the outer shield is held within the cap to aid in removal and allow the components to attach to the syringe together (Fig. 11 outer shield 74 around 78, 74 is held in 34 of the cap, [0033], [0038]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a rigid outer shield around the inner shield connected in the recess of member 30 of Perche et al. as Newton et al. teach this is beneficial to protect the needle from damage and prevent accidental needle sticks as well as aiding in removal and attachment. As combined the outer shield is fixed to the inner shield and integral with the actuator. The first portion and junction are radially outward of the outer shield and the first portion extends from the outer shield.
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With regard to claim 2, there is space between 20 and the barrel into which 40 is inserted (Fig. 26).
With regard to claim 3, Perche et al. show members 40 to be tilted but do not disclose a particular angle. However, Newton et al. teach angled member which grip and remove an inner needle cap which may be at various angles including 40 and 50 degrees (Fig. 11, members 66, Pg. 8 line 14). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use an angle in Perche et al. as recited as Newton et al. teach such is an art effective angle for gripping and would yield the same predictable result.
With regard to claims 8 and 9, Perche et al. is silent as to the material of the inner shield. However, Newton et al. teach rubber to be an effective material for preventing damage to the needle (Pg. 10 lines 11-12). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use rubber for the inner shield in Perche et al. as Newton et al. teach such is an art effective material for needle protection and would yield the same predictable result.
With regard to claim 12, Perche et al. teach a medical assembly comprising: a medical injection device comprising: a barrel adapted to contain a medical composition (Fig. 25, 16 in exemplary Fig. 3); a tip extending from a distal face of the barrel, defining a fluid path extending through the tip and in fluid communication with the barrel (Fig. 25, tip in which the needle is inserted); and a needle attached to the tip and in fluid communication with the fluid path (Fig. 25, 18 in exemplary Fig. 3); and a needle cover according to claim 1, mounted on the tip of the medical injection device (see the rejection above).
With regard to claim 14, there is space between 20 and the barrel into which 40 is inserted (Fig. 26).
With regard to claim 15, Perche et al. teach a method for removing the needle cover of claim 1 from the tip of a medical injection device, comprising the following steps: pinching the at least one actuator radially inwardly to slidingly engage the tilted surface with the distal face of the barrel, so as to cause the needle cover to move in a distal direction along the tip by a wedge effect (see the transition from Fig. 25 to Fig. 26 members 38 are pinched inward); and pulling the needle cover in the distal direction relative to the barrel to remove the needle cover from the tip of the injection device (Fig. 26 device is pulled in the direction of arrow 26, the cover is considered as removed from the tip as the tip is exposed for injection).
With regard to claim 16, the junction bends radially outwardly when 38 flexes and additionally the portion at 66 is bent radially outwardly (Fig. 26).
Claim(s) 11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Perche et al. (WO 2015/044561 A1) and Newton et al. (WO 2017/223354 A1) as applied to claims 10 and 12 above, and further in view of Hudson et al. (US 2012/0029439).
With regard to claims 11 and 13, Perche et al. teach a device substantially as claimed. Perche et al. and Newton et la. teach a rigid material but do not disclose the material of the outer shield or the barrel. However, Hudson et al. teach a syringe with a needle cap removed and discloses glass and plastic are known standard materials for syringe construction ([0002]) and rigid plastics are also known materials for a boot remover ([0016]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a rigid plastic for the outer shield and a glass barrel in Perche et al. as Hudson et al. teach such is a known effective material in the art for syringe components and syringe barrel construction and would yield the same predictable result.
Response to Arguments
Applicant’s arguments with respect to 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 rejection over Perche et al. has changed in light of the amendments. Generally, members 38 form the second portion and are parallel as in Fig. 25. The junction is generally the portion between 65 and 66.
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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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783