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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/947,305, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior filed application does not disclose a core.
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 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Monson et al. (US 2009/0312715 A1) in view of Schraga (US 2012/0123334 A1).
With regard to claims 1-9 and 12, Monson et al. teach a hypodermic interface assembly comprising: a hub having a distal end surface (Fig. 5 member 40); a core member define by a body having a proximal end surface and a distal end surface (Fig. 5 portion around 82 within 86, has a body, proximal and distal ends, a passage, and is received by and extends beyond the carrier); a cannula, wherein a portion of the cannula extends in a distal direction from the distal end surface of the hub and in a proximal direction from the proximal end surface of the body of the core member (Fig. 4 member 82 extends through the hub, core, and carrier and beyond, Fig. 5 one portion non removably connected to the core, the cannula necessarily extends between the portion extending distally of the hub and proximally of the core, Fig. 5 one portion non removably connected to the core and one portion spaced from the carrier); and a cannula carrier having a head portion (Fig. 5 member 86, head in the area of 89), and wherein the cannula carrier is controllably separable from the hub (Fig. 5). Monson et al. do not teach the carrier to have a plurality of leg portions. However, Schraga teaches a threaded cannula carrier which has a plurality of legs which flex outwardly to allow the carrier to be threaded onto the injector as well as inserted and removed in additional fashions which do not include rotation and may enhance safety (Figs. 11- 14 slots 16’’’ form legs which are connected via frangible portions which break when subjected to force to separate the legs from the hub, this would be capable of occurring depending on the force and movement from the subject [0005], [0079], [0081], [0082], [0085], [0086]). 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 plurality of legs which can deflect radially outward in response to a radial force in Monson et al. as Schraga teaches this is beneficial for connecting the cannula carrier in a plurality of manners to enhance safety. Monson et al. do not explicitly recite how the core and cannula and the carrier and core are attached. However, Monson et al. teach various connections include adhesives or press-fit ([0020], [0027]). 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 press-fit connection between the components of Monson et al. as Monson et al. teach such is an art effective connection means to prevent movement and would yield the same predictable result.
With regard to claim 10, See Fig. 4 the proximal end of the carrier is adjacent a shoulder of the hub generally in the area of 46, as combined this is where the proximal end of the leg surface would be located.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Monson et al. (US 2009/0312715 A1) as applied to claim 12 above, and further in view of Bennwik et al. (US 5,709,659).
With regard to claim 13, Monson et al. teach a device substantially as claimed. In Monson et al. member 97 is also considered as part of the hub which has a distal end surface that is spaced from the core. Monson et al. do not disclose the cannula is configured to bend or break. However, Bennwik et al. teach permanently detaching the carrier from the hub of a syringe to break the needle to prevent reuse (abstract, Figs. 5). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the cannula of Monson et al. to break as in Bennwik et al. as this is beneficial for preventing re-use.
Claim(s) 14-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Monson et al. (US 2009/0312715 A1) in view of Zhao (US 2012/0150128 A1).
With regard to claims 14, 20, and 21, Monson et al. teach a subassembly of a hypodermic interface assembly, the subassembly comprising: a hub having a distal end surface (Fig. 5 member 86); a core member having a body defined by a proximal end surface and a distal end surface (Fig. 5 portion around 82 within 86); and a cannula connected to the core member and the hub such that the cannula is not permitted to axially shift relative to the core member or the hub (Fig. 4 member 82, extends through a passage in the core), wherein a portion of the cannula extends in a distal direction from the distal end surface of the hub and in a proximal direction from the proximal end surface of the body of the core member (Fig. 5). Monson et al. do not explicitly recite how the core, cannula, and hub are attached. However, Monson et al. teach various connections include adhesives or press-fit ([0020], [0027]). Further, Zhao teaches adhesive may be used to secure a cannula within a core and hub and to secure a core to a hub (Fig. 4, adhesive secure core 44 to a hub, [0024]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to non-removably connect the components of Monson et al. as Zhao teach such to be an art effective connection means for fixation and Monson et al. teach such is an art effective connection means to prevent movement and would yield the same predictable result.
With regard to claim 15, see Fig. 5.
With regard to claims 16 and 17, distance necessarily exists, see Reference Figure 1 below.
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With regard to claim 18, see the differing passage diameter at the distal end (Fig. 5).
With regard to claim 19, see the outer diameter at the proximal end of the core which is smaller (Fig. 5).
Allowable Subject Matter
Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 newly amended limitations are addressed as above.
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