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 § 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) 20, 22, 25, 26, 28, and 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fournier et al. (US 2015/032291 A1).
With regard to claims 20, 22, and 26, Fournier et al. teach a safety needle device assembly comprising: an introducer needle having an introducer needle hub (Fig. 7 102) and an introducer needle cannula extending from a distal end of the introducer needle hub (Fig. 7 needle 110), the introducer needle hub having a pair of attachment points positioned at the distal end of the introducer needle hub (Figs. 6 and 7 points where 228 attaches); a two-piece hinged cap (Figs. 6 and 7 member 200) having an elongated body connected to the pair of attachment points a pair of corresponding attachment points located on a medial portion of the two-piece hinged cap (Figs. 6 and 7 at 288), the two-piece hinged cap having a proximal surface and a distal surface, the distal surface having a cavity configured to enclose at least the introducer needle cannula within (Fig. 7 space within 320), the medial portion including a pair of tabs extending from the proximal surface (Figs. 6 and 7 tabs 325 extending on either side from 320); and, a sliding block configured to open or close the two-piece hinged cap, the sliding block having a proximal wall, a distal wall and a sidewall therebetween defining a cavity, the distal wall having an opening with a width which is less than a total width of the pair of tabs, the distal wall configured to abut the pair of tabs (Figs. 6-8 310, see Reference Figure 2 below, the arms 315 form the opening of the sliding bock, the arms are inserted into the cap such that they are interior to the tabs 325, thus the opening has a width less than the total with of the pair of tabs, the inner diameter of the opening is less than a distance measure from the outer surface of opposing tabs).
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With regard to claim 25, the proximal wall would be capable of being physically separated.
With regard to claim 28, see [0048], [0050], Figs. 8 and 9.
With regard to claim 33, see [0034] and [0035]. 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.
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) 20-23, 25, 26, 28-30, and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Golba, Jr. (US 5,919,172) in view of Le et al. (US 5,011,479) and Fournier et al. (US 2015/032291 A1).
With regard to claims 20, 22, and 26, Golba Jr. teaches a safety needle device assembly comprising: an introducer needle having an introducer needle hub (Fig. 1 components of 20) and an introducer needle cannula extending from a distal end of the introducer needle hub (Figs. 1 and 2 member 12), the introducer needle hub having a pair of attachment points positioned at the distal end of the introducer needle hub (Figs. 1 and 2 posint on the fixture at the end 14 attached to 32); a cap (Fig. 1 member 40) having an elongated body connected to the pair of attachment points a pair of corresponding attachment points located on a medial portion of the cap (Fig. 2 points of 40 connected to the structure at end 14), the cap having a proximal surface and a distal surface, the distal surface having a cavity configured to enclose at least the introducer needle cannula within (Fig. 2). Golba Jr. does not disclose a hinged cap or sliding block. However, Le et al. teach using a hinged cap over a needle which may be mounted on various types of needles including at least a hypodermic needle or spinal needle (Fig. 6, Col. 5 lines 55-60). Further, Fournier et al. teach a hinged cap for a needle which includes a two-piece hinged cap (Figs. 6 and 7 member 200) having an elongated body connected to the pair of attachment points a pair of corresponding attachment points located on a medial portion of the two-piece hinged cap (Figs. 6 and 7 at 288), the two-piece hinged cap having a proximal surface and a distal surface, the distal surface having a cavity configured to enclose at least the introducer needle cannula within (Fig. 7 space within 320), the medial portion including a pair of tabs extending from the proximal surface (Figs. 6 and 7 tabs 325 extending on either side from 320); and, a sliding block configured to open or close the two-piece hinged cap, the sliding block having a proximal wall, a distal wall and a sidewall therebetween defining a cavity, the distal wall having an opening with a width which is less than a total width of the pair of tabs, the distal wall configured to abut the pair of tabs (Figs. 6-8 310, see Reference Figure 2 above, the arms 315 form the opening of the sliding bock, the arms are inserted into the cap such that they are interior to the tabs 325, thus the opening has a width less than the total with of the pair of tabs, the inner diameter of the opening is less than a distance measure from the outer surface of opposing tabs).
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 hinged cap and sliding block as in Fournier et al. for the cap in Golba Jr. as Le et al. teach using hinged caps equivalently on various types of needles and the cap of Fournier et al. would yield the same predictable result of covering the needle and provides for easier and safer uncovering and recovering after use.
With regard to claims 21 and 29, see Golba Jr. Fig. 1 member 36.
With regard to claim 23, the wings include 32 of Golba Jr.
With regard to claim 25, the proximal wall of Fournier et al. would be capable of being physically separated.
With regard to claim 28, see [0048], [0050], Figs. 8 and 9 (Fournier et al).
With regard to claim 30, see Fig. 7 of Fournier et al. the cross-section of the cavity is rectangular, as combined it would extend to cover both needles of Golba Jr. generally as shown in Fig. 2 which extends from the flange of the spinal needle via its connection to the introducer needle.
With regard to claim 33, see [0034] and [0035] (Fournier et al.). 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.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Golba, Jr. (US 5,919,172), Le et al. (US 5,011,479), and Fournier et al. (US 2015/032291 A1) as applied to claim 23 above, and further in view of Graves et al. (US 5,746,727).
With regard to claim 24, alternatively the wings are taken as the ribs on the connecting portion at 14 connected to 32. The opening is shown in Reference Figure 1 below, which would be narrower than the ribbed portion of the hub. Golba Jr. and Fournier et al. do not disclose the wings interdigitate with a channel inside the sliding block. However, Graves et al. teach a sliding member for a needle shield which has a channel which interacts with a protrusion on a base to aid in retaining the shield in position (Fig. 12 50 moves in slot 76, abstract). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the ribs/wings of Golba Jr. slide in channels of the block as provided by Fournier et al. as Graces et al. teach this is beneficial for ensuring proper positioning.
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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 new limitations to claim 20 are newly explained in view of Fournier et al. As explained above the Examiner finds the opening of the sliding block Fournier et al. to be less than the width of the tabs as 315 is inserted into the cap to open the cap. Applicant argues the tabs are axial tabs which do not extend from a proximal surface of the cap. The Examiner finds the medial portion with the tabs extends from the proximal surface; the Examiner finds the proximal surface to comprises at least surfaces on the proximal half of the cap. Applicant argues one would not combine Golba with Graves. The rationale as provided by the examiner is that this ensures alignment of the sliding block for proper positioning. Though Graves may teach retention this is after the sliding occurs.
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