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 .
Election/Restrictions
Claim(s) 7 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/3/26.
Claim Objections
Claims 5-6, 8-11 are objected to because of the following informalities:
Claim 5 recites “shield including knurled handle” in the penultimate line. This should likely read “shield including a knurled handle”.
Dependent claims inherit the deficiencies of the claims from which they depend.
Appropriate correction is required.
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 of this title, 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, 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woehr (US 2015/0283332 A1), hereafter “Woehr ‘332” in view of Woehr et al. (US 2008/0306451 A1), hereafter “Woehr ‘451”.
As to claim 1, Woehr ‘332 discloses a needle stick protection device (100; see Fig. 1-8), comprising:
a distal shield member (110; see Fig. 1, para 0045) including a slot (129) that allows a needle to freely pass between shielded and unshielded positions an infinite number of times (see para 0065 disclosing cap is retractable – thus needle can be exposed repeatedly);
a proximal base member (140);
a hinge connecting the distal shield member to the proximal base member (see para 0049 discussing hinge system);
a locking mechanism (182, 184) securing the proximal base member to the distal shield member, the locking mechanism including a compressive sleeve (184) of the distal shield member and a distal cylindrical collar (182) of the proximal base member, which frictionally fit together in a manner securing the proximal base member and the distal shield member (see para 0052-0053); and
Woehr ‘332 is silent to a shield actuating tab placed on the distal shield member to assist in one finger use of the needle stick protection device, wherein the shield actuating tab includes a recess shaped and dimensioned for the proximal base member to fit therein.
Woehr ‘451 teaches a shield actuating tab (352; see Fig. 23-26) placed on a distal shield member (314) to assist in one finger use of the needle stick protection device (“assist in one finger use” is purely functional and the claim is silent to how the assisting is done – 352 serves in operation of the device of Woehr ‘451 and could be used to help with one finger use), wherein the shield actuating tab includes a recess shaped and dimensioned for the proximal base member to fit therein (352 which includes hook 354 includes a recess that engages base engagement prong 348 on proximal based member 312 – see para 0072, 0075).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Woehr ‘332 in view of Woehr ‘451 such that Woehr ‘332 includes a shield actuating tab placed on the distal shield member to assist in one finger use of the needle stick protection device, wherein the shield actuating tab includes a recess shaped and dimensioned for the proximal base member to fit therein. One would have been motivated to do so as an addition to or an alternative to the tab/recess (222/214) of Woehr ‘332, as Woehr ‘451 teaches that said prongs 348, 352 can provide a means for releasable engagement that also provides a sound or vibration when engaged (see para 0072, 0075 of Woehr ‘451).
As to claim 3, Woehr ‘332 in view of Woehr ‘451 teaches the needle stick protection device according to claim 1 as described above, and Woehr ‘332 further teaches wherein the proximal base member (140) is an elongated structure including a central passageway allowing for communication between a needle and a syringe body, and the proximal base member includes a first end (distal end of 102) having a connection shaped and dimensioned for selective attachment of a needle (104) and a second end (152) having a hub member shaped and dimensioned for selective attachment to a syringe body (para 0049, 0051).
As to claim 4, Woehr ‘332 in view of Woehr ‘451 teaches the needle stick protection device according to claim 1 as described above. Woehr ‘332 further discloses wherein the distal shield member includes a single cantilevered beam (128) which retains the needle (para 0048), but is silent to cantilevered beams between which the needle may be retained. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the device of Woehr ‘332 to have a first and second cantilevered beams between which the needle may be retained, since it has been held that mere duplication of the essential working parts (latch 128) of a device involves only routine skill in the art. MPEP 2144.04 (VI).
Claim(s) 1, 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woehr ‘332.
As to claim 1, Woehr ‘332 discloses a needle stick protection device (100; see Fig. 1-8), comprising:
a distal shield member (110; see Fig. 1, para 0045) including a slot (129) that allows a needle to freely pass between shielded and unshielded positions an infinite number of times (see para 0065 disclosing cap is retractable – thus needle can be exposed repeatedly);
a proximal base member (140);
a hinge connecting the distal shield member to the proximal base member (see para 0049 discussing hinge system);
a locking mechanism (182, 184) securing the proximal base member to the distal shield member, the locking mechanism including a compressive sleeve (184) of the distal shield member and a distal cylindrical collar (182) of the proximal base member, which frictionally fit together in a manner securing the proximal base member and the distal shield member (see para 0052-0053); and
Woehr ‘332 further discloses to a shield actuating tab (224) placed on the distal shield member to assist in one finger use of the needle stick protection device (the claim is silent to how one finger use is assisted, the examiner maintains that 224 could be used to assist one finger use by manipulating 224), but is silent to wherein the shield actuating tab includes a recess shaped and dimensioned for the proximal base member to fit therein.
However, Woehr ’322 does teach the proximal base member (140) having a recess (214), which receives tab 222 of rib 224 (para 0057, 0058). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have reversed the location of 222 and the recess 224 of Woehr ‘332, such that the shield actuating tab (224) comprises a recess shaped and dimensioned for the proximal base member (i.e. having a tab similar to 222) to fit therein. Generally, it has been held that a reversal and/or rearrangement of parts is prima facie obvious (see MPEP 2144 VI. A & C).
As to claim 3, Woehr ‘332 as described immediately above teaches the needle stick protection device according to claim 1, and Woehr ‘332 further teaches wherein the proximal base member (140) is an elongated structure including a central passageway allowing for communication between a needle and a syringe body, and the proximal base member includes a first end (distal end of 102) having a connection shaped and dimensioned for selective attachment of a needle (104) and a second end (152) having a hub member shaped and dimensioned for selective attachment to a syringe body (para 0049, 0051).
As to claim 4, Woehr ‘332 as described immediately above teaches the needle stick protection device according to claim 1. Woehr ‘332 further discloses wherein the distal shield member includes a single cantilevered beam (128) which retains the needle (para 0048), but is silent to cantilevered beams between which the needle may be retained. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the device of Woehr ‘332 to have a first and second cantilevered beams between which the needle may be retained, since it has been held that mere duplication of the essential working parts (latch 128) of a device involves only routine skill in the art. MPEP 2144.04 (VI).
Allowable Subject Matter
Claims 2, 12, and 13 are 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.
Claims 5, 6, and 8-11 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
As to claim 2, Woehr ‘332 in view of Woehr ‘451 teaches the needle stick protection device according to claim 1 as described above. Woehr ‘332 further discloses wherein the distal shield member includes a distal rotating lock shield adapted for rotation and locking to prevent further use of the needle stick protection device (the hinge pivoting results in rotation of the distal shield member 110 – once rotated enough, the needle is locked by latch 128 – see at least para 0048), but is silent to whereby rotation of the distal rotating lock shield selectively blocks the slot that allows passage of the needle in and out of the needle stick protection device in combination.
Claims 12 and 13 depend from claim 2.
As to claim 5, Woehr ‘332 discloses:
A needle stick protection device (100; see Fig. 1-8), comprising:
a distal shield member (110; see Fig. 1, para 0045) including a slot (129) that allows a needle to freely pass between shielded and unshielded positions an infinite number of times (see para 0065 disclosing cap is retractable – thus needle can be exposed repeatedly);
a proximal base member (140);
a hinge connecting the distal shield member to the proximal base member (see para 0049 discussing hinge system);
a locking mechanism (182, 184) securing the proximal base member to the distal shield member, the locking mechanism including a compressive sleeve (184) of the distal shield member and a distal cylindrical collar (182) of the proximal base member, which frictionally fit together in a manner securing the proximal base member and the distal shield member (para 0052-0053), and further wherein the distal shield member includes a distal rotating lock shield adapted for rotation and locking to prevent further use of the needle stick protection device (the hinge pivoting results in rotation of the distal shield member 110 – once rotated enough, the needle is locked by latch 128 – see at least para 0048).
However, Woehr ‘332 is silent to, the distal rotating lock shield including knurled handle, wherein rotation of the distal rotating lock shield selectively blocks the slot that allows passage of the needle in and out of the needle stick protection device.
Claims 6 and 8-11 depend from claim 5.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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/James D Ponton/Primary Examiner, Art Unit 3783
Prosecution Insights