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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 22, 2026 has been entered.
Response to Amendment
The amendment filed March 18, 2026 and RCE filed April 22, 2026 has been entered. Claims 1-17 remain pending in the application. Applicant’s amendments to the claims have overcome the objection previously set forth in the Non-Final Office Action mailed February 05, 2026.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-9, 11-15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Woehr et al. (US 20080306451) in view of Wang (US 20190343439).
Regarding claim 1, Woehr discloses a safety device (hinged cap device 210) for a needle (needle 252) of a medical device (“The hub 212 has an open end 218 for coupling to a syringe” [0054]), the safety device comprising:
a ring (hub 212) adapted to be fixed with regard to the needle (“The hub 212 has an open end 218 for coupling to a syringe, a flange 219, and a coupling well 220 for receiving a needle having a sharp needle tip (not shown). The coupling well 220 is configured to grip and couple with the needle without a separate needle hub.” [0054]), and
a shield (cap 214) rotatably fixed to the ring (“a hub 212 and a cap 214 connected to one another via a hinge 216.” [0054]), the shield being configured to at least rotate in a closing direction from a retracted position (Figure 14) in which the shield does not cover the needle to a safety position in which the shield covers the needle (“the cap 214 is first rotated upright over the needle until the needle engages the round detent 240. The curved end 232 of the cap is then pushed so that it pivots about the living hinge 236 (FIG. 11). As the curved end 232 pivots, the base wall 230 and the leaf spring 242 moves in a corresponding radial direction. As the leaf spring 242 moves, the needle is forced under the free end of the leaf spring 242 and is trapped under the lower surface of the leaf spring.” [0061]),
wherein the shield comprises a proximal portion (portion of cap 214 proximal to living hinge 236) and a distal portion (portion of cap 214 distal to living hinge 236 including curved end 232) linked to the proximal portion so as to be rotatable from an operating position (“In a semi-locked configuration, the needle is trapped below the round detent 240 and rests against the free side or upper surface of the leaf spring 242.” [0060]) to a tilted position in which the distal portion is tilted with regard to the proximal portion (“To more permanently trap the needle within the channel 222 of the cap 214, the cap 214 is first rotated upright over the needle until the needle engages the round detent 240. The curved end 232 of the cap is then pushed so that it pivots about the living hinge 236 (FIG. 11). As the curved end 232 pivots, the base wall 230 and the leaf spring 242 moves in a corresponding radial direction. As the leaf spring 242 moves, the needle is forced under the free end of the leaf spring 242 and is trapped under the lower surface of the leaf spring.” [0061]),
wherein the distal direction is a direction of injection and the proximal direction is an opposite direction (Figure 14), and
wherein the safety position includes a first safety position in which the shield is in the operating position (“In a semi-locked configuration, the needle is trapped below the round detent 240 and rests against the free side or upper surface of the leaf spring 242. In the semi-locked configuration, the cap 214 may be pivoted away from the needle by activating the lever 238, which deflects the needle away from the round detent 240.” [0060]) and a second safety position in which the shield is in the tilted position (“To more permanently trap the needle within the channel 222 of the cap 214, the cap 214 is first rotated upright over the needle until the needle engages the round detent 240. The curved end 232 of the cap is then pushed so that it pivots about the living hinge 236 (FIG. 11). As the curved end 232 pivots, the base wall 230 and the leaf spring 242 moves in a corresponding radial direction. As the leaf spring 242 moves, the needle is forced under the free end of the leaf spring 242 and is trapped under the lower surface of the leaf spring.” [0061]), the first safety position in which a longitudinal axis of the distal portion is aligned with a longitudinal axis of the proximal portion (“In a semi-locked configuration, the needle is trapped below the round detent 240 and rests against the free side or upper surface of the leaf spring 242. In the semi-locked configuration, the cap 214 may be pivoted away from the needle by activating the lever 238, which deflects the needle away from the round detent 240.” [0060], distal and proximal portions shown aligned longitudinally in Figure 11 for example), and in the second safety position in which in which the longitudinal axis of the distal portion forms an angle with the longitudinal axis of the proximal portion (“A cut-out 234 is incorporated on each side wall 228 thus creating a living hinge 236 at the base wall 230 for pivoting the curved end 232 of the housing over the needle to capture the needle, as further discussed below. In one exemplary embodiment, the cut out has an angle of about 30 degrees, but one of ordinary skill in the art will appreciate that a cut out having an angle of between about 15 degrees to about 45 degrees or greater could also be used to pivot the curved end 232 of the housing over the needle to capture the needle.” [0055], see also [0061])).
Woehr fails to explicitly disclose wherein the shield is configured to bend the needle by rotation of the shield to the safety position such that a deflection point of the needle is maintained in the proximal portion or in the distal portion in the first safety position in which a longitudinal axis of the shield forms an angle with a central axis of the ring, and in the second safety position in which the longitudinal axis of the proximal portion forms an angle with the central axis of the ring.
Wang teaches a safety device (Figure 1) for a needle (needle tube 102 of needle 1), the safety device comprising a ring (needle hub 101) and a shield (safety protective cover 2) rotatably fixed to the ring (Figures 1-5; “the needle hub 101 is connected to a safety protective cover 2 via an elastic flip mechanism 4,” [0033]), the shield being configured to at least rotate in a closing direction from a retracted position (Figure 1) to a safety position in which the shield covers the needle (Figures 3-5), wherein the shield comprises a proximal portion (lower portion 2022) and a distal portion (upper portion 2021), wherein the safety position includes a first safety position in which the shield is in the operating position (Figure 3; “as shown in FIG. 3, upon completion of injection, when the safety protective cover is pressed downward in a direction of a force-exerting point A, the protective cover snap is driven to displace in an arcuate trajectory. When the protective cover snap touches the needle hub hook, the protective cover snap will be blocked, deforms backward via a fulcrum 3 and forms an accumulated force B.” [0041]) and a second safety position in which the shield is in the tilted position (Figures 4-5; “As shown in FIG. 4, pressing continues; when an apex of the protective cover snap goes beyond an apex of the needle hub hook, the protective cover snap forms a direction force C under the release of the accumulated force B, holds and engaged with the needle hub hook under its action, and thereby the engagement action of the two.” [0041]), and wherein the shield is configured to bend the needle by rotation of the shield to the safety position such that a deflection point of the needle is maintained in the proximal portion or in the distal portion in the first safety position (Figure 3, see needle tube 102 bent within cover 2 with the deflection point in the upper portion 2021) in which a longitudinal axis of the shield forms an angle with a central axis of the ring (Figure 3 showing a longitudinal axis of the cover 2 at an angle with the central axis of hub 101), and in the second safety position (Figures 4-5, see needle tube 102 bent within cover 2 with the deflection point in the upper portion 2021) in which the longitudinal axis of the proximal portion (lower portion 2022) forms an angle with the central axis of the ring (Figure 4-5 showing a longitudinal axis of the lower portion 2022 at an angle with the central axis of hub 101).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the shield of Woehr to be configured to bend the needle by rotation of the shield to the safety position such that a deflection point of the needle is maintained in the proximal portion or in the distal portion in the first safety position in which a longitudinal axis of the shield forms an angle with a central axis of the ring, and in the second safety position in which the longitudinal axis of the proximal portion forms an angle with the central axis of the ring based on the teachings of Wang to allow for a single-hand operation of the safety device in a manner that prevents reuse of and access to the needle when in the safety device is in the second safety position (Wang [0005], [0007]).
Regarding claim 2, modified Woehr discloses the safety device according to claim 1, wherein the proximal portion and the distal portion of the shield define a recess (channel 222) adapted to accommodate the needle in the safety positions (“The cap 214 comprises a generally U-shape channel comprising two side walls 228, a base wall 230 and a curved or rounded end 232.” [0055]; Figure 14).
Regarding claim 3, modified Woehr discloses the safety device according to claim 1, wherein the proximal portion and the distal portion are linked by a pivot link (living hinge 236) adapted to face or contact the needle at least in the first safety position of the shield (“After use, the second detent 242 in combination with the living hinge 236 is configured to more permanently secure the cap to the needle to prevent needle stick injuries.
Regarding claim 4, modified Woehr discloses the safety device according to claim 1, wherein the distal portion (portion of cap 214 distal to living hinge 236 including curved end 232) is configured to rotate with regard to the proximal portion when a force equal or greater than an activation force is applied on said distal portion (“To more permanently trap the needle within the channel 222 of the cap 214, the cap 214 is first rotated upright over the needle until the needle engages the round detent 240. The curved end 232 of the cap is then pushed so that it pivots about the living hinge 236 (FIG. 11)” [0061]).
Regarding claim 5, modified Woehr discloses the safety device according to claim 1, wherein the distal portion is configured to rotate with regard to the proximal portion in the closing direction (“To more permanently trap the needle within the channel 222 of the cap 214, the cap 214 is first rotated upright over the needle until the needle engages the round detent 240. The curved end 232 of the cap is then pushed so that it pivots about the living hinge 236 (FIG. 11). As the curved end 232 pivots, the base wall 230 and the leaf spring 242 moves in a corresponding radial direction. As the leaf spring 242 moves, the needle is forced under the free end of the leaf spring 242 and is trapped under the lower surface of the leaf spring.” [0061]).
Regarding claim 6, modified Woehr discloses the safety device according to claim 3, wherein the pivot link is a living hinge (living hinge 236) configured to be permanently deformed by the rotation of the distal portion (“To more permanently trap the needle within the channel 222 of the cap 214, the cap 214 is first rotated upright over the needle until the needle engages the round detent 240. The curved end 232 of the cap is then pushed so that it pivots about the living hinge 236 (FIG. 11). As the curved end 232 pivots, the base wall 230 and the leaf spring 242 moves in a corresponding radial direction. As the leaf spring 242 moves, the needle is forced under the free end of the leaf spring 242 and is trapped under the lower surface of the leaf spring.” [0061]).
Regarding claims 7-8, modified Woehr discloses the safety device according to claim 1.
Modified Woehr fails to explicitly disclose the shield and the ring comprise locking members configured to lock the shield to the ring in the safety position, as required by claim 7; and wherein the locking members comprise at least one dead stop defined on the ring and at least one moving stop defined on the proximal portion of the shield and wherein the moving stop is configured to be on a first side of the dead stop in the retracted position of the shield and to move to a second side of the dead stop when the shield is rotated to the safety position, as required by claim 8.
Wang teaches a safety device (Figure 1) for a needle (needle 1), the safety device comprising a ring (needle hub 101) and a shield (safety protective cover 2), wherein the shield and the ring comprise locking members (needle hub hooks 103 and snaps 203) configured to lock the shield to the ring in the safety position (Figures 4-5; [0034-0036]); and wherein the locking members comprise at least one dead stop (needle hub hooks 103) defined on the ring (“two symmetrically-distributed needle hub hooks 103 are disposed on a sidewall of the needle hub 101” [0033]) and at least one moving stop (snaps 203) defined on a proximal portion of the shield (“two symmetrically-distributed protective cover snaps 203 are disposed in the hollow inner cavity of the safety protective cover 2” [0033]; Figure 3) and wherein the moving stop (snaps 203) is configured to be on a first side of the dead stop (side of hook 103 without hook end 1031) in the retracted position of the shield (Figures 1, 3, 19) and to move to a second side of the dead stop (side of hook 103 having hook end 1031) when the shield is rotated to the safety position (Figure 4 and 21; see all of [0034-0036]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the safety device of Woehr to include locking members configured to lock the shield to the ring in the safety position, wherein the locking members comprise at least one dead stop defined on the ring and at least one moving stop defined on the proximal portion of the shield, wherein the moving stop is configured to be on different sides of the dead stop in the retracted and safety positions based on the teachings of Wang to lock the shield in the safety position such that the needle cannot be accessed after use (Wang [0007]).
Regarding claim 9, modified Woehr discloses the safety device according to claim 1, wherein the distal portion has a length along the longitudinal axis of the shield of half or less than half a length of the proximal portion along the longitudinal axis of the shield (Figure 11, showing the portion distal to the hinge 236 is less than half the length of the portion proximal to hinge 236).
Regarding claim 11, modified Woehr discloses the safety device according to claim 3, wherein the shield comprises a thinned portion (cut-outs 234) including the pivot link (living hinge 236) and provided between the proximal portion and the distal portion (Figure 11).
Regarding claim 12, modified Woehr discloses the safety device according to claim 11, wherein the shield comprises a main surface (base wall 230) and at least a lateral surface (side wall 228), the thinned portion being provided at least on the lateral surface and being configured to fold when the distal portion rotates (“A cut-out 234 is incorporated on each side wall 228 thus creating a living hinge 236 at the base wall 230 for pivoting the curved end 232 of the housing over the needle to capture the needle” [0055]).
Regarding claim 13, modified Woehr discloses a safety needle hub (Figure 14) adapted to be fixed on a tip of a medical device (“The hub 212 has an open end 218 for coupling to a syringe,” [0054]), the safety needle hub comprising a needle (needle 252) and a safety device (hinged cap assembly 210) according to claim 1 (see Claim 1 above).
Regarding claim 14, modified Woehr discloses a medical device (Figure 14) comprising a needle (needle 252) and a safety device (hinged cap assembly 210) according to claim 1 (see Claim 1 above).
Regarding claim 15, modified Woehr discloses the safety needle hub according to claim 13, wherein the needle (needle 252) has a tip (Figure 14) and the distal portion of the shield is adapted to cover at least the tip of the needle when the shield is in the safety position (“coupling well 220 for receiving a needle having a sharp needle tip” [0054]; “As the leaf spring 242 moves, the needle is forced under the free end of the leaf spring 242 and is trapped under the lower surface of the leaf spring.” [0061]; Figure 12).
Regarding claim 17, modified Woehr discloses the safety needle hub according to claim 13, wherein the distal portion of the shield covers at most a distal half portion of the needle when the shield is in the first safety position (Figures 11 and 14, showing the portion distal to the hinge 236 is less than half the length of the portion proximal to hinge 236 and therefor covers at most a distal half of the needle).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Woehr et al. (US 20080306451) in view of Wang (US 20190343439) as applied in claim 1 above, and further in view of Giacomo (IT PR20130027).
Regarding claim 10, modified Woehr discloses the safety device according to claim 9, wherein the shield (cap 214) is configured so that the longitudinal axis of the distal portion forms an angle with the central axis of the ring when the shield is in the safety position and the distal portion is in the tilted position (“A cut-out 234 is incorporated on each side wall 228 thus creating a living hinge 236 at the base wall 230 for pivoting the curved end 232 of the housing over the needle to capture the needle, as further discussed below. In one exemplary embodiment, the cut out has an angle of about 30 degrees, but one of ordinary skill in the art will appreciate that a cut out having an angle of between about 15 degrees to about 45 degrees or greater could also be used to pivot the curved end 232 of the housing over the needle to capture the needle.” [0055]).
Modified Woehr fails to explicitly teach the angle is 75 to 105°.
Giacomo discloses a safety device (cap 1) for a needle of a medical device (Figures 1-7), the safety device comprising a ring (crown 2) centered on a central axis (Figure 1) and a shield (spout 1a) configured so that a longitudinal axis of a distal portion (portion of spout 1a distal of folding section 1b; Figure 1) forms an angle of 75 to 105° with the central axis of the ring when the shield is in the safety position and the distal portion is in the tilted position (Figure 4, showing the portion of spout 1a distal of folding section 1b forms an angle of approximately 90° relative to the central axis).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the angle formed between a longitudinal axis of the distal portion and the central axis when the distal portion is in the tilted position of Woehr to be 75 to 105° based on the teachings of Giacomo to bend the needle in a manner that prevents reuse when in the second safety position (Giacomo Figure 4; Page 1).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Woehr et al. (US 20080306451) in view of Wang (US 20190343439) as applied in claim 1 above, and further in view of Mercereau (USPN 5702369).
Regarding claim 16, modified Woehr discloses the safety needle hub according to claim 15. Modified Woehr fails to explicitly disclose the distal portion comprises an inside pad adapted to contact the tip of the needle when the distal portion is in the tilted position.
Mercereau teaches a safety device (needle protection device 170; Figure 9) for a needle (needle 16) of a medical device (barrel 12), the safety device comprising a shield (arm 184) having a distal portion (cap 188) comprises an inside pad (resilient pad 190) adapted to contact the tip of the needle when the distal portion is in a tilted position (Figure 9; “The user continues to push the lever 176, thereby causing the arm 184 to pivot at the hinge 186 and flex inwardly. This brings the cap 188 into contact with the tip 32 of the needle 16 and embeds the tip in the resilient pad 190.” [Col 10, line 18-21]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the distal portion of the shield of Woehr to include an inside pad based on the teachings of Mercereau to safely secure the needle tip and protect the user from accidental needle sticks (Mercereau [Col 10, lines 18-24).
Response to Arguments
Applicant’s arguments with respect to claims 1-17 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.
Conclusion
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/LEAH J SWANSON/Examiner, Art Unit 3783 /Lauren P Farrar/Primary Examiner, Art Unit 3783
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