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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/14/2026 has been entered.
Response to Amendment
Claim 8 was previously rejected as not being further limiting on a previous claim and has been cancelled; Examiner accordingly withdraws the previous rejection to claim 8 under 35 U.S.C. §112(d).
Claim 1 has been amended; no new matter has been entered.
Priority
All claimed subject matter is properly supported in PRO 62433294 and thus has an effective filing date of 12/13/2016.
Terminal Disclaimer
The terminal disclaimer filed on 05/07/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Pats. No. 10589036 and 11559631 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-7, 9-10, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Targell (US 20050113750, henceforth Targell, previously made of record) in view of Rubinstein et al. (US 20090299295, henceforth Rubinstein, previously made of record), Kuracina et al. (US 20060189934, henceforth Kuracina, previously made of record), and Rubinstein et al. ‘817 (US 20110319817, henceforth Rubinstein ‘817).
Regarding claim 1, Targell discloses a safety needle device (safety needle 20, fig. 1), comprising: a housing (casing 30, fig. 1) configured to couple to a syringe ([0034], since the safety needle 20 is for use with a typical syringe and casing 30 is a part of safety needle 20, casing 30 is configured to couple in some manner to a syringe as claimed), the housing having a proximal end (proximal end 34, fig. 1), a distal end (distal end 32, fig. 1), and a housing body (casing 30, fig. 1); a first guide path (recessed cavity 106 of first track system 66A, fig. 12), a second guide path (passageway 100 of first track system 66A, fig. 12) and a third guide path (passage portion 108 of first track system 66A, fig. 12) disposed on the housing body (see fig. 12, the called out paths are formed on the inner wall 56 of casing 30; this is also disclosed in [0042]), the second guide path intersecting the first guide path and the third guide path (see fig. 12), the first guide path and the third guide path parallel to a central axis (see figs. 7 and 12, cavity 106 and passage portion 108 both extend parallel to a longitudinal axis extending through the center of safety needle 20 along which needle 38 extends concentrically with casing 30 and sleeve 22) which extends along the housing (see figs. 7 and 12); a needle hub (needle mount 38, fig. 1) disposed on the proximal end of the housing (see fig. 1, needle mount 38 is directly adjacent to proximal end 34 as shown); a needle cannula (needle 28, fig. 1) attached to the needle hub (see fig. 4); a retractable sheath (sleeve 22, fig. 7) connected to a rotating cam (first projection 64, fig. 7; note [0042] which discloses that there are two track systems 66A and 66B, each being engaged by one projection 64, meaning that there are two projections 64 – these will be referred to as first projection 64 which cooperates with first track 66A and second projection 64 which cooperates with second track 66B) configured to move between an initial position (position of figs. 4 and 13) wherein the initial position partially exposes a distal tip of the needle cannula (see fig. 4, needle tip 26 is partially exposed as shown), a retracted position (this is a position between figs. 15 and 16 where projection 64 has just begun to be rotated by cam profile 110 and would be between the positions of figs. 5 and 6) wherein the retracted position fully exposes the needle cannula (see figs. 5 and 6, needle 28 is fully exposed in a state between these figures which is the retracted position because the entirety of the distal tip 26 of needle 28 is exposed such as to still be capable of being inserted into a user’s skin) and an extended position with respect to the housing (position of figs. 6 and 17) wherein the extended position fully covers the distal tip of the needle cannula (see fig. 6, sharp needle tip 26 is fully covered), the first guide path and the second guide path disposed on the housing body configured to receive a guiding element on the rotating cam (see figs. 13-15, first projection 64 is shown being received by the called out paths of first track 66A; the guide element is the proximal half of first projection 64 which is received), wherein the retractable sheath is configured to rotate via the rotating cam with respect to the housing ([0044], sheath 22 rotates in a clockwise direction as a result of engagement of first projection 64) during movement from the initial position to the retracted position (since there is some amount of rotation between movement of the position between figs. 13 and the called out retracted position as the cam profile 110 has caused a small amount of rotation, this limitation is met); a first locking element (fingers 62, fig. 7) comprising a tab (second projection 64 which is arranged on fingers 62, see [0042] and [0044]) on a proximal end of the retractable sheath (projections 64 are on a proximal end of sheath 22 where fingers 62 are arranged on the end of sheath 22 which is closer to proximal end 34 of housing 30) and a locking rib (cam profile 110 of second track 66B, see fig. 12) on the housing (see fig. 12, cam profile 110 is formed on the inner wall 56 of casing 30; this is also disclosed in [0042] and [0044]); the rotating cam disposed in the housing body (see fig. 4, first projection 64 is disposed radially inside of and within the walls defined by casing 30); and a spring element (spring 42, fig. 4); wherein movement of the retractable sheath from the initial position to the retracted position is configured to engage the tab on the proximal end of the sheath with the locking rib of the housing (since the movement from the initial position to the called out retracted position involves engagement of the rotating cam, which is the first projection 64, engaging with the first cam profile 110 such as to get to the called out retraction position, the second projection 64 would engage with second cam profile 110 since the two sides are symmetrical and thus function equivalently, see also [0044] which describes the movements of the two tracks 66A and 66B being the same), thereby preventing further rotation of the rotating cam and thus preventing the guide element from returning to the first guide path (since first cam profile 110 prevents first projection 64 from returning to first recessed cavity 106 by preventing rotation in the counterclockwise direction which is a further rotation of the projection 64 towards recessed cavity 106, this claim limitation is met, see at least [0044]) and preventing the retractable sheath from returning to the initial position (see [0044], “The engagement between fingers 64 and undercut portion 114 locks the position of sleeve 22 thus preventing sleeve 22 from returning to its retracted position and exposing needle 28”).
Targell does not disclose a second locking element comprising a metal latch disposed on a distal end of the retractable sheath or that movement of the retractable sheath from the retracted position to the extended position is configured to engage the second locking element to move distally and automatically cover a distal tip of the needle cannula, wherein the second locking element inhibits reuse of the safety needle device by inhibiting translation of the retractable sheath. Rubinstein teaches a locking element (locking collar 138, fig. 3) comprising a latch (arm 150, fig. 3) disposed on a distal end of a retractable sheath (see fig. 3, locking collar 138 is attached to moveable needle sleeve 82 at its distal end, which is the end further from the base of the needle) where movement of the retractable sheath from a retracted position (position of fig. 4) to an extended position (position of fig. 9) is configured to engage the locking element to move distally (see figs. 4 and 9, arm 150 moves distally relative to upper portion 30 as shown) and automatically cover a distal tip of a needle cannula (see fig. 9, in the extended position, foot 154 of locking collar 138 engages and automatically extends beyond tip 46 of needle 42 where tip 46 is a distal tip), wherein the second locking element inhibits reuse of the safety needle device by inhibiting translation of the retractable sheath (see [0034] and [0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the second locking element of Rubinstein to the safety needle device and retractable sheath of Targell for preventing accidental needle prick injuries and for further preventing multiple uses of the safety needle device (see Rubinstein [0034]) as reduce the likelihood of transferring blood or tissue-born diseases from one patient to another (see Rubinstein [0003] and [0004]).
Targell as modified does not disclose that the latch is made of metal. Kuracina teaches that a latch (needle trap 41, fig. 42A) can be made of flexible metal, plastic, or resin based materials ([0191]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the latch of Targell as modified out of flexible metal instead of plastic because using metal provides fatigue resistance for the latch (see Kuracina [0191]) and further because Kuracina teaches that it was known in the art prior to the effective filing date of the claimed device to make latches which cover needles out of metal or plastic (Kuracina [0191]) and thus substituting the plastic of Targell as modified with metal as in Kuracina would have yielded the same, predictable result of having a latch which is resiliently formed to cover the distal tip of the needle in the extended position and which does not fatigue over time (see Kuracina [0191]).
Targell as modified does not explicitly disclose that the movement of the retractable sheath from the initial position to the retracted position is configured to engage the tab on the proximal end of the retractable sheath with the locking rib of the housing via a snap-fit connection. Rubinstein ‘817 teaches a movement of a retractable sheath (sleeve 12, fig. 2) from an initial position (position of fig. 1) to a retracted position (position of fig. 2) which is configured such that an engagement between a tab (guide member 44, fig. 2) and a locking rib of a housing (first track 80, fig. 2) occurs via a snap-fit connection (see [0059], guide member 44 snaps into first track 80).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the tab and locking rib of Targell as modified to have been a snap fit engagement as in Rubinstein ‘817 as Rubinstein ‘817 teaches such a snap fit engagement to be beneficial for preventing disassembly of the relative structures ([0059]). Such a snap fit arrangement would be the radial snapping of the tab and locking rib of Targell as claimed where the tab of Targell snaps radially inwards such as to engage with first cam profile to prevent disassembly as in Rubinstein ‘817.
Regarding claim 2, Targell as modified discloses the device wherein the rotating cam is a peg (see fig. 7, projections 64 are shown as pegs).
Regarding claim 3, Targell as modified discloses the device wherein the first locking element is configured to be passively activated (since the engagement between second projection 64 and second cam profile 110 occurs due to their respective shapes and does not require additional user input beyond the activation of the needle safety device during injection procedures, it is considered to be passively activated as claimed).
{Examiner notes that “passively activated” is interpreted in line with Applicant’s Specification at [0007] where Applicant calls out that passive activation means that additional intervention is not required by a user.}
Regarding claim 4, Targell as modified discloses the device wherein rotation of the retractable sheath from the initial position to the retracted position is configured to transfer the rotating cam of the retractable sheath to slide from the first guide path on the housing to the third guide path on the housing via the second guide path (see [0042]-[0044], the rotation of sleeve 22 as a result of the engagement between first projection 64 and first cam profile 110 allows for first projection 64 to move from recessed cavity 106 of first track 66A to passage portion 108 of first track 66A via passageway 100 of first track 66A as claimed).
Regarding claim 5, Targell as modified discloses the device wherein the second locking element is configured to be passively activated (since the movement of Rubinstein’s locking collar 138 occurs on its own once foot 154 has extended past the distal tip of needle 28 in the modified device and does not require additional user input beyond the activation of the needle safety device during injection procedures, the second locking element is considered to be passively activated as claimed; see Rubinstein [0034]-[0035]).
{Examiner notes that “passively activated” is interpreted in line with Applicant’s Specification at [0007] where Applicant calls out that passive activation means that additional intervention is not required by a user.}
Regarding claim 6, Targell as modified discloses the device wherein the first locking element is configured to inhibit reuse of the safety needle device by inhibiting rotation of the retractable sheath (see [0042] and [0044], second cam profile 110 prevents second projection 64 from returning to recessed cavity 106 of second track 66B due to their interference once the safety needle 20 has been used which is a configuration for inhibiting of reuse as claimed).
Regarding claim 7, Targell as modified discloses the device wherein the spring element biases the retractable sheath toward the extended position ([0036]).
Regarding claim 9, Targell as modified discloses the device wherein the needle cannula is obscured from view when the retractable sheath is in the extended position (see fig. 6, since needle 28 is completely surrounded, it is obscured from view as claimed; further in the modified device, opening 58 does not provide a view to needle 28 as the added second locking member of Rubinstein covers the distal tip 26 of needle 28).
Regarding claim 10, Targell as modified discloses the device wherein the spring element is a coil spring (see figs. 4 and 7, spring 42 is coiled which makes it a coil spring).
Regarding claim 12, Targell as modified does not disclose the device further comprising a cap removably coupled to the housing.
Rubinstein teaches a cap (cap 26, fig. 1) removably coupled to a housing (housing 14, fig. 1) of a safety needle device (cover assembly 10, fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the removable cap of Rubinstein to the safety needle device of Targell for preventing needle stick injuries prior to use of the safety needle device (see Rubinstein [0003]) and to prevent possible contamination of the needle prior to use (Rubinstein [0028]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/ Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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