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 .
Response to Amendment
The Drawings and Specification were previously objected to regarding typographical errors and showing the locking rib on the housing and have each been properly amended. Examiner thus withdraws the previous objections to the Specification and Drawings.
Claim 1 was previously objected to for a typographical error and has been amended. Examiner accordingly withdraws the objections to claim 1.
Claims 1-12 were previously rejected as indefinite and have been amended; Examiner accordingly withdraws the previous rejections to claims 1-12 under 35 U.S.C. §112(b).
Priority
All claimed subject matter is properly supported in PRO 62433294 and thus has an effective filing date of 12/13/2016.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 8, the claim requires that the retractable sheath is configured to translate from the initial position to the retracted position. Claim 1, which claim 8 is dependent on, already requires such a configuration where the claim requires “wherein movement of the retractable sheath from the initial position to the retracted position is configured to engage”, which is thus already a requirement that the retractable sheath is functionally capable of, or configured for, moving from the initial position to the retracted position, and thus claim 8 does not further limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1-10 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) and Kuracina et al. (US 20060189934, henceforth Kuracina, previously made of record).
Regarding claims 1 and 8, 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]).
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]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10589036 in view of Targell (US 20050113750, henceforth Targell, previously made of record) in view of Rubinstein et al. (US 20090299295, henceforth Rubinstein, previously made of record) and Kuracina et al. (US 20060189934, henceforth Kuracina, previously made of record).
Regarding claim 1, claim 1 of the ’036 patent claims: a safety needle device, comprising: a housing configured to couple to a syringe, the housing having a proximal end, a distal end, and a housing body; a first guide path, a second guide path and a third guide path disposed on the housing body, the second guide path intersecting the first guide path and the third guide path; a needle hub disposed on the proximal end of the housing; a needle cannula attached to the needle hub; a retractable sheath having a rotating cam configured to move between an initial position wherein the initial position partially exposes a distal tip of the needle cannula, a retracted position wherein the retracted position fully exposes the needle cannula and an extended position with respect to the housing wherein the extended position fully covers the distal tip of the needle cannula, the first guide path and the second guide path disposed on the housing body configured to receive the guiding element rotating cam, wherein the retractable sheath rotates with respect to the housing during movement from the initial position to the retracted position; a first locking element, a second locking element; the rotating cam disposed in the housing body; and a spring element (see claim 1 of the ‘036 patent).
Examiner notes that while different terms have been used between claim 1 of the ‘036 patent and claim 1 of the instant application where the ‘036 patent refers to locking members instead of locking elements, the specification makes clear that these are the same structures where it uses both terms, and thus the scope is the same.
Claim 1 of the ‘036 patent does not claim that the first guide path and the third guide path extend parallel to a central axis which extends along the housing, that the first locking element comprises a tab on a proximal end of the retractable sheath and a locking rib on the housing, or the device 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 retractable sheath with the locking rib of the housing, thereby preventing further rotation of the rotating cam and thus preventing the guide element from returning to the first guide path and preventing the retractable sheath from returning to the initial position; wherein movement of the retractable sheath from the retracted position to the extended position engages 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 as in instant claim 1.
Targell teaches a first guide path and a third guide path as claimed (recessed cavity 106 of first track system 66A, fig. 12, and passage portion 108 of first track system 66A, fig. 12) which extend parallel to a central axis which extends along the housing (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), and 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]), and the device 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”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arranged the guide paths as in Targell and to have used a locking element as in Targell and with the locking arrangement of Targell for properly covering the tip of the needle once it is used to prevent needle stick injuries, improper reuse of the safety needle device, and potential transfer of blood-borne disease (Targell [0004] and [0005]).
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]).
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 10589036 in view of Targell (US 20050113750, henceforth Targell, previously made of record) in view of Rubinstein et al. (US 20090299295, henceforth Rubinstein, previously made of record) and Kuracina et al. (US 20060189934, henceforth Kuracina, previously made of record) following the same modifications as those made with respect to claim 1 above.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 10589036 in view of Targell (US 20050113750, henceforth Targell, previously made of record) in view of Rubinstein et al. (US 20090299295, henceforth Rubinstein, previously made of record) and Kuracina et al. (US 20060189934, henceforth Kuracina, previously made of record) following the same modifications as those made with respect to claim 1 above.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 10589036 in view of Targell (US 20050113750, henceforth Targell, previously made of record) in view of Rubinstein et al. (US 20090299295, henceforth Rubinstein, previously made of record) and Kuracina et al. (US 20060189934, henceforth Kuracina, previously made of record) following the same modifications as those made with respect to claim 1 above.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 10589036 in view of Targell (US 20050113750, henceforth Targell, previously made of record) in view of Rubinstein et al. (US 20090299295, henceforth Rubinstein, previously made of record) and Kuracina et al. (US 20060189934, henceforth Kuracina, previously made of record) following the same modifications as those made with respect to claim 1 above.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 10589036 in view of Targell (US 20050113750, henceforth Targell, previously made of record) in view of Rubinstein et al. (US 20090299295, henceforth Rubinstein, previously made of record) and Kuracina et al. (US 20060189934, henceforth Kuracina, previously made of record) following the same modifications as those made with respect to claim 1 above.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 10589036 in view of Targell (US 20050113750, henceforth Targell, previously made of record) in view of Rubinstein et al. (US 20090299295, henceforth Rubinstein, previously made of record) and Kuracina et al. (US 20060189934, henceforth Kuracina, previously made of record) following the same modifications as those made with respect to claim 1 above.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 10589036 in view of Targell (US 20050113750, henceforth Targell, previously made of record) in view of Rubinstein et al. (US 20090299295, henceforth Rubinstein, previously made of record) and Kuracina et al. (US 20060189934, henceforth Kuracina, previously made of record) following the same modifications as those made with respect to claim 1 above.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 10589036 in view of Targell (US 20050113750, henceforth Targell, previously made of record) in view of Rubinstein et al. (US 20090299295, henceforth Rubinstein, previously made of record) and Kuracina et al. (US 20060189934, henceforth Kuracina, previously made of record) following the same modifications as those made with respect to claim 1 above.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No. 10589036 in view of Targell (US 20050113750, henceforth Targell, previously made of record) in view of Rubinstein et al. (US 20090299295, henceforth Rubinstein, previously made of record) and Kuracina et al. (US 20060189934, henceforth Kuracina, previously made of record) following the same modifications as those made with respect to claim 1 above.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10589036 in view of Targell (US 20050113750, henceforth Targell, previously made of record) in view of Rubinstein et al. (US 20090299295, henceforth Rubinstein, previously made of record) and Kuracina et al. (US 20060189934, henceforth Kuracina, previously made of record) following the same modifications as those made with respect to claim 1 above.
Claim 1 of the ’036 patent does not claim 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 modified safety needle device of claim 1 of the ‘036 patent 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]).
Claim 1 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11559631 in view of Targell (US 20050113750, henceforth Targell, previously made of record) in view of Rubinstein et al. (US 20090299295, henceforth Rubinstein, previously made of record) and Kuracina et al. (US 20060189934, henceforth Kuracina, previously made of record).
Regarding claim 1, claim 1 of the ‘631 patent claims: a safety needle device, comprising: a housing configured to couple to a syringe, the housing having a proximal end, a distal end, and a housing body; a first guide path, a second guide path and a third guide path disposed on the housing body, the second guide path intersecting the first guide path and the third guide path; a needle hub disposed on the proximal end of the housing; a needle cannula attached to the needle hub; a retractable sheath having a rotating cam configured to move between an initial position, a retracted position, and an extended position with respect to the housing, wherein the retractable sheath rotates with respect to the housing during movement from the initial position to the retracted position; a first locking element comprising a tab on the proximal end of the retractable sheath and a locking rib on the housing, a second locking element; the rotating cam disposed in the housing body; and a spring element; 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 retractable sheath with the locking rib of the housing, thereby preventing further rotation of the rotating cam and thus preventing the guide element from returning to the first guide path (see claim 1 of the ‘631 patent).
Claim 1 of the ‘036 patent does not claim that the first guide path and the third guide path extend parallel to a central axis which extends along the housing, that the initial position partially exposes a distal tip of the needle cannula, that the retracted position fully exposes the needle cannula, that the extended position fully covers the distal tip of the needle cannula, that the first guide path and the second guide path disposed on the housing body are configured to receive the rotating cam, that the configuration from the initial to the retracted position is such to prevent the retractable sheath from returning to the initial position, or the configuration wherein movement of the retractable sheath from the retracted position to the extended position engages 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 as in instant claim 1.
Targell teaches a first guide path and a third guide path as claimed (recessed cavity 106 of first track system 66A, fig. 12, and passage portion 108 of first track system 66A, fig. 12) which extend parallel to a central axis which extends along the housing (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). Targell additionally teaches an initial position (position of figs. 4 and 13) wherein the initial position partially exposes a distal tip of a needle cannula (see fig. 4, needle tip 26 of needle 28 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 (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), with the first guide path and a second guide path (passageway 100 of first track system 66A, fig. 12) disposed on a 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]) configured to receive a rotating cam (see figs. 13-15, first projection 64 is shown being received by the called out paths of first track 66A). Targell additionally teaches the device 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”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arranged the guide paths as in Targell and to have used a locking element as in Targell and with the locking arrangement of Targell for properly covering the tip of the needle once it is used to prevent needle stick injuries, improper reuse of the safety needle device, and potential transfer of blood-borne disease (Targell [0004] and [0005]).
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]).
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11559631 in view of Targell (US 20050113750, henceforth Targell, previously made of record) in view of Rubinstein et al. (US 20090299295, henceforth Rubinstein, previously made of record) and Kuracina et al. (US 20060189934, henceforth Kuracina, previously made of record) following the same modifications as those made with respect to claim 1 above.
Claim 1 of the ‘631 patent does not claim that the rotating cam is a peg. Targell teaches a rotating cam which is a peg (first projection 64 is a peg, see fig. 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a peg for the rotating cam of the modified safety needle device as Targell teaches a peg-shaped protrusion to be an art acceptable shape for a rotating cam which traverses guide paths and causes rotation due to relative movement in a locking arrangement (see Targell [0042]-[0044]), and thus substituting a peg for a rotating cam would have yielded the same, predictable result of a feature which protrudes from the retractable sheath which rotates and engages with guide paths to cause rotation in a locking arrangement of a needle safety device.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 11559631 in view of Targell (US 20050113750, henceforth Targell, previously made of record) in view of Rubinstein et al. (US 20090299295, henceforth Rubinstein, previously made of record) and Kuracina et al. (US 20060189934, henceforth Kuracina, previously made of record) following the same modifications as those made with respect to claim 1 above.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 11559631 in view of Targell (US 20050113750, henceforth Targell, previously made of record) in view of Rubinstein et al. (US 20090299295, henceforth Rubinstein, previously made of record) and Kuracina et al. (US 20060189934, henceforth Kuracina, previously made of record) following the same modifications as those made with respect to claim 1 above.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 11559631 in view of Targell (US 20050113750, henceforth Targell, previously made of record) in view of Rubinstein et al. (US 20090299295, henceforth Rubinstein, previously made of record) and Kuracina et al. (US 20060189934, henceforth Kuracina, previously made of record) following the same modifications as those made with respect to claim 1 above.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 11559631 in view of Targell (US 20050113750, henceforth Targell, previously made of record) in view of Rubinstein et al. (US 20090299295, henceforth Rubinstein, previously made of record) and Kuracina et al. (US 20060189934, henceforth Kuracina, previously made of record) following the same modifications as those made with respect to claim 1 above.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 11559631 in view of Targell (US 20050113750, henceforth Targell, previously made of record) in view of Rubinstein et al. (US 20090299295, henceforth Rubinstein, previously made of record) and Kuracina et al. (US 20060189934, henceforth Kuracina, previously made of record) following the same modifications as those made with respect to claim 1 above.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 11559631 in view of Targell (US 20050113750, henceforth Targell, previously made of record) in view of Rubinstein et al. (US 20090299295, henceforth Rubinstein, previously made of record) and Kuracina et al. (US 20060189934, henceforth Kuracina, previously made of record) following the same modifications as those made with respect to claim 1 above.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No. 11559631 in view of Targell (US 20050113750, henceforth Targell, previously made of record) in view of Rubinstein et al. (US 20090299295, henceforth Rubinstein, previously made of record) and Kuracina et al. (US 20060189934, henceforth Kuracina, previously made of record) following the same modifications as those made with respect to claim 1 above.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11559631 in view of Targell (US 20050113750, henceforth Targell, previously made of record) in view of Rubinstein et al. (US 20090299295, henceforth Rubinstein, previously made of record) and Kuracina et al. (US 20060189934, henceforth Kuracina, previously made of record) following the same modifications as those made with respect to claim 1 above.
Claim 1 of the ‘631 patent does not claim that the spring is a coil spring. Targell teaches the use of a spring in a safety needle device where the spring is a coil spring (see spring 42, fig. 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a coil spring for the spring of the needle safety device as coil springs are taught to be conventional in the use of safety needle devices (see Targell [0041]) and thus using a coil spring for the spring of claim 1 of the ‘631 patent would have yielded the same, predictable result of having an element which is compressible or extensible to provide the desired biasing of the retractable sheath within the housing of the needle safety device in the modified needle safety device.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 11559631 in view of Targell (US 20050113750, henceforth Targell, previously made of record) in view of Rubinstein et al. (US 20090299295, henceforth Rubinstein, previously made of record) and Kuracina et al. (US 20060189934, henceforth Kuracina, previously made of record) following the same modifications as those made with respect to claim 1 above.
Response to Arguments
Applicant's arguments filed 01/09/2026 have been fully considered but they are not persuasive.
Applicant has argued that Targell does not disclose the configuration as modified where 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, thereby preventing further rotation of the rotating cam and thus preventing the guide element from returning to the first guide path and preventing the retractable sheath from returning to the initial position. Examiner respectfully disagrees, as Targell discloses such a configuration as called out in the rejection above where the required structures and functionally capable movements are disclosed especially at [0044]. While Targell may lack the intermediary lock event as argued by Applicant (see Applicant’s remarks at pg. 13), which Examiner does not concede, Targell meets the claim limitations as the claimed engagement of relative structures occurs at Targell [0044] and the claimed prevented rotation and returning occurs at [0044] due to the shaping of the guide paths of Targell and the engagements between elements during the changing of positions. Thus, Examiner respectfully finds Applicant’s arguments unpersuasive and rejects the claims as indicated above.
Additionally, regarding the Terminal Disclaimer, Examiner notes that Applicant indicated they submitted a Terminal Disclaimer, however no Terminal Disclaimer has been filed.
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wong (US 20090157013) is considered relevant prior art regarding the use of a metal latch as a locking element similar to Applicant’s latch. See at least [0042].
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