DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 2 and 14 are objected to because of the following informalities:
Regarding claims 2 and 14, there is a typographical error wherein the claim has improper antecedent basis where it recites “each of the locking clips” and should instead recite “each of the at least one locking clips” to be consistent with claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-8, 10, and 13-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (US 20230355893, henceforth Wang).
Regarding claim 1, Wang discloses a needlestick prevention device, comprising an injector component (assembly of fig. 7), an accumulation member (spring 3, fig. 1), a fixing sleeve (inner sleeve 2, fig. 1), and a limiting sleeve (outer protection sleeve 1, fig. 1); wherein the fixing sleeve and the accumulation member are arranged in the limiting sleeve (see figs. 7 and 8); one end of the accumulation member is fixedly connected with the fixing sleeve (see annotated fig. 11, the called out proximal end of spring 3 is connected to inner sleeve 2 as shown), and another end of the accumulation member is fixedly connected with the limiting sleeve (see annotated fig. 11, the called out distal end of spring 3 is connected to outer sleeve 1 as shown); the injector component includes a pressing cap (pushing head 52, fig. 6), an injector syringe flanging (syringe cam 41, fig. 6), an injector syringe (syringe tube 4, fig. 6), and a needle (needle 6, fig. 7); the fixing sleeve includes one or more locking clips (outer locking jack catch 24, fig. 5), a flanging fixing clip (combination of syringe cam fixing jaw 28, syringe cam fixing groove 29, and guide blocks 23, fig. 4), at least one support plate (backstop jaw 22, fig. 4), and a limiting plate (needle sleeve backstop piece 21, fig. 4), and the flange fixing clip is configured to fix the injector syringe flanging (see [0131]); the limiting sleeve includes at least one guiding feature (guide chute 13, fig. 3), at least one first limiting hole (see annotated fig. 3, the called out first slot inside of the radial protrusion is the first limiting hole), at least one second limiting hole (see annotated fig. 3, the called out second slot inside of the radial protrusion is the second limiting hole), and a limiting buckle (inner locking catch jack 16, fig. 3); the needlestick prevention device has a first state, a second state, and a third state; wherein in the first state, the accumulation member is accumulated (this is the state of fig. 2, spring 3 is accumulated where it is compressed), and the fixing sleeve is in a first position (this is the position of fig. 2); when the fixing sleeve is in the first position, the limiting buckle is connected with the locking clips (see fig. 2, the structures are connected where they are directly contacting each other), the at least one support plate is in the at least one second limiting hole (see fig. 11, backstop jaw 22 is shown sliding in the location where the called out second limiting hole of annotated fig. 3 is located), and the limiting plate is at one end of the at least one guiding feature (see fig. 7, backstop piece 21 is at the distal end of guide chute 13 since piece 21 is distal to chute 13 in this state) near the at least one second limiting hole (see fig. 11, backstop piece 21 is near the distal end of the called out second limiting hole in this state); in the second state, the locking clips rotate to separate from the limiting buckle (see fig. 10, catch 24 rotates radially away from the axis of needle 6 as shown), the fixing sleeve is released from the limiting sleeve (see [0133]), and the accumulation member is released (see figs. 10-14); and in the third state, the fixing sleeve and the injector component move along the at least one guiding feature to a second position (see position of fig. 13); and when the fixing sleeve is in the second position, the support plate is in the at least one first limiting hole (see fig. 14, backstop jaw 22 is shown sliding in the location where the called out first limiting hole of annotated fig. 3 is located), and the limiting plate is at one end of the at least one guiding feature (see fig. 14, backstop piece 21 is at the proximal end of guide chute 13 in this state) near the at least one first limiting hole (see fig. 14, backstop piece 21 is in between the called out first limiting hole and second limiting hole in this state, and thus it is near the first limiting hole as claimed).
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Annotated fig. 11 from Wang
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Annotated fig. 3 from Wang
Regarding claim 2, Wang discloses the device of claim 1 wherein each of the locking clips includes a connecting feature, a clamping rod, a clamping press angle, and a clamping hook angle (see annotated fig. 10 calling out the respective components, note that the clamping press angle is the angled feature and the central axis is the provided dashed line); and the clamping rod is capable of rotating around the connecting feature (see figs. 9-11, the called out rod is shown rotating radially about the called out connecting feature); the connecting feature is arranged in a middle of the clamping rod (see fig. 5, the called out connecting feature extends from the front side of the catch 24 closest to one piece 21 towards the back side of catch 24 closest to the other piece 21, and the middle of the catch 24 between the front and back side), and two ends of the clamping rod are the clamping press angle and clamping hook angle, respectively (see fig. 5, the proximal end of the clamping rod is the clamping press angle and the distal end of the clamping rod is the clamping hook angle); in the first state, the clamping press angle is away from a central axis of the fixing sleeve (see annotated fig. 10, point A of the called out clamping press angle is further away from the called out central axis in fig. 9 as compared to fig. 10 since the arm has pivoted to move point A towards the called out central axis in the second state of fig. 10), and the clamping hook angle is close to the central axis (see fig. 9, the called out clamping hook angle is closer to the central axis in this state than the state of fig. 10); and in the second state, the clamping press angle is near the central axis (see annotated fig. 10, point A is now closer to the called out central axis compared to fig. 9), and the clamping hook angle is away from the central axis (see fig. 10, the called out clamping hook angle is further from the central axis in this state than that of fig. 9).
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Annotated fig. 10 from Wang
Regarding claim 3, Wang discloses the device of claim 2 wherein the limiting buckle includes a hook angle feature (see fig. 2, the angled part of inner locking catch jack 16 which is connected to outer locking catch jack 24 is a hook angle feature as claimed), and the hook angle feature matches the clamping hook angle (see fig. 2); and in the first state, the hook angle feature is engaged with the clamping hook angle (see fig. 2) to limit the fixing sleeve to the first position ([0126]).
Regarding claim 5, Wang discloses the device of claim 1 wherein the accumulation member is an elastic rope (Merriam Webster defines a rope as “a long slender strip of material used as rope” and “a large stout cord of strands of fibers or wire twisted or braided together”; thus, an elastic rope is considered to be a long slender strip of elastic material; spring 3 meets this interpretation as it is a long strip of flexible, resilient material used as a connecting piece between other structures), one end of the elastic rope is fixed to the limiting buckle of the limiting sleeve (see fig. 2, spring 3 is fixed as claimed since it extends between sleeve 1 and sleeve 2 and thus it is fixed to the relative structures of the respective sleeves), and another end of the elastic rope is fixed to the limiting plate of the fixing sleeve (see fig. 2, spring 3 is fixed as claimed since it extends between sleeve 1 and sleeve 2 and thus it is fixed to the relative structures of the respective sleeves).
Regarding claim 6, Wang discloses the device of claim 5 wherein the limiting sleeve is provided with a rope passage groove (see fig. 2, the extension proximally from spring installation seat is considered to be a rope passage groove as it is a hollowed out space which the rope, which is spring 3, is seated within), and the elastic rope passes through the rope passage groove (see fig. 2).
Regarding claim 7, Wang discloses the device of claim 1 wherein the at least one support plate includes a bending portion (see fig. 4, the point at which backstop jaw 22 connects to inner installation sleeve 2 is a bending portion as it allows for deflection of jaw 22) and a reinforcing groove (see fig. 4, the reinforcing groove is the small groove shown at the bending portion) arranged on the bending portion (see fig. 2); the limiting sleeve further includes an accommodating cavity (see fig. 2, the hollow space inside of outer protection sleeve 1 is an accommodating cavity as claimed) configured to accommodate the fixing sleeve (see fig. 2); and a maximum distance between the bending portion and a central axis of the fixing sleeve is greater than an inner diameter of the accommodating cavity (see fig. 10, the distance between the bending portion and a central axis coaxial with needle 6 is greater than the distance from the distalmost end of outer sleeve 1 where the cylindrical portion of the sleeve tapers toward needle 6 as shown).
Regarding claim 8, Wang discloses the device of claim 7 wherein the at least one first limiting hole and the at least one second limiting hole are provided with a reinforcing protrusion, respectively (see annotated fig. 3, the respective reinforcing protrusions are the physical sides of the holes which protrude radially outward from the cylindrical portion of outer sleeve 1 as shown), and the reinforcing protrusion matches the reinforcing groove (see annotated fig. 3, the structures match where they are the same shapes).
Regarding claim 10, Wang discloses the device of claim 1 wherein the limiting plate is arranged on the at least one support plate (see fig. 5, since the structures are integrally connected where they are unitarily formed with one another as parts of inner installation sleeve 2, the structures are considered to be arranged on one another as claimed), the limiting plate is a convex corner (see fig. 5, backstop piece 21 is a convex corner as claimed where it follows a slight curve about the cylindrical shell of sleeve 2, thus making it a corner, and where it is convex as it is flexed and directed towards the central axis of sleeve 2, or arranged in a convex manner), the at least one guiding feature is a groove (guide chute 13 is a groove as claimed, see fig. 5, where it is a long narrow channel) arranged between the at least one first limiting hole and the at least one second limiting hole (see fig. 8, chute 13 is arranged as claimed); and a depth of the groove (see fig. 5, the depth of guide chute 13 is the wall thickness shown) is less than a thickness of the limiting sleeve (see fig. 3, the claimed thickness of the outer sleeve 1 is measured along handling rib 18 from the radial innermost portion of rib 18, which is coplanar with inner locking catch jack 16 as in fig. 3, to the radial exterior most portion of rib 18; this thickness is greater than the wall thickness of chute 13).
Regarding claim 13, Wang discloses the device of claim 1 further comprising a connecting strip (jack catch frame 25, fig. 5) configured to connect with at least two locking clips (see fig. 5, there are a pair of outer locking jack catches 24 which are unitarily molded with and thus connected to jack catch frame 25).
Regarding claim 14, Wang discloses the device of claim 1 further comprising a release member (activation piece 51, fig. 9), wherein each of the locking clips includes a clamping hook angle (see annotated fig. 10 above and see fig. 11, each of the pair of outer locking jack catches 24 have clamping hooking angles), and the release member is capable of being inserted between the locking clips and the limiting buckle (see fig. 10, activation piece 51 is capable of insertion as claimed where it is inserted radially between the structures at a position longitudinally proximal to catch 24 and catch 16 to cause release of the structures when they are engaged with each other).
Regarding claim 15, Wang discloses the device of claim 1 wherein the flanging fixing clip includes two fixing protrusions (fig. 4, the two guide blocks 23 are two fixing protrusions; note that only the outermost corner of the second guide block 23 is shown in fig. 4 as it is primarily hidden from view) and two deforming members (see fig. 4, two of the four syringe cam fixing jaws 28 are two deforming members); the fixing sleeve further includes a fixing cavity (this is the hollow interior of inner sleeve 2, see fig. 4, which extends distally to groove 29), the injector syringe is arranged in the fixing cavity (see fig. 7), and the injector syringe flanging is arranged outside the fixing cavity (see fig. 7, syringe cam 41 is in groove 29 proximal to the fixing cavity); and a minimum distance between the two fixing protrusions (see fig. 16, the claimed distance between the two guide blocks 23 is equal to the outer diameter of syringe tube 4) is less than a minimum outer diameter of the injector syringe flanging (see fig. 6, syringe cam 41 is shown as extending across a greater radial distance than the outer diameter of syringe tube 4).
Under an alternative interpretation, Claim(s) 1, 7, and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (US 20230355893, henceforth Wang).
Regarding claim 1, Wang discloses a needlestick prevention device, comprising an injector component (assembly of fig. 7), an accumulation member (spring 3, fig. 1), a fixing sleeve (inner sleeve 2, fig. 1), and a limiting sleeve (outer protection sleeve 1, fig. 1); wherein the fixing sleeve and the accumulation member are arranged in the limiting sleeve (see figs. 7 and 8); one end of the accumulation member is fixedly connected with the fixing sleeve (see annotated fig. 11, the called out proximal end of spring 3 is connected to inner sleeve 2 as shown), and another end of the accumulation member is fixedly connected with the limiting sleeve (see annotated fig. 11, the called out distal end of spring 3 is connected to outer sleeve 1 as shown); the injector component includes a pressing cap (pushing head 52, fig. 6), an injector syringe flanging (syringe cam 41, fig. 6), an injector syringe (syringe tube 4, fig. 6), and a needle (needle 6, fig. 7); the fixing sleeve includes one or more locking clips (outer locking jack catch 24, fig. 5), a flanging fixing clip (combination of syringe cam fixing jaw 28, syringe cam fixing groove 29, and guide blocks 23, fig. 4), at least one support plate (backstop jaw 22, fig. 4), and a limiting plate (needle sleeve backstop piece 21, fig. 4), and the flange fixing clip is configured to fix the injector syringe flanging (see [0131]); the limiting sleeve includes at least one guiding feature (guide chute 13, fig. 3), at least one first limiting hole (see alternative annotated fig. 11, there are a pair of called out first limiting holes), at least one second limiting hole (see alternative annotated fig. 11, there are a pair of called out second limiting holes), and a limiting buckle (inner locking catch jack 16, fig. 3); the needlestick prevention device has a first state, a second state, and a third state; wherein in the first state, the accumulation member is accumulated (this is the state of fig. 2, spring 3 is accumulated where it is compressed), and the fixing sleeve is in a first position (this is the position of fig. 2); when the fixing sleeve is in the first position, the limiting buckle is connected with the locking clips (see fig. 2, the structures are connected where they are directly contacting each other), the at least one support plate is in the at least one second limiting hole (see fig. 7, backstop jaw 22 is shown sliding in the location where the called out second limiting hole of alternative annotated fig. 11 is located), and the limiting plate is at one end of the at least one guiding feature (see fig. 7, backstop piece 21 is at the distal end of guide chute 13 since piece 21 is distal to chute 13 in this state) near the at least one second limiting hole (see fig. 7, backstop piece 21 is near the distal end of the called out second limiting hole in this state); in the second state, the locking clips rotate to separate from the limiting buckle (see fig. 10, catch 24 rotates radially away from the axis of needle 6 as shown), the fixing sleeve is released from the limiting sleeve (see [0133]), and the accumulation member is released (see figs. 10-14); and in the third state, the fixing sleeve and the injector component move along the at least one guiding feature to a second position (see position of fig. 13); and when the fixing sleeve is in the second position, the support plate is in the at least one first limiting hole (see fig. 14, backstop jaw 22 is shown sliding in the location where the called out first limiting hole of alternative annotated fig. 11 is located), and the limiting plate is at one end of the at least one guiding feature (see fig. 14, backstop piece 21 is at the proximal end of guide chute 13 in this state) near the at least one first limiting hole (see fig. 14, backstop piece 21 which is in the same longitudinal location as jaw 22 is near the called out first limiting hole since it is longitudinally aligned with it).
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Alternative annotated fig. 11 relied upon for alternative rejection from Wang
Regarding claim 7, Wang discloses the device of claim 1 wherein the at least one support plate includes a bending portion (see fig. 4, the point at which backstop jaw 22 connects to inner installation sleeve 2 is a bending portion as it allows for deflection of jaw 22) and a reinforcing groove (see fig. 4, the reinforcing groove is the small groove shown at the bending portion) arranged on the bending portion (see fig. 2); the limiting sleeve further includes an accommodating cavity (see fig. 2, the hollow space inside of outer protection sleeve 1 is an accommodating cavity as claimed) configured to accommodate the fixing sleeve (see fig. 2); and a maximum distance between the bending portion and a central axis of the fixing sleeve is greater than an inner diameter of the accommodating cavity (see fig. 10, the distance between the bending portion and a central axis coaxial with needle 6 is greater than the distance from the distalmost end of outer sleeve 1 where the cylindrical portion of the sleeve tapers toward needle 6 as shown).
Regarding claim 9, Wang discloses the device of claim 7 further comprising two support plates (see fig. 4, there are two), two first limiting holes (see alternative annotated fig. 11, there are two called out), and two second limiting holes (see alternative annotated fig. 11, there are two called out).
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 20230355893, henceforth Wang) as applied to claim 3.
Regarding claim 4, Wang discloses the device of claim 3 wherein an angle of the hook angle feature and the clamping hook angle is the same (see fig. 9, the angles are the same since the surfaces which connect are shown as being coplanar).
Wang does not explicitly disclose that the angle is within a range of 75°- 88°, respectively. However, it appears that the provided angle of the features is within the claimed range at an angle as measured from horizontal (see fig. 9), and no criticality is made as to the exact angles which the features must be made according to.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the angles of Wang as claimed since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 20230355893, henceforth Wang) as applied to claim 15 above.
Regarding claim 16, Wang discloses the device of claim 15.
Wang does not explicitly disclose the device wherein an elastic modulus of each of the two deforming members is less than an elastic modulus of each of the two fixing protrusions. However, Wang discloses that the fixing protrusions (guide blocks 23, fig. 4) are present to prevent separation of elements ([0135]), and that the deforming members (syringe cam fixing jaws 28, fig. 4) are elastically deformable ([0131]) and thus are configured to be bend.
{Examiner notes that an elastic modulus is a term which relates to the stiffness of a material and is defined as stress divided by strain; a material with a higher elastic modulus is stiffer as a larger stress is required to cause a given amount of strain, and a material with a lower elastic modulus is less stiff and more flexible as it requires comparatively less stress to cause the same given amount of strain.}
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 deforming members to have had a lower elastic modulus than the fixing protrusions since the fixing protrusions are required to have stiffness to prevent separation of elements (Wang [0135]) and since the deforming members are required to bend elastically (Wang [0131]) and because such a modification would have yielded the same, predictable result of deformable members being elastically bendable and less stiff as compared to fixing protrusions which are meant to provide stiffness and not bend elastically.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 20230355893, henceforth Wang) as applied to claim 1 above, and further in view of Burkett (US 20200023144, henceforth Burkett).
Regarding claim 17, Wang discloses the device of claim 1.
Wang does not disclose the device further comprising a cooling member, wherein the cooling member is provided with an isolating layer configured to separate the cooling member into two inner chambers; and the cooling member is arranged at one end of the fixing sleeve near the needle and connected with the fixing sleeve. Burkett teaches a device further comprising a cooling member (thermoelectric cooler 232, fig. 2A), wherein the cooling member is provided with an isolating layer (see fig. 2A, the thermoelectric cooler 232 is shown as being made up of multiple layers separated by isolating layers) configured to separate the cooling member into two inner chambers (see fig. 2A, the thermoelectric cooler 232 is shown as being made up of multiple layers); and the cooling member is arranged at one end of an injection device (see fig. 2A and [0083]) near a needle (see fig. 2A and [0083]) and connected with the injection device (see fig. 2A and [0083]).
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 thermoelectric cooling assembly of Burkett to the device of Wang for reducing pain at an injection site through skin cooling (see Burkett Abstract, [0003]-[0004]). The modified device would then include the multi-layered assembly of Burkett separated by an isolating layer, would be arranged at the end of the device of Wang which is where the injection occurs such as to allow the cooling of Burkett to occur near the needle (see Burkett [0004]-[0006] and [0007], the cooling must occur at the distal end) and to connected the cooling assembly with the fixing sleeve of Wang as the fixing sleeve is a part of the device and adding the cooling assembly to the device would thus be a connection of the cooling device to the fixing sleeve as claimed.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 20230355893, henceforth Wang) as applied to claim 1 above, and further in view of Helmer (US 20200282145, henceforth Helmer).
Regarding claim 18, Wang discloses the device of claim 1.
Wang does not disclose the device wherein an inner side of the fixing sleeve is provided with an adjustment member configured to adapt to different diameters of injector syringes; the adjustment member includes a bending edge which is arranged near the needle and bends towards a central axis of the fixing sleeve; or the adjustment member is a ring-shaped open elastic hoop which tightly encircles a middle of the inner side of the fixing sleeve. Helmer teaches a device (data collection device 14, figs. 2, 6, and 8) wherein an inner side is provided with an adjustment member (foam rubber pad of [0063]) configured to adapt to different diameters of injector syringes ([0063]); the adjustment member is a ring-shaped open elastic hoop (see figs. 2, 4, and 6 and see [0063], the foam rubber pad would be an open elastic hoop as claimed since it is taught as being placed on the inner surface of device 14 which is shaped as a ring-shaped open hoop to surround a portion of the syringe and is elastic since it is foam rubber) which tightly encircles a middle of the inner side of the device (this is the arrangement described in [0063]).
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 foam rubber pad of Helmer to the device of Wang to allow for tolerances in the dimensions of the injector of Wang and the device of Wang as in Helmer ([0063]) and further to have arranged the added foam padding of Helmer onto the inner surface of the fixing sleeve of Wang since the fixing sleeve of Wang is what would grip onto the injector of Wang and would need to have the accommodation qualities as described in Helmer ([0063]).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 20230355893, henceforth Wang) as applied to claim 1 above, and further in view of Verespej et al. (US 20090209939, henceforth Verespej).
Regarding claim 19, Wang discloses the device of claim 1 wherein the injector component includes a plunger (piston rod 5, fig. 7), the plunger includes a plug (this is the portion which is distal to piston rod 5 and is shown as being threadedly connected to piston rod 5 as it is not unitarily molded with piston rod 5) and a push plug (threaded portion at the distal end of piston rod 5, fig. 7) which are detachably fixed (the threaded connection is understood to provide a detachable fixation, see fig. 7), and a pre-filled medication (medicine as in [0062]) is sealed between the push plug and the needle ([0062]).
Wang does not explicitly disclose that the plug is made of rubber. Verespej teaches use of a plunger (plunger 30, fig. 1) including a plug (stopper 20, fig. 7) which is made of rubber ([0021]).
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 plug of Wang out of rubber as in Verespej as Verespej teaches rubber to be an preferable material for plugs to be made out of ([0021]) and because such a modification would have yielded the same, predictable result of a plunger with a stopper disposed at its distal end which is provided with pliability and slidability within the injector barrel.
Regarding claim 20, Wang as modified discloses the device of claim 19 wherein the injector component further includes a needle cap (needle sleeve 7, fig. 7).
Allowable Subject Matter
Claims 11-12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art made of record does not disclose or render obvious in combination the claimed device including multiple sets of limiting holes and guiding features as claimed in dependent claim 11. While there could be considered to be multiple limiting holes or guiding features as called out in claim 1, there is not multiple sets of the features having different lengths and having respective multiple guide holes. Additionally, while some references in the prior art, including those cited below, disclose the use of multiple limiting holes and guide features, and while the use of guide holes and features of variable lengths in needle stick prevention devices is known in the art, it is not clear how modifying the device of Wang to include these features would function without destroying the functionality of Wang.
Dependent claim 12 is objected to as allowable by nature of its dependency on, and thus requirement of the allowable subject matter of, objected to claim 11.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chevallier (US 20070179441) is considered relevant prior art where it discloses structures similar to the locking clips claimed but lacking the support plates and limiting plates as claimed. Similarly, see Chevallier et al. (US 20100211017).
Schrul et al. (US 20210353862) is considered relevant prior art where it discloses structures similar to the claimed set of structures but lacking the claimed positions and arrangements. Additionally, the device is an autoinjector and not a passive needlestick prevention device. Similarly, see Schrul et al. (US 20190151564) which teaches distally located clips and alignment components.
Peruzzo (US 20100324492) is considered relevant prior art where it has many structures similar to those claimed but lacking the support plates and limiting plates as claimed.
Doyle et al. (US 20030144631) is considered relevant prior art comprising a multi part construction similar to that which is claimed but lacking the claimed arrangements of structures with respect to the claimed states and positions. Similarly, see Doyle (US 20050101917).
Lowry et al. (US Pat. No. 7300421) is considered relevant prior art where it has multiple interconnected sleeves designed for the same reasons as those claimed but lacking interconnected locking arrangements similar to those claimed.
Daily et al. (US Pat. No. 8376998) is considered relevant prior art where it has interconnected moving sleeves but lacks the arrangement and positions claimed, as well as being an autoinjector instead of a manually operated device.
Fiard et al. (US 20230201482) is considered relevant prior art regarding disclosure of a multi-sleeve apparatus which has locking arrangements similar to those claimed. Similarly, see Fiard et al. (US 20230201481); Fiard et al. (US 20230201479); Fiard et al. (US 20230201475); Fiard et al. (US 20230201473); Fiard et al. (US 20230201476).
Basile et al. (US 20200043372) is considered relevant prior art regarding rotation of locking elements similar to the requirements of claim 2 to allow for unlocking of syringe flange locking clips.
Kuracina et al. (US 20020004650) is considered relevant prior art where it teaches a locking clip arrangement which requires a relative rotation of a plate and clip to allow for release of a previously latched component, see at least figs. 18-21. Similarly Kirk (US Pat. No. 6416497) at figs. 9-11.
Woehr (US 20050080383) is considered relevant prior art where teaches distal clipping elements but lacks flange alignment features and clips as claimed.
Chelak et al. (US 20070239117) is considered relevant prior art where it has a latched multi-sleeve construction with a plurality of supports and interconnected rings, although it appears to lack the claimed rotation of elements of claim 2.
Mills et al. (US 20240139425) is considered relevant prior art where it has interconnected latches on a safety sleeve device similar to those claimed, however it does not disclose the claimed states and positions. Similarly Mills et al. (US 20240139429).
Pessin (US 20060184133) is considered relevant prior art regarding flange alignment elements and locking clips as part of a multi sleeve safety system.
Neale et al. (US 20110230832) is considered relevant prior art where it has structures similar to those claimed but lacks the claimed positions and states as claimed.
Carrel et al. (US 20210016017) is considered relevant prior art where it has structures similar to those claimed but lacks the claimed positions and states as claimed.
Hezkiahu (US 20200282152) is considered relevant prior art where it teaches a flange alignment feature which relies on the flange being placed on a limiting plate and under the influence of flange gripping features.
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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