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 Rejections - 35 USC § 103
Claim(s) 1 and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Staempfli (US 4391272) in view of Pagay (US Patent 5411488) and McConnaughey (US 2895773)
Regarding Claim 1, Staempfli teaches (figs 1a-1c) a prefilled syringe (after step of filling the syringe, the syringe is considered ‘pre-filled’) comprising:
a medical barrel (1) having an inner wall (inner wall of 1) and product containing area (area between 3 and 2 in Fig 1a), the product containing area (area between 3 and 2 in Fig 1a) having disposed therein an injectable product (implied that an injectable product would be in this area), the medical barrel (1) having a distal dispensing end (2) for dispensing the injectable product and an open proximal end configured for receipt of a plunger assembly; and
the plunger assembly (4, 10, 3) for use in the medical barrel, the medical barrel and plunger assembly together forming the pre-filled syringe in which the injectable product is stored (the structure of the plunger assembly and medical barrel is functional to store the injectable product), the pre-filled syringe maintaining container closure integrity to preserve the injectable product for administration of the injectable product to a patient months after the injectable product is initially stored in the pre-filled syringe (this is considered a functional limitation; the syringe is capable of storing injectable product for a period of time), the plunger assembly comprising:
a plunger rod (4) having a distal end (where 10 is located) and a proximal end (where 4a is located);
an axial protrusion (10) secured to, extending from or abutting the distal end of the plunger rod (4), wherein the plunger rod (4) and axial protrusion (10) are provided as a single piece, of unitary construction (col 5 lines 25-27 teach 10 is the neck of rod 4, therefore it is interpreted that the axial protrusion is unitary construction with plunger rod; furthermore this is a product by process limitation, since both structures are taught by Staempfli the limitation is met); and
a plunger comprising a plunger sleeve (3) having an exterior surface (outer surface of 3) and an interior surface (inner surface of 3) surrounding an inner cavity (9),
an opening (area where 7 is labeled) receiving the axial protrusion (10) such that the axial protrusion (10) extends into the inner cavity (9) and contacts an engagement surface (distal most surface of 9) of the interior surface (9), the engagement surface (distal most surface of 9) being configured to receive a force applied in a distal direction (force applied between Fig 1a, 1b) by the axial protrusion (10) to move the plunger assembly (4, 10, 3) in the distal direction when the plunger rod (4) is moved in the distal direction (See Figs 1a-1b, movement in direction b; also see Col 4 lines 28-36);
wherein application of axial force in a proximal direction onto the proximal end of the plunger rod sufficient to axially displace the proximal end of the plunger rod a predetermined distance effectuates axial displacement of the axial protrusion the predetermined distance in the proximal direction sufficient to withdraw the axial protrusion from the plunger, but does not without axially displacing the plunger in the proximal direction (See Figs 1b-1c; Col 4 lines 37-45), and
wherein the axial protrusion (10) is cylindrical (see Fig 1a-c), wherein a cylindrical outer surface of the axial protrusion (10) loosely contacts the interior surface of the plunger sleeve (3) without an interference fit so that the axial protrusion may be manually pulled out of the plunger sleeve when the plunger sleeve is disposed in a medical barrel (See Figs 1b-1c; Col 4 lines 37-45).
Staempfli does not specify the exterior surface comprising a distal nose cone and an outer annular wall extending proximally from the nose cone and leading to an opening at a proximal end of the plunger sleeve; wherein the plunger is disposed within the medical barrel such that the nose cone faces the injectable product and at least a portion of the plunger rod extends proximally from the open proximal end of the medical barrel,
wherein, when the plunger is in a pre-elongation state prior to actuation, the plunger is configured to provide compressive force against the inner wall of the medical barrel to seal and preserve the shelf-life of the injectable product and the distal end of the plunger rod does not initially contact the proximal end of the plunger sleeve, wherein when the axial protrusion initially applies the force in the distal direction, the plunger is converted from the pre-elongation state to a dispensing-mode and stretches axially such that at least a portion of the outer annular wall of the plunger sleeve is constricted so as to reduce radial compression against the inner wall to provide a reduced glide force than would be achievable without stretching the plunger, wherein the plunger advances distally down the medical barrel in the dispensing mode, the plunger maintaining substantially the same shape from an axial section view in both the pre-elongation state and the dispensing mode aside from being axially stretched and thus elongated in the dispensing mode, the nose cone being characterized by a nose cone shape that is present both when the plunger is in the pre- elongation state and the dispensing mode, the nose cone shape being defined by a central distal tip and a tapered surface extending proximally from the central distal tip to the outer annular wall.
Pagay teaches (Figs 4-5) a plunger sleeve (30) with an exterior surface (outer surface of 30, where 36 points to) comprising a distal nose cone (32) and an outer annular wall (40, 41, 42) extending proximally from the nose cone (32) and leading to an opening (opening near 39 where rod 50 is inserted) at a proximal end of the plunger sleeve (30); wherein the plunger (30) is disposed within the medical barrel (20) such that the nose cone (32) faces the injectable product (See Fig 2) and at least a portion of the plunger rod (50) extends proximally from the open proximal end (26) of the medical barrel (20; see Figs 1-2),
wherein, when the plunger (30) is in a pre-elongation state (Fig 4) prior to actuation, the plunger (30) is configured to provide compressive force against the inner wall of the medical barrel to seal and preserve the shelf-life of the injectable product and the distal end (52) of the plunger rod (50) does not initially contact the proximal end (39) of the plunger sleeve (See Fig 4; 52 does not initially contact 39), wherein when the axial protrusion (64) initially applies the force in the distal direction, the plunger is converted from the pre-elongation state (Fig 4) to a dispensing mode (Fig 5) and stretches axially (Fig 5, stretch shown by 'a') such that at least a portion of the outer annular wall of the plunger sleeve is constricted (see Fig 5, 'b', 'c', and 'd' show annular wall constricted) so as to reduce radial compression against the inner wall to provide a reduced glide force than would be achievable without stretching the plunger (necessarily occurs due to the stretch and compression shown in Fig 5; also see Col 6 line 60 - Col 7 line 2), wherein the plunger (30) advances distally down the medical barrel (20) in the dispensing mode, the plunger (30) maintaining substantially the same shape from an axial section view in both the pre-elongation state (Fig 4) and the dispensing mode (Fig 5) aside from being axially stretched and thus elongated in the dispensing mode (Fig 5 shape is substantially the same as Fig 4), the nose cone (32) being characterized by a nose cone shape that is present both when the plunger is in the pre-elongation state (Fig 4) and the dispensing mode (Fig 5), the nose cone shape being defined by a central distal tip and a tapered surface extending proximally from the central distal tip to the outer annular wall (see annotated Fig 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plunger of Staempfli such that it is shaped with a distal cone and is made with a material that is elastomeric so it would result in the exterior surface comprising a distal nose cone and an outer annular wall extending proximally from the nose cone and leading to an opening at a proximal end of the plunger sleeve; wherein the plunger is disposed within the medical barrel such that the nose cone faces the injectable product and at least a portion of the plunger rod extends proximally from the open proximal end of the medical barrel,
wherein, when the plunger is in a pre-elongation state prior to actuation, the plunger is configured to provide compressive force against the inner wall of the medical barrel to seal and preserve the shelf-life of the injectable product and the distal end of the plunger rod does not initially contact the proximal end of the plunger sleeve, wherein when the axial protrusion initially applies the force in the distal direction, the plunger is converted from the pre-elongation state to a dispensing-mode and stretches axially such that at least a portion of the outer annular wall of the plunger sleeve is constricted so as to reduce radial compression against the inner wall to provide a reduced glide force than would be achievable without stretching the plunger, wherein the plunger advances distally down the medical barrel in the dispensing mode, the plunger maintaining substantially the same shape from an axial section view in both the pre-elongation state and the dispensing mode aside from being axially stretched and thus elongated in the dispensing mode, the nose cone being characterized by a nose cone shape that is present both when the plunger is in the pre- elongation state and the dispensing mode, the nose cone shape being defined by a central distal tip and a tapered surface extending proximally from the central distal tip to the outer annular wall as taught by Pagay. One of ordinary skill in the art would have been motivated to do so in order to prevent the plunger from seizing in the barrel over a prolonged period of time the syringe is kept in storage, and allow a reduction of interfacial force between the plunger and inner wall of the syringe, which helps allow smoother use/delivery (Pagay Col 7 lines 2-12).
The combination does not specify the axial protrusion is cylindrical and of uniform diameter substantially along its entire length.
McConnaughey teaches (Fig 1a) an axial protrusion (20) that is cylindrical and of uniform diameter substantially along its entire length (see Col 3 lines 34-37).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the axial protrusion of Staempfli such that it cylindrical and of uniform diameter substantially along its entire length as taught by McConnaughey. It would have been an obvious matter of design choice to modify the shape of the axial protrusion since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
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Annotated Fig 4 (Pagay)
Regarding Claim 12, the combination of Staempfli , Pagay and McConnaughey teaches all elements of claim 1 as described above. Pagay further teaches the pre-filled syringe wherein application of sufficient force onto the plunger rod (50) in the distal direction causes the plunger assembly to displace distally down the medical barrel (Col 6 line 60 – Col 7 line 2).
Regarding Claim 13, the combination of Staempfli , Pagay and McConnaughey teaches all elements of claim 12 as described above. Pagay further teaches the pre-filled syringe, the plunger comprising a stretch zone that is adapted to undergo stretching along a central axis of the plunger upon application of a force in the distal direction by the axial protrusion onto the engagement surface (see Fig 5, showing stretching along central axis – see ‘a’, ‘b’, ‘c’, and ‘d’), wherein the stretching reduces an outer profile of the outer annular wall along the stretch zone (See Fig 5 and Col 6 line 60 – Col 7 line 2).
Regarding Claim 14, the combination of Staempfli , Pagay and McConnaughey teaches all elements of claim 13 as described above. Pagay further teaches the pre-filled syringe, wherein the plunger rod (50) and axial protrusion (64) are configured such that the plunger rod does not contact the proximal end (39) of the plunger sleeve (30) when the assembly is advanced in the distal direction down the medical barrel, so as not to axially compress the plunger during actuation (See Fig 4 and 5; 64 and distal end 52 is not in contact with 39).
Claim(s) 4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lewis (US 5314416) in view of Janish (US Patent Pub. 20090318880).
Regarding Claim 4, Lewis teaches (Figs 1 -7) a pre-filled syringe comprising:
a medical barrel (12) having an inner wall (inner wall of 12) and product containing area (area between 60 and distal end of 12), the product containing area having disposed therein an injectable product (See Col 9 lines 25-26 teaching that a injectable product Is capable of being within the syringe barrel), the medical barrel (12) having a distal dispensing end (28) for dispensing the injectable product and an open proximal end (18) configured for receipt of a plunger assembly (34, 48, 60); and
the plunger assembly (16, 34, 48, 60) for use in the medical barrel (12), the medical barrel and plunger assembly together forming the pre-filled syringe in which the injectable product is stored (combination of 12, 16, 34, 48 and 60 would result in a syringe that could be ‘pre-filled’ and stored), the pre-filled syringe maintaining container closure integrity to preserve the injectable product for administration of the injectable product to a patient months after the injectable product is initially stored in the pre-filled syringe (combination of 12, 16, 34, 48 and 60 would result in a syringe that could be ‘pre-filled’ and stored), the plunger assembly comprising:
a plunger rod (34) having a distal end (44) and a proximal end (End closest to 42);
an axial protrusion (50) secured to, extending from or abutting the distal end of the plunger rod (34); and a plunger comprising a plunger sleeve (36) having an exterior surface (62)
and an interior surface (94, 83 all walls in this area around 90) surrounding an inner cavity (90), the exterior surface (64) comprising a distal nose cone (65) and an outer annular wall (60) extending proximally from the nose cone (65) and leading to an opening (opening at 72, 98) at a proximal end of the plunger sleeve (36), the opening (opening at 72, 98) receiving the axial protrusion (50) such that the axial protrusion (50) extends into the inner cavity (90) and contacts an engagement surface (82, 88) of the interior surface (inner surface of 90), the engagement surface (82, 88) being configured to receive a force applied in a distal direction by the axial protrusion to move the plunger assembly in the distal direction when the plunger rod is moved in the distal direction (Col 10 lines 6-53), the axial protrusion (50) comprising, at a distal end thereof, a head (rim 50) having a greater cross-sectional width or diameter than that of the portion (46) of the axial protrusion leading to the head, wherein the head (50) contacts the engagement surface (82, 88) of the interior surface of the plunger sleeve (36), wherein the head (50) is disposed in a distal compartment (portion of 83) within the inner cavity (90), the distal compartment (portion of 83) having a greater cross-sectional width or diameter than a narrower section (portion of 94) of the inner cavity proximal to the distal compartment (portion of 83), wherein the axial protrusion (50) cannot be readily manually pulled out of the plunger because the head is of greater diameter or cross-sectional width than the narrower section of the inner cavity (See Figs 3-4 and Col 10 lines 6-53), the plunger sleeve (36), including the interior surface (surface forming 90) and exterior surface (62) thereof being made from rubber (Col 7 lines 21-23) or thermoplastic elastomer, there being no physical structure positioned between the interior surface and the portion of the axial protrusion leading to the head (See Figs 3-4);
wherein the plunger (36) is disposed within the medical barrel (12) such that the nose cone (65) faces the injectable product (see Fig 1) and at least a portion of the plunger rod (34) extends proximally from the open proximal end (18) of the medical barrel (12; See Fig 1),wherein, when the plunger (36) is in a pre-elongation state (fig 3) prior to actuation, the plunger is configured to provide compressive force against the inner wall of the medical barrel to seal and preserve the shelf-life of the injectable product (Col 10 lines 6-53) and the distal end (44) of the plunger rod (34) does not initially contact the proximal end (72) of the plunger sleeve (36), wherein when the axial protrusion (50) initially applies the force in the distal direction, the plunger is converted from the pre-elongation state to a dispensing mode and stretches axially such that at least a portion of the outer annular wall of the plunger sleeve is constricted so as to reduce radial compression against the inner wall to provide a reduced glide force than would be achievable without stretching the plunger (Col 10 lines 6-53), wherein the plunger advances distally down the medical barrel in the dispensing mode, the plunger maintaining substantially the same shape from an axial section view in both the pre-elongation state and the dispensing mode aside from being axially stretched and thus elongated in the dispensing mode (Col 10 lines 6-53), the nose cone (65) being characterized by a nose cone shape that is present both when the plunger is in the pre- elongation state (Fig 3) and the dispensing mode (fig 4), the nose cone shape (65) being defined by a central distal tip (tip 65) and a tapered surface (tapered surfaces around where 78 and 80 point to) extending proximally from the central distal tip (65) to the outer annular wall (60), wherein application of axial force in a proximal direction onto the proximal end of the plunger rod sufficient to axially displace the proximal end of the plunger rod a predetermined distance does not axially displace the plunger in the proximal direction (See Col 10 lines 6-53).
Lewis does not teach the prefilled syringe wherein the plunger rod and axial protrusion are provided as a multi-piece assembly comprising a proximal first portion and a distal second portion, the second portion comprising the axial protrusion, wherein the first portion and second portion may be manually pulled apart at least to the predetermined distance, wherein the first portion and the second portion are assembled together in a telescoping arrangement, such that they may be pulled apart to the predetermined distance whereupon they cannot be manually pulled apart any further, wherein the first portion and the second portion may be collapsed until they cannot be pushed together any further, and wherein when fully collapsed, application of sufficient distally directed force onto the plunger rod causes the multi-piece assembly to move as a unit in the distal direction.
Janish teaches (Fig 2) a plunger assembly wherein the plunger rod (300) and axial protrusion (401) are provided as a multi-piece assembly comprising a proximal first portion (310) and a distal second portion (320), the second portion (320) comprising the axial protrusion (401), wherein the first portion and second portion may be manually pulled apart at least to the predetermined distance (see [0037] and Fig 7), wherein the first portion (310) and second portion (320) are assembled together in a telescoping arrangement (See [0037] and Figs 3, 4, and 7), such that they may be pulled apart to the predetermined distance whereupon they cannot be manually pulled apart any further, wherein the first portion and second portion may be collapsed until they cannot be pushed together any further (See [0037], [0039-0040] and Figs 3, 4, and 7), wherein when fully collapsed, application of sufficient distally directed force onto plunger rod causes the multi-piece assembly to move as a unit in the distal direction (See [0037] teaching how the plunger rod is collapsible and how 310 and 320 may be locked in a collapsed position, since the portions 310 and 320 are locked in a collapsed position they would move together in a distal direction when an distal force is applied).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plunger assembly of Lewis such that the plunger rod and axial protrusion are provided as a multi-piece assembly comprising a proximal first portion and a distal second portion, the second portion comprising the axial protrusion, wherein the first portion and second portion may be manually pulled apart at least to the predetermined distance, wherein the first portion and second portion are assembled together in a telescoping arrangement, such that they may be pulled apart to the predetermined distance whereupon they cannot be manually pulled apart any further, wherein the first portion and second portion may be collapsed until they cannot be pushed together any further, and wherein when fully collapsed, application of sufficient distally directed force onto plunger rod causes the multi-piece assembly to move as a unit in the distal direction as taught by Janish. One of ordinary skill in the art would have been motivated to do so in order to allow the overall length of the plunger rod to be adjusted (Janish [0037]).
Regarding Claim 6, the combination of Lewis and Janish teaches the plunger assembly of claim 4, wherein the first portion (Janish 310) includes a hub having a central hollow (Janish 314, Fig. 3) configured to receive a shaft of the second portion (Janish 320).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Staempfli (US 4391272) in view of Pagay (US Patent 5411488).
Regarding Claim 16, Staempfli teaches (figs 1a-1c) a prefilled syringe (after step of filling the syringe, the syringe is considered ‘pre-filled’) comprising:
a medical barrel (1) having an inner wall (inner wall of 1) and product containing area (area between 3 and 2 in Fig 1a), the product containing area (area between 3 and 2 in Fig 1a) having disposed therein an injectable product (implied that an injectable product would be in this area), the medical barrel (1) having a distal dispensing end (2) for dispensing the injectable product and an open proximal end configured for receipt of a plunger assembly; and
the plunger assembly (4, 10, 3) for use in the medical barrel, the medical barrel and plunger assembly together forming the pre-filled syringe in which the injectable product is stored (the structure of the plunger assembly and medical barrel is functional to store the injectable product), the pre-filled syringe maintaining container closure integrity to preserve the injectable product for administration of the injectable product to a patient months after the injectable product is initially stored in the pre-filled syringe (this is considered a functional limitation; the syringe is capable of storing injectable product for a period of time), the plunger assembly comprising:
a plunger rod (4) having a distal end (where 10 is located) and a proximal end (where 4a is located);
an axial protrusion (10) secured to, extending from or abutting the distal end of the plunger rod (4), wherein the plunger rod (4) and axial protrusion (10) are provided as a single piece, of unitary construction (col 5 lines 25-27 teach 10 is the neck of rod 4, therefore it is interpreted that the axial protrusion is unitary construction with plunger rod; furthermore this is a product by process limitation, since both structures are taught by Staempfli the limitation is met); and
a plunger comprising a plunger sleeve (3) having an exterior surface (outer surface of 3) and an interior surface (inner surface of 3) surrounding an inner cavity (9),
an opening (area where 7 is labeled) receiving the axial protrusion (10) such that the axial protrusion (10) extends into the inner cavity (9) and contacts an engagement surface (distal most surface of 9) of the interior surface (9), the engagement surface (distal most surface of 9) being configured to receive a force applied in a distal direction (force applied between Fig 1a, 1b) by the axial protrusion (10) to move the plunger assembly (4, 10, 3) in the distal direction when the plunger rod (4) is moved in the distal direction (See Figs 1a-1b, movement in direction b; also see Col 4 lines 28-36);
wherein application of axial force in a proximal direction onto the proximal end of the plunger rod sufficient to axially displace the plunger rod in the proximal direction to the predetermined distance, removed the axial protrusion (10) from the plunger sleeve(3; see Figs 1b-1c and Col 4 lines 37-45).
Staempfli does not specify the exterior surface comprising a distal nose cone and an outer annular wall extending proximally from the nose cone and leading to an opening at a proximal end of the plunger sleeve; wherein the plunger is disposed within the medical barrel such that the nose cone faces the injectable product and at least a portion of the plunger rod extends proximally from the open proximal end of the medical barrel,
wherein, when the plunger is in a pre-elongation state prior to actuation, the plunger is configured to provide compressive force against the inner wall of the medical barrel to seal and preserve the shelf-life of the injectable product and the distal end of the plunger rod does not initially contact the proximal end of the plunger sleeve, wherein when the axial protrusion initially applies the force in the distal direction, the plunger is converted from the pre-elongation state to a dispensing-mode and stretches axially such that at least a portion of the outer annular wall of the plunger sleeve is constricted so as to reduce radial compression against the inner wall to provide a reduced glide force than would be achievable without stretching the plunger, wherein the plunger advances distally down the medical barrel in the dispensing mode, the plunger maintaining substantially the same shape from an axial section view in both the pre-elongation state and the dispensing mode aside from being axially stretched and thus elongated in the dispensing mode, the nose cone being characterized by a nose cone shape that is present both when the plunger is in the pre- elongation state and the dispensing mode, the nose cone shape being defined by a central distal tip and a tapered surface extending proximally from the central distal tip to the outer annular wall.
Pagay teaches (Figs 4-5) a plunger sleeve (30) with an exterior surface (outer surface of 30, where 36 points to) comprising a distal nose cone (32) and an outer annular wall (40, 41, 42) extending proximally from the nose cone (32) and leading to an opening (opening near 39 where rod 50 is inserted) at a proximal end of the plunger sleeve (30); wherein the plunger (30) is disposed within the medical barrel (20) such that the nose cone (32) faces the injectable product (See Fig 2) and at least a portion of the plunger rod (50) extends proximally from the open proximal end (26) of the medical barrel (20; see Figs 1-2),
wherein, when the plunger (30) is in a pre-elongation state (Fig 4) prior to actuation, the plunger (30) is configured to provide compressive force against the inner wall of the medical barrel to seal and preserve the shelf-life of the injectable product and the distal end (52) of the plunger rod (50) does not initially contact the proximal end (39) of the plunger sleeve (See Fig 4; 52 does not initially contact 39), wherein when the axial protrusion (64) initially applies the force in the distal direction, the plunger is converted from the pre-elongation state (Fig 4) to a dispensing mode (Fig 5) and stretches axially (Fig 5, stretch shown by 'a') such that at least a portion of the outer annular wall of the plunger sleeve is constricted (see Fig 5, 'b', 'c', and 'd' show annular wall constricted) so as to reduce radial compression against the inner wall to provide a reduced glide force than would be achievable without stretching the plunger (necessarily occurs due to the stretch and compression shown in Fig 5; also see Col 6 line 60 - Col 7 line 2), wherein the plunger (30) advances distally down the medical barrel (20) in the dispensing mode, the plunger (30) maintaining substantially the same shape from an axial section view in both the pre-elongation state (Fig 4) and the dispensing mode (Fig 5) aside from being axially stretched and thus elongated in the dispensing mode (Fig 5 shape is substantially the same as Fig 4), the nose cone (32) being characterized by a nose cone shape that is present both when the plunger is in the pre-elongation state (Fig 4) and the dispensing mode (Fig 5), the nose cone shape being defined by a central distal tip and a tapered surface extending proximally from the central distal tip to the outer annular wall (see annotated Fig 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plunger of Staempfli such that it is shaped with a distal cone and is made with a material that is elastomeric so it would result in the exterior surface comprising a distal nose cone and an outer annular wall extending proximally from the nose cone and leading to an opening at a proximal end of the plunger sleeve; wherein the plunger is disposed within the medical barrel such that the nose cone faces the injectable product and at least a portion of the plunger rod extends proximally from the open proximal end of the medical barrel,
wherein, when the plunger is in a pre-elongation state prior to actuation, the plunger is configured to provide compressive force against the inner wall of the medical barrel to seal and preserve the shelf-life of the injectable product and the distal end of the plunger rod does not initially contact the proximal end of the plunger sleeve, wherein when the axial protrusion initially applies the force in the distal direction, the plunger is converted from the pre-elongation state to a dispensing-mode and stretches axially such that at least a portion of the outer annular wall of the plunger sleeve is constricted so as to reduce radial compression against the inner wall to provide a reduced glide force than would be achievable without stretching the plunger, wherein the plunger advances distally down the medical barrel in the dispensing mode, the plunger maintaining substantially the same shape from an axial section view in both the pre-elongation state and the dispensing mode aside from being axially stretched and thus elongated in the dispensing mode, the nose cone being characterized by a nose cone shape that is present both when the plunger is in the pre- elongation state and the dispensing mode, the nose cone shape being defined by a central distal tip and a tapered surface extending proximally from the central distal tip to the outer annular wall as taught by Pagay. One of ordinary skill in the art would have been motivated to do so in order to prevent the plunger from seizing in the barrel over a prolonged period of time the syringe is kept in storage, and allow a reduction of interfacial force between the plunger and inner wall of the syringe, which helps allow smoother use/delivery (Pagay Col 7 lines 2-12).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Staempfli, Pagay and McConnaughey as applied to claim 1 above, and further in view of Sigg et al. (US Patent 9220631 hereinafter “Sigg”).
Regarding Claim 17, the combination of Staempfli, Pagay and McConnaughey teaches all elements of claim 1 as described above. The combination does not specify the prefilled syringe wherein the syringe is a 0.5 mL syringe.
Sigg teaches a syringe with a barrel that has a max fill volume of 0.5 ml (Col 3 line 66 – Col 4 line 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the syringe of Staempfli to be a 0.5 mL syringe as taught by Sigg. One of ordinary skill in the art would have been motivated to do so in order to deliver small quantities of medicament to the eye (Sigg Col 1 lines 22-23).
Claim(s) 18 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Staempfli, Pagay and McConnaughey as applied to claim 1 above, and further in view of Giraud et al. (US Patent 10561795 hereinafter “Giraud”).
Regarding Claim 18, the combination of Staempfli, Pagay and McConnaughey teaches all elements of claim 1 as described above. Staempfli does not specify the prefilled syringe wherein the medical barrel is injection molded from a clear polymer selected from cyclic olefin polymer (COP) or cyclic olefin copolymer (COC).
Giraud teaches a syringe barrel that is injection molded from a clear thermoplastic material selected from cyclic olefin polymer (COP) or cyclic olefin copolymer (COC) (Col 28 line 63 – Col 29 line 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the syringe of Staempfli such that the medical barrel is injection molded from a clear polymer as taught by Giraud. One of ordinary skill in the art would have been motivated to do so in order to ensure the barrel is tight and has precise tolerances (Giraud Col 28 line 53 – Col 29 line 10).
Regarding Claim 21 the combination of Staempfli, Pagay and McConnaughey teaches all elements of claim 1 as described above. Staempfli does not teach the prefilled syringe comprising a coating of flowable lubricant, between the plunger and medical barrel.
Giraud teaches (Col 2 line 34-39) a lubricant that is added to a plunger and container.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the syringe of Staempfli such that it comprises a coating of flowable lubricant, between the plunger and medical barrel as taught by Giraud. One of ordinary skill in the art would have been motivated to do so in order to reduce friction and improve plunger force (Giraud Col 2 line 34).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Staempfli, Pagay, McConnaughey and Giraud as applied to claim 18 above, and further in view of Weikart et al. (US Patent Pub. 20180049945 hereinafter “Weikart”).
Regarding Claim 19, the combination of Staempfli, Pagay, McConnaughey and Giraud teaches all elements of claim 18 as described above. Staempfli does not teach the inner wall of the medical barrel comprising a plasma enhanced chemical vapor deposition (PECVD) coating or coating set.
Weikart teaches [0077-0078] adding an PECVD coating to a container to allow for the container to contain a fluid of a pH greater than 5 for a period of six months.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner wall of the medical barrel of Staempfli such that it comprises a plasma enhanced chemical vapor deposition (PECVD) coating or coating set as taught by Weikart. One of ordinary skill in the art would have been motivated to do so in order to allow for the barrel to contain a fluid of a pH greater than 5 for a period of six months (Weikart [0078]).
Regarding Claim 20, the combination of Staempfli, Pagay, McConnaughey, Giraud and Weikart teaches the prefilled syringe of claim 19, wherein the PECVD coating or coating set is a bilayer coating set, comprising a tie layer and a SiOx barrier layer disposed on the tie layer (See Weikart [0076-0078]).
Claim(s) 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Staempfli, Pagay and McConnaughey as applied to claim 1 above, and further in view of Malmstrom et al. (US Patent Pub. 20100288393 hereinafter “Malmstrom”).
Regarding Claim 22, the combination of Staempfli, Pagay and McConnaughey teaches all elements of claim 1 as described above. Staempfli does not specify the prefilled syringe of wherein the prefilled syringe is a 0.5 mL syringe and the injectable product is a liquid ophthalmic drug formulation.
Malmstrom teaches [0007] a syringe used to deliver 0.5ml of ranibizumab ([0002] teaches ranibizumab is an ophthalmic solution).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the syringe of Staempfli such that the prefilled syringe is a 0.5 mL syringe and the injectable product is a liquid ophthalmic drug formulation as taught by Malmstrom. One of ordinary skill in the art would have been motivated to so in order to deliver the proper dosage of ranibizumab (Malmstrom [0007]).
Regarding Claim 23, the combination of Staempfli, Pagay, McConnaughey and Malmstrom teaches the prefilled syringe of claim 22, wherein the liquid ophthalmic drug formulation is suitable for intravitreal injection and comprises a VEGF antagonist, wherein the VEGF antagonist comprises an anti-VEGF antibody or an antigen-binding fragment of such antibody (See Malmstrom [0054-0055] teaching the preparation of the ranibizumab includes VEGF antibodies).
Regarding Claim 24, the combination of Staempfli, Pagay, McConnaughey and Malmstrom teaches the prefilled syringe of claim 22, wherein the liquid ophthalmic drug formulation comprises Ranibizumab (Malmstrom [0002], [0007]).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Staempfli, Pagay, McConnaughey and Malmstrom as applied to claim 24 above, and further in view of Andino et al. (US Patent Pub. 20150038905 hereinafter “Andino”).
Regarding Claim 25, the combination of Staempfli, Pagay and McConnaughey and Malmstrom all elements of claim 22 as described above. The combination does not teach a method of using the prefilled syringe comprising advancing the plunger down the medical barrel to dispense a portion of the liquid ophthalmic drug formulation in a priming step, followed by inserting a needle into a patient's eye tissue wherein the needle provides fluid communication from the product containing area through the dispensing end of the medical barrel and further advancing the plunger down the barrel to inject the ophthalmic drug formulation into the patient's eye tissue.
Malmstrom teaches priming a needle of the syringe [0039-0044] to prepare for injection of the ranibizumab.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Staempfli such that it includes advancing the plunger down the medical barrel to dispense a portion of the liquid ophthalmic drug formulation in a priming step as taught by Malmstrom. One of ordinary skill in the art would have been motivated to do so in order to avoid having bubbles in the syringe and needle (Malmstrom [0044]).
The combination of Staempfli, Pagay, McConnaughey and Malmstrom does not teach inserting a needle into a patient's eye tissue wherein the needle provides fluid communication from the product containing area through the dispensing end of the medical barrel and further advancing the plunger down the barrel to inject the ophthalmic drug formulation into the patient's eye tissue.
Andino teaches interesting a needle into a patient’s eye tissue [0131] which provides fluid communication from the medical barrel to the eye (Fig 6), and injects ophthalmic drug into the patient’s eye as the plunger is advanced into the barrel (See Fig 6 and [0135]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Staempfli such that it includes inserting a needle into a patient's eye tissue wherein the needle provides fluid communication from the product containing area through the dispensing end of the medical barrel and further advancing the plunger down the barrel to inject the ophthalmic drug formulation into the patient's eye tissue as taught by Andino. One of ordinary skill in the art would have been motivated to do so in order to use the syringe of Holland to deliver medication to a patient’s eye.
Response to Arguments
Applicant’s arguments, see Pgs. 11-15, filed 4/15/2026, with respect to the rejection(s) of claim(s) 1, 4 and 16 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Staempfli, Pagay and McConnaughey for claim 1, Lewis in view of Janish for claim 4 and Staempfli in view of Pagay for claim 16 as described above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sultan (US Patent 4973309) teaches a disposable syringe, which has a plunger rod that may be removed from the plunger sleeve.
Shonfeld (US 5562623) teaches a plunger with a protrusion that disengages from the plunger sleeve.
Wei Li (US 20140296744) teaches a plunger with a protrusion that disengages from the plunger sleeve when moved in the proximal direction.
Hieb (US 9352105) teaches an axial protrusion with a substantially constant diameter.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783 /WESLEY G HARRIS/Examiner, Art Unit 3783
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