DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/21/2025 has been entered.
Claim Rejections - 35 USC § 103
Claim(s) 1 and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pagay (US Patent 5411488) in view of Shimizu et al. (US Patent 10030771 hereinafter “Shimizu”).
Regarding Claim 1, Pagay teaches (Figs 1-5) A pre-filled syringe (10; Col 6 lines 12-13 teach pre-filled) comprising:
a medical barrel (20) having an inner wall (21) and product containing area (Col 6 lines 19-20), the product containing area having disposed therein an injectable product (Col 6 lines 19-20), the medical barrel (20) having a distal dispensing end (22) for dispensing the injectable product and an open proximal end (24, see Fig 1) configured for receipt of a plunger assembly (30, 50); and
the plunger assembly (30, 50) for use in the medical barrel (20), the medical barrel (20) and plunger assembly (30, 50) together forming the pre-filled syringe (Col 6 lines 12-13) in which the injectable product is 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 (Col 6 lines 15-32), the plunger assembly (30, 50) comprising:
a plunger rod (Fig 6, 50) having a distal end (Fig 3, 52) and a proximal end (Fig 6, where 62 points to);
an axial protrusion (64) secured to, extending from or abutting the distal end of the plunger rod (See Fig 2, 64 is on the distal end of 52, wherein the plunger rod and axial protrusion are provided as a single piece, of unitary construction (See Fig 2, 6 and Col 6 lines 2-4 which teaches 64 is the plunger rod tip of plunger rod 50; furthermore, this is considered a product by process limitation, Pagay meets the structural limitations of comprising a plunger rod and an axial protrusion); and
a plunger (30) comprising a plunger sleeve (plunger 30 is considered to be a ‘plunger sleeve’ as it has a cavity where plunger rod 50 is inserted into; similar to instant application plunger sleeve 34 in Fig 4) having an exterior surface (36) and an interior surface (38) surrounding an inner cavity (cavity is where female threads 43 and surface 34 are located in Fig 4; where the male threads 70 of plunger rod 50 are received into plunger 30), the exterior surface (36) 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 plunger rod 50 is inserted into plunger 30) at a proximal end of the plunger sleeve (39), the opening receiving the axial protrusion (64) such that the axial protrusion (64) extends into the inner cavity and contacts an engagement surface (34) of the interior surface (38), see Fig. 5, the engagement surface (34) being configured to receive a force applied in a distal direction by the axial protrusion (64) to move the plunger assembly in the distal direction when the plunger rod (50) is moved in the distal direction (Col 6 line 60 - Col 7 line 2);
wherein the plunger (30) is disposed within the medical barrel (20) such that the nose cone (32) faces the injectable product and at least a portion of the plunger rod (50) extends proximally from the open proximal end (24) 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), and
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, but does not axially displace the plunger in the proximal direction (col 6 lines 45-60 teaches that the plunger and plunger rod are in static engagement, and proximal movement may release gas without moving the plunger).
Pagay does not specify wherein the axial protrusion is cylindrical and of uniform diameter substantially along its entire length, wherein a cylindrical outer surface of the axial protrusion loosely contacts the interior surface of the plunger sleeve 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.
Shimizu teaches (figs 2, 4a-4b) an axial protrusion (40) that is cylindrical and of uniform diameter substantially along its entire length (see Col 6 lines 40-43 teaching a uniform diameter, and see Col 9 lines 60-61 teaching 40 is column shaped), wherein a cylindrical outer surface of the axial protrusion (40) loosely contacts the interior surface of the plunger sleeve (10) without an interference fit so that the axial protrusion (40) may be manually pulled out of the plunger sleeve (10) when the plunger sleeve is disposed in a medical barrel (See Fig 4b; also see Col 9 lines 37-49).
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 Pagay such that the axial protrusion is cylindrical and of uniform diameter substantially along its entire length, wherein a cylindrical outer surface of the axial protrusion loosely contacts the interior surface of the plunger sleeve 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 as taught by Shimizu. One of ordinary skill in the art would have been motivated to do so in order to reduce frictional resistance and improve operability (Shimizu Col 1 lines 50-66). Furthermore, 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 Pagay and Shimizu 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 Pagay and Shimizu 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 Pagay and Shimizu 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 Pagay (US Patent 5411488) in view of Janish (US Patent Pub. 20090318880) and by Lewis (US Patent 5314416).
Regarding Claim 4, Pagay teaches (Figs 1-5) A pre-filled syringe (10; Col 6 lines 12-13 teach pre-filled) comprising:
a medical barrel (20) having an inner wall (21) and product containing area (Col 6 lines 19-20), the product containing area having disposed therein an injectable product (Col 6 lines 19-20), the medical barrel (20) having a distal dispensing end (22) for dispensing the injectable product and an open proximal end (24, See Fig 1) configured for receipt of a plunger assembly (30, 50); and
the plunger assembly (30, 50) for use in the medical barrel (20), the medical barrel (20) and plunger assembly (30, 50) together forming the pre-filled syringe (Col 6 lines 12-13) in which the injectable product is 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 (Col 6 lines 15-32), the plunger assembly (30, 50) comprising:
a plunger rod (Fig 6, 50) having a distal end (Fig 3, 52) and a proximal end (Fig 6, where 62 points to);
an axial protrusion (66,64) secured to, extending from or abutting the distal end of the plunger rod (See Fig 2, 66 is on the distal end of 52); and
a plunger (30) comprising a plunger sleeve (plunger 30 is considered to be a ‘plunger sleeve’ as it has a cavity where plunger rod 50 is inserted into; similar to instant application plunger sleeve 34 in Fig 4) having an exterior surface (36) and an interior surface (38) surrounding an inner cavity (cavity is where female threads 43 and surface 34 are located in Fig 4; where the male threads 70 of plunger rod 50 are received into plunger 30), the exterior surface (36) 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 plunger rod 50 is inserted into plunger 30) at a proximal end of the plunger sleeve (39), the opening receiving the axial protrusion (64) such that the axial protrusion (64) extends into the inner cavity and contacts an engagement surface (34) of the interior surface (38), the engagement surface 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 6 line 60 - Col 7 line 2); the axial protrusion (66,64) comprising, at a distal end thereof (where 64 points to), a head (64) having a greater cross-sectional width or diameter than that of the portion (66) of the axial protrusion leading to the head (64), wherein the head (64) contacts the engagement surface (34) of the interior surface of the plunger sleeve (See Fig 5);
wherein the plunger (30) is disposed within the medical barrel (20) such that the nose cone (32) faces the injectable product and at least a portion of the plunger rod (50) extends proximally from the open proximal end (24) 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 (66, 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 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), and
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, but does not axially displace the plunger in the proximal direction (col 6 lines 45-60 teaches that the plunger and plunger rod are in static engagement, and proximal movement may release gas without moving the plunger).
Pagay 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 Pagay 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]).
The combination does not specify wherein the head is disposed in a distal compartment within the inner cavity, the distal compartment having a greater cross-sectional width or diameter than a narrower section of the inner cavity proximal to the distal compartment, wherein the axial protrusion 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.
Lewis teaches a pre-filled syringe (Fig 6) wherein the head (50, 112) is disposed in a distal compartment (see annotated Fig 6) within the inner cavity, the distal compartment having a greater cross-sectional width or diameter than a narrower section (see annotated Fig 6) of the inner cavity proximal to the distal compartment, wherein the axial protrusion (48) cannot be readily manually pulled out of the plunger (114) because the head (50, 112) is of greater diameter or cross-sectional width than the narrower section of the inner cavity (See annotated Fig 6 and Col 12 lines 60-65).
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Annotated Fig 6 (Lewis)
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 cavity of Pagay such that the head is disposed in a distal compartment within the inner cavity, the distal compartment having a greater cross-sectional width or diameter than a narrower section of the inner cavity proximal to the distal compartment, wherein the axial protrusion 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 as taught by Lewis. One of ordinary skill in the art would have been motivated to do so in order to retain the front portion of the plunger rod/ the plunger protrusion in the inner cavity (Lewis Col 12 lines 60-65).
Regarding Claim 6, the combination of Pagay, Janish and Lewis 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 Pagay (US Patent 5411488) in view of Staempfli (US Patent 4391272).
Regarding Claim 16, Pagay teaches (Figs 1-5) A pre-filled syringe (10; Col 6 lines 12-13 teach pre-filled) comprising:
a medical barrel (20) having an inner wall (21) and product containing area (Col 6 lines 19-20), the product containing area having disposed therein an injectable product (Col 6 lines 19-20), the medical barrel (20) having a distal dispensing end (22) for dispensing the injectable product and an open proximal end (24, see Fig 1) configured for receipt of a plunger assembly (30, 50); and
the plunger assembly (30, 50) for use in the medical barrel (20), the medical barrel (20) and plunger assembly (30, 50) together forming the pre-filled syringe (Col 6 lines 12-13) in which the injectable product is 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 (Col 6 lines 15-32), the plunger assembly (30, 50) comprising:
a plunger rod (Fig 6, 50) having a distal end (Fig 3, 52) and a proximal end (Fig 6, where 62 points to);
an axial protrusion (64) secured to, extending from or abutting the distal end of the plunger rod (See Fig 2, 64 is on the distal end of 52, wherein the plunger rod and axial protrusion are provided as a single piece, of unitary construction (See Fig 2, 6 and Col 6 lines 2-4 which teaches 64 is the plunger rod tip of plunger rod 50; furthermore, this is considered a product by process limitation, Pagay meets the structural limitations of comprising a plunger rod and an axial protrusion); and
a plunger (30) comprising a plunger sleeve (plunger 30 is considered to be a ‘plunger sleeve’ as it has a cavity where plunger rod 50 is inserted into; similar to instant application plunger sleeve 34 in Fig 4) having an exterior surface (36) and an interior surface (38) surrounding an inner cavity (cavity is where female threads 43 and surface 34 are located in Fig 4; where the male threads 70 of plunger rod 50 are received into plunger 30), the exterior surface (36) 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 plunger rod 50 is inserted into plunger 30) at a proximal end of the plunger sleeve (39), the opening receiving the axial protrusion (64) such that the axial protrusion (64) extends into the inner cavity and contacts an engagement surface (34) of the interior surface (38), see Fig. 5, the engagement surface (34) being configured to receive a force applied in a distal direction by the axial protrusion (64) to move the plunger assembly in the distal direction when the plunger rod (50) is moved in the distal direction (Col 6 line 60 - Col 7 line 2);
wherein the plunger (30) is disposed within the medical barrel (20) such that the nose cone (32) faces the injectable product and at least a portion of the plunger rod (50) extends proximally from the open proximal end (24) 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), and
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, but does not axially displace the plunger in the proximal direction (col 6 lines 45-60 teaches that the plunger and plunger rod are in static engagement, and proximal movement may release gas without moving the plunger).
Pagay does not specify the pre-filled syringe wherein application of axial force in the 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, removes the axial protrusion from the plunger sleeve.
Staempfli teaches (Figs 1a-1c) a syringe wherein application of axial force in the proximal direction (direction A in Fig 1a) onto the proximal end of the plunger rod (4) sufficient to axially displace the plunger rod in the proximal direction to the predetermined distance, removes the axial protrusion (10) from the plunger sleeve (3,8).
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 sleeve and plunger rod of Pagay such that application of axial force in the 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, removes the axial protrusion from the plunger sleeve as taught by Staempfli. One of ordinary skill in the art would have been motivated to do so in order to prevent rearward movement of the plunger and prevent re-use of the syringe (Staempfli Col 4 lines 41-45).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pagay and Shimizu 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 Pagay and Shimizu teaches all elements of claim 1 as described above. Pagay 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 Pagay 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 Pagay and Shimizu 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 Pagay and Shimizu teaches all elements of claim 1 as described above. Pagay 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 Pagay 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 Pagay and Shimizu teaches all elements of claim 1 as described above. Pagay 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 Pagay 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 Pagay and Shimizu 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 Pagay, Shimizu and Giraud teaches all elements of claim 18 as described above. Pagay 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 Pagay 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 Pagay, Shimizu and 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 Pagay and Shimizu 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 Pagay and Shimizu teaches all elements of claim 1 as described above. Pagay 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 Pagay 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 Pagay, Shimizu 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 Pagay, Shimizu 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 Pagay, Shimizu 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 Pagay, Shimizu 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 Pagay 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 Pagay 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 Pagay 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 filed 9/22/2025 with respect to claim(s) 1 and 4 have been considered but are moot because the new ground of rejection takes into consideration the amendments filed 9/22/2025.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
McConnaughey (US 2895773) teaches a variable diameter ring piston that stretches/extends when the plunger rod exerts force into the cavity of the ring piston.
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 /QUYNH-NHU H. VU/Primary Examiner, Art Unit 3783