DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed 24 February 2026. As directed by the amendment claims 2, 7, 9 and 16 are cancelled and claims 27-44 are newly presented. Therefore, claims 1, 3, 6, 8, 10, 13-15, 17, 20 and 27-44 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pages 9-17, filed 24 February 2026, with respect to the rejection(s) of claim(s) 1, 3, 6, 8, 10, 13-15, 17, and 20 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 Therefore, the rejection has been withdrawn.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 Minagawa (US 2016/0033042).
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.
Claim(s) 1, 3, 8, 10, 30-33, 35-37, 40-42 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Forlani et al. (US 2017/0246399) in view of Minagawa (US 2016/0033042).
Regarding claim 1, Forlani discloses a plunger (Fig. 2, 52) for use in a drug delivery device (Fig. 2-3, 25) comprising:
a plunger (Fig. 2, 52) including:
a body portion (body 90) having a sidewall (sidewall has radially projecting sealing ribs 98 formed on it), a leading surface (forward end 92), and a trailing surface (rearward end 94), and
a ribbed portion (portion with radially projecting sealing ribs 98) comprising a plurality of ribs projecting (radially projecting sealing ribs 98) radially outwardly from the sidewall of the body portion (body 90) and spaced axially apart from one another by side surfaces of the sidewall (see Fig. 2 and paragraph 40), the plurality of ribs (radially projecting sealing ribs 98) comprising at least a trailing rib (rearmost rib 98, see annotated figure below) and a leading rib (forwardmost rib 98, see annotated figure below), each of the ribs including an annular configuration (see Fig. 2 and paragraph 39);
wherein the side surfaces of the sidewall of the body portion (90) are radially recessed relative to the plurality of ribs (98)(where the ribs 98 are protruding further than the body portion 90 as shown in figure 2)
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Forlani does not specifically teach wherein the leading rib includes a first convex axial portion, a second convex axial portion, and a cylindrical portion disposed between the first and second convex axial portions, and wherein a radius of curvature of the first convex axial portion of the leading rib is greater than a radius of curvature of the second convex axial portion
Minagawa teaches a gasket that includes multiple ribs with convex and concave portions on the body. Minagawa teaches wherein the leading rib (Fig. 1, 14a) includes a first convex axial portion (Fig. 2, 143a), a second convex axial portion (Fig. 2, 142a), and a cylindrical portion disposed between the first and second convex axial portions (Fig. 1, 141a), and wherein a radius of curvature of the first convex axial portion of the leading rib is greater than a radius of curvature of the second convex axial portion (¶[0046]). Changing the device of Forlani to include the gasket of Minagawa would be a simple substitution as the device of Forlani has ribs, concave portions and a main body portion designed to slide within a device. Furthermore, the shape of the device is what is being taught by Minagawa and would not result in a difference of function in the device of Forlani. The claim limitation focuses on the shape of the device and does not point to any critical factors regarding the function of said shape.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Forlani to include a gasket that has the leading rib includes a first convex axial portion, a second convex axial portion, and a cylindrical portion disposed between the first and second convex axial portions, and wherein a radius of curvature of the first convex axial portion of the leading rib is greater than a radius of curvature of the second convex axial portion as a matter of simple substitution with Minagawa. This modification would improve the device of Forlani when combined with Minagawa as it would achieve sliding properties and resistance to liquid leakage with these modified projections (¶[0045]-[0046] from Minagawa).
Regarding claim 3, Forlani discloses the claimed invention as discussed above concerning claim 1, and Forlani further discloses wherein the side surfaces of the sidewall of the body portion (body 90) are flat (see Examiner’s annotated zoomed in Figure 2 below).
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Regarding claim 8, Forlani discloses A drug delivery device (pen-shaped medication injection device 130, and see Fig. 5 and paragraphs 2 and 27) comprising:
a housing (housing 135);
a syringe assembly (cartridge 25/146) at least partially received within the housing (housing 135) (see Fig. 5) and including a syringe barrel (barrel of cartridge 25/146) with an annular sidewall (wall 61) extending between a first, open end (at 65) and a second end having a dispensing opening (at 55);
an actuating mechanism (mechanical drive mechanism 140) at least partially received within the housing (housing 135) (see Fig. 5 and paragraph 57) and including a plunger (plunger 52/144) received within the syringe barrel (barrel of cartridge 25/146), the plunger (plunger 52/144) comprising:
a body portion (body 90) having a sidewall (sidewall has radially projecting sealing ribs 98 formed on it), a leading surface (forward end 92), and a trailing surface (rearward end 94), and
a ribbed portion (portion with radially projecting sealing ribs 98) comprising a plurality of ribs projecting (radially projecting sealing ribs 98) radially outwardly from the sidewall of the body portion (body 90) and spaced axially apart from one another by side surfaces of the sidewall (see Fig. 2 and paragraph 40), the plurality of ribs (radially projecting sealing ribs 98) comprising at least a trailing rib (rearmost rib 98) and a leading rib (forwardmost rib 98), each of the ribs including an annular configuration (see Fig. 2 and paragraph 39) and sized so that the ribs seal against an interior surface of the annular sidewall of the syringe barrel;
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a drive mechanism (drive/advancing mechanism, 141); and
a drive member (output member, see paragraph 57) configured to be driven by the drive mechanism (see paragraph 57) to push the plunger (plunger 52) through the (barrel of cartridge 25/146) to the second end thereof (paragraphs 6, 7, 34 and 57) to thereby force a medicament (medicament 74) within the syringe barrel (barrel of cartridge 25/146) through the dispensing opening,
wherein the side surfaces of the sidewall of the body portion (90) are radially recessed relative to the plurality of ribs (98)(where the ribs 98 are protruding further than the body portion 90 as shown in figure 2).
Forlani does not specifically teach wherein the leading rib includes a first convex axial portion, a second convex axial portion, and a cylindrical portion disposed between the first and second convex axial portions, and wherein a radius of curvature of the fist convex axial portion of the leading rib is greater than a radius of curvature of the second convex axial portion.
Minagawa teaches a gasket that includes multiple ribs with convex and concave portions on the body. Minagawa teaches wherein the leading rib (Fig. 1, 14a) includes a first convex axial portion (Fig. 2, 143a), a second convex axial portion (Fig. 2, 142a), and a cylindrical portion disposed between the first and second convex axial portions (Fig. 1, 141a), and wherein a radius of curvature of the first convex axial portion of the leading rib is greater than a radius of curvature of the second convex axial portion (¶[0046]). Changing the device of Forlani to include the gasket of Minagawa would be a simple substitution as the device of Forlani has ribs, concave portions and a main body portion designed to slide within a device. Furthermore, the shape of the device is what is being taught by Minagawa and would not result in a difference of function in the device of Forlani. The claim limitation focuses on the shape of the device and does not point to any critical factors regarding the function of said shape.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Forlani to include a gasket that has the leading rib includes a first convex axial portion, a second convex axial portion, and a cylindrical portion disposed between the first and second convex axial portions, and wherein a radius of curvature of the first convex axial portion of the leading rib is greater than a radius of curvature of the second convex axial portion as a matter of simple substitution with Minagawa. This modification would improve the device of Forlani when combined with Minagawa as it would achieve sliding properties and resistance to liquid leakage with these modified projections (¶[0045]-[0046] from Minagawa).
Regarding claim 10, Forlani discloses the claimed invention as discussed above concerning claim 1, and Forlani further discloses wherein the side surfaces of the body portion (body 90) are flat (see Examiner’s annotated zoomed in Figure 2 below).
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Regarding claim 30, Forlani and Minagawa teach the plunger of claim 1, Minagawa further teaches wherein at least one of the plurality of ribs has a curved axial profile (¶[0046], where the ribs have curved profiles).
Regarding claim 31, Forlani and Minagawa teach the plunger of claim 1, Forlani further teaches further comprising a plurality of protrusions extending away from the trailing surface of the body portion (Fig. 2, 96).
Regarding claim 32, Forlani and Minagawa teach the plunger of claim 1, Minagawa further teaches further comprising an intermediate rib disposed between the trailing rib and the leading rib, the intermediate rib having an annular configuration (Fig. 1, 14b).
Regarding claim 33, Forlani and Minagawa teach the plunger of claim 32, Minagawa further teaches wherein at least one of the trailing rib or the intermediate rib is axially smaller than the leading rib (¶[0048]).
Regarding claim 35, Forlani and Minagawa teach the plunger of claim 32, Minagawa further teaches wherein an outer diameter of the leading rib is greater than an outer diameter of at least one of the intermediate rib or the trailing rib (¶[0048]).
Regarding claim 36, A drug delivery assembly comprising:
a plunger (Fig. 2, 52) including:
a body portion (body 90) having a sidewall (sidewall has radially projecting sealing ribs 98 formed on it), a leading surface (forward end 92), and a trailing surface (rearward end 94), and
a ribbed portion (portion with radially projecting sealing ribs 98) comprising a plurality of ribs projecting (radially projecting sealing ribs 98) radially outwardly from the sidewall of the body portion (body 90) and spaced axially apart from one another by side surfaces of the sidewall (see Fig. 2 and paragraph 40), the plurality of ribs (radially projecting sealing ribs 98) comprising at least a trailing rib (rearmost rib 98, see annotated figure below) and a leading rib (forwardmost rib 98, see annotated figure below), each of the ribs including an annular configuration (see Fig. 2 and paragraph 39);
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a chamber (barrel 50) with an annular sidewall (wall 61) extending between a first, open end (at 65) and a second end having a dispensing opening (at 55), the plunger (plunger 52) received within the chamber (barrel 50) so that the ribs thereof (radially projecting sealing ribs 98) seal against an interior surface (interior surface 70) of the sidewall (wall 61) (see Fig. 2 and paragraph 35); and
a drive member (drive/advancing mechanism, 57) configured to drive the plunger (plunger 52) through the chamber (barrel 50) to the second end thereof (paragraphs 6, 7 and 34);
wherein the side surfaces of the sidewall of the body portion (90) are radially recessed relative to the plurality of ribs (98)(where the ribs 98 are protruding further than the body portion 90 as shown in figure 2).
Forlani does not specifically teach wherein the leading rib includes a first convex axial portion, a second convex axial portion, and a cylindrical portion disposed between the first and second convex axial portions, and wherein a radius of curvature of the first convex axial portion of the leading rib is greater than a radius of curvature of the second convex axial portion.
Minagawa teaches a gasket that includes multiple ribs with convex and concave portions on the body. Minagawa teaches wherein the leading rib (Fig. 1, 14a) includes a first convex axial portion (Fig. 2, 143a), a second convex axial portion (Fig. 2, 142a), and a cylindrical portion disposed between the first and second convex axial portions (Fig. 1, 141a), and wherein a radius of curvature of the first convex axial portion of the leading rib is greater than a radius of curvature of the second convex axial portion (¶[0046]).
Changing the device of Forlani to include the gasket of Minagawa would be a simple substitution as the device of Forlani has ribs, concave portions and a main body portion designed to slide within a device. Furthermore, the shape of the device is what is being taught by Minagawa and would not result in a difference of function in the device of Forlani. The claim limitation focuses on the shape of the device and does not point to any critical factors regarding the function of said shape.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Forlani to include a gasket that has the leading rib includes a first convex axial portion, a second convex axial portion, and a cylindrical portion disposed between the first and second convex axial portions, and wherein a radius of curvature of the first convex axial portion of the leading rib is greater than a radius of curvature of the second convex axial portion as a matter of simple substitution with Minagawa. This modification would improve the device of Forlani when combined with Minagawa as it would achieve sliding properties and resistance to liquid leakage with these modified projections (¶[0045]-[0046] from Minagawa).
Regarding claim 37, Forlani and Minagawa teach the drug delivery assembly of claim 36, Forlani further teaches wherein the side surfaces of the sidewall of the body portion (body 90) are flat (see Examiner’s annotated zoomed in Figure 2 below).
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Regarding claim 40, Forlani and Minagawa teach the drug delivery assembly of claim 36, Minagawa further teaches wherein at least one of the plurality of ribs has a curved axial profile (¶[0046], where the ribs have curved profiles).
Regarding claim 41, Forlani and Minagawa teach the drug delivery assembly of claim 36, Minagawa further teaches further comprising an intermediate rib disposed between the trailing rib and the leading rib, the intermediate rib having an annular configuration (Fig. 1, 14b).
Regarding claim 42, Forlani and Minagawa teach the drug delivery assembly of claim 41, Minagawa further teaches wherein at least one of the trailing rib or the intermediate rib is axially smaller than the leading rib (¶[0048]).
Regarding claim 44, Forlani and Minagawa teach the drug delivery assembly of claim 41, Minagawa further teaches wherein an outer diameter of the leading rib is greater than an outer diameter of at least one of the intermediate rib or the trailing rib (¶[0048]).
Claim(s) 6, 13, 27-29, 34, 38-39, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Forlani et al. (US 2017/0246399) in view of Minagawa (US 2016/0033042) as applied to claim 1 above, and further in view of, and further in view of Laubach et al. (US 2016/0082193).
Regarding claim 6, Forlani and Minagawa do not specifically teach wherein the side surfaces of the sidewall of the body portion are concavely curved along a longitudinal axis of the body portion.
Laubach et al. teaches a plunger construction where the plunger (piston, see Fig. 1) comprises a body portion (piston body 22) having a sidewall (Figs. 2-3 show a generally cylindrical sidewall), a leading surface (leading surface at the first axial end 22a/face portion 23/24), and a trailing surface (trailing surface at the second axial end 22b); and a ribbed portion comprising a plurality of ribs (formed by sealing portion 26 and stabilizing ribs 32) projecting radially outwardly from the sidewall of the body portion (see Figs. 2-3) and spaced axially apart from one another (see Figs. 2-3), the plurality of ribs comprising at least a trailing rib (stabilizing rib 32 located closes to second axial end 22b) and a leading rib (formed by sealing portion 26), each of the ribs including an annular configuration (see Figs. 2-3). Laubach et al. further teaches that radial surfaces (annular recesses 34) of the sidewall extending between the ribs (formed by sealing portion 26 and stabilizing ribs 32) have curved configurations (see Figs. 2-3 and paragraph 21), and that the radial surfaces (annular recesses 34) of the sidewall extending between the ribs (formed by sealing portion 26 and stabilizing ribs 32) are concave (see Figs. 2-3 and paragraph 21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the radial surfaces of the plunger of Forlani and Minagawa to include radial surface configurations as taught by Laubach since this was a known design for the sidewalls of plungers in the relevant art before the effective fling date of the present invention (see Figs. 1-2 of Laubach) and in order to provide a plunger that produces low break loose and extrusion forces with the inner surface of a syringe (or cartridge) and which creates an acceptable seal with the inner surface of the syringe (or cartridge) (paragraph 4 of Laubach).
Regarding claim 13, Forlani and Minagawa do not specifically teach wherein the side surfaces of the sidewall of the body portion are concavely curved along a longitudinal axis of the body portion.
Laubach et al. teaches a plunger construction where the plunger (piston, see Fig. 1) comprises a body portion (piston body 22) having a sidewall (Figs. 2-3 show a generally cylindrical sidewall), a leading surface (leading surface at the first axial end 22a/face portion 23/24), and a trailing surface (trailing surface at the second axial end 22b); and a ribbed portion comprising a plurality of ribs (formed by sealing portion 26 and stabilizing ribs 32) projecting radially outwardly from the sidewall of the body portion (see Figs. 2-3) and spaced axially apart from one another (see Figs. 2-3), the plurality of ribs comprising at least a trailing rib (stabilizing rib 32 located closes to second axial end 22b) and a leading rib (formed by sealing portion 26), each of the ribs including an annular configuration (see Figs. 2-3). Laubach et al. further teaches that radial surfaces (annular recesses 34) of the sidewall extending between the ribs (formed by sealing portion 26 and stabilizing ribs 32) have curved configurations (see Figs. 2-3 and paragraph 21), and that the radial surfaces (annular recesses 34) of the sidewall extending between the ribs (formed by sealing portion 26 and stabilizing ribs 32) are concave (see Figs. 2-3 and paragraph 21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the radial surfaces of the plunger of Forlani and Minagawa to include radial surface configurations as taught by Laubach since this was a known design for the sidewalls of plungers in the relevant art before the effective fling date of the present invention (see Figs. 1-2 of Laubach) and in order to provide a plunger that produces low break loose and extrusion forces with the inner surface of a syringe (or cartridge) and which creates an acceptable seal with the inner surface of the syringe (or cartridge) (paragraph 4 of Laubach).
Regarding claim 27, Forlani and Minagawa teach the plunger of claim 1, Forlani and Minagawa do not specifically teach wherein a trim edge of the body portion is adjacent to the trailing surface thereof (Fig. 2, 36, where the trim edge portion is adjacent to a trailing surface of the gasket).
Laubach et al. teaches a plunger construction where the plunger (piston, see Fig. 1) comprises a body portion (piston body 22) having a sidewall (Figs. 2-3 show a generally cylindrical sidewall), a leading surface (leading surface at the first axial end 22a/face portion 23/24), and a trailing surface (trailing surface at the second axial end 22b); and a ribbed portion comprising a plurality of ribs (formed by sealing portion 26 and stabilizing ribs 32) projecting radially outwardly from the sidewall of the body portion (see Figs. 2-3) and spaced axially apart from one another (see Figs. 2-3), the plurality of ribs comprising at least a trailing rib (stabilizing rib 32 located closes to second axial end 22b) and a leading rib (formed by sealing portion 26), each of the ribs including an annular configuration (see Figs. 2-3). Laubach further teaches wherein a trim edge of the body portion is adjacent to the trailing surface thereof (Fig. 2, 36, where the trim edge portion is adjacent to a trailing surface of the gasket).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the radial surfaces of the plunger of Forlani and Minagawa to include a trim edge as taught by Laubach since this was a known design for a plunger in the relevant art before the effective fling date of the present invention (see Figs. 1-2 of Laubach) and in order to provide a plunger that produces low break loose and extrusion forces with the inner surface of a syringe (or cartridge) and which creates an acceptable seal with the inner surface of the syringe (or cartridge) (paragraph 4 of Laubach).
Regarding claim 28, Forlani, Minagawa and Laubach teach the plunger of claim 27, Laubach further teaches wherein the trim edge has an outer diameter less than outer diameters of the plurality of ribs (Fig. 2 & 3, where 36 does not axially protrude as far as the rib portions).
Regarding claim 29, Forlani and Minagawa teach the plunger of claim 1, Forlani and Minagawa do not specifically teach wherein the leading surface has a generally cone-shaped configuration.
Laubach et al. teaches a plunger construction where the plunger (piston, see Fig. 1) comprises a body portion (piston body 22) having a sidewall (Figs. 2-3 show a generally cylindrical sidewall), a leading surface (leading surface at the first axial end 22a/face portion 23/24), and a trailing surface (trailing surface at the second axial end 22b); and a ribbed portion comprising a plurality of ribs (formed by sealing portion 26 and stabilizing ribs 32) projecting radially outwardly from the sidewall of the body portion (see Figs. 2-3) and spaced axially apart from one another (see Figs. 2-3), the plurality of ribs comprising at least a trailing rib (stabilizing rib 32 located closes to second axial end 22b) and a leading rib (formed by sealing portion 26), each of the ribs including an annular configuration (see Figs. 2-3). Laubach further teaches wherein the leading surface has a generally cone-shaped configuration (Fig. 2, 24, where the surface is generally cone shaped).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the radial surfaces of the plunger of Forlani and Minagawa to include a cone-shaped leading surface as taught by Laubach since this was a known design for a plunger in the relevant art before the effective fling date of the present invention (see Figs. 1-2 of Laubach) and in order to provide a plunger that produces low break loose and extrusion forces with the inner surface of a syringe (or cartridge) and which creates an acceptable seal with the inner surface of the syringe (or cartridge) (paragraph 4 of Laubach).
Regarding claim 34, Forlani and Minagawa teach the plunger of claim 33, Forlani and Minagawa do not specifically teach wherein both the trailing rib and the intermediate rib are axially smaller than the leading rib.
Laubach teaches where each rib (32) can have a substantially different diameter which can include a smaller diameter for an intermediate and trailing rib (¶[0020]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the radial surfaces of the plunger of Forlani and Minagawa to include differing rib diameters as taught by Laubach since this was a known design for a plunger in the relevant art before the effective fling date of the present invention (see Figs. 1-2 of Laubach) and in order to provide a plunger that produces low break loose and extrusion forces with the inner surface of a syringe (or cartridge) and which creates an acceptable seal with the inner surface of the syringe (or cartridge) (paragraph 4 of Laubach).
Regarding claim 38, Forlani and Minagawa teach the drug delivery assembly of claim 36, Forlani and Minagawa do not specifically teach wherein the side surfaces of the sidewall of the body portion are concavely curved along a longitudinal axis of the body portion.
Laubach et al. teaches a plunger construction where the plunger (piston, see Fig. 1) comprises a body portion (piston body 22) having a sidewall (Figs. 2-3 show a generally cylindrical sidewall), a leading surface (leading surface at the first axial end 22a/face portion 23/24), and a trailing surface (trailing surface at the second axial end 22b); and a ribbed portion comprising a plurality of ribs (formed by sealing portion 26 and stabilizing ribs 32) projecting radially outwardly from the sidewall of the body portion (see Figs. 2-3) and spaced axially apart from one another (see Figs. 2-3), the plurality of ribs comprising at least a trailing rib (stabilizing rib 32 located closes to second axial end 22b) and a leading rib (formed by sealing portion 26), each of the ribs including an annular configuration (see Figs. 2-3). Laubach et al. further teaches that radial surfaces (annular recesses 34) of the sidewall extending between the ribs (formed by sealing portion 26 and stabilizing ribs 32) have curved configurations (see Figs. 2-3 and paragraph 21), and that the radial surfaces (annular recesses 34) of the sidewall extending between the ribs (formed by sealing portion 26 and stabilizing ribs 32) are concave (see Figs. 2-3 and paragraph 21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the radial surfaces of the plunger of Forlani and Minagawa to include radial surface configurations as taught by Laubach since this was a known design for the sidewalls of plungers in the relevant art before the effective fling date of the present invention (see Figs. 1-2 of Laubach) and in order to provide a plunger that produces low break loose and extrusion forces with the inner surface of a syringe (or cartridge) and which creates an acceptable seal with the inner surface of the syringe (or cartridge) (paragraph 4 of Laubach).
Regarding claim 39, Forlani and Minagawa teach the drug delivery assembly of claim 36, Forlani and Minagawa do not specifically teach wherein the leading surface has a generally cone-shaped configuration.
Laubach et al. teaches a plunger construction where the plunger (piston, see Fig. 1) comprises a body portion (piston body 22) having a sidewall (Figs. 2-3 show a generally cylindrical sidewall), a leading surface (leading surface at the first axial end 22a/face portion 23/24), and a trailing surface (trailing surface at the second axial end 22b); and a ribbed portion comprising a plurality of ribs (formed by sealing portion 26 and stabilizing ribs 32) projecting radially outwardly from the sidewall of the body portion (see Figs. 2-3) and spaced axially apart from one another (see Figs. 2-3), the plurality of ribs comprising at least a trailing rib (stabilizing rib 32 located closes to second axial end 22b) and a leading rib (formed by sealing portion 26), each of the ribs including an annular configuration (see Figs. 2-3). Laubach further teaches wherein the leading surface has a generally cone-shaped configuration (Fig. 2, 24, where the surface is generally cone shaped).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the radial surfaces of the plunger of Forlani and Minagawa to include a cone-shaped leading surface as taught by Laubach since this was a known design for a plunger in the relevant art before the effective fling date of the present invention (see Figs. 1-2 of Laubach) and in order to provide a plunger that produces low break loose and extrusion forces with the inner surface of a syringe (or cartridge) and which creates an acceptable seal with the inner surface of the syringe (or cartridge) (paragraph 4 of Laubach).
Regarding claim 43, Forlani and Minagawa teach the drug delivery assembly of claim 42, Forlani and Minagawa do not specifically teach wherein both the trailing rib and the intermediate rib are axially smaller than the leading rib.
Laubach teaches where each rib (32) can have a substantially different diameter which can include a smaller diameter for an intermediate and trailing rib (¶[0020]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the radial surfaces of the plunger of Forlani and Minagawa to include differing rib diameters as taught by Laubach since this was a known design for a plunger in the relevant art before the effective fling date of the present invention (see Figs. 1-2 of Laubach) and in order to provide a plunger that produces low break loose and extrusion forces with the inner surface of a syringe (or cartridge) and which creates an acceptable seal with the inner surface of the syringe (or cartridge) (paragraph 4 of Laubach).
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Forlani et al. (US 2017/0246399) in view of Minagawa (US 2016/0033042) as applied to claim 8 above, and further in view of Berg et al. (US 2018/0243508).
Regarding claim 14, Forlani and Minagawa do not specifically teach wherein the ribs have at least 0.8 MPa contact pressure with the interior surface of the sidewall of the syringe barrel.
Berg teaches a low lubricant syringe barrel with a stopper, designed for a medical delivery device. Berg teaches a plunger (Fig. 11A, 100) that includes ribs (22).
Berg discloses the stopper and ribs having a sliding surface (S) and a contact width (w) of the ribs on the stopper. The seal pressure of the device is variable based on the compressibility (C%). The seal pressure of the device is at minimum adequate to achieve a limit of 6 x 10-6 sccs (¶[0054]-[0057]). Seal pressure in Berg is equivalent to the contact pressure stated in the present application. Therefore, Berg recognizes that the contact pressure is a result effective variable that depends on the construction of the ribs on the stopper which includes the sliding surface and contact width. Therefore, since Berg sets forth that the sealing pressure of the device is able to limit the leak of helium to high degree, it would have been obvious to one of ordinary skill in the art at the time the invention was made to make the stopper of Berg have a contact pressure of at least 0.8 MPa. Since it has been held that when the general conditions are disclosed in the art, discovering the optimum or workable ranges involves only routine skill in the art. Providing stopper that can effectively limit gas leak rate to a high degree would effectively meet the needs of an application which contact pressure against the sidewall of the device is necessary. In re Aller, 105 USPQ 233 (See MPEP § 2144.05).
Claim(s) 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hanson et al. (US 2015/0190588) in view of Forlani et al. (US 2017/0246399) and Minagawa (US 2016/0033042).
Regarding claim 15, Hanson et al, discloses an on-body injector device (drug delivery pump 10, for on-body use (paragraph 41), see Figs, 1A-1C) comprising:
a housing (housing 12) having an interior (Fig. 1B) and a bottom wall (shown in Fig. 1C) within an opening extending therethrough (opening covered by seal 254, through which the needle 214 of insertion mechanism 200 extends; paragraph 57), the housing (housing 12) configured to be secured to the tissue of a user (by way of adhesive pad 26; paragraph 41);
a reservoir (drug container 50) with an annular sidewall (shown in Fig. IB) extending between a first, open end (end closed off by plunger seal; disclosed in paragraph 52 and shown in Fig. 1C) and a second end having a dispensing opening (end with pierceable seal, which is pierced by a piercing member for delivery through a fluid pathway connection, sterile conduit and insertion mechanism into the body of the user; paragraph 52);
a drive mechanism (drive mechanism 100) including a plunger (plunger seal, disclosed in paragraph 52 and shown in Fig. 1C) received within the reservoir (drug container 50),
a drive member (drive biasing member, paragraph 52) configured to drive the plunger (plunger seal) through the reservoir (drug container 50) to the second end thereof (paragraph 52);
an insertion mechanism (insertion mechanism 200) including a delivery member (needle 214) configured to shift from a retracted position (Fig. 6A, for example) within the housing (see Fig. 1B) to a deployed position extending outside of the housing (shown in Fig. 6D) through the opening thereof (needle 214 extends through the opening that is coverable by sea! 254; paragraph 57),
a fluid pathway assembly (formed by fluid pathway connection 300 and the sterile fluid conduit 30; paragraph 52) configured to fluidly couple the reservoir (drug container 50) to the insertion mechanism (insertion mechanism 200); and
an actuator (activation mechanism 14) configured to cause drive mechanism (drive biasing member, paragraph 52) to drive the plunger through the reservoir (drug container 50) to the second end thereof in response to an actuation thereof to thereby dispense medicament within the reservoir (drug container 50) through the insertion mechanism (paragraphs 39, 52).
Hanson et al. does not expressly go into detail about the construction of the plunger.
Forlani et al. discloses a plunger (plunger 52, Fig. 2) for use in a drug delivery device (cartridge 25), the plunger (plunger 52) comprising: a body portion (body 90) having a sidewall (sidewall has radially projecting sealing ribs 98 formed on it), a leading surface (forward end 92), and a trailing surface (rearward end 94), and a ribbed portion (portion with radially projecting sealing ribs 98) comprising a plurality of ribs projecting (radially projecting sealing ribs 98) radially outwardly from the sidewall of the body portion (body 90) and spaced axially apart from one another by recessed surfaces (see Fig. 2 and paragraph 40), the plurality of ribs (radially projecting sealing ribs 98) comprising at least a trailing rib (rearmost rib 98) and a leading rib (forwardmost rib 98), each of the ribs including an annular configuration (see Fig. 2 and paragraph 39) and being sized so that the ribs seal against an interior surface of the annular sidewall (wall 61) of the reservoir (barrel of cartridge 25) (see Fig. 2 and paragraphs 6, 7 and 34); wherein the body portion (body 90) is configured to occupy a first configuration in the absence of an axial load (position/configuration of plunger body portion when the cartridge 25 is full with medication 74, like as shown in Fig. 5-6), and a second configuration in the presence of an axial load (dispensed or dispensing position/configuration, see paragraphs 6, 7and 34) compression from the axial load (applied by the advancing/drive mechanism, see paragraph 7) causing the body portion (body 90) in the second configuration (dispensed or dispensing position/configuration) to have an axial dimension that is less than an axial dimension of the first configuration (see paragraphs 6, 7 and 34, and compare the position of the plunger 52 in Figs. 5-6 and 2-3), and wherein the ribbed portion (portion with radially projecting sealing ribs 98) has a first radial dimension when the body portion (body 90) occupies the first configuration (position/configuration of plunger body portion when the cartridge 25 is full with medication 74, like as shown in Fig. 5-6) and a second radial dimension when the body portion (body 90) occupies the second configuration (dispensed or dispensing position/configuration), the first and second radial dimensions being substantially equal (see paragraphs 6, 7and 34 and compare the plunger 52 in Figs. 5-6 and 2-3) and wherein the side surfaces of the sidewall of the body portion (90) are radially recessed relative to the plurality of ribs (98)(where the ribs 98 are protruding further than the body portion 90 as shown in figure 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the device of Hanson et al. to utilize a plunger like the one taught by Forlani et al. since this was a known design for plungers in the relevant art before the effective fling date of the present invention (see Fig. 2 of Forlani et al.) and in order to provide fluid tight engagement of the plunger with barrel interior surface to seal medication from the barrel rearward end (paragraph 38 of Forlani et al.).
Hanson in view of Forlani fails to disclose wherein the leading rib includes a first convex axial portion, a second convex axial portion, and a cylindrical portion disposed between the first and second convex axial portions, and wherein a radius of curvature of the first convex axial portion of the leading rib is greater than a radius of curvature of the second convex axial portion
Minagawa teaches a gasket that includes multiple ribs with convex and concave portions on the body. Minagawa teaches wherein the leading rib (Fig. 1, 14a) includes a first convex axial portion (Fig. 2, 143a), a second convex axial portion (Fig. 2, 142a), and a cylindrical portion disposed between the first and second convex axial portions (Fig. 1, 141a), and wherein a radius of curvature of the first convex axial portion of the leading rib is greater than a radius of curvature of the second convex axial portion (¶[0046]). Changing the device of Forlani to include the gasket of Minagawa would be a simple substitution as the device of Forlani has ribs, concave portions and a main body portion designed to slide within a device. Furthermore, the shape of the device is what is being taught by Minagawa and would not result in a difference of function in the device of Forlani. The claim limitation focuses on the shape of the device and does not point to any critical factors regarding the function of said shape.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Hanson to include a gasket that has the leading rib includes a first convex axial portion, a second convex axial portion, and a cylindrical portion disposed between the first and second convex axial portions, and wherein a radius of curvature of the first convex axial portion of the leading rib is greater than a radius of curvature of the second convex axial portion and wherein the side surfaces of the sidewall of the body portion are radially recessed relative to the plurality of ribs as a matter of simple substitution with Minagawa. This modification would improve the device of Forlani when combined with Minagawa as it would achieve sliding properties and resistance to liquid leakage with these modified projections (¶[0045]-[0046] from Minagawa).
Regarding claim 17, Forlani discloses the claimed invention as discussed above concerning claim 1, and Forlani further discloses that radial surfaces of the body portion (body 90) extending between the ribs (radially projecting sealing ribs 98) include flat portions (see Examiner’s annotated zoomed in Figure 2 below).
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Hanson et al. (US 2015/0190588) in view of Forlani et al. (US 2017/0246399) and Minagawa (US 2016/0033042) as applied to claim 15 above, and further in view of Laubach et al. (US 2016/0082193).
Regarding claim 20, the combination of Hanson, Forlani and Minagawa does not specifically disclose wherein radial surfaces of the sidewall extending between the ribs are concavely curved along a longitudinal axis of the body portion.
Laubach et al. teaches a plunger construction where the plunger (piston, see Fig. 1) comprises a body portion (piston body 22) having a sidewall (Figs. 2-3 show a generally cylindrical sidewall), a leading surface (leading surface at the first axial end 22a/face portion 23/24), and a trailing surface (trailing surface at the second axial end 22b); and a ribbed portion comprising a plurality of ribs (formed by sealing portion 26 and stabilizing ribs 32) projecting radially outwardly from the sidewall of the body portion (see Figs. 2-3) and spaced axially apart from one another (see Figs. 2-3), the plurality of ribs comprising at least a trailing rib (stabilizing rib 32 located closes to second axial end 22b) and a leading rib (formed by sealing portion 26), each of the ribs including an annular configuration (see Figs. 2-3). Laubach et al. further teaches that radial surfaces (annular recesses 34) of the sidewall extending between the ribs (formed by sealing portion 26 and stabilizing ribs 32) have curved configurations (see Figs. 2-3 and paragraph 21), and that the radial surfaces (annular recesses 34) of the sidewall extending between the ribs (formed by sealing portion 26 and stabilizing ribs 32) are concave (see Figs. 2-3 and paragraph 21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the radial surfaces of the plunger of Forlani to include radial surface configurations as taught by Laubach since this was a known design for the sidewalls of plungers in the relevant art before the effective fling date of the present invention (see Figs. 1-2 of Laubach) and in order to provide a plunger that produces low break loose and extrusion forces with the inner surface of a syringe (or cartridge) and which creates an acceptable seal with the inner surface of the syringe (or cartridge) (paragraph 4 of Laubach).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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