DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant’s election without traverse of group I (claims 1-7, 10-11, 13-15, 25-32) in the reply filed on 5/20/26 is acknowledged.
Claim Objections
Claims 13-15 are objected to because of the following informalities: line 1 should be amended to -The [[prefilled]] pre-filled syringe of claim-. Appropriate correction is required.
Claim 31 is objected to because of the following informalities: line 1 should be amended to - the at least one slot being configured to allow sterilizing gas to pass therethrough-. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7, 10-11 and 13-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1:
The claims limitation “a stem portion having an essentially uniform cross section” in line 4 is unclear. The term “essentially” makes it unclear whether the cross section is uniform or not. For the sake of examination, the office has assumed that the cross section should be uniform however the applicant should amend the claims to address the rejection.
Claims 2-7, 10-11 and 13-15 are rejected due to their dependence on claim 1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 25-27 and 29-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5314416 A to Lewis et al. (Lewis).
Lewis discloses:
Regarding claim 25:
A device (figures 5-7) used in conjunction with medical barrel for delivering liquid drug formulation (column 1, lines 25-30), the device comprising:
a thumb rest (42 in figure 1) at a proximal end of a shaft (16 in figure 1);
an axial protrusion (72/58/56/54/52/112/50) extending distally from a flat or planar distal end (44) of the shaft (16), the axial protrusion (72/58/56/54/52/112/50) having a stem portion (48) having a cylindrical shape (as shown in figure 5) of uniform cross section (as shown in figure 5), a head portion (112/52/54/50/56/58) located at a distal end of the stem portion (48), the head portion (112/52/54/50/56/58) having a proximal end (50/56) with a greater cross-sectional width or diameter than that of the stem portion (48) (as shown in figure 5), the head portion (112/52/54/50/56/58) having a distal end (112) comprising a rounded tip (112 as shown in figure 5), the head portion (112/52/54/50/56/58) having a symmetrical cross-section (as shown in figure 5) with an outer contour (see the contour 54 that flares outward) that flares radially outward in a proximal direction (as shown in figure 5).
Regarding claim 26:
The device of claim 25, wherein the outer contour of the head portion (112/52/54/50/56/58) terminates at an outer edge (56)(as shown in figure 5) at the proximal end (50/56) of the head portion (112/52/54/50/56/58).
Regarding claim 27:
The device of claim 25, wherein the head portion (112/52/54/50/56/58) comprises a shelf (58) extending radially inward (as shown in figure 5) from the outer edge (56) and terminating at the stem portion (48).
Regarding claim 29:
The device of claim 25,wherein the head portion (112/52/54/50/56/58) is integrally formed (as shown in figure 5) with the axial protrusion (72/58/56/54/52/112/50) to form a one-piece construction (as shown in figure 5).
Regarding claim 30:
The device of claim 25, wherein the head portion (112/52/54/50/56/58) is fixed with respect to the axial protrusion (72/58/56/54/52/112/50)(as shown in figure 5).
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) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5314416 A to Lewis et al. (Lewis) in view of WO 2017209800 A1 to Lilly et al. (Lilly).
Regarding claim 1:
Lewis discloses:
A plunger assembly (figures 1 and 5-7) for use in a medical barrel, comprising:
a plunger rod (16) having a distal end (44) and a proximal end (42);
an axial protrusion (72/58/56/54/52/112/50) secured to or extending from the distal end (44) of the plunger rod (16), the axial protrusion (72/58/56/54/52/112/50) comprising a stem portion (48) having an essentially uniform cross section (as shown in figure 5), the stem portion (48) leading to a head portion (112/52/54/50/56/58), the head portion (112/52/54/50/56/58) having a proximal end (50/56) with a greater cross-sectional width or diameter than that of the stem portion (48) (as shown in figure 5), the head portion (112/52/54/50/56/58) having a distal end (112) comprising a rounded tip (112 as shown in figure 5), the head portion (112/52/54/50/56/58) having a symmetrical cross-section (as shown in figure 5) with an outer contour (see the contour 54 that flares outward) that flares radially outward in a proximal direction (as shown in figure 5), the outer contour terminating at an outer edge (56)(as shown in figure 5) at the proximal end of the head portion (112/52/54/50/56/58), the head portion (112/52/54/50/56/58) comprising a shelf (58) extending radially inward (as shown in figure 5) from the outer edge (56) and terminating at the stem portion (48); and
a plunger (36) comprising a plunger sleeve (60) having an exterior surface (as shown in figure 5) and an interior surface (see the inner bore of 90) surrounding an inner cavity (90), the exterior surface comprising a distal nose cone (114) and an outer annular wall (64/60) extending proximally from the nose cone and leading to an opening (96) at a proximal end (98) of the plunger sleeve (60), the opening receiving the axial protrusion (72/58/56/54/52/112/50) such that the axial protrusion (72/58/56/54/52/112/50) extends into the inner cavity (90) and contacts an engagement surface (126) of the interior surface (see the inner bore of 90), the engagement surface (126) configured to receive a force applied (as shown in figure 7) in a distal direction (toward the needle 30) by the axial protrusion (72/58/56/54/52/112/50) to move the plunger assembly in a distal direction when the plunger rod (16) is moved in a distal direction (when moved in the direction toward needle 30);
wherein the distal end (44) of the plunger rod (16) does not initially contact the proximal end (98) of the plunger sleeve (60) when the plunger (36) is in a pre-elongation state (as shown in figure 5), and
wherein the plunger rod (16) and axial protrusion (72/58/56/54/52/112/50) are provided as a single piece of unitary construction (as shown in figure 5).
Lewis fails to disclose:
At least a portion of the outer contour having a curved surface comprising a radius with an imaginary center located outside of the head portion.
Lilly teaches:
A device (figure 12) that includes a plunger/ring (332) that fits over a head portion (332) that includes a transition portion (346) that allows the plunger/ring to seat (as shown in figure 12). Further, the transition portion (outer contour) can be curved to allow the plunger/ring to seat in its proper location (¶00153).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lewis to modify the outer contour to have a curved surface as taught by Lilly in order to help the plunger to better seat on the head portion (Lilly, ¶00153).
Regarding claim 2:
Lewis discloses:
The plunger assembly of claim 1, the inner cavity (90) of the plunger (36) comprising a distal compartment (78) having a wider internal geometry (wider than 94 of 90) than that of a portion of the inner cavity (90) leading up to the distal compartment (78), the distal compartment (78) having a proximal end (116) that defines a ledge (116 as shown in figure 5) configured to catch or engage the shelf (58/50/54) of the head portion head portion (112/52/54/50/56/58) to enable the head portion head portion (112/52/54/50/56/58)to couple to the plunger (36).
Regarding claim 3:
Lewis discloses:
A pre-filled syringe (figure 1) comprising:
a medical barrel (12) having an inner wall (as shown in in figure 1) and product containing area (24), the product containing area having disposed therein an injectable product for example a liquid composition (column 9, lines 23-57), the medical barrel (12) having a distal dispensing end (26) for dispensing the injectable product and an open proximal end (18) configured for receipt of a plunger assembly (16); and
the plunger assembly according to claim 1 (as indicated in the claim 1 rejection above), wherein the plunger (36) is disposed within the medical barrel (12) such that the nose cone (114) faces the injectable product (product within 24/12) and at least a portion of the plunger rod (16) extends proximally from the open proximal end (as shown in figure 1) of the medical barrel (12).
Regarding claim 4:
Lewis discloses:
The pre-filled syringe of claim 3, wherein application of sufficient force (column 9, lines 1-7) onto the plunger rod (16) in a distal direction causes the plunger assembly to displace distally down the medical barrel (12).
Regarding claim 5:
Lewis discloses:
The pre-filled syringe of claim 4, the plunger (36) comprising a stretch zone that is configured to undergo elongation along a central axis of the plunger (36) upon application of a force in the distal direction (as shown in figure 7) by the axial protrusion (72/58/56/54/52/112/50) onto the engagement surface (126), wherein the elongation reduces an outer profile of the outer annular wall along the stretch zone (overall length of the plunger reduces due to the application of force; column 13, line 65-column 14, line 5).
Regarding claim 6:
Lewis discloses:
The pre-filled syringe of claim 5, wherein the plunger rod (16) and axial protrusion (72/58/56/54/52/112/50) are configured such that the plunger rod (16) does not contact the proximal end (98/72) of the plunger sleeve (60) when the assembly is advanced in a distal direction down the medical barrel (12), so as not to axially compress the plunger (36) during actuation (as shown in figure 7 during application of the force in the rightward direction of axis 40 the plunger rod 16/44 does not contact proximal end 72/98 of the plunger 36).
Regarding claim 7:
Lewis discloses:
The pre-filled syringe of claim 6, wherein application of axial force in a proximal direction onto the proximal end (42) of the plunger rod (16) sufficient to axially displace the plunger rod (16) in a proximal direction over a predetermined distance does not disconnect or remove (as shown in figure 6) the axial protrusion (72/58/56/54/52/112/50) from the inner cavity (90).
Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5314416 A to Lewis et al. (Lewis) as applied to claim 3 above, and further in view of WO 2017209800 A1 to Lilly et al. (Lilly).
Regarding claim 10:
Lewis fails to disclose:
The pre-filled syringe of claim 3, wherein the inner wall of the medical barrel comprises a plasma enhanced chemical vapor deposition (PECVD) coating or coating set.
Lilly teaches:
A syringe (figure 1) that includes a inner wall of a medical barrel (12) that can be coated with plasma enhanced chemical vapor deposition (PECVD) coating that further includes a tie coating and a SiOx barrier coating (¶00217) to improve the lubricity (¶00151).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lewis to further include a PECVD coating on the inner wall of the medical barrel that further includes a tie layer and SiOx barrier coating as taught by Lilly to improve the lubricity of the medical barrel (Lilly, ¶00151).
Regarding claim 11:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 10 by Lewis and Lilly:
The prefilled syringe of claim 10, wherein the PECVD coating or coating set is selected from the group consisting of:
a bilayer coating set, comprising a tie layer and a SiOx barrier layer disposed on the tie layer (see the tie layer and SiOx barrier layer of Lilly incorporated into Lewis);
a trilayer coating set, comprising a tie layer, an SiOx barrier layer disposed on the tie layer and an organo-siloxane layer disposed on the SiOx barrier layer; and
a four layer coating set, comprising a tie layer, an SiOx barrier layer disposed on the tie layer, an organo-siloxane layer disposed on the SiOx barrier layer and a lubricity layer disposed on the organo-siloxane layer.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5314416 A to Lewis et al. (Lewis) as applied to claim 3 above, and further in view of US 9220631 B2 to Sigg et al. (Sigg).
Regarding claim 13:
Lewis fails to disclose:
The prefilled syringe of claim 3,wherein the prefilled syringe is a 0.5 mL syringe and the injectable product is a liquid ophthalmic drug formulation.
Sigg teaches:
A syringe that is prefilled with 0.5 ml (column 3, line 65- column 4, line 5) of a liquid ophthalmic drug formulation (column 6, lines 15-30). Further, the solution can contain an anti-VEGF antibody including Ranibizumab (claim 9; column 6, lines 32-36). This solution is used to treat an ocular disease (column 8, line 64 - column 9, line 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lewis to add to the syringe a drug formulation including 0.5 mL of a liquid ophthalmic drug formulation including an anti-VEGF antibody including Ranibizumab as taught by Sigg to treat ocular disease (Sigg, column 8, line 64-column 9, line 4).
Regarding claim 14:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 13 by Lewis and Sigg:
The prefilled syringe of claim 13, 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 (see the anti-VEGF antibody of Sigg incorporated into Lewis) or an antigen-binding fragment of such antibody.
Regarding claim 15:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 13 by Lewis and Sigg:
The prefilled syringe of claim 13, wherein the liquid ophthalmic drug formulation comprises Ranibizumab (see the Ranibizumab of Sigg incorporated into Lewis) and/or Aflibercept.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5314416 A to Lewis et al. (Lewis) as applied to claim 25 above, and further in view of WO 2017209800 A1 to Lilly et al. (Lilly).
Regarding claim 28:
Lewis fails to disclose:
The device of claim 25, wherein at least a portion of the outer contour of the head portion having a curved surface comprising a radius with an imaginary center located outside of the head portion.
Lilly teaches:
A device (figure 12) that includes a plunger/ring (332) that fits over a head portion (332) that includes a transition portion (346) that allows the plunger/ring to seat (as shown in figure 12). Further, the transition portion (outer contour) can be curved to allow the plunger/ring to seat in its proper location (¶00153).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lewis to modify the outer contour to have a curved surface as taught by Lilly in order to help the plunger to better seat on the head portion (Lilly, ¶00153).
Claim(s) 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5314416 A to Lewis et al. (Lewis) as applied to claim 25 above, and further in view of US 5411488 A to Pagay et al. (Pagay).
Regarding claim 31:
Lewis fails to disclose:
The device of claim 25, wherein at least one of the stem portion and the head portion including includes at least one slot extending parallel to a longitudinal axis of the shaft, the slot being configured to allow sterilizing gas to pass therethrough.
Pagay teaches:
A device (figure 1) that includes axial protrusion (66/64) and a plunger (32). Further, the axial seat includes a stem (66) and a head (64). Further, the stem includes 4 slots (see the slots A in figure 1 below) arranged around the exterior.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lewis to replace the stem in Lewis with the slotted stem as taught by Pagay. This is a simple substitution of one known element (cylindrical stem as taught by Lewis) for another (slotted stem of Pagay) to obtain predictable results (to support the head of the axial protrusion).
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Figure 1 - figure 2 of Pagay, annotated by the examiner
Regarding claim 32:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 31 by Lewis with Pagay:
The device of claim 31, wherein the at least one slot includes three radially spaced-apart slots (see the three of four slots of the stem of Pagay incorporated into Lewis).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-3253592-A
VON PECHMANN
See the head portion 20
US-3045674-A
GOLDBERG
See the head portion 32c
US-6511459-B1
Fago
See the head portion 36
US-4266557-A
Merry
See the head portion 32
US-5735825-A
Stevens
See the head portion 52
US-4543093-A
Christinger
See the head portion 36
WO-2010103919-A1
TACHIKAWA
See the head portion 402
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
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