DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 16, 18-19, 23-24, 26-29 are rejected under 35 U.S.C. 102(a)(b) as being anticipated by Karlsson et al (Pub. No.: US 2018/0104414).
Regarding claim 16, Karlsson et al disclose a sub-assembly for a medicament delivery device [see 0059, 0063, 0065];
the sub-assembly comprising:
a sub-assembly housing (hollow cylinder 821) extending along a longitudinal axis between a distal end and a proximal end [see 0059],
wherein the sub-assembly housing comprises a flexible arm extending in a distal direction of the sub-assembly housing [see 0059, figs 5-6b];
wherein the flexible arm comprises a distally directed flexible arm surface [see 0059];
a rotator (coupling member 84) comprising a support wall extending in the direction of the longitudinal axis [see figs 4-6B];
a plunger rod comprising a proximally directed plunger rod surface adjacent to the
distally directed flexible arm surface [see abstract, 0028, 0058-0059];
a biasing member extending in the direction of the longitudinal axis between a
proximally directed sub-assembly housing surface of the sub-assembly housing and a distally
directed surface of the plunger rod [see 0058-0059];
wherein the rotator (coupling member) is rotatable around the longitudinal axis relative to the sub-assembly housing from a first rotator position where the support wall is adjacent to an outer surface of the flexible arm of the sub-assembly housing to a second rotator position (due to a rotation, emphasis added) where the support wall is circumferentially offset (via alignment, 0077) to the outer surface of the flexible arm [see 0062, 0077].
Regarding claim 18, Karlsson et al disclose wherein the flexible arm extends in the distal direction from the distal end of the sub-assembly housing [see figs 4-6B].
Regarding claim 19, Karlsson et al disclose wherein the rotator is axially immovable (via locking element) relative to the sub-assembly housing [see 0008, 0015].
Regarding claim 23, Karlsson et al disclose wherein the rotator comprises a cylindrical or semi-cylindrical rotator body [see fig 4].
Regarding claim 24, Karlsson et al disclose wherein the actuated surface of the rotator is arranged at the proximal end of the rotator body [see 0062, 0077].
Regarding claim 26, Karlsson et al disclose wherein the plunger rod comprises a rod body, wherein a recess or cut-out is arranged in a sidewall of the rod body,
wherein a distal edge of the recess or cut-out defines the proximally directed plunger rod surface [see figs 5A-6B].
Regarding claim 27, Karlsson et al disclose wherein the biasing member is a
compression spring surrounding a portion of the rod body of the plunger rod [see figs 5A-6B].
Regarding claim 28, Karlsson et al disclose wherein the sub-assembly housing comprises an inner arm extending from the distal end towards the proximal end of the sub-assembly housing,
wherein the inner arm comprises a protrusion radially inwardly extending from a proximal end of the inner arm [see figs 5A-6B].
wherein the plunger rod comprises a radially outwardly extending structure configured to interact with the protrusion of the inner arm when the plunger rod moves past the inner arm [see figs 5A-6B].
Regarding claim 29, Karlsson et al disclose wherein the radially outwardly
extending structure of the plunger rod extends from the rod body of the plunger rod,
wherein the radially outwardly extending structure has a surface that is perpendicular to the rod body [see figs 5A-6B].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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) 17 are rejected under 35 U.S.C. 103 as being unpatentable over Karlsson et al (Pub. No.: US 2018/0104414) in view of Holmqvist et al (Pub. No.: US 2020/0197618).
Regarding claim 17, Karlsson et al don’t disclose wherein at least one of the distally directed flexible arm surface of the flexible arm and the proximally directed plunger rod surface of the plunger rod is beveled.
Nonetheless, Holmqvist et al disclose wherein at least one of the distally directed flexible arm surface of the flexible arm and the proximally directed plunger rod surface of the plunger rod is beveled [see 0065, claim 19] by disclosing first arm 21b has a first tangential tab 21c having a distal end face 21c which is beveled in the tangential direction [see 0065].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Karlsson et al and Holmqvist et al by using a plunger rod surface of the plunger rod that is beveled; the beveled leading edge prevents abrasive solids (such as sand or fines) from lodging between the plunger and the pump barrel. This design minimizes contact points that would otherwise cause erosion, extending the life of both the plunger and the barrel.
Claim(s) 20-21, 25, 30 are rejected under 35 U.S.C. 103 as being unpatentable over Karlsson et al (Pub. No.: US 2018/0104414) in view of Sall (Pub. No.: US 2019/0365999).
Regarding claims 20-21, 25, Karlsson et al don’t disclose an actuator surface, wherein the rotator comprises an actuated surface facing towards the actuator surface,
wherein at least one of the actuator surface and the actuated surface is helical relative to the longitudinal axis,
wherein the actuator surface is configured to move along the actuated surface with a movement of the actuator member relative to the rotator in the direction of the longitudinal axis moving the rotator from the first rotator position to the second rotator position.
Nonetheless, Sall discloses an actuator surface, wherein the rotator comprises an actuated surface facing towards the actuator surface,
wherein at least one of the actuator surface and the actuated surface is helical (drive spring) relative to the longitudinal axis [see 0063-0065]
wherein the actuator surface is configured to move along the actuated surface with a movement of the actuator member relative to the rotator in the direction of the longitudinal axis moving the rotator from the first rotator position to the second rotator position [see 0065-0074]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Karlsson et al and Sall by using an actuator surface, wherein the rotator comprises an actuated surface facing towards the actuator surface, wherein at least one of the actuator surface and the actuated surface is helical relative to the longitudinal axis, wherein the actuator surface is configured to move along the actuated surface with a movement of the actuator member relative to the rotator in the direction of the longitudinal axis moving the rotator from the first rotator position to the second rotator position; for activation purposes
Regarding claim 30, Karlsson et al don’t disclose wherein the medicament delivery device is an autoinjector.
Nonetheless, Sall discloses wherein the medicament delivery device is an autoinjector [see 0012].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Karlsson et al and Sall by using an autoinjector; Autoinjectors offer convenience, precision, safety, and improved adherence
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL F BRUTUS whose telephone number is (571)270-3847. The examiner can normally be reached Mon-Sat, 11:00 AM to 7:00 PM.
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/JOEL F BRUTUS/ Primary Examiner, Art Unit 3797
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