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 .
Reopening of Prosecution
In view of the appeal brief filed on 05/26/2026, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/KEVIN C SIRMONS/
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.
Claims 1-2, 4-7, 9-11, 13-18 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Liniger et al. (USPGPub 2021/0085884) in view of Dowds et al. (USPGPub 2014/0025013) and Srinivasan et al. (USPGPub 2017/0361027).
Re Claim 1, Liniger teaches an automatic drug delivery device (1) for dispensing a fluid product (Liniger Figs. 1 and 2), the automatic drug delivery device (1) comprising: a longitudinal housing (3) extending along a longitudinal axis and having a proximal end close to a dispensing site, a distal end opposite to the proximal end and a hollow interior (Linger ¶ 0058); a removable cap (9) mounted to the proximal end of the longitudinal housing (3) (Liniger ¶ 0061); a syringe assembly (4) arranged in a mounting position inside the longitudinal housing (3) and having a hollow syringe body (41) and an injection needle (81) formed with the hollow syringe body (41) including the fluid product (Liniger ¶ 0058); a drive mechanism which can be triggered by a trigger element in order to initiate dispensing of the fluid product (Liniger ¶ 0058 - "spring element 7 arranged between the container holder 2 and the shell 3 forms part of an activation or driving mechanism of the medical delivery device 1"); wherein the drive mechanism is operatively coupled with a safety shield (10) movable within the longitudinal housing (3) (Liniger ¶ 0065 - "projection or retraction of the needle sleeve 10 is preferably activated by a dedicated driving mechanism").
Liniger further teaches wherein the safety shield (10) is biased into a proximal position in which the safety shield (10) protrudes out of the proximal end of the longitudinal housing (3) in order to cover a needle tip of the injection needle (81) (as seen in Liniger Fig. 2), and wherein the safety shield (10) is movable into a distal position in which the injection needle (81) is exposed for injection (Liniger Figs. 3-4; ¶ 0062-0063); wherein the removable cap (9) is axially retained on the proximal end of the longitudinal housing (3) by engagement of retaining elements (5) between the cap (9) and the longitudinal housing (3) (Liniger ¶ 0059-0061), the removable cap (9) holding the safety shield (10) in a capped position between the proximal position and the distal position in which the tip of the injection needle (81) protrudes beyond the safety shield (10) (Liniger ¶ 0065), the retaining elements (5) being disengaged from the cap (9) relative to the longitudinal housing (3) to allow axial movement of the cap (9) relative to the longitudinal housing (3) to remove said cap (9) (Liniger ¶ 0059-0061, 0065), the axial movement of the cap (9) relative to the longitudinal housing (3) being supported by a biasing force applied to the safety shield (10) (Liniger ¶ 0022, 0058).
Liniger fails to teach wherein the retaining elements are disengaged by rotation of the cap relative to the longitudinal housing. Dowds teaches an automatic drug delivery device (10) (Dowds Fig. 1) for dispensing a fluid product, the automatic drug delivery device comprising: a longitudinal housing (60) extending along a longitudinal axis and having a proximal end close to a dispensing site, a distal end opposite to the proximal end (as seen in Dowds Fig. 1); a removable cap (50) mounted to the proximal end of the longitudinal housing (Dowds Figs. 13-14; ¶ 0056); a syringe assembly (20) (Dowds Fig. 2); wherein the removable cap (50) is axially retained on the proximal end of the longitudinal housing (60) by engagement of retaining elements (54) between the cap and the longitudinal housing (Dowds ¶ 0041, 0056-0057; Fig. 14).
Furthermore, Dowds teaches the retaining elements (54) being disengaged by rotation of the cap (50) relative to the longitudinal housing (60) (Dowds ¶ 0056 - "the RNS removal tool 50 is rotated, the barbs 54 push against the edge of the window 62 and are deflected radially inward") to allow axial movement of the removable cap (50) relative to the longitudinal housing (60) to remove said cap (50), the configuration to prevent inadvertent removal of the cap without both a rotation and axial pulling of the cap (Dowds ¶ 0002, 0056-0057). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the removable cap and retaining elements of Linger such that the retaining elements are disengaged by rotation of the cap relative to the longitudinal housing as disclosed by Dowds to prevent inadvertent removal of the cap without both a rotation and axial pulling of the cap (Dowds ¶ 0002, 0056-0057).
Liniger also fails to teach wherein the tip of the injection needle protrudes proximally beyond the safety shield when the safety shield is held in the capped position. Dowds teaches the automatic drug delivery device (10) (Dowds Fig. 1) comprising an injection needle (24) (as seen in Dowds Fig. 2) and a safety shield (80) (as seen in Dowds Fig. 6), wherein a tip (25) of the injection needle (24) protrudes proximally beyond the safety shield (80) when the safety shield (80) is held in a capped position (as seen in Dowds Fig. 20) so that the safety shield (80) does not interfere with the removable cap (50) when the removable cap (50) is in the capped position (Dowds ¶ 0049). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the tip of the injection needle of Liniger protrude proximally beyond the safety shield when the safety shield is held in the capped position as disclosed by so that the safety shield does not interfere with the removable cap when the removable cap is in the capped position (Dowds ¶ 0049).
Furthermore, it would have been an obvious matter of design choice to modify Liniger wherein the tip of the injection needle protrudes proximally beyond the safety shield when the safety shield is held in the capped position since applicant has not disclosed that having the tip of the injection needle protrude proximally beyond the safety shield when the safety shield is held in the capped position solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of the tip of the injection needle protruding proximally beyond the safety shield when the safety shield is held in the capped position, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Finally, Liniger fails to teach the removable cap including an end cap body having at least one inner surface, a plurality of connecting ribs extending radially inwardly from the at least one inner surface, and at least one annular arch fixed to the at least one inner surface via the plurality of connecting ribs. Srinivasan teaches a removable cap (200) (Srinivasan Figs. 20 and 21B) comprising an end cap body having at least one inner surface (221) (Srinivasan Annotated Fig. 21B below), a plurality of connecting ribs (220) extending radially inwardly from the at least one inner surface (221), and at least one annular arch (220-1) fixed to the at least one inner surface (221) via the plurality of connecting ribs (220) (Srinivasan ¶ 0047), wherein the connecting ribs (220) and at least one annular arch (220-1) provide a stop surface for a needle hub (210) and prevent overtightening of the cap (Srinivasan ¶ 0047-0049).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the removable cap of Liniger to include an end cap body having at least one inner surface, a plurality of connecting ribs extending radially inwardly from the at least one inner surface, and at least one annular arch fixed to the at least one inner surface via the plurality of connecting ribs as disclosed by Srinivasan wherein the connecting ribs and at least one annular arch provide a stop surface for a needle hub and prevent overtightening of the cap (Srinivasan ¶ 0047-0049).
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Re Claim 2, Liniger in view of Dowds and Srinivasan teach all of the limitations of Claim 1. Linger further teaches wherein the safety shield (10) engages the removable cap (9) with a proximal contact surface (10-1) formed on or close to a proximal end of the safety shield (10) when the removal cap (9) is mounted to the longitudinal housing (3) (as seen in Liniger Annotated Fig. 1 above).
Re Claim 4, Liniger in view of Dowds and Srinivasan teach all of the limitations of Claim 1. Linger further teaches wherein the removable cap (9) includes an end cap body (9-1) having at least one inner surface, which defines an axially open receiving portion, and having an inner ring (9-2), which is connected to the end cap body (9-1), wherein the inner surface of the removable end cap (9) and the inner ring (9-2) form a space for receiving the proximal end of the longitudinal housing (3) (Linger Annotated Fig. 1 above).
Re Claim 5, Liniger in view of Dowds and Srinivasan teach all of the limitations of Claim 1. Linger fails to teach wherein the removable cap includes at least one cam path surface, wherein the cam path surface is adapted or inclined relative to the longitudinal axis for guiding the removable cap in a proximal direction along at least a portion of the rotation of the removable cap relative to the longitudinal housing. Dowds teaches wherein the removable cap (50) includes at least one cam path surface (67) (Dowds Fig. 14), wherein the cam path surface (67) is adapted or inclined relative to the longitudinal axis for guiding the removable cap (50) in a proximal direction along at least a portion of a rotation of the removable cap (50) relative to the longitudinal housing, the configuration to move the cap axially while the cap is rotated (Dowds ¶ 0064).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the removable cap of Liniger in view of Dowds and Srinivasan to include at least one cam path surface, wherein the cam path surface is adapted or inclined relative to the longitudinal axis for guiding the removable cap in a proximal direction along at least a portion of the rotation of the removable cap relative to the longitudinal housing, the configuration as disclosed by Dowds for moving the cap axially while the cap is rotated (Dowds ¶ 0064).
Re Claim 6, Liniger in view of Dowds and Srinivasan teach all of the limitations of Claim 5. Linger further teaches wherein the removable cap (9) includes an end cap body (9-1) having at least one inner surface (Liniger Annotated Fig. 1 above), which defines an axially open receiving portion, and having an inner ring (9-2), which is connected to the end cap body (9-1), wherein the inner surface of the removable end cap (9) and the inner ring (9-2) form a space for receiving the proximal end of the longitudinal housing (3) (as seen in Liniger Annotated Fig. 1 above). However, Liniger fails to teach wherein the cam path surface is located at an outer circumferential surface of the inner ring.
Dowds teaches wherein the removable cap (50) of the drug delivery device (10) comprises an inner ring (50-1) (Dowds Annotated Fig. 14 below), wherein the cam path surface (67) is located at an outer circumferential surface of the inner ring (50-1), the configuration for creating smooth conjoined surfaces between the inner ring and an end of the cam path surface for ease of rotating the removable cap from the drug delivery device (Dowds Annotated Fig. 14 below). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the cam path surface of Liniger in view of Dowds and Srinivasan to be located at an outer circumferential surface of the inner ring as disclosed by Dowds for creating smooth conjoined surfaces between the inner ring and an end of the cam path surface for ease of rotating the removable cap from the drug delivery device (Dowds Annotated Fig. 14 below).
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Re Claim 7, Liniger in view of Dowds and Srinivasan teach all of the limitations of Claim 1. Linger fails to teach wherein at least one safety shield projection is adapted to engage with a projection or recess of the cap in order to limit movement of the safety shield in a distal direction within the removable cap. Dowds teaches a safety shield (80) comprising a safety shield projection (81) (Dowds Figs. 3 and 6-8; Dowd Annotated Fig. 16 below; ¶ 0041), wherein the at least one safety shield projection (81) (as seen in Dowds Annotated Fig. 16 below) is adapted to engage with a projection (55) of the cap (50) in order to limit movement of the safety shield (80) in a distal direction within the removable cap (50), wherein the engagement between the safety shield projection and the projection of the cap prevents premature safety shield biasing to shield the needle until the cap is rotated off (Dowds ¶ 0041-0042).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the safety shield of Liniger in view of Dowds and Srinivasan comprise a safety shield projection, wherein the at least one safety shield projection is adapted to engage with a projection or recess of the cap in order to limit movement of the safety shield in a distal direction within the removable cap, the configuration as disclosed by Dowds wherein the engagement between the safety shield projection and the projection of the cap prevents premature safety shield biasing to shield the needle until the cap is rotated off (Dowds ¶ 0041-0042).
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Re Claim 9, Liniger in view of Dowds and Srinivasan teach all of the limitations of Claim 1. Linger further teaches wherein the syringe assembly (4) is provided with a rigid needle shield (82) fixed to a proximal end of the hollow syringe body (41) (Liniger ¶ 0058) and covering the needle (81) together with its sharpened needle tip (Liniger Figs. 1 and 2), wherein the removable cap (9) includes a flexible gripping element (9-3) for engaging and/or restraining the rigid needle shield (82) on its outer circumferential surface of the rigid needle shield (82) (Liniger Annotated Fig. 1 above; ¶ 0061).
Re Claim 10, Liniger in view of Dowds and Srinivasan teach all of the limitations of Claim 1. Linger fails to teach a method of removing the removable cap comprising rotating the removable cap relative to the longitudinal housing to disengage the retaining elements between the cap and the longitudinal housing; providing a removal force to separate the removable cap from the longitudinal housing; using the biasing force applied to the safety shield to assist with the separation of the removable cap from the longitudinal housing. Dowds discloses a method of removing the removable cap (50) from the automatic drug delivery device (10) comprising rotating the removable cap (50) relative to the longitudinal housing (60) to disengage the retaining elements (54) between the cap (50) and the longitudinal housing (60); providing a removal force to separate the removable cap (50) from the longitudinal housing (60); using the biasing force applied to the safety shield (80) to assist with the separation of the removable cap (50) from the longitudinal housing (60) (Dowds ¶ 0040-0043; Figs. 13-17).
In the present case, the device of Liniger works in a similar fashion but for the removable cap being rotated. Dowds requiring the additional step of rotation is being viewed as an additional step in cap removal that ensures the removable cap is not inadvertently removed (Dowds ¶ 0002, 0056-0057). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the automatic drug delivery device of Liniger in view of Dowds and Srinivasan wherein removing the removable cap comprises rotating the removable cap relative to the longitudinal housing to disengage the retaining elements between the cap and the longitudinal housing; providing a removal force to separate the removable cap from the longitudinal housing; using the biasing force applied to the safety shield to assist with the separation of the removable cap from the longitudinal housing, the method of using the automatic drug delivery device as disclosed by Dowds wherein the additional step of the cap ensures the removable cap is not inadvertently removed through error (Dowds ¶ 0002, 0056-0057).
Re Claim 11, Liniger in view of Dowds and Srinivasan teach all of the limitations of Claim 10. Linger fails to teach wherein rotating the removable cap beyond the position in which the retaining elements between the cap and the longitudinal housing are disengaged causes the cam path of the removable cap to engage with a portion of the longitudinal housing and provide at least some of the removal force to separate the removable cap from the longitudinal body. Dowds further teaches rotating the removable cap (50) beyond the position in which the retaining elements (54) between the cap (50) and the longitudinal housing (60) are disengaged causes a cam path (66) of the removable cap (50) (Dowds ¶ 0057 - wherein the cam profile 66 is defined by sloped surface 67) to engage with a portion of the longitudinal housing (60) and provide at least some of the removal force to separate the removable cap from the longitudinal body for aiding in removal of the cap when the cap is rotated (Dowds ¶ 0057, 0064).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the removable cap of Liniger in view of Dowds and Srinivasan such that rotating the removable cap beyond the position in which the retaining elements between the cap and the longitudinal housing are disengaged causes the cam path of the removable cap to engage with a portion of the longitudinal housing and provide at least some of the removal force to separate the removable cap from the longitudinal body, the configuration as disclosed by Dowds for aiding in removal of the cap when the cap is rotated (Dowds ¶ 0057, 0064).
Re Claims 13 and 14, Liniger in view of Dowds and Srinivasan teach all of the limitations of Claim 1. Linger fails to teach wherein the removable cap includes an end cap cover having a conical structure formed on a distal side of the end cap cover; and wherein the removable cap includes a flexible gripping element, wherein the conical structure is configured to provide clearance for at least a portion of the flexible gripping element to flex proximally. Dowds teaches the removable cap (50) includes an end cap cover (158) having a cylindrical structure formed on a distal side of the end cap cover (50) (embodiment of Dowds Figs. 18A-18B; ¶ 0061); and wherein the removable cap (50) includes a flexible gripping element (as seen in Dowds Fig. 11), wherein the cylindrical structure is configured to provide clearance for at least a portion of the flexible gripping element to flex proximally (Dowds ¶ 0042), the end cap cover (158) for blocking light from entering the distal end (Dowds ¶ 0055).
It would have been an obvious matter of design choice to modify Liniger in view of Dowds and Srinivasan to include an end cap cover having a conical structure as opposed to a cylindrical structure since applicant has not disclosed that having a conical structure solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of the end cap having a conical structure, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553, 555, 188 USPQ 7, 9 (CCPA 1975).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the end cap of Liniger in view of Dowds and Srinivasan cover include a conical structure formed on a distal side of the end cap cover; and wherein the removable cap includes a flexible gripping element, wherein the conical structure is configured to provide clearance for at least a portion of the flexible gripping element to flex proximally, the end cap as disclosed by Dowds for blocking light from entering the distal end (Dowds ¶ 0055).
Re Claim 15, Liniger in view of Dowds and Srinivasan teach all of the limitations of Claim 1. Linger fails to teach wherein the removable cap includes a flexible gripping element having first and second lobes configured to cooperate with each other to grip a rigid needle shield, wherein the first lobe has a first length, wherein the second lobe has a second length different from the first length. Dowds teaches the removable cap (50) including a flexible gripping element (as seen in embodiment of Dowds Fig. 23) having a first lobe (proximal end of arms 58) and a second lobe (proximal end of arms 58 ending in retention barb 54) configured to cooperate with each other to grip a rigid needle shield (46), wherein the first lobe has a first length, wherein the second lobe has a second length different from the first length, the first lobe for gripping the rigid needle shield where the second lobe adheres the removable cap to the automatic drug delivery device (as seen in Dowds Fig. 23; ¶ 0063).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the removable cap of Liniger in view of Dowds and Srinivasan to include a flexible gripping element having first and second lobes configured to cooperate with each other to grip a rigid needle shield, wherein the first lobe has a first length, wherein the second lobe has a second length different from the first length, the first lobe for gripping the rigid needle shield where the second lobe adheres the removable cap to the automatic drug delivery device (as seen in Dowds Fig. 23; ¶ 0063).
Re Claims 16 and 17, Liniger in view of Dowds and Srinivasan teach all of the limitations of Claim 1. Linger fails to teach the retaining elements being configured to be disengaged by pulling of the cap relative to the longitudinal housing to allow axial movement of the cap relative to the longitudinal housing to remove the cap; and a threshold pulling force for disengaging the retaining elements by pulling of the cap relative to the longitudinal housing being greater than a threshold twisting force for disengaging the retaining elements by rotation of the cap relative to the longitudinal housing.
Dowds teaches wherein the retaining elements (54) are configured to be disengaged by pulling of the removable cap (50) relative to the longitudinal housing (60) to allow axial movement of the removable cap (50) relative to the longitudinal housing (60) to remove the cap (50) (Dowds ¶ 0056, 0063 - wherein the cap is pressed and pulled distally); and a threshold pulling force for disengaging the retaining elements (54) by pulling of the removable cap (50) relative to the longitudinal housing (60) being greater than a threshold twisting force for disengaging the retaining elements (54) by rotation of the removable cap (50) relative to the longitudinal housing (60), wherein rotation of the removable cap maintains the needle shield after removing of the removable cap as opposed to pulling of the removable cap removing the needle shield (Dowds ¶ 0056, 0063).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the retaining elements of Liniger in view of Dowds and Srinivasan configured to be disengaged by pulling of the cap relative to the longitudinal housing to allow axial movement of the cap relative to the longitudinal housing to remove the cap; and a threshold pulling force for disengaging the retaining elements by pulling of the cap relative to the longitudinal housing being greater than a threshold twisting force for disengaging the retaining elements by rotation of the cap relative to the longitudinal housing as disclosed by Dowds wherein rotation of the removable cap maintains the needle shield after removing of the removable cap as opposed to pulling of the removable cap removing the needle shield (Dowds ¶ 0056, 0063).
Re Claim 18, Liniger in view of Dowds and Srinivasan teach all of the limitations of Claim 1. Linger fails to teach wherein the removable cap comprises a flexible gripping element for engagement on a circumferential outer surface of a rigid needle shield such that removal of the removable cap causes removal of the needle shield, the flexible gripping element having a diameter greater than a diameter of a proximal end of the safety shield and the flexible gripping element not extending into the safety shield. Dowds teaches wherein the removable cap (50) comprises a flexible gripping element (75) for engagement on a circumferential outer surface of a rigid needle shield (40) such that removal of the removable cap (50) causes removal of the needle shield (40) (Dowds Fig. 16; ¶ 0042), the flexible gripping element (75) having a diameter greater than a diameter of a proximal end of the safety shield (80) and the flexible gripping element (75) not extending into the safety shield (80) so the removable cap does not interfere with the safety shield when removing the needle shield (as seen in Dowds Figs. 16-17).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the removable cap of Liniger in view of Dowds and Srinivasan comprise a flexible gripping element for engagement on a circumferential outer surface of a rigid needle shield such that removal of the removable cap causes removal of the needle shield, the flexible gripping element having a diameter greater than a diameter of a proximal end of the safety shield and the flexible gripping element not extending into the safety shield as disclosed by Dowds so the removable cap does not interfere with the safety shield when removing the needle shield (as seen in Dowds Figs. 16-17).
Re Claim 21, Liniger in view of Dowds and Srinivasan teach all of the limitations of Claim 1. Linger fails to teach wherein the removable cap includes at least one connection portion extending between the plurality of connecting ribs. Srinivasan teaches wherein the removable cap (200) includes at least one connection portion (220-2) extending between the plurality of connecting ribs (220), the configuration wherein the connecting ribs and at least one annular arch provide a stop surface for a needle hub and prevent overtightening of the cap and wherein the connection portion provides a step-like surface to provide support to all of the connecting ribs and at least one annular arch (Srinivasan ¶ 0047-0049; Annotated Fig. 21B above). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the removable cap of Liniger in view of Dowds and Srinivasan to include at least one connection portion extending between the plurality of connecting ribs as disclosed by Srinivasan wherein the connecting ribs and at least one annular arch provide a stop surface for a needle hub and prevent overtightening of the cap and wherein the connection portion provides a step-like surface to provide support to all of the connecting ribs and at least one annular arch (Srinivasan ¶ 0047-0049; Annotated Fig. 21B above).
Re Claim 22, Liniger in view of Dowds and Srinivasan teach all of the limitations of Claim 1. Linger fails to teach wherein the at least one annular arch includes a pair of opposed annular arches. Srinivasan teaches wherein the at least one annular arch (220-1) includes a pair of opposed annular arches (as seen in Srinivasan Annotated Fig. 21B above) wherein the connecting ribs and at least one annular arch provide a stop surface for a needle hub and prevent overtightening of the cap (Srinivasan ¶ 0047-0049; Annotated Fig. 21B above). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the at least one annular arch of Linger in view of Dowds and Srinivasan include a pair of opposed annular arches as disclosed by Srinivasan wherein the connecting ribs and at least one annular arch provide a stop surface for a needle hub and prevent overtightening of the cap (Srinivasan ¶ 0047-0049; Annotated Fig. 21B above).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Liniger et al. (USPGPub 2021/0085884) in view of Dowds et al. (USPGPub 2014/0025013) and Srinivasan et al. (USPGPub 2017/0361027) as applied to Claim 1 above, and further in view of Carmel et al. (USPGPub 2016/0074584).
Re Claim 3, Liniger in view of Dowds and Srinivasan teach all of the limitations of Claim 1. Liniger in view of Dowds and Srinivasan fail to teach wherein the retaining elements that axially retain the removable cap on the proximal end of the longitudinal housing comprise inner protrusions formed on the proximal end of the longitudinal housing and projections formed inside an end cap body, the projections inside the cap body comprise a recess within which the inner protrusion is circumferentially restrained by chamfered projections.
Carmel teaches an automatic drug delivery device (100) (Carmel Fig. 1) comprising a removable cap (200) (Carmel Fig. 2A) and a longitudinal housing (300) (Carmel Fig. 4A), wherein the longitudinal housing (300) comprises retaining elements (322) that axially retain the removable cap (200) (Carmel ¶ 0162, 0184), wherein the retaining elements (322) that axially retain the removable cap (200) on the proximal end of the longitudinal housing (300) comprise inner protrusions (as seen in Carmel Fig. 4A) formed on the proximal end of the longitudinal housing (300) and projections formed inside an end cap body (as seen in Carmel Fig. 2A), the projections inside the cap body comprise a recess within which the inner protrusion is circumferentially restrained by chamfered projections for maintaining a safety shield in an unshielded position prior to use (Carmel ¶ 0162-0163).
In the present case, Dowds and Carmel are both being viewed as analogous to the claimed invention because they are in the same field of drug delivery devices. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the retaining elements that axially retain the removable cap on the proximal end of the longitudinal housing of Liniger in view of Dowds and Srinivasan to comprise inner protrusions formed on the proximal end of the longitudinal housing and projections formed inside an end cap body, the projections inside the cap body comprise a recess within which the inner protrusion is circumferentially restrained by chamfered projections as disclosed by Carmel for maintaining a safety shield in an unshielded position prior to use (Carmel ¶ 0162-0163).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Liniger et al.
(USPGPub 2021/0085884) in view of Dowds et al. (USPGPub 2014/0025013) and Srinivasan et al. (USPGPub 2017/0361027) as applied to Claim 1 above, and further in view of Kessler et al.
(USPN 7,141,286).
Re Claim 8, Liniger in view of Dowds and Srinivasan teach all of the limitations of Claim 1. Linger in view of Dowds and Srinivasan fail to teach wherein the removable cap when mounted in its retained position to the longitudinal housing is secured to the longitudinal housing by a rupturable seal. Kessler teaches a syringe assembly (1) (Kessler Figs. 1-3; Col. 4 Lines 11-15) comprising a removable cap (4) and housing (2), wherein the removable cap (4), when mounted in its retained position to the longitudinal housing (2), is secured to the longitudinal housing by a rupturable seal (5) for notifying a user that the device may have been tampered with (Kessler Col. 1 Lines 59-67; Col. 4 Line 59 to Col. 5 Line 3).
Dowds and Kessler are both being viewed as analogous to the claimed invention because they are in the same field of drug delivery devices. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the removable cap of Liniger in view of Dowds and Srinivasan such that when mounted in its retained position to the longitudinal housing, is secured to the longitudinal housing by a rupturable seal as disclosed by Kessler, for notifying a user that the device may have been tampered with (Kessler Col. 1 Lines 59-67; Col. 4 Line 59 to Col. 5 Line 3).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Liniger et al. (USPGPub 2021/0085884) in view of Dowds et al. (USPGPub 2014/0025013) and Srinivasan et al. (USPGPub 2017/0361027) as applied to Claim 1 above, and further in view of Jacobs et al. (USPGPub 2007/0197976).
Re Claim 12, Liniger in view of Dowds and Srinivasan teach all of the limitations of Claim 1. Linger in view of Dowds and Srinivasan fail to teach wherein the removable cap includes a generally cylindrical body integrally formed with an arch-like extension to define a non-circular cross-sectional shape for inhibiting rolling of the removable cap. Jacobs teaches an automatic drug delivery device comprising a removable cap (29) Jacobs Fig. 5), wherein the removable cap (50) includes a generally cylindrical body integrally formed with an arch-like extensions to define a non-circular cross-sectional shape for inhibiting rolling of the removable cap (29) (Jacobs ¶ 0026), the configuration for preventing the autoinjector from falling and being damaged when placed on a flat surface. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the cap of Liniger in view of Dowds and Srinivasan to include a generally cylindrical body integrally formed with an arch-like extension to define a non-circular cross- sectional shape for inhibiting rolling of the removable cap as disclosed by Dowds, the configuration for preventing the autoinjector from falling and being damaged when placed on a flat surface (Jacobs ¶ 0026).
Response to Arguments
Applicant’s arguments with respect to Claims 1-18 and 21-22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant’s arguments regarding prior art Winterton are compelling. Therefore, examiner has updated the search in the present case and has now opted to rely upon Srinivasan as opposed to Winterton. Applicant’s arguments directed to prior art Winterton are hereinafter moot.
Applicant's arguments filed 05/26/2026 have been fully considered but they are not persuasive. At the bottom of Page 12 of the response, applicant argues “the Office's numerous proposed modifications of Liniger based on the alleged teachings of Dowds and Winterton are devoid of any valid rationale.” Applicant goes on to argue the Office has failed to provide any valid reason why a person of ordinary skill in the art would have wanted to modify Liniger “to have had the tip of the injection needle of Liniger protrude proximally beyond the safety shield when the safety shield is held in the capped position.” This is simply not the case where examiner has provided motivation for every modification of primary reference Liniger. On Page 13 of the response, applicant argues the rationale for modifying Liniger "to have had the tip of the injection needle of Liniger protrude proximally beyond the safety shield when the safety shield is held in the capped position" based on Dowds's alleged teachings ("so that the safety shield does not interfere with the removable cap when the removable cap is in the capped position") lacks a rational underpinning. What applicant has essentially argued is that the rationale for modifying Liniger lacks a rational underpinning. Clearly, if the safety shield extends in the proximal direction to shield the needle, the removable cap (which acts to shield the needle prior to use) cannot be placed upon the device in a secured manner as can be seen in Dowds Figs. 5-6.
In the first full paragraph of Page 14 of the response, applicant argues “there is nothing in the cited references to suggest that Liniger's alleged safety shield would interfere with Liniger's alleged removable cap, such that there would be no reason to seek a substitute for Liniger's arrangement for the sake of preventing Liniger's alleged safety shield from interfering with Liniger's alleged removable cap in the first place.” Primary reference Liniger teaches the cap 9 holding the safety shield 10 in a retracted position but not retracted beyond the needle (Liniger Figs. 1-2). The removable cap of Dowds is configured to be secured to the auto-injector with the shield retracted beyond the needle. What applicant proposes is a reengineering of the removable cap of Liniger to operate in a fashion not disclosed in the prior art. Applicant’s reference to “PTAB has recently held that there is no motivation to modify a prior art reference to solve a problem which that prior art reference already solves” and “the Federal Circuit has found that where each prior art device independently operates effectively to accomplish similar functions, a person having ordinary skill in the art would have no reason to combine the features of both devices into a single device” are therefore not applicable to the present case.
In the second full paragraph of Page 16, applicant argues examiner has relied upon impermissible hindsight. Both Liniger and Dowds teach caps operating to hold the safety shield in a retracted position. Only Dowds teaches a cap holding the safety shield in a retracted position beyond the needle. It is the position of examiner that one of ordinary skill in the art would be motivated to have the safety shield completely retracted prior to removal of the cap in order to prevent the safety shield from interfering with cap connection. This is not impermissible hindsight, but rather a rational underpinning for modification. Furthermore, it is unclear what the purpose of having this configuration is for. It is further the position of examiner that applicant’s limitation “wherein the tip of the injection needle protrudes proximally beyond the safety shield when the safety shield is held in the capped position” is merely a design choice, amended into the claims for the sole purpose of overcoming prior art primary reference Liniger.
Conclusion
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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