DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 2, 2026 has been entered.
Response to Arguments
Applicant's arguments filed June 2, 2026 have been fully considered but they are not persuasive. Regarding Applicant’s arguments that Mernoe fails to teach the driver moving the segments in the claimed manner, the Examiner respectfully disagrees. The scope of claim 1, as amended, can be interpreted in such a manner that movement of one segment of the plunger rod in a perpendicular direction can move an adjacent segment in a parallel direction. For example, in Figure 7 of Mernoe, it can be seen that two adjacent segments are labeled as 172. The segment which is perpendicular to the axis of the barrel is moved indirectly (but still moved by the driver) via wheel 160. Movement of this perpendicular segment will, by virtue of the connection of all segments together, will move the segment in front of it in a direction, at least partially, parallel to the axis of the barrel. The claim does not require the second segment to move completely parallel throughout the driving process or require the driver to directly engage the perpendicular segment to move the connected segment in a direction only along a parallel axis. Since the second segment moves at least partially parallel as it transitions into the barrel, it’s considered to mee the claim limitation as currently set forth below.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-8, 10-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gross in view of Mernoe (2007/0073236).
Regarding claim 1, Gross discloses a medicament delivery device (20), comprising: a housing (48, 32); a cartridge retainer (70, Figure 4) positioned within the housing and having a longitudinal axis (for receiving the body of the cartridge); a needle (102) having a starting stationary position where the needle is completely within the housing (depicted in Figure 7A, the needle is not passing beyond the skin attachment side of the device and is retracted within the insertion assembly) and being in fluid communication with a medicament container (22) positioned within the cartridge retainer so that a dose of medicament is delivered through the needle (¶ [0181]), where the needle is movably arranged within and relative to the housing (Figures 7A-7C), where the needle has a proximal end that moves from the starting stationary position to a second position that is extended to a position outside the housing (Figures 7A and 7C), and where the movement of the needle from the starting stationary position to the second position defines an axis of movement (orthogonal to the longitudinal axis of the housing and cartridge); and a piston plunger (24, 28, 26; Figure 2) disposed within in the housing, where a pusher plate (e.g., proximal end 42 of coupling portion 30; ¶ [0187]) is positioned on the first portion such that the pusher plate extends into the medicament container during delivery of the dose of medicament (to drive stopper 24), wherein the piston plunger moves parallel to the longitudinal axis of the cartridge retainer in a direction that is generally transverse to the axis of movement of the proximal end of the needle (see Figures 2 and 5A, the plunger moves along the axis of the cartridge while the needle extends orthogonal through the bottom of the housing and into the patient); wherein the proximal end of the needle moves to the second position before delivery of the dose of the medicament begins (the delivery does not begin until the cannula and/or needle are deployed at the target location; ¶ [0195] discloses that the activation mechanism is activated subsequent to needle placement). Gross fails to explicitly disclose where the piston plunger comprises movable segments that define a first portion and a second portion and that the driver moves a first movable segment in a direction perpendicular to the longitudinal axis of the cartridge, wherein movement of the first movable segment causes a second movable segment to move parallel to the longitudinal axis of the cartridge, and wherein the first segment is in direct contact with the second segment.
Mernoe teaches (Figure 16) a similar medical injection device to that of Gross, comprising a segmented piston (670 with segments 672) and a pusher plate (178, depicted in Figure 8) positioned on a first portion such that the pusher plate extends into the medicament container during delivery of the dose of medicament (¶ [0056] discloses the pusher plate and ¶¶ [0087]-[0089] disclose the segmented pushrod); and wherein the movable segments (672) are configured to be removably interconnectable (¶ [0087] discloses the hinge protrusion 692 as snap fit into receiver cavity 696; such a snap fit connection is considered removable as claimed; it can be seen that two adjacent segments are labeled as 172. The segment which is perpendicular to the axis of the barrel is moved indirectly (but still moved by the driver) via wheel 160. Movement of this perpendicular segment will, by virtue of the connection of all segments together, will move the segment in front of it in a direction, at least partially, parallel to the axis of the barrel. The claim does not require the second segment to move completely parallel throughout the driving process or require the driver to directly engage the perpendicular segment to move the connected segment in a direction only along a parallel axis. Since the second segment moves at least partially parallel as it transitions into the barrel, it’s considered to mee the claim limitation as currently set forth).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the patent device to comprise the segmented plunger assembly of Mernoe so as to provide for a plunger rod capable of non-linear motion during an injection procedure which further limits torsional stresses on the hinged portion of the connection during use (¶ [0089] of Mernoe).
Regarding claim 2, Gross further discloses a tube (53) fixed to a distal end of the needle where the needle hub moves in a direction generally transverse to the movement of the piston plunger (the tubing attaches to the proximal needle or cannula end for delivering fluid into the patient; ¶¶ [0174] and [0198]).
Regarding claim 3, Gross further discloses tubing (53) that is in fluid communication with the needle and the medicament within the medicament container (via adapter 44) when positioned within the cartridge retainer (¶¶ [0174] and [0198]; Figure 1A and 2).
Regarding claim 4, Gross further discloses where the needle, when in the second position, is locked relative to the housing to prevent movement in a distal direction (see e.g., ¶ [0198] which discloses that the needle may be inserted and left within the patient for the duration of the treatment; this can only be possible if there is structure maintaining the needle in the deployed configuration of Figure 7C as claimed).
Regarding claim 5, Gross further discloses a biasing member (110; Figures 7A-7C) operatively associated with the housing to move the needle relative to the housing (¶ [0197]).
Regarding claim 6, Gross/Mernoe further teach a driver operatively (wheel 40 of Mernoe and associated structure; ¶¶ [0086], [0091], and [0106] of Mernoe) engaged with the piston plunger to move the piston plunger parallel to the longitudinal axis to deliver the dose of medicament (Figure 5A of Gross depicts the device in the assembled state wherein the piston moves along the longitudinal axis of the housing and retainer).
Regarding claim 7, Gross further discloses an injection speed control mechanism (control unit 51; ¶ [0179]) operatively connected to the driver (via 52, 54 of Gross and ¶ [0106] of Mernoe teach controlling the injection rate via the respective drive assemblies and which feature would be present in the combined device as taught by Mernoe).
Regarding claim 8, Gross further discloses an operation member (80) that protrudes from the housing (Figure 5B) and is accessible to a user to activate the medical device (¶ [0185]; the needle insertion is the activation).
Regarding claim 10, Gross further discloses wherein part of the housing is removable to allow user access to the cartridge retainer (¶ [0195] discloses coupling the top housing portion to the base after the cartridge is inserted).
Regarding claim 11, Gross further discloses wherein the housing has a length at least equal to a length of the cartridge retainer (70) as measured along the longitudinal axis (Figure 1A, the housing is substantially longer than the retainer for holding the cartridge).
Regarding claim 12, Gross discloses a medicament delivery device (20), comprising: a housing (48, 32); a cartridge retainer (70) having a longitudinal axis and located within the housing (Figure 4); an operation member (80) that protrudes from the housing and is accessible to a user (Figure 5B ¶ [0185]); a needle (102) having a proximal end and having a starting stationary position where the needle is completely within the housing such that the needle is in fluid communication with a medicament container positioned in the cartridge retainer prior to the needle moving relative to and exiting from the housing so that a dose of medicament is delivered through the needle (Figures 7A-7C; the needle is fluidly connected to the cartridge via tubing 53), where the proximal end of the needle moves from the starting stationary position within the housing to a second position that is extended to a position outside the housing and where the movement of the needle from the first position to the second position defines an axis of movement (Figures 7A-7C; orthogonal to the longitudinal axis of the housing and cartridge); a piston plunger (24, 28, 26; Figure 2), where a first portion of the piston plunger extends into the medicament container during delivery of the medicament (e.g., proximal end 42 of coupling portion 30; ¶ [0187]) and a second portion of the piston plunger is operatively engaged with a driver (control 51) that causes the first portion to move parallel to the longitudinal axis of the cartridge retainer in a direction that is generally transverse to the axis of movement of the proximal end of the needle (¶ [0179], the piston rod moves along the longitudinal axis of the cartridge which is orthogonal to the needle insertion axis); and an injection speed control mechanism operatively controlling the driver and movement of the piston plunger (control unit 51; ¶ [0179] via 52 and 54), wherein the proximal end of the needle moves to the second position before delivery of the dose of the medicament begins (the delivery does not begin until the cannula and/or needle are deployed at the target location; ¶ [0195] discloses that the activation mechanism is activated subsequent to needle placement). Gross fails to explicitly disclose the piston plunger comprising a stack of segments disposed within in the housing.
Mernoe teaches (Figure 16) a similar medical injection device to that of Gross, comprising a segmented piston formed as a stack of segments disposed within the housing (670 with segments 672) and a pusher plate (178, depicted in Figure 8) positioned on a first portion such that the pusher plate extends into the medicament container during delivery of the dose of medicament (¶ [0056] discloses the pusher plate and ¶¶ [0087]-[0089] disclose the segmented pushrod); and wherein the movable segments (672) are configured to be removably interconnectable (¶ [0087] discloses the hinge protrusion 692 as snap fit into receiver cavity 696; such a snap fit connection is considered removable as claimed; it can be seen that two adjacent segments are labeled as 172. The segment which is perpendicular to the axis of the barrel is moved indirectly (but still moved by the driver) via wheel 160. Movement of this perpendicular segment will, by virtue of the connection of all segments together, will move the segment in front of it in a direction, at least partially, parallel to the axis of the barrel. The claim does not require the second segment to move completely parallel throughout the driving process or require the driver to directly engage the perpendicular segment to move the connected segment in a direction only along a parallel axis. Since the second segment moves at least partially parallel as it transitions into the barrel, it’s considered to mee the claim limitation as currently set forth.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the patent device to comprise the segmented plunger assembly of Mernoe so as to provide for a plunger rod capable of non-linear motion during an injection procedure which further limits torsional stresses on the hinged portion of the connection during use (¶ [0089] of Mernoe).
Regarding claim 13, Gross further discloses wherein upon completion of the medicament delivery the needle moves distally from the second position to a third position wherein the needle is retracted to a position inside the housing to prevent unintentional needle sticks (e.g., Figure 7C, the need is retracted into the insertion assembly via spring 110 which is after needle insertion).
Regarding claim 14, Gross fails to explicitly disclose a window. However, Mernoe further teaches a window (32) in the housing for allowing a user to inspect the amount of medication left in the cartridge.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the housing of Gross to include the window of Mernoe so as to allow a user to determine the amount of medication remaining in the cartridge during use as taught by Mernoe (¶ [0082]).
Regarding claim 15, Gross et al. (henceforth Gross) discloses a medicament delivery device (20), comprising: a housing (48, 32); a compartment (70, Figure 4) having a longitudinal axis and positioned inside the housing for holding a medicament container (22); a needle (102) connected to a flexible tube (53, Figure 2) and movably arranged within the housing (Figures 7A-7C) and in fluid communication with the medicament container through the flexible tube for delivering a dose of medicament (¶ [0174]), where the needle has a proximal end that moves from a first position within the housing to a second position that is extended to a position outside the housing (Figures 7A-7C), where the movement of the needle from the first position to the second position defines an axis of movement; a piston plunger (24, 28, 26, 54; Figure2) disposed in the housing for acting on the medicament container to deliver the dose of medicament (via plunger 24), where a front portion of the piston plunger moves parallel to the longitudinal axis of the compartment (along the axis of the cartridge) in a direction that is transverse to the axis of movement of the proximal end of the needle (the needle moves orthogonal to the cartridge axis during at least a portion of its motion) and where a second portion of the piston plunger (cog wheel 54) moves perpendicular to the longitudinal axis of the compartment (it rotates orthogonal to the cartridge axis; the claim does not require the second portion to translate along the housing in a direction perpendicular to the longitudinal axis); and a driver (51, 52) operatively engaged with the second portion of the piston plunger to deliver the dose of medicament (¶ [0179]), wherein when the medicament device is activated, the proximal end of the needle moves to the second position before delivering the dose of the medicament (the delivery does not begin until the cannula and/or needle are deployed at the target location; ¶ [0195] discloses that the activation mechanism is activated subsequent to needle placement). Gross fails to explicitly disclose the second portion of the piston rod translating along the housing in a direction perpendicular to the longitudinal axis of the compartment.
Mernoe teaches (Figure 16) a similar medical injection device to that of Gross, comprising a segmented piston (670 with segments 672) and a pusher plate (178, depicted in Figure 8) positioned on a first portion such that the pusher plate extends into the medicament container during delivery of the dose of medicament (¶ [0056] discloses the pusher plate and ¶¶ [0087]-[0089] disclose the segmented pushrod); and wherein the movable segments (672) are configured to be removably interconnectable (¶ [0087] discloses the hinge protrusion 692 as snap fit into receiver cavity 696; such a snap fit connection is considered removable as claimed; it can be seen that two adjacent segments are labeled as 172. The segment which is perpendicular to the axis of the barrel is moved indirectly (but still moved by the driver) via wheel 160. Movement of this perpendicular segment will, by virtue of the connection of all segments together, will move the segment in front of it in a direction, at least partially, parallel to the axis of the barrel. The claim does not require the second segment to move completely parallel throughout the driving process or require the driver to directly engage the perpendicular segment to move the connected segment in a direction only along a parallel axis. Since the second segment moves at least partially parallel as it transitions into the barrel, it’s considered to mee the claim limitation as currently set forth). In this manner, as the front portion of the piston moves parallel to the compartment and transverse to the needle, a second segment will be moving perpendicular to the compartment and the needle in a different axis as claimed).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the patent device to comprise the segmented plunger assembly of Mernoe so as to provide for a plunger rod capable of non-linear motion during an injection procedure which further limits torsional stresses on the hinged portion of the connection during use (¶ [0089] of Mernoe).
Regarding claim 16, Gross fails to explicitly disclose the segmented plunger rod. However, Mernoe teaches (Figure 16) a similar medical injection device to that of Gross, comprising a segmented piston formed as a stack of segments disposed within the housing (670 with segments 672) and a pusher plate (178, depicted in Figure 8) positioned on a first portion such that the pusher plate extends into the medicament container during delivery of the dose of medicament (¶ [0056] discloses the pusher plate and ¶¶ [0087]-[0089] disclose the segmented pushrod); and wherein the movable segments (672) are configured to be removably interconnectable (¶ [0087] discloses the hinge protrusion 692 as snap fit into receiver cavity 696; such a snap fit connection is considered removable as claimed).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the patent device to comprise the segmented plunger assembly of Mernoe so as to provide for a plunger rod capable of non-linear motion during an injection procedure which further limits torsional stresses on the hinged portion of the connection during use (¶ [0089] of Mernoe).
Regarding claim 17, Gross fails to disclose the cross-section of the plunger, however, Mernoe further discloses wherein the piston plunger has a generally rectangular cross-section (as depicted in Figure 18, the embodiments of the plunger rod comprise a main body section which is substantially rectangular to form the threads during use; the central portion is cylindrical, but the overall cross-section is considered rectangular as claimed).
Regarding claim 18, Gross fails to disclose the plunger structure, however, Mernoe further discloses wherein the plunger piston (670) comprises a number of distinct separate segments (672) that are successively interconnected during delivery of the dose of medicament (see hinged relation between Figure 16; ¶ [0087]; the claim does not require the connection to occur during operation of the device, but only that the segments are successively interconnected, which they are via hinged connection between 692, 696).
Regarding claim 19, Gross fails to disclose the angle of the plunger rod portions, however, Mernoe teaches (as depicted in Figure 7) that a fist portion of the plunger rod may be orthogonal to a second portion (it can be seen that plunger engaging portion of the plunger rod is moving axially along the syringe barrel while the segment labeled “172” is moving perpendicular to the axis of the housing; this is applicable to all embodiments of the segmented plunger rod).
Regarding claim 20, Gross fails to disclose the threaded drive nut engaged with the plunger, however, Mernoe further teaches (Figures 11 and 16) a drive nut (160; Figure 11) comprising a thread (166) for engaging with the piston plunger such that rotation of the drive nut moves the first portion relative to the medicament container (¶¶ [0065] and [0087], thread 676 of the plunger rod segments 672 engage inner threaded portion 166 of nut 160). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the drive system of Gross to comprise the threaded nut assembly of Mernoe so as to provide a means for precisely driving the piston rod during a procedure (e.g., ¶ [0065] of Mernoe) as taught by Mernoe.
Claim 9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gross in view of Mernoe, and further in view of Carter et al. (US 2007/0282269).
Regarding claim 9, Gross/Mernoe teach the claimed invention substantially as set forth above for claim 1, but fail to explicitly disclose the needle being covered by a membrane.
Carter et al. (henceforth Carter) teaches (Figure 9) a membrane (228) for covering a needle (it closes the distal end of the base until the needle passes through during insertion; ¶ [0058]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the housing of Gross/Mernoe to include the pierceable septum of Carter so as to maintain sterility of the device before and after needle insertion as the septum aids in preventing unwanted fluid from passing between the patient and device.
Conclusion
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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