DETAILED ACTION
Response to Arguments
Applicant's arguments filed February 20, 2026 have been fully considered but they are not persuasive. Regarding Applicant’s arguments that the cited prior art fails to disclose a zero-point adjustment, the Examiner respectfully disagrees. Soerensen clearly discloses the removal of any air gap between the cartridge and piston after installation of the cartridge into the device (see e.g., paragraphs [0020], [0024], [0033], and [0067] of Soerensen which disclose eliminating any potential air gap during installation of a cartridge into the device via positioning of the plunger relative to the cartridge being inserted). The cited paragraph [0024] of Soerensen teaches the structural removal of the air gap via relative positioning of the plunger at the device end before cartridge insertion. This section, taken along with the full disclosure of Soerensen, clearly teaches that it is known to remove air gaps during cartridge loading into a drug delivery device as claimed. Therefore, the cited combination is considered to teach the claim limitations as currently set forth. The rejection is considered proper and is maintained with additional citations for clarity.
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) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bayer et al. (US 20160067417) in view of Leak et al. (US 2013/0267908), and further in view of Soerensen et al. (US 2014/0358093).
Regarding claim 1, Bayer et al. (henceforth Bayer) discloses a drug delivery device comprising: a cartridge unit comprising a cartridge holder (for receiving cartridge 12; Figure 1) carrying a drug cartridge (12) having a cartridge body and a piston structure (14) and a dose expelling unit comprising: a housing (20) extending along a longitudinal axis, a piston rod (120) for pressurizing the drug cartridge, the piston rod comprising a contact surface (distal portion of piston rod engaged with piston 14) adapted to contact the piston structure (Figure 1), and a non-self-locking thread (121), a nut member (e.g., assembly comprising 90, 100, 70, 140, 150) rotationally fixed with respect to the housing (Figure 1) and engaged with the non-self-locking thread (Figure 1; paragraph [0162]), a piston rod drive member (e.g., 80 and associated gearing for driving the piston rod) axially fixed with respect to the housing and rotatable about the longitudinal axis, and wherein the piston rod drive member and the piston rod are rotationally interlocked (paragraph [0037]; the drive member transmits a rotational driving force to the piston rod as claimed), wherein the piston rod drive member and the piston rod are rotationally interlocked (a portion of the drive rotates the piston which is considered to meet the limitation), such that a rotation of the piston rod drive member in a first direction is associated with distal movement of the piston rod through the nut member (Figure 1), and a rotation of the piston rod drive member in a second direction is associated with proximal movement of the piston rod through the nut member (paragraphs [0037]-[0039]), wherein the nut member carries a first coupling part of a unidirectional ratchet coupling (paragraph [0037]), and the piston rod drive member being operatively coupled with a second coupling part of the unidirectional coupling (e.g., the drive spindle comprises a toothed rim for engaging with the ratchet member to allow unidirectional rotation as per paragraph [0037]) wherein in a pre-assembled state the nut member assumes a first nut member position relative to the housing (e.g., when it’s assembled) and the piston rod drive member in which the first coupling part and the second coupling part are disengaged (e.g., before the components are assembled in the final state) and in an assembled state the nut member assumes a second nut member position relative to the housing and the piston rod drive member in which the first coupling part and the second coupling part are engaged to render the piston rod drive member unidirectionally rotatable in the first direction (paragraph [0037]). Bayer fails to explicitly disclose the nut member being configured to undergo irreversible displacement from the first nut member position to the second nut member position during assembly in response to a converging relative axial motion between the housing and the cartridge holder, after contact between the piston structure and the contact surface. Bayer further fails to explicitly teach the removal of the air gap between the piston and plunger.
Leak et al. (henceforth Leak) teaches a drug delivery device (e.g., Figure 2) wherein the drive assembly comprises a nut member (106) which is positioned in a converging relationship between a housing (104) and cartridge assembly (5, 6).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the assembly of Bayer to comprise a separate drive housing so as to allow for the attachment of the drive system to a replaceable cartridge system for subsequent uses as taught by Leak.
Soerensen et al. (henceforth Soerensen) teaches (e.g., Figure 1) a pen-type automatic injection device comprising a plunger rod (221) and piston (231) which are engaged during assembly of the cartridge within the device and wherein no air gap is maintained after connection of a cartridge (see paragraphs [0020], [0024], [0033], and [0067] which clearly disclose removing the air gap during assembly between the plunger and cartridge piston via positioning of the piston rod; this will remove any air gap which results in a zero-point initialization as claimed).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Bayer to include the step of removing an air gap between a plunger and piston during assembly so as to prevent sever under-dosing after attaching a new cartridge to the device as taught by Soerensen (paragraph [0024]).
Regarding claim 2, Leak further teaches wherein the cartridge holder comprises a proximal rim portion (e.g., attachment edge) which applies a proximally directed force to the nut member (e.g., geared connection 106) during the converging relative axial motion between the housing and the cartridge holder (during assembly of the parts), the proximally directed force bringing the nut member from the first nut member position (e.g., before attachment) to the second nut member position (after attachment).
Regarding claim 3, Leak further teaches wherein the cartridge unit comprises a second drug cartridge (5) held in parallel to the first cartridge by the cartridge holder (Figures 1-2), and the dose expelling unit further comprises a second piston rod for pressurizing the second drug cartridge, the second piston rod comprising a second contact surface (e.g., distal portion of second piston rod which engages with the second piston) adapted to contact a second piston structure (Figure 2, within the second cartridge), and a second piston rod thread in engagement with a second thread of the nut member (e.g., Figure 11 depicts the threads of both piston rods 122 and 120), and a second piston rod drive member axially fixed with respect to the housing (driving gear of second cartridge) and rotatable about a second axis parallel with the longitudinal axis, the second piston rod drive member and the second piston rod being rotationally interlocked, and the second piston rod drive member being rotationally coupled with the piston rod drive member, and wherein the second piston rod has an axially variable dimension which is set during assembly of the dose expelling unit and the cartridge, after contact between the second piston structure and the second piston rod has been established (e.g., based upon the dialed dose as per paragraph [0080], [0081], and [0084]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Bayer to include the second cartridge and associated structure of Leak to allow for a secondary medicament to be delivered along with the first during an injection procedure as taught by Leak (e.g., paragraph [0061]).
Regarding claim 4, Leak further teaches a front piston rod portion (e.g., portion engaged with piston in cartridge) and a rear piston rod portion (e.g., torsion spring for biasing the drive gear) which is capable of undergoing relative sliding motion along one another (e.g., the piston rod can slide along the gear as depicted in Figure 2), and wherein the axially variable dimension is set by axially interlocking the front piston rod portion and the rear piston rod portion (e.g., setting the biasing element prior to installation as per paragraph [0076]).
Regarding claim 5, Leak further teaches wherein the piston rod drive member and the second piston rod drive member are arranged in a casing which is fixed to the housing (e.g., Figure 2, within body 118), wherein the casing is provided with a distal slot and a proximal slot axially spaced apart from the distal slot, and wherein the nut member comprises a protrusion adapted to move from a position in the distal slot to a position in the proximal slot during movement of the nut member from the first nut member position to the second nut member position and structured to prevent subsequent movement of the nut member towards the first nut member position (see e.g., Figures 9b to 9c depicting 122 moving within the nut body).
Regarding claim 6, Leak further teaches a central gearwheel, wherein the piston rod drive member comprises a first gearwheel toothing (124) and the second piston rod drive member comprises a second gearwheel toothing (126), and wherein the piston rod drive member and the second piston rod drive member are rotationally coupled via the central gearwheel (e.g., 150 in Figure 8 which connects 108 and 110).
Regarding claim 7, Leak further teaches wherein the second coupling part forms part of the central gear wheel (Figure 8).
Regarding claim 9, in accordance to MPEP 2113, the method of forming the device is not germane to the issue of patentability of the device itself. Therefore, this limitation has not been given patentable weight. Please note that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product, i.e., a connection between portions of a piston rod, does not depend on its method of production, i.e., via laser welding through a bore. In re Thorpe, 227 USPQ 964, 966 (Federal Circuit 1985).
Regarding claim 10, Bayer/Leak further teach wherein the drug cartridges comprise a septum at the drug outlet which are axially aligned relative to the cartridge holder (paragraph [0116] of Bayer, and paragraph [0071] of Leak).
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bayer et al. (US 20160067417) in view of Soerensen et al. (US 2014/0358093).
Regarding claim 11, Bayer discloses a method of performing zero-point adjustment of a drug delivery device comprising: a cartridge unit comprising a cartridge holder (for receiving cartridge 12; Figure 1) carrying a drug cartridge (12) having a cartridge body and a piston structure (14), and a dose expelling unit comprising a housing (20) extending along a longitudinal axis, a piston rod (120) for pressurizing the drug cartridge, the piston rod comprising a contact surface (distal portion of piston rod engaged with piston 14) adapted to contact the piston structure (Figure 1), and a non-self- locking thread (121), a nut member (e.g., assembly comprising 90, 100, 70, 140, 150) rotationally fixed with respect to the housing (Figure 1) and engaged with the non-self-locking thread (Figure 1; paragraph [0162]), the nut member carrying a first coupling part of a unidirectional ratchet coupling (paragraph [0037]), and a piston rod drive member (e.g., 80 and associated gearing for driving the piston) axially fixed with respect to the housing and rotatable about the longitudinal axis, the piston rod drive member being operatively coupled with a second coupling part of the unidirectional ratchet coupling, wherein the piston rod drive member and the piston rod are rotationally interlocked (paragraph [0037]), such that a rotation of the piston rod drive member in a first direction is associated with distal helical movement of the piston rod in the nut member (Figure 1), and a rotation of the piston rod drive member in a second direction is associated with proximal helical movement of the piston rod in the nut member (paragraphs [0037]-[0039]). Bayer fails to explicitly disclose the method of arrangement and zero-point adjustment as claimed.
Soerensen et al. (henceforth Soerensen) teaches (e.g., Figure 1) a pen-type automatic injection device comprising a plunger rod (221) and piston (231) which are engaged during assembly of the cartridge within the device and wherein no air gap is maintained after connection of a cartridge (paragraph [0024]).
(i) arranging the piston rod in the nut member such that the contact surface is positioned distally of a final contact surface assembly position (paragraph [0024] discloses moving the piston to a distal “loading position” before cartridge insertion),
(ii) bringing the piston structure and the contact surface into mutual abutment (paragraph [0024],
(iii) inducing a converging relative axial motion between the cartridge holder and the housing, thereby firstly forcing the piston rod proximally, and
(iv) axially interlocking the cartridge holder and the housing, thereby providing zero-point adjustment by removing any air gaps between the contact surface of the piston rod and the piston structure (paragraph [0024]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Bayer to comprise the method of cartridge insertion taught by Soerensen so as to include the step of removing an air gap between a plunger and piston during assembly so as to prevent sever under-dosing after attaching a new cartridge to the device as taught by Soerensen (paragraph [0024]). It is noted that in the cited combination, the nut assembly of Bayer would function as set forth above as the cartridge and piston/plunger assembly is moved proximally into the delivery configuration).
Regarding claim 12, Bayer/Soerensen teach the structure of claim 11 and further teach wherein bringing the contact surface into mutual abutment involves inducing a converging relative motion between the cartridge holder and the housing (e.g., pressing the geared drive assembly onto the cartridge assembly housing (e.g., paragraph [0024] of Soerensen).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bayer in view of Soerensen, and further in view of Leak (US 2013/0267908).
Regarding claim 13, Bayer discloses a method of performing zero-point adjustment of a drug delivery device comprising: a cartridge unit comprising a cartridge holder carrying:
a first drug cartridge (12) having a first cartridge body and a first piston structure (14) and a dose expelling unit comprising:
a housing (20) extending along a longitudinal central axis,
a first piston rod (120) for pressurizing the first drug cartridge, the first piston rod comprising a first contact surface adapted to contact the first piston structure, and a non-self-locking thread,
a nut member (90, 100, 70, 140, 150) rotationally fixed with respect to the housing and respectively engaged with the non-self-locking thread and the second piston rod thread, the nut member carrying a first coupling part of a unidirectional ratchet coupling,
a first piston rod drive member (80) axially fixed with respect to the housing and rotatable about a first axis parallel with the longitudinal central axis (paragraph [0037]; the drive member transmits a rotational driving force to the piston rod as claimed), the first piston rod drive member being operatively coupled with a second coupling part of the unidirectional ratchet coupling (paragraph [0037]), and the first piston rod drive member and the first piston rod being rotationally interlocked such that a rotation of the first piston rod drive member in a first direction about the first axis is associated with distal helical movement of the first piston rod in the nut member, and a rotation of the first piston rod drive member in a second direction about the first axis is associated with proximal helical movement of the first piston rod in the nut member (paragraphs [0138] and [0160]).
Bayer fails to explicitly disclose the second cartridge and piston rod assemblies as well as the zero point setting and assembly steps.
Soerensen et al. (henceforth Soerensen) teaches (e.g., Figure 1) a pen-type automatic injection device comprising a plunger rod (221) and piston (231) which are engaged during assembly of the cartridge within the device and wherein no air gap is maintained after connection of a cartridge (see paragraphs [0020], [0024], [0033], and [0067] which clearly disclose removing the air gap during assembly between the plunger and cartridge piston via positioning of the piston rod; this will remove any air gap which results in a zero-point initialization as claimed).
(i) arranging the piston rod in the nut member such that the contact surface is positioned distally of a final contact surface assembly position (paragraph [0024] discloses moving the piston to a distal “loading position” before cartridge insertion),
(ii) bringing the piston structure and the contact surface into mutual abutment (paragraph [0024],
(iii) inducing a converging relative axial motion between the cartridge holder and the housing, thereby firstly forcing the piston rod proximally, and
(iv) axially interlocking the cartridge holder and the housing, thereby providing zero-point adjustment by removing any air gaps between the contact surface of the piston rod and the piston structure (paragraph [0024]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Bayer to comprise the method of cartridge insertion taught by Soerensen so as to include the step of removing an air gap between a plunger and piston during assembly so as to prevent sever under-dosing after attaching a new cartridge to the device as taught by Soerensen (paragraph [0024]). It is noted that in the cited combination, the nut assembly of Bayer would function as set forth above as the cartridge and piston/plunger assembly is moved proximally into the delivery configuration).
Leak teaches a medical delivery device comprising a first cartridge and wherein the cartridge unit comprises a second drug cartridge (5) held in parallel to the first cartridge by the cartridge holder (Figures 1-2), and the dose expelling unit further comprises a second piston rod for pressurizing the second drug cartridge, the second piston rod comprising a second contact surface (e.g., distal portion of second piston rod which engages with the second piston) adapted to contact a second piston structure (Figure 2, within the second cartridge), and a second piston rod thread in engagement with a second thread of the nut member (e.g., Figure 11 depicts the threads of both piston rods 122 and 120), and a second piston rod drive member axially fixed with respect to the housing (driving gear of second cartridge) and rotatable about a second axis parallel with the longitudinal axis, the second piston rod drive member and the second piston rod being rotationally interlocked, and the second piston rod drive member being rotationally coupled with the piston rod drive member, and wherein the second piston rod has an axially variable dimension which is set during assembly of the dose expelling unit and the cartridge, after contact between the second piston structure and the second piston rod has been established (e.g., based upon the dialed dose as per paragraph [0080], [0081], and [0084]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Bayer to include the second cartridge and associated structure of Leak to allow for a secondary medicament to be delivered along with the first during an injection procedure as taught by Leak (e.g., paragraph [0061]).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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