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 .
Election/Restrictions
Applicant’s election without traverse of Group 1 encompassing claims 1-23 and 25, and Species 1 encompassing claims 1-13 and 19-23 in the reply filed on 02/11/2025 is acknowledged.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/09/2026 has been entered.
Response to Arguments
The Amendment filed 03/09/2026 has been entered.
Claims 7 and 20 are cancelled.
Claims 14-18, 24, and 25 are withdrawn.
Claims 1-6, 8-13, 19, 21-23 remain pending in the application.
Applicant’s amendments to the Claims have overcome each and every 112(b) rejection previously set forth in the Non-Final Office Action mailed 06/03/2025.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Reference characters 141 and 133 are present in FIG. 2 and are not found in the specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6, 8-13, 19, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Eardley et al. (U.S. Paten Pub. 20170304551), hereinafter Eardley, and further in view of Cowe et al. (U.S. Paten Pub. 20110092905), hereinafter Cowe.
Regarding claim 1, Eardley discloses an injection device (“a drug delivery device in the form of an injection pen”, [0115]; see FIGS. 1-3 the Examiner notes that all reference characters cited below refer to FIGS. 1-3 unless otherwise stated) for delivering a dose from a cartridge (cartridge 100) or syringe, the injection device comprising:
a housing (housing 10) for receiving the cartridge or syringe;
a drive shaft (drive sleeve 40) rotatably mounted within the housing;
a pre-loaded drive spring (drive spring 90) having a first end rotationally fixed to the drive shaft (see FIG. 3) and a second end rotationally fixed to the housing (see [0124]; see pre-wound turns in [0131]) to directly urge the drive shaft to rotate relative to the housing (see [0119]);
a plunger (piston rod 30) coupled to the drive shaft such that rotation of the drive shaft relative to the housing directly or indirectly causes the plunger to move axially relative to the housing for delivering a dose from the cartridge or syringe (“piston rod 30 is rotationally constrained to the drive sleeve 40 via a splined interface. When rotated, the piston rod 30 is forced to move axially relative to the housing 10”, [0118]), in use;
a dose setting member (dose setting element 60) moveable relative to the drive shaft (see [0120]) between a first position for setting a dose and a second position for delivering a dose;
wherein, when the dose setting member is in its first position, the drive shaft is rotationally fixed relative to the housing and the dose setting member is rotatable relative to the drive shaft to set the dose (“The action of rotating the dose selector 80, to set a dose, rotates the dose setting element 60 relative to the housing 10”, [0124]; “The reset plate 150 contains spline teeth 151 that prevent rotation of the drive sleeve 40 during dialing of the device”, [0129]); and
wherein, when the dose setting member is in its second position, the dose setting member is rotationally fixed relative to the drive shaft “With no user torque applied to the dose selector 80, the dose setting element 60 is now prevented from rotating”, [0139]), and the drive shaft is permitted to rotate relative to the housing under the influence of the drive spring, such that the rotation of the drive shaft relative to the housing causes the dose setting member to rotate together with the drive shaft relative to the housing (“When the button 70 is pressed, these spline teeth 41, 151 are disengaged allowing the drive sleeve 40 to rotate under the action of the drive spring 90”, [0119]; “The user selects a variable dose of liquid medicament by rotating the dose selector 80 clockwise, which generates an identical rotation in the dose setting element 60. Rotation of the dose setting element 60 causes charging of the drive spring 90, increasing the energy stored within it.”, [0132]);
the injection device further comprising:
a stop member (nut 50) engaged between the dose setting member and the drive shaft such that relative rotation between the dose setting member and the drive shaft causes the stop member to travel relative to a first stop surface (“Relative rotation of the dose setting element 60 and the drive sleeve 40 causes the last dose nut 50 to travel along its threaded path, towards its last dose abutment on the drive sleeve 40”, [0138]), and rotation of the dose setting member together with the drive shaft does not cause the first stop member to travel relative to the stop surface (“During delivery of a dose, the drive sleeve 40 and dose setting element 60 rotate together, so that no relative motion in the last dose nut 50 occurs. The last dose nut 50 therefore travels axially along the drive sleeve 40 only during dialing (and reset).”, [0148]);
wherein if the stop member abuts the first stop surface during relative rotation between the dose setting member and the drive shaft, continued travel of the stop member and hence continued relative rotation between the dose setting member and the drive shaft is prevented (“last dose nut 50 may contact its last dose abutment with the drive sleeve 40. The abutment prevents further relative rotation between the dose setting element 60 and the drive sleeve 40, and therefore limits the dose that can be selected.”, [0142]).
a clutch member (clutch plate 120) coupled to the dose setting member (“clutch plate 120 is splined to the dose setting element 60”, [0126]) and moveable by the dose setting member between an engaged position and a disengaged position to prevent relative rotation between the drive shaft and the housing (“The drive sleeve 40 extends from the interface 42, 121 with the dose setting element 60 (via the clutch plate 120) down to a splined tooth interface 41, 151 (FIG. 6) with the reset plate 150. This provides a rotational constraint to the drive sleeve 40 during dose setting.”, [0119]), and wherein in the disengaged position the clutch member is not engaged between the drive shaft and the housing such that relative rotation between the drive shaft and the housing is permitted (“The button 70 force acts on the drive sleeve 40, via the clutch plate 120, which travels axially and disconnects the splined engagement with the reset plate 150, allowing rotation of the drive sleeve 40.”, [0145]);
wherein the dose setting member and the clutch member are coupled such that when the dose setting member is moved between its first position and its second position, the clutch member is moved between its engaged position and its disengaged position respectively (“The clutch plate 120 is splined to the dose setting element 60 when in the dialing and dispense conditions.”, [0126]; see [0143]).
However, Eardley does not expressly state wherein when the dose setting member is in its first position, the drive shaft is rotationally fixed relative to the housing and the dose setting member is rotatable relative to the drive shaft to set the dose without applying torque to the drive spring, and wherein in the engaged position the clutch member is in splined engagement with the drive shaft and in splined engagement with the housing.
Cowe teaches a disposable automatic pen type injector (see [0046]) wherein when the dose setting member is in its first position, the drive shaft is rotationally fixed relative to the housing (“during dose setting, the body 10, drive shaft 24, clutch 56 all remain stationary, both axially and rotationally.”, [0052]) and the dose setting member is rotatable relative to the drive shaft to set the dose without applying torque to the drive spring (“dose setting element is isolated from the force of the drive spring during the dose setting routine”, [0012]), and
wherein in the engaged position the clutch member is in splined engagement with the drive shaft and in splined engagement with the housing (“The clutch collar 56 is mounted for axial sliding movement in the body 10 but prevented from rotation with respect thereto by means of two lugs 58 in the body engaging opposed respective slots 60 in the cylindrical wall of the clutch collar 56. At its rear end, the clutch collar 56 has an internal splined arrangement 57 designed to slide into splined engagement with the splines 36 on the drive shaft so as to lock the drive shaft against movement under the influence of the spring by reacting the thrust into the body by via the lugs 58.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Eardley wherein when the dose setting member is in its first position, the drive shaft is rotationally fixed relative to the housing and the dose setting member is rotatable relative to the drive shaft to set the dose without applying torque to the drive spring, and wherein in the engaged position the clutch member is in splined engagement with the drive shaft and in splined engagement with the housing. Doing so would allow for an already energized spring that does not require manual energization or reenergization before or in between doses which is desirable for multi dose or disposable injectors, and allow for restricting movement of the drive shaft from drive spring, as taught by Cowe (see [0022; 0050]).
Regarding claim 2, Eardley in view of Cowe teaches the claimed invention as discussed above concerning the rejection of claim 1, and Eardley further teaches wherein rotation of the dose setting member relative to the drive shaft in a direction to increase the set dose causes the stop member to travel toward the first stop surface (“the user may now choose to increase the selected dose by continuing to rotate the dose selector 80 in the clockwise direction... If the user continues to increase the selected dose until the maximum dose limit is reached, the dose setting element 60 engages with its maximum dose abutment.”, [0140-0141]).
Regarding claim 3, Eardley in view of Cowe teaches the claimed invention as discussed above concerning the rejection of claim 1, and Eardley further teaches wherein the position of the stop member relative to the first stop surface corresponds to the total deliverable volume of substance remaining in the cartridge or syringe “Depending on how many increments (counts) have already been delivered by the mechanism (cartridge), during selection of a dose, the last dose nut 50 may contact its last dose abutment with the drive sleeve 40. The abutment prevents further relative rotation between the dose setting element 60 and the drive sleeve 40, and therefore limits the dose that can be selected. The position of the last dose nut 50 is determined by the total relative rotation between the dose setting element 60 and drive sleeve 40, that has accumulated each time the user has set a dose”, [0142]).
Regarding claim 4, Eardley in view of Cowe teaches the claimed invention as discussed above concerning the rejection of claim 1, and Eardley further teaches wherein the stop member is threadedly engaged with a first helical thread on one of the dose setting member and the drive shaft (“Preferably, the nut member is threaded to the drive member and splined to the dose setting member. As an alternative, the nut member may be threaded to the dose setting member and may be splined to the drive member.”, [0028]), and the stop member is rotationally fixed and axially movable relative to the other of the dose setting member and the drive shaft, such that relative rotation between the dose setting member and the drive shaft causes the stop member to move along the first helical thread (“The last dose nut 50 is located between the dose setting element 60 and the drive sleeve 40. It is rotationally constrained to the dose setting element 60, via a splined interface. It moves along a helical path relative to the drive sleeve 40, via a threaded interface 44, when relative rotation occurs between the dose setting element 60 and drive sleeve 40 (during dialing and resetting only”, [0120]).
Regarding claim 5, Eardley in view of Cowe teaches the claimed invention as discussed above concerning the rejection of claim 4, and Eardley further teaches wherein the first stop surface is located on the first helical thread (“Preferably, the nut member is threaded to the drive member and splined to the dose setting member. As an alternative, the nut member may be threaded to the dose setting member and may be splined to the drive member.”, [0028]).
Regarding claim 6, Eardley in view of Cowe teaches the claimed invention as discussed above concerning the rejection of claim 4, and Eardley further teaches wherein the first stop surface is located on the other of the dose setting member and the drive shaft (“Preferably, the nut member is threaded to the drive member and splined to the dose setting member. As an alternative, the nut member may be threaded to the dose setting member and may be splined to the drive member.”, [0028]).
Regarding claim 8, Eardley in view of Cowe teaches the claimed invention as discussed above concerning the rejection of claim 1, and Eardley further teaches comprising a dose button coupled to the dose setting member (“The button 70 is splined to the dose setting element 60 when in the dose dialing condition. This spline interface is disconnected when the button 70 is pressed to trigger a dispense.”, [0122]), wherein the dose button is rotatable relative to the housing and movable relative to the housing between a first position and a second position, and the dose button and the dose setting member are coupled such that:
when the dose button is in its first position, the dose setting member is in its first position and the dose setting member is rotationally fixed relative to the dose button (“With the device in the at rest condition as shown in FIG. 3, the dose setting element 60 is positioned against its zero dose abutment with the gauge element 110, and the button 70 is not depressed”, [0131]);
when the dose button is in its second position, relative rotation between the dose setting member and the dose button is permitted (“When the button 70 is pressed, these spline teeth 41, 151 are disengaged allowing the drive sleeve 40 to rotate under the action of the drive spring 90, dispensing the set dose.”, [0119]); and
when the dose button is moved between its first position and its second position, the dose setting member is moved between its first position and second position respectively (the Examiner notes when dose button 70 is pressed, sleeve 40 engages moveably with element 60 from one position to another, that can be considered a first and second position, see [0019]).
Regarding claim 9, Eardley in view of Cowe teaches the claimed invention as discussed above concerning the rejection of claim 8, and Eardley further teaches comprising a return spring (trigger spring 130) configured to bias the dose button toward its first position (“The relative axial positions of the drive sleeve 40, clutch plate 120 and button 70 are influenced by the action of the trigger spring 130, which applies a biasing force on the drive sleeve 40 in the proximal direction.”, see [0127]).
Regarding claim 10, Eardley in view of Cowe teaches the claimed invention as discussed above concerning the rejection of claim 1, and Eardley further teaches wherein the dose setting member sets the dose by defining the maximum rotational displacement of the drive shaft during dose delivery (“These helical features on the gauge element 110 also create stop abutments against the ends of the helical cut (thread) in the dose setting element 60 to limit the minimum and maximum dose that can be set.”, [0125]; “As a dose is set by the user the gauge element 110 translates axially, the distance moved proportional to the magnitude of the dose set.”, [0133]).
Regarding claim 11, Eardley in view of Cowe teaches the claimed invention as discussed above concerning the rejection of claim 10, and Eardley further teaches comprising a control member (gauge element 110) engaged between the housing and the dose setting member such that relative rotation between the housing and the dose setting member causes the control member to travel relative to a second stop surface; wherein:
during dose delivery, relative rotation between the dose setting member and the housing under the influence of the drive spring causes the control member to move toward the second stop surface until the control member abuts the second stop surface, whereby continued rotation of the dose setting member relative to the housing is prevented (“The gauge element 110 is constrained to prevent rotation but allow translation relative to the housing 10 via a splined interface. The gauge element 110 has helical features 112 on its inner surface which engage with the helical thread 63 formed in the dose setting element 60 such that rotation of the dose setting element 60 causes axial translation of the gauge element 110. These helical features on the gauge element 110 also create stop abutments against the ends of the helical cut (thread) in the dose setting element 60 to limit the minimum and maximum dose that can be set.”, [0125]); and
during dose setting, relative rotation between the dose setting member and the housing sets the dose by defining the position of the control member relative to the second stop surface (“As the dose setting element 60 rotates, the gauge element 110 translates axially due to its threaded engagement 63, 112 thereby showing the value of the dialed dose.”, [0132]; “If the user continues to increase the selected dose until the maximum dose limit is reached, the dose setting element 60 engages with its maximum dose abutment on the gauge element 110 (FIGS. 4 and 5). This prevents further rotation of the dose setting element 60, clutch plate 120 and dose selector 80.”, [0141]).
Regarding claim 12, Eardley in view of Cowe teaches the claimed invention as discussed above concerning the rejection of claim 11, and Eardley further teaches wherein the control member is threadedly engaged with a helical thread on the housing, and is rotationally fixed and axially movable relative to the dose setting member (“The gauge element 110 is constrained to prevent rotation but allow translation relative to the housing 10 via a splined interface. The gauge element 110 has helical features 112 on its inner surface which engage with the helical thread 63 formed in the dose setting element 60 such that rotation of the dose setting element 60 causes axial translation of the gauge element 110. These helical features on the gauge element 110 also create stop abutments against the ends of the helical cut (thread) in the dose setting element 60 to limit the minimum and maximum dose that can be set.”, [0125]).
Regarding claim 13, Eardley in view of Cowe teaches the claimed invention as discussed above concerning the rejection of claim 1, and Eardley further teaches wherein the drive spring is a torsion spring (“A drive spring, preferably a torsion spring, may be interposed between the housing and the dose setting element”, [0021]).
Regarding claim 19, Eardley in view of Cowe teaches the claimed invention as discussed above concerning the rejection of claim 1, and Eardley further teaches wherein when the dose setting member is in its first position, the dose setting member is completely isolated from the force of the drive spring (“With no user torque applied to the dose selector 80, the dose setting element 60 is now prevented from rotating back under the action of the drive spring 90”, [0139]).
Regarding claim 20, Eardley in view of Cowe teaches the claimed invention as discussed above concerning the rejection of claim 1, and Eardley further teaches wherein during assembly of the injection device, the drive spring is preloaded such that prior to a first dose setting operation, the drive spring has enough energy to supply the force required to perform at least one dose delivery, optionally a plurality of dose deliveries, without any input of energy by the user into the drive spring (“Providing a resilient drive member, such as a torsion spring, generating the force or torque required for dose dispensing reduces the user applied forces for dose dispensing. This is especially helpful for users with impaired dexterity. In addition, the dial extension of the known manually driven devices, which is a result of the required dispensing stroke, may be omitted by providing the resilient member because merely a small triggering stroke may be necessary for releasing the resilient member. The drive spring may be pre-charged, at least partly, and/or may be charged by a user during dose setting.”, [0021]; the Examiner notes "optionally" makes the limitation of "a plurality of dose deliveries" not positively recited and not positively required in claim 20.).
Regarding claim 21, Eardley in view of Cowe teaches the claimed invention as discussed above concerning the rejection of claim 1, and Eardley further teaches wherein during assembly of the injection device, the drive spring is preloaded such that prior to a first dose setting operation, the drive spring has enough energy to supply the force required to deliver the total deliverable volume of substance in the cartridge or syringe over one or more dose deliveries without the user needing to input any energy into the drive spring (“Providing a resilient drive member, such as a torsion spring, generating the force or torque required for dose dispensing reduces the user applied forces for dose dispensing. This is especially helpful for users with impaired dexterity. In addition, the dial extension of the known manually driven devices, which is a result of the required dispensing stroke, may be omitted by providing the resilient member because merely a small triggering stroke may be necessary for releasing the resilient member. The drive spring may be pre-charged, at least partly, and/or may be charged by a user during dose setting.”, [0021]; the Examiner notes "optionally" makes the limitation of "a plurality of dose deliveries" not positively recited and not positively required in claim 20.).
Regarding claim 22, Eardley in view of Cowe teaches the claimed invention as discussed above concerning the rejection of claim 1, and Eardley further teaches wherein the drive shaft (drive sleeve 40) comprises a first drive shaft portion and a separate second drive shaft portion (see proximal and distal halves of sleeve 40 in FIG. 2), wherein:
the drive spring (drive spring 90) is configured to directly or indirectly urge the first drive shaft portion to rotate relative to the housing(“the reset element is axially moved relative to the housing into a position in which the dose setting element is rotationally constrained to the housing and the drive member is allowed to rotate relative to the housing.”, [Claim 16]);
the first drive shaft portion is engaged with the second drive shaft portion such that the first drive shaft portion is rotationally fixed relative to the second drive shaft portion (see FIG. 2); and the stop member is engaged between the dose setting member and the second drive shaft portion (“last dose abutment with the drive sleeve 40. The abutment prevents further relative rotation between the dose setting element 60 and the drive sleeve 40,”, [0142]).
Regarding claim 23, Eardley in view of Cowe teaches the claimed invention as discussed above concerning the rejection of claim 22, and Eardley further teaches wherein:
the clutch member (clutch plate 120) is integrally formed with or is attached to the second drive shaft portion such that the clutch member is axially fixed relative to the second drive shaft portion (“The clutch plate 120 is also coupled to the drive sleeve 40 via a ratchet interface 42, 121 (FIG. 7a), which occurs on an axial abutment.”, [0126]);
the second drive shaft portion is axially movable relative to the first drive shaft portion; and when the clutch member is in its engaged position, the clutch member is engaged between the first drive shaft portion and the housing to prevent relative rotation between the first drive shaft portion and the housing (“If the user releases the button 70, the trigger spring 130 returns the button 70 to its at rest position via the drive sleeve 40 and clutch plate 120, the drive sleeve 40 becomes rotationally constrained to the reset plate via clutch teeth 41, 151 and delivery of a dose is halted.”, [0147]).
Response to Arguments
Applicant’s arguments, see Remarks, filed 03/09/2026, with respect to the rejection(s) of claim(s) 1-13 and 19-23 under 35 U.S.C. 103 over Eardley et al. (U.S. Paten Pub. 20170304551) and further in view of Cowe et al. (U.S. Paten Pub. 20110092905) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 U.S.C. 103 over Eardley et al. (U.S. Paten Pub. 20170304551) and further in view of Cowe et al. (U.S. Paten Pub. 20110092905).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
05/29/2026 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights