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 .
Response to Amendment
This office action is responsive to the amendment filed on 7/17/2026. As directed by the amendment: claim(s) 16, 31-32, and 35 have been amended. Thus, claims 16-35 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 7/17/2026 have been fully considered but they are not fully persuasive.
Regarding applicant’s argument regarding the independent claims on page 7-9:
Applicant argues that the prior art relied upon in the preceding office action does not teach the following limitations of the presently amended independent claims:
"wherein the delivery member cover comprises a single structural trigger configured to directly actuate a single mechanical pin or a single electromechanical switch to trigger the rotational drive unit to move the plunger unit when the delivery member cover is moved distally to the retraction position"
"and wherein a single structural trigger operatively associated with of the delivery member cover is configured to directly actuate a single mechanical pin or a single electromechanical switch to the retraction position causes the rotational drive unit to move the plunger unit based on movement of the delivery member cover to the retraction position."
Applicants arguments are oriented towards the prior art of Marcoz’s disclosure of its switch activation ridge 61, relied upon in the preceding and present office action as the claimed single structural trigger, and its disclosure of being in simultaneous contact with an activation switch 53 and injection ready switch 65 in order to actuate the claimed function of triggering the “rotation drive unit [moving] the plunger based on movement of the delivery member cover to the retraction position”. Examiner notes that the present claim language requires that a single pin/switch be actuated by the single structural trigger. Examiner further notes that where a singular structural trigger actuates a first pin/switch and a second pin/switch, that singular structural trigger is still considered to have actuated a single pin/switch by its actuation of the first pin/switch and/or actuation of the second pin/switch. The present claim language is not so narrow as to limit the claimed single structural trigger from interacting with no elements other than just 1 singular pin/switch.
Applicant further argues that Marcoz’s disclosure of conditions under which its rotational drive unit is triggered to move the plunger unit cannot be interpreted as the claimed direct actuation of single pin/switch with a single structural trigger. However, applicant does not detail the manner why conditional requirements of rotational drive unit activation/plunger unit movement cannot be considered direct actuation. The present claim language is not so narrow as to limit the claimed rotational drive unit from being permitted to move the claimed plunger unit when a plurality of conditions are met when those conditions include a singular structural trigger actuating a single pin/switch to govern this actuation of the rotational drive unit.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Examiner further notes that the status of the condition which applicant references, the status of the condition of Marcoz’s skin sensor circuit 57, permits or denies Marcoz’s needle guard 24 from reaching the “second, injection ready position”, such that activation ridge 61 is only permitted to reach said position – considered the claimed retracted position of the claimed needle guard– after the skin sensor circuit 57’s conditions are satisfied, thus the condition which directly triggers the rotational drive unit performing the claimed function is the activation ridge 61/needle guard 24 reaching the injection ready position and actuating the injection ready switch 65, see paragraph 97 of Marcoz.
With regard to the prior art of Marcoz, see examiner's rejection as necessitated by the amendment, below, which details the manner that the prior art is considered to disclose/teach the amended subject matter of actuating a single pin/switch with a single structural trigger to cause the rotational drive unit to move the plunger unit as claimed.
Regarding applicant’s argument regarding dependent claims on page 9-10:
Applicant argues that their preceding arguments render the independent claims allowable, and consequently likewise the dependent claims are allowable.
See examiner's discussion of the presently amended independent claims above, and prior art rejection below, which details the reasons for why the dependent claims are not considered allowable subject matter.
Claim Rejections - 35 USC § 102
Claims 16, 18-21, 24, 26, 29-30 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20210077723 A1, henceforth written as Marcoz.
Regarding Claim 16, Marcoz discloses:
A medicament delivery device comprising:
(automatic injector device 1; fig 1)
a proximal disposable part arranged with
(paragraph 94; disposable drug assembly 2; fig 1)
a body
(housing 4; fig 1)
and a delivery member cover telescopically arranged in relation to the body;
(needle guard 24; fig 1)
wherein the proximal disposable part is configured to receive a medicament container; and
(syringe assembly 6; fig 1)
a distal reusable power pack detachably arranged with the proximal disposable part,
(paragraph 94; reusable motorized transmission assembly 3; fig 1)
wherein the delivery member cover has an extension position in which the delivery member cover is extended in a proximal direction to cover a medicament delivery member of the medicament container,
(fig 5)
and a retraction position in which the delivery member cover is retracted in a distal direction to expose the medicament delivery member,
(fig 13+15)
wherein the distal reusable power pack comprises a power unit,
(motor 67; fig 1)
a rotational drive unit
(gear assembly 66; fig 1)
and a plunger unit,
(screw threaded piston 69 ; fig 1)
wherein the rotational drive unit is powered by the power unit and is configured to move the plunger unit upon being triggered,
(paragraph 103+117+120-121)
wherein the plunger unit is configured to move a stopper of the medicament container in the proximal direction upon being moved by the rotational drive unit, so that a medicament contained in the medicament container is expelled, and
(paragraph 103+117+120-121; plunger 13 is moved by gear assembly 66 to expel contents of drug chamber 14; fig 2+13)
wherein the delivery member cover comprises a single structural trigger configured to directly actuate a single mechanical pin or a single electromechanical switch to trigger the rotational drive unit to move the plunger unit when the delivery member cover is moved distally to the retraction position.
(paragraph 101-103+114-120; switch engagement ridge 61, considered the claimed single structural trigger, is a switch activation means disposed on needle guard 24 such that upon guard 24 moving distally into the claimed retraction position an injection ready switch 65 is activated/triggered -noting the triggering of switch 65 occurs while switch 53 remains actuated after having been initially activated by ridge 61 and needle guard 24 reaching and surpassing a “wake-up” position- as soon as the switch activation means has reached the ”injection ready” position such that a corresponding “injection ready” signal is sent to programmable control system 54 for system 54 to command motor 67 and gear assembly 66 to drive screw thread piston 69 forward to engage plunger 13 and expel drug out of the drug container chamber; fig 3-4+8+14; injection ready switch 65 can be considered a single mechanical pin in that it is comprised of a spring-loaded projection 85 and can be considered a single electromechanical switch in that depression of projection 85 electronically closes a circuit to send an injection ready signal, see paragraph 102+116+120)
Regarding Claim 18, Marcoz discloses:
The medicament delivery device according to claim 16, wherein the power unit is a motor.
(motor 67; fig 1)
Regarding Claim 19, Marcoz discloses:
The medicament delivery device according to claim 16, wherein the distal reusable power pack comprises a housing,
(housing 56a 56b; fig 1-2)
the housing being configured to receive the rotational drive unit and the power unit, wherein the housing further comprises a locking element configured to prevent the rotational drive unit from rotating in relation to the housing in a locking position.
(paragraph 97-98+103; needle brake drive motor gear 35, shown in fig 1-2 within housing 56ab, engages gear assembly 66 to prevent its rotation before the needle brake 30 is disengaged)
Regarding Claim 20, Marcoz discloses:
The medicament delivery device according to claim 19, wherein the trigger is configured to release the locking element to move out from the locking position, thereby triggering the rotational drive unit to move the plunger unit.
(paragraph 98-99+101-103+114-118; ridge 61 is considered configured to release needle brake drive motor gear 35 from the locking position due to the axial displacement of ridge 61 biasing microswitches 53 65 such that skin sensor circuit 57 communicates a triggering signal based on received information and needle brake 30 disengages from needle brake drive motor gear 35 to permit movement of piston 69 by assembly 66 and control system 54; fig 1-2)
Regarding Claim 21, Marcoz discloses:
The medicament delivery device according to claim 18, wherein the distal reusable power pack further comprises a switch, and wherein the trigger is configured to trigger the motor by switching the switch.
( paragraph 98-99+101-103+114-117; control system 54, considered a switch as it controls the motor 67 and gear assemblies of the system to switch between different power rates/levels, as well as communicating operational status as triggered by activation of microswitches 53 65 being biased by ridge 61; fig 1)
Regarding Claim 24, Marcoz discloses:
The medicament delivery device according to claim 18, wherein the motor is configured to reciprocate the movement of the plunger unit.
(claim language of “configured to” implies a functional language and the prior art must at least be capable of performing the recited function; paragraph 94 demonstrates that motorized transmission assembly 3 is reusable, and accordingly to be functional for subsequent uses with further disposable parts, its piston 69 must be returned to its initial position by its motor 67, as shown in fig 2+15-16 with piston 69 in a pre-use and post-use position, it is apparent the motor 67 is capable of translating piston 69 axially in a singular direction while also being capable of stopping and slowing/accelerating the rate of piston 69's translation, therein motor 67 is functionally capable of reciprocating the movement of piston 69)
Regarding Claim 26, Marcoz discloses:
The medicament delivery device according to claim 16, wherein the rotational drive unit comprises a drive nut configured to rotate about a longitudinal axis of the distal reusable power pack.
(gear assembly 66 includes drive gear 72 which rotates about a longitudinal axis; fig 2 )
Regarding Claim 29, Marcoz discloses:
The medicament delivery device according to claim 26, wherein the plunger unit comprises a thread on its external surface.
(paragraph 103; screw threaded piston 69; fig 1)
Regarding Claim 30, Marcoz discloses:
The medicament delivery device according to claim 16, wherein the delivery member cover comprises a rib
(flange 43 on needle guard body 25 on needle guard 24; fig 1)
and the proximal disposable part comprises a rotator configured with a locking tongue,
(assembly 2 further comprises the rotatable longitudinal body 31, and its position locking elements abutments 37 and 46; fig 1+7)
the rotator being configured to be rotated by a linear movement of the delivery member cover, and
(paragraph 116-117; needle guard 24 sliding linearly trigger's activation circuit 51 communicating with control system 54 and therein allows gear assembly 66 to rotate longitudinal body 31 about its axis)
wherein the rotation aligns the locking tongue with the rib, so that the delivery member cover is prevented from moving to the retraction position.
(fig 10-11 demonstrate that rotation of longitudinal body 31 aligns abutments 37 and 46 with flange 43 such that they are aligned in protruding radially outward, away from a central axis, and as detailed in paragraph 122 this position permits flange 43 to fix needle guard 24 such that it cannot be returned to a retracted position after use)
Claim Rejections - 35 USC § 103
Claims 25, 27-29, and 31-35 are rejected under 35 U.S.C. 103 as being unpatentable over Marcoz, in view of US 20130296778 A1, henceforth written as Damgaard.
Regarding Claim 25,
Marcoz discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Marcoz is silent regarding:
The medicament delivery device according to claim 16, wherein the rotational drive unit comprises a rotational gear wheel configured to rotate about an orthogonal axis of the distal reusable power pack.
However, Damgaard teaches an autoinjector:
wherein the rotational drive unit comprises a rotational gear wheel configured to rotate about an orthogonal axis of the distal reusable power pack.
(fig 2+7-8 and paragraph 83 demonstrate that piston rod 12 moves orthogonal to a longitudinal injection axis, as actuated by the orthogonally rotating pinion gear 220, which enables a shorter and more compact delivery device, see paragraph 43)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement Damgaard’s teaching of a flexible and arcing piston rod translating orthogonally with the support of a orthogonally rotating gear wheel to the claimed plunger unit and corresponding component(s) of the claimed rotational drive unit disclosed by Marcoz in order to arrive at an invention which advantageously can be of a smaller and more compact shape which can be desirable in some circumstances, see paragraph 43 of Damgaard.
Regarding Claim 27, Marcoz discloses:
The medicament delivery device according to claim 25, wherein the plunger unit has a plurality of teeth, the plunger unit being arranged to connect with the gear wheel by means of the teeth.
(piston 69 is threaded, therein a plurality of radially extending teeth; fig 2)
Regarding Claim 28, Marcoz discloses:
The medicament delivery device according to claim 25, wherein the distal reusable power pack further comprises a damper gear arranged to connect to the gear wheel, the damper gear being configured to slow down the rotational speed of the gear wheel.
(paragraph 98+103+115; needle brake motor gear 35, when engaged to needle brake 30 limits, therein slows down, gear 72 by gear 35's mating with gear assembly 66; fig 1+5)
Regarding Claim 31,
Marcoz discloses:
A medicament delivery device comprising:
(automatic injector device 1; fig 1)
a proximal disposable part comprising
(paragraph 94; disposable drug assembly 2; fig 1)
a body
(housing 4; fig 1)
and a delivery member cover axially having a longitudinal axis and movable relative to the body,
(needle guard 24; fig 1)
wherein the proximal disposable part comprises a medicament container;
(syringe assembly 6; fig 1)
and a distal reusable power pack detachably arranged with the proximal disposable part,
(paragraph 94; reusable motorized transmission assembly 3; fig 1)
wherein the delivery member cover has an extension position in which the delivery member cover is extended in a proximal direction to cover a medicament delivery member fixed to the medicament container,
(see fig 5 illustrating the extension position of the delivery member cover)
and a retraction position in which the delivery member cover is moved distally relative to the medicament container to expose the medicament delivery member,
(see fig 13+15 relative to fig 1+5 illustrating the retraction position where the delivery member cover is moved relative to the syringe 6)
wherein the distal reusable power pack comprises a power unit,
(motor 67; fig 1)
a rotational drive unit,
(gear assembly 66; fig 1)
and a plunger unit that moves -- a stopper within the medicament container in the proximal direction when moved by the rotational drive unit,
(paragraph 103; screw threaded piston 69 pushes against plunger 13 to expel drug from the drug container chamber; fig 1)
and wherein a single structural trigger operatively associated with the delivery member cover is configured to directly actuate a single mechanical pin or a single electromechanical switch to the retraction position causes the rotational drive unit to move the plunger unit based on movement of the delivery member cover to the retraction position.
(paragraph 101-103+114-120; switch engagement ridge 61, considered the claimed single structural trigger, is a switch activation means disposed on needle guard 24 such that upon guard 24 moving distally into the claimed retraction position an injection ready switch 65 is activated/triggered -noting the triggering of switch 65 occurs while switch 53 remains actuated after having been initially activated by ridge 61 and needle guard 24 reaching and surpassing a “wake-up” position- as soon as the switch activation means has reached the ”injection ready” position such that a corresponding “injection ready” signal is sent to programmable control system 54 for system 54 to command motor 67 and gear assembly 66 to drive screw thread piston 69 forward to engage plunger 13 and expel drug out of the drug container chamber; fig 3-4+8+14; injection ready switch 65 can be considered a single mechanical pin in that it is comprised of a spring-loaded projection 85 and can be considered a single electromechanical switch in that depression of projection 85 electronically closes a circuit to send an injection ready signal, see paragraph 102+116+120)
Marcoz discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
a plunger unit that moves transverse to the longitudinal axis to move a stopper within the medicament container
However, Damgaard teaches an autoinjector wherein:
a plunger unit that moves transverse to the longitudinal axis to move a stopper within the medicament container
(fig 2+8 and paragraph 83 demonstrate that piston rod 12 moves transverse to a longitudinal injection axis, as actuated by the transversally rotating pinion gear 220, which enables a shorter and more compact delivery device, see paragraph 43)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement Damgaard’s teaching of a flexible and arcing piston rod translating transversally with the support of a transversally rotating gear wheel to the claimed plunger unit and corresponding component(s) of the claimed rotational drive unit disclosed by Marcoz in order to arrive at an invention which advantageously can be of a smaller and more compact shape which can be desirable in some circumstances, see paragraph 43 of Damgaard.
Regarding Claim 32, Marcoz discloses:
The medicament delivery device of claim 31, wherein the delivery member cover comprises a rib
(flange 43 on needle guard body 25 on needle guard 24; fig 1)
and the proximal disposable part comprises a rotator,
(assembly 2 further comprises the rotatable longitudinal body 31, and its position locking elements abutments 37 and 46; fig 1+7)
where movement of the delivery member cover to the retraction position causes the rib to engage the rotator to rotate the rotator and to activate the power unit such that rotational drive unit rotates.
(paragraph 97+116-117; needle guard 24 sliding linearly trigger's activation circuit 51 of control system 54, such that flange 43 engages body 31 via the abutment 46, see fig 7, and therein allows longitudinal body 31 to begin rotation about its axis enabled by motor 67 actuating gear assembly 66)
Regarding Claim 33, Marcoz discloses:
The medicament delivery device of claim 32, wherein the rotator comprises a locking tongue
(assembly 2 further comprises the rotatable longitudinal body 31, and its position locking tongues abutments 37 and 46; fig 1+7)
that is rotated by a linear movement of the delivery member cover such that the locking tongue align with the rib when the delivery member cover has moved from the retraction position to the extension position whereby the delivery member cover is prevented from moving back to the retraction position.
(fig 10-11 demonstrate that rotation of longitudinal body 31 aligns abutments 37 and 46 with flange 43 such that they are aligned in protruding radially outward, away from a central axis, and as detailed in paragraph 122 this position permits flange 43 to fix needle guard 24 such that it cannot be returned to a retracted position after use)
Regarding Claim 34, Marcoz discloses:
The medicament delivery device of claim 31, wherein the plunger unit has a plurality of teeth that engage with a gear wheel fixed to the rotational drive unit such that the gear wheel rotates along an axis transverse to the longitudinal axis.
(Marcoz: paragraph 103; piston 69 is threaded, therein a plurality of radially extending teeth, to engage with piston drive gear 72 secured to assembly 66 to rotate along an axis; fig 2)
Examiner notes that in light of the combination made in claim 31 above, the portions of gear assembly 66 which interact with the claimed plunger unit, i.e. piston driver gear 72, are now disposed such that they rotate transversally to a longitudinal axis to support the transversal and arcing shape of the claimed plunger unit
Regarding Claim 35, Marcoz discloses:
The medicament delivery device of claim 31, further comprising a locking element that when in a locking position prevents the rotational drive unit from rotating relative to a housing of the distal reusable power back,
(paragraph 97-98+103; needle brake drive motor gear 35, shown in fig 1-2 within housing 56ab, engages gear assembly 66 to prevent its rotation before the needle brake 30 is disengaged)
wherein the trigger operatively associated with the delivery member cover releases the locking element from the locking position to cause the rotational drive unit to move the plunger unit.
(paragraph 98-99+101-103+114-118; ridge 61 is considered configured to release needle brake drive motor gear 35 from the locking position due to the axial displacement of ridge 61 biasing microswitches 53 65 such that skin sensor circuit 57 communicates a triggering signal based on received information and needle brake 30 disengages from needle brake drive motor gear 35 to permit movement of piston 69 by assembly 66 and control system 54; fig 1-2)
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Marcoz as presented in claim 16, in view of US 20130218128 A1, henceforth written as Cowe.
Regarding Claim 17,
Marcoz discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Marcoz is silent regarding:
The medicament delivery device according to claim 16, wherein the power unit is a spring, the spring being configured to deliver a spring force along its circumferential direction.
However, Cowe teaches an autoinjector:
wherein the power unit is a spring, the spring being configured to deliver a spring force along its circumferential direction.
(paragraph 11+81; torsion spring is an art recognized example of rotary energy source adequate for governing an injection; examiner further notes that torsion spring are described in applicants disclosure as a class of springs which deliver a spring force along its circumferential direction)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to substitute the power unit as a spring teachings of Cowe for the power unit as motor disclosed by Marcoz, as torsion springs and rotary motors are art recognized equivalents known for the same purpose of providing a rotary force for governing an injection, see MPEP 2144.06 (II) and paragraph 11 of Cowe.
Claim 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Marcoz in view of Cowe as presented in claim 17, in view of US 20160175524 A1 henceforth written as Henderson.
Regarding Claim 22,
Marcoz in view of Cowe discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Marcoz in view of Cowe is silent regarding:
The medicament delivery device according to claim 17, wherein the distal reusable power pack further comprises a reset knob arranged to rotate the rotational drive unit against the restoring force of the spring.
However, Henderson teaches an autoinjector:
wherein the distal reusable power pack further comprises a reset knob arranged to rotate the rotational drive unit against the restoring force of the spring.
(paragraph 52+ 68+70; case 5 is rotatable by a user via its thumb rest 5.2 such that a ratchet drive features 5.1 are engaged and rotate to reset drive spring 15, therein resisting a restoring force; fig 10)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implementing the reusable autoinjector resetting elements taught by Henderson to the reusable autoinjector disclosed by Marcoz in view of Cowe in order to advantageously arrive at an invention which requires manual user resetting and therein ensures a user is aware of the device's reset status for subsequent use, see paragraph 70 of Henderson.
Regarding Claim 23, Marcoz in view of Cowe and Henderson provides:
The medicament delivery device according to claim 22, wherein the rotation of the reset knob actuates the plunger unit to move in the distal direction in relation to the proximal disposable part by the connection between the plunger unit and the rotational drive unit.
Examiner notes in light of the combination made in claim 22 above, rotation of the claimed reset knob, originally of Henderson, results in a resetting of Marcoz's drive mechanism such the claimed plunger unit moves distally as facilitated by the claimed rotational drive unit until the claimed plunger unit returns to the initial position.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FORREST B DIPERT/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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