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 .
DETAILED ACTION
This is the first office action in response to the above identified patent application filed on 12/27/2023. Claims 1-18 are currently pending and being examined.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
No claims are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species. Election was made without traverse in the reply filed on 06/03/2026.
Claim Objections
Claim 12 is objected to because of the following informalities: Claim 12 recites “element” in line 2. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “signal element”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, and 4-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carlsson (2019/0001069).
In reference to independent claim 1, Carlsson discloses an autoinjector (1, fig 1) for dispensing a liquid product, such as a drug, comprising:
a) a housing (10, fig 1) comprising a product container (17 in figure 2) arranged therein, the product container (70) comprising a piston (62) displaceable in a dispensing direction for dispensing the liquid product contained in the product container (para 0091 discloses “The plunger rod 62 may then be forced in the proximal direction by the drive spring 64 and may act on the stopper inside the medicament container 70 so as to deliver a dose of medicament through the medicament delivery member at the dose delivery site.”);
b) a propulsion element (62) configured to act on the piston (the stopper in para 009) during product dispensing, and a first spring (64) configured to act on the propulsion element (para 0091 discloses “The plunger rod 62 may then be forced in the proximal direction by the drive spring 64 and may act on the stopper inside the medicament container 70 so as to deliver a dose of medicament through the medicament delivery member at the dose delivery site.”);
c) a signal element (65 & 66, fig 1), a signal stop (“distal end of delivery device”, para 0113) and a second spring (90), which exerts a spring force on the signal element (65 & 66) counter to the dispensing direction (para 0128 discloses “The force stored in the release member returning spring 90 is then released and the release member 54 is pushed in a proximal direction by the release member returning spring 90”),
wherein the signal element (65 & 66) is in an axially fixed coupling with the propulsion element (62) such that the signal element (65 & 66) is slaved and the second spring (90) is biased during a displacement of the propulsion element (62) in the dispensing direction (para 0123 discloses “When the release member 54 is pressed distally, a force is built up in the release member returning spring 90 when it is compressed.”),
wherein the axially fixed coupling between the signal element (65 & 66) and the propulsion element (62) is releasable, and the signal element (65 & 66) is configured to be accelerated counter to the dispensing direction and relative to the propulsion element (62) and/or the housing by means of the second spring (90), wherein upon the signal element (65 & 66) being released from the axially fixed coupling with the propulsion element (62) and accelerated by the second spring (90; para 0128 discloses “The force stored in the release member returning spring 90 is then released and the release member 54 is pushed in a proximal direction by the release member returning spring 90”), the signal element (65 & 66) strikes against the signal stop (“distal end of delivery device”; para 0113 discloses “the end of dose signaling member 66, e.g. being a u-shaped bracket, is configured to lose its support from the plunger rod 62 when the plunger rod 62 has moved the predetermined length L.sub.pre proximally from its initial position P.sub.initial to the end position P.sub.end. Hereby, the end of dose signaling member 66 is configured to be released from its initial fixed position, which it has up until the delivery is ended. When the end of dose signaling member 66 is released, it performs an axial distal movement, i.e. towards the distal end of the medicament delivery device 1. When the end of dose signaling member 66 is released, also at least one guide rod member 65 arranged within the end of dose signaling member 66 moves distally (as indicated with an arrow in FIG. 5c).”); and
d) an electronic module (100, fig 1) with a sensor (101 & 102, fig 3) configured to measure an axial movement of the signal element (65 & 66) from a position at a start of the product dispensing, wherein the signal element (65 & 66) is slaved in the dispensing direction (in cite below), to a position at an end of the product dispensing, wherein the signal element strikes the signal stop (para 0113 discloses “The distal movement of the end of dose signaling member 66 and/or the at least one guide rod member 65 is detectable by the end of delivery sensor 102.”).
In reference to dependent claim 2, Carlsson discloses an autoinjector according to claim 1, wherein the electronic module is a separate electronic unit (700, in fig 7) and is configured to be connected to the housing of the autoinjector (para 0144 discloses “The electrical information device 700 can, according to an embodiment, be attachable to the medicament delivery device 1 by use of magnetic force.”).
In reference to dependent claim 4, Carlsson discloses the autoinjector according to claim 1, wherein the electronic module comprises an energy source (160) and a processor (150), wherein the processor and the energy source are coupled to the sensor (101 & 102) such that the start and the end of the product dispensing of the autoinjector are sensed by the sensor (para 0117 discloses “the electronical information device 100 includes both at least one start of delivery sensor 101 and at least one end of delivery sensor 102”).
In reference to dependent claim 5, Carlsson discloses the autoinjector according to claim 4, wherein the electronic module comprises a timer configured to measure a duration of the product dispensing of the autoinjector (para 0117 discloses “the detected delivery time period T.sub.del between activation of the at least one start of delivery sensor 101 and activation of the end of delivery sensor 102 can be analyzed. If the delivery time period T.sub.del is shorter than a nominal/expected value, this can e.g. be interpreted as the medicament has not been injected into tissue, which may generate an error code/message”).
In reference to dependent claim 6, Carlsson discloses the autoinjector according to claim 4, wherein the electronic module comprises a wireless communication unit for communicating with an external electronic apparatus and/or a status indicator for indicating at least one position of the signal element (para 0097 discloses “the at least one information communication unit 110 may also include at least one information indication arrangement 130 and/or at least one transmission unit 140”).
In reference to dependent claim 7, Carlsson discloses the autoinjector according to claims 5, wherein a status indicator is activated after a fixed duration after the sensed end and/or after the sensed start of the product dispensing (para 0133 discloses “The at least one indication arrangement 130 can thus be configured to provide the indication during and/or at the end of a predetermined time period after the delivery has ended.”).
In reference to dependent claim 8, Carlsson discloses the autoinjector according to claim 1, wherein the sensor (101 & 102) is configured as a switching detector (101 & 102 ) to sense the start and the end of the product dispensing of the autoinjector (para 0117 discloses “the detected delivery time period T.sub.del between activation of the at least one start of delivery sensor 101 and activation of the end of delivery sensor 102 can be analyzed.”).
In reference to dependent claim 9, Carlsson discloses the autoinjector according to claim 8, wherein the autoinjector comprises a switching actuator (para 0114 discloses “The end of delivery sensor 102 can, according to an embodiment, include at least one mechanical switch 102, which is configured to be compressed by a distal movement of the end of dose signaling member 66” and
Para 0096 discloses “start of delivery sensor 101 configured to detect a distal axial movement of the release member/sleeve 54”) to actuate a switch or button of the switching detector (far left surfaces of 101 and 102, fig 2a and 2b).
In reference to dependent claim 10, Carlsson discloses the autoinjector according to claim 1, wherein the signal element (65 & 66, fig 1) comprises a first engagement element configured to releasably engage in the propulsion element (62) such that the propulsion element (62) is coupled axially fixedly to the signal element (fig 1 shows 65 and 66 fixed to 62), wherein the axially fixed coupling between the propulsion element (62) and the signal element (65 & 66, fig 1) is released when the signal element (65 & 66) is out of the engagement with the propulsion element (when the signal element if moved by the spring 64).
In reference to dependent claim 11, Carlsson discloses the autoinjector according to claim 1, wherein the signal stop (100) is formed by the housing (11) or by an element which is connected to the housing at least in an axially fixed manner, the signal stop being arranged along a longitudinal axis (L) of the housing and in an alignment with the signal element (100 is rotationally fixed by the matching hole/tabs between 100 and 11, see fig 1).
In reference to dependent claim 12, Carlsson discloses the autoinjector according to claim 11, wherein the signal stop (100) is formed by the housing (11) or by the element which is connected to the housing further in a rotationally fixed manner (100 is rotationally fixed by the matching hole/tabs between 100 and 11, see fig 1).
In reference to dependent claim 13, Carlsson discloses the autoinjector according to claim 12, wherein the signal stop (100) is formed by a sealing cap configured to close a proximal end of the housing (100 can be considered a cap of 11).
In reference to dependent claim 14, Carlsson discloses the autoinjector according to claim 1, wherein a needle protection sleeve (10) configured to act on the second spring (90) is displaceable from an initial position relative to the housing along a longitudinal axis of the autoinjector in a proximal direction, in an actuating stroke for triggering the product dispensing, whereby the second spring (90) is biased and the product dispensing is triggered (para 0123-0124 discloses “When the release member 54 is pressed distally, a force is built up in the release member returning spring 90 when it is compressed.
[0124] Then, the injection drive 60, including e.g. the plunger rod 62 and the drive spring 64, is released, and the plunger rod 62 is forced in the proximal direction so as to deliver a dose of medicament through the medicament delivery member at the dose delivery site.”).
In reference to dependent claim 15, Carlsson discloses the autoinjector according to claim 14, further comprising a switching module (54 and 24) arranged kinematically or/and geometrically between the second spring (90) and the needle protection sleeve (10), wherein the switching module is slaved by the needle protection sleeve (10) in the proximal direction when the needle protection sleeve (10) is displaced from a starting position in the proximal direction (para 0086 discloses “release member 54 may comprise a generally tubular distal part arranged with at least one pair of lock arms 55, preferably two pairs on opposite sides, extending in the proximal direction. The two lock arms 55 forming one pair have a small interval between them running in the longitudinal direction. The interval can be of any size as long as the pointed end of the activator leg 30 can wedge in therethrough when the activator 24 is forced distally by the needle guard 10”).
In reference to dependent claim 16, Carlsson discloses the autoinjector according to claim 14, wherein the signal element (65 & 66) comprises a second engagement element (65), which can be moved out of the propulsion element (62) into an axially fixed engagement with the needle protection sleeve (10) or a switching module by movement of a first engagement element (66), wherein the first engagement element (66) and the second engagement element (65) cooperate with one another such that the second engagement element (65) engages axially fixedly in an engagement with the needle protection sleeve (10) or the switching module prior to the first engagement element (66) being disengaged from an engagement with the propulsion element (62; 65 and 66 are axially fixed to 10 as movement of 10 causes the sensors 102 and 101 to be triggered).
In reference to dependent claim 17, Carlsson discloses the autoinjector according to claim 16, wherein the propulsion element (62) is movable in a distal direction relative to the signal element (65 & 66) by means of the first spring (64) when the first engagement element (66) is out of the engagement with the propulsion element (62) and the second engagement element (65) is in the engagement with the needle protection sleeve (10) or the switching module.
In reference to dependent claim 18, Carlsson discloses the autoinjector according to claim 16, wherein the propulsion element (62) prevents the second engagement element from moving out of the axially fixed engagement with the needle protection sleeve (10) or the switching module when the propulsion element (62) moves in a distal direction relative to the signal element (65 & 66), wherein the propulsion element (62) at the end of a product dispensing stroke allows the second engagement element to disengage (65) from the engagement with the needle protection sleeve (10) or the switching module, whereby the signal element (65 & 66) is accelerated by the second spring (90) counter to the dispensing direction and strikes against the signal stop (para 0128 discloses “The proximal movement of the needle guard 10 makes it possible for also the release member 54 to move in the proximal direction. The force stored in the release member returning spring 90 is then released and the release member 54 is pushed in a proximal direction by the release member returning spring 90. Hereby, also the at least one protrusion 59 of the release member 54 is moved away from the at least one start of delivery sensor 101, which is then deactivated.”).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Carlsson (2019/0001069) in view of Schwirtz (USPAP 2016/0144131).
In reference to dependent claim 3, Carlsson discloses the autoinjector according to claim 2, however
Carlsson is silent to the electronic module is connected to the housing of the autoinjector by means of a bayonet lock.
Schwirtz, a similar autoinjector, teaches an activator unit is connected to the housing of the autoinjector by means of a bayonet lock (claim 8 discloses “the activator unit comprises at its distal end a thread or a bayonet lock by which it can be connected to an injector unit”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the bayonet lock as taught in Schwirtz in the autoinjector of Carlsson so it will “not be considerably more complex or costly to produce than prior art activators; it should also be easy and safe to operate as compared with prior art activators and should not have larger outer dimensions” para 0004; Schwirtz.
Conclusion
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pedersen (USPAP 2014/0074041) discloses an injection device monitoring unit.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (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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/CHARLES W NICHOLS/Examiner, Art Unit 3783
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