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 .
Specification
The disclosure is objected to because of the following informalities:
Pg. 4 lines 18-21: “receiving unit” is recited as having the reference character both ‘23’ and ‘24’, where the ‘connection unit’ is also reference character ‘24’.
Pg. 25 line 10: “connection port” is recited as having the reference character ‘32’, pg. 37, the reference character ‘32’ is the counting unit.
Appropriate correction is required.
Drawings
The drawings are objected to because in Figure 2, the reference character ‘10’ does not have an arrow pointing to corresponding structure and should be a consistent referencing system. For reference, Figure 3, ‘30’ is referencing the entire structure, as ‘10’ of Figure 2 should be too. Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “31” has been used to designate both connection port and the container portion in Figures 1 and 3. Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the blocking mechanism, the opening of the blocking unit must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 is rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the exchangeable cartridge" in lines 14-15. There is insufficient antecedent basis for this limitation in the claim.
Additionally, it is unclear as to whether the exchangeable cartridge is the same corresponding structure as the exchangeable reservoir. Under broadest reasonable interpretation without sufficient description of the exchangeable reservoir, it is interpreted that the exchangeable cartridge is the same corresponding structure as the exchangeable reservoir.
Furthermore, it is unclear with the recitation of “a combined counting and blocking assembly”, how the assembly is combined, since the structures are separated between the exchangeable reservoir, and if the counting/ blocking assembly is a different corresponding structure than the counting unit or blocking unit. Under broadest reasonable interpretation, and any recitation thereof, it is interpretated that the counting and blocking assembly are the same as the counting and blocking units, and they are combined in the system, because both mechanisms are present at the same time.
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) 1-3, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Eicher (US 20170128680 A1) in view of Wuttke (EP 3501582 A1).
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Figure 1: annotated Figure 2 of Eicher.
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Figure 2: annotated Figure 3 of Eicher.
Regarding claim 1, Eicher discloses an Inhalation device system for the inhalative administration of a medically active liquid in nebulized form (Eicher [0077]; where the fluid ‘2’ is a liquid in nebulized form that contains a pharmaceutical composition that can be inhaled by a user (inhalative administration of the liquid medicament), [0006]; liquid medicament for the system, Figure 1 above; where the whole figure is the inhalation device system);
the system comprising an inhalation device and an exchangeable reservoir for holding a plurality of doses of the medically active liquid (Figure 1 above; where ‘3’ is an exchangeable reservoir that holds the plurality of doses of medically active liquid ‘2’, Eicher [0078]; where the container (reservoir) ‘3’ is exchangeable and contains multiple doses of the liquid);
wherein the inhalation device comprises - a housing having a receiving unit (Figure 1 above; where ‘16’ is a housing, ‘6’ is a receiving unit that is within the housing ‘16’);
the receiving unit being adapted to receive and fluidically connect to the exchangeable reservoir (Eicher [0087]; where the receiving unit ‘6’ can be fluidly connected to the exchangeable reservoir ‘3’ and the exchangeable reservoir ‘3’ is being reliably held by the receiving unit ‘6’ – thereby being received);
- a nozzle for the nebulization of the medically active liquid; and - a pumping unit arranged within the housing and adapted to be fluidically connected to the exchangeable reservoir and to the nozzle (Figure 1 above; where there is a nozzle ‘12’ that is for the nebulization of medically active liquid (Eicher [0086]), and where ‘5’ is a pumping unit that is a pressure generator for nebulizing the fluid ‘2’ into the mouthpiece, arranged within the housing ‘16’ and is fluidically connected to the exchangeable reservoir ‘3’ and the nozzle ‘12’ by the tube ‘9’);
and being adapted to convey the medically active liquid in a downstream direction from the exchangeable reservoir to the nozzle (Eicher [0086]; where the fluid ‘2’ is nebulized downstream from the exchangeable reservoir to the nozzle ‘12’ thereby defining a downstream direction of the medically active liquid);
characterized in that the inhalation device system comprises a combined counting and blocking assembly comprising a counting unit for counting the number of actuations of the inhalation device system following the insertion of the exchangeable reservoir into the inhalation device (Figure 2 above; ‘25’ is a counting unit, Eicher [0103]; where the counting unit ‘25’ counts the particular actuations of the nebulizer, [0012]; where the exchangeable reservoir (container) has to be inserted to allow the nebulizer to work initially, therefore after the insertion of the exchangeable reservoir into the inhalation device, the counting unit would count an actuation upon use of the nebulizer – therefore following the insertion, Figure 1 above; where ‘8’ is a blocking assembly, making one individual blocking unit ‘8’ comprised of the assembly (2 units together)- where the system is combined because both the blocking unit and counting unit are present);
and a blocking unit for blocking the movement of the exchangeable reservoir from the resting position to the activated position when a defined number of actuations following the insertion of the exchangeable reservoir into the inhalation device is reached (Figure 1 above; where there is a blocking unit ‘8’, Eicher [0085]; ‘8’ where the blocking unit blocks the movement of the receiving unit holding the exchangeable reservoir, [0092]; where the blocking element is in use during “relaxation” (resting position), of the nebulization process, after actuation, [0091]; forcing the spring mechanism to be compressed, because of the blocking unit ‘8’, thereby keeping a resting position, [0092]; where when the spring expands, the pressure forces nebulization (the activated position), [0103]; where after a defined number of actuations the spring can drive or block the actuation of the blocking unit ‘8’ when a certain number of doses has been reached or exceeded – this all would be following the insertion of the exchangeable reservoir into the inhalation device, because [0012]; where the exchangeable reservoir (container) has to be inserted to allow the nebulizer to work initially, therefore after the insertion of the exchangeable reservoir into the inhalation device, the counting unit/ blocking unit would count/ block an actuation upon use/ relaxation of the nebulizer);
wherein the counting unit and the blocking unit are physically separated from each other when the exchangeable cartridge is in the resting position and adapted to physically interact with each other upon each movement of the exchangeable cartridge from the resting position to the activated position (Figure 1 above; where the blocking unit ‘8’, is physically separated from the counting unit ‘25’ of Figure 2 above and Eicher [0201-0207]; where the blocking unit ‘61’ has a resting position when the parts are disconnected, the counting unit sits idle, and you can actuate the device, moving the cartridge ‘3’ forces the blocking and counting unit ‘25’ to physically engage, once the limit of uses or doses has been reached, the blocking unit physically gets in the way, preventing the driving part from fully actuating);
wherein either the blocking unit is attached to the exchangeable reservoir and the counting unit is attached to the housing of the inhalation device or the counting unit is attached to the exchangeable reservoir and the blocking unit is attached to the housing of the inhalation device (Eicher [0112]; where the counting unit ‘25’ is attached to the exchangeable reservoir ‘3’ that is held in a rigid housing ‘29’ for the reservoir, and Figure 1 above; where ‘8’ the blocking unit is attached to the inside of the housing ‘16’ (outer wall) of the inhalation device, Eicher [0123]; attached).
Eicher is silent to one dose of actuation, a connection port with a connection unit and priming of the inhalation device.
Wuttke discloses an inhaler wherein:
one dose of the medically active liquid is dispensed from the inhalation device per actuation of the inhalation device system (Wuttke [0036]; where there is at least about one dose of medically active fluid ‘2’ displaced which helps to nebulize the fluid, where dispensing is per actuation);
the receiving unit having a connection unit adapted to releasably and fluidically connect to a connection port of the exchangeable reservoir (Figure 3 below where there is a receiving unit ‘28’ that has a connection unit (Figure 4 below) ‘24’, where ‘24J’ is the connection port that is releasable and fluidly connect the connection port to the exchangeable reservoir ‘3’ (Figure 3 above), Wuttke [0242]; where the connection port ‘24J’ is for filling the exchangeable reservoir ‘3’ (fluidically connected), releasably connected when the connecting element ‘9’ is displaced into ‘24J’ in order for the fluid to be displaced downstream in the device, Wuttke [0254]);
and being adapted to move the exchangeable reservoir from a resting position to a primed position upon priming of the pumping unit (Wuttke [0091-0092]; where loading the nebulizer withdraws fluid or a dose of fluid to dispense, where the mechanical energy has been stored, then released and the nebulizer is able to dispense pressurized liquid – actions of priming, where the resting position is when the mechanical energy of the device is stored, and the priming is when the tensioning is released, where the exchangeable reservoir ‘3’ that holds the fluid ‘2’ moves from a resting position to a priming position, where the pumping unit is ‘5’ the pump/ pressure generator (Wuttke [0011])).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the inhalation device of Eicher to include a connection unit with a connection port, one dose being actuated, and priming the inhalation device as taught by Wuttke, since, a connection port is useful for the fluid connection between the exchangeable reservoir and the nozzle of the device (Wuttke [0242]), since one dose being actuated helps there to be a displacement volume of the medically active liquid making it nebulized (Wuttke [0036]), and since priming the inhalation device allows for the nozzle to release pressurized medically active liquid and for it to be nebulized, which is normal use of the inhalation device (Wuttke [0091-0092]).
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Figure 3: annotated Figure 2 of Wuttke.
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Figure 4: annotated Figure 4 Wuttke.
Regarding claim 2, modified Eicher further discloses the inhalation device system according to claim 1, wherein the counting unit is attached to the housing of the inhalation device and wherein the blocking unit is attached to the exchangeable reservoir (Eicher [0112]; where the counting unit ‘25’ is attached to the exchangeable reservoir ‘3’ that is held in a rigid housing ‘29’ for the reservoir, and Figure 1 above; where ‘8’ the blocking unit is attached to the inside of the housing ‘16’ (outer wall) of the inhalation device, [0123]; attached).
There is no evidence of record that establishes that changing the orientation of the blocking and counting unit, would result in a functional difference of the modified Eicher device. Further, a person having ordinary skill in the art, being faced with modifying the inhalation device of modified Eicher, would have a reasonable expectation of success in making such a modification and it appears the system would function as intended being given the claimed orientations of the inhalation device with the counting and blocking units. Lastly, Applicant has not disclosed that the claimed orientation of the counting and blocking units, solves any stated problem, that such an orientation produces an unexpected result, and multiple orientations are provided for the counting and blocking units (Specification pg. 23-24, lines 19-34 and 1-25).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the inhalation device of modified Eicher to have the exact orientations of the claimed inhalation device as an obvious matter of design choice within the skill of the art.
Regarding claim 3, modified Eicher further discloses the inhalation device system according to claim 1, wherein the exchangeable reservoir is in the form of an exchangeable cartridge having an upstream end and a downstream end and the blocking unit is attached to the upstream end of the exchangeable cartridge (Eicher [0081]; where the exchangeable reservoir ‘3’ is a cartridge, Figure 1 above; where the upstream end is the end of the cartridge that is conveying the medically active liquid ‘2’, and downstream is opposite to the upstream direction, Figure 2 above; where the blocking unit ‘8’ is attached at the upstream end of the exchangeable cartridge to the receiving unit ‘6’ holding the cartridge ‘3’).
Regarding claim 13, modified Eicher further discloses an exchangeable cartridge system for the inhalation device system comprising the combined counting and blocking assembly according to claim 1 for holding the medically active liquid for nebulization and adapted for use in the inhalation device system according to claim 1 (Figure 1 above; where ‘3’ is an exchangeable reservoir that holds the plurality of doses of medically active liquid ‘2’, Eicher [0078]; where the container (reservoir) ‘3’ is exchangeable and contains multiple doses of the liquid, [0081]; the reservoir ‘3’ is substantially cartridge-shaped, Figure 2 above; ‘25’ is a counting unit, Eicher [0103]; where the counting unit ‘25’ counts the particular actuations of the nebulizer, [0012]; where the exchangeable reservoir (container) has to be inserted to allow the nebulizer to work initially, therefore after the insertion of the exchangeable reservoir into the inhalation device, the counting unit would count an actuation upon use of the nebulizer, Figure 1 above; where ‘8’ is a blocking assembly, making one individual blocking unit ‘8’ comprised of the assembly (2 units together)- where the system is combined because both the blocking unit and counting unit are present, Eicher [0077]; where the fluid ‘2’ is a liquid in nebulized form that contains a pharmaceutical composition that can be inhaled by a user (inhalative administration of the liquid medicament), [0006]; liquid medicament for the system, Figure 1 above; where the whole figure is the inhalation device system, and see claim 1 above for inhalation device system);
wherein the cartridge system comprises a container portion having an effective volume Ve for holding the medically active liquid (Eicher [0078]; where the container ‘3’ has an effective volume of 0.5-20mL, [0102]; where the housing part ‘18’ forms a cap-like portion onto the cartridge ‘3’);
and a connection port adapted to releasably and fluidically connect the cartridge system to the pumping unit, specifically via the connection unit of the receiving unit of the inhalation device ((Eicher [0086]), and where ‘5’ is a pumping unit that is a pressure generator for nebulizing the fluid ‘2’ into the mouthpiece, as modified Wuttke contains the connection port: Figure 3 below where there is a receiving unit ‘28’ that has a connection unit (Figure 4 below) ‘24’, where ‘24J’ is the connection port that is releasable and fluidly connect the connection port to the exchangeable reservoir ‘3’ (Figure 3 above), Wuttke [0242]; where the connection port ‘24J’ is for filling the exchangeable reservoir ‘3’ (fluidically connected), releasably connected when the connecting element ‘9’ is displaced into ‘24J’ in order for the fluid to be displaced downstream in the device, Wuttke [0254], Wuttke Figure 5; where ‘5’ is the pumping unit that is fluidly connected to the connection port ‘24J’, Eicher [0087]; where the receiving unit ‘6’ can be fluidly connected to the exchangeable reservoir ‘3’ and the exchangeable reservoir ‘3’ is being reliably held by the receiving unit ‘6’ – thereby being received);
wherein the cartridge system comprises the blocking unit adapted to interact with the counting unit of the inhalation device system comprising the combined counting and blocking assembly according to claim 1 (Figure 1 above; where the blocking unit ‘8’, is physically separated from the counting unit ‘25’ of Figure 2 above and Eicher [0201-0207]; where the blocking unit ‘61’ has a resting position when the parts are disconnected, the counting unit sits idle, and you can actuate the device, moving the cartridge ‘3’ forces the blocking and counting unit ‘25’ to physically engage, once the limit of uses or doses has been reached, the blocking unit physically gets in the way, preventing the driving part from fully actuating – combined because they are both present, [0081]; the reservoir ‘3’ is substantially cartridge-shaped).
Regarding claim 14, modified Eicher further discloses an inhalation device for the inhalation device system comprising the combined counting and blocking assembly according to claim 1 (see claim 1 above), wherein the inhalation device comprises at least one of:
- the counting unit adapted to interact with the blocking unit of the combined counting and blocking assembly according to claim 1 (Figure 1 above; where the blocking unit ‘8’, is physically separated from the counting unit ‘25’ of Figure 2 above and Eicher [0201-0207]; where the blocking unit ‘61’ has a resting position when the parts are disconnected, the counting unit sits idle, and you can actuate the device, moving the cartridge ‘3’ forces the blocking and counting unit ‘25’ to physically engage, once the limit of uses or doses has been reached, the blocking unit physically gets in the way, preventing the driving part from fully actuating – combined because they are both present);
and/or - the blocking unit, adapted to interact with the counting unit of the combined counting and blocking assembly according to claim 1 (Figure 1 above; where the blocking unit ‘8’, is physically separated from the counting unit ‘25’ of Figure 2 above and Eicher [0201-0207]; where the blocking unit ‘61’ has a resting position when the parts are disconnected, the counting unit sits idle, and you can actuate the device, moving the cartridge ‘3’ forces the blocking and counting unit ‘25’ to physically engage, once the limit of uses or doses has been reached, the blocking unit physically gets in the way, preventing the driving part from fully actuating – combined because they are both present).
Claims 4-12 are rejected under 35 U.S.C. 103 as being unpatentable over Eicher (US 20170128680 A1) in view of Wuttke (EP 3501582 A1), further in view of Decock (WO 2021084092 A1).
Regarding claim 4, modified Eicher further discloses the inhalation device system according to claim 1.
Modified Eicher is silent to the blocking unit having a housing containing a blocking mechanism.
Decock discloses a dispensing device wherein:
the blocking unit has a housing containing a blocking mechanism (Decock [0067]; where the blocking unit (locking means ‘303’) has a pin ‘334’ (blocking mechanism) that extends through an opening in the lower wall (housing) of the locking means ‘303’, such that it drives the locking means (blocking unit) from a locking to an unlocking position, Decock Figure 5A).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the inhalation device of modified Eicher to include a blocking mechanism with a blocking unit as taught by Decock, since, the pin helps to put the device into a locked or unlocked position (Decock [0067]), which helps to reduce the risk of product distribution occurring accidentally, to control conditions of disengagement of the device (Decock [0020]).
Regarding claim 5, modified Eicher in view of Decock further discloses the inhalation device system according to claim 4, comprising interaction between the counting unit and the blocking mechanism (Eicher [0201-0207]; where the blocking unit ‘61’ has a resting position when the parts are disconnected, the counting unit sits idle, and you can actuate the device, moving the cartridge ‘3’ forces the blocking and counting unit ‘25’ to physically engage, once the limit of uses or doses has been reached, the blocking unit physically gets in the way, preventing the driving part from fully actuating).
Modified Eicher fails to disclose the housing of the blocking unit comprising an opening.
Decock discloses the dispensing device wherein:
the housing of the blocking unit comprises an opening (Decock [0067]; where the blocking unit (locking means ‘303’) has a pin ‘334’ (blocking mechanism) that extends through an opening in the lower wall (housing) of the locking means ‘303’, such that it drives the locking means (blocking unit) from a locking to an unlocking position, Decock Figure 5A).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the inhalation device of modified Eicher to include an opening on the housing of the blocking unit as taught by Decock, since, the opening allows for a pin to go through and directly allow for a locking and unlocking position of the device in terms of actuation (Decock [0067]), which helps to reduce the risk of product distribution occurring accidentally, to control conditions of disengagement of the device (Decock [0020]).
Regarding claim 6, modified Eicher in view of Decock further discloses the inhalation device system according to claim 4, wherein the counting unit comprises a counting mechanism and an activation mechanism (Eicher [0127]; where the counting unit ‘25’ has an indicator element ‘35’ (counting mechanism) and an activation element ‘36’ (activation mechanism: ‘25’+’35’+’36’)).
Regarding claim 7, modified Eicher in view of Decock further discloses the inhalation device system according to claim 6.
Modified Eicher discloses:
wherein the activation mechanism interacts with the blocking unit (Eicher [0246], [0204], [0205], [0202]; activation mechanism ’25,35,36’ interacting with the blocking unit ‘8’ and blocking part ‘61’).
Modified Eicher is silent to a blocking mechanism with the blocking unit.
Decock discloses:
the blocking mechanism with the blocking unit (Decock [0067]; where the blocking unit (locking means ‘303’) has a pin ‘334’ (blocking mechanism) that extends through an opening in the lower wall (housing) of the locking means ‘303’, such that it drives the locking means (blocking unit) from a locking to an unlocking position, Decock Figure 5A).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the inhalation device of modified Eicher to include a blocking mechanism with a blocking unit as taught by Decock, since, the pin helps to put the device into a locked or unlocked position (Decock [0067]), which helps to reduce the risk of product distribution occurring accidentally, to control conditions of disengagement of the device (Decock [0020]).
Regarding claim 8, modified Eicher in view of Decock further discloses the inhalation device system according to claim 6, wherein the activation mechanism comprises an activation member for interaction with the blocking mechanism of the blocking unit, wherein said activation member is moveable and a position of the activation member changes with each actuation of the inhaler device system (Eicher [0127]; where an activation element ‘41’ (gear) is provided with the activation mechanism (’25,35,36’), [0161]; the activation element and mechanism are movable and the position changes with a movement of actuation, moves the indicator element, changing the counter number, Eicher [0246], [0204], [0205], [0202]; activation mechanism ’25,35,36’ interacting with the blocking unit ‘8’ and blocking part ‘61’, as modified with Decock, the blocking unit comprising the blocking mechanism: Decock [0067]; where the blocking unit (locking means ‘303’) has a pin ‘334’ (blocking mechanism) that extends through an opening in the lower wall (housing) of the locking means ‘303’, such that it drives the locking means (blocking unit) from a locking to an unlocking position, Decock Figure 5A).
Regarding claim 9, modified Eicher in view of Decock further discloses the inhalation device system according to claim 8, wherein the activation member is moving gradually or step-wise with each actuation (Eicher [0036]; where the counting unit ‘25’ comprises a rotatable indicator element with markings that appears in a stepwise window, [0130]; where the actuation element ‘36’ (activation member) is indexed and moves forwards in increments or steps with the activation mechanism – for each actuation, [0329]).
Regarding claim 10, modified Eicher further in view of Decock further discloses the inhalation device system according to claim 8, wherein the activation member of the blocking unit enters the opening of the blocking unit for interaction with the blocking mechanism upon movement of the exchangeable reservoir from the resting position to the primed position (Eicher [0216]; where the activation member ‘36’ blocks further use of the container ‘3’ in a locked state / blocking position, [0194]; where the activation member goes through an opening, as modified: Wuttke [0091-0092]; where loading the nebulizer withdraws fluid or a dose of fluid to dispense, where the mechanical energy has been stored, then released and the nebulizer is able to dispense pressurized liquid – actions of priming, where the resting position is when the mechanical energy of the device is stored, and the priming is when the tensioning is released, where the exchangeable reservoir ‘3’ that holds the fluid ‘2’ moves from a resting position to a priming position, where the pumping unit is ‘5’ the pump/ pressure generator (Wuttke [0011]) and as further modified: Decock [0067]; where the blocking unit (locking means ‘303’) has a pin ‘334’ (blocking mechanism) that extends through an opening in the lower wall (housing) of the locking means ‘303’, such that it drives the locking means (blocking unit) from a locking to an unlocking position).
Regarding claim 11, modified Eicher in view of Decock further discloses the inhalation device system according to claim 6.
Eicher discloses:
wherein the counting mechanism is operated by interaction with the blocking unit upon movement of the exchangeable reservoir from the resting position to the active position (Eicher [0127]; where the counting unit ‘25’ has an indicator element ‘35’ (counting mechanism), Figure 1 above; where the blocking unit ‘8’, is physically separated from the counting unit ‘25’ of Figure 2 above and Eicher [0201-0207]; where the blocking unit ‘61’ has a resting position when the parts are disconnected, the counting unit sits idle, and you can actuate the device, moving the cartridge ‘3’ forces the blocking and counting unit ‘25’ to physically engage, once the limit of uses or doses has been reached, the blocking unit physically gets in the way, preventing the driving part from fully actuating).
Eicher fails to disclose a primed position.
Wuttke discloses:
movement of the exchangeable reservoir from the resting position to the primed position (Wuttke [0091-0092]; where loading the nebulizer withdraws fluid or a dose of fluid to dispense, where the mechanical energy has been stored, then released and the nebulizer is able to dispense pressurized liquid – actions of priming, where the resting position is when the mechanical energy of the device is stored, and the priming is when the tensioning is released, where the exchangeable reservoir ‘3’ that holds the fluid ‘2’ moves from a resting position to a priming position, where the pumping unit is ‘5’ the pump/ pressure generator (Wuttke [0011])).
Regarding claim 12, modified Eicher in view of Decock further discloses the inhalation device system according to claim 8.
Modified Eicher discloses:
wherein the blocking unit limits the space for the activation member after a predefined number of uses so that movement of the exchangeable reservoir into the primed position is no longer possible (Eicher [0199]; where the movement of the activation member ‘36’ is restricted, [0008]; the container ‘3’ (exchangeable reservoir) is locked when a predetermined number of uses has been reached or exceeded, [0204]; space is limited with the blocking position because it blocks the counting unit ‘25’, as modified a primed position: Wuttke [0091-0092]; where loading the nebulizer withdraws fluid or a dose of fluid to dispense, where the mechanical energy has been stored, then released and the nebulizer is able to dispense pressurized liquid – actions of priming, where the resting position is when the mechanical energy of the device is stored – if the actuation member is blocked/ locked, then there would be no primed position, because the device is not actuating also).
Modified Eicher is silent to a blocking mechanism.
Decock discloses:
the blocking unit comprising the blocking mechanism (Decock [0067]; where the blocking unit (locking means ‘303’) has a pin ‘334’ (blocking mechanism) that extends through an opening in the lower wall (housing) of the locking means ‘303’, such that it drives the locking means (blocking unit) from a locking to an unlocking position, Decock Figure 5A).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the inhalation device of modified Eicher to include a blocking mechanism with a blocking unit as taught by Decock, since, the pin helps to put the device into a locked or unlocked position (Decock [0067]), which helps to reduce the risk of product distribution occurring accidentally, to control conditions of disengagement of the device (Decock [0020]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Eicher (US 20150320948 A1): inhalation device with a similar connection unit and port.
Eicher (CN 108348701 A): inhalative device with a similar opening and blocking/ counting unit.
Augustyn (WO 2005079727 A2): counter for use with a medicament dispenser with locking means.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AISLINN MOIRA JONES whose telephone number is (571)272-3835. The examiner can normally be reached Monday-Friday 7:30-5, EO Friday 7:30-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at 5712707410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AISLINN M JONES/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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