DETAILED ACTION
This Office Action is in response to the filing of a amendments to the claims on 11/12/2025. As per the amendments, claims 90, 104, and 112 have been amended, claim 103 has been cancelled, and no claims have been added. Thus, claims 90-92, 94-97, 99, 101-102, 104, 106, and 108-113 are pending in the application.
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 .
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.
Claims 90-92, 94-95, 97, 101-102, 104, 108, and 110-113 are rejected under 35 U.S.C. 103 as being unpatentable over Allan et al. (US Pat. 6,871,647) in view of Akouka et al. (US Pat. 8,991,390).
Regarding claim 90, Allan discloses a device for releasing discrete doses of medicament (see abstract) carried in a plurality of compartments (compartments 70 in Fig. 4) on a medicament carrier (cartridge base 55, base foil 60, perforated layer 80, and lidding foil 90 together as seen in Fig. 4), each compartment from the plurality of compartments being arranged spaced apart from each other in a carrier (see Fig. 4 where each compartment 70 is spaced some radial distance apart from the adjacent compartment 70), the plurality of compartments being sealed by a single sealing layer on the first side of the carrier of the medicament carrier covering an open end of each compartment from the plurality of compartments (see Fig. 4 where the compartments 70 of base foil 60 are sealed by a single sealing layer of lidding foil 90 which is arranged on a first side (the top side) of the base foil 60 so as to cover the open top end of each compartment), the device comprising: a release mechanism (see Figs. 5 and 10, openers 86/87) arranged to engage between the carrier and the single sealing layer so as to unseal at least a portion of a compartment from the plurality of compartments on a first side of the carrier and expose a medicament dose contained therein (see Figs. 4-5 and Col. 3 lines 11-19 and Col. 4 lines 30-51 where the openers 86/87 open the compartments 70 by lifting the lidding foil 90 on the top side of the carrier to expose the medicament within), wherein the release mechanism comprises two release members (see Figs. 5 and 10, where each opener 86 and 87 are separate release members of the release mechanism), each positioned on the device to engage the medicament carrier between the compartment from the plurality of compartments on the first side of the carrier strip and the single sealing layer of the medicament carrier to remove at least a portion of the sealing layer from the medicament carrier (see Figs. 4-5 and Col. 3 lines 11-19 and Col. 4 lines 30-51 where each of the openers 86/87 are placed so that the wedge sits between the lidding foil 90 and perforated layer 80, so as to separate the lidding foil from each compartment 70), exposing the compartment from the plurality of compartments on the first side of the carrier and the medicament dose contained therein (see Figs. 4-5 and 10-11 as well as Col. 3 lines 11-19 and Col. 4 lines 30-51 where each opener 86/87 is arranged to act between base foil 60 and sealing foil 90, in order to lift the sealing foil 90 to expose the medicament in compartments 70, through perforated layer 80, on the top side of the compartment); wherein each of the two release members is further positioned on the device to engage between the first side of the carrier and the single sealing layer of the medicament carrier such that the carrier passes beneath each of the two release members (see Figs. 4-5 and 10-11 as well as Col. 3 lines 11-19 and Col. 4 lines 30-51 where each opener 86/87 is arranged to act between base foil 60 and sealing foil 90, in order to lift the sealing foil 90 to expose the medicament, which is done by the openers 86/87, and the base foil 60 passes beneath the openers) and the single sealing layer passes over each of the two release members (see Figs. 4-5 and 10-11 as well as Col. 3 lines 11-19 and Col. 4 lines 30-51 where each opener 86/87 is arranged to act between base foil 60 and sealing foil 90, in order to lift the sealing foil 90 to expose the medicament, which is done by the openers 86/87 passing beneath the sealing foil 90), wherein: the release mechanism is arranged to remove at least a portion of the sealing layer covering the compartment from the plurality of compartments and to cover the compartment from the plurality of compartments in place of the removed portion of the sealing layer (see Col. 4 lines 30-51 and Figs. 4-5 and 10-11 where the bottom surface of the openers 86/87 passes over the perforated layer 80 at the location where the lidding foil 90 is pulled away from the perforated layer 80, thus causing some amount of sealing over at least a portion of the compartment 70 that lies below and is blocked by the openers as they pass by), and the release mechanism is further arranged to provide a fluid conduit configured to pass air into or through the compartment from the plurality of compartments so as to aerosolize the medicament contained therein (see Figs. 4-5 and 10-11 and also Col. 4 lines 30-51 where openers 86/87 lift the lidding foil 90 on the inner and outer sections, creating a fluid conduit path from which the powder is able to escape the compartments 70 through perforated layer 80, the powder being entrained into the air to at least partially aerosolize).
Allan lacks a detailed description of wherein the plurality of compartments are carried on a carrier strip (where Allan teaches a carrier disk, but not necessarily a strip).
However, Akouka teaches a similar medicament inhalation system, wherein the plurality of compartments are carried on a carrier strip (see Figs. 4-5 where a cartridge 120 contains a blister strip 130, formed as a strip with a plurality of individual blisters 131 and a film 135 over the blister depressions, and arranged in a roughly ring-like shape (see Fig. 5 where the shape of blister strip 130 is roughly ring-like); see also Col. 8 lines 5-10 where a cartridge with a blister strip is similar to and a replacement for a rotary cassette).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disk-shaped medicament carrier of Allan (e.g. Fig. 4) to be a carrier strip containing the compartments of medicament as taught by Akouka, as it would be a simple substitution of one type of blister carrier for another, to yield the predictable result of providing a series of medicament blisters that can be indexed and individually opened to access the medicament. It is understood that in the modified Allan device, the blister carrier mechanism of Allan (see Fig. 4, the disk-shaped elements substantially including 55, 60, 80, and 90) is instead arranged as a curved strip rather than a disk as taught by Akouka (Allan; for example, by cutting the segment at cut-outs 58, 63, 83 in Fig. 4 so that the disk is no longer continuous, and becomes a curved strip).
Regarding claim 91, the modified Allan device has wherein the carrier strip passes through the release mechanism when engaged (Allan; see Figs. 5 and 10-11 where base 55, foil 60, layer 80, and foil layer 90 (as modified to be a strip in light of Akouka) is indexed such that they interface with and pass through the openers 86/87 in order to be engaged and expel the medicament; see also Col. 4 lines 30-51).
Regarding claim 92, the modified Allan device has wherein the release mechanism is arranged to separate the sealing layer from the carrier strip such that the sealing layer is detached from the carrier strip over the compartment from the plurality of compartments thereby exposing the compartment from the plurality of compartments (Allan; see Figs. 4-5 and 10-11, as well as Col. 4 lines 30-51 where the openers 86/87 act to push up and separate lidding foil layer 90 from the perforated layer 80 of the modified carrier strip, detaching lidding foil and inner and outer surfaces 90a/90b to expose the medicament).
The modified Allan device lacks a detailed description of the sealing layer is completely detached across a full width of the carrier strip.
However, Akouka further teaches the similar medicament inhaling device, where a film covering a blister strip compartment is completely removed from the entire width of the blister strip, and received by a take-up spool (see Col. 8 lines 44-50 and Fig. 7A where film removal device 141 removes the film from the blister strip to be taken by the take-up spool 145).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the foil/ film removal of the modified Allan device to completely remove the foil as taught by Akouka, as it would be a simple substitution of one foil removal mechanism for another, to yield the predictable result of still removing the foil from the compartments to entrain the medicament.
Regarding claim 94, the modified Allan device has wherein each release member has a lower surface arranged to pass closely over each compartment from the plurality of compartments in the carrier strip as the medicament carrier is advanced through the release mechanism (Allan; see Figs. 4-5 and 10-11 and also Col. 4 lines 30-51 where openers 86/87 are wedge-shaped, and have a flat bottom surface that, when lifting the lidding foil 90 up, passes closely over the top of the perforated layer 80 as the carrier passes through the openers) so as to substantially seal the portion of the compartment from the plurality of compartments where the sealing layer is removed (Allan; see Col. 4 lines 30-51 and Figs. 4-5 and 10-11 where the bottom surface of the openers 86/87 passes over the perforated layer 80 at the location where the lidding foil 90 is pulled away from the perforated layer 80, thus causing some amount of sealing over at least a portion of the compartment 70 that lies below and is blocked by the openers as they pass by).
Regarding claim 95, the modified Allan device has wherein each release member has a leading edge arranged to engage between the carrier strip and sealing layer so as to separate the sealing layer from the carrier strip as the carrier moves past the release mechanism (Allan; see Figs. 4-5 and 10-11 and Col. 4 lines 30-51 where each opener 86/87 has an edge that first comes into contact with and lifts the lidding foil 90 during the rotational movement, this edge being a leading edge that engages between the lidding foil 90 and perforated layer 80 to lift the lidding foil 90 from the rest of the modified carrier strip as the compartment moves through the openers 86/87).
Regarding claim 97, the modified Allan device has wherein each release member has a leading edge configured to conform in part to a shape of a perimeter of each compartment from the plurality of compartments (Allan; see Figs. 4-5 and 10-11 and Col. 4 lines 30-51 where each opener 86/87 has an edge that first comes into contact with and lifts the lidding foil 90 during the rotational movement, the leading edge including a bottom portion that runs along in close proximity to the perforated layer 80 (the bottom flat surface of the openers 86/87 having a leading edge part), such that conforms in part (which is broad, and any amount of “conforming” is understood to be “in part”) to the compartment 70 which it partially covers as the openers pass by).
Regarding claim 101, the modified Allan device has wherein the two release members are arranged in a substantially opposed configuration, such that they are opposed across a width of the medicament carrier (Allan; see Fig. 5 where each opener 86/87 is located opposed one another along a width, so as to be oppositely opposed).
Regarding claim 102, the modified Allan device has wherein the release mechanism comprises two separable parts that are configured to be coupled together so as to engage with the medicament carrier (Allan; see Figs. 4-5 and 10-11 where the two openers 86/87 are separated from one another into two distinct openers, which act together as a couple for removing lidding foil 90 and are connected to one another through lower cover 51).
Regarding claim 104, Allan discloses a device for releasing discrete doses of medicament (see abstract) carried in a plurality of spaced-apart compartments (compartments 70 in Fig. 4) on a medicament carrier (cartridge base 55, base foil 60, perforated layer 80, and lidding foil 90 together as seen in Fig. 4), each compartment from the plurality of compartments being arranged spaced apart from each other in a carrier (see Fig. 4 where each compartment 70 is spaced some radial distance apart from the adjacent compartment 70) and sealed by a sealing layer (see Fig. 4 lidding foil 90), the device comprising: a release mechanism (see Figs. 5 and 10, openers 86/87 acting together with the bonding of the lidding foil 90 to the perforated layer 80 as seen in Col. 3 lines 1-5) arranged to engage between the carrier and the sealing layer so as to unseal at least a portion of a compartment from the plurality of compartments and expose a medicament dose contained therein (see Figs. 4-5 and Col. 3 lines 11-19 and Col. 4 lines 30-51 where the openers 86/87 open the compartments 70 by lifting the lidding foil 90 on the top side of the carrier to expose the medicament within), wherein the release mechanism comprises at least one release member (see Figs. 5 and 10, where each opener 86 and 87 are separate release members of the release mechanism) arranged to engage between the compartment and the sealing layer such that the carrier passes beneath the at least one release member (see Figs. 4-5 and 10-11 as well as Col. 3 lines 11-19 and Col. 4 lines 30-51 where each opener 86/87 is arranged to act between base foil 60 and sealing foil 90, in order to lift the sealing foil 90 to expose the medicament, which is done by the openers 86/87, and the base foil 60 passes beneath the openers) and the sealing layer passes over the at least one release member (see Figs. 4-5 and 10-11 as well as Col. 3 lines 11-19 and Col. 4 lines 30-51 where each opener 86/87 is arranged to act between base foil 60 and sealing foil 90, in order to lift the sealing foil 90 to expose the medicament, which is done by the openers 86/87 passing beneath the sealing foil 90) to remove at least a first portion of the sealing layer covering the compartment (see Figs. 4-5 and Col. 4 lines 30-51 where each of the openers 86/87 lift a first part of the lidding foil 90 at an inner section 90a), and wherein the release mechanism comprises means for engaging with a second portion of the sealing layer covering the compartment (see Col. 3 lines 1-5 where there is a bonding means for holding the lidding foil onto the perforated layer 80 over the compartments 70) as the at least one release member engages between the compartment and the sealing layer to remove the first portion of the sealing layer from the compartment such that contact is maintained between the second portion of the sealing layer and the carrier (see Fig. 4 and Col. 4 lines 30-51 where the openers 86/87 only partially lift the lidding foil 90, at inner and outer sections 90a/90b, such that the center of the lidding foil 90 remains bonded to the perforated layer 80 during use of the openers 86/87), wherein: the release mechanism is arranged to remove at least a portion of the sealing layer covering the compartment from the plurality of compartments and to cover the compartment from the plurality of compartments in place of the removed portion of the sealing layer (see Col. 4 lines 30-51 and Figs. 4-5 and 10-11 where the bottom surface of the openers 86/87 passes over the perforated layer 80 at the location where the lidding foil 90 is pulled away from the perforated layer 80, thus causing some amount of sealing over at least a portion of the compartment 70 that lies below and is blocked by the openers as they pass by), and the release mechanism is further arranged to provide a fluid conduit configured to pass air into or through the compartment from the plurality of compartments so as to aerosolize the medicament contained therein (see Figs. 4-5 and 10-11 and also Col. 4 lines 30-51 where openers 86/87 lift the lidding foil 90 on the inner and outer sections, creating a fluid conduit path from which the powder is able to escape the compartments 70 through perforated layer 80, the powder being entrained into the air to at least partially aerosolize).
Allan lacks a detailed description of wherein the plurality of compartments are carried on a carrier strip (where Allan teaches a carrier disk, but not necessarily a strip).
However, Akouka teaches a similar medicament inhalation system, wherein the plurality of compartments are carried on a carrier strip (see Figs. 4-5 where a cartridge 120 contains a blister strip 130, formed as a strip with a plurality of individual blisters 131 and a film 135 over the blister depressions, and arranged in a roughly ring-like shape (see Fig. 5 where the shape of blister strip 130 is roughly ring-like); see also Col. 8 lines 5-10 where a cartridge with a blister strip is similar to and a replacement for a rotary cassette).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disk-shaped medicament carrier of Allan (e.g. Fig. 4) to be a carrier strip containing the compartments of medicament as taught by Akouka, as it would be a simple substitution of one type of blister carrier for another, to yield the predictable result of providing a series of medicament blisters that can be indexed and individually opened to access the medicament. It is understood that in the modified Allan device, the blister carrier mechanism of Allan (see Fig. 4, the disk-shaped elements substantially including 55, 60, 80, and 90) is instead arranged as a curved strip rather than a disk as taught by Akouka (Allan; for example, by cutting the segment at cut-outs 58, 63, 83 in Fig. 4 so that the disk is no longer continuous, and becomes a curved strip).
Regarding claim 108, the modified Allan device has wherein a separated portion of the sealing layer and a separated portion of the carrier strip are brought back together once the compartment from the plurality of compartments that has been unsealed by the first portion of the sealing layer has moved past the at least one release member (Allan; see Col. 4 lines 30-51 where, after the lidding foil 90 is lifted by openers 86/87, the lidding foil is brought back into position to cover the perforated layer 80 by being pushed by trailing bar 47).
Regarding claim 110, the modified Allan device has wherein the at least one release member includes a first release member (Allan; a first of openers 86/87) and a second release member (Allan; a second of openers 86/87), the first release member and the second release member are each arranged to engage between the compartment and the sealing layer (Allan; see Fig. 4 and Col. 4 lines 30-51 where the openers 86/87 engage between the lidding foil 90 and the perforated layer 80) such that the carrier strip passes beneath each of the first release member and the second release member (Allan; see Figs. 4-5 and 10-11 as well as Col. 3 lines 11-19 and Col. 4 lines 30-51 where each opener 86/87 is arranged to act between base foil 60 and sealing foil 90, in order to lift the sealing foil 90 to expose the medicament, which is done by the openers 86/87, and the base foil 60 passes beneath the openers, and thus the modified carrier strip passes beneath the openers) and the sealing layer passes over the first release member and the second release member (Allan; see Figs. 4-5 and 10-11 as well as Col. 3 lines 11-19 and Col. 4 lines 30-51 where each opener 86/87 is arranged to act between base foil 60 and sealing foil 90, in order to lift the sealing foil 90 to expose the medicament, which is done by the openers 86/87 passing beneath the sealing foil 90) to remove the first portion of the sealing layer from the compartment and a third portion of the sealing layer from the compartment (Allan; see Col. 4 lines 30-51 where the openers 86/87 remove inner and outer portions 90a/90b of lidding foil 90 from the area above the compartment 70), wherein the means for engaging with the second portion of the sealing layer engages with the second portion of the sealing layer as the first release member and the second release member engage between the compartment and the sealing layer (Allan; see Col 3 lines 1-5 and Col. 4 lines 30-51 where the lidding foil 90 is bonded to the perforated layer 80, including at a central point over the compartments 70 that is not lifted by the openers 86/87, such that it maintains the bonded engagement while the openers 86/87 lift inner and outer sections 90a/90b).
Regarding claim 111, the modified Allan device has wherein: the means for engaging with the second portion of the sealing layer as the at least one release member engages between the compartment and the sealing layer is positioned at a longitudinal centerline of the carrier strip (Allan; see Fig. 4 and Col. 3 lines 1-5 and Col. 4 lines 30-51 where the lidding foil 90 has a bonding that holds it against the perforated layer 80, such that engagement between the lidding foil 90 and perforated layer 80 occurs along its width, and in particular along a centerline when the openers 86/87 lift the inner and outer sections 90a/90b).
Regarding claim 112, Allan discloses a device for releasing discrete doses of medicament (see abstract) carried in a plurality of compartments (compartments 70 in Fig. 4) on a medicament carrier (cartridge base 55, base foil 60, perforated layer 80, and lidding foil 90 together as seen in Fig. 4), each compartment from the plurality of compartments being arranged spaced apart from each other in a carrier (see Fig. 4 where each compartment 70 of base foil 60 is spaced some radial distance apart from the adjacent compartment 70) and sealed by a sealing layer (see Fig. 4 lidding foil 90), the carrier having a length (see Fig. 4 the circumferential length of base foil 60, from a first part of cut-out 63, to the other part of cut-out 63), width (see Fig. 4 the width of base foil 60) and a depth (see Fig. 4 the depth of base foil 60), the length being greater than the width (see Fig. 4 where the circumferential length of the base foil 60 is greater than the width), the width being greater than the depth (see Fig. 4 where the width of the base foil 60 is greater than the depth), the device comprising: a release mechanism (see Figs. 5 and 10, openers 86/87) arranged to engage between the carrier and the sealing layer so as to unseal at least a portion of a compartment from the plurality of compartments and expose a medicament dose contained therein (see Figs. 4-5 and Col. 3 lines 11-19 and Col. 4 lines 30-51 where the openers 86/87 open the compartments 70 by lifting the lidding foil 90 on the top side of the carrier to expose the medicament within), wherein the release mechanism comprises a first release member and a second release member (see Figs. 5 and 10, where each opener 86 and 87 are separate release members of the release mechanism), the first release member arranged to engage from a first side of the width of the carrier between the compartment from the plurality of compartments and the sealing layer of the medicament carrier (see Figs. 4-5 and Col. 4 lines 30-51 where opener 87 acts on a first side of the carrier to lift inner section 90a of lidding foil 90, being at one side of the width) and the second release member arranged to engage from a second, opposite side of the width of the carrier between the compartment from the plurality of compartments and the sealing layer of the medicament carrier to remove at least a portion of the sealing layer from the medicament carrier (see Figs. 4-5 and Col. 4 lines 30-51 where opener 86 acts on a second side of the carrier to lift outer section 90b of lidding foil 90, being at another side of the width), wherein: the release mechanism is arranged to remove at least a portion of the sealing layer covering the compartment from the plurality of compartments and to cover the compartment from the plurality of compartments in place of the removed portion of the sealing layer (see Col. 4 lines 30-51 and Figs. 4-5 and 10-11 where the bottom surface of the openers 86/87 passes over the perforated layer 80 at the location where the lidding foil 90 is pulled away from the perforated layer 80, thus causing some amount of sealing over at least a portion of the compartment 70 that lies below and is blocked by the openers as they pass by), and the release mechanism is further arranged to provide a fluid conduit configured to pass air into or through the compartment from the plurality of compartments so as to aerosolize the medicament contained therein (see Figs. 4-5 and 10-11 and also Col. 4 lines 30-51 where openers 86/87 lift the lidding foil 90 on the inner and outer sections, creating a fluid conduit path from which the powder is able to escape the compartments 70 through perforated layer 80, the powder being entrained into the air to at least partially aerosolize).
Allan lacks a detailed description of wherein the plurality of compartments are carried on a carrier strip (where Allan teaches a carrier disk, but not necessarily a strip).
However, Akouka teaches a similar medicament inhalation system, wherein the plurality of compartments are carried on a carrier strip (see Figs. 4-5 where a cartridge 120 contains a blister strip 130, formed as a strip with a plurality of individual blisters 131 and a film 135 over the blister depressions, and arranged in a roughly ring-like shape (see Fig. 5 where the shape of blister strip 130 is roughly ring-like); see also Col. 8 lines 5-10 where a cartridge with a blister strip is similar to and a replacement for a rotary cassette).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disk-shaped medicament carrier of Allan (e.g. Fig. 4) to be a carrier strip containing the compartments of medicament as taught by Akouka, as it would be a simple substitution of one type of blister carrier for another, to yield the predictable result of providing a series of medicament blisters that can be indexed and individually opened to access the medicament. It is understood that in the modified Allan device, the blister carrier mechanism of Allan (see Fig. 4, the disk-shaped elements substantially including 55, 60, 80, and 90) is instead arranged as a curved strip rather than a disk as taught by Akouka (Allan; for example, by cutting the segment at cut-outs 58, 63, 83 in Fig. 4 so that the disk is no longer continuous, and becomes a curved strip).
Regarding claim 113, the modified Allan device has wherein: each of the first release member and the second release member is arranged to engage between the carrier strip and the sealing layer of the medicament carrier such that the carrier strip passes beneath the first release member and the second release member (Allan; see Figs. 4-5 and 10-11 as well as Col. 3 lines 11-19 and Col. 4 lines 30-51 where each opener 86/87 is arranged to act between base foil 60 and sealing foil 90, in order to lift the sealing foil 90 to expose the medicament, which is done by the openers 86/87, and the base foil 60 passes beneath the openers) and the sealing layer passes over the first release member and the second release member (Allan; see Figs. 4-5 and 10-11 as well as Col. 3 lines 11-19 and Col. 4 lines 30-51 where each opener 86/87 is arranged to act between base foil 60 and sealing foil 90, in order to lift the sealing foil 90 to expose the medicament, which is done by the openers 86/87 passing beneath the sealing foil 90).
Claims 96 and 99 are rejected under 35 U.S.C. 103 as being unpatentable over Allan in view of Akouka as applied to claims 90 and 95 above, respectively, and further in view of Riley et al. (US Pat. 7,624,733).
Regarding claim 96, the modified Allan device has the leading edge.
The modified Allan device lacks a detailed description of wherein the leading edge has a curved, raised profile along its length.
However, Riley teaches an inhaler device where an opening mechanism has a leading edge with a curved, raised profile along its length (see Figs. 9C-9D where plow 51 has a rising edge portion 51v that is curved along its length to interact with the blister 15b).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the openers of the modified Allan device to have a curved leading edge as taught by Riley, as it would be a simple substitution of one shape of edge interacting with the blister strip for another shape, to yield the predictable result of still being able to fit under the lidding layer and push the foil up and away from the compartment.
Regarding claim 99, the modified Allan device has the trailing edge.
The modified Allan device lacks a detailed description of wherein the trailing edge of each release member has a generally curved configuration.
However, Riley teaches an inhaler device wherein the trailing edge of a release member has a generally curved configuration (Riley; see Figs. 9C-9D where the trailing edge of the blade 50b has a curved configuration as it leads to plow 51).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the openers of the modified Allan device to have a curved trailing edge as taught by Riley, as it would be a simple substitution of one shape of edge interacting with the blister strip for another shape, to yield the predictable result of still being able to fit under the lidding layer and push the foil up and away from the compartment.
Claim 106 is rejected under 35 U.S.C. 103 as being unpatentable over Allan in view of Akouka as applied to claim 104 above, and further in view of Gottenauer et al. (US Pat. 5,881,719).
Regarding claim 106, the modified Allan device has the means for engaging.
The modified Allan device lacks a detailed description of wherein the means for engaging is a protuberance arranged to contact the sealing layer in order to bias or otherwise urge the sealing layer against the carrier strip.
However, Gottenauer teaches an inhaler device, where a blister strip is acted on by a release mechanism, which includes protuberances that remain in contact with a covering foil of a blister while it is being opened (see Figs. 3-4 where webs 6 and 6a are protuberances which hold a portion of the blister in biased tension against its foil covering 39 while the opening operation occurs).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bonding force between the lidding foil and perforated layer of the modified Allan device to include a web protuberance holding the components under tension as taught by Gottenauer, as it would hold the compartment under stress to maintain its position and seal it with respect to the air (Gottenauer; see Col. 7 lines 40-45), while also providing a mechanical bonding that would be unable to accidentally come apart and allow the lidding foil to completely separate. It is understood that in the modified Allan device, the bonding that holds the lidding foil onto the perforated layer is accomplished by the webs as taught by Gottenauer, which mechanically press them together while allowing the lidding foil to still be partially lifted to access the medicament.
Claim 109 is rejected under 35 U.S.C. 103 as being unpatentable over Allan in view of Akouka as applied to claim 104 above, and further in view of Bruna et al. (US Pat. 5,447,151).
Regarding claim 109, the modified Allan device has the at least one release member.
The modified Allan device lacks a detailed description of wherein the at least one release member is removable from the release mechanism.
However, Bruna teaches an inhaler device, wherein the at least one release member is removable from the release mechanism (see Fig. 6a and Col. 9 lines 6-17 where a spring 49c acts on a blade 49a which is slidably mounted in the slot 48a so as to be capable of being removed from the slot).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the openers of the modified Allan device to be removable as taught by Bruna, as it would allow them to be more easily replaced should they become damaged. Further, it is understood that making components separable from one another is seen as an obvious modification to a person of ordinary skill in the art. See MPEP 2144.04(V)(C).
Response to Arguments
Applicant's arguments filed 11/12/2025 have been fully considered but they are not persuasive.
Applicant argues that the claim limitations from now cancelled claim 103, which have been incorporated into the independent claims 90, 104, and 112, are not disclosed or taught by either Allan or Akouka as applied.
Applicant first argues on page 10 of the remarks that Allan does not have the advantages in engineering of the claimed invention, in particular that Allan only does a partial reseal, and no mechanism that covers the compartment in place of the removed sealing layer. The arguments are not well-taken. The resealing limitation appears to come from the language of a dependent claim (e.g. claims 94, 108). However, it is noted that the language used “substantially seal” and “brought back together” do not limit the claims to a full and complete reseal as the purported technical advantage requires. Likewise, to “cover the compartment” does not specifically require that the compartment be fully covered, but rather that there is merely something placed over the top of the compartment, such as the openers of Allan. In order to act as a cover, the openers need to simply exist over the top of the compartment (perhaps best seen in Fig. 10, where the openers 86/87 cover at least some substantial portion of the compartment 70, so as to exist over the top of).
Applicant argues on pages 10-11 of the remarks that Allan does not have the release mechanism providing a fluid conduit for air to pass through to aerosolize the medicament. The argument is not well-taken. Applicant appears to argue that the fluid conduit is formed by the body of the release mechanism. However, all the claim requires is that the conduit is “provided” by the release mechanisms. As such, the openers 86/87 as seen in Fig. 10 help to define the flow path out of the compartment 70, to at least partially shape the conduit the leads the medicament to outlet slot 29 to be aerosolized and inhaled. Hence, the openers both “provide” the conduit by 1) removing the sealing layer so as to allow the air flow path to be formed, and 2) being physical structures in the airflow path to physically bound a conduit leading to the outlet. Rather, Allan must have some conduit to allow the air to flow into the compartment to entrain it (such as described in Col. 3 lines 11-19). Further argument with regards to Akouka are moot, as Akouka is not relied upon to teach the covering of the compartment, nor the conduit.
For the reasons above, the rejections hold.
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 MATTHEW D ZIEGLER whose telephone number is (571)272-3349. The examiner can normally be reached Mon-Thurs 9:00-6:00.
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, Justine Yu can be reached at (571)272-4835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/JUSTINE R YU/Supervisory Patent Examiner, Art Unit 3785