DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Claim 41 was previously rejected under 35 U.S.C. 112(b) and has been amended; the prior rejection of claim 41 under 35 U.S.C. 112(b) is thus withdrawn.
Claims 22-31, 34-35, 38, and 41 have been amended. Claims 22-41 remain pending. No new matter has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 22-32 and 34-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Day (US 20140114258, henceforth Day) in view of Kobayashi et al. (US 20190376852, henceforth Kobayashi).
Regarding claim 22, Day discloses an electronic system (the electrical structures present in the device of fig. 1) for a drug delivery device (assembly of fig. 1), the electronic system comprising: a user interface member (main body 14, fig. 1) which includes at least one exterior operation surface (control panel region 60 and injection button 74, fig. 1). Day additionally teaches that its exterior operation surface is used for numerous functions, including priming, dose setting, and administration, and using duration of button presses to control the device (see at least Day [0026]).
Day does not disclose the sensor electrode system of claim 22.
Kobayashi teaches a sensor electrode system (assembly of fig. 3B which fig. 6 is a plan view of) comprising: a flexible conductor carrier (flexible base material 31, fig. 5) which is electrically insulating (see [0086], the base material is a polymer resin which allows for flexibility and is nonconductive as polymer resins, especially those listed, are insulators; the device would be nonoperative if it base material 31 was conductive as ground electrodes 34a and 34b would be shorted with sensing units 30SE rendering sensing units 30SE nonfunctional as they would be incapable of conducting charges); and an electrode arrangement (sensor electrode unit 30, fig. 5), wherein the electrode arrangement comprises at least two electrically conductive electrode tracks (pulse electrode 32 and sense electrode 33, fig. 6), wherein the at least two electrically conductive electrode tracks extend along the flexible conductor carrier (see fig. 5, both extend along material 31 at wires 32d and 33d and within sensing units 30SE), wherein the at least two electrically conductive electrode tracks are electrically separated from each other along the flexible conductor carrier (see fig. 6, the wires never cross or touch and are only connected via insulating polymer resin materials of flexible base material 31), wherein at least one of the at least two electrically conductive electrode tracks forms a sensing electrode (sense electrode 33, fig. 6), and wherein the sensing electrode extends in a sensing region of the flexible conductor carrier (first sensing region is sensing unit 30SE which is further in the negative X direction in fig. 6, note the provided coordinate axes which are referenced; sense electrode 33 extends along and within sensing unit 30SE as shown).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have controlled the system and drug delivery device of Day with the unit of Kobayashi for the benefit of providing additional control from the sensitivity of the device of Kobayashi and using the pressure sensitivity of Kobayashi instead of dwell time to the device of Day. In the modified device, the buttons 62, 64, 66, and 74 of Day are thus all removed and replaced with the touch sensitive interface of Kobayashi at the location of buttons 62, 64, and 66.
Thus, in the modified device of Day as modified by Kobayashi, Day as modified discloses the device wherein a first sensing electrode (the portion of sense electrode 33 which is in the first sensing unit 30SE which is further in the negative X direction is considered to be the first sensing electrode, see fig. 6) is assigned to a setting surface of the user interface member (the sensing electrode of Kobayashi which is added to the exterior housing of main portion 14 is assigned to the top surface of said housing where it is attached to said housing in the location of buttons 62, 64, and 66 shown in Day fig. 1; this is considered to be a setting surface as claimed where it is a surface used for setting dose amounts as buttons 62, 64, and 66 are used for setting doses as in Day [0050] and [0073] and this functionality would be maintained in the modified device), and wherein a second sensing electrode (the portion of sense electrode 33 which is in the second sensing unit 30SE which is further in the positive X direction is considered to be the claimed second sensing region, see fig. 6) is assigned to a delivery surface of the user interface member (the portion of the device of Day which the called out electrode is arranged on is considered to be a delivery surface where it is a surface which can be touched to cause delivery of the medicament from the device, see at least Day [0100]-[0104]).
{All subsequent references are made to Kobayashi unless otherwise specified.}
Regarding claim 23, Day as modified by Kobayashi (henceforth Day as modified) discloses the system of claim 22 wherein the sensor electrode system is elastically deformable (see [0079], deformations are elastic when pressure is applied).
Regarding claim 24, Day as modified discloses the system of claim 22 wherein one of the at least two electrically conductive electrode tracks of the electrode arrangement forms a reference electrode (pulse electrode 32, fig. 6), wherein the reference electrode extends along the sensing electrode in the sensing region of the flexible conductor carrier (first sensing region is sensing unit 30SE which is further in the negative X direction in fig. 6, note the provided coordinate axes which are referenced; pulse electrode 32 extends along and within sensing unit 30SE as shown as it covers much of the same area as sense electrode 33 which it is interdigitated with), wherein the reference electrode and the sensing electrode are configured to be provided with different electrical potentials when the sensor electrode system is operated (see [0143], a voltage is applied between electrodes 32 and 33, meaning that there must be a difference in their potentials at some instant such as to create the disclosed capacitive coupling which requires the presence of an electric field).
Regarding claim 29, Day as modified discloses the system of claim 24 wherein the first sensing electrode (the portion of sense electrode 33 which is in the first sensing unit 30SE which is further in the negative X direction is considered to be the first sensing electrode, see fig. 6) extends in a first sensing region (sensing unit 30SE which is further in the negative X direction is considered to be the first sensing region, see fig. 6), wherein the second sensing electrode (the portion of sense electrode 33 which is in the second sensing unit 30SE which is further in the positive X direction is considered to be the claimed second sensing region, see fig. 6) extends in a second sensing region of the flexible conductor carrier (second sensing unit 30SE which is further in the positive X direction is considered to be the claimed second sensing region, see fig. 6, where it is located on flexible material 31), and wherein the flexible conductor carrier is configured such that the first sensing region and the second sensing region are movable relative to one another (the two regions which are made up of the two sensing units 30SE shown in fig. 6 are movable relative to one another since they are thin films formed on a flexible base material 31; since all of the materials are flexible, they are considered movable relative to one another especially at the space between the sensing units 30SE), wherein the reference electrode extends along the first sensing electrode in the first sensing region and along the second sensing electrode in the second sensing region (see fig. 6; pulse electrode 32 extends along sense electrode 33 in each of the sensing units 30SE where the electrodes are interdigitated with each other within each of the sensing units 30SE).
Regarding claim 25, Day as modified discloses the system of claim 24 wherein, in the sensing region, the reference electrode has a plurality of reference electrode portions (sub electrodes 32b, fig. 6) and the sensing electrode has a plurality of sensing electrode portions (sub electrodes 33b, fig. 6), wherein the sensing electrode portions and the reference electrode portions are alternatingly disposed (see fig. 6, the sub electrodes 32b and 33b are interdigitated and thus alternatingly disposed as claimed).
Regarding claim 26, Day as modified discloses the system of claim 25 wherein an end of at least one sensing electrode portion faces towards the reference electrode (see fig. 6, the end of sub electrodes 33b in the negative X direction point in the negative X direction where electrode body 32a is positioned), and wherein an end of at least one reference electrode portion faces towards the sensing electrode (see fig. 6, the end of sub electrodes 32b in the positive X direction point in the positive X direction where electrode body 33a is positioned).
Regarding claim 27, Day as modified discloses the system of claim 22 wherein the sensing region is configured to conform to and/or extend along a circumferentially disposed sensing surface of the user interface member (the sensing region is configured to conform to a circumferentially disposed surface as claimed where it is fully made of flexible materials, and thus it is configured to conform to curved surfaces as claimed), and wherein the sensor electrode system is configured such that one reference electrode portion and one sensing electrode portion are disposed at opposite locations when the sensor electrode system is provided in the electronic system (see fig. 6, the portions 32a and 33a are oppositely disposed within each sensing unit 30SE as shown).
Regarding claim 28, Day as modified discloses the system of claim 22 wherein the first sensing electrode (the portion of sense electrode 33 which is in the first sensing unit 30SE which is further in the negative X direction is considered to be the first sensing electrode, see fig. 6) extends in a first sensing region (sensing unit 30SE which is further in the negative X direction is considered to be the first sensing region, see fig. 6), wherein the second sensing electrode extends in a second sensing region of the flexible conductor carrier (the portion of sense electrode 33 which is in the second sensing unit 30SE which is further in the positive X direction is considered to be the claimed second sensing region, see fig. 6), and wherein the flexible conductor carrier is configured such that the first sensing region and the second sensing region are movable relative to one another (the two regions which are made up of the two sensing units 30SE shown in fig. 6 are movable relative to one another since they are thin films formed on a flexible base material 31; since all of the materials are flexible, they are considered movable relative to one another especially at the space between the sensing units 30SE).
Regarding claim 30, Day as modified discloses the system of claim 22,
a) wherein the first sensing electrode (the portion of sense electrode 33 which is in the first sensing unit 30SE which is further in the negative X direction is considered to be the first sensing electrode, see fig. 6) extends in a first sensing region (sensing unit 30SE which is further in the negative X direction is considered to be the first sensing region, see fig. 6), wherein the second sensing electrode extends in a second sensing region of the flexible conductor carrier (the portion of sense electrode 33 which is in the second sensing unit 30SE which is further in the positive X direction is considered to be the claimed second sensing region, see fig. 6), and wherein the flexible conductor carrier is configured such that the first sensing region and the second sensing region are movable relative to one another (the two regions which are made up of the two sensing units 30SE shown in fig. 6 are movable relative to one another since they are thin films formed on a flexible base material 31; since all of the materials are flexible, they are considered movable relative to one another especially at the space between the sensing units 30SE), wherein the flexible conductor carrier comprises a contact connection region (connecting terminal 42, fig. 5), and wherein at least one of the reference electrode, the sensing electrode, or the second sensing electrode is configured to be contacted electrically in the contact connection region (see [0088], electrodes 32 and 33 connect to terminal 42 through portion 41).
{Examiner notes that all of the limitations of part (b) of the claim are only optional and thus not required.}
Regarding claim 31, Day as modified discloses the system of claim 22 further comprising: a user proximity detection unit which is arranged and configured to detect whether the user is close to or touches the exterior operation surface, wherein the user proximity detection unit comprises the sensor electrode system (the claimed detection unit is the sensor electrode system of Kobayashi which is present in the modified system as in claim 22, see the rejection of claim 22 above; since there are no structural features which are positively recited which differentiate the user protection unit and the sensor electrode system, and since the sensor electrode system is configured as claimed as disclosed in Kobayashi, see the rejection of claim 22 above, the claim requirements are met); and an electronic sensor controller (microprocessor control unit of [0049]), the electronic sensor controller being electrically conductively connected to the exterior operation surface (see [0073]). Day additionally teaches that its exterior operation surface is used for numerous functions, including priming, dose setting, and administration, and using duration of button presses to control the device (see at least Day [0026]).
Regarding claim 32, Day as modified discloses the system of claim 31 b) wherein the electronic sensor controller is arranged on a carrier (see Day; the exterior housing of main body 14 is considered to be a carrier, see fig. 1), wherein the carrier is secured to a user interface member part of the user interface member (see Day; the user interface member part as claimed is digital display 80, fig. 1, which is secured to the exterior housing of main body 14 physically), wherein the sensing region extends along an outer surface of the user interface member part (in the modified device, the added system of Kobayashi is added onto the top surface of the system of Day; the sensing regions of Kobayashi thus extend over short parallel lengths along an outer topmost surface of digital display 80 of Day), and wherein a contact connection region extends inwardly (in the modified device, the connector region 41 of Kobayashi must extend inwardly into the interior of the system of Day such that it can connect with the microcontroller of Day) and is conductively connected to the electronic sensor controller (this is how a sensor must be wired such that it could control a device; it must be connected to the microcontroller to provide the microcontroller with its sensed data, see also Day [0049] and [0050]).
Regarding claim 34, Day as modified discloses the system of claim 31 wherein the first sensing electrode (the portion of sense electrode 33 which is in the first sensing unit 30SE which is further in the negative X direction is considered to be the first sensing electrode, see fig. 6) extends in a first sensing region (sensing unit 30SE which is further in the negative X direction is considered to be the first sensing region, see fig. 6), wherein the second sensing electrode (the portion of sense electrode 33 which is in the second sensing unit 30SE which is further in the positive X direction is considered to be the claimed second sensing region, see fig. 6) extends in a second sensing region of the flexible conductor carrier (second sensing unit 30SE which is further in the positive X direction is considered to be the claimed second sensing region, see fig. 6, where it is located on flexible material 31), and wherein the flexible conductor carrier is configured such that the first sensing region and the second sensing region are movable relative to one another (the two regions which are made up of the two sensing units 30SE shown in fig. 6 are movable relative to one another since they are thin films formed on a flexible base material 31; since all of the materials are flexible, they are considered movable relative to one another especially at the space between the sensing units 30SE; Examiner notes that the claim does not require the electrodes to be moveable relative to each other once the device has been assembled, and thus the pre-assembly state in which all structures are still movable due to not being formed on the housing of Day would apply).
Regarding claim 35, Day as modified discloses the system of claim 31 wherein the first sensing electrode (the portion of sense electrode 33 which is in the first sensing unit 30SE which is further in the negative X direction is considered to be the first sensing electrode, see fig. 6) extends in a first sensing region (sensing unit 30SE which is further in the negative X direction is considered to be the first sensing region, see fig. 6), wherein the second sensing electrode (the portion of sense electrode 33 which is in the second sensing unit 30SE which is further in the positive X direction is considered to be the claimed second sensing region, see fig. 6) extends in a second sensing region of the flexible conductor carrier (second sensing unit 30SE which is further in the positive X direction is considered to be the claimed second sensing region, see fig. 6, where it is located on flexible material 31), and wherein the flexible conductor carrier is configured such that the first sensing region and the second sensing region are movable relative to one another (the two regions which are made up of the two sensing units 30SE shown in fig. 6 are movable relative to one another since they are thin films formed on a flexible base material 31; since all of the materials are flexible, they are considered movable relative to one another especially at the space between the sensing units 30SE; Examiner notes that the claim does not require the electrodes to be moveable relative to each other once the device has been assembled, and thus the pre-assembly state in which all structures are still movable due to not being formed on the housing of Day would apply), and wherein the first sensing region and the second sensing region are configured to be assigned to exterior operation surfaces (the first electrode and the second electrode of Kobayashi can be considered to be on exterior operation surfaces as claimed where the top surface of the exterior outer housing of main portion 14 of Day is slightly curved as shown in fig. 2 of Day, with either side of the top surface of main portion 14 being considered to be a separate side surface; since the two electrodes of Kobayashi are disposed to the left and right of each other as shown in Kobayashi fig. 6, the chosen electrodes in the modified device could be arranged to be on either of the two top surfaces) which face in different directions (the two top surfaces of the curved top surface of the exterior housing of main body 14 as called out above face different directions where one surface, which could be the surface on the left in the point of view of Day fig. 2 where second medicament 102 is called out, faces upwards and to the left, while the other surface, which could be the surface on the right in the point of view of Day fig. 2 where first medicament 92 is called out, faces upwards and to the right; these are different directions).
Regarding claim 36, Day as modified discloses the system of claim 31 wherein the exterior operation surface is a setting surface for a dose setting operation (the sensing electrode of Kobayashi which is added to the exterior housing of main portion 14 is assigned to the top surface of said housing where it is attached to said housing in the location of buttons 62, 64, and 66 shown in Day fig. 1; this is considered to be a setting surface as claimed where it is a surface used for setting dose amounts as buttons 62, 64, and 66 are used for setting doses as in Day [0050] and [0073] and this functionality would be maintained in the modified device) and faces in a radial direction (since the topmost surface of main body 14 points out and away from the needle hub 216 in the radial direction, it is considered to face a radial direction as claimed).
Regarding claim 37, Kobayashi discloses the electronic system of claim 31 wherein the exterior operation surface is configured such that the user proximity detection unit has a higher sensitivity for softer or more flexible conductive objects that conform to the exterior operation surface relative to harder or stiffer conductive objects that do not conform as easily to the exterior operation surface (Kobayashi teaches a pressure-sensitive sensor which is deformable under pressure from a user, see at least Kobayashi Abstract and [0005]; this is considered to meet the claim requirements because the elastic deformation of the sensor of Kobayashi, at least at its cover materials, would allow for more flexible objects pressed against it to come into contact with the sensing units 30SE disposed throughout the proximity detection unit as the deforming top layer would bend the sensing units to be in contact with more of the flexible pressing object; meanwhile a nonflexible object which does not conform to the top surface of the sensor of Kobayashi would not so readily deform the pressure sensitive portions to allow more sensing units 30SE to be bent into contact with it since it is rigid and less deformable to distribute its pressure by definition).
Regarding claim 38, Day discloses a drug delivery device (device 10, fig. 1) comprising an electronic system (the electrical structures present in the device of fig. 1), a user interface member (main body 14, fig. 1) which includes at least one exterior operation surface (control panel region 60 and injection button 74, fig. 1). Day additionally teaches that its exterior operation surface is used for numerous functions, including priming, dose setting, and administration, and using duration of button presses to control the device (see at least Day [0026]).
Day does not disclose the drug delivery device comprising a sensor electrode system, the sensor electrode system comprising: a flexible conductor carrier which is electrically insulating; and an electrode arrangement, wherein the electrode arrangement comprises at least two electrically conductive electrode tracks, wherein the at least two electrically conductive electrode tracks extend along the flexible conductor carrier, wherein the at least two electrically conductive electrode tracks are electrically separated from each other along the conductor carrier, wherein one of the at least two electrically conductive electrode tracks forms a sensing electrode, and wherein the sensing electrode extends in a sensing region of the flexible conductor carrier. Kobayashi teaches a sensor electrode system (assembly of fig. 3B which fig. 6 is a plan view of), the sensor electrode system comprising: a flexible conductor carrier (flexible base material 31, fig. 5) which is electrically insulating (see [0086], the base material is a polymer resin which allows for flexibility and is nonconductive as polymer resins, especially those listed, are insulators; the device would be nonoperative if it base material 31 was conductive as ground electrodes 34a and 34b would be shorted with sensing units 30SE rendering sensing units 30SE nonfunctional as they would be incapable of conducting charges); and an electrode arrangement (sensor electrode unit 30, fig. 5), wherein the electrode arrangement comprises at least two electrically conductive electrode tracks (pulse electrode 32 and sense electrode 33, fig. 6), wherein the at least two electrically conductive electrode tracks extend along the flexible conductor carrier (see fig. 5, both extend along material 31 at wires 32d and 33d and within sensing units 30SE), wherein the at least two electrically conductive electrode tracks are electrically separated from each other along the conductor carrier (see fig. 6, the wires never cross or touch and are only connected via insulating polymer resin materials of flexible base material 31), wherein one of the at least two electrically conductive electrode tracks forms a sensing electrode (sense electrode 33, fig. 6), and wherein the sensing electrode extends in a sensing region of the flexible conductor carrier (first sensing region is sensing unit 30SE which is further in the negative X direction in fig. 6, note the provided coordinate axes which are referenced; sense electrode 33 extends along and within sensing unit 30SE as shown).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have controlled the system and drug delivery device of Day with the unit of Kobayashi for the benefit of providing additional control from the sensitivity of the device of Kobayashi and using the pressure sensitivity of Kobayashi instead of dwell time to the device of Day. In the modified device, the buttons 62, 64, 66, and 74 of Day are thus all removed and replaced with the touch sensitive interface of Kobayashi at the location of buttons 62, 64, and 66.
Thus, in the modified device of Day as modified by Kobayashi, Day as modified discloses the device wherein a first sensing electrode (the portion of sense electrode 33 which is in the first sensing unit 30SE which is further in the negative X direction is considered to be the first sensing electrode, see fig. 6) is assigned to a setting surface of the user interface member (the sensing electrode of Kobayashi which is added to the exterior housing of main portion 14 is assigned to the top surface of said housing where it is attached to said housing in the location of buttons 62, 64, and 66 shown in Day fig. 1; this is considered to be a setting surface as claimed where it is a surface used for setting dose amounts as buttons 62, 64, and 66 are used for setting doses as in Day [0050] and [0073] and this functionality would be maintained in the modified device), and wherein a second sensing electrode (the portion of sense electrode 33 which is in the second sensing unit 30SE which is further in the positive X direction is considered to be the claimed second sensing region, see fig. 6) is assigned to a delivery surface of the user interface member (the portion of the device of Day which the called out electrode is arranged on is considered to be a delivery surface where it is a surface which can be touched to cause delivery of the medicament from the device, see at least Day [0100]-[0104]).
Regarding claim 39, Day as modified by Kobayashi discloses the drug delivery device of claim 38, further comprising a reservoir (Day; first cartridge 90, fig. 2) with a drug (Day; first medicament 92, fig. 2).
Regarding claim 40, Day as modified by Kobayashi discloses a method comprising dispensing a drug (see Day [0089]) using a drug delivery device according to claim 39 (see rejection of claim 39 above).
Regarding claim 41, Day discloses an electronic system (the electrical structures present in the device of fig. 1) for a drug delivery device (assembly of fig. 1), the electronic system comprising: a user interface member (main body 14, fig. 1) which includes at least one exterior operation surface (control panel region 60 and injection button 74, fig. 1). Day additionally teaches that its exterior operation surface is used for numerous functions, including priming, dose setting, and administration, and using duration of button presses to control the device (see at least Day [0026]).
Day does not disclose the method of manufacturing of claim 41.
Kobayashi discloses a method of manufacturing an electronic system (electronic apparatus 10, fig. 2) for a drug delivery device (see [0002], the apparatus is similar to a tablet PC, which can be used to actuate drug delivery, and thus the system is capable of use for a drug delivery device; Examiner notes that the claim limitation of the electronic system being for a drug delivery device is a functional requirement as the claim does not require a method step of the system being used with a drug delivery device, nor does it require any further components to a drug delivery device or method steps relating thereto), the method comprising: providing a sensor electrode system (assembly of fig. 3B which fig. 6 is a plan view of), wherein the sensor electrode system comprises: a flexible conductor carrier (flexible base material 31, fig. 5) which is electrically insulating (see [0086], the base material is a polymer resin which allows for flexibility and is nonconductive as polymer resins, especially those listed, are insulators; the device would be nonoperative if it base material 31 was conductive as ground electrodes 34a and 34b would be shorted with sensing units 30SE rendering sensing units 30SE nonfunctional as they would be incapable of conducting charges); and an electrode arrangement (sensor electrode unit 30, fig. 5), wherein the electrode arrangement comprises at least one electrically conductive electrode track (pulse electrode 32 and sense electrode 33, fig. 6), wherein the at least one electrically conductive electrode track extends along the flexible conductor carrier (see fig. 5, both extend along material 31 at wires 32d and 33d and within sensing units 30SE), wherein the at least two electrically conductive electrode tracks are electrically separated from each other along the conductor carrier (see fig. 6, the wires never cross or touch and are only connected via insulating polymer resin materials of flexible base material 31), wherein one of the at least one electrically conductive electrode track forms a sensing electrode (sense electrode 33, fig. 6), and wherein the sensing electrode extends in a sensing region of the flexible conductor carrier (first sensing region is sensing unit 30SE which is further in the negative X direction in fig. 6, note the provided coordinate axes which are referenced; sense electrode 33 extends along and within sensing unit 30SE as shown); deforming the sensor electrode system such that a surface of the flexible conductor carrier extends along the user interface member (the sensor 20 is shaped, or deformed, to fit the shape of the display device 14a as shown in fig. 2 during manufacturing and assembly such that the sensor extends inside of the apparatus 10); and connecting at least one of the at least two electrically conductive electrode tracks conductively with an electronic unit (CPU 13b must be connected with sensor 20 and connecting portion at connecting terminal 42, see at least [0084] and [0131]) to form the electronic system (see at least [0084] and [0131]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have controlled the system and drug delivery device of Day with the unit of Kobayashi for the benefit of providing additional control from the sensitivity of the device of Kobayashi and using the pressure sensitivity of Kobayashi instead of dwell time to the device of Day. In the modified device, the buttons 62, 64, 66, and 74 of Day are thus all removed and replaced with the touch sensitive interface of Kobayashi at the location of buttons 62, 64, and 66.
Thus, in the modified device of Day as modified by Kobayashi, Day as modified discloses the device wherein a first sensing electrode (the portion of sense electrode 33 which is in the first sensing unit 30SE which is further in the negative X direction is considered to be the first sensing electrode, see fig. 6) is assigned to a setting surface of the user interface member (the sensing electrode of Kobayashi which is added to the exterior housing of main portion 14 is assigned to the top surface of said housing where it is attached to said housing in the location of buttons 62, 64, and 66 shown in Day fig. 1; this is considered to be a setting surface as claimed where it is a surface used for setting dose amounts as buttons 62, 64, and 66 are used for setting doses as in Day [0050] and [0073] and this functionality would be maintained in the modified device), and wherein a second sensing electrode (the portion of sense electrode 33 which is in the second sensing unit 30SE which is further in the positive X direction is considered to be the claimed second sensing region, see fig. 6) is assigned to a delivery surface of the user interface member (the portion of the device of Day which the called out electrode is arranged on is considered to be a delivery surface where it is a surface which can be touched to cause delivery of the medicament from the device, see at least Day [0100]-[0104]).
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Day (US 20140114258, henceforth Day) in view of Kobayashi et al. (US 20190376852, henceforth Kobayashi) as applied to claim 32 above, and further in view of Iwasaki (US 20160361500, henceforth Iwasaki).
Regarding claim 33, Day as modified discloses the electronic system of claim 32 wherein the electronic system comprises a drive system including a drive motor (motor 629, fig. 5) and control electronics (controller 700, fig. 5).
Day as modified does not disclose the electronic system comprising a power supply. Iwasaki teaches a drug delivery device similar to that of Day (pharmaceutical injection device 1, fig. 3) having a drive motor (drive motor 15, fig. 4) and control electronics (controller 14, fig. 5) and comprising a power supply (battery 22, figs. 4 and 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the battery of Iwasaki to the system and drug delivery device of Day as modified for providing power to the drive motor, the controller, and the other internal electronics while maintaining device portability and keeping the device compact as in Iwasaki (see at least Iwasaki Abstract, [0011]-[0013], and [0112]). In the modified device and in keeping with the teachings of Iwasaki, the added battery would have been included within the housing of the drug delivery device; in Day, this could be achieved by including the battery of Iwasaki inside of main body 14 (see at least Iwasaki fig. 4).
Day as modified by Kobayashi and Iwasaki discloses the system wherein the power supply is arranged between the carrier and a portion of the flexible conductor carrier (in the modified device, the carrier is the exterior housing of main body 14, which means that the bottom surface of the exterior housing of main body 14 opposite to the added sensor of Kobayashi and the added sensor of Kobayashi would have the added battery of Iwasaki arranged between them since the battery in the modified device is in the interior of the device; the claimed portion is thus the surface of the added sensor which is in direct surface contact with the top surface of main body 14), wherein the flexible conductor carrier is secured to the user interface member part (the sensing electrode of Kobayashi is added to the exterior housing of main portion 14 is secured to the top surface of said housing where it is attached to said housing in the location of buttons 62, 64, and 66 shown in Day fig. 1), wherein a connection region of the flexible conductor carrier (connecting portion 41 and connecting terminal 42 of Kobayashi, shown in fig. 5, make up the claimed connection region of material 31) extends from the portion of the flexible conductor from a side of the power supply (connecting portion 41 of Kobayashi extends from the bottom surface of sensor 20 of Kobayashi from the top side of the battery added from Iwasaki as the connecting portion 41 must extend from the sensor 20 on the exterior housing of main body 14 into the interior of main body 14 such as to electrically connect with controller 700) which is remote from the carrier (the added battery of Iwasaki is considered to be remote from the carrier since it is not integrally formed with the exterior housing of main body 14, see at least Iwasaki fig. 4) towards the carrier (connecting portion 41 must extend from the sensor 20 into the carrier which is the exterior housing of main body 14, and to do this, it must extend towards the interior of main body 14 through the wall of the exterior housing of main body 14), and wherein the connection region is mechanically and/or electrically connected to the carrier (the connection region of material 31 must be at least mechanically connected to the exterior of main body 14 as the sensor of Kobayashi is attached to the main body 14 of Day in the modified device, and this attachment is a mechanical connection).
Response to Arguments
Applicant’s arguments with respect to claim(s) 22, 34, and 41 under 35 U.S.C. 102(a)(1) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 05/19/2026 have been fully considered but they are not persuasive.
Applicant has first argued that Day as modified by Kobayashi does not disclose the claimed setting surface and delivery surface. Examiner respectfully disagrees. The device of Day has a setting surface which is one of the buttons used for dose setting, and a delivery surface which is the “OK” button used for dose delivery, and these buttons are replaced with the sensing electrode system of Kobayashi in the modified device and thus the electrodes are considered to be assigned to the surfaces as claimed. Examiner notes that no relative positions for the setting surfaces or delivery surfaces are defined or claimed, and thus Applicant’s argument regarding the placement of the surfaces is similarly found unpersuasive.
Applicant additionally argues that one of ordinary skill in the art would not have been motivated to have made the modification to Day with Kobayashi as relied upon above, particularly where Day uses distinct controls with different workflows and where Kobayashi deals with a sensor for electronic apparatuses which do not follow the same workflows. Examiner respectfully disagrees; Kobayashi teaches that its sensor electrode system provides beneficial sensitivity to touch which would allow for greater control by a user, and Day’s use of dwell time for button pushes could similarly be substituted with Kobayashi’s pressure sensitivity in the modified device to allow for similar controllability to the modified system as what was present in the original disclosure of Day.
Examiner additionally notes that the substitution of the buttons of Day with the sensor electrode system of Kobayashi is a substitution of user input assemblies; both the buttons of day and the sensors of Kobayashi are directed toward means for a user to provide input into an electrical control system to cause a desired outcome and have multiple variable parameters which can be modulated to cause different responses (in Day, this is which button is pushed and how long for dwell time; in Kobayashi, this is the location of where the sensors are touched and with how much pressure). This shows that the substitution would have been obvious to one of ordinary skill in the art and would have had a reasonable expectation of success since the same types of assemblies with the same number of different variables are being substituted.
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 SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783
/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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