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 .
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 41 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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.
Regarding claim 41, the claim is rendered indefinite due to unclear antecedent basis throughout the claim. Initially, the claim requires “an electrode system, the electrode system comprising a sensor electrode system”, and it is not clear how, if at all, these are meant to be systems. The claim then requires structures of the sensor electrode system, then that “the electrode system comprises a flexible conductor carrier”, which is required of the sensor electrode system, as well as “at least one electrically conductive electrode track” where at least two electrically conductive electrode tracks are already previously required of the sensor electrode system. It is not clear if these are meant to be repeats of one system or if there are meant to be multiple systems each having multiple structures.
For the purposes of compact prosecution and in an attempt to keep the claim as close as possible to what appears to be claimed and disclosed, Examiner has understood claim 41 to mean as follows:
“A method of manufacturing an electronic system for a drug delivery device, the method comprising: providing an electrode system, the electrode system comprisingone electrically conductive electrode [[tracks]]track, wherein the at least [[two]]one electrically conductive electrode track extends 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]]one electrically conductive electrode [[tracks]]track forms a sensing electrode, and wherein the sensing electrode extends in a sensing region of the flexible conductor carrier
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 22-30 and 41 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kobayashi et al. (US 20190376852, henceforth Kobayashi).
Regarding claim 22, Kobayashi discloses a sensor electrode system (assembly of fig. 3B which fig. 6 is a plan view of) for an electronic system (apparatus 10, fig. 1A), 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 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 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).
Regarding claim 23, Kobayashi discloses the sensor electrode system of claim 22 wherein the sensor electrode system is elastically deformable (see [0079], deformations are elastic when pressure is applied).
Regarding claim 24, Kobayashi discloses the sensor electrode 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, Kobayashi discloses the sensor electrode system of claim 24 wherein the sensing electrode is 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) and the sensing region is 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 one of the at least two electrically conductive electrode tracks of the electrode arrangement forms 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) which 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, Kobayashi discloses the sensor electrode 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, Kobayashi discloses the sensor electrode 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, Kobayashi discloses the sensor electrode system of claim 22 wherein the sensing region is configured to conform to and/or extend along a circumferentially disposed sensing surface of a user interface member of an electronic system (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, Kobayashi discloses the sensor electrode system of claim 22 wherein the sensing electrode is 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) and the sensing region is 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 one of the at least two electrically conductive electrode tracks of the electrode arrangement forms a second sensing electrode which 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, Kobayashi discloses the sensor electrode system of claim 22,
a) wherein the sensing electrode is 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) and the sensing region is 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 one of the at least two electrically conductive electrode tracks of the electrode arrangement forms a second sensing electrode which 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 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 an electrode system (assembly of fig. 3B which fig. 6 is a plan view of), the 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 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); providing a user interface member part (display device 14a, fig. 2); deforming the electrode system such that a surface of the flexible conductor carrier extends along the user interface member part (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 the at least one electrically conductive electrode track 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]).
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) 31-32 and 34-40 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 31, 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) which is arranged to be manipulated by a user (see [0050]) for a dose operation (see [0050]); 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]).
Day does not disclose 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 a sensor electrode system of claim 22. Kobayashi teaches a user proximity detection unit (sensor 20, fig. 3) which is arranged and configured to detect whether the user is close to or touches the exterior operation surface (see at least [0043] and [0074]), wherein the user proximity detection unit comprises a sensor electrode system of claim 22 (see rejection of claim 22 above).
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.
{Examiner notes that subsequent citations from Day as modified by Kobayashi, henceforth Day as modified, are from Day unless noted otherwise.}
Regarding claim 32, Day as modified discloses the electronic system of claim 31 b) wherein the electronic sensor controller is arranged on a carrier (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 (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 discloses the electronic system of claim 31 a) wherein the sensing electrode 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).
{Examiner notes that all of the other limitations provided in claim 34 are all optional and thus not required.}
Regarding claim 35, Kobayashi discloses the electronic system of claim 31 wherein the sensing electrode is a first sensing electrode (from Kobayashi: 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) and the sensing region is a first sensing region (from Kobayashi: sensing unit 30SE which is further in the negative X direction is considered to be the first sensing region, see fig. 6), wherein one of the at least two electrically conductive electrode tracks of the electrode arrangement forms a second sensing electrode (from Kobayashi: 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) which extends in a second sensing region of the flexible conductor carrier (from Kobayashi: 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 (from Kobayashi: 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, Kobayashi discloses the electronic 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).
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.
Regarding claim 39, Day as modified by Kobayashi discloses the drug delivery device of claim 38, further comprising a reservoir (first cartridge 90, fig. 2) with a drug (first medicament 92, fig. 2).
Regarding claim 40, Kobayashi discloses a method dispensing a drug (see [0089]) using a drug delivery device according to claim 39 (see rejection of claim 39 above).
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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Byerly et al. (US 20200171246) teaches a device with an optical encoding system for dose setting and detection with alternating electrode tracks at the encoding plate.
De Boer et al. (US 20140049276, previously made of record via IDS) teaches a touch sensor similar to Applicant’s claimed second sensing region.
Bammer et al. (US 20150268656) teaches a deformable foil which is capable of sensing and has capacitive electrode tracks similar to those claimed used in a drug delivery device.
Schabbach et al. (US 20180228977) teaches a foil with conductive electrode tracks which can be used for touch detection.
Langley et al. (US 20030114798) teaches a device similar to that of Day relied upon for the rejection provided above.
Nielsen et al. (US 20110181301) teaches a plurality of electrode tracks similar to those claimed.
Kim (US 20180260051) teaches a device having multiple conductive electrode tracks in a comb configuration similar to that of Applicant, and teaches that sizes of the teeth and tracks can be varied depending on the desired uses ([0128]).
Steel et al. (US 20150367079) teaches an injection device with a rotational encoder for dose setting and determining similar to Byerly.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783