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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 16/956,115, filed on 06/19/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/07/2023, 06/25/2025, 12/24/2025, 04/07/2026, and 08/25/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character not mentioned in the description: 500.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference signs mentioned in the description: temperature sensor 255 and audio module 104.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The use of the term “Bluetooth”, which is a trade name or a mark used in commerce, has been noted in this application. The term can be found on pg. 10 lines 23 and 32, pg. 20 lines 4 and 5, pg. 21 line 36, pg. 23 line 23, and pg. 25 line 2. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. The examiner suggests modifying the term to appears as “Bluetooth®”.
The disclosure is objected to because of the following informalities: On pg. 22 line 12, the specification states “BLE whisper mode”. The acronym “BLE” has not been previously defined in the specification, and is unclear to the examiner. The examiner suggests defining the acronym to provide clarity as to the meaning.
Appropriate correction is required.
The disclosure is objected to because of the following informalities: On pg. 15 line 37, the second use of the word “position” is incorrectly spelled “positon”.
Appropriate correction is required.
Claim Objections
Claims 2-24 are objected to because of the following informalities: Each of the claims start by stating “A device according to claim 1”. However, since “a device” has already been defined by claim 1, the examiner suggests modifying “A device according to claim 1” in claims 2-24 to “The device according to claim 1” for proper antecedent basis. Appropriate correction is required.
Claims 26-29 are objected to because of the following informalities: Each of the claims start by stating “A system according to claim 25”. However, since “a system” has already been defined by claim 25, the examiner suggests modifying “A system according to claim 25” in claims 26-29 to “The system according to claim 25” for proper antecedent basis. Appropriate correction is required.
Claims 7 and 8 are objected to because of the following informalities: Both claims are missing “a” before the word “medicament”, as this is the first mention of “medicament” dependent on claim 1. Appropriate correction is required.
Claims 14, 15, 18, and 19 are objected to because of the following informalities: Each of the claims state the language “a component…associated with the plunger”. This language is unclear and can be interpreted broadly as any part of the injection device that is in some manner affects or affected by the plunger, as well as any part directly attached to the plunger itself. The examiner suggests removing this language to concisely specify the limitation and remove speculation. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: The claim states “a part pressing onto the protrusion of the switch”. If the applicant if referring to the previously mentioned in claim 19 “a plunger of the injection device or a component attached to or associated with the plunger”, the examiner suggests continuing that language to claim 20 for continuity purposes. Therefore, the examiner suggests modifying claim 20 to read, for example, “when the plunger of the injection device moves, the plunger of the injection device or a component attach to or associated with the plunger which depresses the protrusion of the switch moves away from the switch,…” Appropriate correction is required.
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.
Claims 14, 15, and 23 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 claims 14 and 15, the claims state “A device according to claim 1, further comprising a plunger”. However, the drawings (FIG. 1A, 1B, and 3) and the specification (pg. 14 lines 9-12, pg. 22 line 23, pg. 24 line 3) describe the plunger as being part of the injection device and not the attachable “device”. The claim is rendered indefinite by the attempting to claim the plunger as part of “a device”. The examiner suggests modifying the claim to read “The device according to claim 1, wherein the injection device comprises a plunger” to clearly define where the plunger is located.
Claim 23 contains the trademark/trade name “Bluetooth”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a wireless communication method and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-3, 5-7, 9-11, 14, and 22-29 are rejected under 35 U.S.C. 103 as being unpatentable over Helmer et al. (WO 2018/041798 A1).
Regarding claim 1, Helmer discloses a device configured to be attached to an injection device (Fig. 10, supplementary device 150), the device comprising:
a wireless communication unit (Fig. 12, pg. 23 lines 6-10, communication interface 58); and
a sensor (Fig. 12, pg. 22 lines 9-17, sensor arrangement 60);
This embodiment of Helmer does not explicitly disclose wherein the device is configured: to activate the sensor in response to a receipt via the wireless communication unit of a wireless communication from an external device, following activation of the sensor, to use the sensor to detect one or both of a start and an end of an injection by the injection device, and to communicate via the wireless communication unit one or both of the start and the end of the injection to the external device.
However, in another embodiment of Helmer (supplementary device 50), Helmer teaches wherein the device is configured:
to activate the sensor in response to a receipt via the wireless communication unit of a wireless communication from an external device (Fig. 13, pg. 27 line 35 – pg. 28 line 28, step 100),
following activation of the sensor, to use the sensor to detect one or both of a start and an end of an injection by the injection device (Fig. 13, pg. 28 line 9, step 104), and
to communicate via the wireless communication unit one or both of the start and the end of the injection to the external device (Fig. 13, pg. 28 line 32 – pg. 29 line 3, step 112).
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 device disclosed by Helmer to be configured to activate the sensor in response to a receipt via the wireless communication unit of a wireless communication from an external device, use the sensor to detect one or both of a start and an end of an injection by the injection device, and communicate via the wireless communication unit one or both of the start and the end of the injection to the external device as taught by the alternative embodiment of Helmer since supplementary device 150 also comprises sensor arrangement 60 and communicates with external electronic device 80 and thus, one having ordinary skill in the art would have recognized supplementary device would also be operable in the same manner as supplementary device 50 including specific steps of activating, using, and communicating required by the claim (pg. 21 line 23 – pg. 25 line 25).
Regarding claim 2, in the modified device of Helmer, Helmer discloses the device is configured to indicate that the start of the injection by the injection device has not been detected (pg. 25 lines 5-17, pg. 26 line 11 – pg. 27 line 24, second optical coupling 14 cooperating with visual indicators 18 and visual indicator 18 is illuminated white before an injection procedure takes place).
Regarding claim 3, in the modified device of Helmer, Helmer discloses the device is configured to indicate that the start of the injection by the injection device has been detected and that the end of the injection by the injection device has not been detected (pg. 28 lines 9-16, the feedback provided during the injection procedure is an indication that the end of the injection has not yet been detected).
Regarding claim 5, in the modified device of Helmer, Helmer discloses the device is configured to indicate whether the communication to the external device was successful (pg. 24 line 30 – pg. 25 line 3, display 82 can be used to visualize measured or detected parameters or data).
Regarding claim 6, in the modified device of Helmer, Helmer discloses the device further comprising a temperature sensor (pg. 22 line 36 – pg. 23 line 4, temperature sensor 65).
Regarding claim 7, in the modified device of Helmer, Helmer discloses the device is configured to indicate whether medicament included in the injection device meets a predetermined temperature parameter (pg. 23 lines 2-4, predefined temperature range).
Regarding claim 9, in the modified device of Helmer, Helmer discloses the device further comprising an extension (Fig. 12, extension including mechanical connectors 53 and optical coupling 54), wherein the sensor is positioned upon the extension (Fig. 12, sensor arrangement 60 is positioned on optical coupling 54).
Regarding claim 10, in the modified device of Helmer, Helmer discloses the device is configured to communicate via the wireless communication unit the end of the injection to the external device (pg. 28 lines 22-35, external electronic device 80 generates audible sounds in response to received signals via wireless communication interface 58, specifically when detecting the end of an injection).
Regarding claim 11, in the modified device of Helmer, Helmer discloses the device is configured to be releasably attached to an injection device (pg. 23 lines 33-35).
Regarding claim 14, in the modified device of Helmer, Helmer discloses the device further comprising a plunger (plunger 6), wherein the sensor is configured to detect the movement of the plunger or of a component linked to or associated with the plunger (pg. 22 lines 19-25, plunger 6 displacement is tracked by optical sensor 61).
Regarding claim 22, in the modified device of Helmer, Helmer discloses the start or the end of the injection is communicated to the external device after the start of the injection has been detected or after the end of the injection has been detected (pg. 28 lines 26-35, data regarding detection of the end of an injection is transferred from supplementary device 50 to the external electronic device 80).
Regarding claim 23, in the modified device of Helmer, Helmer discloses one or both of the start and the end of the injection is communicated to the external device via near-field communication or Bluetooth (pg. 6 lines 17-24 and pg. 23 lines 6-12, Near-field communication (NFC) antenna establishes wireless signal transmission and data transmission between communication interface 58 and external electronic device 80, which is understood to be the manner in which start and end of injection data is transferred.).
Regarding claim 24, in the modified device of Helmer, Helmer discloses the device is a supplementary device (supplementary device 150).
Regarding claim 25, Helmer discloses a system (Fig. 10, kit 90) comprising:
a device configured to be attached to an injection device (Fig. 10, supplementary device 150), the device comprising:
a wireless communication unit (Fig. 12, pg. 23 lines 6-10, communication interface 58); and
a sensor (Fig. 12, pg. 22 lines 9-17, sensor arrangement 60);
the injection device (injection device 1), wherein the device is attached to the injection device (Fig. 10 and Fig. 12, pg. 21 lines 23-24).
This embodiment of Helmer does not explicitly disclose wherein the device is configured: to activate the sensor in response to a receipt via the wireless communication unit of a wireless communication from an external device, following activation of the sensor, to use the sensor to detect one or both of a start and an end of an injection by the injection device, and to communicate via the wireless communication unit one or both of the start and the end of the injection to the external device.
However, in another embodiment of Helmer (supplementary device 50), Helmer teaches wherein the device is configured:
to activate the sensor in response to a receipt via the wireless communication unit of a wireless communication from an external device (Fig. 13, pg. 27 line 35 – pg. 28 line 28, step 100),
following activation of the sensor, to use the sensor to detect one or both of a start and an end of an injection by the injection device (Fig. 13, pg. 28 line 9, step 104), and
to communicate via the wireless communication unit one or both of the start and the end of the injection to the external device (Fig. 13, pg. 28 line 32 – pg. 29 line 3, step 112).
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 device disclosed by Helmer to be configured to activate the sensor in response to a receipt via the wireless communication unit of a wireless communication from an external device, use the sensor to detect one or both of a start and an end of an injection by the injection device, and communicate via the wireless communication unit one or both of the start and the end of the injection to the external device as taught by the alternative embodiment of Helmer since supplementary device 150 also comprises sensor arrangement 60 and communicates with external electronic device 80 and thus, one having ordinary skill in the art would have recognized supplementary device would also be operable in the same manner as supplementary device 50 including specific steps of activating, using, and communicating required by the claim (pg. 21 line 23 – pg. 25 line 25).
Regarding claim 26, in the modified system of Helmer, Helmer discloses the injection device is a disposable autoinjector (pg. 20 lines 16-18 and pg. 23 line 33).
Regarding claim 27, in the modified system of Helmer, Helmer discloses the device comprises a housing shaped so that, upon attachment to the injection device, the housing of the device is flush with a housing of the injection device (Fig. 12, pg. 21 lines 24-31).
Regarding claim 28, in the modified system of Helmer, Helmer discloses the system is of a uniform width, but has a greater longitudinal length than that of the injection device (Fig. 12, kit 90 includes supplementary device 150 and injection device 1).
Regarding claim 29, in the modified system of Helmer, Helmer discloses the device is configured to attach within a recess located at a distal end of the injection device (Fig. 10 and Fig. 12, pg. 21 lines 31-33correspondingly-shaped mechanical connectors 3).
Claims 4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Helmer as applied to claim 1 above, and further in view of Arenas et al. (WO 2016/193229 A1; herein, Arenas).
Regarding claim 4, in the modified device of Helmer, Helmer discloses the device is configured to indicate that the start of the injection by the injection device has been detected (Fig. 13, pg. 22 lines 22-25 and pg. 28, line 9, step 104).
Helmer does not explicitly disclose as a whole the device is configured to indicate that the start of the injection by the injection device has been detected and that the end of the injection by the injection device has not been detected within a predetermined time of the start of the injection.
However, Arenas teaches the device is configured to indicate that the start of the injection by the injection device has been detected and that the end of the injection by the injection device has not been detected within a predetermined time of the start of the injection (pg. 13 lines 16-26, injection is uncomplete within predefined time period). 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 modified device disclosed by Helmer to be configured to indicate that the start of the injection by the injection device has been detected and that the end of the injection by the injection device has not been detected within a predetermined time of the start of the injection as taught by Arenas in order to provide feedback to the user with information regarding the injection (pg. 13 lines 22-26).
Regarding claim 8, in the modified device of Helmer, Helmer discloses a clock for providing time signal to record and store information regarding the injection procedure (pg. 22 lines 22-25) and predetermined temperature parameter (pg. 23 lines 2-4, predefined temperature range).
Helmer does not explicitly disclose the device is configured to start a timer in response to determining that medicament included in the injection device does not meet a predetermined temperature parameter and to provide an indication when the timer expires.
However, Arenas teaches the device is configured to start a timer in response to determining that medicament included in the injection device does not meet a predetermined temperature parameter and to provide an indication when the timer expires (pg. 16 lines 21-31 and pg. 20 lines 28-30, real time clock is capable of storing information with time and providing alarms). 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 modified device disclosed by Helmer to be configured to start a timer in response to determining that medicament included in the injection device does not meet a predetermined temperature parameter and to provide an indication when the timer expires as taught by Arenas in order to provide feedback to the user with information regarding the injection (pg. 13 lines 22-26).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Hemler as applied to claim 1 above, and further in view of Schleicher et al. (United States Patent Application Publication No. US 2017/0312430 A1; Schleicher).
Regarding claim 12, in the modified device of Hemler, Hemler does not explicitly disclose the receipt of a wireless communication from the external device is based on an optical transmission.
However, Schleicher teaches the receipt of a wireless communication from the external device is based on an optical transmission ([0016], Fluid injection device is able to wirelessly communicate with a remote device, with the wireless communication method being optical transmission.). 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 modified device disclosed by Helmer to specify the receipt of a wireless communication from the external device is based on an optical transmission as taught by Schleicher in order to effectively transport information from device to external device wirelessly ([0016]), as optical transmission is known in the art as a method for wireless communication.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Helmer as applied to claim 1 above, and further in view of Krulevitch et al. (United States Patent Application Publication No. US 2011/0313395 A1; herein, Krulevitch).
Regarding claim 16, in the modified device of Helmer, Helmer does not explicitly disclose the sensor comprises a switch configured to detect the movement of a component of the injection device involved in an injection procedure so as to detect the start of an injection.
However, Krulevitch teaches the sensor comprises a switch (momentary micro-switch 167) configured to detect the movement of a component of the injection device involved in an injection procedure so as to detect the start of an injection ([0045], “a momentary micro-switch…also enables tracking of the injection start point and the injection end point”). 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 modified device disclosed by Helmer to include a switch configured to detect the movement of a component of the injection device involved in an injection procedure as taught by Krulevitch in order to determine an injection event has been properly executed ([0045]).
Regarding claim 17, in the modified device of Helmer, Helmer does not explicitly disclose the switch is configured to detect the start of the injection.
However, Krulevitch teaches the switch is configured to detect the start of the injection ([0045], “a momentary micro-switch…also enables tracking of the injection start point and the injection end point”. An injection start point is interpreted as start of the injection by the examiner.). 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 modified device disclosed by Helmer to include a switch is configured to detect the start of the injection as taught by Krulevitch in order to determine an injection event has been properly executed ([0045]).
Claims 13, 15, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Helmer in view of Krulevitch as applied to claims 1 and 16 above, and further in view of Wilson et al. (United States Patent Application Publication No. US 2019/0282761 A1; herein, Wilson).
Regarding claim 13, in the modified device of Helmer, Helmer does not explicitly disclose the same sensor is configured to detect both the start and the end of the injection.
However, Wilson teaches the same sensor is configured to detect both the start and the end of the injection (FIG. 10A-10B, [0141]-[0144], sensor 64 can detect both that the injection process has begun and the end of the injection process.). 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 modified device disclosed by Helmer to specify the same sensor is configured to detect both the start and the end of the injection as taught by Wilson in order that information regarding injection that is communicated to the external device be provided from the same sensor ([0141]-[0144]).
Regarding claim 15, in the modified device of Helmer, Helmer discloses the device further comprising a plunger (plunger 6), wherein the sensor is configured to detect a movement of a component associated with the plunger (pg. 22 lines 19-25, plunger 6 displacement is tracked by optical sensor 61).
Modified Helmer does not explicitly disclose the movement of a component associated with the plunger into a position specifically associated with the end of the injection.
However, Wilson teaches the movement of a component associated with the plunger into a position specifically associated with the end of the injection (FIG. 10A-10B, [0141]-[0143], Sensor 64 can detect proximity of the needle sleeve and when the needle sleeve has returned to starting position, signaling the end of the injection process.). 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 modified device disclosed by Helmer to specify the sensors ability to detect the end of the injection based on a position of the plunger components as taught by Wilson in order to properly determine the end of an injection by the electronic components ([0141]-[0143]).
Regarding claim 18, in the modified device of Helmer, Helmer does not explicitly disclose the switch is configured such that, when the device is attached to the injection device, the switch is depressed prior to the start of the injection by a projection of a plunger of the injection device or by a component associated with the plunger of the injection device.
However, Wilson teaches the switch is configured such that, when the device is attached to the injection device, the switch is depressed prior to the start of the injection by a projection of a plunger of the injection device or by a component associated with the plunger of the injection device (FIG. 7A-7B, [0092]-[0097], Engaging member 35 of the switch 33 moves from a first state to a second state by movement of the plunger 22. When engaging member 35 moves to a depressed state, that triggers the electronic system to log the beginning of the injection process). 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 modified device disclosed by Helmer to make the switch depressed prior to the start of the injection by a projection of a plunger of the injection device or by a component associated with the plunger of the injection device as taught by Wilson in order to properly determine the start of an injection by the electronic components ([0092]-[0097]).
Regarding claim 19, in the modified device of Helmer, Helmer does not explicitly disclose the switch comprises a protrusion which, when the device is attached to the injection device, is located so as to be depressed by a plunger of the injection device or a component attached to or associated with the plunger.
However, Wilson teaches the switch comprises a protrusion (FIG. 7A-7C, engaging member 35) which, when the device is attached to the injection device, is located so as to be depressed by a plunger of the injection device or a component attached to or associated with the plunger (FIG. 7A-7C, [0092]-[0097], Engaging member 35 of the switch 33 moves from a first state to a second state by movement of the plunger 22. In the second state, engaging member 35 moves from recess 40 to being depressed by outer surface 39 of plunger 22.). 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 modified device disclosed by Helmer to include a protrusion of the switch which can be depressed by a plunger of the injection device or a component attached to or associated with the plunger as taught by Wilson in order to properly determine the start of an injection by the electronic components ([0092]-[0097]).
Regarding claim 20, in the modified device of Helmer, Helmer does not explicitly disclose the device is configured such that, when the plunger of the injection device moves, a part pressing onto the protrusion of the switch moves away from the switch, and so releases the protrusion, allowing the protrusion to relax away from the switch so as to indicate the start of the injection.
However, Wilson teaches the device is configured such that, when the plunger of the injection device moves, a part pressing onto the protrusion of the switch moves away from the switch, and so releases the protrusion, allowing the protrusion to relax away from the switch so as to indicate the start of the injection (FIG. 7A-7C, [0092]-[0100], Engaging member 35 of the switch 33 moves from a first state to a second state and returns back to its non-deflected position by movement of the plunger 22.). 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 modified device disclosed by Helmer to make the device configured to, when the plunger of the injection device moves, a part pressing onto the protrusion of the switch moves away from the switch, and so releases the protrusion, allowing the protrusion to relax away from the switch so as to indicate the start of the injection as taught by Wilson in order to properly determine the start of an injection by the electronic components ([0092]-[0097]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Hemler in view of Krulevitch as applied to claim 16 above, and further in view of So (United States Patent No. US 5,588,760 A).
Regarding claim 21, in the modified device of Helmer, Helmer does not disclose the switch comprises a conductive rubber pad.
However, So teaches the switch comprises a conductive rubber pad (col. 3 line 58 – col. 4 line 8, conductive rubber pad 5a). 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 modified device disclosed by Helmer to include a conductive rubber pad as taught by So in order to conduct electrical contact and produce electrical signals when in use (col. 3 lines 58-66).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Veasey et al. (United States Patent Application Publication No. US 2016/0082192) is considered relevant prior art with regards to a supplemental device for attachment to an injection device that uses an electromechanical switch.
Kuhn et al. (United States Patent Application Publication No. US 2016/0235925 A1) is considered relevant prior art with regards to a supplemental device attachable to an injection device comprising sensors and electronic components.
Michael (United States Patent Application Publication No. US 2017/0182258 A1) is considered relevant prior art with regards to an adjunct device for an injection device that connects to an external device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evelyn A Thoman whose telephone number is (571)272-8496. The examiner can normally be reached Monday-Friday 8:00 a.m-4:30 p.m..
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, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/THEODORE J STIGELL/ Primary Examiner, Art Unit 3783
