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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on November 24, 2025 is acknowledged. The traversal is on the ground(s) that there is no search burden. This is not found persuasive because the inventions having diverging structural and functional features which necessitate different search strategies. For example, group I is drawn to an injection device which requires a search A61M5/3157 [10237 hits] while group II is drawn to a method of determining compliant of an injection event which requires a search in G16H20/17 [44172 hits]. As such, the examiner maintains that a serious search burden exists.
However, the examiner notes that the previous restriction was technically improper. The application is a national stage application submitted under 35 U.S.C. 371 and, as such, a unity of invention standard should be applied. Using the unity of invention standard, the examiner maintains that restriction between groups I and II is still proper. Group I (claims 1-17) and Group II (previous claims 18-20) do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical because even though the inventions of these groups require the technical feature of a wireless module associated with an intelligent injection device, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Cowe modified with the teachings of Edward (see rejection discussion below).
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim(s) 1 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowe (US 20170007765) in view of Edwards (US 20130023825).
Regarding claim 1, Cowe discloses an intelligent injection device for injection of a pharmaceutical into a patient (injection device 1 in fig. 1), the intelligent injection device comprising:
a barrel (cartridge 30 in fig. 1) having an interior for holding a pharmaceutical (paragraph 49 discloses the cartridge contains a medicament), the barrel further having a first end and a second end (fig. 1);
a needle in fluid communication with the barrel and connected with the first end of the barrel (needle 34 in fig. 1);
a piston (drive element 12 with portion 13 in fig. 1; paragraph 52 discloses that portion 13 is part of drive element 12) positioned within the second end of the barrel (fig. 2B shows the drive element 12 positioned in the second end of the barrel), the piston including a plunger having a fluid-tight interaction with the interior of the barrel (piston 32 in fig. 1; fig. 2B-D shows the drive element 12 engaged to the piston 32);
a mechanical switch disposed on the piston (switch 48c in fig. 5A is disposed on a portion 13; paragraph 63 discloses that the switch is “depressed”) and configured to close upon completion of injection of said pharmaceutical into said patient (paragraph 62 discloses that switch 48c is depressed when the drive element 12 is in its most forward position); and
a microprocessor in electrical communication with the mechanical switch (microprocessor 42 in fig. 1; paragraph 63).
However, Cowe does not teach or disclose a wireless module configured to transmit administration data related to injection of said pharmaceutical from the intelligent injection device, wherein the wireless module is coupled to the intelligent injection device; wherein the microprocessor is in electrical communication with the wireless module and is configured to transmit the administration data related to injection of said pharmaceutical via the wireless module in response to completion of the injection of said pharmaceutical into said patient resulting in closing of the mechanical switch.
Edwards teaches an intelligent injection device (fig. 1) comprising a processor (electronic circuit system 3900 in fig. 32) is in electrical communication with a wireless module (“network interface device” in paragraph 194) and is configured to transmit the administration data related to injection of said pharmaceutical via the wireless module in response to completion of the injection of said pharmaceutical into said patient (paragraph 202 discloses sending a wireless signal notifying a remote device that injection is complete).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the intelligent injection device of Cowe to further comprise a wireless module configured to transmit administration data related to injection of said pharmaceutical from the intelligent injection device, wherein the wireless module is coupled to the intelligent injection device; wherein the microprocessor is in electrical communication with the wireless module and is configured to transmit the administration data related to injection of said pharmaceutical via the wireless module in response to completion of the injection of said pharmaceutical into said patient resulting in closing of the mechanical switch, as taught by Edwards. Edwards teaches this modification would enable patient’s compliance and/or adherence with respect to the injection device can be monitored (paragraph 202).
Regarding claim 6, in the modified device of Cowe, Cowe discloses an automatic injection system configured to facilitate automatic delivery of said pharmaceutical by the intelligent injection device into said patient (paragraph 2 discloses that upon activation of a button, the device automatically pierces the skin and administers the medicament; paragraph 50 discloses this function is performed by spring 14 in fig. 1, equated to the claimed “automatic injection system”).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowe in view of Edwards, as applied to claim 1 above, and further in view of Dantsker (US 20190054247).
Regarding claim 2, modified Cowe teaches all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose a temperature sensor in electrical communication with the microprocessor and configured to sense a temperature of said pharmaceutical and transmit temperature data to the microprocessor indicative of the temperature of said pharmaceutical; and a locking mechanism engaged with the piston and in electrical communication with the microprocessor, wherein the microprocessor is configured to transmit a locking signal to the locking mechanism, and the locking mechanism is configured to lock the piston in response to receiving the locking signal.
Dantsker is directed towards an injection device (fig. 7) comprising a temperature sensor (sensor 702 in fig. 7; paragraph 72 discloses the sensor can be a temperature sensor) in electrical communication with the microprocessor (processor 309 in fig. 7)and configured to sense a temperature of said pharmaceutical and transmit temperature data to the microprocessor indicative of the temperature of said pharmaceutical (paragraph 72). Dantsker further teaches a locking mechanism engaged with the piston and in electrical communication with the microprocessor (electronic units 430a/b in fig. 7; paragraph 62), wherein the microprocessor is configured to transmit a locking signal to the locking mechanism (paragraph 62), and the locking mechanism is configured to lock the piston in response to receiving the locking signal (paragraph 62).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the device of modified Cowe to further include the claimed temperature sensor and locking mechanism of Dantsker. This modification would enable injection to be prevented in the event the temperature sensor senses that the pharmaceutical is outside a safe temperature range so to improve patient safety (paragraph 62).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowe in view of Edwards, as applied to claim 1 above, and further in view of Lee (US 20200016331).
Regarding claim 3, modified Cowe teaches all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose a load sensor in electrical communication with the microprocessor and configured to sense force caused by depression of the plunger and transmit force data to the microprocessor indicative of force caused by depression of the plunger.
Lee is directed towards an injection device (fig. 1) comprising a load sensor in electrical communication with the microprocessor (pressure sensor 206 in fig. 17) and configured to sense force caused by depression of the plunger and transmit force data to the microprocessor indicative of force caused by depression of the plunger (paragraph 103). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the device of modified Cowe to further include a load sensor in electrical communication with the microprocessor and configured to sense force caused by depression of the plunger and transmit force data to the microprocessor indicative of force caused by depression of the plunger, as taught by Lee, in order to detect when the piston is engaged to the plunger (paragraph 103).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowe in view of Edwards, as applied to claim 1 above, and further in view of Saint (US 20160012205).
Regarding claim 4, modified Cowe teaches all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose an amount sensor in electrical communication with the microprocessor and configured to sense an amount of said pharmaceutical injected into said patient upon depression of the plunger and transmit pharmaceutical amount data to the microprocessor indicative of said amount of said pharmaceutical injected into said patient upon depression of the plunger.
Saint is directed towards an intelligent injection device (fig. 5) comprising an amount sensor in electrical communication with the microprocessor (paragraph 115 discloses “a sensor unit to detect a dispensed dose” which is in communication with “a processing unit”) and configured to sense an amount of said pharmaceutical injected into said patient upon depression of the plunger (paragraph 115) and transmit pharmaceutical amount data to the microprocessor indicative of said amount of said pharmaceutical injected into said patient upon depression of the plunger (paragraph 115). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the device of modified Cowe to include the claimed amount sensor, as taught by Saint, in order to transmit dosage data to the microprocessor which can then be displayed to a user (paragraph 115) which can ensure that a user administered a proper dose.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowe in view of Edwards, as applied to claim 1 above, and further in view of Juhnke (US 20180017531).
Regarding claim 5, modified Cowe teaches all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose a damage sensor in electrical communication with the microprocessor and configured to sense damage to the intelligent injection device and transmit damage data to the microprocessor indicative of damage to the intelligent injection device.
Juhnke teaches an injection device (drug delivery device 20 in fig. 7) comprising a damage sensor (sensor 34 in fig. 7 and probe 30 in fig. 7) in electrical communication with a microprocessor (processor 42 in fig. 7) and configured to sense damage to the intelligent injection device (paragraph 145 discloses sensing if the cartridge is intact or exhibits a damage) and transmit damage data to the microprocessor indicative of damage to the intelligent injection device (paragraph 146). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the device to further comprise a damage sensor in electrical communication with the microprocessor and configured to sense damage to the intelligent injection device and transmit damage data to the microprocessor indicative of damage to the intelligent injection device, as taught by Juhnke, in order to ensure the cartridge has not splintered which may have contaminated the medicament (paragraph 3).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowe in view of Edwards, as applied to claim 1 above, and further in view of Faught (US 20200139053).
Regarding claim 7, modified Cowe teaches all of the claimed limitations set forth in claim 1, as discussed above. Edwards further discloses an injectable administration compliance management platform (paragraph 173 discloses a remote device which can be a “compliance monitoring device”).
However, modified Cowe does not teach or disclose an Internet of Things-based system at least partially implemented in the microprocessor.
Faught teaches an intelligent injection device (fig. 1A) comprising an Internet of Things-based system at least partially implemented in the microprocessor (paragraph 60). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the microprocessor to comprise an Internet-of Things system, as taught by Faught. Faught teaches that this type of microprocessor provides power savings (paragraph 64).
Regarding claim 8, in the modified device of Cowe, Faught discloses the injectable administration compliance management platform is configured for real-time monitoring of the intelligent injection device and management of adherence to an injectable administration plan (paragraph 4 discloses communicating the real-time state of the device which would encompass sending data in real time to the platform).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowe in view of Edwards, as applied to claim 1 above, and further in view of Vallis (US 20190060577).
Regarding claim 9, modified Cowe teaches all of the claimed limitations set forth in claim 1, as discussed above. Edwards further discloses an injectable administration compliance management platform configured to receive data collected by the intelligent injection device (paragraph 173 discloses a remote device which can be a “compliance monitoring device”). However, modified Cowe does not teach or disclose an injectable administration compliance management platform configured to receive data collected by at least one Internet of Things device and combine with data collected by the intelligent injection device.
Vallis is directed towards an intelligent injection device (smart syringe 100 in fig. 1) which is connected to a platform (app 706 in fig. 7) which is configured to receive data collected by at least one Internet of Things device (fig. 7 and paragraph 41 disclose that IoT front end can send/receive data to WAN 720 which in turn send/receive data to app 706). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the platform of modified Cowe to be configured to receive data collected by at least one Internet of Things device and combine with data collected by the intelligent injection device, as taught by Vallis, since Vallis teaches that this modification enables connectivity of various devices (paragraph 41).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowe in view of Edwards, as applied to claim 1 above, and further in view of Vallis (US 20190060577) in view of O’Connell (US 20190209777).
Regarding claim 10, modified Cowe teaches all of the claimed limitations set forth in claim 1, as discussed above. Edwards further discloses an injectable administration compliance management platform configured to receive data collected by the intelligent injection device (paragraph 173 discloses a remote device which can be a “compliance monitoring device”). However, modified Cowe does not teach or disclose an injectable administration compliance management platform configured to receive data collected by at least one Internet of Things device, at least one wearable device and combine with data collected by the intelligent injection device.
Vallis is directed towards an intelligent injection device (smart syringe 100 in fig. 1) which is connected to a platform (app 706 in fig. 7) which is configured to receive data collected by at least one Internet of Things device (fig. 7 and paragraph 41 disclose that IoT front end can send/receive data to WAN 720 which in turn send/receive data to app 706). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the platform of modified Cowe to be configured to receive data collected by at least one Internet of Things device and combine with data collected by the intelligent injection device, as taught by Vallis, since Vallis teaches that this modification enables connectivity of various devices (paragraph 41).
O’Connell teaches an application (“application platform” in paragraph 91) which is configured to receive data from a wearable device (“wearable device” in paragraph 91) and combine it with data from an intelligent injection device (“drug delivery device” in paragraph 91). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the platform of modified Cowe to be further configured to receive data from a wearable device and combine it with data collected by the intelligent injection device, as taught by O’Connell. This modification would automate the input of biometric data and provide responsive suggestions based on real time flow of data (paragraph 91).
Claim(s) 11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowe in view of Edwards, as applied to claim 1 above, and further in view of Whalley (US 20130310756).
Regarding claim 11, modified Cowe teaches all of the claimed limitations set forth in claim 1, as discussed above. Edwards further discloses an injectable administration compliance management platform configured to receive data collected by the intelligent injection device (paragraph 173 discloses a remote device which can be a “compliance monitoring device”).
While it is assumed that the “compliance monitoring device” of modified Cowe would be configured to receive medical compliance data, modified Cowe does not explicitly teach or disclose this limitation.
Whalley teaches a compliance management platform (health management system 1000 in fig. 17) which is configured to receive medical compliance data and combine with data collected by the intelligent injection device (paragraph 77 discloses comparing dose delivered with a patient medication schedule). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the platform of modified Cowe to be configured to receive medical compliance data, as taught by Whalley, for the purpose of ensuring doses are administered according to schedule.
Regarding claim 13, modified Cowe teaches all of the claimed limitations set forth in claim 1, as discussed above. Edwards further discloses an injectable administration compliance management platform configured to receive data collected by the intelligent injection device (paragraph 173 discloses a remote device which can be a “compliance monitoring device”).
However, modified Cowe does not explicitly teach the injectable administration compliance management platform is configured to receive electronic medical record data and combine with data collected by the intelligent injection device.
Whalley teaches a compliance management platform (health management system 1000 in fig. 17) which is configured to recite electronic medical record data (paragraph 76 discloses receiving exercise and diet data, equated to the claimed medical record data) and combine with data collected by the intelligent injection device (paragraph 76 discloses that the system also receives data from drug delivery device 1110). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the platform of modified Cowe to be configured to receive electronic medical record data and combine with data collected by the intelligent injection device, as taught by Whalley, for the purpose of maintaining patient safety.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowe in view of Edwards, as applied to claim 1 above, and further in view of Sysko (US 20150112703).
Regarding claim 12, modified Cowe teaches all of the claimed limitations set forth in claim 1, as discussed above. Edwards further discloses an injectable administration compliance management platform configured to receive data collected by the intelligent injection device (paragraph 173 discloses a remote device which can be a “compliance monitoring device”). However, modified Cowe does not teach or disclose the injectable administration compliance management platform configured to receive at least one of an artificial intelligence datum, artificial intelligence model or machine learning model and combine with data collected by the intelligent injection device.
Sysko teaches a similar platform (application 1 in fig. 1) which is configured to receive at least one of an artificial intelligence datum, artificial intelligence model or machine learning model and combine with data collected by the intelligent injection device (paragraph 57 discloses applying a machine learning algorithm 26 to patient data). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the platform of modified Cowe to be configured to receive at least one of an artificial intelligence datum, artificial intelligence model or machine learning model and combine with data collected by the intelligent injection device, as taught by Sysko, in order to provide the user with health or illness data over time (paragraph 57).
Claim(s) 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowe in view of Edwards, as applied to claim 1 above, and further in view of O’Connell (US 20190209777).
Regarding claim 14, modified Cowe teaches all of the claimed limitations set forth in claim 1, as discussed above. Edwards further discloses an injectable administration compliance management platform configured to receive data collected by the intelligent injection device (paragraph 173 discloses a remote device which can be a “compliance monitoring device”). However, modified Cowe does not teach or disclose the injectable administration compliance management platform configured to operate an intelligent virtual care assistant module to perform a task for a person associated with a usage of the intelligent injection device.
O’Connell is directed towards a intelligent virtual care assistant module to perform a task for a person associated with a usage of medication device. (“virtual health assistant” in paragraph 210 discloses reminders to administer a medication) which can be used with compliance tracking (paragraph 211 discloses logging compliance). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the platform of modified Cowe to be configured to operate an intelligent virtual care assistant module to perform a task for a person associated with a usage of the intelligent injection device, as taught by O’Connell, for the purpose of providing users with a 24/7 lifestyle coach to enhance health management (paragraph 211)
Regarding claim 15, in the modified device of Cowe, O’Connell discloses the intelligent virtual care assistant module displays an alert to a person associated with a usage of the intelligent injection device (paragraph 210 discloses providing notification/reminder for “administering a medication”).
Regarding claims 16 and 17, modified Cowe teaches all of the claimed limitations set forth in claims 1 and 14, as discussed above but does not teach or disclose the intelligent virtual care assistant module is configured to present a virtual reality displays/an augmented reality displays to a person using the intelligent injection device.
O’Connell teaches a system configured to present a virtual reality displays/an augmented reality displays to a person using the system (paragraph 113). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the module of modified Cowe to be configured to a virtual reality displays/an augmented reality displays to a person using the intelligent injection device, as taught by O’Connell, for the purpose of creating a gamified interface for users which would encourage adherence to a health/treatment plan (paragraph 113).
Conclusion
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/COURTNEY B FREDRICKSON/ Primary Examiner, Art Unit 3783