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 § 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) 1, 3-5, 8, 12-17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/040313 (“Byerly”) in view of U.S. Publication No. 2021/0138156 (“Saint”) and U.S. Publication No. 2019/0343483 (“Kanakasabhaptahi”).
Regarding Claims 1 and 19, Byerly discloses a medication delivery device (10, 82) and associated computerized method of its use comprising:
A housing (12, 14) comprising a reservoir (20) sufficiently sized to hold a medication;
A dose button (32) being rotatable relative to the housing to select a dose size of the medication for an injection (Par. 4);
A printed circuit board (PCB) (76 – Par. 56);
A conductive trace disposed at least partially on the PCB (i.e. “conductive traces” are understood to be inherent to PCBs to adjoin the various components together);
A bias source (e.g. the wireless BLE antenna – Par. 57, as well as various other components such as the various integrated sensors and power source – Par. 56) in electrical communication with the conductive trace; and
A microcontroller (Par. 56) in electrical communication with the conductive trace through a logic input to the microcontroller, then microcontroller being configured to:
receive a signal from the conductive trace through the logic input (Par. 56, 57…etc.)
Byerly discloses the invention substantially as claimed except that, based on received signals, the microcontroller is configured to determine that “moisture may be present” on the PCB. However, it is well-known in the art that moisture intrusion into such circuitry can be damaging to the operation of such an injection device’s electronics. For example, Saint discloses a related injection device (10) which is provided with an electronics module configured to send and receive signals indicative of fault conditions of the injector inclusive to liquid intrusion (Par. 56, 67, 82, 89, 98, 129, 130) via known means which measure voltage levels and other faults in the circuitry encoder. It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the microcontroller logic and PCB of the invention of Byerly to receive suitable signals via the conductive traces to determine that moisture may be present on the electronics/PCB, as disclosed by Saint, in order to monitor the system for fault conditions which might lead to malfunctioning operation of the device.
Byerly, as modified in view of Saint, discloses the invention substantially as claimed except that that the means by which moisture is detected comprises an exposed test pad provided as part of the conductive traces – rather Saint suggests only directly measuring faults in the output signals of the encoder (see Par. 67, 82, 89, 98).
However, Kanakasabhaptahi discloses a PCB (re: PCA – printed circuit assembly 218) which is configured to permit the detection of water or other liquid intrusion (Par. 1). To accomplish this detection Kanakasabhaptahi discloses various detection assemblies (216) which may be used in combination with one another (Par. 56) and may be used inclusive to springs, levers, soluble capacitors, soluble epoxy, LEDs, light sensors, galvanic sensors, a battery, a sense circuit, and/or other elements such as wires, traces, latches, and clock circuits (Par. 28).
Among these solutions Kanakasabhaptahi suggests forming a galvanic circuit using conductive traces (905, 910) which may be provided with exposed contact surfaces (i.e. a test pad – exposed electrical contacts) which when exposed to moisture (920) at their surface will change the conductivity of the circuit (915) thereby generating a signal to be sent to the controller (Par. 6, 7, 54). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the device of Byerly to utilize exposed electrical contacts/traces (i.e. a test pad) which can be joined together via the presence of moisture to generate a voltage in response to completion of a circuit, as disclosed by Kanakasabhaptahi, in order to form a well-known type of moisture sensing arrangement recognized in the prior art to determine fluid/water ingress at a PCB via a expected and predictable outcome.
Here the phrase “test pad” is understood, in accordance with its broadest reasonable interpretation, to refer to exposed, conductive electrical contacts/traces provided on the board. As such the exposed conductive traces (905, 910) of Kanaksabhaptahi constitute a “test pad” since they are exposed (see Fig. 9) conductive wires, traces, and/or plates (see Par. 54).
Regarding Claim 3, Byerly discloses a switch mounted to the printed circuit board, wherein the microcontroller is configured to:
receive a set of signals from the switch;
generate, based on the set of signals, a count of the set of signals (Par. 79-80).
Regarding Claim 4, Byerly discloses the medication delivery device further comprising a rotatable element that is rotatable relative to the printed circuit board, the rotatable element having a series of protrusions that are spaced from one another (see Fig. 7), the rotatable element being positioned to permit the protrusions to slide against the switch to move the switch between a closed position and an open position as the rotatable element rotates (Par. 77-82).
Regarding Claim 5, Byerly discloses wherein the switch comprises a piezoelectric sensor, a magnetic sensor, an accelerometer, an optical sensor, an interrupter sensor, an optical encoder, or some combination thereof (Par. 69, 85, 113).
Regarding Claim 8, Byerly, as modified, discloses the microcontroller is further configured to, upon determining that moisture may be present on the printed circuit board: transmit, via a communication module in communication with the microcontroller, at least one message comprising data indicative of the determination of possible moisture on the printed circuit board (see Saint – Par. 54, 56, 131, 132, 133), said message being obvious to add to the system of Byerly, as disclosed by Saint, in order to ensure that the user is aware of the potential damage to the device due to said moisture exposure and can act accordingly.
Regarding Claim 12, Byerly, as modified, discloses the invention substantially as claimed except that that the PCB is in communication with a bias source which comprises at least one of a diode, a transistor, and a capacitor. However, Kanakasabhaptahi discloses that various bias sources can be used to detect the ingress of fluids in a circuit including soluble capacitors, light emitting diodes, among other solutions (Par. 28). It would have been obvious for one having ordinary skill in the art at the time the invention was made to incorporate additional bias sources such as soluble capacitors and LEDs into the circuit of Byerly, in order to permit the use of additional sources to detect moisture exposure, as disclosed by Kanakasabhaptahi, in order to provide a well-known means for detecting moisture exposure to obtain predictable and expected results. Kanaksabhaptahi discloses that multiple different types of moisture detection system can be used in tandem (Par. 56).
Regarding Claim 13, Byerly, as modified by Kanaksabhaptahi, provides for a moisture detection solution which comprises a bias source (sense circuit 915) provided in association with the conductive trace/test pad (905, 910 - Fig. 9), which is configured to normally provide zero volts to the circuit, but is configured to complete the circuit at the test pad in response to moisture exposure thereby generating a positive voltage (i.e. a logic value of 1) (see e.g. Par. 7 - Kanaksabhaptahi). As discussed above, it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the system of Byerly to utilize such a test pad (see exposed traces/contacts at 905, 910) to detect moisture in a known, predictable, and expected manner.
Regarding Claim 14, Byerly, as modified by Kanaksabhaptahi, suggest that a multiple detectors of different types can be employed to determine moisture intrusion (Par. 56 – Kanaksabhaptahi). Among these solutions Kanaksabhaptahi describes a bias source (i.e. the electrical power source of 400) which may present as a normally closed circuit (see e.g. Fig. 4A) which is configured to provide a positive voltage to an exposed conductive trace (410), i.e. a logical 1, whereby exposure to moisture interrupts and breaks the circuit (see Fig. 4B), thereby removing the voltage and creating a logical 0 to signal to the controller that moisture is present (Par. 43). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the system of Byerly to detect moisture by breaking a circuit at an exposed conductive trace and transitioning a logical 1 to a logical 0, as disclosed by Kanaksabhaptahi, as Kanaksabhaptahi discloses that either alternative will work equally well and that various detectors of differing types can be used in tandem with one another.
Regarding Claim 15-16, Byerly discloses device further comprises medication held within the reservoir wherein the medication is an insulin (Par. 34).
Regarding Claim 17, Byerly discloses the conductive trace is in a plane of the printed circuit board (i.e. a feature inherent to a PCB).
Claim(s) 2, 6, 7, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/040313 (“Byerly”) in view of U.S. Publication No. 2021/0138156 (“Saint”) and U.S. Publication No. 2019/0343483 (“Kanakasabhaptahi”) as applied above, and further in view of U.S. Publication No. 2016/0015957 (“Tieck”).
Regarding Claim 2, Byerly, as modified by Saint, discloses the invention substantially as claimed except explicitly that that the logic input is a general-purpose I/O to the microcontroller. However, Tieck discloses a related injection device which utilizes a general purpose processor (Par. 490). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the processor and corresponding input/output logic of the device of Byerly to comprise a GPIO microprocessor, as disclosed by Tieck, in order to allow for the sourcing of standardized electronics thereby simplifying manufacture of the device.
Regarding Claim 6, Byerly, as modified by Saint, discloses the invention substantially as claimed except that the microcontroller is further configured to, upon determining that moisture may be present on the printed circuit board:
discard the generated count of the set of signals, such that the generated count is:
(a) not stored in a memory in communication with the microcontroller,
(b) not transmitted to a remote device through a communication module in communication with the microcontroller, or some combination thereof.
However, Tieck discloses a related drug delivery device (30) which is also concerned with sensing moisture exposure to the electronics to ensure proper operation of the device (Par. 246, 595, 636, 765). Tieck discloses that because such moisture infiltration can cause corrupt data to be generated and that detecting the presence of moisture can be used to cause the controller to ignore/discard the generated use data such that the data is not stored in memory or transmitted to a remote device (Par. 246, 765). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the invention of Byerly to ignore/delete data generated by the dosing logic when moisture is detected by the system, thereby not storing the data in memory and transmitting the data to the external device for logging, as disclosed by Tieck, in order to omit data which may be corrupt from being used.
Regarding Claim 7, Byerly, as modified, discloses the invention substantially as claimed except that upon determination of moisture the system alters an operating state of the microcontroller to one or more of: enter a hibernation state, powering down, restarting. However, Tieck discloses such systems may be configured to shut down (re: powering down or hibernate) when it is determined that an unsuitbable use condition is present (Pr. 63). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the system of Byerly to shut down/hibernate/power down upon detection of moisture, once a determination of an unsuitable use condition is determined, to prevent damage operation of the device as disclosed by Tieck.
Regarding Claim 9, Byerly, as modified, discloses the invention substantially as claimed except that the at least one message is configured to cause an external mobile device in communication with the medication delivery device to discard or disregard one or more previously transmitted count values. Firstly, Examiner notes that the instant claims do not positively recite the “external mobile device” as part of the claimed workpiece. As such, the instant claim can only be concerned with producing a signal/message/alert and transmitting that signal FOR receipt by some external mobile device and HOW the external mobile device reacts to this device CANNOT be a concern of the claim. Since Byerly, in view of Saint, is configured to generate alerts for receiving by the external controller/monitor that moisture has been detected the instant claim is satisfied.
However, should Examiner’s arguments not be found persuasive it is submitted that in view of suggestion by Tieck (see Par. 246, 765) to ignore/delete suspected corrupt data incident to detected moisture exposure, that it would have been obvious for the ordinary artisan to modify the external controller/monitor (Par. 55) of Byerly to likewise delete/ignore/discard this suspect data in order to avoid using this data to generate improper operational reports.
Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/040313 (“Byerly”) in view of U.S. Publication No. 2021/0138156 (“Saint”) and U.S. Publication No. 2019/0343483 (“Kanakasabhaptahi”) as applied above, and further in view of WO 2020/072299 (“Adams”).
Regarding Claims 10, Byerly discloses the invention substantially as claimed except that that the bias source comprises a resistor disposed as part of a SoC which includes the microcontroller. The antenna of Byerly is understood to constitute a resistor (inasmuch as any such device may be characterized as a resistor since it creates a resistance to electric flow and causes a voltage change commensurate in its internal resistance and power consumption). However, Adams discloses that controllers can be integrated as SoC by providing a single chip which comprises the necessary microprocessors, logic, memory, and antennas (Par. 144). It would have been obvious for one having ordinary skill in the art at the time the invention was integrate the control circuitry of the invention of Bylerly, inclusive to the PCB, microcontroller, antenna, memory…etc. as a SoC, as disclosed by Adams, in order to provide a single integrated computer device which allows for compact construction of the device and ease of assembly.
Regarding Claim 11, Byerly is understood to constitute a resistor (inasmuch as any such device may be characterized as a resistor since it creates a resistance to electric flow and causes a voltage change commensurate in its internal resistance and power consumption), wherein the antenna is provided integrated/disposed at least partially on the PCB as part of the integrated BLE controller (Par. 57). Byerly discloses the invention substantially as claimed except that that the system further comprises an SoC which includes the microcontroller. However, Adams discloses a related medication delivery device (20) with onboard electronics that uses a PCB having a processing circuit in the form of a SoC integrated circuit to provide the necessary processor, memory, and I/O ports (Par. 87). While in “some embodiments” the BLE may be integrated with the SoC (144) in other embodiments the BLE may be provided on the PCB external to the SoC (Par. 101). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the BLE on the PCB separate of a SoC in the invention of Byerly, as disclosed by Adams, in order to provide separate, discrete controllers based on availability of components and mere design preference.
Response to Arguments
Applicant's arguments filed with respect to the claims have been fully considered but they are not persuasive.
Applicant argues (Pg. 7) that “there is no disclosure or mention in those paragraphs, or anywhere else in Kanakasbhapathi, of a “test pad”, much less of using such a test pad to detect moisture.” However, this is not persuasive. As noted by Applicant the generally accepted definition of a “test pad” is “an exposed, conductive metal area usually circular in shape… designed for automated or manual testing of a circuit’s functionality.” Such a description is met by the exposed conductive traces disclosed in Kanakasbhapathi. Specifically, Kanakasbhapathi discloses the PCB/PCA to have provided thereupon first and second portions (905, 910) which are exposed to the surface of the PCB/PCA such that moisture (920) can interact with them, with these portions being “implemented as conductive wires, traces, and/or plates” (Par. 54). As such, these exposed, conductive metal areas of the PCB which form the circuit (900) are structured as “test pads” even if Kanaksbhapathi does not utilize that particular terminology.
Additional evidence that these features would be recognized as “test pads” can be found in related publications WO 98/19159 (“Douglas”). Here Douglas characterizes a similar moisture detection arrangement (Fig. 4, 5B) as a “test pad” (12) whereby the “test pad” comprises a circuit with a pair of exposed conductive metal traces/contacts (54, 55) which can be exposed to a fluid (16) to complete the circuit (see Pg. 14 and 15) like the structure in Kanaksbhapathi. Douglas explicitly calls this structure “the test pad 12” (see Pg. 14 and 15). As such, it is clear that the structure of Kanaksbhapathi may likewise be considered a “test pad” in the broadest reasonable interpretation of the phrase. Here, Douglas is not relied upon to provide modification to Byerly, but rather is supplied as an evidentiary reference establishing the broadest reasonable interpretation of the claim limitations in light of the accepted prior art to establish proper characterization of the disclosure of Kanakshbhapathi as would be understood by the ordinary artisan.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
04/20/2026
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