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 Objections
Claim 14 is objected to because of the following informalities: line 4 reads: “the second real-time used clock”, seems to be a typographical mistake. The claim has been interpreted to read: “the second real time clock is used for synchronization”. 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 9-10 are 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.
Claims 9-10 contain 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 wireless communications and, accordingly, the identification/description is indefinite.
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) 1-17 and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kikuchi et al. (EP 2361647) hereinafter Kikuchi.
Regarding claim 1, KIKUCHI teaches a drug delivery device, comprising:
a housing (2) configured to carry a syringe (11) with a medication;
an extrusion drive (syringe piston 15) for selectively extruding the medication from the syringe during an injection process; and
a main microcontroller (23) and a wireless communication module (30) carried by the housing;
wherein the main microcontroller and the wireless communication module are
communicatively connected via a communication channel,
wherein the main microcontroller includes a first real-time clock (21a),
wherein the main microcontroller is configured to generate injection data based on
the first real-time clock,
wherein the wireless communication module includes a periphery interface and a
second real-time clock (21), and wherein the periphery interface is configured to communicate the injection data to a remote device based on the second real-time clock.
Regarding claim 2, KIKUCHI teaches the main microcontroller is configured to automatically control at least a portion of a medication injection process (Refer to paragraph [0051] “Further, microprocessor 23 also functions as a use time counting means to count the time elapsed from the start of use of the formulation by executing a program described later in FIG's. 7 and 8. Furthermore, microprocessor 23 may inject a predetermined amount of the formulation into a body by automatically controlling the motor drive circuit based on the information of the predetermined formulation injection amount”).
Regarding claim 3, KIKUCHI teaches further comprising: an external wireless device connected and paired to the periphery interface, wherein the second real-time clock is for synchronization (refer to paragraph [0063]).
Regarding claim 4, KIKUCHI teaches further comprising: a memory (Refer to paragraph [0048]), wherein the main microcontroller is configured to automatically store the injection data in the memory.
Regarding claim 5, KIKUCHI teaches the wireless communication module is configured to read injection data from the memory (Refer to paragraph [0063]).
Regarding claim 6, KIKUCHI teaches a method of operating a drug delivery device, the method comprising:
providing a main microcontroller (23) communicatively connected with a wireless
communication module via a communication channel (Refer to paragraph [0063]),
wherein the main microcontroller includes a first real-time clock (21a)
wherein the main microcontroller (23) is configured to generate injection data based on the first real-time clock (embedded timer 21a which is inside microprocessor) and to control at least a portion of a medication injection process based on drug delivery device configuration data,
wherein the wireless communication module includes a periphery interface (10/28) and a second real-time clock (21); and communicating injection data (medicine date), via the periphery interface, based on the second real- time clock (21, REFER TO paragraphs [0073-75]).
Regarding claim 7, KIKUCHI teaches the main microcontroller is
configured to automatically control at least a portion of a medication injection process (Refer to paragraph [0063]).
Regarding claim 8, KIKUCHI teaches wireless communication module is configured to transmit injection data to an external wireless device via the periphery interface (Refer to paragraph [0075]).
Regarding claim 9, KIKUCHI teaches the wireless communication module includes a Bluetooth low energy (BLE) device (Refer to paragraph [0062]).
Regarding claim 10, KIKUCHI teaches external wireless device is Bluetooth low energy (BLE) capable (Refer to paragraph [0062]).
Regarding claim 11, KIKUCHI teaches a time-stamp is based on the first real-time clock (embedded timer 21a which is inside microprocessor, Refer to paragraph [0047 and 0052]) when the main microcontroller is active.
Regarding claim 12, KIKUCHI teaches a non-transitory computer-readable medium storing computer- readable instructions that, when executed by one or more processors, causes the one or more processors to:
receive a first real-time clock (embedded timer 21a which is inside microprocessor) signal from a main microcontroller (30) communicatively
connected with a wireless communication module via a communication channel, wherein the main microcontroller is configured to generate injection data and to control at least a portion of a medication injection process (Refer to paragraph [0051] “Further, microprocessor 23 also functions as a use time counting means to count the time elapsed from the start of use of the formulation by executing a program described later in FIG's. 7 and 8. Furthermore, microprocessor 23 may inject a predetermined amount of the formulation into a body by automatically controlling the motor drive circuit based on the information of the predetermined formulation injection amount”);
receive a second real-time clock signal (21) from the wireless communication module;
and communicating the injection data via a periphery interface of the wireless
communication module based on the second real-time clock (Refer to paragraph [0075]).
Regarding claim 13, KIKUCHI teaches The non-transitory computer-readable medium of claim 12, wherein the main microcontroller is configured to automatically control at least a portion of a medication injection process (refer to paragraphs [0051 and 0063]).
Regarding claim 14, KIKUCHI teaches connecting and paring an external wireless device (paragraph [0062]) to the periphery interface wherein the second real-time used clock (21) is for synchronization (refer to paragraphs [0078-0081]).
Regarding claim 15, KIKUCHI teaches further comprising: automatically storing injection data in a memory using the main microcontroller (refer to paragraph [0048, and 0062]).
Regarding claim 16, KIKUCHI teaches the wireless communication module is configured to retrieve injection data from the main microcontroller (Refer to paragraph [0063]).
Regarding claim 17, KIKUCHI teaches at least one of: a time read request or a date read request is based on the second real-time clock (refer to paragraph [0048]) when the main microcontroller is in a sleep mode (when the power supply button is turned off).
Regarding claim 19, KIKUCHI teaches, wherein the first real-time clock (21A, Refer to paragraph [0049, 0052-0053]) is used for keeping track of date and time-stamps correlated with injection data.
Regarding claim 20, KIKUCHI teaches the drug delivery device is configured to deliver a medication based on the first real-time clock (21a) (Refer to paragraph [0083]).
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.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over KIKUCHI in view of Rosenbluth et al. (WO 2014/113813 A1) hereinafter Rosenbluth.
Regarding claim 18, KIKUCHI fails to explicitly teach the communication channel is selected from a group including: a UART channel, an I2C channel (inter integrated channel), a SPI channel (Serial Peripheral Interface), or a GPIO channel.
Rosenbluth teaches the communication channel is selected from a group including: a UART channel, an I2C channel (inter integrated channel), a SPI channel (Serial Peripheral Interface), or a GPIO channel (Refer to paragraph [000233]).
It would have been obvious to one of ordinary skill in the art to use UAR/I2C or SPI channels as the communication channel between the Bluetooth of Kikuchi and the microcontroller as these channels are well known to be embedded in bluetooth microcontrollers as they are favored for their simplicity, low cost, and minimal wiring.
Conclusion
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EDELMIRA BOSQUES
Supervisory Patent Examiner
Art Unit 3762
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772
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