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 .
Response to Arguments
Applicant’s arguments, see page 8-11, filed 12/12/2025, with respect to prior art rejections of Claims 16 - 35 have been fully considered and are persuasive. The 35 U.S.C. 102 Rejections of Claims 16 - 35 has been withdrawn.
The Examiner agrees with the claim objection corrections for claims 25, 30, and 32.
The Examiner respectfully disagrees Paramananndam does disclose of a continuously powered volatile-memory electronic component used for storing changeable data. Although not explicitly stated one skilled in the art could come to the obvious conclusion volatile memory is used for temporary data and requires constant power to retain data. (Paramananndam: 0022, Analogously to the controller 120, the wireless communication module 130 may be configured to operate in a plurality of modes with different power consumptions or current draws, including active modes and low-power modes. In addition to enabling access to the computing resources within the wireless communication module 130, an active mode of the wireless communication module 130 may also enable wireless communication resources that substantially contribute to power consumption.)
The Examiner agrees Paramananndam does not disclose of a distinguishing "first kind" vs "second kind" of data with the claimed storage scheme. However, Paramananndam does teach saving data to different memories. (0061, Upon activation, the wireless communication module 130 may access an injection log and/or the drug delivery device state data records stored in the memory 122 or from the removable storage device 124. From the injection log and/or drug delivery device state data records, the wireless communication module 130 may obtain at least some data from a data entry indicative of a completed injection and/or state of the drug delivery device. In some implementations, the wireless communication module 130 obtains the data from the controller 120, e.g., via the bus 128 and/or the processor interface 210. To obtain the data from the controller 120, the wireless communication module 130 may first send a controller activation trigger to wake-up or activate the controller 120, causing the drug delivery device 102 to transition into the both-on state 330 from the wireless-on state 340.) This can imply to one skilled in the art the different memories could have different purposes.
The Examiner disagrees Paramananndam teachings do not conflict with "continuous supply" to volatile memory. As mentioned above, volatile memory requires a continuous supply in general to retain data. With this in mind, one skilled in the art could conclude Paramananndam would not use a volatile memory and power consumption implementations if continuous supply to the memory was not accounted for. (0045, The wireless communication module 130 also may be configured to operate in one of different modes with different corresponding current draws, and, consequently, different corresponding power consumption values. In the active mode, the wireless communication module 130 may draw a current of 0.1, 0.2, 0.5, 1, 2, 5, 10, 20, 50, 100, 200, 500 mA or any other suitable current while transmitting and/or receiving wireless signals. In a low-power mode, however, the wireless communication module 130 may draw 0.01, 0.02, 0.05, 0.1, 0.2, 0.5, 1, 2, 5 pA or any other suitably low current. The current draw of the wireless communication module 130 operating in the active mode may be 2, 5, 10, 10, 50, 100, 200, 500, 1000, 2000, 5000, 10000 or any other suitable multiplicative factor higher than the current draw of the wireless communication module 130 in the low-power mode.)
For at least the same reasons discussed with respect to claim 16, all claims are considered but also rejected.
Claims 17 – 30 which depend from amended claim 16, have been considered and rejected.
Claims 32 - 35 which depend from claim 31, have been considered and rejected.
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) 16 – 35 are rejected under 35 U.S.C. 103 as being unpatentable over PARAMANANDAM (WO 2020257137 A1) in view of Vembu (US 9582216 B2).
With regards to claim 16, PARAMANANDAM teaches:
An electronic system configured for application in a drug delivery device or a drug delivery add-on device to implement a data storage, the electronic system comprising: a processor (0018, The controller 120 may include one or more processors; the controller 120 may include one or more electronic memory components, such as one or more registers, random access memory (RAM), read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), and/or flash memory), wherein the electronic component is configured to be continuously supplied with electric power to maintain data stored in the volatile memory (0014, power-efficient operation of the drug delivery device 102 may reduce the need to recharge or replace a battery of the drug delivery device 102), (0018, the memory 122 included in the controller 120 may be disposed on the same chip or IC as a processor, in a system on a chip (SoC) configuration).
PARAMANANDAM fails to teach:
for processing data for distinguishing between a first kind of data and a second kind of data, wherein the first kind of data is provided to not be changed over the lifetime of the drug delivery device and the second kind of data is provided to change over the lifetime of the drug delivery device; and wherein the processor is configured to store the first kind of data in the non-volatile memory and the second kind of data in the volatile memory of the electronic component.
However, Vembu teaches:
for processing data for distinguishing between a first kind of data and a second kind of data, wherein the first kind of data is provided to not be changed over the lifetime of the drug delivery device and the second kind of data is provided to change over the lifetime of the drug delivery device; and wherein the processor is configured to store the first kind of data in the non-volatile memory and the second kind of data in the volatile memory of the electronic component. (59, As mentioned above, according to many embodiments, the code is generally static, as the binary files do not change during execution. On the other hand, data may change or it may not change, depending on a type of data. For example, static data (e.g., constants) will not change but volatile data (e.g., a stored variable that is recalculated based on continually changing input) does change. Thus, code and static data can be placed in a read-only section of memory, whereas volatile data would generally be placed in a read/write section of memory.)
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 system of an electronic system configured for application in a drug delivery device of PARAMANANDAM with the teaching of Vembu, which teaches a first kind of data and a second kind of data and their distinctions in order to implement a structure to the memory storage based on the data retrieved (Vembu: 59, Then when the operating system 204 is allocating memory space to store the structure, it will see the “volatile” bit as set and know to allocate the structure in the volatile data section of DRAM memory space. Alternatively, if a data variable is declared as a constant value, the software application may clear the “volatile” bit to tell the operating system to allocate the data as static.)
With regards to claim 17, PARAMANANDAM teaches the electronic system of claim 16:
wherein the electronic component with the volatile memory is a real time clock with the volatile memory being accessible by the processor, and wherein the processor is configured to access the volatile memory and to store at least part of the processed data in the volatile memory (0003 & 0018, the external device can take time; The controller 120 may include one or more processors; the controller 120 may include one or more electronic memory components, such as one or more registers, random access memory (RAM)).
With regards to claim 18, PARAMANANDAM teaches the electronic system of claim 16:
wherein the processor is configured to store encryption data in the volatile memory (0023 & 0038, the controller 120 and the wireless communication module 130 may be in communicative connection with each other via a communication bus 128. The communication bus 128 may also communicatively connect other components including, for example, the memory 122, the removable storage device 124, the auxiliary circuitry 126, the mechanical drive 140, the controller 120 and/or to the wireless communication module 130. The communication between the wireless communication module 130 and the user device 104 may be encrypted using one or more encryption methods. The encryption may use symmetric and/or public keys).
With regards to claim 19, PARAMANANDAM teaches the electronic system of claim 18:
wherein the encryption data includes one or more encryption keys (0038, The communication between the wireless communication module 130 and the user device 104 may be encrypted using one or more encryption methods. The encryption may use symmetric and/or public keys).
With regards to claim 20, PARAMANANDAM teaches the electronic system of claim 16:
wherein the processor is configured to store data related to a use of the drug delivery device in the non-volatile memory (0018, Additionally or alternatively, the controller 120 may be in communicative connection with the removable storage device 124, such, as a flash drive, an SD (secure digital) card, and/or a microSD card).
With regards to claim 21, PARAMANANDAM teaches the electronic system of claim 20:
wherein the data related to the use of the drug delivery device includes data related to doses delivered with the drug delivery device (0003, Certain automated drug delivery devices include sensors and other electronics for monitoring use of the device. Information collected by such sensors can be wirelessly communicated to an external device such as a smartphone so that this information can be displayed to a user, stored in a memory, or made available to a healthcare provider).
With regards to claim 22, PARAMANANDAM teaches the electronic system of claim 20:
wherein the non-volatile memory has a storage size sufficient for storing entire data related to the use of the drug delivery device, the entire data comprising data related to doses delivered with the drug delivery device and generated during a lifetime of the drug delivery device (0061, the wireless communication module 130 may access an injection log and/or the drug delivery device state data records stored in the memory 122 or from the removable storage device 124).
With regards to claim 23, PARAMANANDAM teaches the electronic system of claim 16:
further comprising a communication interface for data transmission, wherein the processor is configured to store communication related data in the volatile memory (0020, The wireless communication module 130 may include, in communicative connection with at least one processing component, one or more memory components, such as one or more registers, RAM, ROM, EEPROM, and/or on-board flash memory).
With regards to claim 24, PARAMANANDAM teaches the electronic system of claim 23:
wherein the communication related data comprises data required for establishing a data transmission from the electronic system to an external computing device (0020, The wireless communication module 130 may include one or more communication components including at least one transmitter and at least one receiver).
With regards to claim 25, PARAMANANDAM teaches the electronic system of claim 16:
further comprising a primary battery or a cell as a power supply, wherein the primary battery or the cell is mounted together with other components of the electronic system on a printed circuit board and dimensioned to provide electric power over the lifetime of the drug delivery device (0016, the power source 114 is a rechargeable battery, configured to electrically connect to a charging circuit that may be disposed at least partially outside of the drug delivery device 102) wherein, during the lifetime, no erase operation of the non-volatile memory is carried out (0028, The one or more data entries may include error codes generated during self-test routines, the controller 120 detects using the sensors 160a-d, a failed injection attempt and generates a data entry in the injection log in response to the failed injection attempt. After generating the data entry, and also subsequent and/or in response to detecting that the injection mechanism completed an injection, the controller 120 may switch into a low-power mode).
With regards to claim 26, PARAMANANDAM teaches the electronic system of claim 16:
wherein the processor is configured to perform at least one check and/or correction cycle of the data stored or to be stored in the volatile memory to ensure data integrity (0028, The one or more data entries may include error codes generated during self-test routines, the controller 120 detects using the sensors 160a-d, a failed injection attempt and generates a data entry in the injection log in response to the failed injection attempt).
With regards to claim 27, PARAMANANDAM teaches the electronic system of claim 26:
wherein the processor is configured to perform as check cycles a checksum or hash value check on the data before storing the data in the volatile memory and storing the checksum or hash value alongside the stored data and after reading the data and the checksum or hash value from the volatile memory (0046, The controller 120 and the wireless communication module 130 may be configured to communicate with each other via a processor interface 210. The processor interface 210 may employ protocols with flow control that include request to send (RTS) and clear to send (CTS) signals as well as transmit (Tx) and receive (Rx) signals).
With regards to claim 28, PARAMANANDAM teaches the electronic system of claim 26:
wherein the processor is configured to perform as check cycles multiple read operations for reading data from the volatile memory repeatedly and to compare the repeatedly read data in order to detect transient errors (0046, The controller 120 and the wireless communication module 130 may be configured to communicate with each other via a processor interface 210. The processor interface 210 may employ protocols with flow control that include request to send (RTS) and clear to send (CTS) signals as well as transmit (Tx) and receive (Rx) signals).
With regards to claim 29, PARAMANANDAM teaches the electronic system of claim 26:
wherein the processor is configured to perform as a check cycle a read operation of data from the volatile memory after the data was stored in the volatile memory and to compare the read data with the written data in order to ensure the data was stored correctly (0018 & 0046, The memory 122 in the controller 120 or in communicative connection with the controller 120 may include one or more electronic memory components, such as one or more registers, random access memory (RAM), read-only memory (ROM); The controller 120 and the wireless communication module 130 may be configured to communicate with each other via a processor interface 210. The processor interface 210 may employ protocols with flow control that include request to send (RTS) and clear to send (CTS) signals as well as transmit (Tx) and receive (Rx) signals).
With regards to claim 30, PARAMANANDAM teaches the electronic system of claim 26:
wherein the processor is configured to perform as a correction cycle repeating a previous data storing operation in response to detecting, (0033, After broadcasting the message one or more times and/or repeatedly for a prescribed time interval, the wireless communication module 130 may switch into the low-power mode) [[if,]] during [[a]] the check cycle, an error of the data stored during the previous data storing operation (0028, The one or more data entries may include error codes generated during self-test routines, the controller 120 detects using the sensors 160a-d, a failed injection attempt and generates a data entry in the injection log in response to the failed injection attempt).
With regards to claim 31, PARAMANANDAM teaches:
A computer-implemented method for storing data on a drug delivery device or a drug delivery add-on device, the method comprising: processing data by a processor of an electronic system for distinguishing between a first kind of data and a second kind of data (0063, transmitting a message indicative of the first injection and/or the second injection. In some implementations, upon establishing the connection with the user device 104, the wireless communication module 130 sends a controller activation trigger), wherein the electronic system is configured for application in the drug delivery device or the drug delivery add-on device, wherein the electronic system comprises: a processor configured to process data, a non-volatile memory configured to store data, and an electronic component comprising a volatile memory (0018, The controller 120 may include one or more processors; the controller 120 may include one or more electronic memory components, such as one or more registers, random access memory (RAM), read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), and/or flash memory), wherein the electronic component is configured to be continuously supplied with electric power to maintain data stored in the volatile memory, and wherein the processor is configured to store at least a part of processed data in the volatile memory of the electronic component (0014, power-efficient operation of the drug delivery device 102 may reduce the need to recharge or replace a battery of the drug delivery device 102), and storing the first kind of data in a non-volatile memory and the second kind of data in a volatile memory of the electronic component (0018, the memory 122 included in the controller 120 may be disposed on the same chip or IC as a processor, in a system on a chip (SoC) configuration).
With regards to claim 32, PARAMANANDAM teaches the computer-implemented method of claim 31: wherein the processing of data by the processor for distinguishing between a first kind of data and a second kind of data comprises: determining that a dataset among the data to be processed belongs to the first kind of data (Abstract, The controller is also configured to generate in memory a data entry indicative of the injection and/or a state of the drug delivery device) if the dataset contains data related to a use of the drug delivery device, and determining that a dataset among the data to be processed belongs to the second kind of data [[if]] when the dataset contains data related to communication and/or encryption data (0063 & 0038, transmitting a message indicative of the first injection and/or the second injection. In some implementations, upon establishing the connection with the user device 104, the wireless communication module 130 sends a controller activation trigger; The communication between the wireless communication module 130 and the user device 104 may be encrypted using one or more encryption methods).
With regards to claim 33, PARAMANANDAM teaches the computer-implemented method of claim 32: wherein the data related to the use of the drug delivery device comprises data related to doses delivered with the drug delivery device, wherein the data related to communication comprises data required for establishing a data transmission from the electronic device to an external computing device, and the encryption data comprises one or more encryption keys (0038, The communication between the wireless communication module 130 and the user device 104 may be encrypted using one or more encryption methods. The encryption may use symmetric and/or public keys The wireless communication module 130 and the user device 104 may use Wired Equivalency Privacy (WEP), Wi-Fi Protected Access (WPA), and/or WPA2 wireless security protocols. In some implementations, to authenticate the wireless communication module 130 and/or the user device 104).
With regards to claim 34, PARAMANANDAM teaches the computer-implemented method of claim 31: further comprising: performing at least one check and/or correction cycle of the data stored or to be stored in the volatile memory to ensure data integrity, comprising performing one or more of the following: as check cycles a checksum or hash value check on the data before storing the data in the volatile memory and storing the associated checksum or hash value alongside the stored data and after reading the data and its associated checksum or hash value from the volatile memory (0028 & 0018, The one or more data entries may include error codes generated during self-test routines, the controller 120 detects using the sensors 160a-d, a failed injection attempt and generates a data entry in the injection log in response to the failed injection attempt. The memory 122 in the controller 120 or in communicative connection with the controller 120 may include one or more electronic memory components, such as one or more registers, random access memory (RAM)); as check cycles multiple read operations for reading data from the volatile memory repeatedly and comparing the repeatedly read data in order to detect transient errors; as a check cycle a read operation of data from the volatile memory after the data was stored in the volatile memory and comparing the read data with the written data in order to ensure the data was stored correctly; or as a correction cycle repeating a previous data storing operation if, during a check cycle, an error of the data stored during the previous data storing operation was detected (0046, The controller 120 and the wireless communication module 130 may be configured to communicate with each other via a processor interface 210. The processor interface 210 may employ protocols with flow control that include request to send (RTS) and clear to send (CTS) signals as well as transmit (Tx) and receive (Rx) signals).
With regards to claim 35, PARAMANANDAM teaches the computer-implemented method of claim 31: wherein the electronic component is a real time clock with the volatile memory accessible by the processor, and wherein the processor is configured to access the volatile memory and to store at least part of the processed data in the volatile memory (0003 & 0018, the external device can take time; The controller 120 may include one or more processors; the controller 120 may include one or more electronic memory components, such as one or more registers, random access memory (RAM)).
Prior Art Made of Record
The prior art mode of record and not relied upon is considered pertinent to
Applicant’s disclosure:
KUEHNI (EP 3734605 A1): An electronic unit of a drug delivery device is configured to prepare payload data comprising data items according to an allocation scheme, and to encrypt, based on an encryption key, transmit data including the payload data.
Response to Arguments
The Remarks argue that:
By the present amendment, claims 16, 25, 30, and 32 have been amended. The amendments to claim 16 find support in the specification, at least in paragraphs {0029], [0030], and [0051]. The amendments to claims 25, 30, and 32 find support in these claims, as originally filed. Accordingly, no new matter has been entered by the present amendments.
Applicant has amended and/or cancelled claims in order to facilitate expeditious prosecution of this application. Applicant is not conceding that the subject matter encompassed by the claims prior to this Amendment is unpatentable over the art cited by the Office Action. Applicant respectfully reserves the right to pursue claims in one or more continuing applications, including claims capturing the subject matter encompassed prior to this Amendment, and additional claims.
Claim Objections
Claims 25, 30, and 32 objected to because of the informalities, and the following corrections were required:
* In claim 25, line 4, "when" should read "wherein".
* In claim 30, line 2, "if" should read "wherein".
* In claim 32, line 3, "if" should read "wherein".
Applicant has amended claim 25, as indicated above. However, Applicant respectfully disagrees that "if' should be changed to "wherein" in claims 30 and 32, because these claims properly introduce conditional functionality in apparatus claims. In order to more particularly define the claimed subject matter, though, these claims have been amended to replace "if" wording with "in response to" and "when", respectively, preserving the scope of these claims.
Reconsideration and withdrawal of the objections is respectfully requested.
Claim Rejections - 35 U.S.C. § 102
Claim(s) 16-35 stands rejected under 35 U.S.C. § 102(a)(2) over W02020257137 (PARAMANANDAM). These rejections are respectfully traversed, to the extent they are maintained over these claims, as amended.
Claim 16, as amended, now recites:
16. An electronic system configured for application in a drug delivery device
or a drug delivery add-on device to implement a data storage, the electronic system comprising: a processor for processing data for distinguishing between a first kind of data and a second kind of data, wherein the first kind of data is provided to not be changed over the lifetime of the drug delivery device and the second kind of data is provided to change over the lifetime of the drug delivery device, a non-volatile memory configured to store data, and an electronic component comprising a volatile memory, wherein the electronic component is configured to be continuously supplied with electric power to maintain data stored in the volatile memory, and wherein the processor is configured to store at least a part of processed data in the volatile memory of the electronic component, and wherein the processor is configured to store the first kind of data in the non-volatile memory and the
second kind of data in the volatile memory of the electronic component.
These amendments limit claim 16 (and as already being recited in the method claim 31) to require a specific data classification and storage scheme tied to memory type and power mode:
. The processor distinguishes between (i) a first kind of data that is not changed over the device lifetime and (ii) a second kind of data that changes over the device lifetime.
. The first kind is stored in non-volatile memory.
. The second kind is stored in the volatile memory of an electronic component that is continuously powered to maintain the volatile data.
Paramananndam does not teach or suggest these combined limitations
A. No disclosure in Paramananndam of a continuously powered volatile-memory
electronic component used for storing changeable data
Paramananndam describes controller memory 122 (registers, RAM, ROM, EEPROM, flash) generally, and wireless module memory (including on-board flash). See [0018] (controller memory types) and [0020] (wireless module memory types):
o [0018] "The memory 122 ... may include ... random access memory (RAM), read- only memory (ROM), electrically erasable programmable read-only memory (EEPROM), and/or flash memory."
o [0020] "The wireless communication module 130 may include ... one or more memory components, such as one or more registers, RAM, ROM, EEPROM, and/or on-board flash memory."
Further, Paramananndam teaches aggressive power savings, including disconnecting the controller or wireless module from the power source in low-power modes:
o [0044] "In some implementations, a switch is configured to disconnect the controller 120 from the power source 114 ... to zero."
o [0046] "In some implementations, a switch is configured to disconnect the wireless communication module 130 from the power source ... to zero."
o [0049]-[0050] activation lines controlling power connectivity.
Applicant's independent claims 16 and 31 require "an electronic component comprising a volatile memory" that is "configured to be continuously supplied with electric power to maintain data stored in the volatile memory," and that the processor stores processed data in that volatile memory. Dependent claims 17 and 35 further require this electronic component to be a real time clock (RTC) whose volatile memory is accessible by the processor.
Notably, there is no teaching in Paramananndam of an RTC or any "electronic component comprising a volatile memory" that is "configured to be continuously supplied with electric power to maintain data stored in the volatile memory," nor any disclosure that the processor stores changeable data into such continuously powered volatile memory. In fact, this reference discloses neither an RTC, nor any separate electronic component with volatile memory that is continuously powered to preserve its contents. Instead, Paramanandam repeatedly teaches placing the controller and wireless module in low-power states and even physically disconnecting power via switches, which is the opposite of continuous supply to preserve volatile contents. The Examiner's citations (e.g., "power-efficient operation" and SoC integration) do not cure these missing limitations. Mere mention of a power-efficient operation is not continuous powering of a volatile memory to maintain stored data. And referenced "memory on the same chip as a processor" does not anticipate a distinct component with volatile memory that is continuously powered for data retention or an RTC.
B. No disclosure in Paramananndam of distinguishing "first kind" vs "second kind" of
data with the claimed storage scheme
At best, Paramananndam records an "injection log" and other device state data in memory and may access it for communication:
o [0061] "Upon activation, the wireless communication module 130 may access an injection log ... stored in the memory 122 or ... removable storage device 124."
But Paramananndam does not disclose classifying data into two kinds based on lifetime mutability and then storing the immutable kind in non-volatile memory while storing the changeable kind in a continuously powered volatile memory component. Importantly, encryption disclosure in [0038] of the cited reference pertains to using encryption methods and keys during communication (WEP/WPA/WPA2), but does not specify storing encryption keys or communication-related data in a continuously powered volatile memory:
C. Paramananndam teachings conflict with "continuous supply" to volatile memory
Paramananndam emphasizes switching components to low-power and even disconnecting them, see, eg [0044], [0046], [0049], [0050]. These teachings are antithetical to maintaining a continuously powered volatile memory component for persistent changeable data storage as now recited.
Accordingly, it is respectfully requested that the rejections under 35 U.S.C. § 102 be withdrawn, and that claims 16-35 are in condition for allowance.
Conclusion
Applicant’s arguments, see page 8-11, filed 12/12/2025, with respect to prior art rejections of Claims 16 - 35 have been fully considered and are persuasive. The 35 U.S.C. 102 Rejections of Claims 16 - 35 has been withdrawn.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/V.P./Examiner, Art Unit 2111
/GUERRIER MERANT/Primary Examiner, Art Unit 2111 2/6/2026