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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 28 July 2025 has been entered.
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) 21-27, 29, 32-38, 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0173261 (“O’Connor”) in view of U.S. Publication No. 2013/0274576 (“Amirouche”), U.S. Publication No. 2012/0238851 (“Kamen”), U.S. Publication No. 2013/0234656 (“Lambert”), and U.S. Publication No. 2016/0342759 (“Shapely”).
Regarding Claims 21 and 32, O’Connor discloses a user-wearable infusion pump (102), the pump comprising:
A reservoir configured to contain a medicament (Par. 14);
A drive mechanism configured to facilitate delivery of the medicament to a user (i.e. the pumping mechanism which affects release of the medicament from the reservoir, see Par. 14);
A rechargeable battery (Par. 14) configured to be charged wirelessly (Par. 44);
An input button (Par. 45); and
A processor functionally linked to the input button and configured to receive input for control of functions of the user-wearable infusion pump in response to input received via the input button (Par. 16, 39, 46, 53), wherein the processor is configured to detect an input (e.g. “tapping or pressing”) received via the input button to confirm a command to be performed (Par. 39, 46), said command being stored in memory (Par. 11, 32, 50).
O’Connor discloses the invention substantially as claimed except that the processor is configured to determine “types of activation” of the input button to associate each of the different “types” with corresponding functions of the pump device with these functions being stored in the memory of the device. While O’Connor does casually mention two types of activation (e.g. tapping or pressing a button – Par. 39) it is not clear if these are intended to reference to distinctly different types of input (e.g. a short press vs. long press with the duration of the input being relevant for differentiating between types) or are being used as analogs/synonyms of one another to define the same, non-distinct type of input. As such, O’Connor is ambiguous as to the ability for the process of the pump to differentiate between inputs based upon duration or frequency (e.g. a short press vs. a long press and/or a single tap vs. a double tap…etc.)
However, Amirouche discloses a related pump device (100) which like that described by O’Connor may comprise a button which can actuated by the user in order to execute functions. Amirouche discloses that the button may be multi-functional such that the processor can detect and distinguish between different types of input provided at the button by the user and differentiate between these input types to assign different pump functions dependent upon the particularly provided input characteristics (Par. 57 – e.g. the pump of Amirouche is particularly configured to differentiate a short press to provide a first function from a long press to provide a second, different function).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the button and processor of the pump device of O’Connor to be configured to differentiate between input types at the button (e.g. differentiating a long press vs. a short press), as disclosed by Amirouche, in order to allow the button to be multi-function whereby a single button can receive diverse input types to execute two different situationally relevant commands.
Among such diverse, situationally relevant commands that one having ordinary skill in the art would have found obvious to supply to the device of modified O’Connor would comprise examples such as a confirm command and a cancel command (see Kamen – Par. 89) whereby it would have been obvious for one having ordinary skill in the art at the time the invention was made to modify the device of O’Connor to utilize different input types at the button to distinguish a short-press to confirm a command at the pump versus a long-press to cancel a command at the pump (or vice versa). The ordinary artisan would have been motivated to perform such a modification to allow for unwanted or improperly set commands to be canceled, via the pump, to avoid delivering unwanted or mistakenly set operations.
O’Connor, as modified discloses that the pump device is communicatively coupled to a remote control (e.g. 116 – Par. 28) or a remote glucose monitor (108 – Par. 22). O’Connor, as modified, discloses the invention substantially as claimed except that processor is configured to “determine” whether or not a wireless charging signal provided by an inductive charging device is being received by a receiving coil in the pump device. While O’Connor does suggest that wireless charging can be implemented, O’Connor fails to expand upon the exact nature of this wireless charging hardware and software. Likewise, while Amirouche also describes wireless charging (Par. 66, 73) the disclosure as to the exact hardware and software is limited, with Amirouche only broadly reciting that such wireless charging may be performed via “remote power conduction or induction” (Par. 73).
However, such inductive wireless charging systems are well-known in the art. For example, Lambert discloses a wirelessly rechargeable device (see e.g. 16) which is configured to receive a wireless charging signal provided by an inductive charging docking station (10), wherein the rechargeable device comprises a receiving coil for receiving the signal (21). Lambert discloses that this docking station may be configured to provide a two-way communication protocol (re: a “handshake” – Par. 33) such that the charger and the rechargeable device can communicate with one another to provide control over the charging operation such as heat management, i.e. the processor of the rechargeable device is able to “determine” whether or not a wireless charging signal being provided by an inductive charging device is being received by the receiving coil at any given time.
It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the wireless charging system of the invention of O’Connor to comprise an inductive charging coil provided in the pump device and communicating with an inductive wireless charging docking station whereby the processor of the pump executes a handshake protocol to recognize the presence of the wireless charging signal, as disclosed by Lambert, in order to allow the two devices to communicate with one another to adjust the charging operation to account for such factors as heat management and other necessary steps to regulate power exchange between the two devices.
O’Connor, as modified, discloses the invention substantially as claimed except that that the processor is configured to execute different function commands situationally depending on whether or not a wireless charging signal is being provided. Specifically, O’Connor only explicitly contemplates performing a first function (e.g. confirming a command to initiate a delivery – Par. 47, 48, 52) without any situational consideration as to the charging state of the device.
However, Shapley discloses a related delivery pump (2) which can be provided with a charging station (8), wherein the delivery pump is configured to communicate with a wireless remote handset (3) in order to assist in programming and operation of the drug delivery pump (Abstract). In order to allow for communication between the delivery pump and the handset in a secure manner Shapley describes that the delivery device and handset may undergo a “pairing” operation (Abstract; Par. 1; 10-24). To initiate the pairing operation the delivery device (2) processor (25) is configured to determine when the delivery device is received on the charging station (see Fig. 4 – S1; Par. 44) whereby following determination of a proper physical connection of the delivery device to the charger the delivery device can enter into a pairing/discovery process whereby the pump can be seen by unpaired remote handsets (Par. 44) and whereafter the remote and delivery device can be caused by user input to pair with one another.
It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the device of modified O’Connor to initiate a discovery mode when the processor determines it is in the presence of a wireless charging signal indicating that it has been received by an authorized charging device, as disclosed by Shapley, in order to allow the drug delivery device and remote control device to be paired together by the user to ensure that the two devices can communicate with one another.
In the instant case Shapley fails to explicitly require that confirmation of the pairing function is made by pressing a button at the drug delivery device when the drug delivery device determines it is on the charging station, i.e. a “second function” different from the first function. Rather, Shapley appears to expressly provide confirmation of the pairing ONLY at the remote (see S19, S22, S23 – Par. 47). However, as noted above, O’Connor suggests that for security purposes operational change commands should be confirmed at the pump device via the button (Par. 21, 39, 40). However, Kamen discloses that for security purposes confirmation of the pairing should be performed at BOTH the remote interface AND the device to be paired (Par. 338). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the modified invention of O’Connor to receive input at the button while in a pairing mode such that the pairing can be either confirmed (via short press) or denied (via long press) as well as confirming the pairing at the remote control device, as disclosed by Kamen, in order to ensure that pump device cannot be paired to an remote control outside of the immediate control of the user with the user confirming the pairing at the pump itself.
As such, the invention of O’Connor when modified as described above will be configured to perform a first function (i.e. provide delivery of a medicament bolus) of a first type of operation (i.e. a drug handling operation) in situations where the device is not being charged and is in a treatment mode AND perform a second function (i.e. confirm a pairing request) and second type of operation (i.e. a charging/device maintenance operation) when the device has been determined to be have been placed on the charging device and is therefore in the presence of a wireless charging signal, i.e. the presence of the wireless charging signal allows the device to determine that it is in a charging/maintenance mode and causes a change in function of the button to confirm or reject a pairing command instead of being used to perform a first drug delivery bolus function when the device is not being charged and instead being worn by a patient in the delivery mode.
Regarding Claims 22 and 33, O’Connor discloses the invention substantially as claimed except for explicitly reciting that the “button” is “a single button”. Examiner notes that O'Connor only recites “a button” or “the button” in the singular, never the plural, strongly implying that only a single button is present (see Par. 39, 45, 46, 53). Examiner submits that such grammar can be used as evidence to characterize the invention of O'Connor as a single button operation infusion pump. Furthermore, it would have been obvious for a person having ordinary skill in the art at the time the invention was made to construct the device of O’Connor as a single button device (supplying only the one specifically disclosed button) as it has been held that elimination of an element (and is function) requires only routine and customary skill in the art, see Ex Parte Wu,10 USPQ 2031 (Bd. Pat. App. & Inter. 1989), In re Larson, 340 F.2d 965, 144 USPQ 347 (CCPA 1965), and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). Since only a single button (and its function) are described by O’Connor, elimination of any second buttons (not described) would be obvious as no function is given to any hypothetical second button. Lacking any disclosure to a second button (and disclosure of any function associated with a second button) providing the device including only the disclosed button would be clearly obvious.
Regarding Claims 23 and 34, O’Connor explicitly illustrates the pump to not include a display screen (see Fig. 1-3B). However, O’Connor never explicitly recites that the pump positively excludes the presence of a screen, only disclosing that “a visual display” (Note not necessarily a screen) is optional (see Par. 45). It would have been obvious for a person having ordinary skill in the art at the time the invention was made to construct the device of O’Connor without a display screen, allowing other recited structures to serve as the output device (e.g. a speaker, a vibration generator, electrodes, or lights; see Par. 45), as it has been held that elimination of an element (and is function) requires only routine and customary skill in the art, see Ex Parte Wu,10 USPQ 2031 (Bd. Pat. App. & Inter. 1989), In re Larson, 340 F.2d 965, 144 USPQ 347 (CCPA 1965), and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975).
Regarding Claims 24 and 35, O’Connor discloses the processor is further configured to wirelessly communicate (124, 126) pump information to a separate device for display on the separate device (see e.g. 116, 112; Fig. 1B; Par. 29).
Regarding Claims 25 and 36, O'Connor discloses that the pump may include an indicator light (Par. 45, 53).
Regarding Claims 26, 27, 37, and 38, O’Connor discloses the indicator light (RE: output device; see Par. 45, 53, 46) is functionally linked to the input button such that the indicator light illuminates to indicate that input has been received via the input button (Par. 46, i.e. the “output device may similarly alert the user after execution of the action”), the indicator occurring for the commands in general (which would include the first and second function commands described above).
Regarding Claims 29 and 40, O’Connor (as modified – see above particularly Amirouche and Lambert) obviates the implementation of an inductive wireless charging signal, i.e. a specific well-known species within the genus identified by O’Connor to obtain a predictable and expected outcome.
Claim(s) 28 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0173261 (“O’Connor”) in view of U.S. Publication No. 2013/0274576 (“Amirouche”), U.S. Publication No. 2012/0238851 (“Kamen”), U.S. Publication No. 2013/0234656 (“Lambert”), and U.S. Publication No. 2016/0342759 (“Shapely”) as applied above, and further in view of U.S. Publication No. 2014/0175682 (“Johnson”).
Regarding Claims 28 and 39, O’Connor discloses the invention substantially as claimed except that the indicator light is illuminated differently to differentiate between the execution of the first function and the second function. However, Johnson discloses a related medical device (RE: a pump) likewise having an indicator light (Par. 62), the light being illuminated to indicate operation of different commands of the device (Par. 63) wherein the light may be differently illuminated (e.g. color or pattern; Par. 63) depending on the specific command/function being performed. It would have been obvious for a person having ordinary skill in the art at the time the invention was made to configure the indicator light of the invention of O’Connor to distinctly illuminate depending on the confirmed function, as disclosed by Johnson, in order to convey additional information to the user in the form of a user comprehendible code unique to the specific function command thereby permitting the user to visually confirm proper execution of the device.
Regarding Claim 43, as discussed above, O’Connor as modified is configured to differentiate between a short press and a long press (see e.g. Amirouche – Par. 57), whereby such a differentiation is held to constitute “a single press of the input button”, “holding the input button down for a predetermined period of time”, “pressing the input button a number of times [e.g. once] with a certain period”, and “a predefined sequential pattern [e.g. a single press being a single point sequence] of presses of the input button or a predetermined length of time [e.g. the time period necessary to differentiate between a short press and a long press]”. However, should Examiner’s arguments not be found persuasive the following is presented.
Regarding Claim 44, as discussed above, O’Connor, as modified, will be configured to confirm the initiation of delivery operation (e.g. a fluid bolus) with the user-wearable infusion pump as a first function within the first set of function. Here, Examiner submits that the broadest reasonable interpretation does not particularly require the device to be configured to perform EACH of the recited functions as a product of the “first set of functions” incident to button input. Specifically the parent claim recites “cause the user-wearable infusion pump to execute a first function of a first set of functions in response to the input”. Only the execution of the “first function” is positively required and the claim does not require the storage of EACH identified function of the first set of functions.
Regarding Claim 45, as discussed above, O’Connor, as modified, will be configured to confirm the initiation of a “software update protocol” in response to input received while the device is charging, i.e. the altering of a pairing status of the software may be considered an “update” to said protocol. As discussed above, neither the instant claim nor the parent claim necessarily require the system to be configured to perform EACH of the stated functions identified in the second set of functions, but rather the parent claim only particularly requires the execution of a representative second function.
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0173261 (“O’Connor”) in view of U.S. Publication No. 2013/0274576 (“Amirouche”), U.S. Publication No. 2012/0238851 (“Kamen”), U.S. Publication No. 2013/0234656 (“Lambert”), and U.S. Publication No. 2016/0342759 (“Shapely”) as applied above, and further in view of U.S. Publication No. 2009/0128330 (“Monroe”).
Regarding Claim 43, Monroe discloses a related drug delivery device with a button (1050) which is configured to receive and distinguish between diverse types of user input inclusive to registering distinctive patterns, e.g. a short press then a long press then a short press (Par. 232) in order to confirm the performance of different functions. It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the device of O’Connor to distinguish various multi-presses of the button performed in various sequences, patterns, and durations, as disclosed by Monroe, in order to allow certain commands to be locked behind more diverse button press combinations to ensure that a user does not accidentally execute an undesired function or accidentally cancel a desired function.
Claim(s) 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0173261 (“O’Connor”) in view of U.S. Publication No. 2013/0274576 (“Amirouche”), U.S. Publication No. 2012/0238851 (“Kamen”), U.S. Publication No. 2013/0234656 (“Lambert”), and U.S. Publication No. 2016/0342759 (“Shapely”) as applied above, and further in view of U.S. Publication No. 2013/0317837 (“Ballentyne”).
Regarding Claim 45, should Examiner’s argument that altering/updating the pairing status of the device of O’Connor constitutes “initiating a software update protocol” not be found persuasive the following is presented. Ballentyne discloses a related medical pump system (Par. 44) which is configured to, while charging, perform operations including upload/download of data, synchronizing data, and downloading/installing system/software updates (Par. 486). 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 modified O’Connor to upon receipt at the wireless charging station perform a second function comprising initiating a software update protocol, as disclosed by Ballentyne, in order to allow the user to install system updates when the device is not being used by the patient and is being charged to ensure proper operation of the device.
Response to Arguments
Applicant's arguments filed with respect to the claims have been fully considered but they are not persuasive.
Applicant argues (Pg. 10) that “Shapley merely discloses one single type of operation, i.e. paring, related to connectivity of the delivery device to a charger, rather than ‘two different types of operation’ based on ‘whether or not a wireless charging signal provided… was being received’ ‘at a time that the input was received’”. However, this is not persuasive. Specifically the above rejection involves substantially more than consideration of the Shapely reference alone and Shapely is provided only to demonstrate the obviousness modification to O’Connor to, when wireless charging is being performed, allow user input to confirm or reject a pairing mode request incident to the change in charging status. Other types of operation associated with different functions of different operational types are afforded by the other references, including, but not limited to, confirmation of a delivery bolus via button input in a condition where the device is being worn by a patient and is provided in absence of the wireless charging signal.
Applicant argues (Pg. 10) “the combination does not teach or suggest a determination of ‘whether or not a wireless charging signal provided… was being received’ ‘at a time that the input was received’ can cause the pump to execute functions associated with ‘two different types of operation’’…” However, this is not persuasive. O’Connor discloses that when the device is being worn by a patient input at the button can be used to confirm or cancel delivery commands, e.g. the delivery of an infusion bolus, which constitutes a first function of a first set of functions associated with a first type of operation. As modified, the system of O’Connor would have been obvious to configure such that upon being placed on the wireless charging station (i.e. determination as to whether or not a wireless charging signal is being provided) allow a user to confirm or reject a pairing command to enable connection of the device with a remote control device, i.e. a second function of a second set of functions of a second type of operation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Specifically, while not currently applied for the sake of brevity Examiner submits that the broadening of independent Claims 21 and 32 would render the claims again applicable to rejections previously made in the 24 July 2024 Non-Final Rejection. Specifically, consideration of Ballentyne’s discussion of initiating software updates at the device incident to charging (i.e. a second function of a second set of functions of a second type of operation) and Mansour’s discussion of displaying battery charge information incident to charging (i.e. a second function of a second set of functions of a second type of operation) is required and Examiner reserves the right to reintroduce these rejections as necessary.
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).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
11/24/2025