DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 21 January 2026 has been entered.
Status
This First Action Final Office Action is in response to the communication filed on 21 January 2026. Claim 9 has been cancelled, claims 1 and 12 have been amended, and no new claims have been added. Therefore, claims 1-8 and 10-20 are pending and presented for examination.
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 Amendment
A summary of the Examiner’s Response to Applicant’s amendment:
Applicant’s amendment does not overcome the rejection(s) under 35 USC § 101; therefore, the Examiner maintains the rejection(s) while updating phrasing in keeping with current examination guidelines.
Applicant’s amendment does not overcome the prior art rejection(s) under 35 USC §§ 102 or 103; therefore, the Examiner maintains the rejection(s) as below.
Applicant’s arguments are found to be not persuasive; please see the Response to Arguments below.
Inventorship
The Examiner notes that at the first action on the merits (“FAOM” dated 11 August 2025), the Examiner noted MPEP § 2157 in relation to a possible or understood inventorship issue. Applicant responded that “the inventorship of the instant application is correct” (Remarks dated 4 November 2025, at p. 6) despite the Estes application (U.S. Pub. No. 2015/0025498) disclosing the claimed invention yet listing a different inventor as disclosing the claimed invention. MPEP § 2157 says that “A situation in which an application names a person who is not the actual inventor or a joint inventor as the inventor or a joint inventor will be handled in a derivation proceeding under 35 U.S.C. 135 (see MPEP §§ 2310-2315), by a correction of inventorship under 37 CFR 1.48, or through a rejection under 35 U.S.C. 101 and 35 U.S.C. 115, as appropriate”. The Examiner made the §§ 101 and 115 rejections as indicated, but based on the response, the issue is – per MPEP § 2157 – left to be settled after the conclusion of the application prosecution.
As such, the § 115 rejections are currently withdrawn view of this notice.
Claim Interpretation
The Examiner notes that claim 12 is directed to “A wireless communication tag usable with a drug delivery device”. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art (see at least MPEP § 2103(I)(C)).
See e.g. In re Collier, 158 USPQ 266, 267 (CCPA 1968) (where the court interpreted the claimed phrase “a connector member for engaging shield means” and held that the shield means was not a positive element of the claim since “[t]here is no positive inclusion of ‘shield means’ in what is apparently intended to be a claim to structure consisting of a combination of elements” and where the court interpreted the claimed phrase “said ferrule-forming member being crimpable onto said shield means” and held that the shield means was not a positive element of the claim since “[t]here is no positive inclusion of ‘shield means’ in what is apparently intended to be a claim to structure consisting of a combination of elements.... “[t]he ferrule or connector member is crimpable but not required, structurally, to be crimped .... These cannot be regarded as structural limitations and therefore not as positive limitations in a claim directed to structure. They cannot therefore be relied on to distinguish from the prior art.”). See also MPEP § 2115, especially In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967) as indicating "the manner or method in which such machine is to be utilized is not germane to the issue of patentability of the machine itself." Id. at 580.
Therefore, claim 12 is directed to the wireless communication tag that has logic circuitry, a transmission element, and a memory connected to the logic circuitry. The user device and the drug delivery device are not positively recited – they are separate devices from the claimed system, and as such what is sent to the user device, what the mode of operation is of the drug delivery device, what is modified at the drug delivery device, etc. are all regarded as having little if any patentable weight.
Claims 13 and 18-19 depend from claim 12, but do not resolve the above issues and inherit the deficiencies of the parent claim(s); therefore claims 13 and 18-19 are also interpreted in the same manner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-8 and 10-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Please see the following Subject Matter Eligibility (“SME”) analysis:
For analysis under SME Step 1, the claims herein are directed to a system (claims 1-8 and 10-11), and a wireless communication tag that is defined as “a device capable of wireless transmission of data” (at Applicant ¶ 0018) (claims 12-20), which would be classified under one of the listed statutory classifications (SME Step 1=Yes).
For analysis under revised SME Step 2A, Prong 1, independent claim 1 recites a system, comprising: a user device; at least one wireless communication tag, wherein the at least one wireless communication tag is configured to communicate physiology affecting information to the user device, and a drug delivery device, wherein the user device is configured to: determine a mode of operation of the drug delivery device as a function of a historical trend of a plurality of modes of operation and the physiology affecting information and a current time of day; and modify the drug delivery device for delivery of a drug to the user based on the determined mode of operation.
Independent claim 12 recites a wireless communication tag usable with a drug delivery device, comprising: logic circuitry; a transmission element in communication with the logic circuitry; and a memory communicatively connected to the logic circuitry, wherein the memory contains instructions configuring the logic circuitry to: establish a data connection with a user device via the transmission element; and communicate physiology affecting information to the user device through the data connection, wherein the user device is configured to: determine a mode of operation of the drug delivery device as a function of a historical trend of a plurality of modes of operation and the physiology affecting information; and modify the drug delivery device for delivery of a drug to the user based on the determined mode of operation.
The dependent claims (claims 2-8, 10-11 and 13-20) appear to be encompassed by the abstract idea of the independent claims since they merely indicate the drug delivery device being wearable (claims 2 and 13), communicating and/or connecting as a function of proximity of the tag to the user device (claims 3, 14, and 17), the physiology affecting information being generated based on location of the tag (claim 4), the user device animating a GUI, receiving user input, and adjusting a setting as a function of the user input (claim 5), generating an alert (claim 6), the physiology affecting information including meal data, and generating a bolus calculation as a function of the meal data (claims 7, 16, and 18), adjusting a basal setpoint of the drug delivery device (claim 8), generate a user device GUI for mode of operation of a drug delivery device as a function of historical trend (claim 19), the drug delivery device includes an internal tag to communicate with the user device (claim 10) and switching the drug delivery device from a first to a second setting (claim 11), the wireless tag establishing a data connection with the drug delivery device (claim 15), and/or the tag being an NFC tag (claim 20).
The underlined portions of the claims are an indication of elements additional to the abstract idea (to be considered below).
The claim elements may be summarized as the idea of communicating information for drug delivery and modifying a drug delivery parameter (e.g., a setpoint or dose); however, the Examiner notes that although this summary of the claims is provided, the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination). This idea is within the Certain methods of organizing human activity (e.g. fundamental economic principles or practices such as hedging, insurance, mitigating risk; commercial or legal interactions such as agreements, contracts, legal obligations, advertising, marketing or sales activities/behaviors, or business relations; and/or managing personal behavior or relationships between people such as social activities, teaching, and following rules or instructions) grouping of subject matter:
Therefore, the claims are found to be directed to an abstract idea.
For analysis under revised SME Step 2A, Prong 2, the above judicial exception is not integrated into a practical application because the additional elements do not impose a meaningful limit on the judicial exception when evaluated individually and as a combination. The additional elements are using a system comprising: a user device; and at least one wireless communication tag configured to communicate the information to the user device and perform the abstract idea activities (at claim 1) and a wireless communication tag usable with a drug delivery device, the wireless tag comprising: logic circuitry; a transmission element, and a memory for communication and/or connection with the logic circuitry, wherein the memory contains instructions configuring the logic circuitry to: establish a data connection with at least a user device via the transmission element; and communicate information to the user device through the data connection. These additional elements do not reflect an improvement in the functioning of a computer or an improvement to other technology or technical field, effect a particular treatment or prophylaxis for a disease or medical condition (there is no medical disease or condition, much less a treatment or prophylaxis for one), implement the judicial exception with, or by using in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing (there is no transformation/reduction of a physical article), and/or apply or use the judicial exception in some other meaningful way beyond generically linking use of the judicial exception to a particular technological environment. There is no indication of any improvement (or change) to any of the tags, devices, or elements – they are merely used as they are apparently designed and intended, where the claims merely distinguish the tags, devices, or elements based on the data being transmitted and/or used.
The claims appear to merely apply the judicial exception, include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform the abstract idea. The additional elements appear to merely add insignificant extra-solution activity to the judicial exception and/or generally link the use of the judicial exception to a particular technological environment or field of use.
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, as indicated above, are merely “[a]dding the words ‘apply it’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp.” that MPEP § 2106.05(I)(A) indicates to be insignificant activity
There is no indication the Examiner can find in the record regarding any specialized computer hardware or other “inventive” components, but rather, the claims merely indicate computer components which appear to be generic components and therefore do not satisfy an inventive concept that would constitute “significantly more” with respect to eligibility. Applicant ¶ 0055 indicates “[t]he controller 204 may be a programmed general-purpose device that is a portable electronic device, such as any portable electronic device, smartphone, smartwatch, fitness device, tablet or the like”, i.e., that the computer(s) and devices being used are generic or general-purpose in nature.
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself; therefore the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Please see the Subject Matter Eligibility (SME) guidance and instruction materials at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility, which includes the latest guidance, memoranda, and update(s) for further information.
NOTICE
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 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.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Estes (U.S. Patent Application Publication No. 2015/0025498).
Claim 1: Estes discloses a system, comprising:
a user device (see Estes at least at, e.g., ¶ 0096, “the remote control device 770 is a smartphone … [and/or] other types of devices such as a tablet computer, laptop computer, a PDA,” etc.; citation hereafter by number only);
at least one wireless communication tag, wherein the at least one wireless communication tag is configured to communicate physiology affecting information to the user device, (0096, “an infusion pump system 700 an can include an ancillary remote control device 770 configured to communicate with NFC tags 746 and with a pump assembly 760”, 0097, “The remote control device 770 also includes a wireless interface 757 for communicating with a wireless interface 752 of the pump assembly 760. The wireless interfaces 752 and 757 for communicating between the pump assembly 760 and the remote control device 770 can utilize any of a variety of wireless communication technologies, such as Bluetooth, WiFi, RF, infrared, ultrasonic, electromagnetic induction, NFC, or combinations thereof. The pump assembly 760 can be used to dispense insulin or another medication to a user”, 0024, “the data input to the portable pump 60 via NFC may cause the portable pump 60 to execute particular actions, such as automatically calculating an amount of a recommended bolus delivery of insulin (or another medication) and prompting the user with an option to confirm and initiate such a bolus delivery”, 0036, “a particular NCF tag (e.g., NFC tag 45) can be used to automatically trigger a corresponding particular action or change in operation of the portable pump”, 0103, “FIG. 7 depicts an example scenario to illustrate this principle. In this example scenario, the user of infusion pump system 700 has consumed, or will soon consume, about 60 grams of carbohydrates by eating a piece of pie. As such, the user desires to initiate a corresponding bolus dispensation of insulin to counteract the effects of the intake of 60 grams of carbohydrates”); and
a drug delivery device (0096, “an infusion pump system 700 an can include an ancillary remote control device 770 configured to communicate with NFC tags 746 and with a pump assembly 760”, 0097, “The remote control device 770 also includes a wireless interface 757 for communicating with a wireless interface 752 of the pump assembly 760”, 0024, “the data input to the portable pump 60 via NFC may cause the portable pump 60 to execute particular actions, such as automatically calculating an amount of a recommended bolus delivery of insulin (or another medication) and prompting the user with an option to confirm and initiate such a bolus delivery”), wherein the user device is configured to:
determine a mode of operation of the drug delivery device as a function of a historical trend of a plurality of modes of operation and the physiology affecting information and a current time of day (0024, “the data input to the portable pump 60 via NFC may cause the portable pump 60 to execute particular actions, such as automatically calculating an amount of a recommended bolus delivery of insulin (or another medication) and prompting the user with an option to confirm and initiate such a bolus delivery”, 0027, “the infusion pump system 10 can suggest a bolus dosage to the user in a manner that accounts for the user's food intake, the user's recent blood glucose level (e.g., input into the portable pump 60 by the user, from an integral blood test strip analyzer, transmitted to the portable pump 60 from an external blood glucose monitoring device, or the like), the rate of change in the user's blood glucose level, and previously delivered insulin that has not acted on the user. For example, a user can enter a carbohydrate value indicative of a meal into the portable pump 60, and in response thereto, the portable pump 60 can output a suggested bolus dosage to the user”, 0030, “shuffle through a number of menus or program screens that show particular status indicators, settings, and/or data (e.g., review data that shows the medicine dispensing rate, the amount of medicine delivered during the last bolus, the delivery time of the last bolus, the total amount of medicine dispensed in a given time period, the amount of medicine scheduled to be dispensed at a particular time or date, the approximate amount of medicine remaining in the cartridge, or the like)”, 0031, “change the dispensation rate of insulin or to request that a bolus of insulin be dispensed immediately, at a scheduled later time, over a period of time, or following a particular time-based profile”, 0042, “the preferred delivery schedule of insulin for the user to counteract the consumption of a peanut butter and jelly sandwich may be 40% of the bolus insulin amount delivered immediately and 60% spread over the next three hours. Of course, a different user may have a different preferred delivery schedule that can be used in correspondence with NFC tags used by the different user. For another type of food item, the preferred delivery schedule of insulin for the user may be other than 40% immediately and 60% spread over the next three hours. For example, for a piece of pie, as represented by the NFC tag 45, the preferred delivery schedule of insulin for the user may be 50% immediately and 50% spread over the next two hours. As such, the data associated with NFC tag 45 can include the corresponding preferred delivery schedule of insulin of 50% immediately and 50% spread over the next two hours”, 0049, “When reducing basal insulin, the appropriate extent of reduction will depend on factors such as intensity, duration, the individual, and mode of exercise. A basal rate can be reduced prior to, during, and after exercise depending on the situation. For example, in response to performing light exercise over a 30 minute period, the user may present NFC tag 46m to the user's portable pump 60. The NFC tag 46m, for example, may be associated with a command for a 50% reduction of the basal insulin dosages over the next 6 hours. In another example, in response to performing 30 minutes of strenuous exercise, the user may present NFC tag 46n to the user's portable pump 60. The NFC tag 46n may, for example, be associated with a command for a 50% reduction of basal insulin over the next 10 hours. Such factors can be individualized for the particular user, and the particular user's NFC tags 46m and 46n can be programmed accordingly. In some embodiments, the NFC tags 46m and 46n can be used in combinations to additively arrive at other levels of exertion or duration in a manner analogous to that described above in reference to NFC tags 46b-e.”);
modify the drug delivery device for delivery of a drug to the user based on the determined mode of operation (0024, 0027, 0042, 0049 as cited above).
Claim 2: Estes discloses the system of claim 1, wherein the drug delivery device is wearable (0012, “the infusion pump system equipped with NFC equipment may be configured to be portable, wearable, and (in some circumstances) concealable. For example, a user can conveniently wear the infusion pump system”).
Claim 3: Estes discloses the system of claim 1, wherein the at least one wireless communication tag is further configured to communicate the physiology affecting information to the user device as a function of a proximity of the user device to the at least one wireless communication tag (0103, “To initiate the desired bolus dispensation, the user first positions the remote control device 770 containing the NFC circuit 745 in close proximity with the NFC tag”).
Claim 4: Estes discloses the system of claim 1, wherein the physiology affecting information is generated by the wireless communication tag as a function of a location of the at least one wireless communication tag (0103, “the user of infusion pump system 700 has consumed, or will soon consume, about 60 grams of carbohydrates by eating a piece of pie. As such … the user first positions the remote control device 770 containing the NFC circuit 745 in close proximity with the NFC tag 746 (which is programmed to correspond to 60 grams of carbohydrates). Wireless NFC communications can thereby be established between the NFC circuit 745 and the NFC tag 746 (as signified by wireless communication symbol 741)”.
Claim 5: Estes discloses the system of claim 1, wherein the user device is configured to: animate a graphical user interface (GUI) as a function of a proximity to the at least one wireless communication tag; receive user input through the GUI; and adjust a setting of the mode of operation of the drug delivery device as a function of the user input (0104, “In response to the communication from the NFC tag 746 to the remote control device 770, the remote control device 770 can provide a prompt to the user on the touchscreen user interface 775. In this example, the prompt on the touchscreen user interface 775 requests the user to confirm whether the user desires to receive a 4.0 Unit dispensation of insulin because of the intake of 60 grams of carbohydrates. To confirm the dispensation of the suggested bolus amount, the user can simply touch the portion of the touchscreen user interface 775 that is labeled "YES." Or, the user can decline the dispensation of the suggested bolus amount by touching the portion of the touchscreen user interface 775 that is labeled "NO." By this example, it can be appreciated that the incorporation of NFC technology in the infusion pump system 700 can enhance and simplify user interactions with the infusion pump system 700, because to initiate an appropriate bolus dosage of insulin the user simply had to present a NFC tag 746 to the NFC circuit 745 of the remote control device 770 and then touch the portion of the touchscreen user interface 775 that is labeled "YES.").
Claim 6: Estes discloses the system of claim 1, wherein the user device is configured to generate an alert as a function of the physiology affecting information (0030, “the display 65 may be used to communicate a number of status indicators, alarms, settings, and/or menu options for the infusion pump system 10”, 0100, “the display 765 may be used to communicate a number of status indicators, alarms, settings, and/or menu options for the infusion pump system 700”).
Claim 7: Estes discloses the system of claim 1, wherein the physiology affecting information includes meal data, wherein the user device is configured to generate a bolus calculation for the drug delivery device as a function of the meal data (0028, “the infusion pump system 10 may modify a bolus delivery (e.g., a bolus delivery after the user consumes a meal) in response to certain circumstances. For example, the infusion pump system 10 may decrease or otherwise modify a post-meal bolus delivery based on a rapidly falling blood glucose level, a current blood glucose level that is below a threshold limit, based on an increased level of physical activity, or the like”).
Claim 8: Estes discloses the system of claim 1, wherein the mode of operation includes an adjusted basal setpoint of the drug delivery device (0027, “the infusion pump system 10 can be configured to supply scheduled basal dosages of insulin (or another medication) along with user-selected bolus dosages. The basal delivery rate can be selected to maintain a user's blood glucose level in a targeted range during normal activity when the user is not consuming food items”, 0049, “to maintain the user's blood sugar level within a target range it can be beneficial to temporarily reduce the user's basal rate to an extent that correlates to the level of physical exertion performed or to be performed. When reducing basal insulin, the appropriate extent of reduction will depend on factors such as intensity, duration, the individual, and mode of exercise. A basal rate can be reduced prior to, during, and after exercise depending on the situation. For example, in response to performing light exercise over a 30 minute period, the user may present NFC tag 46m to the user's portable pump 60. The NFC tag 46m, for example, may be associated with a command for a 50% reduction of the basal insulin dosages over the next 6 hours. In another example, in response to performing 30 minutes of strenuous exercise, the user may present NFC tag 46n to the user's portable pump 60. The NFC tag 46n may, for example, be associated with a command for a 50% reduction of basal insulin over the next 10 hours”).
Claim 10: Estes discloses the system of claim 1, wherein the drug delivery device includes an internal tag, wherein the internal tag is configured to wirelessly communicate with the user device (0096, “an infusion pump system 700 an can include an ancillary remote control device 770 configured to communicate with NFC tags 746 and with a pump assembly 760”).
Claim 11: Estes discloses the system of claim 10, wherein the internal tag is further configured to switch a connectivity of the drug delivery device from a first connectivity setting to a second connectivity setting (0094, “The NFC circuit 640 can wirelessly communicate with external NFC tags, such as example NFC tags 646a, 646b, 646c, and 646d”, 0095, “the control circuitry housed in the pump assembly 660 be configured to determine when the housing 610 is "bumped" against one of the NFC tags 646a-d so as to activate the NFC transmission via the NFC circuit 640”, 0097, “The remote control device 770 also includes a wireless interface 757 for communicating with a wireless interface 752 of the pump assembly 760”, Fig. 4, items 467, 470, 480).
Claim 12: Estes discloses a wireless communication tag usable with a drug delivery device, comprising:
logic circuitry (0034, “data can be transmitted from the NFC tag to the NFC circuit of the pump 60, and data can be transmitted to the NFC tag from the NFC circuit of the pump 60. In other words, the NFC circuit of the pump 60 can both read from and write to a NFC tag. The data stored in the NFC tag can be written in a variety of formats. One example format is called the NFC Data Exchange Format ("NDEF")”);
a transmission element in communication with the logic circuitry (0034, “data can be transmitted from the NFC tag to the NFC circuit of the pump 60, and data can be transmitted to the NFC tag from the NFC circuit of the pump 60. In other words, the NFC circuit of the pump 60 can both read from and write to a NFC tag. The data stored in the NFC tag can be written in a variety of formats. One example format is called the NFC Data Exchange Format ("NDEF")”); and
a memory communicatively connected to the logic circuitry, wherein the memory contains instructions configuring the logic circuitry (0065, “The processor of the control module 461 can be arranged on a main processor circuit board of the control module 461 along with a number of other electrical components such as computer-readable memory devices. The control circuitry can be programmable in that the user or a clinician may provide one or more instructions to adjust a number of settings for the operation of the infusion pump system 400. Such settings may be stored in the memory devices of the control module 461. Furthermore, the control module 461 may include one or more dedicated memory devices that store executable software instructions for the processor”) to:
establish a data connection with a user device via the transmission element (0034, “data can be transmitted from the NFC tag to the NFC circuit of the pump 60, and data can be transmitted to the NFC tag from the NFC circuit of the pump 60. In other words, the NFC circuit of the pump 60 can both read from and write to a NFC tag. The data stored in the NFC tag can be written in a variety of formats. One example format is called the NFC Data Exchange Format ("NDEF")”); and
communicate physiology affecting information to the user device through the data connection (0024, “the data input to the portable pump 60 via NFC may cause the portable pump 60 to execute particular actions, such as automatically calculating an amount of a recommended bolus delivery of insulin (or another medication) and prompting the user with an option to confirm and initiate such a bolus delivery”, 0036, “a particular NCF tag (e.g., NFC tag 45) can be used to automatically trigger a corresponding particular action or change in operation of the portable pump”, 0103, “FIG. 7 depicts an example scenario to illustrate this principle. In this example scenario, the user of infusion pump system 700 has consumed, or will soon consume, about 60 grams of carbohydrates by eating a piece of pie. As such, the user desires to initiate a corresponding bolus dispensation of insulin to counteract the effects of the intake of 60 grams of carbohydrates”),
wherein the user device is configured to:
determine a mode of operation of the drug delivery device as a function of a historical trend of a plurality of modes of operation and the physiology affecting information and a current time of day (0024, “the data input to the portable pump 60 via NFC may cause the portable pump 60 to execute particular actions, such as automatically calculating an amount of a recommended bolus delivery of insulin (or another medication) and prompting the user with an option to confirm and initiate such a bolus delivery”, 0027, “the infusion pump system 10 can suggest a bolus dosage to the user in a manner that accounts for the user's food intake, the user's recent blood glucose level (e.g., input into the portable pump 60 by the user, from an integral blood test strip analyzer, transmitted to the portable pump 60 from an external blood glucose monitoring device, or the like), the rate of change in the user's blood glucose level, and previously delivered insulin that has not acted on the user. For example, a user can enter a carbohydrate value indicative of a meal into the portable pump 60, and in response thereto, the portable pump 60 can output a suggested bolus dosage to the user”, 0030, “shuffle through a number of menus or program screens that show particular status indicators, settings, and/or data (e.g., review data that shows the medicine dispensing rate, the amount of medicine delivered during the last bolus, the delivery time of the last bolus, the total amount of medicine dispensed in a given time period, the amount of medicine scheduled to be dispensed at a particular time or date, the approximate amount of medicine remaining in the cartridge, or the like)”, 0031, “change the dispensation rate of insulin or to request that a bolus of insulin be dispensed immediately, at a scheduled later time, over a period of time, or following a particular time-based profile”, 0042, “the preferred delivery schedule of insulin for the user to counteract the consumption of a peanut butter and jelly sandwich may be 40% of the bolus insulin amount delivered immediately and 60% spread over the next three hours. Of course, a different user may have a different preferred delivery schedule that can be used in correspondence with NFC tags used by the different user. For another type of food item, the preferred delivery schedule of insulin for the user may be other than 40% immediately and 60% spread over the next three hours. For example, for a piece of pie, as represented by the NFC tag 45, the preferred delivery schedule of insulin for the user may be 50% immediately and 50% spread over the next two hours. As such, the data associated with NFC tag 45 can include the corresponding preferred delivery schedule of insulin of 50% immediately and 50% spread over the next two hours”, 0049, “When reducing basal insulin, the appropriate extent of reduction will depend on factors such as intensity, duration, the individual, and mode of exercise. A basal rate can be reduced prior to, during, and after exercise depending on the situation. For example, in response to performing light exercise over a 30 minute period, the user may present NFC tag 46m to the user's portable pump 60. The NFC tag 46m, for example, may be associated with a command for a 50% reduction of the basal insulin dosages over the next 6 hours. In another example, in response to performing 30 minutes of strenuous exercise, the user may present NFC tag 46n to the user's portable pump 60. The NFC tag 46n may, for example, be associated with a command for a 50% reduction of basal insulin over the next 10 hours. Such factors can be individualized for the particular user, and the particular user's NFC tags 46m and 46n can be programmed accordingly. In some embodiments, the NFC tags 46m and 46n can be used in combinations to additively arrive at other levels of exertion or duration in a manner analogous to that described above in reference to NFC tags 46b-e.”);
modify the drug delivery device for delivery of a drug to the user based on the determined mode of operation (0024, 0027, 0042, 0049 as cited above).
Claim 13: Estes discloses the wireless communication tag of claim 12, wherein physiology affecting information comprises exercise data or sleep data (0049, “When reducing basal insulin, the appropriate extent of reduction will depend on factors such as intensity, duration, the individual, and mode of exercise. A basal rate can be reduced prior to, during, and after exercise depending on the situation. For example, in response to performing light exercise over a 30 minute period, the user may present NFC tag 46m to the user's portable pump 60. The NFC tag 46m, for example, may be associated with a command for a 50% reduction of the basal insulin dosages over the next 6 hours. In another example, in response to performing 30 minutes of strenuous exercise, the user may present NFC tag 46n to the user's portable pump 60. The NFC tag 46n may, for example, be associated with a command for a 50% reduction of basal insulin over the next 10 hours. Such factors can be individualized for the particular user, and the particular user's NFC tags 46m and 46n can be programmed accordingly. In some embodiments, the NFC tags 46m and 46n can be used in combinations to additively arrive at other levels of exertion or duration in a manner analogous to that described above in reference to NFC tags 46b-e.”)).
Claim 14: Estes discloses the wireless communication tag of claim 12, wherein logic circuitry is further configured to determine, through the transmission element, a proximity to the user device and establish the data connection as a function of the proximity (0103, “To initiate the desired bolus dispensation, the user first positions the remote control device 770 containing the NFC circuit 745 in close proximity with the NFC tag”).
Claim 15: Estes discloses the wireless communication tag of claim 12, wherein the wireless communication tag is further configured to establish a data connection with the drug delivery device (0028, “the infusion pump system 10 may modify a bolus delivery (e.g., a bolus delivery after the user consumes a meal) in response to certain circumstances. For example, the infusion pump system 10 may decrease or otherwise modify a post-meal bolus delivery based on a rapidly falling blood glucose level, a current blood glucose level that is below a threshold limit, based on an increased level of physical activity, or the like”).
Claim 16: Estes discloses the wireless communication tag of claim 12, wherein the logic circuitry is configured to receive meal data from an external computing device and communicate the physiology affecting information as a function of the meal data (0028, “the infusion pump system 10 may modify a bolus delivery (e.g., a bolus delivery after the user consumes a meal) in response to certain circumstances. For example, the infusion pump system 10 may decrease or otherwise modify a post-meal bolus delivery based on a rapidly falling blood glucose level, a current blood glucose level that is below a threshold limit, based on an increased level of physical activity, or the like”).
Claim 17: Estes discloses the wireless communication tag of claim 12, wherein the logic circuitry is configured to communicate the physiology affecting information as a function of a location of the wireless communication tag (0103, “To initiate the desired bolus dispensation, the user first positions the remote control device 770 containing the NFC circuit 745 in close proximity with the NFC tag”).
Claim 18: Estes discloses the wireless communication tag of claim 12, wherein logic circuitry is configured to enable the user device to generate a bolus calculation for a drug delivery device as a function of the physiology affecting information (0104, “In response to the communication from the NFC tag 746 to the remote control device 770, the remote control device 770 can provide a prompt to the user on the touchscreen user interface 775. In this example, the prompt on the touchscreen user interface 775 requests the user to confirm whether the user desires to receive a 4.0 Unit dispensation of insulin because of the intake of 60 grams of carbohydrates. To confirm the dispensation of the suggested bolus amount, the user can simply touch the portion of the touchscreen user interface 775 that is labeled "YES." Or, the user can decline the dispensation of the suggested bolus amount by touching the portion of the touchscreen user interface 775 that is labeled "NO." By this example, it can be appreciated that the incorporation of NFC technology in the infusion pump system 700 can enhance and simplify user interactions with the infusion pump system 700, because to initiate an appropriate bolus dosage of insulin the user simply had to present a NFC tag 746 to the NFC circuit 745 of the remote control device 770 and then touch the portion of the touchscreen user interface 775 that is labeled "YES.").
Claim 19: Estes discloses the wireless communication tag of claim 12, wherein the logic circuitry is configured to enable the user device to generate a graphical user interface (GUI) for at least a mode of operation of a drug delivery device as a function of the data connection (0104, “In response to the communication from the NFC tag 746 to the remote control device 770, the remote control device 770 can provide a prompt to the user on the touchscreen user interface 775. In this example, the prompt on the touchscreen user interface 775 requests the user to confirm whether the user desires to receive a 4.0 Unit dispensation of insulin because of the intake of 60 grams of carbohydrates. To confirm the dispensation of the suggested bolus amount, the user can simply touch the portion of the touchscreen user interface 775 that is labeled "YES." Or, the user can decline the dispensation of the suggested bolus amount by touching the portion of the touchscreen user interface 775 that is labeled "NO." By this example, it can be appreciated that the incorporation of NFC technology in the infusion pump system 700 can enhance and simplify user interactions with the infusion pump system 700, because to initiate an appropriate bolus dosage of insulin the user simply had to present a NFC tag 746 to the NFC circuit 745 of the remote control device 770 and then touch the portion of the touchscreen user interface 775 that is labeled "YES.").
Claim 20: Estes discloses the wireless communication tag of claim 12, wherein the wireless communication tag comprises a near field communication (NFC) tag (0004, “an infusion pump system may be configured to send and receive data communications using near field communication ("NFC") technology”, 0052, “NFC tag 46t is an example of a "blank" NFC tag that can be programmed or scripted and thereafter used to input a variety of commands to the portable pump 60”).
Response to Arguments
Applicant's arguments filed 21 January 2026 have been fully considered but they are not persuasive.
Applicant then argues the 101 rejection (Remarks at 6-12), alleging first that the Office Action is “without any explanation as to 1) what limitations are being interpreted as allegedly reciting an abstract idea and 2) why any of claim l's limitation allegedly fall under methods of organizing human activity” (Id. at 6). However, as indicated at the Advisory Action, “pp. 6-7 of the Final Office Action dated 17 November 2025 specifically indicates which elements are considered part of the abstract idea and which elements are considered additional to the abstract idea - the identification and discussion of the additional elements continuing through p. 10.”
Applicant then argues the summary, or mere naming of the abstract idea (Remarks at 7); however, as specifically stated at the rejection, “although this summary of the claims is provided, the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination)” – including through the designation of those elements that are indicated as pointing to the abstract idea and the identification of those elements that are additional to the abstract idea.
Applicant argues that “Claim 1 recites specific technical components including a wireless communication tag, a drug delivery device, and a user device, that work together to automatically determine and modify a mode of operation of the drug delivery device based on physiology affecting information, historical trends, and time of day” (Id.). This appears to show the error or flaw in Applicant’s desired interpretation of eligibility – Applicant does not describe or claim any change in function or improvement to any of the wireless communication tag, the drug delivery device, or the user device. These devices or technology, as components of the claimed invention, are not invented herein – they long pre-exist the claimed invention. These devices or technology operate in the same manner or fashion as they did before the invention – there is no improvement to any of them, they merely are doing what they are/were apparently designed or intended to do. So, individually, they do not constitute a practical application or significantly more – they are merely being used as they pre-existed to implement the abstract idea. As a combination, these devices or technology do not offer or provide anything more beyond what someone would expect from them as individual components – there is no synergy or improvement as a combination or ordered combination that results in something beyond the expected, usual result one would get from using the components individually. This is all currently and previously indicated at the rejections.
Applicant then argues Step 2A, Prong 2, alleging that “Claim 1 does not merely use the recited elements as intended. Rather, claim 1 provides for a specific technical improvement in drug delivery technology. Specifically, claim 1 recites a system that determines a mode of operation of a drug delivery device as a function of a historical trend of a plurality of modes of operation, the physiology affecting information, and a current time of day.” (Remarks at 8-9). However, people have for many, many years communicated (including wirelessly – by talking or writing) data that is “physiology affecting information” (such as glucose readings, insulin doses, time of day, diet, exercise, etc.) to other persons, so that they can identify (and even anticipate) any historical trend from the data (including by time of day) and adjust or modify the dosage to be taken. This is, very literally, managing behavior (if or when someone analyzes the information themselves) and/or relationships between people (if or when another person assists) – i.e., certain methods of organizing human activity.
Applicant then argues MPEP § 2106.05(f), related to mere instructions to apply the abstract idea, alleging in general points 1, 2, and 3 of that MPEP section. However, MPEP § 2106.05(f) at (1) indicates three examples that “recite no more than an idea of a solution or outcome”, including
i. Remotely accessing user-specific information through a mobile interface and pointers to retrieve the information without any description of how the mobile interface and pointers accomplish the result of retrieving previously inaccessible information, Intellectual Ventures v. Erie Indem. Co., 850 F.3d 1315, 1331, 121 USPQ2d 1928, 1939 (Fed. Cir. 2017);
ii. A general method of screening emails on a generic computer without any limitations that addressed the issues of shrinking the protection gap and mooting the volume problem, Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1319, 120 USPQ2d 1353, 1361 (Fed. Cir. 2016); and
iii. Wireless delivery of out-of-region broadcasting content to a cellular telephone via a network without any details of how the delivery is accomplished, Affinity Labs of Texas v. DirecTV, LLC, 838 F.3d 1253, 1262-63, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016).
Applicant’s claims are similar to the above – the claims merely use a tag to accomplish the result of communicating data, the user device merely determines a mode of operation (e.g., what dose to provide) and impliedly whether there is a historical trend in the data so as to modify the mode of operation (e.g., change a dose). There is no apparent limitations as to how this is done – the claims merely say to use the devices in any manner to accomplish the result.
MPEP § 2106.05(f) at (2) lists six examples that “do no more than merely invoke computers or machinery as a tool to perform an existing process” and the instant claims are similar to those examples. Applicant indicates that “claim 1 represents a new technical approach to drug delivery control” (Remarks at 10); however, if all it took to overcome 101 is the use of a computer and technology to do what it is intended to do, then it would appear that literally ANY computerized process would apparently be automatically eligible. But Alice and its progeny of precedent cases specifically indicate this is not true – more is needed that generic computer functions.
MPEP § 2106.05(f) at (3) relates to the particularity or generality of the application of the abstract idea, and Applicant again argues that “claim 1 recites a specific technical implementation involving a wireless communication tag”, etc. (Remarks at 10). The claims, however, recite any form or type of wireless communication tag, any drug delivery device of any type or sort, and any user device regardless of form or type. Therefore, the instant claims appear similar to the examples listed at that MPEP section – ineligible since they did “not provide meaningful limitations that integrate a judicial exception into a practical application or amount to significantly more” (MPEP § 2106.05(f) at (3)).
Applicant then argues MPEP § 2106.05(g) regarding “Insignificant Extra-Solution Activity” (Remarks at 11); however, the rejection does not indicate any analysis regarding insignificant extra-solution activity – the claim elements that are additional to the abstract idea are found to be insignificant for other reasons, or on other bases. Therefore, the argument appears moot. The absence of extra-solution activity related to an abstract idea does not mean that the abstract idea is then eligible.
Applicant then argues Step 2B, alleging that at claim 1, the “ordered combination of elements is not well-understood, routine, or conventional in the field of drug delivery systems. Claim 1 provides for a user device determines the appropriate mode of operation by analyzing multiple inputs including historical trends, which represents a specific technical improvement that goes beyond merely applying an abstract idea using generic computer components” (Remarks at 12). However, first, the rejection does not indicate that elements are insignificant based on well-understood, routine, or conventional (“WURC”) activity. Second, nothing about any of the components, devices, or technology is described or claimed as being invented, modified or changed – the wireless communication tag, the user device, and the delivery device all are described as being used in the same routine, understood, conventional manner that they are/were apparently intended to be in. And the ordered combination offers no extra or symbiotic benefit or result – the data is communicated, if there is some historic trend it can be identified, and if there is a recommended change in dose for a drug (i.e., a modification of the drug delivery device, or its mode of operation), that change can be provided. This apparently is the same as at the abstract idea itself – there is nothing that appears to be significantly more.
Applicant then argues the prior art, alleging that “Estes fails to disclose any trend analysis” (Id. at 12). However, at least Estes at 0027 indicates that it would “suggest a bolus dosage to the user in a manner that accounts for the user's food intake, the user's recent blood glucose level (e.g., input into the portable pump 60 by the user, from an integral blood test strip analyzer, transmitted to the portable pump 60 from an external blood glucose monitoring device, or the like), the rate of change in the user's blood glucose level, and previously delivered insulin that has not acted on the user” (emphasis added) – the recent and rate of change in glucose level indications are specifically indicating a trend analysis. (See also Estes at 0092 and 0100.)
Therefore, the Examiner is not persuaded by Applicant’s argument(s).
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Insulet News Release, Insulet Acquires Insulin Pump Patents from Bigfoot Biomedical as Both Companies Prioritize Improved Insulin Delivery Technologies, dated 13 February 2023, downloaded from https://investors.insulet.com/news/news-details/2023/Insulet-Acquires-Insulin-Pump-Patents-from-Bigfoot-Biomedical-as-Both-Companies-Prioritize-Improved-Insulin-Delivery-Technologies/default.aspx on 7 August 2025, indicating that Insulet Corporation acquired patents from “Bigfoot Biomedical (Bigfoot) … related to Bigfoot’s pump-based automated insulin delivery (AID) technologies”.
Bigfoot Biomedical.com, Bigfoot Biomedical Acquires the Assets of Asante Solutions, dated 28 May 2015, downloaded 7 August 2025 from https://www.bigfootbiomedical.com/about/press-releases/asante_acquisition.html, indicating that “Bigfoot Biomedical, Inc. … today announced it has acquired all assets of Asante Solutions, manufacturer of the Asante Snap insulin pump”.
Estes et al. (U.S. Patent Application Publication No. 2016/0038675, hereinafter Estes ‘675, U.S. Patent Application Publication No. 2019/0054236, hereinafter Estes ‘236, and U.S. Patent Application Publication No. 2021/0244883, hereinafter Estes ‘883) are all related in a continuation string, and disclose that “Some embodiments of an infusion pump assembly may be equipped with one or more components to facilitate wireless operation of an infusion pump via a user-operated mobile device. In some embodiments, the mobile device and/or the infusion pump may prompt the user to confirm acceptance of a wirelessly communicated command to prevent an operation by the infusion pump (e.g., a dispensation of medicine) that is not desired by the user” (at Abstract), bolus and basal dose adjustments (at least at 0009, 0036, and 0038 of Estes ‘675) and “a dosage history is a received via wireless communication (e.g., NFC or short-range wireless communication) with the pump assembly 20. The dosage history may include data indicative of one or more previous bolus dosages initiated by the controller device 200 of the pump assembly 20. In some embodiments, data included in the dosage history can include a date/time data point and a quantity data point corresponding to each of the previous bolus dosages. In operation 810, the user's current blood glucose is received. As described above, the user's current blood glucose level can be received via wireless communication from the glucose monitoring device 50a and/or the blood glucose test strip reader 50b, or entered manually by the user via the user interface 42 of the mobile device 40. In operation 810, the dosage calculator application 44 can determine a rate of change (e.g., increase or decrease) based on the dosage history and the blood glucose level” (at least at 0082 of Estes ‘675).
Yoo et al., Advances in Continuous Glucose Monitoring and Integrated Devices for Management of Diabetes with Insulin-Based Therapy: Improvement in Glycemic Control. Diabetes Metab J. 2023 Jan;47(1):27-41. doi: 10.4093/dmj.2022.0271. Epub 2023 Jan 12. PMID: 36635028; PMCID: PMC9925143. Downloaded from https://pmc.ncbi.nlm.nih.gov/articles/PMC9925143/ on 13 November 2025, indicating “Continuous glucose monitoring (CGM) technology has evolved over the past decade with the integration of various devices including insulin pumps, connected insulin pens (CIPs), automated insulin delivery (AID) systems, and virtual platforms. CGM has shown consistent benefits in glycemic outcomes in type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) treated with insulin. Moreover, the combined effect of CGM and education have been shown to improve glycemic outcomes more than CGM alone. Now a CIP is the expected future technology that does not need to be worn all day like insulin pumps and helps to calculate insulin doses with a built-in bolus calculator. Although only a few clinical trials have assessed the effectiveness of CIPs, they consistently show benefits in glycemic outcomes by reducing missed doses of insulin and improving problematic adherence. AID systems and virtual platforms made it possible to achieve target glycosylated hemoglobin in diabetes while minimizing hypoglycemia, which has always been challenging in T1DM. Now fully automatic AID systems and tools for diabetes decisions based on artificial intelligence are in development. These advances in technology could reduce the burden associated with insulin treatment for diabetes” (at Abstract).
Lee et al. (U.S. Patent Application Publication No. 2017/01323374, hereinafter Lee), indicating “The present invention provides a system for collecting, anonymizing, and communicating information collected from medical pumps without the need for additional effort by medical care professionals. The pump/multi-pump derived information can be aggregated between hospitals and across healthcare institutions to provide global overviews of pump performance and drug use information. This information can assist with the delivery of healthcare by providing automatic guidance warnings, for example, deviating from established ranges for common delivery rates; trend monitoring to anticipate needs of the health care community based upon global health trends; and allocation of healthcare equipment by monitoring the total operating time and lifecycles of the pumps. Knowledge derived from this pump/multi-pump derived information can be used in an administrative capacity and to develop evolving advisory protocols for users of pumps comparing real-time pump protocols to those appropriate for a given drug” (Lee at Abstract).
Breakthrough T1D Community Forum, post from WearsHats Paul-Gabriel and responses, July 2022, downloaded from https://forum.breakthrought1d.org/t/tandem-t-slim-remote-bolus/72091 on 7 March 2026, indicating the capability for at least one Tandem insulin pump (a/the Tandem T:slim remote bolus pump) being controlled via Bluetooth connection with a smartphone was conceived and published before Applicant’s current earliest available filing date.
Keith-Hynes, P.; Mize, B.; Robert, A.; Place, J. The Diabetes Assistant: A Smartphone-Based System for Real-Time Control of Blood Glucose. Electronics 2014, 3, 609-623. https://doi.org/10.3390/electronics3040609, downloaded from https://www.mdpi.com/2079-9292/3/4/609 on 7 March 2026, indicating that “In this paper we present the Diabetes Assistant (DiAs), an ultraportable AP research platform designed to enable home studies of Closed Loop Control (CLC) of blood glucose in subjects with Type 1 Diabetes Mellitus. DiAs consists of an Android (Google Inc., Mountain View, CA, USA) smartphone equipped with communication, control and user interface software wirelessly connected to a continuous glucose monitor and insulin pump. The software consists of a network of mobile applications with well-defined Application Programming Interfaces (APIs) running atop an enhanced version of Android with non-essential elements removed. CLC and safety applications receive real-time data from the CGM and pump, estimate the patient’s metabolic state and risk of hypo- and hyperglycemia, adjust the insulin infusion rate, raise alarms as needed and transmit de-identified data to a secure remote server. Some applications may be replaced by researchers wishing to conduct outpatient ambulatory studies of novel Closed Loop Control, Safety or User Interface modules. Over the past three years the DiAs platform has been used in a series of AP clinical trials sponsored by the National Institutes of Health, the Juvenile Diabetes Research Foundation, the Helmsley Charitable Trust and the European Union AP@Home project. Results of clinical trials using DiAs indicate that a smartphone with targeted operating system modifications and appropriate system software can be successfully used in outpatient clinical trials of FDA Class III medical devices such as Artificial Pancreas.” (at Abstract).
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/SCOTT D GARTLAND/
Primary Examiner, Art Unit 3685