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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 25 August 2025 has been entered.
Response to Amendment
This Office Action is in response to the Applicant’s amendment filed 25 July 2025 wherein Claims 1 and 5 are amended, Claim 2 is previously cancelled, and Claims 11 – 20 are previously withdrawn. Therefore, Claims 1 and 3 – 20 are currently pending within the Application wherein Claims 11 – 20 are withdrawn therefrom.
The Applicant’s amendment to the Specification dated 25 July 2025 has overcome each Drawing Objection set forth in the Final Rejection dated 28 May 2025. Therefore, the Drawing Objection set forth in the Final Rejection dated 28 May 2025 is withdrawn.
The Applicant’s amendment to the Claims dated 25 July 2025 has overcome each Claim Rejection set forth under 35 U.S.C. § 112(b) in the Final Rejection dated 28 May 2025. Therefore, the Claim Rejection set forth under 35 U.S.C. § 112(b) in the Final Rejection dated 28 May 2025 is withdrawn.
Response to Arguments
Applicant’s arguments, see pages 7 – 9, filed 25 July 2025, with respect to the rejection(s) of independent claim(s) 1 and its dependent claims under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Mounce et al. (US 2016/0022914 A1) and Cabiri (US 2016/0296699 A1).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3, 5 – 6, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mounce et al. (US 2016/0022914 A1; hereinafter referred to as “Mounce”) and Cabiri (US 2016/0296699 A1).
Mounce is previously cited in the Notice of References Cited form dated 4 December 2024.
With regards to claim 1, Mounce discloses (Figs. 1 – 3) a drug delivery system (100; see [0125] “an autoinjector system or apparatus 100”) comprising:
a reservoir (600; see [0125] “a removable cassette 600”) adapted to contain a drug (see [0125]);
an identifier (410; see [0167] “a cassette identification arrangement 410”) having drug information (see [0167] and [0183]);
a drug delivery device (300; see [0125] “an autoinjector or injector 300”) adapted to receive the reservoir (see Fig. 1 and [0125]);
a reader (370; see [0131] “A detector 370 may be provided on or in the cassette support surface 301s for sensing the presence of and/or information about the cassette 600”) adapted to read the drug information (see [0131] and [0183]);
a drive (340; see [0131] “a motorized drug extension drive 340”) adapted to expel the drug from the reservoir (see [0131] and [0132]);
a controller (350; see [0127] “microprocessor 350”) functionally coupled to the reader and the drive (see [0131] and [0132]), the controller being programmed to:
identify the drug contained in the reservoir based on the drug information (see [0167] “the cassette identification arrangement 410 may be constructed to generate one of a plurality of different codes, each of which corresponds to certain characteristics of a particular cassette 600…Further, the code communicated by the cassette identification arrangement 410 can tell the autoinjector what the drug contained in the ICS is”)
calculate or determine an acceptable range of injection times for the identified drug (see [0167] “In another example, if the autoinjector detects the insertion of a drug cassette that contains a certain drug, the autoinjector can automatically select appropriate operating parameters for injecting that drug, such as injection speed, needle insertion speed, pre and post-injection wait time, needle insertion depth, temperature limits, etc. Available speed ranges may be dependent upon the ICS fluid chamber fill volume and drug characteristics, such as viscosity (at room temperature 20 to 25º C. [68-77º F.]). Automatic selection by the autoinjector of its operating parameters eliminates the need for the user to have to determine the appropriate operating parameters for a given drug and then manually input them into the autoinjector” by determining the available speed ranges the controller determines an acceptable range of injection times for the identified drug because the faster the speed of injection the shorter the injection time and the slower the speed of injection the longer the injection time),
determine a tailored injection time within the acceptable range of injection times (see [0167] “the autoinjector can automatically select appropriate operating parameters for injecting that drug, such as injection speed”), and
set a delivery speed of the drive such that the drug is expelled from the reservoir over the tailored injection time within the acceptable range of injection times (see [0167] “The autoinjector can be constructed (e.g., with a microprocessor described earlier) to automatically select an appropriate operating program and/or adjust its various operational parameters based on the information communicated by the cassette identification arrangement 410…the autoinjector can automatically select appropriate operating parameters for injecting that drug, such as injection speed”).
However Mounce is silent with regards to calculating or determining an acceptable range of injection times for the identified drug at least in part based on the drug information comprising at least one of minimum injection time to achieve drug efficacy and maximum injection time to achieve drug efficacy.
Nonetheless Cabiri, which is within the analogous art of a method for controlling a multi-state drug delivery device (see abstract), teaches (see Figs. 1A – 1B) a controller (see [0042] “processor may activate 105 the other components of the device” and [0046] “Optionally changing of stages, controlling actuators and/or motors and/or activation of indicators may be controlled by a logic circuit for example a processor.”) calculating or determining an acceptable range of injection times for the identified drug at least in part based on the drug information comprising at least one of minimum injection time (114b) to achieve drug efficacy and maximum injection time (114a) to achieve drug efficacy (see [0056] “The minimal discharge time period 114b and/or maximum time period 114a…The expected time period for discharge may vary for example with the viscosity and/or volume of the drug” and [0109] “The maximum and/or minimum expected injection time may for example be the maximum and/or minimum allowed fill volume divided by an injection rate.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the controller of the drug delivery system of Mounce in view of a teaching of Cabiri such that the controller calculates or determines an acceptable range of injection times for the identified drug at least in part based on the drug information comprising at least one of minimum injection time to achieve drug efficacy and maximum injection time to achieve drug efficacy. One of ordinary skill in the art would have been motivated to make this modification because Cabiri teaches that if discharging does not finish within the determined time period then the device may go into an error state (see [0056] of Cabiri). Additionally, if the system disengages before a determined minimum time period then the system may go into an error state (see [0056] of Cabiri). The error state alerts the user that an error has occurred with regards to the discharge of the medication thereby allowing the user to make the necessary adjustments or corrections in order to properly administer the requisite dosage (see [0054] of Cabiri).
The drug delivery system of Mounce modified in view of Cabiri will hereinafter be referred to as the drug delivery system of Mounce and Cabiri.
With regards to claim 3, the drug delivery system of Mounce and Cabiri teaches the invention of claim 1, and Mounce further teaches (Figs. 1 – 3) wherein the drug information further comprises at least one of viscosity (see [0167] “viscosity”) and dose volume (see [0167] “ICS fluid chamber fill volume”).
With regards to claim 5, the drug delivery system of Mounce and Cabiri teaches the invention of claim 1, and Mounce further teaches (Figs. 1 – 3) wherein the drug delivery system (100; see [0125] “an autoinjector system or apparatus 100”) further comprises an input device (316; see [0127] “a speed selector switch 316”) functionally coupled to the controller (350; see [0132] “the microprocessor 350 of the autoinjector 300 may be programmed with instructions that, when executed by the microprocessor 350, enable it to control and monitor the various operations and functions of the autoinjector”), wherein the controller is further programmed to receive a preferred injection speed from the input device (see [0127] “The speed selector switch 316 may be constructed to allow the user to select among a plurality of preset drug delivery (extrusion) speeds to accommodate personal patient preference” and [0132]), and wherein the tailored injection time is based on the preferred injection speed (see [0127], [0132]).
With regards to claim 6, the drug delivery system of Mounce and Cabiri teaches the invention of claim 5, and Mounce further teaches (Figs. 1 – 3) wherein the input device (316; see [0127] “a speed selector switch 316”) includes two or more relative injection speed options (see [0127] “The speed selector switch may comprise two switch positions. Other embodiments of the speed selector switch may comprise two switch positions, or 4 or more switch positions.”), each relative injection speed option is equal to a percentage of a longest possible injection time within the acceptable range of injection times (see [0127] wherein the various switch positions would be the relative injection speed option equal to a percentage of the longest possible injection time within the range of acceptable injection times), and wherein the preferred injection speed is one of the relative injection speed options selected using the input device (see [0127] “The speed selector switch 316 may be constructed to allow the user to select among a plurality drug delivery (extrusion) speeds to accommodate personal patient preference”).
With regards to claim 10, the drug delivery system of Mounce and Cabiri teaches the invention of claim 1, and Mounce further teaches (Figs. 1 – 3) wherein the identifier (410; see [0167] “a cassette identification arrangement 410”) is an RFID tag (see [0183] “the cassette identification arrangement 410 may comprise a radio-frequency (RF) electromagnetic field (EMF) emitting device 410rf, such as RF identification (RFID) chip.”) or an NFC tag.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mounce and Cabiri as applied to claim 1 above, and further in view of Marlin et al. (US 2018/0236181 A1; hereinafter referred to as “Marlin”).
Marlin is previously cited in the Notice of References Cited form dated 4 December 2024.
With regards to claim 4, the drug delivery system of Mounce and Cabiri teaches the invention of claim 1, however Mounce is silent with regards to wherein the controller includes a memory containing a drug information dataset having a list of possible drugs, each possible drug is associated with the drug information; and wherein calculating or determining the acceptable range of injection times for the identified drug includes accessing the drug information dataset, determining that the identified drug is one possible drug in the list of possible drugs, and receiving the drug information associated with the identified drug in the drug information dataset.
Nonetheless Marlin, which is within the analogous art of drug delivery devices (see abstract), teaches (Fig. 6) the controller (600; see [0071] “the auto injector control system 600”) includes a memory (640; see [0071] “the storage unit 640 of the auto injector control system 600” and [0076] “The memory storage 640 may optionally be a flash memory source, a solid state memory source, an SD memory source, a hard disk storage device, or any means of storage suitable for the application”) containing a drug information dataset having a list of possible drugs (see [0130] “the main control unit may compare the received drug ID (based on the scan) with a plurality of drug IDs that may be stored in a lookup table or a database in the storage units of the auto injector 50”), each possible drug is associated with the drug information (see [0130] “plurality of drug IDs”); and wherein calculating or determining the acceptable range of injection times for the identified drug includes accessing the drug information dataset (see [0117] “speed settings of the injection,” [0130], and [0131] “The main control unit 605, may receive other drug profile information (e.g., based on the scan) of the identified drug, and may cause various activities associated with the delivery of the drug…the main control unit 605 may set appropriate operation parameters” wherein the speed settings of the injection are an example of operating parameters of the device), determining that the identified drug is one possible drug in the list of possible drugs (see [0130] “the main control unit may compare the received drug ID (based on the scan) with a plurality of drug IDs that may be stored in a lookup table or a database in the storage units of the auto injector 50” and [0172]), and receiving the drug information associated with the identified drug in the drug information dataset (see [0130], [0131], and [0172]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the controller of the drug delivery system of Mounce and Cabiri in view of a teaching of Marlin such that the controller includes a memory containing a drug information dataset having a list of possible drugs, each possible drug is associated with the drug information; and wherein calculating or determining the acceptable range of injection times for the identified drug includes accessing the drug information dataset, determining that the identified drug is one possible drug in the list of possible drugs, and receiving the drug information associated with the identified drug in the drug information dataset. One of ordinary skill in the art would have been motivated to make this modification because Marlin teaches adjusting the operation parameters based on the drug information associated with each drug from the drug information data set improves the efficacy of the drug. For example, modifying the temperature at which drugs are warmed to before injection improves their efficacy as some drugs disintegrate or decompose when exposed above or below their operational temperature range (see [0008] of Marlin). Additionally, some drugs have specific temperature ranges at which they should be administered in order to optimize efficacy and reduce pain to the patient (see [0014] of Marlin).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mounce and Cabiri as applied to claim 6 above, and further in view of Henderson et al. (US 2015/0157790 A1; hereinafter referred to as “Henderson”).
Henderson is previously cited in the Notice of References Cited form dated 4 December 2024.
With regards to claim 7, the drug delivery system of Mounce and Cabiri teaches the invention of claim 6, however Mounce is silent with regards to wherein the input device includes a touchscreen, and wherein the controller causes the input device to display the two or more relative injection speed options.
Nonetheless Henderson, which is within the analogous art of autoinjectors (see abstract), teaches (Fig. 3) the input device includes a touchscreen (see [0020] and [0108] “the autoinjector 1 includes a user interface, such as a display screen 8 and one or more buttons 13, or a touch screen”), and wherein the controller (8; see [0105] “data processing unit 8 may include a microprocessor and memory”) causes the input device to display the two or more relative injection speed options (see [0108] “The user interface may allow a user to visually…interact with the autoinjector 1. The user interface may provide functionality including, but not limited to,…configuring operational parameters (e.g., needle insertion depth, injection speed/force”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the drug delivery system of Mounce and Cabiri in view of a teaching of Henderson such that the input device includes a touchscreen, and wherein the controller causes the input device to display the two or more relative injection speed options. One of ordinary skill in the art would have been motivated to make this modification because Henderson teaches a touch screen allows a user to visually, audibly, tactilely, and/or orally interact with the autoinjector to achieve the desired functionality (see [0108] of Henderson).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mounce and Cabiri as applied to claim 6 above, and further in view of Takatsuka et al. (US 2011/0190693 A1; hereinafter referred to as “Takatsuka”).
Takatsuka is previously cited in the Notice of References Cited form dated 4 December 2024.
With regards to claim 8, the drug delivery system of Mounce and Cabiri teaches the invention of claim 6, however Mounce is silent with regards to wherein each of the two or more relative injection speed options are displayed as one of: a written adjective, the percentage of the longest possible injection time, and a point on a sliding scale.
Nonetheless Takatsuka, which is within the analogous art of a computer controlled electric syringe (see abstract), teaches (Figs. 14A – 18E) each of the two or more relative injection speed options (see [0128] “an injection speed is switched between (Low: low speed), M (Medium: medium speed), and H (High: high speed) modes by pushing the mode/speed setting switch 100 lightly, the injection speed can be set.”) are displayed as one of: a written adjective (L, M, and H; see Figs. 14A – 18E and [0128]), the percentage of the longest possible injection time, and a point on a sliding scale.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the drug delivery system of Mounce and Cabiri in view of a teaching of Takatsuka such that each of the two or more relative injection speed options are displayed as one of: a written adjective, the percentage of the longest possible injection time, and a point on a sliding scale. One of ordinary skill in the art would have been motivated to make this modification, as Takatsuka teaches displaying the two or more relative injection speed options as a written adjective informs a user about which of the two or more relative injection speed options has been selected of the drug delivery device (see [0128] of Takatsuka). Additionally, Takatsuka teaches that altering the injection speed alleviates the pain of the patient (see [0005] of Takatsuka).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mounce and Cabiri as applied to claim 6 above, and further in view of Park (US 2016/0271329 A1).
Park is previously cited in the Notice of References Cited form dated 4 December 2024.
With regards to claim 9, the drug delivery system of Mounce and Cabiri teaches the invention of claim 6, however Mounce is silent with regards to wherein the two or more relative injection speed options are each unique physical buttons of the drug delivery device.
Nonetheless Park, which is within the analogous art of drug injection devices (see abstract), teaches the two or more relative injection speed options are each unique physical buttons of the drug delivery device (see [0054] “The operational button 40…further serves to adjust an injection speed of the injectable solution (for example, different four-step injection speeds) step by step” and [0055] “However, the scope of the present invention is not limited thereto, and in order to adjust the injection speed and the like step by step, a plurality of operational buttons 40 may be provided.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the two or more relative injection speed options of the drug delivery system of Mounce in view of a teaching of Park such that the two or more relative injection speed options are each unique physical buttons of the drug delivery device. One of ordinary skill in the art would have been motivated to make this modification, as Park teaches that a plurality of operational buttons may be provided to adjust an injection speed of the injectable solution to reduce the pain to the patient during the injection (see [0008] – [0010], [0054], [0055], and [0079] – [0080] of Park).
Conclusion
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
11/21/2025
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