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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 23 September 2025 has been entered.
Response to Amendment
This Office Action is in response to the Applicant’s amendment filed 23 September 2025 wherein Claims 1, 7, and 18 are amended, Claims 14 – 15 are previously cancelled, and no claims are newly added. Therefore, Claims 1 – 13 and 16 – 18 are currently pending.
The Applicant’s amendment to the Claim 18 has overcome this Claim Objection set forth in the Final Rejection dated 15 July 2025. However, the Applicant’s amendment to Claim 7 has created indefiniteness regarding the subject matter claimed. The Examiner has addressed the outstanding issue to Claim 7 within a 35 U.S.C. § 112(b) rejection below.
Response to Arguments
Applicant's arguments filed 23 September 2025 have been fully considered but they are not persuasive.
The Applicant alleges that Helmer et al. (US 2018/0353699 A1; hereinafter referred to as “Helmer”) does not disclose a system for measuring a set dose or a delivered dose as it provides only qualitative feedback, i.e., whether the injection took place. See page 7 of the Remarks dated 23 September 2025. The Examiner respectfully disagrees.
Claims 21, 29, and 30 and paragraph [0016] of Helmer recite that the processor is configured to cause information relating to a last performed injection operation to be stored in the memory upon determining that the drug delivery device has changed from the pre-activation state to the post-activation state, wherein the information comprises a medicament dose amount. Since the processor causes information related to the medicament dose amount to be stored within the memory then the processor must measure an amount of a set dose or a delivered dose that has been injected.
Paragraph [0062] further describes that the processor transmits data such as an insulin dose including its units to another device. Since the processor is transmitting an insulin dosage amount with its units to another device then the processor must measure an amount of a set dose or a delivered dose that has been injected. Paragraph [0082] likewise further supports that the processor measures an amount of a set dose or a delivered dose because this paragraph describes that the processor can determine that some medicament has been ejected but not the whole amount. The processor’s ability to determine that some medicament has been ejected teaches that the processor is measuring the amount of a set dose or a delivered dose that is injected.
Paragraphs [0060], [0067], [0069], [0073] – [0077], [0084], [0087] and [0090] further describe how the system for measuring an amount of a set dose determines the amount of the set dose or delivered dose based on the magnetic field strength measurements, a sensor for detecting a dose injection, and a spring element for storing an elastic energy for an automatic injection of the set dose.
In view of the aforementioned rationale, the Examiner finds the Applicant’s argument regarding Helmer to be unpersuasive.
Claim Objections
Claims 4 and 18 are objected to because of the following informalities:
Claim 4 recites “the Hall sensors.” The Examiner suggests amending this to recite “[[the]] Hall sensors” as these Hall sensors have not been previously recited before.
Claim 18 recites “the magnetic field measurements.” The Examiner suggests amending this to recite “the magnetic field strength measurements” to improve the clarity of the claim language such that the language is consistent throughout the claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the following:
The drug delivery device of claim 1, wherein the element carrying the magnetic field source is configured so that it moves axially with respect to the element carrying at least one magnetic sensor, wherein the element carrying the magnetic field sensor is a piston rod, a pull-push control nut, a setting sleeve or a dose selector sleeve.
Claim 7 is rejected under 35 U.S.C. § 112(b) for being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because it cannot be determined if the “magnetic field sensor” is referring to the “magnetic field source” or the “at least one magnetic sensor.” This then creates further confusion regarding if the recited “element carrying the magnetic field sensor” is referring to the element carrying the magnetic field source or the element carrying at least one magnetic sensor.
Based on the Specification’s disclosure the element carrying the at least one magnetic sensor is not a piston rod, a pull-push control nut, a setting sleeve or a dose selector sleeve. Rather the element that can be a piston rod, a pull-push control nut, a setting sleeve, or a dose selector sleeve is the element carrying the magnetic field source. See page 7, lines 14 – 22 and page 10, liens 14 – 29 (disclosing the piston rod as carrying the magnet), page 8, lines 22 – 32 (disclosing the pull-push control nut as carrying the magnet), and page 9, lines 19 – 31 and page 12, lines 24 – 31 (disclosing the setting sleeve or dose selector sleeve as carrying the magnet).
The Examiner suggests amending Claim 7 to recite the following to correct the indefiniteness regarding the recited “element carrying the magnetic field sensor.”
The drug delivery device of claim 1, wherein the element carrying the magnetic field source is configured so that it moves axially with respect to the element carrying at least one magnetic sensor, wherein the element carrying the magnetic field source is a piston rod, a pull-push control nut, a setting sleeve or a dose selector sleeve.
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.
Claim(s) 1 – 10, 12 – 13, 16, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Helmer et al. (US 2018/0353699 A1; hereinafter referred to as “Helmer”).
Helmer is cited in the Notice of References Cited form dated 20 March 2025.
With regards to claim 1, Helmer discloses (Figs. 1 and 3) a drug delivery device (2, 10) (see [0052] “a supplementary device 2 to be releasably attached to injection device 10”) comprising:
a system for measuring an amount of a set dose (see [0016], [0033], [0073] – [0075], [0077], [0084], and [0090]) or a delivered dose (see Claims 21, 29, and 30 and paragraphs [0016] “The processor may be configured to cause information relating to a last performed injection operation to be stored in the memory upon determining that the drug delivery device has changed from a pre-activation state to a post-activation state…The information may further comprise a medicament dose amount,” [0033] “monitor the dose administration,” [0073], [0074], [0075] “the processor 24 receives the signals from the Hall sensor 25 and can determine whether the injection device 10 is in a pre-injection or post-injection state,” [0077] “The processor 24 is configured to receive signals from the capacitive sensor 23 and/or Hall sensor 25 and to infer whether the injection device 10 is in a pre-injection state, a post-injection state or whether an injection process is ongoing. The processor 24 may control the display unit 21 to display different indications to a user depending on the state of the device,” [0084] and see [0090] “As previously stated the processor 24 can use the change in signals received from the sensors 23, 25 to determine that an injection is being performed. The processor 24 can infer, when the signals received from the sensors 23, 25 stop changing, that the injection has been completed. This detection can therefore be used as a trigger to display an indication to the user on the display unit 21 instructing them to leave the needle of the injection device 10 in the injection site for a predetermined length of time. The indication may be of any suitable form, for example a timer, which counts up or down, or a graphic which gets larger/smaller or which fills or un-fills. Other methods of indication may also be used, such as sound.”) comprising at least one magnetic sensor (25, 25’) (see Fig. 5a and [0078]) and a magnetic field source (502) (see Fig. 7 and [0074]),
wherein the drug delivery device comprises an element (14) (see [0046] “A stopper, plunger, piston or bung 14” and [0072] “a magnet 500 is mounted within the injection device 10 on either the distal or the proximal end of the plunger.”) carrying the magnetic field source configured so that during dose setting and delivering a dose said element moves axially with respect to an element (2) carrying the at least one magnetic sensor measuring a magnetic field strength (see [0078], Fig. 3 and Fig. 7 which discloses that the supplementary device 2 carries the Hall sensors 25, 25’ which are the at least one magnetic sensor),
wherein the system for measuring an amount of a set dose or a delivered dose further comprises a device (24) configured to determine the amount of a set dose or a delivered dose based on the magnetic field strength measurements (see [0016], [0033], [0060], [0073] “In the pre-activation state, the Hall sensor 25 will detect a very low or no magnetic field due to the relatively large separation between the magnet 500 and Hall sensor 25. During the ejection process, the field detected by the Hall sensor 25 increases. When the injection device 10 is in a post-ejection state, the magnet is located adjacent the Hall sensor 25 and the field detected is relatively high,” [0074], [0075], [0077], [0084], and [0090]), a sensor (23) for detecting a dose injection (see [0087] “When a user performs an injection, this is detected by the capacitive sensor 23 or Hall sensor 25 as described above,” [0090], and Fig. 7), and a spring element (400) for storing an elastic energy for an automatic injection of the set dose (see [0067] and [0069]).
With regards to claim 2, Helmer discloses the claimed invention of claim 1, and Helmer further discloses wherein the magnetic field source is a permanent magnet (see [0076] “The magnet 500, 502 may be a permanent magnet”).
With regards to claim 3, Helmer discloses the claimed invention of claim 1, and Helmer further discloses wherein the system for measuring a set dose or a delivered dose comprises at least two magnetic sensors (25, 25’) (see Fig. 7, [0078] “a first Hall sensor 25 and a second Hall sensor 25’.”).
With regards to claim 4, Helmer discloses the claimed invention of claim 3, and Helmer further discloses wherein the at least two magnetic sensors are the Hall sensors (25, 25’) (see Fig. 7, [0078] “a first Hall sensor 25 and a second Hall sensor 25’.”).
With regards to claim 5, Helmer discloses the claimed invention of claim 3, and Helmer further discloses wherein the at least two magnetic sensors (25, 25’) are disposed collinearly (see Fig. 7).
With regards to claim 6, Helmer discloses the claimed invention of claim 5, and Helmer further discloses wherein the at least two magnetic sensors (25, 25’) are disposed at equal linear intervals (see Fig. 7, [0078], and [0084]).
With regards to claim 7, Helmer discloses the claimed invention of claim 1, and Helmer further discloses wherein the element (14) carrying the magnetic field source (500) is configured so that it moves axially with respect to the element (2) carrying at least one magnetic sensor (25, 25’) (see [0072] and [0078]), wherein the element carrying the magnetic field sensor (see 35 U.S.C. § 112(b) rejection above wherein the “magnetic field sensor” is interpreted as “the magnetic field source”) is a piston rod (14) (see [0046] “A stopper, plunger, piston or bung 14” and [0072] “a magnet 500 is mounted within the injection device 10 on either the distal or the proximal end of the plunger.”), a pull-push control nut, a setting sleeve or a dose selector sleeve.
With regards to claim 8, Helmer discloses the claimed invention of claim 1, and Helmer further discloses wherein the spring element (400) is a helical spring (see [0067], [0069], and Fig. 4a).
With regards to claim 9, Helmer discloses the claimed invention of claim 1, and Helmer further discloses wherein the device configured to determine a set dose or a delivered dose based on the magnetic field strength measurement comprises a processor (24), a microprocessor, a microcomputer or a logic gates system (see [0016], [0033], [0060], [0073] “In the pre-activation state, the Hall sensor 25 will detect a very low or no magnetic field due to the relatively large separation between the magnet 500 and Hall sensor 25. During the ejection process, the field detected by the Hall sensor 25 increases. When the injection device 10 is in a post-ejection state, the magnet is located adjacent the Hall sensor 25 and the field detected is relatively high,” [0074], [0075], [0077], [0084], and [0090]).
With regards to claim 10, Helmer discloses the claimed invention of claim 1, and Helmer further discloses wherein the device (24) configured to determine a set dose or a delivered dose based on the magnetic field strength measurements (see Claims 21, 29, and 30 and paragraphs [0016], [0033], [0060], [0073] “In the pre-activation state, the Hall sensor 25 will detect a very low or no magnetic field due to the relatively large separation between the magnet 500 and Hall sensor 25. During the ejection process, the field detected by the Hall sensor 25 increases. When the injection device 10 is in a post-ejection state, the magnet is located adjacent the Hall sensor 25 and the field detected is relatively high,” [0074], [0075], [0077], [0084], and [0090]) is connected with the at least one magnetic sensor (25, 25’) by means of a multiplexer (see [0057] “These are controlled by a processor 24, which may for instance be a microprocessor, a Digital Signal Processor (DSP), Application Specific Integrated Circuit (ASIC), Field Programmable Gate Array (FPGA) or the like.” Where a FPGA contains multiplexers internally).
With regards to claim 12, Helmer discloses the claimed invention of claim 1, and Helmer further discloses wherein the drug delivery device (2, 10) (see [0052] “a supplementary device 2 to be releasably attached to injection device 10”) comprises a display (21) (see Fig. 3, [0016] “The information may further comprise a medicament dose amount and/or a medicament type,” [0053], [0059] “a display unit 21, which is presently embodied as a Liquid Crystal Display (LCD). Display unit 21 is used to display information to a user of supplementary device 2, for instance on present settings of injection device 1 or on a next injection to be given. Display unit 21 may also be embodied as a touch-screen display, for instance to receive user input,” and [0082] “The supplementary device 2 can additionally sound an alarm and present information to the user via display unit 21. For example, the user can be instructed to seek the advice of their doctor, due to a malfunction of the injection device 10 and can also be informed as to whether any medicament has been ejected from the device.” Wherein the instruction of any medicament that has been ejected is the display of the current set or delivered dose) for displaying at least the currently set or delivered dose.
With regards to claim 13, Helmer discloses the claimed invention of claim 1, and Helmer further discloses wherein the drug delivery device (2, 10) (see [0052] “a supplementary device 2 to be releasably attached to injection device 10”) comprises a wireless communication module (28) (see [0055] “The supplementary device 2 comprises a wireless communication module 28”).
With regards to claim 16, Helmer discloses the claimed invention of claim 13, and Helmer further discloses wherein the wireless communication module (28) (see [0052] “the wireless communication module 28 is a Bluetooth communication module 28”) comprises a Bluetooth module.
With regards to claim 18, Helmer discloses the claimed invention of claim 13, and Helmer further discloses wherein the device (24) configured to determine a set dose or a delivered dose based on the magnetic field measurements (see [0016], [0033], [0060], [0073] “In the pre-activation state, the Hall sensor 25 will detect a very low or no magnetic field due to the relatively large separation between the magnet 500 and Hall sensor 25. During the ejection process, the field detected by the Hall sensor 25 increases. When the injection device 10 is in a post-ejection state, the magnet is located adjacent the Hall sensor 25 and the field detected is relatively high,” [0074], [0075], [0077], [0084], and [0090]) is configured to control at least one of a display (21) (see [0059] “Processor 24 controls a display unit 21”), a wireless communication module (28) (see [0062] “Processor 24 controls a wireless unit 28”), the sensor for detecting a dose injection (23) (see [0060] “Processor 24 also controls a Capacitive Sensor”), and a temperature sensor.
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) 11 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helmer in view of Zur et al. (US 2015/0246179 A1; hereinafter referred to as “Zur”).
Zur is cited in the Notice of References Cited form dated 20 March 2025.
With regards to claim 11, Helmer discloses the claimed invention of Claim 1, however, Helmer is silent with regards to wherein the device configured to determine a set dose or a delivered dose based on the magnetic field strength measurements is connected with an accelerometer.
Nonetheless Zur, which is within the analogous art of devices for drug dosing with administration monitoring (see abstract and title), teaches the device (4) configured to determine a set dose or a delivered dose based on the magnetic field strength measurements is connected with an accelerometer (see [0084] “The device (FIG. 3—denoted 4) with its Gyro, Accelerometer, and Magnetometer (FIG.—denoted 5) detects the dosage selecting dial by proximity to its sensor Magnetometer since on the pen button is located a magnet (FIG. 3—denoted 6).”).
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 device configured to determine a set dose or a delivered dose based on the magnetic field strength measurements of the drug delivery device of Helmer in view of a teaching of Zur such that the device configured to determine a set dose or a delivered dose based on the magnetic field strength measurements is connected with an accelerometer. One of ordinary skill in the art would have been motivated to make this modification because Zur teaches that including an accelerometer assists with determining the sense of the orientation of the device and alerting the user when the device is improperly oriented (see [0027] and [0078] of Zur).
With regards to claim 17, Helmer discloses the claimed invention of Claim 1, however, Helmer is silent with regards to wherein the drug delivery device comprises a temperature sensor.
Nonetheless Zur, which is within the analogous art of devices for drug dosing with administration monitoring (see abstract and title), teaches the drug delivery device (100) (see [0067]) comprises a temperature sensor (141) (see [0067]).
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 device of Helmer in view of a teaching of Zur such that the drug delivery device comprises a temperature sensor. One of ordinary skill in the art would have been motivated to make this modification because Zur teaches that a temperature sensor can be included to sense when the drug is being injected and determine a target amount of dosage to be administered during the drug provision process and an actual amount of the drug that may be administered by the user (see [0031] and [0032]). Further, Zur teaches that
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Krusell (US 2017/0232203 A1) see [0009].
Larsen et al. (US 2014/0243750 A1) see [0020] and [0134].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT F ALLEN whose telephone number is (571)272-6232. The examiner can normally be reached Monday-Friday 8:00 AM - 4:30 PM ET.
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, Chelsea Stinson can be reached at (571)270-1744. 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.
/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
03/12/2026