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 .
Response to Amendment
The amendment filed February 17, 2026 has been entered. Claims 1-32 remain pending in the application.
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.
Claims 4-5 are 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.
Regarding claim 4, the limitation “a transceiver in the plunger rod and configured for bidirectional communication with a second device” in lines 1-2 renders the claim indefinite because claim 1 also requires “a transceiver in the plunger rod and configured for bidirectional communication with a second device” in lines 12-13. It is unclear if the drug delivery devices comprises two, separate transceivers, or if the transceiver introduced in claim 4 is the same transceiver introduced in claim 1. For examination purposes, the examiner has interpreted “a transceiver in the plunger rod and configured for bidirectional communication with a second device” in Claim 4, lines 1-2 to be the same structure as “a transceiver in the plunger rod and configured for bidirectional communication with a second device” in Claim 1, lines 12-13.
Claim 5 is rejected for being dependent upon claim 4.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 fails to further limit claim 1, upon which it depends. Claim 4 requires “a transceiver in the plunger rod and configured for bidirectional communication with a second device”. This limitation is also recited in claim 1, lines 13-14 (“a transceiver in or on the plunger rod and configured for bidirectional communication to a second device”). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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)(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 29 and 31 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mirov et al. (US 20170312445).
Regarding claim 29, Mirov discloses a plunger rod (plunger 14) for a drug injection device (syringe 10; Figure 1), the plunger rod comprising:
a sensor (force sensor 34, temperature sensor 36, and transducer 24 of first component 31) in or on a distal portion of the plunger rod (“first component 31 may be coupled to plunger 14 in order to facilitate easy removal of first component 31 after use.” [0039]), the sensor configured to measure a state of a medicament (medication 20) of a medicament container (barrel 12) of the drug injection device (“Temperature sensor 36 may be configured to measure the ambient temperature, which may be generally representative of a temperature of plunger head 22 and/or medication 20.” [0022]; see all of [0049] regarding transducer 24; see all of [0065] regarding force sensor 34);
a transceiver (transceiver 30 of first component 31) in or on the plunger rod (“first component 31 may be coupled to plunger 14 in order to facilitate easy removal of first component 31 after use.” [0039]) and configured for bidirectional communication to a second device for communicating the measured state of the medicament container to the second device (“Transceiver 30 may be configured to wirelessly communicate with a remote device (e.g., a smart phone, a glucose monitor, an insulin pump, or a computer) using one or more wireless communication methods. The one or more wireless communication methods may include, for example, radio data transmission, Bluetooth, BLE, near field communication (NFC), infrared data transmission, electromagnetic induction transmission, and/or other suitable electromagnetic, acoustic, or optical transmission methods.” [0023]; see also [0064]); and
an energy source (power source 28 of first component 31) in or on the plunger rod (“first component 31 may be coupled to plunger 14 in order to facilitate easy removal of first component 31 after use.” [0039]), the energy source configured to provide electrical energy to the sensor for measuring the state of the medicament container and to the transceiver for communicating the measured state to the second device (“Power source 28 may be configured to power transducer 24, microcontroller 26, transceiver 30, temperature sensor 36, and other electronic components of plunger head 22.” [0023]).
Regarding claim 31, Mirov discloses the plunger rod of claim 29, wherein the second device (remote device 50) is external to the drug injection device (“Antenna or transceiver 30 may be used to communicate with a variety of remote devices (e.g., smart phones, glucose monitors, insulin pumps, computers, etc.).” [0064]; Figure 8).
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.
Claims 1, 4-12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Mirov et al. (US 20170312445) in view of Dette et al. (US 20090264828).
Regarding claim 1, Mirov discloses a drug delivery device (syringe 10) comprising:
a housing configured to be attached to a medicament container (barrel 20; Figure 1);
a plunger rod (plunger 14 and first component 31: “first component 31 may be coupled to plunger 14 in order to facilitate easy removal of first component 31 after use.” [0039]) slidably disposed within the housing (“the plunger 14 of the syringe 10 may be depressed” [0084]), the plunger rod configured to displace a stopper (plunger head 22) within the medicament container (“the plunger 14 of the syringe 10 may be depressed, which forces plunger head 22 down the barrel 12 and forces the medication 20 out the needle 16.” [0084]);
a sensor (transducer 24 of first component 31) in or on the distal portion of the plunger rod (“first component 31 may be coupled to plunger 14 in order to facilitate easy removal of first component 31 after use.” [0039]) and configured to measure a state of the medicament container based on a signal that has passed through at least a portion of the plunger rod and at least a portion of the stopper of the medicament container (“As shown in FIG. 7, transducer 24 may be configured to generate ultrasonic signals 25 (e.g., radiated sound energy waves) and send the ultrasonic signals 25 down barrel 12 toward hub 18 and needle 16. The ultrasonic signals can travel through medication 20 along the length of barrel 12 and bounce or reflect off an end 27 of barrel 12 and travel back through medication 20 to plunger head 22. The reflected ultrasonic signals can be received and detected by transducer 24. The speed of sound in medication 20 may be a known value and thus a distance D can be calculated very accurately based on the time it takes for a ultrasonic signal to travel down and back from transducer 24. As plunger head 22 is moved down barrel 12 distance D will change and by knowing the diameter of barrel 12 then the volume of medication 20 dispensed may be calculated based on the change in distance D.” [0049]; see Figures 3, 4A, and 7 showing the signal passing through the first component 31 and second component 33);
a transceiver (transceiver 30 of first component 31) in or on the plunger rod (“first component 31 may be coupled to plunger 14 in order to facilitate easy removal of first component 31 after use.” [0039]) and configured for bidirectional communication with a second device (“Transceiver 30 may be configured to wirelessly communicate with a remote device (e.g., a smart phone, a glucose monitor, an insulin pump, or a computer) using one or more wireless communication methods. The one or more wireless communication methods may include, for example, radio data transmission, Bluetooth, BLE, near field communication (NFC), infrared data transmission, electromagnetic induction transmission, and/or other suitable electromagnetic, acoustic, or optical transmission methods.” [0023]; see also [0064]) for communicating the measured state of the medicament container ot the second device (“Plunger head 22 may transmit data (e.g., the amount of medication 20 dispensed and time and date it was dispensed) to a remote device (e.g., a smart phone, a glucose monitor, an insulin pump, or a computer) via one or more of the wireless communication methods” [0058]; “the microcontroller is programmed with instructions to calculate data representative of the quantity of medication dispensed from the barrel of the medication injection device and transmit the data to a remote device via the transceiver.” [Claim 9]);
an energy source (power source 28 of first component 31) in or on the plunger rod (“first component 31 may be coupled to plunger 14 in order to facilitate easy removal of first component 31 after use.” [0039]) and configured to provide electrical energy to the sensor for measuring the state of the medicament container (“Power source 28 may be configured to power transducer 24” [0023]).
Mirov fails to explicitly disclose the drug delivery device comprising a housing having an opening at a distal end of the housing for receiving a medicament container, the housing configured such that at least a portion of the medicament container extends distally beyond the distal end of the housing when the medicament container is attached to the housing; the drug delivery device configured such that a distal portion of the plunger rod extends distally beyond the distal end of the housing in at least one position of the plunger rod; a dose dial connected to a proximal end of the housing, the drug delivery device being configured to set a dose of a medicament of the medicament container based on a position of the dose dial; a dosage indicator on the housing and configured to display the set dose; and a trigger button for causing the dose of the medicament to be dispensed from the medicament container.
Dette discloses a drug delivery device (drug delivery device 1) comprising a housing (main housing 4) having an opening at a distal end of the housing for receiving a medicament container (“A first end of the cartridge retaining means 2 and a second end of the main housing 4 are secured together by retaining features 6. In this illustrated arrangement, the cartridge retaining means 2 is secured within the second end of the main housing 4.” [0040]; “A cartridge 8 from which a number of doses of a medicinal product may be dispensed is provided in the cartridge retaining part 2.” [0041]), the housing configured such that at least a portion of the medicament container extends distally beyond the distal end of the housing when the medicament container is attached to the housing (Figure 1, wherein the cartridge 8 extends distally beyond the second end of main housing 4); a plunger rod (piston rod 20) slidably disposed within the housing (Figures 1-5) and configured to displace a stopper (cartridge piston 10) within the medicament container (Figures 1-5), the drug delivery device configured such that a distal portion of the plunger rod extends distally beyond the distal end of the housing in at least one position of the plunger rod (Figures 4-5 showing piston rod 20 extending distally beyond the second end of the main housing 4 as the piston 10 is advanced); a dose dial (dose dial grip 76) connected to a proximal end of the housing (Figure 1), the drug delivery device being configured to set a dose of a medicament of the medicament container based on a position of the dose dial (“To dial a dose in the arrangement illustrated in FIG. 9, a user holds the main housing 4 in his or her left hand and uses the right hand to rotate the dose dial grip 76 (arrow B) in a direction away from the user.” [0056]); a dosage indicator (drug delivery device window 44) on the housing and configured to display the set dose (“This first scale arrangement 122 could provide a user certain visual indication through drug delivery device window 44 as the amount of dosage that a user sets.” [0059]); and a trigger button (button 82) for causing the dose of the medicament to be dispensed from the medicament container (“When the desired dose has been dialed, the user may then dispense this dose by depressing the button 82 (See, e.g., FIG. 11).” [0066]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the drug delivery device of Mirov to be a drug delivery device comprising a housing having an opening at a distal end of the housing for receiving a medicament container and configured such that at least a portion of the medicament container and a portion of the plunger rod extend distally beyond the distal end of the housing, a dose dial, a dosage indicator, and a trigger button based on the teachings of Dette to allow the user to set and self-administer a specific dosage of the medicament from a multi-dose medicament cartridge (Dette [0003]).
Regarding claim 4, modified Mirov discloses the drug delivery device of claim 1, comprising a transceiver (transceiver 30 of first component 31) in the plunger rod (“first component 31 may be coupled to plunger 14 in order to facilitate easy removal of first component 31 after use.” [0039]) and configured for bidirectional communication with a second device (“Transceiver 30 may be configured to wirelessly communicate with a remote device (e.g., a smart phone, a glucose monitor, an insulin pump, or a computer) using one or more wireless communication methods. The one or more wireless communication methods may include, for example, radio data transmission, Bluetooth, BLE, near field communication (NFC), infrared data transmission, electromagnetic induction transmission, and/or other suitable electromagnetic, acoustic, or optical transmission methods.” [0023]; see also [0064]).
Regarding claim 5, modified Mirov discloses the drug delivery device of claim 4, wherein the transceiver is configured to receive a wake up signal from the second device and transmit the measured state of the medicament container to the second device (“Transceiver 30 may be configured to wirelessly communicate with a remote device (e.g., a smart phone, a glucose monitor, an insulin pump, or a computer) using one or more wireless communication methods.” [0030]; “Plunger head 22 may transmit data (e.g., the amount of medication 20 dispensed and time and date it was dispensed) to a remote device (e.g., a smart phone, a glucose monitor, an insulin pump, or a computer) via one or more of the wireless communication methods…plunger head 22 may wait to initiate transmitting of the information to remote device 50 until initiated by remote device 50. For example, a user may initiate information retrieval on remote device 50.” [0058]).
Regarding claim 6, modified Mirov discloses the drug delivery device of claim 1, wherein the drug delivery device is configured to activate the sensor by an impact of the plunger rod (“when compressive forces are applied to first component 31, power source 28 or one or more of the other electronic components may be moved and brought into electrical contact thereby powering up. In other words, in some embodiments, power source 28 may be positioned within first component 31, such that the compressive force applied by plunger 14 acts as an off/off switch, which initiates (e.g., wakes up or powers up) the electronic components of plunger head 22.” [0045]).
Regarding claim 7, modified Mirov discloses the drug delivery device of claim 1, wherein the sensor (transducer 24) is configured to measure the state of the medicament container based on the signal after the signal has been reflected off a portion of the housing (“As shown in FIG. 7, transducer 24 may be configured to generate ultrasonic signals 25 (e.g., radiated sound energy waves) and send the ultrasonic signals 25 down barrel 12 toward hub 18 and needle 16. The ultrasonic signals can travel through medication 20 along the length of barrel 12 and bounce or reflect off an end 27 of barrel 12 and travel back through medication 20 to plunger head 22. The reflected ultrasonic signals can be received and detected by transducer 24. The speed of sound in medication 20 may be a known value and thus a distance D can be calculated very accurately based on the time it takes for a ultrasonic signal to travel down and back from transducer 24. As plunger head 22 is moved down barrel 12 distance D will change and by knowing the diameter of barrel 12 then the volume of medication 20 dispensed may be calculated based on the change in distance D.” [0049]).
Regarding claim 8, modified Mirov discloses the drug delivery device of claim 1, wherein the sensor is configured to measure the state of the medicament container based on the signal after the signal has been reflected off a reflector (porous membrane 19) inside the medicament container (“As shown in FIG. 7, transducer 24 may be configured to generate ultrasonic signals 25 (e.g., radiated sound energy waves) and send the ultrasonic signals 25 down barrel 12 toward hub 18 and needle 16. The ultrasonic signals can travel through medication 20 along the length of barrel 12 and bounce or reflect off an end 27 of barrel 12 and travel back through medication 20 to plunger head 22. The reflected ultrasonic signals can be received and detected by transducer 24.” [0049]; “a porous membrane 19 may be placed within barrel 12 at end 27. Porous membrane 19 may be designed to allow medication 20 to pass through while providing a surface with good reflective properties for the ultrasonic signals 25 to reflect from.” [0050]).
Regarding claim 9, modified Mirov discloses the drug delivery device of claim 1, wherein the signal has been generated from a fixed position within the housing (“As shown in FIG. 7, transducer 24 may be configured to generate ultrasonic signals 25 (e.g., radiated sound energy waves) and send the ultrasonic signals 25 down barrel 12 toward hub 18 and needle 16. The ultrasonic signals can travel through medication 20 along the length of barrel 12 and bounce or reflect off an end 27 of barrel 12 and travel back through medication 20 to plunger head 22. The reflected ultrasonic signals can be received and detected by transducer 24.” [0049]; wherein the end 27 of barrel 12 is fixed).
Regarding claim 10, modified Mirov discloses the drug delivery device of claim 9, wherein the sensor is configured to measure the state of the medicament container based on a received intensity of the signal (“transducer 24 may be configured to generate ultrasonic signals 25 (e.g., radiated sound energy waves) and send the ultrasonic signals 25 down barrel 12 toward hub 18 and needle 16. The ultrasonic signals can travel through medication 20 along the length of barrel 12 and bounce or reflect off an end 27 of barrel 12 and travel back through medication 20 to plunger head 22.” [0049]; “In order to detect air bubbles, transducer 24 of plunger head 22 may be configured to detect small ultrasonic echoes created by the reflection of the ultrasonic waves off the air bubbles in addition to the main echo caused by the end of barrel 12.” [0071], wherein the transducer can distinguish between the intensity of “small ultrasonic echoes” and “main echo”).
Regarding claim 11, modified Mirov discloses the drug delivery device of claim 9, wherein the sensor is configured to measure the state of the medicament container based on a time of flight between the fixed position and a position of the sensor (“Prior to and while plunger 14 is being depressed, plunger head 22 may send and receive ultrasonic signals 25 via transducer 24, at step 108…Plunger head 22 may measure a time it takes for each of the ultrasonic signals to travel through the medication to an end of the barrel and return to the transducer, at step 110.” [0086]; see also [0049]).
Regarding claim 12, modified Mirov discloses the drug delivery device of claim 1, wherein the state of the medicament container represents a fill level of the medicament, a position of the stopper, or a volume of the dose (“transducer 24 may be configured to generate ultrasonic signals 25 (e.g., radiated sound energy waves) and send the ultrasonic signals 25 down barrel 12 toward hub 18 and needle 16. The ultrasonic signals can travel through medication 20 along the length of barrel 12 and bounce or reflect off an end 27 of barrel 12 and travel back through medication 20 to plunger head 22. The reflected ultrasonic signals can be received and detected by transducer 24. The speed of sound in medication 20 may be a known value and thus a distance D can be calculated very accurately based on the time it takes for a ultrasonic signal to travel down and back from transducer 24. As plunger head 22 is moved down barrel 12 distance D will change and by knowing the diameter of barrel 12 then the volume of medication 20 dispensed may be calculated based on the change in distance D.” [0049]).
Regarding claim 14, modified Mirov discloses the drug delivery device of claim 1, wherein the plunger rod (plunger 14 and first component 31: “first component 31 may be coupled to plunger 14 in order to facilitate easy removal of first component 31 after use.” [0039]) is configured to be inserted into the stopper (second component 33; “second component 33 may be preinstalled in barrel 12 and supplied with syringe 10 while first component 31 may be supplied separately and configured to get inserted into second component 33 while it sits in barrel 12. This arrangement can facilitate the reuse of first component 31 which may house the electronic components. In some embodiments, first component 31 may be coupled to plunger 14 in order to facilitate easy removal of first component 31 after use.” [0039]), and the sensor is configured to measure the state of the medicament container when the sensor is within the stopper (Figures 7; see all of [0049]).
Claims 2-3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Mirov et al. (US 20170312445) in view of Dette et al. (US 20090264828) as applied in claim 1 above, and further in view of Pommereau et al. (US 20120195182).
Regarding claim 2, modified Mirov discloses the drug delivery device of claim 1, wherein the sensor (transducer 24) is configured to receive the signal through a ceramic, a glass, or a metal material (“Structural support system 35 may be made generally semi-rigid or rigid and may be formed of a variety of different materials, for example, plastic, elastomers, composites, metals, or combinations thereof.” [0044]) and through the stopper (second component 33; Figures 3, 4A, and 7).
Modified Mirov fails to explicitly disclose a ceramic, a glass, or a metal material of the stopper. Pommereau teaches a drug delivery device (cartridge 10) comprising a stopper (bung 20) made from a ceramic, a glass, or a metal material (“The second material is at least partly arranged inside the bung…The second material can comprise for example glass, metal, ceramic, rubber, plastic or gel.” [0052]). Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the stopper of the drug delivery device of Mirov to be made of a ceramic, glass, or metal material based on the teachings of Pommereau to provide a rigid structure to resist axial compression of the stopper when the plunger rod applies a force to axially displace the stopper (Pommereau [0052]).
Regarding claim 3, modified Mirov in view of Pommereau discloses the drug delivery device of claim 2, wherein the sensor (transducer 24) is configured to receive the signal through the material of the stopper (second component 33; Figures 3, 4A, and 7), the material having a non-zero thickness of less than 0.5 mm (“The thickness of second component 33 may vary. For example, in some embodiments, the thickness of second component may be…less than about 0.5 millimeters.” [0038]).
Modified Mirov fails to explicitly teach the material is a metal material, the metal material having a non-zero thickness of less than 0.1 mm. Pommereau teaches a drug delivery device (cartridge 10) comprising a stopper (bung 20) made from a metal material (“The second material is at least partly arranged inside the bung…The second material can comprise for example glass, metal, ceramic, rubber, plastic or gel.” [0052]). Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the stopper of the drug delivery device of Mirov to be made of metal material based on the teachings of Pommereau to provide a rigid structure to resist axial compression of the stopper when the plunger rod applies a force to axially displace the stopper (Pommereau [0052]).
Modified Mirov fails to explicitly teach the material having a non-zero thickness of less than 0.1 mm. However, Mirov discloses that the thickness of the material of the stopper (second component 33) can vary and be less than 0.5 mm (“The thickness of second component 33 may vary. For example, in some embodiments, the thickness of second component may be…less than about 0.5 millimeters.” [0038]) and that the structure of the stopper is optimized to in order to isolate the electronics components from the medicament (see at least [0025-0027] and [0037-0039]). Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the thickness of the metal material of the stopper of Mirov as modified by Pommereau to have a non-zero thickness of less than 0.1 mm because it has been held that discovering the optimum value of a result effective variable involves only routine skill in the art (MPEP 2144.05(II)). One having ordinary skill in the art would recognize that it is known to vary and optimize the thickness of the stopper to minimize material use while still providing isolation of the sensor (Mirov [0025-0027] and [0037-0039]).
Regarding claim 13, modified Mirov discloses the drug delivery device of claim 1. Modified Mirov fails to explicitly disclose at least a portion of the stopper is substantially rigid. Pommereau teaches a drug delivery device (cartridge 10) comprising a stopper (bung 20), wherein at least a portion of the stopper is substantially rigid (“The second material is at least partly arranged inside the bung and provides a rigid or semi-rigid core…The second material can comprise for example glass, metal, ceramic, rubber, plastic or gel.” [0052]). Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the stopper of the drug delivery device of Mirov such that at least a portion of the stopper is substantially rigid based on the teachings of Pommereau to provide a rigid structure to resist axial compression of the stopper when the plunger rod applies a force to axially displace the stopper (Pommereau [0052]).
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Mirov et al. (US 20170312445) in view of Dette et al. (US 20090264828) as applied in claim 14 above, and further in view of Moberg et al. (US 20010034502).
Regarding claims 15 and 16, modified Mirov discloses the drug delivery device of claim 14.
Modified Mirov fails to explicitly disclose the plunger rod comprises a threaded interface configured to engage a counterpart threaded interface of the stopper for positioning the sensor within the stopper, as required by claim 15; and wherein the sensor is in the plunger rod such that at least a portion of the threaded interface of the plunger rod surrounds the sensor, as required by claim 16.
Moberg teaches a drug delivery device (infusion pump 101 with embodiment of Figure 19) comprising: a plunger rod (slide 2102) slidably disposed within a housing (Figure 21, for example); and a sensor (strain gauge sensor 2105) in a distal portion of the plunger rod (Figure 19; “A strain gauge sensor 2105 is secured to the proximate nose wall 2104.” [0144]), the plunger rod comprises a threaded interface (external threads 2113) configured to engage a counterpart threaded interface (internal threads 2114) of a stopper (stopper 2106) for positioning the sensor within the stopper (Figure 19; “The nose sidewall 2117 has external threads 2113 for removably engaging the internal threads 2114 on the sidewall 2110 of the stopper cavity 2112.” [0144]); and wherein the sensor is in the plunger rod such that at least a portion of the threaded interface of the plunger rod surrounds the sensor (Figure 19, wherein the threads are radially outward of, or surrounding, sensor 2105).
Before the effective filing date of hte claimed invention, it would have been obvious to one having ordinary skill in the art to modify the plunger rod of Mirov to include a threaded interface configured to engage a counterpart threaded interface of the stopper for positioning the sensor within the stopper such that at least a portion of the threaded interface of the plunger rod surrounds the sensor based on the teachings of Moberg to enable the plunger rod to move a stopper bidirectionally and also allow the plunger to be decoupled from the stopper (Moberg [0144]).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Mirov et al. (US 20170312445) in view of Dette et al. (US 20090264828) as applied in claim 1 above, and further in view of Bendix et al. (US 20120136298).
Regarding claims 17-18, modified Mirov discloses the drug delivery device of claim 1.
Modified Mirov fails to explicitly disclose wherein the stopper is a first stopper, and the drug delivery device comprises a second stopper within the medicament container, as required by claim 17; and wherein the second stopper is distal to the first stopper, as required by claim 18.
Bendix teaches a drug delivery device (mixing device 1) comprising a plunger rod (piston rod 7) configured to displace a stopper (rear piston 6) within a medicament container (cartridge 50; Figures 1-4); wherein the stopper is a first stopper (rear piston 6), and the drug delivery device comprises a second stopper (front piston 5) within the medicament container (Figure 1), and wherein the second stopper is distal to the first stopper (Figure 1).
Before the effective filing date of hte claimed invention, it would have been obvious to one having ordinary skill in the art to further modify drug delivery device of Mirov to include a second stopper distal of a first stopper based on the teachings of Bendix to adapt the drug delivery device for mixing two constituents of the medicament together prior to delivery to the patient in order to prolong the shelf life of the drug delivery device (Bendix [0002]).
Claims 19-24, 27-28, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Moberg at al. (US 20010034502) in view of Mirov et al. (US 20170312445).
Regarding claim 19, Moberg discloses a drug delivery device (infusion pump 101 with embodiment of Figure 19) comprising:
a housing (housing 102);
a plunger rod (lead screw 2101 and slide 2102) slidably disposed within a proximal portion of the housing (Figure 21, for example), the plunger rod configured to displace a stopper (stopper 2106) within a medicament container (fluid reservoir 2107) for dispensing a medicament from the medicament container when the medicament container is in or attached to the drug delivery device;
a sensor (strain gauge sensor 2105) in a distal portion of the plunger rod (Figure 19; “A strain gauge sensor 2105 is secured to the proximate nose wall 2104.” [0144]) and configured to measure a state of the medicament of the medicament container (“As the flexible proximate wall 2108 of the stopper 2106 deflects due to fluid pressure, it contacts the proximate nose wall 2104 causing it to deflect, thus deflecting the strain gauge sensor 2105. This provides a measurement of the pressure within the reservoir 2107 independent of the force used to drive the stopper 2106.” [0145]).
Moberg fails to explicitly disclose an energy source in or on the plunger rod and configured to provide electrical energy to the sensor for measuring the state of the medicament container.
Mirov teaches a drug delivery device (syringe 10) comprising a plunger rod (plunger 14 and first component 31: “first component 31 may be coupled to plunger 14 in order to facilitate easy removal of first component 31 after use.” [0039]) configured to displace a stopper (second component 33 of stopper 22); a sensor (force sensor 34, temperature sensor 36, and transducer 24 of first component 31) on a distal portion of the plunger rod (“first component 31 may be coupled to plunger 14 in order to facilitate easy removal of first component 31 after use.” [0039]) and configured to measure a state of a medicament (medication 20) of a medicament container (barrel 12) of the drug injection device (“Temperature sensor 36 may be configured to measure the ambient temperature, which may be generally representative of a temperature of plunger head 22 and/or medication 20.” [0022]; see all of [0049] regarding transducer 24; see all of [0065] regarding force sensor 34); and an energy source (power source 28 of first component 31) in or on the plunger rod (“first component 31 may be coupled to plunger 14 in order to facilitate easy removal of first component 31 after use.” [0039]) and configured to provide electrical energy to the sensor for measuring the state of the medicament container (“Power source 28 may be configured to power transducer 24, microcontroller 26, transceiver 30, temperature sensor 36, and other electronic components of plunger head 22.” [0023]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the drug delivery device of Moberg to include an energy source in or on the plunger rod and configured to provide electrical energy to the sensor for measuring the state of the medicament container based on the teachings of Mirov to power the sensor during use of the drug delivery device (Mirov [0023]).
Regarding claim 20, modified Moberg discloses the drug delivery device of claim 19, wherein an outer portion of the distal portion of the plunger rod (nose sidewall 2117) comprises one or more threads (external threads 2113) configured to engage one or more threads (internal threads 2114) of the stopper (“The nose sidewall 2117 has external threads 2113 for removably engaging the internal threads 2114 on the sidewall 2110 of the stopper cavity 2112.” [0144]).
Regarding claim 21, modified Moberg discloses the drug delivery device of claim 19.
Modified Moberg fails to explicitly disclose the sensor and the energy source are in a single cavity of the plunger rod.
Mirov teaches a drug delivery device (syringe 10) comprising a plunger rod (plunger 14 and first component 31: “first component 31 may be coupled to plunger 14 in order to facilitate easy removal of first component 31 after use.” [0039]); a sensor (force sensor 34, temperature sensor 36, and transducer 24 of first component 31) and an energy source (power source 28 of first component 31) on a distal portion of the plunger rod (“first component 31 may be coupled to plunger 14 in order to facilitate easy removal of first component 31 after use.” [0039]), wherein the sensor and the energy source are in a single cavity of the plunger rod (Figures 3 and 4A showing the sensors 34, 36, 24 and power source 28 contained in a single cavity of the first component 31; “first component 31 may be coupled to plunger 14 in order to facilitate easy removal of first component 31 after use.” [0039]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill it the art to further modify the drug delivery device of Moberg to include the sensor and the energy source are in a single cavity of the plunger rod based on the teachings of Mirov to consolidate the electronic components of the drug delivery device into a single location to facilitate reuse of the electronic components (Mirov [0026-0028, 0039]).
Regarding claim 22, modified Moberg discloses the drug delivery device of claim 19, wherein the distal portion of the plunger rod has a first diameter (slide 2102; Figure 19), and a second portion of the plunger rod (lead screw 2101) has a second diameter that is less than the first diameter (Figure 19, wherein the lead screw 2101 has a diameter less than at least a portion of slide 2102).
Regarding claim 23, modified Moberg discloses the drug delivery device of claim 22, wherein the second portion of the plunger rod (lead screw 2101) extends proximally from the distal portion (Figure 19) and extends an axial length that is greater than an axial length of the distal portion of the plunger rod (Figures 4 and 21, for example).
Regarding claim 24, modified Moberg discloses the drug delivery device of claim 19.
Modified Moberg fails to explicitly disclose the sensor is configured to measure the state of the medicament by transmitting and receiving signals through at least a portion of the plunger rod and at least a portion of the stopper.
Mirov teaches a drug delivery device (syringe 10) comprising a plunger rod (plunger 14 and first component 31: “first component 31 may be coupled to plunger 14 in order to facilitate easy removal of first component 31 after use.” [0039]) configured to displace a stopper (second component 33 of stopper 22) and a sensor (force sensor 34, temperature sensor 36, and transducer 24 of first component 31) configured to measure the state of the medicament by transmitting and receiving signals through at least a portion of the plunger rod (first component 31) and at least a portion of the stopper (second component 33; “transducer 24 may be configured to generate ultrasonic signals 25 (e.g., radiated sound energy waves) and send the ultrasonic signals 25 down barrel 12 toward hub 18 and needle 16. The ultrasonic signals can travel through medication 20 along the length of barrel 12 and bounce or reflect off an end 27 of barrel 12 and travel back through medication 20 to plunger head 22. The reflected ultrasonic signals can be received and detected by transducer 24.” [0049]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the sensor of the drug delivery device of Moberg to be configured to measure the state of the medicament by transmitting and receiving signals through at least a portion of the plunger rod and at least a portion of the stopper based on the teachings of Mirov to enable the drug delivery device to determine the volume of medicament dispensed from the medicament container as the stopper moves through the medicament container (Mirov [0049]).
Regarding claim 27, modified Moberg discloses the drug delivery device of claim 19, wherein the plunger rod is configured to be removably attached to the stopper to bidirectionally couple axial movement between the plunger rod and the stopper (“The nose sidewall 2117 has external threads 2113 for removably engaging the internal threads 2114 on the sidewall 2110 of the stopper cavity 2112. The threaded coupling between the slide 2102 and the stopper 2106 enables the drive system to move the stopper 2106 bi-directionally.” [0144]).
Regarding claim 28, modified Moberg discloses the drug delivery device of claim 19, wherein the plunger rod (lead screw 2101 and slide 2102) is configured to removably engage an insert (inner wall of sidewall 2110 having internal threads 2114) of the stopper (stopper 2106) to bidirectionally couple axial movement between the plunger rod and the stopper (“The nose sidewall 2117 has external threads 2113 for removably engaging the internal threads 2114 on the sidewall 2110 of the stopper cavity 2112. The threaded coupling between the slide 2102 and the stopper 2106 enables the drive system to move the stopper 2106 bi-directionally.” [0144]), the insert being disposed within a shell (outer wall of sidewall 2110) of the stopper (Figure 19).
Regarding claim 32, modified Moberg disclose the drug delivery device of claim 19, wherein the sensor (sensor 2105) is located inside the distal portion of the plunger rod (“A strain gauge sensor 2105 is secured to the proximate nose wall 2104.” [0144]; Figure 19).
Modified Moberg fails to explicitly disclose the sensor is encapsulated inside the distal portion of plunger rod.
Mirov teaches a drug delivery device (syringe 10) comprising a plunger rod (plunger 14 and first component 31: “first component 31 may be coupled to plunger 14 in order to facilitate easy removal of first component 31 after use.” [0039]) configured to displace a stopper (second component 33 of stopper 22); the plunger rod having a distal portion (first component 31: “first component 31 may be coupled to plunger 14” [0039]) and a sensor (force sensor 34, temperature sensor 36, and transducer 24 of first component 31) encapsulated inside the distal portion of plunger rod (Figures 3 and 4A showing the sensors 34, 36, 24 encapsulated by structure support system 31 in first component 31; “first component 31 may be coupled to plunger 14 in order to facilitate easy removal of first component 31 after use.” [0039]; “Structural support system 35 may be, for example, a rigid skeleton, cylinder, container, or frame work that surrounds, encloses, or is embedded in one or more of electronic components 29…first component 31 including structural support system 35 may be encapsulated, over-molded, cast, or sealed within a coating (e.g., elastomer, silicone, plastic, or rubber coating).” [0041]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the drug delivery device of Moberg to include the sensor is encapsulated inside the distal portion of plunger rod based on the teachings of Mirov to protect the sensor from excessive compressive forces during use of the drug delivery device (Mirov [0040]).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Moberg at al. (US 20010034502) in view of Mirov et al. (US 20170312445) as applied in claim 19 above, and further in view of Kietzmann et al. (US 20140330243).
Regarding claim 25, modified Moberg in view of Mirov teaches the drug delivery device of claim 19, wherein the energy source (as provided Mirov) may be any suitable power source (Mirov: “Power source 28 may be any suitable power source.” [0066]).
Modified Moberg in view of Mirov fails to explicitly disclose a piezoelectric element within the housing, the piezoelectric element configured to generate the electrical energy during handling or movement of the drug delivery device.
Kietzmann teaches a drug delivery device (drug delivery device 10) comprising a piezoelectric element (power supply 38; “the power supply 38 may comprise at least one converter, like a piezo-element” [0143]) within a housing (Figure 3), the piezoelectric element configured to generate the electrical energy during handling or movement of the drug delivery device (“the power supply 38 may comprise at least one converter, like a piezo-element, adapted to transfer mechanical power provided by a user into electric energy” [0143]).
Before the effective filing date of the claimed invention it would have been obvious to one having ordinary skill in the art to modify the drug delivery device of Moberg in view of Mirov to include a piezoelectric element within the housing and configured to generate the electrical energy based on the teachings of Kietzmann to allow the user to directly provide the energy to power the sensor (Kietzmann [0143]).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Moberg at al. (US 20010034502) in view of Mirov et al. (US 20170312445) as applied in claim 19 above, and further in view of Forlani et al. (WO 2016036574).
Regarding claim 26, modified Moberg in view of Mirov teaches the drug delivery device of claim 19, wherein the energy source (as provided Mirov) may be any suitable power source (Mirov: “Power source 28 may be any suitable power source.” [0066]).
Modified Moberg in view of Mirov fails to explicitly teach a thermoelectric element within the housing, the thermoelectric element configured to generate the electrical energy during a temperature change of the drug delivery device.
Forlani teaches a drug delivery device (container 25) comprising a thermoelectric element within a housing (Figure 1), the thermoelectric element configured to generate the electrical energy during a temperature change of the drug delivery device (“Controller 40 is shown operatively connected at 46 to light source 30, and at 48 to light detector 35. Connections 46 and 48 allow controller 40 to make light source 30 and light detector 35 operational only when necessary for plunger position determinations, thereby conserving energy when such energy is provided by an external source, other than ambient light as described below. Any necessary electrical power can be provided in one or more of a number of suitable ways, such as…thermoelectric.” [Page 6, lines 10-19]).
Before the effective filing date of the claimed invention it would have been obvious to one having ordinary skill in the art to modify the drug delivery device of Moberg in view of Mirov to include a thermoelectric element within the housing and configured to generate the electrical energy based on the teachings of Forlani to provide power to the sensor in a manner that allows the drug delivery device to conserve power when the sensor is not in use (Forlani [Page 6, lines 10-19]).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Mirov et al. (US 20170312445) in view of Moberg at al. (US 20010034502).
Regarding claim 30, Mirov discloses the plunger rod of claim 29, wherein the plunger rod is releasably coupled to a stopper (second component 33 of plunger head 22; “second component 33 may be preinstalled in barrel 12…while first component 31 may be supplied separately and configured to get inserted into second component 33 while it sits in barrel 12…first component 31 may be coupled to plunger 14 in order to facilitate easy removal of first component 31 after use.” [0039]).
Mirov fails to explicitly discloses wherein an outer portion of the distal portion of plunger rod comprises one or more threads for releasably coupling the plunger rod to a stopper of the medicament container.
Moberg teaches a plunger rod (slide 2102; Figure 19) comprising a sensor (strain gauge sensor 2105) in or on a distal portion of the plunger rod (“A strain gauge sensor 2105 is secured to the proximate nose wall 2104.” [0144]); and wherein an outer portion of the distal portion of plunger rod comprises one or more threads (external threads 2113) for releasably coupling the plunger rod to a stopper (stopper 2106) of the medicament container (“The nose sidewall 2117 has external threads 2113 for removably engaging the internal threads 2114 on the sidewall 2110 of the stopper cavity 2112.” [0144]).
Before the effective filing date of hte claimed invention, it would have been obvious to one having ordinary skill in the art to modify the plunger rod of Mirov to include one or more threads for releasably coupling the plunger rod to a stopper of the medicament container based on the teachings of Moberg to enable the plunger rod to move a stopper bidirectionally and also allow the plunger to be decoupled from the stopper (Moberg [0144]).
Response to Arguments
Applicant's arguments filed February 17, 2026 have been fully considered but they are not persuasive.
Regarding the argument that “the Office Action improperly interpreted the plunger head 22 of Mirov as being the plunger rod 14 itself” with respect to the rejection of claim 29 (Remarks, page 7-8), the examiner respectfully disagrees. As detailed above with respect to the rejection of claim 29, Mirov discloses at least a plunger rod (14) comprising a sensor (34, 36, 24 of first component 31) in or on a distal portion of the plunger rod (“first component 31 may be coupled to plunger 14 in order to facilitate easy removal of first component 31 after use.” [0039]). The first component 31 includes at least a sensor (24, 34, 36) located within the first component 31, which is part of the claimed plunger as a whole, and therefore the sensor is “in or on the distal portion of the plunger rod” as claimed.
Regarding the argument that “Mirov is silent about the type of information wirelessly communicated between the transceiver and the remove device” and therefore “Mirov fails ot disclose a transceiver configured for bidirectional communication to a second device for communicating the measured state of the medicament container to the second device as claimed” (Remarks, page 8 with respect to claim 29 and page 9 with respect to claim 1), the examiner respectfully disagrees. The limitation “a transceiver…configured for bidirectional communication to a second device for communicating the measured state of the medicament container to the second device” in claims 1 and 29 has been interpreted as the transceiver the transceiver is capable of bidirectional communication for communicating the measured state of the medicament container to a second device. As detailed in the rejections of claims 1 and 29 above, Mirov discloses a transceiver (30) configured for bidirectional communication to a second device for communicating the measured state of the medicament container to the second device ([0023]; [0064]). The transceiver 30 is disclosed as being capable of bidirectional communication for communicating the measured state of the medicament container to a second device. This is further evidenced by the full disclosure of Mirov, including “Plunger head 22 may transmit data (e.g., the amount of medication 20 dispensed and time and date it was dispensed) to a remote device (e.g., a smart phone, a glucose monitor, an insulin pump, or a computer) via one or more of the wireless communication methods” [0058] and “the microcontroller is programmed with instructions to calculate data representative of the quantity of medication dispensed from the barrel of the medication injection device and transmit the data to a remote device via the transceiver.” [Claim 9]).
Regarding the argument that Mirov does not disclose “a sensor in or on the distal portion of the plunger rod” or “an energy source in or on the plunger rod” as required by independent claim 1 (Remarks, page 9), the examiner respectfully disagrees. As detailed above in the rejection of claim 1, Mirov discloses a drug delivery device (10) comprising a plunger rod (plunger 14 and first component 31: “first component 31 may be coupled to plunger 14 in order to facilitate easy removal of first component 31 after use.” [0039]). The plunger rod as claimed is considered to be the combination of plunger 14 and first component 31, which can be coupled together as disclosed paragraph [0039]. Mirov discloses numerous embodiment of the stopper 22, however embodiment relied upon in the present rejection is the one in which the first component 31 is supplied separate from the second component 33, wherein the first component 31 is coupled to the plunger 14 as disclosed in paragraph [0039]. The first component 31 includes at least a sensor (24) and an energy source (28). Both the sensor and the energy source are located within the first component 31, which is part of the claimed plunger as a whole, and therefore the sensor and energy source are “in or on the distal portion of the plunger rod” as claimed.
Regarding the argument that “Moberg does not disclose the sensor located in a distal portion of the plunger rod” as required by claim 19 (Remarks, page 9-10), the examiner respectfully disagrees. As detailed above in the rejection of claim 19, Moberg discloses a drug delivery device (101; Figure 19) comprising at least a plunger rod (2101 and 2102) and a sensor (2105) in a distal portion of the plunger rod (Figure 19; “A strain gauge sensor 2105 is secured to the proximate nose wall 2104.” [0144]). Figure 19 shows that that the proximate nose wall 2104 of the slide 2102 at least partially surrounds three sides of the sensor 2105. Therefore, the sensor 2105 is located in a distal portion of the plunger rod.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/ Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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