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 .
Status of the Claims
Claims 14, 16, 20-21, and 27 are currently amended. Claims 15 and 31 are cancelled. Claims 14, 16-30, and 32-33 are currently pending. Claims 14, 16-30, and 32-33 are currently rejected.
Response to Arguments
Applicant's arguments filed 08/04/2026 have been fully considered but they are not persuasive. Due to the amendments to the claims, a new ground(s) of rejection is made in view of Radmer, Gylleby, Byerly, and Madsen, or Radmer, Gylleby, Byerly, and Schleider.
Applicant argues that Radmer differs from the instant application in several ways, (for not teaching a PCBA with a distal surface that is essentially perpendicular to the main longitudinal axis where the electrical contacts extend distally from the distal surface of the PCBA). However, Radmer is not relied on for teaching these particular limitations. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claim Rejections - 35 USC § 103
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 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) 14, 16, 20-22, 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over a first embodiment of Radmer et al (US-20180126088-A1; hereafter Radmer) in view of Gylleby et al (WO-2017032586-A1; hereafter Gylleby), Byerly et al (WO-2019036576-A1; hereafter Byerly), and Madsen et al (US-20160015903-A1; hereafter Madsen). Reference is made to the previously included copies of Gylleby and Byerly.
Regarding claim 14, Radmer discloses a switch assembly (switch assembly 505, fig. 8A, [0112]) for an electronic system of a drug delivery device ([0045] fig. 7 shows a switch and sensor assembly implemented in a drug delivery device),
the switch assembly (505) comprising: a chassis ([0111] four switches of switch assembly 505 are arranged on a chassis/carrier) supporting at least a first electrical contact, a second electrical contact and a third electrical contact ([0112] switch assembly 505 comprises four switches each having a pair of flexible contact fingers);
and a ring (modified clutch element 540, fig. 7, [0111]), wherein the ring (540) comprises a first area (a proximal ring-formed portion 545, fig. 8A) that is an annular continuous electrically conductive area ([0111] clutch element 540 has a conductive ring-formed portion) and a second area (a distal portion with a plurality of circumferentially and equidistantly arranged conductive areas 546, fig. 8A) that is an annular segmented electrically conductive area connected to the first area ([0111] the conductive portion of clutch element 540 has a segmented conductive region, shown connected to the annular/ring-formed portion in fig. 8A);
wherein the chassis (carrier with switches noted in [0111]) moves axially relative to the ring (540) from a first axial position (proximal position noted in [0112] and [0116] and shown in fig. 9A, noted as a dosing position in [0086] in reference to a similar embodiment) to a second axial position (distal position noted in [0112] and [0117] and shown in fig. 9B, noted as an expelling position in [0087] in reference to a similar embodiment) during a first switch operation mode (axial movement from proximal position to distal position shown in fig. 9A and fig. 9B) without relative rotation between the ring and the chassis (see fig. 9A and 9B, no relative rotation occurs, see also [0116] and [0117] which note that both figs. 9A and 9B show the first rotational position),
and wherein the ring (540) rotates relative to the chassis (carrier with switches noted in [0111]) during a second switch operation mode ([0093] clutch element 340, similar to the working of clutch element 540, rotates relative to switches during dose delivery; [0114] clutch element 540, when in the axial distal position, rotates relative to the switches),
wherein each of the first electrical contact, the second electrical contact and the third electrical contact (switches A, B, and C, fig. 8A, [0112]) is formed as an electrically conductive and elastically deformable arm (flexible contact fingers noted in [0112], fig. 8A) extending towards the ring (540) ([0112] each of the four switches A/B/C/D have a pair of flexible contact fingers, see contact in fig. 9A and 9B);
wherein the first electrical contact, the second electrical contact and the third electrical contact are arranged such that:
during the first switch operation mode axial movement alone (see fig. 9A-9B and [0116-0117]; only axial movement occurs) of the chassis towards the ring (relative axial movement of clutch element/ring and switch carrier/chassis from the proximal to the distal position described in [0112]) closes an electrical connection between the first electrical contact (switch A) and the second electrical contact (switch B) via the first area of the ring ([0112] switches A and B are positioned on the clutch element corresponding to the conductive areas 546 and non-conductive spaces 547 when the clutch element is in its proximal position, and corresponding to the conductive ring 545 when the clutch element is in its distal position), and
during the second switch operation mode rotational movement between the ring and the chassis (dose delivery and rotation of clutch element, [0114]) alternately opens and closes an electrical connection between the second electrical contact (switch B, which in the distal position is on the annular conductive portion as noted in [0112]) and the third electrical contact (switch C) via the second area (conductive areas 546) of the ring ([0114] when the clutch element is in its distal and thus rotational position, the switches C and D will open and close as the clutch element rotates).
Examiner notes that the conductive portion includes both the segmented region with conductive areas 546 and the continuous region with the conductive ring 545 the connection between switch B which contacts the ring 545 during rotation and the switch C which intermittently contacts conductive areas 546 during rotation. Thus, the connection between switches B and C will alternately open and close during rotation.
Radmer [0137] suggests incorporating the electronic circuitry of the sensor assembly into a PCB, but Radmer is silent to the form of the PCB.
Gylleby, directed to a monitoring unit for an injection device, teaches a printed circuit board assembly (PCBA) (printed circuit board 400, fig. 20) which has a distal surface (see fig. 20) and comprises a switch (reed switch 502, fig. 20) (pg. 22 ln. 1-9 reed switch 502 is connected to the printed circuit board 400), and a ring (activator element 114 with magnet 504, fig. 21, pg. 22 ln. 1-9) arranged axially from the distal surface of the PCBA (see fig. 21 which shows activator element 114 arranged axially from the distal surface of the PCBA 400 which includes the reed switch 502).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Radmer to have the first, second, and third electrical contacts located on a distal surface of a PCB as suggested by Radmer [0137] and taught by Gylleby pg. 22 ln. 1-9 since both references are in the art of injection devices. One would have been motivated to make the modification because as noted by Radmer [0137], the use of a PCB may facilitate more advanced features such as data storage and wireless communication.
Radmer modified by Gylleby is silent to wherein during the first and second switch operation modes, separate and distinct functions of the electronic system are triggered.
Byerly, in the art of sensors for injection pens, teaches wherein during the first (first mode: pg. 17/42 para. 2 “Wake-up switch 112 is triggered by being pressed against contact 114” see description of axial movement) and second (second mode: pg. 17/42 para. 3 “As sensed element 98 rotates, recesses 104 and projections 106 will successively be positioned in line with the sensing light being emitted in the sensing direction.”; see description of rotational movement) switch operation modes, separate and distinct functions of the electronic system are triggered (function 1: electronics wake-up; pg. 17/42 para. 2 “Wake-up switch 112 is triggered by being pressed against contact 114, and the electronics assembly is activated.”) (function 2: dose sensing; pg. 18/42 para. 2 “light receptor 110 operates to detect when the sensing light is and is not received by light sensor 110 and rotation sensor 86 is thereby able to detect rotation of dose setting member 30 relative to actuator 50 during dose delivery”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Radmer and Gylleby to include the axial movement (and connection of the first and second electrical contacts / switches A and B) causing the electronics to wake up and the subsequent rotation to cause the electronic system to detect rotation as taught by Byerly, since Byerly also deals with a monitoring system for an injection device. One would have been motivated to make the modification because having the axial movement trigger the electronics to wake up ensures that battery is conserved prior to use for monitoring of dose dispensing.
Radmer as modified by Gylleby and Byerly above is silent to wherein the first area is provided on a proximal surface of the ring facing towards the distal surface of the PCBA.
Madsen, in the art of rotary sensors for injection devices, teaches wherein the first area (single contact segments 321, fig. 5, [0037]) is provided on a proximal surface of the ring (first rotary sensor part 320 comprising a ring-formed disc, fig. 5, [0037]) facing towards the switch elements ([0038] contact arms 331/332/333 are arranged corresponding to contact segments) and wherein the second area (discrete arch-formed position contact segments 322, fig. 5, [0037]) is provided on the same proximal surface of the ring radially outside of the first area (see fig. 5).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device so that the first and second areas are positioned on the same side of a ring as taught by Madsen since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). One would have been motivated to make the modification because having the first and second areas on a single face may simplify the construction of the device, thereby decreasing the manufacturing costs and the material costs since both areas need not cover the entire outermost circumference. The modified device could still perform the function of dose monitoring as well with the described arrangement.
Regarding claim 16, Radmer as modified discloses the switch assembly of claim 14, as described above. Radmer further discloses wherein the arm forming the third electrical contact (switch C, fig. 8A, [0112]) is elastically deformable in a radial direction (see fig. 9A/B which shows radial deflection of flexible contact fingers) and extends beyond the arms forming the first electrical contact (switch A) and the second electrical contact (switch B) in the distal direction (see fig. 8A below, the arms of switch C are located distally of the arms of switches A and B) which are elastically deformable in an axial direction (Examiner notes that the contact fingers are flexible, so they could be deformed in an axial direction. Additionally, because fig. 9A and 9B show that the ends of the switch arms are bent, the deflection is not wholly radial but also includes an axial component.).
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Regarding claim 20, Radmer as modified discloses the switch assembly of claim 14, as described above, including wherein the first area (Radmer: 545, fig. 7; Madsen: single contact segments 321, fig. 5, [0037]) is provided on a proximal surface of the ring facing towards the PCBA (Gylleby: printed circuit board 400, fig. 20; Madsen: [0038] contact arms are arranged corresponding to contact segments) and wherein the second area (Radmer: 546, fig. 7; Madsen: discrete arch-formed position contact segments 322, fig. 5, [0037]) is provided on the same proximal surface of the ring radially outside of the first area (see Madsen fig. 5).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device so that the first and second areas are positioned on the same side of a ring as taught by Madsen since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). One would have been motivated to make the modification because having the first and second areas on a single face may simplify the construction of the device, thereby decreasing the manufacturing costs and the material costs since both areas need not cover the entire outermost circumference. The modified device could still perform the function of dose monitoring as well with the described arrangement.
Regarding claim 21, Radmer as modified discloses the switch assembly of claim 14, as described above, including wherein the arms forming the electrical contacts are elastically deformable (Radmer: [0112] each of the four switches A/B/C/D have a pair of flexible contact fingers) in an axial direction (Madsen: [0044] “flexible rotary sensor arms are held in sliding contact with the contact surfaces”; Radmer: Examiner notes that the contact fingers are flexible, so they could be deformed in an axial direction. Additionally, because fig. 9A and 9B show that the ends of the switch arms are bent, the deflection is not wholly radial but also includes an axial component.).
Regarding claim 22, Radmer modified by Gylleby, Byerly, and Madsen discloses the switch assembly of claim 20, as described above.
Radmer, Gylleby, Byerly, and Madsen as applied above disclose all elements of the claim except for the relative radial arrangement of the electrical contacts.
Madsen, in the art of rotary sensors for injection devices, further teaches wherein the arm forming the third electrical contact (outer contact arm 333, fig. 6) is arranged radially outwards of the arms forming the first electrical contact and the second electrical contact (inner contact arms 131, fig. 6, [0038]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device to have the different radial positions of the electrical contacts as taught by Madsen since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). One would have been motivated to make the modification because the different radial positions may better ensure that each electrical contacts engage only with their intended areas. The modified device could still perform the function of dose monitoring as well with the described arrangement.
Regarding claim 24, Radmer as modified discloses the switch assembly of claim 14, as described above. Radmer further discloses wherein the chassis ([0111] four switches of switch assembly 505 are arranged on a chassis/carrier) is closer to the ring (clutch element 540, fig. 7, [0112]) in the first axial position (fig. 9A) than in the second axial position (fig. 9B).
Regarding claim 25, Radmer as modified discloses the switch assembly of claim 14, as described above. Radmer further discloses wherein the first switch operation mode occurs during a transition from the dose setting operation to the dose delivery operation of the drug delivery device ([0112] clutch element/ring 540 moved from proximal position to a distal position which is its rotational position) or when the chassis is pressed in a 0U dialed condition of the drug delivery device ([0093] clutch element/ring rotates during dose delivery).
Regarding claim 26, Radmer modified by Gylleby and Byerly discloses the switch assembly of claim 14, as described above. Radmer further discloses the second switch operation mode occurs during the dose delivery operation of the drug delivery device ([0093] clutch element/ring rotates during dose delivery; [0114] switches C and D track rotation).
Claim(s) 14 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radmer is view of Gylleby, Byerly, and Schleider (US-20190022330-A1; hereafter Schleider).
Alternatively, regarding claim 14, Radmer as modified by Gylleby and Byerly in the first rejection of claim 14 above is silent to wherein the first area is provided on a proximal surface of the ring facing towards the distal surface of the PCBA.
Radmer modified by Gylleby and Byerly discloses all elements of the claim except for first area being on a proximal surface of the ring facing towards the PCBA and the second area being on an inner cylindrical surface of the ring.
Schleider, in the field of dosage measurement, teaches metallic contact areas located on a surface facing conductive finger elements ([0069] conductive finger elements 573 are rotated across metal pattern 583 on circuit board assembly 555).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to rearrange the first area to be on a proximal surface of the ring facing toward the PCB (Schleider shows contacts facing toward metal pattern) and the second area to be on an inner cylindrical surface of the ring since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of dose monitoring as well with the described arrangement.
Regarding claim 18, Radmer modified by Gylleby, Byerly, and Schleider discloses the switch assembly of claim 14, as described above, including wherein the first area (Radmer: proximal ring-formed portion 545, fig. 8A) is provided on a proximal surface of the ring facing towards the PCBA (see Gylleby) and wherein the second area (Radmer: conductive areas 546, fig. 8A) is provided on an inner cylindrical surface of the ring (see rejection of claim 14 above).
Claim(s) 19 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radmer, Gylleby, Byerly, and Schleider as applied to claim 14 or 18 above, and further in view of Madsen.
Regarding claim 19, Radmer modified by Gylleby and Schleider discloses the switch assembly of claim 18, as described above.
Radmer modified by Gylleby discloses all elements of the claim except for wherein the arm forming the third electrical contact is arranged radially inwards of the arms forming the first electrical contact and the second electrical contact.
Madsen, in the art of rotary sensors for injection devices, teaches wherein the arm forming the third electrical contact (inner contact arm 331, fig. 6) is arranged radially inwards of the arms forming the first electrical contact and the second electrical contact (intermediate contact arm 332 and outer contact arm 333, fig. 6, [0036]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device to have the different radial positions of the electrical contacts as taught by Madsen since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). One would have been motivated to make the modification because the different radial positions may better ensure that each electrical contacts engage only with their intended areas. The modified device could still perform the function of dose monitoring as well with the described arrangement.
Regarding claim 23, Radmer modified by Gylleby and Byerly discloses the switch assembly of claim 14, as described above. Radmer further discloses wherein the second area is formed by a plurality of equispaced segments (distal portion with a plurality of circumferentially and equidistantly arranged conductive areas 546, fig. 7, [0111]) attached to the first area (ring-formed portion 545, fig. 7, [0111]).
Radmer as modified is silent to the attachment being hinged.
Madsen, in the art of rotary sensors for injection devices, teaches a metallic disc (330, fig. 6, [0038]) with flexible arms (switch contact arms 333 and laterally extending projection 334, fig. 6, [0039]) which are hinged to the metal disc (see fig. 6).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device to have the hinged connection as taught by Madsen, since Madsen also deals with rotary sensors. One would have been motivated to make the modification because the hinged connection would provide a strong connection but allow flexibility to the first and second areas which may facilitate easier assembly of the device, since the second area could be bent outward so as not to catch any other components during assembly, and firmly pressed down to complete the construction.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radmer modified by Gylleby, Byerly, and Madsen, or Radmer modified by Gylleby, Byerly, and Schleider, and further in view of Makaveev et al (US-20140088556-A1; hereafter Makaveev).
Regarding claim 17, Radmer as modified in either alternative discloses the switch assembly of claim 14, as described above. Radmer further discloses wherein the first area (proximal ring-formed portion 545, fig. 8A) and the second area (conductive areas 546, fig. 8A) are formed as a unitary component ([0111] The conductive structure comprises a proximal ring-formed portion 545 and a distal portion with a plurality of circumferentially and equidistantly arranged conductive areas 546; conductive structure may be applied by printing or plating process).
Radmer as modified in either alternative is silent to the first and second areas being metal.
Makaveev, in the field of infusion devices, teaches wherein a portion of a sensing arrangement is a conductive material such as metal ([0063] detectable feature 804 may be realized as a conductive material, such as a metal material, that provides a capacitance or a change in capacitance between the detectable feature 804 and the sensing arrangement 70).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the conductive structure of Radmer to be metal as taught by Makaveev, since both deal with infusion devices. One would have been motivated to make the modification since metal may be stronger and less susceptible to wear than alternative conductive materials, and metals are widely known to be conductive.
Claim(s) 27-29 and 31-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radmer, Gylleby, Byerly, Schleicher, and Haupt (US-20150202376-A1; hereafter Haupt), and alternatively further in view of Madsen (note alternative rejections of claim 14/switch assembly). Reference is made to the copy of Byerly included in the previous Office Action.
Regarding claim 27, Radmer modified by Gylleby, Byerly, and Madsen, or alternatively Radmer modified by Gylleby, Byerly, and Madsen, discloses a drug delivery device (Radmer [0045] fig. 7 shows in part a further embodiment a switch and sensor assembly implemented in a drug delivery device) comprising: an electronic system having a switch assembly (switch assembly 505, fig. 8A of Radmer, see either alternative rejection of claim 14 above for further claimed details of the subassembly).
Radmer further discloses a dose setting and drive mechanism (assembly 500, fig. 7, [0111] assembly 500 includes a non-modified nut element 525, non-modified drive element 530, and non-modified ratchet tube 550; [0059] drive system comprises a net element 230; [0061] dial system comprises a ratchet tube 250) which is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to perform a dose setting operation for setting a dose to be delivered by the drug delivery device and a dose delivery operation for delivering the set dose,
the dose setting and drive mechanism (assembly 500, fig. 7, [0111]) comprising the ring ([0111] assembly 500 shown in fig. 7 comprises various non-modified drive members and the modified clutch element/ring 540);
Radmer also teaches a use detection unit comprising the switch assembly ([0113] switches can provide a “wake up” signal if dose release member is actuated).
Radmer also teaches wherein the electronic system is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) such that the electronics are switched from a sleeping mode into an operation mode upon closing an electrical connection between the first electrical contact and the second electrical contact via the first area during the first switch operation mode ([0113] switches A and B can provide a “wake up” signal if dose release member is actuated into distal position, see fig. 9B; ), and
wherein the electronic system is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) such that the rotary sensor ([0114] sensor assembly tracks rotation and may be provided with a further sensor system for tracking small rotations) is switched from a sleeping mode into an operation mode ([0114] switch C and D can provide a “wake up” signal when the clutch is moved to the distal position and this signal can turn on the display of an associated electronic device) inducing the rotary sensor to initiate a motion detection upon closing an electrical connection between the second electrical contact and the third electrical contact via the second area during the second switch operation mode ([0114] motion detection occurs as the switches C and D move over the conductive areas 546).
Radmer as modified is silent to a button module, a rotary sensor separate from the second and third electrical contacts, and the electronics comprising an electronic control unit.
Schleicher, in the field of dosage measurement, teaches a button module (pen button 550, fig. 5A, [0060]) comprising an electronic control unit (controller, noted in [0060]), a PCBA (printed circuit board assembly 555, fig. 5A, [0069]), a rotary sensor (encoder 571, fig. 5A, [0060] encoder rotates in response to medication delivery and is electrically coupled to a controller which receives the signal output from the encoder 571), a communication unit ([0034] injection pen controller is connected to a transceiver) with a wireless communication interface for communicating with another device ([0034] transceiver may include wireless technologies such as Bluetooth and sends/receives data to/from a processing device such as a smartphone), and a use detection unit ([0072] device may enter a low power state until first use is detected),
wherein the electronic control unit (controller, noted in [0060]) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to control an operation of the electronic system ([0060] controller may calculate amount of fluid dispensed; [0061] information is collected every dose directs collection of information; reference claim 1 states that the controller executes logic that causes the controller to record signal output).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to add the button module with the controller of Schleicher to the device of Radmer because the controller could direct device operations and transmission of data, and locating the electronics in a button module would make maintenance easier. It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to add the rotary sensor of Schleicher, because, as noted in Radmer [0114] a further sensor system may provide additional safety for detecting small doses.
Radmer as modified is silent to the communication unit transitioning to an operation mode and initiating pairing with a device.
Haupt, directed to an add-on monitoring module, teaches linking the that the communication unit (wireless unit 28, fig. 4, [0216]) being switched from a sleeping mode (default state, [0216]) into an operation mode (pairing process state [0216]) inducing the communication unit to initiate a manual synchronization and/or a pairing with another device ([0216] device 2 initiates pairing process with another device through wireless transmission).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to combine the push of a button triggering the initiation of wireless pairing as taught by Haupt with the press of a button of Radmer which triggers a transition from a sleep state to an operation state since both deal with dose tracking and mention wireless communication. One would have been motivated to make the modification to ensure that when the dosing begins, the device is ready to transmit dosing data.
Radmer as modified is silent to the electronic control unit being on the PCBA and a dose dial assembly rotating relative to the button module during dose delivery but not during dose setting.
Byerly, directed a dosage measurement module for an injection pen, teaches wherein the button module (actuator 50, fig. 4, pg. 6 para. 3 describes the actuator including a dose button 56) and the dose setting and drive mechanism (dose setting member 30, fig. 3, pg. 5 para. 4 describes the dose setting member 30 including a dose dial member 32) are configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) such that a dose dial assembly (dial member 32, fig. 4, see pg. 5 para. 4) rotates relative to the button module (50) during the dose delivery operation (pg. 7 para. 4 pressing the dose button 56 allows rotation of dose setting member 30 while actuator 50 is held from rotating) but does not rotate relative to the button module during the dose setting operation (pg. 7 para. 1 actuator 50, including dose button 56 and clutch 52, move axially and rotationally with dose setting member 30 during the dialing in the dose setting mode) and that the button module moves axially relative to the dose dial assembly during the transition from the dose setting operation to the dose delivery operation, or when the button module is pressed in a 0U dialled condition (pg. 7 para. 4 pressing the button 56 disengages the actuator 50 from the dose setting member 30 through relative axial movement).
Byerly also teaches an electronic control unit (microcontroller/MCU mentioned in pg. 10 para. 2) on a PCBA (pg. 10 para. 2 flexible printed circuit board/FPCB has a plurality of electronic components including an MCU).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the invention of Radmer as modified to have the controller on the PCBA as taught by Byerly, and one would have been motivated to do so in order to place the controller close to the rest of the electronics to simplify the connections within the device. Additionally, it would have been obvious to include the relative motion of the button module and dose dial assembly of Byerly with the device of Radmer as modified and one would have been motivated to do so because the system of Byerly allows for repeated dose dialling and allows for the user to comfortably keep their thumb on the button during injection.
Regarding claim 28, Radmer as modified discloses the drug delivery device of claim 27, as described above, including wherein the rotary sensor (Schleicher: encoder 571, fig. 5A, [0060]) comprises an encoder ring (fig. 5A shows that encoder 571 includes a ring with conductive finger elements 573 attached).
Regarding claim 29, Radmer as modified discloses the drug delivery device of claim 27, as described above. Radmer further discloses a container receptacle (cartridge holder 210, fig. 2) which is permanently or releasably connected ([0059] cartridge holder 210 is fixedly mounted onto housing 201) to the dose setting and drive mechanism (assembly 500, fig. 7, housed in housing 501 which is a modified version of housing 201/301; [0075] modified housing 301) and which is adapted to receive a container containing a medicament (drug-filled transparent cartridge 213, fig. 2, [0056] cartridge is arranged in distal cartridge holder portion).
Regarding claim 32, Radmer as modified discloses the drug delivery device of claim 27, as described above. Radmer further discloses wherein the arm forming the third electrical contact (switch C, fig. 8A, [0112]) is elastically deformable in a radial direction (see fig. 9A/B which shows radial deflection of flexible contact fingers) and extends beyond the arms forming the first electrical contact (switch A) and the second electrical contact (switch B) in the distal direction (see fig. 8A below, the arms of switch C are located distally of the arms of switches A and B) which are elastically deformable in an axial direction (Examiner notes that the contact fingers are flexible, so they could be deformed in an axial direction. Additionally, because fig. 9A and 9B show that the ends of the switch arms are bent, the deflection is not wholly radial but also includes an axial component.).
Regarding claim 33, Radmer as modified discloses the drug delivery device of claim 27, as described above, including the first area (proximal ring-formed portion 545, fig. 8A) and the second area (conductive areas 546, fig. 8A). Radmer further discloses the first area being on a proximal surface of the ring (540, annotated fig. 8A above).
Radmer as modified discloses all elements of the claim except for first area being on a proximal surface of the ring facing towards the PCBA and the second area being on an inner cylindrical surface of the ring.
Schleider, in the field of dosage measurement, teaches metallic contact areas located on a surface facing conductive finger elements ([0069] conductive finger elements 573 are rotated across metal pattern 583 on circuit board assembly 555).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to rearrange the first area to be on a proximal surface of the ring facing toward the PCB (Schleider shows contacts facing toward metal pattern) and the second area to be on an inner cylindrical surface of the ring since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). One would have been motivated to make the modification because having the second area on the inner cylindrical surface of the ring may better protect the second area from damage. The modified device could still perform the function of dose monitoring as well with the described arrangement.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radmer, Gylleby, Madsen, Schleicher, Haupt, Byerly, and Makaveev.
Regarding claim 30, Radmer modified by Gylleby, Schleicher, Haupt, and Byerly, or Radmer modified by Gylleby, Schleicher, Haupt, Byerly, and Madsen, discloses the drug delivery device of claim 27, as described above.
As applied above, these references are silent to the rotary sensor including an optical sensor.
Makaveev, also in the field of medication infusion, teaches a rotary sensor (sensor 500, fig. 5, [0057] sensor 500 monitors rotation of rotary shaft 402) including an optical sensor ([0057] sensor 500 may include an optical sensor light detection).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the rotary sensor of claim 27 to use an optical sensor instead of electrical contacts to monitor the relative rotation of the encoder ring. One would have been motivated to make this modification because this would provide an alternative, non-contact way to monitor dosing different from the ring and third electrical contact, providing a backup system in case the electrical contacts fail to work appropriately.
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.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 10/14/2026
