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 .
Claims 1-13 and 15-19 are examined in this office action.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 8-13, 15, 17, and 18 is/are rejected under 35 U.S.C. 102(1) as being anticipated by Byerly et al. (WO 2018013419 A1).
Regarding claim 1, Byerly discloses an electronic encoder module (dose detection module 20, Fig. 1) for use with a drug delivery device, the electronic encoder module comprising:
at least one sensor unit ("Electronics assembly 140 of FIG. 15 includes a rotation sensor …" - Page 18 Line 3);
a PCBA (flexible printed circuit board (FPCB) 146, Fig. 11) with a processor (microcontroller unit (MCU) 200, Fig. 15) ("…a microcontroller unit (MCU) 200 comprising at least one processing core …" - Page 17 Line 11) configured to control operation of the at least one sensor unit ("MCU 200 includes control logic operative to perform the operations described herein including detecting a dose …" - Page 17 Line 12) and to process and/or store signals from the at least one sensor unit ("MCU 200 is operative to store the detected dose in local memory …" - Page 17 Line 15);
a rechargeable battery connected to the PCBA (battery 152, Fig. 15); and
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a cap-shaped outer shell (dose detection module 20, Fig. 1) ("…electronics assembly 140 of module 20 …" - Page Line, Fig. 90) at least partially encasing the at least one sensor unit ("Electronics assembly 140 of FIG. 15 includes a rotation sensor …" - Page 10 Line 15), the PCBA ("…FPCB 146 of electronics assembly …" - Page 16 Line 18) and the rechargeable battery ("A battery 152, illustratively a coin cell battery, is provided for powering components of FPCB 146." - Page 16 Line 25), wherein the cap-shaped outer shell comprises a lateral surface (See annotated Fig. 6) and a proximally arranged top surface (See annotated Fig. 6), wherein at least two electrical contacts (conductive sliding contact arms 173, Fig. 16) connected to the rechargeable battery and/or the PCBA are provided on the lateral surface and/or on the proximally arranged top surface (Fig. 16).
Regarding claim 2, Byerly discloses the electronic encoder module (dose detection module 20, Fig. 1) as recited above, wherein
said electrical contacts (conductive sliding contact arms 173, Fig. 16) comprise at least one ring, at least one ring segment and/or at least one contact area made from an electrically conductive material and are surrounded by a non-conductive material of the cap-shaped outer shell (first housing portion 102, Fig. 8).
Regarding claim 3, Byerly discloses the electronic encoder module (dose detection module 20, Fig. 1) as recited above, wherein
the electrical contacts (conductive sliding contact arms 173, Fig. 16) are both arranged on the lateral surface of the cap-shaped outer shell (Fig. 16).
Regarding claim 8, Byerly discloses the electronic encoder module (dose detection module 20, Fig. 1) as recited above, further comprising
a communication unit for wirelessly communicating with another device ("… a communication device including a wireless transmitter/transceiver …" - Page 16 Line 23).
Regarding claim 9, Byerly discloses the electronic encoder module (dose detection module 20, Fig. 1) as recited above, wherein
said at least one sensor unit (“… rotation sensor …” – Page 18, Line 6) comprises at least two light sources (light-pipes 144, Fig. 10) and at least two optical sensors ("The rotation sensor … includes a plurality of sliding electrical contacts 172, 174 … other suitable rotational sensors may be provided, including optical …" - Page 18 Line 6), wherein said at least one sensor unit is configured for detecting a movement of an encoder of the drug delivery device if the electronic encoder module is attached to the drug delivery device, wherein the movement is indicative of doses that are dialed and/or delivered from the drug delivery device ("… a rotation sensor operative to detect the relative rotation of coupling wall 112 and inner wall 114 during the dose dispensing operation of device 10 to detect the delivered dose amount." - Page 18 Line 3).
Regarding claim 10, Byerly discloses the electronic encoder module (dose detection module 20, Fig. 1) as recited above, further comprising
retention features for permanently or releasably attaching ("… for use of attachment of module 20 to device 10, the user aligns the visual alignment feature(s) of module 20 and device 20 and module 20 fitted to dose setting member 32 of device 10." - Page 23 Line 17) the electronic encoder module (module 20, Fig. 1) to the drug delivery device (device 10, Fig. 1).
Regarding claim 11, Byerly discloses a drug delivery device (medication delivery device 10, Fig. 1) comprising an electronic encoder module (dose detection module 20, Fig. 1), wherein said drug delivery device comprises at least a housing (housing 12, Fig. 1), a dose setting (dose setting member 32, Fig. 1) and drive mechanism (drive member 30, Fig. 1) which is configured to perform a dose dialing operation for selecting a dose to be delivered by the drug delivery device ("A dose setting member 32 is coupled to housing 12 for setting a dose amount to be dispensed by device 10." - Page 6 Line 22) and a dose delivery operation for delivering the set dose ("… the dose dispensing operation to force the contained medicine through the needled end." - Page 6 Line 18), the electronic encoder module (dose detection module 20, Fig. 1) comprising:
at least one sensor unit ("Electronics assembly 140 of FIG. 15 includes a rotation sensor …" - Page 18 Line 3);
a PCBA (flexible printed circuit board (FPCB) 146, Fig. 11) with a processor (microcontroller unit (MCU) 200, Fig. 15) ("…a microcontroller unit (MCU) 200 comprising at least one processing core …" - Page 17 Line 11) configured to control operation of the at least one sensor unit ("MCU 200 includes control logic operative to perform the operations described herein including detecting a dose …" - Page 17 Line 12) and to process and/or store signals from the at least one sensor unit ("MCU 200 is operative to store the detected dose in local memory …" - Page 17 Line 15);
a rechargeable battery connected to the PCBA (battery 152, Fig. 15); and
a cap-shaped outer shell (dose detection module 20, Fig. 1) ("…electronics assembly 140 of module 20 …" - Page Line, Fig. 90) at least partially encasing the at least one sensor unit ("Electronics assembly 140 of FIG. 15 includes a rotation sensor …" - Page 18 Line 3), the PCBA ("…FPCB 146 of electronics assembly …" - Page 16 Line 18) and the rechargeable battery ("A battery 152, illustratively a coin cell battery, is provided for powering components of FPCB 146." - Page 16 Line 25), wherein the cap-shaped outer shell comprises a lateral surface (See annotated Fig. 6 above) and a proximally arranged top surface (See annotated Fig. 6 above), wherein at least two electrical contacts connected to the rechargeable battery and/or the PCBA (conductive sliding contact arms 173, Fig. 16) are provided on the lateral surface and/or on the proximally arranged top surface (Fig. 16).
Regarding claim 12, Byerly discloses the drug delivery device (medication delivery device 10, Fig. 1) as recited above, wherein
said electronic encoder module (module 20, Fig. 1) is detachably coupled to said drug delivery device ("… a user may attach module 20 to and detach module 20 from the delivery device 10." - Page 5 Line 15).
Regarding claim 13, Byerly discloses the drug delivery device as recited above, further comprising
an encoder with a ring of teeth (contact arms 173, Fig. 16), wherein the electronic encoder module (module 20, Fig. 1) is coupled to the drug delivery device (device 10, Fig. 1) such that a movement of the encoder relative to the at least one sensor unit is detectable by the at least one sensor unit (Electronics assembly 140 of FIG. 15 includes a rotation sensor operative to detect the relative rotation of coupling wall 112 and inner wall 114 during the dose dispensing operation of device 10 to detect the delivered dose amount." - Page 18 Line 3).
Regarding claim 15, Byerly discloses the drug delivery device as recited above, further comprising
a cartridge (cartridge 22, Fig. 2) containing a medicament ("…cartridge 22 configured to hold the medicinal fluid …" - Page 6 Line 13).
Regarding claim 17, Byerly discloses the drug delivery device as recited above, wherein
the retention features ("… for use of attachment of module 20 to device 10, the user aligns the visual alignment feature(s) of module 20 and device 20 and module 20 fitted to dose setting member 32 of device 10." - Page 23 Line 17) attach to a dial grip or button (dose setting member 32, Fig. 3) of the drug delivery device (device 10, Fig. 1).
Regarding claim 18, Byerly discloses the drug delivery device as recited above, wherein
said at least one sensor unit comprises at least two light sources (light-pipes 144, Fig. 10) and at least two optical sensors ("The rotation sensor … includes a plurality of sliding electrical contacts 172, 174 … other suitable rotational sensors may be provided, including optical …" - Page 18 Line 6) , wherein said at least one sensor unit is configured for detecting the movement of the encoder if the electronic encoder module is attached to the drug delivery device, wherein the movement is indicative of doses that are dialed and/or delivered from the drug delivery device ("… a rotation sensor operative to detect the relative rotation of coupling wall 112 and inner wall 114 during the dose dispensing operation of device 10 to detect the delivered dose amount." - Page 18 Line 3).
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.
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Byerly et al. (WO 2018013419 A1) in view of Bechtold et al. (US Pub No. 20230355884 A1).
Regarding claim 4, Byerly in view of Bechtold disclose the electronic encoder module (Byerly, dose detection module 20, Fig. 1) as recited above, wherein
the electrical contacts (Byerly, conductive sliding contact arms 173, Fig. 16) are both arranged on the cap-shaped outer shell (Byerly, module 20, Fig. 1).
Byerly does not expressly disclose that the electrical contacts are both arranged on the proximally arranged top surface of the cap-shaped outer shell.
Bechtold teaches that the electrical contacts are both arranged on the proximally arranged top surface of the cap-shaped outer shell (contact surfaces 201, See annotated Fig. 6).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the electronic encoder module of Byerly to include that the electrical contacts are both arranged on the proximally arranged top surface of the cap-shaped outer shell as taught by Bechtold to make electrical contact (Bechtold, Para [0162]).
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Regarding claim 5, Byerly in view of Bechtold disclose the electronic encoder module (Byerly, dose detection module 20, Fig. 1) as recited above, wherein
the electrical contacts (Byerly, conductive sliding contact arms 173, Fig. 16) are attached to the cap-shaped outer shell (Byerly, dose detection module 20, Fig. 1).
Byerly does not expressly disclose that the electronic contacts are attached by glueing, by press fit and/or by overmolding.
Bechtold teaches that the electronic contacts are attached by glueing, by press fit and/or by overmolding ("…the contact elements of the first sensor element are rigidly attached to the carrier, for example as conductive inserts and/or co-molded with the insulating carrier." - Para [0032]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the electronic encoder module of Byerly to include that the electronic contacts are attached by glueing, by press fit and/or by overmolding as taught by Bechtold in order to yield a compact and sturdy sensor mechanism (Bechtold, Para [0032]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Byerly et al. (WO 2018013419 A1) in view of Brown (US Patent No. 5720733).
Regarding claim 6, Byerly in view of Brown disclose the electronic encoder module (Byerly, dose detection module 20, Fig. 1) as recited above, further comprising
Byerly does not expressly disclose a boost supply unit configured to provide a constant equal voltage.
Brown teaches a boost supply unit (voltage generator 26, Fig. 1) configured to provide a constant equal voltage ("… the voltage generator 26 applies a constant voltage …" - Col. 5 Line 22).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the electronic encoder module of Byerly to include a boost supply unit configured to provide a constant equal voltage as taught by Brown for charging the capacitive element (Brown, Abstract).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Byerly et al. (WO 2018013419 A1) in view of Jones et al. (WO 2019246312 A1).
Regarding claim 7, Byerly in view of Jones disclose the electronic encoder module (Byerly, dose detection module 20, Fig. 1) as recited above, wherein
said rechargeable battery (Byerly, battery 152, Fig. 15) is a coin cell (Byerly, “A battery 152, illustratively a coin cell battery, is provided for powering components of FPCB 146.” – Page 16 Line 25) with a charging capacity between 6 mAh and 25 mAh and/or a height in between 1.5 mm to 4.5 mm.
Byerly does not expressly disclose that said rechargeable battery is a coin cell with a charging capacity between 6 mAh and 25 mAh and/or a height in between 1.5 mm to 4.5 mm.
Jones teaches that said rechargeable battery is a coin cell with a charging capacity between 6 mAh and 25 mAh and/or a height in between 1.5 mm to 4.5 mm ("The battery cells 1631 may have height of 1.65 mm …" - Page 442 Line 16).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the electronic encoder module of Byerly to include that said rechargeable battery is a coin cell with a charging capacity between 6 mAh and 25 mAh and/or a height in between 1.5 mm to 4.5 mm as taught by Jones to provide more space for drug storage (Jones, Page 442, Line 20).
Claim(s) 16 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Byerly et al. (WO 2018013419 A1) in view of Bill David et al. (DE 102017205035 A1) .
Regarding claim 16, Byerly in view of Jones disclose the electronic encoder module (Byerly, dose detection module 20, Fig. 1) as recited above, wherein
the at least two light sources (Byerly, light-pipes 144, Fig. 10) comprise at least one IR-LED or the at least two optical sensors comprise a light detector.
Byerly does not expressly disclose at least one IR-LED or that the at least two optical sensors comprise a light detector.
Bill David teaches at least one IR-LED ("… the light emitting device 103 is an infrared LED." - Para [0040]) or that the at least two optical sensors comprise a light detector.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the electronic encoder module of Byerly to include at least one IR-LED or that the at least two optical sensors comprise a light detector as taught by Bill David to determine and store the injected dose amount (Bill David et al., Para [0041]).
Regarding claim 19, Byerly in view of Jones disclose the electronic encoder module (Byerly, dose detection module 20, Fig. 1) as recited above, wherein
the encoder (Byerly, module 20, Fig. 1) comprises a plurality of light reflecting teeth (Byerly, conductive sliding contact arms 173, Fig. 16) and light at least two light sources (Byerly, light-pipes 144, Fig. 10).
Byerly does not expressly disclose that the encoder comprises a plurality of light reflecting teeth spaced by 30° from each other, and wherein the at least one sensor unit is arranged such that, depending on a rotational position of the encoder, light emitted by one of the at least two light sources is reflected by one of the light reflecting teeth and detected by a respective optical sensor, while light emitted by the other of the at least two light sources is not reflected by one of the light reflecting teeth.
Bill David teaches that the encoder comprises a plurality of light reflecting areas (reflecting areas 106', Fig. 7) spaced by 30° from each other ("The angular resolution depends on the particular application and design …" - Para [0045] ), and wherein the at least one sensor unit is arranged such that, depending on a rotational position of the encoder ("Since the angle of rotation is directly dependent on the dispensed dose, can be through the optical sensor device 100 …" - Para [0045]), light emitted by the light source is reflected by one of the light reflecting teeth and detected by a respective optical sensor ("… light emitted by the light-emitting device encounters hits the light-coding means …" - Para [0021]), while light emitted by the light source is not reflected by one of the light reflecting areas ("This allows the optical sensor device to clearly identify every angle section that rotates past the sensor device …" - Para [0066]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drug delivery device of Byerly to include that an encoder comprising a plurality of light reflecting teeth spaced by 30° from each other, and wherein the at least one sensor unit is arranged such that, depending on a rotational position of the encoder, light emitted is reflected by one of the at least two light sources is reflected by one of the light reflecting teeth and detected by a respective optical sensor, while light emitted by the other light sources is not reflected by one of the light reflecting teeth as taught by Bill David to determine and store the injected dose amount (Bill David et al., Para [0041]).
Byerly also does not expressly disclose a plurality of light reflecting teeth spaced by 30° from each other.
Bill David et al. discloses that the angle between each light reflecting area needs to be optimized in order to change the angular resolution. As seen in Fig. 2 the reflecting areas are arranged at certain angles along the encoder and as such the angle is disclosed to be a result effective variable in that changing the angle would change the angular resolution of the detected velocity or speed. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Bill David et al. device to have an angle in the claimed range as it involves only adjusting the dimension of a component disclosed to require adjustment.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the device of Bill David et al. by making the light reflecting areas spaced by 30 degrees from each other as a matter of routine optimization since it has been held that "where the general conditions of a claimed are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
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/ESHA PRAKASH KASHYAP/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
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