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 on 11/22/2025 has been entered. Claims 16, 18-25, 27, 29-32, and 34-36 are pending in the application. Claims 1-15, 17, 26, 28, and 33 are cancelled. The amendments to the claims overcome each and every objection previously set forth in the Non-Final Office Action mailed on 8/22/2025.
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.
Claims 25, 27, and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Cirillo et al. (US 2010/0286612 A1) in view of Larsen (WO 2017/081051 A1) and further in view of Hartmann (US 6,482,185 B1).
Regarding claim 25, Cirillo discloses an add-on device (universal header 130) configured for monitoring an operation of an injection device (injection pen 110) via a mounting adapter (sleeve 120) (see Figs. 5-7, par. [0034] and [0036]), the mounting adapter (sleeve 120) comprising a carrier (cylindrical portion of sleeve 120), a second mount (rails of sleeve 120) connected to the carrier (cylindrical portion of sleeve 120) and configured to connect to the add-on device (universal header 130) (see Figs. 5-7, par. [0049]), wherein the second mount (rails of sleeve 120) comprises a protrusion (see Figs. 5 and 7, rails of sleeve 120 protrude upward from sleeve 120) protruding from the carrier (cylindrical portion of sleeve 120), and wherein the second mount (rails of sleeve 120) comprises a rigid mounting base comprising a foot, a narrowed neck, and a widened head (see annotated Fig. 7 below), wherein the narrowed neck is located between the widened head and the foot (see annotated Fig. 7 below), and wherein a cross-section of the widened head is larger than a cross-section of the narrowed neck (see annotated Fig. 7 below) (note: Even though Cirillo does not include that "the carrier comprises a pliable plastic foil, a first mount connected to the carrier and configured to connect to a housing of the injection device... wherein an underside of the foot is connected to or integrated into an upper side of the carrier", the mounting adapter is not positively recited in the claim. Since the universal header 130 mounts to just the head and neck of the sleeve 120 and the universal header 130 can mount to different configurations of the sleeve 120 (see Figs. 5 and 7, par. [0036] and [0049]), the universal header 130 would be capable of mounting to a similar mounting adapter which has these features), the add-on device (universal header 130) comprising:
a device housing (outer body of universal header 130) with a third mount (recesses and locking indents of universal header 130 that slide onto rails of sleeve 120, see Figs. 5-6, par. [0036] and [0049]) configured to mechanically engage with the second mount (rails of sleeve 120) of the mounting adapter (sleeve 120) (see Figs. 5-6, par. [0036] and [0049]), wherein the third mount (recesses and locking indents of universal header 130 that slide onto rails of sleeve 120, see Figs. 5-6, par. [0036] and [0049]) comprises a recess correspondingly shaped to the protrusion (see Figs. 5 and 7, rails of sleeve 120 protrude upward from sleeve 120) of the second mount (rails of sleeve 120) (see Figs. 5-7, par. [0036] and [0049]).
However, Cirillo fails to state the add-on device configured for mounting to the mounting adapter comprising a first electrical contact on the second mount, and an electrical conductor arranged in or on the carrier, wherein the electrical conductor is configured to exchange at least one type of electrical signal with the add-on device, and wherein the electrical conductor comprises one of a capacitive sensor, an antenna, or an antenna loop and is electrically connected with the first electrical contact; the add-on device comprising: a first electrical device contact arranged on or inside the third mount, wherein the first electrical device contact is configured to electrically connect with the first electrical contact of the mounting adapter when the add-on device is connected to the mounting adapter.
Larsen teaches an add-on device (add-on unit 760) configured for mounting to a mounting adapter (electronic label 750) comprising a first electrical contact (array of galvanic contacts not shown, see page 17 lines 14-25), and an electrical conductor (conductor circuitry of capacitive sensor of electronic label 750) arranged in or on the carrier (electronic label 750) (see page 17 lines 14-25), wherein the electrical conductor (conductor circuitry of capacitive sensor of electronic label 750) is configured to exchange at least one type of electrical signal with the add-on device (add-on unit 760) (see page 17 lines 8-32), and wherein the electrical conductor (conductor circuitry of capacitive sensor of electronic label 750) comprises a capacitive sensor (see page 17 lines 14-25) or an antenna (see page 19 lines 15-22) and is electrically connected with the first electrical contact (array of galvanic contacts) (see page 17 lines 14-25); the add-on device (add-on unit 760) comprising: a first electrical device contact (corresponding contacts not shown, see page 17 lines 14-25), wherein the first electrical device contact (corresponding contacts) is configured to electrically connect with the first electrical contact (array of galvanic contacts) of the mounting adapter (electronic label 750) when the add-on device (add-on unit 760) is connected to the mounting adapter (electronic label 750) (see Fig. 6B, page 17 lines 8-32).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the add-on unit of Cirillo to include a first electrical device contact which can electrically communicate with a mounting adapter that has a first electrical contact and an electrical conductor, as taught by Larsen, in order to facilitate the add-on unit collecting, communicating, and storing data related to the injection device (see Larsen page 17 lines 14-32).
However, modified Cirillo still fails to state the mounting adapter comprising the first electrical contact on the second mount; the add-on device comprising: the first electrical device contact arranged on or inside the third mount.
Hartmann teaches an add-on device (display apparatus 30) configured for monitoring an operation of an injection device (pen 10) and configured for mounting to the injection device (pen 10) via a mounting adapter (linear guide 19) (see Figs. 1-2, col. 2 lines 58-67, col. 3 lines 19-46), the mounting adapter (linear guide 19) comprising the first electrical contact (contacts 21) on the second mount (flattened portion 20); the add-on device (display apparatus 30) comprising: the first electrical device contact (contacts 34) arranged on or inside the third mount (receptacle 33) (see Figs. 1-2, col. 2 lines 58-67, col. 3 lines 19-46).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the add-on device of modified Cirillo to arrange the first electrical device contact on or inside the third mount, to communicate with the first electrical contact on the second mount, as taught by Hartmann, in order to provide the structure to allow electrical communication between the add-on device, the second mount, and the third mount when mounted to each other (see Hartmann col. 3 lines 19-46).
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Regarding claim 27, modified Cirillo teaches the add-on device according to claim 25 substantially as claimed. Even though Cirillo does not include that "wherein the first mount comprises an adhesive layer arranged on or extending across an underside of the pliable plastic foil", the mounting adapter is not positively recited in either of claims 25 or 27. Since the universal header 130 mounts to just the head and neck of the sleeve 120 (see annotated Fig. 7 above) and the universal header 130 can mount to different configurations of the sleeve 120 (see Figs. 5 and 7, par. [0036] and [0049]), the universal header 130 would be capable of mounting to a similar mounting adapter which has these features.
Regarding claim 29, modified Cirillo teaches the add-on device according to claim 25 substantially as claimed. However, modified Cirillo fails to state a memory and a processor connected to the first electrical device contact.
Larsen teaches an add-on device (add-on unit 760) comprising a memory and a processor connected to the first electrical device contact (corresponding contacts) (see page 17 lines 14-25).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the add-on unit of modified Cirillo to include a memory and a processor connected to the first electrical device contact, as taught by Larsen, in order to facilitate the add-on unit collecting, communicating, and storing data related to the injection device (see Larsen page 17 lines 14-32).
Regarding claim 30, modified Cirillo teaches the add-on device according to claim 25 substantially as claimed. However, modified Cirillo fails to state a communication unit connected to the first electrical device contact, wherein the communication unit is configured to transceive at least one of electromagnetic signals or electromagnetic energy via the electrical conductor of the mounting adapter when the first electrical contact is connected to the first electrical device contact.
Larsen teaches an add-on device (add-on unit 760) comprising a communication unit connected to the first electrical device contact (corresponding contacts) (see page 17 lines 14-32), wherein the communication unit is configured to transceive at least one of electromagnetic signals or electromagnetic energy via the electrical conductor (conductor circuitry of capacitive sensor of electronic label 750) of the mounting adapter (electronical label 750) when the first electrical contact (array of galvanic contacts) is connected to the first electrical device contact (corresponding contacts (see page 17 lines 14-32).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the add-on unit of modified Cirillo to include a communication unit connected to the first electrical device contact, wherein the communication unit is configured to transceive at least one of electromagnetic signals or electromagnetic energy via the electrical conductor of the mounting adapter when the first electrical contact is connected to the first electrical device contact, as taught by Larsen, in order to facilitate the add-on unit collecting, communicating, and storing data related to the injection device (see Larsen page 17 lines 14-32).
Regarding claim 31, modified Cirillo teaches the add-on device according to claim 25 substantially as claimed. However, modified Cirillo fails to state a sensor arrangement, the sensor arrangement comprising at least one of an acceleration sensor, a position sensor, a capacity sensor, an optical sensor, or a magnetic sensor
Larsen teaches an add-on device (add-on unit 760) comprising a sensor arrangement (capacitive sensor of electronic label 750), the sensor arrangement (capacitive sensor of electronic label 750) comprising a capacity sensor (see page 17 lines 14-25).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the add-on unit of modified Cirillo to include a sensor arrangement, the sensor arrangement comprising a capacity sensor, as taught by Larsen, in order to facilitate the add-on unit collecting, communicating, and storing data related to the injection device (see Larsen page 17 lines 14-32).
Response to Arguments
Applicant’s arguments with respect to claim 25 have been considered but are moot because the new ground of rejection does not rely on the prior rejection of record for any teaching or matter specifically challenged in the argument. The amendments to claim 25 change the scope of the claim, necessitating the new ground of rejection.
Allowable Subject Matter
Claims 16, 18-24, 32, and 34-36 are allowable.
The following is a statement of reasons for the indication of allowable subject matter:
In regards to independent claims 16 and 32, the prior art of record fails to disclose or render obvious before the effective filing date of the claimed invention the mounting adapter and the injection system as claimed, specifically including the combination of claimed features with a mounting adapter comprising a second mount comprising a rigid mounting base comprising a foot, a narrowed neck, and a widened head, wherein an underside of the foot is connected to or integrated into the upper side of the carrier.
The closest prior art of record is Larsen (WO 2017/081051 A1) and Cirillo et al. (US 2010/0286612 A1).
Larsen discloses an injection system comprising a mounting adapter (electronic label 750) which connects an add-on device (add-on unit 760) to an injection device (drug delivery device 700) (see Fig. 6B), the mounting adapter (electronic label 750) comprising a carrier (electronic label 750 is a carrier for mounting additional elements of the system, see page 17 lines 8-25) comprising a pliable plastic foil with an upper side (side of electronic label 750) attaching to add-on unit 760) and an underside (side of electronic label 750 attaching to drug delivery device 700) opposite to the upper side (see Fig. 6B, page 17 lines 8-32); a first mount (adhesive not shown) to engage with the injection device (drug delivery device 700) (see Fig. 6B, page 20 lines 21-22); a second mount to engage with the add-on device (add-on unit 760) (see page 17 lines 8-12); and an electrical conductor to exchange at least one type of electrical signal with the add-on device (add-on unit 760) (see page 17 lines 8-32).
Cirillo teaches an injection system comprising a mounting adapter (sleeve 120) which connects an add-on device (universal header 130) to an injection device (injection pen 110) (see Figs. 5-7, par. [0034] and [0036]), the mounting adapter (sleeve 120) comprising a second mount (rails of sleeve 120) to engage with a third mount (recesses and locking indents of universal header 130 that slide onto rails of sleeve 120, see Figs. 5-6, par. [0036] and [0049]) of the add-on device (universal header 130) (see Figs. 5-7, par. [0036] and [0049]), wherein the second mount (rails of sleeve 120) comprises a protrusion protruding from the upper side (see Figs. 5 and 7, rails of sleeve 120 protrude upward from sleeve 120), wherein the second mount (rails of sleeve 120) comprises a rigid mounting base comprising a foot, a narrowed neck, and a widened head (see annotated Fig. 7 above), wherein the narrowed neck is located between the widened head and the foot (see annotated Fig. 7 above), and wherein a cross-section of the widened head is larger than a cross-section of the narrowed neck (see annotated Fig. 7 above).
However, neither of Larsen or Cirillo teach the combination of claimed features with a mounting adapter comprising a second mount comprising a rigid mounting base comprising a foot, a narrowed neck, and a widened head, wherein an underside of the foot is connected to or integrated into the upper side of the carrier.
Claims 18-24 and 34-36 are allowable by virtue of their dependency on allowable claims 16 and 32.
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 AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783