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
Claim 16 is cancelled. Claim 17 is newly added. Claims 1-2, 5, 7, 9, 11, and 15 are currently amended. Claims 1-15 and 17 are currently pending. Claims 1-15 and 17 are currently rejected.
Response to Arguments
Applicant’s arguments, see Remarks, filed 04/16/2026, with respect to the rejection(s) of claim(s) 1 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of further disclosure of Bauss (US-20190217018-A1).
Examiner acknowledges that the cancellation of claim 16 obviates the prior objections to the drawings and the specifications. Furthermore, the amendments to the claims resolve the previously noted objections and 112b issues.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carlsson (US 20200119769 A1; hereafter Carlsson) in view Bauss et al (US 20190217018 A1) and Yin et al (WO 2022228936 A1; hereafter Yin), and alternatively further in view of Radmer et al (US 20180126088 A1; hereafter Radmer). Text citations for Yin are made to the pdf document of Yin included with the previous Office Action.
Regarding claim 1. Carlsson discloses an injection device (medicament delivery device 10, fig. 1, [0024) for dispensing a liquid drug ([0024] medicament is delivered by device 10) from a reservoir (medicament container 22, fig. 2, [0024]), the injection device comprising a reservoir unit (proximal part 24, fig. 2, [0026] the whole proximal part 24 is removed and replaced with a new proximal part 24 containing a new medicament container 22) and a drive unit (distal part 8, fig. 2, [0024] distal part 8 having an electric drive unit 12 with an electric motor 14) releasably attachable to each other by a coupling mechanism ([0030] describes attachment of proximal part 24 and distal part 8 via engagement areas 40 and 50 respectively; [0026] the whole proximal part 24 is removed and replaced with a new proximal part 24), wherein in an attached state the reservoir unit is (24, fig. 2) in a first predefined rotational position (one of the two positions noted in [0031]; [0031] With the design having oppositely positioned attachment members, it is possible to attach the proximal part 24 in two positions rotated 180 degrees in relation to each other) around a longitudinal axis (line from a proximal end of the proximal part 24 to a distal end of the distal part 8, see fig. 2, axis spans from left to right) relative to the drive unit (see [0031-0032]),
the reservoir unit (24, fig. 2) comprising:
the reservoir (22, fig. 2) defining the longitudinal axis (see fig. 2, axis falls along length of reservoir 22);
a reservoir holder (see cylindrical wall of reservoir unit 24 noted in annotated fig. 2 below) for holding the reservoir (see fig. 2 below, the reservoir 22 is within the noted walls);
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a viewing window (see fig. 1 and fig. 4 which both show a viewing window) for viewing a fill level of the liquid drug contained in the reservoir (Examiner notes that claim language of “for viewing” implies functional language and the prior art must only be capable of performing the recited function. Since fig. 1-4 show that the viewing window is aligned with the reservoir 22, the viewing window meets the functional limitation.);
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at least one opening (see aligned openings in fig. 1 vs fig. 4, note: [0020] FIG. 4 is a perspective view of the distal part of the medicament delivery device of FIG. 1, with an outer housing removed) as part of the coupling mechanism or of the viewing window (see figs. 1 and 4, the openings make up the viewing window); and
a machine-readable tag (information carrier 28, fig. 4, [0027]) storing tag information and including a tag antenna (antenna 30, fig. 4, [0027]) ([0027] information carrier 28 comprises an antenna 30 that enables reading of stored data from the tag by an information carrier reader),
the drive unit (distal part 8, fig. 2) comprising:
a drive source (electric motor 14, fig. 2, [0024]) for dispensing the liquid drug; and
a code reader (information carrier reader 34, fig. 4, [0028]) for reading the tag information and including a reader antenna (antenna 38, fig. 4, [0028]) ([0028] information carrier reader 34 may have an information carrier reader chip 36 provided with data and storage means as well as an antenna 38 for enabling reading of information carriers 28),
wherein in the attached state, in the first predefined rotational position of the reservoir unit and the drive unit, a center of the tag antenna (30) (see fig. 4, center of antenna 30 points towards the viewer, out of the page, on a “near side” of the device 10) and a center of the reader antenna (see figs. 4 and 5, center of antenna 38 is arranged on “top” of the device 10 as seen in figs. 4 and 5, note the location of carrier reader chip 36; [0032] antenna 38 is arranged on a flexible holder 60 and extended to cover 180 degrees of circumference of the second engagement area 50 of the distal part 8 so that the range of the antenna 38 covers both positions that the information carrier 28 and its antenna 30 may assume) are arranged relative to each other at an angle between 60° and 120° around the longitudinal axis (Examiner notes that fig. 4 shows carrier reader chip 36, located near the center of reader antenna 38, offset by about 90° from the center of antenna 30 around the longitudinal axis).
Carlsson is silent to wherein the tag antenna and the reader antenna are not rotationally aligned and do not overlap.
Bauss, in the art of monitoring injection devices via an RFID system, teaches wherein in an attached state (see fig. 16A, [0063] describes the two RFID tags becoming part of a single device assembly when two parts are joined), a tag antenna (see annotated fig. 17 below) and a reader antenna (see annotated fig. 17 below) ([0063] Once the two RFID tags become part of a single device assembly, the data can then be read from each RFID tag or the data can be transferred from one RFID tag to the other.) are not rotationally aligned and do not overlap (see annotated fig. 17 below).
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It would have been an obvious matter of rearrangement of parts to one of ordinary skill in the art before the effective filing date to arrange the tag antenna and reader antenna such that the tag antenna and reader antenna are not rotationally aligned and do not overlap, as further taught by Bauss, while maintaining the center positions of the antennas of Carlsson, thereby yielding predictable results without change to inventive function. Furthermore, the new arrangement would be obvious to try by beneficially ensuring that the distance between the center of the reader antenna and the center of the tag antenna would be the same in either of the two positions of Carlsson, rotated 180 degrees from each other, while also reducing the number/length of antenna required. See MPEP 2144.04(VI)(C). Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation, and the device of Carlsson modified by Bauss would still perform correctly.
Carlsson modified by Bauss is silent to the opening in the outer housing of proximal part 24 (see annotated fig. 1 above and [0020]) and the opening in the wall of 24 (see annotated fig. 4 above) explicitly being viewing windows.
Yin, in the art of pen like injection devices receiving medicament containers, teaches a viewing window (window 201 in outer shell 200 and window portion 213 of delivery member guard 21, see fig. 2 and fig. 5) for viewing a fill level of the liquid drug contained in the reservoir (pg. 14 ln. 17-20, “the outer shell 200 may comprise a window 201 aligned with the medicament container, so that the end-user can observe the medicament through the window 201”; pg. 15 ln. 27-29, “window portion 213 can be an aperture or a portion formed by a transparent material”).
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 openings of Carlsson (see annotated figs. 1 and 4 above) to be viewing windows as taught by Yin since both references deal with pen-like drug delivery devices. One would have been motivated to make the modification because having the openings of Carlsson be viewing windows allows the user to easily observe the medicament (see Yin pg. 14 ln. 17-20), keep track of how much medicament is left in the cartridge, and note if the medicament exhibits any concerning discoloration or textures which may indicate the medicament has gone bad and is no longer suitable for injection.
Carlsson modified by Bauss and Yin teaches all limitations of the claim except for wherein the tag antenna is circumferentially arranged around the at least one opening.
It would have been an obvious matter of rearrangement of parts to one of ordinary skill in the art before the effective filing date to arrange the tag antenna circumferentially around the at least one opening, thereby yielding predictable results without change to inventive function. Furthermore, looping the tag antenna 30 of Carlsson modified by Bauss and Yin would be obvious to try by beneficially making efficient use of space, since the antenna is already looped in form as shown in Carlsson fig. 4. An additional benefit would arise in making it clear to the user to location of the tag antenna 30 by associating the antenna with the window, so the user is more likely to notice if the tag antenna 30 is broken or tampered with in some way which may compromise the safety of the medicament cartridge. MPEP 2144.04(VI)(C). Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation, and the modified device of Carlsson modified by Yin still performs the intended function.
Alternatively, Carlsson modified by Bauss and Yin is silent to wherein the tag antenna is circumferentially arranged around the at least one opening.
Radmer, directed to a pen-like injection device, teaches wherein the tag antenna (NFC antenna noted in [0144]; [0144] electronic label may include an NFC antenna through which personal settings can be wirelessly entered electronic label 801, electronic label shown in fig. 13.1, [0141]) is circumferentially arranged around the at least one opening (window 202, fig. 1a, [0141]) ([0141] label has a generally rectangular form with a cutout (not to be seen) specific for the drug delivery device for which the label is intended allowing the display window 202 to be viewed).
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 tag antenna of Carlsson modified by Bauss and Yin to be located around the at least one opening as with the electronic label taught by Radmer, since all three references deal with pen-like injection devices. One would have been motivated to make the modification because the tag antenna 30 of Carlsson is circular in shape as seen in Carlsson fig. 4, and thus it would be an efficient use of space to incorporate the electronic label of Radmer with the tag antenna 30 of Carlsson being around the window, since the tag antenna is already formed in a loop.
Claim(s) 1 is alternatively rejected under 35 U.S.C. 103 as being unpatentable over Carlsson modified by Bauss and Bechmann et al (US 20190336685 A1; hereafter Bechmann) and alternatively modified by Bauss, Bechmann, and Radmer.
Alternatively, regarding claim 1. Carlsson discloses an injection device (medicament delivery device 10, fig. 1, [0024) for dispensing a liquid drug ([0024] medicament is delivered by device 10) from a reservoir (medicament container 22, fig. 2, [0024]), the injection device comprising a reservoir unit (proximal part 24, fig. 2, [0026] the whole proximal part 24 is removed and replaced with a new proximal part 24 containing a new medicament container 22) and a drive unit (distal part 8, fig. 2, [0024] distal part 8 having an electric drive unit 12 with an electric motor 14) releasably attachable to each other by a coupling mechanism ([0030] describes attachment of proximal part 24 and distal part 8 via engagement areas 40 and 50 respectively; [0026] the whole proximal part 24 is removed and replaced with a new proximal part 24), wherein in an attached state the reservoir unit is (24, fig. 2) in a first predefined rotational position (one of the two positions noted in [0031]; [0031] With the design having oppositely positioned attachment members, it is possible to attach the proximal part 24 in two positions rotated 180 degrees in relation to each other) around a longitudinal axis (line from a proximal end of the proximal part 24 to a distal end of the distal part 8, see fig. 2, axis spans from left to right) relative to the drive unit (see [0031-0032]),
the reservoir unit (24, fig. 2) comprising:
the reservoir (22, fig. 2) defining the longitudinal axis (see fig. 2, axis falls along length of reservoir 22);
a reservoir holder (see cylindrical wall of reservoir unit 24 noted in annotated fig. 2 below) for holding the reservoir (see fig. 2 below, the reservoir 22 is within the noted walls);
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a viewing window (see fig. 1 and fig. 4 which both show a viewing window) for viewing a fill level of the liquid drug contained in the reservoir (Examiner notes that claim language of “for viewing” implies functional language and the prior art must only be capable of performing the recited function. Since fig. 1-4 show that the viewing window is aligned with the reservoir 22, the viewing window meets the functional limitation.);
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at least one opening (see aligned openings in fig. 1 vs fig. 4, note: [0020] FIG. 4 is a perspective view of the distal part of the medicament delivery device of FIG. 1, with an outer housing removed) as part of the coupling mechanism or of the viewing window (see figs. 1 and 4, the openings make up the viewing window), and
a machine-readable tag (information carrier 28, fig. 4, [0027]) storing tag information and including a tag antenna (antenna 30, fig. 4, [0027]) ([0027] information carrier 28 comprises an antenna 30 that enables reading of stored data from the tag by an information carrier reader),
the drive unit (distal part 8, fig. 2) comprising:
a drive source (electric motor 14, fig. 2, [0024]) for dispensing the liquid drug; and
a code reader (information carrier reader 34, fig. 4, [0028]) for reading the tag information and including a reader antenna (antenna 38, fig. 4, [0028]) ([0028] information carrier reader 34 may have an information carrier reader chip 36 provided with data and storage means as well as an antenna 38 for enabling reading of information carriers 28),
wherein in the attached state, in the first predefined rotational position of the reservoir unit and the drive unit, a center of the tag antenna (30) (see fig. 4, center of antenna 30 points towards the viewer, out of the page, on a “near side” of the device 10) and a center of the reader antenna (see figs. 4 and 5, center of antenna 38 is arranged on “top” of the device 10 as seen in figs. 4 and 5, note the location of carrier reader chip 36; [0032] antenna 38 is arranged on a flexible holder 60 and extended to cover 180 degrees of circumference of the second engagement area 50 of the distal part 8 so that the range of the antenna 38 covers both positions that the information carrier 28 and its antenna 30 may assume) are arranged relative to each other at an angle between 60° and 120° around the longitudinal axis (Examiner notes that fig. 4 shows carrier reader chip 36, located near the center of reader antenna 38, offset by about 90° from the center of antenna 30 around the longitudinal axis).
Carlsson is silent to wherein the tag antenna and the reader antenna are not rotationally aligned and do not overlap.
Bauss, in the art of monitoring injection devices via an RFID system, teaches wherein in an attached state (see fig. 16A, [0063] describes the two RFID tags becoming part of a single device assembly when two parts are joined), a tag antenna (see annotated fig. 17 below) and a reader antenna (see annotated fig. 17 below) ([0063] Once the two RFID tags become part of a single device assembly, the data can then be read from each RFID tag or the data can be transferred from one RFID tag to the other.) are not rotationally aligned and do not overlap (see annotated fig. 17 below).
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It would have been an obvious matter of rearrangement of parts to one of ordinary skill in the art before the effective filing date to arrange the tag antenna and reader antenna such that the tag antenna and reader antenna are not rotationally aligned and do not overlap, as further taught by Bauss, while maintaining the center positions of the antennas of Carlsson, thereby yielding predictable results without change to inventive function. Furthermore, the new arrangement would be obvious to try by beneficially ensuring that the distance between the center of the reader antenna and the center of the tag antenna would be the same in either of the two positions of Carlsson, rotated 180 degrees from each other, while also reducing the number/length of antenna required. See MPEP 2144.04(VI)(C). Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation, and the device of Carlsson modified by Bauss would still perform correctly.
Carlsson modified by Bauss is silent to the opening in the outer housing of proximal part 24 (see annotated fig. 1 above and [0020]) and the opening in the wall of 24 (see annotated fig. 4 above) explicitly being viewing windows.
Bechmann, in the art of pen like injection devices receiving medicament containers, teaches a viewing window (syringe tube inspection window 802, fig. 9, [0202]) for viewing a fill level of the liquid drug contained in the reservoir (syringe 900, fig. 9, [0214] It is an advantage that a user or patient is able to see the medicament through the inspection windows 402 , 502 and 802 at the time of injection of the medicament, as it gives the user a sense of what is injected.).
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 openings of Carlsson (see annotated figs. 1 and 4 above) to be viewing windows as taught by Bechmann since both references deal with pen-like drug delivery devices. One would have been motivated to make the modification because having the openings of Carlsson be viewing windows allows the user to easily observe the medicament (see Bechmann [0214] “It is an advantage that a user or patient is able to see the medicament through the inspection windows 402 , 502 and 802 at the time of injection of the medicament, as it gives the user a sense of what is injected.”), keep track of how much medicament is left in the cartridge, and note if the medicament exhibits any concerning discoloration or textures which may indicate the medicament has gone bad and is no longer suitable for injection.
Carlsson modified by Bauss and Bechmann teaches all limitations of the claim except for wherein the tag antenna is circumferentially arranged around the at least one opening.
It would have been an obvious matter of rearrangement of parts to one of ordinary skill in the art before the effective filing date to arrange the tag antenna circumferentially around the at least one opening, thereby yielding predictable results without change to inventive function. Furthermore, looping the tag antenna 30 of Carlsson modified by Bauss and Bechmann would be obvious to try by beneficially making efficient use of space, since the antenna is already looped in form as shown in Carlsson fig. 4. An additional benefit would arise in making it clear to the user to location of the tag antenna 30 by associating the antenna with the window, so the user is more likely to notice if the tag antenna 30 is broken or tampered with in some way which may compromise the safety of the medicament cartridge. MPEP 2144.04(VI)(C). Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation, and the modified device of Carlsson modified by Bauss and Bechmann still performs the intended function.
Alternatively, Carlsson modified by Bauss and Bechmann is silent to wherein the tag antenna is circumferentially arranged around the at least one opening.
Radmer, directed to a pen-like injection device, teaches wherein the tag antenna (NFC antenna noted in [0144]; [0144] electronic label may include an NFC antenna through which personal settings can be wirelessly entered electronic label 801, electronic label shown in fig. 13.1, [0141]) is circumferentially arranged around the at least one opening (window 202, fig. 1a, [0141]) ([0141] label has a generally rectangular form with a cutout (not to be seen) specific for the drug delivery device for which the label is intended allowing the display window 202 to be viewed).
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 tag antenna of Carlsson modified by Bauss and Bechmann to be located around the at least one opening as with the electronic label taught by Radmer, since all three references deal with pen-like injection devices. One would have been motivated to make the modification because the tag antenna 30 of Carlsson is circular in shape as seen in Carlsson fig. 4, and thus it would be an efficient use of space to incorporate the electronic label of Radmer with the tag antenna 30 of Carlsson being around the window, since the tag antenna is already formed in a loop.
Claim(s) 2-7, 12, 14, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over any of the alternative rejections of claim 1 presented above, and further in view of Carlsson.
Regarding claim 2. Carlsson as modified above discloses the injection device according to claim 1, as described above. Carlsson further discloses wherein in the attached state, the angle at which the center of the tag antenna (see dotted double arrow below which runs through center of tag antenna 30) and the center of the reader antenna (see solid double arrow which runs parallel to center of reader antenna 38, see fig. 5 which shows full view of reader antenna 38) are arranged relative to each other is between 85° and 95° around the longitudinal axis in the first predefined rotational position of the reservoir unit and the drive unit (see figs. 4 and 5, center of antenna 38 is arranged on “top” of the device 10 as seen in figs. 4 and 5, note the location of carrier reader chip 36; [0032] antenna 38 is arranged on a flexible holder 60 and extended to cover 180 degrees of circumference of the second engagement area 50 of the distal part 8 so that the range of the antenna 38 covers both positions that the information carrier 28 and its antenna 30 may assume).
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Regarding claim 3. Carlsson as modified above discloses the injection device according to claim 1, as described above. Carlsson further discloses wherein the coupling mechanism comprises a protrusion (protrusions 44, figs. 3 and 4, [0030]) and a recess (recess 46, fig. 3, [0030]), and wherein one of the recess and the protrusion is located on the drive unit (8, fig. 2) ([0030] recesses 46 are formed in the drive unit/distal part 8) and the other of the recess and the protrusion is located on the reservoir unit (24, fig. 2) ([0030] protrusions 44 are formed on the reservoir unit/proximal portion 24) ([0030] protrusions 44 are arranged to fit into oppositely positioned recesses 46 on an inner surface of a cavity 48 in the form of a tubular passage in the distal part 8).
Regarding claim 4. Carlsson as modified above discloses the injection device according to claim 1, as described above. Carlsson further discloses wherein the drive unit (8, fig. 2) comprises two counter coupling members (recesses 46, see fig. 3) ([0030] protrusions 44 are arranged to fit into oppositely positioned recesses 46 on an inner surface of a cavity 48 in the form of a tubular passage in the distal part 8) oppositely arranged to each other such that the reservoir unit (24, fig. 2) can be attached to the drive unit (8) either in the first predefined rotational orientation or in a second predefined rotational orientation (second of the two positions noted in [0031]) around the longitudinal axis ([0031] With the design having oppositely positioned attachment members, it is possible to attach the proximal part 24 in two positions rotated 180 degrees in relation to each other.).
Regarding claim 5. Carlsson as modified above discloses the injection device according to claim 1, as described above. Carlsson further discloses wherein the second predefined rotational orientation is offset from the first predefined rotational orientation by approximately 180° ([0031] With the design having oppositely positioned attachment members, it is possible to attach the proximal part 24 in two positions rotated 180 degrees in relation to each other.).
Regarding claim 6. Carlsson as modified above discloses the injection device according to claim 1, as described above, including wherein the tag antenna (Carlsson: 30, fig. 4) is arranged on the reservoir holder (Carlsson: see annotated fig. 2 above, cylindrical wall of reservoir unit 24 forms reservoir holder) (Carlsson: see fig. 4, tag antenna 30 is arranged on the surface of the wall of reservoir unit 24 which forms the reservoir holder), on a needle cover sleeve of the reservoir unit or on a housing of the reservoir unit.
Regarding claim 7. Carlsson as modified above discloses the injection device according to claim 6, as described above, including wherein the reservoir holder (Carlsson: see annotated fig. 2 above, cylindrical wall of reservoir unit 24 forms reservoir holder) (Carlsson: see annotated fig. 4 above which shows an opening arranged on in the wall of reservoir unit 24 which forms the reservoir holder), the needle cover sleeve or the housing (Carlsson: see fig. 1 which shows an opening on the outer housing of the reservoir unit) comprises the at least one opening (see Carlsson fig. 1).
Regarding claim 12. Carlsson as modified above discloses the injection device according to claim 1, as described above. Carlsson further discloses wherein the reservoir (medicament container 22, fig. 2) is a prefilled syringe including a barrel (syringe noted in [0025] and shown in fig. 2 as wall of medicament container 22) and an injection needle (injection needle 26, fig. 2, [0025]) permanently connected to the barrel ([0025] medicament container 22 is a syringe which has an injection needle 26 fixedly attached as seen in FIG. 2) and optionally covered by a needle shield (see annotated fig. 2 below which notes a needle shield) in a shipping state (state shown in fig. 2, with needle shield attached and prior to connection of reservoir unit 24 and drive unit 8).
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Regarding claim 14. Carlsson as modified above discloses the injection device according to claim 1, as described above. Carlsson further discloses wherein the drive source (electric motor 14, fig. 2, [0024]) comprises an electronic motor (electronic motor 14) or a resettable or re-chargeable mechanical spring for emptying an entire volume of the reservoir in a single dispensing stroke.
Regarding claim 17. Carlsson as modified discloses the injection device of claim 1, as described above. Carlsson further discloses including wherein an opening of the at least one opening is elongated along the longitudinal axis (see figs. 1 and 4, the openings extend along the longitudinal axis).
Claim(s) 8 is rejected by Carlsson as modified and applied to claim 6 above, and further in view of Radmer or alternatively Radmer and Bauss et al (US 20190217018 A1; hereafter Bauss).
Regarding claim 8. Carlsson as modified above discloses the injection device according to claims 6, as described above.
Radmer further teaches wherein the tag antenna (NFC antenna noted in [0144] electronic label may include an NFC antenna through which personal settings can be wirelessly entered) is integrated in a label (electronic label 801, [0142], fig. 13.1) affixed to an outer surface (see fig. 13.1 which shows electronic label 801 affixed to an outer surface) of the needle cover sleeve.
Carlsson as modified discloses all limitations of the claim except for wherein the tag antenna is integrated in a label affixed to an outer surface of the needle cover sleeve.
It would have been an obvious matter of rearrangement of parts to one of ordinary skill in the art before the effective filing date to arrange the label including the tag antenna on an outer surface of the needle cover sleeve, thereby yielding predictable results without change to inventive function. Furthermore, locating the label on the needle cover sleeve beneficially associates the tag antenna with the replaceable cartridge, which aligns with the purpose of the tag antenna of Carlsson. MPEP 2144.04(VI)(C). Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation, and the modified device of Carlsson as modified still performs the intended function.
Alternatively, regarding claim 8. Carlsson as modified by Bauss, Yin, and Radmer or Carlsson modified by Bauss, Bachmann and Radmer discloses the injection device according to claims 6, as described above.
Radmer further teaches wherein the tag antenna (NFC antenna noted in [0144] electronic label may include an NFC antenna through which personal settings can be wirelessly entered) is integrated in a label (electronic label 801, [0142], fig. 13.1) affixed to an outer surface (see fig. 13.1 which shows electronic label 801 affixed to an outer surface) of the needle cover sleeve.
Carlsson as modified is silent to the tag antenna with the label affixed to an outer surface of the needle cover sleeve.
Bauss, directed to an RFID tag enabled shield assembly, teaches wherein a tag antenna (antenna 208, fig. 10 and fig. 11, [0059]) is attached to a needle cover sleeve (sheath 203, noted in [0059] as the structure around antenna 208 is attached).
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 label including the tag antenna of Carlsson as modified to be attached to an outer surface of the needle cover sleeve as taught by Bauss, since Bauss also deals with pen-like injection devices employing near field communication technology. One would have been motivated to make the modification because as noted by [0045] of Bauss, incorporating the RFID tag with the needle shield assembly enables tracking and data collection from a point early in the overall manufacturing process of the injection device up until the moment a user performs the injection.
Claim(s) 9 is rejected under 35 U.S.C. 103 as by Carlsson as modified and applied to claim 6 above, and further in view of Carlsson2019 (US 20190001069 A1; hereafter Carlsson2019).
Regarding claim 9. Carlsson as modified discloses the injection device according to claims 6, as described above.
Carlsson as modified is silent to the movement of a needle cover sleeve, although fig. 3 appears to show a needle cover sleeve in a covering position (see annotated fig. 3 below).
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Carlsson2019, directed to a pen-like medicament delivery device, teaches wherein the needle cover sleeve (needle guard 10, fig. 1, [0083]) is movable between a covering position in which the needle (needle 7a, fig. 1, [0083]) is covered (initial state noted in [0073] and [0090], shown in fig. 3b and 7a) and a retracted position in which the needle (71, fig. 1) is exposed (medicament delivery state noted in [0074], position after distal movement noted in [0091] which permits drug delivery, shown in fig. 4a) and wherein the needle cover sleeve (10) is an outermost part of the reservoir unit (needle guard 10, medicament container holder 70, and medicament container 70, fig. 1, [0083] medicament container holder 14 arranged for holding a medicament container 70 may be arranged inside the needle guard 10; see fig. 7a which shows assembled view) and wherein the reservoir holder (medicament container holder 14, fig. 1, [0083]) is concentrically arranged inside the needle cover sleeve (10) ([0083] medicament container holder 14 arranged for holding a medicament container 70 may be arranged inside the needle guard 10).
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 Carlsson as modified to have the needle cover sleeve of Carlsson2019 since Carlsson2019 also deals with a pen-like medicament delivery device with wireless data transmission [0139]. One would have been motivated to make the modification because including the needle cover sleeve which must be pressed against the skin to reveal with needle reduces the risk of accidental needle sticks.
Claim(s) 10-11 is rejected under 35 U.S.C. 103 as being unpatentable over any of the alternative rejections of claim 1 presented above, and further in view of Neer et al (US 20080306443 A1; hereafter Neer).
Regarding claim 10. Carlsson as modified discloses the injection device according to claim 1, as described above.
Carlsson as modified is silent to the drive unit including a tag writer.
Neer, in the field of injection devices with replaceable reservoir units, teaches wherein the drive unit (powerhead 90, fig. 5a, [0089] injector powerhead 90 includes motors within respective plunger drives 95a, 95b. The plunger drives 95a, 95b are operable to move plungers within the respective syringes 20a, 20b in a known manner) further comprises a tag writer (injector control 93, fig. 5a, [0123]) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to write information to the machine-readable tag (RFID tag 60b, fig. 5a, [0123]) ([0123] the injector control writes to the RFID tag 60b, written data may include [0126] amount of pharmaceutical remaining in the container) in the attached state (see attached state in fig. 4) ([0156] After the injection process, the injector control 93 can write to the RFID tag 60b to set a syringe-used flag that will help to prevent a reuse of the syringe 20b. The syringe 20b is then removed from the faceplate 88b).
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 drive unit of Carlsson as modified to further include the tag writer taught by Neer, since Neer also deals with a reusable medicament drive unit engaging with replaceable syringe units and using near field communication between the replaceable reservoir unit and the drive unit. One would have been motivated to make the modification because, as noted by Neer [0156], injector control 93 can write to the RFID tag 60b to set a syringe-used flag that will help to prevent a reuse of the syringe 20b. Preventing re-use of a used syringe beneficially aids in prevention of the spread of disease.
Regarding claim 11. Carlsson as modified, discloses the injection device according to claim 10, as described above, including wherein the written information includes an indication of a condition of use of the injection unit ([0156] After the injection process, the injector control 93 can write to the RFID tag 60b to set a syringe-used flag that will help to prevent a reuse of the syringe 20b).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over any of the alternative rejections of claim 1 presented above, and further in view of Zucker et al (US 20200376200 A1; hereafter Zucker).
Regarding claim 13. Carlsson as modified discloses the injection device according to claim 1, as described above.
Carlsson further discloses wherein the reservoir holder is adapted to hold the reservoir non-movably relative to the drive unit in the longitudinal axis.
Carlsson as modified is silent to wherein the reservoir holder is adapted to hold the reservoir non-movably relative to the drive unit in the longitudinal axis, although Examiner notes that the reservoir 22 as seen best in fig. 2 appears to be restrained from longitudinal motion by structures on either side.
Zucker, in the field of semi-disposable autoinjectors, teaches wherein a reservoir holder ([0183] Rearward facing edge 356 of outwardly-facing protrusion 350 of finger portions 328 and 338, fig. 13b, [0183]) is adapted to hold the reservoir (syringe 124, fig. 13a, [0183]) non-movably relative to the drive unit (plunger element 168 of the drive unit/reusable driving assembly 110, fig. 1, [0163]) in the longitudinal axis ([0183] describes restraints placed on movement of syringe 124, see fig. 13a/b which shows engagement of syringe with restraints; [0184] “Syringe 124 is thus retained in a retracted operative orientation by engagement of flange 126 thereof between backward-facing generally symmetric edges 202 formed in cassette housing element 120 and forward-facing surface 324 of needle guard element 122 (FIGS. 2-7C)”).
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 syringe holder of Carlsson to explicitly hold the syringe against longitudinal movement as taught by Zucker, since Zucker also deals with an injection device having both a reusable and disposable component. One would have been motivated to make the modification because effectively restraining the syringe in the housing ensures that the syringe does not become jostled out of position or cause accidental sticks during movement of the plunger through the barrel of the syringe.
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Carlsson modified by Bauss and Bechmann or over Carlsson modified by Bauss, Bechmann, and Radmer.
Regarding claim 15. Carlsson modified by Bechmann or by Bechmann and Radmer discloses the injection device according to claim 1, as described above.
Carlsson in silent to the drive unit comprising an opening arranged to align with the viewing window of the reservoir unit.
Bechmann further teaches wherein the drive unit (reloadable autoinjector 10, fig. 1, [0167]) comprises an opening of the at least one opening (inspection window 402, fig. 2b, [0170]) arranged to align with the viewing window (syringe tube inspection window 802, fig. 9, [0202]) of the reservoir unit (syringe assembly 20, fig. 1, [0167]; [0207] syringe assembly 20 includes syringe tube 800) in the attached state ([0202] The syringe tube 800 has a syringe tube inspection window 802 configured to interact with syringe lock inspection window 502 and housing inspection window 402).
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 drive unit of Carlsson to comprise a housing portion 400 which overlaps with the reservoir unit as taught by Bechmann, since both references deal with replaceable reservoir units for use with reusable drive units. One would have been motivated to make the modification because, as noted by Bechmann [0214] “It is an advantage that a user or patient is able to see the medicament through the inspection windows 402 , 502 and 802 at the time of injection of the medicament, as it gives the user a sense of what is injected.”). Additionally, having the reservoir unit further overlap with the drive unit allows better securing of the two units together and decreases a risk of the reservoir unit being bent relative to the drive unit during use, which may damage either or both the reservoir unit and drive unit.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ben-Ari (WO 2022013707 A1) - see fig. 1b, “An electromagnetic detector 140 is configured to communicate with the antenna 126 of the data tag 120 formed on the medicament cartridge 100, as seen in Figs. 1A - 1G. It is noted that the electromagnetic detector 140 forms part of the MUCI 130. It is appreciated that the electromagnetic detector 140 communicates wirelessly with the antenna 126 of the data tag 120.”
Kuhni et al (US 20200261654 A1) - see fig. 4 and [0047] “In this case, a single reader antenna 22 and a single transponder tag/antenna 15 may be provided with optimized range, allowing to read a misaligned tag/antenna 15′ even across the injection device at a distance of approximately 20 mm that is comparable to the lateral dimensions of the antennas (leftmost drawing).”
Augustine et al (US 20210361509 A1) - see [0056] which discusses ranges of RFID communication
Relevant art noted in previous Office Action:
Bauss (US 20210220573 A1) - similar structure to Carlsson with different antenna arrangement
Zucker et al (US 20160354556 A1) - needle shield with syringe in semi-disposable auto injector
Steck et al (EP 4129363 A1) - auto injector with disposable syringe unit including a cap and a needle shield which moves between positions when pressed against skin of the patient (date is 2023-02-08, Ypsomed is noted as the Applicant)
Drake et al (US 20100036319 A1) - auto injector with needle shield movable between positions and surrounding a syringe support which in turn surrounds a syringe
Marcoz et al (US 20210077723 A1) - autoinjector with reuseable drive unit and disposable reservoir unit including a needle shield, syringe does not appear to move relative to drive unit, several concentric structures include aligned windows to allow viewing of the reservoir contents
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 05/14/2026
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