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 12/31/2025 has been entered. Claims 1-20 are pending in the application. The amendments to the claims overcome each and every objection previously set forth in the Final Office Action mailed on 10/9/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitations “An injection device, comprising: a housing…to releasably mount a mounting aid…and…to releasably mount a supplementary device…; the mounting aid attached or attachable to the housing…”. It is unclear from these limitations whether the mounting aid and the supplementary device are intended to be positively recited. The limitations in lines 2-5 of the claim appear to set forth that the injection device only positively recites/requires a housing comprising at least one housing engaging member and at least one housing engaging structure and the claim only requires the functional capability of mounting to a mounting aid and a supplementary device. Further, it appears that lines 6-22 of the claim may only be reciting additional functional language regarding the mounting aid and are still not positively reciting the mounting aid; however it is unclear whether Applicant intends for this formatting to positively recite the mounting aid. For examination purposes, the Examiner interprets claim 1 as only positively reciting/requiring an injection device comprising a housing comprising at least one housing engaging member and at least one housing engaging structure and only functionally reciting that the housing is mountable to a mounting aid and supplementary device having the recited structures. Should Applicant wish to positively recite the mounting aid, the claim could be amended to: “An injection device, comprising: a housing; and a mounting aid; the housing extending in a longitudinal direction….”.
Claims 2-14 are rejected by virtue of their dependency on rejected claim 1. For examination purposes, the Examiner interprets any limitations regarding the mounting aid or the supplementary device in claims 2-14 as further functional limitations and not positive recitations.
Claim 15 recites the limitations “A kit, comprising: an injection device…to releasably mount a mounting aid…and…to releasably mount a supplementary device…; the mounting aid attachable to the housing…; and the supplementary device comprising…”. It is unclear from these limitations whether the mounting aid and the supplementary device are intended to be positively recited. The limitations in lines 2-6 of the claim appear to set forth that the kit only positively recites/requires an injection device comprising a housing comprising at least one housing engaging member and at least one engaging structure and the claim only requires the functional capability of mounting to a mounting aid and a supplementary device. Further, it appears that lines 7-26 of the claim may only be reciting additional functional language regarding the mounting aid and the supplementary device and are still not positively reciting the mounting aid or the supplementary device; however it is unclear whether Applicant intends for this formatting to positively recite the mounting aid and the supplementary device. For examination purposes, the Examiner interprets claim 15 as only positively reciting/requiring a kit comprising an injection device comprising a housing comprising at least one housing engaging member and at least one housing engaging structure and only functionally reciting that the housing is mountable to a mounting aid and supplementary device having the recited structures. Should Applicant wish to positively recite the mounting aid and the supplementary device, the claim could be amended to: “A kit, comprising: an injection device; a mounting aid; and a supplementary device; the injection device comprising a housing extending in a longitudinal direction….”.
Claims 16-18 are rejected by virtue of their dependency on rejected claim 15. For examination purposes, the Examiner interprets any limitations regarding the mounting aid or the supplementary device in claims 16-18 as further functional limitations and not positive recitations.
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 1-2 and 4-18 are rejected under 35 U.S.C. 103 as being unpatentable over Nielsen et al. (US 2011/0295215 A1) in view of Plumptre (US 2012/0022462 A1).
Regarding claim 1, Nielsen discloses an injection device (see Fig. 22), comprising:
a housing (main portion 2) extending in a longitudinal direction (see Fig. 22, par. [0062], [0066]) and comprising at least one housing engaging member (coupling means 14) to releasably mount a mounting aid (cap or cover, see par. [0066]) on an outside surface of the housing (main portion 2) (see par. [0062], [0066]), and at least one engaging structure (edge of opening 10) to releasably mount a supplementary device (monitoring device 730) in a device specific position on the outside surface of the housing (main portion 2) (see Fig. 22, par. [0062]-[0063], [0066]);
the mounting aid (cap or cover, see par. [0066]) attached or attachable to the housing (main portion 2) and comprising a body configured to receive at least a portion of the housing (main portion 2) (see par. [0066]).
While Nielsen doesn’t expressly teach the mounting aid having at least one radially extending body engaging member to engage with the at least one housing engaging member of the housing only when in the single specific position on the outside surface of the housing, wherein when mutually engaged the at least one radially extending body engaging member and the at least one housing engaging member provide a rotational interlock between the mounting aid and the housing; and wherein the body of the mounting aid comprises a side wall with an abutment face facing in a proximal direction of the longitudinal direction, wherein, when the mounting aid is mounted in the single specific position on the outside surface of the housing, the abutment face is (i) defined on a plane that is inclined to the longitudinal direction, (ii) configured to serve as a tactile and visually detectable mounting support for correctly assembling the supplementary device onto the outside surface of the housing, and (iii) configured to align with and directly contact a correspondingly-shaped device abutment face of the supplementary device, wherein a device engaging member of the supplementary device is alignable and engageable with the at least one engaging structure of the housing to reach the device specific position on the outside surface of the housing by bringing the device abutment face of the supplementary device and the abutment face of the mounting aid into mutual abutment and alignment; in view of the 112(b) rejection/interpretation of claim 1 above, these limitations are only functional recited and thus not positively recited/required by the claim. Nielsen teaches similar injection device housings capable of mounting to different mounting aids and supplementary devices having differently shaped abutment faces and engagement features (see Figs. 1-2, 5-6, 8-11, 14-15, 22-25). Thus, Nielsen’s housing (main portion 2) of Fig. 22 would be capable of mounting to a mounting aid and supplementary device having the recited features.
However, Nielsen fails to expressly teach wherein the at least one housing engaging member is configured to releasably mount the mounting aid only in a single specific position on the outside surface of the housing.
Plumptre teaches an injection device (see Figs. 1-5, par. [0040]) comprising at least one housing engaging member (snap features 43 and orientation features 44) to releasably mount a mounting aid (cap 3) only in a single specific position on an outside surface of the housing (housing 2) (see Figs. 1 and 3, par. [0049]-[0052]).
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 structure of the at least one housing engaging member of the injection device of Nielsen such that it is configured to releasably mount the mounting aid only in a single specific position on the outside surface of the housing, as taught by Plumptre, in order to prevent a user from incorrectly attaching the components of the injection device (see Plumptre par. [0005], [0010]-[0012], [0049]-[0050]).
Regarding claim 2, modified Nielsen teaches the injection device according to claim 1 substantially as claimed. Nielsen further teaches wherein the housing (main portion 2) comprises a distal section (distal reservoir part 4) and a proximal section (proximal part 3) and wherein the at least one housing engaging member (coupling means 14) is located on an outside of a side wall of the distal section (distal reservoir part 4) (see Figs. 1 and 22, par. [0062], [0066]) and comprises a longitudinal recess (see Fig. 22, a recessed area surrounds coupling means 14) to positively engage with the at least one radially extending body engaging member of the mounting aid (see 112(b) rejection/interpretation of claims 1-2 above; this is interpreted as a functional limitation. Nielsen teaches similar injection device housings capable of mounting to different mounting aids having differently shaped engagement features (see Figs. 1-2, 5-6, 8-11, 14-15, 22-25). Thus, Nielsen’s housing (main portion 2) of Fig. 22 would be capable of mounting to a mounting aid having the recited features).
Regarding claim 4, modified Nielsen teaches the injection device according to claim 1 substantially as claimed. Nielsen further teaches wherein the abutment face of the mounting aid is planar and wherein an imaginary surface normal of the abutment face of the mounting aid extends non-parallel to the longitudinal direction (see 112(b) rejection/interpretation of claims 1 and 4 above; this is interpreted as a functional limitation. Nielsen teaches similar injection device housings capable of mounting to different mounting aids having differently shaped abutment faces (see Figs. 1-2, 5-6, 8-11, 14-15, 22-25). Thus, Nielsen’s housing (main portion 2) of Fig. 22 would be capable of mounting to a mounting aid having the recited features).
Regarding claim 5, modified Nielsen teaches the injection device according to claim 1 substantially as claimed. Nielsen further teaches wherein the body of the mounting aid (cap or cover, see par. [0066]) comprises a tubular shaped receptacle to enclose at least a distal section of the housing (main portion 2) (see Fig. 22, par. [0066], see 112(b) rejection/interpretation of claims 1 and 5 above; this is interpreted as a functional limitation. Nielsen teaches similar injection device housings capable of mounting to different mounting aids having different shapes which each appear to be tubular receptacles (see Figs. 1-2, 5-6, 8-11, 14-15, 22-25). Thus, Nielsen’s housing (main portion 2) of Fig. 22 would be capable of mounting to a mounting aid having the recited features).
Regarding claim 6, modified Nielsen teaches the injection device according to claim 1 substantially as claimed. Nielsen further teaches injection device according to claim 1, wherein the body of the mounting aid (cap or cover, see par. [0066]) is cup shaped and comprises a closed end section towards a longitudinal distal end (see Fig. 22, par. [0066], see 112(b) rejection/interpretation of claims 1 and 6 above; this is interpreted as a functional limitation. Nielsen teaches similar injection device housings capable of mounting to different mounting aids having different shapes which each appear to be cup shaped with closed distal ends (see Figs. 1-2, 5-6, 8-11, 14-15, 22-25). Thus, Nielsen’s housing (main portion 2) of Fig. 22 would be capable of mounting to a mounting aid having the recited features).
Regarding claim 7, modified Nielsen teaches the injection device according to claim 1 substantially as claimed. Nielsen further teaches wherein the at least one radially extending body engaging member protrudes inwardly from the side wall of the body (see 112(b) rejection/interpretation of claims 1 and 7 above; this is interpreted as a functional limitation. Nielsen teaches similar injection device housings capable of mounting to different mounting aids having differently shaped abutment faces and engagement features (see Figs. 1-2, 5-6, 8-11, 14-15, 22-25). Thus, Nielsen’s housing (main portion 2) of Fig. 22 would be capable of mounting to a mounting aid having the recited features).
Regarding claim 8, modified Nielsen teaches the injection device according to claim 1 substantially as claimed. Nielsen further teaches wherein the at least one radially extending body engaging member comprises a longitudinal stop to longitudinally abut with a correspondingly shaped longitudinal counter stop of the at least one housing engaging member (see 112(b) rejection/interpretation of claims 1 and 8 above; this is interpreted as a functional limitation. Nielsen teaches similar injection device housings capable of mounting to different mounting aids having differently shaped abutment faces and engagement features (see Figs. 1-2, 5-6, 8-11, 14-15, 22-25). Thus, Nielsen’s housing (main portion 2) of Fig. 22 would be capable of mounting to a mounting aid having the recited features).
Regarding claim 9, modified Nielsen teaches the injection device according to claim 8 substantially as claimed. Nielsen further teaches wherein the at least one radially extending body engaging member comprises at least two oppositely directed longitudinal stops to simultaneously engage with correspondingly shaped longitudinal counter stops of the at least one housing engaging member (see 112(b) rejection/interpretation of claims 1 and 9 above; this is interpreted as a functional limitation. Nielsen teaches similar injection device housings capable of mounting to different mounting aids having differently shaped abutment faces and engagement features (see Figs. 1-2, 5-6, 8-11, 14-15, 22-25). Thus, Nielsen’s housing (main portion 2) of Fig. 22 would be capable of mounting to a mounting aid having the recited features).
Regarding claim 10, modified Nielsen teaches the injection device according to claim 1 substantially as claimed. Nielsen further teaches wherein the at least one radially extending body engaging member comprises at least one tangential stop to abut in a tangential direction with a correspondingly shaped tangential counter stop of the at least one housing engaging member (see 112(b) rejection/interpretation of claims 1 and 10 above; this is interpreted as a functional limitation. Nielsen teaches similar injection device housings capable of mounting to different mounting aids having differently shaped abutment faces and engagement features (see Figs. 1-2, 5-6, 8-11, 14-15, 22-25). Thus, Nielsen’s housing (main portion 2) of Fig. 22 would be capable of mounting to a mounting aid having the recited features).
Regarding claim 11, modified Nielsen teaches the injection device according to claim 10 substantially as claimed. Nielsen further teaches wherein the at least one tangential stop is formed by at least one tangential side edge of the at least one radially extending body engaging member (see 112(b) rejection/interpretation of claims 1 and 11 above; this is interpreted as a functional limitation. Nielsen teaches similar injection device housings capable of mounting to different mounting aids having differently shaped abutment faces and engagement features (see Figs. 1-2, 5-6, 8-11, 14-15, 22-25). Thus, Nielsen’s housing (main portion 2) of Fig. 22 would be capable of mounting to a mounting aid having the recited features).
Regarding claim 12, modified Nielsen teaches the injection device according to claim 5 substantially as claimed. Nielsen further teaches wherein an inner cross section of a proximal end of the tubular shaped receptacle is larger than or equal to a cross section of a proximal section of the housing (main portion 2) (see Fig. 22, par. [0066], see 112(b) rejection/interpretation of claims 1, 5, and 12 above; this is interpreted as a functional limitation. Nielsen teaches similar injection device housings capable of mounting to different mounting aids having different shapes which each appear to be tubular receptacles (see Figs. 1-2, 5-6, 8-11, 14-15, 22-25). Thus, Nielsen’s housing (main portion 2) of Fig. 22 would be capable of mounting to a mounting aid having the recited features).
Regarding claim 13, modified Nielsen teaches the injection device according to claim 1 substantially as claimed. Nielsen further teaches wherein the body comprises a distally extending recess at a proximal end of the side wall (see Fig. 22, par. [0066], see 112(b) rejection/interpretation of claims 1 and 13 above; this is interpreted as a functional limitation. Nielsen teaches similar injection device housings capable of mounting to different mounting aids having different shapes and recesses (see Figs. 1-2, 5-6, 8-11, 14-15, 22-25). Thus, Nielsen’s housing (main portion 2) of Fig. 22 would be capable of mounting to a mounting aid having the recited features).
Regarding claim 14, modified Nielsen teaches the injection device according to claim 13 substantially as claimed. Modified Nielsen further teaches wherein by the distally extending recess, the mounting aid (Nielsen cap or cover, see par. [0066]) is unambiguously aligned with at least one indicator provided on the outside surface of the housing (Nielsen main portion 2) when the mounting aid is in the single specific position on the outside surface of the housing (see previous modifications in rejection of claim 1 above; see 112(b) rejection/interpretation of claims 1 and 13-14 above; this is interpreted as a functional limitation. Nielsen teaches similar injection device housings capable of mounting to different mounting aids having different shapes and recesses (see Figs. 1-2, 5-6, 8-11, 14-15, 22-25). Thus, Nielsen’s housing (main portion 2) of Fig. 22 would be capable of mounting to a mounting aid having the recited features).
Regarding claim 15, Nielsen discloses a kit (see Fig. 22, par. [0066]), comprising:
an injection device (drug delivery device 1) comprising a housing (main portion 2) extending in a longitudinal direction (see Fig. 22, par. [0062], [0066]) and comprising at least one housing engaging member (coupling means 14) to releasably mount a mounting aid (cap or cover, see par. [0066]) on an outside surface of the housing (main portion 2) (see par. [0062], [0066]), and at least one engaging structure (edge of opening 10) to releasably mount a supplementary device (monitoring device 730) in a device specific position on the outside surface of the housing (main portion 2) (see Fig. 22, par. [0062]-[0063], [0066]);
the mounting aid (cap or cover, see par. [0066]) attached or attachable to the housing (main portion 2) and comprising a body configured to receive at least a portion of the housing (main portion 2) (see par. [0066]); and
the supplementary device (monitoring device 730) comprising a device body (mounting portion 750) and at least one device engaging member (coupling means of the mounting portion 750, see par. [0063], [0066]) to releasably mount the device body (mounting portion 750) in the device specific position on the outside surface of the injection device (drug delivery device 1) (see Fig. 22, par. [0063], [0066]).
While Nielsen doesn’t expressly teach the mounting aid having at least one radially extending body engaging member to engage with the at least one housing engaging member of the housing only when in the single specific position on the outside surface of the housing, wherein when mutually engaged the at least one radially extending body engaging member and the at least one housing engaging member provide a rotational interlock between the mounting aid and the housing, the body comprising a side wall with an abutment face facing in a proximal direction of the longitudinal direction, wherein when the mounting aid is mounted in the single specific position on the outside surface of the housing, the abutment face is (i) defined on a plane that is inclined to the longitudinal direction, and (ii) configured to serve as a tactile and visually detectable mounting support for correctly assembling the supplementary device onto the outside surface of the housing; and wherein the device body comprises a device abutment face to align with and directly contact the abutment face of the mounting aid when the mounting aid is attached to the injection device in the single specific position, wherein the at least one device engaging member of the supplementary device is alignable and engageable with the at least one engaging structure of the housing to reach the device specific position on the outside surface of the housing by bringing the device abutment face of the supplementary device and the abutment face of the mounting aid into mutual abutment and alignment; in view of the 112(b) rejection/interpretation of claim 15 above, these limitations are only functional recited and thus not positively recited/required by the claim. Nielsen teaches similar injection device housings capable of mounting to different mounting aids and supplementary devices having differently shaped abutment faces and engagement features (see Figs. 1-2, 5-6, 8-11, 14-15, 22-25). Thus, Nielsen’s housing (main portion 2) of Fig. 22 would be capable of mounting to a mounting aid and supplementary device having the recited features.
However, Nielsen fails to expressly teach wherein the at least one housing engaging member is configured to releasably mount the mounting aid only in a single specific position on the outside surface of the housing.
Plumptre teaches a kit (see Figs. 1-5, par. [0040]) comprising an injection device (housing 2) comprising at least one housing engaging member (snap features 43 and orientation features 44) to releasably mount a mounting aid (cap 3) only in a single specific position on an outside surface of the housing (housing 2) (see Figs. 1 and 3, par. [0049]-[0052]).
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 structure of the at least one housing engaging member of the kit of Nielsen such that it is configured to releasably mount the mounting aid only in a single specific position on the outside surface of the housing, as taught by Plumptre, in order to prevent a user from incorrectly attaching the components of the injection device (see Plumptre par. [0005], [0010]-[0012], [0049]-[0050]).
Regarding claim 16, modified Nielsen teaches the kit according to claim 15 substantially as claimed. Nielsen further teaches wherein the device abutment face is defined on a plane that is inclined to the longitudinal direction (see 112(b) rejection/interpretation of claims 15-16 above; this is interpreted as a functional limitation. Nielsen teaches similar injection device housings capable of mounting to different mounting aids and supplementary devices having differently shaped abutment faces and engagement features (see Figs. 1-2, 5-6, 8-11, 14-15, 22-25). Thus, Nielsen’s housing (main portion 2) of Fig. 22 would be capable of mounting to a supplementary device having the recited features).
Regarding claim 17, modified Nielsen teaches the kit according to claim 15 substantially as claimed. Nielsen further teaches wherein the device abutment face is in abutment with the abutment face of the mounting aid when the at least one device engaging member (coupling means of the mounting portion 750, see par. [0063], [0066]) is engaged with the at least one engaging structure (edge of opening 10) of the housing (main portion 2) (see Fig. 22, par. [0064], [0066]) (see 112(b) rejection/interpretation of claims 15 and 17 above; this is interpreted as a functional limitation. Nielsen teaches similar injection device housings capable of mounting to different mounting aids and supplementary devices having differently shaped abutment faces and engagement features (see Figs. 1-2, 5-6, 8-11, 14-15, 22-25). Thus, Nielsen’s housing (main portion 2) of Fig. 22 would be capable of mounting to a mounting aid and supplementary device having the recited features).
Regarding claim 18, modified Nielsen teaches the kit according to claim 15 substantially as claimed. Nielsen further teaches wherein the device abutment face is in abutment with the abutment face of the mounting aid when the supplementary device (monitoring device 730) is in the device specific position on the outside surface of the housing (main portion 2) (see 112(b) rejection/interpretation of claims 15 and 18 above; this is interpreted as a functional limitation. Nielsen teaches similar injection device housings capable of mounting to different mounting aids and supplementary devices having differently shaped abutment faces and engagement features (see Figs. 1-2, 5-6, 8-11, 14-15, 22-25). Thus, Nielsen’s housing (main portion 2) of Fig. 22 would be capable of mounting to a mounting aid and supplementary device having the recited features).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Nielsen et al. (US 2011/0295215 A1) in view of Plumptre (US 2012/0022462 A1), as applied to claim 1 above, further in view of Hjertman et al. (US 2004/0010233 A1).
Regarding claim 3, modified Nielsen teaches the injection device according to claim 1 substantially as claimed. However, modified Nielsen fails to expressly state a visual label at a specific circumferential section on the outside surface of the housing.
Hjertman teaches an injection device (see Figs. 1-3) comprising a visual label (element 11 with specific pattern 28) at a specific circumferential section (handle section 3) on the outside surface of the housing (housing portions 1-2) (see Figs. 1-3, par. [0032]-[0033]).
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 injection device of modified Nielsen to include a visual label on the housing, as taught by Hjertman, in order to distinguish injection devices of the same brand from each other and/or to display information regarding the patient or the dosing instructions (see Hjertman par. [0032]-[0033]).
Response to Arguments
Applicant’s arguments, see Remarks, filed 12/31/2025, with respect to the rejections of claims 1-20 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejections has been withdrawn. However, upon further consideration, new grounds of rejection are made in view of 35 U.S.C. 103.
Allowable Subject Matter
Claims 19-20 are allowable.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 19, the prior art of record fails to disclose or render obvious before the effective filing date of the claimed invention the method of attaching a supplementary device to an injection device as claimed, specifically including the combination of: the mounting aid having at least one radially extending body engaging member, the body further comprising a sidewall with an abutment face facing in a proximal direction of the longitudinal direction and defined on a plane that is inclined to the longitudinal direction; wherein the device body comprises a device abutment face; and mounting the supplementary device in the device specific position on the outside surface of the housing after mounting the mounting aid in the single specific position on the outside surface of the housing and bringing the device abutment face in alignment and in direct contact with the abutment face of the mounting aid to thereby align and engage the at least one device engaging member of the supplementary device with the at least one engaging structure of the housing.
The closest prior art of record is Nielsen et al. (US 2011/0295215 A1) and Plumptre (US 2012/0022462 A1). Nielsen teaches a method (see Fig. 22) comprising providing an injection device (drug delivery device 1) comprising a housing (main portion 2), at least one housing engaging member (coupling means 14) to releasably mount a mounting aid (cap or cover, see par. [0066]) (see par. [0062], [0066]), and at least one engaging structure (edge of opening 10) to releasably mount a supplementary device (monitoring device 730) (see Fig. 22, par. [0062]-[0063], [0066]); providing and mounting the mounting aid (cap or cover, see par. [0066]) comprising a body configured to receive at least a portion of the housing (main portion 2) (see par. [0066]); and providing the supplementary device (monitoring device 730) comprising a device body (mounting portion 750) and at least one device engaging member (coupling means of the mounting portion 750, see par. [0063], [0066]) (see Fig. 22, par. [0063], [0066]). Plumptre further teaches mounting the mounting aid (cap 3) in only a single specific position on the outside surface of the housing (housing 2) (see par. [0049]-[0052]).
While Nielsen teaches additional similar injection device housings capable of mounting to different mounting aids and supplementary devices having differently shaped abutment faces and engagement features (see Figs. 1-2, 5-6, 8-11, 14-15, 22-25), neither Nielsen, Plumptre, or any combination of Nielsen and Plumptre teach the combination of each of the recited structures substantially as claimed. Further, neither Nielsen nor Plumptre teach the order of the method steps the claim, specifically mounting the mounting aid before mounting the supplementary device.
Claim 20 is allowable by virtue of its dependency on allowable claim 19.
Conclusion
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783