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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Amendment
This office action is responsive to the amendment filed on October 25, 2024. As directed by the amendment: claims 1-15 have been amended, claims 16-20 have been added, no claims have been canceled. Thus claims 1-20 are presently pending in this application. Applicant’s amendment to the Specification has been entered in the original disclosure, as no substantial information has been added to the specification.
Drawings
The replacement drawings were received on October 25, 2024. These drawings are acceptable.
Claim Objections
Claims 7-8, 11, 15 and 17 are objected to because of the following informalities:
Claim 7 recites “a preset position”, should read “the preset position” for clarity of the antecedent basis established in claim 1.
Claim 8 recites “a preset position”, should read “the preset position” for clarity of the antecedent basis established in claim 1.
Claim 11 recites character references 156, 116, and 18 in the claim language, these character references should be removed for clarity and consistency with the rest of the instant claims.
Claim 15, line 6, recites “ the methos comprising”, should read “the method comprising” for clarity.
Claim 17 recites “a preset position”, should read “the preset position” for clarity of the antecedent basis established in claim 1.
Appropriate correction is required.
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 6-7 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 6 recites the limitation "the preset dose". There is insufficient antecedent basis for this limitation in the claim. Claim 1, which claim 6 depends from instead defines a “set dose”. For examining purposes, “the preset dose” is interpreted to depend from the set dose. Claim 7 depends from claim 6.
Claim Rejections - 35 USC § 103
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 1-8, 10-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Senior et al. (US 20190151557), hereinafter Senior, in view of Keitel et al. (US 20200023136), hereinafter Keitel.
Regarding claim 1, Senior discloses a dose delivery mechanism (Fig. 2, drive mechanism 2) comprising: a housing (Fig. 1-2, outer body 12, which covers the drive mechanism 2); a piston rod (Fig. 2, piston rod 30) configured to act on a plunger sealing a fluid compartment (Fig. 2 and [0187], piston rod 30 acts on bung 82 which seals reservoir 81) and to move in an axial direction relative to the housing to deliver a set dose ([0191, 0208], piston rod 30 moves in a forward axial direction relative to outer body 12 to deliver a set dose) and a dose setting member movable relative to the housing during dose setting (Fig. 2 and [0211], dose setting member comprising dose member 70, driver 140 and display member 160 are moveable relative to outer body 12 during dose setting), a position of the dose setting member relative to the housing defining the set dose ([0211-0212], position of dose setting member defines the set/dialed dose), and in an as-delivered condition, the dose setting member is preset to a position that corresponds to a set dose (Figs. 15-15 and [0222-0223, 0226-0227], in an as-delivered state, the dose member 70 is connected to a blocking ring 180 which may be located in initial gap 46a of blocking structure 40, which is near a distal end of blocking thread 47, wherein the distal end of blocking thread 47 indicates the zero dose configuration).
Senior does not expressly disclose wherein the preset position corresponds to a set dose higher than zero. However, Keitel discloses wherein the preset position corresponds to a set dose higher than zero (Fig. 6 and [0062-0063], dose selector 35 may have a plurality of dose stops (similar to dose gaps 46 in blocking thread 47 of blocking structure 40 of Senior), wherein there is a priming dose stop 55a which the device may initially be positioned in, which is a set dose greater than the zero dose, position 55d).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Senior to incorporate the disclosures of Keitel and modify the preset position to correspond to a set dose higher than zero. Doing so would allow the device to be set in an initial priming position which helps ensure that the first injection accurately dispenses a dose of medicament that corresponds to the desired set dose (Keitel, [0063]).
Regarding claim 2, Senior, in view of Keitel, discloses the dose delivery mechanism according to claim 1, as explained above. As noted above, Senior does not disclose wherein the preset position corresponds to a set dose higher than zero, and is thus silent to wherein in the as-delivered condition, the position of the dose setting member corresponds to a dose between a zero-dose and a minimum dose deliverable by the dose delivery mechanism. However, Keitel further discloses wherein in the as-delivered condition, the position of the dose setting member corresponds to a dose between a zero-dose and a minimum dose deliverable by the dose delivery mechanism (Fig. 6 and [0062-0063], a priming dose stop 55a, which the device may initially be positioned in, which is a set dose greater than the zero dose position 55d but less than the first dose delivery stop 55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Senior, in view of Keitel, to further incorporate the disclosures of Keitel and modify the preset position to correspond to a dose between a zero-dose and a minimum dose deliverable by the dose delivery mechanism. Doing so would allow the device to be set in an initial priming position which helps ensure that the first injection accurately dispenses a dose of medicament that corresponds to the desired set dose (Keitel, [0063]).
Regarding claim 3 and Senior, in view of Keitel, Senior further discloses the dose delivery mechanism according to claim 1, further comprising a dose indication member (Fig. 2, display member 160) configured to indicate a set dose based on a position of the dose indication member relative to the housing ([0014, 0199-0201, 0211-0212], number sleeve 161 and dial sleeve 162 of display member 160 may rotate out of the device body 12 during dose dialing to indicate the set dose).
Regarding claim 4 and Senior, in view of Keitel, Senior further discloses the dose delivery mechanism according to claim 3, wherein the dose setting member is the dose indication member (Fig. 2 and [0199, 0211], display member 160 and its components (number sleeve 161 and dial sleeve 162) are a part of the dose setting member).
Regarding claim 5, Senior, in view of Keitel, discloses the dose delivery mechanism according to claim 4, as explained above. As noted above, Senior does not disclose wherein the preset position corresponds to a set dose higher than zero, and is thus silent to wherein in the as-delivered condition, the dose indication member indicates the set dose to be different from a zero-dose. However, Keitel further discloses wherein in the as-delivered condition, the dose indication member indicates the set dose to be different from a zero-dose (Fig. 2-3, 6 and [0062-0063, 0065], a priming dose stop 55a, which the device may initially be positioned in, which is a set dose greater than the zero dose position 55d but less than the first dose delivery stop 55, said priming dose position corresponds to the dose shown through window 3 on dose sleeve 38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Senior, in view of Keitel, to further incorporate the disclosures of Keitel and modify the preset position to correspond to a dose different than zero, such that in the as-delivered condition, the dose indication member indicates the set dose to be different from a zero-dose. Doing so would allow the device to be set in an initial priming position which helps ensure that the first injection accurately dispenses a dose of medicament that corresponds to the desired set dose (Keitel, [0063]).
Regarding claim 6 and Senior, in view of Keitel, Senior further discloses the dose delivery mechanism according to claim 1, wherein the dose setting member is configured to move relative to the housing to set a dose, that differs from the preset dose ([0211-0212], dose setting member components are configured to collectively move out of outer body 12 during dose setting to set the injection dose, which is different than the set dose from priming).
Regarding claim 7, Senior, in view of Keitel, discloses the dose delivery mechanism according to claim 6, as explained above. As noted above, Senior does not disclose wherein the preset position corresponds to a set dose higher than zero, and is thus silent to wherein the dose setting member is not directly movable from a preset position to a zero-dose position. However, Keitel further discloses wherein the dose setting member is not directly movable from a preset position to a zero-dose position ([0089-0090], dose selector 35 is movable from the priming stop 55a to the appropriate dose stops 55 for dose dialing, therefore it is not moved to the zero-dose position when dose dialing).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Senior, in view of Keitel, to further incorporate the disclosures of Keitel and modify the preset position to correspond to a dose different than zero, such that the dose setting member is not directly movable from a preset position to a zero-dose position. Doing so would allow the device to be set in an initial priming position which helps ensure that the first injection after proper dose dialing accurately dispenses a dose of medicament that corresponds to the desired set dose (Keitel, [0063]).
Regarding claim 8 and Senior, in view of Keitel, Senior further discloses the dose delivery mechanism according to claim 1, further comprising an activation member (Fig. 1-2, dose button 71) configured to be moved to initiate delivery of the set dose ([0230], dose button 71 is moved via a force to initiate delivery of the dialed dose), and the activation member is blocked from initiating delivery of the set dose when the dose setting member is in a preset position (figs. 14-15 and [0229-0230, 0233], dose button 71 cannot activate the dose dispensing mode D when the blocking elements 182 are not aligned in the proper dosing gaps 46, wherein in the pre-set position the blocking ring 180 is not aligned with the dosing gaps 46).
Regarding claim 10 and Senior, in view of Keitel, Senior further discloses the dose delivery mechanism according to claim 8, wherein two parts arranged inside the housing of the dose delivery mechanism are configured to cooperate with each other to prevent unintended movement of the activation member relative to the housing starting from the preset position (Figs. 14-15 and [0223, 0226-0230, 0233], device comprises blocking structure 40 and blocking rings 180 which cooperate to block movement of the dose button 71 starting from when the dose setting member is in its preset position until the dose setting member is set to a proper dose, such that the blocking elements 182 of blocking ring are aligned in the proper dosing gaps 46 of blocking structure 40).
Regarding claim 11 and Senior, in view of Keitel, Senior further discloses the dose delivery mechanism according to claim 10, wherein a first of the two parts forms a blocking structure (156), in particular a circumferentially extending rib (156) (Fig. 14-15, blocking structure comprises threads 47 which form circumferentially extending ribs), and a second of the two parts forms an engagement feature (116) that is configured to engage with the blocking structure (156) when the two parts are moved relative to each other in order to block the activation member (18) from initiating delivery of the set dose when the dose setting member is in the preset position (Fig. 14-15 and [0223,0226-0230, 0233], blocking ring 180 has elements 182 which engage with the threads 47 to prevent dose button 71 from initiating dose delivery when the dose setting member is not in a proper dose position but instead in a position such as the preset position).
Regarding claim 12 and Senior, in view of Keitel, Senior further discloses the dose delivery mechanism according to claim 1, wherein two parts arranged inside the housing of the dose delivery mechanism comprise respective dose definition elements configured to cooperate with each other to define multiple relative positions to each other corresponding to settable doses (Figs. 14-15 and [0225-0229], within the device, blocking structure 40 comprises gaps 46 between blocking elements 41-45 and blocking ring 180 comprises elements 182, wherein elements 182 interact with ).
Regarding claim 13 and Senior, in view of Keitel, Senior further discloses the dose delivery mechanism according to claim 12, wherein the two parts include a first part and a second part (Fig. 14-15, blocking structure 40 and blocking ring 180), and the multiple relative positions are defined by dose stops formed on the first part (Fig. 14 and [0225-0226], gaps 46 between the blocking element 41-45, and defined by their respective tangential ends (41b-43b, 44a-45a), form discrete dose stops) which are configured to contact with a snap element on the second part (Figs. 14-15 and [0225-0229], these dose gaps 46 are configured to come in contact with blocking elements 182 of blocking ring 180, when the elements 182 slide past/off of the tangential ends 41b-43b/44a-45a).
Regarding claim 14 and Senior, in view of Keitel, Senior further discloses a medicament delivery device (Fig. 1, injection device 1), comprising: the dose delivery mechanism according to claim 1 (Fig. 1-2 and claim 1 rejection above).
Regarding claim 15, Senior discloses a method for providing a dose delivery mechanism (method of providing drive mechanism 2 of Fig. 2) having a housing (Fig. 1-2, outer body 12, which covers the drive mechanism 2), a piston rod (Fig. 2, piston rod 30) configured to act on a plunger sealing a fluid compartment (Fig. 2 and [0187], piston rod 30 acts on bung 82 which seals reservoir 81) and to move in an axial direction relative to the housing to deliver a set dose ([0191, 0208], piston rod 30 moves in a forward axial direction relative to outer body 12 to deliver a set dose), and a dose setting member movable relative to the housing during dose setting (Fig. 2 and [0211], dose setting member comprising dose member 70, driver 140 and display member 160 are moveable relative to outer body 12 during dose setting), a position of the dose setting member relative to the housing defining the set dose ([0211-0212], position of dose setting member defines the set/dialed dose), the methos comprising delivering the dose delivery mechanism to a costumer in a state preset to a dose (Figs. 15-15 and [0222-0223, 0226-0227], in an as-delivered state, the dose member 70 is connected to a blocking ring 180 which may be located in initial gap 46a of blocking structure 40, which is near a distal end of blocking thread 47, wherein the distal end of blocking thread 47 indicates the zero dose configuration).
Senior does not expressly disclose wherein the preset state is a dose higher than zero. However, Keitel discloses wherein the preset state is a dose higher than zero (Fig. 6 and [0062-0063], dose selector 35 may have a plurality of dose stops (similar to dose gaps 46 in blocking thread 47 of blocking structure 40 of Senior), wherein there is a priming dose stop 55a which the device may initially be positioned in, which is a set dose greater than the zero dose, position 55d).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Senior to incorporate the disclosures of Keitel and modify the method such that the preset state is a dose higher than zero. Doing so would allow the device to be set in an initial priming position which helps ensure that the first injection accurately dispenses a dose of medicament that corresponds to the desired set dose (Keitel, [0063]).
Regarding claim 16 and Senior, in view of Keitel, Senior further discloses the dose delivery mechanism according to claim 1, further comprising a dose indication member (Fig. 2, display member 160) configured to indicate a set dose based on a rotational or axial position of the dose indication member relative to the housing ([0014, 0199-0201, 0211-0212], number sleeve 161 and dial sleeve 162 of display member 160 may rotate out of the device body 12 during dose dialing to indicate the set dose).
Regarding claim 17 and Senior, in view of Keitel, Senior further discloses the dose delivery mechanism according to claim 1, further comprising an activation member (Fig. 1-2, dose button 71) configured to be moved in a proximal direction to initiate delivery of the set dose ([0230], dose button 71 is moved in direction 4 (see arrow 4 in Fig. 1) via a force to initiate delivery of the dialed dose. Examiner notes: though not indicated as the proximal direction in Senior, direction 4 may be considered the proximal direction as it meets all other limitation of the claim with direction 4 being considered the proximal direction), and the activation member is blocked from initiating delivery of the set dose when the dose setting member is in a preset position (Figs. 14-15 and [0229-0230, 0233], dose button 71 cannot activate the dose dispensing mode D when the blocking elements 182 are not aligned in the proper dosing gaps 46, wherein in the pre-set position the blocking ring 180 is not aligned with the dosing gaps 46).
Regarding claim 19 and Senior, in view of Keitel, Senior further discloses the dose delivery mechanism according to claim 8, wherein two parts arranged inside the housing of the dose delivery mechanism are configured to cooperate with each other to prevent unintended movement in a proximal direction of the activation member relative to the housing starting from the preset position (Figs. 14-15 and [0223, 0226-0230, 0233], device comprises blocking structure 40 and blocking rings 180 which cooperate to block movement of the dose button 71 in direction 4 (see arrow 4 in Fig. 1, Examiner notes: direction 4 may be considered the proximal direction as it meets all other limitation of the claim when direction 4 is considered the proximal direction), starting from when the dose setting member is in its preset position until the dose setting member is set to a proper dose, such that the blocking elements 182 of blocking ring are aligned in the proper dosing gaps 46 of blocking structure 40).
Regarding claim 20 and Senior, in view of Keitel, Senior further discloses the dose delivery mechanism according to claim 12, wherein the two parts include a first part and a second part (Fig. 14-15, blocking structure 40 and blocking ring 180), and the multiple relative positions are defined by dose stops formed on the first part (Fig. 14 and [0225-0226], gaps 46 between the blocking element 41-45, and defined by their respective tangential ends (41b-43b, 44a-45a), form discrete dose stops) which are configured to contact with a snap element on the second part (Figs. 14-15 and [0225-0229], these dose gaps 46 are configured to come in contact with blocking elements 182 of blocking ring 180, when the elements 182 slide past/off of the tangential ends 41b-43b/44a-45a), and the snap element is preloaded against a respective dose stop of the dose stops by a spring ([0052-0053, 0229-0230], when blocking elements 182 slide past/off of the tangential ends 41b-43b/44a-45a and into the gaps 46, the blocking ring enters a release position which allows for the blocking ring to be urged under the effect of a spring towards its initial position for resetting the dose member ).
Claims 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Senior (US 20190151557), in view of Keitel (US 20200023136), as applied to claim 8 above, and further in view of Stamp (US 20050165349).
Regarding claim 9, Senior, in view of Keitel, discloses the dose delivery mechanism according to claim 8.
Senior, in view of Keitel, fails to disclose wherein a separate element configured to prevent a premature movement of the activation member relative to the housing before the separate element is removed. However, Stamp discloses wherein a separate element configured to prevent a premature movement of the activation member relative to the housing before the separate element is removed (Figs. 1-3 and [0066], device may have clip 19 between button 20 and housing 5 (similar to dose button 70 and outer body 12 of Senior) to prevent movement of button 20 before the clip 19 is removed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Senior, in view of Keitel, to incorporate the disclosures of Stamp and modify the device to have a separable clip configured to prevent a premature movement of the activation member relative to the housing before the separable clip is removed. Doing so would ensure any force to the button prior to clip removal would have no effect on the button, preventing undesired firing of device (Stamp, [0066-0067]).
Regarding claim 18, Senior, in view of Keitel, discloses the dose delivery mechanism according to claim 8.
Senior, in view of Keitel, fails to disclose wherein a separate element is configured to prevent premature movement of the activation member due to the dose delivery mechanism falling onto a proximal end of the dose delivery mechanism relative to the housing before the separate element is removed. However, Stamp discloses wherein a separate element is configured to prevent premature movement of the activation member due to the dose delivery mechanism falling onto a proximal end of the dose delivery mechanism relative to the housing before the separate element is removed (Figs. 1-3 and [0066], device may have clip 19 between button 20 and housing 5 (similar to dose button 70 and outer body 12 of Senior) to prevent movement of button 20 before the clip 19 is removed, therefore a force F on button 20, such as that caused by the dose delivery mechanism falling onto a proximal/button end of the dose delivery mechanism, has no effect on the button 20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Senior, in view of Keitel, to incorporate the disclosures of Stamp and modify the device to have a separable clip configured to prevent a premature movement of the activation member due to the dose delivery mechanism falling onto a proximal end of the dose delivery mechanism relative to the housing before the separable clip is removed. Doing so would ensure any force to the button prior to clip removal would have no effect on the button, preventing undesired firing of device (Stamp, [0066-0067]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH D GRASMEDER whose telephone number is (571)272-0258. The examiner can normally be reached M-F 8 am-5 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BHISMA MEHTA can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
