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
Claims 5, 12, and 14 were previously objected to and have been amended; the previous objections are withdrawn.
Claims 1-15 were previously rejected under 35 U.S.C. §112(b) for indefiniteness and have been amended; the previous rejections to claims 1-15 under 35 U.S.C. §112(b) are withdrawn.
Claims 1-15 remain pending.
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.
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.
Claim(s) 1-12 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gerlett (US 20190247585, henceforth Gerlett) in view of Diaz et al. (US 20180361080, henceforth Diaz, previously made of record).
Regarding claim 1, Gerlett discloses a dose setting assembly (the combination of syringe delivery ring 100 and syringe loading guide 120, fig. 5, is the claimed dose setting assembly) for a medical injection device (syringe 201 and needle 207 combine to make the medical injection device, fig. 4; note that the medical injection device is only functionally claimed and is not positively required, and thus the claim only requires that the dose setting assembly is capable of use with such a device; the structures of the injection device are called out for clarity and convenience) comprising a barrel (barrel 203, fig. 3) defining a reservoir (the hollow interior of barrel 203 is a reservoir, fig. 3) adapted to contain a medical injection fluid (medication 352, fig. 15), an open proximal end (proximal end 217 is open for plunger rod 213, fig. 3) and a distal end (distal end 219, fig. 3) comprising a hub portion (the location where needle 207 is attached to syringe 201 as shown in fig. 11A is a hub portion as claimed), a flange (flange 221, fig. 3) disposed at the proximal end of said barrel (see fig. 3), and an elongated plunger rod (plunger rod 213, fig. 3) having a plunger flange (flange 211, fig. 3) at a proximal end (see fig. 3, the proximal end is the end further from distal end 219) and a stopper (plunger seal 215, fig. 3) at a distal end (see fig. 3, the distal end is the end closer to distal end 219), the plunger rod being able to slidably move within the barrel (see [0052]), said dose setting assembly comprising: a distal dose setting member (syringe delivery ring 100, fig. 1A) removably secured to the medical injection device (see figs. 7 and 8) configured to maintain the plunger rod in a distal predetermined position (see [0044], the plunger 205 is maintained in the position of fig. 6 because of proximal segment 114 interfering with flange 211), the distal dose setting member being transversally removable from the backstop (see figs. 7 and 8) to authorize the plunger rod to move towards the backstop (if the apparatus were changed from the state of fig. 8 to the state of fig. 7, the plunger rod 205 would be able to moved towards flange 221 since there wouldn’t be anything restricting it), and a proximal dose setting member (syringe loading guide 120, fig. 2A) secured on the distal dose setting member (see fig. 5), maintaining the plunger rod in a second predetermined position (see fig. 5, an attempt to push flange 211 to abut syringe delivery ring 100 would be stopped by syringe loading guide 120 by a difference in position called out as D1 in the figure), the proximal dose setting member being transversally removable from the distal dose setting member (see figs. 12 and 13, syringe loading guide 120 is removable and able to be placed back onto syringe delivery ring 100) to authorize the plunger rod to move towards the distal dose setting member (removal of syringe loading guide 120 would allow for flange 211 to move closer to syringe delivery ring 100) and abuts onto said distal dose setting member (this is the arrangement shown in fig. 16b as compared to fig. 16A); wherein the distal dose setting member and the proximal dose setting member each comprise a distal part (the distal segment 112 of delivery ring 100 is the distal part of the distal dose setting member, see fig. 1A; the portion of loading guide 120 distal to proximal surface 122 is the distal part of the proximal dose setting member, see fig. 2A) provided with at least one external groove (the external groove of segment 112 is the portion of lumen 106 extending along segment 112, see fig. 1A; the external groove of the portion of loading guide 120 which is distal to proximal surface 122 is the portion of archway 126 which is distal to surface 122, see fig. 2C) oriented perpendicularly to a dose setting member longitudinal axis (the longitudinal axis is the central axis extending along the radial middle of syringe 201 as shown as the downward pointing arrow in fig. 5; the groove of the distal member is perpendicular to this axis where the curved wall defining the lumen creates a U shape, or is oriented, perpendicularly to the axis; the groove of the proximal member is perpendicular to this axis where the curved wall defining the archway creates a U shape, or is oriented, perpendicularly to the axis) and a proximal part (proximal segment 114 of delivery ring 100 is the proximal part of the distal dose setting member, see fig. 1A; proximal surface 122 of loading guide 120 is the proximal part of the proximal dose setting member, see fig. 2A) provided with at least one internal groove (the internal groove of segment 114 is the portion of lumen 106 extending along segment 114, see fig. 1A; the internal groove of the proximal surface 122 is the portion of archway 126 which is coplanar with surface 122, see fig. 2A) oriented perpendicularly to the dose setting member longitudinal axis (the groove of the distal member is perpendicular to this axis where the curved wall defining the lumen creates a U shape, or is oriented, perpendicularly to the axis; the groove of the proximal member is perpendicular to this axis where the curved wall defining the archway creates a U shape, or is oriented, perpendicularly to the axis).
Gerlett does not disclose a backstop as claimed. Diaz teaches a backstop (finger flange 140, fig. 8) as a means of securing a removable device (combination of finger flanger 140 and removable plunger member 150, fig. 8, which are removable relative to syringe body 110, syringe flange 114, connection member 130, and removable cap 132) to a flange (syringe flange 114, fig. 8) of a barrel (syringe body 110, fig. 8) of a medicament injection device (syringe body 110, syringe flange 114, connection member 130, and removable cap 132 make up the claimed injection device), wherein a removable part of the removable device (plunger member 150, fig. 8) is removable from the backstop (see figs. 8 and 9, plunger 150 is shown as being removably arranged relative to the rest of the assembly).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the backstop of Diaz to the dose setting assembly of Gerlett for providing a means for a user to grasp the medical injection device with their fingers while pushing on the plunger (Diaz [0006], this is what finger flanges are used for). The modified device of Gerlett in view of Diaz (henceforth Gerlett as claimed) thus discloses that the distal dose setting member is transversally removable from the backstop to authorize the plunger rod to abut onto the added backstop (in the modified device, if syringe delivery ring 100 was removed from the assembly of Gerlett with the added backstop of Diaz, the plunger 205 of Gerlett would be functionally capable of coming into direct physical abutment with the added backstop of Diaz as there would be no added components which would prevent such an abutment).
Regarding claim 2, Gerlett as modified discloses the dose setting assembly of claim 1 wherein the proximal dose setting member comprises at least one inner locking means (the entirety of coupling archway 126, fig. 2A, is an inner locking means where it is within the outermost exterior of the syringe loading guide 120 and is configured for locking to the plunger 205 via syringe loading guide 100 as disclosed in [0036] and [0037]) configured to maintain the plunger flange in a concealed locked position (the position of fig. 14 is a concealed locked position as the flange 211 is locked from advancing distally to the backstop in that position and is concealed from view when looking at flange 211 from the point of view of needle 207 when assembled due to the presence of the added backstop of Diaz and flange 211).
Regarding claim 3, Gerlett as modified discloses the dose setting assembly of claim 1 wherein the dose setting member comprises an elongated U-shaped wall (inner radius 130, fig. 2A) defining an enclosure (the hollow inner space of coupling archway 126 is an enclosure as claimed).
Regarding claim 4, Gerlett as modified discloses the dose setting assembly of claim 1 wherein said at least one internal groove of the proximal part of the proximal dose setting member being configured and dimensioned to receive the plunger flange in a concealed locked position (the portion of archway 126 which is coplanar with surface 122 is configured to receive the plunger flange where it is a space which plunger 205 can translate longitudinally through such that flange 211 can come into direct contact with archway 126 similar to the state shown in fig. 14 if plunger 205 were moved slightly more distally until flange 211 was in direct abutment with guide 120, with the direct contact being a receiving since they are touching each other; this position similar to what is shown in fig. 14 is a concealed locked position as claimed where flange 211 is locked, or prevented, from moving further in the distal direction, and it is concealed from view when looking at flange 211 from needle 207 since syringe delivery ring 100 and syringe loading guide 120 would occlude a user’s view of flange 211, thus concealing it from that point of view) and said at least one external groove of the distal part of the proximal dose setting member being configured and dimensioned to removably engage the at least one internal groove of the proximal part of distal dose setting member (the external groove is configured to removably engage the internal groove when syringe loading guide 120 is assembled onto syringe delivery ring 100 similar to the assembly shown in fig. 13; the structures engage where archway 126 contacts delivery ring 100 which includes lumen 106 therethrough; the engagement is not required to be a direct physical contact between the structures); and said at least one external groove of the distal part of the distal dose setting member being configured and dimensioned to removably engage the backstop (in the assembled device as shown in fig. 13, lumen 106 engages with the added backstop of Diaz when syringe delivery ring 100 is assembled onto plunger rod 213 as the backstop and the ring are either in direct contact with each other or are in contact, or engagement, via plunger rod 213).
Regarding claim 6, Gerlett as modified discloses the dose setting assembly of claim 4 wherein the at least one external groove of the distal part of the distal dose setting member is dimensioned and configured to fit into the at least one internal groove of the proximal part of the proximal dose setting member (lumen 106 is configured to fit into archway 126 of syringe loading guide 120 as shown in figs. 5 and 13 when the device is completely assembled).
Regarding claim 5, Gerlett as modified discloses the dose setting assembly of claim 1 wherein the dose setting member comprises an internal shoulder (surface 124 is considered to be an internal shoulder as it is internal relative to surface 122 in the assembled state of fig. 14) provided in the U-shaped wall (surface 124 is provided in a U-shaped wall which is made up by inner radius 130 and sidewall opening 108 as shown where radius 130 and surface 124 intersect) and an external shoulder (bearing surface 110, fig. 12) provided in the U-shaped wall (bearing surface 110 is provided in sidewall opening 108 where sidewall opening 108 and surface 110 intersect).
Regarding claim 7, Gerlett as modified discloses the dose setting assembly of claim 1 wherein the backstop comprises a distal plate (see Diaz fig. 10, the flat plate called out as finger flange 140 is a distal plate as claimed) and a proximal funnel (from Diaz: proximally opening funnel 148, fig. 10), which both define a longitudinal enclosure (see Diaz fig. 10, proximally opening funnel 148 and the called out distal plate 140 combine to define plunger member receiving opening 146 as shown).
Regarding claim 8, Gerlett as modified discloses the dose setting assembly of claim 7 wherein the backstop comprises a distal groove (from Diaz: side opening 144, fig. 10) adjacent the distal plate (from Diaz: see fig. 10, side opening 144 is directly next to the distal plate of finger flange 140) and two arcuate portions provided on the distal plate (from Diaz: see annotated fig. 10 and see fig. 9, the two extensions which protrude distally from the distal plate 140 form arcuate portions as claimed).
Regarding claim 9, Gerlett as modified discloses the assembly of claim 7 wherein the backstop comprises a proximal groove provided in the proximal funnel (from Diaz: the slanted opening provided in funnel 148 is a proximal groove as it is a groove proximal to the called out distal plate, see fig. 10).
Regarding claim 10, Gerlett as modified discloses the dose setting assembly of claim 7 wherein the distal plate extends radially from the funnel (from Diaz: see fig. 10).
Regarding claim 11, Gerlett as modified discloses a method of operating a medical injection device, comprising the steps of: providing a medical injection device (syringe 201, fig. 7) having a dose setting assembly of claim 1 (modified dose setting assembly of Gerlett and Diaz, see rejection of claim 1 above) and removing the at least one of the distal dose setting member and the proximal dose setting member from the backstop (syringe loading guide 120 must be removed to render the syringe usable, see [0029]-[0031]).
Regarding claim 12, Gerlett as modified discloses the method of claim 11 further comprising the step of: moving the plunger rod into the syringe barrel towards the backstop (see figs. 16a and 16b, plunger 205 is moved distally towards the added backstop in the modified device) until the barrel flange abuts against the backstop (see fig. 16b; in the modified device, flange 211 abuts the added backstop via contact with syringe delivery ring 100 which is understood to be in direct abutment with the backstop in the modified device).
Regarding claim 15, Gerlett as modified discloses the method of claim 11 wherein the dose setting member is transversely removed from the medical injection device (see figs. 14 and 15, syringe loading guide 120 is transversely removed from syringe 201).
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gerlett (US 20190247585, henceforth Gerlett) in view of Diaz et al. (US 20180361080, henceforth Diaz) as applied to claim 1 above, and further in view of Bowman et al. (US 20180126085, henceforth Bowman).
Regarding claim 13, Gerlett as modified discloses a method of operating a medical injection device, comprising the steps of: providing a medical device (syringe 201, fig. 7) having a dose setting assembly of claim 1 (modified dose setting assembly of Gerlett and Diaz, see rejection of claim 1 above); removing the proximal dose setting member from the distal dose setting member (syringe loading guide 120 must be removed to render the syringe usable, see [0029]-[0031]); moving the plunger rod into the syringe barrel towards the distal dose setting member until the plunger rod abuts onto the distal dose setting member (this is the change in configuration shown between figs. 16a and 16b).
Gerlett as modified does not disclose the method comprising the step of removing the distal dose setting member from the backstop. Bowman teaches a method of using a medical injection device (syringe 100, fig. 1) including use of a dose setting assembly (plunger rod stop device 800, fig. 8A) where a dose setting member is removed from the injection device to allow a plunger of the injection device to be fully depressed (see [0007], the plunger rod stopper can be fully removed in some embodiments to allow the plunger to be fully depressed to allow for a larger volume dosage to be delivered).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have removed the distal dose setting member of Gerlett from the injection device as in Bowman because this allows for an additional dose to be delivered which is a remaining volume set to be dispersed from the injection device if this dosage is desired to be delivered to a patient (see Bowman [0007] and [0073]); if this were desired, it would further be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to then administer this dose by moving the plunger of Gerlett distally as far as possible.
Regarding claim 14, Gerlett as modified discloses the method of claim 13 further comprising the step of: moving the plunger rod into the syringe barrel towards the backstop until the plunger rod abuts onto the backstop (see the rejection of claim 13 above; this is the added step of administering the remaining volume of the injection device which is disclosed to be a step if that dose is desired as in Bowman [0007] and [0073]).
Response to Arguments
Applicant's arguments filed 02/19/2026 have been fully considered but they are not persuasive.
Applicant has argued that Gerlett does not disclose the newly required claim limitations. As indicated above relying on a new interpretation of Gerlett, the structures of Gerlett can be interpreted to meet the amended claim limitations and thus these arguments are found unpersuasive. Examined notes that the claim does not require that the internal grooves or external grooves are meant to be internal or external relative to any other listed structures, and thus the grooves called out above can be said to be the claimed grooves.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/ Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783