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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “at least one of the plurality of airtight rings is…V-shaped” of claim 7 and “the sealing reinforcement ring is sleeved on the movable assembly” of claim 8 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because there are errors in Figure 2 regarding “sealing reinforcement ring 71”. The portion of the drawing indicating the sealing reinforcement ring is misplaced because it appears to be extending through the deformation trigger assembly 6 and the reference number “71” is misplaced. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains phrases which can be implied (“The embodiment of the present disclosure provide booster mechanisms suitable for a liquid container” in line 1). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities: there appears to be a typo in paragraph [0057] regarding “As shown in FIG. 1” as opposed to “As shown in FIG. 4”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4-8, and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pagay et al. (USPN 5411488).
Regarding claim 1, Pagay discloses a booster mechanism suitable for a liquid container (Figure 1),
comprising a liquid storage assembly (barrel 20), wherein a tail end of the liquid storage assembly is provided with a strike space (space within barrel 20 filled: “Barrel 20 is filled with the desired liquid, such as a medicament or a diagnostic imaging medium” [Col 6, lines 18-20]; Figure 2), the strike space is provided with a movable assembly (plunger 20), the movable assembly is capable of performing an axial movement along the strike space (“, the plunger moves relatively easily in the barrel allowing convenient delivery of the liquid into the injection site.” [Col 6, lines 67 – Col 7, line 2]), and a tail end of the movable assembly is provided with:
a booster assembly (plunger rod 50), wherein a front end of the booster assembly is provided with a deformation trigger assembly (plunger rod tip 64 and neck portion 66); and
a deformation space (within plunger 20 bounded by inside wall 38 and inside face 34), wherein a deformation gap is between the deformation space and the deformation trigger assembly (Figure 4).
Regarding claim 2, Pagay discloses the booster mechanism suitable for a liquid container of claim 1, comprising:
a standby state (Figure 4), wherein when the booster mechanism is in the standby state, there is an interference fit between an outer side of the movable assembly and a side wall of the strike space (“At this point of the procedure the plunger rod 50 and plunger 30 are in a static engagement. As shown in FIG. 4, female threads 43 of plunger 30 engage male threads 70 of slideable cylinder 68, but plunger tip 64 does not contact flat or concave face 34 of plunger 30 and does not exert pressure thereon.” [Col 6, lines 39-44]); and
a striking state (Figure 5), when the booster mechanism is in the striking state, a head end of the movable assembly (convex face 32) has a convex deformation (Figure 5), and there is no interference fit between the outer side of the movable assembly and the side wall of the strike space (“The operator then, again, exerts pressure on plunger rod 50 which results in the same circumferential deformation of plunger 30 as described with respect to aspirating the syringe. Referring to proximal ring 41, distal ring 40 and center ring 42, it is clear that the force they now exert on the inside wall 21 of barrel 20 is reduced in direct proportion to the distance "b", "d" and "d" created by the circumferential deformation. As a result, the plunger moves relatively easily in the barrel allowing convenient delivery of the liquid into the injection site…In the syringe of the present invention the force exerted on the plunger pulls the distal, proximal and center rings inwardly and greatly reduces the interfacial force between the plunger and the inside wall of the barrel.” [Col 6, lines 60 – Col 7, line 12]).
Regarding claim 4, Pagay discloses the booster mechanism suitable for a liquid container of claim 1, wherein the deformation space includes a cylindrical groove (within plunger 20 bounded by inside wall 38 and inside face 34), and the deformation trigger assembly includes a cylindrical convex bar (“plunger rod tip 64 having a semi-circular shape with convex face projecting in the direction of plunger” [Col 5, line 62-64]), and a diameter of the cylindrical convex bar is smaller than a diameter of the cylindrical groove (Figure 4).
Regarding claim 5, Pagay discloses the booster mechanism suitable for a liquid container of claim 1, wherein a plurality of airtight rings (distal ring 40, proximal ring 41, center ring 42) are distributed on an outer side of the movable assembly (Figure 4), and the plurality of airtight rings contact a side wall of the strike space (inside wall 21) when the booster mechanism is in a standby state (“Outside wall 36 of plunger 30 comprises: distal ring 40, proximal ring 41, and center ring 42, which are elastically deformable and extend radially outwardly from outside wall 36 and have, when taken together with plunger 30, a minimal diameter slightly in excess of the largest diameter of the working section of barrel 20. The rings form a sealing but slideable engagement with inside wall 21 of barrel 20.” [Col 5, lines 49-56]).
Regarding claim 6, Pagay discloses the booster mechanism suitable for a liquid container of claim 5, wherein the plurality of airtight rings are distributed at an interval distance (Figure 4).
Regarding claim 7, Pagay discloses the booster mechanism suitable for a liquid container of claim 5, wherein at least one of the plurality of airtight rings is trapezoidal or V-shaped (Figure 4, wherein at least proximal ring 41 and center ring 42 are trapezoidal shaped because they have at least one pair of parallel sides).
Regarding claim 8, Pagay discloses the booster mechanism suitable for a liquid container of claim 5, wherein the booster mechanism includes a sealing reinforcement ring (slideable cylinder 68), the sealing reinforcement ring is sleeved on the movable assembly (Figure 4); and an elasticity modulus of the sealing reinforcement ring is greater than an elasticity modulus of the movable assembly (“Syringe barrel 20 is made of an inert gas impermeable material including glass, however, it is preferably made of a substantially transparent material that is somewhat more flexible than glass, such as polyethylene, polypropylene, polystyrenes, acrylic and methacrylic polymers. Plunger 30 is made of a compressible, elastomeric material, such as polyisoprene rubber. Plunger rod 50 is made essentially of the same material as the barrel.” [Col 5, lines 28-35], wherein the slideable cylinder 68 is part of the plunger rod 50, which is made of a harder material than the elastomeric material of the plunger 30).
Regarding claim 17, Pagay discloses the booster mechanism suitable for a liquid container of claim 1, wherein the booster assembly includes a protrusion (upper edge of plunger rod tip 64) and the movable assembly includes a groove (within plunger 20 bounded by inside wall 38 and inside face 34), and the protrusion is slidably disposed in the groove (Figure 5).
Regarding claim 18, Pagay discloses the booster mechanism suitable for a liquid container of claim 17, wherein a length of the groove is positively related to a deformation degree range of the movable assembly (Figure 5).
Regarding claim 19, Pagay discloses the booster mechanism suitable for a liquid container of claim 1, wherein a liquid outlet (bore 23) of the liquid storage assembly is in a shape of a convex circular arc (Figures 1-2).
Regarding claim 20, Pagay discloses the booster mechanism suitable for a liquid container of claim 1, wherein an outer side of the movable assembly is made of a hydrophobic material (“Plunger 30 is made of a compressible, elastomeric material, such as polyisoprene rubber” [Col 5, lines 33-34], wherein polyisoprene rubber is hydrophobic).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Pagay et al. (USPN 5411488) in view of Jugl et al. (US 20150238700).
Regarding claim 3, Pagay discloses the booster mechanism suitable for a liquid container of claim 1.
Pagay fails to explicitly disclose a connection between the deformation trigger assembly and the front end of the booster assembly is provided with a circular arc concave chamfer.
Jugl discloses a booster mechanism suitable for a liquid container (Figure 1-2), comprising a liquid storage assembly (“a cartridge bung 1 for expelling a medicament out of a cartridge (not shown) in a distal direction 2.” [0102]), a movable assembly (cartridge bung 1), and a booster assembly (piston rod/lead screw 8) comprising a deformation trigger assembly (distal end of lead screw 8); wherein a connection (narrow section 12) between the deformation trigger assembly and the front end of the booster assembly is provided with a circular arc concave chamfer (Figure 1; “The distal end of the lead screw 8 is provided with a narrow section 12 or recess following the distal end of the lead screw 8 in proximal direction.” [0105]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the booster mechanism of Pagay to include a connection between the deformation trigger assembly and the front end of the booster assembly is provided with a circular arc concave chamfer based on the teachings of Jugl to enable a snap-fit coupling between the deformation trigger assembly and the movable assembly (Jugl [0105]).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Pagay et al. (USPN 5411488) in view of Mead et al. (USPN 3905521).
Regarding claims 9-10, Pagay discloses the booster mechanism suitable for a liquid container of claim 1.
Pagay fails to explicitly disclose the booster assembly is provided with a spring, as required by claim 9; and wherein an outer side of the booster assembly is provided with a press-slide member, one end of the spring is connected to the press-slide member, and another end of the spring is connected to the movable assembly, as required by claim 10.
Mead discloses a booster mechanism suitable for a liquid container (reagent dispenser 1; Figure 1) comprising a liquid storage assembly (barrel 12), a movable assembly (piston 22) and a booster assembly (piston rod 24), wherein the booster assembly is provided with a spring (spring 28); and wherein an outer side of the booster assembly is provided with a press-slide member (flange 26), one end of the spring is connected to the press-slide member (Figure 2; “A coiled compression spring 28 is arranged with coils 30 of same around rod 24 and between flange 26 and open end 14” [Col 2, lines 36-37]), and another end of the spring is connected to the movable assembly (Figure 2, where the spring 28 is connected to piston 22 via their mutual connection to barrel 12 and piston rod 24).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the booster mechanism of Pagay to include a spring having one end connected to a press-slide member and another end connected to the movable assembly based on the teachings of Mead to bias the booster assembly and movable assembly toward to the standby state when a medicament is not actively being delivered (Mead [Col 1, lines 41-42]).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Pagay et al. (USPN 5411488) in view of Folk et al. (USPN 20170182253).
Regarding claims 11-13, Pagay discloses the booster mechanism suitable for a liquid container of claim 1.
Pagay fails to explicitly discloses the booster assembly includes a thrust amplification member, the thrust amplification member includes a press slider, a thrust slider, and a liquid channel, the liquid channel is disposed between the press slider and the thrust slider, and the liquid channel has a filling liquid, wherein a contact area between the press slider and the filling liquid is smaller than a contact area between the thrust slider and the filling liquid, as required by claim 11; wherein the liquid channel is provided with a connecting member, the connecting member is in a shape of a step, and the thrust slider is detachably connected to the connecting member, as required by claim 12; and wherein the press slider includes an extension member, the extension member is disposed within the liquid channel, and a height of the filling liquid within the liquid channel is related to a length of the extension member, as required by claim 13.
Folk teaches a booster mechanism suitable for a liquid container (injection device 100; Figures 1-3C), comprising a liquid storage assembly (drug storage device 130), a movable assembly (stopper 130); and a booster assembly (injection drive mechanism 140), wherein the booster assembly includes a thrust amplification member (driver damper mechanism 170), the thrust amplification member includes a press slider (plunger head 148), a thrust slider (piston disc member 182), and a liquid channel (dashpot housing 174), the liquid channel is disposed between the press slider and the thrust slider (Figure 3C showing at least a portion of housing 174 between plunger head 148 and piston disc member 182), and the liquid channel has a filling liquid (working fluid 178), wherein a contact area between the press slider and the filling liquid is smaller than a contact area between the thrust slider and the filling liquid (Figures 3A-3C showing that the plunger head 148 has no contact area with fluid 178 while piston disc member 182 is located within and fully contacted by the fluid 178), as required by claim 11;
wherein the liquid channel is provided with a connecting member (at end wall 174ew having aperture 174a; Figure 2), the connecting member is in a shape of a step (Figure 2 showing the end wall 174ew steps down to aperture 174a), and the thrust slider is detachably connected to the connecting member (Figure 3A-3C showing that the piston disc member 182 is first located against the end wall 174ew, then distally), as required by claim 12; and
wherein the press slider includes an extension member (piston rod 184), the extension member is disposed within the liquid channel (Figures 3A-3C), and a height of the filling liquid within the liquid channel is related to a length of the extension member (Figures 3A-3C showing the height of the fluid 178 within housing 174 is the same as the length of the piston rod 184), as required by claim 13.
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the booster mechanism of Pagay to include a thrust amplification member including a press slider, a thrust slider, and a liquid channel having filling liquid, wherein a contact area between the press slider and the filling liquid is smaller than a contact area between the thrust slider and the filling liquid; wherein the liquid channel is provided with a connecting member in the shape of a step, the thrust slider is detachably connected to the connecting member and wherein the press slider includes an extension member disposed within the liquid channel based on the teachings of Folk to provide shock reduction by reducing the kinetic energy applied to the movable assembly while maintaining the desired force to ensure patient comfort and safety (Folk [0091], [0096], [0009]).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Pagay et al. (USPN 5411488) in view of Helmer et al. (US 20210121634).
Regarding claims 14-15, Pagay discloses the booster mechanism suitable for a liquid container of claim 1.
Pagay fails to explicitly disclose the booster mechanism includes a reminder device, the reminder device includes a shrapnel and card members; and the shrapnel and the card members contact to make a sound when the booster mechanism is in a striking state, as required by claim 14; and wherein the card members are disposed on an inner side of the liquid storage assembly, and the shrapnel is disposed on an outer side of the movable assembly or an outer side of the booster assembly, as required by claim 15.
Helmer teaches a booster mechanism (injection device 100; Figures 1 and 11) comprising a liquid storage assembly (medicament container 102), a moveable assembly (stopper 108), and a booster assembly (plunger 118) provided with a deformation trigger assembly (plunger head 122); further comprising a reminder device, the reminder device includes a shrapnel (serrations 144) and card members (flexible arms 142); and the shrapnel and the card members contact to make a sound when the booster mechanism is in a striking state (“the plunger rod 118 further comprises one or more serrations 144 arranged to catch the flexible arms 140 as the plunger is depressed into the medicament cartridge 102…The serrations 144 catching on the flexible arms 140 can also provide audible feedback to the user.” [0073]); and wherein the card members (flexible arms 142) are disposed on an inner side of the liquid storage assembly (“The flexible arms 142 may be provided as a part of the medicament cartridge 102, for example as part of a cap or integrated with the medicament cartridge 102.” [0072]), and the shrapnel (serrations 144) is disposed on an outer side of the booster assembly (“the plunger rod 118 further comprises one or more serrations 144” [0073]; Figure 11).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the booster mechanism of Pagay to include a reminder device including shrapnel disposed on an outer side of the booster assembly and card members disposed on an inner side of the liquid storage assembly based on the teachings of Helmer to provide audible feedback to the user that the booster mechanism is in use (Helmer [0073]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Pagay et al. (USPN 5411488) in view of Helmer et al. (US 2021/0121634) as applied in claim 15 above, and further in view of Jugl et al. (US 20150238700).
Regarding claim 16, modified Pagay discloses the booster mechanism suitable for a liquid container of claim 15.
Modified Pagay fails to explicitly disclose at least one of the card members is in a shape of a convex bar, the card members are disposed on an inner side of the movable assembly, and the shrapnel is disposed on the deformation trigger assembly.
Jugl discloses a booster mechanism suitable for a liquid container (Figure 1-2), comprising a liquid storage assembly (“a cartridge bung 1 for expelling a medicament out of a cartridge (not shown) in a distal direction 2.” [0102]), a movable assembly (cartridge bung 1), and a booster assembly (piston rod/lead screw 8) comprising a deformation trigger assembly (distal end of lead screw 8); further comprising a reminder device (“The present invention is based on the idea to detect a signal indicative for the contact between the drive mechanism and the bung in the cartridge in an efficient way. The bearing and the piston rod are each configured such as to be connected to each other via a snap connection and that the contact between the drive mechanism and the bung is indicated by a measurable signal such as a peak in force and/or torque and/or an audible feedback with either of the effects being produced by the snap connection i.e. in the moment, the bearing and the piston are coupled to each other and the snap connection engages.” [0010]) comprising at least one card member (edges of insertion section 14) in the shape of a convex bar (Figure 1), the card member disposed on an inner side of the movable assembly (Figure 1), and a shrapnel (portion of lead screw 8 distal of narrow section 12) disposed on the deformation trigger assembly (Figure 1-2; “The distal end of the lead screw 8 is provided with a narrow section 12 or recess following the distal end of the lead screw 8 in proximal direction. The bearing 5 is on its proximal side 6 provided with a recess 13 or undercut which is adapted to accommodate the distal end of the lead screw 8, thus forming a snap-fit. The recess 13 is provided with an insertion section 14, which is narrower than the distal end of the lead screw 8. The narrow section 12 and the recess 13 are configured to establish a snap connection, which couples the bearing 5 to the lead screw 8.” [0105]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the reminder device of the booster mechanism of Pagay to include at least one of the card members is in a shape of a convex bar disposed on an inner side of the movable assembly and the shrapnel disposed on the deformation trigger assembly based on the teachings of Jugl to clearly indicate that the booster mechanism is in the striking state (Jugl [0013]).
Conclusion
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/LEAH J SWANSON/Examiner, Art Unit 3783
/LOAN B JIMENEZ/Supervisory Patent Examiner, Art Unit 3784