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 .
Election/Restrictions
Claims 27-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 28, 2026.
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 “head of the movable activator device comprises a second set of sharp-edged notches capable of perforating said membrane after relative compression, preventing reuse of said container” as recited in claim 13 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.
Claim Objections
Claim 10 is objected to because there is a lack of antecedent basis for “the shape of said shell” in line 2 of the claim. 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, 10-13, 17, 19-21, 23-26, and 38-40 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.
Regarding claim 6, the limitation “said shell comprises a first set of sharp-edged notches for perforating said membrane in the second operating position, for ejecting said substance” in lines 1-2 renders the claim indefinite. It is unclear how the notches and their perforation of the membrane are “for ejecting said substance” as claimed. According to the disclosure as originally filed, the substances is ejected through the dispensing organ 1.1.1, followed by the sharp-edged notches 1.8 perforating the membrane (Figures 6A-6C; “the shell 1, in correspondence with the said cavities 3.8 has, in its respective inner surface, sharp-edged notches 1.8, for cutting the membrane 2, following the use of the container 100, in particular, in its end-use The presence of the aforementioned notches 1.8 advantageously allows the container 100 to be prevented from being reused as they are capable of permanently puncturing the membrane 2.” [0158]). It is suggested to amend claim 6 to “said shell comprises a first set of sharp-edged notches for perforating said membrane in the second operating position
Regarding claim 17, the limitation “said ring is coupled to said shell and is configured to accommodate the movable activator device for guiding movement of the ring” in lines 2-3 of the render the claim indefinite. It is unclear if the ring can be configured to guide movement of the ring itself. The specification discloses that “wherein the ring 4 is also capable of guiding the movement of the plunger 3 within the container 100” [0102]. For examination purposes, and consistent with the disclosure as originally filed, the limitation “said ring is coupled to said shell and is configured to accommodate the movable activator device for guiding movement of the ring” has been considered to include a typo and has been interpreted as “said ring is coupled to said shell and is configured to accommodate the movable activator device for guiding movement of the movable activator device”.
Regarding claim 21, the limitation “The container of claim 20, wherein said movable activator device further comprises:…one or more rings…; and a projecting element…” in lines 1-5 renders the claim indefinite. It is unclear if the movable activator further comprises both one or more rings and a projection element, or if the movable activator comprises one or more rings, and the container in general, or more specifically the ring, further comprises a projecting element. For examination purposes, and consistent with the disclosure as originally filed, the limitation “The container of claim 20, wherein said movable activator device further comprises:…one or more rings…; and a projecting element…” has been interpreted as the movable activator comprises one or more rings, and the container in general further comprises a projecting element. It is suggested to amend claim 21, line 5 to “…the ring further comprising a projecting element…”, or similar.
Regarding claim 23, the limitation “said one or more rings comprises a projecting segment of a shape complementary to said transverse portion of the membrane and facing inwardly toward said chamber,” in lines 1-3 renders the claim indefinite. It is unclear if “said one or more rings” refers to the “one or move rings” of the movable activator device introduced in claim 21, line 3 or “a ring” for locking said membrane to said shell introduced in claim 17, line 1. The specification in [0142] discloses “The ring 4, as visible in FIGS. 1D and 1E advantageously comprises a first projecting segment 4.1 of a shape substantially complementary to the transverse portion 2.1 of the membrane 2 and facing inwards from the chamber A of the shell 1, substantially from the side that will contact the plunger 3.” For examination purposes, and consistent with the disclosure as originally filed, the limitation “said one or more rings comprises a projecting segment of a shape complementary to said transverse portion of the membrane and facing inwardly toward said chamber,” has been considered to include a typo and has been interpreted as “said ring comprises a projecting segment of a shape complementary to said transverse portion of the membrane and facing inwardly toward said chamber,”.
Regarding claim 39, the limitation “the membrane and the movable activator device comprise, respectively, a coupling and a hole, such that said coupling is to lock within said hole to enable the membrane to be brought to the first operating position and to aspirate said substance into the chamber” in combination with the limitation “said shell comprises a first set of sharp-edged notches for perforating said membrane in the second operating position, for ejecting said substance” of claim 6, from which claim 29 ultimately depends, renders the claim indefinite. It is unclear how the container would operate to aspirate a substance into the chamber by moving the membrane to the first operating position if the membrane were perforated by the notches when in the second operating position (preventing reuse) prior to the aspiration.
Claims 10-13, 19-21, 24-26, 38, and 40 are rejected for being dependent upon at least one claims 6, 17, 21, 23 and 39
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, 5-6, 8-12, 17, 19-21, and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Modi (US 20070191780).
Regarding claim 1, Modi discloses a container (device 50) for ejecting a substance, comprising:
a hollow shell (housing 52 and reservoir body 70) for containment and ejection of said substance, including:
a containment portion (housing 72) comprising a dispensing organ (aperture 60) of oblong shape (Figure 2A), and
a membrane (filled reservoir body 70), connected to said shell (Figure 2A), and
said container further comprising, in a position contiguous to and transverse with respect to said containment portion, a shaping element (base 56) for connecting said membrane, so that said membrane can move from a first operating position (Figure 2A), in which the membrane has a central portion in a position opposite to the containment portion of the shell, creating with the containment portion a chamber for containment of said substance (Figure 2A), to a second operating position (Figure 2G), wherein the central portion of the membrane collapses within said containment portion of said shell, so as to eject said substance present in the chamber through said dispensing organ (“Referring now to FIGS. 2G and 2H, continued pressure on the actuator 80 compresses the reservoir 70 and forces all the contents to flow through the needle 72 and into the patient” [0040]),
wherein said membrane is of a bi-stable type satisfying at least one of:
a thickness between 0.1 mm and 5 mm;
a membrane hardness in Shore A or D between 10 to 150;
a tensile strength of the membrane from 1 MPa to 85 MPa; or
a material comprising any polymer, elastomer, thermoplastic elastomer (TPE), thermoplastic vulcanizates (TPV), polypropylene, polyethylene, or ethylene-vinyl acetate (EVA) copolymer (“The reservoir is formed between two layers of plastic film.” [0027]);
wherein said membrane independently maintains its own operating position between said first operating position and said second operating position (Figures 2A-2H); and
wherein, depending on the thickness of said membrane, an intensity of a compressive force applied on said membrane and a bistability of said membrane vary (“The reservoir is formed between two layers of plastic film. The two layers can be formed from two sheets or from one sheet folded in half. When two sheets are used, the sheets may comprise the same material, thickness, etc. or they may be two different types of sheets.” [0027]).
Regarding claim 2, Modi discloses the container as in claim 1, wherein said membrane is calibrated with a geometry of said containment portion of said shell, so as to adhere to and be compressible in a direction of said shell, for ejecting said substance contained in said chamber (Figures 2A-2H; “Referring now to FIGS. 2G and 2H, continued pressure on the actuator 80 compresses the reservoir 70 and forces all the contents to flow through the needle 72 and into the patient” [0040]).
Regarding claim 5, Modi discloses the container of claim 1, wherein said membrane (reservoir 70) is a prolate or oblate spheroid or other form suitable for containing said substance and collapsing into the shell (Figures 2A-2H).
Regarding claim 6, Modi discloses the container as in claim 5, wherein said shell comprises a first set of sharp-edged notches (upper end 74 of needle 72) for perforating said membrane in the second operating position, for ejecting said substance (“As the actuator 80 exerts pressure on the reservoir 70, the reservoir 70 contacts the upper end 74 of the needle 72 and is punctured. The cannula of the needle 72 is now in fluid communication with the contents of the reservoir.” [0039]).
Regarding claim 8, Modi discloses the container of claim 1, wherein said dispensing organ of said containment portion of said shell is connected to a dispensing accessory (needle 72; Figure 2A-2J).
Regarding claim 9, Modi discloses the container of claim 1, wherein said shell comprises a support section (upper housing 96, connected outer surface of housing 52; Figure 2A) for fingers of a user.
Regarding claim 10, Modi discloses the container according to claim 6, further comprising a movable activator device (actuator 80 having plunger 82) having a shape corresponding to the shape of said shell (Figures 2A-2H), the movable activator device having a head (stopper 86) adapted to push and compress said membrane inside said shell in order to pass from said first operating position to said second operating position (Figures 2A-2H), and a body (plunger 82) adapted to transmit compression on said membrane during use of the container (Figures 2A-2H).
Regarding claim 11, Modi discloses the container as in claim 10, wherein said head of said movable activator device comprises a plurality of concentric slots (see annotated Figure 2C below) for reducing a weight of said movable activator device and for regulating a force necessary for deformation of said membrane.
Regarding claim 12, Modi discloses the container according to claim 10, wherein said head comprises cavities (see annotated Figure 2C below) for perforating said membrane by means of said first set of sharp-edged notches (upper end of needle 74) present on an inner surface of said shell, preventing reuse of said container.
Regarding claim 17, Modi discloses the container of claim 10, further comprising a ring (reservoir chamber 62) for locking said membrane to said shell (Figure 2A), wherein said ring is coupled to said shell and is configured to accommodate the movable activator device for guiding movement of the ring (Figures 2A-2J), and wherein said shell comprises a first portion which is tubular and hollow contiguous to said containment portion (Figure 2A), and wherein said ring is coupled to fit within the first portion of said shell (“The interior of the housing is adapted to receive a reservoir chamber 62.” [0034]).
Regarding claim 19, Modi discloses the container of claim 17, wherein said membrane comprises an edge (upper surface of reservoir 70) including a transverse portion (Figure 2A) terminating in a first apex contiguous with and transverse to said transverse portion (see annotated Figure 2C).
Regarding claim 20, Modi discloses the container of claim 19, wherein said membrane further comprises: a second apex (see annotated Figure 2C) contiguous and transverse to said transverse portion, wherein said second apex is adjacent to and facing in a same direction as said first apex, and
a third apex (see annotated Figure 2C) transverse to the transverse portion and positioned between the first apex and the second apex, the third apex facing in an opposite direction from said first apex and said second apex to improve a tightness of said membrane.
Regarding claim 21, Modi discloses the container of claim 20, wherein said movable activator device further comprises: along the body of the movable activator device, one or more rings (notch 100 and indent 104) for preventing reuse of the container by preventing the container from returning to the first operating position (Figure 2J; “FIG. 2J shows a retracted reservoir chamber that is locked in position when tab 102 slides into indent 104.” [0041]); and
a projecting element (releasable latch 90 having tab 102) for switching from a rest position corresponding to said first operating position (Figure 2A) to an activation position corresponding to said second operating position (Figure 2G-H), wherein the projecting element is engaged with at least one of the one or more rings to secure the movable activator device to the shell and prevent reuse of the container (Figure 2J; “FIG. 2J shows a retracted reservoir chamber that is locked in position when tab 102 slides into indent 104.” [0041]).
Regarding claim 38, Modi discloses the container of claim 17, wherein said movable activator device comprises a toothed profile (via notch 100 and indent 104) along the body, wherein a pitch between teeth of said toothed profile corresponds to a unit volume of said substance to be ejected (Figures 2A-2J), and wherein the ring further comprises a plurality of hooks (via latches 90) projecting into the container to contact the toothed profile (Figures 2A-2J).
Claims 1, 2, 5, and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nilson (USPN 4236516).
Regarding claim 1, Nilson discloses a container (Figure 1) for ejecting a substance, comprising:
a hollow shell (container 30) for containment and ejection of said substance, including:
a containment portion (first wall portion 31) comprising a dispensing organ (nozzle 32) of oblong shape (Figure 1), and
a membrane (flexible second wall portion 35), connected to said shell (Figures 1-3), and
said container further comprising, in a position contiguous to and transverse with respect to said containment portion, a shaping element (circumferential flange 33) for connecting said membrane (“Said second wall portion is connected to the other side of flange 33 preferably by adhesive, melting or ultra sonic welding” [Col 4, lines 40-42]), so that said membrane can move from a first operating position (Figure 1), in which the membrane has a central portion in a position opposite to the containment portion of the shell, creating with the containment portion a chamber for containment of said substance (Figure 1), to a second operating position, wherein the central portion of the membrane collapses within said containment portion of said shell, so as to eject said substance present in the chamber through said dispensing organ (“In operation, to eject the liquid from the container e.g. for adminstering the medicament or for transferring the blood sample to a test tube, as the case may be, the container is emptied by pressing the plunger head 21 against the filled container…The flexible wall portion 35 will be introverted mechanically by the hemispherical end surface 23 of plunger head 21 and will be collapsed against the inside surface of wall portion 31” [Col 6, lines 20-32]),
wherein said membrane is of a bi-stable type (Figures 1-3) satisfying at least one of:
a thickness between 0.1 mm and 5 mm;
a membrane hardness in Shore A or D between 10 to 150;
a tensile strength of the membrane from 1 MPa to 85 MPa; or
a material comprising any polymer, elastomer, thermoplastic elastomer (TPE), thermoplastic vulcanizates (TPV), polypropylene, polyethylene, or ethylene-vinyl acetate (EVA) copolymer (“Wall portion 35 preferably is made of a flexible plastic material.” [Col 4, lines 42-43]);
wherein said membrane independently maintains its own operating position between said first operating position and said second operating position (Figures 1-3); and
wherein, depending on the thickness of said membrane, an intensity of a compressive force applied on said membrane and a bistability of said membrane vary (Figures 1-3).
Regarding claim 2, Nilson discloses the container as in claim 1, wherein said membrane is calibrated with a geometry of said containment portion of said shell, so as to adhere to and be compressible in a direction of said shell, for ejecting said substance contained in said chamber (“In operation, to eject the liquid from the container e.g. for administering the medicament or for transferring the blood sample to a test tube, as the case may be, the container is emptied by pressing the plunger head 21 against the filled container…The flexible wall portion 35 will be introverted mechanically by the hemispherical end surface 23 of plunger head 21 and will be collapsed against the inside surface of wall portion 31” [Col 6, lines 20-32]).
Regarding claim 5, Nilson discloses the container of claim 1, wherein said membrane (wall portion 35) is a prolate or oblate spheroid or other form suitable for containing said substance and collapsing into the shell (Figure 1).
Regarding claim 8, Nilson discloses the container of claim 1, wherein said dispensing organ of said containment portion of said shell is connected to a dispensing accessory (needle 48; Figure 1).
Regarding claim 9, Nilson discloses the container of claim 1, wherein said shell comprises a support section (finger grip portion 16) for fingers of a user (Figure 1).
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 13 is rejected under 35 U.S.C. 103 as being unpatentable over Modi (US 20070191780) in view of Chiquiar-Arias (USPN 4391273).
Regarding claim 13, Modi discloses the container of claim 10.
Modi fails to explicitly discloses said head of the movable activator device comprises a second set of sharp-edged notches capable of perforating said membrane after relative compression, preventing reuse of said container.
Chiquiar-Arias teaches a container (Figure 1) comprising a movable activator device (plunger formed by flaps 25, pressing disc 26, piston 27), wherein a head (piston 27) of the movable activator device comprises a sharp-edged notch (puncturing pin 67) capable of perforating a membrane (at groove 68) after relative compression, preventing reuse of said container (“Said groove 68 weakens the bottom wall and facilitates, on completion of the stroke of the piston 27, when the solution is injected into the user, the puncturing of cylinder by the puncturing pin 67.” [Col 3, lines 23-27]; “pin would puncture the bottom of the syringe to make it non-reusable after the completion of the injecting stroke of the piston.” [Col 1, lines 23-25]).
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 head of the movable activator device of Modi to include a second set of sharp-edged notches based on the teachings of Chiquiar-Arias to prevent reuse of the container by disallowing the container to be refilled (Chiquiar-Arias [Col 1, lines 10-25]).
Claims 6, 10, 17, and 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over Nilson et al. (USPN 4236516) in view of Morley et al. (GB 2187961).
Regarding claim 6, Nilson discloses the container as in claim 5.
Nilson fails to explicitly discloses said shell comprises a first set of sharp-edged notches for perforating said membrane in the second operating position, for ejecting said substance.
Morley teaches a container (Figure 1) comprising a shell (barrel tube 10) comprising a first set of sharp-edged notches (one or more spikes 18) for perforating a membrane (frangible disc 26) in a second operating position, for ejecting said substance (“The usual procedure then is to hold the syringe with the needle extending upwardly, and gently displace the piston in the ejection direction, first to displace air and secondly (possibly) to eject a portion of the liquid so that the remaining volume corresponds to the required dosage. The injection then follows and when driven to the extreme of its travel in the ejection direction, the spike will pierce the disc and thus render the piston useless for a repeat cycle.” [Page 1, lines 76-86]).
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 shell of the container of Nilson to have a first set of sharp-edged notches based on the teachings of Morley to rupture the membrane after use and prevent re-use of the container (Morley [Page 1, lines 76-86]).
Regarding claim 10, modified Nilson discloses the container according to claim 6, further comprising a movable activator device (plunger 11) having a shape corresponding to the shape of said shell (Figures 1-2), the movable activator device having a head (plunger head 21) adapted to push and compress said membrane inside said shell in order to pass from said first operating position to said second operating position (“In operation, to eject the liquid from the container e.g. for administering the medicament or for transferring the blood sample to a test tube, as the case may be, the container is emptied by pressing the plunger head 21 against the filled container…The flexible wall portion 35 will be introverted mechanically by the hemispherical end surface 23 of plunger head 21 and will be collapsed against the inside surface of wall portion 31” [Col 6, lines 20-32]), and a body (rod 19) adapted to transmit compression on said membrane during use of the container (Figure 1-2).
Regarding claim 17, Nilson discloses the container of claim 10, further comprising a ring (barrel 10) for locking said membrane to said shell (“When the barrel is being slid over rim 34 to receive the rim in socket 13 the rim flexes or gives when sliding against rib or lip 15 and then, after having slipped over the rib or lip, springs out automatically to engage at the edge thereof the inner side of the rib or lip. By the engagement thus obtained between the barrel and the container the container will be retained by the barrel” [Col 5, lines 33-40]), wherein said ring is coupled to said shell and is configured to accommodate the movable activator device for guiding movement of the ring (“Plunger 11 comprises a cylindrical rod 19 which is received in passage 17 and is slidable therein” [Col 3, lines 66-68]), and wherein said shell comprises a first portion which is tubular and hollow contiguous to said containment portion (at circumferential flange 33; Figure 3), and wherein said ring is coupled to fit within the first portion of said shell (Figure 1).
Regarding claim 38, modified Nilson discloses the container of claim 17, wherein said movable activator device comprises a toothed profile (via axially extending grooves 49a-d) along the body (Figure 5), wherein a pitch between teeth of said toothed profile corresponds to a unit volume of said substance to be ejected (“When the plunger is displaced axially the ball rides in the groove and offers increased resistance to movement beyond the ends of the groove to indicate the length of the stroke defined by the groove cooperating with the ball. When the plunger is being displaced for sucking liquid into the container attached to the barrel, the ends of the axial distance represented by a groove such as groove 49a will be felt as a pressure point at each end of the axial distance represented by the groove. The length of each groove may be adjusted to correspond to a predetermined volume of liquid in the container. If a greater volume is desired rod 19 may be rotated in order to bring the proper groove into register with ball 50… The longest groove 49d should preferably correspond to complete filling of the container.” [Col 7, lines 40-60]), and wherein the ring further comprises a plurality of hooks (via detent formed by ball 50, pressure spring 51, cavity 51) projecting into the container to contact the toothed profile (Figure 5).
Regarding claim 39, modified Nilson discloses the container of claim 17, wherein the membrane and the movable activator device comprise, respectively, a coupling (sealing element 25 forming sleeve 26) and a hole (cavity 12), such that said coupling is to lock within said hole to enable the membrane to be brought to the first operating position and to aspirate said substance into the chamber (“As the plunger 11 is retracted the conical lip or sleeve 26 of sealing element 25 will sealingly engage the inside wall of the barrel due to the fact that it will be brought to expand towards that wall by the friction between the lip or sleeve and the wall. The part of cavity 12 enclosed between the plunger head and the inner end of the cavity is vented through the clearance formed around rod 19 in passage 17 so that no pressure builds up behind the plunger head. Thus, a subpressure (partial vacuum) will be created in cavity 12 between the plunger head and the end wall formed at the discharge end of the barrel by container 30 a leakproof seal being provided between the container and shoulder 12' by sealing ring 13'…By the subpressure thus created wall portion 35 will be progressively withdrawn from wall portion 31 as shown in FIG. 2 and the container will be filled with liquid.” [Col 5, line 66 – Col 6, line 19]).
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Nilson et al. (USPN 4236516) in view of Morley et al. (GB 2187961) as applied in claim 39 above, and further in view of Strazdins (GB 1121749 – cited in 12/22/23 IDS).
Regarding claim 40, modified Nilson discloses the container of claim 39.
Modified Nilson fails to explicitly disclose the membrane comprises a protrusion facing in an opposite direction of the coupling, wherein said protrusion is configured to expel the substance remaining in the dispensing organ.
Strazdins teaches a container (Figure 1) comprising a shell including a containment portion (body 8) comprising a dispensing organ (tubular member 11) and a membrane (body 1); wherein the membrane comprises a protrusion (plunger 7), wherein said protrusion is configured to expel the substance remaining in the dispensing organ (“the plunger 7 is only required to displace medicament in the tubular member 11 in an ejecting operation” [Page 2, lines 93-95]).
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 membrane of Nilson to include a protrusion facing in an opposite direction of the coupling based on the teachings of Strazdins to displace all of the substance in the dispensing organ (Strazdins [Page 2, lines 93-95]).
Claims 19-21 and 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Nilson et al. (USPN 4236516) in view of in view of Morley et al. (GB 2187961) as applied in claim 17 above, and further in view of Smith (USPN 2667164).
Regarding claims 19 and 20, modified Nilson discloses the container of claim 17, wherein said membrane comprises an edge (upper surface of second wall portion 35) including a transverse portion (along circumferential flange 33).
Modified Nilson fails to explicitly disclose the edge terminating in a first apex contiguous with and transverse to said transverse portion, as required by claim 19; and wherein said membrane further comprises: a second apex contiguous and transverse to said transverse portion, wherein said second apex is adjacent to and facing in a same direction as said first apex, and a third apex transverse to the transverse portion and positioned between the first apex and the second apex, the third apex facing in an opposite direction from said first apex and said second apex to improve a tightness of said membrane, as required by claim 20.
Smith teaches a container (syringe 10) comprising a shell including a containment portion (front member 11) and a membrane (rear portion 12), said membrane comprising an edge including a transverse portion (flange 33) terminating in a first apex (left side of securement site 38) contiguous with and transverse to said transverse portion (Figure 3), and a second apex (right side of securement site 38) contiguous and transverse to said transverse portion (Figure 3), wherein said second apex is adjacent to and facing in a same direction as said first apex (Figure 3), and a third apex (bead 35) transverse to the transverse portion and positioned between the first apex and the second apex (Figure 3), the third apex facing in an opposite direction from said first apex and said second apex to improve a tightness of said membrane (Figure 3).
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 membrane of Nilson to include a first apex contiguous with and transverse to said transverse portion, a second apex contiguous and transverse to said transverse portion and adjacent to and facing in a same direction as said first apex, and a third apex transverse to the transverse portion and positioned between the first apex and the second apex facing in an opposite direction from said first apex and said second apex based on the teachings of Smith to form a reinforced seal at the edge of the membrane (Smith [Col 2, lines 38-51]).
Regarding claim 21, modified Nilson discloses the container of claim 20, wherein said movable activator device further comprises: along the body of the movable activator device, one or more rings (formed by grooves 49a-d) for preventing reuse of the container by preventing the container from returning to the first operating position (Figure 5; “When the plunger is displaced axially the ball rides in the groove and offers increased resistance to movement beyond the ends of the groove to indicate the length of the stroke defined by the groove cooperating with the ball.” [Col 7, lines 40-45], preventing reuse of at least container 30); and
a projecting element ((via detent formed by ball 50, pressure spring 51, cavity 51) for switching from a rest position corresponding to said first operating position to an activation position corresponding to said second operating position, wherein the projecting element is engaged with at least one of the one or more rings to secure the movable activator device to the shell and prevent reuse of the container (Figure 5; “A detent formed by a ball 50 is biased by a pressure spring 51 received by a cavity 51' formed in the barrel, the ball thus being pressed against rod 19. This rod may be rotated in passage 17 to bring one of the grooves into register with the ball. Such rotation takes place against the resistance offered by ball 50 when it is forced out of the groove in which it is received at the time, against the bias provided by spring 51. In FIG. 5 the ball is received by groove 49a. When the plunger is displaced axially the ball rides in the groove and offers increased resistance to movement beyond the ends of the groove to indicate the length of the stroke defined by the groove cooperating with the ball.” [Col 7, lines 32-45]).
Regarding claim 23, modified Nilson discloses the container of claim 21, wherein said one or more rings [ring, see rejection and interpretation under 112 above] comprises a projecting segment (rib 15) of a shape complementary to said transverse portion of the membrane and facing inwardly toward said chamber (Figures 1-3), configured to lock said transverse portion of the membrane at the shaping element of the shell by holding the transverse portion in place to form a seal (“When the barrel is being slid over rim 34 to receive the rim in socket 13 the rim flexes or gives when sliding against rib or lip 15 and then, after having slipped over the rib or lip, springs out automatically to engage at the edge thereof the inner side of the rib or lip. By the engagement thus obtained between the barrel and the container the container will be retained by the barrel” [Col 5, lines 33-40]; “a leakproof seal being provided between the container and shoulder 12' by sealing ring 13'” [Col 6, lines 10-11]).
Regarding claim 24, modified Nilson discloses the container of claim 23, wherein said ring (barrel 10) comprises, in a position contiguous with and opposite to said projecting segment, a complementary flat segment (sealing ring 13’) configured to contact said first apex of said membrane (Figures 1-2).
Regarding claim 25, modified Nilson discloses the container of claim 24, wherein the projecting segment and said complementary flat segment of the ring are configured to respectively press the first apex and the transverse portion of the membrane within the shaping element of the shell (Figures 1-2; “When the barrel is being slid over rim 34 to receive the rim in socket 13 the rim flexes or gives when sliding against rib or lip 15 and then, after having slipped over the rib or lip, springs out automatically to engage at the edge thereof the inner side of the rib or lip. By the engagement thus obtained between the barrel and the container the container will be retained by the barrel” [Col 5, lines 33-40]; “a leakproof seal being provided between the container and shoulder 12' by sealing ring 13'” [Col 6, lines 10-11]).
Regarding claim 26, modified Nilson discloses the container of claim 23, wherein said ring (barrel 10) comprises, in a position opposite to the projecting segment, a support for fingers of a user (finger grip portion 16; Figure 1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Chen (USPN 7104970) discloses a shell (10) comprising a set of sharp-edged notches (22) for perforating a membrane (77) to prevent reuse ([Col 3, lines 25-27])
Sandegren (USPN 4131217) discloses a container (1) comprising a hollow shell (11) including a containment portion (12) and a membrane (13) connected to the shell (Figure 1); further comprising a movable activator device (3).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LEAH J SWANSON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
Prosecution Insights