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 .
Status of Claims
This office action is responsive to the amendment filed 25 March 2026.
Claims 1, 4, and 10 are amended.
Claims 1-17 are presently pending in this application.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 4, 13, and 14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lee et al. (US Patent Publication No. 20190184096 A1), hereinafter Lee.
Regarding claim 1, Lee teaches a dispensing device (Lee: Fig. 2, injection port 30) for dispensing a product (medicinal solution; para. 0038), comprising: a reservoir (Fig. 3, comprising medicine bottle 70 and outer cap 60) configured to contain the product (para. 0038) is provided with a collar (Fig. 3, inner cap 50) delimiting an opening of the reservoir (Fig. 3, inner cap 50 delimits opening of reservoir; para. 0023), a membrane (Fig. 3, sealing membrane 52) closing the opening of the reservoir (Fig. 3, membrane 52 is shown closing inlet cover 72 and through-hole 82; para. 0023) and having an inner side (Fig. 3, side of membrane 52 facing bottle 70) oriented towards the reservoir (Fig. 3, 52 faces 70) and an outer side (Fig. 3, side of 52 facing needle part 40 and opposite of 70) opposite to the inner side (52 faces 70), a securing ring (Fig. 3, packing holder 90) for securing the membrane (52) to the collar (Fig. 3, membrane 52 is coupled to holder 90 and cap 50, shown as being between the two; para. 0023), the membrane (52) being configured to switch from a first stable position (Fig. 3, membrane 52 is in the first position), in which the membrane (52) bulges out in a first direction (Fig. 3, membrane 52 bulges towards 70 into hole 82; para. 0038) such that it protrudes into the reservoir (70 and 60) and closes the reservoir (Fig. 3, membrane 52 is shown closing off and sealing hole 82; para. 0038), into a second stable position (Fig. 4, membrane 52 is in the second position), in which the membrane (52) bulges out in a second direction opposite to the first direction (Fig. 4, membrane 52 bulges towards needle part 40) so as to be pierced by a needle (Fig. 4, needle 44 punctures through membrane 52; para. 0038) disposed on the outer side (52 faces 40) of the membrane (52).
Regarding claim 3, Lee teaches the device above, wherein the needle (44) is configured to connect the reservoir (Fig. 4, needle 44 fluidly connects to bottle 70 when membrane is in second position; para. 0038) to a product distribution tubing (Fig. 1, inlet 14 is hermetically welded to holder tube 45, thus connecting to needle 44; para. 0034) and configured to be distant from the membrane (52) when the membrane (52) is in the first stable position (Fig. 3, needle 44 is away from membrane 52 in this position; para. 0038) and to pass through the membrane (52) when the membrane (52) is in the second stable position (Fig. 4, needle 44 punctures through membrane 52; para. 0038).
Regarding claim 4, Lee teaches a dispensing device (Lee: Fig. 2, injection port 30) for dispensing a product (medicinal solution; para. 0038), comprising: a reservoir (Fig. 3, comprising medicine bottle 70 and outer cap 60) configured to contain the product (para. 0038) is provided with a collar (Fig. 3, inner cap 50) delimiting an opening (Fig. 3, inner cap 50 delimits opening of reservoir; para. 0023), a membrane (Fig. 3, sealing membrane 52) closing the opening (Fig. 3, membrane 52 is shown closing inlet cover 72 and through-hole 82; para. 0023) and having an inner side (Fig. 3, side of membrane 52 facing bottle 70) oriented towards the reservoir (Fig. 3, 52 faces 70) and an outer side (Fig. 3, side of 52 facing needle part 40 and opposite of 70) opposite to the inner side (52 faces 70), a securing ring (Fig. 3, packing holder 90) for securing the membrane (52) to the collar (Fig. 3, membrane 52 is coupled to holder 90 and cap 50, shown as being between the two; para. 0023), the membrane (52) being configured to switch from a first stable position (Fig. 3, membrane 52 is in the first position), in which the membrane (52) bulges out in a first direction (Fig. 3, membrane 52 bulges towards 70 into hole 82; para. 0038) such that it protrudes into the reservoir (70 and 60) and closes the reservoir (Fig. 3, membrane 52 is shown closing off and sealing hole 82; para. 0038), into a second stable position (Fig. 4, membrane 52 is in the second position), in which the membrane (52) bulges out in a second direction opposite to the first direction (Fig. 4, membrane 52 bulges towards needle part 40) so as to be pierced by a needle (Fig. 4, needle 44 punctures through membrane 52; para. 0038) disposed on the outer side (52 faces 40) of the membrane (52), wherein the needle (44) is fixedly mounted with respect to the reservoir (Fig. 3, needle 44 is mounted on inclined surface 49a, which is fixed horizontally with respect to the bottle 70; para. 0033).
Regarding claim 13, Lee teaches a system (Fig. 2, comprising injection port 30 and pouch container 10) for dispensing a product (para. 0038) comprising the device above and a product dispensing unit (10).
Regarding claim 14, Lee teaches an assembly kit (Fig. 1) for a system (30 and 10) for dispensing a product (para. 0038), comprising the device above and a product dispensing unit (10).
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 2, 6, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Klemm et al. (US Patent Publication No. 20200276389 A1), hereinafter Klemm.
Regarding claim 2, Lee teaches the device above.
Lee does not expressly disclose the membrane is made of an elastomer material.
Klemm teaches a membrane (Fig. 10, membrane 30) that is made of an elastomer material (membrane 30 can be made from a bromobutyl rubber; para. 0027).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the membrane of Lee such that it is made of an elastomer material as taught by Klemm in order to allow the membrane to be biocompatible and inert to the medicament (Klemm: para. 0028).
Regarding claim 6, Lee teaches the device above, wherein the membrane (52) comprises a central part (Fig. 3, protruding part 53) that is deformable between the first stable position (Fig. 3) and the second stable position (Fig. 4).
Lee does not expressly disclose the central part of the membrane has a thickness between 0.3 mm and 2.5 mm.
Klemm teaches a central part of a membrane (Klemm: Fig. 11, region of membrane 30 that flexes) that has a thickness between 0.3 mm and 2.5 mm (membrane comprises a thickness ranging from 10 um to 2mm).
It would have been obvious to one having ordinary skill in the art at the time the invention was made such that the central part of the membrane has a thickness of 0.3 mm to 2.5 mm as taught by Klemm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. As such, the thickness of the membrane of Klemm is dependent on the physical characteristics of the medicament (Klemm: para. 0032).
Regarding claim 15, Lee teaches the device above.
Lee does not expressly disclose the membrane is made of bromobutyl-based material and/or chlorobutyl-based material.
Klemm teaches a membrane (Klemm: 30) is made of bromobutyl-based material and/or chlorobutyl-based material (membrane 30 can be made from a bromobutyl rubber; para. 00247.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the membrane of Lee such that the membrane is made of bromobutyl-based material and/or chlorobutyl-based material as taught by Klemm in order to allow the membrane to be biocompatible and inert to the medicament (Klemm: para. 0028).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Gillespie et al. (US Patent Publication No. 20060178631 A1), hereinafter Gillespie.
Regarding claim 5, Lee teaches the device above, wherein the membrane (52) has a peripheral part (Fig. 3, upper part of the membrane 52 between holder 90 and cap 50; para. 0023) compressed between the securing ring (90) and the collar (50) of the reservoir (70 and 60).
Lee does not expressly disclose that the peripheral part is compressed axially.
Gillespie teaches a peripheral part (Gillespie: Fig. 5, outer portion of upper seal 74) of a membrane (Fig. 5, upper seal 74) that is compressed axially (Fig. 5, seal 74 forms a hermetic seal against sealing surface 80 and is maintained in sealing contact via needle hub 83; para 0055).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the membrane of Lee such that the peripheral part is compressed axially as taught by Gillespie in order to ensure a hermetic seal (Gillespie; para. 0054-0055).
Claim 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Bunch et al. (US Patent Publication No. 20090234323 A1), hereinafter Bunch.
Regarding claim 7, Lee teaches the device above, wherein the membrane (52) is configured to switch from the first stable position (Fig. 3) into the second stable position (Fig. 4).
Lee does not expressly disclose switching from the first stable position into the second stable position when a differential pressure between the inner side and the outer side of the membrane is greater than a predetermined threshold.
Bunch teaches a membrane (Bunch: Fig. 3C and D, membrane 58), wherein switching from a first stable position (Fig. 3C, membrane 58 is in the first stable position; para. 0049) into a second stable position (Fig. 3D, membrane 58 moves into a second stable position; para. 0049) occurs when a differential pressure between the inner side and the outer side (net forward pressure differential across membrane 58; para. 0049) of the membrane (58) is greater than a predetermined threshold (threshold is 150-350 kPa; para. 0049).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the membrane of Lee such that switching from the first stable position into the second stable position when a differential pressure between the inner side and the outer side of the membrane is greater than a predetermined threshold as taught by Bunch in order to allow for the penetration of the membrane using pressure changes (Bunch: para. 0049).
Regarding claim 8, Lee in view of Bunch discloses the device above.
Lee does not expressly disclose that the predetermined threshold is between 0.4 bar and 3 bar.
Bunch teaches a predetermined threshold is between 0.4 bar and 3 bar (threshold is 150-350 kPa, which is 1.5-3.5 bar; para. 0049).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the membrane of Lee such that the predetermined threshold is between 0.4 bar and 3 bar in order to allow for the penetration of the membrane using pressure changes (Bunch: para. 0049).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Bunch, in further view of Murakami et al. (US Patent Publication No. 20140330199 A1), hereinafter Murakami.
Regarding claim 9, Lee in view of Bunch discloses the device above, wherein the membrane (Lee: 52) switches from the first stable position (Fig. 3) into the second stable position (Fig. 4) to dispense the product (medicinal solution; para. 0038) out of the reservoir (70) in the via the needle (44) when the membrane (52) is in the second stable position (Fig. 4, membrane 52 is pierced by needle 44 when in the second position, resulting in medicinal solution to flow through needle 44; para. 0038).
Lee does not expressly disclose a pump, the pump being configured to switch the membrane from the first stable position into the second stable position.
Bunch teaches a pump (Bunch: Fig. 1, comprising plunger assembly 14 and plunger 30), the pump (14 and 30) being configured to switch the membrane (58) from the first stable position (Fig. 3C) into the second stable position (Fig. 3D, the plunger 30 creates net back pressure differential across membrane 58; para. 0050). Bunch also discloses motor driven syringes to drive a plunger of a syringe are known in the art (para. 0002).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Lee such that it included a pump, the pump being configured to switch the membrane from the first stable position into the second stable position as taught by Bunch in order to generate a pressure differential across the membrane to cause the membrane to enter a second stable position (Bunch: para. 0049).
Lee in view of Bunch does not expressly disclose an electric motor to drive the pump.
Murakami teaches an electric motor (Murakami: Fig. 4, motor 14) to drive a pump (Fig. 4, plunger 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Lee in view of Bunch such that an electric motor drives the pump as taught by Murakami in order to drive the piston and perform drug injection with an adequate pressure that corresponds to the controlled operation of the motor (Murakami: para. 0037 and 0078).
Claims 10-12 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Bunch and Murakami, in further view of Alizoti et al. (US Patent Publication No. 20210146079 A1), hereinafter Alizoti.
Regarding claim 10, Lee in view of Bunch and Murakami discloses the device above.
Lee in view of Bunch and Murakami does not expressly disclose a system for determining a position of the membrane.
Alizoti teaches a system (Alizoti: Fig. 7A-B, flex sensor 100) for determining a position of a membrane (pressure increase moves the membrane 102, causing the sensor 100 to detect a position; para. 0142).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Lee in view of Bunch and Murakami such that it included a system for determining a position of the membrane as taught by Alizoti in order to indirectly measure a pressure across the membrane to prevent contamination (Alizoti: para. 0142).
Regarding claim 11, Lee in view of Bunch, Murakami, and Alizoti disclose the device above.
Lee in view of Bunch and Alizoti does not expressly disclose a member for measuring a current or torque of the electric motor driving the pump.
Murakami teaches a member (Murakami: Fig. 5, current detection sensor 16) for measuring a current or torque of the electric motor (sensor 16 senses current flowing in motor 14; para. 0037) driving the pump (motor 14 drives plunger 13; para. 0037).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Lee in view of Bunch and Alizoti such that it included a member for measuring a current or torque of the electric motor driving the pump as taught by Murakami in order to allow for precise detection of motor rotation and sending of signals to stop driving the motor under certain conditions (Murakami: para. 0037 and 0054).
Regarding claim 12, Lee in view of Bunch, Murakami, and Alizoti disclose the device above.
Lee in view of Bunch and Murakami does not expressly disclose the system for determining the position of the membrane comprises a pressure sensor configured to measure a pressure on the inner side and/or the outer side of the membrane.
Alizoti teaches a system (Alizoti: 100) for determining a position of a membrane (Alizoti: 102) comprises a pressure sensor (Fig. 7A-B, flex sensor 100) configured to measure a pressure on an inner side and/or an outer side of the membrane (Fig. 7A-B, sensor 100 indirectly measures the pressure differential from the exterior of the membrane 102; para. 0142).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Lee in view of Bunch and Murakami such that it included the system for determining the position of the membrane comprises a pressure sensor configured to measure a pressure on the inner side and/or the outer side of the membrane as taught by Alizoti in order to indirectly measure a pressure across the membrane to prevent contamination (Alizoti: para. 0142).
Regarding claim 17, Lee in view of Bunch, Murakami, and Alizoti disclose the device above.
Lee in view of Bunch and Murakami does not expressly disclose that the pressure sensor is configured to measure a differential pressure between the inner side and the outer side of the membrane.
Alizoti teaches a pressure sensor (Alizoti: 100) that is configured to measure a differential pressure between an inner side and an outer side of a membrane (Fig. 7A-B, sensor 100 indirectly measures the pressure differential from the exterior of the membrane 102; para. 0142).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Lee in view of Bunch and Murakami such that the pressure sensor is configured to measure a differential pressure between the inner side and the outer side of the membrane as taught by Alizoti in order to indirectly measure a pressure across the membrane to prevent contamination (Alizoti: para. 0142).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Bunch, in further view of Haase et al. (US Patent Publication No. 20110166522 A1), hereinafter Haase.
Regarding claim 16, Lee in view of Bunch discloses the device above.
Lee in view of Bunch does not expressly disclose that the predetermined threshold is between 0.6 bar and 0.7 bar.
Haase teaches a membrane (Haase: septum; para. 0025) predetermined threshold is between 0.6 bar and 0.7 bar (volumetric displacement for pressures between 3.5-138 kPa, which is 0.035-1.38 bar).
It would have been an obvious matter of design choice to modify the membrane of Lee in view of Bunch with the membrane of Haase to have a threshold range of 0.035-1.38 bar, since the applicant has not disclosed that the narrower claimed range of 0.6 to 0.7 bar solves a stated problem or is critical to the invention; therefore, a skilled artisan would have found it obvious to choose a value within the prior art range of 0.035 to 1.38 bar, which encompasses the claimed range, with a reasonable expectation of success.
Response to Arguments
Applicant’s arguments, see page 5, filed 25 March 2025, with respect to the rejection of claim 10 under 35 USC 112(b) have been fully considered and are persuasive. The rejection of claim 10 has been withdrawn.
Applicant’s arguments, see pages 5-8, filed 25 March 2026, with respect to the rejections of claims 1-17 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of an alternative interpretation of Lee cited above.
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.
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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
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