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 .
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.
Claim(s) 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roser (US 6,102,896).
Regarding claim 28, Roser discloses a needleless injection system for a standard syringe including a barrel and a proximal end (Col.13 ll 13-24), the needleless injection system comprising: a needleless nozzle 76 (Col.13 ll 38-42) configured to removably attach to the proximal end of the barrel (fig 5, syringe is inserted into nozzle system as a separate structure and may be removed either during assembly or after its single use), the needleless nozzle configured to generate force necessary to enable needleless injection into a subject to at least a level of an intradermal injection from a standard syringe (fig 6B – liquid jet 20).
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(s) 14-16, 18, 21-25, 27-30 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piehl et al (US 2017/0281875) in view of Magyar et al (US 2021/0338402).
Regarding claim 14, Piehl discloses a needleless injection system, comprising; a housing 42/62 including an opening to allow for removal and insertion of a syringe (figs 14A, 14B and 22), the syringe comprising a barrel 48 and a plunger 41, the barrel having a proximal end and an open distal end (fig 22), the plunger inserted through the open distal end (fig 22); a needleless nozzle 275 removeably attached to the proximal end of the barrel (via 277, ¶189); an actuator 56 connected to the plunger to transfer mechanical energy to the plunger to discharge an injectable from the barrel (¶183); and a controller 158 in signal communication with the actuator, the controller configured to determine a velocity and force for an injection based on an amount of a specified injectable for the injection and a level or distance for the injection, the controller configured to transmit the velocity and force to the actuator in response to an initiation of the injection (¶164 – control motor, modify performance based on inputs; ¶196 – select known infusion rate and/or known volume and “press” infuse button, ¶197 – user manually selects desired pressure and volume, user also chooses access type and then computer chooses pressure based on preprogrammed set points, ¶234 – pressure/volume targets/limits, meaning the controller will limit/determine appropriate velocity and force to be within said targets and especially limits).
While Piehl substantially discloses the invention as claimed, it does not disclose the needleless nozzle configured to needlelessly inject the injectable contained within the barrel to the level for the injection at least the level of an intradermal injection.
Piehl discloses the nozzle may be exchanged based on needs. For example, fig 10 shows a dual check valve nozzle 31 to allow the syringe to act as a syringe pump (¶157) or a lavage tip 275 may be attached as in fig 27A to accelerate fluid to a high velocity to assist with lavage of tissue (¶189).
Magyar discloses an injection system similar in form in many ways (fig 8 of Magyar vs fig 1 of Piehl). Magyar also discloses many different types of nozzles that may be used with the device (fig 9), including needleless 910, which allows the device to inject a substance through a high velocity flow of medicine (¶155; ¶39). This allows a standardized “gun” device to be reconfigured for different use cases (¶81).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Piehl such that it is also configured to needlelessly inject the injectable contained within the barrel to the level for the injection at least the level of an intradermal injection (both physically and via programming) as taught by Magyar to allow the device to be reconfigured for different use cases.
Note that in the combination the needleless nozzle becomes the structure taught by Magyar, but is still capable of all the uses the nozzle 275 of Piehl was asserted as capable of in the first paragraph of the claim rejection.
Regarding claim 15, further comprising a sleeve for enclosing the barrel to prevent the barrel from deforming (figs 22 and 25).
Regarding claim 16, wherein the actuator is capable of transferring mechanical energy to the plunger to draw the injectable into the barrel (¶11, ¶157).
Regarding claim 18, wherein the housing includes a retention mechanism 135 for securing the syringe within the housing (figs 14A-14B).
Regarding claim 21, wherein the actuator includes an electric motor (¶233).
Regarding claim 22, wherein the controller is in signal communication with a database, the database including a velocity profile (¶192, ¶196 – known infusion rate).
Regarding claim 23, wherein the controller further determines velocity based on the velocity profile (¶192 – achieve a known delivery rate).
Regarding claim 24, Piehl discloses a needleless injection system, comprising; a housing 42/62 including an opening to allow for removal of and insertion of a standard syringe (figs 14A, 14B and 22), the standard syringe comprising a barrel 48 and a plunger 41, the barrel having a proximal end and an open distal end, the plunger insertable through the open distal end (fig 22); a needleless nozzle 275 removeably attached to the proximal end of the barrel (via 277, ¶189); an actuator 56 including a piston disposed within the housing, the piston configured to physically interact with the plunger to translate the plunger relative to the barrel (figs 4 and 5, ¶157); and a controller 158 in signal communication with the actuator, the controller configured to determine a velocity and force for an injection based on an amount of an injectable for the injection and a level for the injection, the controller configured to transmit the velocity and force to the actuator in response to an initiation of the injection (¶164 – control motor, modify performance based on inputs; ¶196 – select known infusion rate and/or known volume and “press” infuse button, ¶197 – user manually selects desired pressure and volume, user also chooses access type and then computer chooses pressure based on preprogrammed set points, ¶234 – pressure/volume targets/limits, meaning the controller will limit/determine appropriate velocity and force to be within said targets and especially limits), the actuator configured to translate the plunger based on the velocity and the force transmitted thereto to inject the injectable into a subject at the level for the injection (see citations above, actuator drives translates based on controller).
While Piehl substantially discloses the invention as claimed, it does not disclose the needleless nozzle configured for needleless injection of an injectable contained within the barrel nor the needleless nozzle configured to needlelessly inject the injectable contained within the barrel to the level for the injection at least the level of an intradermal injection.
Piehl discloses the nozzle may be exchanged based on needs. For example, fig 10 shows a dual check valve nozzle 31 to allow the syringe to act as a syringe pump (¶157) or a lavage tip 275 may be attached as in fig 27A to accelerate fluid to a high velocity to assist with lavage of tissue (¶189).
Magyar discloses an injection system similar in form in many ways (fig 8 of Magyar vs fig 1 of Piehl). Magyar also discloses many different types of nozzles that may be used with the device (fig 9), including needleless 910, which allows the device to inject a substance through a high velocity flow of medicine (¶155; ¶39). This allows a standardized “gun” device to be reconfigured for different use cases (¶81).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Piehl such that it is also configured to needlelessly inject the injectable contained within the barrel to the level for the injection at least the level of an intradermal injection (both physically and via programming) and the needleless nozzle configured for needleless injection of an injectable contained within the barrel as taught by Magyar to allow the device to be reconfigured for different use cases.
Note that in the combination the needleless nozzle becomes the structure taught by Magyar, but is still capable of all the uses the nozzle 275 of Piehl was asserted as capable of in the first paragraph of the claim rejection.
Regarding claim 25, further comprising an integrated sleeve for enclosing the barrel to prevent the barrel from deforming (figs 22 and 25).
Regarding claim 27, wherein the housing includes a retention mechanism 135 to secure the standard syringe within the housing (figs 14A and 14B).
Regarding claim 28, Piehl discloses a needleless injection system for a standard syringe including a barrel 48 having a proximal end, the needleless injection system comprising: a needleless nozzle 275 configured to removeably attach to the proximal end of the barrel (via 277, ¶189), the needleless nozzle configured to generate force necessary to enable needleless injection from a standard syringe (¶189, figs 27A and 27B).
While Piehl substantially discloses the invention as claimed, it does not disclose the needleless nozzle configured to generate force necessary to enable needleless injection into a subject to at least a level of an intradermal injection.
Piehl discloses the nozzle may be exchanged based on needs. For example, fig 10 shows a dual check valve nozzle 31 to allow the syringe to act as a syringe pump (¶157) or a lavage tip 275 may be attached as in fig 27A to accelerate fluid to a high velocity to assist with lavage of tissue (¶189).
Magyar discloses an injection system similar in form in many ways (fig 8 of Magyar vs fig 1 of Piehl). Magyar also discloses many different types of nozzles that may be used with the device (fig 9), including needleless 910, which allows the device to inject a substance through a high velocity flow of medicine (¶155; ¶39). This allows a standardized “gun” device to be reconfigured for different use cases (¶81).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to provide a needleless nozzle configured to generate force necessary to enable needleless injection into a subject to at least a level of an intradermal injection as taught by Magyar to allow a standardized “gun” device to be reconfigured for different use cases (¶81).
Regarding claim 29, wherein the needleless nozzle is configured to frictionally attach to the proximal end of the barrel (via threads and friction with Luer 277).
Regarding claim 30, wherein the needleless nozzle includes a fitting 277 configured to interface with a complementary fitting of the proximal end of the barrel (¶189).
Regarding claim 32, further comprising a sleeve configured to receive the barrel therein, the sleeve for preventing deformation of the barrel (figs 22 and 25).
Claim(s) 17, 19, 20 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piehl et al (US 2017/0281875) in view of Jazayeri et al (US 2019/0143047) and Magyar et al (US 2021/0338402).
Regarding claims 17, 19, 20 and 26, while Piehl substantially discloses the invention as claimed, it does not disclose a supply in signal communication with the controller, the supply configured to provide energy to the actuator based on a control signal from the controller such that the actuator transfers mechanical energy to the plunger, nor an electro- pneumatic motor having the actuator and a piston, nor an electrohydraulic motor having the actuator and a piston.
Jazayeri discloses plungers for drug delivery devices, which can be powered by a variety of internal actuators including an electric motor (overlapping with Piehl), pneumatic, hydraulic and/or source of pressurized gas or liquid (the claimed supply can be any of the later three, the fluid used by the pneumatic or hydraulic pumps and/or the pressurized gas/liquid).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Piehl such that it includes a supply in signal communication with the controller, the supply configured to provide energy to the actuator based on a control signal from the controller such that the actuator transfers mechanical energy to the plunger, nor an electro- pneumatic motor having the actuator and a piston, and either an electro- pneumatic motor having the actuator and a piston or an electrohydraulic motor having the actuator and a piston as taught by Jazayeri as they are known alternative actuators for syringes with every expectation of success.
Claim(s) 31 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piehl et al (US 2017/0281875) in view of Neracher (US 2002/0055712) and Magyar et al (US 2021/0338402).
Regarding claim 31, while Piehl substantially discloses the invention as claimed, it does not disclose wherein the needleless nozzle defines an outlet having a diameter in a range of 50 microns to 500 microns.
Neracher discloses a device which delivers via needleless delivery as the lack of needle reduces the chance of transmitting diseases by re-use of the syringe and reduces the pain (¶2-6). The orifice of the nozzle is between 5-100 microns (¶103).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Piehl such that it includes a needleless nozzle attachable to the device which defines an outlet having a diameter in a range of 50 microns to 100 microns as taught by Neracher to allow the device of Piehl to also be used for drug delivery in a painless manner.
Regarding claim 33, while Piehl substantially discloses the invention as claimed, it does not explicitly disclose a reinforced plunger capable of producing linear forces within the barrel suitable for intradermal, subcutaneous, or intramuscular needleless injection.
Neracher discloses a device which delivers via needleless delivery as the lack of needle reduces the chance of transmitting diseases by re-use of the syringe and reduces the pain (¶2-6). A plunger 5/17 is used that is of sufficient strength to operate as a needleless device.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Piehl such that it includes a reinforced plunger capable of producing linear forces within the barrel suitable for intradermal, subcutaneous, or intramuscular needleless injection as taught by Neracher to allow the device of Piehl to also be used for drug delivery in a painless manner.
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 BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783