DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on 10/2/2025. As directed by the amendment: claim(s) 1 has been amended, claim(s) 8 has been cancelled. Thus, claims 1-2, 4-5, 9-10, and 12 are presently pending in this application.
Response to Arguments
Applicant’s arguments with respect to the independent claims, and particularly those pertaining to the amended feature of the piston cover being incorporated in a replaceable unit, have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
Claim 1-2, 5, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over US 20020055707 A1, henceforth written as Slate, in view of WO 2018021846 A1, henceforth written as Yoh, in view of US 20180056004 A1, henceforth written as Gamliel, and further in view of WO 2019092644 A1, henceforth written as Schmitt
Regarding Claim 1,
Slate discloses:
A needleless syringe comprising:
(system 10 of the embodiment of fig 6; fig 1-2 best enumerates/illustrates the invention as a whole)
a body formed in a hollow shape;
(housing of jet injector 14; fig 1)
[an impulse generator]
(impulse generator 54; fig 2)
a cylinder coupled to the body to be in communication with an open front surface of the body
(fig 1 illustrates cassette 12 as a cylindrical shape whose housing mates with the housing of jet injector 14)
and including a drug accommodating portion for accommodating a drug,
(impulse chamber 42; fig 1)
and a nozzle portion for discharging the drug accommodated in the drug accommodating portion to a front;
(nozzle 44; fig 1-2)
a piston, and is provided to penetrate the body and the cylinder, and moves forward by an impact force applied by [the impulse generator], to pressurize the drug in the drug accommodating portion toward the nozzle portion;
(impulse generator 54 accelerates the ram 56 to pressurize chamber 42 by impacting plunger 58; fig 2)
wherein the needleless syringe further comprises a piston cover provided inside the cylinder, and configured to cover an end of the piston, the piston cover being formed of a stretchable material so as to be stretched when the piston moves forward or backward, being stretched by the piston when the piston moves forward, and being restored when the piston moves backward,
(fig 6 demonstrates the manner that elastomeric diaphragm 70 covers ram 56 and is disposed inside cassette 12, deforming and restoring in response to the actuation of ram 56)
wherein the [parts of the invention are] removably coupled to the body as a removable unit,
(paragraph 22+39; certain parts of the invention may be removed and replaced to shield other components from contamination)
and wherein the piston cover is fixedly installed on the cylinder--
(fig 6 demonstrates diaphragm 70 as being disposed within cassette 12 between upper body 28 and lower body 30; fig 2)
Slate discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
the piston cover being a rubber diaphragm,
However Yoh teaches an oscillating membrane for needleless jet action composed of a rubber material which has advantageous elasticity and liquid impermeability, page 14 paragraph 2.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement the membrane material teachings of Yoh to the diaphragm of Slate as such a modification involving selecting a known material suitable for the intended purpose of comprising a diaphragm which oscillates in response to an applied impulse only involves routine skill in the art, see MPEP 2144.07, and is advantageously impermeable to liquid.
However Slate in view of Yoh is silent on:
wherein the cylinder is removably coupled to the body as a removable unit,
and wherein the piston cover is fixedly installed on the cylinder such that the piston cover is a part of the removable unit
and is replaced together with the cylinder as the removable unit is detached from the body for replacement.
However Slate teaches that some of its components, such as the cassette/skin interface and others, may be replaced to reduce contamination of other components, see paragraph 22+39.
Notably, MPEP 2144.04(V)(C) provides that a modification of the invention involving making two elements separable, where it is considered desirable for any reason to disconnect the elements, would only require routine skill in the art and merely a matter of obvious engineering choice.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement Slate’s teachings of replaceable components to the modified invention of Slate in view of Yoh, such that Slate’s cassette 12 is replaceable and separable, see MPEP 2144.04(V)(C), in order to advantageously arrive at an invention which reduces the risks associated with cross contamination of medicaments from Slate’s cartridge 48, see paragraph 22 of Slate, as the components of cassette 12 were exposed to any potential contaminants contained within cartridge 48.
However the modified invention of Slate in view of Yoh is silent on:
a piston, which is inserted in front of the moving magnetic body inside the body and is provided to penetrate the body and the cylinder, and moves forward by an impact force applied by the moving magnetic body when the moving magnetic body moves forward, to pressurize the drug in the drug accommodating portion toward the nozzle portion;
a solenoid coil wound around an outer circumferential surface of the body;
a moving magnetic body, which is long inserted into the body in a longitudinal direction and moves forward by a magnetic force generated when a current is applied to the solenoid coil;
and a forward/backward driving unit repeating forward and backward movement of the piston by repeating the supply and cut off of a current to the solenoid coil at a preset period,
wherein the forward and backward driving unit comprises a current supply unit, which repeatedly supplies a current to the solenoid coil to move the moving magnetic body forward,
However Gamliel teaches:
a piston, which is inserted in front of the moving magnetic body inside the body and is provided to penetrate the body and the cylinder, and moves forward by an impact force applied by the moving magnetic body when the moving magnetic body moves forward, to pressurize the drug in the drug accommodating portion toward the nozzle portion;
(paragraph 67+120+124-125; plunger rod 82 is driven by an impulse from actuation surface 18; fig 1-5)
an [actuator] around -- the body;
(paragraph 54-55+69-70; impulse generator 14 can comprise a magnetostrictive actuator for performing a repeatable linear displacement of an actuation surface 18 as disclosed)
a moving -- body, which is long inserted into the body in a longitudinal direction and moves forward by a magnetic force generated when a current is applied to the [actuator];
(actuation surface 18 of impulse generator 14; fig 5)
and a forward/backward driving unit repeating forward and backward movement of the piston by repeating the supply and cut off of a current to the [actuator] at a preset period, wherein the forward and backward driving unit comprises a current supply unit, which repeatedly supplies a current to the [actuator], to move the moving -- body forward,
(paragraph 91-105; controller 40 includes a power supply 50 whose current is supplied off and on at a particular rate to drive a repetition rate and amplitude of a liquid micro jet 30 ejected during plunger 16 actuation; fig 1-3)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement Gamliel’s impulse generator and impulse generator control mechanism teachings to the impulse generator disclosed by Slate in order to advantageously arrive at an invention's which can actuate its impulse generator repeatedly at a designated amplitude to elicit a desired flow rate, see paragraph 84+95-96 of Gamliel.
However Slate in view of Yoh and Gamliel is silent on:
-- a solenoid coil wound around an outer circumferential surface of the body -- a moving magnetic body, which is long inserted into the body in a longitudinal direction and moves forward by a magnetic force generated when a current is applied to the solenoid coil --
However Schmitt teaches an autoinjector:
a solenoid coil wound around an outer circumferential surface of the body;
(solenoid coil 16, which is wound around outer peripheral recess 15 of housing 14, is energized such that it drives plunger 20; fig 2 )
a moving magnetic body, which is long inserted into the body in a longitudinal direction and moves forward by a magnetic force generated when a current is applied to the solenoid coil;
(magnetic plunger 20 is moved by solenoid coil 16 to eject a media from the injector; fig 2)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement Schmitt's solenoid and magnetic body teachings to the magnetostrictive impulse generator of Slate in view of Gamliel in order to arrive at an invention's driving unit which can accelerate, and therein pressurize, injectable media at a very high rate, see page 13 of Schmitt, an advantageous driving feature for a needleless injector such as Slate and Gamliel.
However Slate in view of Yoh, Gamliel, and Schmitt is silent on:
a nozzle portion opening/closing valve, which is provided to open and close a passage hole between the nozzle portion and the drug accommodating portion and closes the passage hole;
However Gamliel teaches:
a nozzle portion opening/closing valve, which is provided to open and close a passage hole between the nozzle portion and the drug accommodating portion,
(paragraph 81+122; valve 28 opens in response to an increase in pressure in cell 24 due to translation of plunger rod 82; fig 6)
and close the passage hole;
(paragraph 131; valve 28 is closed by a restoration element 96, for instance a spring, therein elastically closing the orifice 27; fig 6)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement the nozzle valve of Gamliel in the nozzle disclosed by Slate, in order to advantageously arrive at an invention which prohibits inadvertent airflow in Slate’s nozzle when suction is applied to a user’s skin, see paragraph 81+122 of Slate.
Regarding Claim 2,
The modified device of Slate in view of Yoh, Gamliel, and Schmitt discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The needleless syringe of claim 1, wherein the current supply unit cuts off the current after applying the current to the solenoid coil for a first preset time,--
Gamliel: (paragraph 99-105; rise time 68 consists of the push phase 62 of the invention, which is the phase when current is being supplied to generator 14 to push plunger 16 distally)
--and the first preset time is set to 250 ms or less.
Gamliel: (paragraph 84+99-105; , the rise time 68 and fall time 69 comprise the cycle time (not enumerated), the cycle time which is less than 1 millisecond. Therein since rise time 68, the claimed preset time, is a component of cycle time, the claimed preset time is less than 1 millisecond; fig 3)
However, Slate in view of Yoh, Gamliel, and Schmitt is silent regarding:
and a mass of the moving magnetic body is 100 g or less,
However, Schmitt further teaches
a mass of the moving magnetic body
(page 16-17; it is desirable for the plunger 20 to not be so large/heavy that its own weight overcomes the strength of the elements supporting it in its retracted position, e.g. a magnet, electromagnet, or etc.,)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement Schmitt's further teachings of limiting magnetic body size to the invention disclosed by Slate in view of Yoh, Gamliel, and Schmitt, by optimizing the result-effective variable of magnetic body mass, in order to arrive at an invention which minimize risk from unintentional actuation if the claimed magnetic body's mass triggers an actuation by overcoming the restoring force from the claimed elastic members, see page 16-17 of Schmitt and MPEP 2144.05.
Regarding claim 5, Slate in view of Yoh, Gamliel, and Schmitt teaches:
The needleless syringe of claim 1, wherein the piston has a second flange portion protruding in a radial direction from an outer circumferential surface of a rear portion located inside the body,
Examiner notes that in light of the modification of Slate in view of Gamliel above, Slate’s ram 56 is biased by Gamliel’s anchor 84 via Gamliel’s component 86 and thus incorporates the proximal end flange from the proximal end 16a of Gamliel for the elastic component 86 to bias against, and further is located inside Slate’s claimed body.
Regarding claim 9, Slate in view of Yoh, Gamliel, and Schmitt teaches:
The needleless syringe of claim 1, wherein the drug accommodating portion is formed in a shape of a diverging nozzle
Examiner notes that in light of the modification of Slate in view of Gamliel above, Slate’s impulse chamber 42 incorporates Gamliel’s nozzle cell 87 at the end of Slate’s orifice 18, such that the modified invention forms a diverging nozzle shape.
including a reduced portion whose cross-sectional area decreases toward the front
Slate’s impulse chamber 42 decreases in cross sectional area as it approaches orifice 18.
and an enlarged portion extending from the reduced portion to increase the cross-sectional area again,
Gamliel: (nozzle cell 87 cross-sectional area increases from aperture 93, which adjoins to Slate’s orifice 18 in the modified invention; fig 6))
and the reduced portion has a drug supply hole in which the drug is supplied from an outside by a pressure difference generated during backward movement of the piston.
Slate: (fluid pathway 32 provides impulse chamber 42 with drug from cartridge 48 when diaphragm 70 is no longer stretched and pathway 32 is unsealed)
Regarding claim 10, Slate in view of Yoh, Gamliel, and Schmitt teaches:
The needleless syringe of claim 9, wherein the nozzle portion opening/closing valve comprises a ball installed in the passage hole so that the nozzle portion opening/closing valve is pushed by a fluidic pressure applied to the drug from the drug accommodation portion when the piston moves forward, and
Gamliel: (paragraph 133; outlet valve stopper 94 is opened when rod 82 moves forward; fig 6)
and an elastic member installed in the nozzle portion to support the ball and elastically restored by the ball when the fluidic pressure is released.
Gamliel: (restoration element 96 restores stopper 94 to its home position in aperture 93 when rod 82 is being retracted, therein pressure having been released; fig 6)
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Slate in view of Yoh, Gamliel, and Schmitt , and further in view of US 20060270983 A1, henceforth written as Lord.
Regarding Claim 4,
Slate in view of Yoh, Gamliel, and Schmitt discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However Slate in view of Yoh, Gamliel, and Schmitt is silent regarding:
wherein the piston has a first flange portion protruding in a radial direction from an outer circumferential surface of a front portion located inside the cylinder.
However, Lord teaches a piston which strikes a diaphragm comprising a greater diameter energy transfer portion 203 extending from a reduced diameter strike pin portion 202, see paragraph 40 and fig 5-6.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement Lord’s narrow piston base and wide mating face teachings to the modified piston of Slate, such that Slate’s ram 56 is thinned relative to its face which mates with Slate’s diaphragm 70, in order to advantageously arrive at an invention which minimizes an inertia of the piston which must be overcome for each actuation cycle of the piston by eliminating material along the base of the piston which does not contribute to transferring energy to the diaphragm it mates with.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Slate in view of Yoh, Gamliel, and Schmitt , and further in view of KR 20120077038 A, henceforth written as Kwon.
Regarding Claim 12,
Slate in view of Yoh, Gamliel, and Schmitt discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However it is silent regarding:
further comprising a cooling chamber provided to surround an outside of the solenoid coil from an outside of the body, to absorb heat generated in the solenoid coil through a cooling fluid and to cool the solenoid coil.
However, Kwon teaches a solenoid coil
further comprising a cooling chamber provided to surround an outside of the solenoid coil from an outside of the body, to absorb heat generated in the solenoid coil through a cooling fluid and to cool the solenoid coil.
(paragraph 31-32; solenoid coil 310 is cooled via cooling fluid (not enumerated/illustrated) in a cooling passage 410; fig 1-2)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement the cooling system taught by Kwon to the modified invention of Slate in view of Yoh, Gamliel, and Schmitt in order arrive at an invention which advantageously inhibits heat transfer from a solenoid coil to a delicate elements contained in the invention which have a high risk of degrading if exposed to excessive heat, such as therapeutic media and springs.
Conclusion
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/FORREST B DIPERT/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783