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 .
Claims 1, 4, 7, 8, 11, 12, 17, and 18 are currently amended.
Claim 3 is cancelled.
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.
Claim(s) 1, 12, 17, and 18 is/are rejected under 35 U.S.C. 102(1) as being anticipated by Gu et al. (KR 20190091160 A).
Regarding claim 1, Gu discloses a needless syringe (“… skin treatment apparatus …” – Para [0023]), comprising:
a body (housing body 111, Fig. 2);
a solenoid coil (coil unit 146, Fig. 4) wound on an outer circumferential surface of the body ("The coil portion 146 is disposed around the center yoke portion 144." - Para [0045]);
a cylinder (housing cap, 115, Fig. 2) coupled to the body ("The housing 110 includes a housing body 111 and a housing cap 115." - Para [0025]) to be in communication with an open front surface of the body ("... The housing cap 115 may be separated and coupled with the housing body 111 …" - Para [0026]) and comprising a drug accommodating portion in which the drug is accommodated (drug storage unit 116, Fig. 2) ("The drug storage unit 116 is formed in the housing 110 to store the drug." - Para [0024]), and a nozzle portion (See annotated Fig. 2) injecting the drug accommodated in the drug accommodating portion forward ("An opening hole 118 is formed at a vertex of the housing cap 115 so that the needle 121 of the needle part 120 passe through and injects a chemical into the skin." - Para [0027]);
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a moving magnetic body (solenoid part 142, Fig. 1) that is inserted into the body in a longitudinal direction (Fig. 1) and moves forward by a magnetic force generated when a current is applied to the solenoid coil ("The solenoid part 142 is connected to the moving shaft 141, and is reciprocated as the direction of the current supplied from the power supply 150 is converted." - Para [0040])(("… the power supply unit 150 supplies current to the coil unit 146 of the driving unit 140 ..." - Para [0040]);
a stationary magnet (stationary magnet 145, Fig. 1) that is inserted and fixed behind the moving body (center yoke unit 144, Fig. 1) inside the body (Fig. 4);
a piston (power transmission unit 130, Fig. 2) that is inserted in front of the moving magnetic body (solenoid part 142) inside the body (Fig. 4) and pressurizes the drug in the drug accommodating portion by an impulse applied by forward movement of the moving magnetic body when the moving magnetic body moves forward ("When the solenoid hits the power transmission unit 130 toward the needle unit 120, the shock plate of the power transmission unit 130 moves the buffer member of the needle unit 120 … as the shock absorbing member 122 of the needle part 120 is hit by the impact plate, the needle 121 protrudes ... to penetrate the skin. When the needle 121 penetrate the skin, the drug storage unit is injected into the skin." - Para [0057]);
a nozzle portion opening/closing valve ("The chemical supply hole 116a is provided with an opening and closing cover (not shown) to seal the chemical storage unit 116 with the outside." - Para [0029]) that is provided to open/close a passage hole (chemical supply hole 116a, Fig. 2) between the nozzle portion (See annotated Fig. 2 above) and the drug accommodating portion (drug storage unit 116, Fig. 2), the passage hole being a hole through which the drug accommodated in the drug accommodating portion flows to the nozzle portion ("… the drug stored in the drug storage part 116 is the needle when the needle 121 is penetrated into the skin … the depth of penetration of the needle 121 into the skin is determined, so that the drug may be injected into various places …" - Para [0030]); and
a forward/backward driving unit (power supply unit 150, Fig. 2) that repeats the supply and cut-off of current to the solenoid coil at a preset period ("… when the current is … not supplied to the first coil unit 146a …" - Para [0046]), thereby repeating the forward movement and the backward movement of the piston ("The power supply unit 150 is disposed in the housing 110 and reciprocates the driving unit 140 as the direction of the current supplied to the driving unit 140 is changed." - Para [0037]),
wherein the solenoid coil (coil unit 146, Fig. 4) comprises:
a first coil (first coil unit 146a, Fig. 4), which is wound on front of the outer circumferential surface of the body ("The coil portion 146 is disposed around the center yoke portion 144." - Para [0045]), to which a current is applied ("The current is separately applied to the first coil portion 146a and the second coil portion 146b." - Para [0045]) during forward movement of the piston and generates a magnetic force in a forward movement direction of the piston ("… the power supply unit 150 supplies current to the coil unit 146 of the driving unit 140 in one direction. When the current is supplied to the coil unit 146 in one direction, the solenoid unit 142 is moved toward the power transmission unit 130." - Para [0056]); and
wherein the forward/backward driving unit (power supply unit 150, Fig. 2) comprises;
a current supply unit that repeatedly supplies a current to the first coil during forward movement of the piston to move the moving magnetic body forward (power supply unit 150, Fig. 2) ("… the power supply unit supplies current to the coil unit 146 of the driving unit 140 in one direction. When the current is supplied to the coil unit 146 in one direction, the solenoid unit 142 is moved toward the power transmission unit 130." - Para [0056]) and repeatedly cuts off supply of current to the first coil ("… when the current is … not supplied to the first coil unit 146a …" - Para [0046]) during backward movement of the piston ("… when a current is supplied to the coil portion 146 of the solenoid portion 142 in a direction opposite to that of the skin treatment, an induction magnetic field is formed around the coil portion 146 in the opposite direction." - Para [0059]) to move the moving magnetic body backward due to a magnetic field of the stationary magnet ("The solenoid portion 142 is returned from the skin to the original position by the induced magnetic field." - Para [0059]).
Examiner interprets the limitation of a needless syringe is only recited within the preamble and is therefore, interpreted as describing the intended use of the claimed invention. However, if applicant argues that the preamble is a recitation of structural limitations, Examiner relies on Gamliel to teach that a needless syringe (needleless injection device 10, Fig. 1) is known in the art.
Regarding claim 12, Gu discloses the needleless syringe (“… skin treatment apparatus …” – Para [0023]) as recited above, wherein
the current supply unit (power supply unit 150, Fig. 2) supplies the current supplied from an external power supply source (… the external power source is connected to … the power supply unit 150 …" - Para [0038]) to the first coil ("… the power supply unit supplies current to the coil unit 146 of the driving unit 140 in one direction …" - Para [0056]).
Regarding claim 17. Gu discloses a needleless syringe (“… skin treatment apparatus …” – Para [0023]) comprising:
a body (housing body 111, Fig. 2);
a solenoid coil (coil unit 146, Fig. 4) wound on an outer circumferential surface of the body ("The coil portion 146 is disposed around the center yoke portion 144." - Para [0045]);
a cylinder (housing cap, 115, Fig. 2) coupled to the body ("The housing 110 includes a housing body 111 and a housing cap 115." - Para [0025]) to be in communication with an open front surface of the body ("... The housing cap 115 may be separated and coupled with the housing body 111 …" - Para [0026]) and comprising a drug accommodating portion in which a drug is accommodated (drug storage unit 116, Fig. 2) ("The drug storage unit 116 is formed in the housing 110 to store the drug." - Para [0024]), and a nozzle portion (See annotated Fig. 2 above) injecting the drug accommodated in the drug accommodating portion forward ("An opening hole 118 is formed at a vertex of the housing cap 115 so that the needle 121 of the needle part 120 passe through and injects a chemical into the skin." - Para [0027]);
a moving magnetic body (solenoid part 142, Fig. 1) that is inserted into the body in a longitudinal direction (Fig. 1) and moves forward by a first magnetic force generated when a current is applied to the solenoid coil ("The solenoid part 142 is connected to the moving shaft 141, and is reciprocated as the direction of the current supplied from the power supply 150 is converted." - Para [0040])(("… the power supply unit 150 supplies current to the coil unit 146 of the driving unit 140 ..." - Para [0040]);
a stationary magnet (stationary magnet 145, Fig. 1) that is inserted behind the moving magnetic body inside the body (Fig. 4) and has a second magnetic force to pull the moving magnetic body when supply of current to the solenoid coil is cut off ("… when a current is supplied to the coil portion 146 of the solenoid portion 142 in a direction opposite to that of the skin treatment, an induction magnetic field is formed around the coil portion 146 in the opposite direction." - Para [0059]), to move the solenoid portion 142 backward ("The solenoid portion 142 is returned from the skin to the original position by the induced magnetic field." - Para [0059]);
a piston (transmission unit 130, Fig. 1) that is inserted in front of the moving magnetic body inside the body (Fig. 4) and pressurizes the drug in the drug accommodating portion by an impulse applied by forward movement of the moving magnetic body when the moving magnetic body moves forward ("When the solenoid hits the power transmission unit 130 toward the needle unit 120, the shock plate of the power transmission unit 130 moves the buffer member of the needle unit 120 … as the shock absorbing member 122 of the needle part 120 is hit by the impact plate, the needle 121 protrudes ... to penetrate the skin. When the needle 121 penetrate the skin, the drug storage unit is injected into the skin." - Para [0057]);
a nozzle portion opening/closing valve ("The chemical supply hole 116a is provided with an opening and closing cover (not shown) to seal the chemical storage unit 116 with the outside." - Para [0029]) that is provided to open/close a passage hole (chemical supply hole 116a, Fig. 2) between the nozzle portion (See annotated Fig. 2 above) and the drug accommodating portion (drug storage unit 116, Fig. 2), the passage hole being a hole through which the drug accommodated in the drug accommodating portion flows to the nozzle portion; and
a forward/backward driving unit (power supply unit 150, Fig. 2) that repeats supply and cut-off of current to the solenoid coil at a preset period, thereby repeating forward movement and backward movement of the piston ("The power supply unit 150 is disposed in the housing 110 and reciprocates the driving unit 140 as the direction of the current supplied to the driving unit 140 is changed." - Para [0037]) ("… when the current is … not supplied to the first coil unit 146a …" - Para [0046]),
wherein the forward/backward driving unit comprises (power supply unit 150, Fig. 2):
a current supply unit (power supply unit 150, Fig. 2) that repeatedly supplies a current to the solenoid coil to generate the first magnetic force greater than the second magnetic force during forward movement of the piston ("… the power supply unit supplies current to the coil unit 146 of the driving unit 140 in one direction. When the current is supplied to the coil unit 146 in one direction, the solenoid unit 142 is moved toward the power transmission unit 130." - Para [0056]) and repeatedly cuts off supply of current to the solenoid coil during backward movement of the piston ("… when the current is … not supplied to the first coil unit 146a …" - Para [0046]) ("… when a current is supplied to the coil portion 146 of the solenoid portion 142 in a direction opposite to that of the skin treatment, an induction magnetic field is formed around the coil portion 146 in the opposite direction." - Para [0059]).
Regarding claim 18, Gu discloses a needleless syringe (“… skin treatment apparatus …” – Para [0023]) comprising:
a body (housing body 111, Fig. 2);
a solenoid coil (coil unit 146, Fig. 4) wound on an outer circumferential surface of the body ("The coil portion 146 is disposed around the center yoke portion 144." - Para [0045]);
a cylinder (housing cap, 115, Fig. 2) coupled to the body ("The housing 110 includes a housing body 111 and a housing cap 115." - Para [0025]) to be in communication with an open front surface of the body ("... The housing cap 115 may be separated and coupled with the housing body 111 …" - Para [0026]) and comprising a drug accommodating portion in which a drug is accommodated (drug storage unit 116, Fig. 2) ("The drug storage unit 116 is formed in the housing 110 to store the drug." - Para [0024]), and a nozzle portion (See annotated Fig. 2 above) injecting the drug accommodated in the drug accommodating portion forward ("An opening hole 118 is formed at a vertex of the housing cap 115 so that the needle 121 of the needle part 120 passe through and injects a chemical into the skin." - Para [0027]);
a moving magnetic body (solenoid part 142, Fig. 2) that is inserted into the body in a longitudinal direction (Fig. 1) and moves forward by a first magnetic force generated when a current in a preset first direction is applied to the solenoid coil ("The solenoid part 142 is connected to the moving shaft 141, and is reciprocated as the direction of the current supplied from the power supply 150 is converted." - Para [0040]);
a stationary magnet (stationary magnet 145, Fig. 1) that is inserted behind the moving magnetic body inside the body (Fig. 1) and has a second magnetic force to pull the moving magnetic body ("… when a current is supplied to the coil portion 146 of the solenoid portion 142 in a direction opposite to that of the skin treatment, an induction magnetic field is formed around the coil portion 146 in the opposite direction." - Para [0059]) when supply of current to the solenoid coil is cut off ("… when the current is … not supplied to the first coil unit 146a …" - Para [0046]), to move the moving magnetic body backward ("The solenoid portion 142 is returned from the skin to the original position by the induced magnetic field." - Para [0059]);
a piston (transmission unit 130, Fig. 1) that is inserted in front of the moving magnetic body inside the body (Fig. 4) and pressurizes the drug in the drug accommodating portion by an impulse applied by forward movement of the moving magnetic body when the moving magnetic body moves forward ("When the solenoid hits the power transmission unit 130 toward the needle unit 120, the shock plate of the power transmission unit 130 moves the buffer member of the needle unit 120 … as the shock absorbing member 122 of the needle part 120 is hit by the impact plate, the needle 121 protrudes ... to penetrate the skin. When the needle 121 penetrate the skin, the drug storage unit is injected into the skin." - Para [0057]);
a nozzle portion opening/closing valve ("The chemical supply hole 116a is provided with an opening and closing cover (not shown) to seal the chemical storage unit 116 with the outside." - Para [0029]) that is provided to open/close a passage hole (chemical supply hole 116a, Fig. 2) between the nozzle portion (See annotated Fig. 2 above) and the drug accommodating portion (drug storage unit 116, Fig. 2), the passage hole being a hole through which the drug accommodated in the drug accommodating portion flows to the nozzle portion; and
a forward/backward driving unit (power supply unit 150, Fig. 2) that repeats supply and cut-off of current to the solenoid coil at a preset period, thereby repeating forward movement and backward movement of the piston ("The power supply unit 150 is disposed in the housing 110 and reciprocates the driving unit 140 as the direction of the current supplied to the driving unit 140 is changed." - Para [0037]) ("… when the current is … not supplied to the first coil unit 146a …" - Para [0046]),
wherein the forward/backward driving unit comprises (power supply unit 150, Fig. 2):
a current supply unit (power supply unit 150, Fig. 2) that repeatedly supplies the current in the first direction to the solenoid coil to generate the first magnetic force (dynamic magnetic field, Fig. 4)) greater than the second magnetic force (static magnetic field, Fig. 4) during forward movement of the piston ("… the power supply unit supplies current to the coil unit 146 of the driving unit 140 in one direction. When the current is supplied to the coil unit 146 in one direction, the solenoid unit 142 is moved toward the power transmission unit 130." - Para [0056]) and repeatedly supplies a current in a second direction opposite to the first direction to the solenoid coil ("… when a current is supplied to the coil portion 146 of the solenoid portion 142 in a direction opposite to that of the skin treatment, an induction magnetic field is formed around the coil portion 146 in the opposite direction." - Para [0059]) during backward movement of the piston ("The solenoid portion 142 is returned from the skin to the original position by the induced magnetic field." - Para [0059]).
Claim Rejections - 35 USC § 103
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 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) 2, 4, 8, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gu et al. (KR 20190091160 A) in view of Chuang et al. (CN 110167615 A) and Gamliel et al. (EP 3294384 B10.
Regarding claim 2, Gu discloses the needleless (“… skin treatment apparatus …” – Para [0023]) as recited above, wherein
the current supply unit (power supply unit 150, Fig. 2) applies a current to the first coil for a first preset time and then cuts off supply of current ("… when the current is supplied or not supplied to the first coil unit 146a …" - Para [0046]),
Gu does not expressly disclose a mass of the moving magnetic body is 100 g or less, and the first preset time is set to be 180 ms or less.
Chuang teaches that a mass of the moving magnetic body is 100 g or less ("… the total weight of the syringe is less than 50 grams …" - Para [0049])
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the needless syringe of Gu to include that a mass of the moving magnetic body is 100 g or less as taught by Chuang for needleless delivery of injection (Chuang, Para [0124]).
Chuang does not expressly disclose that the first preset time is set to be 180 ms or less.
Gamliel teaches that the first preset time is set to be 180 ms or less ("… the cycle may be about 1 millisecond.' - Para [0039]) ("… a cycle time refers to the period of time from application of a pressure pulse until the repetitive needleless injection device and the impulse generator are ready to apply another pulse." - Para [0039]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the needleless syringe of Gu to include that the first preset time is set to be 180 ms or less as taught by Gamliel so the pressurized liquid may exit from the pressure cell (Gamliel, Para [0045]).
Regarding claim 4, Gu discloses a needleless syringe (“… skin treatment apparatus …” – Para [0023]), comprising
a body (housing body 111, Fig. 2);
a solenoid coil (coil unit 146, Fig. 4) wound on an outer circumferential surface of the body ("The coil portion 146 is disposed around the center yoke portion 144." - Para [0045]);
a cylinder (housing cap, 115, Fig. 2) coupled to the body ("The housing 110 includes a housing body 111 and a housing cap 115." - Para [0025]) to be in communication with an open front surface of the body ("... The housing cap 115 may be separated and coupled with the housing body 111 …" - Para [0026]) and comprising a drug accommodating portion in which a drug is accommodated (drug storage unit 116, Fig. 2) ("The drug storage unit 116 is formed in the housing 110 to store the drug." - Para [0024]), and a nozzle portion (See annotated Fig. 2 above) injecting the drug accommodated in the drug accommodating portion forward ("An opening hole 118 is formed at a vertex of the housing cap 115 so that the needle 121 of the needle part 120 passe through and injects a chemical into the skin." - Para [0027]);
a moving magnetic body (solenoid part 142, Fig. 2) that is inserted into the body in a longitudinal direction (Fig. 1) and reciprocates forward and backward by a magnetic force generated when a current is applied to the solenoid coil ("The solenoid part 142 is connected to the moving shaft 141, and is reciprocated as the direction of the current supplied from the power supply 150 is converted." - Para [0040])(("… the power supply unit 150 supplies current to the coil unit 146 of the driving unit 140 ..." - Para [0040]);
a stationary magnetic body (stationary magnet 145, Fig. 1) that is inserted behind the moving magnetic body inside the body (Fig. 1) and has magnetism by a magnetic force generated when a current is applied to the solenoid coil and is fixed (“… when the current is supplied or not supplied to the first coil unit 146a and the second coil unit 146b, the center yoke unit 144, the outer yoke unit 147, and the side yoke unit 148 may have a static magnetic field ( static magnetic field) is formed (dashed arrow in FIG. 4).” – Para [0046]).
a piston (transmission unit 130, Fig. 1) that is inserted in front of the moving magnetic body inside the body (Fig. 4) and pressurizes the drug in the drug accommodating portion by an impulse applied by forward movement of the moving magnetic body when the moving magnetic body moves forward ("When the solenoid hits the power transmission unit 130 toward the needle unit 120, the shock plate of the power transmission unit 130 moves the buffer member of the needle unit 120 … as the shock absorbing member 122 of the needle part 120 is hit by the impact plate, the needle 121 protrudes ... to penetrate the skin. When the needle 121 penetrate the skin, the drug storage unit is injected into the skin." - Para [0057]);
a nozzle portion opening/closing valve ("The chemical supply hole 116a is provided with an opening and closing cover (not shown) to seal the chemical storage unit 116 with the outside." - Para [0029]) that is provided to open/close a passage hole (chemical supply hole 116a, Fig. 2) between the nozzle portion (See annotated Fig. 2 above) and the drug accommodating portion (drug storage unit 116, Fig. 2), the passage hole being a hole through which the drug accommodated in the drug accommodating portion flows to the nozzle portion; and
a forward/backward driving unit (power supply unit 150, Fig. 2) that repeats supply and cut-off of current to the solenoid coil at a preset period, thereby repeating forward movement and backward movement of the piston ("The power supply unit 150 is disposed in the housing 110 and reciprocates the driving unit 140 as the direction of the current supplied to the driving unit 140 is changed." - Para [0037]),
wherein the solenoid coil (coil unit 146, Fig. 4) comprises:
a first coil (first coil unit 146a, Fig. 4), which is wound on front of the outer circumferential surface of the body ("The coil portion 146 is disposed around the center yoke portion 144." - Para [0045]), to which a current is applied ("The current is separately applied to the first coil portion 146a and the second coil portion 146b." - Para [0045]) during forward movement of the piston and generates a magnetic force in a forward movement direction of the moving magnetic body ("… the power supply unit 150 supplies current to the coil unit 146 of the driving unit 140 in one direction. When the current is supplied to the coil unit 146 in one direction, the solenoid unit 142 is moved toward the power transmission unit 130." - Para [0056]); and
a second coil (second coil unit 146b, Fig. 4), which is wound on rear of the first coil on the outer circumferential surface of the body ("… a first coil unit 146a disposed on one side of the permanent magnet 145 and a second coil unit 146b disposed on the other side of the permanent magnet 145." - Para [0045]), to which a current is applied during backward movement of the piston ("… the power supply unit 150 supplies current to the coil unit 146 of the driving unit 140 in one direction." - Para [0056]) and which generates a magnetic force to magnetize the stationary magnetic body (“At this time, the static magnetic field is formed around the … the second coil portion 146b … and the permanent magnet 145 …” – Para [0047]), and
wherein the forward/backward driving unit (power supply unit 150, Fig. 2) comprises:
a current supply unit that repeatedly supplies a current to the first coil to move the moving magnetic body forward (power supply unit 150, Fig. 2) ("… the power supply unit supplies current to the coil unit 146 of the driving unit 140 in one direction. When the current is supplied to the coil unit 146 in one direction, the solenoid unit 142 is moved toward the power transmission unit 130." - Para [0056]) and cuts off supply of current to the second coil during forward movement of the piston ("… when the current is … not supplied to … the second coil unit 146b …" - Para [0046]) and that repeatedly cuts off supply of current to the first coil ("… when the current is … not supplied to the first coil unit 146a …" - Para [0046]) and supplies a current to the second coil to move the moving magnetic body backward due to the magnetic field of the stationary magnetic body ("… when a current is supplied to the coil portion 146 of the solenoid portion 142 in a direction opposite to that of the skin treatment, an induction magnetic field is formed around the coil portion 146 in the opposite direction." - Para [0059]) during backward movement of the piston ("The solenoid portion 142 is returned from the skin to the original position …" - Para [0059]); and
the current supply unit (power supply unit 150, Fig. 2) applies a current to the first coil for a first preset time and then cuts off supply of current ("… when the current is supplied or not supplied to the first coil unit 146a …" - Para [0046]),
Gu does not expressly disclose a mass of the moving magnetic body is 100 g or less, and the first preset time is set to be 180 ms or less.
Chuang teaches that a mass of the moving magnetic body is 100 g or less ("… the total weight of the syringe is less than 50 grams …" - Para [0049])
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the needless syringe of Gu to include that a mass of the moving magnetic body is 100 g or less as taught by Chuang for needleless delivery of injection (Chuang, Para [0124]).
Chuang does not expressly disclose that the first preset time is set to be 180 ms or less.
Gamliel teaches that the first preset time is set to be 180 ms or less ("… the cycle may be about 1 millisecond.' - Para [0039]) ("… a cycle time refers to the period of time from application of a pressure pulse until the repetitive needleless injection device and the impulse generator are ready to apply another pulse." - Para [0039]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the needleless syringe of Gu to include that the first preset time is set to be 180 ms or less as taught by Gamliel so the pressurized liquid may exit from the pressure cell (Gamliel, Para [0045]).
Regarding claim 8, Gu discloses the needleless syringe (“… skin treatment apparatus …” – Para [0023]) as recited above, further comprising
a flange portion (stopper 149, Fig. 1) that protrudes in a radial direction (Fig. 1) ("The stopper 149 may be formed in a disk shape …" - Para [0052]) and is formed on an outer circumferential surface of the piston ("The solenoid portion 142 further includes a stopper 149 …" - Para [0052]) and a blocker (transmission unit 130, Fig. 3) that is provided between the piston and the cylinder (See annotated Fig. 1) and limits a forward movement distance of the piston due to the flange portion blocked when the piston moves forward (“… the stopper 149 limit the reciprocating distance of the solenoid portion 142 …” – Para [0052]).
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Regarding claim 13, Gu discloses the needleless syringe (“… skin treatment apparatus …” – Para [0023]) as recited above, wherein
the current supply unit (power supply unit 150, Fig. 2) supplies the current supplied from an external power supply source (… the external power source is connected to … the power supply unit 150 …" - Para [0038]) to the first coil and the second coil ("… the power supply unit supplies current to the coil unit 146 of the driving unit 140 in one direction …" - Para [0056]).
Claim(s) 5 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gu et al. (KR 20190091160 A) in view of Velis et al. (WO 2018085212 A1).
Regarding claim 5, Gu discloses the needleless (“… skin treatment apparatus …” – Para [0023]) as recited above, further comprising
a cooling chamber that is provided to surround an outside of the solenoid coils (coil unit 146, Fig. 2) … and absorbs and cools heat generated in the solenoid coil (coil unit 146, Fig. 2)
Gu does not expressly disclose a cooling chamber that is provided to surround an outside of the solenoid coil on an outside of the body and absorbs and cools heat generated in the solenoid coil through a cooling fluid.
Velis teaches a cooling chamber (cooling sleeve 600, Fig. 7) that is provided to surround an outside of the interior chamber (interior chamber 640, Fig. 1) on an outside of the body (cylindrical body 110, Fig. 7) and absorbs and cools heat generated in the interior chamber ("… a cooling sleeve 600 that surrounds the cylindrical member 110 and cools or maintains a temperature of the cold slurry within the interior lumen 130." – Page 19, Para [2]) through a cooling fluid ("The cooling sleeve 600 can provide cooling through any number of mechanisms, such as through the use of circulating refrigerant …" - Page 19, Para [2])
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the needleless syringe of Gu to include a cooling chamber that is provided to surround an outside of the solenoid coil on an outside of the body and absorbs and cools heat generated in the solenoid coil through a cooling fluid as taught by Velis to cool or maintain a temperature (Velis, Abstract).
Regarding claim 19, Gu discloses the needleless syringe (“… skin treatment apparatus …” – Para [0023]) as recited above, further comprising
a cooling chamber that is provided to surround an outside of the solenoid coils (coil unit 146, Fig. 2) … and absorbs and cools heat generated in the solenoid coil (coil unit 146, Fig. 2)
Gu does not expressly disclose a cooling chamber that is provided to surround an outside of the solenoid coil on an outside of the body and absorbs and cools heat generated in the solenoid coil through a cooling fluid.
Velis teaches a cooling chamber (cooling sleeve 600, Fig. 7) that is provided to surround an outside of the interior chamber (interior chamber 640, Fig. 1) on an outside of the body (cylindrical body 110, Fig. 7) and absorbs and cools heat generated in the interior chamber ("… a cooling sleeve 600 that surrounds the cylindrical member 110 and cools or maintains a temperature of the cold slurry within the interior lumen 130." – Page 19, Para [2]) through a cooling fluid ("The cooling sleeve 600 can provide cooling through any number of mechanisms, such as through the use of circulating refrigerant …" - Page 19, Para [2])
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the needleless syringe of Gu to include a cooling chamber that is provided to surround an outside of the solenoid coil on an outside of the body and absorbs and cools heat generated in the solenoid coil through a cooling fluid as taught by Velis to cool or maintain a temperature (Velis, Abstract).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gu et al. (KR 20190091160 A) in view of Chuang et al. (CN 110167615 A), Gamliel et al. (EP 3294384 B10), and in further view of Velis et al. (WO 2018085212 A1).
Regarding claim 6, Gu discloses the needleless syringe (“… skin treatment apparatus …” – Para [0023]) as recited above, further comprising
a cooling chamber that is provided to surround an outside of the solenoid coils (coil unit 146, Fig. 2) … and absorbs and cools heat generated in the solenoid coil (coil unit 146, Fig. 2)
Gu does not expressly disclose a cooling chamber that is provided to surround an outside of the solenoid coil on an outside of the body and absorbs and cools heat generated in the solenoid coil through a cooling fluid.
Velis teaches a cooling chamber (cooling sleeve 600, Fig. 7) that is provided to surround an outside of the interior chamber (interior chamber 640, Fig. 1) on an outside of the body (cylindrical body 110, Fig. 7) and absorbs and cools heat generated in the interior chamber ("… a cooling sleeve 600 that surrounds the cylindrical member 110 and cools or maintains a temperature of the cold slurry within the interior lumen 130." – Page 19, Para [2]) through a cooling fluid ("The cooling sleeve 600 can provide cooling through any number of mechanisms, such as through the use of circulating refrigerant …" - Page 19, Para [2])
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the needleless syringe of Gu to include a cooling chamber that is provided to surround an outside of the solenoid coil on an outside of the body and absorbs and cools heat generated in the solenoid coil through a cooling fluid as taught by Velis to cool or maintain a temperature (Velis, Abstract).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gu et al. (KR 20190091160 A) in view of Yamada et al. (US Patent No. 10806863 B20).
Regarding claim 7, Gu discloses the needleless syringe (“… skin treatment apparatus …” – Para [0023]) as recited above, further comprising
a flange portion (stopper 149, Fig. 1) that protrudes in a radial direction (Fig. 1) ("The stopper 149 may be formed in a disk shape …" - Para [0052]) and is formed on an outer circumferential surface of the piston ("The solenoid portion 142 further includes a stopper 149 …" - Para [0052]) and a blocker (transmission unit 130, Fig. 3) that is provided between the piston and the cylinder (See annotated Fig. 1 above) and limits a forward movement distance of the piston due to the flange portion blocked when the piston moves forward. blocker ("The nut part 134 is screwed to the bolt part 133 …" - Para [0034]), adjusts a coupling length at which the length adjustment blocker is coupled to the fixed blocker ("As the adjusting ring part 135b is rotated, the nut part 134 moves in the bolt part 133 …" - Para [0055]), Fig. 3a and 3b).
Gu does not expressly disclose that a blocker limits a forward movement distance of the piston due to the flange portion blocked when the piston moves forward, and that a length adjustment blocker protrudes backward so that the flange portion is blocked by the length adjustment blocker
Yamada teaches that a blocker (front end surface, 4a1, Fig. 1) limits a forward movement distance of the piston due to the flange portion blocked when the piston moves forward ("… the piston 14 collides with the inner wall surface of the front end surface 4a1, and the movement of the piston 14 is suddenly stopped." – Col. 13 Lines 29-31), and that a length adjustment blocker protrudes backward (front end surface, 4a1, Fig. 1) so that the flange portion is blocked by the length adjustment blocker ("… the piston 14 collides with the inner wall surface of the front end surface 4a1, and the movement of the piston 14 is suddenly stopped." - Col. 13 Lines 29-31).
Claim(s) 9 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gu et al. (KR 20190091160 A) in view of Young-bok et al. (KR 102225578 B1).
Regarding claim 9, Gu discloses the needleless syringe (“… skin treatment apparatus …” – Para [0023]) as recited above, wherein
Gu does not expressly disclose that a drug supply hole for supplying the drug from the outside by a pressure difference generated when the piston moves backward, is formed in the drug accommodating portion.
Young-bok teaches that a drug supply hole (See annotated Fig. 1) for supplying the drug from the outside ("The injection device main body 110 and the drug chamber 140 may be connected by a supply pipe 150 for supplying a drug." - Para [0037]) by a pressure difference generated when the piston moves backward ("… the piston 120 is returned to the first space 111 … and the volume of the second space 112 is increased again, and accordingly the drug in the drug chamber 140 is transferred to the second space due to atmospheric pressure." - Para [0037], Fig. 1), is formed in the drug accommodating portion (infusion tube 5, Fig. 3).
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Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the needleless syringe of Gu to include that a drug supply hole for supplying the drug from the outside by a pressure difference generated when the piston moves backward, is formed in the drug accommodating portion as taught by Young-bok so the drug is injected by moving a piston in the injection device (Young-bok, Para [0002]).
Regarding claim 16, Gu discloses the needleless syringe (“… skin treatment apparatus …” – Para [0023]) as recited above, further comprising
Gu does not expressly disclose that an elastic member … applies an elastic force in a backward movement direction to the piston when the moving magnetic body (solenoid part 142, Fig. 2) moves backward.
Young-bok teaches that an elastic member (elastic member 217, Fig. 2) that is installed between the piston (piston 220, Fig. 2) and the cylinder (device main body 210, Fig. 2) and applies an elastic force in a backward movement direction to the piston ("After the piston 220 maximally moves toward the second space 212 to inject the drug, the piston 220 returns to the first space 211 by the elastic force of the elastic member 217." - Para [0048]) when the piston moves backward ("… the piston 220 returns to the first space 211 …" - Para [0048]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the needleless syringe of Gu to include that an elastic member that is installed between the piston and the cylinder and applies an elastic force in a backward movement direction to the piston when the moving magnetic body moves backward as taught by Young-bok so the piston is movable along the longitudinal direction of the main body of the injection device (Young-bok, Abstract).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gu et al. (KR 20190091160 A) in view of Chuang et al. (CN 110167615 A), Gamliel et al. (EP 3294384 B10), and in further view of Young-bok et al. (KR 102225578 B1).
Regarding claim 10, Gu discloses the needleless syringe (“… skin treatment apparatus …” – Para [0023]) as recited above, wherein
Gu does not expressly disclose that a drug supply hole for supplying the drug from the outside by a pressure difference generated when the piston moves backward, is formed in the drug accommodating portion.
Young-bok teaches that a drug supply hole (See annotated Fig. 1 above) for supplying the drug from the outside ("The injection device main body 110 and the drug chamber 140 may be connected by a supply pipe 150 for supplying a drug." - Para [0037]) by a pressure difference generated when the piston moves backward ("… the piston 120 is returned to the first space 111 … and the volume of the second space 112 is increased again, and accordingly the drug in the drug chamber 140 is transferred to the second space due to atmospheric pressure." - Para [0037], Fig. 1), is formed in the drug accommodating portion (infusion tube 5, Fig. 3).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the needleless syringe of Gu to include that a drug supply hole for supplying the drug from the outside by a pressure difference generated when the piston moves backward, is formed in the drug accommodating portion as taught by Young-bok so the drug is injected by moving a piston in the injection device (Young-bok, Para [0002]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gu et al. (KR 20190091160 A) in view of Gamliel (EP 3294384 B1).
Regarding claim 11, Gu discloses the needleless syringe (“… skin treatment apparatus …” – Para [0023]) as recited above, wherein
Gu does not expressly disclose that the nozzle portion opening/closing valve opens the passage hole with a fluidic pressure applied by the drug from the drug accommodating portion when the piston moves forward, and closes the passage holes when the fluidic pressure is released.
Gamliel teaches that the nozzle portion opening/closing valve (inlet valve stopper 92, Fig. 6D) opens the passage hole (inlet valve aperture 95, Fig. 6D) with a fluidic pressure applied by the drug ("As plunger rod 82 is retracted, flow of liquid from reservoir 32 via inlet conduit 34 into pressure cell 24 may separate inlet valve stopper 92 from inlet valve aperture 95." - Para [0122]) from the drug accommodating portion (pressure cell 24, Fig. 6D) when the piston moves forward ("Plunger rod 82 is being pushed distally toward orifice 27." - Para [0118]), and closes the passage holes when the fluidic pressure is released ("… restoration forces may act to return inlet valve stopper 92 to inlet valve aperture 95. When inlet valve stopper 92 has returned to inlet valve aperture 95, the state shown in Fig. 6A is restored." - Para [0125]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the needleless syringe of Gu to include that the nozzle portion opening/closing valve opens the passage hole with a fluidic pressure applied by the drug from the drug accommodating portion when the piston moves forward, and closes the passage holes when the fluidic pressure is released as taught by Gamliel for ejection of another liquid (Gamliel, Para [0125]).
Claim(s) 14 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gu et al. (KR 20190091160 A) in view of Tashjian et al. (WO 2019239384 A1).
Regarding claim 14, Gu discloses the needleless syringe (“… skin treatment apparatus …” – Para [0023]) as recited above, further comprising
Gu does not expressly disclose a piston cover that is provided inside the cylinder to cover an end portion of the piston
Tashjian teaches a piston cover (flexible seal 310, Fig. 13A) that is provided inside the cylinder (body 200, Fig. 13A) to cover an end portion of the piston ("The flexible seal 310 is coupled to a proximal region of the body 200 of the syringe, and expands over at least the distal end of the piston as the plunger 300 is moved distally." - Para [114]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the needleless syringe of Gu to include a piston cover that is provided inside the cylinder to cover an end portion of the piston as taught by Tashjian for the maintenance of a sterile pathway within the cavity volume (Tashjian, Para [40]).
Regarding claim 20, Gu discloses the needleless syringe (“… skin treatment apparatus …” – Para [0023]) as recited above, further comprising
Gu does not expressly disclose a piston cover that is provided inside the cylinder to cover an end portion of the piston
Tashjian teaches a piston cover (flexible seal 310, Fig. 13A) that is provided inside the cylinder (body 200, Fig. 13A) to cover an end portion of the piston ("The flexible seal 310 is coupled to a proximal region of the body 200 of the syringe, and expands over at least the distal end of the piston as the plunger 300 is moved distally." - Para [114]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the needleless syringe of Gu to include a piston cover that is provided inside the cylinder to cover an end portion of the piston as taught by Tashjian for the maintenance of a sterile pathway within the cavity volume (Tashjian, Para [40]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gu et al. (KR 20190091160 A) in view of Chuang et al. (CN 110167615 A), Gamliel et al. (EP 3294384 B10), and in further view of Tashjian et al. (WO 2019239384 A1).
Regarding claim 15, Gu discloses the needleless syringe (“… skin treatment apparatus …” – Para [0023]) as recited above, further comprising
Gu does not expressly disclose a piston cover that is provided inside the cylinder to cover an end portion of the piston
Tashjian teaches a piston cover (flexible seal 310, Fig. 13A) that is provided inside the cylinder (body 200, Fig. 13A) to cover an end portion of the piston ("The flexible seal 310 is coupled to a proximal region of the body 200 of the syringe, and expands over at least the distal end of the piston as the plunger 300 is moved distally." - Para [114]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the needleless syringe of Gu to include a piston cover that is provided inside the cylinder to cover an end portion of the piston as taught by Tashjian for the maintenance of a sterile pathway within the cavity volume (Tashjian, Para [40]).
Response to Arguments
Applicant’s arguments, see pages 12-20, filed 6/17/2026, with respect to the rejection(s) of claim(s) 1-20 under 35 USC 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gu et al. (KR 2019009160 A).
35 U.S.C 102
Applicant argues on page 14 that the present invention is a needleless syringe in which the drug accommodated in the drug accommodating portion is pressurized by the piston and ejected forward through the nozzle portion to be injected into the skin without any needle. The specification describes "a needleless syringe capable of repeatedly injection a certain drug at high speed" (Spec, Para [0252]), and recites that the nozzle portion "injects the drug accommodated in the drug accommodating portion" (Spec, Para [0057]). Gu delivers the drug by a fundamentally different method -- a needle that physically punctures the skin. In Gu, the power transmission unit 130 strikes the needle part 120 so that the needle 121 protrudes through the opening hole 118 and penetrates the skin, and the drug enters only after such penetration: "When the needle 121 penetrate the skin, the drug storage unit is injected into the skin" (Gu, Para [0058]); the needle 121 passes through the opening hole 118 to "inject a chemical into the skin" (Gu, Para [0027]). Gu therefore neither teaches nor suggests the needleless, nozzle-based drug delivery on which the claimed structure is predicated.
Examiner interprets that Gu teaches the limitation of a needleless syringe is only recited within the preamble and is therefore, interpreted as describing the intended use of the claimed invention. However, if applicant argues that the preamble is a recitation of structural limitations, Examiner relies on Gamliel to teach that a needleless syringe (needleless injection device 10, Fig. 1) is known in the art.
Applicant argues on pages 14-15 that amended claims 1, 17, and 18 each recite "a nozzle portion opening/closing valve that is provided to open/close a passage hole between the nozzle portion and the drug accommodating portion, the passage hole being a hole through which the drug accommodated in the drug accommodating portion flows to the nozzle portion." The chemical supply hole 116a relied upon by the Examiner does not meet this limitation. Gu describes the chemical supply hole 116a as a fill port sealed from the outside -- "The chemical supply hole 116a is provided with an opening and closing cover … to seal the chemical storage unit 116 with the outside" (Gu, Para [0029]). In Gu, the chemical supply hole 116a serves only to charge the drug storage unit 116 from the outside, the drug does not flow through the chemical supply hole 116 to a nozzle to be injected into the skin. Gu thus lacks both the claimed nozzle portion opening/closing valve and the claimed passage hole through which the drug accommodated in the drug accommodating portion flows to the nozzle portion. This distinguishing structure is recited in the body of the claim and does not depend upon the preamble term "needleless".
Examiner interprets Gu teaches that the opening and closing cover provided on chemical supply hole 116a as a cover that can open the hole and then close the hole to seal the chemical storage unit 116 with the outside, thus meeting the recited limitation. The drug flows through the needle to be injected into the skin and the needle passes through the drug storage part 116 to the nozzle portion as shown in annotated Fig. 2.
Applicant argues on pages 15-16 that amended claim 1 recites a current supply unit that "repeatedly cuts off supply of current to the first coil during backward movement of the piston to move the moving magnetic body backward due to a magnetic field of the stationary magnet", and claim 17 recites a stationary magnet that "has a second magnetic force to pull the moving magnetic body when supply of current to the solenoid coil is cut off, to move the moving magnetic body backward". Gu does not return its moving member by a stationary magnet upon cut-off of current; instead Gu reverses the direction of the current. Gu states that the power supply unit 150 "reciprocates the driving unit 140 as the direction of the current supplied to the driving unit 140 is changed" (Gu, Para [0037]), and that the solenoid part 142 "is reciprocated as the direction of the current supplied from the power supply 150 is converted" (Gu, Para [0040]). Gu returns the solenoid by an inducted magnetic field produced by the reversed current -- "The solenoid portion 142 is returned from the skin to the original position by the inducted magnetic field" (Gu, Para [0059]). Gu's permanent magnet 145, relied upon by the Examiner as the claimed stationary magnet, is merely a component of Gu's solenoid actuator. Gu discloses the permanent magnet 145 disposed about the center yoke 144 with "a first coil unit 146a disposed on one side of the permanent magnet 145 and a second coil unit 146b disposed on the other side of the permanent magnet 145" (Gu, Para [0045]). Gu's permanent magnet 145 is not positioned behind a separate moving magnetic body to pull that body backward, is not provided to retract Gu's power transmission unit 130, and Gu does not move its moving member backward upon cut-off of current. Gu accordingly lacks any component corresponding to the claimed stationary magnet that moves the moving magnetic body backward due to the magnetic field of the stationary magnet when current is cut off, as required by amended claims 1 and 17.
Examiner interprets Gu teaches the permanent magnet 145 to be positioned behind the moving body of the center yoke 144, a part that is separate from the permanent magnet even though both are part of the solenoid actuator. Additionally, Gu discloses cutting current off to the solenoid ("… when the current is … not supplied to the first coil unit 146a …" - Para [0046]) so that a static magnetic field is formed.
35 U.S.C 103
Applicant argues that claims 2, 4 - 11, 14 - 16, and 19 - 20 do not teach the limitations of the nozzle portion opening/closing valve and passage hole or the stationary-magnet return of the independent claims and therefore does not cure the deficiencies of Gu.
Examiner interprets Gu teaches the limitations of the nozzle portion opening/closing valve and passage hole and the stationary-magnet return as recited in the rejection and arguments above.
The rejection above is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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